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    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Contents</UNITNAME>
    <CNTNTS>
        <AGCY>
            <EAR>
                Agency Toxic
                <PRTPAGE P="iii"/>
            </EAR>
            <HD>Agency for Toxic Substances and Disease Registry</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Toxicological Profiles, </DOC>
                    <PGS>3870-3871</PGS>
                    <FRDOCBP>2025-00827</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agricultural Marketing</EAR>
            <HD>Agricultural Marketing Service</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Increased Assessment Rate:</SJ>
                <SJDENT>
                    <SJDOC>Oranges and Grapefruit Grown in Lower Rio Grande Valley, TX, </SJDOC>
                    <PGS>3720-3723</PGS>
                    <FRDOCBP>2025-00193</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agriculture</EAR>
            <HD>Agriculture Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Agricultural Marketing Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Consumer Financial Protection</EAR>
            <HD>Bureau of Consumer Financial Protection</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Truth in Lending (Regulation Z):</SJ>
                <SJDENT>
                    <SJDOC>Consumer Credit Offered to Borrowers in Advance of Expected Receipt of Compensation for Work, </SJDOC>
                    <PGS>3622-3624</PGS>
                    <FRDOCBP>2025-00381</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Electronic Fund Transfers through Accounts Established Primarily for Personal, Family, or Household Purposes using Emerging Payment Mechanisms, </DOC>
                    <PGS>3723-3727</PGS>
                    <FRDOCBP>2025-00565</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Request for Information:</SJ>
                <SJDENT>
                    <SJDOC>The Collection, Use, and Monetization of Consumer Payment and Other Personal Financial Data, </SJDOC>
                    <PGS>3804-3808</PGS>
                    <FRDOCBP>2025-00811</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Medicare</EAR>
            <HD>Centers for Medicare &amp; Medicaid Services</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>3871-3873</PGS>
                    <FRDOCBP>2025-00695</FRDOCBP>
                      
                    <FRDOCBP>2025-00696</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Children</EAR>
            <HD>Children and Families Administration</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Parentage Establishment in the Child Support Services Program; Withdrawal, </DOC>
                    <PGS>3752-3753</PGS>
                    <FRDOCBP>2025-00638</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Civil Rights</EAR>
            <HD>Civil Rights Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Guam Advisory Committee, </SJDOC>
                    <PGS>3787</PGS>
                    <FRDOCBP>2025-00697</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Coast Guard</EAR>
            <HD>Coast Guard</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Safety Zone:</SJ>
                <SJDENT>
                    <SJDOC>Cable Laying Corridor, Atlantic Ocean, Virginia Beach, VA, </SJDOC>
                    <PGS>3729-3731</PGS>
                    <FRDOCBP>2024-31420</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Commerce</EAR>
            <HD>Commerce Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Industry and Security Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>International Trade Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Institute of Standards and Technology</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Oceanic and Atmospheric Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Council Environmental</EAR>
            <HD>Council on Environmental Quality</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Office of Environmental Quality Management Fund, </DOC>
                    <PGS>3703-3706</PGS>
                    <FRDOCBP>2025-00473</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Defense Department</EAR>
            <HD>Defense Department</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Civil Monetary Penalty Inflation Adjustment, </DOC>
                    <PGS>3693-3695</PGS>
                    <FRDOCBP>2025-00715</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Acquisition Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Protests of Orders under Certain Multiple-Award Contracts, </SJDOC>
                    <PGS>3761-3763</PGS>
                    <FRDOCBP>2025-00616</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Small Business Participation on Certain Multiple-Award Contracts, </SJDOC>
                    <PGS>3753-3761</PGS>
                    <FRDOCBP>2025-00615</FRDOCBP>
                </SJDENT>
                <SJ>Federal Acquisition Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Preventing Organizational Conflicts of Interest in Federal Acquisition, </SJDOC>
                    <PGS>4376-4395</PGS>
                    <FRDOCBP>2024-31561</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Delaware</EAR>
            <HD>Delaware River Basin Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Hearings, Meetings, Proceedings etc., </DOC>
                    <PGS>3808-3809</PGS>
                    <FRDOCBP>2025-00740</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Education Department</EAR>
            <HD>Education Department</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Income-Contingent Repayment Plan Options, </DOC>
                    <PGS>3695-3702</PGS>
                    <FRDOCBP>2025-00724</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Best Interest Determination, Prison Education Program, </SJDOC>
                    <PGS>3818-3819</PGS>
                    <FRDOCBP>2025-00705</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>School Pulse Panel 2025-26 Data Collection Activities, </SJDOC>
                    <PGS>3819-3820</PGS>
                    <FRDOCBP>2025-00781</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Student Assistance General Provisions-Annual Fire Safety Report, </SJDOC>
                    <PGS>3819</PGS>
                    <FRDOCBP>2025-00682</FRDOCBP>
                </SJDENT>
                <SJ>Applications for New Awards:</SJ>
                <SJDENT>
                    <SJDOC>Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities;  Demonstration and Training Programs, National Technical Assistance Center on Transition for Students and Youth with Disabilities, </SJDOC>
                    <PGS>3809-3818</PGS>
                    <FRDOCBP>2025-00691</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Employee Benefits</EAR>
            <HD>Employee Benefits Security Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Prohibited Transaction Exemption 2002-51 to Permit Certain Transactions Identified in the Voluntary Fiduciary Correction Program, </DOC>
                    <PGS>3667-3673</PGS>
                    <FRDOCBP>2025-00328</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Voluntary Fiduciary Correction Program, </DOC>
                    <PGS>4192-4231</PGS>
                    <FRDOCBP>2025-00327</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Enhancing Coverage of Preventive Services under the Affordable Care Act, </DOC>
                    <PGS>3728-3729</PGS>
                    <FRDOCBP>2025-00774</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Exemption:</SJ>
                <SJDENT>
                    <SJDOC>Certain Prohibited Transaction Restrictions involving  Memorial Sloan Kettering Cancer Center Located in New York, NY, </SJDOC>
                    <PGS>3947-3957</PGS>
                    <FRDOCBP>2025-00813</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Certain Prohibited Transaction Restrictions involving Boilermakers Western States Apprenticeship Fund Located in Page, A-Z, </SJDOC>
                    <PGS>3923-3929</PGS>
                    <FRDOCBP>2025-00810</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Certain Prohibited Transaction Restrictions Involving UBS AG Located in Zurich, Switzerland, </SJDOC>
                    <PGS>3929-3947</PGS>
                    <FRDOCBP>2025-00812</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Employment and Training</EAR>
            <HD>Employment and Training Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Adjudication of Temporary and Seasonal Need for Herding and Production of Livestock on the Range Applications under the H2A Program, </DOC>
                    <PGS>3625-3626</PGS>
                    <FRDOCBP>2025-00829</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <PRTPAGE P="iv"/>
                    <DOC>Temporary Agricultural Employment of H-2A Foreign Workers in the Herding or Production of Livestock on the Range in the United States, </DOC>
                    <PGS>3626-3627</PGS>
                    <FRDOCBP>2025-00828</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Nonmonetary Determination Activity Report, </SJDOC>
                    <PGS>3958-3960</PGS>
                    <FRDOCBP>2025-00662</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Unemployment Insurance Data Validation Program, </SJDOC>
                    <PGS>3957-3958</PGS>
                    <FRDOCBP>2025-00807</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Work Application/Job Order Recordkeeping, </SJDOC>
                    <PGS>3960</PGS>
                    <FRDOCBP>2025-00808</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Energy Department</EAR>
            <HD>Energy Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Energy Regulatory Commission</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Environmental Protection</EAR>
            <HD>Environmental Protection Agency</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Fuels Regulatory Streamlining Sampling and Testing Updates, </DOC>
                    <PGS>4320-4373</PGS>
                    <FRDOCBP>2024-31218</FRDOCBP>
                </DOCENT>
                <SJ>New Source Performance Standards for Greenhouse Gas Emissions from New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units:</SJ>
                <SJDENT>
                    <SJDOC>Emission Guidelines for Greenhouse Gas Emissions from Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule, </SJDOC>
                    <PGS>3702-3703</PGS>
                    <FRDOCBP>2025-00659</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Air Quality State Implementation Plans; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>Kansas; Annual Emission Inventory and Fees, </SJDOC>
                    <PGS>3731-3734</PGS>
                    <FRDOCBP>2024-31626</FRDOCBP>
                </SJDENT>
                <SJ>Standards of Performance for New, Reconstructed, and Modified Sources and Emissions Guidelines for Existing Sources:</SJ>
                <SJDENT>
                    <SJDOC>Oil and Natural Gas Sector Climate Review, </SJDOC>
                    <PGS>3734-3752</PGS>
                    <FRDOCBP>2024-31227</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Draft National Recommended Ambient Water Quality Criteria:</SJ>
                <SJDENT>
                    <SJDOC>Protection of Human Health for Perfluorooctanoic Acid, Perfluorooctane Sulfonic Acid, and Perfluorobutane Sulfonic Acid; Correction, </SJDOC>
                    <PGS>3827-3828</PGS>
                    <FRDOCBP>2025-00710</FRDOCBP>
                </SJDENT>
                <SJ>Draft Sewage Sludge Risk Assessment:</SJ>
                <SJDENT>
                    <SJDOC>Perfluorooctanoic Acid and Perfluorooctane Sulfonic Acid, </SJDOC>
                    <PGS>3859-3864</PGS>
                    <FRDOCBP>2025-00734</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2023, </DOC>
                    <PGS>3827</PGS>
                    <FRDOCBP>2024-31058</FRDOCBP>
                </DOCENT>
                <SJ>Preliminary Regulatory Determinations:</SJ>
                <SJDENT>
                    <SJDOC>Contaminants on the Fifth Drinking Water Contaminant Candidate List, </SJDOC>
                    <PGS>3830-3859</PGS>
                    <FRDOCBP>2025-00133</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Risk Evaluations for Chemical Substances, </DOC>
                    <PGS>3828-3830</PGS>
                    <FRDOCBP>2025-00730</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Farm Credit</EAR>
            <HD>Farm Credit Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Civil Monetary Penalty Inflation Adjustment, </DOC>
                    <PGS>3617-3618</PGS>
                    <FRDOCBP>2025-00963</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Aviation</EAR>
            <HD>Federal Aviation Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Petition for Exemption:</SJ>
                <SJDENT>
                    <SJDOC>Houff Corporation, </SJDOC>
                    <PGS>3988-3989</PGS>
                    <FRDOCBP>2025-00699</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Communications</EAR>
            <HD>Federal Communications Commission</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Civil Monetary Penalty Inflation Adjustment, </DOC>
                    <PGS>3710-3713</PGS>
                    <FRDOCBP>2025-00494</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>3864</PGS>
                    <FRDOCBP>2025-00645</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Emergency</EAR>
            <HD>Federal Emergency Management Agency</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>National Flood Insurance Program:</SJ>
                <SJDENT>
                    <SJDOC>Assistance to Private Sector Property Insurers, Fiscal Year 2026 Arrangement, </SJDOC>
                    <PGS>3891-3899</PGS>
                    <FRDOCBP>2025-00511</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Energy</EAR>
            <HD>Federal Energy Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Application and Establishing Intervention Deadline:</SJ>
                <SJDENT>
                    <SJDOC>Transwestern Pipeline Co., LLC, </SJDOC>
                    <PGS>3821-3823</PGS>
                    <FRDOCBP>2025-00833</FRDOCBP>
                </SJDENT>
                <SJ>Application:</SJ>
                <SJDENT>
                    <SJDOC>Virginia Electric and Power Co. Doing Business as Dominion Energy Virginia, Allegheny Generating Co., and Bath County Energy, LLC, </SJDOC>
                    <PGS>3824-3826</PGS>
                    <FRDOCBP>2025-00836</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Combined Filings, </DOC>
                    <PGS>3820-3821, 3826-3827</PGS>
                    <FRDOCBP>2025-00765</FRDOCBP>
                      
                    <FRDOCBP>2025-00766</FRDOCBP>
                </DOCENT>
                <SJ>Environmental Assessments; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Columbia Gas Transmission, LLC, </SJDOC>
                    <PGS>3824</PGS>
                    <FRDOCBP>2025-00837</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Presumpscot Hydro, LLC, Dichotomy Power Maine, LLC, </SJDOC>
                    <PGS>3823-3824</PGS>
                    <FRDOCBP>2025-00838</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Privacy Act; Systems of Records, </DOC>
                    <PGS>3821</PGS>
                    <FRDOCBP>2025-00839</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Housing Finance Agency</EAR>
            <HD>Federal Housing Finance Agency</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>3865-3867</PGS>
                    <FRDOCBP>2025-00729</FRDOCBP>
                </DOCENT>
                <SJ>Annual Adjustment:</SJ>
                <SJDENT>
                    <SJDOC>Cap on Average Total Assets That Defines Community Financial Institutions, </SJDOC>
                    <PGS>3865</PGS>
                    <FRDOCBP>2025-00720</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Maritime</EAR>
            <HD>Federal Maritime Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agreements Filed, </DOC>
                    <PGS>3870</PGS>
                    <FRDOCBP>2025-00777</FRDOCBP>
                </DOCENT>
                <SJ>Complaint:</SJ>
                <SJDENT>
                    <SJDOC>20230930-DK-BUTTERFLY-1, Inc., Complainant v. BAL Container Line Co., Ltd., Respondent, </SJDOC>
                    <PGS>3869-3870</PGS>
                    <FRDOCBP>2025-00779</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Euromarket Designs, Inc., Complainant v. MSC Mediterranean Shipping Co. SA, Ocean Network Express Pte. Ltd., et al., Respondents, </SJDOC>
                    <PGS>3868-3869</PGS>
                    <FRDOCBP>2025-00780</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Nielsen and Bainbridge, LLC, Complainant v. Orient Overseas Container Line, Ltd., et al., Respondents, </SJDOC>
                    <PGS>3867-3868</PGS>
                    <FRDOCBP>2025-00784</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Motor</EAR>
            <HD>Federal Motor Carrier Safety Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Transportation of Household Goods; Consumer Protection, </SJDOC>
                    <PGS>3995-3997</PGS>
                    <FRDOCBP>2025-00819</FRDOCBP>
                </SJDENT>
                <SJ>Exemption Application:</SJ>
                <SJDENT>
                    <SJDOC>Commercial Driver's License; Bianco Trucking Services, LLC, d.b.a. CDL and Operator Training, </SJDOC>
                    <PGS>3990-3992</PGS>
                    <FRDOCBP>2025-00818</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Qualification of Drivers; Epilepsy and Seizure Disorders, </SJDOC>
                    <PGS>3989-3990, 3994-3995, 3998-3999</PGS>
                    <FRDOCBP>2025-00747</FRDOCBP>
                      
                    <FRDOCBP>2025-00748</FRDOCBP>
                      
                    <FRDOCBP>2025-00820</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Qualification of Drivers; Hearing, </SJDOC>
                    <PGS>3992-3994</PGS>
                    <FRDOCBP>2025-00745</FRDOCBP>
                      
                    <FRDOCBP>2025-00746</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Qualification of Drivers; Implantable Cardioverter Defibrillators, </SJDOC>
                    <PGS>3997-3998</PGS>
                    <FRDOCBP>2025-00749</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Reserve</EAR>
            <HD>Federal Reserve System</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Extensions of Credit by Federal Reserve Banks:</SJ>
                <SJDENT>
                    <SJDOC>Regulation A, </SJDOC>
                    <PGS>3614-3615</PGS>
                    <FRDOCBP>2025-00429</FRDOCBP>
                </SJDENT>
                <SJ>Reserve Requirements of Depository Institutions:</SJ>
                <SJDENT>
                    <SJDOC>Regulation D, </SJDOC>
                    <PGS>3615-3616</PGS>
                    <FRDOCBP>2025-00430</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Formations of, Acquisitions by, and Mergers of Bank Holding Companies:</SJ>
                <SJDENT>
                    <SJDOC>Correction, </SJDOC>
                    <PGS>3870</PGS>
                    <FRDOCBP>2025-00832</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Fish
                <PRTPAGE P="v"/>
            </EAR>
            <HD>Fish and Wildlife Service</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Endangered and Threatened Species:</SJ>
                <SJDENT>
                    <SJDOC>12-Month Finding for the Greater Yellowstone Ecosystem of the Grizzly Bear in the Lower-48 States, </SJDOC>
                    <PGS>3763-3765</PGS>
                    <FRDOCBP>2025-00325</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>12-Month Finding for the Northern Continental Divide Ecosystem of the Grizzly Bear in the Lower-48 States, </SJDOC>
                    <PGS>3783-3786</PGS>
                    <FRDOCBP>2025-00330</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Designation of Critical Habitat for the San Francisco Bay-Delta Distinct Population Segment of the Longfin Smelt, </SJDOC>
                    <PGS>3765-3783</PGS>
                    <FRDOCBP>2024-29641</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Grizzly Bear Listing on the List of Endangered and Threatened Wildlife, </SJDOC>
                    <PGS>4234-4276</PGS>
                    <FRDOCBP>2025-00329</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Food and Drug</EAR>
            <HD>Food and Drug Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Priority Review Voucher:</SJ>
                <SJDENT>
                    <SJDOC>Alhemo (concizumabmtci); Rare Pediatric Disease Product, </SJDOC>
                    <PGS>3880</PGS>
                    <FRDOCBP>2025-00750</FRDOCBP>
                </SJDENT>
                <SJ>Request for Information:</SJ>
                <SJDENT>
                    <SJDOC>Growing, Harvesting, Processing, and Distribution of Poppy Seeds—Industry Practices Related to Opiate Alkaloids, </SJDOC>
                    <PGS>3873-3876</PGS>
                    <FRDOCBP>2025-00757</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>High-Protein Yogurt, </SJDOC>
                    <PGS>3878-3880</PGS>
                    <FRDOCBP>2025-00754</FRDOCBP>
                </SJDENT>
                <SJ>Withdrawal of Approval of Drug Application:</SJ>
                <SJDENT>
                    <SJDOC>Teva Branded Pharmaceutical Products R and D, Inc., et al., </SJDOC>
                    <PGS>3877-3878</PGS>
                    <FRDOCBP>2025-00743</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Teva Pharmaceuticals USA, Inc., et al., </SJDOC>
                    <PGS>3876-3877</PGS>
                    <FRDOCBP>2025-00742</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Foreign Assets</EAR>
            <HD>Foreign Assets Control Office</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Civil Monetary Penalty Inflation Adjustment, </DOC>
                    <PGS>3687-3693</PGS>
                    <FRDOCBP>2025-00786</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Sanctions Action, </DOC>
                    <PGS>4002-4003</PGS>
                    <FRDOCBP>2025-00762</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>General Services</EAR>
            <HD>General Services Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Federal Travel Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Relocation Allowances; Miscellaneous Expenses Allowance, </SJDOC>
                    <PGS>3706-3710</PGS>
                    <FRDOCBP>2025-00497</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Acquisition Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Protests of Orders under Certain Multiple-Award Contracts, </SJDOC>
                    <PGS>3761-3763</PGS>
                    <FRDOCBP>2025-00616</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Small Business Participation on Certain Multiple-Award Contracts, </SJDOC>
                    <PGS>3753-3761</PGS>
                    <FRDOCBP>2025-00615</FRDOCBP>
                </SJDENT>
                <SJ>Federal Acquisition Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Controlled Unclassified Information, </SJDOC>
                    <PGS>4278-4317</PGS>
                    <FRDOCBP>2024-30437</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Preventing Organizational Conflicts of Interest in Federal Acquisition, </SJDOC>
                    <PGS>4376-4395</PGS>
                    <FRDOCBP>2024-31561</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Government Ethics</EAR>
            <HD>Government Ethics Office</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Civil Monetary Penalty Inflation Adjustment, </DOC>
                    <PGS>3610-3612</PGS>
                    <FRDOCBP>2025-00671</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Health and Human</EAR>
            <HD>Health and Human Services Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Agency for Toxic Substances and Disease Registry</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Centers for Medicare &amp; Medicaid Services</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Children and Families Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Food and Drug Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Health Resources and Services Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Institutes of Health</P>
            </SEE>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; Basic Health Program, </DOC>
                    <PGS>4424-4542</PGS>
                    <FRDOCBP>2025-00640</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Enhancing Coverage of Preventive Services under the Affordable Care Act, </DOC>
                    <PGS>3728-3729</PGS>
                    <FRDOCBP>2025-00774</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Reports on Alcoholic Beverages and Health to Inform the Dietary Guidelines for Americans, 2025-2030, </DOC>
                    <PGS>3883-3884</PGS>
                    <FRDOCBP>2025-00416</FRDOCBP>
                </DOCENT>
                <SJ>Requests for Nominations:</SJ>
                <SJDENT>
                    <SJDOC>Center for Indigenous Innovation and Health Equity Tribal Advisory Committee; Correction, </SJDOC>
                    <PGS>3883</PGS>
                    <FRDOCBP>2025-00701</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Health Resources</EAR>
            <HD>Health Resources and Services Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Drug Pricing Program; Initiation of the Administrative Dispute Resolution Process, </SJDOC>
                    <PGS>3881-3882</PGS>
                    <FRDOCBP>2025-00831</FRDOCBP>
                </SJDENT>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>National Advisory Council on the National Health Service Corps, </SJDOC>
                    <PGS>3882-3883</PGS>
                    <FRDOCBP>2024-30715</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Homeland</EAR>
            <HD>Homeland Security Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Coast Guard</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Emergency Management Agency</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Transportation Security Administration</P>
            </SEE>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Protection of Federal Property, </DOC>
                    <PGS>4398-4421</PGS>
                    <FRDOCBP>2024-31206</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Uyghur Forced Labor Prevention Act Entity List, </DOC>
                    <PGS>3899-3906</PGS>
                    <FRDOCBP>2025-00901</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Indian Affairs</EAR>
            <HD>Indian Affairs Bureau</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Federal Acknowledgment of American Indian Tribes, </DOC>
                    <PGS>3627-3645</PGS>
                    <FRDOCBP>2025-00709</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Indian Gaming:</SJ>
                <SJDENT>
                    <SJDOC>Approval of the Fifth Amendment to the Tribal-State Class III Gaming Compact Amendment between Stillaguamish Tribe of Indians of Washington and the State of Washington, </SJDOC>
                    <PGS>3908</PGS>
                    <FRDOCBP>2025-00772</FRDOCBP>
                </SJDENT>
                <SJ>Land Acquisition:</SJ>
                <SJDENT>
                    <SJDOC>Coquille Indian Tribe, Medford Site, City of Medford, Jackson County, OR, </SJDOC>
                    <PGS>3907-3908</PGS>
                    <FRDOCBP>2025-00761</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Scotts Valley Band of Pomo Indians, Vallejo Site, Solano County, CA, </SJDOC>
                    <PGS>3906-3907</PGS>
                    <FRDOCBP>2025-00744</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Industry</EAR>
            <HD>Industry and Security Bureau</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Framework for Artificial Intelligence Diffusion, </DOC>
                    <PGS>4544-4584</PGS>
                    <FRDOCBP>2025-00636</FRDOCBP>
                </DOCENT>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Framework for Artificial Intelligence Diffusion, </SJDOC>
                    <PGS>3624-3625</PGS>
                    <FRDOCBP>2025-00637</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Interior</EAR>
            <HD>Interior Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Fish and Wildlife Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Indian Affairs Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Land Management Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Ocean Energy Management Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Surface Mining Reclamation and Enforcement Office</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Adoption of Categorical Exclusions under the National Environmental Policy Act, </DOC>
                    <PGS>3908-3911</PGS>
                    <FRDOCBP>2025-00452</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Internal Revenue</EAR>
            <HD>Internal Revenue Service</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Clean Electricity Production Credit and Clean Electricity Investment Credit, </DOC>
                    <PGS>4006-4127</PGS>
                    <FRDOCBP>2025-00196</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Resolution of Federal Tax Controversies by the Independent Office of Appeals, </DOC>
                    <PGS>3645-3665</PGS>
                    <FRDOCBP>2025-00426</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <PRTPAGE P="vi"/>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Enhancing Coverage of Preventive Services under the Affordable Care Act, </DOC>
                    <PGS>3728-3729</PGS>
                    <FRDOCBP>2025-00774</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Board</EAR>
            <HD>International Broadcasting Advisory Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>3787</PGS>
                    <FRDOCBP>2025-00902</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>International Trade Adm</EAR>
            <HD>International Trade Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Antidumping or Countervailing Duty Investigations, Orders, or Reviews:</SJ>
                <SJDENT>
                    <SJDOC>Active Anode Material from the People's Republic of China, </SJDOC>
                    <PGS>3788-3792</PGS>
                    <FRDOCBP>2025-00657</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Certain Cold-Rolled Steel Flat Products from the Republic of Korea, </SJDOC>
                    <PGS>3797-3798</PGS>
                    <FRDOCBP>2025-00815</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Hard Empty Capsules from Brazil, the People's Republic of China, India, and the Socialist Republic of Vietnam, </SJDOC>
                    <PGS>3788</PGS>
                    <FRDOCBP>2025-00658</FRDOCBP>
                </SJDENT>
                <SJ>Sales at Less Than Fair Value; Determinations, Investigations, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Active Anode Material from the People's Republic of China, </SJDOC>
                    <PGS>3792-3797</PGS>
                    <FRDOCBP>2025-00656</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>International Trade Com</EAR>
            <HD>International Trade Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Caribbean Basin Economic Recovery Act:</SJ>
                <SJDENT>
                    <SJDOC>Impact on U.S. Industries and Consumers and on Beneficiary Countries, </SJDOC>
                    <PGS>3921-3923</PGS>
                    <FRDOCBP>2025-00677</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Justice Department</EAR>
            <HD>Justice Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Proposed Settlement Agreement, Stipulation, Order, and Judgment, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Clean Water Act and Safe Drinking Water Act, </SJDOC>
                    <PGS>3923</PGS>
                    <FRDOCBP>2025-00686</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Labor Department</EAR>
            <HD>Labor Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Employee Benefits Security Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Employment and Training Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Occupational Safety and Health Administration</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Alien Claims Activity Report, </SJDOC>
                    <PGS>3960-3961</PGS>
                    <FRDOCBP>2025-00809</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Claims and Payment Activities, </SJDOC>
                    <PGS>3962</PGS>
                    <FRDOCBP>2025-00661</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Guam Military Base Realignment Contractors Recruitment Standards, </SJDOC>
                    <PGS>3961-3962</PGS>
                    <FRDOCBP>2025-00653</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Land</EAR>
            <HD>Land Management Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Director's Response to the Appeals by the Governors of California and Utah; Consistency Review Determination for Utility-Scale Solar Energy Development Resource Management Plan Amendments, </SJDOC>
                    <PGS>3912-3914</PGS>
                    <FRDOCBP>2025-00753</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Record of Decision and Approved Resource Management Plan; North Dakota, </SJDOC>
                    <PGS>3915-3916</PGS>
                    <FRDOCBP>2025-00840</FRDOCBP>
                </SJDENT>
                <SJ>Proposed Withdrawal:</SJ>
                <SJDENT>
                    <SJDOC>Amargosa Valley, NV, </SJDOC>
                    <PGS>3914-3915</PGS>
                    <FRDOCBP>2025-00700</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Sloan Utility and Transportation Corridor, Clark County, NV, </SJDOC>
                    <PGS>3911-3912</PGS>
                    <FRDOCBP>2025-00814</FRDOCBP>
                </SJDENT>
                <SJ>Public Land Order:</SJ>
                <SJDENT>
                    <SJDOC>No. 7958; Extension of Public Land Order No. 6597, as Extended; White Mountain Petroglyphs Site, WY, </SJDOC>
                    <PGS>3916-3917</PGS>
                    <FRDOCBP>2025-00776</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Legal</EAR>
            <HD>Legal Services Corporation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>3962-3963</PGS>
                    <FRDOCBP>2025-00944</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Management</EAR>
            <HD>Management and Budget Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Request for Information:</SJ>
                <SJDENT>
                    <SJDOC>Advancing the Domestic Manufacturing of Semi-Conductors in Commercial Information Technology, </SJDOC>
                    <PGS>3963-3965</PGS>
                    <FRDOCBP>2025-00727</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Millenium</EAR>
            <HD>Millennium Challenge Corporation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Report on the Selection of Eligible Countries for Fiscal Year 2025:</SJ>
                <SJDENT>
                    <SJDOC>Albania, </SJDOC>
                    <PGS>3966-3967</PGS>
                    <FRDOCBP>2025-00899</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>NASA</EAR>
            <HD>National Aeronautics and Space Administration</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Acquisition Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Protests of Orders under Certain Multiple-Award Contracts, </SJDOC>
                    <PGS>3761-3763</PGS>
                    <FRDOCBP>2025-00616</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Small Business Participation on Certain Multiple-Award Contracts, </SJDOC>
                    <PGS>3753-3761</PGS>
                    <FRDOCBP>2025-00615</FRDOCBP>
                </SJDENT>
                <SJ>Federal Acquisition Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Preventing Organizational Conflicts of Interest in Federal Acquisition, </SJDOC>
                    <PGS>4376-4395</PGS>
                    <FRDOCBP>2024-31561</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Aerospace Safety Advisory Panel, </SJDOC>
                    <PGS>3967</PGS>
                    <FRDOCBP>2025-00666</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Licenses; Exemptions, Applications, Amendments, etc., </DOC>
                    <PGS>3967-3968</PGS>
                    <FRDOCBP>2025-00669</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Archives</EAR>
            <HD>National Archives and Records Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>3968-3969</PGS>
                    <FRDOCBP>2025-00714</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Credit</EAR>
            <HD>National Credit Union Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Civil Monetary Penalty Inflation Adjustment, </DOC>
                    <PGS>3618-3622</PGS>
                    <FRDOCBP>2025-00737</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Endowment for the Arts</EAR>
            <HD>National Endowment for the Arts</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Arts Advisory Panel, </SJDOC>
                    <PGS>3969</PGS>
                    <FRDOCBP>2025-00752</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Foundation</EAR>
            <HD>National Foundation on the Arts and the Humanities</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Endowment for the Arts</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>National Highway</EAR>
            <HD>National Highway Traffic Safety Administration</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Automated Driving Systems-Equipped Vehicle Safety, Transparency, and Evaluation Program, </DOC>
                    <PGS>4130-4190</PGS>
                    <FRDOCBP>2024-30854</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Institute</EAR>
            <HD>National Institute of Standards and Technology</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Draft Document:</SJ>
                <SJDENT>
                    <SJDOC>Managing Misuse Risk for Dual-Use Foundation Models, </SJDOC>
                    <PGS>3798-3799</PGS>
                    <FRDOCBP>2025-00698</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Institute</EAR>
            <HD>National Institutes of Health</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Division of Police Law Enforcement Forms, </SJDOC>
                    <PGS>3884-3885</PGS>
                    <FRDOCBP>2025-00650</FRDOCBP>
                </SJDENT>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Center for Scientific Review, </SJDOC>
                    <PGS>3886-3888, 3890</PGS>
                    <FRDOCBP>2025-00660</FRDOCBP>
                      
                    <FRDOCBP>2025-00689</FRDOCBP>
                      
                    <FRDOCBP>2025-00845</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <PRTPAGE P="vii"/>
                    <SJDOC>National Cancer Institute, </SJDOC>
                    <PGS>3888</PGS>
                    <FRDOCBP>2025-00739</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Heart, Lung, and Blood Institute, </SJDOC>
                    <PGS>3885-3886</PGS>
                    <FRDOCBP>2025-00687</FRDOCBP>
                      
                    <FRDOCBP>2025-00688</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Allergy and Infectious Diseases, </SJDOC>
                    <PGS>3885</PGS>
                    <FRDOCBP>2025-00851</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Dental and Craniofacial Research, </SJDOC>
                    <PGS>3889</PGS>
                    <FRDOCBP>2025-00844</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Diabetes and Digestive and Kidney Diseases, </SJDOC>
                    <PGS>3887</PGS>
                    <FRDOCBP>2025-00850</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Mental Health, </SJDOC>
                    <PGS>3888</PGS>
                    <FRDOCBP>2025-00843</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Neurological Disorders and Stroke, </SJDOC>
                    <PGS>3889</PGS>
                    <FRDOCBP>2025-00738</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute on Aging, </SJDOC>
                    <PGS>3885-3886, 3888-3889</PGS>
                    <FRDOCBP>2025-00841</FRDOCBP>
                      
                    <FRDOCBP>2025-00842</FRDOCBP>
                      
                    <FRDOCBP>2025-00846</FRDOCBP>
                      
                    <FRDOCBP>2025-00849</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Office of the Director, </SJDOC>
                    <PGS>3887-3888</PGS>
                    <FRDOCBP>2025-00690</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Oceanic</EAR>
            <HD>National Oceanic and Atmospheric Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Licensing of Private Remote-Sensing Space Systems, </SJDOC>
                    <PGS>3800-3801</PGS>
                    <FRDOCBP>2025-00741</FRDOCBP>
                </SJDENT>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Fisheries of the South Atlantic, Gulf of Mexico, and Caribbean; Southeast Data, Assessment, and Review, </SJDOC>
                    <PGS>3803</PGS>
                    <FRDOCBP>2025-00655</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>North Pacific Fishery Management Council, </SJDOC>
                    <PGS>3799-3800</PGS>
                    <FRDOCBP>2025-00758</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>South Atlantic Fishery Management Council, </SJDOC>
                    <PGS>3801-3802</PGS>
                    <FRDOCBP>2025-00652</FRDOCBP>
                      
                    <FRDOCBP>2025-00654</FRDOCBP>
                </SJDENT>
                <SJ>Permits; Applications, Issuances, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Marine Mammals and Endangered Species, </SJDOC>
                    <PGS>3802-3803</PGS>
                    <FRDOCBP>2025-00717</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Science</EAR>
            <HD>National Science Foundation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>2025 National Survey of College Graduates, </SJDOC>
                    <PGS>3969-3970</PGS>
                    <FRDOCBP>2025-00683</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Nuclear Regulatory</EAR>
            <HD>Nuclear Regulatory Commission</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Civil Monetary Penalty Inflation Adjustment, </DOC>
                    <PGS>3612-3614</PGS>
                    <FRDOCBP>2024-31471</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Occupational Safety Health Adm</EAR>
            <HD>Occupational Safety and Health Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Occupational Exposure to COVID-19 in Healthcare Settings, </DOC>
                    <PGS>3665-3667</PGS>
                    <FRDOCBP>2025-00632</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Ocean Energy Management</EAR>
            <HD>Ocean Energy Management Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Proposed Vineyard Mid-Atlantic Project on the U.S. Outer Continental Shelf Offshore New York, </SJDOC>
                    <PGS>3917-3921</PGS>
                    <FRDOCBP>2025-00733</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Personnel</EAR>
            <HD>Personnel Management Office</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Appeal Procedures:</SJ>
                <SJDENT>
                    <SJDOC>Recoupment of Awards, Bonuses, or Relocation Expenses Awarded or Approved for all Employees of the Department of Veterans Affairs, </SJDOC>
                    <PGS>3601-3610</PGS>
                    <FRDOCBP>2025-00583</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Privacy Act; Systems of Records, </DOC>
                    <PGS>3970-3972</PGS>
                    <FRDOCBP>2025-00584</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Pipeline</EAR>
            <HD>Pipeline and Hazardous Materials Safety Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Pipeline Safety:</SJ>
                <SJDENT>
                    <SJDOC>Safety of Gas Transmission Pipelines:  Repair Criteria, Integrity Management Improvements, Cathodic Protection, Management of Change, and Other Related Amendments;  Corrections to Conform to Judicial Review, </SJDOC>
                    <PGS>3713-3716</PGS>
                    <FRDOCBP>2025-00073</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Postal Regulatory</EAR>
            <HD>Postal Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>New Postal Products, </DOC>
                    <PGS>3972-3976</PGS>
                    <FRDOCBP>2025-00702</FRDOCBP>
                      
                    <FRDOCBP>2025-00817</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Postal Service</EAR>
            <HD>Postal Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Product Change:</SJ>
                <SJDENT>
                    <SJDOC>Priority Mail and USPS Ground Advantage Negotiated Service Agreement, </SJDOC>
                    <PGS>3976-3979</PGS>
                    <FRDOCBP>2025-00803</FRDOCBP>
                      
                    <FRDOCBP>2025-00804</FRDOCBP>
                      
                    <FRDOCBP>2025-00805</FRDOCBP>
                      
                    <FRDOCBP>2025-00806</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Priority Mail Express, Priority Mail, and USPS Ground Advantage Negotiated Service Agreement, </SJDOC>
                    <PGS>3976-3979</PGS>
                    <FRDOCBP>2025-00787</FRDOCBP>
                      
                    <FRDOCBP>2025-00788</FRDOCBP>
                      
                    <FRDOCBP>2025-00789</FRDOCBP>
                      
                    <FRDOCBP>2025-00790</FRDOCBP>
                      
                    <FRDOCBP>2025-00791</FRDOCBP>
                      
                    <FRDOCBP>2025-00792</FRDOCBP>
                      
                    <FRDOCBP>2025-00793</FRDOCBP>
                      
                    <FRDOCBP>2025-00794</FRDOCBP>
                      
                    <FRDOCBP>2025-00795</FRDOCBP>
                      
                    <FRDOCBP>2025-00796</FRDOCBP>
                      
                    <FRDOCBP>2025-00797</FRDOCBP>
                      
                    <FRDOCBP>2025-00798</FRDOCBP>
                      
                    <FRDOCBP>2025-00799</FRDOCBP>
                      
                    <FRDOCBP>2025-00800</FRDOCBP>
                      
                    <FRDOCBP>2025-00801</FRDOCBP>
                      
                    <FRDOCBP>2025-00802</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Railroad Retirement</EAR>
            <HD>Railroad Retirement Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>3979-3983</PGS>
                    <FRDOCBP>2025-00767</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Securities</EAR>
            <HD>Securities and Exchange Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>3983-3984</PGS>
                    <FRDOCBP>2025-00664</FRDOCBP>
                      
                    <FRDOCBP>2025-00665</FRDOCBP>
                      
                    <FRDOCBP>2025-00680</FRDOCBP>
                </DOCENT>
                <SJ>Self-Regulatory Organizations; Proposed Rule Changes:</SJ>
                <SJDENT>
                    <SJDOC>Nasdaq ISE, LLC, </SJDOC>
                    <PGS>3984-3985</PGS>
                    <FRDOCBP>2025-00684</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Small Business</EAR>
            <HD>Small Business Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>3985</PGS>
                    <FRDOCBP>2025-00782</FRDOCBP>
                </DOCENT>
                <SJ>Licenses; Exemptions, Applications, Amendments, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Small Business Investment Company, </SJDOC>
                    <PGS>3985-3986</PGS>
                    <FRDOCBP>2025-00759</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Social</EAR>
            <HD>Social Security Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>3986-3987</PGS>
                    <FRDOCBP>2025-00668</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>State Department</EAR>
            <HD>State Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Delegation of Authority:</SJ>
                <SJDENT>
                    <SJDOC>Authorities of the Under Secretary for Civilian Security, Democracy, and Human Rights, </SJDOC>
                    <PGS>3987-3988</PGS>
                    <FRDOCBP>2025-00679</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Authorities of the Under Secretary for Economic Growth, Energy, and the Environment, </SJDOC>
                    <PGS>3988</PGS>
                    <FRDOCBP>2025-00678</FRDOCBP>
                </SJDENT>
                <SJ>Designation as Terrorist or Global Terrorist:</SJ>
                <SJDENT>
                    <SJDOC>The Terrorgram Collective, Ciro Daniel Amorim Ferreira, Noah Licul, and Hendrik-Wahl Muller, </SJDOC>
                    <PGS>3987</PGS>
                    <FRDOCBP>2025-00756</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Surface Mining</EAR>
            <HD>Surface Mining Reclamation and Enforcement Office</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Montana Regulatory Program, </DOC>
                    <PGS>3673-3687</PGS>
                    <FRDOCBP>2025-00333</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Tennessee</EAR>
            <HD>Tennessee Valley Authority</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Regional Energy Resource Council, </SJDOC>
                    <PGS>3988</PGS>
                    <FRDOCBP>2025-00783</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Transportation Department</EAR>
            <HD>Transportation Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Aviation Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Motor Carrier Safety Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Highway Traffic Safety Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Pipeline and Hazardous Materials Safety Administration</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Buy America Waiver for the Pacific Island Territories and the Freely Associated States, </DOC>
                    <PGS>3999-4002</PGS>
                    <FRDOCBP>2025-00713</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Security
                <PRTPAGE P="viii"/>
            </EAR>
            <HD>Transportation Security Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Recordkeeping Requirements for Criminal History Record Checks:</SJ>
                <SJDENT>
                    <SJDOC>Airport and Aircraft Operator Security; Technical Amendments, </SJDOC>
                    <PGS>3716-3719</PGS>
                    <FRDOCBP>2025-00773</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Treasury</EAR>
            <HD>Treasury Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Foreign Assets Control Office</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Internal Revenue Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Veteran Affairs</EAR>
            <HD>Veterans Affairs Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Architect-Engineer Fee Proposal and Contractor Production Report, </SJDOC>
                    <PGS>4003</PGS>
                    <FRDOCBP>2025-00694</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <PTS>
            <HD SOURCE="HED">Separate Parts In This Issue</HD>
            <HD>Part II</HD>
            <DOCENT>
                <DOC>Treasury Department, Internal Revenue Service, </DOC>
                <PGS>4006-4127</PGS>
                <FRDOCBP>2025-00196</FRDOCBP>
            </DOCENT>
            <HD>Part III</HD>
            <DOCENT>
                <DOC>Transportation Department, National Highway Traffic Safety Administration, </DOC>
                <PGS>4130-4190</PGS>
                <FRDOCBP>2024-30854</FRDOCBP>
            </DOCENT>
            <HD>Part IV</HD>
            <DOCENT>
                <DOC>Labor Department, Employee Benefits Security Administration, </DOC>
                <PGS>4192-4231</PGS>
                <FRDOCBP>2025-00327</FRDOCBP>
            </DOCENT>
            <HD>Part V</HD>
            <DOCENT>
                <DOC>Interior Department, Fish and Wildlife Service, </DOC>
                <PGS>4234-4276</PGS>
                <FRDOCBP>2025-00329</FRDOCBP>
            </DOCENT>
            <HD>Part VI</HD>
            <DOCENT>
                <DOC>General Services Administration, </DOC>
                <PGS>4278-4317</PGS>
                <FRDOCBP>2024-30437</FRDOCBP>
            </DOCENT>
            <HD>Part VII</HD>
            <DOCENT>
                <DOC>Environmental Protection Agency, </DOC>
                <PGS>4320-4373</PGS>
                <FRDOCBP>2024-31218</FRDOCBP>
            </DOCENT>
            <HD>Part VIII</HD>
            <DOCENT>
                <DOC>Defense Department, </DOC>
                <PGS>4376-4395</PGS>
                <FRDOCBP>2024-31561</FRDOCBP>
            </DOCENT>
            <DOCENT>
                <DOC>General Services Administration, </DOC>
                <PGS>4376-4395</PGS>
                <FRDOCBP>2024-31561</FRDOCBP>
            </DOCENT>
            <DOCENT>
                <DOC>National Aeronautics and Space Administration, </DOC>
                <PGS>4376-4395</PGS>
                <FRDOCBP>2024-31561</FRDOCBP>
            </DOCENT>
            <HD>Part IX</HD>
            <DOCENT>
                <DOC>Homeland Security Department, </DOC>
                <PGS>4398-4421</PGS>
                <FRDOCBP>2024-31206</FRDOCBP>
            </DOCENT>
            <HD>Part X</HD>
            <DOCENT>
                <DOC>Health and Human Services Department, </DOC>
                <PGS>4424-4542</PGS>
                <FRDOCBP>2025-00640</FRDOCBP>
            </DOCENT>
            <HD>Part XI</HD>
            <DOCENT>
                <DOC>Commerce Department, Industry and Security Bureau, </DOC>
                <PGS>4544-4584</PGS>
                <FRDOCBP>2025-00636</FRDOCBP>
            </DOCENT>
        </PTS>
        <AIDS>
            <HD SOURCE="HED">Reader Aids</HD>
            <P>Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.</P>
            <P>To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.</P>
        </AIDS>
    </CNTNTS>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <RULES>
        <RULE>
            <PREAMB>
                <PRTPAGE P="3601"/>
                <AGENCY TYPE="F">OFFICE OF PERSONNEL MANAGEMENT</AGENCY>
                <CFR>5 CFR Part 755</CFR>
                <DEPDOC>[Docket ID: OPM-2025-0003]</DEPDOC>
                <RIN>RIN 3206-AO71</RIN>
                <SUBJECT>Appeal Procedures for Recoupment of Awards, Bonuses, or Relocation Expenses Awarded or Approved for All Employees of the Department of Veterans Affairs</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Personnel Management.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Interim final rule; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Office of Personnel Management (OPM) is issuing an interim final rule to implement provisions of the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 that permit current and former employees of the Department of Veterans Affairs (VA) to appeal the recoupment of awards, bonuses, or relocation expenses awarded or approved for these individuals. This regulation prescribes general procedures applicable to appeals to the Director of OPM regarding an order by the Secretary of the VA, or designee, directing the employee or former employee to repay the amount, or a portion of the amount, of any award or bonus paid to the employee. This regulation also prescribes general procedures applicable to appeals regarding an order by the Secretary of the VA, or designee, directing the employee or former employee to repay the amount, or a portion of the amount, paid to or on behalf of an employee for relocation expenses.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         This rule is effective on January 15, 2025.
                    </P>
                    <P>
                        <E T="03">Comment date:</E>
                         OPM must receive comments on the rule on or before March 17, 2025.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments by the following method:</P>
                    <P>
                        Federal eRulemaking Portal: 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments. All submissions received must include the agency name and docket number or RIN for this document. All comments must be received by the end of the comment period for them to be considered. All comments and other submissions received generally will be posted on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         as they are received, without change, including any personal information provided. However, OPM retains discretion to redact personal or sensitive information, including but not limited to, personal or sensitive information pertaining to third parties.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Timothy Curry by email at 
                        <E T="03">employeeaccountability@opm.gov</E>
                         or by telephone at (202) 606-2930.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>The Department of Veterans Affairs (VA) Accountability and Whistleblower Protection Act of 2017, Public Law 115-41 (June 23, 2017), authorizes the Secretary of the VA to issue an order directing a VA employee to repay, in whole or in part, any award or bonus paid on or after June 23, 2017, to an employee under title 5, United States Code, including chapters 45 or 53, or title 38, United States Code, if it is determined the employee engaged in misconduct or poor performance prior to the payment of the award or bonus, and the award or bonus would not have been paid, in whole or in part, had the misconduct or poor performance been known prior to payment. Furthermore, the law authorizes the Secretary of the VA to issue an order to an employee to repay the amount, or a portion of the amount, paid to or on behalf of an employee under title 5, United States Code, for relocation expenses, including 5 U.S.C. 5724 and 5724a, or title 38, United States Code, if it is determined the relocation expenses were paid on or after June 23, 2017, following an act of fraud or malfeasance that influenced the authorization of the relocation expenses. Finally, the law authorizes the Secretary of the VA to reduce retirement benefits of employees convicted of certain crimes and removed for performance or misconduct. In all cases, the law provides that, upon issuance of an order by the Secretary, the individual has the right to appeal the order to the Director of the Office of Personnel Management (OPM). However, this rulemaking will only address appeals to the Director of OPM regarding recoupment of awards, bonuses, and relocation expenses. Appeals of orders regarding reduction of retirement benefits of employees convicted of certain crimes will be addressed in a future rulemaking.</P>
                <HD SOURCE="HD1">Legislative Requirements</HD>
                <P>
                    Section 204 of Public Law 115-41 amended subchapter I of chapter 7 of title 38, United States Code, by adding a new section 721. Specifically, 38 U.S.C. 721 outlines procedural requirements for recoupment of awards or bonuses paid to VA employees. If the Secretary determines an individual has engaged in misconduct or poor performance prior to payment of the award or bonus and that such award or bonus would not have been paid, in whole or in part, had the misconduct or poor performance been known prior to payment, the Secretary must provide certain procedural protections before issuing an order for repayment. Before such repayment, the employee is afforded (A) notice of the proposed order; and (B) an opportunity to respond to the proposed order by not later than 10 business days after the receipt of such notice. If the individual responds to the proposed order, the Secretary will issue an order not later than five business days after receiving the individual's response. If the individual does not respond to the proposed order, the Secretary will issue an order not later than 15 business days after the Secretary provides notice to the individual. These procedures are outlined in VA policies 
                    <SU>1</SU>
                    <FTREF/>
                     and are not part of this rulemaking. It is important to note that neither the law nor VA policies require the VA to have taken a disciplinary action, adverse action, or performance-based action for the Secretary to seek recoupment of any awards or bonuses, nor do they prohibit recouping an award or bonus in addition to taking a disciplinary, adverse, or performance-based action. 
                    <PRTPAGE P="3602"/>
                    The order by the Secretary only needs to show that the Secretary has determined the employee has engaged in misconduct or poor performance and that the award or bonus would not have been paid had the misconduct or poor performance been known at the time of the award. Upon the issuance of an order by the Secretary, the individual may appeal the order to the Director of OPM before the date that is seven business days after the date of such issuance. This rulemaking establishes the appeal procedures to OPM.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         See VA Handbook 5017/20, January 29, 2024, Procedures for Recoupment of Award or Bonus, Page VI-3, available at 
                        <E T="03">https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=1483.</E>
                    </P>
                </FTNT>
                <P>
                    Section 205 of Public Law 115-41 amended subchapter I of chapter 7 of title 38, United States Code, by adding a new section 723. Specifically, 38 U.S.C. 723 outlines procedural requirements for recoupment of relocation expenses paid to or on behalf of VA employees. If the Secretary determines that relocation expenses were paid following an act of fraud or malfeasance that influenced the authorization of the relocation expenses, the Secretary must provide certain procedural protections before the Secretary decides to issue an order directing an individual to repay the amount, or a portion of the amount, paid to or on behalf of the individual for relocation expenses. Before such repayment, the employee is afforded (A) notice of the proposed order; and (B) an opportunity to respond to the proposed order by not later than 10 business days after the receipt of such notice. If the individual responds to the proposed order, the Secretary will issue an order not later than five business days after receiving the individual's response. If the individual does not respond to the proposed order, the Secretary will issue an order not later than 15 business days after the Secretary provides notice to the individual. These procedures are also outlined in VA policies 
                    <SU>2</SU>
                    <FTREF/>
                     and are not part of this rulemaking. It is important to note that neither the law nor VA policies require the VA to have taken a disciplinary action or adverse action for the Secretary to seek recoupment of relocation expenses, nor do they prohibit recouping relocation expenses in addition to taking a disciplinary, adverse, or performance-based action. The order by the Secretary only needs to show that the Secretary has determined the employee has engaged in an act of fraud or malfeasance that influenced the authorization of the relocation expenses. Upon the issuance of an order by the Secretary, the individual may appeal the order to the Director of OPM before the date that is seven business days after the date of such issuance. As noted earlier, this rulemaking addresses the appeal procedures to OPM.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         See 
                        <E T="03">Id.,</E>
                         Procedures for Recoupment of Relocation Expenses, Page VI-6.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Interim Final Rule With Request for Comments</HD>
                <P>This interim final rule establishes a new part in the Code of Federal Regulations at 5 CFR part 755 with subparts A and B. Subpart A outlines appeal procedures for recoupment of awards and bonuses for all employees of the VA. Subpart B outlines appeal procedures for recoupment of relocation expenses for all employees of the VA. In addition to the statutory requirements guiding OPM in the development of this interim final rule, OPM was informed by the procedures established by the VA regarding recoupment of awards, bonuses, or relocation expenses outlined in VA Handbook 5017/20, Employee Recognition and Awards.</P>
                <HD SOURCE="HD1">5 CFR Part 755: Appeal Procedures for Recoupment of Awards, Bonuses, or Relocation Expenses Awarded or Approved for All Employees of the Department of Veterans Affairs</HD>
                <P>OPM is adding a new part at 5 CFR part 755 to implement the appeals procedures for recoupment of awards, bonuses, and relocation expenses for employees of the VA. This new part is entitled “Appeal Procedures for Recoupment of Awards, Bonuses, or Relocation Expenses Awarded or Approved for All Employees of the Department of Veterans Affairs.” The following sections discuss the scope and procedures within the subparts of part 755.</P>
                <HD SOURCE="HD1">Subpart A: Awards and Bonuses</HD>
                <P>Under part 755, OPM is adding a new subpart A which will be known as “Awards and Bonuses.” These new procedures are outlined below.</P>
                <HD SOURCE="HD2">Section 755.101 Scope of Subpart and Definitions</HD>
                <P>Subpart A applies to a current or former civil service employee of the Department of Veterans Affairs (VA). OPM has concluded that a “current employee” is an individual appointed in the civil service as outlined in 5 U.S.C. 2105 or under title 38 regarding VA civil service employees. This subpart does not apply to contractor employees performing work at the VA on behalf of a contractor because contractor employees are not appointed in the civil service. In recognition of the possibility that VA may issue a recoupment order after an employee has left the VA, for example through transfer to another agency, removal, resignation, or retirement from Federal service, former VA employees are also covered by this appeal process.</P>
                <P>Specifically, subpart A is limited to appeals filed pursuant to 38 U.S.C. 721 by an “employee” of the VA to the Director of OPM, or designee, regarding an order by the Secretary of the VA, or designee, directing the employee to repay the amount, or a portion of the amount, of any award or bonus paid to the employee under title 5, United States Code, including chapters 45 or 53 of such title, or title 38, United States Code. OPM has determined this includes, among other provisions under title 5, awards and bonuses paid pursuant to 5 U.S.C. chapter 45 (Awards); 5 U.S.C. 5336 (Additional Step Increases commonly known as Quality Step Increases); 5 U.S.C. 5384 (Performance awards in the Senior Executive Service); 5 U.S.C. 5753 and 5754 (Recruitment, Relocation, and Retention Bonuses); and any title 38 authorities regarding awards and bonuses.</P>
                <P>
                    OPM's review on appeal is limited to whether the procedures in VA's policies on recoupment were followed or, in the absence of any such policies, the VA's order was otherwise in compliance with 38 U.S.C. 721. As discussed in more detail elsewhere in this rule (see, 
                    <E T="03">e.g.,</E>
                     discussion regarding § 755.103), OPM believes the statutory timeframes established by Congress suggest that Congress did not intend for OPM to conduct a more fulsome or comprehensive review of the merits concerning the VA's order. Furthermore, Congress did not provide OPM the authority to adjudicate the underlying decisions by the VA regarding any disciplinary or adverse action or any performance-based action. Accordingly, subpart A does not cover appeals regarding any disciplinary or adverse action, or any performance-based action taken by the VA, even if such action serves as the basis for the Secretary of the VA, or designee, to order recoupment of a bonus or award paid to an employee of the VA. Likewise, OPM will not review any discrimination claim or prohibited personnel practice claim raised in any appeal. Depending on the employee, VA may have multiple legal authorities available for addressing misconduct and performance issues, such as 5 U.S.C. chapter 75 (Adverse Actions); 5 U.S.C. 4303 (Actions based on unacceptable performance); 5 U.S.C. 3592 (addressing unacceptable performance for SES); and various title 38, United States Code, authorities for addressing misconduct or unacceptable performance. These statutory authorities have separate appeals or grievance 
                    <PRTPAGE P="3603"/>
                    procedures to address any adverse actions or performance-based actions taken by the VA and may serve as the basis for the Secretary of the VA, or designee, to order recoupment of awards or bonuses. Employees may file discrimination complaints to the Equal Employment Opportunity Commission (EEOC) and prohibited personnel practice complaints with the U.S. Office of Special Counsel (OSC). VA employees should consult with their servicing human resources office with questions regarding applicable grievance or appeal rights regarding any disciplinary or adverse action, or performance-based actions, that may be taken against an employee.
                </P>
                <P>
                    To implement the statutory timeframes established by Congress, OPM is defining the term “business days” to mean weekdays, which are Monday through Friday, except when such a day is designated as a Federal holiday by OPM, or the employee's assigned facility or OPM is closed for regular business, 
                    <E T="03">e.g.,</E>
                     inclement weather, lapse in appropriations. OPM notes that this definition is similar to the definition of “Business Days” outlined in VA's policy regarding the recoupment of awards and bonuses but notes that the calculation of business days is slightly different from that established in VA's policy. VA's definition of a business day is based upon the employee's receipt of an order, whereas OPM defines a business day, for the purposes of an appeal to OPM, as beginning on the first business day after the issuance of the order to the employee. OPM's approach to calculating business days mirrors the statutory language in 38 U.S.C. 721(b)(1), promotes consistent use of an objective timeframe, and avoids the risk of presumption of delivery.
                </P>
                <HD SOURCE="HD2">Section 755.102 Procedures for Submitting Appeals</HD>
                <P>
                    This section describes the procedures for VA employees to follow when submitting an appeal regarding a VA order for recoupment of an award or bonus under 38 U.S.C. 721. An employee may file an appeal to the Director of OPM by U.S. mail or by email, within seven business days after the date of issuance of the order pursuant to 38 U.S.C. 721(a)(3). This time limit is established in law. Appeals which are untimely filed may be dismissed resulting in the VA's decision being upheld. OPM, for good cause shown, may accept an untimely appeal. OPM adopts the approach taken by the Merit Systems Protection Board in 
                    <E T="03">Alonzo</E>
                     v. 
                    <E T="03">Department of the Air Force,</E>
                     4 MSPB 262, 4 M.S.P.R. 180 (1980), in determining whether an employee establishes good cause for the untimely filing of an appeal.
                </P>
                <P>
                    If the employee elects to file by the U.S. mail, it must be addressed to Director, U.S. Office of Personnel Management, 1900 E Street NW, Room 7H28 (Attention: Accountability and Workforce Relations), Washington, DC 20415. OPM will rely upon the postmark to determine timeliness for filing the appeal. If the employee elects to file by email, it must be sent to 
                    <E T="03">employeeaccountability@opm.gov.</E>
                     OPM will rely upon the date the email was sent to determine timeliness for filing the appeal.
                </P>
                <P>The law does not specify the content for any appeal filed with OPM. Therefore, OPM has determined what information OPM needs to adequately consider the appeal. OPM is requiring that minimum information to be included in any appeal to reflect the narrow grant of authority 38 U.S.C. 721 gives to OPM. The appeal must be submitted in writing and must be signed by the employee or their representative. OPM is not requiring a specific form be used in filing the appeal, but any appeal must include the specified information for OPM to properly adjudicate the appeal. The written appeal must include (1) a copy of the notice of proposed order received pursuant to 38 U.S.C. 721(a)(2)(A); (2) a copy of the employee's response to the proposed order, if any; (3) a copy of the order received pursuant to 38 U.S.C. 721(a)(3); (4) a statement explaining why the employee believes the order received pursuant to 38 U.S.C. 721(a)(3) is in error; (5) the name, mailing address, telephone number, and email address of the employee and, if applicable, the same information for their representative; and (6) the name, mailing address, telephone number, and email address of the VA official who issued the order pursuant to 38 U.S.C. 721(a)(3). OPM will notify the VA upon receipt of a complete, timely appeal. The VA must provide OPM a copy of the evidence file relied upon in proposing and deciding its recoupment order as soon as possible but no later than five business days after OPM sends its notice to the VA. For OPM to make an appropriate decision, OPM must have all necessary facts and evidence relied upon by the VA when making its recoupment decision. If necessary, OPM may request VA provide information in addition to the evidence file. For example, OPM may need additional information to address the employee's belief the order by the VA was in error. Any additional information requested by OPM must be provided to OPM within five business days after OPM's request. VA must also furnish a copy of any additional information requested by and provided to OPM to the employee. VA's failure to provide the evidence file or any requested additional information to OPM will result in a finding against the VA.</P>
                <P>An employee covered by this subpart is entitled to be represented by an attorney or other representative. OPM may disallow as an employee's representative an individual whose activities as representative would cause a conflict of interest or position, or an employee of any agency whose release from their official position would give rise to unreasonable costs or whose priority work assignments preclude their release. This is consistent with other complaint processes regulated by OPM.</P>
                <P>Finally, it is unclear to OPM whether the appeal rights to OPM are the exclusive process for bargaining unit employees to challenge a VA order on recoupment of awards or bonuses or whether VA bargaining unit employees may file a grievance under any applicable negotiated grievance procedure which ends in binding arbitration. OPM requests comment on whether bargaining unit employees may use the negotiated grievance process under 5 U.S.C. 7121 to challenge a VA order in lieu of filing an appeal with OPM. OPM also requests comment on whether this determination is impacted by whether the award or bonus was originally paid under title 5 authority or under title 38 authority.</P>
                <HD SOURCE="HD2">Section 755.103 Basis of Appeal Decision</HD>
                <P>The law provides that, upon the issuance of an order by the Secretary, an individual shall have an opportunity to appeal the order to the Director of OPM within seven business days after the date of such issuance. The law further provides that the Director shall make a final decision regarding the appeal within 30 business days after receiving the appeal. Therefore, due to this compressed timeline, OPM has determined the best way to fulfill its obligations to render a timely decision on any appeal is to base the decision on the written record only, which will include the submissions by the employee and the agency. There will be no formal hearing procedures for this appeal.</P>
                <P>
                    The burden is upon the employee to establish the timeliness of the appeal and to explain why the VA's order is in error as to one or both of the bases found in 38 U.S.C. 721(a)(1). OPM may uphold the VA order if the employee or 
                    <PRTPAGE P="3604"/>
                    their designated representative fails to provide required information. As noted previously, OPM will also uphold the VA order if the appeal was untimely filed without good cause shown for the delay.
                </P>
                <P>
                    Since Congress did not provide OPM the authority to adjudicate decisions by the VA regarding any disciplinary or adverse action, or any performance-based action, OPM's review of the VA order is limited to whether the procedures in VA's policies on recoupment of awards and bonuses 
                    <SU>3</SU>
                    <FTREF/>
                     pursuant to 38 U.S.C. 721 were followed, or, in the absence of such policies, whether the order was otherwise in compliance with the statute. In other words, OPM will not review whether any disciplinary or adverse action, or performance-based action, which may have been relied upon by the VA in its recoupment order, was appropriate. OPM will accept the facts found by the VA regarding the disciplinary or adverse action, performance-based action, or other type of finding or action, if any, which was relied upon by the VA in making its recoupment decision. As noted earlier, OPM will not review any discrimination claim or prohibited personnel practice claim raised in any appeal. Employees may file complaints with the EEOC or OSC, where appropriate.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         See 
                        <E T="03">Id.,</E>
                         Procedures for Recoupment of Award or Bonus, Page VI-3.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Section 755.104 Form of Appeal Decision</HD>
                <P>Within 30 business days after receiving an appeal, OPM will make a decision on the employee's appeal. OPM will then send a written appeal decision to the employee or to the employee's representative, if any, advising whether the VA order is upheld by OPM. OPM will send the VA a copy of the appeal decision. This time limit is consistent with the statutory requirements.</P>
                <HD SOURCE="HD2">Section 755.105 Finality of Appeal Decision</HD>
                <P>Pursuant to 38 U.S.C. 721(b)(2), the OPM decision on appeal is final. There will not be any further administrative review available within OPM, and thus this rule does not establish any process for requests for reconsideration. The law is silent regarding any statutory right to judicial review of an OPM appeal decision. Accordingly, although OPM will send its appeal decision to the employee, OPM will not provide an accompanying statement of “appeal rights.” OPM requests comment on whether a VA employee may seek judicial review of an OPM final decision. If so, where would judicial review occur? OPM may revise its procedures to address appeals based on comments received.</P>
                <HD SOURCE="HD1">Subpart B: Relocation Expenses</HD>
                <P>Under part 755, OPM is adding a new subpart B which will be known as “Relocation Expenses.” These new procedures are outlined below.</P>
                <HD SOURCE="HD2">Section 755.201 Scope of Subpart and Definitions</HD>
                <P>Like subpart A, subpart B applies to a current or former civil service employee of the Department of Veterans Affairs (VA). OPM has concluded that a “current employee” is an individual appointed in the civil service as outlined in 5 U.S.C. 2105 or under title 38, United States Code, regarding VA civil service employees. This subpart does not apply to contractor employees performing work at the VA on behalf of a contractor because contractor employees are not appointed in the civil service. In recognition of the possibility that VA may issue a recoupment order for relocation expenses after an employee has left the VA, for example through transfer to another agency, resignation from Federal service, removal, or retirement from Federal service, former VA employees are covered by this appeal process.</P>
                <P>Specifically, subpart B is limited to appeals filed pursuant to 38 U.S.C. 723 by an “employee” of the VA to the Director of OPM, or designee, regarding an order by the Secretary of the VA, or designee, directing the employee to repay the amount, or a portion of the amount, paid to or on behalf of the employee for relocation expenses under title 5, United States Code, including any expenses under section 5724 or 5724a of title 5, or under title 38, United States Code.</P>
                <P>
                    OPM's review on appeal is limited to whether the procedures in VA's policies on recoupment of relocation expenses were followed or, in the absence of any such policies, whether the VA's order was otherwise in compliance with 38 U.S.C. 723. As discussed in more detail elsewhere in this rule (see, 
                    <E T="03">e.g.,</E>
                     discussion regarding § 755.203), OPM believes the statutory timeframes established by Congress suggest that Congress did not intend for OPM to conduct a more fulsome or comprehensive review of the merits concerning the VA's order. Furthermore, as previously discussed in subpart A, Congress did not provide OPM the authority to adjudicate the underlying decisions by the VA regarding any disciplinary or adverse action or any performance-based action. Accordingly, subpart B does not cover appeals regarding any disciplinary or adverse action, or any performance-based action taken by the VA and which can serve as the basis for the Secretary of the VA, or designee, to order recoupment of relocation expenses paid to an employee of the VA. Likewise, OPM will not review any discrimination claim or prohibited personnel practice claim raised in any appeal. Depending on the employee, VA may have multiple legal authorities for addressing misconduct and performance issues such as 5 U.S.C. chapter 75 (Adverse Actions); 5 U.S.C. 4303 (Actions based on unacceptable performance); 5 U.S.C. 3592 (addressing unacceptable performance for SES); and any title 38 authorities for addressing misconduct or unacceptable performance. These statutory authorities have separate appeals or grievance procedures which address any adverse actions or performance-based actions taken by the VA and which may happen to serve as the basis for the Secretary of the VA, or designee, to order recoupment of relocation expenses. Employees may file complaints with the EEOC or OSC, where appropriate. VA employees should consult with their servicing human resources office with questions regarding applicable grievance or appeal rights regarding any disciplinary or adverse action, or performance-based actions that may be taken against an employee.
                </P>
                <P>
                    OPM is defining “business days” to mean weekdays, which are Monday through Friday, except when such a day is designated as a Federal holiday by OPM, or the employee's assigned facility or OPM is closed for regular business, 
                    <E T="03">e.g.,</E>
                     inclement weather, lapse in appropriations. OPM notes that this definition is similar to the definition of “Business Days” outlined in VA's policy regarding the recoupment of relocation expenses but notes that the calculations of business days is slightly different from that established in VA's policy. VA's definition of a business day is based upon the employee's receipt of an order, whereas OPM defines a business day, for the purposes of an appeal to OPM, as beginning on the first business day after the issuance of the order to the employee. OPM's approach to calculating business days mirrors the statutory language in 38 U.S.C. 721(b)(1), promotes consistent use of an objective timeframe, and avoids the risk of presumption of delivery.
                </P>
                <HD SOURCE="HD2">Section 755.202 Procedures for Submitting Appeals</HD>
                <P>
                    This section describes the procedures for VA employees to follow when 
                    <PRTPAGE P="3605"/>
                    submitting an appeal regarding a VA order for recoupment of relocation expenses as provided by 38 U.S.C. 723. An employee may file an appeal to the Director of OPM by U.S. mail or by email, within seven business days after the date of issuance of the order pursuant to 38 U.S.C. 723(a)(3). Like the time limit established for recoupment of awards and bonuses, this time limit is established in law. Appeals which are untimely filed may be dismissed resulting in the VA's decision being upheld. OPM, for good cause shown, may accept an untimely appeal. OPM adopts the approach taken by the Merit Systems Protection Board in 
                    <E T="03">Alonzo</E>
                     v. 
                    <E T="03">Department of the Air Force,</E>
                     4 MSPB 262, 4 M.S.P.R. 180 (1980), in determining whether an employee establishes good cause for the untimely filing of an appeal.
                </P>
                <P>
                    If the employee elects to file by the U.S. mail, it must be addressed to Director, U.S. Office of Personnel Management, 1900 E Street, NW, Room 7H28 (Attention: Accountability and Workforce Relations), Washington, DC 20415. OPM will rely upon the postmark to determine timeliness for filing the appeal. If the employee elects to file by email, it must be sent to 
                    <E T="03">employeeaccountability@opm.gov.</E>
                     OPM will rely upon the date the email was sent to determine timeliness for filing the appeal.
                </P>
                <P>The law does not specify the content for any appeal filed with OPM. Therefore, OPM has determined what information OPM needs to adequately consider the appeal. The appeal must be submitted in writing and must be signed by the employee or their representative. OPM is not requiring a specific form be used in filing the appeal, but any appeal must include the specified information for OPM to properly adjudicate the appeal. The written appeal must include (1) a copy of the notice of proposed order received pursuant to 38 U.S.C. 723(a)(2)(A); (2) a copy of the employee's response to the proposed order, if any; (3) a copy of the order received pursuant to 38 U.S.C. 723(a)(3); (4) a statement explaining why the employee believes the order received pursuant to 38 U.S.C. 723(a)(3) is in error; (5) the name, mailing address, telephone number, and email address of the employee and their representative if the employee has elected to be represented; and (6) the name, mailing address, telephone number, and email address of the VA official who issued the order pursuant to 38 U.S.C. 723(a)(3). OPM will notify the VA upon receipt of a complete, timely appeal. The VA must provide OPM a copy of the evidence file relied upon in proposing and deciding its recoupment order as soon as possible but no later than five business days after OPM sends its notice to the VA. For OPM to make an appropriate decision, OPM must have all necessary facts and evidence relied upon by the VA when making its recoupment decision. If necessary, OPM may request VA provide information in addition to the evidence file. For example, OPM may need additional information to address the employee's belief the order by the VA was in error. Any additional information requested by OPM must be provided to OPM within five business days after OPM's request. VA must also furnish a copy of any additional information requested by and provided to OPM to the employee. VA's failure to provide the evidence file or any requested additional information to OPM will result in a finding against the VA.</P>
                <P>An employee covered by this subpart is entitled to be represented by an attorney or other representative. OPM may disallow as an employee's representative an individual whose activities as representative would cause a conflict of interest or position, or an employee of any agency whose release from their official position would give rise to unreasonable costs or whose priority work assignments preclude their release. This is consistent with other complaint processes regulated by OPM.</P>
                <P>Finally, like the appeal process for recoupment of awards and bonuses, it is unclear to OPM whether the appeal rights to OPM are the exclusive process for bargaining unit employees to challenge a VA order on recoupment of relocation expenses or whether VA bargaining unit employees may file a grievance under any applicable negotiated grievance procedure which ends in binding arbitration. OPM requests comment on whether bargaining unit employees may use the negotiated grievance process under 5 U.S.C. 7121 to challenge a VA order in lieu of filing an appeal with OPM. OPM also requests comment on whether this determination is impacted by whether the relocation expense was originally paid under title 5 authority or under title 38 authority.</P>
                <HD SOURCE="HD2">Section 755.203 Basis of Appeal Decision</HD>
                <P>The law provides that, upon the issuance of an order by the Secretary, an individual shall have an opportunity to appeal the order to the Director of OPM within seven business days after the date of such issuance. The law further provides that the Director shall make a final decision regarding the appeal within 30 business days after receiving the appeal. Therefore, due to this compressed timeline, OPM has determined the best way to fulfill its obligations to render a timely decision on any appeal is to base the decision on the written record only, which will include the submissions by the employee and the agency. Like the appeal process for recoupment of awards and bonuses, there will be no formal hearing procedures for this appeal.</P>
                <P>The burden is upon the employee to establish the timeliness of the appeal and to explain why the VA's order is in error under 38 U.S.C. 723. OPM may uphold the VA order if the employee or their designated representative fails to provide required information. As noted previously, OPM will also uphold the VA order if the appeal was untimely filed without good cause shown for the delay.</P>
                <P>
                    Since Congress did not provide OPM the authority to adjudicate decisions by the VA regarding any disciplinary or adverse action, or any performance-based action, OPM's review of the VA order is limited to whether the procedures in VA's policies on recoupment of relocation expenses 
                    <SU>4</SU>
                    <FTREF/>
                     pursuant to 38 U.S.C. 723 were followed, or, in the absence of such policies, compliance with the statute. In other words, OPM will not review whether any disciplinary or adverse action, or performance-based action, which may have been relied upon by the VA in its recoupment order was appropriate. OPM will accept the facts found by the VA regarding the disciplinary or adverse action, or performance-based action, which was relied upon by the VA in making its recoupment decision. OPM will not review any discrimination claim or prohibited personnel practice claim raised in any appeal. Employees may file complaints with the EEOC or OSC, where appropriate.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         See 
                        <E T="03">Id.,</E>
                         Procedures for Recoupment of Relocation Expenses, Page VI-6.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Section 755.204 Form of Appeal Decision</HD>
                <P>
                    Within 30 business days after receiving an appeal, OPM will make a decision on the employee's appeal. OPM will then send a written appeal decision to the employee or to the employee's representative, if any, advising whether the VA order is upheld by OPM. OPM will send the VA a copy of the appeal decision. This time limit is consistent with the statutory requirements.
                    <PRTPAGE P="3606"/>
                </P>
                <HD SOURCE="HD2">Section 755.205 Finality of Appeal Decision</HD>
                <P>Pursuant to 38 U.S.C. 723(b)(2), the OPM appeal decision is final. There will not be any further administrative review available within OPM, and thus this rule does not establish any process for requests for reconsideration. Like appeals of recoupment of awards and bonuses, the law is silent regarding any statutory right to judicial review of an OPM appeal decision. Accordingly, although OPM will send its appeal decision to the employee, OPM will not provide an accompanying statement of “appeal rights.” OPM requests comment on whether a VA employee may seek judicial review of an OPM final decision. If so, where would judicial review occur? OPM may revise its procedures to address appeals based on comments received.</P>
                <HD SOURCE="HD1">Waiver of Notice of Proposed Rule Making</HD>
                <P>OPM is issuing this rulemaking as an interim final rule because it has determined that, under the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), it would be impracticable to delay a final regulation until a public notice and comment process has been completed. VA finalized its internal policies regarding implementation of the authority to recoup awards, bonuses, and relocation expenses on January 29, 2024. Following the issuance of that policy, VA began using the authority to pursue recoupment actions, which could be appealed to OPM imminently if an order to recoup is issued. Therefore, OPM must be ready to receive and adjudicate appeals from VA employees. As explained in further detail below, OPM was unable to develop procedures until it had a better understanding of what process VA would provide and what record would be available for OPM review. VA finalized its internal policies regarding implementation of the authority to recoup awards, bonuses, and relocation expenses on January 29, 2024. OPM developed this interim final rule after review of VA's policies and procedures, consideration of legal and policy options, and consultation with VA. OPM also believes that waiver of notice and comment is in the public interest. Although OPM has statutory authority to hear appeals, the public is better served to have clear, established procedures that are easily accessible in the Code of Federal Regulations than for OPM to operate under uncodified procedures that could be variable or haphazard pending a final rule. This interim final rule is intended to provide near-term appellants with certainty with respect to the process for appealing a decision of the VA. OPM will seek to finalize this rule with the benefit of public insight as soon as possible. Accordingly, to ensure the regulations accurately reflect the current state of the law and to provide clear procedures for an employee seeking OPM review of a VA recoupment order, OPM finds that good cause exists to waive the general notice of proposed rulemaking pursuant to 5 U.S.C. 553(b)(B). Expeditious issuance of this interim final regulation is required to prevent confusion and promote fairness as VA exercises its statutory authority resulting in appeals to OPM. OPM will promulgate a final rule, reflecting consideration of public comments, as soon as practical after receiving public comments on the interim final rule. In addition to welcoming comment on the provisions codified in this interim final rule, OPM invites comment on a number of additional procedural topics outlined below that OPM could address in the final rule.</P>
                <HD SOURCE="HD1">Waiver of Delay in Effective Date</HD>
                <P>
                    Pursuant to 5 U.S.C. 553(d)(3), OPM finds that good cause exists to waive the 30-day delay in effective date and make these procedural regulations effective in upon publication. The delay in effective date is being waived because the provisions of the law regarding recoupment of bonuses, awards, or relocation expenses (
                    <E T="03">see</E>
                     38 U.S.C. 721 and 723) became effective upon enactment, June 23, 2017, and the VA finalized its internal procedures regarding this law on January 29, 2024. In crafting this rule, OPM considered the VA's internal procedures, first, to ensure it designed an effective and efficient process for adjudicating appeals given the limited period of time afforded OPM by sections 721(b) and 723(b) to issue a decision. Additionally, OPM's jurisdiction is limited to a review of whether the procedures in VA's policies on recoupment of relocation expenses were followed or, in the absence of any such policies, whether the VA's order was otherwise in compliance with section 721 or 723. To issue a rule before VA established its internal procedures would have been unworkable and may have created inefficiencies that would either delay or rush OPM in reaching a decision; both of which would unnecessarily prejudice VA employees and the VA.
                </P>
                <P>OPM also believes that after VA finalized its policy, the VA began exercising its authority under this statute and, if an order to recoup is issued, that OPM could receive an appeal prior to the standard 30-day effective date. A delay in the effective date could result in confusion and inconsistency in how to file an appeal with OPM and the content needed for such an appeal. In the interest of fairness and timely resolution for any VA employee who is subjected to a recoupment order in the near future, it is imperative to give effect to this rule as soon as practicable.</P>
                <HD SOURCE="HD1">Regulatory Impact Analysis</HD>
                <HD SOURCE="HD2">A. Statement of Need</HD>
                <P>This interim final rule implements portions of sections 204 and 205 of Public Law 115-41, the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017, which provides VA employees certain appeal rights to the Director of OPM regarding decisions by the VA to recoup awards, bonuses, or relocation expenses. These sections of Public Law 115-41 amend chapter 7 of title 38, United States Code. Under these authorities, OPM is prescribing additional details of the appeal process to provide consistency and transparency.</P>
                <HD SOURCE="HD2">B. Regulatory Alternatives</HD>
                <P>An alternative to this rulemaking is to not issue a regulation or any procedures regarding the appeals process. The law is silent on whether OPM must issue any policies or rules governing the appeals process. However, if OPM does not issue any policies or rules on the appeals process, this likely will result in confusion regarding how OPM will administer the appeals process as the law only outlines the right to appeal to the Director of OPM; the time limit for a VA employee to file an appeal; and a time limit for the Director to issue a decision regarding any appeal. The rule includes procedural protections for both the VA and employees during the appeal process that are not included in the statute that help inform OPM's decision-making and protect against prejudice. We view these risks in the absence of this rule as particularly elevated given the VA's past use of recoupment authority and stated intention to continue its use. Without further clarification of and inclusion of additional procedures OPM, the VA, and VA employees will follow, there will likely be confusion on procedural requirements, less-informed decision-making, and procedural prejudice to the parties. </P>
                <P>
                    Another alternative is to publish these procedures on OPM's public facing website. This provides some transparency regarding how OPM will administer the process. However, the 
                    <PRTPAGE P="3607"/>
                    public and interested stakeholders would not be provided an opportunity to review and provide comments and recommendations regarding the procedures since the procedures would not be published through a rulemaking process. Furthermore, 5 U.S.C. 552(a)(1) requires agencies to publish administrative adjudicatory procedures in the 
                    <E T="04">Federal Register</E>
                    . Moreover, given that the regulations apply only to VA employees, publishing these procedures on OPM's public facing website may cause confusion for the many non-VA employees who visit OPM's website for information.
                </P>
                <P>Finally, another alternative is to publish this as a proposed rule seeking public comment instead of an interim final rule seeking public comment. This would mean the public and interested stakeholders would be provided an opportunity to review and provide comments and recommendations regarding the procedures in the traditional rulemaking process. However, following issuance of its final policy, VA began exercising its authority to recoup awards, bonuses, and relocation expenses. If the VA issues an order to recoup a bonus, award, or relocation expense before any final rule is published, the employee has a right under the law to appeal to the Director of OPM. This means OPM would be obligated to render a decision on any appeal before OPM has finalized and publicized any appeal process. As discussed in greater detail above in the sections on Waiver of Notice of Proposed Rule Making and Waiver of Delay in Effective Date and in the interest of fairness and transparency to all VA employees, OPM believes it is imperative to publish procedures as soon as possible now that VA has finalized its internal policies on these matters.</P>
                <HD SOURCE="HD2">C. Impact</HD>
                <P>OPM is issuing this interim final rule to provide consistency and transparency regarding appeals by VA employees regarding orders by the VA to recoup awards, bonuses, or relocation expenses previously paid to these employees. Congress provided VA employees appeal rights regarding such orders by the VA. OPM's interim final rule provides more clarity regarding this appeal process. It provides VA employees with structure and an explanation of what to expect and provides employees with security that they will receive fair, consistent treatment in the consideration of an appeal.</P>
                <HD SOURCE="HD2">D. Costs</HD>
                <P>The costs associated with the interim final rule are minimal. Most costs of this rule are expected to only impact OPM with some minor costs to the VA as it relates to the appeal process. No other Federal agencies are affected by this rule. We do not believe this rule will substantially increase the ongoing administrative costs to OPM or the VA. We anticipate OPM will leverage existing staff and resources to administer the appeal process. To a lesser extent, we anticipate VA will leverage existing staff and resources to respond to requests from OPM for information regarding decisions by the VA to recoup awards, bonuses, or relocation expenses. For VA employees appealing to OPM, we view the costs imposed upon these employees by this interim rule as minimal and limited to submitting existing information and a statement supporting any appeal.</P>
                <P>With the above in mind, we estimate this rule will involve such activities as reviewing and analyzing VA employee appeals by OPM subject matter experts; requesting additional information from the VA as necessary; drafting a recommended appeal decision for the OPM Director or designee; meeting between OPM subject matter experts with the OPM Director or designee, if needed, regarding the recommended appeal decision; and taking steps to communicate the appeal decision by the OPM Director or designee to the employee or their representative and the VA. For this cost analysis, the assumed staffing for Federal employees performing the work required by the regulation is one executive; one GS-15, step 5; one GS-14, step 5; and one GS-13, step 5, in the Washington, DC, locality area. The 2024 basic rate of pay for an executive at an agency with a certified SES performance appraisal system is $246,400 annually, or $118.06 per hour. For General Schedule employees in the Washington, DC, locality area, the 2024 pay table rates are $185,824 annually and $89.04 hourly for GS-15, step 5; $157,982 annually and $75.70 hourly for GS-14; and $133,692 annually and $64.06 hourly for GS-13, step 5. We assume that the total dollar value of labor, which includes wages, benefits, and overhead, is equal to 200 percent of the wage rate, resulting in assumed hourly labor costs of $236.13 for an executive; $178.08 for a GS-15, step 5; $151.40 for a GS-14, step 5; and $128.12 for a GS-13, step 5. While OPM has no baseline data to estimate how many appeals will be filed with OPM, OPM is estimating that each appeal received will require an average of 40 hours of work by employees with an average hourly cost of $173.43. This would result in estimated costs of about $6,937.20 for OPM for each appeal filed with OPM.</P>
                <P>As already noted, the VA will provide OPM a copy of the evidence file for the appeal process. OPM anticipates a negligible cost to the VA for providing the requested file. While VA may incur some costs regarding decisions it makes regarding recoupment of awards, bonuses, or relocation expenses, such matters are not covered by this interim final rule and are covered by VA policies.</P>
                <P>Finally, the costs to VA employees appealing an order will be limited to the submission of the required information necessary for processing an appeal. All required information of an appeal is limited and readily available to the employee as nearly all of the required information is provided to the employee by VA or previously submitted by the employee to the VA. The only new information required of the employee is a statement supporting an appeal to OPM which we anticipate repeats much of the information previously provided to VA and which is required to be submitted as part of any appeal.</P>
                <HD SOURCE="HD2">E. Benefits</HD>
                <P>This interim final rule will benefit VA employees. This interim rule will provide consistency and transparency regarding the procedures OPM will follow when processing appeals by VA employees regarding decisions by the VA regarding recoupment of awards, bonuses, or relocations expenses. This final rule provides clarity regarding the procedural protections Congress has provided VA employees on such matters.</P>
                <HD SOURCE="HD2">F. Request for Comment</HD>
                <P>In addition to the questions posed in the description of the procedural regulations (repeated below) and given the unique nature of OPM's responsibility for adjudicating employee appeals on matters unique to only one Federal agency, OPM requests comments on the implementation and impact of this interim final rule. The types of information on which OPM is interested in public comments includes, but is not limited to, the following:</P>
                <P>
                    • If a disciplinary or adverse action, or performance-based action, relied upon by the VA in recoupment of an award, bonus, or relocation expense is subject to a grievance or appeal in a separate process and the grievance or appeal is still pending, how should this impact any decision by OPM? What if the disciplinary or adverse action, or 
                    <PRTPAGE P="3608"/>
                    performance-based action, relied upon by the VA is later overturned in the separate process after any decision by OPM regarding the recoupment by the VA?
                </P>
                <P>• May VA bargaining unit employees use the negotiated grievance process under 5 U.S.C. 7121 to challenge a VA recoupment order in lieu of filing an appeal with OPM? Or do 38 U.S.C. 721 and 723 provide the sole method to challenge a VA recoupment order?</P>
                <P>• Does coverage by the negotiated grievance procedure depend on whether the award or bonus was paid under title 5 authority or by title 38 authority?</P>
                <P>• May a VA employee seek judicial review of an OPM final decision? If so, where would judicial review occur?</P>
                <P>• Should OPM publish its appeal decisions and make them publicly available?</P>
                <P>OPM welcomes comments on the answers to these questions and recommendations regarding whether and how these questions should be addressed in OPM regulations in a final rule. OPM may adopt additional procedures to address these and other issues identified in public comments in a final rule.</P>
                <HD SOURCE="HD1">Executive Orders 14094, 13563 and 12866, Regulatory Review</HD>
                <P>OPM has examined the impact of this rulemaking as required by Executive Orders 12866 (Sept. 30, 1993), 13563 (Jan. 18, 2011), and 14094 (Apr. 6, 2023), which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public, health, and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for major rules with effects of $200 million or more in any one year. This rulemaking does not reach that threshold but has otherwise been designated as a “significant regulatory action” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094.</P>
                <HD SOURCE="HD1">Regulatory Flexibility Act</HD>
                <P>The Director of OPM certifies that this regulation will not have a significant impact on a substantial number of small entities.</P>
                <HD SOURCE="HD1">Executive Order 13132, Federalism</HD>
                <P>This regulation will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Aug. 10, 1999), it is determined that this interim final rule does not have sufficient federalism implications to warrant preparation of a Federalism Assessment.</P>
                <HD SOURCE="HD1">Executive Order 12988, Civil Justice Reform</HD>
                <P>This regulation meets the applicable standard set forth in Executive Order 12988.</P>
                <HD SOURCE="HD1">Unfunded Mandates Reform Act of 1995</HD>
                <P>Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule that would impose spending costs on State, local, or Tribal governments in the aggregate, or on the private sector, in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold is currently approximately $183 million. This regulation will not result in the expenditure by State, local, or Tribal governments, in the aggregate, or by the private sector, in excess of the threshold. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.</P>
                <HD SOURCE="HD1">Congressional Review Act</HD>
                <P>The Office of Information and Regulatory Affairs in the Office of Management and Budget has determined that this rule does not satisfy the criteria listed in 5 U.S.C. 804(2).</P>
                <HD SOURCE="HD1">Paperwork Reduction Act</HD>
                <P>
                    Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) (PRA), unless the collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule does not result in a collection of information subject to the PRA.
                </P>
                <P>
                    OPM anticipates that the case records would be subject to the Privacy Act and will be covered by the new OPM System of Records Notice (SORN) “OPM/Internal-29, VA Recoupment and Reduction Appeals to OPM,” which is published elsewhere in this issue of the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 5 CFR Part 755</HD>
                    <P>Administrative practices and procedures, Government employees.</P>
                </LSTSUB>
                <SIG>
                    <NAME>Kayyonne Marston,</NAME>
                    <TITLE>Federal Register Liaison. Office of Personnel Management.</TITLE>
                </SIG>
                <REGTEXT TITLE="5" PART="755">
                    <AMDPAR>Accordingly, for the reasons stated in the preamble, OPM adds part 755 to title 5 of the Code of Federal Regulations to read as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 755—APPEAL PROCEDURES FOR RECOUPMENT OF AWARDS, BONUSES, OR RELOCATION EXPENSES AWARDED OR APPROVED FOR ALL EMPLOYEES OF THE DEPARTMENT OF VETERANS AFFAIRS (VA)</HD>
                        <CONTENTS>
                            <SECHD>Sec.</SECHD>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart A—Awards and Bonuses</HD>
                                <SECTNO>755.101</SECTNO>
                                <SUBJECT>Scope of subpart and definitions.</SUBJECT>
                                <SECTNO>755.102</SECTNO>
                                <SUBJECT>Procedures for submitting appeals.</SUBJECT>
                                <SECTNO>755.103</SECTNO>
                                <SUBJECT>Basis of appeal decision.</SUBJECT>
                                <SECTNO>755.104</SECTNO>
                                <SUBJECT>Form of appeal decision.</SUBJECT>
                                <SECTNO>755.105</SECTNO>
                                <SUBJECT>Finality of appeal decision.</SUBJECT>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart B—Relocation Expenses</HD>
                                <SECTNO>755.201</SECTNO>
                                <SUBJECT>Scope of subpart and definitions.</SUBJECT>
                                <SECTNO>755.202</SECTNO>
                                <SUBJECT>Procedures for submitting appeals.</SUBJECT>
                                <SECTNO>755.203</SECTNO>
                                <SUBJECT>Basis of appeal decision.</SUBJECT>
                                <SECTNO>755.204</SECTNO>
                                <SUBJECT>Form of appeal decision.</SUBJECT>
                                <SECTNO>755.205</SECTNO>
                                <SUBJECT>Finality of appeal decision.</SUBJECT>
                            </SUBPART>
                        </CONTENTS>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>5 U.S.C. 1103; 38 U.S.C. 721 and 723.</P>
                        </AUTH>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—Awards and Bonuses</HD>
                            <AUTH>
                                <HD SOURCE="HED">Authority:</HD>
                                <P>38 U.S.C. 721.</P>
                            </AUTH>
                            <SECTION>
                                <SECTNO>§ 755.101</SECTNO>
                                <SUBJECT>Scope of subpart and definitions.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Employees covered.</E>
                                     A current or former civil service employee of the Department of Veterans Affairs (VA) as defined by title 38 of the U.S. Code, or by 5 U.S.C. 2105.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Appeals covered.</E>
                                     This subpart prescribes general procedures applicable to appeals, pursuant to 38 U.S.C. 721, by a covered employee to the Director of the Office of Personnel Management (OPM), or designee, regarding an order by the Secretary of the VA, or designee, directing the employee to repay the amount, or a portion of the amount, of any award or bonus paid to the employee under title 5 of the U.S. Code, including 5 U.S.C. chapter 45 or 53, or under title 38 of the U.S. Code.
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Appeals not covered.</E>
                                     Any disciplinary or adverse action, or any performance-based action taken by the VA (including any such action that may have served as a basis for the Secretary of the VA, or designee, to order recoupment of an award or bonus paid to an employee of the VA) is not 
                                    <PRTPAGE P="3609"/>
                                    appealable under this subpart. Discrimination claims or prohibited personnel practice claims raised in an appeal are not subject to OPM review.
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Business days.</E>
                                     Weekdays, which are Monday through Friday, except when such a day is designated as a Federal holiday by OPM, or the employee's assigned facility or OPM is closed for regular business, 
                                    <E T="03">e.g.,</E>
                                     inclement weather, lapse in appropriations.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 755.102</SECTNO>
                                <SUBJECT>Procedures for submitting appeals.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Filing an appeal and time limits.</E>
                                     An employee may file an appeal to the Director, U.S. Office of Personnel Management, 1900 E Street NW, Room 7H28 (Attention: Accountability and Workforce Relations), Washington, DC 20415 or by email to 
                                    <E T="03">employeeaccountability@opm.gov,</E>
                                     within seven business days after the date of issuance of the order pursuant to 38 U.S.C. 721(a)(3). OPM, for good cause shown, may accept an untimely appeal.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Content of appeals.</E>
                                     An appeal must be submitted by the employee in writing and must be signed by the employee or their representative. While no specific form is required, the appeal must include:
                                </P>
                                <P>(1) A copy of the notice of proposed order received pursuant to 38 U.S.C. 721(a)(2)(A);</P>
                                <P>(2) A copy of the employee's response to the proposed order, if any;</P>
                                <P>(3) A copy of the order received pursuant to 38 U.S.C. 721(a)(3);</P>
                                <P>(4) A statement explaining why the employee believes the order received pursuant to 38 U.S.C. 721(a)(3) is in error;</P>
                                <P>(5) The name, mailing address, telephone number, and email address of the employee and their representative (if applicable); and</P>
                                <P>(6) The name, mailing address, telephone number, and email address of the VA official who issued the order pursuant to 38 U.S.C. 721(a)(3).</P>
                                <P>
                                    (c) 
                                    <E T="03">VA submission of evidence file.</E>
                                     OPM will notify the VA upon receipt of a complete, timely appeal. The VA must provide OPM a copy of the evidence file as soon as possible but no later than five business days. If necessary, OPM may request VA provide information in addition to the evidence file. Any additional information requested by OPM must be provided to OPM within five business days after OPM's request. VA must also furnish a copy of any additional information requested by and provided to OPM to the employee. VA's failure to provide the evidence file or any requested additional information to OPM will result in a finding against VA.
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Employee representative.</E>
                                     An employee may select a representative of their choice to assist in the preparation and submission of an appeal. An appeal filed by their representative must be supported by a duly executed power of attorney or other written documentation by the employee designating the representative. OPM may disallow as an employee's representative an individual whose activities as representative would cause a conflict of interest or position; an employee of any agency who cannot be released from official duties because of the priority needs of the Government; or an employee of any agency whose release would give rise to unreasonable costs to the Government.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 755.103</SECTNO>
                                <SUBJECT>Basis of appeal decision.</SUBJECT>
                                <P>The burden is upon the employee to establish the timeliness of the appeal and to explain why the VA's order is in error. OPM's decision is based upon the written record only, which will include the submissions by the employee and the agency. OPM will accept the facts found by the VA regarding the disciplinary or adverse action, or performance-based action, or other type of finding or action, if any, which was relied upon by the VA in making its recoupment decision. OPM may uphold the VA order if the employee or their designated representative fails to provide requested information. OPM's review of the VA order is limited to whether the procedures in VA's policies on recoupment of awards and bonuses pursuant to 38 U.S.C. 721 were followed. In the absence of such policies, OPM's review is limited to compliance with 38 U.S.C. 721.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 755.104</SECTNO>
                                <SUBJECT>Form of appeal decision.</SUBJECT>
                                <P>Within 30 business days after receiving an appeal, OPM will make a decision on the employee's appeal. OPM will then send a written appeal decision to the employee or their representative advising whether the VA order is upheld by OPM. OPM will send the VA a copy of the appeal decision.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 755.105</SECTNO>
                                <SUBJECT>Finality of appeal decision.</SUBJECT>
                                <P>Pursuant to 38 U.S.C. 721(b)(2), the OPM appeal decision is final; no further administrative review is available within OPM.</P>
                            </SECTION>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart B—Relocation Expenses</HD>
                            <AUTH>
                                <HD SOURCE="HED">Authority:</HD>
                                <P> 38 U.S.C. 723.</P>
                            </AUTH>
                            <SECTION>
                                <SECTNO>§ 755.201</SECTNO>
                                <SUBJECT>Scope of subpart and definitions.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Employees covered.</E>
                                     A current or former civil service employee of the Department of Veterans Affairs (VA) as defined by title 38 of the U.S. Code, or by 5 U.S.C. 2105.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Appeals covered.</E>
                                     This subpart prescribes general procedures applicable to appeals, pursuant to 38 U.S.C. 723, by a covered employee to the Director of the Office of Personnel Management (OPM), or designee, regarding an order by the Secretary of the VA, or designee, directing the employee to repay the amount, or a portion of the amount, paid to or on behalf of an employee for relocation expenses under title 5 of the U.S. Code, including any expenses under 5 U.S.C. 5724 or 5724(a), or under title 38 of the U.S. Code.
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Appeals not covered.</E>
                                     Any disciplinary or adverse action, or any performance-based action taken by the VA (including any such action that may have served as a basis for the Secretary of the VA, or designee, to order repayment of a relocation expense by an employee of the VA) is not appealable under this subpart. Discrimination claims or prohibited personnel practice claims raised in an appeal are not subject to OPM review.
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Business days.</E>
                                     Weekdays, which are Monday through Friday, except when such a day is designated as a Federal holiday by OPM, or the employee's assigned facility or OPM is closed for regular business, 
                                    <E T="03">e.g.,</E>
                                     inclement weather, lapse in appropriations.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 755.202</SECTNO>
                                <SUBJECT>Procedures for submitting appeals.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Filing an appeal and time limits.</E>
                                     An employee may file an appeal to the Director, U.S. Office of Personnel Management, 1900 E Street NW, Room 7H28 (Attention: Accountability and Workforce Relations), Washington, DC 20415 or by email to 
                                    <E T="03">employeeaccountability@opm.gov,</E>
                                     within seven business days after the date of issuance of the order pursuant to 38 U.S.C. 723(a)(3). OPM, for good cause shown, may accept an untimely appeal.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Content of appeals.</E>
                                     An appeal must be submitted by the employee in writing and must be signed by the employee or their representative. While no specific form is required, the appeal must include:
                                </P>
                                <P>(1) A copy of the notice of proposed order received pursuant to 38 U.S.C. 723(a)(2)(A);</P>
                                <P>(2) A copy of the employee's response to the proposed order, if any;</P>
                                <P>(3) A copy of the order received pursuant to 38 U.S.C. 723(a)(3);</P>
                                <P>
                                    (4) A statement explaining why the employee believes the order received pursuant to 38 U.S.C. 723(a)(3) is in error;
                                    <PRTPAGE P="3610"/>
                                </P>
                                <P>(5) The name, mailing address, telephone number, and email address of the employee and their representative (if applicable); and</P>
                                <P>(6) The name, mailing address, telephone number, and email address of the VA official who issued the order pursuant to 38 U.S.C. 723(a)(3).</P>
                                <P>
                                    (c) 
                                    <E T="03">VA submission of evidence file.</E>
                                     OPM will notify the VA upon receipt of a complete, timely appeal. The VA must provide OPM a copy of the evidence file-as soon as possible but no later than five business days. If necessary, OPM may request VA provide information in addition to the evidence file. Any additional information requested by OPM must be provided to OPM within five business days after OPM's request. VA must also furnish a copy of any additional information requested by and provided to OPM to the employee. VA's failure to provide the evidence file or any requested additional information to OPM will result in a finding against VA.
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Employee representative.</E>
                                     An employee may select a representative of their choice to assist in the preparation and submission of an appeal. An appeal filed by their representative must be supported by a duly executed power of attorney or other written documentation by the employee designating the representative. OPM may disallow as an employee's representative an individual whose activities as representative would cause a conflict of interest or position; an employee of any agency who cannot be released from official duties because of the priority needs of the Government; or an employee of any agency whose release would give rise to unreasonable costs to the Government.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 755.203</SECTNO>
                                <SUBJECT>Basis of appeal decision.</SUBJECT>
                                <P>The burden is upon the employee to establish the timeliness of the appeal and to explain why the VA's order is in error. OPM's decision is based upon the written record only, which will include the submissions by the employee and the agency. OPM will accept the facts found by the VA regarding the disciplinary or adverse action, performance-based action, or other type of finding or action, if any, which was relied upon by the VA in making its recoupment decision. OPM may uphold the VA order if the employee or their designated representative fails to provide requested information. OPM's review of the VA order is limited to whether the procedures in VA's policies on recoupment of relocation expenses pursuant to 38 U.S.C. 723 were followed. In the absence of such policies, OPM's review is limited to compliance with 38 U.S.C. 723.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 755.204</SECTNO>
                                <SUBJECT>Form of appeal decision.</SUBJECT>
                                <P>Within 30 business days after receiving an appeal, OPM will make a decision on the employee's appeal. OPM will then send a written appeal decision to the employee or their representative advising whether the VA order is upheld by OPM. OPM will send the agency a copy of the appeal decision.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 755.205</SECTNO>
                                <SUBJECT>Finality of appeal decision.</SUBJECT>
                                <P>Pursuant to 38 U.S.C. 723(b)(2), the OPM appeal decision is final; no further administrative review is available within OPM.</P>
                            </SECTION>
                        </SUBPART>
                    </PART>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00583 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6325-39-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">OFFICE OF GOVERNMENT ETHICS</AGENCY>
                <CFR>5 CFR Parts 2634 and 2636</CFR>
                <RIN>RIN 3209-AA71</RIN>
                <SUBJECT>2025 Civil Monetary Penalties Inflation Adjustments for Ethics in Government Act Violations</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Government Ethics.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, the U.S. Office of Government Ethics is issuing this final rule to make the 2025 annual adjustments to the Ethics in Government Act civil monetary penalties.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Margaret Dylus-Yukins, Assistant Counsel, General Counsel and Legal Policy Division, Office of Government Ethics, Telephone: 202-482-9300; TTY: 800-877-8339; FAX: 202-482-9237.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>In November 2015, Congress passed the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (sec. 701 of Pub. L. 114-74) (the 2015 Act), which further amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410). The 2015 Act required Federal agencies to make annual inflationary adjustments to the civil monetary penalties (CMPs) within their jurisdiction, to be effective no later than January 15 of each year.</P>
                <P>
                    The Ethics in Government Act as amended, chapter 131, title 5 of the United States Code, provides for five CMPs.
                    <SU>1</SU>
                    <FTREF/>
                     Specifically, the Ethics in Government Act provides for penalties that can be assessed by an appropriate United States district court, based upon a civil action brought by the Department of Justice, for the following five types of violations:
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         OGE has previously determined, after consultation with the Department of Justice, that the $200 late filing fee for public financial disclosure reports that are more than 30 days overdue (see 5 U.S.C. 13106(d) and 5 CFR 2634.704 of OGE's regulations thereunder) is not a CMP as defined under the Federal Civil Penalties Inflation Adjustment Act, as amended. Therefore, that fee is not being adjusted in this rulemaking (nor was it adjusted by OGE in previous CMP rulemakings). The late filing fee for public financial disclosure reports that are more than 30 days overdue will remain at its current amount of $200.
                    </P>
                </FTNT>
                <P>(1) knowing and willful failure to file, report required information on, or falsification of a public financial disclosure report, 5 U.S.C. 13106(a)(1), 5 CFR 2634.701(b);</P>
                <P>(2) knowing and willful breach of a qualified trust by trustees and interested parties, 5 U.S.C. 13104(f)(6)(C)(i), 5 CFR 2634.702(a);</P>
                <P>(3) negligent breach of a qualified trust by trustees and interested parties, 5 U.S.C. 13104(f)(6)(C)(ii), 5 CFR 2634.702(b);</P>
                <P>(4) misuse of a public report, 5 U.S.C. 13107(c)(2), 5 CFR 2634.703; and</P>
                <P>(5) violation of outside employment/activities provisions, 5 U.S.C. 13145(a), 5 CFR 2636.104(a).</P>
                <P>In compliance with the 2015 Act and guidance issued by the Office of Management and Budget (OMB), the U.S. Office of Government Ethics (OGE) made previous inflationary adjustments to the five Ethics in Government Act CMPs, and is issuing this rulemaking to effectuate the 2025 annual inflationary adjustments to those CMPs. In accordance with the 2015 Act, these adjustments are based on the percent change between the Consumer Price Index for all Urban Consumers (CPI-U) for the month of October preceding the date of the adjustment, and the prior year's October CPI-U. Pursuant to OMB guidance, the cost-of-living adjustment multiplier for 2025, based on the CPI-U for October 2024, not seasonally adjusted, is 1.02598. To calculate the 2025 annual adjustment, agencies must multiply the most recent penalty by the 1.02598 multiplier, and round to the nearest dollar.</P>
                <P>Applying the formula established by the 2015 Act and OMB guidance, OGE is amending the Ethics in Government Act CMPs through this rulemaking to:</P>
                <P>
                    (1) Increase the three penalties reflected in 5 CFR 2634.702(a), 2634.703, and 2636.104(a)—which were previously adjusted to a maximum of $24,496—to a maximum of $25,132;
                    <PRTPAGE P="3611"/>
                </P>
                <P>(2) Increase the penalty reflected in 5 CFR 2634.702(b)—which was previously adjusted to a maximum of $12,249—to a maximum of $12,567; and</P>
                <P>(3) Increase the penalty reflected in 5 CFR 2634.701(b)—which was previously adjusted to a maximum of $73,627—to a maximum of $75,540.</P>
                <P>These adjusted penalty amounts will apply to penalties for violations that occurred after November 2, 2015 and that are assessed after January 15, 2025 (the effective date of this final rule). OGE will continue to make future annual inflationary adjustments to the Ethics in Government Act CMPs in accordance with the statutory formula set forth in the 2015 Act and OMB guidance.</P>
                <HD SOURCE="HD1">II. Matters of Regulatory Procedure</HD>
                <HD SOURCE="HD2">Administrative Procedure Act</HD>
                <P>Pursuant to 5 U.S.C. 553(b), as Director of the Office of Government Ethics, I find that good cause exists for waiving the general notice of proposed rulemaking and public comment procedures as to these technical amendments. The notice and comment procedures are being waived because these amendments, which concern matters of agency organization, procedure and practice, are being adopted in accordance with statutorily mandated inflation adjustment procedures of the 2015 Act, which specifies that agencies shall adjust civil monetary penalties notwithstanding Section 553 of the Administrative Procedure Act. It is also in the public interest that the adjusted rates for civil monetary penalties under the Ethics in Government Act become effective as soon as possible in order to maintain their deterrent effect.</P>
                <HD SOURCE="HD2">Regulatory Flexibility Act</HD>
                <P>As the Director of the Office of Government Ethics, I certify under the 5 U.S.C. 553(b) that this final rule would not have a significant economic impact on a substantial number of small entities because it primarily affects current Federal executive branch employees.</P>
                <HD SOURCE="HD2">Paperwork Reduction Act</HD>
                <P>The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply because this regulation does not contain information collection requirements that require approval of the Office of Management and Budget.</P>
                <HD SOURCE="HD2">Unfunded Mandates Reform Act</HD>
                <P>For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 25, subchapter II), this rule would not significantly or uniquely affect small governments and will not result in increased expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.</P>
                <HD SOURCE="HD2">Executive Order 13563 and Executive Order 12866</HD>
                <P>Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select the regulatory approaches that maximize net benefits (including economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Office of Management and Budget has determined that rulemakings such as this implementing annual inflationary adjustments under the 2015 Act are not significant regulatory actions under Executive Order 12866.</P>
                <HD SOURCE="HD2">Executive Order 12988</HD>
                <P>As Director of the Office of Government Ethics, I have reviewed this rule in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>5 CFR Part 2634</CFR>
                    <P>Certificates of divestiture, Conflict of interests, Financial disclosure, Government employees, Penalties, Privacy, Reporting and recordkeeping requirements, Trusts and trustees.</P>
                    <CFR>5 CFR Part 2636</CFR>
                    <P>Conflict of interests, Government employees, Penalties.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>David Huitema,</NAME>
                    <TITLE>Director, U.S. Office of Government Ethics.</TITLE>
                </SIG>
                <P>For the reasons set forth in the preamble, the U.S. Office of Government Ethics is amending 5 CFR parts 2634 and 2636 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 2634—EXECUTIVE BRANCH FINANCIAL DISCLOSURE, QUALIFIED TRUSTS, AND CERTIFICATES OF DIVESTITURE</HD>
                </PART>
                <REGTEXT TITLE="5" PART="2634">
                    <AMDPAR>1. The authority citation for part 2634 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 5 U.S.C. ch. 131; 26 U.S.C. 1043; Pub. L. 101-410, 104 Stat. 890, 28 U.S.C. 2461 note, as amended by sec. 31001, Pub. L. 104-134, 110 Stat. 1321 and sec. 701, Pub. L. 114-74; Pub. L. 112-105, 126 Stat. 291; E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="5" PART="2634">
                    <AMDPAR>2. Section 2634.701 is amended by revising paragraph (b) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 2634.701</SECTNO>
                        <SUBJECT>Failure to file or falsifying reports.</SUBJECT>
                        <STARS/>
                        <P>
                            (b) 
                            <E T="03">Civil action.</E>
                             The Attorney General may bring a civil action in any appropriate United States district court against any individual who knowingly and willfully falsifies or who knowingly and willfully fails to file or report any information required by filers of public reports under subpart B of this part. The court in which the action is brought may assess against the individual a civil monetary penalty in any amount, not to exceed the amounts set forth in table 1 to this paragraph (b), as provided by 5 U.S.C. 13106(a)(1), and as adjusted in accordance with the inflation adjustment procedures prescribed in the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended.
                        </P>
                        <GPOTABLE COLS="2" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,7">
                            <TTITLE>
                                Table 1 to § 2634.701(
                                <E T="01">b</E>
                                )
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Date of violation</CHED>
                                <CHED H="1">Penalty</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Violation occurring between Sept. 14, 2007 and Nov. 2, 2015</ENT>
                                <ENT>$50,000</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Violation occurring after Nov. 2, 2015</ENT>
                                <ENT>75,540</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>3. Section 2634.702 is revised to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 2634.702</SECTNO>
                        <SUBJECT>Breaches by trust fiduciaries and interested parties.</SUBJECT>
                        <P>(a) The Attorney General may bring a civil action in any appropriate United States district court against any individual who knowingly and willfully violates the provisions of § 2634.408(d)(1) or (e)(1). The court in which the action is brought may assess against the individual a civil monetary penalty in any amount, not to exceed the amounts set forth in table 1 to this paragraph (a), as provided by section 5 U.S.C. 13104(f)(6)(C)(i) and as adjusted in accordance with the inflation adjustment procedures prescribed in the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended.</P>
                        <GPOTABLE COLS="2" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,7">
                            <TTITLE>
                                Table 1 to § 2634.702(
                                <E T="01">a</E>
                                )
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Date of violation</CHED>
                                <CHED H="1">Penalty</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Violation occurring between Sept. 29, 1999 and Nov. 2, 2015</ENT>
                                <ENT>$11,000</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Violation occurring after Nov. 2, 2015</ENT>
                                <ENT>25,132</ENT>
                            </ROW>
                        </GPOTABLE>
                        <P>
                            (b) The Attorney General may bring a civil action in any appropriate United States district court against any individual who negligently violates the provisions of § 2634.408(d)(1) or (e)(1). 
                            <PRTPAGE P="3612"/>
                            The court in which the action is brought may assess against the individual a civil monetary penalty in any amount, not to exceed the amounts set forth in table 2 to this paragraph (b), as provided by 5 U.S.C. 13104(f)(6)(C)(ii) and as adjusted in accordance with the inflation adjustment procedures of the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended.
                        </P>
                        <GPOTABLE COLS="2" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,7">
                            <TTITLE>
                                Table 2 to § 2634.702(
                                <E T="01">b</E>
                                )
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Date of violation</CHED>
                                <CHED H="1">Penalty</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Violation occurring between Sept. 29, 1999 and Nov. 2, 2015</ENT>
                                <ENT>$5,500</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Violation occurring after Nov. 2, 2015</ENT>
                                <ENT>12,567</ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                    <AMDPAR>4. Section 2634.703 is revised to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 2634.703</SECTNO>
                        <SUBJECT>Misuse of public reports.</SUBJECT>
                        <P>(a) The Attorney General may bring a civil action against any person who obtains or uses a report filed under this part for any purpose prohibited by 5 U.S.C. 13107(c)(1), as incorporated in § 2634.603(f). The court in which the action is brought may assess against the person a civil monetary penalty in any amount, not to exceed the amounts set forth in table 1 to this paragraph (a), as provided by 5 U.S.C. 13107(c)(2) and as adjusted in accordance with the inflation adjustment procedures prescribed in the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended.</P>
                        <GPOTABLE COLS="2" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,7">
                            <TTITLE>
                                Table 1 to § 2634.703(
                                <E T="01">a</E>
                                )
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Date of violation</CHED>
                                <CHED H="1">Penalty</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Violation occurring between Sept. 29, 1999 and Nov. 2, 2015</ENT>
                                <ENT>$11,000</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Violation occurring after Nov. 2, 2015</ENT>
                                <ENT>25,132</ENT>
                            </ROW>
                        </GPOTABLE>
                        <P>(b) This remedy shall be in addition to any other remedy available under statutory or common law.</P>
                    </SECTION>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 2636—LIMITATIONS ON OUTSIDE EARNED INCOME, EMPLOYMENT AND AFFILIATIONS FOR CERTAIN NONCAREER EMPLOYEES </HD>
                </PART>
                <REGTEXT TITLE="5" PART="2636">
                    <AMDPAR>5. The authority citation for part 2636 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 5 U.S.C. ch. 131; Pub. L. 101-410, 104 Stat. 890, 28 U.S.C. 2461 note, as amended by sec. 31001, Pub. L. 104-134, 110 Stat. 1321 and sec. 701, Pub. L. 114-74; E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="5" PART="2636">
                    <AMDPAR>6. Section 2636.104 is amended by revising paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 2636.104</SECTNO>
                        <SUBJECT>Civil, disciplinary and other action.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Civil action.</E>
                             Except when the employee engages in conduct in good faith reliance upon an advisory opinion issued under § 2636.103, an employee who engages in any conduct in violation of the prohibitions, limitations, and restrictions contained in this part may be subject to civil action under 5 U.S.C. 13145(a), and a civil monetary penalty of not more than the amounts set in table 1 to this paragraph (a), as adjusted in accordance with the inflation adjustment procedures prescribed in the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended, or the amount of the compensation the individual received for the prohibited conduct, whichever is greater.
                        </P>
                        <GPOTABLE COLS="2" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,7">
                            <TTITLE>
                                Table 1 to § 2636.104(
                                <E T="01">a</E>
                                )
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Date of violation</CHED>
                                <CHED H="1">Penalty</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Violation occurring between Sept. 29, 1999 and Nov. 2, 2015</ENT>
                                <ENT>$11,000</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Violation occurring after Nov. 2, 2015</ENT>
                                <ENT>25,132</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00671 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6345-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <CFR>10 CFR Parts 2 and 13</CFR>
                <DEPDOC>[NRC-2023-0070]</DEPDOC>
                <RIN>RIN 3150-AK96</RIN>
                <SUBJECT>Adjustment of Civil Penalties for Inflation for Fiscal Year 2025</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to adjust the maximum civil monetary penalties it can assess under statutes enforced by the agency. These changes are mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The NRC is amending its regulations to adjust the maximum civil monetary penalty for a violation of the Atomic Energy Act of 1954, as amended, or any regulation or order issued under the Atomic Energy Act from $362,814 to $372,240 per violation, per day. Additionally, the NRC is amending provisions concerning program fraud civil penalties by adjusting the maximum civil monetary penalty under the Program Fraud Civil Remedies Act from $13,946 to $14,308 for each false claim or statement.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective on January 15, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Please refer to Docket ID NRC-2023-0070 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal Rulemaking Website:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov</E>
                         and search for Docket ID NRC-2023-0070. Address questions about NRC dockets to Helen Chang; telephone: 301-415-3228; email: 
                        <E T="03">Helen.Chang@nrc.gov.</E>
                         For technical questions, contact the individual listed in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section of this document.
                    </P>
                    <P>
                        • 
                        <E T="03">NRC's Agencywide Documents Access and Management System (ADAMS):</E>
                         You may obtain publicly available documents online in the ADAMS Public Documents collection at 
                        <E T="03">https://www.nrc.gov/reading-rm/adams.html.</E>
                         To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to 
                        <E T="03">PDR.Resource@nrc.gov</E>
                        . The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section.
                    </P>
                    <P>
                        • 
                        <E T="03">NRC's PDR:</E>
                         The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to 
                        <E T="03">PDR.Resource@nrc.gov</E>
                         or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time, Monday through Friday, except Federal holidays.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Krupskaya Castellon, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-287-9221, email: 
                        <E T="03">Krupskaya.Castellon@nrc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Background</FP>
                    <FP SOURCE="FP-2">II. Discussion</FP>
                    <FP SOURCE="FP-2">III. Rulemaking Procedure</FP>
                    <FP SOURCE="FP-2">IV. Section-by-Section Analysis</FP>
                    <FP SOURCE="FP-2">V. Regulatory Analysis</FP>
                    <FP SOURCE="FP-2">VI. Regulatory Flexibility Act</FP>
                    <FP SOURCE="FP-2">VII. Backfitting and Issue Finality</FP>
                    <FP SOURCE="FP-2">VIII. Plain Writing</FP>
                    <FP SOURCE="FP-2">IX. National Environmental Policy Act</FP>
                    <FP SOURCE="FP-2">X. Paperwork Reduction Act</FP>
                    <FP SOURCE="FP-2">XI. Congressional Review Act</FP>
                </EXTRACT>
                <PRTPAGE P="3613"/>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    Congress passed the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA) to allow for regular adjustment for inflation of civil monetary penalties (CMPs), maintain the deterrent effect of such penalties and promote compliance with the law, and improve the collection of CMPs by the Federal government (Pub. L. 101-410, 104 Stat. 890; 28 U.S.C. 2461 note). Pursuant to this authority, and as amended by the Debt Collection Improvement Act of 1996 (Pub. L. 104-34, 110 Stat. 1321-373), the NRC increased via rulemaking the CMP amounts for violations of the Atomic Energy Act of 1954, as amended (AEA) (codified at § 2.205 of title 10 of the 
                    <E T="03">Code of Federal Regulations</E>
                     (10 CFR), “Civil penalties”) and Program Fraud Civil Remedies Act (codified at § 13.3, “Civil penalties and assessments”) on four occasions between 1996 and 2008.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Adjustment of Civil Penalties for Inflation (73 FR 54671; Sept. 23, 2008); Adjustment of Civil Penalties for Inflation (69 FR 62393; Oct. 26, 2004); Adjustment of Civil Penalties for Inflation; Miscellaneous Administrative Changes (65 FR 59270; Oct. 4, 2000); Adjustment of Civil Monetary Penalties for Inflation (61 FR 53554; Oct. 11, 1996). An adjustment was not performed in 2012 because the FCPIAA at the time required agencies to round their CMP amounts to the nearest multiple of $1,000 or $10,000, depending on the size of the CMP amount, and the 2012 percentages based on the statutory formula were small enough that no adjustment resulted.
                    </P>
                </FTNT>
                <P>On November 2, 2015, Congress amended the FCPIAA through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Improvements Act) (Sec. 701, Pub. L. 114-74, 129 Stat. 599). The 2015 Improvements Act required that the head of each agency perform an initial “catch-up” adjustment via rulemaking, adjusting the CMPs enforced by that agency according to the percentage change in the Consumer Price Index (CPI) between the month of October 2015 and the month of October of the calendar year when the CMP amount was last established by Congress. The NRC published this catch-up rulemaking on July 1, 2016 (81 FR 43019).</P>
                <P>The 2015 Improvements Act also requires that the head of each agency continue to adjust CMP amounts, rounded to the nearest dollar, on an annual basis. Specifically, each CMP is to be adjusted based on the percentage change between the CPI for the month of October, and the CPI for the month of October for the previous year. The NRC most recently adjusted its civil penalties for inflation according to this statutory formula on January 12, 2024 (89 FR 2112). This year's adjustment is based on the increase in the CPI from October 2023 to October 2024.</P>
                <HD SOURCE="HD1">II. Discussion</HD>
                <P>Section 234 of the AEA limits civil penalties for violations of the AEA to $100,000 per day, per violation (42 U.S.C. 2282). However, as discussed in Section I, “Background,” of this document, the NRC has increased this amount several times since 1996 per the FCPIAA, as amended. Using the formula in the 2015 Improvements Act, the $362,814 amount last established in January 2024 will increase by 2.598 percent, resulting in a new CMP amount of $372,240. This is based on the increase in the CPI from October 2023 (307.671) to October 2024 (315.664). Therefore, the NRC is amending § 2.205 to reflect a new maximum CMP under the AEA in the amount of $372,240 per day, per violation. This represents an increase of $9,426.</P>
                <P>Monetary penalties under the Program Fraud Civil Remedies Act were established in 1986 at $5,000 per claim (Pub. L. 99-509, 100 Stat. 1938; 31 U.S.C. 3802). The NRC also has adjusted this amount (currently set at $13,946) multiple times pursuant to the FCPIAA, as amended, since 1996. Using the formula in the 2015 Improvements Act, the $13,946 amount last established in January 2024 will increase by 2.596 percent, resulting in a new CMP amount of $14,308. Therefore, the NRC is amending § 13.3 to reflect a new maximum CMP amount of $14,308 per claim or statement. This represents an increase of $362.</P>
                <P>As permitted by the 2015 Improvements Act, the NRC may apply these increased CMP amounts to any penalties assessed by the agency after the effective date of this final rule (January 15, 2024), regardless of whether the associated violation occurred before or after this date (Pub. L. 114-74, 129 Stat. 600; 28 U.S.C. 2461 note). The NRC assesses civil penalty amounts for violations of the AEA based on the class of licensee and severity of the violation, in accordance with the NRC Enforcement Policy, which is available under ADAMS Accession No. ML24205A249.</P>
                <HD SOURCE="HD1">III. Rulemaking Procedure</HD>
                <P>The 2015 Improvements Act expressly exempts this final rule from the notice and comment requirements of the Administrative Procedure Act by directing agencies to adjust CMPs for inflation “notwithstanding section 553 of title 5, United States Code” (Pub. L. 114-74, 129 Stat. 599; 28 U.S.C. 2461 note). As such, this final rule is being issued without prior public notice or opportunity for public comment, with an effective date of January 15, 2024.</P>
                <HD SOURCE="HD1">IV. Section-by-Section Analysis</HD>
                <HD SOURCE="HD2">§ 2.205 Civil Penalties</HD>
                <P>This final rule revises paragraph (j) by replacing “$362,814” with “$372,240.”</P>
                <HD SOURCE="HD2">§ 13.3 Basis for Civil Penalties and Assessments</HD>
                <P>This final rule revises paragraphs (a)(1)(iv) and (b)(1)(ii) by replacing “$13,946” with “$14,308.”</P>
                <HD SOURCE="HD1">V. Regulatory Analysis</HD>
                <P>This final rule adjusts for inflation the maximum CMPs the NRC may assess under the AEA and under the Program Fraud Civil Remedies Act of 1986. The formula for determining the amount of the adjustment is mandated by Congress in the FCPIAA, as amended by the 2015 Improvements Act (codified at 28 U.S.C. 2461 note). Congress passed this legislation on the basis of its findings that the power to impose monetary civil penalties is important to deterring violations of Federal law and furthering the policy goals of Federal laws and regulations. Congress has also found that inflation diminishes the impact of these penalties and their effect. The principal purposes of this legislation are to provide for adjustment of civil monetary penalties for inflation, maintain the deterrent effect of civil monetary penalties, and promote compliance with the law. Therefore, these are the anticipated impacts of this rulemaking. Direct monetary impacts fall only upon licensees or other persons subjected to NRC enforcement for violations of the AEA and regulations and orders issued under the AEA (§ 2.205), or those licensees or persons subjected to liability pursuant to the provisions of the Program Fraud Civil Remedies Act of 1986 (31 U.S.C. 3801-3812) and the NRC's implementing regulations (10 CFR part 13).</P>
                <HD SOURCE="HD1">VI. Regulatory Flexibility Act</HD>
                <P>
                    The Regulatory Flexibility Act does not apply to regulations for which a Federal agency is not required by law, including the rulemaking provisions of the Administrative Procedure Act, 5 U.S.C. 553(b), to publish a general notice of proposed rulemaking (5 U.S.C. 604). As discussed in this notice under Section III, “Rulemaking Procedure,” of this document, this final rule is exempt from the requirements of 5 U.S.C. 553(b) and notice and comment need not be provided. Accordingly, the NRC also determines that the requirements of the Regulatory Flexibility Act do not apply to this final rule.
                    <PRTPAGE P="3614"/>
                </P>
                <HD SOURCE="HD1">VII. Backfit and Issue Finality</HD>
                <P>The NRC has not prepared a backfit analysis for this final rule. This final rule does not involve any provision that would impose a backfit, nor is it inconsistent with any issue finality provision, as those terms are defined in 10 CFR chapter I. As mandated by Congress, this final rule increases CMP amounts for violations of already-existing NRC regulations and requirements. This final rule does not modify any licensee systems, structures, components, designs, approvals, or procedures required for the construction or operation of any facility.</P>
                <HD SOURCE="HD1">VIII. Plain Writing</HD>
                <P>The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31885).</P>
                <HD SOURCE="HD1">IX. National Environmental Policy Act</HD>
                <P>The NRC has determined that this final rule is the type of action described as a categorical exclusion in § 51.22(c)(1). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.</P>
                <HD SOURCE="HD1">X. Paperwork Reduction Act</HD>
                <P>
                    This final rule does not contain a collection of information as defined in the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) and, therefore, is not subject to the requirements of the Paperwork Reduction Act of 1995.
                </P>
                <HD SOURCE="HD1">XI. Congressional Review Act</HD>
                <P>This final rule is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>10 CFR Part 2</CFR>
                    <P>Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Confidential business information, Freedom of information, Environmental protection, Hazardous waste, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal.</P>
                    <CFR>10 CFR Part 13</CFR>
                    <P>Administrative practice and procedure, Claims, Fraud, Organization and function (Government agencies), Penalties.</P>
                </LSTSUB>
                <P>For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; 28 U.S.C. 2461 note; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 2 and 13:</P>
                <PART>
                    <HD SOURCE="HED">PART 2—AGENCY RULES OF PRACTICE AND PROCEDURE </HD>
                </PART>
                <REGTEXT TITLE="10" PART="2">
                    <AMDPAR>1. The authority citation for part 2 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> Atomic Energy Act of 1954, secs. 29, 53, 62, 63, 81, 102, 103, 104, 105, 161, 181, 182, 183, 184, 186, 189, 191, 234 (42 U.S.C. 2039, 2073, 2092, 2093, 2111, 2132, 2133, 2134, 2135, 2201, 2231, 2232, 2233, 2234, 2236, 2239, 2241, 2282); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); Nuclear Waste Policy Act of 1982, secs. 114(f), 134, 135, 141 (42 U.S.C. 10134(f), 10154, 10155, 10161); Administrative Procedure Act (5 U.S.C. 552, 553, 554, 557, 558); National Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note.</P>
                    </AUTH>
                    <EXTRACT>
                        <P>Section 2.205(j) also issued under Sec. 31001(s), Pub. L. 104-134, 110 Stat. 1321-373 (28 U.S.C. 2461 note).</P>
                    </EXTRACT>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 2.205</SECTNO>
                    <SUBJECT>[Amended] </SUBJECT>
                </SECTION>
                <REGTEXT TITLE="10" PART="2">
                    <AMDPAR>2. In § 2.205, amend paragraph (j) by removing the amount “$362,814” and adding in its place the amount “$372,240”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 13—PROGRAM FRAUD CIVIL REMEDIES </HD>
                </PART>
                <REGTEXT TITLE="10" PART="13">
                    <AMDPAR>3. The authority citation for part 13 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 31 U.S.C. 3801 through 3812; 44 U.S.C. 3504 note.</P>
                    </AUTH>
                    <EXTRACT>
                        <P>Section 13.3 also issued under 28 U.S.C. 2461 note.</P>
                        <P>Section 13.13 also issued under 31 U.S.C. 3730.</P>
                    </EXTRACT>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 13.3</SECTNO>
                    <SUBJECT>[Amended] </SUBJECT>
                </SECTION>
                <REGTEXT TITLE="10" PART="13">
                    <AMDPAR>4. In § 13.3, amend paragraphs (a)(1)(iv) and (b)(1)(ii) by removing the amount “$13,946” and adding in its place the amount “$14,308”.</AMDPAR>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>Mirela Gavrilas,</NAME>
                    <TITLE>Executive Director for Operations.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31471 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL RESERVE SYSTEM</AGENCY>
                <CFR>12 CFR Part 201</CFR>
                <DEPDOC>[Docket No. R-1862; RIN 7100-AG89]</DEPDOC>
                <SUBJECT>Regulation A: Extensions of Credit by Federal Reserve Banks</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Board of Governors of the Federal Reserve System.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Board of Governors of the Federal Reserve System (“Board”) has adopted final amendments to its Regulation A to reflect the Board's approval of a decrease in the rate for primary credit at each Federal Reserve Bank. The secondary credit rate at each Reserve Bank automatically decreased by formula as a result of the Board's primary credit rate action.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         This rule (amendments to part 201 (Regulation A)) is effective January 15, 2025.
                    </P>
                    <P>
                        <E T="03">Applicability date:</E>
                         The rate changes for primary and secondary credit were applicable on December 19, 2024.
                    </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>M. Benjamin Snodgrass, Senior Counsel (202-263-4877), Legal Division, or Kristen Payne, Lead Financial Institution &amp; Policy Analyst (202-306-9573), Division of Monetary Affairs; for users of telephone systems via text telephone (TTY) or any TTY-based Telecommunications Relay Services, please call 711 from any telephone, anywhere in the United States; Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Federal Reserve Banks make primary and secondary credit available to depository institutions as a backup source of funding on a short-term basis, usually overnight. The primary and secondary credit rates are the interest rates that the twelve Federal Reserve Banks charge for extensions of credit under these programs. In accordance with the Federal Reserve Act, the primary and secondary credit rates are established by the boards of directors of the Federal Reserve Banks, subject to review and determination of the Board.</P>
                <P>
                    On December 18, 2024, the Board voted to approve a 0.25 percentage point decrease in the primary credit rate, thereby decreasing the primary credit rate from 4.75 percent to 4.50 percent. In addition, the Board had previously approved the renewal of the secondary credit rate formula, the primary credit rate plus 50 basis points. Under the formula, the secondary credit rate 
                    <PRTPAGE P="3615"/>
                    decreased by 0.25 percentage points as a result of the Board's primary credit rate action, thereby decreasing the secondary credit rate from 5.25 percent to 5.00 percent. The amendments to Regulation A reflect these rate changes.
                </P>
                <P>
                    The 0.25 percentage point decrease in the primary credit rate was associated with a 0.25 percentage point decrease in the target range for the federal funds rate (from a target range of 4
                    <FR>1/2</FR>
                     percent to 4
                    <FR>3/4</FR>
                     percent to a target range of 4
                    <FR>1/4</FR>
                     percent to 4
                    <FR>1/2</FR>
                     percent) announced by the Federal Open Market Committee on December 18, 2024, as described in the Board's amendment of its Regulation D published elsewhere in today's 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">Administrative Procedure Act</HD>
                <P>
                    In general, the Administrative Procedure Act (“APA”) 
                    <SU>1</SU>
                    <FTREF/>
                     imposes three principal requirements when an agency promulgates legislative rules (rules made pursuant to Congressionally delegated authority): (1) publication with adequate notice of a proposed rule; (2) followed by a meaningful opportunity for the public to comment on the rule's content; and (3) publication of the final rule not less than 30 days before its effective date. The APA provides that notice and comment procedures do not apply if the agency for good cause finds them to be “unnecessary, impracticable, or contrary to the public interest.” 
                    <SU>2</SU>
                    <FTREF/>
                     Section 553(d) of the APA also provides that publication at least 30 days prior to a rule's effective date is not required for (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) a rule for which the agency finds good cause for shortened notice and publishes its reasoning with the rule.
                    <SU>3</SU>
                    <FTREF/>
                     The APA further provides that the notice, public comment, and delayed effective date requirements of 5 U.S.C. 553 do not apply “to the extent that there is involved . . . a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.” 
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         5 U.S.C. 551 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         5 U.S.C. 553(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         5 U.S.C. 553(d).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         5 U.S.C. 553(a)(2).
                    </P>
                </FTNT>
                <P>Regulation A establishes the interest rates that the twelve Reserve Banks charge for extensions of primary credit and secondary credit. The Board has determined that the notice, public comment, and delayed effective date requirements of the APA do not apply to these final amendments to Regulation A. The amendments involve a matter relating to loans and are therefore exempt under the terms of the APA. Furthermore, because delay would undermine the Board's action in responding to economic data and conditions, the Board has determined that “good cause” exists within the meaning of the APA to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to the final amendments to Regulation A.</P>
                <HD SOURCE="HD1">Regulatory Flexibility Analysis</HD>
                <P>
                    The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
                    <SU>5</SU>
                    <FTREF/>
                     As noted previously, a general notice of proposed rulemaking is not required if the final rule involves a matter relating to loans. Furthermore, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         5 U.S.C. 603, 604.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Paperwork Reduction Act</HD>
                <P>
                    In accordance with the Paperwork Reduction Act (“PRA”) of 1995,
                    <SU>6</SU>
                    <FTREF/>
                     the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         44 U.S.C. 3506; 
                        <E T="03">see</E>
                         5 CFR part 1320, appendix A.1.
                    </P>
                </FTNT>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 12 CFR Part 201</HD>
                    <P>Banks, banking, Federal Reserve System, Reporting and recordkeeping.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Authority and Issuance</HD>
                <P>For the reasons set forth in the preamble, the Board is amending 12 CFR chapter II as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 201—EXTENSIONS OF CREDIT BY FEDERAL RESERVE BANKS (REGULATION A)</HD>
                </PART>
                <REGTEXT TITLE="12" PART="201">
                    <AMDPAR>1. The authority citation for part 201 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                            12 U.S.C. 248(i)-(j), 343 
                            <E T="03">et seq.,</E>
                             347a, 347b, 347c, 348 
                            <E T="03">et seq.,</E>
                             357, 374, 374a, and 461.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="12" PART="201">
                    <AMDPAR>2. In § 201.51, paragraphs (a) and (b) are revised to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 201.51</SECTNO>
                        <SUBJECT>
                            Interest rates applicable to credit extended by a Federal Reserve Bank.
                            <SU>3</SU>
                        </SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Primary credit.</E>
                             The interest rate at each Federal Reserve Bank for primary credit provided to depository institutions under § 201.4(a) is 4.50 percent.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Secondary credit.</E>
                             The interest rate at each Federal Reserve Bank for secondary credit provided to depository institutions under § 201.4(b) is 5.00 percent.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <P>
                    <SU>3</SU>
                     The primary, secondary, and seasonal credit rates described in this section apply to both advances and discounts made under the primary, secondary, and seasonal credit programs, respectively.
                </P>
                <SIG>
                    <P>By order of the Board of Governors of the Federal Reserve System.</P>
                    <NAME>Ann E. Misback,</NAME>
                    <TITLE>Secretary of the Board.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00429 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6210-02-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL RESERVE SYSTEM</AGENCY>
                <CFR>12 CFR Part 204</CFR>
                <DEPDOC>[Docket No. R-1863; RIN 7100-AG90]</DEPDOC>
                <SUBJECT>Regulation D: Reserve Requirements of Depository Institutions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Board of Governors of the Federal Reserve System.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Board of Governors of the Federal Reserve System (“Board”) has adopted final amendments to its Regulation D to revise the rate of interest paid on balances (“IORB”) maintained at Federal Reserve Banks by or on behalf of eligible institutions. The final amendments specify that IORB is 4.4 percent, a 0.25 percentage point decrease from its prior level. The amendment is intended to enhance the role of IORB in maintaining the federal funds rate in the target range established by the Federal Open Market Committee (“FOMC” or “Committee”).</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         This rule (amendments to part 204 (Regulation D)) is effective January 15, 2025.
                    </P>
                    <P>
                        <E T="03">Applicability date:</E>
                         The IORB rate change was applicable on December 19, 2024.
                    </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        M. Benjamin Snodgrass, Senior Counsel (202-263-4877), Legal Division, or Kristen Payne, Lead Financial Institution &amp; Policy Analyst (202-306-9573); for users of telephone systems via text telephone (TTY) or any TTY-based Telecommunications Relay Services, please call 711 from any telephone, anywhere in the United States; Board of Governors of the Federal Reserve 
                        <PRTPAGE P="3616"/>
                        System, 20th and C Streets, NW, Washington, DC 20551.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Statutory and Regulatory Background</HD>
                <P>
                    For monetary policy purposes, section 19 of the Federal Reserve Act (“Act”) imposes reserve requirements on certain types of deposits and other liabilities of depository institutions.
                    <SU>1</SU>
                    <FTREF/>
                     Regulation D, which implements section 19 of the Act, requires that a depository institution meet reserve requirements by holding cash in its vault, or if vault cash is insufficient, by maintaining a balance in an account at a Federal Reserve Bank (“Reserve Bank”).
                    <SU>2</SU>
                    <FTREF/>
                     Section 19 also provides that balances maintained by or on behalf of certain institutions in an account at a Reserve Bank may receive earnings to be paid by the Reserve Bank at least once each quarter, at a rate or rates not to exceed the general level of short-term interest rates.
                    <SU>3</SU>
                    <FTREF/>
                     Institutions that are eligible to receive earnings on their balances held at Reserve Banks (“eligible institutions”) include depository institutions and certain other institutions.
                    <SU>4</SU>
                    <FTREF/>
                     Section 19 also provides that the Board may prescribe regulations concerning the payment of earnings on balances at a Reserve Bank.
                    <SU>5</SU>
                    <FTREF/>
                     Prior to these amendments, Regulation D established IORB at 4.65 percent.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         12 U.S.C. 461(b). In March 2020, the Board set all reserve requirement ratios to zero percent. See Interim Final Rule, 85 FR 16525 (Mar. 24, 2020); Final Rule, 86 FR 8853 (Feb. 10, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         12 CFR 204.5(a)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         12 U.S.C. 461(b)(1)(A) and (b)(12)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         See 12 U.S.C. 461(b)(1)(A) &amp; (b)(12)(C); 
                        <E T="03">see</E>
                         also 12 CFR 204.2(y).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         See 12 U.S.C. 461(b)(12)(B).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         See 12 CFR 204.10(b)(1).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Amendment to IORB</HD>
                <P>
                    The Board is amending § 204.10(b)(1) of Regulation D to establish IORB at 4.4 percent. The amendment represents a 0.25 percentage point decrease in IORB. This decision was announced on December 18, 2024, with an effective date of December 19, 2024, in the Federal Reserve Implementation Note that accompanied the FOMC's statement on December 18, 2024. The FOMC statement stated that the Committee decided to lower the target range for the federal funds rate to 4
                    <FR>1/4</FR>
                     to 4
                    <FR>1/2</FR>
                     percent.
                </P>
                <P>The Federal Reserve Implementation Note stated:</P>
                <EXTRACT>
                    <P>The Board of Governors of the Federal Reserve System voted unanimously to lower the interest rate paid on reserve balances to 4.4 percent, effective December 19, 2024.</P>
                </EXTRACT>
                <P>As a result, the Board is amending § 204.10(b)(1) of Regulation D to establish IORB at 4.4 percent.</P>
                <HD SOURCE="HD1">III. Administrative Procedure Act</HD>
                <P>
                    In general, the Administrative Procedure Act (“APA”) 
                    <SU>7</SU>
                    <FTREF/>
                     imposes three principal requirements when an agency promulgates legislative rules (rules made pursuant to Congressionally-delegated authority): (1) publication with adequate notice of a proposed rule; (2) followed by a meaningful opportunity for the public to comment on the rule's content; and (3) publication of the final rule not less than 30 days before its effective date. The APA provides that notice and comment procedures do not apply if the agency for good cause finds them to be “unnecessary, impracticable, or contrary to the public interest.” 
                    <SU>8</SU>
                    <FTREF/>
                     Section 553(d) of the APA also provides that publication at least 30 days prior to a rule's effective date is not required for (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) a rule for which the agency finds good cause for shortened notice and publishes its reasoning with the rule.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         5 U.S.C. 551 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         5 U.S.C. 553(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         5 U.S.C. 553(d).
                    </P>
                </FTNT>
                <P>The Board has determined that good cause exists for finding that the notice, public comment, and delayed effective date provisions of the APA are unnecessary, impracticable, or contrary to the public interest with respect to these final amendments to Regulation D. The rate change for IORB that is reflected in the final amendment to Regulation D was made with a view towards accommodating commerce and business and with regard to their bearing upon the general credit situation of the country. Notice and public comment would prevent the Board's action from being effective as promptly as necessary in the public interest and would not otherwise serve any useful purpose. Notice, public comment, and a delayed effective date would create uncertainty about the finality and effectiveness of the Board's action and undermine the effectiveness of that action. Accordingly, the Board has determined that good cause exists to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to this final amendment to Regulation D.</P>
                <HD SOURCE="HD1">IV. Regulatory Flexibility Analysis</HD>
                <P>
                    The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
                    <SU>10</SU>
                    <FTREF/>
                     As noted previously, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         5 U.S.C. 603, 604.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">V. Paperwork Reduction Act</HD>
                <P>
                    In accordance with the Paperwork Reduction Act (“PRA”) of 1995,
                    <SU>11</SU>
                    <FTREF/>
                     the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         44 U.S.C. 3506; see 5 CFR part 1320 Appendix A.1.
                    </P>
                </FTNT>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 12 CFR Part 204</HD>
                    <P>Banks, Banking, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Authority and Issuance</HD>
                <P>For the reasons set forth in the preamble, the Board amends 12 CFR part 204 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 204—RESERVE REQUIREMENTS OF DEPOSITORY INSTITUTIONS (REGULATION D)</HD>
                </PART>
                <REGTEXT TITLE="12" PART="204">
                    <AMDPAR>1. The authority citation for part 204 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>12 U.S.C. 248(a), 248(c), 461, 601, 611, and 3105.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="12" PART="204">
                    <AMDPAR>2. Section 204.10 is amended by revising paragraph (b)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 204.10</SECTNO>
                        <SUBJECT>Payment of interest on balances.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) For balances maintained in an eligible institution's master account, interest is the amount equal to the interest on reserve balances rate (“IORB rate”) on a day multiplied by the total balances maintained on that day. The IORB rate is 4.4 percent.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <P>By order of the Board of Governors of the Federal Reserve System.</P>
                    <NAME>Ann E. Misback,</NAME>
                    <TITLE>Secretary of the Board.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00430 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6210-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="3617"/>
                <AGENCY TYPE="N">FARM CREDIT ADMINISTRATION</AGENCY>
                <CFR>12 CFR Part 622</CFR>
                <RIN>RIN 3052-AD64</RIN>
                <SUBJECT>Rules of Practice and Procedure; Adjusting Civil Money Penalties for Inflation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Farm Credit Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This regulation implements inflation adjustments to civil money penalties (CMPs) that the Farm Credit Administration (FCA) may impose or enforce pursuant to the Farm Credit Act of 1971, as amended (Farm Credit Act), and pursuant to the Flood Disaster Protection Act of 1973, as amended by the National Flood Insurance Reform Act of 1994, and further amended by the Biggert-Waters Flood Insurance Reform Act of 2012 (Biggert-Waters Act) (collectively FDPA, as amended).</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This regulation is effective on January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>Brian Camp, Accountant, Office of Regulatory Policy, Farm Credit Administration, (703) 883-4320, TTY (703) 883-4056, Or</P>
                    <P>Heather LoPresti, Senior Counsel, Office of General Counsel, Farm Credit Administration, (703) 883-4318, TTY (703) 883-4056.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Objective</HD>
                <P>The objective of this regulation is to adjust the maximum CMPs for inflation through a final rulemaking to retain the deterrent effect of such penalties.</P>
                <HD SOURCE="HD1">II. Background</HD>
                <HD SOURCE="HD2">A. Introduction</HD>
                <P>
                    The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 (1996 Act) and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act) (collectively, 1990 Act, as amended), requires all Federal agencies with the authority to enforce CMPs to evaluate and adjust, if necessary, those CMPs each year to ensure that they continue to maintain their deterrent value and promote compliance with the law. Section 3(2) of the 1990 Act, as amended, defines a civil monetary penalty 
                    <SU>1</SU>
                    <FTREF/>
                     as any penalty, fine, or other sanction that: (1) either is for a specific monetary amount as provided by Federal law or has a maximum amount provided for by Federal law; (2) is assessed or enforced by an agency pursuant to Federal law; and (3) is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal courts.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         While the 1990 Act, as amended by the 1996 and 2015 Acts, uses the term “civil monetary penalties” for these penalties or other sanctions, the Farm Credit Act and FCA regulations use the term “civil money penalties.” Both terms have the same meaning. Accordingly, this rule uses the term civil money penalty, and both terms may be used interchangeably.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         28 U.S.C. 2461 
                        <E T="03">note.</E>
                    </P>
                </FTNT>
                <P>
                    The FCA imposes and enforces CMPs through the Farm Credit Act 
                    <SU>3</SU>
                    <FTREF/>
                     and the FDPA, as amended.
                    <SU>4</SU>
                    <FTREF/>
                     FCA's regulations governing CMPs are found in 12 CFR parts 622 and 623. Part 622 establishes rules of practice and procedure applicable to formal and informal hearings held before the FCA, and to formal investigations conducted under the Farm Credit Act. Part 623 prescribes rules regarding persons who may practice before the FCA and the circumstances under which such persons may be suspended or debarred from practice before the FCA.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Public Law 92-181, as amended.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         42 U.S.C. 4012a and Public Law 103-325, title V, 108 Stat. 2160, 2255-87 (September 23, 1994).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. CMPs Issued Under the Farm Credit Act</HD>
                <P>
                    Section 5.32(a) of the Farm Credit Act provides that any Farm Credit System (System) institution or any officer, director, employee, agent, or other person participating in the conduct of the affairs of a System institution who violates the terms of an order that has become final pursuant to section 5.25 or 5.26 of the Farm Credit Act must pay a maximum daily amount of $1,000,
                    <SU>5</SU>
                    <FTREF/>
                     for each day such violation continues. This CMP maximum was set by the Farm Credit Amendments Act of 1985, which amended the Farm Credit Act. Orders issued by the FCA under section 5.25 or 5.26 of the Farm Credit Act include temporary and permanent cease-and-desist orders. In addition, section 5.32(h) of the Farm Credit Act provides that any directive issued under sections 4.3(b)(2), 4.3A(e), or 4.14A(i) of the Farm Credit Act “shall be treated” as a final order issued under section 5.25 of the Farm Credit Act for purposes of assessing a CMP.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The inflation-adjusted CMP in effect on January 15, 2024, for a violation of a final order is $2,830 per day, as set forth in § 622.61(a)(1) of FCA regulations.
                    </P>
                </FTNT>
                <P>
                    Section 5.32(a) of the Farm Credit Act also states that “[a]ny such institution or person who violates any provision of the [Farm Credit] Act or any regulation issued under this Act shall forfeit and pay a civil penalty of not more than $500 
                    <SU>6</SU>
                    <FTREF/>
                     per day for each day during which such violation continues.” This CMP maximum was set by section 423 of the Agricultural Credit Act of 1987, which was enacted in 1988 and amended the Farm Credit Act. Current inflation-adjusted CMP maximums are set forth in existing § 622.61 of FCA regulations.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         The inflation-adjusted CMP in effect on January 15, 2024, for a violation of the Farm Credit Act or a regulation issued under the Farm Credit Act is $1,280 per day for each violation, as set forth in § 622.61(a)(2) of FCA regulations.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Prior adjustments were made under the 1990 Act and continue to be made each year.
                    </P>
                </FTNT>
                <P>
                    The FCA also enforces the FDPA, as amended, which requires FCA to assess CMPs for a pattern or practice of committing certain specific actions in violation of the National Flood Insurance Program. The FDPA states that the maximum CMP for a violation of that Act is $2,000.
                    <E T="51">8 9</E>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Public Law 112-141, 126 Stat. 405 (July 6, 2012); 42 U.S.C. 4012a(f)(5).
                    </P>
                    <P>
                        <SU>9</SU>
                         The inflation-adjusted CMP in effect on January 15, 2024, for a flood insurance violation is $2,661, as set forth in § 622.61(b) of FCA regulations.
                    </P>
                </FTNT>
                  
                <HD SOURCE="HD2">C. Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015</HD>
                <HD SOURCE="HD3">1. In General</HD>
                <P>The 2015 Act required all Federal agencies to adjust the CMPs yearly, starting January 15, 2017.</P>
                <P>
                    Under section 4(b) of the 1990 Act, as amended, annual adjustments are to be made no later than January 15.
                    <SU>10</SU>
                    <FTREF/>
                     Section 6 of the 1990 Act, as amended, states that any increase to a civil monetary penalty under this 1990 Act applies only to civil monetary penalties, including instances in which an associated violation predated the annual increase, which are assessed after the date the increase takes effect.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Public Law 114-74, sec. 701(b)(1).
                    </P>
                </FTNT>
                <P>
                    Section 5(b) of the 1990 Act, as amended, defines the term “cost-of-living adjustment” as the percentage (if any) for each civil monetary penalty by which (1) the Consumer Price Index (CPI) for the month of October of the calendar year preceding the adjustment, exceeds (2) the CPI for the month of October one year before the month of October referred to in (1) of the calendar year in which the amount of such civil monetary penalty was last set or adjusted pursuant to law.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         The CPI is published by the Department of Labor, Bureau of Statistics, and is available at its website: 
                        <E T="03">https://www.bls.gov/cpi/.</E>
                    </P>
                </FTNT>
                <P>
                    The increase for each CMP adjusted for inflation must be rounded using a method prescribed by section 5(a) of the 
                    <PRTPAGE P="3618"/>
                    1990 Act, as amended, by the 2015 Act.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Pursuant to section 5(a)(3) of the 2015 Act, any increase determined under the subsection shall be rounded to the nearest $1.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Other Adjustments</HD>
                <P>
                    If a civil monetary penalty is subject to a cost-of-living adjustment under the 1990 Act, as amended, but is adjusted to an amount greater than the amount of the adjustment required under the Act within the 12 months preceding a required cost-of-living adjustment, the agency is not required to make the cost-of-living adjustment to that CMP in that calendar year.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Pursuant to section 4(d) of the 1990 Act, as amended.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Yearly Adjustments</HD>
                <HD SOURCE="HD2">A. Mathematical Calculations of 2025 Adjustments</HD>
                <P>
                    The adjustment requirement affects two provisions of section 5.32(a) of the Farm Credit Act. For the 2025 yearly adjustments to the CMPs set forth by the Farm Credit Act, the calculation required by the 2024 White House Office of Management and Budget (OMB) guidance 
                    <SU>14</SU>
                    <FTREF/>
                     is based on the percentage by which the CPI for October 2024 exceeds the CPI for October 2023. The OMB set forth guidance, as required by the 2015 Act,
                    <SU>15</SU>
                    <FTREF/>
                     with a multiplier for calculating the new CMP values.
                    <SU>16</SU>
                    <FTREF/>
                     The 2024 OMB multiplier for the 2025 CMPs is 1.02598.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         OMB Circular M-25-02, Implementation of Penalty Inflation Adjustments for 2025, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         28 U.S.C. 2461 
                        <E T="03">note,</E>
                         section 7(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         OMB Circular M-25-02, Implementation of Penalty Inflation Adjustments for 2025, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
                    </P>
                </FTNT>
                <P>The adjustment also affects the CMPs set by the Flood Disaster Protection Act of 1973, as amended. The adjustment multiplier is the same for all FCA enforced CMPs, set at 1.02598. The maximum CMPs for violations were created in 2012 by the Biggert-Waters Act, which amended the Flood Disaster Protection Act of 1973.</P>
                <HD SOURCE="HD3">1. New Penalty Amount in § 622.61(a)(1)</HD>
                <P>
                    The inflation-adjusted CMP currently in effect for violations of a final order occurring on or after January 15, 2024, is a maximum daily amount of $2,830.
                    <SU>17</SU>
                    <FTREF/>
                     Multiplying the $2,830 CMP by the 2024 OMB multiplier, 1.02598, yields a total of $2,903.52. When that number is rounded as required by section 5(a) of the 1990 Act, as amended, the inflation-adjusted maximum increases to $2,904. Thus, the new CMP maximum is $2,904, for violations that occur on or after January 15, 2025.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         12 CFR 622.61(a)(1).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. New Penalty Amount in § 622.61(a)(2)</HD>
                <P>
                    The inflation-adjusted CMP currently in effect for violations of the Farm Credit Act or regulations issued under the Farm Credit Act occurring on or after January 15, 2024, is a maximum daily amount of $1,280.
                    <SU>18</SU>
                    <FTREF/>
                     Multiplying the $1,280 CMP maximum by the 2024 OMB multiplier, 1.02598, yields a total of $1,313.25. When that number is rounded as required by section 5(a) of the 1990 Act, as amended the inflation-adjusted maximum increases to $1,313. Thus, the new CMP maximum is $1,313, for violations that occur on or after January 15, 2025.
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         12 CFR 622.61(a)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. New Penalty Amounts for Flood Insurance Violations Under § 622.61(b)</HD>
                <P>The existing maximum CMP for a pattern or practice of flood insurance violations pursuant to 42 U.S.C. 4012a(f)(5) occurring on or after January 15, 2024, is $2,661. Multiplying $2,661 by the 2024 OMB multiplier, 1.02598, yields a total of $2,730.13. When that number is rounded as required by section 5(a) of the 1990 Act, as amended, the new maximum assessment of the CMP for violating 42 U.S.C. 4012a(f)(5) is $2,730. Thus, the new CMP maximum is $2,730, for violations that occur on or after January 15, 2025.</P>
                <HD SOURCE="HD1">IV. Notice and Comment Not Required by the Administrative Procedure Act</HD>
                <P>Section 4(b)(2) of the 1990 Act, as amended by section 701 of the 2015 Act (28 U.S.C. 2461 note), provides an exemption from the Administrative Procedure Act notice and comment requirements in 5 U.S.C. 553. Further, these revisions are ministerial, technical, and noncontroversial. For these reasons, the FCA has determined to adopt this rule in final form.</P>
                <HD SOURCE="HD1">V. Regulatory Flexibility Act</HD>
                <P>
                    Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ), the FCA hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. Each of the banks in the System, considered together with its affiliated associations, has assets and annual income in excess of the amounts that would qualify them as small entities. Therefore, System institutions are not “small entities” as defined in the Regulatory Flexibility Act.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 12 CFR Part 622</HD>
                    <P>Administrative practice and procedure, Crime, Investigations, Penalties.</P>
                </LSTSUB>
                <P>For the reasons stated in the preamble, part 622 of chapter VI, title 12 of the Code of Federal Regulations is amended to read as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 622—RULES OF PRACTICE AND PROCEDURE</HD>
                </PART>
                <REGTEXT TITLE="12" PART="622">
                    <AMDPAR>1. The authority citation for part 622 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> Secs. 5.9, 5.10, 5.17, 5.25-5.37 of the Farm Credit Act (12 U.S.C. 2243, 2244, 2252, 2261-2273); 28 U.S.C. 2461 note; and 42 U.S.C. 4012a(f).</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="12" PART="622">
                    <AMDPAR>2. Revise § 622.61 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 622.61</SECTNO>
                        <SUBJECT>Adjustment of civil money penalties by the rate of inflation under the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended.</SUBJECT>
                        <P>
                            (a) The maximum amount of each civil money penalty within FCA's jurisdiction is adjusted in accordance with the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended (28 U.S.C. 2461 
                            <E T="03">note</E>
                            ), as follows:
                        </P>
                        <P>(1) Amount of civil money penalty imposed under section 5.32 of the Act for violation of a final order issued under section 5.25 or 5.26 of the Act: The maximum daily amount is $2,904 for violations that occur on or after January 15, 2025.</P>
                        <P>(2) Amount of civil money penalty for violation of the Act or regulations: the maximum daily amount is $1,313 for each violation that occurs on or after January 15, 2025.</P>
                        <P>(b) The maximum civil money penalty amount assessed under 42 U.S.C. 4012a(f) is $2,730 for each violation that occurs on or after January 15, 2025, with no cap on the total amount of penalties that can be assessed against any single institution during any calendar year.</P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Ashley Waldron,</NAME>
                    <TITLE>Secretary to the Board, Farm Credit Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00963 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6705-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL CREDIT UNION ADMINISTRATION</AGENCY>
                <CFR>12 CFR Part 747</CFR>
                <RIN>RIN 3133-AF65</RIN>
                <SUBJECT>Civil Monetary Penalty Inflation Adjustment</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Credit Union Administration (NCUA).</P>
                </AGY>
                <ACT>
                    <PRTPAGE P="3619"/>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The NCUA Board (Board) is amending its regulations to adjust the maximum amount of each civil monetary penalty (CMP) within its jurisdiction to account for inflation. This action, including the amount of the adjustments, is required under the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Gira Bose, Senior Staff Attorney, at 1775 Duke Street, Alexandria, VA 22314, via email at 
                        <E T="03">gbose@ncua.gov,</E>
                         or by telephone at (703) 518-6562.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Legal Background</FP>
                    <FP SOURCE="FP-2">II. Regulatory Procedures </FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Legal Background</HD>
                <HD SOURCE="HD2">A. Statutory Requirements</HD>
                <P>
                    Every Federal agency, including the NCUA, is required by law to adjust its maximum CMP amounts each year to account for inflation. Prior to this being an annual requirement, agencies were required to adjust their CMPs at least once every four years. The previous four-year requirement stemmed from the Debt Collection Improvement Act of 1996,
                    <SU>1</SU>
                    <FTREF/>
                     which amended the Federal Civil Penalties Inflation Adjustment Act of 1990.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Public Law 104-134, Sec. 31001(s), 110 Stat. 1321-373 (Apr. 26, 1996). The law is codified at 28 U.S.C. 2461 note.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Public Law 101-410, 104 Stat. 890 (Oct. 5, 1990), codified at 28 U.S.C. 2461 note.
                    </P>
                </FTNT>
                <P>
                    The current annual requirement stems from the Bipartisan Budget Act of 2015,
                    <SU>3</SU>
                    <FTREF/>
                     which contains the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 amendments).
                    <SU>4</SU>
                    <FTREF/>
                     This legislation provided for an initial “catch-up” adjustment of CMPs in 2016, followed by annual adjustments. The catch-up adjustment reset CMP maximum amounts by setting aside the inflation adjustments that agencies made in prior years and instead calculated inflation with reference to the year when each CMP was enacted or last modified by Congress. Agencies were required to publish their catch-up adjustments in an interim final rule by July 1, 2016, and make them effective by August 1, 2016.
                    <SU>5</SU>
                    <FTREF/>
                     The NCUA complied with these requirements in a June 2016 interim final rule, followed by a November 2016 final rule to confirm the adjustments as final.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Public Law 114-74, 129 Stat. 584 (Nov. 2, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         129 Stat. 599.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Public Law 114-74, Sec. 701(b)(1), 129 Stat. 584, 599 (Nov. 2, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         81 FR 40152 (June 21, 2016); 81 FR 78028 (Nov. 7, 2016).
                    </P>
                </FTNT>
                <P>
                    The 2015 amendments also specified how agencies must conduct annual inflation adjustments after the 2016 catch-up adjustment. Following the catch-up adjustment, agencies must make the required adjustments and publish them in the 
                    <E T="04">Federal Register</E>
                     by January 15 each year.
                    <SU>7</SU>
                    <FTREF/>
                     For 2017, the NCUA issued an interim final rule on January 6, 2017,
                    <SU>8</SU>
                    <FTREF/>
                     followed by a final rule issued on June 23, 2017.
                    <SU>9</SU>
                    <FTREF/>
                     For each of the years 2018 through 2024, the NCUA issued a final rule to satisfy the agency's annual requirements.
                    <SU>10</SU>
                    <FTREF/>
                     This final rule satisfies the agency's requirement for the 2025 annual adjustment.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Public Law 114-74, Sec. 701(b)(1), 129 Stat. 584, 599 (Nov. 2, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         82 FR 7640 (Jan. 23, 2017).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         82 FR 29710 (June 30, 2017).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         83 FR 2029 (Jan. 16, 2018); 84 FR 2052 (Feb. 6, 2019); 85 FR 2009 (Jan. 14, 2020); 86 FR 933 (Jan. 7, 2021); 87 FR 377 (Jan. 5, 2022); 88 FR 1323 (Jan. 10, 2023); 89 FR 1441 (Jan. 10, 2024).
                    </P>
                </FTNT>
                <P>
                    The law provides that the adjustments shall be made notwithstanding the section of the Administrative Procedure Act (APA) that requires prior notice and public comment for agency rulemaking.
                    <SU>11</SU>
                    <FTREF/>
                     The 2015 amendments also specify that each CMP maximum must be increased by the percentage by which the consumer price index for urban consumers (CPI-U) 
                    <SU>12</SU>
                    <FTREF/>
                     for October of the year immediately preceding the year the adjustment is made exceeds the CPI-U for October of the prior year.
                    <SU>13</SU>
                    <FTREF/>
                     Thus, for the adjustment to be made in 2025, an agency must compare the October 2023 and October 2024 CPI-U figures.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Public Law 114-74, Sec. 701(b)(1), 129 Stat. 584, 599 (Nov. 2, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         This index is published by the Department of Labor, Bureau of Labor Statistics, and is available at its website: 
                        <E T="03">https://www.bls.gov/cpi/.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Public Law 114-74, Sec. 701(b)(2)(B), 129 Stat. 584, 600 (Nov. 2, 2015).
                    </P>
                </FTNT>
                <P>
                    An annual adjustment under the 2015 amendments is not required if a CMP has been amended in the preceding 12 months pursuant to other authority. Specifically, the statute provides that an agency is not required to make an annual adjustment to a CMP if in the preceding 12 months it has been increased by an amount greater than the annual adjustment required by the 2015 amendments.
                    <SU>14</SU>
                    <FTREF/>
                     The NCUA did not make any adjustments in the preceding 12 months pursuant to other authority. Therefore, this rulemaking adjusts all of the NCUA's CMPs pursuant to the 2015 amendments.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Public Law 114-74, Sec. 701(b)(1), 129 Stat. 584, 600 (Nov. 2, 2015).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Application to the 2025 Adjustments and Office of Management and Budget Guidance</HD>
                <P>This section applies the statutory requirements and the Office of Management and Budget's (OMB) guidance to the NCUA's CMPs and sets forth the Board's calculation of the 2025 adjustments.</P>
                <P>
                    The 2015 amendments directed OMB to issue guidance to agencies on implementing the inflation adjustments.
                    <SU>15</SU>
                    <FTREF/>
                     OMB is required to issue its guidance each December and, with respect to the 2025 annual adjustment, did so on December 17, 2024.
                    <SU>16</SU>
                    <FTREF/>
                     For 2025, Federal agencies must adjust the maximum amounts of their CMPs by the percentage by which the October 2024 CPI-U (315.664) exceeds the October 2023 CPI-U (307.671). The resulting increase can be expressed as an inflation multiplier (1.02598) to apply to each current CMP maximum amount to determine the adjusted maximum. The OMB guidance also addresses rulemaking procedures and agency reporting and oversight requirements for CMPs.
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         Public Law 114-74, Sec. 701(b)(4), 129 Stat. 584, 601 (Nov. 2, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See</E>
                         OMB Memorandum M-25-02, Implementation of Penalty Inflation Adjustments for 2025, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Dec. 17, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    The following table presents the adjustment calculations. The current maximums are found at 12 CFR 747.1001, as adjusted by the final rule that the Board approved in January 2024. This amount is multiplied by the inflation multiplier to calculate the new maximum in the far-right column. Only these adjusted maximum amounts, and not the calculations, will be codified at 12 CFR 747.1001 under this final rule. The adjusted amounts will be effective upon publication in the 
                    <E T="04">Federal Register</E>
                     and can be applied to violations that occurred on or after November 2, 2015, the date the 2015 amendments were enacted.
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         Public Law 114-74, 129 Stat. 600 (Nov. 2, 2015).
                    </P>
                </FTNT>
                <PRTPAGE P="3620"/>
                <GPOTABLE COLS="5" OPTS="L2,nj,p7,7/8,i1" CDEF="s30,r50,r25,12,r25">
                    <TTITLE>Table—Calculation of Maximum CMP Adjustments</TTITLE>
                    <BOXHD>
                        <CHED H="1">Citation</CHED>
                        <CHED H="1">
                            Description and tier 
                            <SU>19</SU>
                        </CHED>
                        <CHED H="1">
                            Current maximum
                            <LI>($)</LI>
                        </CHED>
                        <CHED H="1">Multiplier</CHED>
                        <CHED H="1">
                            Adjusted maximum
                            <LI>($)</LI>
                            <LI>(current maximum</LI>
                            <LI>X multiplier, rounded to</LI>
                            <LI>nearest dollar)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1782(a)(3)</ENT>
                        <ENT>Inadvertent failure to submit a report or the inadvertent submission of a false or misleading report</ENT>
                        <ENT>4,899</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>5,026.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1782(a)(3)</ENT>
                        <ENT>Non-inadvertent failure to submit a report or the non-inadvertent submission of a false or misleading report</ENT>
                        <ENT>48,992</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>50,265.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1782(a)(3)</ENT>
                        <ENT>Failure to submit a report or the submission of a false or misleading report done knowingly or with reckless disregard</ENT>
                        <ENT>Lesser of 2,449,575 or 1% of total credit union (CU) assets</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>Lesser of 2,513,215 or 1% of total CU assets.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1782(d)(2)(A)</ENT>
                        <ENT>Tier 1 CMP for inadvertent failure to submit certified statement of insured shares and charges due to the National Credit Union Share Insurance Fund (NCUSIF), or inadvertent submission of false or misleading statement</ENT>
                        <ENT>4,480</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>4,596.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1782(d)(2)(B)</ENT>
                        <ENT>Tier 2 CMP for non-inadvertent failure to submit certified statement or submission of false or misleading statement</ENT>
                        <ENT>44,783</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>45,946.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1782(d)(2)(C)</ENT>
                        <ENT>Tier 3 CMP for failure to submit a certified statement or the submission of a false or misleading statement done knowingly or with reckless disregard</ENT>
                        <ENT>Lesser of 2,239,210 or 1% of total CU assets</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>Lesser of 2,297,385 or 1% of total CU assets.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1785(a)(3)</ENT>
                        <ENT>Non-compliance with insurance logo requirements</ENT>
                        <ENT>153</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>157.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1785(e)(3)</ENT>
                        <ENT>Non-compliance with NCUA security requirements</ENT>
                        <ENT>356</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>365.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1786(k)(2)(A)</ENT>
                        <ENT>Tier 1 CMP for violations of law, regulation, and other orders or agreements</ENT>
                        <ENT>12,249</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>12,567.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1786(k)(2)(B)</ENT>
                        <ENT>Tier 2 CMP for violations of law, regulation, and other orders or agreements and for recklessly engaging in unsafe or unsound practices or breaches of fiduciary duty</ENT>
                        <ENT>61,238</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>62,829.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1786(k)(2)(C)</ENT>
                        <ENT>Tier 3 CMP for knowingly committing the violations under Tier 1 or 2 (natural person)</ENT>
                        <ENT>2,449,575</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>2,513,215.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1786(k)(2)(C)</ENT>
                        <ENT>Tier 3 CMP for knowingly committing the violations under Tier 1 or 2 (insured credit union)</ENT>
                        <ENT>Lesser of 2,449,575 or 1% of total CU assets</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>Lesser of 2,513,215 or 1% of total CU assets.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12 U.S.C. 1786(w)(5)(A)(ii)</ENT>
                        <ENT>Non-compliance with senior examiner post-employment restrictions</ENT>
                        <ENT>402,920</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>413,388.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">15 U.S.C. 1639e(k)</ENT>
                        <ENT>Non-compliance with appraisal independence standards (first violation)</ENT>
                        <ENT>14,069</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>14,435.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">15 U.S.C. 1639e(k)</ENT>
                        <ENT>Subsequent violations of the same</ENT>
                        <ENT>28,135</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>28,866.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">42 U.S.C. 4012a(f)(5)</ENT>
                        <ENT>Non-compliance with flood insurance requirements</ENT>
                        <ENT>2,661</ENT>
                        <ENT>1.02598</ENT>
                        <ENT>2,730.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">
                    II. Regulatory Procedures
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         The table uses condensed descriptions of CMP tiers. Refer to the U.S. Code citations for complete descriptions.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">A. Final Rule Under the APA</HD>
                <P>
                    In the 2015 amendments, Congress provided that agencies shall make the required inflation adjustments in 2017 and subsequent years notwithstanding 5 U.S.C. 553, which generally requires agencies to follow notice-and-comment procedures in rulemaking and to make rules effective no sooner than 30 days after publication in the 
                    <E T="04">Federal Register</E>
                    .
                    <SU>20</SU>
                    <FTREF/>
                     The 2015 amendments provide a clear exception to these requirements.
                    <SU>21</SU>
                    <FTREF/>
                     In addition, the Board finds that notice-and-comment procedures would be impracticable and unnecessary under the APA because of the largely ministerial and technical nature of the final rule, which affords agencies limited discretion in promulgating the rule, and the statutory deadline for making the adjustments.
                    <SU>22</SU>
                    <FTREF/>
                     In these circumstances, the Board finds good cause to issue a final rule without issuing a notice of proposed rulemaking or soliciting public comments. The Board also finds good cause to make the final rule effective upon publication because of the statutory deadline. Accordingly, this final rule is issued without prior notice and comment and will become effective immediately upon publication.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         Public Law 114-74, Sec. 701(b)(1), 129 Stat. 584, 599 (Nov. 2, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         5 U.S.C. 559; 
                        <E T="03">Asiana Airlines</E>
                         v. 
                        <E T="03">Fed. Aviation Admin.,</E>
                         134 F.3d 393, 396-99 (D.C. Cir. 1998).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         5 U.S.C. 553(b)(3)(B); 
                        <E T="03">see Mid-Tex. Elec. Co-op., Inc.</E>
                         v. 
                        <E T="03">Fed. Energy Regulatory Comm'n,</E>
                         822 F.2d 1123 (D.C. Cir. 1987). For the same reasons, this final rule does not include the usual 60-day comment period under NCUA Interpretive Ruling and Policy Statement (IRPS) 87-2, as amended by IRPS 03-2 and 15-1 (Sept. 24, 2015).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Regulatory Flexibility Act</HD>
                <P>
                    The Regulatory Flexibility Act (RFA) generally requires that when an agency issues a proposed rule or a final rule pursuant to the APA 
                    <SU>23</SU>
                    <FTREF/>
                     or another law, the agency must prepare a regulatory flexibility analysis that meets the requirements of the RFA and publish such analysis in the 
                    <E T="04">Federal Register</E>
                    .
                    <SU>24</SU>
                    <FTREF/>
                     Specifically, the RFA normally requires agencies to describe the impact of a rulemaking on small entities by providing a regulatory impact analysis. For purposes of the RFA, the Board considers federally insured credit unions with assets less than $100 million to be small entities.
                    <SU>25</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         5 U.S.C. 553(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         5 U.S.C. 603, 604.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         NCUA IRPS 15-1.
                    </P>
                </FTNT>
                <P>
                    As discussed previously, consistent with the APA, the Board has determined for good cause that general notice and opportunity for public comment is unnecessary, and therefore the Board is not issuing a notice of proposed rulemaking.
                    <SU>26</SU>
                    <FTREF/>
                     Rules that are exempt from notice and comment procedures are also exempt from the RFA requirements, including conducting a regulatory flexibility analysis, when among other things the agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest.
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         5 U.S.C. 553(b)(3)(B).
                    </P>
                </FTNT>
                <P>
                    Accordingly, the Board has concluded that the RFA's requirements relating to 
                    <PRTPAGE P="3621"/>
                    initial and final regulatory flexibility analysis do not apply.
                </P>
                <P>
                    Nevertheless, the Board notes that this final rule will not have a significant economic impact on a substantial number of small credit unions because it affects only the maximum amounts of CMPs that may be assessed in individual cases, which are not numerous and generally do not involve assessments at the maximum level. In addition, several of the CMPs are limited to a percentage of a credit union's assets. Finally, in assessing CMPs, the Board generally must consider a party's financial resources.
                    <SU>27</SU>
                    <FTREF/>
                     Because this final rule will affect few, if any, small credit unions, the Board certifies that the final rule will not have a significant economic impact on a substantial number of small entities.
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         12 U.S.C. 1786(k)(2)(G)(i).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Paperwork Reduction Act</HD>
                <P>
                    The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency creates a new paperwork burden on regulated entities or modifies an existing burden.
                    <SU>28</SU>
                    <FTREF/>
                     For purposes of the PRA, a paperwork burden may take the form of either a reporting or a recordkeeping requirement, both referred to as information collections. This final rule adjusts the maximum amounts of certain CMPs that the Board may assess against individuals, entities, or credit unions but does not require any reporting or recordkeeping. Therefore, this final rule will not create new paperwork burdens or modify any existing paperwork burdens.
                </P>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         44 U.S.C. 3507(d); 5 CFR part 1320.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. Executive Order 13132</HD>
                <P>Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. In adherence to fundamental federalism principles, the NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order. This final rule adjusts the maximum amounts of certain CMPs that the Board may assess against individuals, entities, and federally insured credit unions, including state-chartered credit unions. However, the final rule does not create any new authority or alter the underlying statutory authorities that enable the Board to assess CMPs. Accordingly, this final rule will not have a substantial direct effect on the states, on the connection between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The Board has determined that this final rule does not constitute a policy that has federalism implications for purposes of the executive order.</P>
                <HD SOURCE="HD2">E. Assessment of Federal Regulations and Policies on Families</HD>
                <P>
                    The Board has determined that this final rule will not affect family well-being within the meaning of Section 654 of the Treasury and General Government Appropriations Act, 1999.
                    <SU>29</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Public Law 105-277, 112 Stat. 2681 (Oct. 21, 1998).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">F. Congressional Review Act</HD>
                <P>
                    For purposes of the Congressional Review Act,
                    <SU>30</SU>
                    <FTREF/>
                     the OMB determines whether a final rule constitutes a “major rule.” If the OMB deems a rule to be a “major rule,” the Congressional Review Act generally provides that the rule may not take effect until at least 60 days following its publication. As required by the Congressional Review Act, the Board submitted the final rule and other appropriate reports to the OMB which determined that this rule is not a “major rule.” The Board will also be submitting this rule to Congress and the Government Accountability Office for review.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         5 U.S.C. 801-808.
                    </P>
                </FTNT>
                <P>
                    The Congressional Review Act defines a “major rule” as any rule that the Administrator of the Office of Information and Regulatory Affairs of the OMB finds has resulted in or is likely to result in (A) an annual effect on the economy of $100,000,000 or more; (B) a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies or geographic regions; or (C) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         5 U.S.C. 804(2).
                    </P>
                </FTNT>
                <P>
                    For the reasons previously stated, the Board is adopting the final rule without the delayed effective date generally prescribed under the Congressional Review Act. The delayed effective date required by the Congressional Review Act does not apply to any rule for which an agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rule issued) that notice and public procedures thereon are impracticable, unnecessary, or contrary to the public interest.
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         5 U.S.C. 808.
                    </P>
                </FTNT>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 12 CFR Part 747</HD>
                    <P>Civil monetary penalties, Credit unions.</P>
                </LSTSUB>
                <SIG>
                    <DATED>By the National Credit Union Administration Board on January 10, 2025.</DATED>
                    <NAME>Ji Kwon,</NAME>
                    <TITLE>Acting Secretary of the Board.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, the Board amends 12 CFR part 747 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 747—ADMINISTRATIVE ACTIONS, ADJUDICATIVE HEARINGS, RULES OF PRACTICE AND PROCEDURE, AND INVESTIGATIONS</HD>
                </PART>
                <REGTEXT TITLE="12" PART="747">
                    <AMDPAR>1. The authority for part 747 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>12 U.S.C. 1766, 1782, 1784, 1785, 1786, 1787, 1790a, 1790d; 15 U.S.C. 1639e; 42 U.S.C. 4012a; Public Law 101-410; Public Law 104-134; Public Law 109-351; Public Law 114-74.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="12" PART="747">
                    <AMDPAR>2. Revise § 747.1001 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 747.1001</SECTNO>
                        <SUBJECT>Adjustment of civil monetary penalties by the rate of inflation.</SUBJECT>
                        <P>(a) The NCUA is required by the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note)), to adjust the maximum amount of each civil monetary penalty (CMP) within its jurisdiction by the rate of inflation. The following chart displays those adjusted amounts, as calculated pursuant to the statute:</P>
                        <GPOTABLE COLS="3" OPTS="L2,nj,tp0,p7,7/8,i1" CDEF="s30,r75,r50">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">U.S. Code citation</CHED>
                                <CHED H="1">CMP description</CHED>
                                <CHED H="1">New maximum amount</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">(1) 12 U.S.C. 1782(a)(3)</ENT>
                                <ENT>Inadvertent failure to submit a report or the inadvertent submission of a false or misleading report</ENT>
                                <ENT>$5,026.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(2) 12 U.S.C. 1782(a)(3)</ENT>
                                <ENT>Non-inadvertent failure to submit a report or the non-inadvertent submission of a false or misleading report</ENT>
                                <ENT>$50,265.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(3) 12 U.S.C. 1782(a)(3)</ENT>
                                <ENT>Failure to submit a report or the submission of a false or misleading report done knowingly or with reckless disregard</ENT>
                                <ENT>$2,513,215 or 1% of the total assets of the credit union, whichever is less.</ENT>
                            </ROW>
                            <ROW>
                                <PRTPAGE P="3622"/>
                                <ENT I="01">(4) 12 U.S.C. 1782(d)(2)(A)</ENT>
                                <ENT>Tier 1 CMP for inadvertent failure to submit certified statement of insured shares and charges due to the National Credit Union Share Insurance Fund (NCUSIF), or inadvertent submission of false or misleading statement</ENT>
                                <ENT>$4,596.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(5) 12 U.S.C. 1782(d)(2)(B)</ENT>
                                <ENT>Tier 2 CMP for non-inadvertent failure to submit certified statement or submission of false or misleading statement</ENT>
                                <ENT>$45,946.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(6) 12 U.S.C. 1782(d)(2)(C)</ENT>
                                <ENT>Tier 3 CMP for failure to submit a certified statement or the submission of a false or misleading statement done knowingly or with reckless disregard</ENT>
                                <ENT>$2,297,385 or 1% of the total assets of the credit union, whichever is less.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(7) 12 U.S.C. 1785(a)(3)</ENT>
                                <ENT>Non-compliance with insurance logo requirements</ENT>
                                <ENT>$157.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(8) 12 U.S.C. 1785(e)(3)</ENT>
                                <ENT>Non-compliance with NCUA security requirements</ENT>
                                <ENT>$365.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(9) 12 U.S.C. 1786(k)(2)(A)</ENT>
                                <ENT>Tier 1 CMP for violations of law, regulation, and other orders or agreements</ENT>
                                <ENT>$12,567.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(10) 12 U.S.C. 1786(k)(2)(B)</ENT>
                                <ENT>Tier 2 CMP for violations of law, regulation, and other orders or agreements and for recklessly engaging in unsafe or unsound practices or breaches of fiduciary duty</ENT>
                                <ENT>$62,829.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(11) 12 U.S.C. 1786(k)(2)(C)</ENT>
                                <ENT>Tier 3 CMP for knowingly committing the violations under Tier 1 or 2 (natural person)</ENT>
                                <ENT>$2,513,215.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(12) 12 U.S.C. 1786(k)(2)(C)</ENT>
                                <ENT>Tier 3 CMP for knowingly committing the violations under Tier 1 or 2 (insured credit union)</ENT>
                                <ENT>$2,513,215 or 1% of the total assets of the credit union, whichever is less.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(13) 12 U.S.C. 1786(w)(5)(A)(ii)</ENT>
                                <ENT>Non-compliance with senior examiner post-employment restrictions</ENT>
                                <ENT>$413,388.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(14) 15 U.S.C. 1639e(k)</ENT>
                                <ENT>Non-compliance with appraisal independence requirements</ENT>
                                <ENT>
                                    First violation: $14,435
                                    <LI>Subsequent violations: $28,866.</LI>
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">(15) 42 U.S.C. 4012a(f)(5)</ENT>
                                <ENT>Non-compliance with flood insurance requirements</ENT>
                                <ENT>$2,730.</ENT>
                            </ROW>
                        </GPOTABLE>
                        <P>(b) The adjusted amounts displayed in paragraph (a) of this section apply to civil monetary penalties that are assessed after the date the increase takes effect, including those whose associated violation or violations pre-dated the increase and occurred on or after November 2, 2015.</P>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00737 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7535-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">CONSUMER FINANCIAL PROTECTION BUREAU</AGENCY>
                <CFR>12 CFR Part 1026</CFR>
                <DEPDOC>[Docket No. CFPB-2024-0032]</DEPDOC>
                <SUBJECT>Truth in Lending (Regulation Z); Consumer Credit Offered to Borrowers in Advance of Expected Receipt of Compensation for Work</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Consumer Financial Protection Bureau.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Advisory opinion rescinding previous advisory opinion.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Consumer Financial Protection Bureau (CFPB) is issuing this advisory opinion to rescind an advisory opinion it issued in November 2020 that described how one particular type of “earned wage” product does not involve the offering or extension of “credit” as that term is defined in the Truth in Lending Act and Regulation Z.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This advisory opinion is applicable January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        George Karithanom, Regulatory Implementation &amp; Guidance Program Analyst, Office of Regulations, at 202-435-7700 or at: 
                        <E T="03">https://reginquiries.consumerfinance.gov/.</E>
                         If you require this document in an alternative electronic format, please contact 
                        <E T="03">CFPB_Accessibility@cfpb.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Advisory Opinion</HD>
                <HD SOURCE="HD2">A. Background</HD>
                <P>One major source of demand for consumer credit is derived from the mismatch of when American workers receive compensation for their labor and when they incur expenses. While there have long been sources of credit for consumers to pay expenses in advance of receiving their compensation, there are a number of new offerings that seek to provide additional choices for consumers.</P>
                <P>
                    Instead of being paid daily or upfront, American workers generally provide services before employers pay for those services some time later—typically on a biweekly or semi-monthly wage cycle.
                    <SU>1</SU>
                    <FTREF/>
                     Employers have a strong incentive to delay payment, since these delays reduce working capital needs. Nearly three-quarters of non-farm payroll employees remain paid biweekly or even less frequently, and the remainder are generally paid their wages weekly. To address liquidity challenges, many consumers therefore turn to credit products, such as payday loans, personal installment loans, and credit cards. In recent years, American consumers have significantly expanded their use of products sometimes marketed as “earned wage access” or “earned wage advance.” 
                    <SU>2</SU>
                    <FTREF/>
                     As these paycheck advance products generally have features that make them subject to the CFPB's jurisdiction, the CFPB has sought to understand these and other products, particularly those offered online, by engaging in ongoing monitoring of the market, including, for example, collecting and analyzing data, engaging with stakeholders (
                    <E T="03">e.g.,</E>
                     market participants, consumer groups, and States), tracking and studying market developments, and conducting market research, among other things.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         While the terms “employer” and “employee” are used throughout, this advisory opinion applies more broadly to situations where consumers receive payment for work performed.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         A recent CFPB report describes rapid recent growth in one part of this developing market. 
                        <E T="03">See</E>
                         CFPB, 
                        <E T="03">Developments in the Paycheck Advance Market,</E>
                         at 3 (July 2024) (hereinafter 
                        <E T="03">2024 Paycheck Advance Report</E>
                        ).
                    </P>
                </FTNT>
                <P>While many of these products have similarities to payday loans, there are important distinctions. The CFPB has found that there are two emerging models of earned wage products: employer-partnered and direct-to-consumer.</P>
                <P>
                    For “employer-partnered” products, providers contract with employers to offer funds in amounts not exceeding accrued wages. Those funds are recovered via one or more payroll deductions, lowering the consumer's paychecks accordingly, with other recourse options generally unavailable to the provider. In contrast, “direct-to-consumer” products provide funds to employees in amounts that are not as strictly limited by accrued wages. Some of these products limit advances to an amount 
                    <E T="03">estimated</E>
                     to be below accrued wages and do not consider other factors. Others consider estimated accrued wages as one of several factors when determining the amount to advance. Still others do not expressly state that estimated accrued wages are a factor considered despite being marketed as earned wage products. Regardless of the exact model, funds are generally recovered via automated withdrawal 
                    <PRTPAGE P="3623"/>
                    from the consumer's bank account,
                    <SU>3</SU>
                    <FTREF/>
                     and generally without limit to the provider's ability to seek further recourse as necessary.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         This includes, without limitation, prepaid and payroll card accounts.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         As described, direct-to-consumer products lie outside the scope of the “wage advance” (12 CFR 1041.3(d)(7)) and “no cost advance” (12 CFR 1041.3(d)(8)) exclusions from the CFPB's 2017 Payday Rule. Employer-partnered products, however, may be (but are not necessarily) within the scope of one exclusion or both, with their revenue model particularly relevant to that determination. 
                        <E T="03">See</E>
                         12 CFR 1041.3(d)(7)(ii)(A), (d)(8).
                    </P>
                </FTNT>
                <P>
                    Some of the differences between these two types of earned wage products, however, are starting to erode. For example, some direct-to-consumer providers are now connecting directly to payroll records and recouping funds from payroll deductions, and ongoing State legal developments may cause them to limit their recourse options as well.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See 2024 Paycheck Advance Report, supra</E>
                         note 2, n.7. Several recently enacted State laws prohibit providers of earned wage products, including direct-to-consumer products, from compelling consumer repayment of earned wage amounts and fees through various means, such as lawsuits or third-party debt collection. 
                        <E T="03">See, e.g.,</E>
                         Mo. Rev. Stat. § 361.749(5)(6) (2023); Wis. Stat. § 203.04(2)(f) (2023); 
                        <E T="03">cf.</E>
                         Mont. Op. Att'y Gen., Vol. 59, Op. 2 (Dec. 22, 2023) (finding earned wage products do not meet the state law definitions of “consumer loan” or “deferred deposit loan” when they are “fully non-recourse,” among other criteria).
                    </P>
                </FTNT>
                <P>
                    Before the CFPB's market monitoring of these products intensified, the CFPB issued an advisory opinion in November 2020,
                    <SU>6</SU>
                    <FTREF/>
                     that described how one particular type of earned wage product does not involve the offering or extension of “credit” as that term is defined in the Truth in Lending Act (TILA) and Regulation Z (2020 Advisory Opinion).
                    <SU>7</SU>
                    <FTREF/>
                     The opinion explained that an earned wage product is not TILA or Regulation Z credit if it meets 
                    <E T="03">all</E>
                     of several identified conditions, including: providing the consumer with no more than the amount of accrued wages earned; provision by a third party fully integrated with the employer; no consumer payment, voluntary or otherwise, beyond recovery of paid amounts via a payroll deduction from the next paycheck, and no other recourse or collection activity of any kind; and no underwriting or credit reporting.
                    <SU>8</SU>
                    <FTREF/>
                     The 2020 Advisory Opinion was silent about whether earned wage products that do not meet all of these conditions are credit under TILA and Regulation Z.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Truth in Lending (Regulation Z); Earned Wage Access Programs, 85 FR 79404 (Dec. 10, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Regulation Z defines credit at section 12 CFR 1026.2(a)(14).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See 2020 Advisory Opinion, supra</E>
                         note 6, at 79405-06.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         The opinion stated that it had no application to such products. 
                        <E T="03">Id.</E>
                         at 79408 (“This advisory opinion applies solely to the question of whether Covered EWA Programs (
                        <E T="03">i.e.,</E>
                         those meeting all of the characteristics described in part I.B above) fall under the definition of credit in section 1026.2(a)(14) of Regulation Z identified above. This advisory opinion has no application to any other circumstance, and it does not offer a legal interpretation of any other provisions of law.”).
                    </P>
                </FTNT>
                <P>In July 2024, the CFPB proposed an interpretive rule on this same topic (2024 Proposed Interpretive Rule) and voluntarily sought public comment. The comment period closed on August 30, 2024.</P>
                <HD SOURCE="HD2">B. Legal Analysis</HD>
                <P>The CFPB is rescinding the 2020 Advisory Opinion for two fundamental reasons: (i) its legal analysis is significantly flawed in numerous respects; and (ii) it engendered substantial regulatory uncertainty.</P>
                <HD SOURCE="HD3">1. The 2020 Advisory Opinion's Legal Analysis Is Significantly Flawed in Numerous Respects</HD>
                <P>
                    Section 1026.2(a)(14) of Regulation Z defines “credit” as “the right to defer payment of debt or to incur debt and defer its payment.” 
                    <SU>10</SU>
                    <FTREF/>
                     TILA defines “credit” virtually identically as “the right granted by a creditor to a debtor to defer payment of debt or to incur debt and defer its payment.” 
                    <SU>11</SU>
                    <FTREF/>
                     However, TILA and Regulation Z do not define “debt.” Regulation Z provides that undefined terms “have the meanings given to them by state law or contract.” 
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         12 CFR 1026.2(a)(14).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         15 U.S.C. 1602(f).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         12 CFR 1026.2(b)(3).
                    </P>
                </FTNT>
                <P>
                    The first analytical flaw of the 2020 Advisory Opinion is that its consideration of the meaning of “debt” under state law was insufficient. It did not mention the Regulation Z rule of construction that undefined terms have the meanings given to them by state law or contract. It only cited a portion of the definition of debt in a recent edition of Black's Law Dictionary, and did not survey the definitions of debt in state laws, or other relevant bodies of law, including applicable circuit court case law on the definition of “debt” in TILA and Regulation Z.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">Pollice</E>
                         v. 
                        <E T="03">Nat'l Tax Funding, L.P.,</E>
                         225 F.3d 379, 410 (3d Cir. 2000) (“Although [TILA] does not contain a definition of the term `debt,' we believe the term as used in [TILA] should be construed as it is defined in the FDCPA.”).
                    </P>
                </FTNT>
                <P>
                    Second, the 2020 Advisory Opinion inferred that the consumer does not incur a liability when using the narrowly limited type of earned wage product covered by the opinion, but did not sufficiently justify the inference. The main rationale provided for the inference was that this type of product “
                    <E T="03">functionally operates like</E>
                     an employer that pays its employees earlier than the scheduled payday.” 
                    <SU>14</SU>
                    <FTREF/>
                     The opinion did not elaborate on what constitutes functional operation, or the relevance of the fact that the employer is not 
                    <E T="03">literally</E>
                     paying the employee's wages early.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         85 FR 79404 at 79406 (emphasis added).
                    </P>
                </FTNT>
                <P>
                    Third, the 2020 Advisory Opinion did not consider all relevant factors as part of the “totality of the circumstances” approach it applied to determine what is “credit.” The opinion stated only that “features 
                    <E T="03">often</E>
                     found in credit transactions are absent from” this type of product and that transactions involving this type of product are “[u]nlike 
                    <E T="03">many</E>
                     credit transactions. . . .” 
                    <SU>15</SU>
                    <FTREF/>
                     The 2020 Advisory Opinion, however, did not consider any of the features of wage advance products commonly found in credit transactions, including a consumer's receipt of funds, consumer repayment of those funds, and the wage garnishment tool used to effectuate repayment. Nor did the 2020 Advisory Opinion explain how its “totality of the circumstances” approach derived from the definition of “credit.”
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">2020 Advisory Opinion, supra</E>
                         note 6, at 79407 (emphasis added).
                    </P>
                </FTNT>
                <P>
                    Fourth, the opinion's claim that it was supported by certain statements in the 2017 Payday Rule is unpersuasive. The Payday Rule did not make a determination as to whether earned wage products are credit, stating only that some product constructs “may not be” credit. The CFPB declined to perform the more detailed analysis necessary to come to a considered conclusion on the boundaries of TILA and Regulation Z at that time because the rulemaking was based on the CFPB's UDAAP authority, not TILA and Regulation Z. Some earned wage products may not be covered by the Payday Rule because of its “wage advance” and “no cost advance” exclusions.
                    <SU>16</SU>
                    <FTREF/>
                     However, these exclusions can only apply to earned wage products to the extent that such products are TILA and Regulation Z credit. As a result, the CFPB's earlier decision to exclude certain earned wage product constructs from the Payday Rule has no impact on the credit status of such products under TILA or Regulation Z.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1041.3(d)(7), 1041.3(d)(8).
                    </P>
                </FTNT>
                <PRTPAGE P="3624"/>
                <HD SOURCE="HD3">2. The 2020 Advisory Opinion Engendered Substantial Regulatory Uncertainty</HD>
                <P>
                    In the months and years following issuance of the 2020 Advisory Opinion, it became increasingly evident that it failed to clarify the status of earned wage products under TILA and Regulation Z. Indeed, in 2023, the U.S. Government Accountability Office issued a report recommending that the CFPB clarify their status.
                    <SU>17</SU>
                    <FTREF/>
                     This muddying of the waters flowed directly from the extreme narrowness of the opinion. Few if any of the products in the market at the time of or subsequent to issuance fit the mold outlined by the opinion. As a result, stakeholders were left to speculate about the CFPB's view about the credit status of the many products actually being offered.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         U.S. Gov't Accountability Off., GAO-23-105536, Financial Technology: Products Have Benefits and Risks to Underserved Consumers, and Regulatory Clarity is Needed 36-37 (2023) (citing industry requests for clarification). The CFPB has acknowledged the need for clarification in this area. 
                        <E T="03">See, e.g.,</E>
                         Letter from Rohit Chopra, Dir., Consumer Fin. Prot. Bureau, to Michael Clements, Dir. of Fin. Mkts. and Cmty. Inv., U.S. Gov't Accountability Off., (Feb. 13, 2023) in U.S. Gov't Accountability Off., GAO-23-105536, 
                        <E T="03">supra,</E>
                         at 51; Letter from Seth Frotman, Acting General Counsel, Consumer Fin. Prot. Bureau, to Beverly Brown Ruggia, N.J. Citizen Action, 
                        <E T="03">et al.,</E>
                         at 2 (Jan. 18, 2022).
                    </P>
                </FTNT>
                <P>
                    Worse still, the 2020 Advisory Opinion has been widely cited in support of legal conclusions that it did not reach. For example, it has erroneously been cited for the general propositions that no-fee earned wage products are not credit,
                    <SU>18</SU>
                    <FTREF/>
                     and that employer-partnered earned wage products are also not credit.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Off. of the Att'y Gen., State of Ariz., Opinion No. I22-005 (Dec. 16, 2022), available at 
                        <E T="03">https://www.azag.gov/sites/default/files/2022-12/I22-005.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See, e.g.,</E>
                         ZayZoon, Comment Letter on Cal. Dep't of Fin. Prot. and Innovation Notice of Proposed Rulemaking [PRO 01-21], at 4 (May 17, 2023), 
                        <E T="03">https://dfpi.ca.gov/wp-content/uploads/sites/337/2023/08/46-PRO-01-21-ZayZoon-US-Inc.-5.17.23_Redacted.pdf;</E>
                         Innovative Payments Ass'n, Comment Letter on Cal. Dep't of Fin. Prot. and Innovation Notice of Proposed Rulemaking [PRO 01-21], at 4 (May 11, 2023), 
                        <E T="03">https://dfpi.ca.gov/wp-content/uploads/sites/337/2023/08/10-PRO-01-21-Innovative-Payments-Association-5.11.23_Redacted.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    In addition, some regulatory uncertainty may have resulted from the near-contemporaneous issuance of an “Approval Order” that gave one provider a temporary safe harbor from liability under TILA and Regulation Z with respect to a specific product that did not satisfy all the conditions that the 2020 Advisory Opinion identified as taking such a product outside the reach of TILA and Regulation Z.
                    <SU>20</SU>
                    <FTREF/>
                     The 2020 Advisory Opinion applied only to products that had all of the numerous characteristics identified above, including that they were free to consumers. In contrast, the Approval Order encompassed earned wage transactions in connection with which the consumer incurred fees.
                    <SU>21</SU>
                    <FTREF/>
                     However, it was never of general interpretative applicability,
                    <SU>22</SU>
                    <FTREF/>
                     and was terminated even before its temporary status expired.
                    <SU>23</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See</E>
                         Consumer Fin. Prot. Bureau, 
                        <E T="03">Payactiv Approval Order,</E>
                         at 5 (Dec. 30, 2020), 
                        <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_payactiv_approval-order_2020-12.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See id.</E>
                         at 4 n.15.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Consumer Fin. Prot. Bureau, Order to Terminate Sandbox Approval Order (June 30, 2022), 
                        <E T="03">cfpb_payactiv_termination-order_2022-06.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Regulatory Matters</HD>
                <P>
                    This is an advisory opinion issued under the CFPB's authority to interpret TILA and Regulation Z, including under section 1022(b)(1) of the Consumer Financial Protection Act of 2010, which authorizes guidance “as may be necessary or appropriate to enable the Bureau to administer and carry out the purposes and objectives of the Federal consumer financial laws. . . .” 
                    <SU>24</SU>
                    <FTREF/>
                     By operation of TILA section 130(f), no provision of TILA sections 130, 108(b), 108(c), 108(e), or section 112 imposing any liability would apply to any act done or omitted in good faith in conformity with this advisory opinion, notwithstanding that after such act or omission has occurred, the advisory opinion is amended, rescinded, or determined by judicial or other authority to be invalid for any reason.
                    <SU>25</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         12 U.S.C. 5512(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         15 U.S.C. 1640(f).
                    </P>
                </FTNT>
                <P>
                    The CFPB has determined that this advisory opinion would not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring approval by the Office of Management and Budget under the Paperwork Reduction Act.
                    <SU>26</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         44 U.S.C. 3501-3521.
                    </P>
                </FTNT>
                <P>
                    Pursuant to the Congressional Review Act,
                    <SU>27</SU>
                    <FTREF/>
                     the CFPB will submit a report containing this advisory opinion and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to the rule's published effective date. The Office of Information and Regulatory Affairs has designated this advisory opinion as not a “major rule” as defined by 5 U.S.C. 804(2).]
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         5 U.S.C. 801-808.
                    </P>
                </FTNT>
                <SIG>
                    <NAME>Rohit Chopra,</NAME>
                    <TITLE>Director, Consumer Financial Protection Bureau.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00381 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-AM-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Bureau of Industry and Security</SUBAGY>
                <CFR>15 CFR Parts 732, 734, 740, 742, 744, 748, 750, 762, 772, and 774</CFR>
                <DEPDOC>[Docket No. 250107-0002]</DEPDOC>
                <RIN>RIN 0694-XC112</RIN>
                <SUBJECT>Public Briefing on Framework for Artificial Intelligence Diffusion</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Industry and Security, U.S. Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notification of public briefing on regulatory action.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On January 10, 2025, the Office of the Federal Register posted for public inspection a Bureau of Industry and Security (BIS) interim final rule: “Framework for Artificial Intelligence Diffusion” (RIN 0694-AJ90). This document announces that, on January 15, 2025, BIS will host a virtual public briefing on this rule. This document also provides details on the procedures for participating in the virtual public briefing.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Virtual public briefing:</E>
                         The virtual public briefing will be held on January 15, 2025. The public briefing will begin at 12 p.m. Eastern Standard Time (EST) and conclude at 1 p.m. EST.
                    </P>
                    <P>
                        <E T="03">Deadline to register:</E>
                         Register by 9 a.m. EST on January 15, 2025, for virtual participation.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To attend this event virtually, register at: 
                        <E T="03">https://events.gcc.teams.microsoft.com/event/a0c17530-aae8-43e0-b64c-e2f9bafbbcf4@44cf3ec3-840c-4086-b7de-e3bc9a6c2db4.</E>
                    </P>
                    <P>
                        <E T="03">Recordkeeping:</E>
                         A summary of the briefing will be posted for the record at: 
                        <E T="03">https://regulations.gov</E>
                         under the regulations.gov ID for this notice (BIS-2025-0001).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For questions on this virtual public briefing, contact Hillary Hess, Regulatory Policy Division, Office of Exporter Services, Bureau of Industry and Security, U.S. Department of Commerce at 202-482-2440 or by email: 
                        <E T="03">RPD2@bis.doc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">
                    SUPPLEMENTARY INFORMATION:
                    <PRTPAGE P="3625"/>
                </HD>
                <HD SOURCE="HD1">Background</HD>
                <P>With the Framework for Artificial Intelligence Diffusion interim final rule, the Commerce Department's Bureau of Industry and Security (BIS) revises the Export Administration Regulations' (EAR) controls on advanced computing integrated circuits (ICs) and adds a new control on artificial intelligence (AI) model weights for certain advanced closed-weight dual-use AI models. In conjunction with the expansion of these controls, which BIS has determined are necessary to protect U.S. national security and foreign policy interests, BIS is adding new license exceptions and updating the Data Center Validated End User authorization to facilitate the export, reexport, and transfer (in-country) of advanced computing ICs to end users in destinations that do not raise national security or foreign policy concerns.Together, these changes will cultivate secure ecosystems for the responsible diffusion and use of AI and advanced computing ICs.</P>
                <HD SOURCE="HD1">Public Briefing</HD>
                <P>On January 15, 2025, BIS will host a public briefing to address the details of this rule. The virtual public briefing will be held on January 15, 2025. The virtual public briefing will begin at 12 p.m. EST and conclude at 1 p.m. EST.</P>
                <HD SOURCE="HD1">Procedure for Requesting Participation</HD>
                <P>
                    To participate in the public meeting virtually, register at: 
                    <E T="03">https://events.gcc.teams.microsoft.com/event/a0c17530-aae8-43e0-b64c-e2f9bafbbcf4@44cf3ec3-840c-4086-b7de-e3bc9a6c2db4</E>
                     no later than 9 a.m. EST on January 15, 2025, for virtual participation. This web page will also display the agenda of the public meeting and any other necessary information.
                </P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>
                    For any special accommodation needs, please send an email to: 
                    <E T="03">rpd2@bis.doc.gov.</E>
                </P>
                <SIG>
                    <NAME>Thea D. Rozman Kendler,</NAME>
                    <TITLE>Assistant Secretary of Commerce for Export Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00637 Filed 1-13-25; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-33-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employment and Training Administration</SUBAGY>
                <CFR>20 CFR Part 655</CFR>
                <DEPDOC>[DOL Docket No. ETA-2020-0005]</DEPDOC>
                <SUBJECT>Adjudication of Temporary and Seasonal Need for Herding and Production of Livestock on the Range Applications Under the H-2A Program; Ratification of Department's Actions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Employment and Training Administration, Department of Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Ratification.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Labor is publishing notification of the Assistant Secretary for Employment and Training's ratification of the rule published December 16, 2021, titled 
                        <E T="03">Adjudication of Temporary and Seasonal Need for Herding and Production of Livestock on the Range Applications Under the H-2A Program.</E>
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This ratification was signed on January 10, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For further information regarding 20 CFR part 655, contact Brian Pasternak, Administrator, Office of Foreign Labor Certification, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210, telephone: (202) 693-8200 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone numbers above via Teletypewriter (TTY)/Telecommunications Device for the Deaf (TDD) by calling the toll-free Federal Information Relay Service at 1 (877) 889-5627.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    On May 6, 2021, the Department of Labor (“DOL” or “Department”) issued a notice of proposed rulemaking (“NPRM”) in the 
                    <E T="04">Federal Register</E>
                     (“FR”) to amend its regulations regarding the adjudication of temporary and seasonal need for employers seeking herding or production of livestock on the range job opportunities under the H-2A program. 
                    <E T="03">See Adjudication of Temporary and Seasonal Need for Herding and Production of Livestock on the Range Applications Under the H-2A Program,</E>
                     86 FR 24368 (May 6, 2021) (“NPRM”). The NPRM was open for public comment for 30 days until June 7, 2021. 
                    <E T="03">See Adjudication of Temporary and Seasonal Need for Herding and Production of Livestock on the Range Applications Under the H-2A Program,</E>
                     86 FR 71373, 71376 (Dec. 16, 2021) (“Final Rule”). On December 16, 2021, DOL published the Final Rule in the FR. 
                    <E T="03">See</E>
                     Final Rule, 86 FR 71373. The Final Rule went into effect on January 18, 2022. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    Since publication of the Final Rule, a question has been raised in litigation concerning whether a separate rule, 
                    <E T="03">Adverse Effect Wage Rate Methodology for the Temporary Employment of H-2A Nonimmigrants in the Non-Range Occupations in the United States,</E>
                     88 FR 12760 (Feb. 28, 2023), was approved by the Attorney General in consultation with the Secretary of Labor and the Secretary of Agriculture. 8 U.S.C. 1188, Statutory Note.
                    <SU>1</SU>
                    <FTREF/>
                     With respect to the Final Rule, prior to its issuance on December 16, 2021, the Final Rule was provided to the Departments of Homeland Security and Agriculture through the interagency review process prescribed by Executive Order 12866. Further, on December 31, 2024, the Secretary of Homeland Security, in consultation with the Secretary of Labor and Secretary of Agriculture, approved the Final Rule.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Although this provision vests approval authority in the “Attorney General,” the Secretary of Homeland Security now may exercise this authority. 
                        <E T="03">See</E>
                         6 U.S.C. 202(3)-(4), 251, 271(b), 291, 551(d)(2), 557; 8 U.S.C. 1103(c) (2000).
                    </P>
                </FTNT>
                <P>
                    To resolve any possible uncertainty with respect to the Final Rule, the Department, through its Assistant Secretary for Employment and Training, is ratifying the Final Rule. Under established case law, an agency may, through ratification, “purge[ ] any residual taint or prejudice left over from” a potential defect in a prior governmental action.
                    <SU>2</SU>
                    <FTREF/>
                     The Department is issuing this ratification out of an abundance of caution, and this ratification is not a statement that the Final Rule is invalid absent this ratification.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">Guedes</E>
                         v. 
                        <E T="03">Bureau of Alcohol, Tobacco, Firearms &amp; Explosives,</E>
                         920 F.3d 1, 13 (D.C. Cir. 2019).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Ratification</HD>
                <P>
                    By virtue of the authority vested in the Secretary of Labor by law, including by the Immigration and Nationality Act of 1952, as amended, 8 U.S.C. 1101 
                    <E T="03">et seq.</E>
                     (“INA”), and as delegated to the Assistant Secretary for Employment and Training, 75 FR 66268, I am affirming and ratifying a prior action by Angela Hanks, Acting Assistant Secretary for Employment and Training. On December 16, 2021, the Employment and Training Administration published in the FR the Final Rule codifying amendments to the Department's 
                    <PRTPAGE P="3626"/>
                    regulations regarding the adjudication of temporary need for employers seeking to employ nonimmigrant workers in job opportunities covering the herding or production of livestock on the range. 86 FR 71373 (Dec. 16, 2021).
                </P>
                <P>
                    The Final Rule was signed by Acting Assistant Secretary Hanks. I have full and complete knowledge of the Final Rule action taken by former Acting Assistant Secretary Hanks. Subsequent to the Secretary of Homeland Security's documented approval of the Final Rule dated December 31, 2024, in consultation with the Secretary of Labor and Secretary of Agriculture, and out of an abundance of caution and to avoid any doubt as to its validity, I have independently evaluated the Final Rule and the basis for adopting it. I have determined that the amendments to the regulations in the Final Rule are consistent with the Secretary of Labor's statutory responsibility to certify that there are insufficient able, willing, and qualified U.S. workers available to perform the needed work and that the employment of H-2A workers will not adversely affect the wages and working conditions of workers in the United States similarly employed. I have also determined that the changes adopted in the Final Rule strike an appropriate balance between the statute's competing goals of providing employers with an adequate supply of legal agricultural labor and protecting the wages of workers in the United States similarly employed by ensuring the Department's adjudication of temporary or seasonal need is conducted in the same manner for all applications for temporary agricultural labor certification, consistent with statute's requirements. I also agree with the Department's certification that the Final Rule does not have a significant economic impact on a substantial number of small entities. 
                    <E T="03">See</E>
                     Final Rule, 86 FR 71382.
                </P>
                <P>Therefore, pursuant to my authority as the Assistant Secretary for Employment and Training, and based on my independent review of the action and the reasons for taking it, I hereby affirm and ratify the Final Rule, as of January 10, 2025, including all regulatory analysis certifications contained therein. This action is taken without prejudice to any right to litigate the validity of the Final Rule as approved and published on December 16, 2021. Nothing in this action is intended to suggest any legal defect or infirmity in the approval or publication of the Final Rule.</P>
                <SIG>
                    <NAME>José Javier Rodríguez,</NAME>
                    <TITLE>Assistant Secretary, Employment and Training Administration, Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00829 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FP-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employment and Training Administration</SUBAGY>
                <CFR>20 CFR Part 655</CFR>
                <DEPDOC>[DOL Docket No. ETA-2015-0004]</DEPDOC>
                <SUBJECT>Temporary Agricultural Employment of H-2A Foreign Workers in the Herding or Production of Livestock on the Range in the United States; Ratification of Department's Actions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Employment and Training Administration, Department of Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Ratification.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Labor is publishing notification of the Assistant Secretary for Employment and Training's ratification of the rule published October 16, 2015, titled 
                        <E T="03">Temporary Agricultural Employment of H-2A Foreign Workers in the Herding or Production of Livestock on the Range in the United States.</E>
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This ratification was signed on January 10, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For further information regarding 20 CFR part 655, contact Brian Pasternak, Administrator, Office of Foreign Labor Certification, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210, telephone: (202) 693-8200 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone numbers above via Teletypewriter (TTY)/Telecommunications Device for the Deaf (TDD) by calling the toll-free Federal Information Relay Service at 1 (877) 889-5627.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    On April 15, 2015, the Department of Labor (“DOL” or “Department”) issued a notice of proposed rulemaking (“NPRM”) in the 
                    <E T="04">Federal Register</E>
                     (“FR”) to amend its regulations regarding the certification of temporary employment of nonimmigrant workers in temporary or seasonal agricultural employment in herding or the production of livestock on the range in the United States. 
                    <E T="03">See Temporary Agricultural Employment of H-2A Foreign Workers in the Herding or Production of Livestock on the Open Range in the United States,</E>
                     80 FR 20300 (Apr. 15, 2015) (“NPRM”). The NPRM was open for public comment for 45 days until June 1, 2015. 
                    <E T="03">See Temporary Agricultural Employment of H-2A Foreign Workers in the Herding or Production of Livestock on the Range in the United States,</E>
                     80 FR 62958 (Oct. 16, 2015) (“Final Rule”). On October 16, 2015, DOL published a final rule in the FR. 
                    <E T="03">See</E>
                     Final Rule, 80 FR at 62958. The Final Rule went into effect on November 16, 2015. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    Since publication of the Final Rule, a question has been raised in litigation concerning whether a separate rule, 
                    <E T="03">Adverse Effect Wage Rate Methodology for the Temporary Employment of H-2A Nonimmigrants in the Non-Range Occupations in the United States,</E>
                     88 FR 12760 (Feb. 28, 2023), was approved by the Attorney General in consultation with the Secretary of Labor and the Secretary of Agriculture. 8 U.S.C. 1188, Statutory Note.
                    <SU>1</SU>
                    <FTREF/>
                     With respect to the Final Rule, prior to its issuance on October 15, 2015, the Final Rule was provided to the Departments of Homeland Security and Agriculture through the interagency review process prescribed by Executive Order 12866. Further, on December 31, 2024, the Secretary of Homeland Security, in consultation with the Secretary of Labor and Secretary of Agriculture, approved the Final Rule.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Although this provision vests approval authority in the “Attorney General,” the Secretary of Homeland Security now may exercise this authority. 
                        <E T="03">See</E>
                         6 U.S.C. 202(3)-(4), 251, 271(b), 291, 551(d)(2), 557; 8 U.S.C. 1103(c) (2000).
                    </P>
                </FTNT>
                <P>
                    To resolve any possible uncertainty with respect to the Final Rule, the Department, through its Assistant Secretary for Employment and Training, is ratifying the Final Rule. Under established case law, an agency may, through ratification, “purge[ ] any residual taint or prejudice left over from” a potential defect in a prior governmental action.
                    <SU>2</SU>
                    <FTREF/>
                     The Department is issuing this ratification out of an abundance of caution, and this ratification is not a statement that the Final Rule is invalid absent this ratification.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">Guedes</E>
                         v. 
                        <E T="03">Bureau of Alcohol, Tobacco, Firearms &amp; Explosives,</E>
                         920 F.3d 1, 13 (D.C. Cir. 2019).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Ratification</HD>
                <P>
                    By virtue of the authority vested in the Secretary of Labor by law, including by the Immigration and Nationality Act of 1952, as amended, 8 U.S.C. 1101 
                    <E T="03">et seq.</E>
                     (“INA”), and as delegated to the 
                    <PRTPAGE P="3627"/>
                    Assistant Secretary for Employment and Training, 75 FR 66268, I am affirming and ratifying a prior action by Portia Wu, Assistant Secretary for Employment and Training. On October 16, 2015, the Employment and Training Administration published in the FR the Final Rule codifying amendments to the Department's regulations regarding the certification of temporary employment of nonimmigrant workers employed in temporary or seasonal agricultural employment, establishing standards and procedures for employers seeking to hire foreign temporary agricultural workers for job opportunities in herding and production of livestock on the range. 80 FR 62958 (Oct. 16, 2015).
                </P>
                <P>
                    The Final Rule was signed by Assistant Secretary Wu. I have full and complete knowledge of the Final Rule action taken by former Assistant Secretary Wu. Subsequent to the Secretary of Homeland Security's documented approval of the Final Rule dated December 31, 2024, in consultation with the Secretary of Labor and Secretary of Agriculture, and out of an abundance of caution and to avoid any doubt as to its validity, I have independently evaluated the Final Rule and the basis for adopting it. I have determined that the amendments to the regulations in the Final Rule are consistent with the Secretary of Labor's statutory responsibility to certify that there are insufficient able, willing, and qualified U.S. workers available to perform the needed work and that the employment of H-2A workers will not adversely affect the wages and working conditions of workers in the United States similarly employed. I have also determined that the changes adopted in the Final Rule strike an appropriate balance between the statute's competing goals of providing employers with an adequate supply of legal agricultural labor and protecting the wages of workers in the United States similarly employed by establishing regulatory standards and procedures applicable to the employment of workers in these unique occupations, which occur in remote areas and require workers to be on call for long periods of time. I also agree with the Department's certification that the Final Rule has a significant economic impact on a substantial number of small entities. 
                    <E T="03">See</E>
                     Final Rule, 80 FR 63039.
                </P>
                <P>Therefore, pursuant to my authority as the Assistant Secretary for Employment and Training, and based on my independent review of the action and the reasons for taking it, I hereby affirm and ratify the Final Rule, as of January 10, 2025, including all regulatory analysis certifications contained therein. This action is taken without prejudice to any right to litigate the validity of the Final Rule as approved and published on October 16, 2015. Nothing in this action is intended to suggest any legal defect or infirmity in the approval or publication of the Final Rule.</P>
                <SIG>
                    <NAME>José Javier Rodríguez,</NAME>
                    <TITLE>Assistant Secretary, Employment and Training Administration, Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00828 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FP-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Indian Affairs</SUBAGY>
                <CFR>25 CFR Part 83</CFR>
                <DEPDOC>[BIA-2022-0001; 256A2100DD/AAKC001030/A0A501010.999900]</DEPDOC>
                <RIN>RIN 1076-AF67</RIN>
                <SUBJECT>Federal Acknowledgment of American Indian Tribes</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Indian Affairs, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The United States Department of the Interior (Department) revises the regulations governing the process through which the Secretary acknowledges an Indian Tribe, creating a conditional, time-limited opportunity for denied petitioners to re-petition for Federal acknowledgment.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on February 14, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        On request to the program contact person listed under 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        , individuals can obtain this document in an alternate format, usable by people with disabilities, at the Office of Federal Acknowledgment, Room 4071, 1849 C Street NW, Washington, DC 20240.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Oliver Whaley, Director, Office of Regulatory Affairs and Collaborative Action, Office of the Assistant Secretary—Indian Affairs, (202) 738-6065. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Since 1994, the regulations governing the Federal acknowledgment process, located at 25 CFR part 83 (part 83), have included an express prohibition on re-petitioning (ban). When the Department revised the part 83 regulations in 2015 (2015 regulations), the Department decided to retain the ban; however, two Federal district courts held that the Department's stated reasons for doing so, as articulated in the final rule updating the regulations, were arbitrary and capricious under the Administrative Procedure Act. The courts remanded the ban to the Department for further consideration. In a 2022 notice of proposed rulemaking (2022 proposed rule), the Department initially proposed to retain the ban. Subsequently, in a second notice of proposed rulemaking published at 89 FR 57097 on July 12, 2024 (2024 proposed rule), the Department proposed to create a limited exception to the ban, through implementation of a re-petition authorization process. In this final rule, the Department adopts a limited exception to the ban.</P>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Background</FP>
                    <FP SOURCE="FP1-2">A. Federal Acknowledgment Process</FP>
                    <FP SOURCE="FP1-2">B. 1994 and 2015 Revisions of Part 83</FP>
                    <FP SOURCE="FP1-2">C. Ban on Re-Petitioning</FP>
                    <FP SOURCE="FP1-2">D. Remand of the Ban</FP>
                    <FP SOURCE="FP1-2">E. 2022 Proposed Rule</FP>
                    <FP SOURCE="FP1-2">F. 2024 Proposed Rule</FP>
                    <FP SOURCE="FP-2">II. Summary of the Final Rule</FP>
                    <FP SOURCE="FP1-2">A. Re-Petition Authorization Process</FP>
                    <FP SOURCE="FP1-2">B. Additional, Related Revisions</FP>
                    <FP SOURCE="FP1-2">C. Technical Revisions</FP>
                    <FP SOURCE="FP-2">III. Discussion of the Comments on the 2024 Proposed Rule</FP>
                    <FP SOURCE="FP1-2">A. Overview</FP>
                    <FP SOURCE="FP1-2">B. Comments Citing Fairness as a Justification for the Re-Petition Authorization Process</FP>
                    <FP SOURCE="FP1-2">C. Additional Discussion of Third-Party Opposition To Re-Petitioning</FP>
                    <FP SOURCE="FP1-2">D. Comments Citing Departmental Workload as a Justification for Retaining the Ban on Re-Petitioning</FP>
                    <FP SOURCE="FP1-2">E. Comments on the Standard Applied in the Re-Petition Authorization Process</FP>
                    <FP SOURCE="FP1-2">F. Comments on the Conditions for Obtaining Authorization To Re-Petition</FP>
                    <FP SOURCE="FP1-2">1. Comments on the “Change” Condition</FP>
                    <FP SOURCE="FP1-2">2. Comments on the “New Evidence” Condition</FP>
                    <FP SOURCE="FP1-2">3. Comments on Possible Other Conditions for Obtaining Authorization To Re-Petition</FP>
                    <FP SOURCE="FP1-2">G. Comments on the Processing of a Re-Petition Request</FP>
                    <FP SOURCE="FP1-2">1. Comments on the Time Limit for Submitting a Re-Petition Request</FP>
                    <FP SOURCE="FP1-2">2. Comments on Third-Party Notice-and-Comment Provisions</FP>
                    <FP SOURCE="FP1-2">3. Comments on the Finality of a Grant of Authorization To Re-Petition</FP>
                    <FP SOURCE="FP-2">IV. Procedural Requirements</FP>
                    <FP SOURCE="FP1-2">A. Regulatory Planning and Review (E.O. 12866 and 13563)</FP>
                    <FP SOURCE="FP1-2">B. Regulatory Flexibility Act</FP>
                    <FP SOURCE="FP1-2">C. Congressional Review Act</FP>
                    <FP SOURCE="FP1-2">D. Unfunded Mandates Reform Act</FP>
                    <FP SOURCE="FP1-2">E. Takings (E.O. 12630)</FP>
                    <FP SOURCE="FP1-2">F. Federalism (E.O. 13132)</FP>
                    <FP SOURCE="FP1-2">G. Civil Justice Reform (E.O. 12988)</FP>
                    <FP SOURCE="FP1-2">H. Consultation With Indian Tribes (E.O. 13175)</FP>
                    <FP SOURCE="FP1-2">
                        I. Paperwork Reduction Act
                        <PRTPAGE P="3628"/>
                    </FP>
                    <FP SOURCE="FP1-2">J. National Environmental Policy Act (NEPA)</FP>
                    <FP SOURCE="FP1-2">K. Effects on the Energy Supply (E.O. 13211)</FP>
                    <FP SOURCE="FP1-2">L. Privacy Act of 1974, Existing System of Records</FP>
                    <FP SOURCE="FP1-2">M. Clarity of This Regulation</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background</HD>
                <HD SOURCE="HD2">A. Federal Acknowledgment Process</HD>
                <P>
                    Congress granted the Secretary of the Interior, as delegated to the Assistant Secretary—Indian Affairs (AS-IA), authority for “the management of all Indian affairs and of all matters arising out of Indian relations.” 
                    <SU>1</SU>
                    <FTREF/>
                     This authority includes the authority to implement an administrative process to acknowledge Indian Tribes.
                    <SU>2</SU>
                    <FTREF/>
                     As the congressional findings that support the Federally Recognized Indian Tribe List Act of 1994 indicate, Indian Tribes may be recognized “by the administrative procedures set forth in part 83 of the Code of Federal Regulations.” 
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         25 U.S.C. 2; 
                        <E T="03">see also</E>
                         25 U.S.C. 9; 43 U.S.C. 1457.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See, e.g., Muwekma Ohlone Tribe</E>
                         v. 
                        <E T="03">Salazar,</E>
                         708 F.3d 209, 211 (D.C. Cir. 2013); 
                        <E T="03">James</E>
                         v. 
                        <E T="03">United States Dep't of Health &amp; Human Servs.,</E>
                         824 F.2d 1132, 1137 (D.C. Cir. 1987).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Public Law 103-454, section 103(3) (1994).
                    </P>
                </FTNT>
                <P>
                    Part 83 codifies the process through which a group may petition the Department for acknowledgment as a federally recognized Indian Tribe. Part 83 requires groups petitioning for Federal acknowledgment to meet seven mandatory criteria, the satisfaction of which has been central to the Federal acknowledgment process since its inception.
                    <SU>4</SU>
                    <FTREF/>
                     The Department refers to the seven criteria as the (a) “Indian Entity Identification” criterion, (b) “Community” criterion, (c) “Political Authority” criterion, (d) “Governing Document” criterion, (e) “Descent” criterion, (f) “Unique Membership” criterion, and (g) “Congressional Termination” criterion.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         25 CFR 83.11(a) through (g) (2015 version of the criteria); 25 CFR 83.7(a) through (g) (1994) (1994 version); 25 CFR 54.7(a) through (g) (1978) (1978 version).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         25 CFR 83.5.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. 1994 and 2015 Revisions of Part 83</HD>
                <P>
                    First promulgated in 1978 at 25 CFR part 54 (1978 regulations),
                    <SU>6</SU>
                    <FTREF/>
                     the Federal acknowledgment regulations were subsequently moved to part 83 
                    <SU>7</SU>
                    <FTREF/>
                     and revised in 1994 (1994 regulations),
                    <SU>8</SU>
                    <FTREF/>
                     in part, “to clarify requirements for acknowledgment and define more clearly standards of evidence.” 
                    <SU>9</SU>
                    <FTREF/>
                     The 1994 regulations also implemented procedural changes to the acknowledgment process, including “an independent review” of a final determination on a part 83 petition by the Interior Board of Indian Appeals and an “opportunity for a formal hearing on proposed findings.” 
                    <SU>10</SU>
                    <FTREF/>
                     In the final rule promulgating the 1994 regulations, the Department explained that, notwithstanding the revisions, “the standards of continuity of tribal existence that a petitioner must meet remain unchanged” and that “none of the changes . . . will result in the acknowledgment of petitioners which would not have been acknowledged under the [1978] regulations.” 
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         43 FR 39361 (Sept. 5, 1978).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         47 FR 13326 (Mar. 30, 1982).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         59 FR 9280 (Feb. 25, 1994).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">Id.; see also</E>
                         25 CFR 83.11 (1994) (describing the process for IBIA review).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         59 FR 9280.
                    </P>
                </FTNT>
                <P>
                    The Department revised part 83 again in 2015 (2015 regulations). In the final rule promulgating the 2015 regulations (2015 final rule), the Department explained that the purpose of the revision was to “increase timeliness and efficiency, while maintaining the integrity and substantive rigor of the [Federal acknowledgment] process.” 
                    <SU>12</SU>
                    <FTREF/>
                     To that end, the Department introduced several process-related reforms, including a two-phased review of the seven mandatory criteria. In Phase I, the Office of Federal Acknowledgment (OFA) reviews criteria (d) (Governing Document) through (g) (Congressional Termination), and in Phase II, OFA evaluates criteria (a) (Indian Entity Identification) through (c) (Political Authority).
                    <SU>13</SU>
                    <FTREF/>
                     If a petitioner does not satisfy any of the Phase I criteria, then, instead of moving to Phase II, OFA publishes a negative proposed finding, which can then serve as the basis for a final determination on the Phase I criteria alone,
                    <SU>14</SU>
                    <FTREF/>
                     saving time and resources.
                    <SU>15</SU>
                    <FTREF/>
                     Additionally, to promote efficiency, the Department limited the number of technical assistance reviews that OFA can provide to a petitioner, permitting only one during each phase.
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         80 FR 37862 (July 1, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         25 CFR 83.26.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         25 CFR 83.43(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         80 FR 37862 (explaining that the “two-phased review of petitions . . . establishes certain criteria as threshold criteria, potentially resulting in the issuance of proposed findings and final determinations earlier in the process”); 80 FR 37877 (explaining that the two-phased review “is likely to produce any negative decisions in a quicker manner, thereby resolving petitions sooner, reducing time delays, increasing efficiency, and preserving resources”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         80 FR 37877.
                    </P>
                </FTNT>
                <P>
                    The Department emphasized in the 2015 final rule that the rule “clarifies the criteria” but “does not substantively change the Part 83 criteria, except in two instances.” 
                    <SU>17</SU>
                    <FTREF/>
                     In the first instance, the Department revised criterion (a) (Indian Entity Identification) to accept “the petitioner's own contemporaneous records, as evidence that the petitioner has been an Indian entity since 1900,” 
                    <SU>18</SU>
                    <FTREF/>
                     not only the records of external observers.
                    <SU>19</SU>
                    <FTREF/>
                     Second, the Department revised a provision under criterion (b) (Community) describing how the Department evaluates evidence of endogamy (that is, marriages within a petitioner's membership).
                    <SU>20</SU>
                    <FTREF/>
                     Other changes to the criteria in the 2015 regulations include the following:
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         80 FR 37863.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         80 FR 37866.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         80 FR 37863.
                    </P>
                </FTNT>
                <P>
                    1. A new evaluation start date for criterion (b) (Community) and (c) (Political Authority), from 1789 or the time of first sustained contact, to 1900, consistent with the 1900 start date for criterion (a) (Indian Entity Identification); 
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    2. A change to criterion (e) (Descent) to emphasize the “great weight” that the Department places on “tribal Federal rolls prepared at the direction of Congress or by the Department” during the evaluation of the criterion; 
                    <SU>22</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         80 FR 37867.
                    </P>
                </FTNT>
                <P>
                    3. The deletion of a condition in criterion (f) (Unique Membership) that required a petitioner to show that its members do not maintain a “bilateral political relationship” with a federally recognized Indian tribe, in the event that the petitioner's membership is composed principally of members of the federally recognized tribe; 
                    <SU>23</SU>
                    <FTREF/>
                     and
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         80 FR 37873.
                    </P>
                </FTNT>
                <P>
                    4. The insertion of a new provision under criteria (b) (Community) and (c) (Political Authority), clarifying that evidence of “land set aside by a State for the petitioner or collective ancestors of the petitioner” may be used to satisfy the criteria.
                    <SU>24</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         80 FR 37865.
                    </P>
                </FTNT>
                <P>
                    In proposed rules published in April 2022 and July 2024, the Department discussed each of the changes identified above,
                    <SU>25</SU>
                    <FTREF/>
                     as well as the Department's view that none of the 2015 final rule's changes to part 83 “would affect the outcome of the Department's previous, negative final determinations.” 
                    <SU>26</SU>
                    <FTREF/>
                     The 2022 and 2024 proposed rules are discussed in subsequent sections of this rule.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         87 FR 24908, 24912-14 (Apr. 27, 2022).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         89 FR 57097, 57102-03 (July 12, 2024) (citation omitted).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Ban on Re-Petitioning</HD>
                <P>
                    The 1978 regulations were silent on the question of re-petitioning, but since the 1994 revision of part 83, the Federal 
                    <PRTPAGE P="3629"/>
                    acknowledgment regulations have expressly prohibited petitioners that receive a negative final determination from the Department from re-petitioning.
                    <SU>27</SU>
                    <FTREF/>
                     The final rule updating the regulations in 1994 notes that although some commenters had expressed concern that “undiscovered evidence which might change the outcome of decisions could come to light in the future,” the Department reasoned that “there should be an eventual end to the present administrative process.” 
                    <SU>28</SU>
                    <FTREF/>
                     Additionally, the Department pointed out that “petitioners who were denied went through several stages of review with multiple opportunities to develop and submit evidence.” 
                    <SU>29</SU>
                    <FTREF/>
                     The Department also explained that “[t]he changes in the regulations are not so fundamental that they can be expected to result in different outcomes for cases previously decided.” 
                    <SU>30</SU>
                    <FTREF/>
                     Finally, the Department observed that “[d]enied petitioners still have the opportunity to seek legislative recognition if substantial new evidence develops.” 
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         25 CFR 83.3(f) (1994); 59 FR 9294.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         59 FR 9291.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Id.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         Id.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Id.
                    </P>
                </FTNT>
                <P>
                    In a 2014 notice of proposed rulemaking (2014 proposed rule), the Department proposed giving previously denied petitioners a conditional opportunity to re-petition.
                    <SU>32</SU>
                    <FTREF/>
                     The 2014 proposed rule would have allowed re-petitioning only if:
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         79 FR 30766, 30767 (May 29, 2014).
                    </P>
                </FTNT>
                <P>(i) Any third parties that participated as a party in an administrative reconsideration or Federal Court appeal concerning the petitioner has consented in writing to the re-petitioning; and</P>
                <P>(ii) The petitioner proves, by a preponderance of the evidence, that either:</P>
                <P>(a) A change from the previous version of the regulations to the current version of the regulations warrants reconsideration of the final determination; or</P>
                <P>
                    (b) The “reasonable likelihood” standard was misapplied in the final determination.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         25 CFR 83.4(b)(1) (proposed 2014); 
                        <E T="03">see also</E>
                         79 FR 30774 (containing the proposed provision).
                    </P>
                </FTNT>
                <P>
                    In the preamble of the 2014 proposed rule, the Department explained that the requirement of third-party consent would “recognize[ ] the equitable interests of third parties that expended sometimes significant resources to participate in the adjudication [of a final determination in a reconsideration or appeal] and have since developed reliance interests in the outcome of such adjudication.” 
                    <SU>34</SU>
                    <FTREF/>
                     The Department did not discuss the extent to which the third-party consent condition might limit the number of re-petitioners.
                    <SU>35</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         79 FR 30767.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See Burt Lake Band of Ottawa and Chippewa Indians</E>
                         v. 
                        <E T="03">Bernhardt,</E>
                         613 F. Supp. 3d 371, 385 (D.D.C. 2020) (noting that the record “does not provide statistics to show . . . how many [petitioners] would be able to re-apply under the limited proposed exception”). The Department has since identified eleven denied petitioners that would have been subject to the third-party consent condition under the 2014 proposed rule: the Duwamish Tribe, the Tolowa Nation, the Nipmuc Nation (Hassanamisco Band), the Webster/Dudley Band of Chaubunagungamaug Nipmuck Indians, the Eastern Pequot Indians of Connecticut and Paucatuck Eastern Pequot Indians of Connecticut (collectively, the “Eastern Pequot Indians”), the Schaghticoke Tribal Nation, the Golden Hill Paugussett Tribe, the Snohomish Tribe of Indians, the Chinook Indian Nation, and the Ramapough Mountain Indians.
                    </P>
                </FTNT>
                <P>
                    Similarly, the Department did not specify the extent to which the other conditions listed above—requiring an unsuccessful petitioner to prove that either a change in the regulations or a misapplication of the reasonable likelihood standard warrants reconsideration—might limit the number of re-petitioners. However, as a general matter, the Department noted that “the changes to the regulations are generally intended to provide uniformity based on previous decisions” (that is, uniformity between decisions predating and postdating the revision), so the circumstances in which re-petitioning might be “appropriate” would be “limited.” 
                    <SU>36</SU>
                    <FTREF/>
                     The proposed rule did not identify any change to the seven mandatory criteria that “would likely change [any negative] previous final determination[s].” 
                    <SU>37</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         79 FR 30767.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    Ultimately, in the 2015 final rule updating part 83, the Department expressly retained the ban on re-petitioning.
                    <SU>38</SU>
                    <FTREF/>
                     In the preamble of the rule, the Department summarized its reasoning as follows: “The final rule promotes consistency, expressly providing that evidence or methodology that was sufficient to satisfy any particular criterion in a previous positive decision on that criterion will be sufficient to satisfy the criterion for a present petitioner. The Department has petitions pending that have never been reviewed. Allowing for re-petitioning by denied petitioners would be unfair to petitioners who have not yet had a review, and would hinder the goals of increasing efficiency and timeliness by imposing the additional workload associated with re-petitions on the Department, and OFA in particular. The part 83 process is not currently an avenue for re-petitioning.” 
                    <SU>39</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         25 CFR 83.4(d); 
                        <E T="03">see</E>
                         80 FR 37888-89.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         80 FR 37875.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. Remand of the Ban</HD>
                <P>
                    In 2020, two Federal district courts—one in a case brought by a former petitioner seeking acknowledgement as the Chinook Indian Nation 
                    <SU>40</SU>
                    <FTREF/>
                     and one in a case brought by a former petitioner seeking acknowledgement as the Burt Lake Band of Ottawa and Chippewa Indians 
                    <SU>41</SU>
                    <FTREF/>
                    —held that the Department's reasons for implementing the ban, as articulated in the preamble to the 2015 final rule revising part 83, were arbitrary and capricious under the Administrative Procedure Act (APA). As an initial matter, both courts agreed with the Department that the Department's authority over Indian affairs generally authorized a re-petition ban.
                    <SU>42</SU>
                    <FTREF/>
                     Additionally, both courts noted that their review was highly deferential to the agency's decision under applicable tenets of administrative law.
                    <SU>43</SU>
                    <FTREF/>
                     As a result, the narrow question left for the courts to decide was whether the Department, in retaining the ban, “examine[d] the relevant data and articulate[d] a satisfactory explanation for its action including a `rational connection between the facts found and the choice made.' ” 
                    <SU>44</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">Chinook Indian Nation</E>
                         v. 
                        <E T="03">Bernhardt,</E>
                         No. 3:17-cv-05668-RBL, 2020 WL 128563 (W.D. Wash. Jan. 10, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">Burt Lake Band of Ottawa and Chippewa Indians</E>
                         v. 
                        <E T="03">Bernhardt,</E>
                         613 F. Supp. 3d 371 (D.D.C. 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">Chinook,</E>
                         2020 WL 128563, at *6 (stating that “the Court agrees with DOI that its expansive power over Indian affairs encompasses the re-petition ban” (citation omitted)); 
                        <E T="03">Burt Lake,</E>
                         613 F. Supp. 3d at 378 (stating that “the regulation [banning re-petitioning] comports with the agency's authority”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         
                        <E T="03">Chinook,</E>
                         2020 WL 128563, at *7 (citation omitted); 
                        <E T="03">Burt Lake,</E>
                         613 F. Supp. 3d at 379 (citation omitted).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         
                        <E T="03">Motor Vehicle Mfrs. Ass'n of U.S., Inc.</E>
                         v. 
                        <E T="03">State Farm Mut. Auto. Ins. Co.,</E>
                         463 U.S. 29, 43 (1983) (quoting 
                        <E T="03">Burlington Truck Lines</E>
                         v. 
                        <E T="03">United States,</E>
                         371 U.S. 156, 168 (1962)).
                    </P>
                </FTNT>
                <P>
                    Both courts concluded that the Department had not satisfied this standard. The 
                    <E T="03">Chinook</E>
                     court held that the Department's reasons were “illogical, conclusory, and unsupported by the administrative record,” as well as not “rationally connect[ed] . . . to the evidence in the record.” 
                    <SU>45</SU>
                    <FTREF/>
                     Similarly, the 
                    <E T="03">Burt Lake</E>
                     court concluded that the Department's reasons were “neither well-reasoned nor rationally connected to the facts in the record.” 
                    <SU>46</SU>
                    <FTREF/>
                     Both courts concluded that, despite the Department's argument that the 2015 revisions to part 83 did not make any substantive changes to the criteria other 
                    <PRTPAGE P="3630"/>
                    than those specifically identified, the Department had failed to explain why the Department could permissibly maintain the ban given those changes and others, after having proposed a limited re-petition process in the 2014 proposed rule.
                    <SU>47</SU>
                    <FTREF/>
                     The 
                    <E T="03">Chinook</E>
                     court focused in particular on a provision introduced in the 2015 final rule that sought to promote consistent implementation of the criteria and stated that “[t]here is no reason why new petitioners should be entitled to this `consistency' while past petitioners are not.” 
                    <SU>48</SU>
                    <FTREF/>
                     The 
                    <E T="03">Burt Lake</E>
                     court linked reform of the Federal acknowledgment process generally with an “opportunity to re-petition and to seek to satisfy the new criterion.” 
                    <SU>49</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">Chinook,</E>
                         2020 WL 128563, at *8.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         
                        <E T="03">Burt Lake,</E>
                         613 F. Supp. 3d at 386.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         
                        <E T="03">See Chinook,</E>
                         2020 WL 128563, at *4-5 (identifying five “notable” changes in the 2015 version of part 83); 
                        <E T="03">Burt Lake,</E>
                         613 F. Supp. 3d at 383-84 (highlighting two changes that the court deemed “not minor”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         
                        <E T="03">Chinook,</E>
                         2020 WL 128563, at *8.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         
                        <E T="03">Burt Lake,</E>
                         613 F. Supp. 3d at 384.
                    </P>
                </FTNT>
                <P>
                    Neither the 
                    <E T="03">Chinook</E>
                     nor 
                    <E T="03">Burt Lake</E>
                     courts struck down the 2015 final rule in whole or in part. Rather, both courts remanded the ban to the Department for further consideration.
                    <SU>50</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         
                        <E T="03">Chinook,</E>
                         2020 WL 128563, at *10; 
                        <E T="03">Burt Lake,</E>
                         613 F. Supp. 3d at 387.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">E. 2022 Proposed Rule</HD>
                <P>
                    Pursuant to the courts' orders, on December 18, 2020, the Department announced an intent to reconsider the ban and invited federally recognized Indian Tribes to consult on whether to allow or deny re-petitioning. On February 25, 2021, the Department held a Tribal consultation session. The Department also solicited written comments on the ban through March 31, 2021. On April 27, 2022, the Department published a proposed rule (2022 proposed rule) to retain the ban, albeit based on revised justifications in light of the courts' rejection of the reasoning set forth in the 2015 final rule.
                    <SU>51</SU>
                    <FTREF/>
                     The 2022 proposed rule highlighted the following in proposing to retain the ban:
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         87 FR 24908.
                    </P>
                </FTNT>
                <P>(1) The substantive integrity of the Department's previous, negative determinations;</P>
                <P>(2) The due process that has already been afforded to unsuccessful petitioners;</P>
                <P>(3) The non-substantive nature of the revisions to part 83 in the 2015 final rule;</P>
                <P>(4) The interests of the Department and third parties in finality; and</P>
                <P>
                    (5) The inappropriateness of allowing re-petitioning based on new evidence.
                    <SU>52</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         87 FR 24910-16.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">F. 2024 Proposed Rule</HD>
                <P>Following publication of the 2022 proposed rule, the Department held two Tribal consultation sessions with federally recognized Indian Tribes and a listening session with present, former, and prospective petitioners for Federal acknowledgment. The Department also solicited written comments through July 6, 2022, and received approximately 270 comments from federally recognized Indian Tribes and a wide range of stakeholders, including former and prospective part 83 petitioners, various State and local government representatives, individuals, and others.</P>
                <P>
                    After reviewing the written comments, as well as the transcripts of the consultation and listening sessions, the Department engaged in further deliberation of three options: (1) keeping the ban in place; (2) creating a limited avenue for re-petitioning; and (3) creating an open-ended avenue for re-petitioning, with few or no limitations. On July 12, 2024, the Department published a proposed rule (2024 proposed rule) to create a limited exception to the ban,
                    <SU>53</SU>
                    <FTREF/>
                     in line with the second option, through implementation of a re-petition authorization process.
                    <SU>54</SU>
                    <FTREF/>
                     In the preamble of the rule, the Department explained that its proposal “reflect[ed] a reconsidered policy on re-petitioning for Federal acknowledgment.” 
                    <SU>55</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         89 FR 57097.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         
                        <E T="03">See</E>
                         89 FR 57097, 57100-02 (summarizing the proposed re-petition authorization process).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         89 FR 57100.
                    </P>
                </FTNT>
                <P>
                    Following publication of the 2024 proposed rule, the Department again held two Tribal consultation sessions with federally recognized Indian Tribes and a listening session with present, former, and prospective petitioners for Federal acknowledgment. The Department also solicited written comments through September 13, 2024, and received 163 comments from federally recognized Indian Tribes and a wide range of stakeholders.
                    <SU>56</SU>
                    <FTREF/>
                     What follows is a summary of this final rule, as well as a discussion of the comments that informed the Department's deliberations.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         
                        <E T="03">https://www.regulations.gov/document/BIA-2022-0001-0194/comment.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Summary of the Final Rule</HD>
                <HD SOURCE="HD2">A. Re-Petition Authorization Process</HD>
                <P>
                    This final rule appends a new subpart titled “Subpart D—Re-Petition Authorization Process” to the end of the current part 83 regulations. The new subpart applies to “unsuccessful petitioner[s],” which is a new term defined in § 83.1.
                    <SU>57</SU>
                    <FTREF/>
                     Pursuant to the new subpart, an unsuccessful petitioner that seeks to re-petition must first plausibly allege that the outcome of the previous, negative final determination would change to positive on reconsideration based on one or both of the following: (1) a change in part 83 (from the 1978 or 1994 regulations to the 2015 regulations); and/or (2) new evidence.
                    <SU>58</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         25 CFR 83.1 (defining an “unsuccessful petitioner” as “an entity that was denied Federal acknowledgment after petitioning under the acknowledgment regulations at part 54 of this chapter (as they existed before March 30, 1982) or part 83”). The term “unsuccessful petitioner” applies only to those that have received a final agency decision, not to those that have received only a proposed finding or that have withdrawn from the process prior to receiving a final agency decision. For a complete list of unsuccessful petitioners, see Petitions Denied Through 25 CFR part 83 (34 Petitions), Office of Fed. Acknowledgment, 
                        <E T="03">https://www.bia.gov/as-ia/ofa/petitions-resolved/denied</E>
                         (last visited Jan. 7, 2025) (listing thirty-four unsuccessful petitioners as of November 9, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         25 CFR 83.48.
                    </P>
                </FTNT>
                <P>
                    This standard, requiring a petitioner to state a plausible claim for re-petitioning based on one of the conditions above, is similar to the standard for surviving a motion to dismiss,
                    <SU>59</SU>
                    <FTREF/>
                     except that the Department may conduct limited fact-finding to assess the reasonableness of the claim (for example, cross-referencing alleged facts with facts discussed during the original evaluation of a petition, if able to be done in a timely manner). Under the standard, a petitioner's allegations regarding changes in part 83 and/or new evidence must address the deficiencies that, according to the Department, prevented the petitioner from satisfying all seven mandatory criteria (located at § 83.11(a) through (g) in the 2015 regulations). Otherwise, even if the allegations were taken as true, they would not change the previous, negative outcome and, therefore, would not justify reconsideration. That is, because Federal acknowledgment requires satisfaction of all seven criteria,
                    <SU>60</SU>
                    <FTREF/>
                     the petitioner's re-petition request must address all of the criteria that the petitioner did not satisfy. For example, if the Department determined in the previous, negative final determination that the petitioner did not satisfy criteria (a) (Indian Entity Identification), (b) (Community), and (c) (Political Authority), then the petitioner must plausibly allege that application of the 2015 regulations, consideration of new 
                    <PRTPAGE P="3631"/>
                    evidence, or both would address the deficiencies relating to all three criteria, not only one or two.
                </P>
                <FTNT>
                    <P>
                        <SU>59</SU>
                         
                        <E T="03">See Ashcroft</E>
                         v. 
                        <E T="03">Iqbal,</E>
                         556 U.S. 662, 678 (2009) (explaining that, “[t]o survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to `state a claim to relief that is plausible on its face'” (quoting 
                        <E T="03">Bell Atlantic Corp.</E>
                         v. 
                        <E T="03">Twombly,</E>
                         550 U.S. 544, 570 (2007)).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>60</SU>
                         25 CFR 83.43(a); 25 CFR 83.5.
                    </P>
                </FTNT>
                <P>
                    A decision granting authorization to re-petition (grant of authorization to re-petition) is not the same as a final agency decision granting Federal acknowledgment. Rather, a decision granting authorization to re-petition simply permits the petitioner to proceed with a new documented petition through the Federal acknowledgment process.
                    <SU>61</SU>
                    <FTREF/>
                     Upon authorization to re-petition, the petitioner must submit a complete documented petition under § 83.21 to request Federal acknowledgment and will then receive substantive review of the petitioner's claims and evidence.
                </P>
                <FTNT>
                    <P>
                        <SU>61</SU>
                         25 CFR 83.61(a).
                    </P>
                </FTNT>
                <P>
                    In the interest of finality, any petitioner denied prior to the effective date of this final rule must request to re-petition within five years of the effective date of the rule.
                    <SU>62</SU>
                    <FTREF/>
                     Any petitioner denied after the effective date of the final rule will have to request to re-petition within five years of the date of issuance of the petitioner's negative final determination.
                    <SU>63</SU>
                    <FTREF/>
                     However, the five-year time limit applicable to a petitioner denied after the effective date of the final rule will be tolled during any period of judicial review of the negative final determination.
                    <SU>64</SU>
                    <FTREF/>
                     Additionally, any petitioner denied authorization to re-petition under the re-petition authorization process—or denied Federal acknowledgment upon re-petitioning, after receiving authorization to do so—will be prohibited from submitting a new re-petition request based on new evidence.
                    <SU>65</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>62</SU>
                         25 CFR 83.49(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>63</SU>
                         25 CFR 83.49(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>64</SU>
                         25 CFR 83.49(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>65</SU>
                         25 CFR 83.47(c). This provision does not prevent a petitioner from resubmitting a re-petition request withdrawn prior to receipt of a decision on the request. 25 CFR 83.56.
                    </P>
                </FTNT>
                <P>
                    In many respects, the Department's processing of a re-petition request will mirror the processing of a group's documented petition, particularly the procedures relating to notice and comment. To initiate the re-petition authorization process, an unsuccessful petitioner must submit a complete re-petition request to OFA, explaining how the petitioner meets the conditions of §§ 83.47 through 83.49.
                    <SU>66</SU>
                    <FTREF/>
                     Upon receipt of a request containing all of the documentation required under § 83.50, OFA will publish notice of the request in the 
                    <E T="04">Federal Register</E>
                     and on the OFA website.
                    <SU>67</SU>
                    <FTREF/>
                     Additionally, OFA will provide notice to certain third parties, including specific government officials of the State in which the petitioner is located, federally recognized Indian Tribes that may have an interest in the petitioner's acknowledgment determination, and any third parties that participated in an administrative reconsideration or Federal Court appeal concerning the petitioner's original documented petition.
                    <SU>68</SU>
                    <FTREF/>
                     OFA will also provide notice to individuals and entities that had interested-party or informed-party status under the 1994 regulations,
                    <SU>69</SU>
                    <FTREF/>
                     with the understanding that those individuals and entities previously “request[ed] to be kept informed of general actions regarding a specific petitioner” and presumably wish to remain informed.
                    <SU>70</SU>
                    <FTREF/>
                     The Department will then allow for comment on the re-petition request and give the petitioner an opportunity to respond to comments received.
                    <SU>71</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>66</SU>
                         25 CFR 83.50(a)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>67</SU>
                         25 CFR 83.51(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>68</SU>
                         25 CFR 83.51(b)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>69</SU>
                         25 CFR 83.1 (1994) (defining “[i]nterested party” and “[i]nformed party”); 59 FR 9293.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>70</SU>
                         25 CFR 83.22(d)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>71</SU>
                         25 CFR 83.52 (stating that publication of notice of the re-petition request will be followed by a 120-day comment period and that, if OFA receives a timely objection and evidence challenging the request, then the petitioner will have 60 days to submit a written response).
                    </P>
                </FTNT>
                <P>
                    After the close of the comment-and-response period, the Department will consider the re-petition request ready for active consideration, and within 30 days of the close of the comment-and-response period, OFA will place the request on a register listing all requests that are ready for active consideration.
                    <SU>72</SU>
                    <FTREF/>
                     The order of consideration of re-petition requests will be determined by the date on which OFA places each request on OFA's register.
                </P>
                <FTNT>
                    <P>
                        <SU>72</SU>
                         25 CFR 83.52(d); 
                        <E T="03">see also</E>
                         25 CFR 83.53(a) (describing the register of re-petition requests that OFA will maintain and make available on its website).
                    </P>
                </FTNT>
                <P>
                    Pursuant to § 83.23(a)(2), the Department's highest priority is to complete reviews of documented petitions already under review, and those reviews will take precedence over reviews of re-petition requests.
                    <SU>73</SU>
                    <FTREF/>
                     Pursuant to this final rule, the Department will also prioritize review of documented petitions awaiting review and new documented petitions over review of re-petition requests, at least initially.
                    <SU>74</SU>
                    <FTREF/>
                     Re-petition requests pending on OFA's register for more than two years will have priority over any subsequently filed documented petitions.
                    <SU>75</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>73</SU>
                         25 CFR 83.53(c) (stating, in part, that “the Department will prioritize review of documented petitions over review of re-petition requests”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>74</SU>
                         
                        <E T="03">See</E>
                         25 CFR 83.53(c).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>75</SU>
                         25 CFR 83.53(c).
                    </P>
                </FTNT>
                <P>
                    Once AS-IA is ready to begin review of a specific request, OFA will notify the petitioner and third parties accordingly.
                    <SU>76</SU>
                    <FTREF/>
                     In making a decision, AS-IA will consider the claims and evidence in the re-petition request and in any comments and responses received.
                    <SU>77</SU>
                    <FTREF/>
                     AS-IA may also consider other information,
                    <SU>78</SU>
                    <FTREF/>
                     such as documentation contained in the record associated with the petitioner's denied petition and additional explanations and information requested by AS-IA from commenting parties or the petitioner. Any such additional material considered by AS-IA will be added to the record and shared with the petitioner.
                    <SU>79</SU>
                    <FTREF/>
                     The petitioner then will have an opportunity to respond to any additional material considered.
                    <SU>80</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>76</SU>
                         25 CFR 83.54.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>77</SU>
                         25 CFR 83.55(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>78</SU>
                         25 CFR 83.55(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>79</SU>
                         25 CFR 83.55(c).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>80</SU>
                         25 CFR 83.55(c) (providing the petitioner with a 60-day opportunity to respond to the additional material).
                    </P>
                </FTNT>
                <P>
                    AS-IA will issue a decision on a re-petition request within 180 days of the date on which OFA notifies the petitioner that AS-IA has begun review, subject to any suspension period.
                    <SU>81</SU>
                    <FTREF/>
                     AS-IA will grant the petitioner authorization to re-petition if AS-IA finds that the petitioner meets the conditions of §§ 83.47 through 83.49.
                    <SU>82</SU>
                    <FTREF/>
                     Conversely, AS-IA will deny authorization to re-petition if AS-IA finds that the petitioner has not met the conditions of §§ 83.47 through 83.49.
                    <SU>83</SU>
                    <FTREF/>
                     OFA will then provide notice of AS-IA's decision to the petitioner and third parties.
                    <SU>84</SU>
                    <FTREF/>
                     Additionally, OFA will publish notice of the decision in the 
                    <E T="04">Federal Register</E>
                     and on the OFA website.
                    <SU>85</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>81</SU>
                         
                        <E T="03">See</E>
                         25 CFR 83.57 and 83.58 (discussing suspension of review). The way that the clock runs during the review of a re-petition request is similar to the way that it runs during the review of a documented petition. 
                        <E T="03">See, e.g.,</E>
                         25 CFR 83.32 (requiring OFA to complete its review under Phase I “within six months after notifying the petitioner . . . that OFA has begun review of the petition,” subject to suspension “any time the Department is waiting for a response or additional information from the petitioner”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>82</SU>
                         25 CFR 83.59(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>83</SU>
                         25 CFR 83.59(c).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>84</SU>
                         25 CFR 83.60.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>85</SU>
                         25 CFR 83.60.
                    </P>
                </FTNT>
                <P>
                    AS-IA's decision will become effective immediately and will not be subject to administrative appeal.
                    <SU>86</SU>
                    <FTREF/>
                     Furthermore, a grant of authorization to re-petition is not final for the Department. Rather, as noted above, it simply permits the petitioner to proceed through the Federal acknowledgment process with a new documented 
                    <PRTPAGE P="3632"/>
                    petition.
                    <SU>87</SU>
                    <FTREF/>
                     By contrast, a decision denying a re-petition request (denial of authorization to re-petition) represents the consummation of the Department's decision-making about the petitioner's recognition status, is final for the Department, and is a final agency decision under the APA.
                    <SU>88</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>86</SU>
                         25 CFR 83.61.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>87</SU>
                         25 CFR 83.61(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>88</SU>
                         25 CFR 83.61(b).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Additional, Related Revisions</HD>
                <P>Consistent with the introduction of a new re-petition authorization process, this final rule inserts new definitions for “re-petition authorization process” and “re-petitioning” in § 83.1, as well as a new definition for “unsuccessful petitioner,” as noted above. This rule also makes a change to § 83.4(d), the provision that previously prohibited re-petitioning. The change notes a limited exception to the re-petition ban for unsuccessful petitioners that meet the conditions of §§ 83.47 through 83.49, as determined by AS-IA in the re-petition authorization process.</P>
                <P>
                    This final rule also gives any petitioner currently proceeding under the 1994 regulations the choice to proceed instead under the 2015 regulations.
                    <SU>89</SU>
                    <FTREF/>
                     In doing so, the rule presents a choice similar to the one given to pending petitioners in the 2015 regulations.
                    <SU>90</SU>
                    <FTREF/>
                     Absent the choice, a petitioner proceeding under the 1994 regulations that wants to proceed under the 2015 regulations would have to await a final determination and then receive authorization to re-petition if the determination is negative. By allowing a petitioner to switch directly to the current regulations, the relevant provision promotes efficiency.
                </P>
                <FTNT>
                    <P>
                        <SU>89</SU>
                         25 CFR 83.47(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>90</SU>
                         
                        <E T="03">See</E>
                         25 CFR 83.7(b) (giving “each petitioner that . . . has not yet received a final agency decision” the choice “to proceed under these revised regulations” or “to complete the petitioning process under the previous version of the acknowledgment regulations as published in 25 CFR part 83, revised as of April 1, 1994”).
                    </P>
                </FTNT>
                <P>
                    Finally, this final rule clarifies the Department's position on the severability of the provisions in the regulations promulgated here.
                    <SU>91</SU>
                    <FTREF/>
                     Notwithstanding the Department's position that the provisions, taken together, properly balance competing interests, the Department considered whether the provisions could stand alone and has concluded that they could. Specifically, the Department considered whether, if one of the conditions on re-petitioning set forth at §§ 83.47 through 83.49 were held to be invalid, the other conditions should remain valid. The Department's position is that they should because each provision could “function sensibly” without the others.
                    <SU>92</SU>
                    <FTREF/>
                     For example, a change in part 83 would remain a valid basis for a re-petition request under § 83.48(a) even if a court held § 83.48(b) (allowing new evidence to be basis for a re-petition request) to be invalid, and vice versa. The Department also considered whether the provisions describing the processing of a re-petition request, set forth at §§ 83.50 through 83.61, could stand alone, and the Department's position is that they could. For example, provisions relating to notice and comment and the order of priority for review could each function independently if other requirements were determined to be invalid.
                </P>
                <FTNT>
                    <P>
                        <SU>91</SU>
                         25 CFR 83.62.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>92</SU>
                         
                        <E T="03">Belmont Mun. Light Dep't</E>
                         v. 
                        <E T="03">FERC,</E>
                         38 F. 4th 173, 188 (D.C. Cir. 2022) (citation omitted).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Technical Revisions</HD>
                <P>Finally, this final rule makes technical revisions to the legal authority citation for part 83 because 25 U.S.C. 479a-1 has been transferred to 25 U.S.C. 5131 and Public Law 103-454 Sec. 103 (Nov. 2, 1994) has been reprinted in the United States Code at 25 U.S.C. 5130 note (Congressional Findings). This final rule also makes a technical revision to the mailing address listed in § 83.9.</P>
                <HD SOURCE="HD1">III. Discussion of the Comments on the 2024 Proposed Rule</HD>
                <HD SOURCE="HD2">A. Overview</HD>
                <P>The Department conducted three virtual sessions to seek input on the 2024 proposed rule. The Department hosted two virtual consultation sessions with federally recognized Indian Tribes and a listening session with present, former, and prospective petitioners. In each virtual session, the AS-IA engaged with participants, provided background on the proposed changes to part 83, and provided a detailed explanation of the proposed changes.</P>
                <P>The sessions and written comment period (which closed on September 13, 2024) garnered comments from the following federally recognized Indian Tribes: (1) Santa Ynez Band of Chumash Mission Indians; (2) the Morongo Band of Mission Indians; (3) the Puyallup Tribe; (4) the Confederated Tribes of Siletz Indians; (5) the Yuhaaviatam of San Manuel Nation; (6) the Tunica-Biloxi Indian Tribe; (7) the Tulalip Tribes; (8) the Eastern Band of Cherokee Indians; (9) the Swinomish Indian Tribal Community; (10) the Suquamish Indian Tribe; (11) the Muckleshoot Indian Tribe; (12) the Shawnee Tribe; (13) the Seneca Nation of Indians; (14) the Delaware Nation; (15) the Federated Indians of Graton Rancheria; and (16) the Shinnecock Indian Nation.</P>
                <P>Others that participated in the listening session and that submitted written comments included State-recognized Tribes; non-federally recognized groups (including unsuccessful petitioners for Federal acknowledgment); national associations (including inter-Tribal organizations), State and local government representatives, congressional delegations and coalitions; and individuals associated with educational institutions, including Yale University, Stanford University, and the Indian Legal Clinic of Arizona State University's College of Law.</P>
                <P>The federally recognized Indian Tribes that commented either verbally or through written comments generally oppose re-petitioning, with the exception of the Tunica-Biloxi Indian Tribe and the Shinnecock Indian Nation. By contrast, non-federally recognized groups (including unsuccessful petitioners) support an avenue for re-petitioning.</P>
                <P>State and local government representatives mostly aligned with the federally recognized Indian Tribes that oppose re-petitioning. Those commenters noted the resources already expended to oppose petitions for Federal acknowledgment and that would have to be spent opposing requests to re-petition. They also highlighted the potential consequences of Federal acknowledgment on local communities, including detrimental economic impacts. However, not all of the State and local government representatives who submitted comments oppose re-petitioning. A Connecticut State senator and group of State representatives submitted a letter in support of the 2024 proposed rule, as well as in support of three unsuccessful petitioners based in Connecticut: the Golden Hill Paugussett Tribe, the Schaghticoke Tribal Nation, and the Eastern Pequot Indians. The Mayor of Charlestown, Indiana, also submitted a comment in support of the 2024 proposed rule and of unsuccessful petitioners, stating that “[i]t is important for . . . all of Indiana to acknowledge and respect the legacy and resilience of the Indigenous communities that occupied the land where our cities were established.” Indiana Senators Todd Young and Mike Braun similarly submitted a letter in support of the 2024 proposed rule, while also asserting that the rulemaking has taken too much time to complete.</P>
                <P>
                    Over one hundred individuals submitted either written comments or verbal comments in support of re-
                    <PRTPAGE P="3633"/>
                    petitioning, often in support of specific groups previously denied Federal acknowledgment. Many individual commenters expressed support for the Golden Hill Paugussett Tribe, the Schaghticoke Tribal Nation, and the Eastern Pequot Indians. Individual commenters also expressed support for the Chinook Indian Nation, the Muwekma Ohlone Tribe, and the Ma-Chis Lower Creek Indian Tribe.
                </P>
                <P>The consultations, listening session, and comment period provided a valuable opportunity for federally recognized Indian Tribes and stakeholders, including non-federally recognized groups and State and local government representatives, to offer comments on whether the Department should implement a re-petition authorization process. The comments ranged from wholly supportive to strongly opposed. Although most federally recognized Indian Tribes that commented oppose re-petitioning, many offered constructive feedback on the 2024 proposed rule. The majority of non-Tribal commenters were supportive of a re-petition authorization process.</P>
                <P>What follows is a summary of the comments received, organized by issue, and the Department's responses to the comments.</P>
                <HD SOURCE="HD2">B. Comments Citing Fairness as a Justification for the Re-Petition Authorization Process</HD>
                <P>Numerous commenters cited fairness as a justification for allowing re-petitioning. Commenters emphasized the significant impact of Federal recognition on the lives of a petitioner's members, for example, linking recognition with increased access to federal funding for housing, healthcare, and education. Some cited the potential economic benefit of recognition, like a boost in tourism that would benefit surrounding communities as well, while others focused on the “dignity and respect” accorded through Federal acknowledgment. The Indian Legal Clinic of Arizona State University's College of Law commented that a “lack of recognition can negatively impact a Tribe's ability to exercise its self-determination in areas such as defending sovereignty, protecting culture, accessing resources, and ensuring the survival of tribal ways of life.” The Shinnecock Indian Nation commented that leaving any Tribe entitled to acknowledgment off of the Department's list of federally recognized Indian Tribes is a “horrible mistake that lasts for generations.” The Haliwa-Saponi Indian Tribe (a State-recognized Tribe in North Carolina) relatedly stated that the re-petitioning process “safeguards against unintentional error in the evaluation of evidence from petitioners.” The MOWA Band of Choctaw Indians (an unsuccessful petitioner) stated that implementing a re-petition authorization process “not only aligns with the principles of justice and fairness but also provides a necessary administrative pathway for tribes to seek reconsideration without resorting to the courts.”</P>
                <P>Several commenters stated that prohibiting unsuccessful petitioners denied under the previous regulations from re-petitioning under the 2015 regulations would be unfair given that the changes in the 2015 regulations were intended to promote consistency, efficiency, and fairness. For example, one unsuccessful petitioner (the Muwekma Ohlone Tribe) stated that the proposed process will ensure “equal protection to all tribal petitioners.” Echoing that point, another unsuccessful petitioner (the Miami Nation of Indians) asserted that “all petitioners” should be allowed to avail themselves of the process set forth in the 2015 regulations. The Alliance of Colonial Era Tribes, an inter-Tribal organization, similarly stated that “all petitions” should be “measured against the same written standards,” to “improve the consistency and integrity of the process as a whole.”</P>
                <P>Others asserted that the Department should allow re-petitioning because of the difficulty of satisfying the seven mandatory criteria under the previous regulations. The Tunica-Biloxi Indian Tribe, for example, stated that many unsuccessful petitioners “may not have had the resources or expertise required to meet the [Department's] evidentiary standards at the time of their initial petitions.”</P>
                <P>Several petitioners claimed that they were treated unfairly during the review of their respective petitions. Based on the allegedly unfair treatment of unsuccessful petitioners, a number of commenters expressed support for a re-petition process broader than that in the 2024 proposed rule. For example, the Steilacoom Tribe (an unsuccessful petitioner) stated that all petitioners “harmed by this broken system should have an opportunity to re-petition.” Other unsuccessful petitioners shared similar comments, as did individual supporters of those petitioners.</P>
                <P>By contrast, those opposed to re-petitioning defended the integrity of the Federal acknowledgment process. The Swinomish Indian Tribal Community explained that the process afforded to unsuccessful petitioners was “extensive, lengthy, [and] fact-intensive” and involved “an exhaustive review of facts and claims.” Quoting language from the preambles of the 2022 proposed rule and 2024 proposed rules, the Eastern Band of Cherokee Indians similarly stated that the Department's previous, negative determinations are “substantively sound.” The Tribe emphasized that unsuccessful petitioners had ample opportunities to address apparent deficiencies in their materials, respond to the Department's preliminary findings, and appeal their negative determinations administratively and in Federal court. The Santa Ynez Band of Chumash Mission Indians and the Morongo Band of Mission Indians likewise noted that unsuccessful petitioners had opportunities for redress through the Federal courts, and they noted that unsuccessful petitioners retain the option to seek Federal recognition through Congress. The Connecticut Towns of Ledyard, North Stonington, and Preston (Connecticut Towns) echoed that point, asserting the Department “ignore[d] that unsuccessful petitioners still have the option of seeking congressional acknowledgment.”</P>
                <P>
                    The Connecticut Towns otherwise described the re-petition authorization process in the 2024 proposed rule as “illogical, unfair, and time-consuming.” Other commenters shared that sentiment and proposed alternatives to the process. The Eastern Band of Cherokee Indians, for example, stated that, to comply with the 
                    <E T="03">Chinook</E>
                     and 
                    <E T="03">Burt Lake</E>
                     decisions, “the Department need only provide a fuller, more detailed explanation for its already sound policy” banning re-petitioning. Another commenter suggested that, instead of removing the ban, the Department should withdraw the 2015 final rule revising the regulations and reinstate the 1994 regulations.
                </P>
                <P>
                    <E T="03">Response:</E>
                     As the Department explained in the 2024 proposed rule, the Department considers fairness to unsuccessful petitioners to be a valid justification for implementing a re-petition authorization process, particularly given the high-stakes nature of the Federal acknowledgment process. Even if the reasons for upholding the ban in the 2022 proposed rule were valid, the Department has decided to create a conditional, time-limited opportunity to re-petition based on a reconsidered policy that reflects greater consideration of the interests of unsuccessful petitioners. The Department's reconsidered policy, in turn, aligns more closely with the decisions in 
                    <E T="03">Chinook</E>
                     and 
                    <E T="03">Burt Lake</E>
                     than the policy underlying the 2022 proposed rule. Both courts suggested 
                    <PRTPAGE P="3634"/>
                    that fairness is a valid justification for re-petitioning, particularly given the Department's references to “reforms” made in the 2015 revision to part 83.
                    <SU>93</SU>
                    <FTREF/>
                     The 
                    <E T="03">Burt Lake</E>
                     court noted, for example, that the plaintiff in that case “persuasively contend[ed] that the only way for previously-denied petitioners to get `fair' and `consistent' results would be by allowing them to re-petition.” 
                    <SU>94</SU>
                    <FTREF/>
                     Additionally, “although it is true that, in the absence of a re-petition authorization process, unsuccessful petitioners could still `seek legislative recognition if substantial new evidence develops,” 
                    <SU>95</SU>
                    <FTREF/>
                     the Department believes that the part 83 process, as conditioned by this rule, “should continue to be an option given the Department's familiarity with the petitioner, expertise in evaluating evidence, and management of all Indian affairs, including decisions regarding Federal acknowledgment.” 
                    <SU>96</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>93</SU>
                         80 FR 37862.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>94</SU>
                         
                        <E T="03">Burt Lake,</E>
                         613 F. Supp. 3d at 384.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>95</SU>
                         89 FR 57103 (quoting 87 FR 24916).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>96</SU>
                         89 FR 57103 (citing 25 U.S.C. 2).
                    </P>
                </FTNT>
                <P>
                    In response to comments recommending that the Department withdraw or vacate the 2015 final rule, the Department rejects that suggestion in light of the interests in fairness mentioned above. As stated in the preamble of the 2015 final rule, there was “wide agreement by the public” that the part 83 process prior to the 2015 revision was “broken,” 
                    <SU>97</SU>
                    <FTREF/>
                     a point that both the 
                    <E T="03">Chinook</E>
                     and 
                    <E T="03">Burt Lake</E>
                     courts highlighted.
                    <SU>98</SU>
                    <FTREF/>
                     Although the Department does not adopt that characterization and maintains the validity of Department's process under the previous regulations, as well as the validity of Departmental precedent, the Department is nevertheless willing to give unsuccessful petitioners a path for arguing why reconsideration under the 2015 regulations is warranted. Furthermore, the Department considers a threshold, re-petition authorization process an appropriate way to balance interests in re-petitioning with third-party interests in keeping the ban in place. Those interests are discussed further below.
                </P>
                <FTNT>
                    <P>
                        <SU>97</SU>
                         80 FR 37864.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>98</SU>
                         
                        <E T="03">Burt Lake,</E>
                         613 F. Supp. 3d at 380; 
                        <E T="03">Chinook,</E>
                         2020 WL 128563, at *2.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Additional Discussion of Third-Party Opposition to Re-Petitioning</HD>
                <P>Most federally recognized Indian Tribes and State and local government representatives that submitted comments on the 2024 proposed rule oppose re-petitioning. Numerous Tribes recommended that the Department keep in place the Department's longstanding ban on re-petitioning.</P>
                <P>Several Tribes explained that the re-petition authorization process undermines their ability to protect their respective Tribal identities. The Shawnee Tribe, for example, commented that the appropriation of Shawnee Tribal identity by non-federally recognized groups is an ongoing problem and that “the Federal acknowledgment process provides some protection against groups . . . that make false claims” to Shawnee sovereignty and culture. Similarly, the Eastern Band of Cherokee Indians highlighted the threat posed by “six groups that have falsely and fraudulently claimed to be Cherokee and that have already undergone and completed the Part 83 process.” The Tribe expressed concern about the burden that opposing re-petition requests will impose on the Tribe's resources, resources that the Tribe “should be able to utilize . . . to improve the lives of [its] citizens rather than . . . to repeatedly defend our identifies against fraudulent groups.”</P>
                <P>Several other Tribes echoed the Eastern Band of Cherokee Indians' concern about the threat that re-petitioning would pose to their limited resources. The Santa Ynez Band of Chumash Mission Indians asserted that re-petitioning would unfairly subject third parties to “the burden of responding to petitioners' arguments,” even though those third parties already expended considerable resources to oppose the petitions. The Tribe also highlighted the considerable resources that State and local governments in Connecticut expended to oppose petitions submitted by various Connecticut-based petitioners. Additionally, the Tribe highlighted the resources that several Tribes in Washington expended to monitor or oppose petitions that potentially threaten their “sovereignty, membership, and/or treaty fishing rights.” The Morongo Band of Mission Indians similarly emphasized the considerable investment of “time, energy, and resources over many years” by Tribes and other third parties “to protect their legitimate interests” in safeguarding “their economies, jurisdiction, or membership.”</P>
                <P>Consistent with the concerns discussed above, the Tulalip Tribes described the 2024 proposed rule as “fatally flawed” and asserted that it “contravenes settled expectations of finality for those parties who fought—sometimes for decades—in favor of negative final determinations.” The Suquamish Indian Tribe, Muckleshoot Indian Tribe, and Puyallup Tribe likewise asserted that the finality interests of third parties weigh strongly against what they perceive as “[e]ndless” opportunities to re-petition. They stated that, “[a]fter almost 50 years of decisions under the Part 83 process, States, local governments, federally recognized Indian Tribes, and the federal government have a compelling interest in repose and the finality of tribal acknowledgment decisions.”</P>
                <P>State and local government representatives in Connecticut shared similar concerns about the perceived threat that re-petitioning would pose to their interests in finality. The Connecticut Attorney General asserted that the 2024 proposed rule fails to “meaningfully consider or address any of the consequences Federal acknowledgment has on State and local communities.” The commenter identified “renewed threats resulting from acknowledged tribes,” including “extensive land claims, federal trust and reservation land, loss of state and local government jurisdiction and tax base, adverse environmental and land use impacts, casino development, and other issues.” Connecticut's congressional delegation expressly supported the Connecticut Attorney General's comments. Other Connecticut-based commenters (the Kent School and the Town of Kent) stated that they “have spent over three decades and hundreds of thousands of dollars reluctantly participating in DOI's acknowledgment process and a lands claim suit filed by the Schaghticoke Tribal Nation,” an unsuccessful petitioner.</P>
                <P>Numerous commenters objected to the notion that third-party interests should influence the Department's decision on whether to implement a re-petition authorization process. For example, the Muwekma Ohlone Tribe (an unsuccessful petitioner) stated in the listening session that the interests of groups denied Federal acknowledgment outweigh those of third parties and expressed support for the 2024 proposed rule. Other unsuccessful petitioners, like the Chinook Indian Nation and Eastern Pequot Indians, contended that third parties should not be allowed to exert political influence on the proposed re-petition authorization process. The Chinook Indian Nation stated that third-party involvement should be limited to commenting on re-petition requests and that the Department should prohibit “ex parte contacts or other attempts to influence the agency's decision” on a re-petition request or on a subsequently filed re-petition.</P>
                <P>
                    <E T="03">Response:</E>
                     The Department recognizes that third parties often expended 
                    <PRTPAGE P="3635"/>
                    considerable time and resources participating in the Federal acknowledgment process and agrees that third parties have significant, legitimate interests in the finality of the Department's final determinations. As explained in the 2024 proposed rule, those interests informed the Department's decision not to give unsuccessful petitioners an open-ended opportunity to re-petition that might “make[ ] worthless” third parties' substantial past investment.
                    <SU>99</SU>
                    <FTREF/>
                     Relevant here, a petitioner's disagreement with the Department's evaluation of the petitioner's claims and evidence in a previous, negative final determination is not a basis for requesting to re-petition. By maintaining the integrity of the Department's past determinations, the Department by extension recognizes the value of third-party investment in the Federal acknowledgment process, specifically, the value of third-party comments and evidence that informed those past determinations.
                </P>
                <FTNT>
                    <P>
                        <SU>99</SU>
                         
                        <E T="03">Bowen</E>
                         v. 
                        <E T="03">Georgetown Univ. Hosp.,</E>
                         488 U.S. 204, 220 (1988).
                    </P>
                </FTNT>
                <P>Although the Department's proposal in the 2022 proposed rule (which would have retained the longstanding, blanket ban on re-petitioning) would have aligned more closely with third-party interests in finality, the approach that the Department adopts in this final rule seeks to balance those interests with competing, compelling interests in re-petitioning (discussed above). The re-petition authorization process will subject prospective re-petitioners to a threshold review. By limiting the types of arguments that unsuccessful petitioners can raise in the threshold review, the Department seeks to minimize the burden on third parties that choose to participate in the process and respond to those arguments. Additionally, by imposing a limit on the amount of time that unsuccessful petitioners will have to request to re-petition, the Department seeks to account for third-party interests in finality.</P>
                <P>
                    By subjecting prospective re-petitioners to a threshold review, this final rule not only seeks to balance third-party interests with denied petitioners' interests but also seeks to be responsive to the 
                    <E T="03">Chinook</E>
                     court's “skeptic[ism] that res judicata is applicable in a situation such as this where legal standards changed between the 1994 and 2015 regulations.” 
                    <SU>100</SU>
                    <FTREF/>
                     As discussed at length in the 2022 proposed rule,
                    <SU>101</SU>
                    <FTREF/>
                     and as stated in the 2024 proposed rule,
                    <SU>102</SU>
                    <FTREF/>
                     the Department maintains that the legal standards in the 2015 regulations are not significantly different from those in the previous regulations and do not compel the Department to allow re-petitioning. However, in the interest of fairness to unsuccessful petitioners, the Department has decided to give those petitioners an opportunity to argue that specific changes warrant reconsideration of their respective negative final determinations.
                </P>
                <FTNT>
                    <P>
                        <SU>100</SU>
                         
                        <E T="03">See Chinook,</E>
                         2020 WL 128563, at *9 (explaining that “res judicata does not apply when legal standards governing the issues are `significantly different'” (citing 
                        <E T="03">Golden Hill Paugussett Tribe of Indians</E>
                         v. 
                        <E T="03">Rell,</E>
                         463 F. Supp. 2d 192, 199 (D. Conn. 2006))).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>101</SU>
                         
                        <E T="03">See</E>
                         87 FR 24911-14.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>102</SU>
                         89 FR 57105.
                    </P>
                </FTNT>
                <P>
                    Finally, in response to third-party concerns about the potential consequences of Federal acknowledgment on local communities (for example, land claims, loss of tax bases, and gaming development), affected third parties will be able to avail themselves of due process afforded in connection with those specific issues.
                    <SU>103</SU>
                    <FTREF/>
                     A review of a re-petition request, a grant of authorization to re-petition, or even a positive final determination would not result in the adverse impacts described by third parties. In general, the part 83 process concerns only whether a group constitutes a distinct social and political entity entitled to a government-to-government relationship with the United States.
                    <SU>104</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>103</SU>
                         
                        <E T="03">See, e.g., City of Sherrill</E>
                         v. 
                        <E T="03">Oneida Indian Nation,</E>
                         544 U.S. 197, 220 (2005) (explaining that “Congress has provided a mechanism for the acquisition of lands for Tribal communities that takes account of the interests of others with stakes in the area's governance and well-being”); 80 FR 37881 (explaining that “if the newly acknowledged tribe seeks to have land taken into trust and that application is approved, state or local governments may challenge that action under the land-into-trust process (25 CFR part 151), an entirely separate and distinct decision from the Part 83 process”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>104</SU>
                         
                        <E T="03">See</E>
                         25 CFR 83.2 (describing the purpose of part 83).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. Comments Citing Departmental Workload as a Justification for Retaining the Ban on Re-Petitioning</HD>
                <P>Several commenters expressed concern about the impact of re-petitioning on the Department's workload and ability to process petitions and re-petition requests efficiently. For example, the Burt Lake Band of Ottawa and Chippewa Indians (an unsuccessful petitioner) generally supports a re-petition process but fears that the process proposed in the 2024 proposed rule would result in significant delays. The commenter estimated that the time frame to receive a decision on a re-petition request “could approach 44 years,” a time frame that would provide “insufficient justice for re-petitioners.”</P>
                <P>Among those that oppose re-petitioning, the Swinomish Indian Tribal Community commented that re-petitioning would create “an ongoing cycle of review” that would exhaust not only the resources of federally recognized Indian Tribes but also Departmental resources and delay or prevent the review of new petitions. The Shawnee Tribe similarly commented on the amount of additional work required to implement a re-petition authorization process, stating that the process would “more than double[ ] the amount of resources required.” According to the Tribe, “[t]he Department and Indian country would be better served by allocation of the Department's precious, limited resources to existing areas of need—of which there are many,” as well as to the review of new and pending petitions.</P>
                <P>The Eastern Band of Cherokee Indians likewise asserted that re-petitioning would be “unfair to pending and future petitioners who may have legitimate petitions.” According to the Tribe, “[r]equiring groups with valid claims to wait their turn for review of their original documented petitions while [re-petition] requests from unsuccessful petitioners are considered would be an affront to legitimate sovereign nations whose status has not yet been recognized by the United States.”</P>
                <P>
                    <E T="03">Response:</E>
                     The Department considers implementation of a threshold review, limiting the types of arguments that unsuccessful petitioners can raise in their re-petition requests, to be an appropriate way to address concerns about the effect of re-petitioning on the Department's workload. By allowing prospective re-petitioners to raise only certain arguments in their re-petition requests, namely, arguments relating to (1) changes in the 2015 regulations or (2) the availability of new evidence—both developments likely to postdate the date of the petitioners' previous, negative final determinations—the Department seeks to avoid the overwhelming administrative burdens that would be associated with an open-ended re-petitioning process, including the potential reopening of decades-old administrative records that “rang[e] in excess of 30,000 pages to over 100,000 pages.” 
                    <SU>105</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>105</SU>
                         Barbara N. Coen, 
                        <E T="03">Tribal Status Decision Making: A Federal Perspective on Acknowledgment,</E>
                         37 NEW ENG. L. REV. 491, 495 (2003) (citing 
                        <E T="03">Work of the Department of the Interior's Branch of Acknowledgment and Research within the Bureau of Indian Affairs: Hearing Before the S. Comm. on Indian Affs.,</E>
                         107th Cong. 2, 19-20 (2002) (statement 
                        <PRTPAGE/>
                        of Michael R. Smith, Dir., Office of Tribal Servs., U.S. Dep't of the Interior)).
                    </P>
                </FTNT>
                <PRTPAGE P="3636"/>
                <P>
                    This final rule gives AS-IA oversight over the re-petition authorization process, in line with the 2024 proposed rule. Although AS-IA's oversight over the process might increase the workload within the Office of the AS-IA, AS-IA is in the best position to review re-petition requests efficiently given AS-IA's expertise and experience in evaluating part 83 petitioners' claims and evidence. In response to commenters' concerns about the effect of re-petitioning on the review of new and pending petitions, AS-IA oversight will also ensure that the Department “prioritize[s] review of documented petitions over review of re-petition requests,” at least initially.
                    <SU>106</SU>
                    <FTREF/>
                     The Department notes that prospective petitioners have had notice of the opportunity to petition for Federal acknowledgment since 1978, when the Department first promulgated regulations governing the Federal acknowledgment process, and still have a time window under this final rule to proceed through the part 83 process ahead of prospective re-petitioners.
                </P>
                <FTNT>
                    <P>
                        <SU>106</SU>
                         25 CFR 83.53(c).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">E. Comments on the Standard Applied in the Re-Petition Authorization Process</HD>
                <P>Most of the federally recognized Indian Tribes that submitted comments on the 2024 proposed rule oppose any re-petition authorization process. However, many nevertheless suggested changes that, in their view, would improve the process, should the Department finalize it.</P>
                <P>In particular, several of the Tribes that commented focused on the standard that the Department would apply in the Department's threshold review. Some questioned whether the standard would indeed create a “limited” or “narrow” path to re-petition, as the Department stated in the 2024 proposed rule, and argued that the standard was improperly low. For example, the Puyallup Tribe commented that the standard “throws the door wide open to re-petitioning by unnecessarily limiting the Department's ability to evaluate the truth of previously denied petitioners' allegations in support of a request to re-petition and excluding only re-petition requests that are facially frivolous.” The Muckleshoot Indian Tribe echoed that comment and also asserted that the “`plausibly allege' threshold standard” in the 2024 proposed rule is lower than the standard that the Department had proposed in the 2014 proposed rule (which also would have allowed limited re-petitioning). By contrast, the Duwamish Tribe (an unsuccessful petitioner) described the “plausible allegation” requirement as an “undue and burdensome restriction[].”</P>
                <P>Both the Puyallup Tribe and Muckleshoot Indian Tribe commented that the Department's reference to the “plausibly allege” standard as “akin” to that for surviving a motion to dismiss is unclear, and they requested clarification on whether the standard is the same as that for surviving a motion to dismiss or different in some respect. The Muckleshoot Indian Tribe specifically asked whether the Department “would engage in fact finding at the threshold stage.”</P>
                <P>Several Tribes suggested that the Department should adopt a different standard. For example, the Eastern Band of Cherokee Indians recommended that the Department adopt a “`preponderance of the evidence'/`more likely than not'” standard. The Swinomish Indian Tribal Community recommended that the Department adopt a “clear and convincing evidence” standard. Others recommended adoption of the standard for a new trial or relief from a judgment under Federal Rule of Civil Procedure (FRC.P.) 59 or 60, respectively. The Federated Indians of Graton Rancheria described that standard as stricter and, therefore, more appropriate given that “there has already been a lengthy agency review process and final determination.” According to the Tribe, a standard akin to that under FRC.P. 59 or 60 would allow petitions to be “reopen[ed]” only in “limited situations, to be used sparingly and in extraordinary circumstances.” The Puyallup Tribe and the Connecticut Attorney General similarly recommended adoption of the standard under FRC.P. 60 in lieu of the standard for surviving a motion to dismiss under FRC.P. 12(b)(6), with the Puyallup Tribe specifically citing FRC.P. 60(b)(6).</P>
                <P>Finally, several commenters took issue with the discretion afforded to AS-IA under the “plausibly allege” standard in the 2024 proposed rule. The Connecticut Towns of Ledyard, North Stonington, and Preston asserted that the Department does not have the authority to allow re-petitioning (or even to acknowledge Indian Tribes) but that, if the Department implements a re-petition authorization process, OFA is better suited to the review re-petition requests than AS-IA. The Seneca Nation of Indians likewise commented that the reviewer of re-petition requests should be OFA, not AS-IA.</P>
                <P>Conversely, the Burt Lake Band of Ottawa and Chippewa Indians stated that an “Independent Reviewer,” like an administrative law judge or retired judge, should oversee the re-petition authorization process. The commenter also recommended that “[t]he decision on whether there is a factual basis to grant an application for repetitioning [should] be shortened to 90 days” and that, “[i]f the Independent Reviewer does not decide the matter in 90 days, the application for repetitioning [should be] approved and [the] petitioner move[d] to the next step.”</P>
                <P>
                    <E T="03">Response:</E>
                     The Department does not consider the “plausibly allege” standard in the 2024 proposed rule to be improperly low. Although the standard for obtaining authorization to re-petition in the 2014 proposed rule might seem higher because it would have required a petitioner to prove “by a preponderance of the evidence” that “[a] change from the previous version of the regulations to the current version of the regulations warrants reconsideration of the final determination” 
                    <SU>107</SU>
                    <FTREF/>
                    —that is at best unclear because the 2014 proposed rule did not clarify what was meant by “warrants reconsideration.”
                </P>
                <FTNT>
                    <P>
                        <SU>107</SU>
                         79 FR 30774.
                    </P>
                </FTNT>
                <P>
                    In the 2024 proposed rule, the Department proposed alternative language—adopted here—to make the standard more precise than that in the 2014 proposed rule. Pursuant to this final rule, to warrant reconsideration, a petitioner must first plausibly allege that the outcome of the petitioner's previous, negative final determination would change to positive based on one or both of the following: (1) a change in part 83 (from the 1978 or 1994 regulations to the 2015 regulations); and/or (2) new evidence.
                    <SU>108</SU>
                    <FTREF/>
                     Because Federal acknowledgment requires satisfaction of all seven criteria,
                    <SU>109</SU>
                    <FTREF/>
                     the petitioner's re-petition request would have to address all of the criteria that the petitioner did not satisfy. Otherwise, even if the allegations were taken as true, they would not change the previous, negative outcome and, therefore, would not justify reconsideration.
                </P>
                <FTNT>
                    <P>
                        <SU>108</SU>
                         25 CFR 83.48.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>109</SU>
                         25 CFR 83.43(a); 25 CFR 83.5.
                    </P>
                </FTNT>
                <P>
                    Application of a “plausibly allege” standard is appropriate. Under the standard, fact-finding in the Department's threshold review will be limited, which will help ensure that the re-petition authorization process proceeds efficiently. To the extent that assessment of a petitioner's claims and evidence requires a complex or in-depth analysis, AS-IA would reserve that analysis for the eventual evaluation of a re-petition, at which point the 
                    <PRTPAGE P="3637"/>
                    Department would apply part 83's “reasonable likelihood” standard.
                </P>
                <P>In response to comments expressing confusion about whether the “plausibly allege” standard in the 2024 proposed rule is identical to that for surviving a motion to dismiss under FRC.P. 12(b)(6), the Department clarifies here that the Department intended for the standard to be slightly different, in that the Department envisioned AS-IA conducting limited fact-finding during the threshold review. For example, pursuant to § 83.55(b)(1) (as proposed and adopted here), AS-IA may refer to the administrative record created during the evaluation of a petitioner's original petition to assess the plausibility of certain, alleged facts. However, the comparison to the standard for surviving a motion to dismiss remains apt because, at a minimum, the petitioner must present allegations that, if taken as true, would change the outcome of the petitioner's previous, negative final determination to positive.</P>
                <P>
                    The Department does not consider application of the standard for a new trial or relief from a judgment under FRC.P. 59 or 60, respectively, to be a more appropriate alternative. The purpose of the threshold review is not to determine whether a petitioner's previous, negative final determination is contrary to the “clear or great weight of the evidence” 
                    <SU>110</SU>
                    <FTREF/>
                     or is “clearly erroneous.” 
                    <SU>111</SU>
                    <FTREF/>
                     That kind of determination would require a thorough assessment of the strength of the evidence both for and against acknowledgment, better suited for the eventual evaluation of a re-petition.
                </P>
                <FTNT>
                    <P>
                        <SU>110</SU>
                         
                        <E T="03">Standard Havens Prods., Inc.</E>
                         v. 
                        <E T="03">Gencor Indus., Inc.,</E>
                         953 F.2d 1360, 1367 (Fed. Cir. 1991) (explaining the standard for a new trial).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>111</SU>
                         
                        <E T="03">Am. Council of the Blind</E>
                         v. 
                        <E T="03">Mnuchin,</E>
                         977 F.3d 1, 5 (DC Cir. 2020) (explaining the standard of review of a motion filed pursuant to FRC.P. 60(b)).
                    </P>
                </FTNT>
                <P>
                    In response to comments asserting that either OFA or an official other than AS-IA should be the decision-maker, AS-IA is in the best position to review re-petition requests efficiently given AS-IA's expertise and experience in evaluating part 83 petitioners' claims and evidence, as discussed above. Furthermore, AS-IA can solicit OFA's assistance throughout the process given that OFA is located within the Office of the AS-IA.
                    <SU>112</SU>
                    <FTREF/>
                     Finally, the Department's authority to acknowledge Indian Tribes through part 83, discussed in section I above and supported by relevant legal authorities, is well-established.
                    <SU>113</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>112</SU>
                         
                        <E T="03">See</E>
                         110 DM 8.4(C) (listing OFA as under the oversight of the Deputy Assistant Secretary—Policy and Economic Development, who reports to the Principal Deputy Assistant Secretary and AS-IA).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>113</SU>
                         
                        <E T="03">See, e.g., James</E>
                         v. 
                        <E T="03">U.S. Dep't of Health &amp; Hum. Servs.,</E>
                         824 F.2d 1132, 1139 (D.C. Cir. 1987) (requiring appellants to exhaust administrative remedies on the issue of Federal recognition prior to seeking judicial review); 
                        <E T="03">Miami Nation of Indians of Ind., Inc.</E>
                         v. 
                        <E T="03">U.S. Dep't of the Interior,</E>
                         255 F.3d 342, 346 (7th Cir. 2001) (stating that the appellants' argument that Part 83 is invalid “because not authorized by Congress” is “clearly incorrect” and also noting that “[r]ecognition is . . . traditionally an executive function”).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">F. Comments on the Conditions for Obtaining Authorization To Re-Petition</HD>
                <P>Numerous commenters submitted comments on the conditions for re-petitioning, located at § 83.48. Pursuant to that provision, as noted above, an unsuccessful petitioner would be allowed to re-petition if the petitioner plausibly alleged that the outcome of the petitioner's previous, negative final determination would change to positive based on one or both of the following: (1) a change in part 83 (from the 1978 or 1994 regulations to the 2015 regulations); and/or (2) new evidence.</P>
                <HD SOURCE="HD3">1. Comments on the “Change” Condition</HD>
                <P>
                    Commenters that oppose re-petitioning were divided on the significance of the changes to part 83 in the 2015 regulations. On the one hand, the Yuhaaviatam of San Manuel Nation contended that the Department should retain the ban on re-petitioning because the changes are “unlikely to result in any change” to the outcome of a negative final determination. On the other hand, the Kent School and the Town of Kent contended that the Department should retain the ban on re-petitioning because the changes weakened the criteria for Federal acknowledgment. The Puyallup Tribe similarly criticized the proposal to allow limited re-petitioning given what it described as “truncated” standards for satisfying criteria (b) (Community) and (c) Political Authority under the 2015 regulations (a reference to the potentially shorter time frame subject to evaluation under the 2015 regulations, beginning in 1900 instead of 1789 or “the time of first sustained contact” 
                    <SU>114</SU>
                    <FTREF/>
                    ). According to the Tribe, the Department does not have the authority to acknowledge a petitioner under the 2015 regulations if that petitioner was previously denied acknowledgment for failing to satisfy criterion (b) (Community) or (c) (Political Authority) for any time period prior to 1900.
                </P>
                <FTNT>
                    <P>
                        <SU>114</SU>
                         80 FR 37863.
                    </P>
                </FTNT>
                <P>Others commented on the provision located at § 83.48(b) in the 2024 proposed rule, which would have allowed unsuccessful petitioners to request to re-petition a second time if the Department were to revise part 83 again in the future. The Shawnee Tribe cautioned that, in light of that provision, the Department “should expect new requests for authorization to re-petition each time it revises the regulations.” The Tulalip Tribes similarly stated that the 2024 proposed rule would allow “unending” re-petitioning, “as any future changes to or interpretations of Part 83 [would] allow for denied petitioners to initiate the entire process again and again.”</P>
                <P>
                    <E T="03">Response:</E>
                     As the Department indicated in the 2024 proposed rule, the Department does not anticipate that any of the 2015 final rule's changes to part 83 will affect the outcome of the Department's previous, negative final determinations,
                    <SU>115</SU>
                    <FTREF/>
                     including the change in the evaluation start date.
                    <SU>116</SU>
                    <FTREF/>
                     However, in the interest of fairness to unsuccessful petitioners, the Department has decided to give those petitioners a narrow path for arguing, on a case-by-case basis, why specific changes warrant reconsideration of their specific final determinations.
                    <SU>117</SU>
                    <FTREF/>
                     By conditioning re-petitioning in the manner set forth in § 83.48(a), this rule is responsive to the 
                    <E T="03">Chinook</E>
                     court's observation that some of the changes in the 2015 final rule constitute “significant revisions that could prove dispositive for some re-petitioners.” 
                    <SU>118</SU>
                    <FTREF/>
                     Additionally, it is responsive to the 
                    <E T="03">Burt Lake</E>
                     court's opinion that “the agency's breezy assurance . . . that nothing has changed” in the 2015 regulations is an insufficient basis to keep the ban in place.
                    <SU>119</SU>
                    <FTREF/>
                     Pursuant to this rule, if an unsuccessful petitioner plausibly alleges that a change in part 83 would, if applied on reconsideration, change the outcome of the previous, negative determination to positive, then the petitioner may re-petition.
                </P>
                <FTNT>
                    <P>
                        <SU>115</SU>
                         89 FR 57102-03.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>116</SU>
                         
                        <E T="03">See</E>
                         80 FR 37863 (stating that “[t]he Department does not classify the start date change, from 1789 or the time of first sustained contact to 1900, as a substantive change to the existing criteria,” for reasons discussed in the preamble).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>117</SU>
                         
                        <E T="03">See</E>
                         25 CFR 83.48(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>118</SU>
                         
                        <E T="03">Chinook,</E>
                         2020 WL 128563, at *8.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>119</SU>
                         
                        <E T="03">Burt Lake,</E>
                         613 F. Supp. 3d at 384.
                    </P>
                </FTNT>
                <P>
                    In response to the comments that are expressly or impliedly critical of the provision in the 2024 proposed rule at § 83.48(b), the Department agrees that the provision risks undermining finality and has removed the provision from this final rule accordingly. If the Department decides to revise part 83 again in the future, it can decide then whether to give unsuccessful petitioners a new opportunity to request to re-petition in light of the revision.
                    <PRTPAGE P="3638"/>
                </P>
                <HD SOURCE="HD3">2. Comments on the “New Evidence” Condition</HD>
                <P>
                    The Department received many comments on the Department's proposal in the 2024 proposed rule to include the availability of new evidence as a justification for re-petitioning. As a preliminary matter, several commenters expressed confusion about what constitutes new evidence. The Shawnee Tribe commented that “the term `new evidence' is not defined” and that “the proposed rule sets forth no standard a petitioner must meet regarding what constitutes `new' evidence.” The Swinomish Indian Tribal Community commented that, based on the description of new evidence in 2024 proposed rule, unsuccessful petitioners could argue that “new evidence” includes evidence previously submitted during the evaluation of a petitioner's original petition but allegedly not “considered by the Department.” 
                    <SU>120</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>120</SU>
                         25 CFR 83.48(a)(2) (proposed 2024).
                    </P>
                </FTNT>
                <P>The Federated Indians of Graton Rancheria suggested that the Department refer to F.R.C.P. 59 and 60 for guidance on what constitutes new evidence. According to the Tribe, in line with the standard applied under those rules, a petitioner should have to show that the evidence “was discovered after the previous, negative final determination and could not have been discovered by the unsuccessful petitioner through the exercise of reasonable diligence.”</P>
                <P>Many commenters stated their objection to the “new evidence” condition in the 2024 proposed rule. The Eastern Band of Cherokee Indians argued that new evidence is not a valid basis for allowing re-petitioning because petitioners had notice of the criteria and evidence required for Federal acknowledgment, received technical assistance identifying evidentiary gaps in their materials, and had the opportunity to supplement or revise their petitions. Relatedly, the Suquamish Indian Tribe and the Muckleshoot Indian Tribe commented that petitioners had “unlimited time to research and assemble documentation for their claims before seeking Departmental consideration.” Commenters also stated that the availability of new evidence is not a valid basis for allowing re-petitioning because, under the 2015 regulations, petitioners have the option to withdraw and resubmit their petitions if new evidence arises, pursuant to § 83.30.</P>
                <P>Several commenters asserted that allowing re-petitioning based on new evidence would undermine finality. For example, the Seneca Nation of Indians asked rhetorically how the Department could justify “a one-time opportunity to re-petition based on `new evidence' and not grant another opportunity to re-petition based on new evidence 10 or 20 years later.” The Eastern Band of Cherokee Indians similarly expressed concern about “limitless opportunities to re-petition.” The Tribe explained that if “improved technology” is the rationale for allowing re-petitioning based on new evidence, the five-year time limit on submitting a re-petition request is arbitrary because “technology can improve in ten years or two months and will only continue to improve thereafter.”</P>
                <P>Other commenters expressed support for the “new evidence” condition. For example, the Shinnecock Indian Nation, although generally critical of the Federal acknowledgment process (particularly the evidentiary burden on petitioners), suggested that the Department should allow re-petitioning based on alleged new evidence because “[t]he search for truth must be the most important goal of the federal acknowledgment process.” The Tribe commented in one of the consultation sessions that “in the Jim Crow era . . . [Tribal] records were either destroyed or [Tribes] were not even allowed to acknowledge themselves as being Indians,” making it “difficult . . . to find documents” to support petitions. Another commenter similarly stated that “[c]olonial practices, including forced relocations and boarding school policies, caused many tribes to lose essential documents and evidence needed for federal acknowledgment” and that “there should be additional ways for Tribes to make up for those gaps.” Finally, many commenters stated that technological advancements would help petitioners retrieve historical records.</P>
                <P>
                    <E T="03">Response:</E>
                     The Department considers improved technology to be a compelling justification for allowing unsuccessful petitioners to request to re-petition, particularly those denied Federal acknowledgment decades ago. Since the evaluation of those petitions, there have been numerous technological advancements that would aid petitioners in their research, like user-friendly, electronic databases containing genealogical information and tools that make old records text-searchable.
                </P>
                <P>
                    Another significant technological advancement is the digitization of countless records. Digitization has increased petitioners' ability to access and search potentially relevant records. For petitioners with limited resources, digitization will help them retrieve records that might have been cost-prohibitive to retrieve manually in the past (for example, because of the costs associated with hiring experts, paying for travel to and from research sites, and paying for research time). As noted in the 2024 proposed rule, “[t]he application of improved technology, particularly in the context of a shorter evaluation period, might lead to the discovery of new evidence, and there is at least some possibility that the new evidence could affect the outcome of a previous, negative final determination.” 
                    <SU>121</SU>
                    <FTREF/>
                     However, for reasons stated in section III.G.1. (“Comments on the Time Limit for Submitting a Re-Petition Request”) below, the Department considers a five-year time limit appropriate, notwithstanding the likelihood of further technological advancements after expiration of the five-year time limit.
                </P>
                <FTNT>
                    <P>
                        <SU>121</SU>
                         89 FR 57103.
                    </P>
                </FTNT>
                <P>In response to the assertion that new evidence should constitute only evidence that “with reasonable diligence, could not have been discovered” during the original evaluation of a petition, the Department does not consider that limitation appropriate. The lengthy administrative records associated with part 83 petitions indicate that, in general, unsuccessful petitioners exercised diligence in pursuing their respective claims. Additionally, application of the standard above would likely lead to arguments about the reasonableness of an unsuccessful petitioner's research efforts (potentially conducted decades ago), distracting the parties from the review of the evidence. Furthermore, the Department deems it appropriate to give petitioners the opportunity to argue that evidence previously discovered but not submitted during the evaluation of the petitioner's original petition is now relevant because of a change to part 83.</P>
                <P>
                    In response to another comment above, which noted that an unsuccessful petitioner might try to claim that evidence previously submitted during the evaluation of a petitioner's original petition constitutes new evidence because it was allegedly not “considered by the Department,” 
                    <SU>122</SU>
                    <FTREF/>
                     the Department clarifies here that evidence submitted during the evaluation of a petitioner's original petition and contained in the corresponding administrative record does not constitute new evidence. To address the potential for misunderstanding noted by the commenter, the Department has removed the language quoted above from § 83.48(a)(2), as it appeared in the 
                    <PRTPAGE P="3639"/>
                    2024 proposed rule.
                    <SU>123</SU>
                    <FTREF/>
                     Allegations that the Department failed to consider previously submitted evidence amount to “mere criticism of a past final determination,” which is “not a sufficient or appropriate basis, standing alone, to justify re-petitioning” under this final rule.
                    <SU>124</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>122</SU>
                         25 CFR 83.48(a)(2) (proposed 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>123</SU>
                         
                        <E T="03">See</E>
                         25 CFR 83.48(b) (containing the relevant provision, as revised by this final rule).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>124</SU>
                         89 FR 57104.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. Comments on Possible Other Conditions for Obtaining Authorization To Re-Petition</HD>
                <P>Several commenters stated that the Department should impose additional conditions on prospective re-petitioners beyond those contained in the 2024 proposed rule. For example, Connecticut's congressional delegation, which opposes a re-petition authorization process, stated that, should the Department finalize a process, “any re-petitioning should exclude those Tribes where a U.S. District Court has reviewed the denial and upheld it.” The delegation stated that, in those instances, “not only has the [Department] determined the petitioner has failed to provide sufficient evidence to meet all the regulatory criteria, but an independent judicial body has also made a similar determination.”</P>
                <P>Citing the Department's proposal in the 2014 proposed rule, the Shawnee Tribe commented that the Department should condition re-petitioning on the consent of interested parties, “regardless of whether they participated in a prior proceeding involving the original petition.” According to the Tribe, a third-party consent condition would “protect the vested interests of such third parties who have already sunk significant time and expense into participating in the exhaustive part 83 process and/or who have reliance interests based on the outcome of the original proceeding.” The Eastern Band of Cherokee Indians likewise supported a third-party consent condition. Other commenters expressly opposed a third-party consent condition.</P>
                <P>
                    <E T="03">Response:</E>
                     That courts have consistently upheld the Department's final determinations on the merits reinforces the integrity of the Federal acknowledgment process. However, those decisions do not prevent the Department from reconsidering the final determinations if there are good reasons for doing so; agencies have inherent authority to reconsider past decisions and to revise, replace, or repeal decisions to the extent permitted by law and supported by a reasoned explanation, even “when its prior policy has engendered serious reliance interests.” 
                    <SU>125</SU>
                    <FTREF/>
                     If an unsuccessful petitioner plausibly alleges that consideration of a change in part 83 (from the 1978 or 1994 regulations to the 2015 regulations) or new evidence would change the outcome of the petitioner's previous, negative final determination, then there is a good reason to reconsider the determination, even if previously upheld by a court.
                    <SU>126</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>125</SU>
                         
                        <E T="03">FCC</E>
                         v. 
                        <E T="03">Fox Television Stations, Inc.,</E>
                         556 U.S. 502, 515 (2009); 
                        <E T="03">see also Motor Vehicle Mfrs. Ass'n of U.S., Inc.</E>
                         v. 
                        <E T="03">State Farm Mut. Auto. Ins. Co.,</E>
                         463 U.S. 29, 42 (1983).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>126</SU>
                         
                        <E T="03">See Canonsburg Gen. Hosp.</E>
                         v. 
                        <E T="03">Burwell,</E>
                         807 F.3d 295, 306 (D.C. Cir. 2015) (explaining that “issue preclusion is inappropriate if there has been an intervening “change in controlling legal principles”); 
                        <E T="03">Early</E>
                         v. 
                        <E T="03">Comm'r of Soc. Sec.,</E>
                         893 F.3d 929, 930 (6th Cir. 2018) (explaining that the “key principles” protected by res judicata, including “finality with respect to resolved applications,” “do not prevent the agency from giving a fresh look to a new application containing new evidence or satisfying a new regulatory threshold”); 
                        <E T="03">cf. Cal. Dump Truck Owners Ass'n</E>
                         v. 
                        <E T="03">Davis,</E>
                         302 F. Supp. 2d 1139 (E.D. Cal. 2002) (explaining that “reconsideration of a final judgment is appropriate, in part, where “the court is presented with newly-discovered evidence” or “there is an intervening change in the controlling law” (quoting 
                        <E T="03">Sch. Dist. No. 1J</E>
                         v. 
                        <E T="03">AC&amp;S, Inc.,</E>
                         5 F.3d 1255, 1262 (9th Cir. 1993))).
                    </P>
                </FTNT>
                <P>
                    In response to the suggestion that the Department subject prospective re-petitioners to a third-party consent condition, the Department does not consider a third-party consent condition appropriate. The purpose of the part 83 process is to determine whether a group constitutes a distinct social and political entity entitled to a government-to-government relationship with the United States.
                    <SU>127</SU>
                    <FTREF/>
                     Third-party participation in the Federal acknowledgment process is valuable, in part, because third parties often provide arguments and evidence that shed light on the merits of a petition. However, the question whether a group “is an Indian tribe eligible for the special programs and services provided by the United States to Indians because of their status as Indians” does not hinge on third-party support or opposition.
                    <SU>128</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>127</SU>
                         
                        <E T="03">See</E>
                         25 CFR 83.2; 
                        <E T="03">see also</E>
                         59 FR 9287 (“Distinctness is an essential requirement for the acknowledgment of tribes which are separate social and political entities.”); 25 CFR 54.3(a) (1978) (explaining the Department's intent to acknowledge as Indian tribes “groups which can establish a substantially continuous tribal existence and which have functioned as autonomous entities throughout history until the present”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>128</SU>
                         25 CFR 83.2.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">G. Comments on the Processing of a Re-Petition Request</HD>
                <P>Numerous commenters provided comments on the procedures set forth in the 2024 proposed rule for processing a re-petition request.</P>
                <HD SOURCE="HD3">1. Comments on the Time Limit for Submitting a Re-Petition Request</HD>
                <P>Commenters shared varying opinions on the five-year time limit for submitting a re-petition request. For example, the Shawnee Tribe and the Seneca Nation of Indians commented that the Department provided no explanation for the five-year time limit in the 2024 proposed rule and that the limit is arbitrary. The Tulalip Tribes, which opposes any re-petition authorization process, stated that, if the Department nevertheless implements a process, the five-year time limit should be reduced to one year. The Eastern Band of Cherokee Indians argued that “there should be no tolling [of the five-year period] pending judicial review.”</P>
                <P>Other commenters expressed support for a longer time limit, to give unsuccessful petitioners additional time to conduct research, especially given some petitioners' limited resources. For example, the Haliwa-Saponi Indian Tribe (a State-recognized Tribe in North Carolina) recommended that the time limit be increased from five years to ten years. The North Carolina Commission of Indian Affairs advocated against “any time limits for a denied petitioner to submit a request to re-petition.” The Steilacoom Tribe (an unsuccessful petitioner) relatedly asserted that “[t]here should not be a moratorium on our rights to be federally recognized.”</P>
                <P>
                    <E T="03">Response:</E>
                     In the 2024 proposed rule, as in the 2022 proposed rule, the Department noted the difficulty of imposing a time limit on the submission of requests to re-petition, particularly in light of the “new evidence” condition. The Department acknowledged that “such evidence is not static but could be discovered at any point.” 
                    <SU>129</SU>
                    <FTREF/>
                     Nevertheless, the Department considers the five-year time limit to submit a re-petition request an appropriate way to balance the petitioners' interests in using improved technology and rationing limited resources to conduct additional research with legitimate interests in finality. Like a statute of limitations, the five-year time limit “encourage[s] diligence.” 
                    <SU>130</SU>
                    <FTREF/>
                     Although it may be true that technological advancements could facilitate the discovery of new evidence after the five-year time limit, “there should be an eventual end to the . . . administrative process,” as the Department explained in the final rule promulgating the 1994 regulations.
                    <SU>131</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>129</SU>
                         89 FR 57103 (quoting 87 FR 24916).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>130</SU>
                         
                        <E T="03">Schweihs</E>
                         v. 
                        <E T="03">Burdick,</E>
                         96 F.3d 917, 920 (7th Cir. 1996) (citation omitted).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>131</SU>
                         59 FR 9291.
                    </P>
                </FTNT>
                <PRTPAGE P="3640"/>
                <P>In response to the recommendation that the Department not toll the five-year time limit during judicial review of a negative final determination, the Department considers tolling appropriate given that litigation can take many years to resolve. Moreover, it is unlikely that the Department will need to toll the time limit for many petitioners. The time limit for seeking judicial review has long since expired for most unsuccessful petitioners reviewed under the 1978 and 1994 regulations, and any petitioner seeking judicial review of a negative final determination after the effective date of this final rule will most likely have been reviewed under the 2015 regulations. Those petitioners, in turn, are less likely than petitioners denied in the past (under the previous versions of the part 83 regulations) to request to re-petition based on a change to part 83 or new evidence. The “change” condition does not apply to petitioners already proceeding under the 2015 regulations, and the “new evidence” condition will be of limited value to current and prospective petitioners that not only can take advantage of modern technology to discover relevant evidence but also withdraw and resubmit their petitions if new evidence arises during the Federal acknowledgment process, pursuant to § 83.30, as some commenters noted.</P>
                <HD SOURCE="HD3">2. Comments on Third-Party Notice-and-Comment Provisions</HD>
                <P>Several commenters stated that the Department should provide notice of re-petition requests to more parties than those entitled to notice under the 2024 proposed rule. For example, the Puyallup Tribe, Suquamish Indian Tribe, and Muckleshoot Indian Tribe commented that notices provided under § 83.51 should be provided to “[a]ctive [p]articipants in [a]ny [p]revious [a]dministrative [p]roceeding or [f]ederal [c]ourt [p]roceeding [c]oncerning a [p]reviously [d]enied [p]etitioner,” including any that participated as an amicus curiae or were granted formal intervention.</P>
                <P>
                    Additionally, several commenters stated that the 90-day time frame to comment on re-petition requests in the 2024 proposed rule should be longer. The Yuhaaviatam of San Manuel Nation highlighted the contrast between the 90-day comment period and the five-year time limit for submitting a re-petition request. The Tulalip Tribes, Puyallup Tribe, Suquamish Indian Tribe, Muckleshoot Indian Tribe, and the Connecticut Towns of Ledyard, North Stonington, and Preston commented that the time frame for submitting comments should be extended to at least 180 days, or six months. The Seneca Nation of Indians stated that the time frame should be extended to at least one year from the date of notice of the re-petition request in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>
                    The Connecticut Towns also noted their objection to the Department's practice of withholding “personal information” contained in part 83 petitioners' materials from third parties, including personal information contained in any forthcoming re-petition requests.
                    <SU>132</SU>
                    <FTREF/>
                     The Connecticut Towns asserted that, before any comment period begins, the Department must ensure that “information directly relevant to the decision being made [is] made available to interested parties.”
                </P>
                <FTNT>
                    <P>
                        <SU>132</SU>
                         
                        <E T="03">See, e.g.,</E>
                         25 CFR 83.50(b) (stating that “[t]he Department will not publicly release information that is protectable under Federal law”).
                    </P>
                </FTNT>
                <P>
                    <E T="03">Response:</E>
                     The Department agrees with the commenters above that any third parties that participated in an administrative or judicial proceeding relating to a final determination on a part 83 petition, whether technically a party or not, should receive notice of any associated re-petition request. For that reason, the Department has deleted the phrase “as a party” from § 83.51(b)(2). Additionally, the Department clarifies here that OFA will also provide notice to individuals and entities that had interested-party or informed-party status under the 1994 regulations,
                    <SU>133</SU>
                    <FTREF/>
                     with the understanding that those individuals and entities previously “request[ed] to be kept informed of general actions regarding a specific petitioner” and presumably wish to remain informed.
                    <SU>134</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>133</SU>
                         25 CFR 83.1 (1994) (defining “[i]nterested party” and “[i]nformed party”); 59 FR 9293.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>134</SU>
                         25 CFR 83.22(d)(5).
                    </P>
                </FTNT>
                <P>
                    The Department also agrees with the commenters above that a longer comment period than that in the 2024 proposed rule is warranted to ensure that third parties have a meaningful opportunity to provide their input on re-petition requests. Accordingly, the Department extends the comment period from 90 days to 120 days, which is the amount of time that third parties have to comment on a new documented petition.
                    <SU>135</SU>
                    <FTREF/>
                     Based on the Department's experience processing new documented petitions under the 2015 regulations and receiving comments on those petitions, a 120-day comment period is sufficient. Additionally, the length of comment period is subject to extension for good cause.
                    <SU>136</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>135</SU>
                         
                        <E T="03">See</E>
                         25 CFR 83.22(b)(1)(iv).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>136</SU>
                         25 CFR 83.8(a).
                    </P>
                </FTNT>
                <P>
                    Finally, in response to the comment requesting that personal information contained in re-petition requests be disclosed prior to the beginning of the comment period, the Department has decided to implement a procedure consistent with that for processing a new documented petition under the 2015 regulations. Pursuant to that procedure, the publication of notice in the 
                    <E T="04">Federal Register</E>
                    , the posting of certain petition materials to the OFA website (with any redactions appropriate under § 83.21(b)), and the delivery of notice to third parties occur at approximately the same time. Based on the Department's experience processing new documents petitions, that procedure gives third parties sufficient notice and a meaningful opportunity to comment, while also protecting “information that is protectable under Federal law such as the Privacy Act and Freedom of Information Act.” 
                    <SU>137</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>137</SU>
                         25 CFR 83.21(b) (stating also that “[t]he Department will not publicly release information that is protectable under Federal law”); 
                        <E T="03">see also</E>
                         25 CFR 83.50(b) (stating the same).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. Comments on the Finality of a Grant of Authorization To Re-Petition</HD>
                <P>Several commenters that opposed the Department's proposed re-petition authorization process stated that a grant of authorization to re-petition should be subject to judicial review.</P>
                <P>
                    <E T="03">Response:</E>
                     A grant of authorization to re-petition simply allows an unsuccessful petitioner to proceed with a new documented petition through the Federal acknowledgment process. It does not confer any substantive right on the petitioner analogous to the rights extended to newly acknowledged Indian Tribes; rather, it only results in additional due process afforded to the unsuccessful petitioner. Allowing third parties to challenge a grant of authorization would frustrate the Department's goal to promote efficiency in a process already “criticized as too slow.” 
                    <SU>138</SU>
                    <FTREF/>
                     Third parties that disagree with a decision allowing an unsuccessful petitioner to re-petition will have several opportunities after that decision to oppose the re-petition.
                    <SU>139</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>138</SU>
                         80 FR 37862.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>139</SU>
                         
                        <E T="03">See, e.g.,</E>
                         25 CFR 83.22(b)(1)(iv) (giving third parties the opportunity to “submit comments and evidence supporting or opposing the petitioner's request for acknowledgment” upon notice of receipt of a documented petition); 25 CFR 83.35 (giving “any individual or entity” the opportunity to “rebut or support” a Phase I negative proposed finding or Phase II proposed finding); 25 CFR 83.44 (deeming AS-IA's final determination a “final agency action” subject to judicial review).
                    </P>
                </FTNT>
                <PRTPAGE P="3641"/>
                <HD SOURCE="HD1">IV. Procedural Requirements</HD>
                <HD SOURCE="HD2">A. Regulatory Planning and Review (E.O. 12866 and 13563)</HD>
                <P>Executive Order (E.O.) 12866, as amended by E.O. 14094, provides that the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB) will review all significant rules. This rule will not have an annual effect on the economy of $200 million. OIRA has determined that this rule is a significant regulatory action.</P>
                <P>E.O. 14094 amends E.O. 12866 and reaffirms the principles of E.O. 12866 and E.O. 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and be consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, shall recognize distributive impacts and equity, to the extent permitted by law.</P>
                <P>E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The E.O. directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.</P>
                <P>
                    This rulemaking is necessary to comply with the orders of the 
                    <E T="03">Chinook</E>
                     and 
                    <E T="03">Burt Lake</E>
                     courts, both of which remanded the re-petition ban in part 83 to the Department for further consideration. It affects federally recognized Indian Tribes and a variety of stakeholders in the Federal acknowledgment process, including previously denied part 83 petitioners, State and local governments, current and prospective petitioners, and others. To date, there have been eighteen acknowledged petitioners and thirty-four denied petitioners through part 83.
                    <SU>140</SU>
                    <FTREF/>
                     By implementing a limited exception to the re-petition ban, the regulations promulgated in this final rule benefit unsuccessful petitioners that previously had no avenue to re-petition for Federal acknowledgment. However, it is unclear how many of the petitioners will submit a request to re-petition or how many can meet the conditions set forth at proposed §§ 83.47 through 83.49.
                </P>
                <FTNT>
                    <P>
                        <SU>140</SU>
                         
                        <E T="03">See</E>
                         Petitions Resolved, Office of Fed. Acknowledgment, 
                        <E T="03">https://www.bia.gov/as-ia/ofa/petitions-resolved</E>
                         (last visited Jan. 7, 2025).
                    </P>
                </FTNT>
                <P>
                    The costs of the Department's re-petition authorization process include the additional workload on the Department that will stem from reviewing requests to re-petition for Federal acknowledgment and preparing decisions granting or denying authorization to re-petition. Implementation of the process also may result in an increase in the number of requests that the Department receives pursuant to the Freedom of Information Act, from federally recognized Indian Tribes and various stakeholders seeking copies of documents associated with part 83 petitions.
                    <SU>141</SU>
                    <FTREF/>
                     Furthermore, the process may result in an increase in litigation, particularly given that a denial of authorization to re-petition would be a final agency action under the APA. Additional costs include the time and resources that unsuccessful petitioners will have to spend reviewing this final rule and preparing re-petition requests, as well as the time and resources that others invested in the Federal acknowledgment process (including federally recognized Indian Tribes and State and local governments that oppose certain petitions) will have to spend reviewing this rule and commenting on re-petition requests. In regard to the “speculative consequences” of a positive determination on a re-petition, like the pursuit of land in trust or the pursuit of gaming on trust land, the processes relating to those actions are “entirely separate and distinct . . . from the Part 83 process,” and “administrative and judicial review is available for those separate decisions,” 
                    <SU>142</SU>
                    <FTREF/>
                     for example, under 25 CFR parts 151 and 292.
                    <SU>143</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>141</SU>
                         
                        <E T="03">See</E>
                         87 FR 24915-16 (discussing the potential for a “marked increase” in the number of FOIA requests received as a result of the creation of a re-petitioning process).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>142</SU>
                         80 FR 37880-81.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>143</SU>
                         
                        <E T="03">See, e.g.,</E>
                         88 FR 86222 (Dec. 12, 2023) (providing “the procedures governing the discretionary acquisition of lands into trust”); 73 FR 29354 (May 20, 2008) (establishing “a process for submitting and considering applications from Indian tribes seeking to conduct class II or class III gaming activities on lands acquired in trust after October 17, 1988”).
                    </P>
                </FTNT>
                <P>
                    In accordance with 5 U.S.C. 553(b)(4), a summary of this rule may be found at 
                    <E T="03">https://www.regulations.gov</E>
                     at Docket ID BIA-2022-0001 or by searching for “RIN 1076-AF67.”
                </P>
                <HD SOURCE="HD2">B. Regulatory Flexibility Act</HD>
                <P>
                    The Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ) (RFA) requires Federal agencies to prepare a regulatory flexibility analysis for rules subject to notice-and-comment rulemaking requirements under the Administrative Procedure Act (5 U.S.C. 500 
                    <E T="03">et seq.</E>
                    ) to determine whether a regulation would have a significant economic impact on a substantial number of small entities.
                </P>
                <P>The Department's analysis leads to a finding that this final rule will not have a significant economic impact on a substantial number of small entities (including small businesses, not-for-profit organizations, and “small governmental jurisdictions,” defined in 5 U.S.C. 601 to include “governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand”). The final rule minimizes the burden on unsuccessful petitioners (one type of small entity) by narrowing the scope of arguments at issue in the re-petition authorization process. Although petitioners preparing re-petition requests might incur non-hour cost burdens for contracted services, such as anthropologists, attorneys, genealogists, historians, and law clerks, the narrow scope of arguments at issue—focused on changes in part 83 and/or new evidence—would reduce the risk of petitioners incurring excessive costs for contracted services.</P>
                <P>
                    Additionally, by limiting the types of arguments that unsuccessful petitioners can raise in the re-petition authorization process, the final rule minimizes the economic impacts on small entities that oppose Federal acknowledgment of the petitioners and that might prepare arguments in rebuttal. Although those entities might later incur additional costs to challenge actions taken by a newly acknowledged Indian Tribe following a positive determination on a re-petition (like the pursuit of land in trust or the pursuit of gaming on trust land), those costs would arise in processes “entirely separate and distinct . . . from the Part 83 process” at issue here,
                    <SU>144</SU>
                    <FTREF/>
                     as discussed above.
                </P>
                <FTNT>
                    <P>
                        <SU>144</SU>
                         80 FR 37881.
                    </P>
                </FTNT>
                <P>
                    Finally, the limit on the amount of time that unsuccessful petitioners have to request to re-petition will help small entities participating in the Federal acknowledgment process (including small government jurisdictions) plan for the allocation and expenditure of limited resources accordingly. By contrast, an open-ended avenue for re-
                    <PRTPAGE P="3642"/>
                    petitioning, with few or no limitations, would have increased uncertainty about those burdens. Additional discussion of the conditional, time-limited opportunity to re-petition created here, and the alternatives that the Department considered, is contained in sections I through III of the preamble, above.
                </P>
                <P>The Department certifies that the regulations promulgated in this final rule will not have a significant economic impact on a substantial number of small entities. Accordingly, a regulatory flexibility analysis is not required by the RFA.</P>
                <HD SOURCE="HD2">C. Congressional Review Act</HD>
                <P>This final rule is does not meet the criteria set forth in 5 U.S.C. 804(2).</P>
                <HD SOURCE="HD2">D. Unfunded Mandates Reform Act</HD>
                <P>
                    This rule would not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. The rule would not have a monetarily significant or unique effect on State, local, or Tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ) is not required.
                </P>
                <HD SOURCE="HD2">E. Takings (E.O. 12630)</HD>
                <P>This rule does not effect a taking of private property or otherwise have taking implications under E.O. 12630. A takings implication assessment is not required.</P>
                <HD SOURCE="HD2">F. Federalism (E.O. 13132)</HD>
                <P>Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. A federalism summary impact statement is not required.</P>
                <HD SOURCE="HD2">G. Civil Justice Reform (E.O. 12988)</HD>
                <P>This rule complies with the requirements of E.O. 12988. Specifically, this rule: (a) meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and (b) meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.</P>
                <HD SOURCE="HD2">H. Consultation With Indian Tribes (E.O. 13175)</HD>
                <P>The Department strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in E.O. 13175 and have hosted consultation with federally recognized Indian Tribes before publication of this final rule.</P>
                <P>• Following the announcement of the Department's intent to reconsider the ban on re-petitioning in 2020, the Department held a Tribal consultation session with federally recognized Indian Tribes.</P>
                <P>• Following the publication of the 2022 proposed rule, the Department held two Tribal consultation sessions with federally recognized Indian Tribes.</P>
                <P>• Following the publication of the 2024 proposed rule, the Department held two Tribal consultation sessions with federally recognized Indian Tribes.</P>
                <HD SOURCE="HD2">I. Paperwork Reduction Act</HD>
                <P>
                    This final rule contains a revision to a collection of information which is currently approved under the Office of Management and Budget (OMB) Control Number 1076-0104 through February 28, 2026. The revisions have been submitted to OMB for review and approval under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) and is available at 
                    <E T="03">https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202310-1076-001.</E>
                     We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number:
                </P>
                <P>
                    • 
                    <E T="03">Title of Collection:</E>
                     Federal Acknowledgment as an Indian Tribe, 25 CFR part 83.
                </P>
                <P>
                    • 
                    <E T="03">OMB Control Number:</E>
                     1076-0104.
                </P>
                <P>
                    • 
                    <E T="03">Form Number:</E>
                     BIA-8304, BIA-8305, and BIA-8306.
                </P>
                <P>
                    • 
                    <E T="03">Type of Review:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    • 
                    <E T="03">Summary of revision/supplement:</E>
                     Pursuant to this final rule creating a conditional, time-limited opportunity for denied petitioners to re-petition for Federal acknowledgment as an Indian Tribe, the Department requires prospective re-petitioners to plausibly allege that the outcome of the previous, negative final determination would change to positive on reconsideration based on one or both of the following: (1) a change in part 83 (from the 1978 or 1994 regulations to the 2015 regulations); and/or (2) new evidence. The information will be collected in the unsuccessful petitioners' respective requests to re-petition for Federal acknowledgment. The collection of information will be unique for each petitioner.
                </P>
                <P>
                    • 
                    <E T="03">Respondents/Affected Public:</E>
                     Groups petitioning for Federal acknowledgment as Indian Tribes and groups seeking to re-petition for Federal acknowledgment.
                </P>
                <P>
                    • 
                    <E T="03">Total Estimated Number of Annual Respondents:</E>
                     2 per year, on average.
                </P>
                <P>○ 1 petitioning group.</P>
                <P>○ 1 group seeking to re-petition.</P>
                <P>
                    • 
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     2 per year, on average.
                </P>
                <P>○ 1,436 hours for 1 petitioning group.</P>
                <P>○ 700 hours for 1 group seeking to re-petition.</P>
                <P>
                    • 
                    <E T="03">Estimated Completion:</E>
                     Time per Response: 2,136 hours.
                </P>
                <P>○ 1,436 hours for 1 petitioning group.</P>
                <P>○ 700 hours for 1 group seeking to re-petition.</P>
                <P>
                    • 
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     2,136 hours.
                </P>
                <P>
                    • 
                    <E T="03">Respondent's Obligation:</E>
                     Required to Obtain a Benefit.
                </P>
                <P>
                    • 
                    <E T="03">Frequency of Collection:</E>
                     Once.
                </P>
                <P>
                    • 
                    <E T="03">Total Estimated Annual Nonhour Burden Cost:</E>
                     $3,150,000.
                </P>
                <P>○ $2,100,000 for contracted services obtained by 1 petitioning group.</P>
                <P>○ $1,050,000 for contracted services obtained by 1 group seeking to re-petition.</P>
                <P>
                    • 
                    <E T="03">Annual Cost to Federal Government:</E>
                     $778,801.
                </P>
                <P>○ $628,938 to review 1 petitioning group: (6,000 hours × $90.08 wage for GS-13) plus (666 hours × $132.82 for GS-15 wage).</P>
                <P>○ $149,863 to review 1 group seeking to re-petition: (1,500 hours times $90.08 wage for GS-13) plus (111 hours × 132.82 wage for GS-15).</P>
                <HD SOURCE="HD2">J. National Environmental Policy Act (NEPA)</HD>
                <P>
                    Under NEPA, categories of Federal actions that normally do not significantly impact the human environment may be categorically excluded from the requirement to prepare an environmental assessment or impact statement. 
                    <E T="03">See</E>
                     40 CFR 1501.4. Under the Department, regulations that are administrative or procedural are categorially excluded from NEPA analysis because they normally do not significantly impact the human environment. 
                    <E T="03">See</E>
                     43 CFR 46.210(i). This rule is administrative and procedural in nature. Consequently, it is categorically excluded from the NEPA requirement to prepare a detailed environmental analysis. The Department also determined that the rule does not involve any of the extraordinary circumstances under a categorical exclusion that would necessitate environmental analysis. 
                    <E T="03">See</E>
                     43 CFR 46.215.
                    <PRTPAGE P="3643"/>
                </P>
                <HD SOURCE="HD2">K. Effects on the Energy Supply (E.O. 13211)</HD>
                <P>This final rule is not a significant energy action under the definition in E.O. 13211. A Statement of Energy Effects is not required.</P>
                <HD SOURCE="HD2">L. Privacy Act of 1974, Existing System of Records</HD>
                <P>INTERIOR/BIA-7, Tribal Enrollment Reporting and Payment System, published September 27, 2011 (76 FR 59733), contains documents supporting individual Indian claims to interests in Indian Tribal groups and includes name, maiden name, alias, address, date of birth, social security number, blood degree, enrollment/BIA number, date of enrollment, enrollment status, certification by the Tribal governing body, telephone number, email address, account number, marriages, death notices, records of actions taken (approvals, rejections, appeals), rolls of approved individuals; records of actions taken (judgment distributions, per capita payments, shares of stock); ownership and census data taken using the rolls as a base, records concerning individuals which have arisen as a result of that individual's receipt of funds or income to which that individual was not entitled or the entitlement was exceeded in the distribution of such funds.</P>
                <HD SOURCE="HD2">M. Clarity of This Regulation</HD>
                <P>The Department is required by E.O. 12866 (section 1(b)(12)), 12988 (section 3(b)(l)(B)), and E.O. 13563 (section l(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This final rule meets the criteria of:</P>
                <P>(a) Being logically organized;</P>
                <P>(b) Using the active voice to address readers directly;</P>
                <P>(c) Using common, everyday words and clear language rather than jargon;</P>
                <P>(d) Being divided into short sections and sentences; and</P>
                <P>(e) Using lists and tables wherever possible.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 25 CFR Part 83</HD>
                    <P>Administrative practice and procedure, Indians—Tribal government.</P>
                </LSTSUB>
                <P>For the reasons stated in the preamble, the Department of the Interior amends 25 CFR part 83 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 83—PROCEDURES FOR FEDERAL ACKNOWLEDGMENT OF INDIAN TRIBES</HD>
                </PART>
                <REGTEXT TITLE="25" PART="83">
                    <AMDPAR>1. The authority citation for part 83 is revised to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 5 U.S.C. 301; 25 U.S.C. 2, 9, 5131; 25 U.S.C. 5130 note (Congressional Findings); and 43 U.S.C. 1457.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="25" PART="83">
                    <AMDPAR>2. In § 83.1, add in alphabetical order definitions for “Re-petition authorization process”, “Re-petitioning”, and “Unsuccessful petitioner” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 83.1</SECTNO>
                        <SUBJECT>What terms are used in this part?</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Re-petition authorization process</E>
                             means the process by which the Department handles a request for re-petitioning filed with OFA by an unsuccessful petitioner under §§ 83.47 through 83.62, from receipt to issuance of a decision as to whether the unsuccessful petitioner is authorized to re-petition for acknowledgment as a federally recognized Indian tribe. A grant of authorization to re-petition allows a petitioner to proceed through the Federal acknowledgment process by submitting a new documented petition for consideration under subpart C of this part.
                        </P>
                        <P>
                            <E T="03">Re-petitioning</E>
                             means, after receiving a negative final determination that is final and effective for the Department and receiving subsequent authorization to re-petition, the submission of a new documented petition for consideration under subpart C of this part.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Unsuccessful petitioner</E>
                             means an entity that was denied Federal acknowledgment after petitioning under the acknowledgment regulations at part 54 of this chapter (as they existed before March 30, 1982) or part 83.
                        </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="25" PART="83">
                    <AMDPAR>3. In § 83.4, revise paragraph (d) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 83.4</SECTNO>
                        <SUBJECT>Who cannot be acknowledged under this part?</SUBJECT>
                        <STARS/>
                        <P>(d) An entity that previously petitioned and was denied Federal acknowledgment under part 54 of this chapter (as it existed before March 30, 1982) or part 83 (including reconstituted, splinter, spin-off, or component groups who were once part of previously denied petitioners) unless the entity meets the conditions of §§ 83.47 through 83.49.</P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="25" PART="83">
                    <AMDPAR>4. Revise § 83.9 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 83.9</SECTNO>
                        <SUBJECT>How does the Paperwork Reduction Act affect the information collections in this part?</SUBJECT>
                        <P>
                            The collections of information contained in this part have been approved by the Office of Management and Budget under 44 U.S.C. 3501 
                            <E T="03">et seq.</E>
                             and assigned OMB Control Number 1076-0104. Response is required to obtain a benefit. A Federal agency may not conduct or sponsor, and you are not required to respond to, a collection of information unless the form or regulation requesting the information displays a currently valid OMB Control Number. Send comments regarding this collection of information, including suggestions for reducing the burden, to the Information Collection Clearance Officer—Indian Affairs, 1001 Indian School Road NW, Suite 229, Albuquerque, NM 87104.
                        </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="25" PART="83">
                    <AMDPAR>5. Add subpart D, consisting of §§ 83.47 through 83.62 to read as follows:</AMDPAR>
                    <CONTENTS>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart D—Re-Petition Authorization Process</HD>
                            <SECHD>Sec.</SECHD>
                            <SECTNO>83.47</SECTNO>
                            <SUBJECT>Who can seek authorization to re-petition under this subpart?</SUBJECT>
                            <SECTNO>83.48</SECTNO>
                            <SUBJECT>When will the Department allow a re-petition?</SUBJECT>
                            <SECTNO>83.49</SECTNO>
                            <SUBJECT>How long does an unsuccessful petitioner have to submit a request for authorization to re-petition?</SUBJECT>
                            <SECTNO>83.50</SECTNO>
                            <SUBJECT>How does an unsuccessful petitioner request authorization to re-petition?</SUBJECT>
                            <SECTNO>83.51</SECTNO>
                            <SUBJECT>What notice will OFA provide upon receipt of a request for authorization to re-petition?</SUBJECT>
                            <SECTNO>83.52</SECTNO>
                            <SUBJECT>What opportunity to comment will there be before the Assistant Secretary reviews the re-petition request?</SUBJECT>
                            <SECTNO>83.53</SECTNO>
                            <SUBJECT>How will the Assistant Secretary determine which re-petition request to consider first?</SUBJECT>
                            <SECTNO>83.54</SECTNO>
                            <SUBJECT>Who will OFA notify when the Assistant Secretary begins review of a re-petition request?</SUBJECT>
                            <SECTNO>83.55</SECTNO>
                            <SUBJECT>What will the Assistant Secretary consider in his/her review?</SUBJECT>
                            <SECTNO>83.56</SECTNO>
                            <SUBJECT>Can a petitioner withdraw its re-petition request?</SUBJECT>
                            <SECTNO>83.57</SECTNO>
                            <SUBJECT>When will the Assistant Secretary issue a decision on a re-petition request?</SUBJECT>
                            <SECTNO>83.58</SECTNO>
                            <SUBJECT>Can AS-IA suspend review of a re-petition request?</SUBJECT>
                            <SECTNO>83.59</SECTNO>
                            <SUBJECT>How will the Assistant Secretary make the decision on a re-petition request?</SUBJECT>
                            <SECTNO>83.60</SECTNO>
                            <SUBJECT>What notice of the Assistant Secretary's decision will OFA provide?</SUBJECT>
                            <SECTNO>83.61</SECTNO>
                            <SUBJECT>When will the Assistant Secretary's decision become effective, and can it be appealed?</SUBJECT>
                            <SECTNO>83.62</SECTNO>
                            <SUBJECT>What happens if some portion of this subpart is held to be invalid by a court of competent jurisdiction?</SUBJECT>
                        </SUBPART>
                    </CONTENTS>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart D—Re-Petition Authorization Process</HD>
                        <SECTION>
                            <SECTNO>§ 83.47</SECTNO>
                            <SUBJECT>Who can seek authorization to re-petition under this subpart?</SUBJECT>
                            <P>(a) The re-petition authorization process is available to unsuccessful petitioners denied Federal acknowledgment, subject to the exceptions in paragraph (c) of this section.</P>
                            <P>
                                (b) Any petitioner that, as of February 14, 2025, has not yet received a final 
                                <PRTPAGE P="3644"/>
                                agency decision and is proceeding under the acknowledgment regulations as published in this part, effective March 28, 1994, may remain under those regulations and, if denied under those regulations, may seek authorization to re-petition under this subpart. These petitioners may also choose by April 15, 2025, to proceed instead under the acknowledgment regulations, as published in this part 83, effective July 31, 2015, and to supplement their petitions, and, if the petition is denied, may seek authorization to re-petition under this subpart. Petitioners choosing to proceed under the regulations as published in this part 83, effective July 31, 2015 must notify OFA of their choice in writing by April 15, 2025, in any legible electronic or hardcopy form.
                            </P>
                            <P>(c) The re-petition authorization process is not available to the following:</P>
                            <P>(1) Unsuccessful petitioners that submit a re-petition request pursuant to this process, are granted authorization to re-petition, and are denied Federal acknowledgment a second time;</P>
                            <P>(2) Unsuccessful petitioners that submit a re-petition request pursuant to this process and are denied authorization to re-petition.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.48</SECTNO>
                            <SUBJECT>When will the Department allow a re-petition?</SUBJECT>
                            <P>An unsuccessful petitioner may re-petition only if AS-IA determines that the petitioner has plausibly alleged one or both of the following:</P>
                            <P>(a) A change from part 54 of this chapter (as it existed before March 30, 1982) or part 83 (as it existed before July 31, 2015) to this part 83 would, if applied on reconsideration, change the outcome of the previous, negative final determination to positive; and/or</P>
                            <P>
                                (b) New evidence (
                                <E T="03">i.e.,</E>
                                 evidence not previously submitted by the petitioner) would, if considered on reconsideration, change the outcome of the previous, negative final determination to positive.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.49</SECTNO>
                            <SUBJECT>How long does an unsuccessful petitioner have to submit a request for authorization to re-petition?</SUBJECT>
                            <P>(a) An unsuccessful petitioner denied Federal acknowledgment prior to February 14, 2025, may request authorization to re-petition by submitting a complete request under § 83.50 no later than February 14, 2030.</P>
                            <P>(b) An unsuccessful petitioner denied Federal acknowledgment after February 14, 2025, may request authorization to re-petition by submitting a complete request under § 83.50 no later than five years after issuance of the negative final determination. However, if the petitioner pursues judicial review of the negative final determination:</P>
                            <P>(1) The five-year period will be tolled during any period of judicial review, from the date of filed litigation to the date of entry of judgment and expiration of appeal rights for said litigation; and</P>
                            <P>(2) Upon expiration of the appeal rights, OFA will notify the petitioner and those listed in § 83.51(b)(2) of the resumption of the five-year time limit and the date by which the petitioner must submit a request for re-petitioning.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.50</SECTNO>
                            <SUBJECT>How does an unsuccessful petitioner request authorization to re-petition?</SUBJECT>
                            <P>(a) To initiate the re-petition authorization process, the petitioner must submit to OFA, in any legible electronic or hardcopy form, a re-petition request that includes the following:</P>
                            <P>(1) A certification, signed and dated by the petitioner's governing body, stating that the submission is the petitioner's official request for authorization to re-petition;</P>
                            <P>(2) A concise written narrative, with citations to supporting documentation, thoroughly explaining how the petitioner meets the conditions of §§ 83.47 through 83.49; and</P>
                            <P>(3) Supporting documentation cited in the written narrative and containing specific, detailed evidence that the petitioner meets the conditions of §§ 83.47 through 83.49.</P>
                            <P>(b) If the re-petition request contains any information that is protectable under Federal law such as the Privacy Act and Freedom of Information Act, the petitioner must provide a redacted version, an unredacted version of the relevant pages, and an explanation of the legal basis for withholding such information from public release. The Department will not publicly release information that is protectable under Federal law, but may release redacted information if not protectable under Federal law.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.51</SECTNO>
                            <SUBJECT>What notice will OFA provide upon receipt of a request for authorization to re-petition?</SUBJECT>
                            <P>When OFA receives a re-petition request that satisfies § 83.50, it will do all of the following:</P>
                            <P>(a) Within 30 days of receipt, acknowledge receipt in writing to the petitioner.</P>
                            <P>(b) Within 60 days of receipt:</P>
                            <P>
                                (1) Publish notice of receipt of the re-petition request in the 
                                <E T="04">Federal Register</E>
                                 and publish the following on the OFA website:
                            </P>
                            <P>(i) The narrative portion of the re-petition request, as submitted by the petitioner (with any redactions appropriate under § 83.50(b));</P>
                            <P>(ii) Other portions of the re-petition request, to the extent feasible and allowable under Federal law, except documentation and information protectable from disclosure under Federal law, as identified by the petitioner under § 83.50(b) or by the Department;</P>
                            <P>(iii) The name, location, and mailing address of the petitioner and other information to identify the entity;</P>
                            <P>(iv) The date of receipt;</P>
                            <P>(v) The opportunity for individuals and entities to submit comments and evidence supporting or opposing the petitioner's request for re-petitioning within 120 days of publication of notice of the request; and</P>
                            <P>(vi) The opportunity for individuals and entities to request to be kept informed of general actions regarding a specific petitioner.</P>
                            <P>(2) Notify, in writing, the parties entitled to notification of a documented petition under § 83.22(d) and any third parties that participated in an administrative reconsideration or Federal Court appeal concerning the petitioner.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.52</SECTNO>
                            <SUBJECT>What opportunity to comment will there be before the Assistant Secretary reviews the re-petition request?</SUBJECT>
                            <P>(a) Publication of notice of the request will be followed by a 120-day comment period. During this comment period, any individual or entity may submit the following to OFA to rebut or support the request:</P>
                            <P>(1) Comments, with citations to and explanations of supporting evidence; and</P>
                            <P>(2) Evidence cited and explained in the comments.</P>
                            <P>(b) Any individual or entity that submits comments and evidence to OFA must provide the petitioner with a copy of their submission.</P>
                            <P>(c) If OFA has received a timely objection and evidence challenging the request, then the petitioner will have 60 days to submit a written response, with citations to and explanations of supporting evidence, and the supporting evidence cited and explained in the response. The Department will not consider additional comments or evidence on the request submitted by individuals or entities during this response period.</P>
                            <P>(d) After the close of the comment-and-response period, the Department will consider the re-petition request ready for active consideration, and within 30 days of the close of the comment-and-response period, OFA will place the request on the register that OFA maintains under § 83.53(a).</P>
                        </SECTION>
                        <SECTION>
                            <PRTPAGE P="3645"/>
                            <SECTNO>§ 83.53</SECTNO>
                            <SUBJECT>How will the Assistant Secretary determine which re-petition request to consider first?</SUBJECT>
                            <P>(a) OFA shall maintain and make available on its website a register of re-petition requests that are ready for active consideration.</P>
                            <P>(b) The order of consideration of re-petition requests shall be determined by the date on which OFA places each request on OFA's register of requests ready for active consideration.</P>
                            <P>(c) The Department will prioritize review of documented petitions over review of re-petition requests, except that re-petition requests pending on OFA's register for more than two years shall have priority over any subsequently filed documented petitions.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.54</SECTNO>
                            <SUBJECT>Who will OFA notify when the Assistant Secretary begins review of a re-petition request?</SUBJECT>
                            <P>OFA will notify the petitioner and those listed in § 83.51(b)(2) when AS-IA begins review of a re-petition request and will provide the petitioner and those listed in § 83.51(b)(2) with the name, office address, and telephone number of the staff member with primary administrative responsibility for the request.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.55</SECTNO>
                            <SUBJECT>What will the Assistant Secretary consider in his/her review?</SUBJECT>
                            <P>(a) In any review, AS-IA will consider the re-petition request and evidence submitted by the petitioner, any comments and evidence on the request received during the comment period, and petitioners' responses to comments and evidence received during the response period.</P>
                            <P>(b) AS-IA may also:</P>
                            <P>(1) Initiate and consider other research for any purpose relative to analyzing the re-petition request; and</P>
                            <P>(2) Request and consider timely submitted additional explanations and information from commenting parties to support or supplement their comments on the re-petition request and from the petitioner to support or supplement their responses to comments.</P>
                            <P>(c) OFA will provide the petitioner with the additional material obtained in paragraph (b) of this section, and provide the petitioner with a 60-day opportunity to respond to the additional material. The additional material and any response by the petitioner will become part of the record.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.56</SECTNO>
                            <SUBJECT>Can a petitioner withdraw its re-petition request?</SUBJECT>
                            <P>A petitioner can withdraw its re-petition request at any point in the process and re-submit the request at a later date within the five-year time limit applicable to the petitioner under § 83.49. Upon re-submission, the re-petition request will lose its original place in line and be considered after other re-petition requests awaiting review.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.57</SECTNO>
                            <SUBJECT>When will the Assistant Secretary issue a decision on a re-petition request?</SUBJECT>
                            <P>(a) AS-IA will issue a decision within 180 days after OFA notifies the petitioner under § 83.54 that AS-IA has begun review of the request.</P>
                            <P>(b) The time set out in paragraph (a) of this section will be suspended any time the Department is waiting for a response or additional information from the petitioner.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.58</SECTNO>
                            <SUBJECT>Can AS-IA suspend review of a re-petition request?</SUBJECT>
                            <P>(a) AS-IA can suspend review of a re-petition request, either conditionally or for a stated period, if there are technical or administrative problems that temporarily preclude continuing review.</P>
                            <P>(b) Upon resolution of the technical or administrative problems that led to the suspension, the re-petition request will have the same priority for review to the extent possible.</P>
                            <P>(1) OFA will notify the petitioner and those listed in § 83.51(b)(2) when AS-IA suspends and when AS-IA resumes review of the re-petition request.</P>
                            <P>(2) Upon the resumption of review, AS-IA will have the full 180 days to issue a decision on the request.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.59</SECTNO>
                            <SUBJECT>How will the Assistant Secretary make the decision on a re-petition request?</SUBJECT>
                            <P>(a) AS-IA's decision will summarize the evidence, reasoning, and analyses that are the basis for the decision regarding whether the petitioner meets the conditions of §§ 83.47 through 83.49.</P>
                            <P>(b) If AS-IA finds that the petitioner meets the conditions of §§ 83.47 through 83.49, AS-IA will issue a grant of authorization to re-petition.</P>
                            <P>(c) If AS-IA finds that the petitioner has not met the conditions of §§ 83.47 through 83.49, AS-IA will issue a denial of authorization to re-petition.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.60</SECTNO>
                            <SUBJECT>What notice of the Assistant Secretary's decision will OFA provide?</SUBJECT>
                            <P>
                                In addition to publishing notice of AS-IA's decision in the 
                                <E T="04">Federal Register</E>
                                , OFA will:
                            </P>
                            <P>(a) Provide copies of the decision to the petitioner and those listed in § 83.51(b)(2); and</P>
                            <P>(b) Publish the decision on the OFA website.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.61</SECTNO>
                            <SUBJECT>When will the Assistant Secretary's decision become effective, and can it be appealed?</SUBJECT>
                            <P>AS-IA's decision under § 83.59 will become effective immediately and is not subject to administrative appeal.</P>
                            <P>(a) A grant of authorization to re-petition is not a final determination granting or denying acknowledgment as a federally recognized Indian tribe. Instead, it allows the petitioner to proceed through the Federal acknowledgment process by submitting a new documented petition for consideration under subpart C of this part, notwithstanding the Department's previous, negative final determination. A grant of authorization to re-petition is not subject to appeal.</P>
                            <P>(b) A denial of authorization to re-petition is final for the Department and is a final agency action under the Administrative Procedure Act (5 U.S.C. 704).</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 83.62</SECTNO>
                            <SUBJECT>What happens if some portion of this subpart is held to be invalid by a court of competent jurisdiction?</SUBJECT>
                            <P>If any portion of this subpart is determined to be invalid by a court of competent jurisdiction, the other portions of the subpart remain in effect. For example, if one of the conditions on re-petitioning set forth at §§ 83.47 through 83.49 is held to be invalid, it is the Department's intent that the other conditions remain valid.</P>
                        </SECTION>
                    </SUBPART>
                </REGTEXT>
                <SIG>
                    <NAME>Bryan Newland,</NAME>
                    <TITLE>Assistant Secretary—Indian Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00709 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4337-15-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>Internal Revenue Service</SUBAGY>
                <CFR>26 CFR Part 301</CFR>
                <DEPDOC>[TD 10030]</DEPDOC>
                <RIN>RIN 1545-BP72</RIN>
                <SUBJECT>Resolution of Federal Tax Controversies by the Independent Office of Appeals</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Internal Revenue Service (IRS), Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final regulation.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document contains final regulations that provide guidance on the resolution of Federal tax controversies by the IRS Independent Office of Appeals (Appeals) under the Taxpayer First Act of 2019 (TFA). The final regulations provide that while the Appeals resolution process is generally available to all taxpayers to resolve 
                        <PRTPAGE P="3646"/>
                        Federal tax controversies, there are certain exceptions to consideration by Appeals. The final regulations also address certain procedural and timing rules that must be met before Appeals consideration is available. The regulations affect taxpayers requesting Appeals consideration of Federal tax controversies.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         These regulations are effective on January 15, 2025.
                    </P>
                    <P>
                        <E T="03">Applicability date:</E>
                         The regulations in §§ 301.7803-2 and 301.7803-3 apply to 
                        <E T="03">all requests for consideration by Appeals that are received on or after February 14, 2025.</E>
                    </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Joshua P. Hershman at (202) 317-4311 (not a toll-free number).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority</HD>
                <P>This document contains amendments to the Procedure and Administration Regulations under 26 CFR part 301 to implement section 7803(e) of the Internal Revenue Code (Code), which Congress enacted in the TFA (final regulations). The final regulations are issued under section 7805(a) of the Code, which expressly delegates to the Secretary of the Treasury or her delegate (Secretary) the authority to “prescribe all needful rules and regulations for the enforcement of [the Code], including all rules and regulations as may be necessary by reason of any alteration of law in relation to internal revenue.”</P>
                <HD SOURCE="HD1">Background</HD>
                <P>Section 7803(e)(3) provides that it is the function of Appeals to resolve Federal tax controversies without litigation on a basis that is fair and impartial to both the Government and the taxpayer, promotes a consistent application and interpretation of, and voluntary compliance with, the Federal tax laws, and enhances public confidence in the integrity and efficiency of the IRS. Section 7803(e)(4) states that the resolution process to resolve Federal tax controversies described in section 7803(e)(3) “shall be generally available to all taxpayers.”</P>
                <P>
                    On September 13, 2022, the Treasury Department and the IRS published in the 
                    <E T="04">Federal Register</E>
                     (87 FR 55934) a notice of proposed rulemaking (REG-125693-19) proposing amendments to implement section 7803(e) (proposed regulations). The proposed regulations proposed to adopt the function of Appeals as stated in section 7803(e)(3) and that the Appeals resolution process is generally available to all taxpayers to resolve Federal tax controversies as stated in section 7803(e)(4). The proposed regulations defined what constitutes a Federal tax controversy involving disputes over administrative determinations made by the IRS and, consistent with the historical practice and functions of Appeals, listed certain additional topics involving disputes over administrative determinations by the IRS that are treated as Federal tax controversies. Proposed § 301.7803-2(c)(1) through (24) also proposed an exclusive list of twenty-four exceptions to consideration of a Federal tax controversy by Appeals, almost all of which existed before the enactment of the TFA. This preamble refers to the exceptions in proposed § 301.7803-2(c), such as proposed § 301.7803-2(c)(1), (2), and (3), for example, as “Exception 1,” “Exception 2,” and “Exception 3.”
                </P>
                <P>Additionally, the proposed regulations proposed certain procedural and timing rules that must be met before Appeals consideration is available: the originating IRS office must have completed its review; a taxpayer must have submitted the request for Appeals consideration in the prescribed time and manner; and Appeals must have had sufficient time remaining on the appropriate limitations period for it to consider the matter. Further, if a Federal tax controversy is eligible for consideration by Appeals and the procedural and timing requirements are followed, a taxpayer would generally have only one opportunity for Appeals consideration. The proposed regulations also proposed two special rules for docketed cases. First, if Appeals issued a notice of deficiency, notice of liability, or other determination, without having fully considered one or more issues because of an impending expiration of the statute of limitations on assessment, Appeals may choose to have the Office of Chief Counsel (Chief Counsel) return the case to Appeals for full consideration of the issue or issues once the case is docketed in the United States Tax Court (Tax Court). Second, Appeals and Chief Counsel may determine how settlement authority is transferred between the two offices. Similar prerequisites to Appeals consideration as those described in this paragraph existed before the enactment of the TFA.</P>
                <P>Besides soliciting public comments on the rules in the proposed regulations, the Treasury Department and the IRS also solicited public comments in the proposed regulations on whether certain exclusions from Appeals' consideration currently provided in the Internal Revenue Manual (IRM) relating to requests for relief under §§ 301.9100-1 through 301.9100-22 (9100 relief) and requests for a change in accounting method (CAM) should be included in the list of exceptions in the regulations.</P>
                <P>Lastly, the proposed regulations proposed requirements to implement section 7803(e)(5). Enacted by the TFA, section 7803(e)(5) requires the IRS to follow the special notification procedures set forth in section 7803(e)(5) if a taxpayer who is in receipt of a notice of deficiency under section 6212 of the Code requests to have the Federal tax controversy referred to Appeals and that request is denied.</P>
                <P>
                    The 
                    <E T="03">Summary of Comments and Explanation of Revisions</E>
                     of these final regulations summarizes the provisions of the proposed regulations, which are explained in greater detail in the preamble to the proposed regulations. In response to the proposed regulations, the Treasury Department and the IRS received fourteen comments. A public hearing was requested and held on November 29, 2022.
                </P>
                <P>
                    After careful consideration of the comments and hearing testimony, the Treasury Department and the IRS adopt the proposed regulations, as modified by this Treasury decision, in response to such comments as described in the 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                     The final regulations also include minor typographical and editorial edits, including non-substantive clarifications, to the proposed regulations.
                </P>
                <HD SOURCE="HD1">Summary of Comments and Explanation of Revisions</HD>
                <HD SOURCE="HD2">I. Proposed § 301.7803-2</HD>
                <HD SOURCE="HD3">A. Intent of the TFA To Grant Authority To Make Exceptions</HD>
                <P>Numerous comments addressed the scope of the proposed exceptions to Appeals consideration in proposed § 301.7803-2(c) or the authority of the Treasury Department and the IRS to make exceptions that exclude or limit access to Appeals.</P>
                <P>
                    Several comments agreed that the TFA generally authorizes the Treasury Department and the IRS to provide exceptions to Appeals consideration. A comment agreed that the statutory text and legislative history of the TFA confirm Congress did not intend for Appeals access to be universally available. This comment supported the proposed regulations' identification of particular situations in which Appeals access should not be available. While disagreeing with Exception 19 (Challenges Alleging That a Treasury Regulation Is Invalid) and Exception 20 (Challenges Alleging That a Notice or Revenue Procedure Is Invalid) and exceptions for 9100 relief and CAMs, another comment generally agreed with 
                    <PRTPAGE P="3647"/>
                    the Treasury Department and the IRS that not every case is appropriate for Appeals consideration. The comment also stated that the TFA did not require that the IRS grant all requests for Appeals to consider any dispute because the Secretary may provide exceptions to Appeals consideration. Another comment stated there was “ample reason, rooted in logic and past practice, for the majority of [the] proposed exceptions.” It opined that some of the proposed exceptions, which were not identified, were not necessary to the proper administration of the Appeals process or were not consistent with the statute's mandate that the Appeals process be generally available. Another comment stated that some of the historic exclusions in the proposed regulations should be accepted and specifically mentioned penalties and determinations under sections 6702 or 6682 of the Code. Other comments stated that the proposed exceptions or exceptions framework laid out in the proposed regulations generally ran afoul of the intent of the TFA by limiting access to Appeals, or that certain proposed exceptions such as Exception 18 (Challenges Alleging That a Statute Is Unconstitutional), Exception 19, and Exception 20 did so. These comments gave several reasons in support of their arguments, as described in greater detail in section I.D. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                     Two comments claimed that providing exceptions to review by Appeals would deny taxpayers a statutory right to Appeals, and two comments claimed exceptions to review by Appeals would inappropriately restrict Appeals access and suggested the proposed regulations should instead expand Appeals access.
                </P>
                <P>
                    As explained in more detail in section I.C. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     Congress did not provide for an absolute right to administrative consideration by Appeals, which is reflected in the statute and the TFA's legislative history. Rather, Appeals review is “generally available,” under section 7803(e)(4) and the Treasury Department and the IRS may provide reasonable exceptions in their discretion, whether existing or new. In addition to this statutory language, TFA's legislative history also reflects the intention of Congress that the Treasury Department and the IRS retain their historical discretion to determine whether the resolution of particular types of disputes is appropriate for the Appeals resolution process, and for the IRS to retain the discretion to determine whether a particular Federal tax controversy is appropriate for the Appeals resolution process:
                </P>
                <EXTRACT>
                    <P>
                        Independent Appeals is intended to perform functions similar to those of the current Appeals. Independent Appeals is to resolve tax controversies and review administrative decisions of the IRS in a fair and impartial manner, for the purposes of enhancing public confidence, promoting voluntary compliance, and ensuring consistent application and interpretation of Federal tax laws. Resolution of tax controversies in this manner is generally available to all taxpayers, 
                        <E T="03">subject to reasonable exceptions that the Secretary may provide.</E>
                         Thus, cases of a type that are referred to Appeals under present law remain eligible for referral to Independent Appeals.
                    </P>
                </EXTRACT>
                <FP>
                    <E T="03">See</E>
                     H.R. Rep. No. 39, Part 1, 116th Cong., 1st Session (House TFA Report), 30-31 (2019) (emphasis added).
                </FP>
                <P>
                    Contrary to one comment's suggestion, the Committee reports for the IRS Restructuring and Reform Act of 1998, Public Law 105-206 (112 Stat. 685, 689 (July 22, 1998)), and any earlier version of the TFA that Congress did not enact, are not informative when interpreting the TFA. The legislative history of the TFA reflects Congressional intent that the Treasury Department and the IRS retain their historical discretion to determine whether the resolution of particular types of disputes is appropriate for Appeals, and the discretion of the IRS to determine whether a particular Federal tax controversy is appropriate for the Appeals resolution process. 
                    <E T="03">See</E>
                     House TFA Report, at 29.
                </P>
                <P>Several comments expressed concern that excluding a matter from Appeals consideration adversely affects the independence or impartiality of Appeals. Some of the comments specifically asserted that prohibiting Appeals from considering validity challenges to a regulation, notice, or revenue procedure as set forth in Exception 19 or Exception 20 undermines its independence. The Treasury Department and the IRS disagree with this comment. Exceptions from review by Appeals do not inhibit the independence or impartiality of Appeals for matters or issues under consideration. If a matter is not reviewed by Appeals, there is no independent analysis to be performed. Appeals still would be free to settle a Federal tax controversy that is referred to it using its own standards and an exception to review by Appeals would have no bearing on the cases or issues that are referred to Appeals.</P>
                <P>
                    One comment opined that the proposed exceptions in general are not reasonable or narrowly construed. The Treasury Department and the IRS disagree with this comment. As reflected in the proposed regulations' 
                    <E T="03">Explanation of Provisions</E>
                     in section I.C., the proposed exceptions are narrowly tailored and are based on reasonable rationales. Additionally, the proposed regulations and these final regulations reinforce the statutory presumption that Federal tax controversies may be considered by Appeals and require a regulatory exception for consideration to be unavailable.
                </P>
                <P>The same comment suggested there would be no “whipsaw” if Appeals settles any of the cases or issues outlined in the proposed exceptions because Appeals settlements are not binding on any other taxpayer or on Chief Counsel's litigation position. It is unclear what is intended by this comment. The term whipsaw refers to the situation produced when the Government is subjected to conflicting claims of taxpayers. The issue of whipsaw has no bearing on the Appeals exceptions listed in the proposed regulations nor on the rationales set forth in the proposed regulations that support these exceptions and so the Treasury Department and the IRS do not agree that revisions to the proposed regulations are necessary.</P>
                <P>
                    A few comments focused on costs and opined that Congress intended for Appeals to resolve Federal tax controversies without expensive litigation. A comment asserted the establishment of Appeals was an attempt by Congress to make resolving controversies less cost-prohibitive for lower income individuals. Another comment stated the proposed regulations' approach granting exceptions to Appeals consideration would be a waste of resources of the Government and taxpayers. The Treasury Department and the IRS agree that part of Appeals' mission is to resolve Federal tax controversies without litigation, but do not agree that exceptions to review by Appeals will result in a waste of resources. There is no reason to assume that the cost to litigate a particular Federal tax controversy will significantly increase as a result of the proposed regulations, or that litigation expenses will increase at all in circumstances in which an exception existed before the TFA. Appeals consideration will still be available for most cases, which can be resolved without litigation (or without further litigation if the taxpayer has petitioned the Tax Court). The proposed regulations' procedural requirements, timing requirements, and almost all of the exceptions to consideration by 
                    <PRTPAGE P="3648"/>
                    Appeals already exist in previously established guidance regarding Appeals. As in the past, the proposed exceptions are limited in number and scope. The vast majority of taxpayers, including low-income taxpayers, will have the opportunity to have Appeals consider their Federal tax controversies.
                </P>
                <P>
                    Similarly, two comments asserted that Exception 18, Exception 19, and/or Exception 20 waste taxpayer and Government resources. As discussed in more detail in sections I.D.11.a. and 12. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions,</E>
                     in contrast to a single decision by Appeals that is applicable and communicated only to one taxpayer, a final decision from a Federal court is publicly available and applied consistently to all taxpayers. As a result, these exceptions promote efficiency rather than wasting taxpayer and Government resources. Furthermore, even if Appeals were to review the matter covered by these exceptions, there is no guarantee that Appeals would settle or resolve it.
                </P>
                <P>
                    One comment recommended that the Treasury Department and the IRS should take a conservative approach to Appeals exceptions because recent Supreme Court decisions such as 
                    <E T="03">CIC Services, LLC</E>
                     v. 
                    <E T="03">Internal Revenue Service,</E>
                     593 U.S. 209 (2021) and 
                    <E T="03">Boechler, P.C.</E>
                     v. 
                    <E T="03">Commissioner,</E>
                     596 U.S. 199 (2022) defined limits on the IRS's contentions concerning its prerogatives under the Administrative Procedure Act (APA), equitable tolling, and Tax Court jurisdiction. The Treasury Department and the IRS disagree with the premise of this comment that a more conservative approach is needed or that the referenced cases are relevant in construing section 7803(e). The exceptions in these regulations are reasonable and narrowly tailored to achieve their purposes. None of the cited cases addressed the meaning of section 7803(e) or the availability of Appeals review. Instead, these cases address different issues and have no bearing on these regulations.
                </P>
                <P>
                    Another comment noted that litigation arguing that the TFA provides taxpayers with access to Appeals is pending in the 
                    <E T="03">Hancock</E>
                     and 
                    <E T="03">Rocky Branch</E>
                     cases in the United States Court of Appeals for the Eleventh Circuit (Eleventh Circuit), implying that the regulations should be withheld due to the litigation. The Treasury Department and the IRS disagree that these two cases serve to limit or prevent the publication of regulations. Neither case is pending any longer. In 
                    <E T="03">Hancock,</E>
                     the U.S. District Court for the Northern District of Georgia held that the taxpayer had no absolute right to Appeals consideration under the circumstances. The Eleventh Circuit upheld the decision on Anti-Injunction Act grounds (
                    <E T="03">see</E>
                     section 7421 of the Code), and the Supreme Court denied certiorari. 
                    <E T="03">See Hancock County Land Acquisitions LLC, et. al.</E>
                     v. 
                    <E T="03">United States,</E>
                     553 F. Supp. 3d 1284, 1294 fn. 9 (N.D. Ga. 2021), 
                    <E T="03">aff'd</E>
                     130 AFTR 2d 2022-5529 (11th Cir. Aug. 17, 2022), 
                    <E T="03">cert. denied</E>
                     143 S.Ct. 577 (January 9, 2023). 
                    <E T="03">Rocky Branch</E>
                     has facts similar to the facts in 
                    <E T="03">Hancock,</E>
                     and as in 
                    <E T="03">Hancock</E>
                     the Eleventh Circuit upheld the decision on Anti-Injunction grounds, and the Supreme Court denied certiorari. 
                    <E T="03">See Rocky Branch Timberlands LLC, et. al.</E>
                     v. 
                    <E T="03">United States,</E>
                     129 AFTR 2d 2022-2137 (N.D. Ga. 2022), 
                    <E T="03">aff'd</E>
                     132 AFTR 2d 2023-5788 (11th Cir. Sept. 6, 2023), 
                    <E T="03">cert. denied</E>
                     144 S.Ct. 812 (Feb. 20, 2024).
                </P>
                <P>
                    One comment asserted that some of the exceptions in the proposed regulations, in particular, Exception 3 (Whistleblower Awards); Exception 4 (Administrative Determinations Made by Other Agencies); Exception 7 (Denial of Access Under the Privacy Act); and Exception 14 (Authority Over the Matter Rests With Another Office) leave a taxpayer without any administrative recourse. The comment suggested an interagency discussion over how and whether administrative appeals processes, whether residing in the IRS Independent Office of Appeals or outside of the IRS, could be developed for these types of cases. The Treasury Department and the IRS agree with the comment's premise that the language of section 7803(e) does not cover Exception 3, Exception 4, and Exception 7, or cover Exception 14 with respect to referrals to the Department of Justice (Justice Department). 
                    <E T="03">See</E>
                     sections I.D.2., 3., 4., and 8. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                     The disputes involved in Exception 3, Exception 4, and Exception 7 are not Federal tax controversies, and Appeals lacks settlement authority after a referral of a case to the Justice Department, as described in Exception 14. The inclusion of Exception 3, Exception 4, Exception 7, and Exception 14 in the list of proposed exceptions in proposed § 301.7803-2(c) was to clarify these points. These exceptions to Appeals consideration all existed before the TFA. Expanding the role of Appeals as suggested is not administratively feasible and is outside the scope of these regulations and section 7803. Furthermore, lack of consideration by Appeals does not leave the taxpayer without an administrative option to resolve a controversy as issues can always be resolved during an examination. Accordingly, these final regulations do not adopt this comment.
                </P>
                <HD SOURCE="HD3">B. Definition of a Federal Tax Controversy: Proposed § 301.7803-2(b)(2)</HD>
                <P>
                    Section 7803(e)(3) provides that the function of Appeals is “to resolve Federal tax controversies without litigation,” without defining the term “Federal tax controversy.” Proposed § 301.7803-2(b)(1), consistent with the statutory text of section 7803(e)(4), provides that the Appeals resolution process is generally available to all taxpayers to resolve Federal tax controversies. Proposed § 301.7803-2(b)(2) defined a 
                    <E T="03">Federal tax controversy</E>
                     as a dispute over an administrative determination with respect to a particular taxpayer made by the IRS in administering or enforcing the internal revenue laws, related Federal tax statutes, and tax conventions to which the United States is a party (collectively referred to as internal revenue laws) that arises out of the examination, collection, or execution of other activities concerning the amount or legality of the taxpayer's income, employment, excise, or estate and gift tax liability; a penalty; or an addition to tax under the internal revenue laws.
                </P>
                <P>As proposed in the proposed regulations and consistent with the statute, the definition of a Federal tax controversy is broad. Although the proposed definition does not specifically refer to tax-exempt organizations, it includes an IRS determination that an organization is not tax-exempt because the determination concerns whether the organization has or will have a tax liability in some amount. Similarly, determinations of private foundation or qualified employee plan status and tax-exempt or other tax-advantaged bond status are included in the proposed regulations' definition of a Federal tax controversy because these determinations concern whether there is or will be a tax liability for the foundation; plan, or its participants; or bond issuers or holders. In these final regulations, the Treasury Department and the IRS have modified the definition of a Federal tax controversy to clarify that such determinations are included in the definition.</P>
                <P>
                    Consistent with section 7803(e), the definition of Federal tax controversy means that determinations that Appeals historically may not have considered may now be considered by Appeals. These determinations include the classification or reclassification of a non-exempt charitable trust under 
                    <PRTPAGE P="3649"/>
                    section 4947(a)(1) of the Code as described in section 509(a)(3) of the Code; the classification or reclassification of the organization as an exempt operating foundation under section 4940(d)(2) of the Code; relief from retroactive revocation or modification of a determination letter under section 7805(b) of the Code; denials of relief requested under § 301.9100-3 to permit the organization to be recognized and treated as tax-exempt effective as of a date earlier than the date of application; and pursuant to section 7611 of the Code relating to restrictions on church tax inquiries and examinations, revocation of the exempt or church status of an organization that is listed as, or claims to be, a church.
                </P>
                <HD SOURCE="HD3">C. Disputes Not Meeting the Definition of a Federal Tax Controversy That Are Treated as Federal Tax Controversies: Proposed § 301.7803-2(b)(3)</HD>
                <P>Proposed § 301.7803-2(b)(3) provided that notwithstanding the definition of a Federal tax controversy, disputes over administrative determinations made by the IRS with respect to a particular person regarding certain topics listed in proposed § 301.7803-2(b)(3) are treated as Federal tax controversies.</P>
                <HD SOURCE="HD3">1. Additional Disputes Treated as Federal Tax Controversies: Proposed § 301.7803-2(b)(3)(iv) Through (vi)</HD>
                <P>
                    As explained previously in section I.B. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions,</E>
                     the final regulations clarify that the definition of Federal tax controversy includes determinations concerning the status of tax-exempt organizations, private foundations, and qualified plans, and the status of tax-exempt or other tax-advantaged bonds. Accordingly, the final regulations delete these items from proposed § 301.7803-2(b)(3)(iv) through (vi), because inclusion would be unnecessary and duplicative. The final regulations retain the language in proposed § 301.7803-2(b)(3)(vi) referring to arbitrage claims, because such claims do not involve a tax and therefore do not meet the definition of a Federal tax controversy, as defined in § 301.7803-2(b)(2). That language is now included in the final regulations and redesignated as § 301.7803-2(b)(3)(iv).
                </P>
                <HD SOURCE="HD3">2. FOIA Cases Treated as Federal Tax Controversies: Proposed § 301.7803-2(b)(3)(ii)</HD>
                <P>
                    One comment was received on proposed § 301.7803-2(b)(3)(ii) relating to a request under the Freedom of Information Act (5 U.S.C. 552) (FOIA). This comment recommended removing proposed § 301.7803-2(b)(3)(ii) because FOIA does not affect the collection of taxes or the liability for taxes of the FOIA requester. The Treasury Department and the IRS do not adopt this recommendation. Appeals consideration of IRS administrative determinations listed in proposed § 301.7803-2(b)(3), including in proposed § 301.7803-2(b)(3)(ii), is consistent with the historical practice and functions of Appeals as codified in section 7803(e)(3). 
                    <E T="03">See</E>
                     § 301.7803-2(b)(3)(i) through (vi). As a matter of tax policy and administration, it is important that FOIA requesters have, consistent with past practice, the opportunity for consideration by Appeals. The TFA does not prohibit Appeals from reviewing determinations by the IRS that are not Federal tax controversies, and retaining the ability for review by Appeals is beneficial to the public.
                </P>
                <HD SOURCE="HD3">D. Exceptions to Appeals Consideration: Exception 1 Through Exception 24</HD>
                <P>The Treasury Department and the IRS received several comments concerning the exceptions to Appeals consideration listed in proposed § 301.7803-2(c)(1) through (24). The exceptions that were subject to the greatest number of comments were Exception 19 and Exception 20.</P>
                <HD SOURCE="HD3">1. Frivolous Position and Penalties Related to Frivolous Positions and False Information: Exception 1 and Exception 2</HD>
                <P>Two comments were received on Exception 1 and Exception 2. Exception 1 provides that Appeals consideration is not available for an administrative determination made by the IRS with respect to a particular taxpayer in which the IRS rejects a frivolous position. Similarly, Exception 2 provides that Appeals consideration is not available regarding a penalty assessed by the IRS with respect to a particular taxpayer for asserting a frivolous position, for making a frivolous submission, or for providing false information.</P>
                <P>One comment agreed with excepting from Appeals consideration penalties and determinations under section 6702 or section 6682 of the Code. A second comment alleged the exceptions would curtail the independence of Appeals by eliminating its right to review determinations of frivolousness because such determinations are not infallible. That comment recommended Appeals should have the option, but not the obligation, to decide whether positions have been wrongly labeled frivolous to strike a balance between its independence and the IRS's need to weed out frivolous arguments.</P>
                <P>
                    The Treasury Department and the IRS do not adopt this recommendation to give Appeals the option to consider whether the IRS has mistakenly labeled a taxpayer's position as frivolous or wrongly imposed a frivolous filing penalty. Referring every frivolous argument to Appeals upon the request of a taxpayer, for Appeals to then determine whether or not to grant consideration, would be unnecessarily resource intensive and inconsistent with the historic, reasonable limitations on access to Appeals. Section I.C.1. of the proposed regulations' 
                    <E T="03">Explanation of Provisions</E>
                     identified similar existing restrictions precluding the consideration of frivolous positions by Appeals that can be found in § 601.106(b) of the Statement of Procedural Rules (26 CFR part 601) (regarding appeal procedures not extending to cases involving solely the failure or refusal to comply with tax laws because of frivolous moral, religious, political, constitutional, conscientious, or similar grounds), IRM 5.14.3.3(1) (10-20-2020) (relating to installment agreement requests made to delay collection action), and IRM 8.22.5.5.3 (11-08-2013) (relating to frivolous issues). There are sound policy reasons for these historic limitations. As explained in sections I.C.1. and 2. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     Appeals consideration of frivolous positions would facilitate abuse of the tax system by allocating IRS and Appeals resources to reviewing positions that have already been designated as frivolous. Penalties imposed under section 6702 or section 6682 are designed to deter frivolous behavior or improper conduct by a taxpayer. If Appeals does not consider the merits of a taxpayer's frivolous position, it follows that Appeals should not consider the IRS's assessment of a penalty with respect to the taxpayer as well. The exceptions are consistent with the restriction in section 7803(e)(5)(D) that the notice and protest procedures under section 7803(e)(5) do not apply to a request if the issue is frivolous within the meaning of section 6702(c). Also, as explained in section I.A. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions,</E>
                     excluding a matter from Appeals consideration has no bearing on its independence.
                </P>
                <HD SOURCE="HD3">2. Whistleblower Awards: Exception 3</HD>
                <P>
                    Two comments were received on Exception 3, which provides that Appeals consideration is not available for any administrative determination made by the IRS under section 7623 of 
                    <PRTPAGE P="3650"/>
                    the Code relating to awards to whistleblowers.
                </P>
                <P>
                    The first comment suggested creating an interagency administrative review process, and it is discussed in section I.A. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                </P>
                <P>The second comment asserted that the authority relied upon for Exception 3 is the proposed definition of Federal tax controversy in the proposed regulations and alleged that the language of the TFA authorizes Appeals to review whistleblower matters. The Treasury Department and the IRS do not adopt this comment. The exception for whistleblower awards under section 7623 in Exception 3 is a historic exception that has existed before the enactment of the TFA. For example, section 7623 was one of the exclusions listed in section 4 of Rev. Proc. 2016-22, 2016-15 IRB 577 (April 11, 2016), which provides procedures for Chief Counsel referrals of cases docketed in the Tax Court to Appeals for settlement. Its inclusion in the list of proposed exceptions was to clarify the point that section 7803(e) does not cover whistleblower awards because they do not involve a Federal tax controversy. In a whistleblower case, the IRS determination involves whether the whistleblower is entitled to an award. The whistleblower's tax liability is not at issue, and Appeals is not reviewing a determination by the IRS in its examination, collection, or execution of other activities with respect to the whistleblower's tax liability. This award determination is separate and distinct from a determination of tax liability.</P>
                <HD SOURCE="HD3">3. Administrative Determinations Made by Other Agencies: Exception 4</HD>
                <P>
                    One comment concerned Exception 4, which provides that Appeals consideration is not available for an administrative determination issued by an agency other than the IRS. An example is a determination by the Alcohol and Tobacco Tax and Trade Bureau (TTB) concerning an excise tax administered by and within its jurisdiction. The comment suggested creating an interagency administrative review process, and it is discussed in section I.A. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                </P>
                <HD SOURCE="HD3">4. Denials of Access Under the Privacy Act: Exception 7</HD>
                <P>
                    One comment was received on Exception 7, which provides that Appeals consideration is not available for any dispute regarding a determination of the IRS resulting in denial of access under the Privacy Act (5 U.S.C. 552a(d)(1)) (relating to access to records) to a particular person. The comment suggested creating an interagency administrative review process, and it is discussed in section I.A. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                </P>
                <HD SOURCE="HD3">5. IRS Erroneously Returns or Rejects an Offer in Compromise: Exception 9</HD>
                <P>
                    Exception 9 provides that Appeals consideration is not available regarding the application of section 7122(f) of the Code when the IRS erroneously returns or rejects a taxpayer's offer in compromise (OIC) submitted under section 7122 as nonprocessable. As explained in section I.C.9. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     Exception 9 includes, for example, the claim that the IRS's mistaken rejection or return was in bad faith. Because the IRS returned or rejected the offer without making a determination regarding the OIC, there is no administrative determination made by the IRS for Appeals to review.
                </P>
                <P>Two comments were received concerning OICs. The first comment recommended that Appeals should be authorized to review when the IRS erroneously returns or rejects a taxpayer's OIC as nonprocessable or no longer processable. The comment stated that such a return or rejection is an administratively reviewable determination, that not allowing Appeals review is a significant loss of rights for the taxpayer including low-income taxpayers in particular, that excepting this issue from Appeals review circumvents section 7122(f), and that Appeals review would promote consistency.</P>
                <P>
                    The Treasury Department and the IRS do not adopt this comment. Appeals has not historically reviewed such returned or rejected OICs. Exception 9 is narrow, and it is consistent with the pre-existing OIC regulations. Section 301.7122-1(f)(5)(ii) states, in part, that if an OIC is returned following a “determination” that the offer was nonprocessable, that return of the OIC “does not constitute a rejection of the offer for purposes of this provision and does not entitle the taxpayer to appeal the matter to appeals under the provisions of this paragraph (f)(5) . . .” Also, the comment's recommendation is not consistent with the function of Appeals, which is to weigh litigation hazards in applying the law to specific facts. Reviewing the completeness of an OIC is not a weighing of hazards. There would be no hazards of litigation for Appeals to consider or merits to weigh—either the OIC request is complete or not complete. Further, the recommendation, if adopted, would conflict with the OIC regulations. The return of an OIC as nonprocessable is an example of a premature review in § 301.7803-2(d)(1) because the originating IRS office has not completed its action. It has been a longstanding practice of the IRS to return incomplete or otherwise nonprocessable OICs that taxpayers fail to perfect. 
                    <E T="03">See</E>
                     for example, sec. 5 of Rev. Proc. 2003-71, 2003-36 I.R.B. 517 (September 8, 2003) (relating to offers in compromise).
                </P>
                <P>The second comment opined that Exception 9 is too loosely defined and its focus should be limited to those taxpayers who are abusing the process such as by creating undue delay. This comment is not adopted. Exception 9 is narrowly limited to a case in which the IRS erroneously returns or rejects an OIC as nonprocessable or no longer processable and the taxpayer requests Appeals consideration to assert that the OIC should be deemed to be accepted under section 7122(f). This exception is narrowly defined to sufficiently meet the administrative goals of the rule.</P>
                <HD SOURCE="HD3">6. Criminal Prosecution Is Pending Against Taxpayer: Exception 10</HD>
                <P>One comment was submitted on Exception 10, which provides that Appeals consideration is not available for a Federal tax controversy with respect to a taxpayer while a criminal prosecution or a recommendation for criminal prosecution is pending against the taxpayer for a tax-related offense other than with the concurrence of Chief Counsel and the Justice Department, as applicable.</P>
                <P>
                    The comment recommended that the final regulations should limit Exception 10 to only cases in which the pending criminal matter pertains to the same subtitle of the Code and that Exception 10 not be applied to matters within a single subtitle that are completely unrelated to each other and do not involve common facts or tax transactions. The Treasury Department and the IRS do not adopt this comment. Exception 10 allows for Appeals consideration with the concurrence of Chief Counsel and the Justice Department, as applicable. Such concurrence is fact-based and case specific and would accommodate the situations addressed in the comment because if they were to arise, Chief Counsel and/or the Justice Department could determine whether concurrence would be appropriate under the facts and circumstances of the particular case. Limiting the exception as suggested in the comment could require that Appeals consideration be afforded, when such consideration could interfere 
                    <PRTPAGE P="3651"/>
                    with a pending criminal matter. It would also be contrary to regulations under 26 CFR part 601, which provide general procedural rules for Appeals functions and limit Appeals' authority to act in a case in which criminal prosecution is recommended, except with the concurrence of Chief Counsel. 
                    <E T="03">See</E>
                     § 601.106(a)(2)(vi).
                </P>
                <HD SOURCE="HD3">7. IRS's Automated Process of Certifying a Seriously Delinquent Tax Debt: Exception 12</HD>
                <P>One comment was received on Exception 12, which provides that consideration by Appeals is not available for the certification or issuance of a notice of certification of a seriously delinquent Federal tax debt of a particular taxpayer to the Department of State (State Department) under section 7345 of the Code (relating to the revocation or denial of a taxpayer's passport in the case of serious tax delinquencies). According to the comment, if Appeals consideration is not available for certification or issuance of a notice of certification of a seriously delinquent tax debt, the taxpayer lacks an important check on the automated system and does not have an opportunity to contest whether the statutory requirements for passport certification have been met under section 7345(b).</P>
                <P>
                    The Treasury Department and the IRS do not adopt this comment. In the event of a mistake in the automated process, a taxpayer has the opportunity to contact the IRS personnel identified in the notice, which provides a check on the automated process. Specifically, the taxpayer receives Notice CP508C, 
                    <E T="03">Notice of certification of your seriously delinquent Federal tax debt to the State Department,</E>
                     informing the taxpayer to contact the IRS at the phone number in that notice to request reversal of the certification if the taxpayer contends the certification is erroneous. The role of Appeals is to review administrative determinations and to weigh the hazards of litigation, not to provide a backstop to an automated process. This exception existed before the TFA. 
                    <E T="03">See</E>
                     Notice 2018-1, 2018-3 I.R.B. 299 (January 16, 2018).
                </P>
                <P>
                    The comment also alleged Exception 12 violates the Taxpayer Bill of Rights (TBOR). 
                    <E T="03">See https://www.irs.gov/taxpayer-bill-of-rights.</E>
                     The Treasury Department and the IRS do not adopt this comment; this exception is consistent with the TBOR. The TBOR does not grant new enforceable rights but instead it obligates the IRS to ensure that its employees are familiar with and act in accord with rights established in other Code provisions. 
                    <E T="03">See Facebook, Inc.</E>
                     v. 
                    <E T="03">Internal Revenue Service,</E>
                     2018 WL 2215743, at *13-14 (N.D. Cal. 2018). 
                    <E T="03">See also Hancock County Land Acquisitions LLC, et. al.</E>
                     v. 
                    <E T="03">United States,</E>
                     553 F. Supp. 3d 1284, 1296 n. 11 (N.D. Ga. 2021). As discussed in section I.A. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions,</E>
                     section 7803(e)(4) does not confer an absolute right to Appeals consideration.
                </P>
                <HD SOURCE="HD3">8. Authority Over the Matter Rests With Another Office: Exception 14</HD>
                <P>
                    One comment was received on Exception 14. Exception 14 provides that consideration by Appeals is not available for any case, determination, matter, decision, request, or issue with respect to a particular taxpayer that Appeals lacks the authority to settle. Proposed § 301.7803-2(c)(14)(i) through (v) provides a non-exclusive list of examples illustrating this rule, including the example in proposed § 301.7803-2(c)(14)(i) that Appeals does not have authority to resolve an issue with respect to a particular taxpayer in a docketed case after a referral has been made to the Justice Department. The comment suggested creating an interagency administrative review process, which is discussed in section I.A. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                     The settlement authority for any litigation under the jurisdiction of the Justice Department already vests with the Justice Department.
                </P>
                <HD SOURCE="HD3">9. Certain Technical Advice Memoranda and Technical Advice From an Associate Office in a Docketed Case: Exception 15 and Exception 16</HD>
                <P>One comment was submitted concerning Exception 15 and Exception 16. Exception 15 provides that Appeals consideration is not available for certain adverse actions related to the initial or continuing recognition of tax-exempt status, an entity's classification as a foundation, the initial or continuing determination of employee plan qualification, or a determination involving an obligation and the issuer of an obligation under section 103 of the Code, when the adverse action is based upon a technical advice memorandum (TAM) issued by an Associate Office of Chief Counsel (Associate Office) before an appeal is requested. Similarly, Exception 16 provides that Appeals consideration is not available for any case docketed in the Tax Court if the notice of deficiency, notice of liability, or final adverse determination letter is based upon a TAM issued by an Associate Office in that case involving an adverse action described in Exception 15.</P>
                <P>The comment asserted that granting an exception for an appeal in cases of tax-exempt status in which a TAM has been issued would unnecessarily narrow an already small area of appeal rights, and suggested that it would be beneficial to all parties to bring the matter to Congress' attention if this is more a matter in need of statutory clarification.</P>
                <P>
                    The Treasury Department and the IRS do not adopt this comment, which suggested a change but did not provide a rationale for a change, refute the rationale given in the proposed regulations, or explain its conclusion that the two proposed exceptions would unnecessarily narrow Appeals review. As reflected in the proposed regulations' 
                    <E T="03">Explanation of Provisions</E>
                     in sections I.C.15. and 16., these two exceptions are supported by reasonable rationales and are narrowly tailored to achieve their purposes. If the legal issues and determinations in Exception 15 and Exception 16 are the subject of a TAM from an Associate Office, they are excepted from Appeals consideration because traditionally Chief Counsel has exclusive authority over the dispute administratively or upon litigation. A TAM is advice furnished by an Associate Office in a memorandum that responds to any request for assistance on any technical or procedural legal question involving the interpretation and proper application of any legal authority that is submitted in accordance with an applicable revenue procedure. Chief Counsel's decision with respect to the issues related to the initial or continuing recognition of tax-exempt status, an entity's classification as a foundation, the initial or continuing determination of employee plan qualification, or a determination involving an obligation and the issuer of an obligation under section 103 is the legal position of the IRS with respect to the particular facts and circumstances that are the subject of the TAM. These exceptions are important to preserving Chief Counsel's authority to resolve these sensitive legal issues. As noted in section I.C.15. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     these exceptions are consistent with historical practice as found in § 601.106(a)(1)(v)(
                    <E T="03">a</E>
                    ) and IRM 8.1.1.2.1(1)(c.) (02-10-2012) (currently found in IRM 8.1.1.3.1 (01-09-2024)). Furthermore, a broad range of tax-exempt status issues are reviewable by Appeals under these final regulations.
                </P>
                <HD SOURCE="HD3">10. Letter Rulings Issued by Associate Office: Exception 17</HD>
                <P>
                    Two comments were received on Exception 17, which excepts from 
                    <PRTPAGE P="3652"/>
                    Appeals consideration a decision by an Associate Office regarding whether to issue a letter ruling or the content of a letter ruling. However, the subject of the letter ruling may be considered by Appeals if all other requirements in § 301.7803-2 are met. For example, if the taxpayer subsequently files a return taking a position that is contrary to the letter ruling and that position is examined by the IRS, Appeals could consider that Federal tax controversy if all other requirements in § 301.7803-2 are met.
                </P>
                <P>
                    The first comment stated that the provision in Exception 17 helpfully makes clear that the subject of the letter ruling may be considered by Appeals if all other requirements in proposed § 301.7803-2 are met, and recommended that this provision should be strengthened to offer an affirmative safe harbor for appeals for taxpayers who in good faith attempt to fulfill the terms of § 301.7803-2. The Treasury Department and the IRS do not adopt this recommendation. The criteria for a “safe harbor” would not be practical because meeting some but not all of the requirements would not be sufficient. A taxpayer must comply with all the requirements in § 301.7803-2 in order to have Appeals consider the taxpayer's Federal tax controversy. The second comment on Exception 17 relates to 9100 relief and CAMs and is discussed in section I.H. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                </P>
                <HD SOURCE="HD3">11. Challenges Alleging That a Statute Is Unconstitutional: Exception 18</HD>
                <P>Exception 18 provides that Appeals consideration is not available for any issue based on a taxpayer's argument that a statute violates the United States Constitution unless there is an unreviewable decision from a Federal court holding that the cited statute is unconstitutional. Exception 18 does not preclude Appeals from considering a Federal tax controversy based on arguments other than the constitutionality of a statute, such as whether the statute applies to the taxpayer's facts and circumstances.</P>
                <P>
                    Proposed § 301.7803-2(c)(18) defined the phrase 
                    <E T="03">unreviewable decision</E>
                     as a decision of a Federal court that can no longer be appealed to any Federal court because all appeals in a case have been exhausted or the time to appeal has expired and no appeal was filed, and no further action can be taken in the case by any Federal court once there is an unreviewable decision. An unreviewable decision means an unreviewable decision of any Federal court, regardless of where the taxpayer resides. The proposed language “and no further action can be taken in the case by any Federal court once there is an unreviewable decision” has been deleted in the final regulations because it is inaccurate in certain circumstances. For example, even if a district court grants a motion to dismiss and the decision is appealed and a reversal of that motion becomes unreviewable, the case would have further action such as discovery, dispositive motions, or trial. 
                    <E T="03">See</E>
                     § 301.7803-2(c)(18).
                </P>
                <P>
                    The Treasury Department and the IRS received several comments on Exception 18. One comment agreed with Exception 18 to not allow Appeals to consider constitutional challenges to Federal tax statutes unless there is an unreviewable court decision. It recommended the final regulations should strengthen the concept of an “unreviewable decision.” 
                    <E T="03">See</E>
                     section I.D.11.a. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions</E>
                     regarding the phrase 
                    <E T="03">unreviewable decision.</E>
                </P>
                <P>Two comments objected to Exception 18 as inconsistent with the TFA and recommended Appeals should be allowed to consider constitutional challenges to Federal tax statutes in the absence of an unreviewable decision. One objected that denial of Appeals consideration in Exception 18 strips taxpayers of a statutory right to Appeals. The other objected that Exception 18 improperly restricts access to Appeals and forces taxpayers to sacrifice legal arguments.</P>
                <P>
                    The Treasury Department and the IRS do not adopt these two comments; Exception 18 is consistent with the TFA. As discussed previously, the TFA does not provide an absolute statutory right to an administrative appeal. Rather, the Treasury Department and the IRS have the statutory authority to provide exceptions to Appeals consideration. Exception 18 is one such exception, and it is narrowly tailored and supported with reasonable rationales. As proposed, Exception 18 does not exclude the constitutionality issue from Appeals consideration totally but merely provides that Appeals will not be the first forum to hear such a challenge because it is not the appropriate forum without a final decision from a Federal court. The Treasury Department and the IRS still agree with the rationales in section I.C.18. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     namely that questions within the IRS regarding the constitutionality of a statute, and positions taken by the IRS in light of such questions, are determinations of general applicability resolved at the highest levels of the Treasury Department and the IRS, in consultation with the Office of Legal Counsel of the Justice Department, and subject to the ultimate resolution by a court of relevant jurisdiction. Moreover, a constitutional determination should be communicated and applied consistently to all taxpayers. It would be inappropriate for Appeals to consider the constitutionality of a statute for a particular taxpayer in the absence of an unreviewable court decision, which is accessible to all taxpayers and the IRS.
                </P>
                <P>
                    A comment asserted Appeals has historically analyzed legal arguments concerning tax statutes, regulations, and IRS procedures and so Appeals is capable of considering these arguments. This comment insinuated that Exception 18, Exception 19, and Exception 20 are premised on Appeals' training, skills, or competency to review legal arguments related to statutes, regulations, or IRS procedures. The rationales for Exception 18, Exception 19, and Exception 20 provided in sections I.C.18., 19., and 20. of the proposed regulations' 
                    <E T="03">Explanation of Provisions</E>
                     do not relate to Appeals' training, skills, or competency. Appeals will continue to review taxpayer arguments about whether the relevant statutes, regulations, or IRS procedures apply to the taxpayer's factual circumstances just as Appeals has historically done.
                </P>
                <P>
                    A comment construed the definition of an 
                    <E T="03">unreviewable decision</E>
                     to mean an unreviewable decision only from a Federal court within the circuit in which the taxpayer resides. Neither the proposed regulations, nor these final regulations, require the unreviewable decision to be in the taxpayer's own circuit. Another comment recommended eliminating Exception 19 and Exception 20 but, in the alternative, it recommended clarifying the phrase 
                    <E T="03">unreviewable decision.</E>
                     The comment interpreted the phrase as the proposed regulations intended, that is, as an unreviewable decision of any Federal court, regardless of where the taxpayer resides, but stated it was unclear and should be clarified. In response to these comments, the language in the proposed regulations, “a decision of a Federal court,” is clarified in the final regulations to “a decision of any Federal court regardless of where the taxpayer resides.” 
                    <E T="03">See</E>
                     § 301.7803-2(c)(18).
                </P>
                <P>
                    A comment recommended the final regulations modify the definition of 
                    <E T="03">unreviewable decision</E>
                     to provide the decision must be one that would govern the taxpayer's case. In other words, the final regulations should ensure, according to the comment, that Appeals access is available only if there is a 
                    <PRTPAGE P="3653"/>
                    relevant decision that would bind the taxpayer and the Government if the dispute proceeded to litigation. The Treasury Department and the IRS do not adopt this comment because it is too limiting. If the only unreviewable decision that Appeals should consider is one that is binding on the IRS and the taxpayer, then it would not be a matter of Appeals weighing the hazards of litigation because that decision would be controlling on the taxpayer. Also, such a rule would prevent Appeals from weighing the hazards of litigation by evaluating how a court in another circuit ruled on the issue. Like the proposed regulations would have done, the final regulations allow Appeals to consider that final decision in considering the hazards of litigation.
                </P>
                <P>A comment stated that the Treasury Department and the IRS have no basis to hold Appeals to a different, and higher standard than that of the Justice Department or the Solicitor General. The comment's reference to the Justice Department and Solicitor General appeared to be a reference to those offices resolving cases in a manner that Appeals could not under Exception 19 and Exception 20. The comment appeared to suggest that Appeals should be able to do the same in fulfilling its function of considering hazards of litigation.</P>
                <P>
                    The Treasury Department and the IRS do not adopt this comment because the authority of employees of the Justice Department and the Solicitor General to take certain actions in fulfilling their distinct functions and roles does not mean employees of Appeals, like Appeals Officers (AO), can take the same actions. As explained in section I.D.12. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions,</E>
                     questions regarding the validity of a regulation, or the procedural validity of a notice or revenue procedure, involve determinations of general applicability resolved at the highest levels of the Treasury Department and the IRS and must be followed by all IRS employees, including AOs. Such validity decisions should be communicated and applied consistently to all taxpayers. It would be inappropriate for Appeals to act in contravention with those decisions in a specific case involving one taxpayer and consider validity issues in the absence of an unreviewable court decision.
                </P>
                <P>
                    Three comments recommended Appeals be allowed to consider the hazards of litigation on a validity issue for a notice or regulation based on a similar or analogous court decision on a different notice or regulation. The comments mentioned 
                    <E T="03">Green Valley Investors</E>
                     v. 
                    <E T="03">Commissioner,</E>
                     159 T.C. 5 (2022) (Tax Court setting aside Notice 2017-10, 2017-4 IRB 544 for failure to comply with the Administrative Procedure Act's (APA's) notice and comment requirements) as an example and suggested that if a court decision invalidated a notice for the same APA reason that a taxpayer is raising to challenge the validity of other guidance, Appeals should consider the hazards of litigation in the taxpayer's analogous case.
                </P>
                <P>
                    The Treasury Department and the IRS do not adopt these comments because it would defeat the purposes of Exception 18, Exception 19, and Exception 20. Appeals consideration is limited to unreviewable decisions involving the validity of the particular regulation, notice, or revenue procedure being challenged. As described previously, in this 
                    <E T="03">Summary of Comments and Explanation of Revisions</E>
                     and sections I.C.18., 19., and 20. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     the promulgation of a regulation, notice, or revenue procedure consists of multiple levels of review at the highest levels within the Treasury Department and the IRS, and taxpayers are not well-served by confidential decisions by Appeals on a validity matter that is applicable to only a single taxpayer. Appeals does not have the authority to unilaterally contradict the decisions made through the regulatory or subregulatory process. In addition, there may be other defenses to APA challenges that the IRS might assert, and therefore the Tax Court having ruled on an unrelated notice or regulation is not a reason to provide the carve-out suggested here.
                </P>
                <P>A comment recommended eliminating the unreviewable decision requirement and allowing Appeals to consider a judicial decision in weighing the hazards of a case. Similarly, another comment recommended allowing Appeals to consider hazards pending the appeal of a decision. The Treasury Department and the IRS do not adopt these recommendations because they would defeat the purpose of the unreviewable decision rule in Exception 18, Exception 19, and Exception 20. Until the pending decision becomes unreviewable by a Federal court, as described in proposed § 301.7803-2(c)(18), it would not be sufficiently final. The finality of the judicial decision is important because the judicial branch is charged with independently interpreting Federal statutes and a Federal court's decision on the merits may reject the determinations made by the Treasury Department or the IRS. There must be a final decision, however, before Appeals can weigh the hazards of litigation with respect to these specific challenges because a lower court decision that is not final might be overturned on appeal and the challenges under Exception 18, Exception 19, and Exception 20 relate to determinations of general applicability resolved at the highest levels of the Treasury Department and the IRS. Until a judicial decision is unreviewable and final, Appeals must respect the decision of the Secretary and the Commissioner of Internal Revenue (Commissioner). In that regard, the final regulations clarify that the definition of unreviewable decision includes decision of any Federal court regardless of where the taxpayer resides.</P>
                <HD SOURCE="HD3">12. Challenges Alleging That a Treasury Regulation Is Invalid and Challenges Alleging That a Notice or Revenue Procedure Is Invalid: Exception 19 and Exception 20</HD>
                <P>Exception 19 provides that Appeals consideration is not available for any issue based on a taxpayer's argument that a Treasury regulation is invalid unless there is an unreviewable decision from a Federal court invalidating the regulation as a whole or the provision in the regulation that the taxpayer is challenging. Exception 20 provides that Appeals consideration is not available for any issue based on a taxpayer's argument that a notice or revenue procedure published in the Internal Revenue Bulletin is procedurally invalid unless there is an unreviewable decision from a Federal court holding it to be invalid. As proposed, Exception 19 and Exception 20 do not preclude Appeals from considering a Federal tax controversy based on arguments other than the validity of a regulation, or procedural validity of a notice or revenue procedure, such as whether the regulation, notice, or revenue procedure applies to the taxpayer's facts and circumstances.</P>
                <P>The Treasury Department and the IRS received several comments on Exception 19 and Exception 20. In response to these comments, the Treasury Department and the IRS have modified the language in proposed § 301.7803-2(c)(19) and (20), as explained below.</P>
                <P>
                    A comment agreed with the rationales described in the proposed regulations for Exception 19 and Exception 20 that Appeals should not consider these types of challenges. Another comment made the same objection it made to Exception 18 that denial of Appeals consideration in Exception 19 and Exception 20 strips taxpayers of a statutory right to Appeals. Another comment made the same objection it made to Exception 18 that 
                    <PRTPAGE P="3654"/>
                    Exception 19 and Exception 20 improperly restrict access to Appeals and forces taxpayers to sacrifice legal arguments.
                </P>
                <P>
                    Like Exception 18, Exception 19 and Exception 20 are consistent with the TFA, which does not provide an absolute statutory right to an administrative appeal, and permits the Treasury Department and the IRS to provide exceptions. The rationales for Exception 19 and Exception 20 are similar to the rationales for Exception 18, as discussed previously. 
                    <E T="03">See</E>
                     sections I.C.18., 19., and 20. of the proposed regulations' 
                    <E T="03">Explanation of Provisions.</E>
                     Questions regarding the validity of a regulation, or the procedural validity of a notice or revenue procedure, involve determinations of general applicability resolved at the highest levels of the Treasury Department and the IRS and must be followed by IRS employees, including AOs. Such validity decisions also should be communicated and applied consistently to all taxpayers. It therefore would be inappropriate for Appeals to act in contravention with those institutional decisions in a specific case involving one taxpayer and consider the validity issues in the absence of an unreviewable court decision.
                </P>
                <P>A comment stated Exception 19 and Exception 20 are not narrowly tailored because they encompass any challenge to almost any level of published guidance. The Treasury Department and the IRS do not adopt this comment. Exception 19 and Exception 20 are narrowly tailored and expressly allow Appeals to consider arguments other than the validity of a regulation, or procedural validity of a notice or revenue procedure, such as whether the regulation, notice, or revenue procedure applies to the taxpayer's facts and circumstances. They do not exclude the validity challenges from Appeals consideration totally but merely provide Appeals will not be the first forum to hear these challenges because it is not the appropriate forum for such challenges without an unreviewable decision of a court. Further, Exception 20 is even narrower in scope, applying only to a taxpayer's argument that a notice or revenue procedure published in the Internal Revenue Bulletin is procedurally invalid.</P>
                <P>A comment asserted that Exception 19 and Exception 20 did not exist prior to the TFA and taxpayers historically could at least raise validity challenges to published IRS guidance and have those challenges be considered by Appeals; therefore Exception 19 and Exception 20 appear contrary to the TFA's intent to expand taxpayer access to Appeals. As explained previously, Exception 19 and Exception 20 are consistent with the intent of the TFA to grant the Treasury Department and the IRS the authority to make exceptions, which includes the authority to provide new exceptions that did not exist before the enactment of the TFA.</P>
                <P>A comment asserted that Exception 19 and Exception 20 are contrary to Appeals' mission or function because they will force the parties into litigation instead of providing an opportunity for Appeals to resolve the case. Another comment similarly stated that Exception 20 tries to cast the validity determination as a high-level policy decision, while Appeals' function is to hear and settle cases and in doing so it is not making policy.</P>
                <P>
                    The Treasury Department and the IRS do not adopt these comments. Unlike most Appeals analyses that weigh litigation hazards in applying the law to specific facts, Appeals' potential consideration of the validity of a regulation or the procedural validity of a notice or revenue procedure does not necessarily involve taxpayer-specific facts. As explained in section I.C.20. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     the issue of whether an IRS notice or revenue procedure is procedurally valid involves a determination regarding whether specific IRS subregulatory guidance complied with administrative law requirements, such as notice and comment under 5 U.S.C. 553. Whether a notice or revenue procedure was properly issued involves facts solely related to the Treasury Department and the IRS and is unlike the application of the tax law to a taxpayer's specific facts. Furthermore, the procedurally validity of a notice or revenue procedure is a determination of general applicability resolved at the highest levels of the Treasury Department and the IRS and such a determination would not be appropriate for Appeals to consider in a specific case involving one taxpayer.
                </P>
                <P>The latter comment regarding Exception 20 did not address the other rationale in support of Exception 20, namely, that the issue of whether a notice or revenue procedure failed to comply with administrative law requirements should be communicated and applied consistently. As explained in the proposed regulations, an unreviewable decision of a Federal court is the appropriate means of accomplishing this objective because a settlement before Appeals is specific to a taxpayer and cannot be made available to other taxpayers. An unreviewable decision makes information accessible to all taxpayers and the IRS regarding whether a notice or revenue procedure was prescribed in accordance with applicable Federal law. A determination by the judicial branch on the merits of the validity challenge may reject the determinations made by the Treasury Department or the IRS with regard to the validity of a regulation or the procedural validity of a notice or revenue procedure, thereby providing a basis for Appeals to consider those issues. If no unreviewable decision has been issued on the validity challenge, Appeals would not be weighing hazards with respect to that particular guidance of general applicability because it has not been successfully challenged in court yet. Instead, absent an unreviewable decision, Appeals would be contravening the decision made at the highest levels of the Treasury Department and the IRS.</P>
                <P>Four comments related to Appeals' competency to consider validity challenges to a regulation, notice, or revenue procedure. A comment alleged Appeals has historically analyzed legal arguments concerning statutes, tax regulations, and IRS procedures. A similar comment asserted that under Exception 19 and Exception 20 Appeals is unable to assess the hazards of litigation in a way that a Chief Counsel trial attorney is not restricted and that specialists within Appeals are competent to consider these arguments when evaluating other hazards of litigation in the case. A comment stated that AOs have the training and qualifications to consider all hazards of litigation, including challenges to the validity of regulations, notices, or revenue procedures, or if they lack such training and qualifications, the IRS should provide them instead of preventing Appeals from considering these issues. Another comment asserted Appeals is familiar with considering all arguments made by a taxpayer regarding the applicability of regulations, notices, and revenue procedures, and it should be able to consider in docketed cases credible arguments about hazards involving validity challenges to a regulation, notice, or revenue procedure because the APA and ordinary judicial methods for review of legislative rules apply to tax cases.</P>
                <P>
                    The Treasury Department and the IRS do not adopt these comments. None of these exceptions relate to Appeals' training, skills, or competency. Appeals' competency does not pertain to the rationales of Exception 19 and Exception 20 to prevent a decision for one taxpayer regarding guidance of general applicability, which has been approved at the highest levels within 
                    <PRTPAGE P="3655"/>
                    the Treasury Department and the IRS. Also, like Appeals employees, Chief Counsel attorneys handling docketed cases in Tax Court must follow regulations, notices, and revenue procedures. 
                    <E T="03">See</E>
                     Chief Counsel Directives Manual (CCDM) or IRM 32.1.1.2.5(1) (08-02-2018) (relating to Treasury decisions); CCDM/IRM 32.2.2.10 (08-11-2004) (relating to force and effect of specified publications). Further, Appeals applying the APA and ordinary judicial methods to invalidate guidance would lack consistency because Appeals' action, unlike an unreviewable decision, is not public and is applicable to only that taxpayer challenging the guidance. A final court decision is applicable to, and accessible by, all taxpayers and the IRS, which promotes consistency. Furthermore, a final, unreviewable court decision ensures that Appeals does not act in contravention of a decision made at the highest levels of the Treasury Department and the IRS. In the absence of an unreviewable decision, Appeals would not have a court decision with respect to a particular document to weigh or evaluate any hazards.
                </P>
                <P>
                    Two comments recommended that if the Justice Department has conceded that an unrelated notice was invalid on the same basis as in the holding by the United States Court of Appeals for the Sixth Circuit (Sixth Circuit) in 
                    <E T="03">Mann Construction Inc.</E>
                     v. 
                    <E T="03">United States,</E>
                     27 F.4th 1138 (6th Cir. 2022) (holding a different notice invalid because it was required to follow APA notice and comment procedures and failed to do so), Appeals should consider the hazards of litigation on a notice validity issue in a taxpayer's case involving a different notice. Similarly, another comment recommended allowing Appeals to consider the hazards of litigation on a regulation validity issue in a taxpayer's case if the Justice Department has settled or conceded that an unrelated regulation was invalid.
                </P>
                <P>
                    The Treasury Department and the IRS do not adopt these comments for the same reasons they disagree with the similar comments regarding analogous court decisions. 
                    <E T="03">See</E>
                     section I.D.11.a. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                     If adopted, these recommendations would defeat the purposes of Exception 19 and Exception 20. Moreover, there are numerous factors that go into determining whether a case should be settled, and a recommendation for a settlement in one case may not dictate the same result in another case. There may be other defenses to APA challenges that the IRS might assert and therefore the Justice Department having settled an issue based on hazards of litigation involving an unrelated notice or regulation is not a reason to provide the suggested carve-out. Regarding the transaction in the case cited by the comment, for cases within the Sixth Circuit, the Treasury Department and the IRS have represented in court that APA matters conceded by the Government in the 
                    <E T="03">Mann</E>
                     case would not be subject to examination by the IRS in other listed transaction cases and therefore such cases would not come up for Appeals review.
                </P>
                <P>
                    A comment agreed with the policy expressed in Exception 19, but with a caveat that “invalidity” should be further defined. Specifically, the comment asked whether a change in the law would make regulations invalid or would fit within the provision in proposed § 301.7803-2(c)(19) that states Exception 19 would not prevent a taxpayer from arguing that a regulation does not apply to their position. Generally, a regulation would still be valid for prior tax years before any repeal of or amendment to the statute upon which the regulation is based, and a change in the statute would have precedent over the regulation for tax years after the change. These regulations do not prohibit a taxpayer from arguing whether the statute applies to the taxpayer's own facts and circumstances. In that case, Appeals is considering the applicability of the statute to the taxpayer for the relevant period. In response to this comment, the Treasury Department and the IRS have revised the language in Exception 19 and Exception 20 by adding a reference to the statute to clarify that Appeals may consider arguments based on whether a statute applies to the taxpayer's facts and circumstances. 
                    <E T="03">See</E>
                     § 301.7803-2(c)(19) and (20). Also, for the sake of clarity, Exception 19 is revised to define the term 
                    <E T="03">invalid. See</E>
                     § 301.7803-2(c)(19).
                </P>
                <P>The same comment asked that if regulations overlap in a factual situation whether reconciliation of such a situation would involve a determination that a regulation is invalid. As proposed, Exception 19 would still allow Appeals to consider whether the regulations apply to a taxpayer's facts and circumstances, but to the extent the taxpayer argues that the regulations are invalid, Exception 19 would preclude Appeals from considering that validity issue in the absence of an unreviewable decision. The concern raised in this comment appeared to relate to ensuring consistency. Appeals is not the only administrative function within the IRS; there are other offices and other ways within the IRS to ensure such consistency short of consideration by Appeals or litigating the issue.</P>
                <P>
                    A comment on Exception 20 expressed some confusion as to the meaning of the term 
                    <E T="03">procedurally invalid</E>
                     and stated the comment had little concern regarding Exception 20 if its intent is only that Appeals would not be allowed to consider whether a notice or revenue procedure was properly adopted or promulgated. As explained in section I.C.20. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     the term 
                    <E T="03">procedurally invalid</E>
                     in proposed § 301.7803-2(c)(20) was intended to mean challenges to procedural determinations regarding notices and revenue procedures, including determinations regarding compliance with administrative law requirements. This comment recommended defining the term 
                    <E T="03">procedurally invalid</E>
                     for the sake of clarity. The Treasury Department and the IRS adopt this recommendation and have defined the term to mean “any determination regarding whether a notice or revenue procedure failed to comply with administrative law requirements, such as notice and comment under 5 U.S.C. 553.” 
                    <E T="03">See</E>
                     § 301.7803-2(c)(20).
                </P>
                <P>The same comment noted that the rationale behind Exception 19 is generally sound but opined that that rationale does not support Exception 20 because a notice or revenue procedure does not undergo the public notice and comment process under the APA, lacks the same approval process, and does not carry the same weight or level of authority of a regulation. The Treasury Department and the IRS do not adopt this comment. The same rationale for Exception 19 applies to Exception 20 because whether a notice or revenue procedure is procedurally valid is a determination of general applicability resolved at the highest levels of the Treasury Department and the IRS. As discussed previously, such a determination would not be appropriate for Appeals to consider in a specific case involving one taxpayer.</P>
                <P>
                    A comment asserted that Appeals has historically heard arguments about the application of Treasury regulations and that the meaning of a regulation, notice, or revenue procedure is not exclusively determined by senior officials at the Treasury Department and the IRS. This comment appears to misperceive the scope of Exception 19 and Exception 20. These exceptions do not preclude Appeals from considering a Federal tax controversy based on arguments other than the validity of a Treasury regulation or procedural validity of a notice or revenue procedure. As stated 
                    <PRTPAGE P="3656"/>
                    in the text of Exception 19 and Exception 20, such arguments include whether the Treasury regulation, notice, or revenue procedure applies to the taxpayer's facts and circumstances. Appeals may resolve the Federal tax controversy by weighing the likelihood a court would agree with the position of the taxpayer or the Government. As for the comment's suggestion that guidance is not exclusively determined by senior officials at the Treasury Department and the IRS, the final regulations do not adopt this comment. While employees of all levels of the Treasury Department and the IRS have a role in promulgating a regulation, notice, or revenue procedure, such guidance is reviewed and approved by senior officials in the Treasury Department and the IRS, including the Assistant Secretary of the Treasury (Tax Policy) and the Deputy Commissioner of the IRS as appropriate. 
                    <E T="03">See</E>
                     generally IRM 32.1.1 (November 13, 2019).
                </P>
                <P>Two comments related to consistency by Appeals. A comment alleged the proposed regulations did not explain why consistency cannot be accomplished if Appeals reviews the validity issues. The same comment argued Exception 19 and Exception 20 will result in bad policy because they will make the Appeals process more inconsistent, random, and less responsive to legal developments, causing additional costs and delay for taxpayers who otherwise could access Appeals while invalidity arguments work through the court system. Another comment stated that Appeals can reach a coordinated position on validity challenges and forcing taxpayers to litigate will decrease uniformity of tax administration because the IRS can settle or concede issues to avoid adverse opinions and because years may pass before there is an unreviewable judicial decision deciding the validity challenge.</P>
                <P>
                    Sections I.C.18., 19., and 20. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     provides the Treasury Department and the IRS' position on consistency. Any determinations with respect to constitutional challenges to a statute, the validity of a regulation, or procedural validity of a revenue procedure or notice should be communicated and applied consistently to all taxpayers. An unreviewable decision of a Federal court is the appropriate means of making information accessible to taxpayers, and the Treasury Department and the IRS do not agree that Exception 19 and Exception 20 will result in bad policy. A court's unreviewable decision on the validity of a regulation, or procedural validity of a revenue procedure or notice ensures the judicial branch decides questions of law. The Treasury Department and the IRS recognize the deliberateness of the judicial process, but absent that process, Appeals lacks the authority to take actions contrary to the reasoned decisions of the Secretary and the Commissioner. An unreviewable decision is publicly available, and generally applicable, to all taxpayers and the IRS, which promotes consistency and uniformity. Having Appeals weigh hazards of litigation based on an unreviewable decision that is publicly available and generally applicable to all taxpayers is sounder policy than a confidential decision by Appeals on a matter that is applicable to only a single taxpayer. The question of whether Appeals can reach a coordinated position on validity challenges is irrelevant because under these exceptions the issues would not be considered by Appeals in the first place in the absence of an unreviewable decision.
                </P>
                <P>
                    A comment opined that Appeals should have the right to determine all hazards of litigation, including challenges to all levels of IRS published guidance on an unlimited basis and including rationale from all court opinions because this approach is consistent with the Treasury Department's 2019 Policy Statement on the Tax Regulatory Process (Policy Statement). Policy Statement on the Tax Regulatory Process (March 5, 2019), 
                    <E T="03">https://home.treasury.gov/policy-issues/tax-policy/tax-regulatory-process.</E>
                     The Treasury Department and the IRS do not adopt this comment. An unreviewable decision is necessary because it is publicly available to the IRS and taxpayers and generally applicable, which promotes consistency and uniformity. The Policy Statement is unrelated to Exception 19 and Exception 20 because it concerns the tax regulatory process and does not address Appeals or its function. The Policy Statement also explicitly states it does not create any right or benefit, either substantive or procedural.
                </P>
                <P>
                    A comment alleged that Exception 19 and Exception 20 undercut the key focus area for Appeals in fiscal year 2023 to improve taxpayer experience. To the contrary, Exception 19 and Exception 20 are consistent with the TFA as it relates to taxpayer experience. Section 1101 of the TFA requires the IRS to develop a comprehensive strategy for customer service and submit the plan to Congress. The strategy will include best practices of customer service provided in the private sector, including, online services, telephone call back, and training of employees, and the strategy must incorporate best practices of businesses to meet reasonable customer expectations. The strategic plan, updated guidance, and training materials must also be available to the public. The taxpayer experience requirement does not address whether a taxpayer can have the taxpayer's case or issue considered by Appeals. The strategic plan addresses topics like communications with the IRS and taxpayer information services, such as expanded digital services, guides to taxpayer resources and IRS communication channels, and outreach and education. 
                    <E T="03">See</E>
                     Publication 5426, 
                    <E T="03">Taxpayer First Act Report to Congress</E>
                     (January 2021).
                </P>
                <P>
                    A comment alleged that Appeals' consideration of all of a taxpayer's arguments, including validity challenges, does not harm the Government but instead provides the taxpayer and the Government the opportunity to resolve the issue without litigation. Appeals' consideration of validity challenges would harm the Government because in the absence of an unreviewable decision, such consideration would undermine the decisions based on the regulatory and subregulatory guidance process as described in sections I.C.19. and I.C.20. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     and result in a decision by Appeals for one taxpayer on an issue that is not related to the taxpayer's specific facts and that would not be publicly available to other taxpayers and the IRS.
                </P>
                <P>Another comment recommended that Appeals should consider APA challenges as part of its weighing of hazards of litigation. The comment argued that Treasury regulations are not necessarily in compliance with the APA because they go through an extensive review process involving numerous offices within the Treasury Department and the IRS. The comment alleged that challenges to a regulation's validity is taxpayer specific because any controversy before Appeals will involve the IRS enforcing an agency rule against a taxpayer based on that taxpayer's facts. Finally, the comment also suggested that the exceptions would prove unworkable because final, unreviewable decisions may be limited to one district court or circuit.</P>
                <P>
                    The Treasury Department and the IRS do not adopt this comment. As explained previously in this section and section I.D.12. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions,</E>
                     the promulgation of a regulation, or publication of a notice or revenue procedure goes through multiple levels of review within the 
                    <PRTPAGE P="3657"/>
                    Treasury Department and the IRS. An individual AO does not have the authority to unilaterally contradict the decisions made through the regulatory or subregulatory process. Furthermore, as explained above and in section I.C.20. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     the validity of a regulation or the procedural validity of a notice of revenue procedure does not involve taxpayer-specific facts. The validity of a regulation or the procedurally validity of a notice or revenue procedure is a determination of general applicability and does not involve the application of tax law to a specific set of facts and circumstances. Lastly, as explained in section I.D.11. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions,</E>
                     the Treasury Department and the IRS have clarified the final regulations to specify that an unreviewable decision means “a decision of any Federal court regardless of where the taxpayer resides.” 
                    <E T="03">See</E>
                     § 301.7803-2(c)(18).
                </P>
                <HD SOURCE="HD3">13. Cases or Issues Designated for Litigation or Withheld From Appeals: Exception 21</HD>
                <P>Four comments were received on Exception 21, which provides that Appeals consideration is not available for any case or issue designated for litigation, or withheld from Appeals consideration in a Tax Court case, in accordance with guidance regarding designating or withholding a case or issue. As proposed, designation for litigation means that the Federal tax controversy, comprising an issue or issues in a case, will not be resolved without a full concession by the taxpayer or by decision of the court.</P>
                <P>
                    A comment proposed that Chief Counsel attorneys should have the flexibility to refer all docketed cases to Appeals for resolution. This comment is not adopted. To the extent this comment invites a Chief Counsel attorney to disregard the Office of Chief Counsel's decision to designate or withhold a case, trial attorneys do not operate independently of managerial direction. In addition, such flexibility would defeat the exception's purpose. As explained in section I.C.21. of the proposed regulations' 
                    <E T="03">Explanation of Provisions,</E>
                     cases are designated for litigation or withheld in the interest of sound tax administration to establish judicial precedent, promote consistency, conserve resources, or reduce litigation costs for the taxpayers and the IRS. Moreover, section 3.01 of Rev. Proc. 2016-22 provides that docketed cases are not referred to Appeals if Appeals issued the notice of deficiency or made the determination that is the basis of the Tax Court's jurisdiction. This exclusion also is set forth in Exception 22, 
                    <E T="03">see</E>
                     § 301.7803-2(c)(22), and prevents duplicative review by Appeals.
                </P>
                <P>
                    Two comments stated that Exception 21 provides too much deference to Chief Counsel and recommended that the exception delete the reference to withheld cases. The Treasury Department and the IRS do not adopt these comments. The withholding of cases or issues from Appeals has been, and will continue to be, limited and rare.
                    <SU>1</SU>
                    <FTREF/>
                     The determination to withhold a case or issue from Appeals requires a high-level review, with the decision ultimately resting with the Division Counsel or a higher-level Chief Counsel official. 
                    <E T="03">See</E>
                     section 3.03 of Rev. Proc. 2016-22. When Congress enacted the TFA, it was aware of the historic exceptions to Appeals consideration, including Chief Counsel's authority to designate a case for litigation or withhold a case from Appeals consideration on the basis of a referral not being in the interest of sound tax administration under Rev. Proc. 2016-22. Congress recognized that the Treasury Department and the IRS retain their historical discretion to determine whether the resolution of particular types of disputes is appropriate for Appeals, and the discretion of the IRS to determine whether a particular Federal tax controversy is appropriate for the Appeals resolution process. As proposed, Exception 21 is narrowly tailored, and it does not encroach on Appeals' independence for the reasons discussed previously in section I.A. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Since the TFA was enacted on July 1, 2019, the IRS has denied three requests for referral to Appeals, as described in section 7803(e)(5)(A), on the basis of sound tax administration. Because section 7803(e)(5)(A) is limited to denials of a request for referral to Appeals by those taxpayers in receipt of a notice of deficiency authorized under section 6212, fewer than 130 cases not subject to section 7803(e)(5)(A) were otherwise withheld from Appeals review during that period by Division Counsel under section 3.03 of Rev. Proc. 2016-22. For example, these cases include cases involving partnerships in which a final partnership administrative adjustment was issued instead of a notice of deficiency.
                    </P>
                </FTNT>
                <P>Two comments that objected to Exception 19 and Exception 20, in the alternative, recommended the regulations provide notice and protest rules for any taxpayer with a case or issue withheld or designated for litigation. One of the comments recommended at least requiring meetings with Chief Counsel executives to explain the decision. Similarly, another comment recommended that low-income taxpayers should receive a written explanation and given an opportunity to object.</P>
                <P>
                    The Treasury Department and the IRS do not adopt these comments. If Chief Counsel determines that a docketed case or issue will be withheld from Appeals, Chief Counsel will notify the taxpayer that the case will not be referred to Appeals. 
                    <E T="03">See</E>
                     section 3.03 of Rev. Proc. 2016-22. Taxpayer cases that are withheld from Appeals consideration under Exception 21 and meet the requirements of proposed § 301.7803-3 already would receive a written notice detailing the facts of the case, the reason for the denial, and the opportunity to protest the denial pursuant to section 7803(e)(5). As discussed in section 2 of this 
                    <E T="03">Summary of Comments and Explanation of Revisions,</E>
                     section 7803(e)(5) only requires notice and denial protest rights be given to a taxpayer in receipt of a notice of deficiency. Consistent with the statute, these final regulations do not extend notice and denial protest rights to taxpayers who did not receive a notice of deficiency. With respect to situations involving low-income taxpayers, as described by the comment, such taxpayers would similarly receive an explanation and opportunity to protest under proposed § 301.7803-3 after they receive a notice of deficiency.
                </P>
                <P>Another comment alleged that the designation of cases or issues for litigation is not rare and prevents sound tax administration in thousands of cases because Appeals could arrive at the correct amount of tax or a deduction and the IRS's approach of settling a designated case only if taxpayers concede all issues, including all penalties, has created a backlog in the IRS and the court. The comment is factually incorrect because designation of a case or issue is rare. The IRS has designated fewer than 10 cases since 2013.</P>
                <P>
                    A comment recommended the IRS make public a list of all designated cases docketed in Tax Court and all designated issues and publish the total number of taxpayers affected by cases or issues being designated for litigation. The Treasury Department and the IRS do not adopt this comment. The comment raises potential disclosure concerns under section 6103 of the Code relating to the prohibition of the disclosure of return information. Even if such disclosure was not prohibited by law, it is beyond the scope of these regulations.
                    <PRTPAGE P="3658"/>
                </P>
                <HD SOURCE="HD3">14. Appeals Consideration Is a Prerequisite to Jurisdiction of the Tax Court: Exception 23</HD>
                <P>One comment was received on Exception 23. Exception 23 provides that Appeals consideration is not available for a case in which timely consideration by Appeals must be requested before a petition is filed in the Tax Court because exhaustion of administrative review, including Appeals consideration, is a prerequisite for the Tax Court's jurisdiction, and the taxpayer failed to timely request Appeals consideration.</P>
                <P>
                    The comment opined the heading for this exception in the proposed regulations' preamble (that is, 
                    <E T="03">Appeals Consideration is a Prerequisite to the Jurisdiction of Tax Court</E>
                    ) did not mention whether there could be exceptions to the requirement to exhaust administrative remedies. The comment recommended adding language to the regulation's text to explicitly indicate that Exception 23 does not apply when there is an exception to the requirement to exhaust administrative remedies as provided in a statute or other guidance. The Treasury Department and the IRS do not adopt this recommendation. The text of the regulation adequately covers the comment's point, as the text makes clear that this exception applies only when timely Appeals consideration itself is a prerequisite to the Tax Court's jurisdiction.
                </P>
                <HD SOURCE="HD3">E. Procedural and Timing Requirements Are Followed: Proposed § 301.7803-2(e)</HD>
                <P>One comment was received on proposed § 301.7803-2(e), which provides the procedural and timing requirements that a taxpayer must meet before Appeals may consider the taxpayer's Federal tax controversy. Specifically, proposed § 301.7803-2(e) provides that a request for Appeals consideration must be submitted in the time and manner prescribed in applicable forms, instructions, or other administrative guidance and that all procedural requirements must be complied with for Appeals to consider a Federal tax controversy.</P>
                <P>The comment recommended that the final regulations explicitly direct the IRS to list specific requirements that the IRS must meet for accessibility, to explain the processes in a way that is easy to understand for the unrepresented taxpayer and feasible for all taxpayers, including low-income taxpayers who may face financial and other barriers to following traditional mailing processes. The comment suggested including notices with appeal rights delivered by mail and to a taxpayer's online IRS account if they have one; deadlines to file an appeal should be clearly and accurately stated in plain language on the first page of a notice that has an appeal right; the IRS should have an easy-to-understand fill-in form that contains all required elements to request an appeal, and the form should be available for every level of appeal; each notice from the IRS that carries an appeal right should enclose a copy of the simple form along with an envelope and instructions for certified mailing to prove the mailing date; and each notice from the IRS that carries an appeal right should also include both a simple URL link and QR code link to the online simplified form, the form should be easily fillable on a computer or a smartphone and be available in multiple languages, and the taxpayer should be able to submit this form online to meet the deadline for the Appeals request.</P>
                <P>The Treasury Department and the IRS do not adopt this comment's recommendations because they are outside the scope of these final regulations. The comment is better suited to be addressed in the specific correspondence sent from the IRS to taxpayers. Promoting taxpayer communication, understanding, and efficiency, including in accessing Appeals, are important topics that the IRS will continue to look at as it improves and develops its systems and procedures. In that regard, the IRS will carefully consider the suggestions in this comment as part of that process.</P>
                <HD SOURCE="HD3">F. One Opportunity for Consideration by Appeals: Proposed § 301.7803-2(f)</HD>
                <P>
                    One comment was received with a suggestion relating to the general rule of one opportunity for Appeals consideration in proposed § 301.7803-2(f)(1). Another comment was received on the exceptions to that general rule. Those comments are addressed in this section I.F. of the 
                    <E T="03">Summary of Comments and Explanation of Revisions.</E>
                </P>
                <HD SOURCE="HD3">1. In General. Proposed § 301.7803-2(f)(1)</HD>
                <P>Proposed § 301.7803-2(f)(1) provides that if a Federal tax controversy is eligible for consideration by Appeals and the procedural and timing requirements are followed, a taxpayer generally has one opportunity for Appeals to consider such matter or issue in the same case for the same period or in any type of future case for the same period. The comment on proposed § 301.7803-2(f)(1) recommended that the final regulations should explicitly include the situation in which the taxpayer and the Government have run out of time for Appeals consideration prior to the expiration of the statute of limitations and a notice of deficiency being issued, thereby confirming that a taxpayer's case can be heard by Appeals either before or after a case is docketed (although not both).</P>
                <P>The Treasury Department and the IRS agree that if there is insufficient time remaining on the limitations period for Appeals consideration, a taxpayer in receipt of a notice of deficiency would have the opportunity to have Appeals consider the taxpayer's case after the taxpayer has filed a petition with the Tax Court and the case is docketed, assuming the issue being considered by Appeals is not subject to an exception described in the final regulations. An example has been added to § 301.7803-2(e) to illustrate this point, which is a more appropriate place in the regulations for this addition.</P>
                <HD SOURCE="HD3">2. Exceptions. Proposed § 301.7803-2(f)(1) and (2)</HD>
                <P>There are several exceptions to the general rule in proposed § 301.7803-2(f)(1). Proposed § 301.7803-2(f)(1) provides an exception to the proposed general rule in a case in which the Tax Court remands a collection due process (CDP) case for reconsideration. Proposed § 301.7803-2(f)(2) provides an exception for a taxpayer that participated in an Appeals early consideration program but did not reach an agreement with Appeals. Proposed § 301.7803-2(f)(2) also provides an exception to the general rule in proposed § 301.7803-2(f)(1) for taxpayers who provide new information to the IRS and who meet the conditions and requirements for audit reconsideration or for reconsideration of liability issues previously considered by Appeals. Appeals may consider the new information.</P>
                <P>
                    A comment recommended clarifying in proposed § 301.7803-2(f)(2) that a new development in the law is “new information” that would allow Appeals reconsideration of the same matter. The Treasury Department and the IRS recognize that the original phrasing in the paragraph was unclear. For purposes of these final regulations, new information is intended to mean additional facts that the taxpayer did not provide during the original examination. It is not intended to mean a new development in the law. Additional language has been added to § 301.7803-2(f)(2) in the final regulations to clarify the intended meaning.
                    <PRTPAGE P="3659"/>
                </P>
                <HD SOURCE="HD3">G. Special Rules. Proposed § 301.7803-2(g)</HD>
                <P>
                    A comment suggested that Chief Counsel delaying Appeals review of a case was tantamount to a denial of Appeals review. The Treasury Department and the IRS disagree. As explained in section I.H.2. of the proposed regulations' 
                    <E T="03">Explanation of Provisions</E>
                     regarding the special rule in proposed § 301.7803-2(g), Chief Counsel may delay forwarding a docketed case to Appeals when Chief Counsel anticipates filing a dispositive motion such as a motion for summary or partial summary judgment, or a motion to dismiss for lack of jurisdiction, in which case Chief Counsel will retain jurisdiction over the case until the Tax Court rules on the motion. This flexibility to respond to the needs of specific Federal tax controversies promotes the efficient disposition of a taxpayer's case, including developing or narrowing the issues in dispute. The taxpayer will continue to be eligible for consideration by Appeals if the litigation continues and all other requirements in § 301.7803-2 are met. Accordingly, these final regulations do not adopt this comment.
                </P>
                <HD SOURCE="HD3">H. Section 9100 Relief and Change of Accounting Method</HD>
                <P>The list of exclusions in proposed § 301.7803-2(c) does not include certain exclusions from Appeals consideration currently provided in the IRM relating to requests for 9100 relief and CAMs. In the proposed regulations, the Treasury Department and the IRS requested comments on whether these items should be included in the list of exclusions. Specifically, comments were requested on whether the binary nature of decisions by an Associate Office regarding 9100 relief or CAM requests makes these decisions unsuitable for Appeals review; whether a different review standard should apply if Appeals considers the decisions; and what impact would Appeals review of the decisions have on later years that are not before Appeals.</P>
                <P>
                    In response, the Treasury Department and the IRS received four comments. One comment in support of adopting an Appeals exception recommended that Exception 17 relating to letter rulings issued by an Associate Office be finalized as proposed so that the regulations ensure, consistent with the historical IRS position, that Appeals not be permitted to consider an Associate Office decision concerning whether to issue 9100 relief or CAM letter rulings. 
                    <E T="03">See</E>
                     section I.D.10. of this 
                    <E T="03">Summary of Comments and Explanation of Revisions</E>
                     regarding Exception 17. According to this comment, letter ruling decisions regarding 9100 relief and CAMs should not be considered by Appeals for the reasons described in the proposed regulations that apply to other types of letter rulings. In particular, a letter ruling interprets internal revenue laws and applies them to the taxpayer's specific set of facts. A voluntary request for a letter ruling is not an administrative determination that is a part of the IRS's compliance function. A taxpayer receiving a letter ruling is not obligated to file a return consistent with that letter ruling. Generally, the program is designed instead to provide taxpayers with information regarding whether the IRS will accept a position to be taken on the taxpayer's return. For letter rulings responding to a taxpayer's request for a CAM, the letter ruling grants or denies consent under section 446(e) of the Code. The Treasury Department and the IRS adopt this recommendation for those reasons and added language to clarify this point that Exception 17 includes Associate Office decisions on 9100 relief requests and CAM requests. 
                    <E T="03">See</E>
                     § 301.7803-2(c)(17). While Appeals cannot consider an Associate Office's decision on whether to issue a letter ruling or the content of a letter ruling, Exception 17 recognizes that Appeals may consider the subject of the letter ruling if all other requirements in § 301.7803-2 are met. For example, if an Associate Office issues an adverse letter ruling to a taxpayer, the taxpayer cannot immediately appeal the issuance of the adverse letter ruling. If the taxpayer later files a return taking a position that is contrary to the letter ruling and that position is examined by the IRS, Appeals can consider that Federal tax controversy if all other requirements in § 301.7803-2 are met.
                </P>
                <P>The comment also recommended a separate exclusion for Appeals consideration of decisions by an Associate Office regarding 9100 relief or CAM requests. The Treasury Department and the IRS do not adopt this recommendation. As previously described, if a taxpayer files a tax return contrary to the Associate Office's decision and a Federal tax controversy arises that involves the subject of the adverse decision, Appeals could consider the subject of that Associate Office's decision in the dispute if all other requirements in § 301.7803-2 are met.</P>
                <P>
                    Another comment suggested the final regulations should empower Appeals to consider an Associate Office's decisions regarding 9100 relief or CAM requests because Appeals consideration would protect taxpayer rights. Two comments suggested the final regulations should allow Appeals to consider such cases because judicial review is costly and time consuming and Appeals consideration would reduce litigation. The Treasury Department and the IRS agree Appeals review as described in the preceding paragraph is consistent with the function of Appeals to resolve Federal tax controversies without litigation and is consistent with the provision that such resolution be generally available to all taxpayers. A comment suggested the final regulations should empower Appeals to consider such cases because Appeals consideration would promote impartial resolution. The Treasury Department and the IRS disagree with this reasoning because, as explained previously in this 
                    <E T="03">Summary of Comments and Explanation of Revisions,</E>
                     impartiality presupposes that the matter is being considered by Appeals in the first place. Once a Federal tax controversy is referred to Appeals, Appeals will consider the hazards of litigation while impartially considering the positions of the taxpayer and of the IRS.
                </P>
                <P>A comment asserted accounting method issues do not have to be viewed as binary and noted Appeals already reviews adjustments initiated by the IRS through an examination. According to this comment, Appeals should review accounting method issues consistently regardless of whether the originating function was through an IRS examination or an Associate Office. Similarly, another comment asserted that Appeals consideration of a CAM letter ruling denial that was issued on the basis that the requested change would not clearly reflect income or would otherwise not be in the interest of sound tax administration would allow Appeals review of the substantive positions in these cases, similar to Appeals review of the substantive issue in cases arising in examination or a docketed case, and that foreclosing Appeals consideration would create inconsistencies and be counterproductive to tax administration. The Treasury Department and the IRS agree that Appeals should have the ability to review accounting method issues arising in an examination, even when the accounting method issue relates to an Associate Office's denial of a CAM letter ruling request.</P>
                <P>
                    Another comment suggested Appeals consideration of an Associate Office's decisions regarding 9100 relief or CAM requests would promote consistent application of laws and public confidence in the IRS. Appeals consideration of an Associate Office's 
                    <PRTPAGE P="3660"/>
                    decisions regarding 9100 relief or CAM requests would promote public confidence in the IRS and is consistent with the purpose of the TFA.
                </P>
                <P>A comment asserted the ultimate decision may be binary, in that an Associate Office either does or does not permit 9100 relief or a CAM. According to this comment, the binary nature of decisions on these matters should not automatically exclude them from Appeals review. To the extent an Associate Office's decision regarding a 9100 relief or CAM request is viewed as a binary decision, the Treasury Department and the IRS agree with the comment's general premise that the binary nature of such decisions would not automatically exclude them from Appeals review. If a taxpayer files a tax return contrary to the Associate Office's decision and a Federal tax controversy arises that involves the subject of the adverse decision, Appeals may consider the subject of that Associate Office's decision in the dispute if all other requirements in § 301.7803-2 are met.</P>
                <P>The IRM currently provides that Appeals will not partially or fully concede an issue in a case in which an Associate Office's decision would be reviewed by a court using an abuse of discretion standard. One comment urged that if Appeals is permitted to consider a decision by an Associate Office that denied a 9100 relief or a CAM request, then the final regulations should apply a different standard of review than the abuse of discretion standard used for other administrative determinations. The comment recommended that Appeals should only be permitted to make concessions if it determines there is a significant risk that, if litigated, a court would find that the IRS abused its discretion in issuing an adverse letter ruling. Another comment observed that a CAM request may be denied by an Associate Office for many different reasons, including, for example, on the basis of substantive issues or due to procedural issues when the Associate Office determines that the taxpayer has not complied with all the procedural terms and conditions, such as filing requirements and deadlines. The comment urged the Treasury Department and the IRS to look through the superficial similarities of these denials to the underlying legal issues when determining whether Appeals review is warranted. The Treasury Department and the IRS agree that an Associate Office may issue a denial letter on a 9100 relief request or CAM request for a variety of different reasons, which are generally expressed in the applicable statute, regulations, or other guidance published in the Internal Revenue Bulletin. A decision to deny such a request, whether on a procedural or a substantive basis, is based on all the facts and circumstances. The final regulations do not provide a standard of review because it is outside the scope of these regulations, and the Treasury Department and the IRS expect the existing review standard would be used by Appeals for such cases.</P>
                <P>
                    A comment stated Appeals may need to enter into closing agreements with taxpayers to ensure that future taxable years are consistent with the request that was denied by the Associate Office, but that closing agreements would be more difficult for the taxpayer and the Government to reverse in future years compared to a letter ruling issued by an Associate Office. These regulations do not alter the authority delegated to the Associate Offices over 9100 relief or CAM requests or to restrict Appeals' ability to use its existing settlement authority to review or settle such cases. 
                    <E T="03">See, e.g.,</E>
                     Rev. Proc. 2002-18, 2002-1 C.B. 678 (regarding procedures relating to the settling of method change issues). Likewise, these regulations do not alter the IRS's authority to review these issues during an examination of a taxpayer's Federal income tax return.
                </P>
                <HD SOURCE="HD2">I. Miscellaneous Recommendations Regarding Proposed § 301.7803-2</HD>
                <P>A comment expressed concern that the proposed regulations could make the Appeals review process more confusing and stressful for taxpayers, including low-income taxpayers, but did not specify how or why this could happen. The Treasury Department and the IRS disagree with this comment. The procedural requirements, timing requirements, and almost all of the exceptions to consideration by Appeals already exist in previously established guidance regarding Appeals. As in the past, the proposed exceptions are limited in number and the vast majority of taxpayers, including low-income taxpayers, would have the opportunity to have Appeals consider their Federal tax controversies.</P>
                <P>
                    The same comment suggested considering the impact of the regulations on closed cases in Appeals. To the extent this comment is suggesting these regulations should cover procedures for reopening a closed case, that topic is beyond the scope of these regulations. Procedures for reopening closed Appeals cases already exist in other guidance. 
                    <E T="03">See</E>
                     IRM 8.6.1.7 (09-25-2019).
                </P>
                <P>A comment suggested that the proposed regulations overlap with § 601.106. To the extent that the Treasury Department and the IRS are not repealing or revising § 601.106, the comment recommended Treasury explicitly harmonize areas of overlap and consolidate all Appeals regulations into adjacent sections of the regulations to prevent ambiguity and controversy. In the alternative, even if no actual or perceived conflict exists, the comment recommended adding cross-references in § 301.7803-2 to avoid creating a trap for the unwary.</P>
                <P>The Treasury Department and the IRS do not agree with this comment and do not adopt these recommendations. The Statement of Procedural Rules, 26 CFR part 601, are procedural rules governing internal IRS affairs. Those rules do not concern the substantive resolution of Federal tax controversies by Appeals.</P>
                <P>Two comments recommended additional funding, including funding for Appeals in order to more effectively and fairly serve taxpayers, and limit the need for the exceptions in these regulations. The recommendation addresses operational matters of Appeals and is beyond the scope of these regulations because it does not address the proposed regulations or recommend any changes.</P>
                <P>One comment addressed the Interim Guidance (IG) Memorandum (Control Number AP-08-0922-0011) that Appeals issued on September 14, 2022, relating to validity challenges to regulations and relating to procedural validity challenges to notices or revenue procedures. This comment alleged that the IRS has already begun to make the substance of Exception 19 and Exception 20 effective even though, as proposed in the proposed regulations, they would not take effect until 30 days after the publication of a final regulation. The comment recommended that Appeals pause using these exceptions before the regulations are finalized.</P>
                <P>The Treasury Department and the IRS decline to adopt the comment's recommendation because it is outside the scope of these regulations. The IG Memorandum provides interim guidance by Appeals to AOs and does not have bearing on these final regulations.</P>
                <HD SOURCE="HD2">II. Notice and Protest of Denial Procedures Following Issuance of a Notice of Deficiency: Proposed § 301.7803-3</HD>
                <P>
                    Two comments were received on proposed § 301.7803-3, which implements the notice and protest procedures of section 7803(e)(5). As proposed, these procedures apply if any taxpayer requests Appeals consideration of a matter or issue, the request is denied, and the taxpayer meets the 
                    <PRTPAGE P="3661"/>
                    requirements of proposed § 301.7803-3(a)(1) through (5). Proposed § 301.7803-3(a)(1) adopts the statutory language in section 7803(e)(5)(A), which refers to any taxpayer in receipt of a notice of deficiency authorized under section 6212 (relating to notice of deficiency).
                </P>
                <P>The comments recommended that the notice and protest procedures should not be limited to taxpayers in receipt of a notice of deficiency. The Treasury Department and the IRS do not adopt this recommendation because it is contrary to the TFA. Section 7803(e)(5) does not grant the right to notice and protest a denial to all taxpayers. That statute requires the provision of such rights when the taxpayer is in receipt of a notice of deficiency, the taxpayer requests referral to Appeals, and that request is denied. Thus, a taxpayer would not be entitled to notice and protest procedures under section 7803(e)(5) and proposed § 301.7803-3 in the absence of a notice of deficiency.</P>
                <P>A comment described the notice and protest procedures in proposed § 301.7803-3 as not applying when a taxpayer is ineligible for Appeals consideration because one of the exceptions listed in proposed § 301.7803-2(c) applies to the taxpayer. This description is incorrect. As written and intended, proposed § 301.7803-3 does not except such cases or issues from the notice and protest procedures. Thus, that one of the exceptions listed in proposed § 301.7803-2(c) applies to a taxpayer does not prevent these procedures from applying if the taxpayer otherwise meets the requirements of proposed § 301.7803-3(a)(1) through (5), although it may be a reason why the request for referral to Appeals was denied. In response to the comments, the final regulations make clarifying edits to the text of § 301.7803-3(a).</P>
                <HD SOURCE="HD2">III. Comments on Topics That Are Outside the Scope of These Regulations</HD>
                <P>
                    Although the 
                    <E T="03">Explanation of Provisions</E>
                     of the proposed regulations discussed other new sections of the TFA, such as section 7803(e)(6) relating to Appeals' authority to obtain legal assistance and advice from Chief Counsel attorneys with regard to cases pending at Appeals, the proposed regulations stated that sections 7803(e)(4) and 7803(e)(5) were the primary focus of the guidance provided in the proposed regulations. Some comments received in response to the proposed regulations concerned topics and issues that are outside the scope of these final regulations.
                </P>
                <P>
                    One such comment recommended that these final regulations include the assurances currently provided in subregulatory guidance regarding the 
                    <E T="03">ex parte</E>
                     rules; limitations on the IRS examination function or Appeals raising new issues; conference rights; or the longstanding policies regarding the reopening of mutual concession cases. A comment was offered on access to administrative files under new section 7803(e)(7). Another comment recommended that the Treasury Department should adopt the National Taxpayer Advocate's proposal that a taxpayer has the right to a conference with Appeals that does not include personnel from Chief Counsel or the IRS examination function unless the taxpayer specifically consents to the participation of those parties in the conference, and another comment recommended that neither Appeals nor any IRS personnel involved in the Appeals conference should offer “nuisance” settlement offers of zero or small numbers.
                </P>
                <P>The Treasury Department and the IRS do not adopt these comments because their topics are outside the scope of sections 7803(e)(4) and 7803(e)(5), which were the primary focus of the proposed regulations. Section 7803(e)(4) provides for the general availability of Appeals consideration for taxpayers and section 7803(e)(5) provides for the limitation on designation of cases as not eligible for referral to Appeals. These comments do not address those areas and are already contained in other existing guidance. The IRS will consider and evaluate the comments for inclusion in the IRM or other guidance, as appropriate.</P>
                <HD SOURCE="HD1">Special Analyses</HD>
                <HD SOURCE="HD2">I. Regulatory Planning and Review</HD>
                <P>Pursuant to the Memorandum of Agreement, Review of Treasury Regulations under Executive Order 12866 (June 9, 2023), tax regulatory actions issued by the IRS are not subject to the requirements of section 6 of Executive Order 12866, as amended. Therefore, a regulatory impact assessment is not required.</P>
                <HD SOURCE="HD2">II. Regulatory Flexibility Act</HD>
                <P>
                    In accordance with the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ) it is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities.
                </P>
                <P>These regulations affect any person who would like to have a Federal tax controversy considered by Appeals, including any small entity. Because any small entity could potentially request consideration by Appeals, these regulations are expected to affect a substantial number of small entities. However, the IRS has determined that the economic impact on small entities affected by these regulations would not be significant.</P>
                <P>The regulations provide procedural and timing requirements for consideration by Appeals. The regulations also establish the general availability of consideration by Appeals and exceptions to that consideration. The procedural requirements, timing requirements, and the vast majority of the exceptions to eligibility for consideration by Appeals already exist in previously established guidance regarding Appeals. The regulations also provide rules regarding certain circumstances in which a written explanation will be provided regarding why Appeals consideration was not provided. None of the regulations affect entities' substantive tax liability nor do they affect the process that Appeals follows when it considers an eligible Federal tax controversy. Any significant economic impact on small entities will result from the application of the substantive tax provisions and will not be a result of these final regulations. Accordingly, the Secretary hereby certifies that these regulations will not have a significant economic impact on a substantial number of small entities.</P>
                <P>Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking was submitted to the Chief Counsel for the Office of Advocacy of the Small Business Administration for comment on its impact on small business, and no comments were received.</P>
                <HD SOURCE="HD2">III. Unfunded Mandates Reform Act</HD>
                <P>Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a State, local, or Indian tribal government, in the aggregate, or by the private sector, of $100 million (updated annually for inflation). These final regulations do not include any Federal mandate that may result in expenditures by State, local, or Indian tribal governments, or by the private sector in excess of that threshold.</P>
                <HD SOURCE="HD2">IV. Executive Order 13132: Federalism</HD>
                <P>
                    Executive Order 13132 (Federalism) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial, direct compliance costs on State and 
                    <PRTPAGE P="3662"/>
                    local governments, and is not required by statute, or preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. These final regulations do not have federalism implications and do not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.
                </P>
                <HD SOURCE="HD2">V. Congressional Review Act</HD>
                <P>
                    Pursuant to the Congressional Review Act (5 U.S.C. 801 
                    <E T="03">et seq.</E>
                    ), the Office of Information and Regulatory Affairs designated this rule as not a major rule as defined by 5 U.S.C. 804(2).
                </P>
                <HD SOURCE="HD1">Statement of Availability of IRS Documents</HD>
                <P>
                    IRS Revenue Procedures, Revenue Rulings notices, and other guidance cited in this document are published in the Internal Revenue Bulletin (or Cumulative Bulletin) and are available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at 
                    <E T="03">https://www.irs.gov.</E>
                </P>
                <HD SOURCE="HD1">Drafting Information</HD>
                <P>The principal author of these regulations is Joshua Hershman of the Office of the Associate Chief Counsel (Procedure and Administration). Other personnel from the Treasury Department and the IRS participated in their development.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 26 CFR Part 301</HD>
                    <P>Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Adoption of Amendments to the Regulations</HD>
                <P>Accordingly, the Treasury Department and the IRS amend 26 CFR part 301 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 301—PROCEDURE AND ADMINISTRATION</HD>
                </PART>
                <REGTEXT TITLE="26" PART="301">
                    <AMDPAR>
                        <E T="04">Paragraph 1.</E>
                        The authority citation for part 301 is amended by adding entries in numerical order for §§ 301.7803-2 and 301.7803-3 to read, in part, as follows:
                    </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 26 U.S.C. 7805.</P>
                    </AUTH>
                    <STARS/>
                    <EXTRACT>
                        <P>Section 301.7803-2 is also issued under 26 U.S.C. 7803(e).</P>
                        <P>Section 301.7803-3 is also issued under 26 U.S.C. 7803(e).</P>
                    </EXTRACT>
                    <STARS/>
                </REGTEXT>
                <REGTEXT TITLE="26" PART="301">
                    <AMDPAR>
                        <E T="04">Par. 2.</E>
                         Sections 301.7803-2 and 301.7803-3 are added to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 301.7803-2</SECTNO>
                        <SUBJECT>Internal Revenue Service Independent Office of Appeals resolution of Federal tax controversies without litigation.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Function of the Internal Revenue Service Independent Office of Appeals.</E>
                             The Internal Revenue Service Independent Office of Appeals (Appeals) resolves Federal tax controversies without litigation on a basis that is fair and impartial to both the Government and the taxpayer, promotes a consistent application and interpretation of, and voluntary compliance with, the Federal tax laws, and enhances public confidence in the integrity and efficiency of the Internal Revenue Service (IRS).
                        </P>
                        <P>
                            (b) 
                            <E T="03">Consideration of a Federal tax controversy by Appeals</E>
                            —(1) 
                            <E T="03">In general.</E>
                             The Appeals resolution process is generally available to all taxpayers to resolve Federal tax controversies.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Definition of Federal tax controversy.</E>
                             For purposes of this section, a 
                            <E T="03">Federal tax controversy</E>
                             is defined as a dispute over an administrative determination with respect to a particular taxpayer made by the IRS in administering or enforcing the internal revenue laws, related Federal tax statutes, and tax conventions to which the United States is a party (collectively referred to as internal revenue laws) that arises out of the examination, collection, or execution of other activities concerning the amount or legality of the taxpayer's income, employment, excise, or estate and gift tax liability; a penalty; or an addition to tax under the internal revenue laws. For purposes of this section, a Federal tax controversy includes, for example, a dispute over an administrative determination made by the IRS concerning a taxpayer's proposed deficiency, a taxpayer's claim for credit or refund, the tax-exempt nature of a particular organization, private foundation, or qualified employee plan under the internal revenue laws, or the status of a tax-exempt or other tax-advantaged bond.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Other administrative determinations treated as Federal tax controversies.</E>
                             Notwithstanding the definition of a Federal tax controversy in paragraph (b)(2) of this section, disputes over administrative determinations made by the IRS with respect to a particular person regarding the following topics are treated as Federal tax controversies for purposes of this section:
                        </P>
                        <P>(i) Liabilities and penalties administered by the IRS that are outside the Internal Revenue Code (Code), such as a liability or penalty pursuant to 31 U.S.C. 5321 (relating to Report of Foreign Bank and Financial Accounts or Bank Secrecy Act civil penalties);</P>
                        <P>(ii) A request under the Freedom of Information Act (5 U.S.C. 552);</P>
                        <P>(iii) Application to become, or the sanction of, an Electronic Return Originator or Authorized IRS e-file Provider;</P>
                        <P>(iv) An IRS-proposed determination to a bond issuer that denies a claim for recovery of an asserted overpayment of arbitrage rebate, yield reduction payment, or penalty in lieu of rebate under section 148 of the Code (relating to arbitrage) with respect to tax-exempt bonds or under section 148 as modified by relevant provisions of the Code with respect to other tax-advantaged bonds;</P>
                        <P>(v) Administrative costs under section 7430 of the Code (relating to awarding of costs and certain fees); or</P>
                        <P>(vi) Any other topic that the IRS has determined may be considered by Appeals.</P>
                        <P>
                            (c) 
                            <E T="03">Exceptions to consideration by Appeals.</E>
                             The following are Federal tax controversies that are excepted from consideration by Appeals or matters or issues that are otherwise ineligible for consideration by Appeals because they are neither a Federal tax controversy nor treated as a Federal tax controversy under paragraph (b)(3) of this section. If a matter or issue not eligible for consideration by Appeals is present in a case that otherwise is eligible for consideration by Appeals, the ineligible matter or issue will not be considered by Appeals during resolution of the case. The exceptions are:
                        </P>
                        <P>(1) Any administrative determination made by the IRS rejecting a position of a taxpayer that the IRS has identified as frivolous for purposes of section 6702(c) of the Code (regarding listing of frivolous positions) and any case solely involving the taxpayer's failure or refusal to comply with the internal revenue laws because of frivolous moral, religious, political, constitutional, conscientious, or similar grounds.</P>
                        <P>
                            (2) Penalties assessed by the IRS under section 6702 (relating to frivolous tax submissions) or section 6682 of the Code (relating to false information with respect to withholding) or any other penalty imposed for a frivolous position or false information. Appeals, however, may obtain verification that the assessment of the penalties complied with sections 6203 (relating to method of assessment) and 6751(b) (relating to supervisory approval of assessment) of the Code in a collection due process (CDP) hearing under sections 6320 (relating to a hearing upon filing of a notice of lien) and 6330 (relating to a hearing before levy) of the Code. 
                            <PRTPAGE P="3663"/>
                            Appeals also may consider a non-frivolous substantive challenge to a section 6702 or section 6682 penalty in a CDP hearing.
                        </P>
                        <P>(3) Any administrative determination made by the IRS under section 7623 of the Code (relating to awards to whistleblowers).</P>
                        <P>(4) Any administrative determination issued by an agency other than the IRS, such as a determination by the Alcohol and Tobacco Tax and Trade Bureau (TTB) concerning an excise tax administered by and within the jurisdiction of TTB.</P>
                        <P>(5) Any decision made by the IRS not to issue a Taxpayer Assistance Order (TAO) under section 7811 of the Code (relating to TAOs).</P>
                        <P>(6) Any decision made by the IRS concerning material to be deleted from the text of a written determination pursuant to section 6110 of the Code (relating to public inspection of written determinations) unless the written determination is otherwise being considered by Appeals.</P>
                        <P>(7) Any denial of access under the Privacy Act (5 U.S.C. 552a(d)(1)).</P>
                        <P>(8) Any issue resolved in an agreement described in section 7121 of the Code (regarding closing agreements) that the taxpayer entered into with the IRS, and any decision made by the IRS to enter into or not enter into such agreement. Appeals may consider the question of whether an item or items are covered, and how the item or items are covered, in a closing agreement.</P>
                        <P>(9) Any case in which the IRS erroneously returns or rejects an offer in compromise (OIC) submitted under section 7122 of the Code (relating to compromises) as nonprocessable or no longer processable and the taxpayer requests Appeals consideration to assert that the OIC should be deemed to be accepted under section 7122(f).</P>
                        <P>(10) Any case in which a criminal prosecution, or a recommendation for criminal prosecution, is pending against the taxpayer for a tax-related offense, except with the concurrence of the Office of Chief Counsel or the Department of Justice, as applicable.</P>
                        <P>(11) Any issues relating to allocation among different fee payers of the branded prescription drug and health insurance providers fees in section 9008 of the Patient Protection and Affordable Care Act (PPACA), Public Law 111-148 (124 Stat. 119 (2010)), as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010 (HCERA), Public Law 111-152 (124 Stat. 1029 (2010)), and section 9010 of PPACA, as amended by section 10905 of PPACA, and as further amended by section 1406 of HCERA.</P>
                        <P>(12) Any certification or issuance of a notice of certification of a seriously delinquent Federal tax debt to the Department of State under section 7345 of the Code (relating to the revocation or denial of a passport in the case of serious tax delinquencies).</P>
                        <P>(13) Any issue barred from consideration under section 6320 or section 6330, §§ 301.6320-1 and 301.6330-1, or any other administrative guidance related to CDP hearings or equivalent hearings.</P>
                        <P>(14) Any case, determination, matter, decision, request, or issue that Appeals lacks the authority to settle. The following is a non-exclusive list of examples:</P>
                        <P>(i) Any case or issue in a case that has been referred to the Department of Justice.</P>
                        <P>(ii) Any competent authority case (including a competent authority resolution previously accepted by the taxpayer) under a United States tax treaty that is within the exclusive authority of the United States Competent Authority.</P>
                        <P>(iii) Any decision of the Commissioner of Internal Revenue or the Commissioner's delegate to not rescind a penalty under section 6707A of the Code for a non-listed reportable transaction.</P>
                        <P>(iv) Any request for relief under section 6015 of the Code (relating to relief from joint and several liability on a joint return) when the nonrequesting spouse is a party to a docketed case in the United States Tax Court (Tax Court) and does not agree to granting full or partial relief under section 6015 to the requesting spouse.</P>
                        <P>(v) Any criminal restitution-based assessment under section 6201(a)(4) of the Code (relating to certain orders of criminal restitution and restriction on challenge of assessment).</P>
                        <P>(15) Any adverse action related to the initial or continuing recognition of tax-exempt status, an entity's classification as a foundation, the initial or continuing determination of employee plan qualification, or a determination involving an obligation and the issuer of an obligation under section 103 of the Code. The exception in this paragraph (c)(15) applies only if the tax-exempt recognition, classification, determination of employee plan qualification, or determination involving an obligation and the issuer of an obligation under section 103 is based upon a technical advice memorandum issued by an Office of Associate Chief Counsel before an appeal is requested.</P>
                        <P>(16) Any case docketed in the Tax Court if the notice of deficiency, notice of liability, or final adverse determination letter is based upon a technical advice memorandum issued by an Office of Associate Chief Counsel in that case involving an adverse action described in paragraph (c)(15) of this section.</P>
                        <P>(17) Any decision by an Office of Associate Chief Counsel regarding whether to issue a letter ruling or the content of a letter ruling. This includes decisions regarding requests for relief under §§ 301.9100-1 through 301.9100-22 and requests for a change in method of accounting. The subject of the letter ruling may be considered by Appeals if all other requirements in this section are met. For example, if an Office of Associate Chief Counsel issues an adverse letter ruling to a taxpayer, the taxpayer cannot immediately appeal the issuance of the adverse letter ruling. If the taxpayer subsequently files a return taking a position that is contrary to the letter ruling and that position is audited by the IRS, Appeals may consider that Federal tax controversy if all other requirements in this section are met.</P>
                        <P>
                            (18) Any issue based on a taxpayer's argument that a statute violates the United States Constitution unless there is an unreviewable decision from a Federal court holding that the cited statute is unconstitutional. For purposes of this paragraph (c)(18), an argument that a statute violates the United States Constitution includes any argument that a statute is unconstitutional on its face or as applied to a particular person. The exception in this paragraph (c)(18) does not preclude Appeals from considering a Federal tax controversy based on arguments other than the constitutionality of a statute, such as whether the statute applies to the taxpayer's facts and circumstances. For purposes of this section, the phrase 
                            <E T="03">unreviewable decision</E>
                             is a decision of any Federal court regardless of where the taxpayer resides that can no longer be appealed to any Federal court because all appeals in a case have been exhausted or the time to appeal has expired and no appeal was filed.
                        </P>
                        <P>
                            (19) Any issue based on a taxpayer's argument that a Treasury regulation is invalid unless there is an unreviewable decision from a Federal court invalidating the regulation as a whole or the provision in the regulation that the taxpayer is challenging. The exception in this paragraph (c)(19) does not preclude Appeals from considering a Federal tax controversy based on arguments other than the validity of a Treasury regulation, such as whether the Treasury regulation applies to the taxpayer's facts and circumstances. For purposes of this paragraph (c)(19), the term 
                            <E T="03">invalid</E>
                             means any challenge to 
                            <PRTPAGE P="3664"/>
                            validity, whether substantively invalid or procedurally invalid in scope. 
                            <E T="03">See</E>
                             paragraph (c)(20) of this section for definition of the term 
                            <E T="03">procedurally invalid.</E>
                        </P>
                        <P>
                            (20) Any issue based on a taxpayer's argument that a notice or revenue procedure published in the Internal Revenue Bulletin is procedurally invalid unless there is an unreviewable decision from a Federal court holding it to be invalid. This exception does not preclude Appeals from considering a Federal tax controversy based on arguments other than the procedural validity of a notice or revenue procedure, such as whether the notice or revenue procedure applies to the taxpayer's facts and circumstances. For purposes of this section, the term 
                            <E T="03">procedurally invalid</E>
                             is defined as any determination regarding whether a notice or revenue procedure failed to comply with administrative law requirements, such as notice and comment under 5 U.S.C. 553.
                        </P>
                        <P>
                            (21) Any case or issue designated for litigation, or withheld from Appeals consideration in a Tax Court case, in accordance with guidance regarding designating or withholding a case or issue. For purposes of this section, 
                            <E T="03">designated for litigation</E>
                             means that the Federal tax controversy, comprising an issue or issues in a case, will not be resolved without a full concession by the taxpayer or by decision of the court.
                        </P>
                        <P>(22) Any case docketed in the Tax Court if the notice of deficiency, notice of liability, or other determination was issued by Appeals unless the exception in paragraph (f)(1) of this section (regarding when the Tax Court remands a CDP case for reconsideration) applies.</P>
                        <P>(23) Any case in which timely Appeals consideration must be requested before a petition is filed in the Tax Court because exhaustion of administrative review, including consideration by Appeals, is a prerequisite for the Tax Court to have jurisdiction, and the taxpayer failed to timely request Appeals consideration. For example, Appeals consideration must be requested before a petition is filed in the Tax Court regarding a declaratory judgment request under section 7428 (relating to declaratory judgment on the classification of specified organizations), section 7476 (relating to declaratory judgment on qualification of certain retirement plans), or section 7477 (relating to declaratory judgment on the value of certain gifts) of the Code.</P>
                        <P>(24) Any administrative determination made by the IRS to deny or revoke a Certified Professional Employer Organization certification.</P>
                        <P>
                            (d) 
                            <E T="03">Originating office has completed its review</E>
                            —(1) 
                            <E T="03">In general.</E>
                             Appeals consideration of a matter or issue is appropriate only after the originating IRS office has completed its action on the Federal tax controversy and issued an administrative determination or a proposed administrative determination accompanied by an offer for consideration by Appeals. If the originating office has not completed its action regarding the Federal tax controversy, the request for Appeals consideration is premature. Appeals may consider the Federal tax controversy if the taxpayer requests consideration after the originating office's action is complete and if all requirements in this section are met.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Exception for early consideration programs.</E>
                             If administrative guidance permits the originating office to engage Appeals prior to completing its action regarding the Federal tax controversy, Appeals may consider the Federal tax controversy under the terms of that administrative guidance, such as mediation under a fast track settlement program or early consideration of some issues under an early referral program.
                        </P>
                        <P>
                            (e) 
                            <E T="03">Procedural and timing requirements are followed</E>
                            —(1) 
                            <E T="03">In general.</E>
                             A request for Appeals consideration of a Federal tax controversy must be submitted in the time and manner prescribed in applicable forms, instructions, or other administrative guidance. All procedural requirements must be complied with before Appeals will consider a Federal tax controversy. In addition, there must be sufficient time remaining on the appropriate limitations period for Appeals to consider the Federal tax controversy, as provided in administrative guidance. In a case docketed in the Tax Court, if the Office of Chief Counsel has recalled the case from Appeals or, if not recalled, Appeals has returned the case to the Office of Chief Counsel so that it is received by the Office of Chief Counsel prior to the date of the calendar call for the trial session, further consideration by Appeals will not be available if there is insufficient time for such consideration.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Example.</E>
                             The following example illustrates the application of the rule of insufficient time remaining on the limitations periods for Appeals consideration: The IRS examines Taxpayer X's Form 1040, 
                            <E T="03">U.S. Individual Income Tax Return,</E>
                             and determines a deficiency in income tax due to the IRS disallowing some of the deductions reported on the return. Because the expiration date of the assessment period of limitations with respect to the proposed deficiency is imminent, there is insufficient time for Appeals to receive the case and determine whether the case is susceptible to settlement. Consequently, the IRS issues a notice of deficiency under section 6212 of the Code to Taxpayer X. Under section 6213(a) of the Code, the issuance of this notice suspends the running of the assessment period while a taxpayer seeks judicial review of the notice. Taxpayer X timely files a petition with the Tax Court. After the case is docketed in the Tax Court, Taxpayer X generally would have the opportunity to have Appeals consider the case.
                        </P>
                        <P>
                            (f) 
                            <E T="03">One opportunity for consideration by Appeals</E>
                            —(1) 
                            <E T="03">In general.</E>
                             If a Federal tax controversy is eligible for consideration by Appeals and the procedural and timing requirements are followed, a taxpayer generally has one opportunity for Appeals to consider such matter or issue in the same case for the same period or in any type of future case for the same period, unless the Tax Court remands for reconsideration in a CDP case. Appeals has considered a Federal tax controversy if the Federal tax controversy was before Appeals for consideration and Appeals issued a determination or made a settlement offer, Appeals decided the Federal tax controversy was not susceptible to settlement, or the person who requested consideration was issued and failed to respond to Appeals' communications and as a result of that failure Appeals issued or made a determination. Appeals also has considered a Federal tax controversy if the taxpayer notified the Office of Chief Counsel or the IRS that the taxpayer wanted to discontinue settlement consideration by Appeals or requested to transfer from Appeals to the Office of Chief Counsel settlement consideration of a Federal tax controversy that is currently before the Tax Court.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Exceptions.</E>
                             Notwithstanding paragraph (f)(1) of this section, taxpayers retain the opportunity for a traditional appeal after participating in an early consideration program as described in paragraph (d)(2) of this section if no agreement was reached between the taxpayer and the IRS originating office. Taxpayers may be able to request post-Appeals mediation under the terms of administrative guidance after a traditional appeal if no agreement was reached between the taxpayer and Appeals. Notwithstanding paragraph (f)(1), taxpayers who provide new factual information to the IRS and who meet the conditions and requirements for audit reconsideration or for reconsideration of issues 
                            <PRTPAGE P="3665"/>
                            previously considered by Appeals may have an opportunity for Appeals consideration, as provided in administrative guidance.
                        </P>
                        <P>
                            (g) 
                            <E T="03">Special rules.</E>
                             The following special rules apply to this section:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Appeals reconsideration.</E>
                             Notwithstanding the exception in paragraph (c)(22) of this section, if Appeals issued a notice of deficiency, notice of liability, or other determination without having fully considered one or more issues because of an impending expiration of the statute of limitations on assessment, Appeals may choose to have the Office of Chief Counsel return the case to Appeals for full consideration of the issue or issues once the case is docketed in the Tax Court.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Coordination between Office of Chief Counsel and Appeals.</E>
                             Appeals and the Office of Chief Counsel may determine how settlement authority in a Federal tax controversy that is before the Tax Court is transferred between the two offices.
                        </P>
                        <P>
                            (h) 
                            <E T="03">Applicability date.</E>
                             This section is applicable to requests for consideration by Appeals made on or after February 14, 2025.
                        </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 301.7803-3</SECTNO>
                        <SUBJECT>Requests for referral to the Internal Revenue Service Independent Office of Appeals following the issuance of a notice of deficiency.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Notice and protest.</E>
                             If any taxpayer requests consideration by the Internal Revenue Service Independent Office of Appeals (Appeals) of any matter or issue under section 7803(e)(5) of the Internal Revenue Code (Code) (relating to limitation on designation of cases as not eligible for referral to Appeals) and the request is denied, the Commissioner of Internal Revenue (Commissioner) or the Commissioner's delegate must provide the taxpayer a written notice that provides a detailed description of the facts involved, the basis for the decision to deny the request, a detailed explanation of how the basis for the decision applies to such facts, and the procedures for protesting the decision to deny the request, but only if the requirements of paragraphs (a)(1) through (5) of this section are met:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Notice of deficiency.</E>
                             The taxpayer received a notice of deficiency authorized under section 6212 of the Code (relating to notice of deficiency) before the taxpayer requested consideration by Appeals.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Frivolous positions.</E>
                             The issue involved is not a frivolous position within the meaning of section 6702(c) of the Code (regarding listing of frivolous positions).
                        </P>
                        <P>
                            (3) 
                            <E T="03">Multiple requests for referral to Appeals.</E>
                             The taxpayer has not previously requested consideration by Appeals, pursuant to section 7803(e)(5), of the same matter or issue in a taxable year or period.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Previous Appeals consideration.</E>
                             Appeals has not previously considered the matter or issue in a taxable year or period that is the subject of the request and determined that the matter or issue could not be settled or a settlement offer was rejected, except as provided in § 301.7803-2(f)(2) with respect to a taxpayer participating in an early consideration program.
                        </P>
                        <P>
                            (5) 
                            <E T="03">Notice of deficiency with more than one matter or issue.</E>
                             If the notice of deficiency for which the taxpayer requests Appeals consideration includes more than one matter or issue in a taxable year or period, the taxpayer must request referral for Appeals consideration and submit all such matters or issues at the same time.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Applicability date.</E>
                             This section is applicable to relevant requests for consideration by Appeals made on or after February 14, 2025.
                        </P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <NAME>Douglas W. O'Donnell,</NAME>
                    <TITLE>Deputy Commissioner.</TITLE>
                    <DATED>Approved: January 3, 2025.</DATED>
                    <NAME>Aviva R. Aron-Dine,</NAME>
                    <TITLE>Deputy Assistant Secretary of the Treasury (Tax Policy).</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00426 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4830-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Occupational Safety and Health Administration</SUBAGY>
                <CFR>29 CFR Part 1910</CFR>
                <DEPDOC>[Docket No. OSHA-2020-0004]</DEPDOC>
                <RIN>RIN 1218-AD36</RIN>
                <SUBJECT>Occupational Exposure to COVID-19 in Healthcare Settings</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Occupational Safety and Health Administration (OSHA), Labor</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; termination of rulemaking</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>OSHA is terminating its COVID-19 rulemaking.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective dates:</E>
                         The termination of the rulemaking is effective January 15, 2025.
                    </P>
                    <P>
                        <E T="03">Compliance dates:</E>
                         There are no relevant compliance dates.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        In accordance with 28 U.S.C. 2112(a), the Agency designates Edmund C. Baird, Associate Solicitor of Labor for Occupational Safety and Health, Office of the Solicitor, U.S. Department of Labor, to receive petitions for review of this final agency action. Service can be accomplished by email to 
                        <E T="03">zzSOLCovid19ruleterm@dol.gov.</E>
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         To read or download comments or other material in the docket, go to Docket No. OSHA-2020-0004 at 
                        <E T="03">www.regulations.gov</E>
                         index; however, some information (
                        <E T="03">e.g.,</E>
                         copyrighted material) is not publicly available to read or download through that website. All comments and submissions, including copyrighted material, are available for inspection through the OSHA Docket Office. Documents submitted to the docket by OSHA or stakeholders are assigned document identification numbers (Document ID) for easy identification and retrieval. The full Document ID is the docket number plus a unique four-digit code. For example, the Document ID number for OSHA's COVID-19 Healthcare ETS is OSHA-2020-0004-1033. Some Document ID numbers also include one or more attachments.
                    </P>
                    <P>
                        When citing exhibits in the docket, OSHA includes the term “Document ID” followed by the last four digits of the Document ID number. For example, document OSHA-2020-0004-1033 would appear as Document ID 1033. Citations also include the attachment number or other attachment identifier, if applicable, page numbers (designated “p.” or “Tr.” for pages from a hearing transcript), and in a limited number of cases a footnote number (designated “Fn.”). In a citation that contains two or more Document ID numbers, the Document ID numbers are separated by semi-colons (
                        <E T="03">e.g.,</E>
                         “Document ID 1231, Attachment 1, p. 6; 1383, Attachment 1, p. 2”).
                    </P>
                    <P>
                        This information can be used to search for a supporting document in the docket at 
                        <E T="03">www.regulations.gov.</E>
                         Contact the OSHA Docket Office at (202) 693-2350 (TTY number: 877-889-5627) for assistance in locating docket submissions.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">For press inquiries:</E>
                         Contact Frank Meilinger, Director, Office of Communications, Occupational Safety and Health Administration, U.S. Department of Labor; telephone (202) 693-1999; email 
                        <E T="03">oshacomms@dol.gov.</E>
                    </P>
                    <P>
                        <E T="03">For general information:</E>
                         Contact Andrew Levinson, Director, Directorate of Standards and Guidance, Occupational Safety and Health Administration, U.S. Department of Labor; telephone (202) 693-1950; email: 
                        <E T="03">osha.dsg@dol.gov.</E>
                        <PRTPAGE P="3666"/>
                    </P>
                    <P>
                        <E T="03">For copies of this</E>
                          
                        <E T="04">Federal Register</E>
                          
                        <E T="03">document:</E>
                         Electronic copies of this 
                        <E T="04">Federal Register</E>
                         notice are available at 
                        <E T="03">http://www.regulations.gov.</E>
                         This notice, as well as news releases and other relevant information, are also available at OSHA's web page at 
                        <E T="03">www.osha.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On June 21, 2021, OSHA issued an Emergency Temporary Standard (ETS) to protect workers in healthcare settings, finding that COVID-19 presented a grave danger to those workers and that the ETS was necessary to protect them (86 FR 32376).
                    <SU>1</SU>
                    <FTREF/>
                     As of that date, nearly a half million healthcare workers had contracted COVID-19 and more than 1600 of those workers had died. Under the Occupational Safety and Health Act of 1970 (OSH Act or Act) (29 U.S.C. 655(c)(3)), the ETS served as a proposed rule for a rulemaking on occupational exposure to COVID-19 in healthcare settings. OSHA is now terminating the rulemaking via this rule because the public health emergency is over and any ongoing risk by COVID-19 or other coronavirus hazards faced by healthcare workers would be better addressed at this time in a rulemaking addressing infectious diseases more broadly.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         OSHA defined the grave danger as workplace exposure to SARS-CoV-2, the virus that causes the development of COVID-19. COVID-19 is the disease that can occur in people exposed to SARS-CoV-2, and that leads to the health effects that were described in the ETS (see 86 FR 32381, FN 4). As in the ETS, OSHA uses the two terms interchangeably in this notice because it is consistent with common usage in the regulated community.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Events Leading to This Agency Action Terminating the Rulemaking</HD>
                <P>
                    OSHA issued the healthcare ETS under section 6(c) of the Act (29 U.S.C. 655(c)) (
                    <E T="03">Occupational Exposure to COVID-19; Emergency Temporary Standard,</E>
                     86 FR 32376 (June 21, 2021), codified at 29 CFR 1910.502, 1910.504-.505, and 1910.509). Pursuant to section 6(c)(3) (29 U.S.C. 655(c)(3)), an ETS initiates rulemaking proceedings under section 6(b) and the ETS “as published shall also serve as a proposed rule for the proceeding.” (
                    <E T="03">Id.</E>
                     § 655(c)).
                </P>
                <P>When the COVID-19 pandemic started in 2020, OSHA initially responded to COVID-19 in the workplace by creating guidance documents and using its existing enforcement tools. The agency pursued a two-pronged strategy: (1) enforcing existing standards such as those for Personal Protective Equipment (PPE), Respiratory Protection, and Bloodborne Pathogens, as well as the General Duty Clause of the OSH Act (29 U.S.C. 654(a)(1)), and (2) working proactively to assist employers by developing guidance documents addressing how to reduce occupational COVID-19 hazards.</P>
                <P>
                    On January 21, 2021, President Biden issued Executive Order 13999 directing OSHA to consider whether “any emergency temporary emergency standards on COVID-19” were necessary (86 FR 7211). On June 21, 2021, the agency promulgated the COVID-19 ETS applicable to healthcare.
                    <SU>2</SU>
                    <FTREF/>
                     Because, under the OSH Act, this ETS also served as a proposal for a final standard, OSHA received 481 unique public comments on the ETS during the first open comment period between June 2021 and August 2021 (Docket OSHA-2020-0004).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         In the same June 2021 
                        <E T="04">Federal Register</E>
                         document in which OSHA implemented this ETS, OSHA also promulgated recordkeeping and reporting provisions pursuant to section 8(c)(1)-(3) (29 U.S.C. 657(c)(1)-(3)). For these, OSHA invoked an independent exemption from APA notice and comment requirement to make permanent the COVID-19 log and reporting provisions at 29 CFR 1910.502(q)(2)(ii), (q)(3)(ii)-(iv), and (r). OSHA found good cause under 5 U.S.C. 553(b)(3)(B) to forgo notice and comment given the grave danger presented by the pandemic. (
                        <E T="03">See</E>
                         86 FR 32559). Those requirements are therefore permanent and remain in effect.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         OSHA extended the original comment period by an additional 30 days to give stakeholders more time to opine on the ETS and a possible permanent standard (86 FR 38232).
                    </P>
                </FTNT>
                <P>Following the issuance of the ETS, OSHA received petitions urging the agency to adopt a permanent standard to protect healthcare workers from COVID-19 from the American Nurses Association, the International Association of Fire Chiefs, the Service Employees International Union (SEIU), and National Nurses United (NNU) (Document ID 1518; 1519; 1521; 1522; 1524; 2175). Over forty unions and organizations supported the NNU petition urging OSHA to adopt a permanent standard for COVID-19 in healthcare establishments and to also issue a separate, broader Infectious Diseases standard.</P>
                <P>On December 27, 2021, OSHA announced on its website that it would be unable to finalize a COVID-19 standard for healthcare “in a timeframe approaching the one contemplated by the OSH Act” (see Document ID 2491) and since the end of December 2021, OSHA has not enforced the ETS beyond the recordkeeping and reporting requirements in 29 CFR 1910.502(q) and (r). Instead, OSHA has relied on existing standards and the General Duty Clause of the OSH Act (29 U.S.C. 654(a)) to protect workers in workplaces that were previously covered by the ETS. OSHA emphasized in the website announcement that the agency “continues to work expeditiously to issue a final standard that will protect healthcare workers from COVID-19 hazards and will do so as it also considers its broader infectious disease rulemaking.”</P>
                <P>
                    On January 5, 2022, several labor organizations, including NNU, filed a petition with the United States Court of Appeals for the District of Columbia Circuit seeking a writ of mandamus compelling OSHA to issue a permanent COVID-19 standard for healthcare within 30 days and to continue enforcement of the ETS in the meantime. On August 26, 2022, the court issued a decision denying NNU's petition in part and dismissing it in part for lack of jurisdiction, while also noting that the ETS would continue to serve as a proposed rule for the rulemaking proceedings (
                    <E T="03">In re National Nurses United,</E>
                     47 F.4th 746, 754 (D.C. Cir. 2022)). The court determined that while the OSH Act created an obligation for OSHA to follow the issuance of an ETS with a notice and comment rulemaking process, “that process may result in a determination that no permanent standard is necessary.” (Id.)
                </P>
                <P>
                    While the NNU case was ongoing, OSHA continued its efforts to finalize a permanent COVID-19 standard for healthcare. However, after the ETS comment period closed on August 20, 2021, the available COVID-19 scientific literature, approaches to controls, and CDC guidance evolved significantly, based in part on the emergence of the Delta and Omicron variants. OSHA determined that it needed to reopen the record to ensure that the agency relied on the best available evidence and that the public had an opportunity to provide and comment on new data and information. On March 23, 2022, OSHA published a 
                    <E T="04">Federal Register</E>
                     notice announcing a limited re-opening of the comment period for 30 days (until April 22, 2022) and announcing public hearings beginning on April 27, 2022 (87 FR 16426, March 23, 2022).
                </P>
                <P>The reopening of the comment period and the hearing and post-hearing comment period allowed OSHA to revise and provide notice of potential changes to policy options and regulatory provisions to reflect up-to-date science, control approaches, and perspectives, as well as supporting analyses required for a final standard. At the closing of the comment period on April 22, 2022, OSHA had received approximately 250 additional comments.</P>
                <P>
                    The public hearings were held April 27-29 and May 2, 2022. Participating stakeholders included labor organizations, workers, employers, industry/trade groups, professional associations, public health experts, and 
                    <PRTPAGE P="3667"/>
                    concerned individuals, with some 39 organizations or individuals presenting their perspectives in the hearings (Document ID 2153; 2156; 2168; 2171). The presiding Administrative Law Judge permitted stakeholders to submit post-hearing comments and briefs until May 23, 2022. OSHA received nearly 150 additional comments from stakeholders during the post-hearing comment period. In total, over the three different comment periods, OSHA received 873 timely public comments on this rulemaking.
                </P>
                <P>OSHA submitted a draft final COVID-19 rule to the White House Office of Management and Budget (OMB) on December 7, 2022. On April 10, 2023, President Biden signed into law House Joint Resolution 7, which terminated the national emergency related to the COVID-19 pandemic. While the COVID-19 draft remained under review at OMB, OSHA pushed ahead with development of an Infectious Diseases standard for healthcare workers.</P>
                <HD SOURCE="HD1">Basis for Terminating the Rulemaking</HD>
                <P>OSHA always intended for an Infectious Diseases standard for healthcare workers to supplant any COVID-19 healthcare standard, and that a COVID-19 standard would be an interim measure pending the completion of the Infectious Diseases healthcare standard. OSHA concludes that the most effective and efficient use of agency resources to protect healthcare workers from occupational exposure to COVID-19, as well as a host of other infectious diseases, is to focus its resources on the completion of an Infectious Diseases rulemaking for healthcare rather than a disease-specific standard.</P>
                <P>In addition, even if OSHA were to finalize a separate COVID-19 standard at this time, the agency would need to conduct an additional review and possibly supplement the record again before it could issue a final rule to ensure the rule reflects the most current science. For example, guidance from the Centers for Disease Control and Prevention and other experts has changed since OSHA submitted its draft rule to OMB. Moreover, focusing on a separate COVID-19 standard would likely consume agency staff time and other agency resources in a way that would inhibit the promulgation of a more broadly protective Infectious Diseases healthcare standard. For these independently sufficient reasons, OSHA is terminating this rulemaking. In sum, the agency will have a greater impact at this time by adopting a standard that would provide protections to healthcare workers from occupational exposure to many different infectious diseases, including COVID-19 and future variants.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 29 CFR Part 1910</HD>
                    <P>COVID-19, Disease, Health facilities, Health, Health care, Incorporation by reference, Occupational health and safety, Public health, Quarantine, Reporting and recordkeeping requirements, Respirators, SARS-CoV-2, Telework, Vaccines, Viruses.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Authority and Signature</HD>
                <P>Douglas L. Parker, Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this document under the authority granted by sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); 5 U.S.C. 553, Secretary of Labor's Order No. 8-2020 (85 FR 58393), and 29 CFR part 1911.</P>
                <SIG>
                    <P>Signed at Washington, DC.</P>
                    <NAME>Douglas L. Parker,</NAME>
                    <TITLE>Assistant Secretary of Labor for Occupational Safety and Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00632 Filed 1-13-25; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-26-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employee Benefits Security Administration</SUBAGY>
                <CFR>29 CFR Part 2550</CFR>
                <DEPDOC>[Application No. D-11799]</DEPDOC>
                <RIN>RIN 1210-ZA23</RIN>
                <SUBJECT>Prohibited Transaction Exemption (PTE) 2002-51 To Permit Certain Transactions Identified in the Voluntary Fiduciary Correction Program</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Employee Benefits Security Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Exemption amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document amends Prohibited Transaction Exemption 2002-51, an exemption for certain transactions identified in the Department of Labor's Voluntary Fiduciary Correction Program (VFC Program or Program). The VFC Program is designed to encourage correction of fiduciary breaches and compliance with the law by permitting persons to avoid potential Department of Labor civil enforcement actions and civil penalties if they voluntarily correct eligible transactions in a manner that meets the requirements of the Program. PTE 2002-51 is a related class exemption that allows excise tax relief from excise taxes imposed by the Internal Revenue Code of 1986, as amended, for certain eligible transactions corrected pursuant to the VFC Program. This amendment to PTE 2002-51 is being finalized in connection with the Department's amendment and restatement of the VFC Program, published elsewhere in this issue of the 
                        <E T="04">Federal Register</E>
                         (2025 VFC Program). These amendments simplify and expand the VFC Program and exemptive relief to make the Program and exemption easier to use and more useful for employers and others who wish to avail themselves of the relief provided. The amendment to PTE 2002-51 affects plans, participants and beneficiaries of such plans, and certain other persons engaging in such transactions.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This amendment will be in effect on March 17, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Emily Harris, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor, telephone number (202) 693-8540. Brian J. Buyniski or Yolanda Wartenberg, Office of Regulations and Interpretations, Employee Benefits Security Administration (EBSA), (202) 693-8500, for questions regarding the VFC Program amendments. James Butikofer, Office of Research and Analysis, EBSA, (202) 693-8410, for questions regarding the regulatory impact analysis. (These are not toll-free numbers.)</P>
                    <P>
                        <E T="03">For general questions regarding the VFC Program:</E>
                         contact Dawn Miatech-Plaska, Office of Enforcement, EBSA, (202) 693-8691. For questions regarding specific applications and self-corrections under the VFC Program: contact the appropriate EBSA Regional Office listed in appendix C to the 2025 VFC Program. (These are not toll-free numbers.)
                    </P>
                    <P>
                        <E T="03">Customer Service Information:</E>
                         Individuals interested in obtaining information from the Department concerning the Employee Retirement Income Security Act of 1974 (ERISA) and employee benefit plans may call the Employee Benefits Security Administration's Toll-Free Hotline, at 1-866-444-EBSA (3272) or visit the Department's website (
                        <E T="03">www.dol.gov/ebsa</E>
                        ).
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <HD SOURCE="HD2">History of the VFC Program and Class Exemption</HD>
                <P>
                    The VFC Program gives plans and fiduciaries a ready means to correct violations of ERISA, without the transaction costs and burden associated 
                    <PRTPAGE P="3668"/>
                    with enforcement actions for violations of the fiduciary standards in title I of ERISA. As an enforcement policy, the VFC Program simultaneously promotes compliance with the law, correction of violations, and the efficient use of scarce enforcement resources. The Department also has the authority under ERISA section 408(a) to issue exemptions from the prohibited transaction rules in ERISA sections 406 and 407 and Internal Revenue Code (Code) section 4975.
                    <SU>1</SU>
                    <FTREF/>
                     Accordingly, in tandem with an amendment to the VFC Program published elsewhere in this issue of the 
                    <E T="04">Federal Register</E>
                    , the Department is publishing this associated amendment to Prohibited Transaction Exemption (PTE) 2002-51, which implements important components of the VFC Program.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Under Reorganization Plan No. 4 of 1978, 5 U.S.C. App., the authority of the Secretary of Treasury to issue exemptions pursuant to Code section 4975 was transferred, with certain exceptions not relevant here, to the Secretary of Labor.
                    </P>
                </FTNT>
                <P>
                    The Department of Labor's Employee Benefits Security Administration (EBSA) originally adopted the VFC Program in 2002, and later revised it in 2005 and 2006.
                    <SU>2</SU>
                    <FTREF/>
                     EBSA designed the VFC Program to encourage employers and plan fiduciaries to voluntarily comply with ERISA and allow those potentially liable for certain specified fiduciary breaches under ERISA to voluntarily apply for relief from enforcement actions and certain penalties, provided they meet the VFC Program's criteria and follow the procedures outlined in the VFC Program.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         67 FR 15062 (March 28, 2002); 70 FR. 17516 (April 6, 2005); 71 FR. 20262 (April 19, 2006).
                    </P>
                </FTNT>
                <P>The VFC Program describes how to apply for relief and lists the specific transactions covered and the acceptable methods for correcting fiduciary breaches under the Program. The most frequently corrected transaction under the Program is the correction of delinquent participant contributions. The Program provides a model application form, a checklist, and an online calculator for determining amounts to be restored to plans. The VFC Program has been, and will continue to be, administered in EBSA's Regional Offices.</P>
                <P>
                    The Department granted PTE 2002-51 in connection with the VFC Program. Some of the breaches that may be corrected under the VFC Program are also prohibited transactions subject to excise tax under Code section 4975. Reorganization Plan No. 4 of 1978 transferred the authority of the Secretary of Treasury to issue exemptions from the prohibited transaction provisions of Code section 4975 to the Secretary of Labor.
                    <SU>3</SU>
                    <FTREF/>
                     The exemption allows excise tax relief for certain specified breaches under the VFC Program. PTE 2002-51 is subject to several general conditions, including that the breach be appropriately corrected and the party applying must satisfy all the conditions of the VFC Program. The exemption also includes certain transaction-specific conditions.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         5 U.S.C. App.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">2022 Proposal</HD>
                <P>
                    On November 21, 2022, the Department published in the 
                    <E T="04">Federal Register</E>
                     proposed revisions to the VFC Program with a request for public comments.
                    <SU>4</SU>
                    <FTREF/>
                     The 2022 VFC Program proposed revisions would establish a self-correction feature for certain delinquent participant contributions and loan repayments to pension plans (the SCC). On the same date, the Department also published in the 
                    <E T="04">Federal Register</E>
                     a proposed amendment to PTE 2002-51 that would make certain conforming amendments to the class exemption.
                    <SU>5</SU>
                    <FTREF/>
                     The Department received seven comments on the proposed amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         87 FR 71164 (Nov. 21, 2022).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         87 FR 70753 (Nov. 21, 2022).
                    </P>
                </FTNT>
                <P>
                    On February 14, 2023, the Department reopened the comment period on both the 2022 Program VFC Program proposed revisions and the proposed amendment to PTE 2002-51 in light of section 305(b)(2) of the SECURE 2.0 Act of 2022 (SECURE 2.0 Act.
                    <SU>6</SU>
                    <FTREF/>
                     This provision requires the Department to treat eligible inadvertent failures related to participant loans that are self-corrected under the Employee Plans Compliance Resolution System 
                    <SU>7</SU>
                    <FTREF/>
                     (IRS's EPCRS) as meeting the requirements of the VFC Program “if, with respect to the violation of the fiduciary standards of the ERISA, there is a similar loan error eligible for correction under EPCRS and the loan error is corrected in such manner.” The Department requested comments on what revisions, if any, it should make to the VFC Program and exemption to reflect the treatment of corrections of loans to participants as described in SECURE 2.0 Act. Only one commenter addressed PTE 2002-51 in response and stated that no further amendments are required to the exemption.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Enacted on December 29, 2022, as Division T of the Consolidated Appropriations Act, 2023, Public Law 117 328, 136 Stat. 4459 (2022).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         As described in Rev. Proc. 2021-30, or any successor guidance).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">2025 VFC Program</HD>
                <P>
                    The Department is finalizing the amendment to the VFC Program elsewhere in this edition of the 
                    <E T="04">Federal Register</E>
                    . With these amendments, EBSA intends to facilitate more efficient and less costly corrections of fiduciary breaches under the VFC Program, encourage greater participation in the VFC Program, and respond to requests from stakeholders for adjustments based on their experiences using the VFC Program. In this regard, the amendments are designed to simplify the VFC Program and make it easier to use by employers and others who wish to avail themselves of the relief provided. Notably, the new self-correction procedures will apply to the transaction most frequently corrected under the VFC Program—the delinquent transmittal of participant contributions and loan repayments to pension plans—as well as to certain participant loan failures that are self-corrected under the IRS's EPCRS. The Department anticipates that many users of the amended Program will find it improved and less resource intensive to comply with, without sacrificing protections of their affected plans.
                </P>
                <P>The 2025 VFC Program retains the fundamentals of the 2006 VFC Program. The Program describes how to apply for relief, lists the specific transactions covered, and sets forth acceptable methods for correcting fiduciary breaches under the VFC Program. It also provides examples of potential breaches and related permissible corrective actions. The VFC Program defines the term “Breach” to mean any transaction that is or may be a violation of the fiduciary responsibilities contained in part 4 of title I of ERISA. The VFC Program also provides a model application form, a checklist, and an Online Calculator for determining correction amounts. The VFC Program will continue to be administered in EBSA Regional Offices. Eligible applicants that satisfy the terms and conditions of the VFC Program application process receive a “no action” letter from EBSA and are not subject to civil monetary penalties for the corrected transactions.</P>
                <P>
                    The most significant changes in the 2025 VFC Program involve the addition of two new self-correction features. The first is in section 7.1(b) for certain failures to timely transmit participant contributions (and participant loan repayments) to pension plans,
                    <SU>8</SU>
                    <FTREF/>
                     and the second is in section 7.3(c) for certain 
                    <PRTPAGE P="3669"/>
                    participant loan failures that are self-corrected under the IRS's EPCRS. The other 2025 VFC Program amendments: (1) clarify existing transactions eligible for correction under the VFC Program; (2) expand the scope of certain transactions currently eligible for correction; and (3) simplify certain administrative or procedural requirements for participation in the VFC Program and correction of transactions under the VFC Program.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The term pension plans include both defined contribution plans and defined benefit plans. 
                        <E T="03">See</E>
                         ERISA section 3(34) and 3(35).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Description of the Amendments to PTE 2002-51</HD>
                <P>
                    The Department is amending PTE 2002-51 to provide excise tax relief for transactions that are corrected pursuant to the SCC in the 2025 VFC Program and to make certain administrative or procedural changes for participation in, and correction of, transactions under the VFC Program.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         As noted above, under Reorganization Plan No. 4 of 1978, 5 U.S.C. App., the authority of the Secretary of Treasury to issue exemptions pursuant to Code section 4975 was transferred to the Secretary of Labor.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Self-Correction Feature for Delinquent Participant Contributions and Loan Repayments to Pension Plans</HD>
                <P>The 2025 VFC Program establishes the SCC for certain delinquent contributions to pension plans. The SCC allows “self-correctors” to make a plan whole and receive relief under the VFC Program without submitting an application to EBSA and receiving a no-action letter. Instead, self-correctors provide a notice (the SCC notice) to EBSA through an electronic tool on EBSA's website and receive an email acknowledgement from EBSA of a properly completed and submitted SCC notice.</P>
                <P>The Department is amending PTE 2002-51 to allow excise tax relief to self-correctors. The Department is adding transactions that are corrected under the SCC to section I.A. These transactions must comply with the applicable exemption conditions, including the requirement that delinquent contributions may not have been transmitted to the plan more than 180 calendar days from the date they were either received by the employer or otherwise would have been payable to the participant in cash. The Department is also amending section III.B of the exemption, which provides that the exemption will apply only if the applicant receives an EBSA no-action letter pursuant to the VFC Program. Since self-correctors will receive an email acknowledgement instead of a no-action letter from EBSA, this condition is amended to add a specific reference to the email acknowledgement of a properly completed and submitted SCC notice.</P>
                <HD SOURCE="HD2">Frequency of Use</HD>
                <P>Historically, PTE 2002-51 was generally not available to VFC Program applicants that had taken advantage of the relief provided by the VFC Program and the exemption for a similar type of transaction within the previous three years. The Department proposed to eliminate the three-year limitation to encourage greater use of the VFC Program.</P>
                <P>The Department requested comment in the proposal regarding whether the proposed removal of the three-year limitation would encourage greater use of the VFC Program without loss of meaningful protections for participants and beneficiaries. Several commenters supported the proposal and stated that the existing limitation was unnecessary to protect participants. However, one commenter disagreed with the proposal and cautioned that removing the three-year limitation may encourage more employers to delay depositing employee contributions and instead use that money for business expenses. This commenter suggested that if the Department chose to eliminate the three-year limitation period, it should do so on a trial basis so that the Department could monitor how often employers are using the VFC Program. After considering this comment, the Department has decided to finalize the amendment as proposed; however, it will monitor how frequently plan fiduciaries rely on the VFC Program (including the SCC) and may consider further amendments in the future.</P>
                <HD SOURCE="HD2">Sale and Leaseback of Real Property to an Employer</HD>
                <P>Section I.D. of PTE 2002-51 applies to the sale of real property to a plan by the sponsoring employer and the leaseback of such property to the same employer if it is corrected as required under the VFC Program. The Department is amending this section as proposed. The amendment expands the covered transactions in section I.D. to include affiliates of plan sponsors, which reflects a change made in the 2025 VFC Program. Accordingly, the amended exemption is available for a sale of real property by an affiliate of the employer sponsoring the plan, to the plan, and a leaseback of such property to the affiliate of the sponsoring employer.</P>
                <P>As amended, the term “affiliate” of a person is defined as follows—</P>
                <EXTRACT>
                    <P>(1) any person directly, or indirectly through one or more intermediaries, controlling, controlled by, or under common control with the person; (2) any officer, director, partner, employee, or member of the family (as defined in Code section 4975(e)(6)) of the person; or (3) any corporation or partnership of which such person is an officer, director, partner or employee.</P>
                </EXTRACT>
                <FP>
                    The term “control” is defined as the power to exercise a controlling influence over the management of a person other than an individual.
                    <SU>10</SU>
                    <FTREF/>
                </FP>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Both terms are defined in a new section V.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Deletion of Section II.E.</HD>
                <P>The Department is deleting section II.E. of the exemption as proposed. The condition related to all the covered transactions under section I and required that “the transaction was not part of an agreement, arrangement or understanding designed to benefit a disqualified person.” The Department believes that this condition is unnecessary in light of the other, more specific conditions of the exemption, including the requirement that the transaction must have been corrected in accordance with the applicable requirements of the VFC Program for the exemption to apply.</P>
                <HD SOURCE="HD2">Notice to Interested Persons</HD>
                <P>Section IV governs notice to interested persons. VFC Program applicants generally must inform interested persons of the prohibited transaction(s) that occurred and the steps taken to correct those violations. The notice must give participants and beneficiaries the opportunity to comment on the transactions and corrections to the applicable EBSA Regional Office.</P>
                <P>The Department proposed two key changes to the notice requirement for VFC Program applicants. First, the Department proposed that the notice could not be provided through posting alone. The Department explained that although section IV.B. had historically allowed notice through “posting, regular mail, or electronic mail, or any combination thereof,” the Department no longer believed that posting is reasonably calculated to ensure that interested persons actually receive the notice. Therefore, the Department is finalizing this provision as proposed.</P>
                <P>
                    The Department also included a model notice to interested persons as an appendix to the proposal. The Department drafted this model notice after reviewing several notices to interested persons that were submitted to the Regional Offices but did not meet the applicable requirements of section IV. The Department is publishing the model notice as an appendix to the final amendment to ensure that participants and beneficiaries receive meaningful 
                    <PRTPAGE P="3670"/>
                    notice of transactions for which relief is sought by their plans. The only change to the model notice from the proposal is that the final model notice states that you may “contact” the appropriate EBSA Regional Office instead of “mail.” The Department intends for the model notice to facilitate compliance with the exemption, but it is not requiring VFC Program applicants to use the model notice.
                </P>
                <P>
                    Regardless of whether a VFC Program applicant uses the model notice, the notice must be written in a manner reasonably calculated to be understood by the average Plan participant or beneficiary. In this regard, if a plan fiduciary knows or has reason to know that the average Plan participant or beneficiary covered by its plan would not understand a notice written in English, the fiduciary must take appropriate action to ensure that these interested parties have a reasonable opportunity to become informed of their rights described in the notice.
                    <SU>11</SU>
                    <FTREF/>
                     As a compliance aid, the Department is making the model notice available on its website in twelve non-English languages.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         See 
                        <E T="03">e.g.,</E>
                         29 CFR 2520.102-2(c)(2) regarding summary plan descriptions.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Notice Exception for Self-Correctors</HD>
                <P>In light of the streamlined procedure for self-correction and the SCC's limitation to corrections when the amount of lost earnings is $1,000 or less, the proposed exemption provided that self-correctors would not have to provide notice to interested persons. Instead, they would be required to pay the amount of the excise tax that would otherwise be imposed by Code section 4975 to the plan. Self-correctors would be required to retain a completed Form 5330 or other written documentation that shows the calculation of the amount of otherwise applicable excise taxes and proof they paid that amount to the plan. However, there would no requirement to provide this documentation to EBSA. The Department is finalizing the special notice rule for self-correctors as proposed.</P>
                <P>
                    Some commenters expressed concern that this contribution requirement would discourage use of the SCC and suggested that the Department should allow self-correctors to choose whether (a) to provide notice to interested persons (but 
                    <E T="03">not</E>
                     to EBSA) or (b) make the plan contribution. After considering these comments, the Department has not made this change. Self-correctors have a streamlined procedure for self-correction and the amount of otherwise applicable excise taxes that will be owed to their plans will be small due to the $1,000 limitation on lost earnings. The Department has determined that requiring these amounts to be paid to the plan is the most beneficial to and protective of participants in plans that self-correct under the SCC.
                </P>
                <HD SOURCE="HD2">Other Ministerial Amendments</HD>
                <P>The Department is finalizing certain ministerial changes to PTE 2002-51 to improve readability. For example, the Department is replacing references “to sections of the Code” to instead refer to “Code section.”</P>
                <HD SOURCE="HD1">Executive Order 12866 (Regulatory Planning and Review), Executive Order 14094 (Modernizing Regulatory Review), and 13563 (Improving Regulation and Regulatory Review)</HD>
                <P>
                    Under Executive Order 12866 (as amended by Executive Order 14094), the Office of Management and Budget (OMB)'s Office of Information and Regulatory Affairs determines whether a regulatory action is significant and, therefore, subject to the requirements of the Executive order and review by OMB. 58 FR 51735. As amended by Executive Order 14094, section 3(f) of Executive Order 12866 defines a “significant regulatory action” as a regulatory action that is likely to result in a rule that may: (1) have an annual effect on the economy of $200 million or more; or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the Executive order. OMB has determined that this amendment is a significant regulatory action under Executive Order 12866.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         2022 VFC Program proposed revisions, section D, “Regulatory Impact Analysis.”
                    </P>
                </FTNT>
                <P>
                    Executive Order 13563 directs agencies to propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; the regulation is tailored to impose the least burden on society, consistent with achieving the regulatory objectives; and in choosing among alternative regulatory approaches, the agency has selected those approaches that maximize net benefits. Executive Order 13563 recognizes that some benefits are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitative values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts. See the 2025 VFC Program amendment published elsewhere in this issue of the 
                    <E T="04">Federal Register</E>
                     for the regulatory impact analysis.
                </P>
                <HD SOURCE="HD1">Paperwork Reduction Act</HD>
                <P>In accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), the Department solicited comments concerning the information collection request (ICR) included in the 2022 VFC Program proposed revisions. At the same time, the Department also submitted the ICR to OMB, in accordance with 44 U.S.C. 3507(d).</P>
                <P>The Department received comments that addressed the burden estimates used in the analysis of the 2022 VFC Program proposed revisions. The Department reviewed these public comments in developing the paperwork burden analysis.</P>
                <P>
                    The changes made by these final rules affect the existing OMB control number, 1210-0118. A copy of the ICR for OMB Control Number 1210-0118 may be obtained at 
                    <E T="03">RegInfo.gov</E>
                     (
                    <E T="03">reginfo.gov/public/do/PRAMain</E>
                    ) or by contacting the PRA addressee:
                </P>
                <GPOTABLE COLS="2" OPTS="L2,nj,tp0,p1,8/9,i1" CDEF="xs72,r100">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1"> </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">By mail</ENT>
                        <ENT>PRA Officer, Office of Research and Analysis, Employee Benefits Security Administration, U.S. Department of Labor, 200 Constitution Avenue NW, Room N-5718, Washington, DC 20210.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">By email</ENT>
                        <ENT>
                            <E T="03">ebsa.opr@dol.gov.</E>
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    See the 2025 VFC Program amendment published elsewhere in this issue of the 
                    <E T="04">Federal Register</E>
                     for the paperwork burden of the amended VFC Program and the amended PTE 2002-51.
                    <PRTPAGE P="3671"/>
                </P>
                <HD SOURCE="HD1">Regulatory Flexibility Analysis</HD>
                <P>
                    The Regulatory Flexibility Act (RFA) 
                    <SU>13</SU>
                    <FTREF/>
                     imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act, or any other law, and are likely to have a significant economic impact on a substantial number of small entities.
                    <SU>14</SU>
                    <FTREF/>
                     Pursuant to section 605 of the RFA, the Department certifies that these proposed amendments to PTE 2002-51 will not have a significant economic impact on a substantial number of small entities.
                    <SU>15</SU>
                    <FTREF/>
                     See the 2025 VFC Program amendment published elsewhere in this issue of the 
                    <E T="04">Federal Register</E>
                     for the factual basis for the certification.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         5 U.S.C. 601 
                        <E T="03">et seq.</E>
                         (1980).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         5 U.S.C. 551 
                        <E T="03">et seq.</E>
                         (1946).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         5 U.S.C. 605 (1980).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">General Information</HD>
                <P>The attention of interested persons is directed to the following:</P>
                <P>(1) The fact that a transaction is the subject of an exemption under Code section 4975(c)(2) does not relieve a fiduciary or other disqualified person with respect to a plan from certain other provisions of ERISA and the Code, including any prohibited transaction provisions to which the exemption does not apply, the requirement that all assets of an employee benefit plan be held in trust by one or more trustees, and the general fiduciary responsibility provisions of ERISA which require, among other things, that a fiduciary discharge their duties respecting the plan solely in the interests of the participants and beneficiaries of the plan and in a prudent fashion; nor does it affect the requirement of Code section 401(a) that the plan must operate for the exclusive benefit of the employees of the employer maintaining the plan and their beneficiaries.</P>
                <P>(2) The amendment to PTE 2002-51 does not extend to transactions prohibited under Code section 4975(c)(1)(F).</P>
                <P>(3) The Department finds that the amendment is administratively feasible, in the interests of plans and their participants and beneficiaries, and protective of the rights of participants and beneficiaries of such plans.</P>
                <P>(4) The exemption, as amended, is supplemental to, and not in derogation of other provisions of ERISA and the Code, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive of whether the transaction is in fact a prohibited transaction.</P>
                <P>(5) The exemption, as amended, is applicable to a transaction only if the conditions specified in the class exemption are satisfied.</P>
                <P>The Department has republished the entire text of the amended PTE 2002-51 for the convenience of readers.</P>
                <HD SOURCE="HD1">Amendment to PTE 2002-51</HD>
                <P>Under Code section 4975(c)(2) and in accordance with the procedures set forth in 29 CFR 2570, subpart B (76 FR 66637, October 27, 2011), the Department amends and restates PTE 2002-51 as set forth below.</P>
                <HD SOURCE="HD2">Section I. Eligible Transactions</HD>
                <P>The sanctions resulting from the application of Code section 4975(a) and (b), by reason of Code section 4975(c)(1)(A) through (E), shall not apply to the following eligible transactions described in section 7 of the Voluntary Fiduciary Correction (VFC) Program, as amended, provided that the applicable conditions set forth in sections II, III, and IV are met:</P>
                <P>
                    A. Failure to forward participant contributions and/or loan repayments to a pension plan for investment within the time frames determined with reference to the principles of the Department's regulation at 29 CFR 2510.3-102 so that the employer retains such contributions or loan repayments for a longer period of time. (
                    <E T="03">See</E>
                     VFC Program, sections 7.1(a) and (b).)
                </P>
                <P>
                    B. Loan at a fair market interest rate to a disqualified person with respect to a plan. (
                    <E T="03">See</E>
                     VFC Program, section 7.2(a).)
                </P>
                <P>
                    C. Purchase or sale of an asset (including real property) between a plan and a disqualified person at fair market value. (
                    <E T="03">See</E>
                     VFC Program, sections 7.4(a) and (b).)
                </P>
                <P>
                    D. Sale of real property to a plan by the employer or an affiliate of such an employer and the leaseback of the property to the employer or the affiliate, at fair market value and fair market rental value, respectively. (
                    <E T="03">See</E>
                     VFC Program, section 7.4(c).)
                </P>
                <P>
                    E. Purchase of an asset (including real property) by a plan, where the asset has later been determined to be illiquid as described under the VFC Program in a transaction which was a prohibited transaction pursuant to Code section 4975(c)(1), or in which the asset was acquired from an unrelated third party, and/or the subsequent sale of such asset in a transaction prohibited pursuant to Code section 4975(c)(1). (
                    <E T="03">See</E>
                     VFC Program, section 7.4(f).)
                </P>
                <P>
                    F. Use of plan assets to pay expenses, including commissions or fees, to a service provider (
                    <E T="03">e.g.,</E>
                     attorney, accountant, recordkeeper, actuary, financial advisor, or insurance agent) for services provided in connection with the establishment, design or termination of the plan (settlor expenses), which relate to the activities of the plan sponsor in its capacity as settlor, provided that the payment of the settlor expense was not expressly prohibited by a plan provision relating to the payment of expenses by the plan. (
                    <E T="03">See</E>
                     VFC Program, section 7.6(b).)
                </P>
                <HD SOURCE="HD2">Section II. Conditions</HD>
                <P>A. With respect to a transaction involving participant contributions or loan repayments to pension plans described in section I.A., the contributions or repayments were transmitted to the pension plan not more than 180 calendar days from the date the amounts were received by the employer (in the case of amounts that a participant or beneficiary pays to an employer) or the date the amounts otherwise would have been payable to the participant in cash (in the case of amounts withheld by an employer from a participant's wages).</P>
                <P>B. With respect to the transactions described in sections I.B., I.C., I.D., or I.E., the plan assets involved in the transaction, or series of related transactions, did not, in the aggregate, exceed 10 percent of the fair market value of all the assets of the plan at the time of the transaction.</P>
                <P>C. The fair market value of any plan asset involved in a transaction described in sections I.C., I.D., or I.E., was determined in accordance with section 5 of the VFC Program.</P>
                <P>D. The terms of a transaction described in sections I.B., I.C., I.D., I.E., or I.F., were at least as favorable to the plan as the terms generally available in arm's-length transactions between unrelated parties.</P>
                <P>E. With respect to a transaction involving a sale of an illiquid asset under the VFC Program described in section I.E., the plan paid no brokerage fees, or commissions in connection with the sale of the asset.</P>
                <P>F. With respect to any transaction described in section I.F., the amount of plan assets involved in the transaction or series of related transactions did not, in the aggregate, exceed the lesser of $10,000 or five (5) percent of the fair market value of all the assets of the plan at the time of the transaction.</P>
                <HD SOURCE="HD2">Section III. Compliance With the VFC Program</HD>
                <P>
                    A. The applicant or self-corrector, as applicable, has met all applicable requirements of the VFC Program.
                    <PRTPAGE P="3672"/>
                </P>
                <P>B. EBSA has issued a no-action letter to the applicant pursuant to the VFC Program with respect to a transaction described in section I, other than for transactions corrected pursuant to the SCC of the VFC Program. For transactions corrected pursuant to the SCC of the VFC Program, the terms of this section will be satisfied if EBSA has acknowledged receipt of the SCC notice in accordance with section 6.2 of the VFC Program.</P>
                <HD SOURCE="HD2">Section IV. Notice to Interested Persons and Special Rules for Self-Correctors</HD>
                <P>A. Written notice of the transaction(s) for which the applicant is seeking relief pursuant to the VFC Program, and this exemption, and the method of correcting the transaction, was provided to interested persons within 60 calendar days following the date of the submission of an application under the VFC Program. A copy of the notice was provided to the appropriate Regional Office of the United States Department of Labor, Employee Benefits Security Administration, within the same 60-day period, and the applicant indicated the date upon which notice was distributed to interested persons. Plan assets were not used to pay for the notice. The notice included an objective description of the transaction and the steps taken to correct it, written in a manner reasonably calculated to be understood by the average Plan participant or beneficiary. The notice provided for a period of 30 calendar days, beginning on the date the notice was distributed, for interested persons to provide comments to the appropriate Regional Office, and it included the address and telephone number of such Regional Office. The Model Notice to Interested Persons contained in Appendix A may be used to satisfy the written notice requirement contained in this section IV.</P>
                <P>B. The notice to interested persons described in section IV.A. was provided in a manner that was reasonably calculated, taking into consideration the circumstances of the plan, to result in the receipt of such notice by interested persons, including but not limited to regular mail, or electronic mail, or any combination thereof. The notice informed interested persons of the applicant's participation in the VFC Program and intention of availing itself of relief under the exemption.</P>
                <P>C. Notwithstanding the foregoing and solely with respect to applicants seeking relief with respect to the VFC Program other than through the SCC, section IV.A. and IV.B. shall not apply to a transaction described in section I.A., provided that: (1) the applicant under the VFC Program has met all of the other applicable Program requirements; (2) the amount of the excise tax that otherwise would be imposed by Code section 4975 with respect to any transaction(s) described in section I.A would be less than or equal to $100; (3) the amount of the excise tax that otherwise would be imposed by Code section 4975 was paid to the plan and allocated to the individual accounts of participants and beneficiaries in the same manner as provided under the plan with respect to plan earnings; and (4) the applicant under the VFC Program provides a copy of a completed IRS Form 5330 or written documentation containing the information required by IRS Form 5330 and proof of payment with the submission of the application to the appropriate EBSA Regional Office. For the sole purpose of determining whether the excise tax due under Code section 4975 on the “amount involved” with respect to the prohibited transaction involving the failure to timely transmit participant contributions and loan repayments is less than or equal to $100, an applicant may calculate the excise tax due based upon the Lost Earnings amount computed using the online calculator provided under the Program.</P>
                <P>D. Notwithstanding the foregoing and solely with respect to self-correctors seeking relief with respect to transactions corrected pursuant to the SCC of the VFC Program, section IV.A. and B. shall not apply, and additionally the self-corrector must: (1) pay to the plan the amount of the excise tax that otherwise would be imposed by Code section 4975 and allocate such amount to the individual accounts of participants and beneficiaries in the same manner as provided under the plan with respect to plan earnings, and (2) retain a copy of a completed IRS Form 5330 or written documentation regarding the determination of the otherwise applicable excise tax and proof of payment of the amounts paid to the plan pursuant to the VFC Program and this exemption and (3) provide to the plan administrator a copy of such documentation. Self-correctors must calculate the excise tax otherwise due based upon the Lost Earnings amount computed using the online calculator provided under the Program.</P>
                <HD SOURCE="HD2">Section V. Definitions</HD>
                <P>A. For purposes of this exemption the term “affiliate” of a person means (1) any person directly, or indirectly through one or more intermediaries, controlling, controlled by, or under common control with the person; (2) any officer, director, partner, employee, member of the family (as defined in Code section 4975(e)(6)) of the person; or (3) any corporation or partnership of which such person is an officer, director, partner or employee.</P>
                <P>B. For purposes of this section V, the term “control” means the power to exercise a controlling influence over the management or policies of a person other than an individual.</P>
                <SIG>
                    <DATED>Signed at Washington, DC, this 3rd day of January 2025.</DATED>
                    <NAME>Lisa M. Gomez,</NAME>
                    <TITLE>Assistant Secretary, Employee Benefits Security Administration, U.S. Department of Labor.</TITLE>
                </SIG>
                <APPENDIX>
                    <HD SOURCE="HED">Appendix A—Model Notice to Interested Persons</HD>
                    <FP>Dear [Participant or Beneficiary],</FP>
                    <P>The purpose of this letter is to notify you that the [Insert Name of Applicant] is participating in the U.S. Department of Labor's Voluntary Fiduciary Correction (VFC) Program with respect to the [Insert Name of Plan]. The VFC Program is a voluntary enforcement program that encourages the correction of possible breaches of Title I of the Employee Retirement Income Security Act (ERISA).</P>
                    <P>ERISA is the federal law that covers most employee benefit plans in the private sector. The U.S. Department of Labor's Employee Benefits Security Administration (EBSA) enforces many parts of ERISA. If the terms and conditions of the VFC Program are met by [Insert Name of Applicant], EBSA will not initiate a civil investigation under Title I of ERISA with respect to the transaction and voluntary correction described below.</P>
                    <P>The VFC Program is accompanied by a “class exemption” from certain excise taxes imposed under the Internal Revenue Code on parties participating in “prohibited transactions” as defined in ERISA and the Code. The purpose of the prohibited transaction rules is to prevent dealings with persons or entities that may be in a position to exercise improper influence over employee benefit plan assets including [Name of the Plan]. If the terms of the class exemption are met, [Insert Name of Applicant] will qualify for relief from the excise taxes that would otherwise apply.</P>
                    <P>
                        One of the requirements for excise tax relief is for [Insert Name of Applicant] to provide you with this notice so you have an opportunity to provide comments to EBSA about the prohibited transaction and the steps taken to correct the prohibited transaction, both of which are described below. To the extent that you are interested in providing your written comments to EBSA, you may contact them [Insert the Name of the Appropriate EBSA Regional Office from the VFC Program Notice, Appendix C]. The written comments should be made to the attention of the “VFC Program Coordinator.” The address and telephone number for this office are [Insert from VFC Program Notice, Appendix C]. You have 30 calendar days, beginning on the date this notice was distributed, to provide written comments. Individuals submitting written 
                        <PRTPAGE P="3673"/>
                        comments on this matter are advised not to disclose sensitive personal data such as social security numbers.
                    </P>
                    <P>[Insert An Objective Description of the Transaction and the Steps Taken to Correct the Transaction]</P>
                    <P>Please feel free to contact me if you have any questions at [Insert Telephone Number of a Person Employed by the Applicant Who Is Knowledgeable About this Matter].</P>
                    <FP>Sincerely,</FP>
                    <FP>[Insert Name and Title of Person Employed by the Applicant]</FP>
                </APPENDIX>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00328 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-29-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Office of Surface Mining Reclamation and Enforcement</SUBAGY>
                <CFR>30 CFR Part 926</CFR>
                <DEPDOC>[SATS No. MT-042-FOR; Docket No. OSM-2023-0007; S1D1S SS08011000 SX064A000 231S180110; S2D2S SS08011000 SX064A000 23XS501520]</DEPDOC>
                <SUBJECT>Montana Regulatory Program</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Surface Mining Reclamation and Enforcement, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; approving, in part.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving, in part, and denying, in part, an amendment to the Montana regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA). Montana submitted this proposed amendment to OSMRE on its own initiative in response to a State law passed by the Montana Legislature (House Bill (HB) 576). The proposed amendment generally concerns proposed changes to the definition of material damage and changes to permit requirements related to hydrologic information.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The effective date is February 14, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jeffrey Fleischman, Field Office Director, Office of Surface Mining Reclamation and Enforcement, 100 East B Street, Casper, Wyoming 82602, Telephone: (307) 261-6550, Email: 
                        <E T="03">jfleischman@osmre.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Background on the Montana Program</FP>
                    <FP SOURCE="FP-2">II. Submission of the Amendment</FP>
                    <FP SOURCE="FP-2">III. OSMRE's Findings</FP>
                    <FP SOURCE="FP1-2">
                        A. 
                        <E T="03">Montana Code Annotated (MCA) 82-4-203(32)(a)</E>
                    </FP>
                    <FP SOURCE="FP1-2">
                        B. 
                        <E T="03">MCA 82-4-203(32)(b)</E>
                    </FP>
                    <FP SOURCE="FP1-2">
                        C. 
                        <E T="03">MCA 82-4-203(32)(c)</E>
                    </FP>
                    <FP SOURCE="FP1-2">
                        D. 
                        <E T="03">MCA 82-4-222(1)(m)</E>
                    </FP>
                    <FP SOURCE="FP1-2">
                        E. 
                        <E T="03">Sections 4, 5, 6, and 7 of House Bill 576</E>
                    </FP>
                    <FP SOURCE="FP-2">IV. Summary and Disposition of Comments</FP>
                    <FP SOURCE="FP-2">V. OSMRE's Decision</FP>
                    <FP SOURCE="FP-2">VI. Procedural Determinations</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background on the Montana Program</HD>
                <P>
                    Section 503(a) of SMCRA permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with SMCRA and consistent with the Federal implementing regulations. 
                    <E T="03">See</E>
                     30 U.S.C. 1253(a)(1) and (7); 30 CFR 730.5 and 732.15(a). On the basis of these criteria, the Secretary of the Interior conditionally approved the Montana program on April 1, 1980. You can find background information on the Montana program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Montana program in the April 1, 1980, 
                    <E T="04">Federal Register</E>
                     (45 FR 21560). You can also find later actions concerning the Montana program and program amendments at 30 CFR 926.15.
                </P>
                <HD SOURCE="HD1">II. Submission of the Amendment</HD>
                <P>
                    By letter dated June 1, 2023 (Administrative Record No. MT-042-01), Montana sent us an amendment to its program under SMCRA (30 U.S.C. 1201 
                    <E T="03">et seq.</E>
                    ). We found Montana's proposed amendment to be administratively complete on June 5, 2023. Montana submitted the proposed amendment to us, on its own volition, after the Montana legislature passed HB 576 during the 2023 legislative session. HB 576 amends the Montana Strip and Underground Mine Reclamation Act (MSUMRA) as well as sections 82-4-203 and 82-4-222 of the Montana Code Annotated (MCA). Among other things, HB 576 also directed the Montana Department of Environmental Quality (MDEQ) to amend the Administrative Rules of Montana (ARM) to “remove the two subsections defining `material damage' and the subsection defining `material damage to the quantity or quality of water'.”
                </P>
                <P>Specifically, Montana proposes several changes to MCA sec. 82-4-203(32), which defines and describes “material damage” for both underground and surface coal mining operations (referred to herein as “coal mining and reclamation operations”). As currently approved by OSMRE, this section dictates how “material damage” applies to the protection of the hydrologic balance. Montana now proposes to create three subsections under section 82-4-203(32) to define how “material damage” is defined with respect to: (a) protection of the hydrologic balance; (b) an alluvial valley floor; and (c) subsidence caused by an underground coal mining operation.</P>
                <P>Proposed section 82-4-203(32)(a) would create two requirements for an action or inaction to be considered “material damage” to the hydrologic balance. The first requirement is that the coal mining operation would cause significant, lasting, or permanent adverse changes to water quality or quantity that affect the beneficial uses of, or rights to, the water outside the permit area. This requirement incorporates the current language of section 82-4-203(32) but modifies it to replace the phrase “degradation or reduction” with “significant long term or permanent adverse change.” The second requirement for an action or inaction to be considered “material damage” to the hydrologic balance is that a coal mining or reclamation operation would cause a lasting or permanent exceedance of a water quality standard (WQS) outside a permit area. There is an exception to this second requirement for water bodies for which the WQSs are stricter than the baseline conditions as determined by MDEQ's assessment of the cumulative hydrologic impact findings conducted pursuant to section 82-4-222. For those water bodies, this second requirement is met if the coal mining and reclamation operation causes an adverse effect to land use, beneficial uses of water, or water rights.</P>
                <P>Proposed section 82-4-203(32)(b) would apply when determining if an alluvial valley floor is “materially damaged.” Montana proposes to modify the definition of “material damage” by adding language that accounts for the degradation or a reduction of water quality or quantity supplied to an alluvial valley floor by a coal mining and reclamation operation, but only if those actions or inactions significantly decrease the alluvial valley floor's ability to support agricultural activities.</P>
                <P>
                    Proposed section 82-4-203(32)(c) would apply when determining if subsidence caused by underground coal mining operation is “material damage.” Subsidence caused by underground coal mines would constitute “material damage” when there are (1) significant impairments to surface lands, features, and structures; (2) physical changes that have significant adverse effects on a lands current and reasonably foreseeable uses, production, or income; or (3) when there is any significant change to a structure's pre-subsidence condition, appearance, or utility.
                    <PRTPAGE P="3674"/>
                </P>
                <P>Next, Montana proposes to amend its coal mine operation permit requirements related to hydrologic information by removing two sentences from section 82-4-222(1)(m). The first sentence Montana proposes to remove states that the applicant's determination of the probable hydrologic consequences of a coal mining and reclamation operation is not required until the necessary hydrologic information is made available from an appropriate Federal or State agency. The second sentence that Montana proposes to remove prohibits the MDEQ from approving a coal mining permit application until the necessary hydrologic information is incorporated into the application.</P>
                <P>Lastly, HB 576 adds four contingencies to the proposed amendments of sections 82-4-203(32) and 82-4-222(1)(m) that are not codified into the MCA but apply to the sections amended by the legislation. Section 4 of HB 576 states that if any or all parts of HB 576 is found invalid, any parts found valid will remain in effect. Section 5 of HB 576 states that if the Secretary of the Interior disapproves any provision of the HB 576, then that portion is void. Section 6 of HB 576 states that HB 576 is effective upon passage and approval. Last, Section 7 of HB 576 states that HB 576 applies retroactively to actions for judicial review or other actions challenging permits, amendments, license, arbitration, action, certificate, or inspection that are pending on or after the effective date.</P>
                <P>
                    We announced receipt of the proposed amendment in the August 7, 2023, 
                    <E T="04">Federal Register</E>
                     (88 FR 52084). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. After a request from several public interest groups, we announced a 60-day extension of the comment period until November 6, 2024, in the September 20, 2023, 
                    <E T="04">Federal Register</E>
                     (88 FR 64853). We also held a Public Hearing on November 1, 2023, in Billings, MT, where we received testimony from 23 individuals. (Administrative Record No. MT-042-23). We also received 232 written comments on the proposed rule. On March 28, 2024, OSMRE sent a letter to MDEQ detailing concerns that OSMRE had with the proposed amendment (Administrative Record No. MT-042-34). The letter offered two options for MDEQ: suspend the amendment to allow MDEQ to make necessary changes or proceed to the Final Rule stage with no changes. MDEQ responded on April 26, 2024, that, because the proposed amendments were the result of legislative action, MDEQ is unable to submit further modifications to address OSMRE's concerns. While OSMRE's letter only solicited a response from MDEQ, several individuals and organizations sent OSMRE responses to the letter as well. Due to the increased interest generated by OSMRE's March 28, 2024, letter to MDEQ, and, in the interest of fairness for public participation, OSMRE announced the re-opening of the public comment period for 15 days, ending August 14, 2024. (Administrative Record No. MT-042-39).
                </P>
                <HD SOURCE="HD1">III. OSMRE's Findings</HD>
                <P>OSMRE reviewed Montana's submittal according to the requirements of SMCRA and the Federal regulations at 30 CFR 730.5, 732.15, and 732.17. As described below, we are approving Montana's submittal in part and disapproving it in part. The severability clause in section 4 of HB 576 indicates that it was the legislature's intent for any parts of the law that are not disapproved by OSMRE to remain in effect. The legislature did not define “part,” but in analyzing this proposed amendment, OSMRE analyzed the smallest reasonable elements of the proposed amendment, usually a section, and treated those as individual parts for purposes of severability.</P>
                <P>For each part, OSMRE evaluated the cumulative effect of the changes to determine whether each part is in accordance with SMCRA and consistent with the Federal implementing regulations. The individual parts evaluated by OSMRE were MCA sections 82-4-203(32)(a), (b), and (c), and MCA 82-4-222(1)(m). We are approving only those parts of the amendment determined to be in accordance with SMCRA and consistent with the requirements of the Federal regulations, and we are disapproving those sections of the amendment that are not in accordance with SMCRA or are not consistent with the requirements of the Federal regulations.</P>
                <P>Specifically, we are: (1) approving Montana's decision to move the currently approved definition of material damage “with respect to protection of the hydrologic balance” to subsection (a) of 84-4-203(32) but disapproving any proposed changes to that definition; (2) approving the addition of the proposed definition of material damage “with respect to an alluvial valley floor” at section 84-4-203(32)(b); and (3) disapproving the proposed definition of material damage “with respect to subsidence caused by underground coal mining operation” at proposed section 84-4-203(23)(c). We are also disapproving the proposed changes to section 82-4-222(1)(m).</P>
                <HD SOURCE="HD2">A. Montana Code Annotated (MCA) 82-4-203(32)(a)</HD>
                <P>For section 82-4-203(32)(a), Montana proposes several changes to its definition of “material damage” as it relates to impacts to the hydrologic balance from surface and underground coal mining operations. Existing section 82-4-203(32) of the MCA defines “material damage” with respect to protection of the hydrologic balance as the “degradation or reduction by coal mining and reclamation operations of the quality or quantity of water outside of the permit area in a manner or to an extent that land uses or beneficial uses of water are adversely affected, water quality standards are violated, or water rights are impacted. Violation of a water quality standard, whether or not an existing water use is affected, is material damage.” This definition was previously determined by OSMRE to be in accordance with SMCRA and consistent with the Federal implementing regulations when OSMRE conditionally approved Montana's Permanent coal program. 45 FR 21560.</P>
                <P>Montana's proposed revision would define “material damage” with respect to protection of the hydrologic balance as: “(i) significant long-term or permanent adverse change by coal mining and reclamation operations to the quality or quantity of water outside of the permit area in a manner or to an extent that land uses or beneficial uses of water are adversely affected or water rights are impacts; and (ii) long-term or permanent exceedances of a water quality standard outside a permit area if caused by coal mining or reclamation operations, except that in water bodies for which the water quality standard is more stringent than baseline conditions as determined by the department's assessment of the cumulative hydrologic impact findings conducted pursuant to 82-4-222.” In addition, the definition would specify that “[f]or those water bodies, a significant, long-term adverse change to the baseline condition of water quality outside of a permit area is material damage if coal mining or reclamation operations cause adverse effects to and use, beneficial uses of water, or water rights.”</P>
                <P>
                    Under this proposed revision, for an event or condition to be considered “material damage to the hydrologic balance” there must be significant and adverse change to the quality and quantity of water outside the permit area caused by a coal mining and 
                    <PRTPAGE P="3675"/>
                    reclamation operation; the change must be long-term or permanent; and there must be a long-term or permanent exceedance of a WQS outside the permit area. The proposed revision would provide an exception for long-term or permanent exceedance of a WQS for water bodies where WQSs are more stringent than baseline conditions. Those areas instead must show long-term adverse change to the baseline condition of water where coal mining and reclamation operations cause adverse effects to land use, beneficial uses of water, or water rights.
                </P>
                <P>
                    The phrase “material damage to the hydrologic balance outside the permit area” appears in SMCRA and within the Federal regulations (30 CFR 816.41) and these references, and other elements of SMCRA and the Federal regulations, provide parameters for interpreting this phase. As a threshold matter, SMCRA's performance standards require that all surface coal mining and reclamation operations “minimize the disturbances to the prevailing hydrologic balance at the mine-site and in associated offsite areas and to the quality and quantity of water in surface and ground water systems both during and after surface coal mining operations and during reclamation.” 30 U.S.C. 1265(b)(10). This standard is accomplished by avoiding acid forming materials, preventing “to the extent possible using the best technology currently available” contributions of material to streams but under no circumstances allowing violations of any State or Federal water quality laws, and other practices designed to protect the existing hydrologic systems. 
                    <E T="03">Id.</E>
                     Similarly, SMCRA requires that underground coal mining operations “minimize the disturbances to the prevailing hydrologic balance at the minesite and in associated offsite areas and to the quantity of water in surface ground water systems both during and after surface coal mining operations and during reclamation.” 30 U.S.C. 1266(b)(9).
                </P>
                <P>Section 510(b)(3) of SMCRA also states that no application for surface coal mining operations, defined at 30 U.S.C. 1291(28) as including activities related to surface coal mining and reclamation operations and surface effects from underground coal mining and reclamation operations, can be approved unless the application affirmatively demonstrates, and the regulatory authority finds in writing based on the application and available information, that “the assessment of the probable cumulative impact of all anticipated mining in the area on the hydrologic balance specified in Section 507(b) has been made by the regulatory authority and the proposed operation thereof has been designed to prevent material damage to the hydrologic balance outside the permit area.” 30 U.S.C. 1260(b)(3). Section 507(b)(11) requires that an applicant submit “a determination of the probable hydrologic consequences of the mining and reclamation operations, both on and off the mine site, with respect to the hydrologic regime, quantity and quality of water in surface and ground water systems including the dissolved and suspended solids under seasonal flow conditions and the collection of sufficient data for the mine site and surrounding areas so that an assessment can be made by the regulatory authority of the probable cumulative impacts of all anticipated mining in the area upon the hydrology of the area and particularly upon water availability.” 30 U.S.C. 1257(b)(11).</P>
                <P>
                    In addition to the statutory standards, the Federal regulations add additional contours to the meaning of “material damage to the hydrologic balance outside the permit area.” First, the regulations at 30 CFR 773.15(e) require the regulatory authority to perform an assessment to determine if “the proposed operation has been designed to prevent material damage to the hydrologic balance outside the permit area.” Second, the regulations at 30 CFR 780.21(g) and 784.14(f) require a finding that the Cumulative Hydrologic Impact Assessment (CHIA) is “sufficient to determine, for the purposes of permit approval, whether the proposed operation has been designed to prevent material damage to the hydrologic balance outside the permit area.” Third, the regulations at 30 CFR 780.21(h) and 784.14(g) require a permit applicant to provide a Hydrologic Reclamation Plan. These sections state, in relevant part, that the plan must “contain the steps to be taken during mining and reclamation through bond release to minimize disturbance to the hydrologic balance within the permit and adjacent areas; to prevent material damage outside the permit area; [and] to meet applicable Federal and State water quality laws and regulations.” 
                    <E T="03">Id.</E>
                     The fact that the Hydrologic Reclamation Plan must outline how an operation will (1) minimize disturbance to the hydrologic balance within the permit area and the adjacent areas, (2) prevent material damage outside the permit area, and (3) meet all applicable Federal and State water quality laws indicates that each element provides a distinct protective benefit and that merely satisfying one element is not sufficient.
                </P>
                <P>Fourth, the regulations at 30 CFR 816.41(a) and 817.41(a) require that all surface and underground mining and reclamation activities must be conducted “to minimize disturbance to the hydrologic balance within the permit and adjacent areas [and] . . . prevent material damage to the hydrologic balance outside the permit area,” and that the “regulatory authority may require additional preventative, remedial or monitoring measures to assure that material damage to the hydrologic balance outside the permit area is prevented.” Last, the regulations at 30 CFR 816.41(c) and (e), as well as section 817.41(c) and (e), authorize the regulatory authority to modify the monitoring requirements, including parameters and frequency, if the monitoring data demonstrate that the operation has “minimized disturbance to the hydrologic balance in the permit and adjacent area and prevented material damage to the hydrologic balance outside the permit area.”</P>
                <P>
                    While neither SMCRA nor the current Federal regulations define “material damage to the hydrologic balance outside a permit area,” for the Federal and Indian lands programs, OSMRE has defined the phrase, as recently as 2024 in various CHIAs as meaning “any quantifiable adverse impact from surface coal mining and reclamation operations on the quality or quantity of surface water or groundwater that would preclude any existing or reasonably foreseeable use of surface water or groundwater outside the permit area.” 
                    <E T="03">See</E>
                     Cumulative Hydrologic Impact Assessment for the Pacific Coast Coal Company John Henry No. 1 Mine, p. 2 (Jan. 2014); Cumulative Hydrologic Impact Assessment of the Navajo Mine and Pinabete Permit Areas, p. 14 (Mar. 2015); Cumulative Hydrologic Impact Assessment of the Peabody Western Coal Company Kayenta Mine Complex, App. A (Sept. 2016); Review and Analysis of Navajo Aquifer Material Damage Criteria for Peabody Western Coal Company's Kayenta Mine Complex, p. 14 (Aug. 2024). These documents recognize that surface coal mining operations will cause hydrologic impacts but indicate OSMRE's interpretation that disturbances to the hydrologic balance within the permit area should be minimized and material damage outside the permit area should be prevented. 
                    <E T="03">Id.</E>
                     The CHIAs also direct that material damage criteria for both groundwater and surface water quality should be related to existing standards that generally are based on the maintenance and protection of specified water uses such as public and domestic 
                    <PRTPAGE P="3676"/>
                    water supply, agriculture, industry, aquatic life, recreation, and other parameters of local significance to water use. OSMRE also provided a definition of material damage to the hydrologic balance in a 2016 rule (81 FR 93066); however, that rule was disapproved under the Congressional Review Act in 2017 and is no longer in effect.
                </P>
                <P>SMCRA and the Federal program, thus, require that: (1) the regulatory authority must make a written finding that the operation is designed to prevent material damage to the hydrologic balance outside the permit area before the permit can be issued; (2) a permit application must include a plan that shows the operation has been designed to prevent such damage; (3) the operation must be conducted in a manner to prevent such damage; (4) the water monitoring requirements can be modified if warranted to determine whether or not such damage is occurring; and (5) applicable Federal and State water quality laws and regulations must be followed.</P>
                <P>With this background in mind, we have evaluated the proposed amendment to the Montana program in relation to Federal statutory and regulatory requirements for preventing “material damage to the hydrologic balance outside the permit area” and determined that Montana's proposed changes to section 82-4-203(32)(a) are not in accordance with SMCRA and not consistent with the Federal regulations.</P>
                <P>First, Montana's proposed requirement that an impact must be a “significant long-term or permanent adverse change . . . to the quality of water outside of the permit area” to be considered material damage is not in accordance with the requirements of SMCRA and not consistent with the Federal regulations. The phrase “long-term or permanent” is not defined in the Montana code or regulations. Without a definition or guidance on what constitutes a “long-term or permanent” adverse change, it would be very difficult to establish a metric for what constitutes a long-term impact, and such a metric would likely exclude significant short-term impacts to the quality or quantity of water outside the permit area from ever being considered material damage to the hydrologic balance. As a result, this proposed change to the definition would appear to explicitly authorize minor, short-term adverse changes caused by coal mining and reclamation operations to the quality or quantity of water outside the permit area, which is contrary to SMCRA's requirement that all surface coal mining and reclamation operations must de designed to “minimize the disturbance to the prevailing hydrologic balance . . . both during and after” mining, without limit to duration. 30 U.S.C. 1265(b)(10). Thus, this proposed change renders the definition of material damage to the hydrologic balance less stringent than SMCRA and less effective than the Federal regulations.</P>
                <P>Second, the requirement that material damage to the hydrologic balance can only be found where there are also “long-term or permanent exceedances of a water quality standard outside a permit area” caused by coal mining or reclamation operation is not in accordance with SMCRA or consistent with the Federal regulations. A violation of a State or Federal WQS as a result of a surface coal mining and reclamation operation is not allowed under SMCRA and would constitute material damage to the hydrologic balance. However, material damage to the hydrologic balance could also occur without a long-term or permanent exceedance of a WQS outside the permit area. Requiring that an impact be a “significant long-term or permanent adverse change” and also a long-term or permanent exceedance of a WQS would significantly weaken the standard for material damage to the hydrologic balance. Therefore, this change would make Montana's program neither in accordance with SMCRA nor consistent with the Federal regulations.</P>
                <P>A regulatory authority will set and monitor WQSs to ensure that surface coal mining operations are preventing “material damage to the hydrologic balance.” These standards are underpinned by a combination of State and Federal water quality laws and regulations. General effluent limitations for coal mining are promulgated by the U.S. Environmental Protection Agency (EPA) as set forth in 40 CFR part 434, and the individualized standards for an operation are determined by the regulatory authority based on the information provided in a permit application. As required in 30 CFR 780.21(i) and (j), a surface coal mining operation permit application must include both a groundwater monitoring plan and surface water monitoring plan. These plans identify the water quality and quantity parameters to be monitored, how often they are to be sampled, and where they are to be sampled. The sampling data are then used to assess the suitability of the water for current and approved postmining land uses and to meet the objectives for protection of the hydrologic balance, as described in 30 CFR 780.21(h), which includes preventing “material damage to the hydrologic balance outside the permit area.”</P>
                <P>
                    In a 1983 rulemaking, commenters urged OSMRE to define “material damage to the hydrologic balance” or establish guidelines to evaluate whether material damage would occur from a proposed operation. In response, OSMRE stated that it agreed that a regulatory authority should establish guidelines, but, “because the gauges for measuring material damage may vary from area to area and from operation to operation, [OSMRE] has not established fixed criteria, 
                    <E T="03">except for those established under §§ 816.42 and 817.42 related to compliance with water-quality standards and effluent limitations.</E>
                    ” 48 FR 43973 (emphasis added). Thus, OSMRE intended the WQSs set by 30 CFR 816.42 and 817.42 to be used as criteria for determining “material damage to the hydrologic balance,” and an exceedance of those WQSs is inherently “material damage to the hydrologic balance.”
                </P>
                <P>
                    Because a violation of a WQS is an established criterion for determining if “material damage to the hydrologic balance” has occurred, any regulations proposed by Montana must be in accordance with and consistent with this Federal standard. In Montana's proposal, it moves its requirement that violations of WQSs are “material damage to the hydrologic balance” to the newly created section 82-4-203(32)(a)(ii). The structure of the proposed new section makes the rule less effective than the Federal regulations because, for something to constitute “material damage to the hydrologic balance,” it would need to be both (1) a significant, long-term or permanent, adverse change to water quality or quantity, 
                    <E T="03">and</E>
                     (2) a long-term of permanent exceedance of a WQS (emphasis added). While, as discussed above, a violation of a WQS is an established criteria to categorize an event as causing “material damage to the hydrologic balance” in the Federal regulations, it is incorrect to assume that “material damage to the hydrologic balance” will 
                    <E T="03">always</E>
                     include an exceedance of a WQS. The determinations of Probable Hydrologic Consequences (PHC) and CHIA both require information on water quantity as well as water quality. 30 CFR 780.21. The CHIA and PHC are used to determine if a proposed operation is designed to prevent “material damage to the hydrologic balance,” and the permittee is required to operate the mine in such a way that prevents “material damage to the hydrologic balance.” Under the Federal regulations, both water quality and quantity issues 
                    <PRTPAGE P="3677"/>
                    can be used to determine if material damage to the hydrologic balance has occurred. There is nothing in the Federal regulations that suggests a water quantity violation on its own would not be considered “material damage to the hydrologic balance” or that some additional “significant, long-term or permanent, adverse change to water quality or quantity” must also be present to find that material damage has occurred. Thus, Montana's assertion that there must always be a violation of a WQS for an event or condition to be considered “material damage to the hydrologic balance” is inconsistent with the Federal regulations.
                </P>
                <P>Finally, Montana's proposed changes would also add a requirement that an exceedance of a WQS must be “long-term or permanent” to be considered “material damage to the hydrologic balance.” As discussed above, any exceedance of a WQS caused by a surface coal mining and reclamation operation is a violation of SMCRA. Requiring that a water quality exceedance be “long-term or permanent” ignores the destructive capabilities of a single short-term disturbance event. For example, a large amount of a regulated pollutant could be accidently discharged into a river and cause a WQS exceedance. The pollutant could then quickly move downstream with the flow of water and adversely affect the water quality at the mine site and adjacent area; while of short duration, the event could negatively impact aquatic life, drinking water, or recreational uses. If this disturbance was instead an unintended groundwater capture leading to de-watering of local wells or increased sedimentation into a nearby creek causing channel diversions, the vagueness of the term “long-term” makes it unclear whether it would rise to the level of material damage to the hydrologic balance. Under no circumstances should a WQS violation caused by a mining or reclamation operation be “long-term,” and Montana's proposal to require that a water quality exceedance must be “long-term or permanent” to be considered material damage to the hydrologic balance would make the Montana program less effective than SMCRA and the Federal regulations. As an example, under this proposed amendment, an operator could repeatedly exceed WQSs outside of the permit area but attempt to avoid a determination that the impact was material damage to the hydrologic balance by MDEQ by starting and stopping pollution events before meeting the vague “long-term or permanent” threshold.</P>
                <P>For the reasons above, we are disapproving the proposed changes to subsection (a) of Montana's new definition to material damage with respect to protection of the hydrologic balance. We are, however, approving the non-substantive restructuring of this section so that the prior definition of material damage to the hydrologic balance is included in subsection (a). All other proposed changes to section 82-4-203 (32)(a) are denied. Approved subsection (a) now states: “with respect to protection of the hydrologic balance, degradation or reduction-by coal mining and reclamation operations of the quality or quantity of water outside of the permit area in a manner or to an extent that land uses or beneficial uses of water are adversely affected, water quality standards are violated, or water rights are impacted. Violation of a water quality standard, whether or not an existing water use is affected, is material damage.”</P>
                <HD SOURCE="HD2">B. MCA 82-4-203(32)(b)</HD>
                <P>We are approving the proposed changes to MCA section 82-4-203(32)(b) because we find that the changes to section 82-4-203(32)(b) are in accordance with SMCRA and consistent with the Federal regulations.</P>
                <P>Section 82-4-203(32)(b) proposed to define “material damage” with respect to alluvial valley floors as “degradation or reduction by coal mining and reclamation operations of the water quality or quantity supplied to the alluvial valley floor that significantly decreases the capability of the alluvial valley floor to support agricultural activities[.]”</P>
                <P>This proposed definition is nearly identical to the Federal definition of “materially damage the quantity or quality of water” in 30 CFR 701.5, which provides that, “with respect to alluvial valley floors, [material damage the quantity or quality of water is] to degrade or reduce by surface coal mining and reclamation operations the water quantity or quality supplied to the alluvial valley floor to the extent that resulting changes would significantly decrease the capability of the alluvial valley floor to support farming.” The biggest difference between the proposed State definition and the Federal regulation is that the Federal definition limits the definition to how the water supplied to the alluvial valley floor affects “farming,” while Montana's definition expands this to “agricultural activities.” Farming, with respect to alluvial valley floors, is defined in 30 CFR 701.5 and means “the primary use of those areas for the cultivation, cropping or harvesting of plants which benefit from irrigation, or natural subirrigation, that results from the increased moisture content in the alluvium of the valley floors. For purposes of this definition, harvesting does not include the grazing of livestock.” The term “Agricultural activities” is defined in 30 CFR 701.5 as, with respect to alluvial valley floors, “the use of any tract of land for production of animal or vegetable life based on regional agricultural practices, where the use is enhanced or facilitated by subirrigation or flood irrigation. These uses include, but are not limited to, farming and the pasturing or grazing of livestock. These uses do not include agricultural activities which have no relationship to the availability of water from subirrigation or flood irrigation practices.” Thus, under the Federal regulations, the term “agricultural activities” is broader than the term “farming” because it includes animal production in addition to cultivating crops.</P>
                <P>Montana's approved program does not include a definition of farming or agricultural activities, making it difficult to understand the exact scope of activities included in Montana's definition. However, despite the lack of definition, the similarity in the language and common understanding that agricultural activities would at a minimum include farming lead OSMRE to determine that Montana's definition of material damage with respect to alluvial valley floors at section 82-4-203(32)(b) is in accordance with SMCRA and consistent with the Federal regulations.</P>
                <HD SOURCE="HD2">C. MCA 82-4-203(32)(c)</HD>
                <P>
                    We are denying the proposed addition of MCA section 82-4-203(32)(c). This proposed change would add paragraph (c) to section 82-4-203(32) to provide a definition of “material damage” resulting from subsidence caused by an underground coal mining operation. As proposed, this definition would mean: “any functional impairment of surface lands, features, or structures; (ii) any physical change that has a significant adverse impact on the affected land's capability to support any current or reasonably foreseeable uses or causes significant loss in production or income; or (iii) any significant change in the condition, appearance, or utility of any structure or facility from its presubsidence condition.” Following our review, we find that proposed section 82-4-203(32)(c) is inconsistent with the Federal regulations and are not approving this proposed change.
                    <PRTPAGE P="3678"/>
                </P>
                <P>Montana's proposed definition of “material damage” caused by subsidence is nearly identical to the Federal definition of “material damage” as it relates to subsidence at 30 CFR 701.5. However, unlike the Federal regulations, Montana's definition does not include “facilities” in its list of features that can be considered functionally impaired by subsidence in proposed section 82-4-203(32)(c)(i). Montana has not provided clarification as to why “facilities” was omitted from this proposed paragraph. In deciding whether this proposed regulation can be approved, we must determine if grouping the term “facilities” within the term “structure” would make this paragraph as effective as the Federal regulations.</P>
                <P>Neither the Federal nor the Montana regulations formally define “facility” or “structure,” so we use the plain language definition of both terms, as well as how they are used throughout the Federal regulations to determine their meanings. “Structure” generally is used to refer to a standalone, human-made formation that performs an intended job, such as a diversion, sediment pond, refuse pile, or road. Defined terms in § 701.5 of the Federal regulations that use the term “structure” in their definitions but not the term “facility” include: “head-of-hollow fill,” “impoundments,” and “valley fill.” “Facility,” on the other hand, generally is used to describe a place, or collection of structures that performs a more complex task. Defined terms in § 701.5 of the Federal regulations that use the term “facility” in their definitions but not “structure” include: “public office” and “coal preparation plant.” The two terms have distinct and separate meanings, and the plain language definition of “structure” does not fully encapsulate the meaning of “facilities” as there are facilities that do not contain structures. Furthermore, Montana uses the phrase “structure or facility” in proposed section 82-4-203(32)(c)(iii). Listing both terms here, and using “or” to connect them, indicates that Montana understands the two terms have distinct and separate meanings. Thus, omitting “facilities” from the list of features that can be considered functionally impaired by subsidence in proposed section 82-4-203(32)(c)(i) would not be in accordance with SMCRA or consistent with the requirements of the Federal regulations.</P>
                <HD SOURCE="HD2">D. MCA 82-4-222(1)(m)</HD>
                <P>We are denying all proposed changes to MCA section 82-4-222(1)(m). HB 576, in part, modified MCA sec. 82-4-222(1)(m) to delete the following two sentences: “However, this determination is not required until hydrologic information on the general area prior to mining is made available from an appropriate Federal or State agency. The permit may not be approved until the information is available and is incorporated into the application.” Section 82-4-222 pertains to permit applications for the Montana program, and paragraph (1)(m) discusses the determination of the probable hydrologic consequences of coal mining and reclamation operations. By this change, Montana proposes to remove two requirements from section 82-4-222(1)(m). First, Montana proposes to remove the requirement that the permit applicant's determination of probable hydrologic consequences is not required until hydrologic information of the pre-mining area is made available from an appropriate Federal or State agency. Second, Montana proposes to remove the requirement that the relevant permit may not be approved until the hydrologic information is available and incorporated into the application.</P>
                <P>The Federal counterparts to this requirement are found in 30 U.S.C. 1257(b)(11) and 30 CFR 780.21(c)(1), (c)(2), (f)(1), and (f)(2). The statutory provisions at 30 U.S.C. 1257(b)(11) require that a determination of probable hydrologic consequences of a mining operation “shall not be determined until hydrologic information on the general area prior to mining is made available from an appropriate Federal or State agency . . . .” The regulations at 30 CFR 780.21(c)(1) state that hydrologic and geologic information are necessary to assess probable cumulative hydrologic impacts and that, if the necessary hydrologic and geologic information is available from an appropriate Federal or State agency, then that information must be provided to the regulatory authority in order for it to assess probable cumulative hydrologic impacts. The regulations at 30 CFR 780.21(c)(2) state that, if the necessary hydrologic and geologic information is not available from a Federal or State agency, the operator may submit hydrologic and geologic information that it has collected on its own. The regulations at 30 CFR 780.21(f)(1) state that an application must have a PHC determination, and paragraph (f)(2) continues by providing that the PHC must be determined using hydrologic and geologic information that is collected for the permit application.</P>
                <P>The removal of the two requirements from section 82-4-222(1)(m), as described above, would mean that the MDEQ's hydrological determination is not required until hydrologic information is available from an appropriate Federal or State agency and would also mean that the Montana program would no longer meet all of the requirements set forth in 30 U.S.C. 1257(b)(11) and would make the Montana program less effective than 30 CFR 780.21(f)(2). The regulations at 30 CFR 780.21(f)(2) require a determination of PHC to be made using the baseline hydrologic information that was collected for the permit application. By proposing to remove the provision that permit applicant's PHC determination is not required until hydrologic information of the pre-mining area is made available from an appropriate Federal or State agency, Montana's program would allow an applicant to make a PHC determination before all of the necessary hydrologic information is gathered, which could limit the quality of the PHC.</P>
                <P>The regulations at 30 CFR 780.21(c)(3) state that a permit must not be approved until the necessary hydrologic and geologic information is available to the regulatory authority. Because this Federal regulation requires hydrologic and geographic information to be provided to a regulatory authority before an application is approved, Montana's proposed removal of the same requirement in section 82-4-222(1)(m) would make it inconsistent with the Federal regulations. Thus, we are denying all of Montana's proposed changes to section 82-4-222(1)(m) of the MCA.</P>
                <HD SOURCE="HD2">E. Section 4, 5, 6, &amp; 7 of House Bill 576</HD>
                <P>During the 2023 legislative session, Montana passed HB 576, which modified sections 82-4-203(32) and 82-4-222(1)(m). HB 576 also added contingencies that are not codified into the MCA but that affect the amended parts of the MCA.</P>
                <HD SOURCE="HD3">1. Section 4. Severability</HD>
                <P>
                    Section 4 of HB 576 states that if any part of HB 576 is found invalid, the remainder of the bill that is found valid will be severable from the invalid part and remain in effect. While this is legislative language and not part of Montana's surface mining program, we note that the Federal regulations at 30 CFR 732.17(h)(7) require the Director to consider all relevant information, using the criteria set forth in 30 CFR 732.15, to approve or disapprove the amendment. The Director may approve all or parts of an amendment that are in accordance with SMCRA and consistent with the Federal regulations. Here, notwithstanding section 4 of HB 576, OSMRE has identified the sections that 
                    <PRTPAGE P="3679"/>
                    are approved and the sections that are disapproved.
                </P>
                <HD SOURCE="HD3">2. Section 5. Contingent Voidness</HD>
                <P>Section 5 of HB 576 states that, if the Secretary of the Interior disapproves of any provision of HB 576 under 30 CFR part 732, then that portion of the bill is void. Furthermore, MDEQ is required to notify the code commissioner of a disapproval within 15 days of the effective date of disapproval. Notwithstanding HB 576, the Federal regulations give the Director the authority to approve or disapprove all or part of a proposed amendment to a State program. 30 CFR 732.17(h)(7). Any program amendment or part of a program amendment disapproved by the Director would be void and would not become part of Montana's approved program.</P>
                <HD SOURCE="HD3">3. Section 5: Immediate Effectiveness</HD>
                <P>Section 6 of HB 576 states that its provisions are effective on passage and approval of the bill. This provision is contrary to SMCRA and the Federal regulations that state that no change to law or programs can take effect for purposes of a State program until the amendment is approved by the Director. 30 CFR 732.17(g).</P>
                <HD SOURCE="HD3">4. Section 7: Retroactive Applicability</HD>
                <P>
                    Section 7 of HB 576 states that amendments to the MCA apply retroactively to actions for judicial review, amendment, license, arbitration, action, certificate, or inspection that are pending but not yet decided on or after the effective date of HB 576. Section 7 of HB 576 attempts to make the proposed changes to sections 82-4-203(32) and 82-4-222(1)(m) apply retroactively to pending issues that have not been decided on or after the effective date of HB 576. As with the attempt to make the changes in HB 576 effective immediately, this section is contrary to SMCRA and the Federal regulations. Specifically, the Federal regulations at 30 CFR 732.17(g) mandate that no changes to laws will take effect until OSMRE approves the amendment, and section 723.17(i)(12) states that all decisions of the Secretary to approve or disapprove program amendments must be published in the 
                    <E T="04">Federal Register</E>
                    . The Administrative Procedure Act generally requires a 30-day delay before a rule becomes effective. 5 U.S.C. 553(d).
                </P>
                <HD SOURCE="HD1">IV. Summary and Disposition of Comments</HD>
                <P>We asked for initial public comments on the amendment during a public comment period that ended on November 6, 2023. We received 232 written comments during our initial comment period, and we received testimony from 23 individuals at a public hearing held in Billings, MT on November 1, 2023. (Administrative Record No. MT-042-23). As mentioned above, on March 28, 2024, OSMRE sent a letter to MDEQ. (Administrative Record No. MT-042-34). The letter detailed concerns that OSMRE had with the proposed amendment, all of which is described in Section III above. While the letter only solicited a response from MDEQ, OSMRE received several unsolicited responses for other parties. Due to the increased interest in the proposed amendment generated by that letter, and, in the interest of fairness for public participation, OSMRE announced the re-opening of the public comment period for 15 days on July 30, 2024. (Administrative Record No. MT-042-39).</P>
                <P>
                    Due to the large number of comments, substantially similar comments and points have been consolidated to avoid redundancy. Over 190 commenters were opposed to the approval of this amendment and raised similar concerns, discussed below. Comments expressing generalized support for or opposition to the proposed amendment, generalized concerns about environmental impacts from mining operations, concerns about the mining industry, fossil fuel use, and the need for the United States to transition to renewable energy, general statements about the public's opposition to HB 576 and prior legislative efforts, comments about SB 392 and the topic of litigation and attorney's fees (which will be discussed in a separate Final Rule Notice (MT-043-FOR)), and other non-responsive comments are beyond the scope of this amendment and no response is necessary. To view comments in full, visit 
                    <E T="03">https://www.regulations.gov/.</E>
                </P>
                <P>
                    <E T="03">Comment 1:</E>
                     There was consensus among the group of 190 commenters in opposition to the proposed amendment that the use of “significant long-term or permanent,” as applied to the definition of “material damage to the hydrologic balance,” was too ambiguous. They expressed concern that because these terms are not defined, MDEQ or a judge could interpret these terms too subjectively, and that the ambiguity of this language “all but guarantee[s] some degree of damage outside of a permit boundary.”
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE agrees with commenters' concerns that, without a definition or guidance on what constitutes a “long-term or permanent” adverse change, it would be very difficult to establish a metric for what constitutes a long-term impact and that this proposed change renders the definition of material damage to the hydrologic balance not in accordance with SMCRA and inconsistent with the Federal regulations. Please see Section III(A) to see OSMRE's full discussion about the proposed definition of “material damage to the hydrologic balance.”
                </P>
                <P>
                    <E T="03">Comment 2:</E>
                     Similarly, commenters opposed to this proposed amendment repeatedly considered Montana's proposed changes to baseline condition requirements to be inadequate because the proposed amendment removes the requirement that an operation submit baseline water information while also having a determination of “material damage to the hydrologic balance” rely on baseline water information.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE agrees that Montana's proposed edits to section 82-4-222(1)(m) would make Montana's program not in accordance with SMCRA and inconsistent with the Federal regulations. Please see Section III(D) for OSMRE's discussion on the proposed changes to baseline hydrologic information.
                </P>
                <P>
                    <E T="03">Comment 3:</E>
                     Several commenters stated that the immediate effective date and retroactive applicability of the bill are inconsistent with Federal regulations, citing 30 CFR 732.17(g), which requires that no State coal regulations go into effect until approved by OSMRE, and 30 U.S.C. 1202(i), which requires all appropriate procedures are followed for public participation in the revision of a State's program.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We agree with these commenters on the proposed immediate effective date and retroactive applicability provisions; please see OSMRE's full discussion in Section III(E).
                </P>
                <P>
                    <E T="03">Comment 4:</E>
                     Some commenters opined that the proposed change of definition for “material damage to the hydrologic balance” is inadequate and pointed to 
                    <E T="03">Ohio River Valley Envtl. Coalition, Inc.</E>
                     v. 
                    <E T="03">Norton,</E>
                     2005 WL 2428159 (S.D.W. Va. Sept. 30, 2005), a case where a court found similar language in a West Virginia Amendment to be less effective than the Federal regulations. They noted that the court found that West Virginia's amendment to its definition of “material damage” failed because it did not provide a reasoned analysis to explain how a subjective standard with vague terms (“long-term or permanent change”) can ensure that the State program amendment was not less effective than the Federal regulations. Commenters stated that HB 576 fails on the same 
                    <PRTPAGE P="3680"/>
                    grounds, as the proposed definition of “material damage to the hydrologic balance” and its use of the terms “long-term or permanent” does not give MDEQ clear standards when applying the definition. They stated that, as written, the Montana amendment would allow an operator to violate WQSs so long as they are not “long-term or permanent” violations.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE has disapproved this portion of Montana's proposed amendment. Please see OSMRE's discussion of the definition of “material damage to the hydrologic balance” and its effects on WQSs in Section III(A). Additionally, OSMRE notes that the West Virginia definition of “material damage to the hydrologic balance” that was discussed in 
                    <E T="03">Ohio River Valley Envtl. Coalition, Inc.</E>
                     v. 
                    <E T="03">Norton,</E>
                     2005 WL 2428159 (S.D.W. Va. Sept. 30, 2005), was later approved by OSMRE in 2008, 73 FR 78979, and OSMRE's approval of the definition was upheld by the Fourth Circuit in 
                    <E T="03">Ohio River Valley Envtl. Coalition, Inc.</E>
                     v. 
                    <E T="03">Salazar,</E>
                     466 Fed. Appx. 161, 167 (4th Cir. 2012). While OSMRE approved West Virginia's definition of “material damage of the hydrologic balance,” the definition was applied only in the context of a CHIA and, thus, is different from Montana's proposed definition in this amendment.
                </P>
                <P>
                    <E T="03">Comment 5:</E>
                     Commenters stated that, as proposed, the Montana amendment conflicts with 30 U.S.C. 1292(a)(4), a provision of SMCRA that prevents the law from altering the Clean Water Act (CWA). The preamble to the Federal rulemaking stated that there are no fixed criteria for “material damage” except for compliance with WQSs, and, as proposed, Montana would allow long term or permanent violations of water quality; thus, the commenters concluded that Montana would be violating the protections of the CWA.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE disagrees with the comment that the proposed change to “material damage to the hydrologic balance” would violate the CWA. As discussed in more detail below, the EPA submitted a comment on this amendment stating that the proposed amendment would not impact or alter MDEQ's obligations under the CWA. (Administrative Record No. MT-042-07). OSMRE does agree that requiring a “long-term or permanent” violation of WQSs in order to trigger “material damage to the hydrologic balance” would not be in accordance with SMCRA and would not be consistent with the Federal regulations, and we have denied this portion of Montana's proposal. Please see Section III(A) for our full discussion on this topic.
                </P>
                <P>
                    <E T="03">Comment 6:</E>
                     Commenters contended that the proposed changes to section 82-4-222(1)(m) conflict with SMCRA and that the proposed deletions violate 30 CFR 780.21(c)(1), (f), and (g)(1), and 30 U.S.C. 1257(b)(11).
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We agree that Montana's proposed changes to section 82-4-222(1)(m) are inconsistent with the Federal regulations and have denied the portion of Montana's proposal. Please see our full discussion in Section III(D).
                </P>
                <P>
                    <E T="03">Public Comment 7:</E>
                     A commenter stated that HB 576 will further deepen ongoing issues around water quality and quantity for cattle and subsidence cracks.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE determined that the proposed definition for “material damage to the hydrologic balance” was neither in accordance with SMCRA nor consistent with the Federal regulations and denied substantive changes to the amendment. Please see Section III(A) and III(C) for OSMRE's discussion on Montana's proposed changes.
                </P>
                <P>
                    <E T="03">Public Comment 8:</E>
                     Commenters agreed with OSMRE's preliminary findings in its OSMRE's March 28, 2024, letter to MDEQ that the use of “significant” and “permanent or long-term” in the proposed definition of “material damage to the hydrologic balance” is less stringent and effective than SMCRA and the Federal regulations. They disagreed with industry comments to the effect that Montana's definition of “material damage to the hydrologic balance” cannot “run afoul” of Federal law because there is no Federal definition of the term. The commenters stated that this argument has been rejected by Federal courts, citing 
                    <E T="03">Ohio River Valley Envt'l Coal., Inc.</E>
                     v. 
                    <E T="03">Kempthorne,</E>
                     473 F.3d 94, 103 (4th Cir. 2006).
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     Consistent with our preliminary findings in our March 28, 2024, letter to MDEQ, we have denied the proposed changes to the definition of “material damage to the hydrologic balance.” For further information, please see OSMRE's discussion of the use of “significant” and “long-term or permanent” within this definition in Section III(A), as well as our response to industry commenters below.
                </P>
                <P>
                    <E T="03">Public Comment 9:</E>
                     Commenters expressed concern that a requirement that harm to the hydrologic balance must be “permanent or long-term” to rise to the level of “material damage” and asserted that such an interpretation would contradict SMCRA requirements at 30 U.S.C. 1202(b), 1259, and 1307(b). Commenters raised concerns that HB 576 would allow short- or medium-term impacts of high magnitude to water quality and quantity, contrary to comments submitted by industry.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We are denying Montana's proposed definition of material damage with respect to protection of the hydrologic balance because it not in accordance with SMCRA and is inconsistent with the Federal regulations. Please see Section III(A) for the discussion of our decision.
                </P>
                <P>
                    <E T="03">Public Comment 10:</E>
                     Commenters expressed concern that HB 576 is inconsistent with the Montana Water Quality Act and the CWA because the proposal would allow pollution events that violate WQSs in short- and medium-term timeframes. Thus, commenters argue that HB 576 also violates SMCRA by superseding provisions of the CWA.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We note that the EPA found that the proposed changes would not violate the CWA because the statute could not supersede the EPA's regulations regarding WQSs. Nevertheless, for the reasons set forth in Section III(A) above, we are denying the portion of Montana's proposal that would change the current definition of material damage to the hydrologic balance because it is not in accordance with SMCRA and not consistent with the Federal regulations. Further discussion of EPA's comment can be found below.
                </P>
                <P>
                    <E T="03">Public Comment 11:</E>
                     Commenters stated that Montana's proposed definition is distinguishable from the Wyoming and West Virginia definitions. They allege that OSMRE's decision for Wyoming shows the agency's long-standing position that “material damage” cannot be “time limited” and that, unlike West Virginia, Montana's proposed definition of “material damage” is a performance standard as well as a reclamation standard and would have much broader applicability than the West Virginia definition.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     Please see OSMRE's response to Industry Comment 2 below.
                </P>
                <P>
                    <E T="03">Public Comment 12:</E>
                     Commenters agreed with OSMRE's preliminary findings in our March 28, 2024, letter to MDEQ, that Montana's proposed requirement that water quality violations be “long-term or permanent” to be considered “material damage to the hydrologic balance” is inconsistent with SMCRA and the Federal regulations. The commenters noted that the proposed change to the definition of “material damage to the hydrologic balance” was not necessary to enable 
                    <PRTPAGE P="3681"/>
                    strip-mining adjacent to water bodies that had failed water quality standards prior to the permittee's mining, as long as the mine does not cause additional harms to water quality. The Montana Supreme Court in 
                    <E T="03">Montana Env't Info. Ctr.</E>
                     v. 
                    <E T="03">Westmoreland Rosebud Mining, LLC,</E>
                     2023 MT 224, 68-70, 414 Mont. 80. 545 P.3d 623, held that under Montana's current definition of “material damage,” an existing impairment to a water body does not prevent additional mining unless the mining threatens to cause additional harm to water quality.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE is disapproving Montana's proposed definition of “material damage” with respect to protection of the hydrologic balance. Because other non-segregable elements of this definition rendered the proposed definition not in accordance with SMCRA and not consistent with the Federal regulations, we did not reach a determination of appropriateness about this provision. Please see OSMRE's discussion of the topic in Section III(A), as well as our response to Industry Comment 10.
                </P>
                <P>
                    <E T="03">Public Comment 13:</E>
                     Commenters concurred with OSMRE's preliminary finding in the March 28, 2024, letter that we sent to MDEQ that stated that the omission of “facilities” from the proposed definition of “material damage” in relation to subsidence is less stringent than SMCRA and less effective than the Federal regulations. Commenters noted that even if the omission of “facilities” was a mistake, the definition should not be approved because the provision, as written, is less protective than the Federal standards and courts and regulators are supposed to apply statutes as written, without adding or subtracting language.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE agrees. Please see OSMRE's discussion of “material damage” regarding subsidence in Section III(C).
                </P>
                <P>
                    <E T="03">Public Comment 14:</E>
                     Commenters supported OSMRE's preliminary finding in the March 28, 2024, letter that we sent to MDEQ that stated that Montana's proposed deletion of the requirement to obtain and submit baseline information from State and Federal agencies, and the prohibition on permit issuance until such information is available, is inconsistent with and less stringent than SMCRA. The commenters stated that industry comments indicating that the amendment would not allow permit issuance without the necessary information baseline information is without support.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     Please see OSMRE's discussion of Montana's proposed changes to baseline hydrologic information in Section III(D), as well as our response to industry comments, below.
                </P>
                <P>
                    <E T="03">Public Comment 15:</E>
                     Commenters expressed support for OSMRE's preliminary finding in the March 28, 2024, letter that we sent to MDEQ that stated that State program amendments cannot be made immediately effective by an act of a State legislature because it is inconsistent with SMCRA. Commenters noted that section 505(a) of SMCRA is not a declaration of State law supremacy but is instead a clarification that State law may not be superseded by SMCRA, except when it is inconsistent with SMCRA or its regulations. Commenters added that 
                    <E T="03">W. Virginia Highlands Conservancy</E>
                     v. 
                    <E T="03">Norton,</E>
                     137 F. Supp.2d 687, 697 (S.D.W. Va. 2001), supports their position that SMCRA does not violate the Tenth Amendment of the constitution and Federal law is not supplanted when a State gains primacy over its own coal program. Commenters argued that OSMRE possesses the statutory authority to determine whether sections 6 and 7 of HB 576 are inconsistent with the Federal regulations.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     Please see OSMRE's discussion of the topic in Section III(E), as well as our response to Industry Comment 13, below.
                </P>
                <P>
                    <E T="03">Public Comment 16:</E>
                     Commenters stated that the fact that there is not a Federal definition of “material damage to the hydrologic balance” does not give states the ability to establish definitions of “material damage to the hydrologic balance” that conflict with other provisions of SMCRA or the Federal regulations. Citing 30 CFR 730.5, commenters stated that if a term is found to be less stringent or less effective than SMCRA or the Federal implementing regulations, then it may not be approved.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE agrees that any definition of “material damage to the hydrologic balance” must be in accordance with all provisions of SMCRA and consistent with all provision of the Federal regulations as those terms are defined in 30 CFR 730.5. The absence of a Federal definition of a term does not allow a State program to create definition that is in conflict with any provision in SMCRA or the Federal implementing regulations.
                </P>
                <P>
                    <E T="03">Public Comment 17:</E>
                     Commenters stated that every part of HB 576 is inconsistent with SMCRA, except Section 4, Severability, and Section 5, Contingent Voidness, and that, because all substantive portions of the bill should be disapproved by OSMRE, the entire amendment should be disapproved.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE, when processing program amendments, has the discretion to approve, disapprove, or approve portions of an amendment while disapproving other portions of an amendment. Here, OSMRE reviewed each proposed provision to determine if it was in accordance with SMCRA and consistent with the Federal regulations. After this analysis, OSMRE is disapproving the proposed changes to MCA 82-4-203(32)(a) and (c) and MCA 82-4-222(32)(1)(m) but approving the proposed definition at 82-4-203(32)(b) and approving the renumbering of the existing definition of material damage “with respect to protection of the hydrologic balance” from section 82-4-203(32) to section 82-4-203(32)(a).
                </P>
                <P>
                    <E T="03">Public Comment 18:</E>
                     Commenters stated that the proposed revisions to the requirements for hydrologic information for permit applications would allow mining to begin before necessary data collection and risk analyses are finished. They state that the requirements for hydrologic information are supposed to prevent unforeseen circumstances and dire effects to water quality and quantity, as most mining is detrimental to water pre-existing on the land before the mine is permitted. They stated that they were opposed to any changes that would allow for permit approval before hydrologic information is assessed.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We are denying the proposed changes to MCA 82-4-222(1)(m). Please see our full discussion in Section III(D).
                </P>
                <P>
                    <E T="03">Industry Comment 1:</E>
                     Industry commenters stated that the proposed definition of “material damage to the hydrologic balance” is more consistent with the plain meaning of “material damage” than the current definition. They alleged that removing the requirement that any water quality exceedance is per se “material damage” prevents a company from being accused of having caused “material damage” simply because they remain consistent with pre-existing exceedances of WQSs that are caused by factors other than coal mining. Commenters maintained that Montana's addition of “significant” to its definition of “material damage to the hydrologic balance” is consistent with SMCRA and the Federal regulations. Commenters pointed to the Federal definitions of “material damage” with respect to subsidence and alluvial valley floors, both of which use “significant” in their definitions.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE does not agree that the proposed definition of “material damage to the hydrologic balance” or that the addition of “significant” to the definition is in 
                    <PRTPAGE P="3682"/>
                    accordance with SMCRA or consistent with the Federal regulations, and we have disapproved the proposed change to that definition. For a complete discussion of OSMRE's analysis of the proposed definition, please look to Section III(A).
                </P>
                <P>
                    <E T="03">Industry Comment 2:</E>
                     Commenters noted that Montana's proposed definition of “material damage to the hydrologic balance” is very similar to the definitions used in Wyoming (WCWR 020-0006-1 (cf)) and West Virginia (W.Va. CSR 38-2-3(3.22.e)). Both definitions require that “material damage to the hydrologic balance” must be “significant” and “long-term.” Commenters stated that, like West Virginia, Montana's definition of “Material damage to the hydrologic balance,” is limited to CHIAs and the assessment of Probable Cumulative Impact (PCI). For Wyoming, commenters alleged that OSMRE erred in relying on an “informal clarification” provided by the Wyoming State program to approve the Wyoming definition. They claim that this extra-statutory evidence overrules the plain text of the State law, and that the plain language of Wyoming's definition encompassed both short and long-term events just as the plain language of Montana's proposed amendment would cover both short-term and long-term events.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We acknowledge that Montana's proposed definition of “material damage the hydrologic balance” is superficially similar to that of Wyoming and West Virginia, but upon closer examination, Montana's proposed use of “long-term or permanent” in its definition of “material damage of the hydrologic balance” is distinguishable. Wyoming, for instance, defines “material damage to the hydrologic balance” as “a significant long-term or permanent adverse change to the hydrologic regime.” WCWR 020-0006-1 (cf). Our approval of the Wyoming definition, however, was informed by Wyoming's clarification that this definition was not time-restricted and that “its regulations and statutes require, by common usage and definition, prevention of long- and short-term adverse changes and uses.” 45 FR 20940 (Mar. 31, 1980). Montana, to the contrary, has provided no similar clarity for its definition, so we interpreted the proposed change based on the plain meaning of the language provided to mean that it has a time-based restriction.
                </P>
                <P>
                    Similarly, West Virginia defines “material damage to the hydrologic balance” within its regulations on CHIAs to mean “any long term or permanent change in the hydrologic balance caused by surface mining operation(s), which has a significant adverse impact on the capability of the affected water resource(s) to support existing conditions and uses.” W.Va. CSR 38-2-3(3.22.e); 
                    <E T="03">see also</E>
                     73 FR 78970, 78974 (Dec. 24, 2008). This definition of “material damage to the hydrologic balance” is limited to CHIAs and does not apply more broadly to the West Virginia program, such as determining whether a violation of the material damage to the hydrologic balance standard exists. This is an important distinction because CHIAs are cumulative assessments performed 
                    <E T="03">before</E>
                     issuing any coal mining permit, and thus it is reasonable that they would look to “long term or permanent” effects on the hydrologic balance. West Virginia's definition of “material damage to the hydrologic balance,” however, does not apply in other places within the regulations. Conversely, contrary to the assertions of this commenter, the way this proposal is drafted, the requirement that impacts must be “long-term or permanent” would be applied for all iterations of “material damage to the hydrologic balance.” Therefore, as discussed above, this would make Montana's regulations inconsistent with the Federal regulations.
                </P>
                <P>
                    <E T="03">Industry Comment 3:</E>
                     Commenters stated that the removal of language from section 82-4-222(1)(m) removes an implication that the issuance of a permit under MSUMRA requires input from some agency other than the MDEQ and, they opined that, as proposed, this section closely tracks the Federal regulations at 30 CFR 780.21(f). They also added that nothing in the proposed language compels MDEQ to issue permits absent the required information.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     Please see Section III(D) to see OSMRE's findings about baseline hydrologic information. OSMRE disagrees with this commenter's statement that Montana's proposed changes to section 82-4-222(1)(m) remove an implication that the appropriate hydrologic information must be provided by an agency other than MDEQ. No such implication exists. Montana's current language requires that hydrologic information be “made available from an appropriate federal or state agency.” MDEQ is an appropriate State agency.
                </P>
                <P>
                    <E T="03">Industry Comment 4:</E>
                     Commenters stated that, because there is no Federal definition of “material damage to the hydrologic balance,” Montana has broad discretion to define the term. A member of the Montana Legislature made a similar comment.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We acknowledge that there is no Federal definition for this term, but any definition proposed by Montana must be in accordance with SMCRA and consistent with the Federal regulations. We have determined that Montana's proposed definition does not meet that standard, even though there is no definition of that term in the Federal regulations. Please see Section III(A) for a more thorough discussion of our analysis on this topic.
                </P>
                <P>
                    <E T="03">Industry Comment 5:</E>
                     Commenters stated that the proposed amendment clarifies the distinction between SMCRA's protection of the hydrologic balance and the CWA's application to point source pollution. They note that, on one hand, the NPDES program is a regulatory scheme that regulates the discharge of surface and stormwater that interacts with areas of mining activity and protects acute water quality issues, whether temporary or permanent, within the permit area. According to the commenters, SMCRA, on the other hand, protects the hydrologic balance of the area, which is an assessment of cumulative impacts from coal mining and its impact outside the permit area. Commenters state that by removing the current language in section 82-4-203(32), which provides that a WQS violation is considered material damage to the hydrologic balance, the proposed Montana regulations will better distinguish the separate roles of SMCRA and the CWA.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We are disapproving the proposed section of amendment. Please see Section III(A) for our discussion on the relationship between EPA WQSs and the definition of “material damage of the hydrologic balance.”
                </P>
                <P>
                    <E T="03">Industry Comment 6:</E>
                     Commenters opined that OSMRE should not dictate how a State implements SMCRA in its own program. They stated that OSMRE's role is to determine if a State's regulations are in accordance with and consistent with the provisions of SMCRA and that a State is consistent with SMCRA when it is no less stringent than, meets the requirements of, and include all applicable provisions of SMCRA.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     This particular proposed amendment was submitted voluntarily by Montana. Under 30 CFR 732.17(b), a State with primacy over its coal regulatory program is required to submit any proposed amendments to its approved State program to OSMRE. OSMRE's role is then to determine, for regulatory program amendments, whether the proposed changes are in accordance with SMCRA and consistent with the Federal regulations as those 
                    <PRTPAGE P="3683"/>
                    terms are defined in 30 CFR 730.5. For more information on a State's and OSMRE's procedures and criteria for approving amendments, please refer to 30 CFR 732.17.
                </P>
                <P>
                    <E T="03">Industry Comment 7:</E>
                     After OSMRE sent a letter to MDEQ on March 28, 2024, an industry commenter noted that it disagreed with OSMRE's preliminary finding that Montana's proposed use of “long-term or permanent adverse impacts” did not meet the Federal standards. The commenter explained that, because there is no definition of the term in Federal regulations, Montana's definition cannot “run afoul” of Federal law and that OSMRE should not evaluate Montana's definition of “material damage to the hydrologic balance” until OSMRE either promulgates a definition of the term in the Federal regulations or Congress defines it. Further, the industry commenter alleged that OSMRE is using an improvised definition in its evaluation of Montana's proposed definition of “material damage to the hydrologic balance.”
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     As explained in Section III(A) and in response to Industry Comment 4, we do not agree with the contention that, because there is no current definition of “material damage to the hydrologic balance” in the Federal regulations, Montana's definition cannot “run afoul” Federal standards.
                </P>
                <P>
                    <E T="03">Industry Comment 8:</E>
                     The same industry commenter stated that the proposed amendment's use of the word “significant” is in line with the use of “significant” for the Federal definitions of material damage in the context of alluvial valley floors and subsidence.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     Please see the response to State Representative Comment 2.
                </P>
                <P>
                    <E T="03">Industry Comment 9:</E>
                     The same industry commenter did not agree with OSMRE's concern that a “short-term high pollution event” could evade enforcement because of Montana's proposed definition. The commenter stated that a “short-term high pollution event” would still meet Montana's proposed definition of “material damage to the hydrologic balance” because it would cause long-term or permanent damage and that such events would be subject to enforcement under Montana's coal regulations and other Montana laws.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We disagree with the contention that a short-term pollution event like the one mentioned in our May 28, 2024, letter to MDEQ would necessarily be considered “long-term or permanent” damage under the plain language of the proposed definition of “material damage to the hydrologic balance” or that the fact that the proposed definition omits a less-than-long term or permanent event should not matter because it would be covered under other Montana coal regulations and laws. Please see Section III(A) for our discussion as to why the proposed definition is not in accordance with SMCRA or consistent with the Federal regulations.
                </P>
                <P>
                    <E T="03">Industry Comment 10:</E>
                     Industry commenters disagreed with OSMRE's preliminary finding in its March 28, 2024, letter to MDEQ, that Montana's use of “long-term or permanent” is too vague. The commenters stated that Montana's definition provides more context than the Federal regulations, which are “silent” on the issue, and that Montana added the requirement of “long-term or permanent exceedance of water quality standards” to its definition of “material damage to the hydrologic balance” to account for situations where water exceeded water quality standards due to historic mining or environmental conditions not caused by the permittee.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     As stated above, the Federal regulations are not “silent” on the issue of “material damage to the hydrologic balance.” While there is no single, consolidated Federal definition of the term, the Federal regulations, and decades of experience, provide sufficient context into what the minimum standard for “material damage to the hydrologic balance” should be. For further discussion of this issue, please see Section III(A).
                </P>
                <P>
                    <E T="03">Industry Comment 11:</E>
                     Industry commenters stated that Montana's omission of the term “facilities” from its definition of “material damage” with respect to subsidence seems to be a mistake and that there is no basis to deny the entire section due to the omission of a single word. They suggested that the severability clause was a reason not to deny the entire section for the omission of this one word.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     Please see our discussion of the omission of the word “facilities” in the proposed definition of “material damage” with respect to subsidence in Section III(C). We cannot verify that the omission of this term was a mistake as Montana had not provided any clarification about the omission, and we disagree that the omission of a single word cannot be a basis to deny an entire section. As discussed in Section III(C), the omission of “facilities” from the definition makes the entire definition inconsistent with the Federal regulations, which means that this section cannot be approved, in whole or in part, because of the missing critical term.
                </P>
                <P>
                    <E T="03">Industry Comment 12:</E>
                     Commenters stated that Montana's proposed changes to the hydrologic information section was intended to clarify who can submit the hydrologic information for the permit application. A commenter clarified their understanding that, unlike the Federal regulations at 30 CFR 780.21(c)(2), Montana's current regulations do not allow the permittee to submit the hydrologic information themselves; thus, Montana's proposal deletes the hydrologic information submittal language to align itself with the Federal regulations. The commenter explained that the changes cannot be reasonably construed to allow permit issuance without the gathering of hydrologic information; thus, OSMRE has no basis to disapprove of the proposed changes in this section.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We disagree with the commenter's assessment that the changes cannot be reasonably construed to allow permit issuances without gathering hydrologic information. As discussed in Section III(D), we found that the plain meaning of the provision after deletion did effectually allow permit issuance without hydrologic information being submitted to the regulatory authority. We agree that under Montana's current regulations a permittee is not able to submit hydrologic information collected by themselves to MDEQ, which is a standard more stringent than the Federal regulations at 30 CFR 780.21(c)(2).
                </P>
                <P>
                    <E T="03">Industry Comment 13:</E>
                     This commenter stated that the immediate effective date in House Bill 576 was a valid exercise of the State's sovereignty. The commenter stated that OSMRE's regulations at 30 CFR 732.17(g) are contrary to the principles of federalism and violate SMCRA. They also maintain that 30 U.S.C. 1255(a), which states that “no State law or regulation . . . shall be superseded by any provision of' SMCRA or its implementing regulations . . . except insofar as such State law or regulation is inconsistent with the provisions of this act[,]” supports their position. The commenter argues that under SMCRA, a State coal regulation may remain in place until it is found to be inconsistent with SMCRA. In support of this comment, the commenter cites to 
                    <E T="03">Bragg</E>
                     v. 
                    <E T="03">W.VA. Coal Ass'n,</E>
                     248 F.3d 275, 295 (4th Cir. 2001), and the Tenth Amendment to the U.S. Constitution.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     Please see Section III(E) for our discussion on this topic. We do not agree that OSMRE's regulations at 30 CFR 732.17(g) violate SMCRA or that 30 CFR 732.17(g) goes 
                    <PRTPAGE P="3684"/>
                    against the principles of federalism. The Supreme Court of the United States found that SMCRA does not violate the Tenth Amendment. 
                    <E T="03">Hodel</E>
                     v. 
                    <E T="03">Va. Surface Mining and Reclamation Ass'n,</E>
                     452 U.S. 264 (1981). And 30 U.S.C. 1255 does not allow proposed changes to an approved State program to go into effect before OSMRE reviews those changes to determine whether a State law or regulation is consistent with the provisions of SMCRA. That statute confirms that “[n]o State law or regulation . . . which 
                    <E T="03">may</E>
                     become effective thereafter, shall be superseded by any provision of this Act or any regulation issued pursuant thereto, 
                    <E T="03">except insofar as such State law or regulation is inconsistent with the provisions of this act.</E>
                    ” 30 U.S.C. 1255(a) (emphasis added). The use of “may” in combination with the exception that changes to a State program must meet SMCRA and Federal regulation requirements demonstrates that SMCRA requires amendments to be approved before being effective.
                </P>
                <P>
                    <E T="03">State Representative Comment 1:</E>
                     A member of the Montana State Legislature commented that that the proposed exception to the “long-term or permanent exceedance of a water quality standard outside a permit area” was intended to protect downstream users, as it would require an applicant to demonstrate that there would be no change to the water quality classification for groundwater or beneficial use.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We appreciate being informed of at least one member of the legislature's intent for the change to material damage as it relates to the hydrologic balance; however, we must first review the plain language of the proposed amendment and, as described in Section III(A) above, the language of this portion of the proposed amendment is not in accordance with SMCRA or consistent with the Federal regulations. As such, we have denied the portion of the proposed amendment that would have included this phrase.
                </P>
                <P>
                    <E T="03">State Representative Comment 2:</E>
                     The commenter indicated that the definitions for “material damage with respect to the alluvial valley floor” and “material damage with respect to subsidence” mirror the Federal definitions at 30 CFR 701.5.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We agree with the comment that the proposed changes to “material damage” in the context of alluvial valley floors substantively mirrors the Federal definition at 30 CFR 701.5; thus, we have approved that portion of the proposed amendment. Please see Section III(B) for OSMRE's discussion on the topic. We disagree with the commenter that the proposed changes to “material damage” in the context of subsidence mirror the Federal definition at § 701.5 because it does not include the “facilities.” Therefore, we have disapproved that definition. Please see Section III(C) for OSMRE's discussion on this topic.
                </P>
                <P>
                    <E T="03">State Representative Comment 3:</E>
                     Similar to Industry Comment 3, the commenter explains that the current language from section 82-4-222(1)(m) that Montana proposes to remove had incorrectly implied that MDEQ must rely on baseline hydrologic information from another State or Federal agency. The commenter notes that, in practice, MDEQ is solely responsible for gathering such information and including it in its analysis. The commenter considered this change to be entirely clerical and not altering MDEQ's current or future practice.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     The commenter is incorrect that MDEQ is the only agency responsible for gathering hydrologic information for a permit. Current, section 82-4-222(1)(m) requires that hydrologic information be “made available from an appropriate federal or state agency.” This language is substantively identical to the Federal requirements at 30 CFR 780.21(c). While we recognize that MDEQ is an appropriate State agency to gather baseline hydrologic information and may be the primary agency to do so, there is nothing in SMCRA or the Federal agency to suggest that MDEQ is the 
                    <E T="03">only</E>
                     appropriate State or Federal agency to do so.
                </P>
                <P>
                    <E T="03">State Representative Comment 4:</E>
                     The commenter quoted a portion of the EPA's comment (Administrative Record No. MT-042-07) stating that HB 576 does not appear to impact or alter MDEQ's obligations under the CWA to illustrate that the proposed changes to “material damage to the hydrologic balance” would still maintain water quality at the same level as pre-mining conditions.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE notes that the commenter misinterprets the EPA's comment. As explained below in the discussion of EPA's comments, while the EPA did find that the proposed amendment would not impact or alter MDEQ's obligations under the CWA, the EPA also stated that “[the revisions] likely alter substantive compliance requirements for surface and underground mines in the context of mine permitting in a way that could result in negative impacts on water quality.” (Administrative Record No. MT-042-07). The EPA's comments only offer confirmation that MDEQ's CWA obligations would still be required to be met under the proposed revisions, but that is not dispositive when determining whether the proposed revisions are in accordance with SMCRA and consistent with the Federal SMCRA implementing regulations.
                </P>
                <P>
                    <E T="03">State Representative Comment 5:</E>
                     The commenter expressed concern that OSMRE held a public hearing on the proposed amendment. The commenter asserted that, in the spirit of SMCRA's cooperative federalism principles, OSMRE should have instead relied on the public record created during the legislative session to pass HB 576.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE disagrees with this comment. The Federal regulations at 30 CFR 732.17(h)(5) specify that OSMRE may hold public hearings for State program amendments and states that comments provided at a public hearing will be considered in OSMRE's decision on a program amendment. Thus, OSMRE's actions were consistent with Federal law.
                </P>
                <P>
                    <E T="03">MDEQ Comments.</E>
                     On April 26, 2024, MDEQ sent us a response to our March 28, 2024, letter. (Administrative Record No. MT-042-35). MDEQ stated that because the proposed amendment was the result of legislative action, MDEQ is unable to submit any revision to address the concerns OSMRE identified and that MDEQ understood that OSMRE intends to proceed, as necessary, with the publication of its decision in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>MDEQ commented that it found OSMRE's proposed finding about Montana's proposed definition of “material damage to the hydrologic balance” to be inconsistent with OSMRE's application of the term in the Federal program. MDEQ specifically points to a 2016 CHIA for the Peabody Western Coal Company—Kayenta Mining Complex, and OSMRE's statement within the CHIA that “[t]he term `material damage to the hydrologic balance' may have various interpretations” and that “[t]he Permanent Program Regulations do not define `material damage' but do define `hydrologic balance' as `the relationship between the * * * water inflow to, water outflow from, and water storage in a hydrologic unit, such as a drainage basin, aquifer, soil zone, lake, or reservoir' (30 CFR 701.5).”</P>
                <P>
                    MDEQ states that OSMRE has not produced additional national guidance on CHIAs and the definition of “material damage to the hydrologic balance” since this draft document. They state that the definition of “material damage to the hydrologic balance” remains at the discretion of the regulatory authority, and OSMRE has 
                    <PRTPAGE P="3685"/>
                    created site specific criteria in their CHIAs.
                </P>
                <P>Finally, MDEQ states that “material damage to the hydrologic balance” remains undefined in SMCRA since the Congressional disapproval of the Stream Protection Rule in 2017. MDEQ states further that, because of that lack of a definition, OSMRE's rejection of a more stringent program amendment request from MDEQ is contrary to OSMRE's actual implementation of this issue.</P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     OSMRE disagrees with MDEQ's assertion that our findings on the proposed definition of “material damage to the hydrologic balance” are inconsistent with our use of the term in the Federal program. MDEQ is correct that OSMRE has not published a definition of the term in the Federal regulations and that OSMRE has stated that the term does not have fixed criteria since “material damage will vary from area to area and operation to operation,” (
                    <E T="03">see</E>
                     48 FR 43973, Sept. 26, 1983). The lack of a definition for “material damage to the hydrologic balance” in the Federal regulations, however, does not mean that 
                    <E T="03">any</E>
                     definition will be acceptable. SMCRA and the Federal regulations require that a State program must have rules and regulations that are in accordance with SMCRA and consistent with the Federal regulations. 30 CFR 730.5. This analysis requires a comprehensive comparison between the entire State and Federal programs. While the Federal regulations do not have an official definition for “material damage to the hydrologic balance,” that term is used multiple times throughout the Federal regulations. Where the term appears in the Federal regulations and how it affects operations are guidelines for our assessment of the Montana program's proposed definition. Please see Section III(A) to see our detailed assessment of this issue.
                </P>
                <P>
                    <E T="03">Montana Department of Justice (MDOJ).</E>
                     On May 10, 2024, MDOJ sent a letter to OSMRE in response to our March 28, 2024, letter to MDEQ. MDOJ offered their support for comments provided by MDEQ and industry in response to our March 28, 2024, letter. (Administrative No. MT-042-35 and MT-042-36.). Next, MDOJ urged OSMRE to reconsider its preliminary analysis and to promptly approve the MT-042-FOR. MDOJ pointed specifically to the discussion in comments submitted by industry that alleged that OSMRE's concerns with the Montana amendment ignore the text of governing Federal statutory and regulatory provisions and that OSMRE's decision deviates from prior OSMRE decisions. Finally, MDOJ commented that OSMRE must give effect to the bill's severability clause by approving the remaining sections with which OSMRE did not find any issues.
                </P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     For our discussion on the MDEQ letter and industry comments, please see our respective responses above. As for the severability clause, OSMRE structured its approval and disapproval of the provisions in the proposed amendment to accommodate the severability clause and allow individual sections that are found to be consistent with SMCRA and as effective as the Federal regulations to be effective despite the disapproval of other proposed sections.
                </P>
                <HD SOURCE="HD2">Federal Agency Comments</HD>
                <P>On June 6, 2023, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies that have an actual or potential interest in the Montana program (Administrative Record No. MT-042-05). On August 28, 2023, following the extension of the comment period for a further 60 days, we sent an additional request for comments on the amendment (Administrative Record No. MT-042-13). We did not receive any comments.</P>
                <HD SOURCE="HD2">EPA Concurrence and Comments</HD>
                <P>
                    Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the CWA (33 U.S.C. 1251 
                    <E T="03">et seq.</E>
                    ) or the Clean Air Act (42 U.S.C. 7401 
                    <E T="03">et seq.</E>
                    ). On June 6, 2023, under 30 CFR 732.17(h)(11)(i), we requested comments from the EPA on the amendment (Administrative Record No. MT-042-05). The EPA submitted its comment to us on August 1, 2023. (Administrative Record No. MT-042-07). On August 28, 2023, following the extension of the comment period for a further 60 days, we sent another request for comments on the Amendment (Administrative Record No. MT-042-13). No additional EPA comments were submitted in response to the extended comment period.
                </P>
                <P>In its comment, the EPA interpreted Montana's proposed changes to MCA sec. 82-4-203(32)(a)(ii), “material damage to the hydrologic balance,” to mean a violation of a WQS alone is no longer “material damage.” Instead, any material damage would only be a long-term or permanent exceedances of a WQS.</P>
                <P>Despite the change in definition, the EPA found that they did not have the authority and duty to approve or disapprove the change, as it is not deemed a new or revised WQS under section 303(c)(3) of the CWA. But the EPA did comment that, while the proposed changes are likely not WQS, they do likely alter substantive compliance requirements for coal mines in a way that could result in negative impacts on water quality.</P>
                <P>The EPA ended its comment by stating that the proposed changes would likely not impact or alter MDEQ's obligations under the CWA. EPA-approved WQS would remain in effect in Montana, despite the language deletion here, and MDEQ must continue to implement those WQS programs despite the deletion.</P>
                <P>
                    <E T="03">OSMRE Response:</E>
                     We appreciate EPAs comments and agree that the proposed changes would likely substantively and negatively alter compliance requirements and water quality, but that MDEQ would still be obliged to comply with all CWA requirements because section 702 of SMCRA provides that nothing in SMCRA can be construed as superseding, amending, modifying, or repealing Federal laws related to water quality. 30 U.S.C. 1292(3). For the reasons explained in our response in Section III(A), we are denying Montana's proposed change to its current definition of “material damage to the hydrologic balance.”
                </P>
                <HD SOURCE="HD2">State Historical Preservation Officer (SHPO) and the Advisory Council on Historic Preservation (ACHP)</HD>
                <P>Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On June 6, 2023, we requested comments on the amendment (Administrative Record No. MT-042-03, and MT-042-04). On August 28, 2023, following the extension of the comment period for a further 60 days, we sent another request for comments on the amendment (Administrative Record No. MT-042-11, and MT-042-12). The Montana SHPO responded on June 15, 2023, to say they have no comment and the ACHP did not comment (Administrative Record No. MT-042-06).</P>
                <HD SOURCE="HD1">V. OSMRE's Decision</HD>
                <P>Based on the above findings, we are approving in part and disapproving in part Montana's proposed amendment (MT-042-FOR) sent to us on June 1, 2023 (Administrative Record No. MT-042-01).</P>
                <P>
                    To implement this decision, we are amending the Federal regulations, at 30 CFR part 926, that codify decisions concerning the Montana program. In 
                    <PRTPAGE P="3686"/>
                    accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. SMCRA requires that a State program must have rules and regulations that are in accordance with SMCRA and consistent with Federal regulations.
                </P>
                <HD SOURCE="HD1">VI. Procedural Determinations</HD>
                <HD SOURCE="HD2">Executive Order 12630—Governmental Actions and Interference With Constitutionally Protected Property Rights</HD>
                <P>This rule would not effect a taking of private property or otherwise have taking implications that would result in public property being taken for government use without just compensation under the law. Therefore, a takings implication assessment is not required. This determination is based on an analysis of the corresponding Federal regulations.</P>
                <HD SOURCE="HD2">Executive Orders 12866—Regulatory Planning and Review and 13563—Improving Regulation and Regulatory Review</HD>
                <P>Executive Order 12866, as amended by Executive Order 14094, provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance, dated October 12, 1993 (OMB Memo M-94-3), the approval of State program and/or plan amendments is exempted from OMB review under Executive Order 12866. Executive Order 13563, which reaffirms and supplements Executive Order 12866, retains this exemption.</P>
                <HD SOURCE="HD2">Executive Order 13771—Reducing Regulation and Controlling Regulatory Costs</HD>
                <P>State program and/or plan amendments are not regulatory actions under Executive Order 13771 because they are exempt from review under Executive Order 12866.</P>
                <HD SOURCE="HD2">Executive Order 12988—Civil Justice Reform</HD>
                <P>
                    The Department of the Interior has reviewed this rule as required by Section 3 of Executive Order 12988. The Department determined that this 
                    <E T="04">Federal Register</E>
                     document meets the criteria of section 3 of Executive Order 12988, which is intended to ensure that the agency review proposed regulations to eliminate drafting errors and ambiguity; that the agency write its regulations to minimize litigation; and that the agency's regulations provide a clear legal standard for affected conduct rather than a general standard, and promote simplification and burden reduction. Because Section 3 focuses on the quality of Federal regulations, the Department limited its review under this Executive Order to the quality of this 
                    <E T="04">Federal Register</E>
                     document and to changes to the Federal regulations. The review under this Executive Order did not extend to the language of the State regulatory program amendment that Montana drafted.
                </P>
                <HD SOURCE="HD2">Executive Order 13132—Federalism</HD>
                <P>This rule has potential Federalism implications, as defined under section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. Montana, through its approved regulatory program, implements and administers SMCRA and its implementing regulations at the State level. This rule approves an amendment to the Montana program submitted and drafted by the State, and thus is consistent with the direction to provide maximum administrative discretion to States.</P>
                <HD SOURCE="HD2">Executive Order 13175—Consultation and Coordination With Indian Tribal Governments</HD>
                <P>The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on federally recognized Tribes or on the distribution of power and responsibilities between the Federal government and Tribes. Therefore, consultation under the Department's tribal consultation policy is not required. The basis for this determination is that our decision is on the Montana State program that does not include the regulation of Indian lands or regulation of activities on Indian lands as that term is defined in 30 U.S.C. 1291(9). Indian lands are regulated independently under the applicable, approved Federal Indian lands program, with the exception of the Crow Tribe's “Ceded Strip” in Montana, which represents a unique and special situation because under the terms of the MOU, the Department of the Interior and Montana agreed to coordinate the administration of applicable surface mining requirements in the Crow Ceded Strip. However, as we are disapproving the majority of the substantive changes made by this proposed amendment, our action will not have any significant effects on the regulation of surface coal mining operations within the Crow Ceded Strip. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the State proposing the amendment encompasses ancestral lands in areas with mineable coal. We are currently working to identify and engage appropriate Tribal stakeholders to devise a constructive approach for consulting on these amendments.</P>
                <HD SOURCE="HD2">Executive Order 13211—Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</HD>
                <P>Executive Order 13211 requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not a significant energy action under the definition in Executive Order 13211, a statement of energy effects is not required.</P>
                <HD SOURCE="HD2">Executive Order 13045—Protection of Children From Environmental Health Risks and Safety Risks</HD>
                <P>This rule is not subject to Executive Order 13045 because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.</P>
                <HD SOURCE="HD2">National Environmental Policy Act</HD>
                <P>Consistent with sections 501(a) and 702(d) of SMCRA (30 U.S.C. 1251(a) and 1292(d), respectively) and the U.S. Department of the Interior Departmental Manual, part 516, section 13.5(A), a State program amendment is a not major Federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C).</P>
                <HD SOURCE="HD2">National Technology Transfer and Advancement Act</HD>
                <P>
                    Section 12(d) of the National Technology Transfer and Advancement Act (15 U.S.C. 3701 
                    <E T="03">et seq.</E>
                    ) directs OSMRE to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent 
                    <PRTPAGE P="3687"/>
                    with applicable law or otherwise impractical. (OMB Circular A-119 at p. 14). This action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with SMCRA.
                </P>
                <HD SOURCE="HD2">Paperwork Reduction Act</HD>
                <P>
                    This rule does not include requests and requirements of an individual, partnership, or corporation to obtain information and report it to a Federal agency. As this rule does not contain information collection requirements, a submission to OMB under the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) is not required.
                </P>
                <HD SOURCE="HD2">Regulatory Flexibility Act</HD>
                <P>
                    This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ). The State submittal, which is the subject of this rule, is based on corresponding Federal regulations for which an economic analysis was prepared, and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the corresponding Federal regulations.
                </P>
                <HD SOURCE="HD2">Small Business Regulatory Enforcement Fairness Act</HD>
                <P>This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to constitute a major rule.</P>
                <HD SOURCE="HD2">Unfunded Mandates Reform Act</HD>
                <P>
                    This rule does not impose an unfunded mandate on State, local, or Tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to impose an unfunded mandate. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ) is not required.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 30 CFR Part 926</HD>
                    <P>State regulatory program approval, State program provisions and amendments not approved, Approval of Montana program amendments, and State-federal cooperative agreement.</P>
                </LSTSUB>
                <SIG>
                    <NAME>David A. Berry,</NAME>
                    <TITLE>Regional Director, Unified Regions, 5, 7-11.</TITLE>
                </SIG>
                <P>For the reasons set out in the preamble, 30 CFR part 926 is amended as set forth below:</P>
                <PART>
                    <HD SOURCE="HED">PART 926—Montana</HD>
                </PART>
                <REGTEXT TITLE="30" PART="926">
                    <AMDPAR>1. The authority citation for part 926 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             30 U.S.C. 1201 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="30" PART="926">
                    <AMDPAR>2. Amend § 926.12 by adding paragraph (c) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 926.12</SECTNO>
                        <SUBJECT>State program provisions and amendments not approved.</SUBJECT>
                        <STARS/>
                        <P>(c) The following portions of the amendment submitted by letter dated June 1, 2023, Administrative Record No. MT-042-01, which proposed changes to the Montana approved program as a result of the Montana Legislature's 2023 passage of a House Bill (HB 576) are not approved: MCA 82-4-203(32)(a) to the extent that it changed the prior definition of material damage as it relates to the hydrologic balance; MCA 82-4-203(32)(c) definition of material damage as it relates to subsidence; MCA 82-4-222(1)(m) hydrologic information requirements.</P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="30" PART="926">
                    <AMDPAR>3. Amend § 926.15 in the table by adding a new entry in chronological order by “Date of final publication” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 926.15</SECTNO>
                        <SUBJECT>Approval of Montana regulatory program amendments.</SUBJECT>
                        <STARS/>
                        <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s50,r50,r200">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Original amendment submission date</CHED>
                                <CHED H="1">
                                    Date of final 
                                    <LI>publication</LI>
                                </CHED>
                                <CHED H="1">Citation/description</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">June 1, 2023</ENT>
                                <ENT>January 15, 2025</ENT>
                                <ENT>MCA 82-4-203(32)(a) existing definition of material damage with respect to protection of the hydrologic balance recodified; MCA 82-4-203(32)(b) adding a definition of material damage with respect to an alluvial valley floor.</ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00333 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-05-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>Office of Foreign Assets Control</SUBAGY>
                <CFR>31 CFR Parts 501, 510, 525, 526, 535, 536, 539, 542, 544, 546, 547, 548, 549, 551, 552, 553, 555, 558, 560, 561, 566, 570, 576, 578, 583, 584, 588, 589, 590, 592, 594, 597, and 598</CFR>
                <SUBJECT>Inflation Adjustment of Civil Monetary Penalties</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Foreign Assets Control, Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of the Treasury's Office of Foreign Assets Control (OFAC) is issuing this final rule to adjust certain civil monetary penalties for inflation pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        OFAC: Assistant Director for Licensing, 202-622-2480; Assistant Director for Regulatory Affairs, 202-622-4855; 
                        <PRTPAGE P="3688"/>
                        Assistant Director for Compliance, 202-622-2490.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Electronic Availability</HD>
                <P>
                    This document and additional information concerning OFAC are available from OFAC's website (
                    <E T="03">https://ofac.treasury.gov/</E>
                    ).
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>Section 4 of the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, 104 Stat. 890; 28 U.S.C. 2461 note), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. 114-74, 129 Stat. 599, 28 U.S.C. 2461 note) (the FCPIA Act), requires each federal agency with statutory authority to assess civil monetary penalties (CMPs) to adjust CMPs annually for inflation according to a formula described in section 5 of the FCPIA Act. One purpose of the FCPIA Act is to ensure that CMPs continue to maintain their deterrent effect through periodic cost-of-living-based adjustments.</P>
                <P>OFAC has adjusted its CMPs ten times since the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 went into effect on November 2, 2015: an initial catch-up adjustment on August 1, 2016 (81 FR 43070, July 1, 2016); an additional initial catch-up adjustment related to CMPs for failure to comply with a requirement to furnish information, the late filing of a required report, and failure to maintain records (“recordkeeping CMPs”) that were inadvertently omitted from the August 1, 2016 initial catch-up adjustment on October 5, 2020 (85 FR 54911, September 3, 2020); and annual adjustments on February 10, 2017 (82 FR 10434, February 10, 2017); March 19, 2018 (83 FR 11876, March 19, 2018); June 14, 2019 (84 FR 27714, June 14, 2019); April 9, 2020 (85 FR 19884, April 9, 2020); March 17, 2021 (86 FR 14534, March 17, 2021); February 9, 2022 (87 FR 7369, February 9, 2022); January 13, 2023 (88 FR 2229, January 13, 2023); and January 12, 2024 (89 FR 2139, January 12, 2024).</P>
                <HD SOURCE="HD2">Method of Calculation</HD>
                <P>The method of calculating CMP adjustments applied in this final rule is required by the FCPIA Act. Under the FCPIA Act and the Office of Management and Budget guidance required by the FCPIA Act, annual inflation adjustments subsequent to the initial catch-up adjustment are to be based on the percent change between the Consumer Price Index for all Urban Consumers (“CPI-U”) for the October preceding the date of the adjustment and the prior year's October CPI-U. As set forth in Office of Management and Budget Memorandum M-25-02 of December 17, 2024, the adjustment multiplier for 2024 is 1.02598. In order to complete the 2025 annual adjustment, each current CMP is multiplied by the 2025 adjustment multiplier. Under the FCPIA Act, any increase in CMP must be rounded to the nearest multiple of $1.</P>
                <HD SOURCE="HD2">New Penalty Amounts</HD>
                <P>OFAC imposes CMPs pursuant to the penalty authority in five statutes: the Trading With the Enemy Act (50 U.S.C. 4301-4341, at 4315) (TWEA); the International Emergency Economic Powers Act (50 U.S.C. 1701-1706, at 1705) (IEEPA); the Antiterrorism and Effective Death Penalty Act of 1996 (18 U.S.C. 2339B) (AEDPA); the Foreign Narcotics Kingpin Designation Act (21 U.S.C. 1901-1908, at 1906) (FNKDA); and the Clean Diamond Trade Act (19 U.S.C. 3901-3913, at 3907) (CDTA).</P>
                <P>The table below summarizes the existing and new maximum CMP amounts for each statute.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12,15">
                    <TTITLE>Table 1—Maximum CMP Amounts for Relevant Statutes</TTITLE>
                    <BOXHD>
                        <CHED H="1">Statute</CHED>
                        <CHED H="1">
                            Existing
                            <LI>maximum</LI>
                            <LI>CMP amount</LI>
                        </CHED>
                        <CHED H="1">
                            Maximum
                            <LI>CMP amount</LI>
                            <LI>effective</LI>
                            <LI>January 15, 2025</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">TWEA</ENT>
                        <ENT>$108,489</ENT>
                        <ENT>$111,308</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">IEEPA</ENT>
                        <ENT>368,136</ENT>
                        <ENT>377,700</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AEDPA</ENT>
                        <ENT>97,178</ENT>
                        <ENT>99,703</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FNKDA</ENT>
                        <ENT>1,829,177</ENT>
                        <ENT>1,876,699</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CDTA</ENT>
                        <ENT>16,630</ENT>
                        <ENT>17,062</ENT>
                    </ROW>
                </GPOTABLE>
                <P>In addition to updating these maximum CMP amounts, OFAC is also updating two references to one-half the IEEPA maximum CMP from $184,068 to $188,850, and is adjusting the recordkeeping CMP amounts found in OFAC's Economic Sanctions Enforcement Guidelines in appendix A to 31 CFR part 501. The table below summarizes the existing and new maximum CMP amounts for OFAC's recordkeeping CMPs.</P>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s100,12,15">
                    <TTITLE>Table 2—Maximum CMP Amounts for Recordkeeping CMPs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Violation</CHED>
                        <CHED H="1">
                            Existing
                            <LI>maximum</LI>
                            <LI>CMP amount</LI>
                        </CHED>
                        <CHED H="1">
                            Maximum
                            <LI>CMP amount</LI>
                            <LI>effective</LI>
                            <LI>January 15, 2025</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Failure to furnish information pursuant to 31 CFR 501.602 irrespective of whether any other violation is alleged</ENT>
                        <ENT>$28,412</ENT>
                        <ENT>$29,150</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Failure to furnish information pursuant to 31 CFR 501.602 where OFAC has reason to believe that the apparent violation(s) involves a transaction(s) valued at greater than $500,000, irrespective of whether any other violation is alleged</ENT>
                        <ENT>71,031</ENT>
                        <ENT>72,876</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Late filing of a required report, whether set forth in regulations or in a specific license, if filed within the first 30 days after the report is due</ENT>
                        <ENT>3,550</ENT>
                        <ENT>3,642</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Late filing of a required report, whether set forth in regulations or in a specific license, if filed more than 30 days after the report is due</ENT>
                        <ENT>7,104</ENT>
                        <ENT>7,289</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Late filing of a required report, whether set forth in regulations or in a specific license, if the report relates to blocked assets, an additional CMP for every 30 days that the report is overdue, up to five years</ENT>
                        <ENT>1,422</ENT>
                        <ENT>1,459</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="3689"/>
                        <ENT I="01">Failure to maintain records in conformance with the requirements of OFAC's regulations or of a specific license</ENT>
                        <ENT>71,162</ENT>
                        <ENT>73,011</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Public Participation</HD>
                <P>The FCPIA Act expressly exempts this final rule from the notice and comment requirements of the Administrative Procedure Act by directing agencies to adjust CMPs for inflation “notwithstanding section 553 of title 5, United States Code” (Pub. L. 114-74, 129 Stat. 599; 28 U.S.C. 2461 note). As such, this final rule is being issued without prior public notice or opportunity for public comment, with an effective date of January 15, 2025.</P>
                <HD SOURCE="HD1">Regulatory Flexibility Act</HD>
                <P>
                    Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ) do not apply.
                </P>
                <HD SOURCE="HD1">Executive Order 12866</HD>
                <P>This rule is not a significant regulatory action as defined in section 3.f. of Executive Order 12866 of September 30, 1993, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), as amended.</P>
                <HD SOURCE="HD1">Paperwork Reduction Act</HD>
                <P>
                    The Paperwork Reduction Act does not apply because this rule does not impose information collection requirements that would require the approval of the Office of Management and Budget under 44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 31 CFR Parts 501, 510, 526, 535, 536, 539, 542, 544, 546, 547, 548, 549, 551, 552, 553, 555, 558, 560, 561, 566, 570, 576, 578, 583, 584, 588, 589, 590, 592, 594, 597, and 598</HD>
                    <P>Administrative practice and procedure, Banks, banking, Blocking of assets, Exports, Foreign trade, Licensing, Penalties, Sanctions.</P>
                </LSTSUB>
                <P>For the reasons set forth in the preamble, OFAC amends 31 CFR chapter V as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 501—REPORTING, PROCEDURES AND PENALTIES REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="501">
                    <AMDPAR>1. The authority citation for part 501 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 8 U.S.C. 1189; 18 U.S.C. 2332d, 2339B; 19 U.S.C. 3901-3913; 21 U.S.C. 1901-1908; 22 U.S.C. 287c, 2370(a), 6009, 6032, 7205, 8501-8551; 31 U.S.C. 321(b); 50 U.S.C. 1701-1706, 4301-4341; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note).</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart D—Trading With the Enemy Act (TWEA) Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 501.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="501">
                    <AMDPAR>2. In § 501.701, in paragraph (a)(3) introductory text, remove “$“$108,489” and add in its place “$111,308”.</AMDPAR>
                </REGTEXT>
                <REGTEXT TITLE="31" PART="501">
                    <AMDPAR>3. Amend appendix A to part 501 as follows:</AMDPAR>
                    <AMDPAR>a. In paragraph IV.A., remove “$28,412” and add in its place “$29,150” and remove “$71,031” and add in in its place “$72,876”.</AMDPAR>
                    <AMDPAR>b. In paragraph IV.B., remove “$3,550” and add in its place “$3,642”, remove “$7,104” and add in its place “$7,289”, and remove “$1,422” and add in its place “$1,459”.</AMDPAR>
                    <AMDPAR>c. In paragraph IV.C., remove “$71,162” and add in its place “$73,011”.</AMDPAR>
                    <AMDPAR>d. In paragraph V.B.2.a.i., remove “$184,068” and add in its place “$188,850” and remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                    <AMDPAR>e. In paragraph V.B.2.a.ii., remove “$368,136” in all three locations where it appears and add in its place in all three locations “$377,700”.</AMDPAR>
                    <AMDPAR>f. In paragraph V.B.2.a.v., remove “$368,136” and add in its place “$377,700”, remove “$108,489” and add in its place “$111,308”, remove “$1,829,177” and add in its place “$1,876,699”, remove “$97,178” and add in its place “$99,703”, and remove “$16,630” and add in its place “$17,062”.</AMDPAR>
                    <AMDPAR>g. Revise paragraph V.B.2.a.vi.</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <HD SOURCE="HD1">Appendix A to Part 501—Economic Sanctions Enforcement Guidelines.</HD>
                    <EXTRACT>
                        <STARS/>
                        <P>V. * * *</P>
                        <P>B. * * *</P>
                        <P>2. * * *</P>
                        <P>a. * * *</P>
                        <P>vi. The following matrix represents the base amount of the proposed civil penalty for each category of violation:</P>
                        <GPH SPAN="3" DEEP="302">
                            <PRTPAGE P="3690"/>
                            <GID>ER15JA25.063</GID>
                        </GPH>
                        <STARS/>
                    </EXTRACT>
                      
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 510—NORTH KOREA SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="510">
                    <AMDPAR>4. The authority citation for part 510 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 287c, 9201-9255; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Pub. L. 115-44, 131 Stat. 886 (codified in scattered sections of 22 U.S.C.); E.O. 13466, 73 FR 36787, 3 CFR, 2008 Comp., p. 195; E.O. 13551, 75 FR 53837, 3 CFR, 2010 Comp., p. 242; E.O. 13570, 76 FR 22291, 3 CFR, 2011 Comp., p. 233; E.O. 13687, 80 FR 819, 3 CFR, 2015 Comp., p. 259; E.O. 13722, 81 FR 14943, 3 CFR, 2016 Comp., p. 446; E.O. 13810, 82 FR 44705, 3 CFR, 2017 Comp., p. 379.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Finding of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 510.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="510">
                    <AMDPAR>5. In § 510.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 525—BURMA SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="525">
                    <AMDPAR>6. The authority citation for part 525 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 14014, 86 FR 9429, 3 CFR, 2021 Comp., p. 514.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 525.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="525">
                    <AMDPAR>7. In § 525.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 526—HOSTAGES AND WRONGFUL DETENTION SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="526">
                    <AMDPAR>8. The authority citation for part 526 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             3 U.S.C. 301; 22 U.S.C. 1741 
                            <E T="03">et seq.;</E>
                             31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 14078, 87 FR 43389, 3 CFR, 2022 Comp., p. 407.
                        </P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 526.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="526">
                    <AMDPAR>9. In § 526.701, in paragraph (a)(2), remove “$356,579” and add in its place “$365,843”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 535—IRANIAN ASSETS CONTROL REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="535">
                    <AMDPAR>10. The authority citation for part 535 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 18 U.S.C. 2332d; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 12170, 44 FR 65729, 3 CFR, 1979 Comp., p. 457; E.O. 12205, 45 FR 24099, 3 CFR, 1980 Comp., p. 248; E.O. 12211, 45 FR 26685, 3 CFR, 1980 Comp., p. 253; E.O. 12276, 46 FR 7913, 3 CFR, 1981 Comp., p. 104; E.O. 12279, 46 FR 7919, 3 CFR, 1981 Comp., p. 109; E.O. 12280, 46 FR 7921, 3 CFR, 1981 Comp., p. 110; E.O. 12281, 46 FR 7923, 3 CFR, 1981 Comp., p. 112; E.O. 12282, 46 FR 7925, 3 CFR, 1981 Comp., p. 113; E.O. 12283, 46 FR 7927, 3 CFR, 1981 Comp., p. 114; E.O. 12294, 46 FR 14111, 3 CFR, 1981 Comp., p. 139.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 535.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="535">
                    <AMDPAR>11. In § 535.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 536—NARCOTICS TRAFFICKING SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="535">
                    <AMDPAR>12. The authority citation for part 536 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 12978, 60 FR 54579, 3 CFR, 1995 Comp., p. 415; E.O. 13286, 68 FR 10619, 3 CFR, 2003 Comp., p. 166.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <PRTPAGE P="3691"/>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 536.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="536">
                    <AMDPAR>13. In § 536.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 539—WEAPONS OF MASS DESTRUCTION TRADE CONTROL REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="539">
                    <AMDPAR>14. The authority citation for part 539 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 22 U.S.C. 2751-2799aa-2; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13094, 63 FR 40803, 3 CFR, 1998 Comp., p. 200; E.O. 13382, 70 FR 38567, 3 CFR, 2005 Comp., p. 170.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 539.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="539">
                    <AMDPAR>15. In § 539.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 542—SYRIAN SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="542">
                    <AMDPAR>16. The authority citation for part 542 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 18 U.S.C. 2332d; 22 U.S.C. 287c; 22 U.S.C. 8791-8793; 22 U.S.C. 9528; 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 108-175 (22 U.S.C. 2151 note); Pub. L. 116-92, Div. F, Title LXXIV, 133 Stat. 2291 (22 U.S.C. 8791 note); Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 168; E.O. 13399, 71 FR 25059, 3 CFR, 2006 Comp., p. 218; E.O. 13460, 73 FR 8991, 3 CFR 2008 Comp., p. 181; E.O. 13572, 76 FR 24787, 3 CFR 2011 Comp., p. 236; E.O. 13573, 76 FR 29143, 3 CFR 2011 Comp., p. 241; E.O. 13582, 76 FR 52209, 3 CFR 2011 Comp., p. 264; E.O. 13606, 77 FR 24571, 3 CFR 2012 Comp., p. 243; E.O.13608, 77 FR 26409, 3 CFR, 2012 Comp., p. 252.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 542.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="542">
                    <AMDPAR>17. In § 542.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 544—WEAPONS OF MASS DESTRUCTION PROLIFERATORS SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="544">
                    <AMDPAR>18. The authority citation for part 544 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13094, 63 FR 40803, 3 CFR, 1998 Comp., p. 200; E.O. 13382, 70 FR 38567, 3 CFR, 2005 Comp., p. 170.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 544.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="544">
                    <AMDPAR>19. In § 544.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 546—SUDAN STABILIZATION SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="546">
                    <AMDPAR>20. The authority citation for part 546 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 287c; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13067, 62 FR 59989, 3 CFR, 1997 Comp., p. 230; E.O. 13400, 71 FR 25483, 3 CFR, 2006 Comp., p. 220; E.O. 14098, 88 FR 29529.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 546.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="546">
                    <AMDPAR>21. In § 546.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 547—DEMOCRATIC REPUBLIC OF THE CONGO SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="547">
                    <AMDPAR>22. The authority citation for part 547 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 287c; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13413, 71 FR 64105, 3 CFR, 2006 Comp., p. 247; E.O. 13671, 79 FR 39949, 3 CFR, 2015 Comp., p. 280.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Finding of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 547.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="547">
                    <AMDPAR>23. In § 547.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 548—BELARUS SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="548">
                    <AMDPAR>24. The authority citation for part 548 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13405, 71 FR 35485, 3 CFR, 2006 Comp., p. 231; E.O. 14038, 86 FR 43905, 3 CFR, 2021 Comp., p. 626.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 548.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="548">
                    <AMDPAR>25. In § 548.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 549—LEBANON SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="549">
                    <AMDPAR>26. The authority citation for part 549 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13441, 72 FR 43499, 3 CFR, 2008 Comp., p. 232.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 549.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="549">
                    <AMDPAR>27. In § 549.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 551—SOMALIA SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="551">
                    <AMDPAR>28. The authority citation for part 551 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 287c; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13536, 75 FR 19869, 3 CFR, 2010 Comp., p. 203; E.O. 13620, 77 FR 43483, 3 CFR, 2012 Comp., p. 281.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 551.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="551">
                    <AMDPAR>29. In § 551.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 552—YEMEN SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="552">
                    <AMDPAR>30. The authority citation for part 552 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13611, 77 FR 29533, 3 CFR, 2012 Comp., p. 260.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 552.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="552">
                    <AMDPAR>31. In § 552.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 553—CENTRAL AFRICAN REPUBLIC SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="553">
                    <AMDPAR>32. The authority citation for part 553 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 287c; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13667, 79 FR 28387, 3 CFR, 2014 Comp., p. 243.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <PRTPAGE P="3692"/>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 553.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="553">
                    <AMDPAR>33. In § 553.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 555—MALI SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="555">
                    <AMDPAR>34. The authority citation for part 555 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 22 U.S.C. 287c; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13882, 84 FR 37055, 3 CFR, 2019 Comp., p. 346.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 555.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="555">
                    <AMDPAR>35. In § 555.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 558—SOUTH SUDAN SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="558">
                    <AMDPAR>36. The authority citation for part 558 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13664, 79 FR 19283, 3 CFR, 2014 Comp., p. 238.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 558.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="558">
                    <AMDPAR>37. In § 558.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 560—IRANIAN TRANSACTIONS AND SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="560">
                    <AMDPAR>38. The authority citation for part 560 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 18 U.S.C. 2339B, 2332d; 22 U.S.C. 2349aa-9, 7201-7211, 8501-8551, 8701-8795; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 12613, 52 FR 41940, 3 CFR, 1987 Comp., p. 256; E.O. 12957, 60 FR 14615, 3 CFR, 1995 Comp., p. 332; E.O. 12959, 60 FR 24757, 3 CFR, 1995 Comp., p. 356; E.O. 13059, 62 FR 44531, 3 CFR, 1997 Comp., p. 217; E.O. 13599, 77 FR 6659, 3 CFR, 2012 Comp., p. 215; E.O. 13846, 83 FR 38939, 3 CFR, 2018 Comp., p. 854.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 560.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="560">
                    <AMDPAR>39. In § 560.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 561—IRANIAN FINANCIAL SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="561">
                    <AMDPAR>40. The authority citation for part 561 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 8501-8551, 8701-8795; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 12957, 60 FR 14615, 3 CFR, 1995 Comp., p. 332; E.O. 13553, 75 FR 60567, 3 CFR, 2010 Comp., p. 253; E.O. 13599, 77 FR 6659, 3 CFR, 2012 Comp., p. 215; E.O. 13846, 83 FR 38939, 3 CFR, 2018 Comp., p. 854; E.O. 13871, 84 FR 20761, 3 CFR, 2019 Comp., p. 309.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 561.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="561">
                    <AMDPAR>41. In § 561.701, in paragraph (a)(4), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 566—HIZBALLAH FINANCIAL SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="566">
                    <AMDPAR>42. The authority citation for part 566 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Pub. L. 114-102, 129 Stat. 2205 (50 U.S.C. 1701 note); Pub. L. 115-272, 132 Stat. 4144 (50 U.S.C. 1701 note).</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Finding of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 566.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="566">
                    <AMDPAR>43. In § 566.701, in paragraph (b), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 570—LIBYAN SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="570">
                    <AMDPAR>44. The authority citation for part 570 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 287c; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13566, 76 FR 11315, 3 CFR, 2011 Comp., p. 222; E.O. 13726, 81 FR 23559, 3 CFR, 2016 Comp., p. 454.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 570.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="570">
                    <AMDPAR>45. In § 570.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 576—IRAQ STABILIZATION AND INSURGENCY SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="576">
                    <AMDPAR>46. The authority citation for part 576 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 22 U.S.C. 287c; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13303, 68 FR 31931, 3 CFR, 2003 Comp., p. 227; E.O. 13315, 68 FR 52315, 3 CFR, 2003 Comp., p. 252; E.O. 13350, 69 FR 46055, 3 CFR, 2004 Comp., p. 196; E.O. 13364, 69 FR 70177, 3 CFR, 2004 Comp., p. 236; E.O. 13438, 72 FR 39719, 3 CFR, 2007 Comp., p. 224; E.O. 13668, 79 FR 31019, 3 CFR, 2014 Comp., p. 248.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 576.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="576">
                    <AMDPAR>47. In § 576.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 578—CYBER-RELATED SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="578">
                    <AMDPAR>48. The authority citation for part 578 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Pub. L. 115-44, 131 Stat. 886 (codified in scattered sections of 22 U.S.C.); E.O. 13694, 80 FR 18077, 3 CFR 2015 Comp., p. 297; E.O. 13757, 82 FR 1, 3 CFR 2016 Comp., p. 659.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 578.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="578">
                    <AMDPAR>49. In § 578.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 583—GLOBAL MAGNITSKY SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="583">
                    <AMDPAR>50. The authority citation for part 583 is revised to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 22 U.S.C. 10101-10103; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Pub. L. 116-145, 134 Stat. 651, as amended (22 U.S.C. 6901 note); Pub. L. 117-78, 135 Stat. 1531 (22 U.S.C. 6901 note); E.O. 13818, 82 FR 60839, 3 CFR, 2017 Comp., p. 399.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 583.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="583">
                    <AMDPAR>51. In § 583.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 584—MAGNITSKY ACT SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="584">
                    <AMDPAR>52. The authority citation for part 584 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 
                            <PRTPAGE P="3693"/>
                            U.S.C. 2461 note); Pub. L. 112-208, Title IV, 126 Stat. 1502 (22 U.S.C. 5811 note).
                        </P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Finding of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 584.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="584">
                    <AMDPAR>53. In § 584.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 588—WESTERN BALKANS STABILIZATION REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="588">
                    <AMDPAR>54. The authority citation for part 588 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 287c; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13219, 66 FR 34777, 3 CFR, 2001 Comp., p. 778; E.O. 13304, 68 FR 32315, 3 CFR, 2004 Comp., p. 229; E.O. 14033, 86 FR 43905, 3 CFR, 2022 Comp., p. 591.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 588.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="588">
                    <AMDPAR>55. In § 588.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 589—UKRAINE-/RUSSIA-RELATED SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="589">
                    <AMDPAR>56. The authority citation for part 589 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 22 U.S.C. 8901-8910, 8921-8930; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Pub. L. 115-44, 131 Stat. 886 (codified in scattered sections of 22 U.S.C.); E.O. 13660, 79 FR 13493, 3 CFR, 2014 Comp., p. 226; E.O. 13661, 79 FR 15535, 3 CFR, 2014 Comp., p. 229; E.O. 13662, 79 FR 16169, 3 CFR, 2014 Comp., p. 233; E.O. 13685, 79 FR 77357, 3 CFR, 2014 Comp., p. 313., E.O. 13849, 3 CFR, 2018 Comp., p. 875, E.O. 14065, 87 FR 10293, 3 CFR, 2022 Comp., p. 340.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 589.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="589">
                    <AMDPAR>57. In § 589.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 590—TRANSNATIONAL CRIMINAL ORGANIZATIONS SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="590">
                    <AMDPAR>58. The authority citation for part 590 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13581, 76 FR 44757, 3 CFR, 2011 Comp., p. 260; E.O. 13863, 84 FR 10255, 3 CFR, 2019 Comp., p. 267.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties and Findings of Violation</HD>
                    <SECTION>
                        <SECTNO>§ 590.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="590">
                    <AMDPAR>59. In § 590.701, in paragraph (a)(2), remove “$368,136” and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 592—ROUGH DIAMONDS CONTROL REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="592">
                    <AMDPAR>60. The authority citation for part 592 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 19 U.S.C. 3901-3913; 31 U.S.C. 321(b); Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13312, 68 FR 45151, 3 CFR, 2003 Comp., p. 246.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart F—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 592.601</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="592">
                    <AMDPAR>61. In § 592.601, in paragraph (a)(2), remove “$16,630” and add in its place “$17,062”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 594—GLOBAL TERRORISM SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="594">
                    <AMDPAR>62. The authority citation for part 594 is revised to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 22 U.S.C. 287c; 22 U.S.C. 9404-9411; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); Pub. L. 114-102, 129 Stat. 2205, as amended (50 U.S.C. 1701 note); Pub. L. 115-348, 132 Stat. 5055 (50 U.S.C. 1701 note); E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13268, 67 FR 44751, 3 CFR 2002 Comp., p. 240; E.O. 13284, 68 FR 4075, 3 CFR, 2003 Comp., p. 161; E.O. 13372, 70 FR 8499, 3 CFR, 2006 Comp., p. 159; E.O. 13886, 84 FR 48041, 3 CFR, 2019 Comp., p. 356.</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 594.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="594">
                    <AMDPAR>63. In § 594.701, in paragraph (a)(2), remove “$368,136”and add in its place “$377,700”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 597—FOREIGN TERRORIST ORGANIZATIONS SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="597">
                    <AMDPAR>64. The authority citation for part 597 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 8 U.S.C. 1189; 18 U.S.C. 2339B; 31 U.S.C. 321(b); Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note).</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 597.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="597">
                    <AMDPAR>65. In § 597.701, in paragraph (b)(3), remove “$97,178” and add in its place “$99,703”.</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 598—FOREIGN NARCOTICS KINGPIN SANCTIONS REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="31" PART="598">
                    <AMDPAR>66. The authority citation for part 598 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 3 U.S.C. 301; 21 U.S.C. 1901-1908; 31 U.S.C. 321(b); Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note).</P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G—Penalties</HD>
                    <SECTION>
                        <SECTNO>§ 598.701</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </SUBPART>
                <REGTEXT TITLE="31" PART="598">
                    <AMDPAR>67. In § 598.701, in paragraph (a)(4), remove “$1,829,177” and add in its place “$1,876,699”.</AMDPAR>
                </REGTEXT>
                <SIG>
                    <NAME>Lisa M. Palluconi,</NAME>
                    <TITLE>Acting Director, Office of Foreign Assets Control.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00786 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-AL-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <CFR>32 CFR Part 269</CFR>
                <DEPDOC>[Docket ID: DOD-2016-OS-0045]</DEPDOC>
                <RIN>RIN 0790-AL82</RIN>
                <SUBJECT>Civil Monetary Penalty Inflation Adjustment</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Under Secretary of Defense (Comptroller), Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The DoD is issuing this final rule to adjust each of its statutory civil monetary penalties (CMP) to account for inflation. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), requires the head of each agency to adjust for inflation its CMP levels in effect as of November 2, 2015, under a revised methodology that was effective for 2016 and for each year thereafter.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Nicole Gleicher-Bye, 703-692-2754.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background Information</HD>
                <P>
                    The Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, 104 Stat. 890 (28 U.S.C. 2461, note), as amended by the Debt Collection Improvement Act of 1996, Public Law 104-134, April 26, 1996, and further amended by the Federal 
                    <PRTPAGE P="3694"/>
                    Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), Public Law 114-74, November 2, 2015, required agencies to annually adjust the level of CMPs for inflation to improve their effectiveness and maintain their deterrent effect. The 2015 Act required that not later than July 1, 2016, and not later than January 15 of every year thereafter, the head of each agency must adjust each CMP within its jurisdiction by the inflation adjustment described in the 2015 Act. The inflation adjustment is determined by increasing the maximum CMP or the range of minimum and maximum CMPs, as applicable, for each CMP by the cost-of-living adjustment, rounded to the nearest multiple of $1. The cost-of-living adjustment is the percentage (if any) for each CMP by which the Consumer Price Index (CPI) for the month of October preceding the date of the adjustment, exceeds the CPI for the month of October in the previous calendar year.
                </P>
                <P>
                    The initial catch up adjustments for inflation to the DoD's CMPs were published as an interim final rule in the 
                    <E T="04">Federal Register</E>
                     on May 26, 2016 (81 FR 33389-33391), and became effective on that date. The interim final rule was published as a final rule without change on  September 12, 2016 (81 FR 62629-62631), effective that date. The revised methodology for agencies for 2017 and each year thereafter provides for the improvement of the effectiveness of CMPs and to maintain their deterrent effect. The Department of Defense is adjusting the level of all civil monetary penalties under its jurisdiction by the Office of Management and Budget (OMB) directed cost-of-living adjustment multiplier for 2025 of 1.02598 prescribed in OMB Memorandum M-25-02, “Implementation of Penalty Inflation Adjustments for 2025, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” dated December 19, 2024. The DoD's 2025 adjustments for inflation to CMPs apply only to those CMPs, including those whose associated violation predated such adjustment, which are assessed by the DoD after the effective date of the new CMP level.
                </P>
                <HD SOURCE="HD1">Statement of Authority and Costs and Benefits</HD>
                <P>Pursuant to 5 U.S.C. 553(b)B, there is good cause to issue this rule without prior public notice or opportunity for public comment because it would be impracticable and unnecessary. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Section 2461) requires agencies, effective 2017, to make annual adjustments for inflation to CMPs notwithstanding 5 U.S.C. 553. Additionally, the methodology used, effective 2017, for adjusting CMPs for inflation is established in statute, with no discretion provided to agencies regarding the substance of the adjustments for inflation to CMPs. The DoD is charged only with performing ministerial computations to determine the dollar amount of adjustments for inflation to CMPs. Accordingly, prior public notice and an opportunity to comment are not required for this rule. For the same reasons, there is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date.</P>
                <P>Further, there are no significant costs associated with the regulatory revisions that would impose any mandates on the DoD, Federal, State or local governments, or the private sector. Accordingly, prior public notice and an opportunity for public comment are not required for this rule. The benefit of this rule is the DoD anticipates that civil monetary penalty collections may increase in the future due to new penalty authorities and other changes in this rule. However, it is difficult to accurately predict the extent of any increase, if any, due to a variety of factors, such as budget and staff resources, the number and quality of civil penalty referrals or leads, and the length of time needed to investigate and resolve a case.</P>
                <HD SOURCE="HD1">Regulatory Procedures</HD>
                <HD SOURCE="HD2">Executive Order 12866, “Regulatory Planning and Review,” as Amended by Executive Order 14094, “Modernizing Regulatory Review” and Executive Order 13563, “Improving Regulation and Regulatory Review”</HD>
                <P>Executive Orders 12866 (as amended by Executive Order 14094) and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distribution of impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated not significant, under section 3(f) of Executive Order 12866, as amended by E.O. 14094.</P>
                <HD SOURCE="HD2">Congressional Review Act, 5 U.S.C. 804(2)</HD>
                <P>
                    The Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. A major rule may take effect no earlier than 60 calendar days after Congress receives the rule report or the rule is published in the 
                    <E T="04">Federal Register</E>
                    , whichever is later. This rule is not a major rule, as defined by 5 U.S.C. 804(2).
                </P>
                <HD SOURCE="HD2">Unfunded Mandates Reform Act (2 U.S.C. Chapter 25)</HD>
                <P>Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule the mandates of which require spending in any year of $100 million in 1995 dollars, updated annually for inflation. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.</P>
                <HD SOURCE="HD2">Public Law 96-354, “Regulatory Flexibility Act” (5 U.S.C. Chapter 6)</HD>
                <P>The Under Secretary of Defense (Comptroller) certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require DoD to prepare a regulatory flexibility analysis.</P>
                <HD SOURCE="HD2">Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35)</HD>
                <P>The Paperwork Reduction Act was enacted to minimize the paperwork burden for individuals; small businesses; educational and nonprofit institutions; Federal contractors; State, local and Tribal governments; and other persons resulting from the collection of information by or for the Federal Government. The Act requires agencies obtain approval from the OMB before using identical questions to collect information from ten or more persons. This rule does not impose reporting or recordkeeping requirements on the public.</P>
                <HD SOURCE="HD2">Executive Order 13132, “Federalism”</HD>
                <P>
                    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or 
                    <PRTPAGE P="3695"/>
                    otherwise has federalism implications. This final rule will not have a substantial effect on State and local governments.
                </P>
                <HD SOURCE="HD2">Executive Order 13175, “Consultation and Coordination With Indian Tribe Governments”</HD>
                <P>It has been determined that this rule will not have a substantial effect on Indian Tribal governments. This rule does not impose substantial direct compliance costs on one or more Indian Tribes, preempt tribal law, or effect the distribution of power and responsibilities between the Federal Government and Indian Tribes.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 32 CFR Part 269</HD>
                    <P>Administrative practice and procedure, Penalties.</P>
                </LSTSUB>
                <P>Accordingly, 32 CFR part 269 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 269—CIVIL MONETARY PENALTY INFLATION ADJUSTMENT</HD>
                </PART>
                <REGTEXT TITLE="32" PART="269">
                    <AMDPAR>1. The authority citation for 32 CFR part 269 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 28 U.S.C. 2461 note.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="32" PART="269">
                    <AMDPAR>2. In § 269.4, revise paragraph (d) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 269.4</SECTNO>
                        <SUBJECT>Cost of living adjustments of civil monetary penalties.</SUBJECT>
                        <STARS/>
                        <P>
                            (d) 
                            <E T="03">Inflation adjustment.</E>
                             Maximum civil monetary penalties within the jurisdiction of the Department are adjusted for inflation as follows:
                        </P>
                        <GPOTABLE COLS="4" OPTS="L2,nj,i1" CDEF="s100,r150,16,16">
                            <TTITLE>
                                Table 1 to Paragraph (
                                <E T="01">d</E>
                                )
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">United States Code</CHED>
                                <CHED H="1">Civil monetary penalty description</CHED>
                                <CHED H="1">
                                    Maximum penalty
                                    <LI>amount as of</LI>
                                    <LI>01/12/24</LI>
                                </CHED>
                                <CHED H="1">
                                    New adjusted
                                    <LI>maximum penalty</LI>
                                    <LI>amount</LI>
                                </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">National Defense Authorization Act for FY 2005, 10 U.S.C. 113, note</ENT>
                                <ENT>Unauthorized Activities Directed at or Possession of Sunken Military Craft</ENT>
                                <ENT>161,168</ENT>
                                <ENT>165,355</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">10 U.S.C. 1094(c)(1)</ENT>
                                <ENT>Unlawful Provision of Health Care</ENT>
                                <ENT>14,152</ENT>
                                <ENT>14,519</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">10 U.S.C. 1102(k)</ENT>
                                <ENT O="xl">Wrongful Disclosure—Medical Records:</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT O="oi3">First Offense</ENT>
                                <ENT>8,368</ENT>
                                <ENT>8,586</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT O="oi3">Subsequent Offense</ENT>
                                <ENT>55,788</ENT>
                                <ENT>57,237</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">10 U.S.C. 2674(c)(2)</ENT>
                                <ENT>Violation of the Pentagon Reservation Operation and Parking of Motor Vehicles Rules and Regulations</ENT>
                                <ENT>2,306</ENT>
                                <ENT>2,366</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">31 U.S.C. 3802(a)(1)</ENT>
                                <ENT>Violation Involving False Claim</ENT>
                                <ENT>13,946</ENT>
                                <ENT>14,308</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">31 U.S.C. 3802(a)(2)</ENT>
                                <ENT>Violation Involving False Statement</ENT>
                                <ENT>13,946</ENT>
                                <ENT>14,308</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(1)</ENT>
                                <ENT>False claims</ENT>
                                <ENT>24,946</ENT>
                                <ENT>25,594</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(1)</ENT>
                                <ENT>Claims submitted with a false certification of physician license</ENT>
                                <ENT>24,946</ENT>
                                <ENT>25,594</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(2)</ENT>
                                <ENT>Claims presented by excluded party</ENT>
                                <ENT>24,946</ENT>
                                <ENT>25,594</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(2); (b)(2) (ii)</ENT>
                                <ENT>Employing or contracting with an excluded individual</ENT>
                                <ENT>24,946</ENT>
                                <ENT>25,594</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(1)</ENT>
                                <ENT>Patterns of claims for medically unnecessary services/supplies</ENT>
                                <ENT>24,946</ENT>
                                <ENT>25,594</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(2)</ENT>
                                <ENT>Ordering or prescribing while excluded</ENT>
                                <ENT>24,946</ENT>
                                <ENT>25,594</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(5)</ENT>
                                <ENT>Known retention of an overpayment</ENT>
                                <ENT>24,946</ENT>
                                <ENT>25,594</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(4)</ENT>
                                <ENT>Making or using a false record or statement that is material to a false or fraudulent claim</ENT>
                                <ENT>124,731</ENT>
                                <ENT>127,972</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(6)</ENT>
                                <ENT>Failure to grant timely access to OIG for audits, investigations, evaluations, or other statutory functions of OIG</ENT>
                                <ENT>37,420</ENT>
                                <ENT>38,392</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.210(a)(3)</ENT>
                                <ENT>Making false statements, omissions, misrepresentations in an enrollment application</ENT>
                                <ENT>124,731</ENT>
                                <ENT>127,972</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">42 U.S.C. 1320a-7a(a); 32 CFR 200.310(a)</ENT>
                                <ENT>Unlawfully offering, paying, soliciting, or receiving remuneration to induce or in return for the referral of business in violation of 1128B(b) of the Social Security Act</ENT>
                                <ENT>124,731</ENT>
                                <ENT>127,972</ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Aaron T. Siegel,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00715 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <CFR>34 CFR Part 685</CFR>
                <DEPDOC>[Docket ID ED-2024-OPE-0135]</DEPDOC>
                <RIN>RIN 1840-AD97</RIN>
                <SUBJECT>Income-Contingent Repayment Plan Options</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Postsecondary Education, Department of Education.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Education (Department) adopts as final, without changes, the interim final rule published in the 
                        <E T="04">Federal Register</E>
                         on November 15, 2024. This final rule amends the regulations governing income-contingent repayment plans available to Federal student loan borrowers to satisfy the Department's statutory obligation under the Higher Education Act of 1965, as amended, (HEA) to offer borrowers access to an income-contingent repayment plan. The scope of this rule is narrow. It revises the last date for most borrowers to enroll in the Income-Contingent Repayment or Pay As You Earn plans from July 1, 
                        <PRTPAGE P="3696"/>
                        2024, to July 1, 2027. Changing the eligibility restrictions that went into effect on July 1, 2024, to July 1, 2027, allows the Department to meet its statutory obligations while it undertakes the necessary administrative changes to make its repayment plans compliant with the terms of an injunction pending appeal from the U.S. Court of Appeals for the Eighth Circuit (Eighth Circuit).
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         These regulations are effective on July 1, 2026.
                    </P>
                    <P>
                        <E T="03">Implementation date:</E>
                         For the implementation date of these regulatory changes, see the 
                        <E T="03">Implementation Date of These Regulations</E>
                         section of this document.
                    </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For further information contact Tamy Abernathy, U.S. Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, 5th Floor, Washington, DC 20202. Telephone: (202) 245-4595. Email: 
                        <E T="03">tamy.abernathy@ed.gov.</E>
                    </P>
                    <P>If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>In this final rule, the Department uses the term “income-contingent repayment plans” to include the original Income-Contingent Repayment (ICR) plan established by the Department in 1994 as well as the Pay As You Earn (PAYE), Revised Pay As You Earn (REPAYE), and the Saving on a Valuable Education (SAVE) plans.</P>
                <P>
                    <E T="03">Implementation Date of These Regulations:</E>
                     These regulations are effective on July 1, 2026. Section 482(c) of the HEA requires that regulations affecting programs under title IV of the HEA be published in final form by November 1, prior to the start of the award year (July 1) to which they apply. However, that section also permits the Secretary to designate any regulation as one that an entity subject to the regulations may choose to implement earlier, as well as the conditions for early implementation.
                </P>
                <P>
                    As described in the interim final rule (IFR) (89 FR 90221), the Secretary exercised the authority under section 482(c) of the HEA to designate the regulatory changes to 34 CFR part 685 included in the IFR (and reaffirmed in this document) for early implementation on December 16, 2024, for the reasons set forth in the IFR and 
                    <E T="03">Background</E>
                     and 
                    <E T="03">Need for Regulatory Action</E>
                     sections of this document.
                </P>
                <HD SOURCE="HD1">Executive Summary</HD>
                <HD SOURCE="HD2">Purpose of This Regulatory Action</HD>
                <P>
                    The regulations in the November 15, 2024, interim final rule enact a time-limited fix to make certain the Department meets its obligations under section 455(d)(1) of the HEA. That section requires the Secretary of Education (Secretary) to offer Federal Direct Loan borrowers a variety of student loan repayment plans, including an “income-contingent repayment plan,” under which a borrower makes payments “based on the borrower's income” for “an extended period of time prescribed by the Secretary, not to exceed 25 years.” 
                    <SU>1</SU>
                    <FTREF/>
                     On November 15, 2024, the Department published an IFR to satisfy the Department's statutory obligation under the HEA to offer borrowers an income-contingent repayment plan.
                    <SU>2</SU>
                    <FTREF/>
                     This final rule and the IFR that preceded it allow the Department to comply with this requirement. The rule titled “Improving Income Driven Repayment for the William D. Ford Federal Direct Loan Program and the Federal Family Education Loan (FFEL) Program” that took effect on July 1, 2024 (income-driven repayment [IDR] final rule), limited new enrollments in the PAYE and ICR plans for student borrowers so that they would have one clear option under this authority—the Saving on a Valuable Education (SAVE) plan (88 FR 43820). However, legal challenges to the SAVE plan resulted in an injunction pending appeal from the Eighth Circuit that prevents the Department from implementing significant aspects of the SAVE plan.
                    <SU>3</SU>
                    <FTREF/>
                     The Department cannot immediately execute the operational work needed to conform the SAVE plan to the court's Eighth Circuit's injunction pending appeal, so we have placed borrowers who had enrolled in the SAVE plan in a forbearance to avoid violating that injunction. With SAVE not available and other ICR plans closed to new enrollments, the Department was therefore not in compliance with the statutory requirement to offer an income-contingent repayment plan to borrowers.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         HEA section 455(d)(1)(D) (20 U.S.C. 1087e(d)(1)(D)).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         89 FR 90221 (November 15, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Specifically, in the 
                        <E T="03">Missouri</E>
                         case, the U.S. District Court for the Eastern District of Missouri entered a preliminary injunction on June 24, 2024, enjoining the shortened time to forgiveness that had been offered by the SAVE Plan. 
                        <E T="03">Missouri</E>
                         v. 
                        <E T="03">Biden,</E>
                         No. 4:24-CV-00520-JAR, 2024 WL 3104514, at *1 (E.D. Mo. June 24, 2024) (preliminary injunction). The challengers appealed and on July 18, 2024, the Eighth Circuit stayed the entire rule pending appeal, 
                        <E T="03">Missouri</E>
                         v. 
                        <E T="03">Biden,</E>
                         No. 24-2332, 2024 WL 3462265, at *1 (8th Cir. July 18, 2024), and then on August 9, 2024, the Eighth Circuit entered an injunction pending appeal that replaced the previously entered stay, 
                        <E T="03">Missouri</E>
                         v. 
                        <E T="03">Biden,</E>
                         112 F.4th 531 (8th Cir. 2024) (per curiam) (injunction pending appeal). In the 
                        <E T="03">Alaska</E>
                         case, the U.S. District Court for the District of Kansas entered a preliminary injunction on June 24, 2024. 
                        <E T="03">See Alaska</E>
                         v. 
                        <E T="03">Cardona,</E>
                         No. 24-1057-DDC-ADM, 2024 WL 3104578, at *1 (D. Kan. June 24, 2024). Thereafter, the Tenth Circuit Court of Appeals stayed the preliminary injunction pending appeal. 
                        <E T="03">See Alaska</E>
                         v. 
                        <E T="03">Cardona,</E>
                         No. 20-3089, Order Staying Prelim. Inj. (10th Cir. June 30, 2024). That Tenth Circuit appeal has been held in abeyance pending the outcome of the Eighth Circuit proceedings.
                    </P>
                </FTNT>
                <P>The IFR announced the reopening of the PAYE and ICR plans to new enrollments until July 1, 2027. This reopening allows the Department to offer borrowers an income-contingent repayment option as required under the HEA.</P>
                <HD SOURCE="HD2">Summary of the Major Provisions of This Regulatory Action</HD>
                <P>This final rule adopts without change the provisions in the IFR, which—</P>
                <P>• Adjust the date after which borrowers cannot begin to repay a loan under the PAYE plan unless they are already enrolled in the plan as provided in § 685.209(c)(4)(iv) from July 1, 2024, to July 1, 2027.</P>
                <P>• Revise the date after which borrowers cannot begin to repay a loan under the ICR plan unless they are already enrolled in that plan or have a consolidation loan that repaid a Parent PLUS loan as provided in § 685.209(c)(5)(i)(B) from July 1, 2024, to July 1, 2027.</P>
                <HD SOURCE="HD2">Costs and Benefits</HD>
                <P>
                    As further detailed in the 
                    <E T="03">Regulatory Impact Analysis (RIA),</E>
                     this final rule does not create significant budgetary costs for the Department. For existing borrowers, the Department already assumes in our budget baseline that borrowers who would receive more benefit from being enrolled in PAYE or ICR rather than SAVE over the long term are already in those plans. The budget baseline also assumes that borrowers seeking Public Service Loan Forgiveness (PSLF) would continue to make payments. So, a borrower who leaves SAVE to join PAYE or ICR so they can qualify for forgiveness under PSLF does not generate additional costs. The final rule provides some non-monetary benefits to the Department by allowing it to comply with requirements in the HEA. For borrowers, the final rule provides benefits to those who now enroll in PAYE or ICR and make payments that allow them to reach forgiveness sooner than they would by staying in forbearance. The Department anticipates these benefits would be most likely to occur for borrowers seeking PSLF due to the shorter number of 
                    <PRTPAGE P="3697"/>
                    required payments before receiving forgiveness.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Section 455(d)(1) of the HEA directs the Secretary to offer borrowers a range of loan repayment plans, including an income-contingent repayment plan. The Secretary first met this requirement by issuing final regulations for the original ICR plan in 1994,
                    <SU>4</SU>
                    <FTREF/>
                     and then expanded the options available to borrowers under this authority with the creation of PAYE and REPAYE as income-contingent repayment plans in 2012 and 2015, respectively.
                    <SU>5</SU>
                    <FTREF/>
                     On July 10, 2023, the Department published the IDR final rule amending the terms of REPAYE and renaming it the SAVE plan.
                    <SU>6</SU>
                    <FTREF/>
                     Among other changes, that rule prevented student borrowers from enrolling in the PAYE or ICR plans after July 1, 2024, if they were not already enrolled in those plans or if they were a parent PLUS borrower with a consolidation loan looking to enroll in the ICR plan. The Department explained this change on the grounds that the SAVE plan was the best option for most borrowers. Because the SAVE plan would be available to all student borrowers, the Department would fulfill its obligations under Sec. 455(d)(1) of the HEA to offer an income-contingent repayment plan.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         59 FR 61664 (December 1, 1994).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         77 FR 66088 (November 1, 2012); 80 FR 67204 (October 30, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         88 FR 43820 (July 10, 2023).
                    </P>
                </FTNT>
                <P>
                    The changes made in the IDR final rule were challenged in Federal court following publication. On August 9, 2024, the Eighth Circuit issued an injunction pending appeal that, among other things, enjoins changes in loan repayment terms that would: increase the amount of income protected from payments; decrease the share of income borrowers pay on undergraduate loans; and cease charging monthly interest that is not covered by a borrower's payment.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">Missouri,</E>
                         112 F.4th at 538.
                    </P>
                </FTNT>
                <P>The Department is undertaking efforts to implement a version of the SAVE plan compliant with the Eighth Circuit injunction. However, until that work is complete, the regulatory limitations affecting access to older plans meant that the Department was not complying with the HEA requirement to offer borrowers an income-contingent repayment plan.</P>
                <P>The IFR and this final rule address this problem through a time-limited reopening of the PAYE and ICR plans to new enrollments. Under the IFR and this final rule, borrowers may select these plans until July 1, 2027. As explained in the IFR, we chose this date to also allow time for the Department to offer an income-contingent repayment plan that is compliant with the Eighth Circuit's injunction pending appeal and to issue any new regulations that may be needed.</P>
                <HD SOURCE="HD1">Public Comment</HD>
                <P>In response to our invitation in the IFR, 107 parties submitted comments on the IFR. In this preamble, we respond to those comments, which we have grouped by subject. Generally, we do not address technical or other minor changes.</P>
                <P>
                    <E T="03">Analysis of Comments and Changes:</E>
                     An analysis of the public comments and of changes since publication of the IFR follows.
                </P>
                <HD SOURCE="HD2">General Support</HD>
                <P>
                    <E T="03">Comments:</E>
                     Several commenters appreciated that the Department re-opened the PAYE and ICR plans to borrowers. One commenter, a borrower who is currently affected by the litigation putting the SAVE plan on hold, expressed the view that reinstitution of PAYE is a critically necessary and sensible step. This commenter noted borrowers have made innumerable financial and other decisions that were dependent on the continued availability of PAYE and PSLF. There are specific terms to the PAYE and SAVE programs that make the availability of at least one of them crucial for households like the commenter's. The commenter also urged the Department to proceed expeditiously with processing applications for the PAYE and ICR plans as the current state of uncertainty around student loan repayment imposes a substantial burden on borrowers. Another commenter expressed the hope that the Department would process ICR and PAYE applications within three months of receiving the application.
                </P>
                <P>Another commenter stated that reopening more income-contingent repayment plans would not only make for a better repayment system for most borrowers, but it would improve the fairness and accuracy of loan repayments. This commenter stated that the current repayment option has proved inaccurate when considering those who are primarily affected by student loan debt. By implementing this new rule, they said many will be able to pay off their debt by affordable means. Implementation of the rule would also result in a fairer consideration of income, global issues like inflation, and overall financial stability when determining monthly payment amounts. Similarly, one commenter suggested that by implementing this new rule the income-contingent repayment options will help borrowers pay off their debts, as well as help improve the fairness and accuracy of loan repayments.</P>
                <P>One association agreed that the Department should offer borrowers an income-contingent repayment option during these uncertain times. This association urged the Department to be transparent and clear about all future action on IDR plans. This association also stated that many borrowers would benefit more from the provisions of the 2015 REPAYE plan until the courts issue a final decision on the SAVE plan.</P>
                <P>
                    <E T="03">Discussion:</E>
                     We appreciate the commenters' support. The Department does not regulate the processing time for repayment plan applications but will work through pending applications as quickly as possible. The Department is working to build a version of the SAVE plan that complies with the Eighth Circuit's injunction. That plan would generally have the same terms as the 2015 REPAYE rule with respect to the monthly payment amounts for borrowers. At this time, the Department anticipates that such work will not be completed until at least the early fall of 2025.
                </P>
                <P>
                    <E T="03">Changes:</E>
                     None.
                </P>
                <HD SOURCE="HD2">General Opposition</HD>
                <P>
                    <E T="03">Comments:</E>
                     Several commenters noted that they did not find the reopening of PAYE and ICR to be sufficient to address borrower challenges with loan repayment. Many noted that they were enrolled in the REPAYE plan before it converted to SAVE and had no issues with payments under REPAYE. They asked for a restoration of the REPAYE terms or asked to be placed on an alternative payment plan with the same payments that they had previously. Many stated that being placed in forbearance when they had not requested forbearance was unfair.
                </P>
                <P>
                    <E T="03">Discussion:</E>
                     The Department is working to create a version of the SAVE plan that complies with the terms of the Eighth Circuit injunction. This plan will be largely similar to the terms of the REPAYE plan, with the exception that the injunction prevents the Department from providing the interest benefits that were also provided under the REPAYE plan. Both the 2015 REPAYE plan and the SAVE plan provided that a borrower with a subsidized loan would not be charged any unpaid interest for the first three years while enrolled in the plan and that all borrowers with subsidized or unsubsidized loans would only be charged 50 percent of unpaid interest after the first three years enrolled in the 
                    <PRTPAGE P="3698"/>
                    plan. Until that revised plan is available, the Department will keep borrowers who remain enrolled in the SAVE plan in forbearance and interest will not accrue.
                </P>
                <P>
                    <E T="03">Changes:</E>
                     None.
                </P>
                <P>
                    <E T="03">Comments:</E>
                     One commenter believed that the regulations in the IFR represented an inadequate solution to a problem that ultimately was created from another inadequate solution: the Department moved people who were enrolled in the REPAYE plan into the SAVE plan and ultimately forced those borrowers into forbearance. This commenter recommended that the Department simply roll back the SAVE regulations and bring back REPAYE. This commenter asserted that by forcing people into SAVE, millions of borrowers will be left with no option but to default shortly otherwise.
                </P>
                <P>Commenters also suggested that REPAYE be reinstated and that borrowers who were previously enrolled in the REPAYE plan automatically be re-enrolled in that plan.</P>
                <P>
                    <E T="03">Discussion:</E>
                     We disagree with commenters regarding their proposed changes to IDR plans. As we explained in the 2023 IDR final rule, the changes to the REPAYE plan that resulted in renaming it the SAVE plan made it the best choice for the vast majority of borrowers. And, for borrowers with a non-zero payment enrolled in REPAYE, the new SAVE plan would provide them with more affordable monthly payments. Automatically providing those benefits to borrowers without requiring the borrower to switch plans was simpler and more efficient.
                </P>
                <P>Regarding the requests to restore REPAYE, the Department is working to update the SAVE plan to make it compliant with the Eighth Circuit's injunction. That would result in monthly payment amounts that are similar to those that were available to borrowers enrolled in REPAYE.</P>
                <P>
                    <E T="03">Changes:</E>
                     None.
                </P>
                <P>
                    <E T="03">Comments:</E>
                     Several commenters noted the reopening of PAYE would not benefit them because they did not qualify for that plan because their loans were older. Many noted that being ineligible for PAYE meant that the IDR options available to them would result in much higher payments than what they had owed while enrolled in REPAYE. Some commenters called for the Department to expand eligibility for PAYE to older loans that are not currently eligible for that plan or to make Direct Consolidation Loans made after 2007 eligible. Others said that if the Department did not make REPAYE available then it should expand the eligibility for PAYE.
                </P>
                <P>
                    <E T="03">Discussion:</E>
                     In pursuing changes through the IFR the Department considered narrow and time-limited solutions that address the current situation, and the IFR therefore restored the eligibility for other repayment plans to what was in effect prior to the issuance of the IDR final rule. The reopening of PAYE and ICR to borrowers not previously enrolled in those plans fulfills the Department's obligations because a borrower who is ineligible for PAYE could still choose ICR. We recognize that the ICR plan may not result in the lowest payment for many borrowers. However, as explained in the IFR, we are making a time-limited and narrow change to address the Department's compliance with the HEA. Any other changes to PAYE would need to be considered through the full regulatory process.
                </P>
                <P>
                    <E T="03">Changes:</E>
                     None.
                </P>
                <P>
                    <E T="03">Comments:</E>
                     One commenter argued that if the Department cannot provide equivalent repayment options regardless of loan origination date, then the Department should write off those older loans.
                </P>
                <P>
                    <E T="03">Discussion:</E>
                     The commenter did not identify a legal basis for writing off the loans they addressed. The eligibility dates for PAYE were established through a separate rulemaking process conducted in 2012 and a similar process would be needed to adjust the eligibility dates for PAYE.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         77 FR 66088 (November 1, 2012).
                    </P>
                </FTNT>
                <P>
                    <E T="03">Changes:</E>
                     None.
                </P>
                <P>
                    <E T="03">Comments:</E>
                     Several commenters raised concerns about the inability of borrowers to make progress on PSLF while enrolled in the SAVE forbearance. They called for the Department to make that forbearance eligible for PSLF.
                </P>
                <P>
                    <E T="03">Discussion:</E>
                     As the Department has indicated, we do not have the ability to award credit toward forgiveness on PSLF during the SAVE-related forbearance. The reopening of the PAYE and ICR plans provides a path for some additional PSLF borrowers to make payments that will count toward forgiveness.
                </P>
                <P>
                    <E T="03">Changes:</E>
                     None.
                </P>
                <P>
                    <E T="03">Comments:</E>
                     One group strongly opposed the Department's rule to exclude the “double consolidation loophole” for consolidation loans that repaid a parent PLUS loan from repayment plans and argued that it was contrary to the HEA. They called for the Department to at least extend the deadline after which double consolidated parent PLUS loans could not access repayment plans besides ICR from July 1, 2025.
                </P>
                <P>
                    <E T="03">Discussion:</E>
                     The Department declines to adopt any changes to the treatment of parent PLUS borrowers in this final rule. As noted in the IFR, the Department is focused on a narrow change to make sure that we are meeting our obligation to offer borrowers an income-contingent repayment plan under section 455(d)(1) of the HEA. The Department already met this obligation with respect to Parent PLUS borrowers with a consolidation loan because there was no deadline for them to access the ICR plan. The Eighth Circuit's injunction does not affect the ability of borrowers to consolidate their loans as processing of those applications continues. As such, we see no grounds for extending that deadline.
                </P>
                <P>The Department also declines to change the overall eligibility for consolidated Parent PLUS borrowers. This issue was carefully considered during negotiated rulemaking and the notice and comment process that produced the IDR final rule.</P>
                <P>
                    <E T="03">Changes:</E>
                     None.
                </P>
                <HD SOURCE="HD1">Executive Orders 12866, 13563, and 14094</HD>
                <HD SOURCE="HD1">Regulatory Impact Analysis</HD>
                <P>Under Executive Order 12866, the Office of Management and Budget (OMB) must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive Order and subject to review by OMB. Section 3(f) of Executive Order 12866, as amended by Executive Order 14094, defines a “significant regulatory action” as an action likely to result in a rule that may—</P>
                <P>(1) Have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) at OMB for changes in gross domestic product), or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities;</P>
                <P>(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;</P>
                <P>(3) Materially alter the budgetary impacts of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or</P>
                <P>
                    (4) Raise legal or policy issues for which centralized review would meaningfully further the President's priorities, or the principles stated in the Executive Order, as specifically authorized in a timely manner by the Administrator of OIRA in each case.
                    <PRTPAGE P="3699"/>
                </P>
                <P>This proposed regulatory action is a significant regulatory action subject to review by OMB under section 3(f)(4) of Executive Order 12866, as amended by Executive Order 14094. However, the proposed annual net budget effect is not larger than $200 million, and as a result this regulatory action is not significant under section 3(f)(1) of Executive Order 12866, as amended by Executive Order 14094. We have assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action and have determined that the benefits will justify the costs.</P>
                <P>We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—</P>
                <P>(1) Propose or adopt regulations only on a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);</P>
                <P>(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and considering—among other things and to the extent practicable—the costs of cumulative regulations;</P>
                <P>(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);</P>
                <P>(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and</P>
                <P>(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.</P>
                <P>Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” OIRA has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”</P>
                <P>We are issuing these final regulations only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that in the Department's estimation best balance the size of the estimated transfer and qualitative benefits and costs. Based on the analysis that follows, the Department believes that these final regulations are consistent with the principles in Executive Order 13563.</P>
                <P>We have also determined that this regulatory action will not unduly interfere with State, local, territorial, and Tribal governments in the exercise of their governmental functions.</P>
                <P>Consistent with Circular A-4, we compare the final regulations to the current regulations. In this regulatory impact analysis, we discuss the need for regulatory action and summarize key provisions, potential costs and benefits, net budget impacts, and the regulatory alternatives we considered.</P>
                <P>
                    Elsewhere in this section under 
                    <E T="03">Paperwork Reduction Act,</E>
                     we identify and explain burdens specifically associated with information collection requirements.
                </P>
                <HD SOURCE="HD2">1. Congressional Review Act</HD>
                <P>
                    Pursuant to the Congressional Review Act (5 U.S.C. 801 
                    <E T="03">et seq.</E>
                    ), OIRA has found that this rule does not meet the criteria in 5 U.S.C. 804(2).
                </P>
                <HD SOURCE="HD2">2. Need for Regulatory Action</HD>
                <P>As discussed earlier in this document, these regulations allow the Department to offer at least one repayment option under the income-contingent repayment authority to borrowers on a time-limited basis while the Department actively works to carry out the operational steps necessary to offer an injunction-compliant version of the SAVE plan.</P>
                <HD SOURCE="HD2">3. Summary of Comments and Changes From the Interim Final Rule</HD>
                <P>None of the submitted comments addressed the RIA, and there are no changes from the interim final rule to the final rule.</P>
                <HD SOURCE="HD2">4. Discussion of Costs, Benefits and Transfers</HD>
                <P>This rule finalizes an adjustment to the eligibility requirements that allow borrowers to enroll in the ICR and PAYE plans until July 1, 2027, an extension from the prior date of July 1, 2024.</P>
                <P>
                    As described further in the 
                    <E T="03">Net Budget Impact</E>
                     section of this RIA, the Department does not estimate a significant budgetary impact from this regulation. For existing borrowers, the Department already assumes in our budget baseline that borrowers who would benefit from PAYE or ICR over SAVE in the long term are already enrolled in those plans. As noted in the IDR Final Rule that established the SAVE plan,
                    <SU>9</SU>
                    <FTREF/>
                     the Department's budget modeling assigns IDR borrowers to specific plans based on a comparison of the net present value of the payments the borrower makes under the various plans for which they are eligible. For future borrowers, we anticipate continued availability of the SAVE plan and do not evaluate borrowers having the choice of ICR or PAYE against income-based repayment (IBR) in the absence of SAVE. Moreover, the time-limited nature of these changes means that only a future borrower who enters repayment by July 1, 2027, would be able to select the ICR or PAYE plans.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         88 FR 43820 (July 10, 2023).
                    </P>
                </FTNT>
                <P>The primary benefit of these changes for the Department is that they allow us to meet our statutory obligation under the HEA to offer payments under the income-contingent repayment authority. There may also be secondary benefits to the Department. One is the possibility that borrowers will choose to enroll in PAYE or ICR instead of becoming delinquent or going into default. Another is a possible reduction in questions or concerns from borrowers, such as those seeking PSLF forgiveness, who are trying to determine how to make qualifying monthly payments.</P>
                <P>
                    Borrowers who elect to enroll in the PAYE or ICR plans during this time-limited period may also see benefits, which could include additional certainty about their payment amounts in the face of litigation as well as the ability to make progress toward certain types of forgiveness during the time until the pending cases are resolved. For instance, there are approximately 200,000 borrowers enrolled in the SAVE plan who have certified at least some employment toward PSLF, and who are eligible for the PAYE plan, but who are not eligible for the terms of the IBR plan offered to borrowers who first took out a loan on or after July 1, 2014. If these individuals choose to sign up for PAYE, they would be able to continue making progress toward PSLF by making payments equal to 10 percent of their discretionary income. By contrast, if these borrowers did not have access to PAYE, they would have to choose a version of the IBR plan that sets their payments at 15 percent of discretionary income. For instance, a single borrower who makes $60,000 a year would pay $318 a month when enrolled in PAYE instead of $477 if enrolled in the older IBR plan, a savings of $159. It is possible that there may be other borrowers enrolled in SAVE who would consider a switch on a temporary basis, such as a borrower who would have a $0 payment when enrolled in either 
                    <PRTPAGE P="3700"/>
                    PAYE or ICR. There were also just over 800,000 borrowers who switched from either of these plans into SAVE after its creation.
                </P>
                <P>
                    Beyond borrowers currently enrolled in SAVE, there are approximately 13.9 million borrowers who are in repayment and who do not have Parent PLUS loans who are not currently enrolled in an income-contingent repayment plan.
                    <SU>10</SU>
                    <FTREF/>
                     While the Department cannot speculate on how many of these borrowers may want to sign up for either ICR or PAYE, depending on their eligibility, the Department is not currently meeting its obligations under the HEA to provide these borrowers with an income-contingent repayment option.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         We exclude borrowers with a Parent PLUS loan because those who consolidate would have access to the ICR plan regardless of this final rule. This number also excludes borrowers in deferments.
                    </P>
                </FTNT>
                <P>The monthly payment savings described above would be similar for any borrower with older loans that are not eligible for the version of IBR for newer borrowers but who is eligible for PAYE. This could include borrowers who have recently returned to repayment through the Department's Fresh Start Initiative, which allowed borrowers to take certain steps to get their loans out of default. It also could include borrowers with older loans who are now considering IDR plans.</P>
                <P>The IFR anticipated administrative costs of $400,000 to reflect the costs of updating systems to allow borrowers to access PAYE and ICR. Those costs have already been incurred and paid as we implemented the IFR. There are no additional administrative costs from this final rule.</P>
                <P>
                    The ability to select PAYE or ICR could also create costs in the form of transfers if borrowers are able to select plans that produce lower payments over the borrower's time in repayment. The nature and extent of these costs depends on baseline policy, namely what other plans are available and the terms of those plans. We do not anticipate these costs will be significant, as we discuss in the 
                    <E T="03">Net Budget Impact</E>
                     section.
                </P>
                <P>There may be additional costs related to the potential that borrowers may have a harder time choosing among repayment plans. However, we think several factors mitigate this concern. One is that, until a version of the SAVE plan that is compliant with the court injunction is available, the number of options for borrowers to make payments while enrolled in an income-contingent repayment plan will not be appreciably larger. For some borrowers, the ICR plan may be their only option, while the choice for borrowers who are eligible for PAYE and ICR should be simple, because the former generally produces lower payments for most borrowers. Over the long run, the time-limited nature of these changes means that eventually borrowers will go back to choosing the SAVE plan, or the ICR plan if they have a consolidation loan that repaid a Parent PLUS loan. The Department will also continue working to improve and update tools available to help borrowers choose their repayment plan.</P>
                <HD SOURCE="HD2">5. Net Budget Impact</HD>
                <P>
                    As the Department expects the SAVE plan to be available and advantageous to most borrowers in the long run, we do not estimate a significant budget impact from making PAYE and ICR available again to eligible borrowers, including those who had chosen SAVE. As was noted in the IDR final rule that created the SAVE plan (88 FR 43820), the Department's budget modeling assigns IDR borrowers to specific plans based on a comparison of the net present value of the payments the borrower makes under the various plans for which they are eligible.
                    <SU>11</SU>
                    <FTREF/>
                     That means the borrowers we estimate would be better off enrolled in PAYE or ICR are already in that plan in the President's Budget for FY 2025 (PB2025) baseline. These borrowers are generally going to be those who have graduate school related debt and those with incomes that are expected to rise to the point where their calculated payment would eventually be equal to or greater than what they would owe while enrolled in the 10-year standard repayment plan. These borrowers might be better off enrolled in PAYE because the terms of PAYE, absent the current injunction, provide for forgiveness after 20 years of payments instead of the 25 years when enrolled in IBR if the loan was borrowed before July 1, 2014, or the 25 years for graduate borrowers enrolled in SAVE.
                    <SU>12</SU>
                    <FTREF/>
                     In addition, PAYE caps payments at the amount determined under the 10-year standard plan for borrowers so long as their payments were below that level when they first enrolled. By contrast, there is no payment cap in SAVE. With this assumption that borrowers know their income and family profile trajectories over the life of their loans and choose the plan that offers the lowest lifetime, present-discounted payments, the regulation provides borrowers with an option to enroll in a non-SAVE income-contingent repayment plan that does not have a significant scoreable budgetary impact.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         88 FR 43886 (July 10, 2023).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Forgiveness on income-contingent repayment plans that is based on the income-contingent repayment authority is currently enjoined, but the modeling discussed here took place prior to that injunction.
                    </P>
                </FTNT>
                <P>However, there is considerable uncertainty regarding when borrowers who enroll in SAVE may see their payments resume due to ongoing litigation. A lengthy forbearance for borrowers enrolled in the SAVE plan could lead some borrowers to decide to enroll in a different income-contingent repayment plan if that would result in a lower net present value of payments. To evaluate this, the Department has done a sensitivity analysis that includes a nine-month forbearance in FY 2025 that does not count toward IDR forgiveness with the PB2025 baseline SAVE borrowers and compared that to a run with the SAVE or PAYE/ICR choice redone to include that forbearance in the choice decision. As is the case for the baseline choice decision, the plan choice for the sensitivity is based on the net present value (NPV) at a 30 percent discount rate between the cashflow streams for each plan generated for the borrower sample. This is the approach the Department has used for modeling IDR plan choice decisions and considers changes across the entire payment stream. This approach assumes borrowers know their income and family profile trajectories over the life of their loans and choose the plan that offers the lowest lifetime, present-discounted payments. The Department recognizes that borrowers may use different logic when choosing a repayment plan, such as comparing near-term monthly payments, and will not have information about their future incomes and family patterns to match this type of analysis, but we believe any decision logic would result in a relatively small percentage of borrowers choosing to revert to PAYE or ICR long-term. The sensitivity run resulted in a cost of $70.5 million, which represents the effect of the change in payments on the estimated net present value of all future non-administrative Federal costs associated with cohorts of loans.</P>
                <HD SOURCE="HD2">6. Accounting Statement</HD>
                <P>
                    Consistent with OMB Circular A-4, we have prepared an accounting statement showing the classification of the expenditures associated with the provisions of these regulations. These effects occur over the lifetime of the first ten loan cohorts following implementation of this rule. The cashflows are discounted to the year of the origination cohort in the modeling process and then those amounts are discounted at two percent to the present year in this Accounting Statement. This 
                    <PRTPAGE P="3701"/>
                    table provides our best estimate of the changes in annualized monetized transfers that result from these final regulations. Expenditures are classified as transfers from the Federal government to affected student loan borrowers.
                </P>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s200,xs72">
                    <TTITLE>Table 6.1—Accounting Statement: Classification of Estimated Expenditures</TTITLE>
                    <TDESC>[In millions]</TDESC>
                    <BOXHD>
                        <CHED H="1">Category</CHED>
                        <CHED H="1">Benefits</CHED>
                    </BOXHD>
                    <ROW RUL="s">
                        <ENT I="01">Complying with statutory requirements to offer an income-contingent repayment plan</ENT>
                        <ENT>Not quantified.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="25">Category</ENT>
                        <ENT>
                            Costs
                            <LI>2%</LI>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">One-time administrative costs to Federal government to update systems and contracts to implement the final regulations</ENT>
                        <ENT>$0.4.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="25">Category</ENT>
                        <ENT>
                            Transfers
                            <LI>2%</LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Reduced transfers from borrowers based on borrowers now accessing PAYE or ICR</ENT>
                        <ENT>Not quantified.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD2">7. Alternatives Considered</HD>
                <P>The Department considered one alternative in issuing this final rule. We considered further adjusting the eligibility dates of PAYE to allow borrowers with older loans to access this plan. Doing so would have been responsive to commenters who noted that they are not currently eligible for PAYE and that their options while enrolled in IBR would result in significant payment increases, and that the entire situation was created by reasons outside of their control. However, we determined such a change would need to be made by following a full rulemaking process.</P>
                <HD SOURCE="HD2">8. Regulatory Flexibility Act</HD>
                <P>
                    The Secretary certifies, under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ), that this final regulatory action will not have a significant economic impact on a substantial number of “small entities.” 
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         5 U.S.C. 601(3), (4), (5), and (6) defines 
                        <E T="03">small business, small organization, small governmental jurisdiction,</E>
                         and 
                        <E T="03">small entity,</E>
                         respectively.
                    </P>
                </FTNT>
                <P>These regulations will not have a significant impact on a substantial number of small entities because they are focused on arrangements between individual borrowers and the Department. There are no small entities that are impacted by this rule. This rule does not affect institutions of higher education in any way, and those entities are typically the focus of the Regulatory Flexibility Act analysis for the Department of Education.</P>
                <HD SOURCE="HD2">9. Paperwork Reduction Act</HD>
                <P>We have determined that there are no Paperwork Reduction Act of 1995 implications specifically associated with regulations in this final rule. Borrowers who wish to sign up for PAYE or ICR repayment plans under this Final Rule will be completing the form that already exists for enrollment in other IDR plans, OMB Control Number 1845-0102. To accommodate the changes made to the programs in the IDR final rule and the court challenges, we are separately updating the current IDR form and will be providing a public comment period. We do not estimate any new burden to 1845-0102 from this final rule.</P>
                <HD SOURCE="HD2">10. Intergovernmental Review</HD>
                <P>This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive Order is to foster an intergovernmental partnership and a strengthened Federalism. The Executive Order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.</P>
                <HD SOURCE="HD2">11. Assessment of Educational Impact</HD>
                <P>In the IFR we requested comments on whether the proposed regulations would require transmission of information that any other agency or authority of the United States gathers or makes available. Based on the response to the IFR and on our review, we have determined that these final regulations do not require transmission of information that any other agency or authority of the United States gathers or makes available.</P>
                <HD SOURCE="HD2">12. Federalism</HD>
                <P>Executive Order 13132 requires us to provide meaningful and timely input by State and local elected officials in the development of regulatory policies that have Federalism implications. “Federalism implications” means substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. The regulations do not have Federalism implications.</P>
                <P>
                    <E T="03">Accessible Format:</E>
                     On request to the program contact person(s) listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    , individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, Braille, large print, audiotape, or compact disc, or another accessible format.
                </P>
                <P>
                    <E T="03">Electronic Access to This Document:</E>
                     The official version of this document is the document published in the 
                    <E T="04">Federal Register</E>
                    . You may access the official edition of the 
                    <E T="04">Federal Register</E>
                     and the Code of Federal Regulations at 
                    <E T="03">www.govinfo.gov.</E>
                     You can view this document, as well as all other Department documents published in the 
                    <E T="04">Federal Register</E>
                    , in text or Adobe Portable Document Format (PDF) at this site. To use PDF, you must have Adobe Acrobat Reader, which is available free at the site.
                </P>
                <P>
                    You may also access Department documents published in the 
                    <E T="04">Federal Register</E>
                     by using the article search feature at 
                    <E T="03">www.federalregister.gov.</E>
                     Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 34 CFR Part 685</HD>
                    <P>
                        Administrative practice and procedure, Colleges and universities, Education, Loan programs-education, Reporting and recordkeeping 
                        <PRTPAGE P="3702"/>
                        requirements, Student aid, Vocational education.
                    </P>
                </LSTSUB>
                <SIG>
                    <NAME>Miguel Cardona,</NAME>
                    <TITLE>Secretary of Education.</TITLE>
                </SIG>
                <REGTEXT TITLE="34" PART="685">
                    <AMDPAR>For the reasons stated in the preamble, the Department adopts the interim rule published on November 15, 2024, at 89 FR 90221, as final without change.</AMDPAR>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00724 Filed 1-13-25; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 60</CFR>
                <DEPDOC>[EPA-HQ-OAR-2023-0072; FRL-12547-01-OAR]</DEPDOC>
                <SUBJECT>New Source Performance Standards for Greenhouse Gas Emissions From New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for Greenhouse Gas Emissions From Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule; Final Action</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of final action denying or partially denying petitions for reconsideration.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The U.S. Environmental Protection Agency (EPA) is providing notice that it has responded to two petitions for reconsideration of the final action titled, “New Source Performance Standards for Greenhouse Gas Emissions From New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for Greenhouse Gas Emissions From Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule”, published in the 
                        <E T="04">Federal Register</E>
                         on May 9, 2024. The Administrator has denied or partially denied the requests for reconsideration in separate letters to the petitioners. The basis for the EPA's action is set out fully in the accompanying decision document, available in the rulemaking docket. At this time, the EPA is not addressing other grounds for reconsideration that have been raised by these or other petitioners.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Lisa Thompson (she/her), Sector Policies and Programs Division (D243-02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-5158; and email address: 
                        <E T="03">thompson.lisa@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Where can I get a copy of this document and other related information?</HD>
                <P>
                    A copy of this 
                    <E T="04">Federal Register</E>
                     notice, the petitions for reconsideration, the letters denying the petitions and the accompanying decision document describing the full basis for the partial denial of these petitions are available in the docket the EPA established under Docket ID No. EPA-HQ-OAR-2023-0072. In addition, an electronic copy of this final action will be available on the internet at 
                    <E T="03">https://www.epa.gov/stationary-sources-air-pollution/greenhouse-gas-standards-and-guidelines-fossil-fuel-fired-power.</E>
                </P>
                <HD SOURCE="HD1">II. Judicial Review</HD>
                <P>
                    This final action may be challenged in the United States Court of Appeals for the District of Columbia Circuit. Pursuant to CAA section 307(b)(1), petitions for judicial review of this action must be filed in that court within 60 days after the date notice of this final action is published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>Section 307(b)(1) of the Clean Air Act (CAA) governs judicial review of final actions by the EPA. This section provides, in part, that “a petition for review of action of the Administrator in promulgating . . . any standard of performance or requirement under section [111] of [the CAA],” or “any other nationally applicable regulations promulgated, or final action taken, by the Administrator under [the CAA] may be filed only in the United States Court of Appeals for the District of Columbia.” This final action is “nationally applicable” within the meaning of CAA section 307(b)(1) because it denies or partially denies petitions to reconsider the “New Source Performance Standards for Greenhouse Gas Emissions From New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for Greenhouse Gas Emissions From Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule,” which is a nationally applicable final action promulgating standards of performance and requirements under section 111 of the CAA. 89 FR 39798 (May 9, 2024) (“Carbon Pollution Standards”). This final action is nationally applicable because the result of this denial or partial denial of the petitions identified herein is that the Carbon Pollution Standards remain in place and undisturbed, and because any judicial order disturbing the EPA's reasoning herein would affect regulated entities throughout the nation.</P>
                <P>Thus, any petitions for review of this final action denying or partially denying petitioners' requests for reconsideration must be filed in the United States Court of Appeals for the District of Columbia Circuit by March 17, 2025.</P>
                <HD SOURCE="HD1">III. Description of Action</HD>
                <P>
                    On May 9, 2024, pursuant to CAA section 111 of the CAA, the EPA published a final action titled “New Source Performance Standards for Greenhouse Gas Emissions From New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for Greenhouse Gas Emissions From Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule.” 89 FR 39798 (May 9, 2024). Following publication of this final action, the Administrator received petitions for reconsideration of certain aspects of the Carbon Pollution Standards pursuant to the Administrative Procedure Act and Clean Air Act.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         One petitioner (Mountain State Energy Holdings, LLC) cited both the APA and CAA as bases for reconsideration and rulemaking; the second petitioner (Edison Electric Institute) did not cite any specific authority for its request for reconsideration.
                    </P>
                </FTNT>
                <P>The EPA carefully reviewed and evaluated each of these issues raised in the petitions for reconsideration based on the CAA section 307(d)(7)(B) criteria for reconsideration, as well as under section 553(e) of the Administrative Procedure Act (APA). For the reasons explained below, the EPA is denying, in part or whole, two petitions for reconsideration; specifically, the objections raised regarding EPA's treatment of grid reliability, financing assertions related to new baseload natural gas-fired electric generation units (EGUs), and the inclusion of an enforceable backstop emissions rate in conjunction with mass-based compliance flexibilities for existing coal-fired steam-generating EGUs.</P>
                <P>
                    We discuss each of the petitions we are denying or partially denying and the basis for those denials in the accompanying decision document titled “The EPA's Basis for Denying, in Part or Whole, Petitions for Reconsideration of the New Source Performance Standards for Greenhouse Gas Emissions From New, Modified, and Reconstructed Fossil Fuel-Fired Electric Generating Units; Emission Guidelines for 
                    <PRTPAGE P="3703"/>
                    Greenhouse Gas Emissions From Existing Fossil Fuel-Fired Electric Generating Units; and Repeal of the Affordable Clean Energy Rule,” available in the rulemaking docket. At this time, the EPA is not addressing other grounds for reconsideration that have been raised by these or other petitioners.
                </P>
                <SIG>
                    <NAME>Jane Nishida,</NAME>
                    <TITLE>Acting Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00659 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">COUNCIL ON ENVIRONMENTAL QUALITY</AGENCY>
                <CFR>40 CFR Part 1518</CFR>
                <RIN>RIN 0331-AA09</RIN>
                <SUBJECT>Office of Environmental Quality Management Fund</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Council on Environmental Quality.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Council on Environmental Quality (CEQ) is amending its Office of Environmental Quality Management Fund regulations to clarify their meaning, modernize them to reflect developments in CEQ's practices in administering the Office of Environmental Quality Management Fund (the Management Fund) since CEQ first adopted its regulations, and make administrative changes.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Samuel Roth, Associate General Counsel, 202-395-5750, 
                        <E T="03">Samuel.E.Roth@ceq.eop.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    The Environmental Quality Improvement Act, as amended (Pub. L. 91-224, Title II, April 3, 1970; Pub. L. 97-258, September 13, 1982; and Pub. L. 98-581, October 30, 1984) established the Management Fund to receive advance payments from other agencies or accounts that may be used solely to finance (1) study contracts that are jointly sponsored by the Office of Environmental Quality (OEQ) and one or more other Federal agencies; and (2) Federal interagency environmental projects (including task forces) in which OEQ participates. 42 U.S.C. 4375(a). The statute requires the Director of the Office of Environmental Quality (OEQ) to promulgate regulations setting forth policies and procedures for operation of the OEQ Management Fund. 42 U.S.C. 4375(c).
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         OEQ houses the professional and administrative staff of CEQ, and the Chair of CEQ is the Director of OEQ 
                        <E T="03">ex officio.</E>
                         42 U.S.C. 4372(a), (d)(1). This preamble refers to the Chair of CEQ and the Director of OEQ, and to CEQ and OEQ, interchangeably.
                    </P>
                </FTNT>
                <P>
                    The CEQ Chair approved internal policies and procedures for operation of the Management Fund in January 1985. On October 4, 2002, the CEQ Chair promulgated regulations governing the operation of the Management Fund.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         CEQ, Office of Environmental Quality Management Fund, 67 FR 62189 (Oct. 4, 2002).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Summary of the Final Rule</HD>
                <P>
                    CEQ is amending its Management Fund regulations to clarify their meaning, including for consistency with the Plain Writing Act of 2010 (Pub. L. 111-274) and the Federal Plain Language Guidelines,
                    <SU>3</SU>
                    <FTREF/>
                     modernize them to reflect developments in CEQ's practices in administering the Management Fund since CEQ first adopted its regulations, and make administrative changes.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Federal Plain Language Guidelines (1st rev. May 2011), 
                        <E T="03">https://www.plainlanguage.gov/media/FederalPLGuidelines.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    <E T="03">Section 1518.1</E>
                    —
                    <E T="03">Purpose.</E>
                     CEQ revises this section to describe the purpose of the Office of Environmental Quality Management Fund as well as the purpose of part 1518, which is to set forth CEQ's procedures for administering the Management Fund.
                </P>
                <P>
                    <E T="03">Section 1518.2</E>
                    —
                    <E T="03">Definitions.</E>
                     CEQ revises this section to define key terms that appear throughout part 1518. In particular, CEQ removes the definitions of the terms “advance payment,” which the prior regulations defined but did not use elsewhere in part 1518, and “source,” which no longer appears in the regulations as revised. CEQ adds definitions for “environmental project” and “study contract” to clarify the meaning of those terms. These definitions are consistent with CEQ's authorities under National Environmental Policy Act of 1969 (NEPA) and the Environmental Quality Improvement Act of 1970. CEQ also adds a definition of “personnel costs” to clarify the types of expenditures that CEQ may make from the Management Fund. Finally, CEQ adds definitions for “payment” and “reallocation” to clarify how the regulations use those terms to describe the movement of funds to and from the Management Fund.
                </P>
                <P>
                    <E T="03">Section 1518.3</E>
                    —
                    <E T="03">Policy and general requirements.</E>
                     CEQ revises this section to more clearly explain the internal policies and procedures by which CEQ administers the Management Fund, including the types of expenditures that CEQ may make from the Management Fund, and to eliminate outdated provisions that no longer reflect CEQ's business processes.
                </P>
                <P>
                    <E T="03">Section 1518.4</E>
                    —
                    <E T="03">Charters.</E>
                     CEQ revises this section, which describes the purpose of charters for environmental projects and study contracts that receive support from the Management Fund, to more clearly set forth what a charter must contain and to better explain the roles of the Director and the Project Officer in approving and amending a charter.
                </P>
                <P>
                    <E T="03">Section 1518.5</E>
                    —
                    <E T="03">Finances and accounting.</E>
                     CEQ moves the provisions on Management Fund finances and accounting from the previous 40 CFR 1518.4(b) to § 1518.5. This section explains how agencies make payments into the Management Fund and specifies procedures for making expenditures from the Management Fund. CEQ makes clarifying changes to this section to improve its readability and better reflect current practices. Paragraph (a) requires the Project Officer for each environmental project or study contract receiving support from the Management Fund to prepare a budget estimate and update it annually. CEQ adds a new provision in paragraph (c)(1) that, consistent with longstanding practice, requires the Director to transmit a letter to an agency when requesting a payment into the Management Fund.
                </P>
                <HD SOURCE="HD1">III. Regulatory Analysis and Notices</HD>
                <HD SOURCE="HD2">A. Administrative Procedure Act</HD>
                <P>This rule relates to a matter of agency management or personnel and is a rule of agency organization, procedure, or practice. As such, this rule is exempt from the usual requirements of prior notice and comment and a 30-day delay in effective date. See 5 U.S.C. 553(a)(2), (b), and (d). The rule is effective upon signature.</P>
                <HD SOURCE="HD2">B. Regulatory Flexibility Act and Executive Order 13272, Proper Consideration of Small Entities in Agency Rulemaking</HD>
                <P>
                    The Regulatory Flexibility Act (RFA), as amended, 5 U.S.C. 601 
                    <E T="03">et seq.,</E>
                     and E.O. 13272, 
                    <E T="03">Proper Consideration of Small Entities in Agency Rulemaking,</E>
                    <SU>4</SU>
                    <FTREF/>
                     require agencies to assess the impacts of rules on small entities. Under the RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. An agency must prepare a final regulatory flexibility analysis unless it determines and certifies that a final rule, if 
                    <PRTPAGE P="3704"/>
                    promulgated, would not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 605(b).
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         67 FR 53461 (Aug. 16, 2002).
                    </P>
                </FTNT>
                <P>This rule relates to a matter of agency management or personnel and is a rule of agency organization, procedure, or practice. Accordingly, CEQ hereby certifies that the rule will not have a significant economic impact on a substantial number of small entities.</P>
                <HD SOURCE="HD2">C. Unfunded Mandates Reform Act</HD>
                <P>Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), requires Federal agencies to assess the effects of their regulatory actions on state, local, and Tribal governments, and the private sector to the extent that such regulations incorporate requirements specifically set forth in law. Before promulgating a rule that may result in the expenditure by a state, Tribal, or local government, in the aggregate, or by the private sector of $100 million, adjusted annually for inflation, in any 1 year, an agency must prepare a written statement that assesses the effects on state, Tribal, and local governments and the private sector. 2 U.S.C. 1532. This rule relates to a matter of agency management or personnel and is a rule of agency organization, procedure, or practice, and accordingly will not result in expenditures of $100 million or more for state, local, and Tribal governments, in the aggregate, or the private sector in any 1 year. This rule also does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of 2 U.S.C. 1531 through 1538.</P>
                <HD SOURCE="HD2">D. Executive Order 12866, Regulatory Planning and Review</HD>
                <P>
                    E.O. 12866, as supplemented and affirmed by E.O. 13563 and amended by E.O. 14094, provides that the Office of Information and Regulatory Affairs will review any regulatory action that qualifies as a “significant regulatory action” within the meaning of the E.O.
                    <SU>5</SU>
                    <FTREF/>
                     The rule does not qualify as a significant regulatory action.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         E.O. 12866, 
                        <E T="03">Regulatory Planning and Review,</E>
                         58 FR 51735, 51737 (Oct. 4, 1993); E.O. 14094, 
                        <E T="03">Modernizing Regulatory Review,</E>
                         88 FR 21879, 21879-80 (Apr. 11, 2023); E.O. 13563, 
                        <E T="03">Improving Regulation and Regulatory Review,</E>
                        76 FR 3821, 3822 (Jan. 21, 2011).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">E. Executive Order 12988, Civil Justice Reform</HD>
                <P>
                    Under section 3(a) of E.O. 12988,
                    <SU>6</SU>
                    <FTREF/>
                     agencies must review their regulations to eliminate drafting errors and ambiguities, draft them to minimize litigation, and provide a clear legal standard for affected conduct. Section 3(b) provides a list of specific matters that agencies must consider when conducting the review required by section 3(a). CEQ has conducted this review and determined that this rule complies with the requirements of E.O. 12988.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         61 FR 4729 (Feb. 7, 1996).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">F. Paperwork Reduction Act</HD>
                <P>
                    This rule does not impose any new information collection burden that would require additional review or approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                </P>
                <HD SOURCE="HD2">G. National Environmental Policy Act (NEPA)</HD>
                <P>
                    The National Environmental Policy Act of 1969 (NEPA) (Pub. L. 118-5, 42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ), as amended, and the CEQ regulations that implement NEPA, 40 CFR parts 1500 through 1508, require consideration of the environmental effects of proposed actions in agency decision making. NEPA provides for three levels of review. First, agencies may establish in their agency-specific NEPA procedures categorical exclusions (CEs) for categories of actions that normally do not have a significant effect on the human environment, individually or in the aggregate, and apply CEs to individual actions, as appropriate.
                    <SU>7</SU>
                    <FTREF/>
                     If an agency proposes to take an action that does not fall within a CE but is not likely to have significant environmental effects (or the significance of whose effects is unknown), CEQ's NEPA regulations direct the agency to prepare an environmental assessment (EA).
                    <SU>8</SU>
                    <FTREF/>
                     If, as a result of this assessment, the agency determines that the proposed action will not have significant effects, the agency may make a finding of no significant impact (FONSI), in which case the agency may proceed with the action.
                    <SU>9</SU>
                    <FTREF/>
                     Otherwise, the agency must prepare an environmental impact statement (EIS).
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         40 CFR 1501.4(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">Id.</E>
                         § 1501.5(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">Id.</E>
                         § 1501.6.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         40 CFR part 1502.
                    </P>
                </FTNT>
                <P>CEQ has not established a CE for the preparation, revision, and adoption of regulations generally. Accordingly, CEQ has prepared an EA to determine whether the revisions to the Management Fund regulations would have a significant effect on the human environment. Because, as set forth below, the regulation will likely have no discernable effect on the use of resources in CEQ's administration of the Management Fund, CEQ finds that the regulation will have no significant impact on the human environment and that it is therefore unnecessary to prepare an EIS.</P>
                <HD SOURCE="HD3">1. Environmental Assessment</HD>
                <P>
                    <E T="03">Purpose and Need:</E>
                     As set forth in the Background (part I of this preamble) and Summary of the Final Rule (part II of this preamble), CEQ adopted its Management Fund regulations in 2010 and has not updated them to reflect developments in CEQ's practices in administering the Management Fund since then. Furthermore, clarifying the regulations and making administrative changes will make the regulations easier to understand and use.
                </P>
                <P>
                    <E T="03">Proposed Action and Alternatives:</E>
                     A summary of the proposed action is set forth above in the Summary of the Final Rule. Under a “no action” alternative, CEQ would continue to operate under its current regulations, resolving ambiguities and addressing inconsistencies between the regulations and current CEQ practices on a case-by-case basis. CEQ has decided that this approach is undesirable because it requires CEQ staff to address ambiguities and inconsistencies that CEQ can obviate by updating the regulation.
                </P>
                <P>CEQ's preferred alternative is to amend its regulations as set forth in this Final Rule, for the reasons set forth in part II of this preamble.</P>
                <P>
                    <E T="03">Environmental Effects of Alternatives:</E>
                     CEQ's administration of the Management Fund affects the environment primarily through CEQ's use of energy and other office resources. CEQ's use of resources for these purposes has remained within the range typical of the operations of a small office. CEQ anticipates that the amendments set forth in this rulemaking will have minimal or no discernable effects on its use of resources in administering the Management Fund.
                </P>
                <P>
                    <E T="03">List of Agencies and Persons Consulted:</E>
                     CEQ's NEPA staff reviewed and commented on this EA and this final rulemaking.
                </P>
                <HD SOURCE="HD3">2. Finding of No Significant Impact</HD>
                <P>
                    Based on the foregoing EA, CEQ finds that implementation of the regulations in this notice would have minimal or no discernable effects on CEQ's use of energy and other office resources in CEQ's administration of the Management Fund. Thus, there would be no significant effects associated with implementation of the proposed action, and it is not necessary for CEQ to prepare an EIS.
                    <PRTPAGE P="3705"/>
                </P>
                <P>CEQ further finds that the action is not one that normally requires the preparation of an EIS, closely similar to such an action, or an action without precedent.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 1518</HD>
                    <P>Accounting, Administrative practice and procedure, Environmental impact statements and Environmental Quality Office.</P>
                </LSTSUB>
                <SIG>
                    <NAME>Brenda Mallory,</NAME>
                    <TITLE>Chair, Council on Environmental Quality, and Director, Office of Environmental Quality.</TITLE>
                </SIG>
                <P>For the reasons discussed in the preamble, the Council on Environmental Quality amends 40 CFR part 1518 by revising and republishing it to read as follows:</P>
                <REGTEXT TITLE="40" PART="1518">
                    <PART>
                        <HD SOURCE="HED">PART 1518—OFFICE OF ENVIRONMENTAL QUALITY MANAGEMENT FUND</HD>
                        <CONTENTS>
                            <SECTNO>1518.1</SECTNO>
                            <SUBJECT>Purpose.</SUBJECT>
                            <SECTNO>1518.2</SECTNO>
                            <SUBJECT>Definitions.</SUBJECT>
                            <SECTNO>1518.3</SECTNO>
                            <SUBJECT>Policy and general requirements.</SUBJECT>
                            <SECTNO>1518.4</SECTNO>
                            <SUBJECT>Charters.</SUBJECT>
                            <SECTNO>1518.5</SECTNO>
                            <SUBJECT>Finances and accounting. </SUBJECT>
                        </CONTENTS>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P> 42 U.S.C. 4375.</P>
                        </AUTH>
                        <SECTION>
                            <SECTNO>§ 1518.1</SECTNO>
                            <SUBJECT>Purpose.</SUBJECT>
                            <P>(a) The purpose of the Office of Environmental Quality Management Fund is to finance:</P>
                            <P>(1) Study contracts that the Office of Environmental Quality and at least one other Federal agency jointly sponsor; and</P>
                            <P>(2) Federal interagency environmental projects (including task forces) in which the Office of Environmental Quality participates.</P>
                            <P>(b) The purpose of the regulations in this part is to set forth policies and procedures for operation of the Management Fund, in order to support its effective administration and to set forth the Office of Environmental Quality's internal procedures and practices with respect to the Management Fund.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1518.2</SECTNO>
                            <SUBJECT>Definitions.</SUBJECT>
                            <P>
                                <E T="03">Council on Environmental Quality,</E>
                                 as used in this part, includes the Office of Environmental Quality.
                            </P>
                            <P>
                                <E T="03">Director</E>
                                 means the Director of the Office of Environmental Quality (or delegate). The Environmental Quality Improvement Act, 42 U.S.C. 4372(a), specifies that the Chair of the Council on Environmental Quality serves as the Director of the Office of Environmental Quality.
                            </P>
                            <P>
                                <E T="03">Environmental project</E>
                                 means an official activity pertaining to the environment that requires coordination by or the involvement of the Council on Environmental Quality and other Federal agencies, such as an interagency task force.
                            </P>
                            <P>
                                <E T="03">Interagency agreement</E>
                                 means a document jointly executed by the Office of Environmental Quality and at least one other Federal agency that sets forth the details of a jointly sponsored study contract or environmental project and the funding arrangements for such a study or project.
                            </P>
                            <P>
                                <E T="03">Management Fund</E>
                                 means the Office of Environmental Quality Management Fund.
                            </P>
                            <P>
                                <E T="03">Payment</E>
                                 means a transfer of funds from an agency or another account to the Management Fund.
                            </P>
                            <P>
                                <E T="03">Personnel costs</E>
                                 include an employee's salary or wages and benefits and other direct expenses of employment, such as administrative costs associated with an official background investigation of the employee.
                            </P>
                            <P>
                                <E T="03">Project Officer</E>
                                 means the Federal employee responsible for direct supervision of a study contract or environmental project that receives support from the Management Fund.
                            </P>
                            <P>
                                <E T="03">Reallocation</E>
                                 means a transfer of funds from the Management Fund to another account or between subaccounts of the Management Fund.
                            </P>
                            <P>
                                <E T="03">Study contract</E>
                                 means an agreement with a public or private agency, institution, organization, or individual (including, without limitation, an agency, committee, or official of the Federal Government) to prepare or support the development of a report, analysis, or recommendation.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1518.3</SECTNO>
                            <SUBJECT>Policy and general requirements.</SUBJECT>
                            <P>
                                (a) To receive support from the Management Fund, an environmental project or study contract must advance the purposes and goals of the National Environmental Policy Act, 42 U.S.C. 4321 
                                <E T="03">et seq.,</E>
                                 or the Environmental Quality Improvement Act, 42 U.S.C. 4371 
                                <E T="03">et seq.</E>
                            </P>
                            <P>(b) When the Director accepts agency funds for payment into the Management Fund, the interagency agreement must specify the permissible uses of the funds, and any restrictions relating thereto, such as a limitation on the funds' period of availability, consistent with § 1518.5 of this part.</P>
                            <P>(c) The Director may authorize the Project Officer to make expenditures to support Management Fund study contracts and environmental projects, including:</P>
                            <P>(1) Acquisition of office space, equipment, supplies, and other goods and services, whether by purchase, lease, or otherwise;</P>
                            <P>(2) Personnel costs;</P>
                            <P>(3) Official travel;</P>
                            <P>(4) Publication of documents;</P>
                            <P>(5) Services of consultants, experts, or contractors;</P>
                            <P>(6) Conferences, public meetings, and events;</P>
                            <P>(7) Access to information, such as scientific and technical data;</P>
                            <P>(8) Public engagement activities; and</P>
                            <P>(9) Other necessary expenses.</P>
                            <P>(d) The Director must not authorize expenditures from the Management Fund that would solely benefit the Council on Environmental Quality or another Federal agency or that would reimburse the Council on Environmental Quality or another Federal agency for expenses not related to an environmental project or a study contract. For example:</P>
                            <P>(1) The Director may authorize expenditures pursuant to paragraph (c)(2) of this section for the personnel costs of an employee whose duties are limited to carrying out the objectives of a study contract or an environmental project, but not for the personnel costs of an employee who carries out duties unrelated to a study contract or an environmental project.</P>
                            <P>(2) If a portion of an employee's duties will carry out the objectives of an environmental project or a study contract, the Director may authorize expenditures pursuant to paragraph (c)(2) of this section for a proportional share of the employee's personnel costs.</P>
                            <P>(e) In carrying out the purposes of the Management Fund, 42 U.S.C. 4372(e) authorizes the Director to contract with public or private agencies, institutions, organizations and individuals, by negotiation, without regard to 31 U.S.C. 3324(a) and (b), 41 U.S.C. 6101.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1518.4</SECTNO>
                            <SUBJECT>Charters.</SUBJECT>
                            <P>(a) The Director must not authorize expenditures from the Management Fund for an environmental project or a study contract until the Director has approved a charter for the environmental project or study contract.</P>
                            <P>(b) The Project Officer must prepare a charter for each environmental project or a study contract and obtain the Director's approval of the charter.</P>
                            <P>(c) The charter must:</P>
                            <P>(1) Describe the environmental project or study contract;</P>
                            <P>(2) Clearly explain how the environmental project or study contract is consistent with the goals, purposes, and statutory authority of the Office of Environmental Quality;</P>
                            <P>
                                (3) Identify the Federal agency or agencies (and any State, Tribal, or local agencies) participating in the environmental project or study contract; and
                                <PRTPAGE P="3706"/>
                            </P>
                            <P>(4) Provide the names, titles, and contact information of the Project Officer and an administrative point of contact.</P>
                            <P>(d) The Project Officer may amend a charter in writing with the Director's approval of the amended charter.</P>
                            <P>(e) The Office of Environmental Quality must provide the Office of Administration in the Executive Office of the President with a copy of each charter and amendment that the Director approves.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1518.5</SECTNO>
                            <SUBJECT>Finances and accounting.</SUBJECT>
                            <P>(a) The Project Officer for each environmental project or study contract receiving support from the Management Fund must prepare a budget estimate as part of the charter and update the budget estimate annually following the charter's approval. The Office of Environmental Quality must provide copies of these budget estimates to the Office of Administration.</P>
                            <P>(b) The Council on Environmental Quality may make a payment into the Management Fund by a letter of transmittal that specifies the particular environmental project or study contract it is funding. The Office of Environmental Quality will provide a copy of each such transmittal letter to the Office of Administration.</P>
                            <P>(c) Agencies other than the Council on Environmental Quality may make advance payments to the Management Fund using the following procedure:</P>
                            <P>(1) The Director must provide the agency with a letter that specifies the particular environmental project or study contract to which the Director will apply the payment.</P>
                            <P>(2) The Director and the agency must enter an interagency agreement for the payment. The interagency agreement should indicate any statutory authority appropriate to the transaction, including 42 U.S.C. 4375(a).</P>
                            <P>
                                (d) The Management Fund is a no-year appropriations account, which can accept funds with any period of availability or funds that remain available until expended (
                                <E T="03">i.e.,</E>
                                 “one-year,” “multiple-year,” or “no-year” funds). Appropriated funds that an agency pays into the Management Fund expire under the terms of the appropriation under which they originated. The Office of Environmental Quality must account separately for each payment of funds into the Management Fund and track when each such payment will expire.
                            </P>
                            <P>(e) In addition to or in lieu of an advance payment into the Management Fund, any agency, including the Council on Environmental Quality, may support an environmental project or study contract by providing technical expertise, physical resources, facilities, equipment, or other assets; performing support or administrative services; or assigning detailees or agency representatives.</P>
                            <P>(f) The Office of Environmental Quality must maintain a separate subaccount within the Management Fund for each environmental project or study contract.</P>
                            <P>(g) The Director or the Project Officer must approve all of the expenditures for a particular environmental project or study contract. The Management Fund may only accept payments in advance of expenditure; accordingly, the Director or the Project Officer may only approve expenditures for which the Management Fund has received adequate payments in advance.</P>
                            <P>(h) The Director may approve the reallocation of funds from the Management Fund to another Federal account (or from one Management Fund subaccount to another) provided that:</P>
                            <P>(1) The agency that originally made the payment of the funds in question to the Management Fund approves the reallocation in writing;</P>
                            <P>(2) The reallocation would promote the statutory mission of the Office of Environmental Quality; and</P>
                            <P>(3) The Director determines the reallocation is in the best interest of the Federal Government.</P>
                            <P>(i) The Office of Environmental Quality must classify each financial transaction involving a Management Fund subaccount in sufficient detail to meet the Office of Environmental Quality's management planning, fiscal control, and financial audit requirements.</P>
                        </SECTION>
                    </PART>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00473 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3325-FA-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <CFR>41 CFR Part 302-16</CFR>
                <DEPDOC>[FTR Case 2022-04 Docket No. GSA-FTR-2023-0017, Sequence No. 2]</DEPDOC>
                <RIN>RIN 3090-AK65</RIN>
                <SUBJECT>Federal Travel Regulation (FTR); Relocation Allowances—Miscellaneous Expenses Allowance</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Government-wide Policy (OGP), General Services Administration (GSA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The United States (U.S.) General Services Administration (GSA) is issuing a final rule amending the Federal Travel Regulation (FTR) to remove the relocation miscellaneous expenses allowance (MEA) lump sum amounts from the FTR. These lump sum amounts will be published in FTR Bulletins on an intermittent basis, much like what is done for per diem and mileage rates. The relocation MEA actual expense (as opposed to lump sum) amounts are unchanged and will remain in the FTR. This final rule also updates the types of expenses that may or may not be reimbursed by relocation MEA when employees itemize under actual expense. Additionally, this final rule updates and clarifies other relocation MEA regulatory sections and rearranges them into a more sequential order.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For clarification of content, contact Mr. Rodney (Rick) Miller, Program Analyst, Office of Government-wide Policy (OGP), at 202-501-3822 or 
                        <E T="03">travelpolicy@gsa.gov.</E>
                         For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202-501-4755 or 
                        <E T="03">GSARegSec@gsa.gov.</E>
                         Please cite FTR Case 2022-04.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>GSA published a proposed rule at 89 FR 4268 on January 23, 2024, which proposed FTR changes to relocation MEA. This rule finalizes those proposed changes as summarized above, and as set forth in greater detail below.</P>
                <P>Pursuant to 5 United States Code (U.S.C.) 5738, the Administrator of General Services is authorized to prescribe regulations necessary to implement laws regarding Federal employees when assigned a temporary change of station (TCS) or when otherwise transferred in the interest of the Government. The overall implementing authority is the FTR, codified in title 41 of the Code of Federal Regulations, chapters 300 through 304.</P>
                <P>GSA's OGP continually reviews and adjusts policies and regulations under its purview to address Government relocation needs and to incorporate best practices, where appropriate, as a part of its ongoing mission to provide policies for travel by Federal civilian employees and others authorized to travel at Government expense.</P>
                <P>
                    Pursuant to 5 U.S.C. 5724a(f) and 5737(a)(6), an employee transferred in the interest of the Government from one official station to another, assigned to a TCS location, or who has completed a TCS assignment and returned to their 
                    <PRTPAGE P="3707"/>
                    previous official station is authorized a relocation MEA.
                </P>
                <P>The purpose of the relocation MEA is to defray some of the costs incurred due to relocating. The allowance is related to expenses that are common to living quarters, such as fees for disconnecting and connecting appliances; cutting and fitting rugs, draperies, and curtains moved from one residence to another; utility fees or deposits that are not offset by eventual refunds; forfeiture of medical, dental, and other non-transferrable contracts; and the cost of changing automobile registration(s) and driver's licenses.</P>
                <P>The FTR provides that a relocation MEA may be paid using one of two methods: lump sum or actual expense. Under the lump sum method, the agency pays a lump sum amount without requiring employee documentation of expenses. Under the current regulatory language, the lump sum amounts are “either $650 or the equivalent of one week's basic gross pay, whichever is the lesser amount” for an employee without immediate family members relocating with them, and “$1300 or the equivalent of two weeks' basic gross pay, whichever is the lesser amount” for an employee with immediate family members relocating with them.</P>
                <P>Under the actual expense method, the agency may authorize the employee to claim actual costs depending on the type of expenses incurred, in an amount in excess of the prescribed lump sum amount. The employee justifies any actual expenses by itemizing with supporting documentation. Reimbursement is limited to one or two weeks' basic gross pay depending on whether or not the employee has immediate family relocating with them, not to exceed the maximum rate payable for a position at GS-13, Step 10, of the General Schedule (base) (see 5 U.S.C. 5332).</P>
                <P>This final rule amends the FTR by removing the relocation MEA lump sum amounts from the FTR and directing readers to an FTR bulletin with the relocation MEA lump sum amounts. GSA will publish the initial FTR bulletin with the relocation MEA lump sum amounts concurrent with the final rule's effective date. Agencies are advised that the relocation MEA lump sum amounts are expected to increase since they were last updated in 2011. Moving forward, GSA will publish FTR bulletins to update the relocation MEA lump sum amounts, as needed, based on changes to the Consumer Price Index (CPI). The final rule also clarifies in the regulatory text that “basic gross pay”, as referenced in FTR part 302-16, does not include “locality pay.” See 5 U.S.C. 5302 and 5304.</P>
                <P>This final rule also updates and clarifies the relocation MEA sections in the FTR and rearranges them into a more sequential order, to include replacing the table at FTR § 302-16.2 with an updated list of examples for which the relocation MEA may be authorized, and updating the list of examples for which the relocation MEA may not be authorized. It also removes the relocation MEA employee eligibility table at FTR § 302-16.3 and reformats it as an employee eligibility listing.</P>
                <HD SOURCE="HD1">II. Discussion of the Final Rule</HD>
                <HD SOURCE="HD2">A. Summary of Significant Changes</HD>
                <P>GSA has not made any significant changes to the regulatory language from the proposed to final rule.</P>
                <HD SOURCE="HD2">B. Analysis of Public Comments</HD>
                <P>
                    GSA received one comment to the proposed rule suggesting that the relocation MEA lump sum match the amounts listed in the Department of State Standardized Regulations (DSSR) and urged that the relocation MEA lump sum amounts remain in the FTR instead of being published in a bulletin due to intra-agency distribution concerns. In response, GSA notes that it will determine the lump sum amounts based on the Consumer Price Index (CPI). While GSA expects its relocation MEA lump sum amounts to be similar to the DSSR's, the CPI fluctuates. Accordingly, the amounts to be determined by GSA in the present day may not exactly match the DSSR amounts since those were last updated in 2019. In response to the commenter's distribution concerns, publication of the relocation MEA lump sum in an FTR Bulletin affords GSA the flexibility to update the relocation MEA lump sum as needed to more fairly compensate travelers in line with the CPI. If GSA were to continue publishing the amounts in the FTR, such numbers can only be updated via a regulatory amendment, by which time, it may not accurately reflect the current CPI. Also, a bulletin takes less time and administrative effort to publish than a rule. Finally, note 1 to § 302-16.6 includes a direct link to GSA's FTR Bulletins for ease of distribution, in addition to the fact that notices of FTR Bulletins are published in the 
                    <E T="04">Federal Register</E>
                     and include a link to the Bulletin. GSA's OGP also emails all Federal agencies' travel and relocation operations and policy program managers to inform them of all FTR rules and bulletins when they are published, and recommends that such information be shared with relevant offices within their agency. GSA's OGP also briefs FTR changes to agency Senior Travel Official Council (STOC) members at regular intervals. Therefore, GSA will not change the final rule based on this comment.
                </P>
                <HD SOURCE="HD2">C. Expected Cost Impact to the Public</HD>
                <P>
                    This rule does not result in cost impacts to the public. However, the changes may result in a slight increase in cost to the Federal Government as the relocation MEA lump sum amounts are expected to increase. Specifically, GSA will publish an FTR bulletin containing the relocation MEA lump sum amounts for an employee relocating without immediate family members and for an employee relocating with immediate family members. As detailed in the proposed rule, GSA expects the average relocation MEA lump sum amount across Federal agencies to increase to $1,125, for an estimated total increase of $312,973 per year agencywide (for those agencies subject to the FTR).
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         GSA used data from the GSA's Business Travel and Relocation Dashboard for each agency to determine what was the average cost per MEA from FY18-FY22, and what the additional cost would be given the MEA increase of $650 to $750 for single employees and $1,300 to $1,500 for employees with families. GSA calculated the difference between the average MEA cost against $1,125 IF the average MEA cost was less than $1,125. This is because if the MEA cost is greater than the new MEA amount, then the employee would be more likely to do actual expense and there wouldn't be an additional cost to the MEA increase because the employee would be more likely to do actual expense rather than the old MEA amount as well. As a result, only 4 agencies had an average MEA cost lower than the average of the new MEAs. GSA multiplied the difference for those 4 agencies against the number of MEAs for those 4 agencies and summed it up to $312K.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Executive Orders 12866, 13563, and 14904</HD>
                <P>
                    Executive Order (E.O.) 12866 (Regulatory Planning and Review) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. E.O. 14094 (Modernizing Regulatory Review) amends section 3(f) of E.O. 12866 and supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review established in E.O. 12866 and E.O. 13563. The Office of Management 
                    <PRTPAGE P="3708"/>
                    and Budget's Office of Information and Regulatory Affairs (OIRA) determined that the proposed rule was a significant regulatory action; however, after further discussion between GSA and OIRA, OIRA has determined that this final rule is not a significant regulatory action, and therefore, it is not subject to review under section 6(b) of E.O. 12866.
                </P>
                <HD SOURCE="HD1">IV. Congressional Review Act</HD>
                <P>OIRA has determined that this rule is not a “major rule” under 5 U.S.C. 804(2). Title II, Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (codified at 5 U.S.C. 801-808), also known as the Congressional Review Act or CRA, generally provides that before a rule may take effect, unless excepted, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. This rule is excepted from CRA reporting requirements prescribed under 5 U.S.C. 801 as it relates to agency management or personnel under 5 U.S.C. 804(3)(B).</P>
                <HD SOURCE="HD1">V. Regulatory Flexibility Act</HD>
                <P>
                    This final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, 
                    <E T="03">et seq.</E>
                     This final rule is also exempt from the Administrative Procedure Act pursuant to 5 U.S.C. 553(a)(2) because it applies to agency management or personnel. Therefore, an Initial Regulatory Flexibility Analysis was not performed.
                </P>
                <HD SOURCE="HD1">VI. Paperwork Reduction Act</HD>
                <P>
                    The Paperwork Reduction Act does not apply because the changes to the FTR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget (OMB) under 44 U.S.C. 3501, 
                    <E T="03">et seq.</E>
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 41 CFR Part 302-16</HD>
                    <P>Government employees, Relocation, Travel and transportation expenses.</P>
                </LSTSUB>
                <SIG>
                    <NAME>Robin Carnahan,</NAME>
                    <TITLE>Administrator of General Services.</TITLE>
                </SIG>
                <P>For reasons set forth in the preamble, GSA revises 41 CFR part 302-16 to read as follows:</P>
                <REGTEXT TITLE="41" PART="302-16">
                    <PART>
                        <HD SOURCE="HED">PART 302-16—ALLOWANCE FOR MISCELLANEOUS EXPENSES</HD>
                        <CONTENTS>
                            <SECHD>Sec.</SECHD>
                            <SECTNO>302-16.0</SECTNO>
                            <SUBJECT>In general.</SUBJECT>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart A—General Rules</HD>
                                <SECTNO>302-16.1</SECTNO>
                                <SUBJECT>What is the purpose of the miscellaneous expenses allowance (MEA)?</SUBJECT>
                                <SECTNO>302-16.2</SECTNO>
                                <SUBJECT>Who is and who is not eligible for a MEA?</SUBJECT>
                                <SECTNO>302-16.3</SECTNO>
                                <SUBJECT>Must my agency authorize payment of a MEA?</SUBJECT>
                                <SECTNO>302-16.4</SECTNO>
                                <SUBJECT>How will I receive the MEA?</SUBJECT>
                                <SECTNO>302-16.5</SECTNO>
                                <SUBJECT>May I receive an advance of funds for MEA?</SUBJECT>
                                <SECTNO>302-16.6</SECTNO>
                                <SUBJECT>What amount may my agency reimburse me for miscellaneous expenses?</SUBJECT>
                                <SECTNO>302-16.7</SECTNO>
                                <SUBJECT>May I claim an amount in excess of that prescribed in this part?</SUBJECT>
                                <SECTNO>302-16.8</SECTNO>
                                <SUBJECT>What are examples of types of costs covered by the MEA?</SUBJECT>
                                <SECTNO>302-16.9</SECTNO>
                                <SUBJECT>What are examples of types of costs not covered by the MEA?</SUBJECT>
                                <SECTNO>302-16.10</SECTNO>
                                <SUBJECT>What standard of care must I use in incurring miscellaneous expenses?</SUBJECT>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart B—Agency Responsibilities</HD>
                                <SECTNO>302-16.100</SECTNO>
                                <SUBJECT>What governing policies must we establish for MEA?</SUBJECT>
                                <SECTNO>302-16.101</SECTNO>
                                <SUBJECT>How should we administer the authorization and payment of miscellaneous expenses?</SUBJECT>
                                <SECTNO>302-16.102</SECTNO>
                                <SUBJECT>Are there any restrictions to the types of costs we may cover?</SUBJECT>
                            </SUBPART>
                        </CONTENTS>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>5 U.S.C. 5738; 20 U.S.C. 905(a); E.O. 11609, as amended, 3 CFR, 1971-1975 Comp., p. 586.</P>
                        </AUTH>
                        <SECTION>
                            <SECTNO>§ 302-16.0</SECTNO>
                            <SUBJECT>In general.</SUBJECT>
                            <P>(a) Use of pronouns “I”, “you”, and their variants throughout subpart A of this part refers to the employee, unless otherwise noted.</P>
                            <P>(b) Use of pronouns “we”, “you”, and their variants throughout subpart B of this part refers to the agency.</P>
                        </SECTION>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—General Rules</HD>
                            <SECTION>
                                <SECTNO>§ 302-16.1</SECTNO>
                                <SUBJECT>What is the purpose of the miscellaneous expenses allowance (MEA)?</SUBJECT>
                                <P>The miscellaneous expenses allowance (MEA) is intended to help defray various costs incurred due to relocation, assignment to a temporary official station (TCS), and return to the previous official station upon completion of a TCS assignment.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.2</SECTNO>
                                <SUBJECT>Who is and who is not eligible for a MEA?</SUBJECT>
                                <P>(a) You are eligible for a MEA if:</P>
                                <P>(1) Your agency authorized or approved a transfer or a TCS;</P>
                                <P>(2) You discontinued and established a residence in connection with your transfer or TCS;</P>
                                <P>(3) You meet the applicable eligibility conditions in part 302-1 of this chapter; and</P>
                                <P>(4) You signed a required service agreement in part 302-2 of this chapter, if transferred.</P>
                                <P>(b) You are not eligible for a MEA if you are:</P>
                                <P>(1) A new appointee;</P>
                                <P>(2) A Senior Executive Service (SES) employee authorized “last move home” benefits upon separation from Government service;</P>
                                <P>(3) Assigned under the Government Employees Training Act (5 U.S.C. 4109);</P>
                                <P>(4) Returning from an Outside the Continental United States (OCONUS) official station to place of actual residence for separation from Government service; or</P>
                                <P>(5) Returning from an OCONUS official station to a new CONUS official station if relocation expenses have not been authorized to the new CONUS official station.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.3</SECTNO>
                                <SUBJECT>Must my agency authorize payment of a MEA?</SUBJECT>
                                <P>Yes, if you meet the applicable eligibility conditions in § 302-16.2, your agency must authorize payment of a MEA.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.4</SECTNO>
                                <SUBJECT>How will I receive the MEA?</SUBJECT>
                                <P>You will be reimbursed your MEA in accordance with your agency's internal relocation policy.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.5</SECTNO>
                                <SUBJECT>May I receive an advance of funds for MEA?</SUBJECT>
                                <P>No, your agency may not authorize an advance of funds for MEA. MEA may be paid after you have transferred to the new official station, upon assignment to your TCS, or upon completion of your TCS and return to your previous official station, as applicable.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.6</SECTNO>
                                <SUBJECT>What amount may my agency reimburse me for miscellaneous expenses?</SUBJECT>
                                <P>The following amounts will be paid for miscellaneous expenses without support or documentation of expenses:</P>
                                <P>(a) Either a lump sum amount set in a Federal Travel Regulation (FTR) bulletin or the equivalent of one week's basic gross pay, whichever is the lesser amount, if you have no immediate family relocating with you; or</P>
                                <P>(b) Either a lump sum amount set in an FTR bulletin or the equivalent of two weeks' basic gross pay, whichever is the lesser amount, if you have immediate family relocating with you.</P>
                                <NOTE>
                                    <HD SOURCE="HED">Note 1 to § 302-16.6:</HD>
                                    <P>
                                        GSA publishes the lump sum amounts in an FTR bulletin on an intermittent basis at 
                                        <E T="03">https://gsa.gov/ftrbulletins.</E>
                                    </P>
                                </NOTE>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.7</SECTNO>
                                <SUBJECT>May I claim an amount in excess of that prescribed in this part?</SUBJECT>
                                <P>Yes, you may claim an amount in excess of that prescribed in § 302-16.6 if authorized by your agency; and</P>
                                <P>
                                    (a) Supported by acceptable statements of fact, paid bills or other acceptable evidence (documentation) justifying the amounts claimed; and
                                    <PRTPAGE P="3709"/>
                                </P>
                                <P>(b) The aggregate amount does not exceed your basic gross pay (at the time you reported for duty, at your new official station) for:</P>
                                <P>(1) One week if you are relocating without immediate family; or</P>
                                <P>(2) Two weeks if you are relocating with immediate family.</P>
                                <P>(c) The amount authorized cannot exceed the maximum rate of grade GS-13, Step 10 General Schedule (base) salary (excluding locality pay) (see 5 U.S.C. 5332) at the time you reported for duty at your new official station.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.8</SECTNO>
                                <SUBJECT>What are examples of types of costs covered by the MEA?</SUBJECT>
                                <P>Miscellaneous expenses are costs associated with relocating that are not covered by other relocation benefits detailed in this chapter. Expenses allowable include but are not limited to the following, and similar, items:</P>
                                <P>(a) Fees for disconnecting and connecting utilities (such as gas, water, electricity), appliances, equipment (such as a security system or electric vehicle charging station), or conversion of appliances for operation on available utilities;</P>
                                <P>(b) Fees for cutting and fitting rugs, draperies, and curtains when they are moved from one residence to another;</P>
                                <P>(c) Deposits or fees for utilities not offset by eventual refunds;</P>
                                <P>
                                    (d) Losses that cannot be recovered by transfer or refund and are incurred due to early termination of a contract (
                                    <E T="03">e.g.,</E>
                                     medical, dental, private institutional care for immediate family members with disabilities, nonrefundable education enrollment fee, real estate expenses connected with the cancellation of a contract when a new transfer prevented the employee from completing a purchase of a residence);
                                </P>
                                <P>(e) Automobile registration, driver's license, and use taxes imposed when initially bringing privately-owned vehicles (POVs) into certain jurisdictions;</P>
                                <P>(f) Reinstalling or removing automobile parts upon vehicle reentry into the United States or entry into a foreign country, when removal or installation of those automobile parts was required by host country law;</P>
                                <P>(g) Post office box rental fee when rented to provide a constant mailing address between the time an employee departs the old residence and occupies a residence at the new official station;</P>
                                <P>(h) Rental agent fees customarily charged for securing housing in foreign countries;</P>
                                <P>(i) Reassembly, set up, and tuning of a piano moved for relocation;</P>
                                <P>(j) Pet care (for cats and dogs only), child care, or adult care for dependent parents or other adult dependents incapable of self-care at home while the employee or spouse are away on a househunting trip, or are packing or unpacking;</P>
                                <P>(k) Rental car fees while awaiting a delayed POV shipment to or from OCONUS if the transportation service provider (TSP) has not arranged for the employee's use of a rental car at TSP expense. Reimbursement may be authorized starting after the shipping company designated delivery date, shall not exceed 10 days, and does not include the days after the POV is delivered or a new POV is purchased at location. The rental car for the employee and immediate family members must be the same or comparable size or model as the POV the employee shipped;</P>
                                <P>(l) Transportation and quarantine of pets (cats and dogs only). Costs normally associated with the transportation, quarantine fees, and handling of dogs and cats. This includes pet-related costs due to air carrier rules or imposed by the law of the jurisdiction of the employee's new residence as an integral part of the process of admissions and licensing;</P>
                                <P>(m) Professional relicensing fees required by the new official station that are directly related to the employee's occupation, such as fees required to take the bar exam or teaching certification; and professional relicensing fees or business costs (including exam, continuing education courses, business license, permit, and registration fees) that are directly related to the immediate family member's occupation, when the immediate family member was licensed or certified in a profession, or owned a business, at the employee's previous official station and is required to secure or maintain a new professional license or certification, or business license or permit, to engage in that profession in a new jurisdiction because of unique licensing or certification requirements and authorities; or</P>
                                <P>(n) Specialized shipment of hazardous materials, such as lithium batteries, when Federal, state, local, and foreign country laws or carrier regulations prohibit commercial shipment of certain articles not included as part of household goods, which cannot be otherwise transported to the new official station because of shipping and transportation restrictions.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.9</SECTNO>
                                <SUBJECT>What are examples of types of costs not covered by the MEA?</SUBJECT>
                                <P>Examples of costs that are not reimbursable from the MEA are:</P>
                                <P>(a) Losses in selling or buying real and personal property and costs related to such transactions;</P>
                                <P>(b) Cost of additional insurance on household goods while in transit to the new official station or cost of loss or damage to such property;</P>
                                <P>(c) Additional costs of moving household goods caused by exceeding the maximum weight limitation;</P>
                                <P>(d) Costs of newly acquired items, such as the purchase or installation cost of new rugs or draperies;</P>
                                <P>(e) Higher income, real estate, sales, or other taxes as the result of establishing residence in the new locality;</P>
                                <P>(f) Fines imposed for traffic infractions while en route to the new official station locality;</P>
                                <P>(g) Accident insurance premiums or liability costs incurred in connection with travel to the new official station locality, or any other liability imposed upon the employee for uninsured damages caused by accidents for which the employee or their immediate family is held responsible;</P>
                                <P>(h) Losses as the result of sale or disposal of items of personal property (such as lithium batteries, gasoline, and natural gas) not considered convenient or practicable to move;</P>
                                <P>(i) Damage or loss of clothing, luggage, or other personal effects while traveling to the new official station locality;</P>
                                <P>(j) Subsistence, transportation, or mileage expenses in excess of the amounts reimbursed as per diem or other allowances under this subtitle;</P>
                                <P>(k) Medical expenses due to illness or injuries while en route to the new official station or while living in temporary quarters at Government expense under the provisions of this chapter;</P>
                                <P>
                                    (l) Costs incurred in conjunction with structural alterations (such as remodeling or modernizing of living quarters, garages or other buildings to accommodate privately-owned automobiles, appliances or equipment [
                                    <E T="03">e.g.,</E>
                                     a security system or electric vehicle charging station]); or replacing or repairing worn-out or defective appliances, or equipment shipped to the new location;
                                </P>
                                <P>
                                    (m) Costs incurred in connection with preparing a residence for sale or purchase (
                                    <E T="03">e.g.,</E>
                                     maintenance, repairs, cleaning);
                                </P>
                                <P>(n) Delivery charges or costs associated with newly-acquired items (such as appliances, security systems, locksmith service, or new vehicle) at the new official station for reasons of personal taste or preference and not required because of the relocation;</P>
                                <P>
                                    (o) Costs unrelated to the quarantine, transportation, and handling of pets. Additional costs for lodging for a second room or boarding fees, micro-chipping, veterinary expenses (
                                    <E T="03">e.g.,</E>
                                     inoculations, 
                                    <PRTPAGE P="3710"/>
                                    examinations, medical care and certification fees), routine care and grooming of pets, and purchases of crates and tags for the pets. Expenses for other animals (horses, fish, birds, reptiles, rodents, etc.) are not authorized because of their size, exotic nature, restrictions on shipping, host country restrictions, and special handling difficulties; or
                                </P>
                                <P>(p) Costs related to obtaining a visa, passport, immigration green card, birth certificate or other acceptable evidence of birth when required for official travel to foreign locations; charges for immunization, inoculations, other disease-preventative medical prophylaxis, including disease testing, that are required for official travel if not obtained through the agency. The expenses in this paragraph (p) may be reimbursable as part of the employee's relocation en route travel miscellaneous expenses as specified in 41 CFR 301-12.1.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.10</SECTNO>
                                <SUBJECT>What standard of care must I use in incurring miscellaneous expenses?</SUBJECT>
                                <P>You must exercise the same care in incurring expenses that a prudent person would exercise if relocating at personal expense.</P>
                            </SECTION>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart B—Agency Responsibilities</HD>
                            <SECTION>
                                <SECTNO>§ 302-16.100</SECTNO>
                                <SUBJECT>What governing policies must we establish for MEA?</SUBJECT>
                                <P>For MEAs, you must establish policies and procedures governing:</P>
                                <P>(a) Who will determine whether payment for an amount in excess of the lump sum MEA is appropriate; and</P>
                                <P>(b) How you will pay a MEA in accordance with §§ 302-16.2 and 302-16.3.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.101</SECTNO>
                                <SUBJECT>How should we administer the authorization and payment of miscellaneous expenses?</SUBJECT>
                                <P>You should limit payment of miscellaneous expenses to only those expenses that are necessary.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 302-16.102</SECTNO>
                                <SUBJECT>Are there any restrictions to the types of costs we may cover?</SUBJECT>
                                <P>Yes, a MEA cannot be used to reimburse:</P>
                                <P>(a) Costs or expenses incurred which exceed maximums provided by statute or in this subtitle;</P>
                                <P>(b) Costs or expenses incurred but which are disallowed elsewhere in this subtitle;</P>
                                <P>(c) Costs reimbursed under other provisions of law or regulations;</P>
                                <P>(d) Costs or expenses incurred for reasons of personal taste or preference and not required because of the move;</P>
                                <P>(e) Losses covered by insurance;</P>
                                <P>(f) Fines or other penalties imposed upon the employee or members of their immediate family;</P>
                                <P>(g) Judgments, court costs, and similar expenses growing out of civil actions; or</P>
                                <P>(h) Any other expenses brought about by circumstances, factors, or actions in which the move to a new official station was not the proximate cause.</P>
                            </SECTION>
                        </SUBPART>
                    </PART>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00497 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-14-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <CFR>47 CFR Part 1</CFR>
                <DEPDOC>[DA 25-5; FR ID 272288]</DEPDOC>
                <SUBJECT>Annual Adjustment of Civil Monetary Penalties To Reflect Inflation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation Adjustment Act) requires the Federal Communications Commission to revise its forfeiture penalty rules to reflect annual adjustments for inflation in order to improve their effectiveness and maintain their deterrent effect. The Inflation Adjustment Act provides that the new penalty levels shall apply to penalties assessed after the effective date of the increase, including when the penalties whose associated violation predate the increase.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         The rule is effective January 15, 2025.
                    </P>
                    <P>
                        <E T="03">Applicability date:</E>
                         The civil monetary penalties are applicable beginning January 15, 2025.
                    </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Hunter Deeley, Acting Chief of Staff, Enforcement Bureau, at 
                        <E T="03">Hunter.Deeley@fcc.gov</E>
                         or 202-418-2765.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This is a summary of the Commission's Order, DA 25-5, adopted and released on January 3, 2025. The complete text of this document is available for download at 
                    <E T="03">https://docs.fcc.gov/public/attachments/DA-25-5A1.pdf.</E>
                     To request this document in accessible formats for people with disabilities (
                    <E T="03">e.g.,</E>
                     Braille, large print, electronic files, audio format, etc.) or to request reasonable accommodations (
                    <E T="03">e.g.,</E>
                     accessible format documents, sign language interpreters, CART, etc.), send an email to 
                    <E T="03">fcc504@fcc.gov</E>
                     or call the FCC's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice).
                </P>
                <HD SOURCE="HD1">Synopsis</HD>
                <P>The Bipartisan Budget Act of 2015 included, as section 701 thereto, the Inflation Adjustment Act, which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410), to improve the effectiveness of civil monetary penalties and maintain their deterrent effect. Under the Inflation Adjustment Act, agencies are required to make annual inflationary adjustments by January 15 each year, beginning in 2017. The adjustments are calculated pursuant to Office of Management and Budget (OMB) guidance. OMB issued guidance on December 17, 2024, and this Order follows that guidance. The Commission therefore updates the civil monetary penalties for 2024, to reflect an annual inflation adjustment based on the percent change between each published October's CPI-U; in this case, October 2024 CPI-U (315.664)/October 2023 CPI-U (307.671) = 1.02598. The Commission multiplies 1.02598 by the most recent penalty amount and then rounds the result to the nearest dollar.</P>
                <P>For 2025, the adjusted penalty or penalty range for each applicable penalty is calculated by multiplying the most recent penalty amount by the 2025 annual adjustment (1.02598), then rounding the result to the nearest dollar. The adjustments in civil monetary penalties that we adopt in this Order apply only to such penalties assessed on and after January 15, 2025.</P>
                <P>
                    The Order also re-codifies the text of a footnote to Table 1 of § 1.80(b)(11) that was inadvertently removed. The footnote text specifies that the base forfeiture amount for “misrepresentation/lack of candor” is the statutory maximum. Because the prior removal of this language was inadvertent, we find good cause to make this re-codification of the footnote text effective immediately upon publication in the 
                    <E T="04">Federal Register</E>
                    , pursuant to section 553(d)(3) of the APA.
                </P>
                <HD SOURCE="HD1">Paperwork Reduction Act</HD>
                <P>
                    This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 
                    <E T="03">see</E>
                     44 U.S.C. 3506(c)(4).
                </P>
                <HD SOURCE="HD1">Congressional Review Act</HD>
                <P>
                    The Commission has determined, and the Administrator of the Office of 
                    <PRTPAGE P="3711"/>
                    Information and Regulatory Affairs, Office of Management and Budget, concurs that this rule is non-major under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of this Order to Congress and the Government Accountability Office pursuant to 5 U.S.C. 801(a)(1)(A).
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 47 CFR Part 1</HD>
                    <P>Administrative practice and procedure, Penalties.</P>
                </LSTSUB>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Peter Hyun,</NAME>
                    <TITLE>Acting Chief, Enforcement Bureau.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Final Rules</HD>
                <P>For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 1 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 1—PRACTICE AND PROCEDURE</HD>
                </PART>
                <REGTEXT TITLE="47" PART="1">
                    <AMDPAR>1. The authority citation for part 1 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>47 U.S.C. chs. 2, 5, 9, 13; 28 U.S.C. 2461 note; 47 U.S.C. 1754, unless otherwise noted.</P>
                    </AUTH>
                    <AMDPAR>2. Amend § 1.80 by:</AMDPAR>
                    <AMDPAR>a. Revising paragraphs (b)(1) through (10);</AMDPAR>
                    <AMDPAR>b. Adding footnote 1 to “Table 1 to paragraph (b)(11)”; and</AMDPAR>
                    <AMDPAR>c. Revising “Table 4 to paragraph (b)(11)” and “Table 5 to paragraph (b)(12)(ii)”.</AMDPAR>
                    <P>The revisions and addition read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 1.80</SECTNO>
                        <SUBJECT>Forfeiture proceedings.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>
                            (1) 
                            <E T="03">Forfeiture penalty for a broadcast station licensee, permittee, cable television operator, or applicant.</E>
                             If the violator is a broadcast station licensee or permittee, a cable television operator, or an applicant for any broadcast or cable television operator license, permit, certificate, or other instrument of authorization issued by the Commission, except as otherwise noted in this paragraph (b)(1), the forfeiture penalty under this section shall not exceed $62,829 for each violation or each day of a continuing violation, except that the amount assessed for any continuing violation shall not exceed a total of $628,305 for any single act or failure to act described in paragraph (a) of this section. There is no limit on forfeiture assessments for EEO violations by cable operators that occur after notification by the Commission of a potential violation. See section 634(f)(2) of the Communications Act (47 U.S.C. 554). Notwithstanding the foregoing in this section, if the violator is a broadcast station licensee or permittee or an applicant for any broadcast license, permit, certificate, or other instrument of authorization issued by the Commission, and if the violator is determined by the Commission to have broadcast obscene, indecent, or profane material, the forfeiture penalty under this section shall not exceed $508,373 for each violation or each day of a continuing violation, except that the amount assessed for any continuing violation shall not exceed a total of $4,692,668 for any single act or failure to act described in paragraph (a) of this section.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Forfeiture penalty for a common carrier or applicant.</E>
                             If the violator is a common carrier subject to the provisions of the Communications Act or an applicant for any common carrier license, permit, certificate, or other instrument of authorization issued by the Commission, the amount of any forfeiture penalty determined under this section shall not exceed $251,322 for each violation or each day of a continuing violation, except that the amount assessed for any continuing violation shall not exceed a total of $2,513,215 for any single act or failure to act described in paragraph (a) of this section.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Forfeiture penalty for a manufacturer or service provider.</E>
                             If the violator is a manufacturer or service provider subject to the requirements of section 255, 716, or 718 of the Communications Act (47 U.S.C. 255, 617, or 619), and is determined by the Commission to have violated any such requirement, the manufacturer or service provider shall be liable to the United States for a forfeiture penalty of not more than $144,329 for each violation or each day of a continuing violation, except that the amount assessed for any continuing violation shall not exceed a total of $1,443,275 for any single act or failure to act.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Forfeiture penalty for a 227(e) violation.</E>
                             Any person determined to have violated section 227(e) of the Communications Act or the rules issued by the Commission under section 227(e) of the Communications Act shall be liable to the United States for a forfeiture penalty of not more than $14,432 for each violation or three times that amount for each day of a continuing violation, except that the amount assessed for any continuing violation shall not exceed a total of $1,443,275 for any single act or failure to act. Such penalty shall be in addition to any other forfeiture penalty provided for by the Communications Act.
                        </P>
                        <P>
                            (5) 
                            <E T="03">Forfeiture penalty for a 227(b)(4)(B) violation.</E>
                             Any person determined to have violated section 227(b)(4)(B) of the Communications Act or the rules in 47 CFR part 64 issued by the Commission under section 227(b)(4)(B) of the Communications Act shall be liable to the United States for a forfeiture penalty determined in accordance with paragraphs (A)-(F) of section 503(b)(2) plus an additional penalty not to exceed $12,266.
                        </P>
                        <P>
                            (6) 
                            <E T="03">Forfeiture penalty for pirate radio broadcasting.</E>
                             (i) Any person who willfully and knowingly does or causes or suffers to be done any pirate radio broadcasting shall be subject to a fine of not more than $2,453,218; and
                        </P>
                        <P>(ii) Any person who willfully and knowingly violates the Act or any rule, regulation, restriction, or condition made or imposed by the Commission under authority of the Act, or any rule, regulation, restriction, or condition made or imposed by any international radio or wire communications treaty or convention, or regulations annexed thereto, to which the United States is party, relating to pirate radio broadcasting shall, in addition to any other penalties provided by law, be subject to a fine of not more than $122,661 for each day during which such offense occurs, in accordance with the limit described in this section.</P>
                        <P>
                            (7) 
                            <E T="03">Forfeiture penalty for a section 6507(b)(4) Tax Relief Act violation.</E>
                             If a violator who is granted access to the Do-Not-Call registry of public safety answering points discloses or disseminates any registered telephone number without authorization, in violation of section 6507(b)(4) of the Middle Class Tax Relief and Job Creation Act of 2012 or the Commission's implementing rules in 47 CFR part 64, the monetary penalty for such unauthorized disclosure or dissemination of a telephone number from the registry shall be not less than $135,161 per incident nor more than $1,351,606 per incident depending upon whether the conduct leading to the violation was negligent, grossly negligent, reckless, or willful, and depending on whether the violation was a first or subsequent offense.
                        </P>
                        <P>
                            (8) 
                            <E T="03">Forfeiture penalty for a section 6507(b)(5) Tax Relief Act violation.</E>
                             If a violator uses automatic dialing equipment to contact a telephone number on the Do-Not-Call registry of public safety answering points, in violation of section 6507(b)(5) of the Middle Class Tax Relief and Job Creation Act of 2012 or the Commission's implementing rules in 47 CFR part 64, the monetary penalty for contacting such a telephone number 
                            <PRTPAGE P="3712"/>
                            shall be not less than $13,516 per call nor more than $135,161 per call depending on whether the violation was negligent, grossly negligent, reckless, or willful, and depending on whether the violation was a first or subsequent offense.
                        </P>
                        <P>
                            (9) 
                            <E T="03">Forfeiture penalty for a failure to block.</E>
                             Any person determined to have failed to block illegal robocalls pursuant to §§ 64.6305(g) and 64.1200(n) of this chapter shall be liable to the United States for a forfeiture penalty of no more than $25,132 for each violation, to be assessed on a per-call basis.
                        </P>
                        <P>
                            (10) 
                            <E T="03">Maximum forfeiture penalty for any case not previously covered.</E>
                             In any case not covered in paragraphs (b)(1) through (9) of this section, the amount of any forfeiture penalty determined under this section shall not exceed $25,132 for each violation or each day of a continuing violation, except that the amount assessed for any continuing violation shall not exceed a total of $188,491 for any single act or failure to act described in paragraph (a) of this section.
                        </P>
                        <P>(11) * * *</P>
                        <GPOTABLE COLS="2" OPTS="L1,i1" CDEF="s100,15">
                            <TTITLE>
                                Table 1 to Paragraph (
                                <E T="01">b</E>
                                )(11)—Base Amounts for Section 503 Forfeitures
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Forfeitures</CHED>
                                <CHED H="1">Violation amount</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Misrepresentation/lack of candor</ENT>
                                <ENT>
                                    (
                                    <SU>1</SU>
                                    )
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <TNOTE>
                                <SU>1</SU>
                                 Statutory Maximum for each Service.
                            </TNOTE>
                        </GPOTABLE>
                        <GPOTABLE COLS="2" OPTS="L2,nj,i1" CDEF="s100,r100">
                            <TTITLE>
                                Table 4 to Paragraph (
                                <E T="01">b</E>
                                )(11)—Non-Section 503 Forfeitures That Are Affected by the Downward Adjustment Factors 
                                <SU>1</SU>
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Violation</CHED>
                                <CHED H="1">Statutory amount after 2025 annual inflation adjustment</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Sec. 202(c) Common Carrier Discrimination</ENT>
                                <ENT>$15,079, $754/day.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 203(e) Common Carrier Tariffs</ENT>
                                <ENT>$15,079, $754/day.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 205(b) Common Carrier Prescriptions</ENT>
                                <ENT>$30,159.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 214(d) Common Carrier Line Extensions</ENT>
                                <ENT>$3,015/day.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 219(b) Common Carrier Reports</ENT>
                                <ENT>$3,015/day.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 220(d) Common Carrier Records &amp; Accounts</ENT>
                                <ENT>$15,079/day.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 223(b) Dial-a-Porn</ENT>
                                <ENT>$156,267/day.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 227(e) Caller Identification</ENT>
                                <ENT>$14,432/violation.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$43,296/day for each day of continuing violation, up to $1,443,275 for any single act or failure to act.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 364(a) Forfeitures (Ships)</ENT>
                                <ENT>$12,567/day (owner).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 364(b) Forfeitures (Ships)</ENT>
                                <ENT>$2,515 (vessel master).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 386(a) Forfeitures (Ships)</ENT>
                                <ENT>$12,567/day (owner).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 386(b) Forfeitures (Ships)</ENT>
                                <ENT>$2,515 (vessel master).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 511 Pirate Radio Broadcasting</ENT>
                                <ENT>$2,453,218, $122,661/day.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 634 Cable EEO</ENT>
                                <ENT>$1,114/day.</ENT>
                            </ROW>
                            <TNOTE>
                                <SU>1</SU>
                                 Unlike section 503 of the Act, which establishes maximum forfeiture amounts, other sections of the Act, with two exceptions, state prescribed amounts of forfeitures for violations of the relevant section. These amounts are then subject to mitigation or remission under section 504 of the Act. One exception is section 223 of the Act, which provides a maximum forfeiture per day. For convenience, the Commission will treat this amount as if it were a prescribed base amount, subject to downward adjustments. The other exception is section 227(e) of the Act, which provides maximum forfeitures per violation, and for continuing violations. The Commission will apply the factors set forth in section 503(b)(2)(E) of the Act and this table 4 to determine the amount of the penalty to assess in any particular situation. The amounts in this table 4 are adjusted for inflation pursuant to the Debt Collection Improvement Act of 1996 (DCIA), 28 U.S.C. 2461. These non-section 503 forfeitures may be adjusted downward using the “Downward Adjustment Criteria” shown for section 503 forfeitures in table 3 to this paragraph (b)(11).
                            </TNOTE>
                        </GPOTABLE>
                        <P>(12) * * *</P>
                        <P>(ii) The application of the annual inflation adjustment required by the foregoing Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 results in the following adjusted statutory maximum forfeitures authorized by the Communications Act:</P>
                        <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s100,r100">
                            <TTITLE>
                                Table 5 to Paragraph (
                                <E T="01">b</E>
                                )(12)(
                                <E T="01">ii</E>
                                )
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">U.S. Code citation</CHED>
                                <CHED H="1">Maximum penalty after 2025 annual inflation adjustment</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">47 U.S.C. 202(c)</ENT>
                                <ENT>$15,079.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$754.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 203(e)</ENT>
                                <ENT>$15,079.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$754.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 205(b)</ENT>
                                <ENT>$30,159.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 214(d)</ENT>
                                <ENT>$3,015.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 219(b)</ENT>
                                <ENT>$3,015.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 220(d)</ENT>
                                <ENT>$15,079.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 223(b)</ENT>
                                <ENT>$156,267.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 227(b)(4)(B)</ENT>
                                <ENT>$62,829, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$628,305, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$251,322, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$2,513,215, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$508,373, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <PRTPAGE P="3713"/>
                                <ENT I="22"> </ENT>
                                <ENT>$4,692,668, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$25,132, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$188,491, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$144,329, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$1,443,275, plus an additional penalty not to exceed $12,266.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 227(e)</ENT>
                                <ENT>$14,432.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$43,296.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$1,443,275.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 362(a)</ENT>
                                <ENT>$12,567.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 362(b)</ENT>
                                <ENT>$2,515.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 386(a)</ENT>
                                <ENT>$12,567.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 386(b)</ENT>
                                <ENT>$2,515.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 503(b)(2)(A)</ENT>
                                <ENT>$62,829.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$628,305.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 503(b)(2)(B)</ENT>
                                <ENT>$251,322.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$2,513,215.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 503(b)(2)(C)</ENT>
                                <ENT>$508,373.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$4,692,668.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 503(b)(2)(D)</ENT>
                                <ENT>$25,132.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$188,491.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 503(b)(2)(F)</ENT>
                                <ENT>$144,329.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$1,443,275.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 507(a)</ENT>
                                <ENT>$2,489.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 507(b)</ENT>
                                <ENT>$365.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 511</ENT>
                                <ENT>$2,453,218.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                                <ENT>$122,661.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">47 U.S.C. 554</ENT>
                                <ENT>$1,114.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 6507(b)(4) of Tax Relief Act</ENT>
                                <ENT>$1,351,606/incident.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Sec. 6507(b)(5) of Tax Relief Act</ENT>
                                <ENT>$135,161/call.</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00494 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Pipeline and Hazardous Materials Safety Administration</SUBAGY>
                <CFR>49 CFR Part 192</CFR>
                <DEPDOC>[Docket No. PHMSA-2011-0023; Amdt. No. 192-138]</DEPDOC>
                <RIN>RIN 2137-AF39</RIN>
                <SUBJECT>Pipeline Safety: Safety of Gas Transmission Pipelines: Repair Criteria, Integrity Management Improvements, Cathodic Protection, Management of Change, and Other Related Amendments: Corrections To Conform to Judicial Review</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Correcting amendments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>These amendments conform part 192 of the Code of Federal Regulations (CFR) to the August 2024 order of the United States Court of Appeals for the District of Columbia Circuit by removing several vacated provisions.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective on January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Robert Jagger, Senior Transportation Specialist, by email at 
                        <E T="03">robert.jagger@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On August 24, 2022, PHMSA published a final rule titled “Safety of Gas Transmission Pipelines: Repair Criteria, Integrity Management Improvements, Cathodic Protection, Management of Change, and Other Related Amendments” (2022 Gas Transmission Final Rule) 
                    <SU>1</SU>
                    <FTREF/>
                     amending the federal pipeline safety regulations at 49 CFR part 192 to improve the safety of onshore gas transmission pipelines. The 2022 Gas Transmission Final Rule updated and expanded requirements pertaining to corrosion control, repair criteria and timelines for various pipeline integrity anomalies (including various manifestations of metal loss, cracking, and denting), and other integrity management improvements.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         87 FR 52224 (Aug. 24, 2022).
                    </P>
                </FTNT>
                <P>
                    The Interstate Natural Gas Association of America (INGAA) filed a petition for judicial review challenging several provisions of the 2022 Gas Transmission Final Rule. On August 16, 2024, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) ordered the following provisions vacated: 
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">INGAA</E>
                         v. 
                        <E T="03">PHMSA,</E>
                         No. 23-1173, 114 F.4th 744, 756 (D.C. Cir. Aug. 16, 2024).
                    </P>
                </FTNT>
                <P>(1) Monitoring and mitigation of internal corrosive constituents at § 192.478;</P>
                <P>(2) The immediate repair criterion for cracks or crack-like anomalies with predicted failure pressures below 1.25 × maximum allowable operating pressure (MAOP) at §§ 192.714(d)(1)(v)(C) and 192.933(d)(1)(v)(C); and</P>
                <P>
                    (3) High-frequency electric resistance welded seams as one of the seam types qualifying for the immediate repair criterion of preferential metal loss on certain seam types at §§ 192.714(d)(1)(iv) and 192.933(d)(1)(iv).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Preferential metal loss on direct current, low-frequency electric resistance welded pipe, and electric flash welded pipe remain immediate repair conditions when an anomaly on pipe with these seam types meet the conditions under §§ 192.714(d)(1)(iv) and 192.933(d)(1)(iv). 
                        <E T="03">INGAA</E>
                         v. 
                        <E T="03">PHMSA,</E>
                         114 F.4th at 756 (vacating the provisions “only as applied to seams formed by high-frequency electric resistance welding”).
                    </P>
                </FTNT>
                <P>
                    This notice removes those vacated provisions and makes conforming revisions to align the federal pipeline safety regulations to the result of judicial review.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         PHMSA also removes now obsolete cross-references to § 192.478 located in §§ 192.9 and 
                        <PRTPAGE/>
                        192.927, without making any other changes to those provisions.
                    </P>
                </FTNT>
                <PRTPAGE P="3714"/>
                <P>
                    Additionally, the court's August 16, 2024, decision found the dent engineering critical assessment method at § 192.712(c) to be inadequately justified. However, the D.C. Circuit subsequently, in a December 10, 2024 order, granted an unopposed petition for rehearing by INGAA and remanded this provision to PHMSA without vacatur. Accordingly, the engineering critical assessment method for dents articulated at § 192.712(c) remains in the federal pipeline safety regulations, thereby allowing operators complying with the process to, where appropriate, monitor rather than repair certain dents according to the requirements of §§ 192.714(d) and 192.933(d). Section 192.712(c) will remain in effect as PHMSA considers its approach to address the deficiencies in PHMSA's adoption of § 192.712(c) identified in the court's August 16, 2024, decision. PHMSA will announce such regulatory actions in the 
                    <E T="04">Federal Register</E>
                     in ordinary course.
                </P>
                <P>
                    PHMSA has good cause to make these conforming corrections without notice and comment pursuant to Section 553(b)(B) of the Administrative Procedure Act (APA, 5 U.S.C. 551, 
                    <E T="03">et seq.</E>
                    ) because, the D.C. Circuit having vacated these provisions of the 2022 Gas Transmission Final Rule, no comment could “change[ ] that fact” and additional comment would be “utterly unnecessary.” 
                    <E T="03">EME Homer City Generation, LP</E>
                     v. 
                    <E T="03">EPA,</E>
                     795 F.3d 118, 134-35 (D.C. Cir. 2015) (internal quotations omitted). Section 553(b)(B) of the APA provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue amendments without providing notice and an opportunity for public comment. Notice and comment on these correction amendments is unnecessary for this ministerial action conforming the pipeline safety regulations to the result ordered by the D.C. Circuit. The Agency simply removes the three discrete provisions (two of which are found at both §§ 192.714 and 192.933) which have been vacated by the court. PHMSA finds that notice and opportunity for public comment are unnecessary under section 553(b)(B) of the APA.
                </P>
                <P>
                    PHMSA also finds good cause for the immediate effective date on publication of these conforming corrections. Section 553(d) of the APA provides that a rule should take effect not less than 30 days after publication in the 
                    <E T="04">Federal Register</E>
                    , except for when a rule relieves a restriction or when good cause is found by the agency and published within the rule allowing for earlier effect. 5 U.S.C. 553(d)(1) &amp; (3). These conforming corrections relieve discrete requirements of the 2022 Gas Transmission Final Rule. 5 U.S.C. 553(d)(1). Moreover, good cause exists for immediate effect as, the D.C. Circuit having entered its judgment, the provisions of the code being removed herein are no longer effective, operators and the public will benefit from regulatory text reflecting the accurate regulatory environment, and no additional time is necessary to conform operator behavior. 
                    <E T="03">Omnipoint Corp.</E>
                     v. 
                    <E T="03">F.C.C.,</E>
                     78 F.3d 620, 630 (D.C. Cir. 1996); 5 U.S.C. 553(d)(3).
                </P>
                <HD SOURCE="HD1">I. Regulatory Analyses and Notices</HD>
                <HD SOURCE="HD2">
                    A. 
                    <E T="03">Legal Authority</E>
                </HD>
                <P>
                    These conforming corrections are published under the authority of the Secretary of Transportation delegated to PHMSA pursuant to 49 CFR 1.97. Among the statutory authorities delegated to PHMSA are the authorities vested in the Secretary under the Federal Pipeline Safety Statutes (49 U.S.C. 60101 
                    <E T="03">et seq.</E>
                    ). Section 60102(a) authorizes issuance of regulations governing design, installation, inspection, emergency plans and procedures, testing, construction, extension, operation, replacement, and maintenance of pipeline facilities.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         87 FR at 52263 (2022 Gas Transmission Final Rule statutory authorities).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    B. 
                    <E T="03">Executive Order 12866 and DOT Regulatory Policies and Procedures</E>
                </HD>
                <P>
                    These conforming corrections have been evaluated in accordance with Executive Order 12866 (“Regulatory Planning and Review”),
                    <SU>6</SU>
                    <FTREF/>
                     Executive Order 14094 (“Modernizing Regulatory Review”),
                    <SU>7</SU>
                    <FTREF/>
                     and DOT Order 2100.6A (“Rulemaking and Guidance Procedures”) and are considered not significant; therefore, these conforming corrections have not been reviewed by the Office of Management and Budget (OMB). As the conforming corrections herein merely reflect the current state of the regulations following judicial review, PHMSA finds that the conforming corrections themselves impose no incremental compliance costs, nor do they adversely impair safety.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         58 FR 51735 (Oct. 4, 1993).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         88 FR 21879 (Apr. 11, 2023).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    C. 
                    <E T="03">Regulatory Flexibility Act</E>
                </HD>
                <P>
                    The analytical requirements of the Regulatory Flexibility Act, as amended by the Small Business Regulatory Flexibility Fairness Act of 1996 (RFA, 5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ), do not apply when the agency finds good cause under the APA to adopt a rule without prior notice and comment.
                    <SU>8</SU>
                    <FTREF/>
                     Because PHMSA has “good cause” under the APA to forgo comment on the corrections herein, no RFA analysis is required.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         5 U.S.C. 603-604. 
                        <E T="03">See also</E>
                         Small Business Administration, “A Guide for Government Agencies: How to Comply with the Regulatory Flexibility Act” 55 (2017).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    D. 
                    <E T="03">Paperwork Reduction Act</E>
                </HD>
                <P>These conforming corrections impose no new or revised information collection requirements. As explained above, the conforming corrections are non-substantive as they reflect the outcome of judicial review, and they will require no change to the current incident and annual reporting forms and their respective instructions as discussed in the preamble of the 2022 Gas Transmission Final Rule.</P>
                <HD SOURCE="HD2">
                    E. 
                    <E T="03">Unfunded Mandates Reform Act of 1995</E>
                </HD>
                <P>
                    PHMSA analyzed these conforming corrections pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA, 2 U.S.C. 1501 
                    <E T="03">et seq.</E>
                    ) and determined that the corrections do not impose enforceable duties of $100 million or more, adjusted for inflation, in any one year, on state, local, or tribal governments, or on the private sector. Because the corrections impose no new incremental compliance costs beyond those already assessed in the 2022 Gas Transmission Final Rule, PHMSA's earlier UMRA analysis need not be changed.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Final Regulatory Impact Analysis, Doc. No. PHMSA-2011-0023-0637 (2022).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    F. 
                    <E T="03">National Environmental Policy Act</E>
                </HD>
                <P>
                    The National Environmental Policy Act of 1969 (NEPA, 42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ) requires federal agencies to prepare a detailed statement on major federal actions significantly affecting the quality of the human environment. PHMSA analyzed the 2022 Gas Transmission Final Rule in accordance with NEPA, consistent with Council on Environmental Quality regulations (40 CFR parts 1500 through 1508), and DOT implementing policies (DOT Order 5610.1C, “Procedures for Considering Environmental Impacts”) and determined the 2022 Gas Transmission Final Rule would not significantly affect the quality of the human environment.
                    <SU>10</SU>
                    <FTREF/>
                     PHMSA has determined that the corrections in this document have no effect on its earlier NEPA analysis, as 
                    <PRTPAGE P="3715"/>
                    the corrections simply reflect the 2022 Gas Transmission Final Rule as modified by judicial review.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Final Environmental Assessment, Doc. No. PHMSA-2011-0023-0635 (2022).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    G. 
                    <E T="03">Privacy Act Statement</E>
                </HD>
                <P>
                    In accordance with 5 U.S.C. 553(c), the DOT solicits comments from the public to inform its rulemaking process. The DOT posts these comments, without edit, including any personal information the commenter provided, to 
                    <E T="03">www.regulations.gov,</E>
                     as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
                    <E T="03">www.dot.gov/privacy.</E>
                </P>
                <HD SOURCE="HD2">
                    H. 
                    <E T="03">Executive Order 13132 (Federalism)</E>
                </HD>
                <P>
                    PHMSA has analyzed these conforming corrections in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”).
                    <SU>11</SU>
                    <FTREF/>
                     PHMSA has previously determined that the 2022 Gas Transmission Final Rule did not impose any substantial direct effect on the States, the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government.
                    <SU>12</SU>
                    <FTREF/>
                     Because the judicially conforming corrections herein are consistent with the 2022 Gas Transmission Final Rule as modified by judicial review, the consultation and funding requirements of Executive Order 13132 do not apply.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         64 FR 43255 (Aug. 10, 199).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         87 FR at 20978.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Moreover, PHMSA determined that the 2022 Gas Transmission Final Rule did not impose substantial direct compliance costs on state and local governments.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    I. 
                    <E T="03">Executive Order 13211</E>
                </HD>
                <P>
                    PHMSA analyzed the 2022 Gas Transmission Final Rule and determined that the requirements of Executive Order 13211 (“Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use”) 
                    <SU>14</SU>
                    <FTREF/>
                     did not apply. These judicially conforming corrections to the 2022 Gas Transmission Final Rule are not a “significant energy action” under Executive Order 13211, as they are not a significant regulatory action, and they are not likely to have a significant adverse effect on supply, distribution, or energy use. Further, OMB has not designated the corrections herein as a significant energy action.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         66 FR 28355 (May 22, 2001).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    J. 
                    <E T="03">Executive Order 13175</E>
                </HD>
                <P>
                    This document was analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”) 
                    <SU>15</SU>
                    <FTREF/>
                     and DOT Order 5301.1 (“Department of Transportation Policies, Programs, and Procedures Affecting American Indians, Alaska Natives, and Tribes”). Because none of these corrections have tribal implications or impose substantial direct compliance costs on Indian tribal governments, the funding and consultation requirements of Executive Order 13175 do not apply.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         65 FR 67249 (Nov. 6, 2000).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    K. 
                    <E T="03">Executive Order 13609 and International Trade Analysis</E>
                </HD>
                <P>
                    Under Executive Order 13609 (“Promoting International Regulatory Cooperation”),
                    <SU>16</SU>
                    <FTREF/>
                     agencies must consider whether the impacts associated with significant variations between domestic and international regulatory approaches are unnecessary or may impair the ability of American business to export and compete internationally. In meeting shared challenges involving health, safety, labor, security, environmental, and other issues, international regulatory cooperation can identify approaches that are at least as protective as those that are or would be adopted in the absence of such cooperation. International regulatory cooperation can also reduce, eliminate, or prevent unnecessary differences in regulatory requirements. These conforming corrections do not impact international trade.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         77 FR 26413 (May 4, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    L. 
                    <E T="03">Regulation Identifier Number (RIN)</E>
                </HD>
                <P>A RIN is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this notice can be used to cross-reference this action with the Unified Agenda.</P>
                <HD SOURCE="HD2">
                    M. 
                    <E T="03">Severability</E>
                </HD>
                <P>This makes discrete corrections which conform the regulations with the outcome of judicial review on the 2022 Gas Transmission Final Rule. Each amendment is severable and operates independently.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 49 CFR Part 192</HD>
                    <P>Corrosion control, Installation of pipe in a ditch, Integrity management, Internal inspection device, Management of change, Pipeline safety, Repair criteria, Surveillance.</P>
                </LSTSUB>
                <P>In consideration of the foregoing, PHMSA corrects 49 CFR part 192 by making the following correcting amendments:</P>
                <PART>
                    <HD SOURCE="HED">PART 192—TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM FEDERAL SAFETY STANDARDS</HD>
                </PART>
                <REGTEXT TITLE="49" PART="192">
                    <AMDPAR>1. The authority citation for part 192 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             30 U.S.C. 185(w)(3), 49 U.S.C. 5103, 60101 
                            <E T="03">et seq.,</E>
                             and 49 CFR 1.97.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="49" PART="192">
                    <AMDPAR>2. Amend § 192.9 by revising paragraphs (b), (c), (d)(2), and (e)(1)(ii) as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 192.9</SECTNO>
                        <SUBJECT>What requirements apply to gathering pipelines?</SUBJECT>
                        <STARS/>
                        <P>
                            (b) 
                            <E T="03">Offshore lines.</E>
                             An operator of an offshore gathering line must comply with requirements of this part applicable to transmission lines, except the requirements in §§ 192.13(d), 192.150, 192.285(e), 192.319(d) through (g), 192.461(f) through (i), 192.465(d) and (f), 192.473(c), 192.485(c), 192.493, 192.506, 192.607, 192.613(c), 192.619(e), 192.624, 192.710, 192.712, and 192.714, and in subpart O of this part. Further, operators of offshore gathering lines are exempt from the requirements of §§ 192.617(b) through (d) and 192.635. Lastly, operators of offshore gathering lines are exempt from the requirements of § 192.615 (but an operator of an offshore gathering line must comply with the requirements of 49 CFR 192.615, effective as of October 4, 2022).
                        </P>
                        <P>
                            (c) 
                            <E T="03">Type A lines.</E>
                             An operator of a Type A regulated onshore gathering line must comply with the requirements of this part applicable to transmission lines, except the requirements in §§ 192.13(d), 192.150, 192.285(e), 192.319(d) through (g), 192.461(f) through (i), 192.465(d) and (f), 192.473(c), 192.485(c) 192.493, 192.506, 192.607, 192.613(c), 192.619(e), 192.624, 192.710, 192.712, and 192.714, and in subpart O of this part. However, an operator of a Type A regulated onshore gathering line in a Class 2 location may demonstrate compliance with subpart N of this part by describing the processes it uses to determine the qualification of persons performing operations and maintenance tasks. Further, operators of Type A regulated onshore gathering lines are exempt from the requirements of §§ 192.179(e) through (g), 192.610, 192.617(b) through (d), 192.634, 192.635, 192.636, and 192.745(c) through (f). Lastly, operators of Type A regulated onshore gathering lines are exempt from the requirements of § 192.615 (but an operator of a Type A regulated onshore gathering line must comply with the requirements of 49 CFR 192.615, effective as of October 4, 2022).
                            <PRTPAGE P="3716"/>
                        </P>
                        <P>(d) * * *</P>
                        <P>(2) If the pipeline is metallic, control corrosion according to requirements of subpart I of this part applicable to transmission lines, except the requirements in §§ 192.461(f) through (i), 192.465(d) and (f), 192.473(c), 192.485(c), and 192.493;</P>
                        <STARS/>
                        <P>(e) * * *</P>
                        <P>(1) * * *</P>
                        <P>(ii) If the pipeline is metallic, control corrosion according to requirements of subpart I of this part applicable to transmission lines, except the requirements in §§ 192.461(f) through (i), 192.465(d) and (f), 192.473(c), 192.485(c), and 192.493;</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 192.478</SECTNO>
                    <SUBJECT>[Removed] </SUBJECT>
                </SECTION>
                <REGTEXT TITLE="49" PART="192">
                    <AMDPAR>3. Remove § 192.478.</AMDPAR>
                </REGTEXT>
                <REGTEXT TITLE="49" PART="192">
                    <AMDPAR>4. Amend § 192.714 by revising paragraphs (d)(1)(iv) and (v) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 192.714</SECTNO>
                        <SUBJECT>Transmission lines: Repair criteria for onshore transmission pipelines.</SUBJECT>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(1) * * *</P>
                        <P>(iv) Metal loss preferentially affecting a detected longitudinal seam, if that seam was formed by direct current, low-frequency electric resistance welding, electric flash welding, or has a longitudinal joint factor less than 1.0, and the predicted failure pressure determined in accordance with § 192.712(d) is less than 1.25 times the MAOP.</P>
                        <P>(v) A crack or crack-like anomaly meeting any of the following criteria:</P>
                        <P>(A) Crack depth plus any metal loss is greater than 50 percent of pipe wall thickness; or</P>
                        <P>(B) Crack depth plus any metal loss is greater than the inspection tool's maximum measurable depth.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="49" PART="192">
                    <AMDPAR>5. Amend § 192.927 by revising paragraph (c)(4)(iii)(A) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 192.927</SECTNO>
                        <SUBJECT>What are the requirements for using Internal Corrosion Direct Assessment (ICDA)?</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(4) * * *</P>
                        <P>(iii) * * *</P>
                        <P>(A) Conduct excavations of, and detailed examinations at, locations downstream from where the electrolytes might have entered the pipe to investigate and accurately characterize the nature, extent, and root cause of the corrosion; or</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="49" PART="192">
                    <AMDPAR>6. Amend § 192.933 by revising paragraphs (d)(1)(iv) and (v) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 192.933</SECTNO>
                        <SUBJECT>What actions must be taken to address integrity issues?</SUBJECT>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(1) * * *</P>
                        <P>(iv) Metal loss preferentially affecting a detected longitudinal seam, if that seam was formed by direct current, low-frequency electric resistance welding, electric flash welding, or has a longitudinal joint factor less than 1.0, and the predicted failure pressure determined in accordance with § 192.712(d) is less than 1.25 times the MAOP.</P>
                        <P>(v) A crack or crack-like anomaly meeting any of the following criteria:</P>
                        <P>(A) Crack depth plus any metal loss is greater than 50 percent of pipe wall thickness; or</P>
                        <P>(B) Crack depth plus any metal loss is greater than the inspection tool's maximum measurable depth.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Washington, DC, on December 30, 2024, under authority delegated in 49 CFR 1.97.</DATED>
                    <NAME>Tristan H. Brown,</NAME>
                    <TITLE>Deputy Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00073 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-60-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Transportation Security Administration</SUBAGY>
                <CFR>49 CFR Parts 1542 and 1544</CFR>
                <SUBJECT>Recordkeeping Requirements for Criminal History Record Checks; Airport and Aircraft Operator Security; Technical Amendments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Transportation Security Administration, Department of Homeland Security (DHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; technical amendments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Transportation Security Administration (TSA) is issuing technical amendments to certain aviation security regulations. The technical amendments to the regulations clarify that airport operators and aircraft operators are required to retain only the criminal records, including the application for a criminal history records check (CHRC), associated with an individual's current CHRC, CHRC certification, or authorization to perform a covered function and not records associated with previous CHRCs or employment investigations. Also, the technical amendments clarify that the records may be stored in paper or electronic form.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective as of January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Siegmund; Airport Security Programs; Aviation Division; Policy, Plans, and Engagement; (571) 227-4325; 
                        <E T="03">david.siegmund@tsa.dhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    You can find an electronic copy of this rule using the internet by accessing the Government Publishing Office's web page at 
                    <E T="03">https://www.govinfo.gov/app/collection/FR</E>
                     to view the daily published 
                    <E T="04">Federal Register</E>
                     edition or by accessing the Office of the Federal Register's web page at 
                    <E T="03">https://www.federalregister.gov.</E>
                     Copies are also available by contacting the individual identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <HD SOURCE="HD1">Small Entity Inquiries</HD>
                <P>
                    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires TSA to comply with small entity requests for information and advice about compliance with statutes and regulations within TSA's jurisdiction. Any small entity that has a question regarding this document may contact the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section. Persons can obtain further information regarding SBREFA on the Small Business Administration's web page at 
                    <E T="03">https://advocacy.sba.gov/resources/reference-library/sbrefa/.</E>
                </P>
                <HD SOURCE="HD1">I. Discussion of the Rule</HD>
                <P>
                    TSA is making technical amendments to regulatory recordkeeping requirements related to CHRCs that workers for airport and aircraft operators are required to undergo. Beginning in 1996, the FAA required airport and aircraft operators to conduct employment investigations for certain workers. Following the terrorist attacks on September 11, 2001, the FAA determined that the employment investigations did not adequately protect transportation security and published the CHRCs final rule on December 6, 2001.
                    <SU>1</SU>
                    <FTREF/>
                     The rule required the completion of CHRCs for individuals with unescorted Security Identification Display Area security functions such as screening of cargo or 
                    <PRTPAGE P="3717"/>
                    accepting checked baggage for transport.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         66 FR 63474 (Dec. 6, 2001). FAA aviation security functions were transferred to TSA under 67 FR 7939 (Feb. 20, 2002).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See also</E>
                         49 CFR 1544.229 and 1544.330 (expanding CHRC requirements to include flightcrew members).
                    </P>
                </FTNT>
                <P>
                    For airport operators, the current regulations require retention of all employment history investigation files conducted before December 6, 2001, the fingerprint application and CHRC results conducted after December 6, 2001, and any CHRC certifications received after December 6, 2001.
                    <SU>3</SU>
                    <FTREF/>
                     For aircraft operators, the current regulations require retention of employment history investigation files conducted before December 6, 2001, and fingerprint application and CHRC results conducted after December 6, 2001.
                    <SU>4</SU>
                    <FTREF/>
                     The regulations also require airport and aircraft operators to retain these records until 180 days after the individual's access has expired or their authority to perform a covered function is terminated.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         49 CFR 1542.209(k)(1) through (3).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         49 CFR 1544.229(k)(1) and (2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         49 CFR 1542.209(k)(5), 1544.229(k)(4).
                    </P>
                </FTNT>
                <P>
                    When these regulations were promulgated, airport and aircraft operators were required to complete only one CHRC for covered individuals.
                    <SU>6</SU>
                    <FTREF/>
                     However, as a result of the terrorist attacks of September 11, 2001, the modern threat environment, and TSA's risk-based approach to aviation security, TSA has issued security program amendments and security directives requiring airport and certain aircraft operator workers to undergo recurrent CHRCs. For instance, TSA required workers with unescorted access to airport Security Identification Display Areas and sterile areas to complete CHRCs every 2 years, and then to participate in the Rap Back program. As a result of the recurrent CHRC requirements and a strict reading of the recordkeeping regulations, covered entities retain numerous copies of CHRC applications and results. Retaining these records is burdensome and costly. Moreover, TSA does not need prior CHRC applications and results to assess compliance with the existing CHRC requirements. Therefore, TSA is clarifying the existing regulations to state that operators must retain only the records relating to the current CHRC.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         66 FR 63474 (Dec. 6, 2001).
                    </P>
                </FTNT>
                <P>For §§ 1542.209 and 1544.229, the technical amendments remove the date of December 6, 2001, and the requirements concerning employment investigations that applied before that date in the rule text because that language is no longer necessary. Also, the technical amendments now include the phrase “in electronic or paper form as authorized by TSA” to clarify that either hard copy or electronic forms are permissible. When the regulation was originally published, the primary means of record maintenance was in paper/hard copy, which has changed over time to electronic document storage. TSA is adding the phrase “associated with the individual's current ID media, CHRC certification, or authorization to perform a covered function” to clarify that only the current CHRC records must be retained. TSA is revising the title of “Certification” to “Certifications” to grammatically conform with other references to certifications in the rule text. Finally, TSA is removing the phrase “all investigations” to more accurately reflect that airport and aircraft operators are only required to preserve certain records.</P>
                <P>For § 1544.230, the technical amendments add the phrase “[t]he airport operator must maintain the following information associated with an individual's current authorization to be a flightcrew member, in electronic or paper form, as authorized by TSA.” This change clarifies that either hard copy or electronic forms are permissible and that only the current CHRC records must be retained for flightcrew records checks. The technical amendments also delete extraneous phrases from § 1544.230 so that the recordkeeping language is similar to §§ 1542.209 and 1544.229.</P>
                <HD SOURCE="HD1">II. Good Cause and Procedural Rule Exceptions From Notice and Comment and Delayed Effective Date</HD>
                <P>
                    TSA is issuing this final rule change as a technical amendment without a notice of proposed rulemaking or delayed effective date. The Administrative Procedure Act authorizes agencies to forgo the notice and comment requirements if it “for good cause finds . . . that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(B); 
                    <E T="03">see also</E>
                     5 U.S.C. 553(d)(3) (allowing agency to forgo a delayed effective date for a substantive rule upon a finding of good cause).
                </P>
                <P>TSA believes notice and comment concerning reducing the recordkeeping requirements is unnecessary as it is a limited amendment to reflect processes and security needs that have changed overtime. It is unnecessary to seek notice and comment on the rule changes because the new language imposes no new substantive burden and reflects current security and compliance procedures. Further, it is unnecessary for the rule to have a delayed effective date as the amendment merely reduces recordkeeping requirements. Operators may continue to retain old criminal applications and records but are not required to do so. For these reasons, TSA believes that bypassing the ordinary notice and comment procedure and the delayed effected date requirement is justified in the totality of the circumstances.</P>
                <P>
                    In addition, 5 U.S.C. 553(b)(A) permits agencies to forgo notice and comment when issuing “rules of agency organization, procedure, or practice,” 
                    <E T="03">i.e.,</E>
                     a procedural rule. “A useful articulation of the exemption's critical feature is that it covers agency actions that do not themselves alter the rights or interests of parties, although it may alter the manner in which the parties present themselves or their viewpoints to the agency.” 
                    <SU>7</SU>
                    <FTREF/>
                     The exemption “preserve[s] agency flexibility when dealing with limited situations where substantive rights are not at stake.” 
                    <SU>8</SU>
                    <FTREF/>
                     Here, TSA is removing a requirement to retain the old CHRC records that were written when only one CHRC was required. As a matter of agency procedure and practice, TSA does not need to review old CHRC records and applications in order to assess an operator's current compliance with the vetting regulations. In addition, the delayed effective date requirements under 5 U.S.C. 553(d) do not apply to procedural rules.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">Batterton</E>
                         v. 
                        <E T="03">Marshall,</E>
                         648 F.2d 694, 707 (D.C. Cir. 1980).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">American Hospital Ass'n</E>
                         v. 
                        <E T="03">Bowen,</E>
                         834 F.2d 1037, 1045 (D.C. Cir. 1987).
                    </P>
                </FTNT>
                <P>
                    TSA is issuing these final rule changes through technical amendments and not as a notice of proposed rulemaking. The technical amendments reflect current Agency procedures and impose no new substantive requirements. However, it is important to note that even if these revisions were not considered technical amendments, they fall within other exceptions to notice and comment under the Administrative Procedure Act.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         5 U.S.C. 551-559.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Regulatory Analyses</HD>
                <HD SOURCE="HD2">A. Paperwork Reduction Act</HD>
                <P>
                    The Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) requires that TSA consider the impact of paperwork and other information collection burdens imposed on the public, and under the provisions of PRA section 3507(d), obtain approval from the Office of Management and Budget (OMB) for each collection of information it conducts, sponsors, or requires through regulations. This rule does not call for a new collection of information under the PRA. CHRC 
                    <PRTPAGE P="3718"/>
                    recordkeeping requirements are currently covered under Information Collection Request 1652-002 (Airport Security Program). CHRC recordkeeping burden estimates within the Information Collection Request already align with CHRC recordkeeping clarifications identified in the technical amendment and thus do not require revision at this time.
                </P>
                <HD SOURCE="HD2">B. Executive Orders 12866 and 13563 Assessment</HD>
                <P>Executive Orders 12866 (Regulatory Planning and Review), as amended by Executive Order 14094 (Modernizing Regulatory Review), and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying costs and benefits, reducing costs, harmonizing rules, and promoting flexibility.</P>
                <P>The OMB has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866, as amended by Executive Order 14094. Accordingly, OMB has not reviewed this regulatory action.</P>
                <P>This technical amendment clarifies CHRC recordkeeping requirements which may result in cost savings associated with no longer retaining old CHRCs and storing such records electronically. This technical amendment does not impose any new substantive burden and reflects current security and compliance procedures.</P>
                <HD SOURCE="HD2">C. Regulatory Flexibility Analysis</HD>
                <P>
                    The Regulatory Flexibility Act of 1980 (RFA) 
                    <SU>10</SU>
                    <FTREF/>
                     requires that agencies consider the impacts of their rules on small entities. For purposes of the RFA, small entities include small businesses, not-for-profit organizations, and small governmental jurisdictions. The RFA's regulatory flexibility analysis requirements apply only to those rules for which an agency is required to publish a general notice of proposed rulemaking pursuant to 5 U.S.C. 553 or any other law. 
                    <E T="03">See</E>
                     5 U.S.C. 604(a). As discussed previously, TSA did not issue a notice of proposed rulemaking for this action as exempted by 5 U.S.C. 553(b). Therefore, a regulatory flexibility analysis is not required for this rule.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Public Law 96-354 (94 Stat. 1164, Sept. 19, 1980), codified at 5 U.S.C. 601 
                        <E T="03">et seq.,</E>
                         as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. Unfunded Mandates Reform Act</HD>
                <P>Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-38, UMRA) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed rule or final rule for which the agency published a proposed rule, which includes any Federal mandate that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector.</P>
                <P>
                    Regulations are only reviewable under UMRA when an agency has published a notice of proposed rulemaking as defined by 5 U.S.C. 553(b).
                    <SU>11</SU>
                    <FTREF/>
                     This rule is exempted from notice and comment under 5 U.S.C. 553(b). TSA did not publish a notice of proposed rulemaking; thus, this rule is exempt from UMRA's requirements pertaining to the preparation of a written statement.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         2 U.S.C. 658(10); 5 U.S.C. 601(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">E. Executive Order 13132</HD>
                <P>Under Executive Order 13132 (Federalism), agencies must consider whether a rule has federalism implications. TSA has determined that this rule does not have federalism implications because it does not create a substantial direct effect on States, on the relationship between the National Government and States, or the distribution of power and responsibilities among the various levels of government.</P>
                <HD SOURCE="HD2">F. International Trade Impact Assessment</HD>
                <P>The Trade Agreement Act of 1979 prohibits Federal agencies from establishing any standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. The Trade Agreement Act does not consider legitimate domestic objectives, such as essential security, as unnecessary obstacles. The statute also requires that international standards be considered, and where appropriate, that they be the basis for U.S. standards. This technical amendment will not have an adverse impact on international trade.</P>
                <HD SOURCE="HD2">G. Energy Impact Analysis</HD>
                <P>
                    TSA assessed the energy impact of this action in accordance with the Energy Policy and Conservation Act,
                    <SU>12</SU>
                    <FTREF/>
                     and determined that this technical amendment is not a major regulatory action under the provisions of the Energy Policy and Conservation Act.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         As codified at 42 U.S.C. 6362.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">H. Environmental Analysis</HD>
                <P>
                    TSA has reviewed this technical amendment for purposes of the National Environmental Policy Act of 1969 
                    <SU>13</SU>
                    <FTREF/>
                     and has determined that this action will not have a significant effect on the human environment. This action is covered by categorical exclusion numbers A3(a) (for actions of a strictly administrative or procedural nature) and (b) (that implement, without substantive change, statutory or regulatory requirements) in DHS Management Directive 023-01 (formerly Management Directive 5100.1), Environmental Planning Program, and Instruction Manual 023-01-001-01, Rev. 1, which guides TSA compliance with the National Environmental Policy Act.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         As codified at 42 U.S.C. 4321-4347.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">I. The Congressional Review Act</HD>
                <P>Before a rule can take effect, 5 U.S.C. 801, the Congressional Review Act (CRA), requires agencies to submit the rule and a report indicating whether it is a major rule to Congress and the Comptroller General. Under 5 U.S.C. 804(3)(C), rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties are not considered to be a rule for the purposes of the CRA. This technical amendment is a rule of agency organization, procedure, or practice that will not substantially affect the rights or obligations of non-agency parties, thus is not required to be submitted for review under the CRA.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>49 CFR Part 1542</CFR>
                    <P>Airports, Aviation safety, Law enforcement officers, Reporting and recordkeeping requirements, Security measures.</P>
                    <CFR>49 CFR Part 1544</CFR>
                    <P>Air carriers, Aircraft, Airmen, Airports, Aviation safety, Explosives, Freight forwarders, Law enforcement officers, Reporting and recordkeeping requirements, Security measures.</P>
                </LSTSUB>
                <P>For the reasons stated in the preamble, the Transportation Security Administration amends chapter XII, of title 49, Code of Federal Regulations as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 1542—AIRPORT SECURITY</HD>
                </PART>
                <REGTEXT TITLE="49" PART="1542">
                    <AMDPAR>1. The authority citation for part 1542 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <PRTPAGE P="3719"/>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 49 U.S.C. 114, 5103, 40113, 44901-44905, 44907, 44913-44914, 44916-44917, 44935-44936, 44942, 46105.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="49" PART="1542">
                    <AMDPAR>2. Revise § 1542.209(k) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1542.209</SECTNO>
                        <SUBJECT>Fingerprint-based criminal history records checks (CHRC).</SUBJECT>
                        <STARS/>
                        <P>
                            (k) 
                            <E T="03">Recordkeeping.</E>
                             The airport operator must maintain the following information associated with an individual's current identification (ID) media in electronic or paper form, as authorized by TSA:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Fingerprint application.</E>
                             Except when the airport operator has received a certification under paragraph (n) of this section, the airport operator must physically maintain, control, and, as appropriate, destroy the fingerprint application and the criminal record. Only direct airport operator employees may carry out the responsibility for maintaining, controlling, and destroying criminal records.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Certifications.</E>
                             The airport operator must maintain the certifications provided under paragraph (n) of this section.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Protection of records.</E>
                             The records required by this section must be maintained in a manner that is acceptable to TSA and in a manner that protects the confidentiality of the individual.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Duration.</E>
                             The records identified in this section with regard to an individual must be maintained until 180 days after the termination of the individual's unescorted access authority. When files are no longer maintained, the criminal record must be destroyed.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 1544—AIRCRAFT OPERATOR SECURITY: AIR CARRIERS AND COMMERCIAL OPERATORS</HD>
                </PART>
                <REGTEXT TITLE="49" PART="1542">
                    <AMDPAR>3. The authority citation for part 1544 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 49 U.S.C. 114, 5103, 40113, 44901-44905, 44907, 44913-44914, 44916-44918, 44932, 44935-44936, 44942, 46105.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="49" PART="1542">
                    <AMDPAR>4. Revise § 1544.229(k) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1544.229</SECTNO>
                        <SUBJECT>Fingerprint-based criminal history records checks (CHRC): Unescorted access authority, authority to perform screening functions, and authority to perform check baggage or cargo functions.</SUBJECT>
                        <STARS/>
                        <P>
                            (k) 
                            <E T="03">Recordkeeping.</E>
                             The aircraft operator must maintain the following information associated with an individual's current identification (ID) media, CHRC certification, or authorization to perform a covered function in electronic or paper form, as authorized by TSA:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Fingerprint application.</E>
                             The aircraft operator must physically maintain, control, and, as appropriate, destroy the fingerprint application and the criminal record. Only direct aircraft operator employees may carry out the responsibility for maintaining, controlling, and destroying criminal records.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Protection of records.</E>
                             The records required by this section must be maintained in a manner that is acceptable to TSA and in a manner that protects the confidentiality of the individual.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Duration.</E>
                             The records identified in this section with regard to an individual must be maintained until 180 days after the termination of the individual's authority to perform a covered function. When files are no longer maintained, the criminal record must be destroyed.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="49" PART="1542">
                    <AMDPAR>5. Revise § 1544.230(h) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1544.230</SECTNO>
                        <SUBJECT>Fingerprint-based criminal history records checks (CHRC): Flightcrew members.</SUBJECT>
                        <STARS/>
                        <P>
                            (h) 
                            <E T="03">Recordkeeping.</E>
                             The aircraft operator must maintain the following information associated with a current authorization to be a flightcrew member, in electronic or paper form, as authorized by TSA:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Fingerprint application process.</E>
                             The aircraft operator must physically maintain, control, and, as appropriate, destroy the fingerprint application and the criminal record. Only direct aircraft operator employees may carry out the responsibility for maintaining, controlling, and destroying criminal records.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Protection of records.</E>
                             The records required by this section must be maintained by the aircraft operator in a manner that is acceptable to TSA and in a manner that protects the confidentiality of the individual.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Duration.</E>
                             The records identified in this section with regard to an individual must be made available upon request by TSA and maintained until 180 days after the termination of the individual's privileges to perform flightcrew member duties with the aircraft operator. When files are no longer maintained, the criminal record must be destroyed.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>David P. Pekoske,</NAME>
                    <TITLE>Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00773 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-05-P</BILCOD>
        </RULE>
    </RULES>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <PRORULES>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="3720"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Agricultural Marketing Service</SUBAGY>
                <CFR>7 CFR Part 906</CFR>
                <DEPDOC>[Doc. No. AMS-SC-24-0046]</DEPDOC>
                <SUBJECT>Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Increased Assessment Rate</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Agricultural Marketing Service, Department of Agriculture (USDA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This proposed rule would implement a recommendation from the Texas Valley Citrus Committee (Committee) to increase the assessment rate established for the 2024-2025 and subsequent fiscal periods from $0.03 to $0.04 per 7/10-bushel carton or equivalent of oranges and grapefruit grown in Texas. The proposed assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by February 14, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Interested persons are invited to submit written comments concerning this proposed rule. Comments can be sent to the Docket Clerk, Market Development Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237. Comments can also be sent to the Docket Clerk electronically by Email: 
                        <E T="03">MarketingOrderComment@usda.gov</E>
                         or via the internet at: 
                        <E T="03">https://www.regulations.gov.</E>
                         Comments should reference the document number and the date and page number of this issue of the 
                        <E T="04">Federal Register</E>
                        . Comments submitted in response to this proposed rule will be included in the record, will be made available to the public and can be viewed at: 
                        <E T="03">https://www.regulations.gov.</E>
                         Please be advised that the identity of the individuals or entities submitting the comments will be made public on the internet at the address provided above.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Delaney Fuhrmeister, Marketing Specialist, or Christian D. Nissen, Chief, Southeast Region Branch, Market Development Division, Specialty Crops Program, AMS, USDA; telephone: (863) 324-3375 or email: 
                        <E T="03">Delaney.Fuhrmeister@usda.gov</E>
                         or 
                        <E T="03">Christian.Nissen@usda.gov.</E>
                    </P>
                    <P>
                        Small businesses may request information on complying with this regulation by contacting Antoinette Carter, Market Development Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; telephone: (202) 720-8085, or email: 
                        <E T="03">Antoinette.Carter@usda.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This action, pursuant to 5 U.S.C. 553, proposes to amend regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Order No. 906 as amended (7 CFR part 906), regulating the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas. Part 906 (referred to as “the Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of producers and handlers of oranges and grapefruit operating within the area of production.</P>
                <P>The Agricultural Marketing Service (AMS) is issuing this proposed rule in conformance with Executive Orders 12866, 13563, and 14094. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 14094 reaffirms, supplements and updates Executive Order 12866 and further directs agencies to solicit and consider input from a wide range of affected and interested parties through a variety of means. This proposed action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.</P>
                <P>This proposed rule has been reviewed under Executive Order 13175—Consultation and Coordination with Indian Tribal Governments, which requires Federal agencies to consider whether their rulemaking actions would have Tribal implications. AMS has determined that this proposed rule is unlikely to have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.</P>
                <P>This proposed rule has been reviewed under Executive Order 12988—Civil Justice Reform. Under the Order now in effect, Texas orange and grapefruit handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the proposed assessment rate would be applicable to all assessable Texas citrus for the 2024-2025 fiscal period, and continue until amended, suspended, or terminated.</P>
                <P>The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with the U.S. Department of Agriculture (USDA) a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.</P>
                <P>This proposed rule would increase the assessment rate for Texas oranges and grapefruit handled under the Order from $0.03 to $0.04 per 7/10-bushel carton or equivalent for the 2024-2025 fiscal period and subsequent fiscal periods.</P>
                <P>
                    Sections 906.33 and 906.34 of the Order authorize the Committee, with the 
                    <PRTPAGE P="3721"/>
                    approval of AMS, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are familiar with the Committee's needs and with the costs of goods and services in their local area and can formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting, and all directly affected persons have an opportunity to participate and provide input.
                </P>
                <P>For the 2022-23 and subsequent fiscal periods, the Committee recommended, and AMS approved, an assessment rate of $0.03 per 7/10-bushel carton or equivalent of Texas citrus within the production area. That rate continues in effect from fiscal period to fiscal period until modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other information available to AMS.</P>
                <P>The Committee met on June 18, 2024, and unanimously recommended 2024-2025 fiscal period expenditures of $134,970 and an increased assessment rate of $0.04 per 7/10-bushel carton or equivalent of Texas oranges and grapefruit handled for 2024-2025 fiscal periods. The budgeted expenditures remain unchanged compared to last year's recommended expenditures. The proposed assessment rate of $0.04 is $0.01 higher than the rate currently in effect. The Committee recommended increasing the assessment rate to cover expenses for the current fiscal year and replenish reserves. The Committee estimates shipments for the 2024-2025 fiscal period to be around 4,000,000 7/10-bushel cartons or equivalents, similar to the 3,976,000 7/10-bushel cartons or equivalents handled in the 2023-2024 fiscal period.</P>
                <P>The major expenditures recommended by the Committee for the 2024-2025 fiscal period include $66,220 for management expenses, $50,000 for compliance, and $18,750 for general administrative expenses, the same as budgeted for these items during the 2023-2024 fiscal period.</P>
                <P>At the current assessment rate of $0.03, the expected 4,000,000 7/10-bushel cartons or equivalents would generate $120,000 in assessment revenue (4,000,000 7/10-bushel cartons or equivalents multiplied by $0.03 assessment rate), which would not cover budgeted expenses. Further, shipments from the 2023-2024 fiscal period were approximately 4,000,000 7/10-bushel cartons or equivalents of citrus, which was well below the estimated crop of 5,000,000 7/10-bushel cartons or equivalents. The smaller crop forced the Committee to use the remainder of their reserves to help cover 2023-2024 fiscal period expenses. Consequently, the Committee recommended increasing the assessment rate to meet necessary expenses and restore reserves. By increasing the assessment rate from $0.03 to $0.04, assessment income would generate $160,000 in assessment revenue (4,000,000 7/10-bushel cartons or equivalents multiplied by $0.04 assessment rate). This amount should be appropriate to ensure the Committee has sufficient revenue to fully fund its recommended 2024-2025 budgeted expenditures and replenish the Committee's reserve funds.</P>
                <P>The Committee derived the recommended assessment rate by reviewing anticipated expenses, the estimated volume of assessable Texas citrus, and the level of funds available in the financial reserve. Income generated from handler assessments should be sufficient to meet the Committee's estimated program expenditures of $134,970. Funds available in the financial reserve (currently about $0) would be kept within the maximum permitted by the Order (approximately one fiscal period's expenses as authorized in § 906.35).</P>
                <P>The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by AMS upon recommendation and information submitted by the Committee or other available information. Although this assessment rate would be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or AMS. Committee meetings are open to the public and interested persons may express their views at these meetings. AMS would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2024-2025 fiscal period budget, and those for subsequent fiscal periods, will be reviewed and, as appropriate, approved by AMS.</P>
                <HD SOURCE="HD1">Initial Regulatory Flexibility Analysis</HD>
                <P>Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.</P>
                <P>The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.</P>
                <P>There are approximately 17 handlers of Texas oranges and grapefruit subject to regulation under the Order and approximately 75 orange and grapefruit producers in the regulated area. At the time this analysis was prepared, the Small Business Administration (SBA) defined small agricultural producers as those having annual receipts equal to or less than $4 million for orange producers (North American Industry Classification System (NAICS) code 111310), and $4.25 million for other citrus producers (including grapefruit) (NAICS code 111320). Small agricultural service firms, including handlers, are defined as those whose annual receipts are equal to or less than $34 million (NAICS code 115114) (13 CFR 121.201).</P>
                <P>According to data from the National Agricultural Statistics Service (NASS), the producer prices for U.S. fresh oranges and grapefruit were $11.63 and $15.63 per carton, respectively. The prices for U.S. fresh oranges and grapefruit are used for this RFA because NASS does not publish fresh citrus prices for Texas. Based on data provided by the Committee, the number of orange and grapefruit 7/10-bushel cartons or equivalents shipped in the 2023-2024 season were 1,462,800 and 2,513,258, respectively.</P>
                <P>Using the producer prices, shipment data, and the total number of Texas orange and grapefruit producers, and assuming a normal distribution, the majority of producers have estimated average annual receipts of significantly less than the SBA threshold of $4 million ($11.63 multiplied by 1,462,800 cartons plus $15.63 multiplied by 2,513,258 cartons equals $112,564,041, divided by 75 producers equals $750,594 per producer).</P>
                <P>
                    In addition, based on the NASS data, the average prices of fresh U.S. oranges and grapefruit handled for 2023-2024 were $18.40 and $23.05, respectively. Using the same shipment data from the Committee, the number of orange and grapefruit cartons shipped in the 2023-2024 season, and assuming a normal distribution, the majority of Texas orange and grapefruit handlers have 
                    <PRTPAGE P="3722"/>
                    average annual receipts of less than $34 million ($18.40 multiplied by 1,462,800 cartons plus $23.05 multiplied by 2,513,258 cartons equals $84,846,117, divided by 17 handlers equals $4,990,948 per handler). Thus, the majority of Texas orange and grapefruit producers and handlers may be classified as small entities.
                </P>
                <P>This proposal would increase the assessment rate collected from handlers for the 2024-2025 fiscal period and subsequent fiscal periods from $0.03 to $0.04 per 7/10-bushel carton or equivalent of Texas oranges and grapefruit. The Committee unanimously recommended 2024-2025 expenditures of $134,970 and an assessment rate of $0.04 per 7/10-bushel carton or equivalent. The recommended assessment rate of $0.04 is $0.01 higher than the current assessment rate. The 2024-2025 crop year is estimated to be 4,000,000 7/10-bushel cartons or equivalents. The $0.04 per 7/10-bushel carton or equivalent assessment rate should provide $160,000 in assessment income (4,000,000 7/10-bushel cartons or equivalents multiplied by $0.04 assessment rate). Income derived from handler assessments should be sufficient to cover budgeted expenses.</P>
                <P>The major expenditures recommended by the Committee for the 2024-25 fiscal period include $66,220 for management expenses, $50,000 for compliance, and $18,750 for general administrative expenses. This is the same as budgeted for these items during the 2023-2024 fiscal period.</P>
                <P>The Committee recommended increasing the assessment rate to meet necessary expenses and restore reserves. The reserves were depleted when shipments from the 2023-2024 fiscal period were approximately 4,000,000 7/10-bushel cartons or equivalents, which was well below the estimated crop of 5,000,000 7/10-bushel cartons or equivalents. The Committee estimates shipments for the 2024-2025 season to be around 4,000,000 7/10-bushel cartons or equivalents. Given the estimated number of shipments, the current assessment rate of $0.03 would generate $120,000 in assessment income (4,000,000 7/10-bushel cartons or equivalents multiplied by $0.03 assessment rate), which would not cover budgeted expenses. By increasing the assessment rate from $0.03 to $0.04, assessment income would be $160,000 (4,000,000 7/10-bushel cartons or equivalents multiplied by $0.04 assessment rate). This amount should provide sufficient funds to meet anticipated 2024-2025 expenses, while adding money to the financial reserve.</P>
                <P>Prior to arriving at this budget and assessment rate recommendation, the Committee considered alternatives from the Committee staff during a discussion at the June 18, 2024, meeting. Staff prepared fifteen different proposed budgets with different combinations of assessment rates, estimated shipments, and alternate expenditure levels. The Committee determined maintaining expenses and estimated shipments of 4,000,000 7/10-bushel cartons or equivalent of oranges and grapefruit were representative of the 2024-2025 fiscal period, and an assessment rate of $0.04 would cover expenditures and add funds to the financial reserve. Consequently, the other alternatives were rejected.</P>
                <P>A review of historical and preliminary information pertaining to the 2024-2025 fiscal period indicates the average producer price for Texas oranges and grapefruit for the 2024-2025 season should be approximately $14.15 per 7/10-bushel carton or equivalent. Therefore, utilizing the recommended assessment rate of $0.04 per 7/10-bushel carton or equivalent, assessment revenue for the 2024 fiscal period as a percentage of total producer revenue would be approximately 0.2 percent ($0.04 divided by $14.15 times 100).</P>
                <P>This proposed rule would increase the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, these costs are expected be offset by the benefits derived by the operation of the Order.</P>
                <P>The Committee's meetings are widely publicized throughout the Texas citrus industry and all interested persons are invited to attend the meetings and participate in Committee deliberations on all issues. Like all Committee meetings, the June 18, 2024, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this action on small businesses.</P>
                <P>In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0189, Fruit Crops. No changes in those requirements would be necessary because of this proposed rule. Should any changes become necessary, they would be submitted to OMB for approval.</P>
                <P>This proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large Texas citrus handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.</P>
                <P>AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.</P>
                <P>AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.</P>
                <P>
                    A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: 
                    <E T="03">https://www.ams.usda.gov/rules-regulations/moa/small-businesses.</E>
                     Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <P>After consideration of all relevant material presented, including the information and recommendations submitted by the Committee and other available information, AMS has determined that this proposed rule is consistent with, and would effectuate the purposes of, the Act.</P>
                <P>A 30-day comment period is provided to allow interested persons to respond to this proposed rule. All written comments timely received will be considered before a final determination is made on this proposed rule.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 7 CFR Part 906</HD>
                    <P>Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <P>For the reasons set forth in the preamble, the Agricultural Marketing Service proposes to amend 7 CFR part 906 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 906—ORANGES AND GRAPEFRUIT GROWN IN LOWER RIO GRANDE VALLEY IN TEXAS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 906 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>7 U.S.C. 601-674.</P>
                </AUTH>
                <AMDPAR>2. Section 906.235 is revised to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 906.235 </SECTNO>
                    <SUBJECT>Assessment rate.</SUBJECT>
                    <P>
                        On and after August 1, 2024, an assessment rate of $0.04 per 7/10-bushel 
                        <PRTPAGE P="3723"/>
                        carton or equivalent is established for oranges and grapefruit grown in the Lower Rio Grande Valley in Texas.
                    </P>
                </SECTION>
                <SIG>
                    <NAME>Erin Morris,</NAME>
                    <TITLE>Associate Administrator, Agricultural Marketing Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00193 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">CONSUMER FINANCIAL PROTECTION BUREAU</AGENCY>
                <CFR>12 CFR Part 1005</CFR>
                <DEPDOC>[CFPB-2025-0003]</DEPDOC>
                <SUBJECT>Electronic Fund Transfers Through Accounts Established Primarily for Personal, Family, or Household Purposes Using Emerging Payment Mechanisms</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Consumer Financial Protection Bureau.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed interpretive rule; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In light of interest by electronic fund transfer system market participants to offer new types of products to transfer funds and make purchases through accounts established primarily for personal, family, or household purposes, the Consumer Financial Protection Bureau (CFPB) is proposing this interpretive rule to assist companies, investors, and other market participants evaluating existing statutory and regulatory requirements governing electronic fund transfers (EFTs).</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by March 31, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by Docket No. CFPB-2025-0003, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments. A brief summary of this document will be available at 
                        <E T="03">https://www.regulations.gov/docket/CFPB-2025-0003.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Email: 2025-Emerging-Payments-Interpretive-Rule@cfpb.gov.</E>
                         Include Docket No. CFPB-2025-0003 in the subject line of the message.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail/Hand Delivery/Courier:</E>
                         Comment Intake—2025 Emerging Payments Interpretive Rule, c/o Legal Division Docket Manager, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         The CFPB encourages the early submission of comments. All submissions should include the agency name and docket number. Because paper mail is subject to delay, commenters are encouraged to submit comments electronically. In general, all comments received will be posted without change to 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>All submissions, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. Proprietary information or sensitive personal information, such as account numbers or Social Security numbers, or names of other individuals, should not be included. Submissions will not be edited to remove any identifying or contact information.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        George Karithanom, Program Analyst, Office of Regulations at (202) 435-7700 or 
                        <E T="03">https://reginquiries.consumerfinance.gov.</E>
                         If you require this document in an alternative electronic format, please contact 
                        <E T="03">CFPB_Accessibility@cfpb.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Background</HD>
                <HD SOURCE="HD2">A. The Passage and Evolution of the Electronic Fund Transfer Act</HD>
                <P>Advances in automation brought about enormous innovation in the middle of the twentieth century with respect to the movement of funds. In 1969, Chemical Bank installed the first automated teller machine in Rockville Center, New York. New payment networks also launched, forming the foundation of mechanisms facilitating EFTs. However, adoption of these new technologies raised questions about the rights and liabilities of consumers who use EFT services, and the responsibilities of financial institutions that offer them. In particular, while financial firms would reap benefits from automation, consumer adoption might be stymied by concerns about and risks of errors and fraud.</P>
                <P>
                    To provide fairness, efficiency, and confidence in burgeoning technologies to make payments outside of paper currency, coins, and paper checks, Congress enacted the Electronic Fund Transfer Act (EFTA) in 1978.
                    <SU>1</SU>
                    <FTREF/>
                     To ensure that industry participants in electronic fund transfers (EFTs) had appropriate incentives to guard against errors and fraud, EFTA provides a considerable set of rights to consumers to dispute errors and limit their liability for unauthorized EFTs, among other things. To help vindicate the rights established in EFTA, Congress provided mechanisms for both public and private enforcement.
                    <SU>2</SU>
                    <FTREF/>
                     In addition, courts have held that EFTA is a “remedial statute accorded a broad, liberal construction in favor of the consumer.” 
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         Electronic Fund Transfers, Public Law 95-630, tit. XX, section 2001, 92 Stat. 3728 (1978); 
                        <E T="03">see also</E>
                         S. Rept. 95-1273 at 10 (1978) (“EFT payment systems, which now involve billions of dollars annually and are growing in size, must have clearly defined rules to operate fairly, efficiently, and with public confidence.”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         15 U.S.C. 1693m, 1693
                        <E T="03">o.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">Clemmer</E>
                         v. 
                        <E T="03">Key Bank Nat. Ass'n,</E>
                         539 F.3d 349, 353 (6th Cir. 2008) (citation omitted); 
                        <E T="03">see also Curtis</E>
                         v. 
                        <E T="03">Propel Prop. Tax Funding, LLC,</E>
                         915 F.3d 234, 239 (4th Cir. 2019).
                    </P>
                </FTNT>
                <P>
                    The United States was among the first to adopt a framework like EFTA, providing greater certainty and protection for consumers, financial firms, and other participants in electronic fund transfer systems. In enacting that legislation, Congress recognized that electronic fund transfer services would continue to develop in the future. In particular, EFTA's legislative history demonstrates that Congress drafted the definitions used in the statute in a broad manner to ensure that EFTA was “sufficiently flexible to accommodate the continued evolution of electronic fund transfer services.” 
                    <SU>4</SU>
                    <FTREF/>
                     Congress also granted the Board of Governors of the Federal Reserve System (the Board) and later the CFPB the authority to issue regulations and guidance to implement the broad provisions of EFTA.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Electronic Fund Transfer Act, H. Rept. 95-1315, at 5 (1978) (discussing definition of “financial institution”); 
                        <E T="03">see also, e.g.,</E>
                         S. Rept. 95-1273 at 25 (1978) (“The definition of `electronic fund transfer' is intended to give the Federal Reserve Board flexibility in determining whether new or developing electronic services should be covered by the act and, if so, to what extent.”); 
                        <E T="03">id.</E>
                         at 26 (noting that “[t]he definitions of `financial institution' and `account' are deliberately broad so as to assure that all persons who offer equivalent EFT services involving any type of asset account are subject to the same standards and consumers owning such accounts are assured of uniform protection”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         15 U.S.C. 1693b, 1693m(d).
                    </P>
                </FTNT>
                <P>
                    The Board implemented EFTA through Regulation E shortly after the statute's passage in 1978.
                    <SU>6</SU>
                    <FTREF/>
                     Over time, the Board and then the CFPB have amended and interpreted Regulation E in response to the emergence of new electronic payment instruments and systems, broader developments in the market, and new congressional legislation.
                    <SU>7</SU>
                    <FTREF/>
                     Most recently, in 2016, the 
                    <PRTPAGE P="3724"/>
                    CFPB issued a final rule to create comprehensive consumer protections for prepaid accounts under Regulation E.
                    <SU>8</SU>
                    <FTREF/>
                     The CFPB noted in the rule that its analysis with respect to virtual currencies and related products and services was ongoing, and that the rule did not resolve issues with respect to the application of existing regulations or the prepaid rule to such products and services.
                    <SU>9</SU>
                    <FTREF/>
                     The CFPB therefore treated comments addressing crypto-assets and related products and services as outside the scope of the rulemaking.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         44 FR 18468 (Mar. 28, 1979); 44 FR 59464 (Oct. 15, 1979).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See, e.g.,</E>
                         61 FR 19662, 19662 (May 2, 1996) (amending Regulation E as part of periodic review to “reflect technological and other developments”); 62 FR 43467 (Aug. 14, 1997) (amending Regulation E with respect to government-administered EBT programs); 71 FR 51437 (Aug. 30, 2006) (amending Regulation E with respect to payroll cards). The CFPB also issued new requirements in subpart B of Regulation E relating to remittance transfers in final rules issued in 2012 and 2013. 
                        <E T="03">See</E>
                         78 FR 30662, 
                        <PRTPAGE/>
                        30662 (May 22, 2013) (summarizing 2012 and 2013 rules).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         81 FR 83934 (Nov. 22, 2016). The prepaid rule also amended Regulation Z, which implements the Truth in Lending Act, to create consumer protections for prepaid accounts.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">Id.</E>
                         at 83978 (discussing “virtual currencies”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Facebook's 2019 Libra Proposal</HD>
                <P>While most payment networks rely on significant network effects, like those that exist among banks and merchants through card networks, advances in mobile technology spawned new networks for payments. More recently, large technology firms have begun to explore additional ways to leverage their network effects to facilitate payments.</P>
                <P>
                    In 2019, the technology firm Facebook announced the creation of a new global currency known as Libra.
                    <SU>11</SU>
                    <FTREF/>
                     Libra was a proposed “stablecoin.” 
                    <SU>12</SU>
                    <FTREF/>
                     Rather than offering Libra to the public for speculative trading, the goal of Libra was to provide a mechanism to make payments throughout the digital world.
                    <SU>13</SU>
                    <FTREF/>
                     Users would transmit Libra through a Calibra wallet account, which would also be established by Facebook. A broad range of merchants, including app-based services, indicated that they would participate in the Libra scheme.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         Mike Isaac &amp; Nathaniel Popper, 
                        <E T="03">Facebook Plans Global Financial System Based on Cryptocurrency,</E>
                         N.Y. Times (June 18, 2019), 
                        <E T="03">https://www.nytimes.com/2019/06/18/technology/facebook-cryptocurrency-libra.html.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         Rebecca Nelson &amp; David Perkins, 
                        <E T="03">Libra: A Facebook-led Cryptocurrency Initiative,</E>
                         Congressional Research Service (Oct. 21, 2019), 
                        <E T="03">https://crsreports.congress.gov/product/pdf/IN/IN11183/2.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         Libra, 
                        <E T="03">White Paper</E>
                         (June 18, 2019), 
                        <E T="03">https://web.archive.org/web/20190618085610/https://libra.org/en-US/white-paper/</E>
                         (“[t]he mission for Libra is a simple global currency and financial infrastructure that empowers billions of people”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         PYMNTS, 
                        <E T="03">A Brief History of Libra</E>
                         (July 15, 2019), 
                        <E T="03">https://www.pymnts.com/cryptocurrency/2019/a-brief-history-of-facebook-libra/.</E>
                    </P>
                </FTNT>
                <P>
                    Regulators around the world charged with assuring compliance with privacy, consumer protection, and anti-money laundering laws raised concerns about many aspects of the Libra proposal.
                    <SU>15</SU>
                    <FTREF/>
                     Central banks and authorities charged with ensuring stability of the financial system also sought clarity on how the Libra stablecoin would fit into existing regulatory frameworks.
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Off. of the Priv. Comm'r of Can., 
                        <E T="03">Joint statement on global privacy expectations of the Libra network</E>
                         (Aug. 5, 2019), 
                        <E T="03">https://www.priv.gc.ca/en/opc-news/speeches-and-statements/2019/s-d_190805/;</E>
                         Foo Yun Chee, 
                        <E T="03">EU antitrust regulators raise concerns about Facebook's Libra currency: sources,</E>
                         Reuters (Aug. 21, 2019), 
                        <E T="03">https://www.reuters.com/article/technology/eu-antitrust-regulators-raise-concerns-about-facebooks-libra-currency-sources-idUSKCN1VB1C1/.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Zachary Warmbrodt, 
                        <E T="03">Jerome Powell: Facebook's Libra poses potential risk to financial system,</E>
                         Politico (July 10, 2019), 
                        <E T="03">https://www.politico.com/story/2019/07/10/jerome-powell-facebook-libra-1578306.</E>
                    </P>
                </FTNT>
                <P>
                    Ultimately, Libra was abandoned.
                    <SU>17</SU>
                    <FTREF/>
                     However, questions surrounding the safety and utility of emerging forms of fund transfers for “personal, family, or household purposes” operating outside of traditional bank and credit union accounts have persisted.
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         Katie Paul, 
                        <E T="03">Facebook's cryptocurrency venture to wind down after asset sale to Silvergate,</E>
                         Reuters (Jan. 31, 2022), 
                        <E T="03">https://www.reuters.com/technology/facebooks-cryptocurrency-venture-wind-down-after-asset-sale-silvergate-2022-02-01.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         CFPB, 
                        <E T="03">Prepared Remarks of CFPB Director Rohit Chopra at the Brookings Institution Event on Payments in a Digital Century</E>
                         (Oct. 6, 2023), 
                        <E T="03">https://www.consumerfinance.gov/about-us/newsroom/prepared-remarks-of-cfpb-director-rohit-chopra-at-the-brookings-institution-event-on-payments-in-a-digital-century/</E>
                         (“Libra never became a new global currency. But the questions it provoked in the West for consumer and data protection regulators . . . live on.”).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. CFPB Research Into Emerging Payments</HD>
                <P>
                    While there has been considerable attention paid to cryptocurrencies acquired for speculation and other purposes, the CFPB has conducted research to evaluate emerging forms of payments, fund transfers, and digital technologies for “personal, family, or household purposes.” For example, in 2021, the CFPB launched an inquiry into the payment products and services offered by large technology firms and by widely used digital payment applications.
                    <SU>19</SU>
                    <FTREF/>
                     There were many insights from the research, including developments in how firms were offering accounts for storing and transmitting funds. While firms primarily offered the ability to transfer funds by relying on balances in a consumer's bank or credit union account, many of the firms offered stored balance products, where funds held in an account were not necessarily deposited in a traditional insured account. There were indicia that some of the firms were actively developing proprietary products, including stablecoins similar to Libra.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Press Release, CFPB, 
                        <E T="03">CFPB Orders Tech Giants to Turn Over Information on their Payment System Plans</E>
                         (Oct. 21, 2021), 
                        <E T="03">https://www.consumerfinance.gov/about-us/newsroom/cfpb-orders-tech-giants-to-turn-over-information-on-their-payment-system-plans/.</E>
                    </P>
                </FTNT>
                <P>
                    Because gaming platforms served as early adopters of technologies that inevitably become more broadly adopted, the CFPB also undertook a study of payments in fund transfers used on such platforms.
                    <SU>20</SU>
                    <FTREF/>
                     In a report from April 2024, the CFPB detailed some of the business practices on how game players convert U.S. dollars into virtual currencies. The payment systems on these gaming platforms have rapidly evolved. Rather than relying on a business model in which players make a one-time payment to buy or play the game, some gaming platforms have developed elaborate economies where the platforms accept U.S. dollars in exchange for virtual currency that can be transacted among players and other platform participants, and even exchanged back to U.S. dollars in certain circumstances. The report described how players and other platform participants maintain an account where these virtual currencies are stored, and how some consumers have experienced the loss of assets in these accounts through hacking attempts, account theft, scams, and unauthorized transactions. The developments described in the report raise questions about responsibilities and liabilities when errors or fraud take place.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See</E>
                         CFPB, 
                        <E T="03">Banking in video games and virtual worlds</E>
                         (Apr. 4, 2024), 
                        <E T="03">https://www.consumerfinance.gov/data-research/research-reports/issue-spotlight-video-games/.</E>
                    </P>
                </FTNT>
                <P>
                    The CFPB has also conducted research into online services that offer betting on sporting events and casino games.
                    <SU>21</SU>
                    <FTREF/>
                     Some of these services allow bettors to maintain accounts that allow individuals to make a range of electronic transfers, including to and from linked accounts. These accounts may be denominated in U.S. dollars, or in proprietary currencies.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">Id.</E>
                         (“Third-party websites also facilitate a growing skin gambling industry that supports wagering skins, similar to casino chips, in virtual games such as blackjack, roulette, or craps. . . . competitive gaming contests, also known as esports, and games between professional sports teams. Winnings can be converted to fiat currency or other forms of virtual currency and withdrawn for a fee directly to the player's digital wallet.”)
                    </P>
                </FTNT>
                <P>
                    Recognizing that many arrangements, such as stablecoins and virtual currencies, constitute alternative electronic fund transfer mechanisms, private sector participants have made certain determinations about how to treat transactions to obtain these currencies. For example, many large credit card issuers categorize purchases of virtual currencies as “cash 
                    <PRTPAGE P="3725"/>
                    advances,” reflecting the money-like nature of the funds held in these accounts.
                </P>
                <HD SOURCE="HD2">D. 2021 Report on Stablecoins</HD>
                <P>
                    In November 2021, the President's Working Group on Financial Markets (consisting of the Secretary of the Treasury, the Chairperson of the Board of Governors of the Federal Reserve System, the Chairperson of the Securities and Exchange Commission, and the Chairperson of the Commodity Futures Trading Commission), in conjunction with the Federal Deposit Insurance Commission and the Office of the Comptroller of the Currency, issued a report on stablecoins.
                    <SU>22</SU>
                    <FTREF/>
                     The report described certain financial stability concerns, as well as issues related to the issuance of stablecoins by banks and nonbanks. The report did not include a specific assessment on consumer protection issues, but noted that existing laws (including EFTA) accord certain consumer protections to payments services used by consumers.
                    <SU>23</SU>
                    <FTREF/>
                     The report further urged regulators to continue to coordinate on these issues and for Congress to consider legislation on a prudential framework for so-called “payment stablecoins.” 
                    <SU>24</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         President's Working Grp. on Fin. Mkts., Fed. Deposit Ins. Corp.&amp; Off. of the Comptroller of the Currency, 
                        <E T="03">Report on Stablecoins</E>
                         (Nov. 2021), 
                        <E T="03">https://home.treasury.gov/system/files/136/StableCoinReport_Nov1_508.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">Id.</E>
                         at 18.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">Id.</E>
                         at 2, 16-18.
                    </P>
                </FTNT>
                <P>
                    Consistent with the report, the CFPB has coordinated with regulators on issues with respect to stablecoins and emerging payments.
                    <SU>25</SU>
                    <FTREF/>
                     There has been considerable legislative discussion on many aspects of stablecoins and digital assets, but these discussions have primarily focused on stablecoins' status under the securities and commodities trading laws, rather than their potential use as a payment mechanism.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         
                        <E T="03">See</E>
                         CFPB, 
                        <E T="03">Statement of CFPB Director Chopra on Stablecoin Report</E>
                         (Nov. 1, 2021), 
                        <E T="03">https://www.consumerfinance.gov/about-us/newsroom/statement-cfpb-director-chopra-stablecoin-report/.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD2">E. Rationale for Development of Interpretive Rule</HD>
                <P>The CFPB is concerned that if market participants do not apply EFTA and Regulation E in a consistent manner, consumers making electronic fund transfers using accounts established primarily for personal, family, or household purposes might face challenges in vindicating their rights in the event of unauthorized transfers and other errors. The CFPB is also concerned that inconsistent application of EFTA and Regulation E might put certain providers at an unfair, competitive disadvantage.</P>
                <P>
                    While the application of Federal consumer financial protection laws, such as EFTA, to new methods of payments is often developed through case-by-case adjudications by courts, consumers and market participants may face conflicting guidance from case law. Consistent with the CFPB's mandate to promote fair, transparent, and competitive markets, as well as its mandate to advance the underlying goal of EFTA to create confidence in electronic fund transfer mechanisms by establishing a framework of rights, liabilities, and responsibilities,
                    <SU>26</SU>
                    <FTREF/>
                     this proposed interpretive rule, if adopted, would provide a consistent framework for the applicability of EFTA and Regulation E with respect to a range of emerging payment mechanisms. The proposed interpretive rule seeks to synthesize the range of insights developed by the CFPB in recent years derived from research and coordination to outline how market participants can develop beneficial products and services in compliance with EFTA and Regulation E, by ensuring that similar products are treated similarly under the law.
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 5511(a); 15 U.S.C. 1693(b).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Proposed Interpretive Rule</HD>
                <P>The text of the proposed interpretive rule is as follows.</P>
                <HD SOURCE="HD2">A. Legal Analysis</HD>
                <P>
                    EFTA and Regulation E apply to an electronic fund transfer (EFT) that authorizes a “financial institution” to debit or credit a consumer's account.
                    <SU>27</SU>
                    <FTREF/>
                     The term “electronic fund transfer” generally means any transfer of “funds” that is initiated through an electronic terminal, telephone, computer, or magnetic tape for the purpose of ordering, instructing, or authorizing a financial institution to debit or credit a consumer's account.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         12 CFR 1005.3(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         EFTA section 903(7); 15 U.S.C. 1693a(7).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">1. “Financial Institution”</HD>
                <P>
                    The term “financial institution” under EFTA, as implemented in Regulation E, means a bank, savings association, credit union, or any other person that directly or indirectly holds an account belonging to a consumer, or that issues an access device and agrees with a consumer to provide EFT services.
                    <SU>29</SU>
                    <FTREF/>
                     It is well-established that financial institutions include nonbank entities that directly or indirectly hold an account belonging to a consumer, or that issue an access device and agree with a consumer to provide EFT services.
                    <SU>30</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         12 CFR 1005.2(i). Regulation E defines “access device” as a card, code, or other means of access to a consumer's account, or any combination thereof, that may be used by the consumer to initiate electronic fund transfers. 12 CFR 1005.2(a)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         
                        <E T="03">See, e.g.,</E>
                         S. Rept. 95-1273 at 26 (“The term `financial institution' is defined to mean traditional depository institutions as well as any other person who directly or indirectly holds a consumer's account.”); Electronic Fund Transfer Act, H. Rept. 95-1315, at 5 (1978) (“Section 903(h) of the bill defines the term `financial institution' to include not only traditional depository institutions that are normally considered to be financial institutions but also `. . . any other person who, . . . indirectly, holds a consumer account belonging to an individual; . . . .' This language is intended by the Committee to assure that the legislation remains sufficiently flexible to accommodate the continued evolution of electronic fund transfer services.”); 
                        <E T="03">see also</E>
                         81 FR 83934 at 83964 (noting that the prepaid rule's “requirements apply equally to depositories and non-depositories alike”).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. “Funds”</HD>
                <P>The term “funds” is not specifically defined in EFTA or Regulation E, but has been broadly construed to cover a broad array of assets, beyond those held in a traditional bank or credit union account. Specifically, at the time of EFTA's enactment in 1978, as well as today, the term was and is broadly understood to cover much more than the U.S. dollar and other fiat currencies.</P>
                <P>
                    For example, one leading court decision from before the enactment of EFTA recognized that the dictionary defined “funds” “as `available pecuniary resources ordinarily including cash and negotiable paper' ” and that “in a legal context the courts have also taken it to include property of value which may be converted into cash.” 
                    <SU>31</SU>
                    <FTREF/>
                     Another decision from that time stated that the term “ `[f]unds' includes moneys, and much more, such as notes, bills, checks, drafts, stocks, and bonds. In other words the general term can and does include not only currency but also other types of pecuniary resources which are readily converted into cash.” 
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         
                        <E T="03">Keene</E>
                         v. 
                        <E T="03">Keene,</E>
                         371 P.2d 329, 332 (Cal. 1962) (quoting definition of “funds” in Webster's New International Dictionary 921 (3d ed. 1961)); 
                        <E T="03">see also Funds,</E>
                         Webster's New International Dictionary 921 (3d ed. 1961) (defining “funds” as “available pecuniary resources ordinarily including cash and negotiable paper that can be converted to cash at any time without loss”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         
                        <E T="03">In re Plich's Est.,</E>
                         348 P.2d 706, 708-09 (Colo. 1960); 
                        <E T="03">see also, e.g., Zamora</E>
                         v. 
                        <E T="03">United States,</E>
                         369 F.2d 855, 859 (10th Cir. 1966) (“The word `funds' is broader than but in its usual sense includes `moneys.' ”).
                    </P>
                </FTNT>
                <P>
                    Similarly, Black's Law Dictionary at that time defined “fund” as “[a] generic term and all-embracing as compared with [the] term `money,' etc., which is 
                    <PRTPAGE P="3726"/>
                    specific.” 
                    <SU>33</SU>
                    <FTREF/>
                     Modern dictionaries (both legal and general-use) similarly define “funds” in reference to pecuniary resources and further define “pecuniary” as “concerning or involving money” or “of or relating to money.” 
                    <SU>34</SU>
                    <FTREF/>
                     The term “money” means “something generally accepted as a medium of exchange, a measure of value, or a means of payment.” 
                    <SU>35</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">Fund,</E>
                         Black's Law Dictionary (4th ed.1957); 
                        <E T="03">see also Funds,</E>
                         Black's Law Dictionary (4th ed.1957) (“Moneys and much more, such as notes, bills, checks, drafts, stocks and bonds, and in broader meaning may include property of every kind.”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">Funds,</E>
                         Collins English Dictionary, 
                        <E T="03">https://www.collinsdictionary.com/us/dictionary/english/funds</E>
                         (last visited Dec. 11, 2024); 
                        <E T="03">Pecuniary,</E>
                         Collins English Dictionary, 
                        <E T="03">https://www.collinsdictionary.com/us/dictionary/english/pecuniary</E>
                         (last visited Dec. 16, 2024); 
                        <E T="03">Funds,</E>
                         Merriam-Webster Dictionary, 
                        <E T="03">https://www.merriam-webster.com/dictionary/money</E>
                         (last visited Dec. 11, 2024); 
                        <E T="03">Pecuniary,</E>
                         Merriam-Webster Dictionary, 
                        <E T="03">https://www.merriam-webster.com/dictionary/pecuniary</E>
                         (last visited Dec. 16, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">Money,</E>
                         Merriam-Webster Dictionary, 
                        <E T="03">https://www.merriam-webster.com/dictionary/money</E>
                         (last visited Dec. 11, 2024).
                    </P>
                </FTNT>
                <P>
                    Based on the plain language used in EFTA and the reasoning of judicial decisions, as well as the CFPB's experience in market monitoring, it has long been clear that the term “funds” in EFTA is not limited to fiat currency like U.S. dollars. The CFPB interprets the term “funds” to include assets that act or are used like money, in the sense that they are accepted as a medium of exchange, a measure of value, or a means of payment. Under this interpretation, the term “funds” would include stablecoins, as well as any other similarly-situated fungible assets that either operate as a medium of exchange or as a means of paying for goods or services.
                    <SU>36</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Whether a specific digital asset is included in the term “funds” for purposes of EFTA and Regulation E is fact specific, and there are likely some digital assets that are not “funds” because, for example, they cannot be used to make payments or cannot be readily exchanged for fiat currency. For example, most nonfungible tokens (“NFTs”) are unlikely to be “funds.”
                    </P>
                </FTNT>
                <P>
                    In addition, the fact that the asset may fluctuate in value does not exempt it from this definition. Several courts interpreting “funds” in the context of Federal money transmitter and money laundering statutes have similarly held that the term “funds” is not limited to fiat currency and encompasses other types of assets, including widely held currencies like Bitcoin.
                    <SU>37</SU>
                    <FTREF/>
                     A Federal district court also recently held that cryptocurrency, as a “digital form of liquid, monetary assets,” unambiguously constitutes “funds” under EFTA.
                    <SU>38</SU>
                    <FTREF/>
                     These interpretations of “funds” accord with Congress's intent by ensuring that consumers are adequately protected and have access to the benefits of innovative electronic fund transfer systems and technology.
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         
                        <E T="03">See, e.g.,</E>
                          
                        <E T="03">United States</E>
                         v. 
                        <E T="03">Day,</E>
                         700 F.3d 713, 726 (4th Cir. 2012) (holding that “gold can constitute `funds' under the . . . statute where it is moved as a liquid, monetary asset”); 
                        <E T="03">United States</E>
                         v. 
                        <E T="03">Iossifov,</E>
                         45 F.4th 899, 913 (6th Cir. 2022), 
                        <E T="03">cert. denied,</E>
                         143 S. Ct. 812 (2023) (holding that the ordinary meaning of “funds” is “available pecuniary resources,” and noting that courts have “unanimously determined that Bitcoin” is encompassed by the terms “funds” and “monetary instrument”); 
                        <E T="03">United States</E>
                         v. 
                        <E T="03">Murgio,</E>
                         209 F. Supp. 3d 698, 707 (S.D.N.Y. 2016) (“[t]he ordinary meaning of `funds' . . . is `available pecuniary resources' ”) (citation omitted); 
                        <E T="03">United States</E>
                         v. 
                        <E T="03">Budovsky,</E>
                         No. 13CR368 DLC, 2015 WL 5602853 (S.D.N.Y. Sept. 23, 2015) (assigning “funds” its ordinary meaning, “assets that `can be used to pay for things in the colloquial sense,' ” and holding that “funds” encompassed the digital currency at issue); 
                        <E T="03">see also United States</E>
                         v. 
                        <E T="03">Harmon,</E>
                         474 F. Supp. 3d 76 (D.D.C. 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">Rider</E>
                         v. 
                        <E T="03">Uphold HQ Inc.,</E>
                         657 F. Supp. 3d 491, 498 (S.D.N.Y. 2023).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. “Account” and “Other Consumer Asset Account”</HD>
                <P>Given the breadth of the term “funds,” the applicability of EFTA and Regulation E will often turn on the definition of “account” in EFTA and Regulation E.</P>
                <P>
                    EFTA section 903(2) defines “account” to mean “a demand deposit, savings deposit, or other asset account . . . as described in regulations of the [CFPB], established primarily for personal, family, or household purposes,” subject to limited exceptions. The legislative history confirms that Congress intended EFTA to cover more than checking or savings accounts, noting that EFTA's definition of “account” is intended to be broad enough “to assure that all persons who offer equivalent EFT services involving any type of asset account are subject to the same standards and consumers owning such accounts are assured of uniform protections.” 
                    <SU>39</SU>
                    <FTREF/>
                     The legislative history also explained that the term “account” was intended to go beyond a consumer's checking or savings account. It provided several examples of nonbank asset accounts that were within EFTA's coverage because they could potentially be used to make electronic payments from consumer accounts.
                    <SU>40</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         S. Rept. 95-915 at 9.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">Id.</E>
                         at 4, 9 (providing as examples mutual fund accounts that provide an EFT card that can be used to make payments, money market mutual fund accounts, and positive balances in margin accounts at a stock brokerage).
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>Both EFTA and Regulation E generally define “account” to mean:</P>
                    <P>
                        [A] demand deposit (checking), savings, or other consumer asset account (other than an occasional or incidental credit balance in a credit plan) held directly or indirectly by a financial institution and established primarily for personal, family, or household purposes.
                        <SU>41</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             12 CFR 1005.2(b)(1); 
                            <E T="03">see also</E>
                             15 U.S.C. 1693a(2).
                        </P>
                    </FTNT>
                      
                </EXTRACT>
                <P>
                    Essentially, “other consumer asset accounts” include prepaid accounts,
                    <SU>42</SU>
                    <FTREF/>
                     and other asset accounts established primarily for a consumer's individual, family, or household use, that are not checking accounts or savings accounts, but into which funds can be deposited by the consumer or on their behalf and which have features of deposit or savings accounts. Such features include, but are not limited to: paying for goods or services from multiple merchants, ability to withdraw funds or obtain cash, or conducting person-to-person transfers.
                    <SU>43</SU>
                    <FTREF/>
                     Depending on the facts and circumstances, the following could be considered “accounts” under EFTA: video game accounts used to purchase virtual items from multiple game developers or players; virtual currency wallets that can be used to buy goods and services or make person-to-person transfers; and credit card rewards points accounts that allow consumers to buy points that can be used to purchase goods from multiple merchants.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1005.2(b)(3). Whether a particular product meets the definition of “prepaid account” in Regulation E depends on the features of the product and is outside the scope of this interpretive rule.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1005.2(b)(1). Whether a particular account sufficiently resembles a checking or savings account, and thus qualifies as an “other consumer asset account” for purposes of Regulation E, will depend on the account's specific features.
                    </P>
                </FTNT>
                <P>
                    This interpretation of the term “other consumer asset account” is consistent with the legislative history discussed above, and longstanding provisions in both Regulation E's regulatory text and the Official Staff Interpretations to Regulation E, where certain types of accounts that are functionally similar to checking and savings accounts are Regulation E “accounts.” Examples include club accounts,
                    <SU>44</SU>
                    <FTREF/>
                     retail repurchase agreements,
                    <SU>45</SU>
                    <FTREF/>
                     margin accounts,
                    <SU>46</SU>
                    <FTREF/>
                     as well as any securities and commodities accounts that are functionally similar to checking or savings accounts.
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         Regulation E comment 2(b)-1.i.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         Regulation E comment 2(b)-1.ii.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         12 CFR 1005.11(c)(2)(i)(B).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         12 CFR 1005.3(c)(4); Regulation E comment 3(c)(4)-3.i; 
                        <E T="03">see also,</E>
                         61 FR 19680 (May 2, 1996).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">4. Exceptions for Securities and Commodities</HD>
                <P>
                    EFTA and Regulation E both contain specific securities and commodities exceptions to the definition of EFT.
                    <SU>48</SU>
                    <FTREF/>
                     As implemented in Regulation E, these specific exceptions include any transfer 
                    <PRTPAGE P="3727"/>
                    of funds the primary purpose of which is the purchase or sale of a security or commodity if, among other things, the security or commodity is regulated by the Securities and Exchange Commission (SEC) or the Commodity Futures Trading Commission (CFTC) or purchased or sold through a broker-dealer regulated by the SEC or through a futures commissions merchant regulated by the CFTC.
                    <SU>49</SU>
                    <FTREF/>
                     This exception is limited to EFTs which have as their primary purpose the purchase or sale of commodities or securities, and does not reach instances where securities or commodities are used as “funds” in an “account” to purchase goods or services.
                    <SU>50</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         EFTA section 903(7); 15 U.S.C. 1693a(7); 12 CFR 1005.3(c).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         12 CFR 1005.3(c)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         
                        <E T="03">See</E>
                         S. Rept. 95-915 at 4 (explaining that EFTA would cover, for example, instances where a mutual fund issues “an EFT card which would draw on the consumer's fund shares. Each time the card would be used, the fund could instantaneously redeem shares necessary to cover a payment and transfer the funds to the payee”).
                    </P>
                </FTNT>
                <P>
                    Put another way, EFTA generally does not apply to the purchase or sale of a stock or bond.
                    <SU>51</SU>
                    <FTREF/>
                     But it could apply if a stock, bond, or other form of funds in an investment account—including funds and accounts also regulated by the SEC or CFTC—is used to purchase goods or services from a retailer. Indeed, the longstanding Official Commentary to Regulation E makes clear that EFTs from a securities account to purchase goods or services or obtain cash are regulated under EFTA.
                    <SU>52</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">Nero</E>
                         v. 
                        <E T="03">Uphold HQ Inc.,</E>
                         688 F. Supp. 3d 134, 144 (S.D.N.Y. 2023). (“[P]ersonal asset accounts that are investment accounts like the money market mutual fund accounts identified in the Senate Report or [certain] cryptocurrency accounts . . . , are accounts covered by the EFTA. This is true even though a transaction from those accounts may not be subject to the EFTA in the event it is a transaction for the purchase or sale of a security regulated by the SEC.”)
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         Regulation E comment 3(c)(4)-3.i; 
                        <E T="03">see also,</E>
                         61 FR 19680 (May 2, 1996). The SEC has authority to enforce EFTA against broker-dealers that are subject to the Securities Exchange Act. 15 U.S.C. 1693o(a)(4). This interpretive rule is not intended to limit the authority of the SEC under the Securities Exchange Act or the CFTC under the Commodities Exchange Act.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">5. Consumer Protections Under EFTA and Regulation E</HD>
                <P>
                    Financial institutions have a number of legal obligations under EFTA and Regulation E. Among the most important are error resolution and limits on consumers' liability for unauthorized EFTs, and well as initial and ongoing disclosures. A financial institution has investigation and error resolution obligations under Regulation E when a consumer notifies the financial institution of an error, with limited exceptions.
                    <SU>53</SU>
                    <FTREF/>
                     EFTA and Regulation E define the term “error” to include, among other things, “an unauthorized electronic fund transfer.” 
                    <SU>54</SU>
                    <FTREF/>
                     Subject to certain exceptions, Regulation E defines an unauthorized EFT to mean an EFT from a consumer's account initiated by a person other than the consumer without actual authority to initiate the transfer and from which the consumer receives no benefit.
                    <SU>55</SU>
                    <FTREF/>
                     Unauthorized EFTs include transfers initiated by a person who obtained a consumer's access device through fraud or robbery and consumer transfers at an ATM that were induced by force. Another example of an unauthorized EFT is when a bad actor obtains a consumer's account credential through computer hacking or other forms of cyber theft and uses that credential to steal funds.
                    <SU>56</SU>
                    <FTREF/>
                     EFTA and Regulation E place limits on a consumer's liability for unauthorized EFTs, based on a number of factors.
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         15 U.S.C. 1693f(a); 12 CFR 1005.11(b). Regulation E also tailored certain error resolution obligations for prepaid accounts. 12 CFR 1005.18(e).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         15 U.S.C. 1693f(f)(1); 12 CFR 1005.11(a)(1)(i).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         However, the CFPB reiterates here that nothing in this proposed interpretive rule would change the existing statutory or regulatory exceptions to the definition of EFT.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         12 CFR 1005.2(m); Regulation E comments 2(m)-3 and 4; 
                        <E T="03">see also</E>
                         CFPB, 
                        <E T="03">Electronic Fund Transfers FAQs, https://www.consumerfinance.gov/compliance/compliance-resources/deposit-accounts-resources/electronic-fund-transfers/electronic-fund-transfers-faqs/#unauthorized-eft</E>
                         (last visited Dec. 2, 2024).
                    </P>
                </FTNT>
                <P>
                    A financial institution must provide initial disclosures of the terms and conditions of EFT services before the first EFT is made or at the time the consumer contracts for an EFT service.
                    <SU>57</SU>
                    <FTREF/>
                     The disclosures must include a summary of various consumer rights under Regulation E, including the consumer's liability for unauthorized EFTs, the types of EFTs the consumer may make, limits on the frequency or dollar amount, fees charged by the financial institution, and the error-resolution procedures. Regulation E also requires a financial institution to provide regular, periodic statements, and change-in-terms notices.
                    <SU>58</SU>
                    <FTREF/>
                     Regulation E contains model forms and clauses with respect to the required disclosures.
                    <SU>59</SU>
                    <FTREF/>
                     Note that accounts that separately meet the definition of a gift card would have different obligations under the Gift Card Rule and generally would not be subject to the remainder of subpart A of Regulation E.
                    <SU>60</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         EFTA section 905; 15 U.S.C. 1693c; 
                        <E T="03">see generally</E>
                         12 CFR 1005.7.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         12 CFR 1005.8 and 1005.9(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>59</SU>
                         
                        <E T="03">See generally</E>
                         12 CFR part 1005, app. A.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>60</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1005.20; 
                        <E T="03">see also</E>
                         81 FR 83934 at 83977 (discussing interaction of the Gift Card Rule and the Prepaid Rule).
                    </P>
                </FTNT>
                <P>In sum, market participants offering new types of payment mechanisms to facilitate electronic fund transfers should understand whether their account meets the definition of “other consumer asset account,” including whether it is established for “personal, family, or household purposes.”</P>
                <HD SOURCE="HD1">III. Regulatory Matters</HD>
                <P>
                    This is a proposed interpretive rule issued under the CFPB's authority to interpret EFTA and Regulation E, including under section 1022(b)(1) of the Consumer Financial Protection Act of 2010, which authorizes guidance as may be necessary or appropriate to enable the CFPB to administer and carry out the purposes and objectives of Federal consumer financial laws.
                    <SU>61</SU>
                    <FTREF/>
                     While not required under the Administrative Procedure Act (APA), the CFPB is soliciting comments on the proposal and may make revisions when it issues a final interpretive rule as appropriate in light of feedback received.
                </P>
                <FTNT>
                    <P>
                        <SU>61</SU>
                         12 U.S.C. 5512(b)(1).
                    </P>
                </FTNT>
                <P>
                    By operation of EFTA section 916(d), no provision of EFTA sections 916 or 917 imposing liability would apply to any act done or omitted in good faith in conformity with the final interpretive rule, notwithstanding that after such act or omission has occurred, the final interpretive rule is amended, rescinded, or determined by judicial or other authority to be invalid for any reason.
                    <SU>62</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>62</SU>
                         15 U.S.C. 1693m(d).
                    </P>
                </FTNT>
                <P>
                    The CFPB has determined that this proposed interpretive rule, if finalized, would not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring approval by the Office of Management and Budget under the Paperwork Reduction Act.
                    <SU>63</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>63</SU>
                         44 U.S.C. 3501 through 3521.
                    </P>
                </FTNT>
                <SIG>
                    <NAME>Rohit Chopra,</NAME>
                    <TITLE>Director, Consumer Financial Protection Bureau.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00565 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-AM-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="3728"/>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>Internal Revenue Service</SUBAGY>
                <CFR>26 CFR Part 54</CFR>
                <DEPDOC>[REG-110878-24]</DEPDOC>
                <RIN>RIN 1545-BR35</RIN>
                <AGENCY TYPE="O">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employee Benefits Security Administration</SUBAGY>
                <CFR>29 CFR Part 2590</CFR>
                <RIN>RIN 1210-AC25</RIN>
                <AGENCY TYPE="O">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <CFR>45 CFR Part 147</CFR>
                <DEPDOC>[CMS-9887-WN]</DEPDOC>
                <RIN>RIN 0938-AV57</RIN>
                <SUBJECT>Enhancing Coverage of Preventive Services Under the Affordable Care Act</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Withdrawal of notice of proposed rulemaking.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document withdraws a notice of proposed rulemaking that appeared in the 
                        <E T="04">Federal Register</E>
                         on October 28, 2024, regarding coverage of certain preventive services under the Affordable Care Act.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        As of January 15, 2025, the notice of proposed rulemaking that appeared in the 
                        <E T="04">Federal Register</E>
                         on October 28, 2024, at 89 FR 85750 is withdrawn.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments received on the proposed rule can be viewed at 
                        <E T="03">https://www.regulations.gov/docket/HHS_FRDOC_0001/document.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Regan Rusher, Internal Revenue Service, Department of the Treasury, at (202) 317-5500. Matthew Meidell, Employee Benefits Security Administration, Department of Labor, at (202) 693-8335. Rebecca Miller, Employee Benefits Security Administration, Department of Labor, at (202) 693-8335. Geraldine Doetzer, Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services at (667) 290-8855.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 2713 of the Public Health Service Act (PHS Act), as added by the Affordable Care Act and incorporated into the Employee Retirement Income Security Act and the Internal Revenue Code, requires non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage to provide coverage of certain recommended preventive services without imposing any cost-sharing requirements. Section 2715A of the PHS Act provides that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage must comply with section 1311(e)(3) of the Affordable Care Act, which addresses transparency in health coverage and imposes certain reporting and disclosure requirements for health plans that are seeking certification as qualified health plans to be offered on an American Health Benefits Exchange (generally referred to as an Exchange).</P>
                <P>
                    On October 28, 2024, the Departments of the Treasury, Labor, and Health and Human Services (collectively, the Departments) issued proposed rules under PHS Act sections 2713 and 2715A titled, “Enhancing Coverage of Preventive Services Under the Affordable Care Act.” 
                    <SU>1</SU>
                    <FTREF/>
                     The proposed rules sought to address ongoing complaints and reports of noncompliance with section 2713 of the PHS Act and its implementing regulations. These complaints and reports indicate that participants, beneficiaries, and enrollees face barriers when attempting to use their coverage to access recommended preventive services without cost sharing. As a result of these concerns, the Departments proposed to amend the regulations governing coverage of recommended preventive services to ensure that participants, beneficiaries, and enrollees would be able to access the full range of recommended preventive services to which they are entitled, with particular focus on strengthening coverage requirements with respect to recommended contraceptive items for women.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         89 FR 85750 (Oct. 28, 2024).
                    </P>
                </FTNT>
                <P>The proposed rules would have required plans and issuers that utilize reasonable medical management techniques with respect to any recommended preventive services to provide an easily accessible, transparent, and sufficiently expedient exceptions process that allows an individual to receive coverage without cost sharing for the preventive service according to the frequency, method, treatment, or setting that is medically necessary for them, as determined by the individual's attending provider. The proposed rules would also have required plans and issuers to cover certain recommended over-the-counter contraceptive items without requiring a prescription and without imposing cost-sharing requirements. In addition, the proposed rules would have required plans and issuers to cover certain recommended contraceptive items that are drugs and drug-led combination products without imposing cost-sharing requirements, unless a therapeutic equivalent of the drug or drug-led combination product is covered without cost sharing. Finally, the proposed rules would have required plans and issuers to provide a disclosure pertaining to coverage and cost-sharing requirements for recommended over-the-counter contraceptive items in plans' and issuers' Transparency in Coverage internet-based self-service tools or, if requested by the individual, on paper.</P>
                <P>The Departments requested comments on all aspects of the proposed rules, as well as on a number of specific issues. The comment period on the proposed rules closed on December 27, 2024, and the Departments received 268 comments to review. The comments addressed a range of issues, including operational and cost issues related to the Departments' contraceptive coverage proposals.</P>
                <P>
                    The Departments have determined it is appropriate to withdraw the proposed rules at this time, focusing instead on other matters. For example, the Departments have identified Cost Sharing Under the Affordable Care Act (RIN 0938-AV59); Requirements Related to Advanced Explanation of Benefits and Other Provisions Under the Consolidated Appropriations Act, 2021 (RIN 0938-AU98); Independent Dispute Resolution Operations (RIN 0938-AV15); Requirements Related to Air Ambulance Services, Agent and Broker Disclosures, and Provider Enforcement (RIN 0938-AU61); and Provider Nondiscrimination Requirements for Group Health Plans and Health Insurance Issuers in the Group and Individual Markets (RIN 0938-AU64) in their respective Fall 2024 Regulatory Agendas, as potential matters on which to focus. Moreover, should the Departments decide in the future that it is a priority to move forward with rulemaking regarding all or a subset of the preventive services coverage requirements of PHS Act section 2713, the Departments want to ensure that they will have the benefit of the most up-to-date facts and information on the basis of any specific proposals that they determine to put forward at such time. 
                    <PRTPAGE P="3729"/>
                    For these independently sufficient reasons, the Departments are withdrawing the proposed rules, and may propose new rules in the future, as appropriate to meet these goals.
                </P>
                <P>This withdrawal action does not limit the Departments' ability to make new regulatory proposals in the areas addressed by the withdrawn proposed rules, including new proposals that may be substantially identical or similar to those described therein. In addition, this withdrawal action does not affect the Departments' ongoing application of existing statutory and regulatory requirements or their responsibility to faithfully administer the statutory requirements the proposed rules would have implemented if finalized.</P>
                <SIG>
                    <NAME>Douglas W. O'Donnell,</NAME>
                    <TITLE>Deputy Commissioner, Internal Revenue Service.</TITLE>
                    <NAME>Lisa M. Gomez, </NAME>
                    <TITLE>Assistant Secretary, Employee Benefits Security Administration, Department of Labor.</TITLE>
                    <NAME>Xavier Becerra,</NAME>
                    <TITLE>Secretary, Department of Health and Human Services.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00774 Filed 1-13-25; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 4830-01;-P; 4510-29-P; 4120-;01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Part 165</CFR>
                <DEPDOC>[Docket Number USCG-2024-1093]</DEPDOC>
                <RIN>RIN 1625-AA00</RIN>
                <SUBJECT>Safety Zone; Cable Laying Corridor, Atlantic Ocean, Virginia Beach, Virginia</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard is proposing to establish a temporary moving safety zone to surround nearshore operations conducted by a cable laying barge. Cable lay and burial operations will create navigational hazards moving along a corridor from shore extending seaward 12 NM. This action is necessary to provide for the safety of life on these navigable waters near Virginia Beach, Virginia. This proposed rulemaking would prohibit persons and vessels from entering the safety zone unless authorized by the Captain of the Port Sector Virginia or a designated representative. We invite your comments on this proposed rulemaking.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments and related material must be received by the Coast Guard on or before January 29, 2025. A shorter comment period is necessary for this rule to provide ample time to review and address comments on the proposed rule prior to the day the rule is needs to take effect to protect the public from the hazards it addresses.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments identified by docket number USCG-2024-1093 using the Federal Decision-Making Portal at 
                        <E T="03">https://www.regulations.gov.</E>
                         See the “Public Participation and Request for Comments” portion of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section for further instructions on submitting comments. This notice of proposed rulemaking with its plain-language, 100-word-or-less proposed rule summary will be available in this same docket.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions about this proposed rulemaking, call or email LCDR Justin Strassfield, Sector Virginia, Waterways Management Division, U.S. Coast Guard, Telephone: (757) 668-5581; or 
                        <E T="03">virginiawaterways@uscg.mil</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Table of Abbreviations</HD>
                <EXTRACT>
                    <FP SOURCE="FP-1">CLB Cable Laying Barge</FP>
                    <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                    <FP SOURCE="FP-1">COTP Captain of the Port</FP>
                    <FP SOURCE="FP-1">DHS Department of Homeland Security</FP>
                    <FP SOURCE="FP-1">FR Federal Register</FP>
                    <FP SOURCE="FP-1">NM Nautical Miles</FP>
                    <FP SOURCE="FP-1">NPRM Notice of proposed rulemaking</FP>
                    <FP SOURCE="FP-1">§ Section </FP>
                    <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Background, Purpose, and Legal Basis</HD>
                <P>On December 3, 2024, Dominion Energy notified the Coast Guard with a request for a moving safety zone to encompass the operations conducted by the CLB ULISSE, to extend 1000-yards from the center of the barge. The Sector Virgnia COTP has determined that potential hazards associated with the anchorage arrangements necessary for the cable laying barge to conduct operations would be a safety concern for anyone within a 1000-yard radius of the barge.</P>
                <P>The purpose of this proposed rulemaking is to ensure the safety of vessels and the navigable waters within a 1000-yard radius of the CLB during its operations. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034.</P>
                <HD SOURCE="HD1">III. Discussion of Proposed Rule</HD>
                <P>The COTP is proposing to establish a safety zone on January 25, 2025, for 365 days. The safety zone would cover all navigable waters within 1000 yards of the CBL ULISSE, only while it conducts cable handling and burial in the Atlantic Ocean beginning roughly 300 yards from the shore of the State Military Reservation in Virginia Beach, Virginia out to 12 NM, the U.S. Territorial Seas border. The duration of the zone is intended to ensure the safety of vessels and these navigable waters during the 365-day period. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. Due to the stability required for the cable laying and burial process, the multipoint anchorage configurations used are highly dynamic and create large unseen hazards to navigation requiring someone familiar with the current anchoring positions to determine if safe transit corridors exist or if a transiting vessel must avoid the full 1000 yards radius of the zone to mitigate the hazards present. A designated representative, in communication with the anchor handling vessels, can communicate these hazards and possible safe transit corridors, decreasing the burden on the non-project vessels seeking access through or around the zone. The regulatory text we are proposing appears at the end of this document.</P>
                <HD SOURCE="HD1">IV. Regulatory Analyses</HD>
                <P>We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.</P>
                <HD SOURCE="HD2">A. Regulatory Planning and Review</HD>
                <P>Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This NPRM has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).</P>
                <P>
                    This regulatory action determination is based on the size, location, and duration of the safety zone. Vessel traffic would be able to safely transit around this safety zone to the east initially without losing sight of land and the impact the nearshore recreational boaters near Rudee Inlet in Virginia Beach, Virginia would be reduced further as the CLB moves further from shore, providing safe transit options to the west along the shoreline.
                    <PRTPAGE P="3730"/>
                </P>
                <HD SOURCE="HD2">B. Impact on Small Entities</HD>
                <P>The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.</P>
                <P>While some owners or operators of vessels intending to transit the safety zones may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.</P>
                <P>
                    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see 
                    <E T="02">ADDRESSES</E>
                    ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.
                </P>
                <P>
                    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.
                </P>
                <HD SOURCE="HD2">C. Collection of Information</HD>
                <P>This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).</P>
                <HD SOURCE="HD2">D. Federalism and Indian Tribal Governments</HD>
                <P>A rule has implications for federalism under Executive Order 13132 (Federalism), if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.</P>
                <P>
                    Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <HD SOURCE="HD2">E. Unfunded Mandates Reform Act</HD>
                <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the potential effects of this proposed rule elsewhere in this preamble.</P>
                <HD SOURCE="HD2">F. Environment</HD>
                <P>
                    We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves the establishment of safety zones to protect the public from hazards created by cable laying and burial operations, as well as the anchoring configurations, required for the operations of the CLB ULISSE. Normally such actions are categorically excluded from further review under paragraph L[60a] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A preliminary Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the 
                    <E T="02">ADDRESSES</E>
                     section of this preamble. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
                </P>
                <HD SOURCE="HD2">G. Protest Activities</HD>
                <P>
                    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.
                </P>
                <HD SOURCE="HD1">V. Public Participation and Request for Comments</HD>
                <P>We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.</P>
                <P>
                    <E T="03">Submitting comments.</E>
                     We encourage you to submit comments through the Federal Decision-Making Portal at 
                    <E T="03">https://www.regulations.gov.</E>
                     To do so, go to 
                    <E T="03">https://www.regulations.gov,</E>
                     type USCG-2024-1093 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using 
                    <E T="03">https://www.regulations.gov,</E>
                     call or email the person in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this proposed rule for alternate instructions.
                </P>
                <P>
                    <E T="03">Viewing material in docket.</E>
                     To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting &amp; Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the 
                    <E T="03">https://www.regulations.gov</E>
                     Frequently Asked Questions web page. Also, if you click on the Dockets tab and then the proposed rule, you should see a “Subscribe” option for email alerts. The option will notify you when comments are posted, or a final rule is published.
                </P>
                <P>We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.</P>
                <P>
                    <E T="03">Personal information.</E>
                     We accept anonymous comments. Comments we post to 
                    <E T="03">https://www.regulations.gov</E>
                     will 
                    <PRTPAGE P="3731"/>
                    include any personal information you have provided. For more about privacy and submissions to the docket in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 33 CFR Part 165</HD>
                    <P>Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 165 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 165 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.</P>
                </AUTH>
                <AMDPAR>2. Add § 165.T05-1093 to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 165.T05-1093</SECTNO>
                    <SUBJECT> Safety Zone; Cable Laying Corridor, Atlantic Ocean, Virginia Beach, Virginia.</SUBJECT>
                    <P>
                        (a) 
                        <E T="03">Location.</E>
                         The following area is a moving safety zone: Any navigable waters located within 1000 yards in all directions from the Cable Laying Barge (CLB) ULISSE while operating off the coast of Virginia Beach, Virginia while it conducts work within 12 nm of the shore. The CLB operations will occur within a perimeter enclosed by positions: 36°49′4.8″ N, 75°57′43.2″ W; 36°49′13.9″ N, 75°42′39.8″ W; 36°47″ 11.7″ N, 75°41″ 50.8″ W and 36°48″ 28.8″ N, 75°57″ 43.2″ W.
                    </P>
                    <P>
                        (b) 
                        <E T="03">Definitions.</E>
                         As used in this section, 
                        <E T="03">designated representative</E>
                         means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port Sector Virginia (COTP) in the enforcement of the safety zone. The term also includes the master of a U.S.-flagged vessel supporting the CLB ULISSE for the sole purpose of designating and establishing safe transit corridors, to permit passage into or through this safety zones, or to notify vessels and individuals of the actual hazards present if they have entered the safety zone and inform them of the safe direction to which they should depart.
                    </P>
                    <P>
                        (c) 
                        <E T="03">Regulations.</E>
                    </P>
                    <P>(1) Under the general safety zone regulations in subpart C of this part, no vessel or person may enter or remain in any safety zone described in paragraph (a) of this section unless authorized by the COTP, or designated representative. If a vessel or person is notified by the COTP, or designated representative that they have entered one of these safety zones without permission, they are required to immediately depart in a safe manner following the directions given.</P>
                    <P>(2) Mariners requesting to transit this safety zone must first contact the designated representative who will be monitoring VHF-FM channels 13 and 16 while work is ongoing. If permission is granted, mariners must proceed at their own risk and strictly observe any and all instructions provided by the COTP, or designated representative to the mariner regarding the conditions of entry to and exit from any location within the moving safety zone.</P>
                    <P>
                        (d) 
                        <E T="03">Enforcement.</E>
                         The Sector Virginia COTP may enforce the regulations in this section and may be assisted by any Federal, state, county, or municipal law enforcement agency.
                    </P>
                    <P>
                        (e) 
                        <E T="03">Enforcement period.</E>
                         This section will be subject to enforcement from January 25, 2025, until January 25, 2026. If cable laying work is completed before January 25, 2026, or for a different reason the COTP determines the zone need no longer be enforced, they will issue a general permission to enter.
                    </P>
                </SECTION>
                <SIG>
                    <DATED> Dated: December 26, 2024. </DATED>
                    <NAME>Peggy M. Britton,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port Sector Virginia.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31420 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Parts 52 and 70</CFR>
                <DEPDOC>[EPA-R07-OAR-2023-0462; FRL-11395-01-R7]</DEPDOC>
                <SUBJECT>Air Plan Approval; Kansas; Annual Emission Inventory and Fees</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is proposing to approve revisions to the State Implementation Plan (SIP) and Operating Permits Program and the 112(l)plan submitted by the State of Kansas on February 20, 2023. The revised Kansas rules update the Class I emission fee and emissions inventory regulations, establish a Class II fee schedule and ensure that Kansas's Operating Permits Program is adequately funded. Approval of these revisions ensures consistency between the State and federally-approved rules and does not impact air quality.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before February 14, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may send comments, identified by Docket ID No. EPA-R07-OAR-2023-0462 to 
                        <E T="03">www.regulations.gov.</E>
                         Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the Docket ID No. for this rulemaking. Comments received will be posted without change to 
                        <E T="03">www.regulations.gov,</E>
                         including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the “Written Comments” heading of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section of this document.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        William Stone, Environmental Protection Agency, Region 7 Office, Air Permitting and Planning Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-7714; email address: 
                        <E T="03">stone.william@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document “we,” “us,” and “our” refer to the EPA.</P>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Written Comments</FP>
                    <FP SOURCE="FP-2">II. What is being addressed in this document?</FP>
                    <FP SOURCE="FP-2">III. What operating permit plan revisions are being proposed by EPA?</FP>
                    <FP SOURCE="FP-2">IV. What SIP revisions are being proposed by EPA?</FP>
                    <FP SOURCE="FP-2">V. Have the requirements for approval of a SIP and the operating permit plan revisions been met?</FP>
                    <FP SOURCE="FP-2">VI. What action is the EPA taking?</FP>
                    <FP SOURCE="FP-2">VII. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">VIII. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Written Comments</HD>
                <P>
                    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2023-0462, at 
                    <E T="03">www.regulations.gov.</E>
                     Once submitted, comments cannot be edited or removed from 
                    <E T="03">Regulations.gov</E>
                    . The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
                    <E T="03">i.e.,</E>
                     on the web, cloud, or other file sharing system). For 
                    <PRTPAGE P="3732"/>
                    additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                    <E T="03">www.epa.gov/dockets/commenting-epa-dockets.</E>
                </P>
                <HD SOURCE="HD1">II. What is being addressed in this document?</HD>
                <P>The EPA is proposing to approve revisions to the Kansas SIP and the Operating Permits Program received on February 20, 2023.</P>
                <P>The revisions incorporate recent changes to Kansas Administrative Regulations (K.A.R.). The following regulations are amended:</P>
                <P>
                    • K.A.R. 28-19-517. 
                    <E T="03">Class I operating permits; annual emission inventory and fees.</E>
                </P>
                <P>
                    • K.A.R. 28-19-546. 
                    <E T="03">Class II operating permits; annual emission inventory and fees.</E>
                     and
                </P>
                <P>
                    • K.A.R. 28-19-564. 
                    <E T="03">Class II operating permits; permits-by-rule; sources with actual emissions less than 50 percent of major source thresholds.</E>
                </P>
                <P>The revisions restructure and update the Kansas Class I Operating Permit Program fee schedule for calendar year 2025 and beyond to bring in adequate revenue to support the Class I Operating Permit Program and establish a fee schedule for the Class II Federally Enforceable State Operating Permit (FESOP) Program. EPA proposes to find that these revisions meet the requirements of the Clean Air Act, do not impact the stringency of the SIP, and do not adversely impact air quality. The full text of these changes can be found in the State's submission, which is included in the docket for this action.</P>
                <P>On November 26, 2024, Kansas requested that EPA exclude the term “electronically” from two places in the February 20, 2023, submittal because KDHE's State and Local Emissions Inventory System (SLEIS) is not currently approved by the EPA to meet the Cross-Media Electronic Reporting Rule (CROMERR) at 40 CFR part 3.</P>
                <HD SOURCE="HD1">III. What operating permit plan revisions are being proposed by EPA?</HD>
                <P>The EPA is proposing to approve the following revision to the Operating Permit Program:</P>
                <P>
                    K.A.R. 28-19-517. 
                    <E T="03">Class I operating permits; annual emission inventory and fees.</E>
                     The State amended K.A.R. 28-19-517(b) annual emission fee language to maintain the existing fee schedule of $1,000 base fee or $53 per ton criteria emissions fee for calendar year 2022, 2023 and 2024 and to establish a new fee schedule for calendar year 2025 and each subsequent year to be the sum of the facility fee, the hazardous air pollutant (HAP) emissions fee, and the criteria emissions fee. The revisions to K.A.R. 28-19-517(b)(2)(A) maintains the minimum $1,000 facility fee, but applies it in addition to the revised criteria emissions fee and new hazardous air pollutant (HAP) fee; all applied in calendar year 2025 and beyond. The revision to K.A.R. 28-19-517(b)(2)(B) establishes an annual hazardous air pollutant (HAP) fee of $80.00 per ton of total HAP emissions for calendar year 2025 and beyond. The revisions to K.A.R. 28-19-517(b)(2)(C) amends the existing criteria emissions fee from $53.00 (effective through calendar year 2024) to $56.00 per ton of criteria emissions for calendar year 2025 and beyond.
                </P>
                <P>EPA finds these changes meet the requirements of 40 CFR part 70 and do not negatively impact the stringency of the Operating Permit Program.</P>
                <HD SOURCE="HD1">IV. What SIP revisions are being proposed by EPA?</HD>
                <P>The EPA is proposing the following revisions to the Kansas SIP:</P>
                <P>
                    K.A.R. 28-19-546. 
                    <E T="03">Class II operating permits; annual emission inventory and</E>
                     fees: The State amended K.A.R. 28-19-546 by adding new paragraphs (a) through (d) to align with the Class I annual emissions inventory and fee regulation K.A.R. 28-19-517. New paragraph (b) establishes annual emission fees beginning in calendar year 2025 of $56 per ton of criteria emissions and $80 per ton of HAP emissions. New paragraph (c) describes the submittal requirements for both inventory and fees and new paragraph (d) adds late fee and refund language. EPA finds this change meets the requirements of CAA section 110 and does not negatively impact the stringency of the SIP.
                </P>
                <P>
                    K.A.R. 28-19-564. 
                    <E T="03">Class II operating permits; permits-by-rule; sources with actual emissions less than 50 percent of major source thresholds:</E>
                     The State amended K.A.R. 28-19-564 paragraph (e) to require all permits-by-rule Class II sources and those with actual emissions less than 50 percent of major source thresholds to submit annual emissions inventory and fees by April 1 of each year (currently February 15) as required by the proposed K.A.R. 28-19-546. EPA finds this change meets the requirements of CAA section 110 and does not negatively impact the stringency of the SIP.
                </P>
                <HD SOURCE="HD1">V. Have the requirements for approval of a SIP and the operating permit plan revisions been met?</HD>
                <P>The State submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice on this SIP revision from August 25, 2022, to November 3, 2022, and received four comments. Kansas did not revise the rule based on public comment prior to submitting to EPA, as noted in the State submission included in the docket for this action. In addition, as explained above the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.</P>
                <HD SOURCE="HD1">VI. What action is the EPA taking?</HD>
                <P>We are processing this as a proposed action because we are soliciting comments on this proposed action. Final rulemaking will occur after consideration of any comments.</P>
                <HD SOURCE="HD1">VII. Incorporation by Reference</HD>
                <P>
                    In this document, the EPA is proposing to include regulatory text in an EPA final rule that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of K.A.R. 28-19-546 and K.A.R. 28-19-564 as discussed in sections II and IV of this preamble and set forth below in the proposed amendments to 40 CFR part 52. The EPA has made, and will continue to make, these materials generally available through 
                    <E T="03">www.regulations.gov</E>
                     and at the EPA Region 7 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information).
                </P>
                <HD SOURCE="HD1">VIII. Statutory and Executive Order Reviews</HD>
                <P>Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:</P>
                <P>• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);</P>
                <P>
                    • Does not impose an information collection burden under the provisions 
                    <PRTPAGE P="3733"/>
                    of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and</P>
                <P>• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.</P>
                <P>In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).</P>
                <P>Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. Executive Order (E.O.) 14096 (Revitalizing Our Nation's Commitment to Environmental Justice for All, 88 FR 25251, April 26, 2023) builds on and supplements E.O. 12898 and defines EJ as, among other things, the just treatment and meaningful involvement of all people, regardless of income, race, color, national origin, or Tribal affiliation, or disability in agency decision-making and other Federal activities that affect human health and the environment.</P>
                <P>The Kansas Department of Health and Environment (KDHE) did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898/14096 of achieving EJ for communities with EJ concerns.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>40 CFR Part 52</CFR>
                    <P>Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.</P>
                    <CFR>40 CFR Part 70</CFR>
                    <P>Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Operating permits, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: December 30, 2024.</DATED>
                    <NAME>Meghan A. McCollister,</NAME>
                    <TITLE>Regional Administrator, Region 7.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, the EPA proposes to amend 40 CFR part 52 as set forth below:</P>
                <PART>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                         42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SUBPART>
                    <HD SOURCE="HED">Subpart R—Kansas</HD>
                </SUBPART>
                <AMDPAR>2. In § 52.870, the table in paragraph (c) is amended by revising the entries “K.A.R. 28-19-546” and “K.A.R. 28-19-564” to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 52.870 </SECTNO>
                    <SUBJECT>Identification of plan.</SUBJECT>
                    <STARS/>
                    <P>(c) * * *</P>
                    <GPOTABLE COLS="5" OPTS="L1,nj,i1" CDEF="xs72,r50,12,r75,xs60">
                        <TTITLE>EPA-Approved Kansas Regulations</TTITLE>
                        <BOXHD>
                            <CHED H="1">Kansas citation</CHED>
                            <CHED H="1">Title</CHED>
                            <CHED H="1">
                                State
                                <LI>effective</LI>
                                <LI>date</LI>
                            </CHED>
                            <CHED H="1">EPA approval date</CHED>
                            <CHED H="1">Explanation</CHED>
                        </BOXHD>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Kansas Department of Health and Environment Ambient Air Quality Standards and Air Pollution Control</E>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="28">*         *         *         *         *         *         *</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Class II Operating Permits</E>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="28">*         *         *         *         *         *         *</ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">K.A.R. 28-19-546</ENT>
                            <ENT>Definitions Class II operating permits; annual emission inventory</ENT>
                            <ENT>12/23/2022</ENT>
                            <ENT>
                                [Date of publication of the final rule in the 
                                <E T="02">Federal Register</E>
                                ], [
                                <E T="02">Federal Register</E>
                                 citation of the final rule]
                            </ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="28">*         *         *         *         *         *         *</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">K.A.R. 28-19-564</ENT>
                            <ENT>Permit-by-Rule; Sources with Actual Emissions Less Than 50 Percent of Major Source Thresholds</ENT>
                            <ENT>12/23/2022</ENT>
                            <ENT>
                                [Date of publication of the final rule in the 
                                <E T="02">Federal Register</E>
                                ], [
                                <E T="02">Federal Register</E>
                                 citation of the final rule]
                            </ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="28">*         *         *         *         *         *         *</ENT>
                        </ROW>
                    </GPOTABLE>
                    <PRTPAGE P="3734"/>
                    <STARS/>
                </SECTION>
                <PART>
                    <HD SOURCE="HED">PART 70—STATE OPERATING PERMIT PROGRAMS</HD>
                </PART>
                <AMDPAR>3. The authority citation for part 70 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        42 U.S.C. 7401, 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <AMDPAR>4. Appendix A to part 70 is amended by adding paragraph (h) under “Kansas” to read as follows:</AMDPAR>
                <HD SOURCE="HD1">Appendix A to Part 70—Approval Status of State and Local Operating Permits Programs</HD>
                <EXTRACT>
                    <STARS/>
                    <HD SOURCE="HD1">Kansas</HD>
                    <STARS/>
                    <P>
                        (h) The Kansas Department of Health and Environment submitted revisions to Kansas rules K.A.R. 28-19-517, on February 20, 2023. The State effective date is December 23, 2022. This revision is effective [30 days after date of publication of the final rule in the 
                        <E T="04">Federal Register</E>
                        ].
                    </P>
                    <STARS/>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31626 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 60</CFR>
                <DEPDOC>[EPA-HQ-OAR-2024-0358; FRL-12031-01-OAR]</DEPDOC>
                <RIN>RIN 2060-AW35</RIN>
                <SUBJECT>Reconsideration of Standards of Performance for New, Reconstructed, and Modified Sources and Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate Review</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is proposing amendments to the New Source Performance Standards and Emission Guidelines for Existing Sources for the Crude Oil and Natural Gas Source Category in response to petitions for reconsideration. Specifically, this action proposes discrete technical changes to two different aspects of the rules. First, this action proposes discrete technical changes to the temporary flaring provisions for associated gas in certain situations. Second, this action proposes discrete technical changes to the vent gas net heating value (NHV) continuous monitoring requirements and alternative performance test (sampling demonstration) option for flares and enclosed combustion devices. In a letter dated May 6, 2024, the EPA notified petitioners and the public that the Agency granted reconsideration on these two aspects of the March 8, 2024 (89 FR 16820) final rule. These amendments neither propose changes to any other aspect of the final rule, nor propose to alter the substance of any emission standards within the final rule. Also, in this action, the EPA proposes to make formatting changes to the regulatory text to meet the required formatting standards of the Office of the Federal Register.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments.</E>
                         Comments must be received on or before March 3, 2025.
                    </P>
                    <P>
                        <E T="03">Public Hearing.</E>
                         If anyone contacts us requesting a public hearing on or before January 20, 2025, we will hold a virtual public hearing. Please refer to the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         for information on requesting and registering for a public hearing.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, identified by Docket ID No. EPA-HQ-OAR-2024-0358, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov</E>
                         (our preferred method). Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Email: a-and-r-docket@epa.gov.</E>
                         Include Docket ID No. EPA-HQ-OAR-2024-0358 in the subject line of the message.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Environmental Protection Agency, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2024-0358, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand/Courier Delivery:</E>
                         EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal Holidays).
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to 
                        <E T="03">https://www.regulations.gov,</E>
                         including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section of this document.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Frank Benjamin-Eze, Sector Policies and Programs Division (E143-05), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, 109 T.W. Alexander Drive, P.O. Box 12055 RTP, North Carolina 27711; telephone number: (919) 541-3753; and email address: 
                        <E T="03">benjamineze.frank@epa.gov.</E>
                         Additional questions may be directed to the following email address: 
                        <E T="03">O&amp;GMethaneRule@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Participation in virtual public hearing.</E>
                     To request a virtual public hearing, contact the public hearing team at (888) 372-8699 or by email at 
                    <E T="03">SPPDpublichearing@epa.gov.</E>
                     If requested, the virtual public hearing will be held via virtual platform. The EPA will announce the date of the hearing and further details on the virtual public hearing at 
                    <E T="03">https://www.epa.gov/controlling-air-pollution-oil-and-natural-gas-operations.</E>
                     The hearing will convene at 11:00 a.m. Eastern Time (ET) and will conclude at 4:00 p.m. ET. The EPA may close a session 15 minutes after the last pre-registered speaker has testified if there are not additional speakers.
                </P>
                <P>
                    The EPA will begin pre-registering speakers for the hearing no later than 1 business day after a request has been received. To register to speak at the virtual hearing, please use the online registration form available at 
                    <E T="03">https://www.epa.gov/controlling-air-pollution-oil-and-natural-gas-operations</E>
                     or contact the public hearing team at (888) 372-8699 or by email at 
                    <E T="03">SPPDpublichearing@epa.gov.</E>
                     The last day to pre-register to speak at the hearing will be January 27, 2025. Prior to the hearing, the EPA will post a general agenda that will list pre-registered speakers at: 
                    <E T="03">https://www.epa.gov/controlling-air-pollution-oil-and-natural-gas-operations.</E>
                </P>
                <P>The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing; however, please plan for the hearings to run either ahead of schedule or behind schedule. Each commenter will have 4 minutes to provide oral testimony. The EPA encourages commenters to submit a copy of their oral testimony as written comments to the rulemaking docket. The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearing.</P>
                <P>
                    Please note that any updates made to any aspect of the hearing will be posted online at 
                    <E T="03">https://www.epa.gov/controlling-air-pollution-oil-and-natural-gas-operations.</E>
                     While the EPA expects the hearing to go forward as set forth above, please monitor these websites or contact the public hearing team at (888) 372-8699 or by email at 
                    <E T="03">SPPDpublichearing@epa.gov</E>
                     to 
                    <PRTPAGE P="3735"/>
                    determine if there are any updates. The EPA does not intend to publish a document in the 
                    <E T="04">Federal Register</E>
                     announcing updates.
                </P>
                <P>If you require the services of a translator or a special accommodation such as audio description, please pre-register for the hearing with the public hearing team and describe your needs by January 22, 2025. The EPA may not be able to arrange accommodations without advance notice.</P>
                <P>
                    <E T="03">Docket.</E>
                     The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2024-0358. All documents in the docket are listed in the 
                    <E T="03">Regulations.gov</E>
                     index. Although listed in the index, some information is not publicly available, 
                    <E T="03">e.g.,</E>
                     Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only as pdf versions that can only be accessed on the EPA computers in the docket office reading room. Certain data bases and physical items cannot be downloaded from the docket but may be requested by contacting the docket office at (202) 566-1744. The docket office has up to 10 business days to respond to these requests. With the exception of such material, publicly available docket materials are available electronically in 
                    <E T="03">Regulations.gov</E>
                    .
                </P>
                <P>
                    <E T="03">Written Comments.</E>
                     Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2024-0358, at 
                    <E T="03">https://www.regulations.gov</E>
                     (our preferred method), or the other methods identified in the 
                    <E T="02">ADDRESSES</E>
                     section. Once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. Do not submit to the EPA's docket at 
                    <E T="03">https://www.regulations.gov</E>
                     any information you consider to be CBI or other information whose disclosure is restricted by statute. This type of information should be submitted as discussed in the 
                    <E T="03">Submitting CBI</E>
                     section of this document.
                </P>
                <P>
                    Multimedia submissions (audio, video, 
                    <E T="03">etc.</E>
                    ) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
                    <E T="03">i.e.,</E>
                     on the Web, cloud, or other file sharing system). Please visit 
                    <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets</E>
                     for additional submission methods; the full EPA public comment policy; information about CBI or multimedia submissions; and general guidance on making effective comments.
                </P>
                <P>
                    The 
                    <E T="03">https://www.regulations.gov</E>
                     website allows you to submit your comment anonymously, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through 
                    <E T="03">https://www.regulations.gov,</E>
                     your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any digital storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should not include special characters or any form of encryption and be free of any defects or viruses.
                </P>
                <P>
                    <E T="03">Submitting CBI.</E>
                     Do not submit information containing CBI to the EPA through 
                    <E T="03">https://www.regulations.gov.</E>
                     Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, note the docket ID, mark the outside of the digital storage media as CBI, and identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in the 
                    <E T="03">Written Comments</E>
                     section of this document. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI and note the docket ID. Information not marked as CBI will be included in the public docket and the EPA's electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.
                </P>
                <P>
                    Our preferred method to receive CBI is for it to be transmitted electronically using email attachments, File Transfer Protocol (FTP), or other online file sharing services (
                    <E T="03">e.g.,</E>
                     Dropbox, OneDrive, Google Drive). Electronic submissions must be transmitted directly to the Office of Air Quality Planning and Standards (OAQPS) CBI Office at the email address 
                    <E T="03">oaqps_cbi@epa.gov,</E>
                     and as described above, should include clear CBI markings and note the docket ID. If assistance is needed with submitting large electronic files that exceed the file size limit for email attachments, and if you do not have your own file sharing service, please email 
                    <E T="03">oaqps_cbi@epa.gov</E>
                     to request a file transfer link. If sending CBI information through the postal service, please send it to the following address: OAQPS Document Control Officer (C404-02), OAQPS, U.S. Environmental Protection Agency, 109 T.W. Alexander Drive P.O. Box 12055 RTP, North Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2024-0358. The mailed CBI material should be double wrapped and clearly marked. Any CBI markings should not show through the outer envelope.
                </P>
                <P>
                    <E T="03">Preamble acronyms and abbreviations.</E>
                     Throughout this document the use of “we,” “us,” or “our” is intended to refer to the EPA. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:
                </P>
                <EXTRACT>
                    <FP SOURCE="FP-1">AGR Acid gas removal</FP>
                    <FP SOURCE="FP-1">AMP Alternative Monitoring Plan</FP>
                    <FP SOURCE="FP-1">API American Petroleum Institute</FP>
                    <FP SOURCE="FP-1">ASTM American Society for Testing and Materials</FP>
                    <FP SOURCE="FP-1">BPV back pressure valve</FP>
                    <FP SOURCE="FP-1">BSER best system of emission reduction</FP>
                    <FP SOURCE="FP-1">Btu/lb British thermal units per pound</FP>
                    <FP SOURCE="FP-1">Btu/scf British thermal units per standard cubic feet</FP>
                    <FP SOURCE="FP-1">°C degrees Celsius</FP>
                    <FP SOURCE="FP-1">CAA Clean Air Act</FP>
                    <FP SOURCE="FP-1">CBI Confidential Business Information</FP>
                    <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                    <FP SOURCE="FP-1">
                        CO
                        <E T="52">2</E>
                         carbon dioxide
                    </FP>
                    <FP SOURCE="FP-1">CRA Congressional Review Act</FP>
                    <FP SOURCE="FP-1">CVS closed vent systems</FP>
                    <FP SOURCE="FP-1">EG emission guidelines</FP>
                    <FP SOURCE="FP-1">EJ environmental justice</FP>
                    <FP SOURCE="FP-1">EOR enhanced oil recovery</FP>
                    <FP SOURCE="FP-1">EPA Environmental Protection Agency</FP>
                    <FP SOURCE="FP-1">FR Federal Register</FP>
                    <FP SOURCE="FP-1">
                        ft
                        <E T="51">3</E>
                         cubic feet
                    </FP>
                    <FP SOURCE="FP-1">GC gas chromatograph</FP>
                    <FP SOURCE="FP-1">GHG greenhouse gas</FP>
                    <FP SOURCE="FP-1">GHGRP Greenhouse Gas Reporting Program</FP>
                    <FP SOURCE="FP-1">ICR information collection request</FP>
                    <FP SOURCE="FP-1">MACT maximum achievable control technology</FP>
                    <FP SOURCE="FP-1">MS mass spectrometer</FP>
                    <FP SOURCE="FP-1">NAICS North American Industry Classification System</FP>
                    <FP SOURCE="FP-1">NHV net heating value</FP>
                    <FP SOURCE="FP-1">
                        NHV
                        <E T="52">cz</E>
                         combustion zone NHV
                    </FP>
                    <FP SOURCE="FP-1">
                        NHV
                        <E T="52">dil</E>
                         NHV dilution parameter
                    </FP>
                    <FP SOURCE="FP-1">
                        NHV
                        <E T="52">S</E>
                         net heating values
                    </FP>
                    <FP SOURCE="FP-1">NSPS new source performance standards</FP>
                    <FP SOURCE="FP-1">
                        NTTAA National Technology Transfer and Advancement Act
                        <PRTPAGE P="3736"/>
                    </FP>
                    <FP SOURCE="FP-1">
                        O
                        <E T="52">2</E>
                         oxygen
                    </FP>
                    <FP SOURCE="FP-1">OAQPS Office of Air Quality Planning and Standards</FP>
                    <FP SOURCE="FP-1">OMB Office of Management and Budget</FP>
                    <FP SOURCE="FP-1">PRA Paperwork Reduction Act</FP>
                    <FP SOURCE="FP-1">RFA Regulatory Flexibility Act</FP>
                    <FP SOURCE="FP-1">RIA regulatory impact analysis</FP>
                    <FP SOURCE="FP-1">RLSO redline strike out</FP>
                    <FP SOURCE="FP-1">scf standard cubic feet</FP>
                    <FP SOURCE="FP-1">TAR Tribal Authority Rule</FP>
                    <FP SOURCE="FP-1">UMRA Unfunded Mandates Reform Act</FP>
                    <FP SOURCE="FP-1">U.S. United States</FP>
                    <FP SOURCE="FP-1">VISR Video Imaging Spectro-Radiometry</FP>
                    <FP SOURCE="FP-1">VOC volatile organic compound(s)</FP>
                </EXTRACT>
                <P>
                    <E T="03">Organization of this document.</E>
                     The information in this preamble is organized as follows: 
                </P>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. General Information</FP>
                    <FP SOURCE="FP1-2">A. Does this action apply to me?</FP>
                    <FP SOURCE="FP1-2">B. Where can I get a copy of this document and other related information?</FP>
                    <FP SOURCE="FP-2">II. Statutory Background and Regulatory History</FP>
                    <FP SOURCE="FP1-2">A. Statutory Background of CAA Sections 111(b), 111(d), and General Implementing Regulations</FP>
                    <FP SOURCE="FP1-2">B. What is the regulatory history and background of NSPS and EG for the Crude Oil and Natural Gas Source Category?</FP>
                    <FP SOURCE="FP-2">III. Summary and Rationale of Proposed Amendments to NSPS OOOOb and EG OOOOc</FP>
                    <FP SOURCE="FP1-2">A. Temporary Flaring Provisions for Associated Gas in Certain Situations</FP>
                    <FP SOURCE="FP1-2">B. Vent Gas Net Heating Value (NHV) Continuous Monitoring Requirements and Alternative Performance Test (Sampling Demonstration) Option for Flares and Enclosed Combustion Devices</FP>
                    <FP SOURCE="FP-2">IV. How do these proposed amendments impact the implementation of EG OOOOc?</FP>
                    <FP SOURCE="FP-2">V. Summary of Cost, Environmental, and Economic Impacts</FP>
                    <FP SOURCE="FP-2">VI. Statutory and Executive Order Reviews</FP>
                    <FP SOURCE="FP1-2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review</FP>
                    <FP SOURCE="FP1-2">B. Paperwork Reduction Act (PRA)</FP>
                    <FP SOURCE="FP1-2">C. Regulatory Flexibility Act (RFA)</FP>
                    <FP SOURCE="FP1-2">D. Unfunded Mandates Reform Act (UMRA)</FP>
                    <FP SOURCE="FP1-2">E. Executive Order 13132: Federalism</FP>
                    <FP SOURCE="FP1-2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</FP>
                    <FP SOURCE="FP1-2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</FP>
                    <FP SOURCE="FP1-2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</FP>
                    <FP SOURCE="FP1-2">I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR Part 51</FP>
                    <FP SOURCE="FP1-2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. General Information</HD>
                <HD SOURCE="HD2">A. Does this action apply to me?</HD>
                <P>The source category that is the subject of this proposal is the Crude Oil and Natural Gas Source Category regulated under Clean Air Act (CAA) section 111, New Source Performance Standards (NSPS) and Emission Guidelines (EG). The 2022 North American Industry Classification System (NAICS) code for the source category is summarized in table 1. The NAICS codes serve as a guide for readers outlining the entities that this proposed action is likely to affect. The NSPS codified in 40 CFR part 60, subpart OOOOb, are directly applicable to affected facilities that begin construction, reconstruction, or modification after December 6, 2022. As shown in table 1, Federal, State, and local government entities would not be affected by the NSPS action.</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,10,r100">
                    <TTITLE>Table 1—Industrial Source Categories Affected by NSPS Action</TTITLE>
                    <BOXHD>
                        <CHED H="1">Category</CHED>
                        <CHED H="1">NAICS code</CHED>
                        <CHED H="1">Examples of regulated entities</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Industry</ENT>
                        <ENT>211120</ENT>
                        <ENT>Crude Petroleum Extraction.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>211130</ENT>
                        <ENT>Natural Gas Extraction.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>221210</ENT>
                        <ENT>Natural Gas Distribution.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>486110</ENT>
                        <ENT>Pipeline Distribution of Crude Oil.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>486210</ENT>
                        <ENT>Pipeline Transportation of Natural Gas.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Federal Government</ENT>
                        <ENT>. . . .</ENT>
                        <ENT>Not affected.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">State and Local Government</ENT>
                        <ENT>. . . .</ENT>
                        <ENT>Not affected.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tribal Government</ENT>
                        <ENT>921150</ENT>
                        <ENT>American Indian and Alaska Native Tribal Governments.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    This table is not intended to be exhaustive but rather provides a guide for readers regarding entities likely to be affected by the NSPS action. Other types of entities not listed in the table could also be affected by these NSPS action. To determine whether your entity is affected by any of the NSPS action, you should carefully examine the applicability criteria found in the final NSPS rule. If you have questions regarding the applicability of the NSPS rule to a particular entity, consult the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section, your State air pollution control agency with delegated authority for NSPS, or your EPA Regional Office.
                </P>
                <P>
                    The issuance of the CAA section 111(d) EG in March of 2024 did not impose binding requirements directly on existing sources. The EG codified in 40 CFR part 60, subpart OOOOc, applies to States in the development, submittal, and implementation of State plans to establish performance standards to reduce emissions of GHGs from designated facilities that are existing sources on or before December 6, 2022. Under the Tribal Authority Rule (TAR), eligible Tribes may seek approval to implement a plan under CAA section 111(d) in a manner similar to a State. See 40 CFR part 49, subpart A. Tribes may, but are not required to, seek approval for treatment in a manner similar to a State for purposes of developing a Tribal implementation plan (TIP) implementing the EG codified in 40 CFR part 60, subpart OOOOc. The TAR authorizes Tribes to develop and implement their own air quality programs, or portions thereof, under the CAA. However, it does not require Tribes to develop a CAA program. Tribes may implement programs that are most relevant to their air quality needs. If a Tribe does not seek and obtain the authority from the EPA to establish a TIP, the EPA has the authority to establish a Federal CAA section 111(d) plan for designated facilities that are located in areas of Indian country.
                    <SU>1</SU>
                    <FTREF/>
                     A Federal plan would apply to all designated facilities located in the areas of Indian country covered by the Federal plan unless and until the EPA approves a TIP applicable to those facilities.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         See the EPA's website, 
                        <E T="03">https://www.epa.gov/tribal/tribes-approved-treatment-state-tas,</E>
                         for information on those Tribes that have treatment as a state for specific environmental regulatory programs, administrative functions, and grant programs.
                    </P>
                </FTNT>
                <PRTPAGE P="3737"/>
                <HD SOURCE="HD2">B. Where can I get a copy of this document and other related information?</HD>
                <P>
                    In addition to being available in the docket, at Docket ID No. EPA-HQ-OAR-2024-0358 located at 
                    <E T="03">https://www.regulations.gov/,</E>
                     an electronic copy of this action is available on the internet at 
                    <E T="03">https://www.epa.gov/controlling-air-pollution-oil-and-natural-gas-operations.</E>
                     In accordance with 5 U.S.C. 553(b)(4), a brief summary of this proposed rule may be found at 
                    <E T="03">www.regulations.gov,</E>
                     Docket ID No. EPA-HQ-OAR-2024-0358. Following publication in the 
                    <E T="04">Federal Register</E>
                    , the EPA will post the 
                    <E T="04">Federal Register</E>
                     version of the proposal and key technical documents at this same website.
                </P>
                <P>
                    A memorandum showing the edits that would be necessary to incorporate the changes to 40 CFR part 60 subpart OOOOb and 40 CFR part 60 subpart OOOOc proposed in this action is available in the docket (Docket ID No. EPA-HQ-OAR-2024-0358). Following signature by the EPA Administrator, the EPA also will post a copy of this document to 
                    <E T="03">https://www.epa.gov/controlling-air-pollution-oil-and-natural-gas-operations.</E>
                </P>
                <HD SOURCE="HD1">II. Statutory Background and Regulatory History</HD>
                <HD SOURCE="HD2">A. Statutory Background of CAA Sections 111(b), 111(d), and General Implementing Regulations</HD>
                <P>The EPA's authority for this rulemaking is CAA section 111, 42 U.S.C. 7411,which governs the establishment of standards of performance for stationary sources. This CAA section requires the EPA to list source categories to be regulated, establish standards of performance for air pollutants emitted by new sources in that source category, and establish EG for States to establish standards of performance for certain pollutants emitted by existing sources in that source category. For a comprehensive discussion of the statutory background of CAA sections 111(b), 111(d), and general implementing regulations, refer to the discussion provided in section IV.A (Statutory Background of the CAA sections 111(b), 111(d), and General Implementing Regulations) of the March 2024 final rule preamble. (89 FR 16846-16848; March 8, 2024).</P>
                <HD SOURCE="HD2">B. What is the regulatory history and background of NSPS and EG for the Crude Oil and Natural Gas Source Category?</HD>
                <P>
                    On November 15, 2021, the EPA published a proposed rule (November 2021 Proposal) to mitigate climate-destabilizing pollution and protect human health by reducing greenhouse gas (GHG) and volatile organic compound (VOC) emissions from the oil and natural gas industry,
                    <SU>2</SU>
                    <FTREF/>
                     specifically the Crude Oil and Natural Gas source category.
                    <E T="51">3 4</E>
                    <FTREF/>
                     In the November 2021 Proposal, the EPA proposed new and updated standards of performance under section 111(b) of the CAA for GHGs (in the form of methane limitations) and VOC emissions from new, modified, and reconstructed sources in this source category, as well as revisions to standards of performance already codified at 40 CFR part 60, subparts OOOO and OOOOa. The EPA also proposed EG under section 111(d) of the CAA for GHGs emissions (in the form of methane limitations) from existing sources (designated facilities).
                    <SU>5</SU>
                    <FTREF/>
                     The EPA also proposed several related actions stemming from the joint resolution of Congress, adopted on June 30, 2021, under the Congressional Review Act (CRA), disapproving the EPA's final rule titled, “Oil and Natural Gas Sector: Emission Standards for New, Reconstructed, and Modified Sources Review,” September 14, 2020 (2020 Policy Rule). Lastly, in the November 2021 Proposal the EPA proposed a protocol for optical gas imaging (OGI) under the part 60 general provisions. The only portions of the November 2021 Proposal that are relevant to this rulemaking are specific limited provisions of the NSPS (OOOOb) and EG (OOOOc) identified in this proposal.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The EPA characterizes the oil and natural gas industry operations as being generally composed of 4 segments: (1) Extraction and production of crude oil and natural gas (“oil and natural gas production”), (2) natural gas processing, (3) natural gas transmission and storage, and (4) natural gas distribution.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">“Standards of Performance for New, Reconstructed, and Modified Sources and Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate Review.”</E>
                         Proposed rule (86 FR 63110; November 15, 2021).
                    </P>
                    <P>
                        <SU>4</SU>
                         The EPA defines the Crude Oil and Natural Gas source category to mean: (1) Crude oil production, which includes the well and extends to the point of custody transfer to the crude oil transmission pipeline or any other forms of transportation; and (2) natural gas production, processing, transmission, and storage, which include the well and extend to, but do not include, the local distribution company custody transfer station, commonly referred to as the “city-gate.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The term “designated facility” means “any existing facility which emits a designated pollutant and which would be subject to a standard of performance for that pollutant if the existing facility were an affected facility.” See 40 CFR 60.21a(b).
                    </P>
                </FTNT>
                <P>
                    On December 6, 2022, the EPA published a supplemental proposed rule (“December 2022 Supplemental Proposal”) that was composed of two main additions.
                    <SU>6</SU>
                    <FTREF/>
                     First, the EPA proposed updated, strengthened, and expanded NSPS OOOOb standards compared to those proposed in November 2021 under CAA section 111(b) for GHGs (in the form of methane limitations) and VOC emissions from new, modified, and reconstructed facilities. Second, the EPA proposed updated, strengthened, and expanded presumptive standards compared to those proposed for EG OOOOc in the November 2021 Proposal as part of the CAA section 111(d) EG for GHGs emissions (in the form of methane limitations) from designated facilities. For purposes of EG OOOOc, the EPA also proposed the implementation requirements for State plans developed to limit GHGs pollution (in the form of methane limitations) from designated facilities in the Crude Oil and Natural Gas source category under CAA section 111(d).
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">“Standards of Performance for New, Reconstructed, and Modified Sources and Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate Review.”</E>
                         Supplemental notice of proposed rulemaking (87 FR 74702; December 6, 2022).
                    </P>
                </FTNT>
                <P>On March 8, 2024, at 89 FR 16820 (hereafter, referred to as the March 2024 final rule), the EPA published the final rule with multiple separate actions to reduce air pollution emissions from the Crude Oil and Natural Gas source category. First, the EPA finalized NSPS OOOOb regulating GHG (in the form of a limitation on emissions of methane) and VOCs emissions for the Crude Oil and Natural Gas source category pursuant to CAA section 111(b)(1)(B). Second, the EPA finalized the EG in OOOOc to limit GHGs. Third, the EPA finalized several related actions (including final amendments to NSPS OOOOa) stemming from the joint resolution of Congress, adopted on June 30, 2021, under the CRA, disapproving the 2020 Policy Rule. Fourth, the EPA finalized a protocol under the General Provisions for optical gas imaging (OGI). The final rule became effective 60 days after publication, which was May 7, 2024.</P>
                <P>
                    After the publication of the March 2024 final rule, the EPA identified, through its own internal reassessment of the regulatory text, as well as through communications with stakeholders and the Office of the Federal Register, erroneous cross-references and typographical errors within the regulatory text. Through those same processes, the EPA also identified the need for some minor wording changes to clarify erroneous language (or, in some cases, erroneous omissions) in the regulatory text, and to ensure that the 
                    <PRTPAGE P="3738"/>
                    regulatory text aligns with the descriptions of the relevant provisions in the final rule preamble and other parts of the regulation(s). The EPA published an interim final rule (89 FR 62872; August 1, 2024) 
                    <SU>7</SU>
                    <FTREF/>
                     which made minor and non-substantive corrections to the March 2024 final rule in order to correct the identified inadvertent errors.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Docket ID No. EPA-HQ-OAR-2021-0317-4057.
                    </P>
                </FTNT>
                <P>
                    Further, after the publication of the March 2024 final rule, the EPA received multiple petitions 
                    <SU>8</SU>
                    <FTREF/>
                     for reconsideration. On May 6, 2024,
                    <SU>9</SU>
                    <FTREF/>
                     we notified certain petitioners and the public that we granted reconsideration on two narrow and discrete aspects of the March 2024 final rule: (1) The temporary flaring provisions for associated gas in certain situations; and (2) the vent gas NHV continuous monitoring requirements and alternative performance test (sampling demonstration) option for flares and enclosed combustion devices. These issues were raised in petitions for reconsideration from: (1) The American Petroleum Institute (API) and the American Exploration and Production Council (AXPC); 
                    <SU>10</SU>
                    <FTREF/>
                     (2) Second petition from API/AXPC; 
                    <SU>11</SU>
                    <FTREF/>
                     (3) The Texas Oil &amp; Gas Association (TXOGA); 
                    <SU>12</SU>
                    <FTREF/>
                     (4) GPA Midstream Association (GPA Midstream); and (4) Environmental Integrity Project et. al.
                    <SU>13</SU>
                    <FTREF/>
                     This action proposes amendments to the March 2024 final rule as a result of our reconsideration of these two narrow issues.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         See Docket No. EPA-HQ-OAR-2024-0358 for petitions for reconsideration received.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         See Docket No. EPA-HQ-OAR-2024-0358 for May 6, 2024, letter granting reconsideration.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Letter to Michael S. Regan, EPA Administrator, from API and AXPC. Re: Provisions in the EPA's Final Rule “New Source Performance Standards and Emission Guidelines for Crude Oil and Natural Gas Facilities: Climate Review.” Reconsideration of the Final Rule. May 6, 2024. Hereinafter referred to as the “May 2024 API and AXPC petition.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Letter to Michael S. Regan, EPA Administrator, from TXOGA. Request for Reconsideration of the EPA's Final Rule “New Source Performance Standards and Emission Guidelines for Crude Oil and Natural Gas Facilities: Climate Review.” May 7, 2024. Hereinafter referred to as the “May 2024 TXOGA petition.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Letter to Michael S. Regan, EPA Administrator; Gautam Srinivasan, Associate General Counsel, EPA; and Amy Hambrick, SPPD, EPA; from GPA Midstream Association. GPA Midstream Association Petition for Reconsideration and Request for Stay of Standards of Performance for New, Reconstructed, and Modified Sources and Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate Review. May 2, 2024. Hereinafter referred to as the “May 2024 GPA Midstream petition.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Letter to Michael S. Regan, EPA Administrator, from Air Alliance Houston; Clean Air Council; and Environmental Integrity Project. Re: Petition for Reconsideration of the Standards of Performance for New, Reconstructed, and Modified Sources and Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate Review; Final Rule, 89 FR 16,820 (March 8, 2024), Docket No. EPA-HQ-OAR-2021-0317. May 7, 2024. Hereinafter referred to as the “May 2024 EIP, 
                        <E T="03">et al.</E>
                         petition.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         In the May 6, 2024, letter to petitioners, the EPA also took the opportunity to clarify the applicable timeframe for performance testing with respect to NHV sampling.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Summary and Rationale of Proposed Amendments to NSPS OOOOb and EG OOOOc</HD>
                <P>
                    The amendments proposed in this action only relate to two narrow aspects of the March 2024 final rule: (1) The temporary flaring provisions for associated gas in certain situations; and (2) the vent gas NHV continuous monitoring requirements and alternative performance test (sampling demonstration) option for flares and enclosed combustion devices. This proposal does not address, and therefore the EPA is not reopening, any other aspects of the March 2024 final rule aside from these two specific aspects. Further, the two issues addressed in this proposal are separate and distinct from each other. Each of these two issues concern different portions of the March 2024 final rule that do not rely on the other. Also, in this action, the EPA proposes to make formatting changes to the regulatory text to meet the required formatting standards of the Office of the Federal Register.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         To view the proposed formatting changes, see the full redline strike out (RLSO) of the regulatory text located in the public docket at EPA-HQ-OAR-2024-0358.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">A. Temporary Flaring Provisions for Associated Gas in Certain Situations</HD>
                <P>
                    The final NSPS OOOOb requirements, and EG OOOOc presumptive standards (model rules), allow oil wells that are not routinely flaring associated gas (
                    <E T="03">i.e.,</E>
                     oil wells that route associated gas to sales line or equivalent alternative), to route associated gas to a flare or control device temporarily in certain situations. During situations where a malfunction or incident endangers the safety of operator personnel or the public, and during repair, maintenance including blow downs, a production test, or commissioning, owners and operators are allowed to route to a flare or control device for 24 hours or less per incident. Petitions for reconsideration include information that suggest that 24 hours for temporary flaring may not be sufficient time in these situations to troubleshoot and repair equipment. A summary of the relevant promulgated provisions being reconsidered is presented in section III.A.1, and specific concerns and supporting information provided by petitioners and other industry representatives are presented in section III.A.2 of this preamble. After consideration of the petitioners' concerns and supporting information, the EPA is proposing certain discrete changes to these particular requirements finalized in the March 2024 final rule. The proposed changes are presented in section III.A.3 of this preamble and the EPA's rationale for those proposed changes is presented in section III.A.4 of this preamble.
                </P>
                <HD SOURCE="HD3">1. Summary of Promulgated Provisions Being Reconsidered</HD>
                <P>When developing the March 2024 final rule requirements for associated gas, the EPA recognized that temporary situations may occur beyond the reasonable control of an owner or operator that could make it technically infeasible or unsafe to comply with the standard that requires the associated gas be recovered and either routed into a gas gathering flow line or collection system to a sales line, used as an onsite fuel source, used for another useful purpose that a purchased fuel or raw material would serve, or reinjected into the well or inject the recovered gas into another well. Therefore, for all associated gas wells subject to NSPS OOOOb and complying with one of these four options, the final rule allows owners and operators to route the associated gas to a flare or control device temporarily. 40 CFR 60.5377b(d). The EG also includes similar provisions as part of the model rule at 40 CFR 60.5391c(c). The NSPS OOOOb final rule allow temporary flaring for the following situations:</P>
                <P>(1) During a malfunction or incident that endangers the safety of operator personnel or the public, an owner or operator is allowed to route to a flare or control device for 24 hours or less per incident.</P>
                <P>(2) During repair, maintenance including blow downs, a production test, or commissioning, an owner or operator is allowed to route to a flare or control device for 24 hours or less per incident.</P>
                <P>(3) During a temporary interruption in service from the gathering or pipeline system, an owner or operator is allowed to route to a flare or route to a control device for the duration of the temporary interruption not to exceed 30 days per incident.</P>
                <P>
                    (4) During periods when the composition of the associated gas does not meet pipeline specifications for sources, or when the composition of the associated gas does not meet the quality requirements for use as a fuel for sources, or when the composition of the associated gas does not meet the quality requirements for another useful purpose, an owner or operator is 
                    <PRTPAGE P="3739"/>
                    allowed to route to a flare or control device until the associated gas meets the required specifications or for 72 hours per incident, whichever is less.
                </P>
                <P>This proposed rule only concerns the first two situations listed above: (1) Malfunction/safety, and (2) repair/maintenance. The EPA is not reopening the other two situations listed. Specifically, the EPA is proposing changes to the following regulatory text only: 40 CFR 60.5377b(d)(1) and (2), and 60.5391c(c)(1) and (2). To view the proposed changes, see the full redline strike out (RLSO) of the regulatory text located in the public docket at EPA-HQ-OAR-2024-0358.</P>
                <HD SOURCE="HD3">2. Petitioner's Concerns and Supporting Information</HD>
                <P>
                    The EPA received a petition for reconsideration of the March 2024 final rule from API-AXPC 
                    <SU>16</SU>
                    <FTREF/>
                     that included support for the EPA's general approach finalized at 40 CFR 60.5377b(d) that allows temporary flaring of associated gas for unique situations. However, petitioners highlighted that there are certain oil and natural gas production operations that are remote and spread out over many miles that are prone to severe winter weather events that could prevent operators from accessing these remote sites for longer than 24 hours. They provided, for example, that seasonal weather in North Dakota may cause local agencies to close roads whereby people and equipment would be prevented from arriving at a location within 24 hours. They requested that the EPA extend the temporary flaring provisions for malfunction and repair or maintenance activity to 72 hours from 24 hours as finalized. They added that the March 2024 final rule's specific timing restrictions for flaring were not in the proposals and therefore they did not have the opportunity to comment on the timelines finalized.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         April 2024 API and AXPC petition.
                    </P>
                </FTNT>
                <P>
                    The petitioners added that the March 2024 final rule preamble includes language that they believe indicates that the EPA intended to allow up to 72 hours for temporary flaring, “. . .during repair, maintenance including blowdowns, a packer leakage test, a production test, or commissioning.” 
                    <SU>17</SU>
                    <FTREF/>
                     Petitioners asking the EPA to reconsider this issue interpreted that it was the EPA's intention that 72 hours be allowed for temporary flaring, “. . . during repair, maintenance including blowdowns, a packer leakage test, a production test, or commissioning,” based on language in the final rule preamble.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         89 FR 16820, at 16949.
                    </P>
                </FTNT>
                <P>
                    However, the EPA is now clarifying that the language cited by Petitioners was an inadvertent error. Elsewhere in the final rule preamble (
                    <E T="03">e.g.,</E>
                     Table 17—Situations and Durations where Associated Gas May Temporarily be Routed to a Flare or Control Device) and the final rule regulatory text correctly specify 24 hours as the allowance for temporary routing to a flare or control device during repair and maintenance. The final rule does allow for up to 72 hours in a different scenario, if associated gas does not meet pipeline specifications. In the March 2024 final rule, the EPA did not intend, and the existing regulatory text does not permit, to allow up to 72 hours for repair and maintenance.
                </P>
                <P>
                    As a follow-up to their petition, API conducted a survey 
                    <SU>18</SU>
                    <FTREF/>
                     from June through July 2024 with its members to understand the distribution of temporary associated gas flaring duration due to malfunction or maintenance and repair and submitted to the EPA for consideration. The API survey-provided responses include information on duration, data (month and year), and cause of temporary flaring events due to malfunction or maintenance or repair based on readily available data collected over 6 years (with 70 percent of the data collected within the last 3 years). The API survey data set represents over 2,800 total data points from six operators across three basins. The majority of the information (92 percent of the data points) was from the Permian Basin, with 6 percent and 2 percent from the Williston and San Juaquin Basins, respectively. Overall, according to API, the results indicate that over 17 percent of events across the three basins required temporary flaring greater than 24 hours per event and over 15 percent of events required temporary flaring greater than 72 hours per event. Broken down by basin, 12 percent of the events in the Permian Basin required temporary flaring greater than 24 hours, and 11 percent required flaring durations greater than 72 hours. For the Williston Basin, 92 percent of events required flaring for greater than 24 hours and 78 percent required flaring for greater than 72 hours. For the San Joaquin Basin, 7 percent of events required flaring greater than 24 hours and 0 percent required flaring greater than 72 hours. The average duration of a temporary flaring event for all basins was reported to be 46 hours. The average flaring event durations by basin were 26 hours for the Permian Basin, 378 hours for the Williston Basin, and 8 hours for the San Joaquin Basin. API reported that inclement weather is one of many factors that contributes to the need for longer temporary flaring durations, which is reflected in the longer durations in the Williston Basin.
                    <SU>19</SU>
                    <FTREF/>
                     They concluded that the data set supports their position that a 24-hour limit is a potential issue across various causes of temporary flaring including planned events, with geographically dispersed sites presenting additional challenges to rapid response.
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         API (Prepared for API by John Beath Environmental, LLC). 
                        <E T="03">Operator Survey: Temporary Flaring.</E>
                         Slide Presentation and Excel Workbook. July 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         The Williston Basin spans western North Dakota, northwestern South Dakota, eastern Montana and into a southern section of Canada.
                    </P>
                </FTNT>
                <P>Additional takeaways from the survey data, according to API, are that: (1) Operators are already making efforts to reduce the duration of temporary flaring, with approximately 83 percent of flaring events represented in the data set being less than 24 hours; and (2) API believes that a 72-hour flaring limit would be more realistic, force operational innovation, minimize emissions, and would reduce the duration of roughly 15 percent of events. API acknowledged that although the results of the survey may not be statistically representative of the entire population (the entire industry in terms of all wells with associated gas), they believe that the collected data indicates that 72 hours is more appropriate than 24 hours as a national standard for temporary flaring due to malfunction or planned repair and maintenance.</P>
                <P>
                    The EPA had also received a briefing by Hess Corporation prior to receiving the April 2024 API and AXPC petition on temporary flaring concerns.
                    <SU>20</SU>
                    <FTREF/>
                     Their briefing stressed that well sites are unmanned facilities that are spread over hundreds of miles throughout North Dakota. They stressed that seasonal conditions such as road restrictions in spring and fall and extreme winter conditions can prevent personnel and equipment from getting to site, and that it may take days and up to over a week until access roads to a well site are cleared of snow. They added that, if a maintenance crew is required for repair, it can take multiple days even with equipment available. They suggested that it would be more appropriate and achievable for the EPA to allow 72 
                    <PRTPAGE P="3740"/>
                    hours for temporary flaring due to safety and repair conditions.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         Hess Briefing for the EPA: 
                        <E T="03">Oil and Natural Gas Final Methane Rule NSPS OOOOb and EG OOOOc.</E>
                         February 29, 2024, Slide Presentation. See slides 19-23.
                    </P>
                </FTNT>
                <P>Hess Corporation provided two specific scenarios in their briefing that they believe would require the need for flaring greater than 24 hours: (1) Back pressure valve (BPV) failure; and (2) frozen sales gas piping on well site. Under the first scenario, they reported that it can take over a week to fix a BPV where an operator cannot fix it without involving others to perform corrective work and to obtain the necessary parts. Under the second scenario, once a freeze is identified, mitigation needs to be scheduled with a 3rd party and work can entail over a day to remove snow to provide access to thaw piping.</P>
                <P>
                    In June of 2024, Hess Corporation presented an updated briefing 
                    <SU>21</SU>
                    <FTREF/>
                     to the EPA on their concerns related to the temporary flaring provisions which included additional supporting information for the above-mentioned scenarios. For example, for the first scenario above, Hess provided BPV failure notification to resolution timeline data indicating that it takes anywhere from a half day to 8 days (with an average resolution time of 3.2 days). Hess emphasized that weather-related closures/restrictions that prevent personnel and repair equipment from getting to a site, and well sites in North Dakota that are unmanned facilities spread over hundreds of miles are both instances that would prevent maintenance and repair within 24 hours as required by the March 2024 final rule. Hess represented that their operations in North Dakota span an area of roughly 7,200 square miles. Thus, the company stated that even under normal business processes—that incorporate efficiencies—maintenance and repair within 24 hours is unlikely and infeasible in many instances, even without a reason beyond an operator's control.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         Hess Briefing for the EPA: 
                        <E T="03">NSPS OOOOb Safety, Malfunction &amp; Repair Temporary Flaring Allowance.</E>
                         June 3, 2024. Slide Presentation.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. Summary of Proposed Changes</HD>
                <P>After consideration of the petitioners' concerns and supporting information, the EPA is proposing to revise the temporary flaring provisions for associated gas in certain situations finalized in the March 2024 final rule. Specifically, these proposed revisions only apply to situations during: (1) Malfunction/safety, and (2) repair/maintenance. The EPA is proposing to extend the allowable time for temporary flaring from 24 to 48 hours for malfunction, including for reasons of safety, and during all repairs and maintenance.</P>
                <P>
                    Further, the EPA recognizes Petitioners' claim that there may be some instances in which an owner or operator encounters a malfunction, safety, repair, or maintenance event that requires routing to a flare or control device beyond 48 hours. To address such instances, the EPA is soliciting comment on allowing owners or operators of associated gas affected facilities to route to a flare or control device for up to 72 hours if “exigent circumstances” exist. Such “exigent circumstances” would include situations where an owner or operator cannot physically access a site due to weather or other conditions (
                    <E T="03">e.g.,</E>
                     road closures). In addition to extreme weather events/road closures, the EPA is also soliciting comment on whether there are other specific “exigent circumstances” where the EPA should consider allowing an owner or operator to include as a basis of a “exigent circumstance” claim requiring the need to route to a flare or control device beyond the proposed 48-hour allowance for repairs and malfunctions. The EPA also solicits comment on the records and reports that should be required if the EPA were to include an allowance for owners or operators of associated gas affected facilities to route to a flare or control device for up to 72 hours for “exigent circumstances.” Specifically, the EPA solicits comment on requiring an owner or operator who must make use of the extended timeframe to maintain records that include: (1) A written description of the “exigent circumstance”; (2) the rationale for the need to route to a flare or control device beyond 48 hours; (3) a description of the measures taken to minimize temporary flaring/routing to a control device; and (4) the duration of temporary flaring/routing to a control device due to the identified “exigent circumstance.” Lastly, the EPA solicits comment on requiring an owner or operator to include a summary of their annual “exigent circumstance” recorded events in their annual report.
                </P>
                <P>The basis for the EPA's proposed changes and solicitations is discussed in III.A.4 of this preamble.</P>
                <HD SOURCE="HD3">4. Basis for Proposed Changes</HD>
                <P>
                    The March 2024 final rule allows temporarily routing associated gas to a flare or control device for 24 hours during situations where a malfunction or incident endangers the safety of operator personnel or the public, and during repair, maintenance including blow downs, a production test, or commissioning. These provisions were based on requirements of existing State rules, information from the World Bank Global Flaring and Methane Reduction Partnership, and specific recommendations provided by comments received on the proposal and supplemental proposal.
                    <SU>22</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         89 FR 16943 to 16944 and 89 FR 16948 to 16950.
                    </P>
                </FTNT>
                <P>As discussed in section III.A.2 of this preamble, industry petitioners indicated that the 24-hour limitation for temporary routing to a flare or control device in the final rule during situations where a malfunction or incident endangers the safety of operator personnel or the public, and during repair, maintenance including blow downs, a production test, or commissioning, is not sufficient. They claim that a 72-hour timeframe for all these situations is more appropriate for temporary routing to a flare or control device due to the unique characteristics of some well sites, weather conditions, or a combination of both.</P>
                <P>
                    The EPA considered this information, and examined the scenarios provided by the petitioners where they claimed there was a need for temporary routing to a flare or control device beyond 24 hours. First, the information provided by petitioners is persuasive in demonstrating that a blanket 24-hour limit on temporary flaring can pose compliance challenges for certain owners and operators. While we still expect that owners and operators can feasibly limit temporary flaring to less than 24 hours in a large majority of situations (and this is supported by the API survey data cited above), we acknowledge that in certain instances, fundamental aspects of well site operational schedules can make this requirement challenging, particularly for remote unmanned sites. The EPA understands that owners' and operators' operational schedules outline the staffing and work shifts of oil and gas operations, ensuring that personnel are available to monitor and respond to issues within a designated timeframe while maintaining safe and efficient operations. We recognize that challenges arise when problems occur outside of an operator's working hours, such as during night shifts, shift changes or when fewer staffs are present leading to delays in identifying and addressing repairs and malfunctions. Hess has shared information with the EPA highlighting how the 24 hour operational schedule may not be sufficient for quick response in such cases, particularly with the remote 
                    <PRTPAGE P="3741"/>
                    nature of these sites.
                    <SU>23</SU>
                    <FTREF/>
                     We also recognize that the gathering of available parts and prioritization of corrective work to correct a situation, such as the BPV failure example cited by Hess, could require the need for routing to a flare or control device for a period greater than 24 hours. Further, we also recognize that circumstances outside of the control of the owner/operator, such as weather events, can also impact the ability to address the situation within 24 hours.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         An example of the timeline challenges with well site operational schedules is presented in slide 5 of Hess Briefing for the EPA: 
                        <E T="03">NSPS OOOOb Safety, Malfunction &amp; Repair Temporary Flaring Allowance.</E>
                         June 3, 2024. Slide Presentation.
                    </P>
                </FTNT>
                <P>
                    However, the EPA believes at this time that proposing to change the requirement to allow temporary routing to a flare or control device for up to 48 hours is likely to address most of the issues raised by the petitioners. We maintain that equipment needs for failures should be planned for in advance to minimize routing to a flare or control device (
                    <E T="03">i.e.,</E>
                     owners and operators should plan to have equipment on hand for failures on site), and that additional time beyond 48 hours should not be necessary to address issues at remote sites since these sites are typically accessible within a 24 hour period (except during certain conditions 
                    <E T="03">e.g.,</E>
                     seasonal weather, road closures that may prevent operators from accessing the site). Therefore, we are proposing to double the time frame for which temporary routing to a flare or control device is allowed during situations where a malfunction or incident endangers the safety of operator personnel or the public, and during repair, maintenance including blow downs, a production test, or commissioning, from 24 hours per event to 48 hours per event. This timeframe is supported by API's survey, which found the average duration of temporary flaring was 46 hours per event.
                </P>
                <P>
                    While the EPA is proposing to change the allowed duration for temporarily routing associated gas to a flare or control device from 24 to 48 hours, we recognize that there is some information that could support retaining the 24-hour time frame. As noted above, the API survey indicated that 83 percent of the circumstances encountered that required temporary flaring were resolved in 24 hours or less. Further, Colorado 2 Colo. Code. Regs. sec. 4041:903 allow gas to be flared (or vented during an upset condition), but for a period not to exceed 24 cumulative hours per event. In addition, information from New Mexico 
                    <SU>24</SU>
                    <FTREF/>
                     indicates that only 11 percent of the total volume of gas flared (from all sources, not only associated gas) results from flaring activities with durations greater than 8 hours. We request information and data on whether the proposed temporary flaring duration of 48 hours has the potential to increase the amount of primary or secondary emissions. The duration of flaring will vary by basin and by the reason for flaring. We request that any data on changes in emissions due to flaring specifically identify the basin, reasons for flaring, and duration of the temporary flaring. We request that commenters consider this information in submitting comments related to the proposed change to 48 hours. We also request additional information to support the proposal, or to support retaining the 24-hour period in the final rule.
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">https://wwwapps.emnrd.nm.gov/OCD/OCDPermitting/Reporting/NaturalGasWaste/UpstreamNaturalGasWasteSummaryReportExpanded.aspx.</E>
                    </P>
                </FTNT>
                <P>While the EPA expects that the vast majority of temporary flaring situations can be addressed within the 48-hour timeframe proposed in these amendments, we recognize that incidents might not be resolved within 48 hours due to circumstances beyond an owner or operator's control. Examples of such “exigent circumstances” mentioned by the petitioners include road closures and seasonal weather that could prevent operators from accessing the site to conduct a necessary repair. As discussed above, EPA is not proposing to allow temporary flaring beyond 48 hours during such circumstances; however, we are soliciting comment on the need to allow routing to a flare or control device for up to 72 hours where a legitimate and supported “exigent circumstance” claim is made. We solicit comment on what would constitute an exigent circumstance and defining these incidences. Relatedly, we are soliciting comment on the potential “exigent circumstances” recordkeeping criteria explained above, and on when an “exigent circumstance” claim should be sent to the Agency (in the annual report or otherwise). This longer time frame of up to 72 hours for special situations is consistent with the duration recommended by reconsideration petitioners. We acknowledge that such circumstances represent real-life scenarios that are beyond an owner or operator's control but seek more information on this as an option. See section III.A.3 of this preamble for more explanation on our solicitation for information.</P>
                <HD SOURCE="HD2">B. Vent Gas Net Heating Value (NHV) Continuous Monitoring Requirements and Alternative Performance Test (Sampling Demonstration) Option for Flares and Enclosed Combustion Devices</HD>
                <P>A summary of the relevant promulgated provisions being reconsidered related to the vent gas NHV continuous monitoring requirements and alternative performance test (sampling demonstration) option for flares and enclosed combustion devices is presented in section III.B.1, and specific concerns and supporting information provided by petitioners and other industry representatives are presented in section III.B.2 of this preamble. After consideration of the petitioners' concerns and supporting information, the EPA is proposing certain discrete changes to these particular requirements finalized in the March 2024 final rule. The proposed changes are presented in section III.B.3 of this preamble and the EPA's rationale for those proposed changes is presented in III.B.4 of this preamble.</P>
                <HD SOURCE="HD3">1. Summary of Promulgated Provisions Being Reconsidered</HD>
                <P>
                    The EPA finalized compliance requirements for continuous monitoring and initial and periodic performance testing for flares and enclosed combustion devices in the March 2024 final rule. Of relevance to this proposal are the final requirements for those two control devices regarding the NHV monitoring requirements and alternative performance test (sampling demonstration) option. In the March 2024 final rule, with exceptions for catalytic vapor incinerators, boilers and process heaters, and enclosed combustors where temperature is an indicator of destruction efficiency, all flares and enclosed combustors must maintain the NHV of the gas sent to the device above a minimum NHV value if the combustion device is pressure-assisted or uses no assist gas. If an owner or operator uses a steam- or air-assisted enclosed combustion device or flare, the owner or operator must maintain the combustion zone NHV (NHV
                    <E T="52">cz</E>
                    ) above a minimum level. If the owner or operator uses an air-assisted enclosed combustion device or flare, the owner or operator must maintain the NHV dilution parameter (NHV
                    <E T="52">dil</E>
                    ) above a minimum level. The NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     parameter terms account for the reduction in heating value caused by the introduction of air or steam. These 
                    <PRTPAGE P="3742"/>
                    terms ensure that the assist gas does not overwhelm the heating value provided by the vent gas to the point where proper combustion is no longer occurring. Owners or operators also have the option to apply to use an alternative test method that either demonstrates continuous compliance with the combustion efficiency limit or directly demonstrates cont inuous compliance with the NHV
                    <E T="52">cz</E>
                     operating limit and, if applicable, the NHV
                    <E T="52">dil</E>
                     operating limit.
                </P>
                <P>
                    Associated gas from a well site affected facility was exempt from NHV monitoring (
                    <E T="03">i.e.,</E>
                     assumed to always have high NHV) under the March 2024 final rule. For each enclosed combustor and flare used to control gases other than associated gas from a well site affected facility, the owner or operator must conduct continuous monitoring using a calorimeter, gas chromatograph (GC), or mass spectrometer (MS) in order to determine the NHV of the vent stream. As an alternative to continuous monitoring of NHV, the owner or operator may conduct a performance test to demonstrate the NHV of the vent stream consistently exceeds the applicable NHV operating limit in one of two ways: (1) Continuous sampling for 14 consecutive days plus ongoing (3 samples every 5 years) sampling, or (2) manual sampling (twice daily for 14 consecutive days) plus ongoing (3) samples every 5 years) sampling. The minimum collection time for each individual manually collected sample must be at least one hour. If inlet gas flow is intermittent such that collecting 28 samples in 14 days is infeasible, an owner or operator must continue to collect samples beyond 14 days in order to collect a minimum of 28 samples. Owners or operators also have the option to use an alternative test method 
                    <E T="51">25 26</E>
                    <FTREF/>
                     that demonstrates continuous compliance with the combustion efficiency limit; if there are no values of the combustion efficiency measured by the alternative test method over the 14-day period that are less than 95 percent, the gas stream is considered to consistently exceed the applicable NHV operating limit and the owner or operator is not required to continuously monitor or conduct sampling of the NHV of the inlet gas to the enclosed combustion device or flare. Owners or operators of steam-assisted and air-assisted enclosed combustors and flares also must monitor the vent gas and assist gas flow rates and calculate NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     in accordance with the provisions in 40 CFR 63.670 (
                    <E T="03">i.e.,</E>
                     the refinery maximum achievable control technology rule, or Refinery MACT). Alternatively, owners or operators of air-assisted flares may provide a one-time demonstration based on maximum air assist rates, minimum waste gas flow rates (based on back pressure regulator setting), and minimum NHV from the most recent sampling rather than continuously monitor vent gas and assist gas flow rates.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Under the provisions outlined in 40 CFR 60.5412b(d) and 60.5415b(f)(1)(xi), sources can request to use an “equivalent method” pursuant to 40 CFR 60.8(b)(2), or “an alternative method the results of which [the Administrator] has determined to be adequate for indicating whether a specific source is in compliance” pursuant to 40 CFR 60.8(b)(3). The EPA is currently accepting and reviewing applications for alternative (ALT) test methods for NHV monitoring in the oil and natural gas sector. See 
                        <E T="03">https://www.epa.gov/emc/oil-and-gas-alternative-test-methods#:~:text=The%20application%20portal%20can%20be,Air%20Emission%20Measurement%20Center%20web page.</E>
                         Since the rule's publication date of March 8, 2024, two alternative test method requests have been approved by the EPA for use under NSPS subpart OOOOb: (1) ALT-156 Alternative Test Method to monitor the NHV of the flare combustion zone at facilities Subject to NSPS OOOOb and (2) ALT-157 Alternative Test Method for determining NHV from gas sent to an ECD or Flare subject to NSPS OOOOb. A list of the EPA's approved alternative test methods can be found at 
                        <E T="03">https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods.</E>
                    </P>
                    <P>
                        <SU>26</SU>
                         Per 40 CFR 60.8(b)(5), the EPA has more general authority to approve alternative test methods involving “shorter sampling times and smaller sample volumes when necessitated by process variables or other factors.”
                    </P>
                </FTNT>
                <P>
                    Finally, as discussed in section II.B of this preamble, the EPA issued a letter on May 6, 2024, whereby the EPA clarified performance testing deadlines with respect to the alternative NHV sampling demonstration that owners or operators must meet in order to demonstrate compliance with the applicable NSPS subpart OOOOb emission standard. The EPA stated that as applied to the March 2024 final rule, affected sources that were new, modified, or reconstructed after the supplemental proposal (December 6, 2022), but before the rule's effective date of May 7, 2024, have 180 calendar days after the effective date of the rule to conduct performance (
                    <E T="03">i.e.,</E>
                     compliance) testing. For NSPS subpart OOOOb sources that are new, modified or reconstructed after the final rule's effective date of May 7, 2024, the applicable monitoring requirements (including the 14-day NHV performance test) must be completed within 180 calendar days after initial startup of the source.
                </P>
                <HD SOURCE="HD3">2. Petitioners' Concerns and Supporting Information</HD>
                <P>
                    API and AXPC 
                    <E T="51">27 28</E>
                    <FTREF/>
                    , TXOGA 
                    <SU>29</SU>
                    <FTREF/>
                    , GPA Midstream 
                    <SU>30</SU>
                    <FTREF/>
                    , and EIP 
                    <SU>31</SU>
                    <FTREF/>
                     raised issues in their petitions relating to the March 2024 final rule requirements for the NHV compliance demonstration, which consists of either monitoring the NHV content of the vent gas on a continuous basis, or utilizing the alternative performance test option. The April and May 2024 API and AXPC petitions, May 2024 TXOGA petition, and May 2024 GPA Midstream Association petitions raised issues regarding the need for the NHV compliance demonstration, technical infeasibility of the demonstration, and compliance timing (including supply chain issues). The May 2024 EIP, et. al. petition contended that the EPA did not support its conclusion in the March 2024 final rule that initial assessments of flares and other control devices, in lieu of continuous monitoring, can capture the variability of NHV in the oil and gas sector, and that no sampling or monitoring of NHV is needed when only associated gas from wells is sent to control devices.
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         April 2024 API and AXPC petition.
                    </P>
                    <P>
                        <SU>28</SU>
                         May 2024 API and AXPC petition.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         May 2024 TXOGA petition.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         May 2024 GPA Midstream petition.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         May 2024 EIP, 
                        <E T="03">et al.</E>
                         petition.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">a. Need for NHV Compliance Demonstration</HD>
                <P>
                    The April and May 2024 API and APXC and May 2024 GPA Midstream petitions state that vent gases in this industry are not expected to fall below the minimum NHV unless diluted by inert gases,
                    <SU>32</SU>
                    <FTREF/>
                     and therefore the NHV requirements in the March 2024 final rule are unnecessary. The May 2024 GPA Midstream petition raised concerns with operations in the midstream and stated that waste gas streams routed to combustion devices have very high British thermal unit (Btu) values, when compared to the minimum NHV values finalized in the March 2024 final rule, because these midstream gas streams consist of natural gas and field gas with NHVs typically in excess of 1,000 Btu/standard cubic feet (scf). Further, this petitioner stated that inert gases, such as nitrogen, are rarely used at midstream sources and any water in the gas is eliminated well before the control device. This petitioner also cited to prior responses to public comments 
                    <PRTPAGE P="3743"/>
                    from the EPA which acknowledged the NHV of the vent gas to a flare in this sector is likely to be well above the minimum required NHV 
                    <SU>33</SU>
                    <FTREF/>
                     and questioned what it perceived as a change in the EPA's position 
                    <SU>34</SU>
                    <FTREF/>
                     in the March 2024 final rule. In a letter 
                    <SU>35</SU>
                    <FTREF/>
                     to the EPA dated July 31, 2024, GPA Midstream provided additional information, not previously provided during the course of the prior rulemaking, regarding operating scenarios in midstream operations where vent gases may have a lower NHV than typical gathering, boosting, and processing operations. In this same letter, GPA Midstream also provided new NHV data from gathering, boosting, and processing vent gas streams routed to controls, along with four new operating scenarios for the EPA's consideration, where the NHV content in vent gas streams may be lower than normal:
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         For the purposes of the NHV compliance provisions, inert gases (or inerts) are gases that do not readily undergo combustion. Inert gases consist of or contain high concentrations of nitrogen, carbon dioxide (CO
                        <E T="52">2</E>
                        ), water, or other compounds that have a net heating value of zero.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         See RTC, Response II-17-46 and II-17-47.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         See 89 FR 16966.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         GPA Midstream—EPA 06/24/24 Meeting Follow-Up. Re: Response to EPA Request for Additional Information regarding OOOOb GPA Midstream Net Heating Value Case Scenarios and Data. (Attachment Summarizing NHV Data Included as an Attachment). Hereinafter referred to as the “July 2024 GPA Midstream Letter.”
                    </P>
                </FTNT>
                <P>
                    1. Combining acid gas removal (AGR) system amine regenerator still column vent gas with affected facility vent gas streams—GPA Midstream explained that AGR amine regenerator still column vent gases typically are routed to an individual control device due to the low flow rate, low pressure, and corrosive nature of the vent stream, and that the low NHV of the stream typically requires supplemental gas for proper control device operation. However, GPA Midstream explained it is possible to combine the still column vent gas with other vent gas streams, which would lower the NHV of the combined stream, primarily due to the high CO
                    <E T="52">2</E>
                     content of the still column vent gas.
                </P>
                <P>2. Combining glycol dehydration unit reboiler vent gas with affected facility vent gas streams without water removal—GPA Midstream explained that typically glycol dehydration unit reboiler vent gas is routed through a condenser to remove liquids (including VOC and water vapor) and then routed to a process or control device. However, it is possible to combine the glycol dehydration unit reboiler gas, without routing through a condenser, with other vent gases routed to common control. The high water content of the reboiler vent gas stream could lower the NHV of the combined vent gas streams.</P>
                <P>3. Use of inert gases and entrainment in affected facility vent gas stream—GPA Midstream explained that midstream operations usually do not employ the use of inert gases such as nitrogen because if a blanket gas is needed, its midstream operations use natural gas as it is readily available and compatible with control devices due to the high NHV. In instances where an inert gas such as nitrogen is used as a blanket gas, this could cause lower NHV of the vent gas stream.</P>
                <P>4. High water content in vent gas streams from storage vessels—Finally, GPA Midstream explained that midstream operations employ the use of storage vessels for storing hydrocarbons and produced water, which typically have NHVs well above the thresholds required by the March 2024 final rule. However, it is possible that some production areas could have higher water content in the vent stream coming from the storage vessels, which would lower the NHV. GPA Midstream notes that in these cases, the high water content would increase the probability that the storage vessel emissions thresholds for applicability would not be exceeded. In any event, GPA Midstream explained that in such scenarios, the NHVs are still above the lower NHV thresholds of the rule.</P>
                <P>GPA Midstream summarized that midstream operators would be aware of the operating scenarios provided and should be allowed to use process knowledge to assess whether the NHV could not meet the requirements of the March 2024 final rule, and thus would require the use of supplemental gas.</P>
                <P>
                    GPA Midstream also provided a new data set 
                    <SU>36</SU>
                    <FTREF/>
                     of sampled data and modeled data from midstream operations, stating that the data indicate that the vent gas streams are well above the NHV requirements of the rule and hence should not require continuous NHV monitoring. GPA Midstream further explained technical difficulties in collecting the data, which are described in section III.B.b of this preamble.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         July 2024 GPA Midstream Letter.
                    </P>
                </FTNT>
                <P>
                    The April 2024 API and AXPC petition referred to an NHV data set 
                    <SU>37</SU>
                    <FTREF/>
                     that they provided to the EPA after publication of the March 2024 final rule which included over 22,000 data points from 18 operators across approximately 4,200 sites. The petitioners stated that this data set showed that more than 99.5 percent of the time NHV values were at least 800 Btu/scf and more than 99.9 percent of the time the NHV value was at least 300 Btu/scf. API and AXPC further stated that the results appeared consistent across five basins, representing 99 percent of the data. While some sources with multiple data points showed variability, the NHV was still well above 800 Btu/scf for those sources. API and AXPC stated that all NHV data ≤ 900 Btu/scf in the survey were from known scenarios where large amounts of inert gas(es) are expected. The petitioners stated that operators know which scenarios or sites have the potential for large amounts of inert gases to reduce the NHV of vent streams below the required minimum; these known scenarios include: (1) Sites in fields using water or CO
                    <E T="52">2</E>
                     flood Enhanced Oil Recovery (EOR), and (2) produced water tanks not co-located with oil tanks in certain dry gas plays.
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         API/AXPC-EPA 03/18/24 Meeting Follow-Up. 
                        <E T="03">Operator Survey: Net Heating Value.</E>
                         API-AXPC Meeting Slide Presentation to the EPA. (Attachment Summarizing NHV Data Included as an Attachment. Excel Sheet Provided of 
                        <E T="03">Analysis of NHV Data Provided by Operators: Supporting Data</E>
                         (Prepared by John Beath Environmental, LLC for API/AXPC).)
                    </P>
                </FTNT>
                <P>
                    The April 2024 API and AXPC petition also included a letter from SPL, which stated it is the largest laboratory in the United States (U.S.) specializing in the analysis of hydrocarbon products, processing more than 225,000 natural gas samples each year. SPL stated that based on its direct experience analyzing thousands of vent gas samples from every major oil and gas producing region of the U.S. annually, it would be exceptionally uncommon for the NHV content of vent gas to fall below the threshold levels established by the March 2024 final rule. SPL explained that vent gases are exceptionally heavy gases (relative to air) that are typically depleted with respect to lighter hydrocarbon molecules such as methane and ethane, and enriched in molecules like propane, butane and pentane. As a result, SPL explained that these heavy gases have a lower vapor pressure (relative to a methane-enriched sales gas, for example) and therefore do not “flash” from the liquid hydrocarbon stream until the final stage of separation. The vendor provided NHV data for methane (909.4 Btu/ft
                    <SU>3</SU>
                    ), propane, n-butane and n-pentane (2,315 Btu/ft
                    <SU>3</SU>
                    , 3,000 Btu/ft
                    <SU>3</SU>
                     and 3,707 Btu/ft
                    <SU>3</SU>
                     respectively).
                    <SU>38</SU>
                    <FTREF/>
                     Therefore, SPL explained that, unless there is a source of inert gas diluting the vent gas stream (sources of inert gas could be added by design, or, due to leaking equipment), there should be no compositional reason the NHV of that gas would be under the threshold set by the EPA.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         See: GPA 2145—“Table of Physical Properties for Hydrocarbons and Other Compounds of Interest to the Natural Gas Industry.”
                    </P>
                </FTNT>
                <HD SOURCE="HD3">b. Technical Infeasibility</HD>
                <P>
                    The April and May 2024 API and AXPC petitions, May 2024 TXOGA 
                    <PRTPAGE P="3744"/>
                    petition, and May 2024 GPA Midstream petitions raised new issues regarding the feasibility of conducting the sampling for the alternative NHV performance test (sampling demonstration), given the intermittent flow to control devices. The petitioners explained that in some cases, flow to the control device may occur for as little as a few minutes, making continuous monitoring or collection of single (or 28) one-hour samples impossible. The May 2024 TXOGA petition also explained that sampling equipment is not designed to operate in low temperatures or with all types of gases.
                </P>
                <P>The April 2024 API and AXPC petition pointed out that while the March 2024 final rule reduced the number of required samples from 240 (as proposed in the December 6, 2022 supplemental rule) to 28, it did not address the feasibility of collecting the samples. API and AXPC also contended that extending the sampling duration from 10 to 14 days added time and costs to an already technically infeasible option. As noted above, these petitioners submitted information from SPL, a laboratory that stated that the minimum one-hour sampling requirement in the alternative performance test (sampling demonstration) option goes against traditional norms for the collection of natural gas grab samples and requires all sampling entities to deploy alternative strategies which are not currently available. SPL explained that typical methods for the collection of natural gas samples call for spot sampling techniques that procure gas on very short (seconds to minutes) timescales, but the one-hour requirement requires composite sampling techniques typically used in custody-transfer applications (and elsewhere) to be adapted to a more rugged and transportable setup. SPL suggested that the EPA allow sample collection methods such as those referenced in GPA 2166-22 instead. SPL also pointed out what it considered to be several issues with the use of Summa canisters for vent gas collection. SPL explained that Summa cannisters were designed primarily for atmospheric gas sampling and that in order to collect 1-hour samples by Summa cannister, restrictive flow metering devices will be required, which rely on a restrictive orifice to meter the gas into the Summa cannister. SPL explained that the potentially wet and dirty nature of flare gas will rapidly foul these devices, resulting in errors in collection and potential contamination bias. Instead, SPL recommended that, for operators and laboratories to meet sample demand in a reasonable manner, single cavity stainless steel constant volume cylinders should be allowed for sample collection so long as they are maintained according to the requirements set forth in 43 CFR 3175 (Onshore Oil and Gas Operations; Federal and Indian Oil and Gas Leases; Measurement of Gas).</P>
                <P>
                    The May 2024 GPA Midstream petition explained that vent gas flow from midstream sources to control devices tended to be sporadic and at low pressure. They stated that intermittent flow was particularly an issue for storage vessels that either have low flows generally or have pressure control valves that only release short bursts of gas to control devices. GPA Midstream stated it is not possible to achieve the necessary flow rate for establishing a temperature limit, continuous monitoring, or one-hour sampling without adding gas pressure. It further explained that storage vessels will frequently be unable to add sweep gas because the necessary headspace is limited; in situations where facilities add gas, those situations will not be representative of normal operating conditions. In the July 2024 GPA Midstream letter, GPA Midstream provided further examples of sample collection issues. In addition to the availability of sampling ports, discussed below, GPA Midstream noted that closed vent systems (CVS) operate under a slight vacuum or close to atmospheric pressure and temperature, which can draw oxygen (O
                    <E T="52">2</E>
                    ) in with the vent stream sample. Also, because vent gas samples are obtained at atmospheric pressures, explained GPA Midstream, running the vent gas samples through the GC upon capture causes issues due to liquids (
                    <E T="03">e.g.,</E>
                     water) condensing during analysis, which often requires repairs to the GC.
                </P>
                <P>
                    The April 2024 API and AXPC petition contended that NHV monitoring is not required in existing State regulations governing upstream flares and combustion emissions control devices and that upstream operators are not currently conducting NHV monitoring for operational or other non-regulatory reasons.
                    <SU>39</SU>
                    <FTREF/>
                     Thus, the petitioners argued that the NHV monitoring at upstream flares and combustion emissions control devices has not been demonstrated to be feasible or cost-effective.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         API and AXPC specifically point to Colorado and New Mexico as examples.
                    </P>
                </FTNT>
                <P>
                    The April 2024 API and AXPC petition also expressed concerns that the Refinery MACT-based NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     requirements for devices which use steam- and air-assist and perimeter-assist air, respectively, are overly burdensome because well sites, central production facilities, and compressor stations are fundamentally different than petroleum refineries. The petitioners explained that the oil and natural gas production sector does not operate at steady state conditions and equipment design must be tailored to the conditions and fluid compositions supplied by the reservoir. They added that hydrocarbon fluids (including oil, condensate, and produced water) and natural gas are located thousands of feet below the surface and must flow to the surface for separation. API and AXPC explained that separation occurs in either a two- or three-phase separator with intermittent pulses of produced water sent from the bottom of the separator to its storage vessel, hydrocarbon liquids from the middle to its storage vessel, and natural gas off the top of the separator to the gathering system. These petitioners further explained that as production declines, management of liquids can mean that flow to the storage vessel can vary from essentially zero to high flow rates and quickly back to zero rapidly and often. According to the petitioners, the same is true for how vapors from the storage vessel will be expected to flow to a control device since emissions occur from flashing and working losses as liquid periodically flows into the storage vessel from the separator. The petitioners explained that this highly variable, non-steady state flow requires equipment to be sized much larger than ideal steady state conditions would dictate and makes flow measurement infeasible. The petitioners also provided that the cost for Refinery MACT controls and monitoring equipment at refineries are $1 million or more, with major ongoing costs. The petitioners explained that these costs will be much greater at upstream facilities without the necessary utilities and instrumentation resources available for a large complex facility such as a refinery and it is unclear whether instrumentation that is available that would work reliably under these varying operating conditions.
                </P>
                <P>
                    The April and May API and AXPC and May 2024 GPA Midstream petitions also raised issues with the alternative test method approval process, stating that alternative test methods are costly to implement (and unlikely to be used by small operators) and take time for agency approval (and which is related to issues regarding compliance timing discussed in section IV.B.2.c of this preamble). The May 2024 GPA 
                    <PRTPAGE P="3745"/>
                    Midstream petition requested that the EPA revise the March 2024 final rule to allow alternative test methods for air and steam-assisted combustion devices, such as Video Imaging Spectro-Radiometry (VISR), as the March 2024 final rule preamble and regulatory text conflict with respect to what is allowable. Specifically, the petitioner cited to 89 FR 16968, which indicates that “an owner or operator could request an alternative test method to use a technology such as VISR that continuously monitors combustion efficiency or a technology such as Simplified VISR that continuously monitors NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                    ,” but noted that the associated monitoring requirements at 40 CFR 60.5417b(d)(8)(iii)(H) appear to not allow alternative test methods to continuously monitor NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                    .
                </P>
                <P>
                    The May 2024 GPA Midstream petition also stated that the EPA should allow for compliance demonstration alternatives. This petitioner explained that design evaluations using process simulation software will be more than sufficient for midstream sources to document that waste streams consistently exceed the EPA's minimum NHV values. The petitioner repeated prior comments to the EPA 
                    <SU>40</SU>
                    <FTREF/>
                    , that owners and operators can perform and document source-specific design evaluations to demonstrate that waste gas streams will consistently exceed the required minimum NHV thresholds in a manner similar to the evaluations used for condensers and carbon absorption units under 40 CFR 60.5413b(c). If the EPA does not allow for compliance demonstration alternatives, the petitioner requested that the EPA allow for alternative sampling locations. In the July 2024 GPA Midstream letter, GPA Midstream explained that prior to NSPS OOOOb, operators were not required to collect NHV data because process knowledge would support the vent stream as having a high NHV. Because of this, CVS were not designed to include sampling ports. In addition to the compliance timing reasons discussed in section IV.B.2.c of this preamble relating to “hot taps,” the petitioner requested that the EPA allow sampling from existing access points, such as thief hatches, which would avoid the compliance timing issues, unnecessary costs, and creation of a new opening that would be another potential source of fugitive emissions. The petitioner also requested that owners or operators be able to draw samples from storage vessel headspace, as there are always vapors present in the vessel headspace and it will be representative of the vent gas routed to the control devices.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         See GPA Midstream Comments on the Supplemental Proposed Rule (February 13, 2023) at 42-43. See Docket ID No. EPA-HQ-OAR-2021-0317.
                    </P>
                </FTNT>
                <P>
                    The May 2024 API and AXPC petition also requested that the EPA require a re-evaluation of the of the vent gas stream NHV only when there are process or equipment changes that could result in a lowering of the NHV and requested that the EPA provide guidance regarding the analytical methods required for NHV sampling. The petitioners noted that the March 2024 final rule requires the use of American Society for Testing and Materials (ASTM) Method D1945-14 for NHV analysis but stated that this method is not widely available for well sites, centralized production facilities, compressor stations, and gas plants since it evaluates components not typically found in vent gas from these operations (
                    <E T="03">e.g.,</E>
                     helium). The petitioners requested that the EPA revise the March 2024 final rule, or at a minimum provide guidance, to allow the use of GPA 2261 and other appropriate alternative methods to measure NHV. In support of this, the petitioner provided information from SPL, which stated that ASTM D1945-14 is not widely available and will require additional time for method development, as well as purchase or modification of equipment.
                </P>
                <HD SOURCE="HD3">c. Compliance Timing</HD>
                <P>In addition to the compliance timing issues discussed above relating to alternative test method approval and test method capability development, the May 2024 GPA Midstream petition raised the issue that the March 2024 final rule does not provide adequate time to conduct the testing after such an approval is granted. The petitioner explained that while 40 CFR 60.5412b(d)(1) through (5) provides requirements for how the alternative test is performed, it provides no period of time by which it should be performed, unlike 40 CFR 60.5413b(b)(5)(i) which specifies that performance testing is required within 180 days after initial startup. The petitioner further notes that unlike continuous monitoring, which can be installed prior to startup of a new source, the alternative testing protocol requires the combustion device to already be operating in order to determine the destruction efficiency and inspect of visible emissions. The petitioner is concerned that the March 2024 final rule can be read so that any period of operation before or during the alternative testing (dating back to December 2022 for modified sources) may be a deviation. The petitioner requests that the EPA allow 30 days after startup to perform alternative testing.</P>
                <P>The May 2024 TXOGA and April 2024 API and AXPC petitions expressed concerns about the availability of sampling vendors that can perform the sampling. The May 2024 TXOGA petitioner also pointed out that finding viable sampling periods cannot be predicted due to the intermittent flow to the devices. The April 2024 API and AXPC petition estimated that a single sampling crew can typically visit no more than two or three sites in a day due to the geographically dispersed nature of upstream operations. This same petitioner provided statements from SPL stating that the number of samples required would be greater than the capacity of labs to collect and process in the 60-day window and that there are not enough gas chromatographs, sample cylinders, and human resources to make compliance within 60 days a possibility.</P>
                <P>
                    The May 2024 GPA Midstream petition raised concerns with the feasibility of meeting compliance timelines for installation of sampling ports. The petitioner stated that the EPA has underestimated the number of sources that would be considered “modified” under the Final Rule, resulting in the need to install monitors and sampling ports on thousands of sources in an impracticably short time.
                    <SU>41</SU>
                    <FTREF/>
                     The petitioner stated that it will take owners and operators several months to procure continuous monitoring equipment and installation will take additional time. The petitioner provided purchase quotations from vendors which indicated that calorimeters would take eight to 12 weeks for delivery and continuous monitoring devices would take up to 26 weeks; installation would require an additional 2 to 3 weeks. Additional concerns expressed by the May 2024 GPA Midstream petition were that installation of monitoring equipment or sampling ports on existing control devices requires specialized “hot tap” work, which they stated cannot be accomplished across the industry prior to the deadline for compliance demonstrations, due to a limited number of qualified contractors and the 
                    <PRTPAGE P="3746"/>
                    need to properly time unit shutdowns for the hot tap work.
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         See GPA Midstream Comments on Supplemental Proposed Rule at 37-38 (need for additional compliance time for storage vessels); 42 (discussing supply chain shortages contributing to long lead times). See Docket ID No. EPA-HQ-OAR-2021-0317.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">d. Other</HD>
                <P>The May 2024 EIP, et. al. petition contended that the EPA did not support the March 2024 final rule conclusion that initial assessments of flares and other control devices, in lieu of continuous monitoring, can capture the variability of NHVs in the oil and gas sector and asserted that no sampling or monitoring at all is needed when only associated gas from wells is sent to control devices.</P>
                <HD SOURCE="HD3">3. Summary of Proposed Changes</HD>
                <P>
                    The EPA is proposing to revise numerous aspects of the NHV monitoring and testing provisions in the March 2024 final rule. The EPA is proposing to expand the streams that are exempt from monitoring due to high NHV content to include unassisted flares or enclosed combustion devices at new sources and to include unassisted, air-assisted, and steam-assisted flares or enclosed combustion devices at existing sources. We are proposing that the NHV monitoring that is currently required should continue to be required for all pressure-assisted, air-assisted, and steam assisted flares or enclosed combustion devices at new sources and for pressure-assisted flares or enclosed combustion devices at existing sources. We are proposing to remove the general exemption from NHV monitoring for associated gas from well site affected facilities for any control device. For flares or enclosed combustion devices that are subject only to a minimum NHV content in the vent gas of 200 Btu/scf or 300 Btu/scf, we are proposing to require NHV monitoring only in cases where inert gases are added, or for other miscellaneous scenarios which decreases the NHV content of the inlet stream gas to the enclosed combustion device or flare. These known operational scenarios include combining AGR system amine regenerator still column vent gas with affected facility vent gas, combining glycol dehydration unit reboiler vent gas with affected facility vent gas streams without water removal, high water content in vent streams from certain storage vessels, and EOR sites in fields using water or CO
                    <E T="52">2</E>
                     flooding. The EPA is proposing recordkeeping and reporting to indicate whether the flare or enclosed combustion device receives inert gases or other streams which may lower the NHV of the combined stream, and if so, a description of the operating scenario(s) which may lower the NHV of the combined stream through the introduction of those inert gases or other streams.
                </P>
                <P>
                    In addition, when an owner or operator opts to meet the NHV compliance demonstration by conducting the alternative performance test via the NHV grab sampling option, the EPA is proposing revisions to clarify that sampling may be conducted on “the inlet gas 
                    <E T="03">which is routed</E>
                     to the enclosed combustion device or flare” [emphasis denotes proposed revision]. The EPA intends that this revised phrasing will clarify that sampling upstream of the inlet to the control device is allowed, provided that the sample is representative of the gas inlet to the control device. For example, sampling may be conducted from a location on the control device piping header, provided the sampling location is downstream of all waste gas inlets into the header. The EPA is proposing to clarify that the NHV of the vent stream shall be determined in Btu/scf, where standard conditions are 20 degrees Celsius (°C), not Btu per pound (Btu/lb). If the composition is determined in weight percent, those concentrations can be used, but they will need to be converted to volume percent (equivalent to mole percent) based on the molecular weight of the constituents. Other changes in this proposal include specifying that the 14-day period for the performance test (sampling demonstration) option shall be consecutive operating days and that for the purposes of determining the hourly average for continuous samples, the average shall be a block hourly average. The EPA is not proposing to amend the sampling frequency (
                    <E T="03">i.e.,</E>
                     2 samples per day for 14 days with an ongoing demonstration of 3 samples every 5 years) for the performance test (sampling demonstration) option for neither NSPS OOOOb nor EG OOOOc. However, the EPA is proposing to allow for breaks for weekends and holidays which may occur during the 14-day sampling period, such that the 14 days do not have to be consecutive. The EPA is also proposing to retain the one-hour minimum sampling time for the twice daily samples, except in cases where low or intermittent flow makes one-hour sampling infeasible. In such a case, the EPA is proposing to allow less than one-hour sampling times and proposing that the sampling time used and the reason for the reduced sampling time must be documented and reported. The EPA is proposing to more clearly allow the use of the sampling methodology alternative to continuous monitoring in 40 CFR 60.5417b(d)(8)(iii) for all types of air and steam assisted flares or enclosed combustion devices. The EPA is proposing these same changes in both NSPS OOOOb and EG OOOOc.
                </P>
                <P>
                    In addition, for NSPS OOOOb, the EPA is proposing to retain the NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     monitoring requirements, but more clearly including the provisions at 40 CFR 60.5417b(d)(8)(vi) to allow the use of approved alternative test methods as provided in 40 CFR 60.5412b(d)(1)(i) and (ii) for continuous monitoring of NHV
                    <E T="52">cz</E>
                     and, if applicable, NHV
                    <E T="52">dil</E>
                    . We are also proposing to more fully delineate in 40 CFR 60.5417b(d)(8)(iv) when flare flow or assist rates are not required to be monitored. On the other hand, for EG OOOOc, the EPA is proposing to remove the requirement to comply with and conduct monitoring for NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     for air- and steam-assisted enclosed combustion devices and flares used for existing sources. This series of proposed revisions in EG OOOOc include changes in the initial compliance requirements for air- or steam-assisted enclosed combustion devices or flares in 40 CFR 60.5412c, the continuous compliance requirements for these control devices in 40 CFR 60.5415c, and the continuous monitoring requirements for these control devices in 40 CFR 60.5417c. We are proposing under EG OOOOc that air- or steam-assisted enclosed combustion devices or flares must meet a minimum NHV in the vent gas of 300 Btu/scf.
                </P>
                <HD SOURCE="HD3">4. Basis for Proposed Changes</HD>
                <HD SOURCE="HD3">a. Proposed Revisions to Inlet Gas Streams Exempt From Monitoring</HD>
                <P>
                    As discussed in section III.B of this preamble, based on new information provided by petitioners regarding NHV characteristics of sample streams, the EPA is proposing changes to the requirements in the March 2024 final rule that would, if finalized, expand the scope of the exclusion for the NHV continuous monitoring requirements and alternative performance test (sampling demonstration) option so that the following control devices would not be required to make any such demonstration: unassisted flares or enclosed combustion devices at a new source and for unassisted, air-assisted, or steam-assisted flares or enclosed combustion devices at existing sources. New data submitted in the April 2024 API and AXPC petition demonstrated that, for over 22,000 NHV data points, 99.5 percent of those data points showed that the NHV was at least 800 Btu/scf and more than 99.9 percent of those data points showed that NHV was at least 300 Btu/scf. Notably, these data were consistent across different 
                    <PRTPAGE P="3747"/>
                    basins.
                    <SU>42</SU>
                    <FTREF/>
                     Data supplied in the July 2024 GPA Midstream letter supported their prior petition submittals that gas streams in the midstream consist of natural gas and field gas with NHV values greater than 1,000 Btu/scf, with the exception of certain streams in which inert gases or other known low-NHV streams were added. Because these new data appear to demonstrate that the NHV of the vent gas is consistently well above the 200 or 300 Btu/scf vent gas requirements for these control devices when inerts are not present, and because there are no combustion zone or dilution parameters for these control devices, the EPA is proposing to determine that an expanded exclusion from the monitoring requirements is appropriate.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         99 percent of the data were from five basins: Permian, Anadarko, Gulf Coast (Eagleford), Williston (Bakken), and Powder River. See March 18, 2024, API/AXPC Slides in Docket ID No. EPA-HQ-OAR-2024-0358.
                    </P>
                </FTNT>
                <P>
                    While we previously excluded monitoring for associated gas from the NHV compliance demonstration requirements, some petitioners have now identified instances where the NHV for associated gas streams could be compromised. Specifically, the use of water or CO
                    <E T="52">2</E>
                     flooding EOR could introduce significant inerts as part of the associated gas produced and thereby lower NHV of the associated gas. We find the information presented by the petitioners compelling and therefore propose to conclude that the March 2024 final rule's exclusion of associated gas from the NHV compliance demonstration requirements is overly broad. Because the definition of associated gas in the March 2024 final rule does specifically exclude these inert gases that may be released with the natural gas during the initial stage of separation after the wellhead, there are cases where associated gas can have high levels of inerts and low NHV. Therefore, we are proposing to remove this exclusion for associated gas in its entirety. The proposed removal of this exclusion would impact pressure-assisted flares and enclosed combustion devices at both new and existing sources and air- and steam-assisted flares and enclosed combustion devices at new sources.
                </P>
                <P>
                    The EPA is not proposing to exclude pressure-assisted flares or enclosed combustion devices from the NHV compliance demonstration requirements. For pressure-assisted flares or enclosed combustion devices, the required minimum NHV of 800 Btu/scf is not significantly higher than the NHV of methane, which is 896 Btu/scf (using standard conditions of 68 °F (20 °C); this value is lower than the value provided by SPL because they used 60 °F as standard conditions). Therefore, sources that contain primarily methane would not require much dilution from inert components (
                    <E T="03">e.g.,</E>
                     nitrogen, CO
                    <E T="52">2</E>
                    , or air) to be below the 800 Btu/scf NHV threshold for pressure-assisted flares or enclosed combustion devices. While the data provided by petitioners indicated that the majority of samples had NHVs above 800 Btu/scf, we find that it is much easier for the NHV in the vent gas samples from these control devices to decrease and approach the 800 Btu/scf NHV threshold and that, therefore, continuous NHV monitoring or an alternative performance test (sampling demonstration) is still warranted for pressure-assisted flares or enclosed combustion devices. Accordingly, we are proposing to retain the requirement that, as currently required in the March 2024 final rule, pressure-assisted flares must either continuously monitor NHV or conduct the 14-day performance test sampling demonstration in order to ensure that the gases sent to those control devices have NHVs well above the regulatory threshold.
                </P>
                <P>
                    For reasons described in section III.B.4.d of this preamble, the EPA is proposing to retain the NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     requirements for air- and steam assisted flares for sources subject to NSPS subpart OOOOb. Because these parameters are not only dependent on the NHV of the vent gas but also on the flow rate of the vent gas and the assist gas, we propose that the NHV demonstration is necessary (when continuous monitoring is not used) to determine a minimum NHV to use in the assessments under 40 CFR 60.5417b(d)(8)(iv) and in the calculation of the NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     parameters in 40 CFR 60.5417b(d)(8)(vi).
                </P>
                <P>
                    As demonstrated by the July 2024 GPA Midstream data set, the addition of inert gases or streams from amine units or produced water tanks can decrease the NHV content of the gas stream to the point that the minimum NHV thresholds for non-pressure-assisted flares or enclosed combustion devices may not be achieved. In addition to sources of inert streams previously identified in the March 2024 final rule (
                    <E T="03">i.e.,</E>
                     streams from compressors in acid gas service and streams from EOR facilities), the July 2024 GPA Midstream letter explained that other operating scenarios can result in the addition of low-Btu value streams into the vent gas stream, which lowers the overall NHV for the vent stream. Therefore, we are proposing to require NHV monitoring for unassisted flares and enclosed combustion devices at new sources and for unassisted, air-assisted, and steam-assisted flares and enclosed combustion devices at existing sources in cases where there are contributions from inerts. In the example cases provided in section III.B. of this preamble, the EPA expects that these operational scenarios can be easily validated through the physical presence (or absence) of process equipment, process piping, engineering analysis, or process flow diagrams in order to determine when the owner or operator should monitor the NHV of the stream. For example, in the case of the AGR system amine regenerator still column vent gas, it would be easy to trace process piping to determine if the vent stream was routed to a dedicated control device or was combined with affected facility vent gas streams. Similarly, for the glycol dehydration unit reboiler vent gas, the lack of a process condenser would indicate that higher water content (and lower Btu) reboiler vent gas streams was combined with affected facility vent gas streams. The use of nitrogen as a blanket gas can be readily determined through the presence of nitrogen storage, supply systems, and process piping. Finally, regarding vent streams from storage tanks with higher water content, the EPA expects that tanks with water content high enough to depress overall NHV values typically would not meet the applicability thresholds of the rule and would not be combined with other vent streams routed to an enclosed combustion device or flare. However, when gas streams from produced water tanks are vented to control, vent lines from these tanks can be traced to identify sources that require monitoring or sampling.
                </P>
                <P>
                    Regarding the concerns raised in the May 2024 EIP, et. al. petition, since we are proposing to remove the general monitoring exemption for when the only inlet gas stream to the enclosed combustion device or flare is associated gas from a well affected facility, we directly resolve one of the issues raised in that petition. We consider the data submitted by the industry petitioners to support the proposed exemption from monitoring for flares and enclosed combustion devices subject to a vent gas NHV requirement of 200 or 300 Btu/scf (and not subject to NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     requirement) when no inerts are present because the results were consistently much higher than these levels. The May 2024 EIP, et. al. petition also contended that the EPA did not support its conclusion in the March 2024 final rule that initial assessments of flares and other control devices, in lieu of continuous monitoring, can capture the 
                    <PRTPAGE P="3748"/>
                    variability of NHV in the oil and gas sector. We consider the data submitted by the industry petitioners also supports that the NHV demonstrations required for pressure-, air-, and steam-assisted control devices would be adequate data to show that the NHV from those demonstrations is well above the limits required by the rule and that continuous monitoring is not needed. When inerts are added intermittently or process operations change that may lower the NHV, the proposed standards require re-demonstration with a new 14-day sampling effort. The new demonstration would consider the variability associated with these operations and determine a reasonable lower-range value to use in the compliance assessments. As such, we propose to find that the sampling requirements, with the revisions proposed, are robust and sufficient for the demonstration and that continuous monitoring is not needed when the demonstration shows the NHV value of the gas stream being controlled is sufficiently high, when considering the range of vent gas and assist gas flow rates, to meet the required standards.
                </P>
                <P>
                    The EPA is also requesting comment on the proposed removal of the associated gas monitoring exemption and the proposed requirement for continuous measurement or sampling requirements for pressure-assisted flares and enclosed combustion devices at new and existing sources and for air- and steam-assisted flares or enclosed combustion devices at new sources. The EPA is requesting comment on whether there are other known process or upset condition scenarios which may introduce inert gases or other low-Btu streams into affected facility vent gas streams, resulting in NHV values which could be below the thresholds in the March 2024 final rule for flares and enclosed combustion devices subject to the vent gas NHV requirements of 200 or 300 Btu/scf and necessitating a determination of the NHV of the combined stream(s). The EPA also is requesting comment on how the EPA can determine (
                    <E T="03">e.g.,</E>
                     the presence or absence of certain process equipment or piping configurations) that these scenarios are present at an affected facility and, therefore, require NHV continuous monitoring or the use of the sampling option to demonstrate that the mixed gas stream has sufficient NHV content to afford proper combustion efficiencies.
                </P>
                <HD SOURCE="HD3">b. Sampling Location and Duration for the Alternative Performance Test</HD>
                <P>
                    The EPA is reconsidering the requirements in the March 2024 final rule regarding the sampling duration for the alternative performance test (sampling demonstration) option for the NHV compliance demonstration, and is proposing to allow for shorter sampling times when it is technically infeasible to collect a grab sample for a minimum of one hour. While the March 2024 final rule included provisions for sampling periods of longer than 14 days (where needed) to collect a total of 28 samples, and the general provisions in 40 CFR 60.8(b)(5) also allow for “shorter sampling times and smaller sample volumes when necessitated by process variables or other factors,” the EPA finds compelling the petitioners' arguments and newly presented supporting information regarding the potential instances of intermittent flow of gas streams, which makes sampling for one hour technically infeasible in those cases (
                    <E T="03">e.g.,</E>
                     intermittent flow from sources with low pressure). As such, the EPA finds it appropriate to propose additional flexibility in the final rule to fully address these intermittent flow situations. Therefore, the EPA is proposing that sampling must be conducted for a minimum of one hour, when technically feasible. When it is not technically feasible to collect the sample for a minimum of one hour, the owner or operator should collect the sample for as long as possible, up to one hour. For samples taken during low or intermittent flow events, the collection time and the reason for not obtaining a full one-hour sample must be documented and reported with the NHV sampling results. We request comment on the actual duration of flow that is achievable in practice for those cases where sampling for one hour is technically infeasible on low pressure and intermittent gas streams, and why a one hour sample would be technically infeasible for those cases.
                </P>
                <P>
                    Regarding the location for sampling, the EPA notes that, according to the March 2024 final rule, the sample must be taken of the inlet gas to the control device, but the gas need not be taken directly at the inlet of the control device. We consider a sample within the control device header system in a location after all vent streams sources have been added to the control device header as an inlet gas sample. While the EPA recognizes petitioners' concerns with installing sampling ports or “taps” on these source types, the March 2024 final rule does not specify a physical location where the sampling must occur. The EPA therefore does not believe it is necessary to specify that sampling may occur at another “representative” location or specify such “representative” locations. The EPA also notes that the General Provisions in 40 CFR part 60 include procedures for alternatives to monitoring, including alternative locations for monitoring, “when the owner or operator can demonstrate that installation at alternate locations will enable accurate and representative measurements” 
                    <SU>43</SU>
                    <FTREF/>
                    —these provisions already address site-specific issues with conducting the alternative performance test (sampling demonstration) option. Accordingly, the EPA is proposing not to change the current provisions in the March 2024 final rule regarding sampling location for the NHV grab sample option.
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         Per 40 CFR 60.5417b(d), requests for approval to monitor different monitoring parameters can be made under the Alternative Monitoring Plan (AMP) provisions in 40 CFR 60.13(i).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">c. Methodologies for Compositional Analysis of the Gas Stream</HD>
                <P>
                    The EPA is reconsidering the requirements in the March 2024 final rule which limited the test method available for determining the compositional analysis of the gas stream to ASTM-D1945-14 (R2019). The EPA recognizes that other rules in which vent gases are analyzed, such as 40 CFR part 63 subpart CC (Refinery MACT) and the Greenhouse Gas Reporting Program (GHGRP) rule allow the use of other test methods. The EPA is soliciting comment to expand the use of similar consensus-based standards (
                    <E T="03">e.g.,</E>
                     GPA 2166 and GPA 2261) to consider if these additional available methods would alleviate petitioners' concerns that ASTM-D1945 is not widely available and that testing laboratories do not have the capacity currently to enable its use.
                </P>
                <P>
                    Regarding the units in which NHV is determined as prescribed in the March 2024 final rule, the EPA does not disallow the use of measurement methods that determine concentrations in terms of weight fractions, but the weight fractions must be converted to volume fractions because the calculations referenced therein from part 63 use Btu/scf (not Btu/lb). Therefore, the EPA is not proposing to change the units in the March 2024 final rule, but rather proposing to clarify that NHV for individual components must be determined in units of Btu/scf consistent with the existing specification using published values of the component NHV per mole at 25 °C and 1 atmosphere and using 20 °C as the standard temperature for determining the volume corresponding to one mole of vent gas. We noted that SPL reported 
                    <PRTPAGE P="3749"/>
                    the NHV of common constituents in vent gas streams at the incorrect temperature. Therefore, we are proposing to clarify that the standard temperature for 40 CFR part 60 (at 40 CFR 60.18(f)(3)) is 20 °C and that the NHV values must be determined at this standard temperature. These clarifications are proposed to ensure the NHV determinations are conducted consistently and accurately. The EPA is requesting comment on the proposed clarifications of the NHV units of measure and calculation procedures.
                </P>
                <P>We are also proposing to clarify that Tedlar bags may be used to satisfy the grab sampling requirements, provided that the Tedlar bag qualifies as an “evacuated container” as prescribed by section 8.2.1.1 of EPA Method 18. We request comment on the need to clarify that Tedlar bags can be used and the limitation proposed on when Tedlar bags can be used.</P>
                <HD SOURCE="HD3">
                    d. NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     for Air- and Steam-Assisted Flares and Enclosed Combustion Devices at Existing and New Sources
                </HD>
                <P>
                    The EPA is proposing to retain the NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     requirements for air- and steam assisted flares for sources subject to NSPS subpart OOOOb because, as noted in the November 2021 Proposal (86 FR 63246; November 15, 2021), the EPA had received some data indicating air-assisted and steam-assisted flares have been found operating outside of the conditions necessary to achieve at least 98 percent control efficiency on a continuous basis. We disagree with petitioners that these NHV-related parameters are not appropriate for assisted flares in the oil and gas industry because we had evidence of poor-performing assisted flares in the oil and gas industry. The EPA therefore proposes to conclude (as in the March 2024 final rule) that sufficient evidence exists demonstrating poor destruction efficiencies due to over-assisting a flare or enclosed combustion device, such that NHV compliance demonstrations are necessary to show that these particular control devices are meeting the requisite efficiency. The EPA requests comment on the proposed retention of the NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     provisions for new sources. The EPA is also requesting comment on whether the NHV
                    <E T="52">dil</E>
                     parameter is appropriate for enclosed combustion devices with perimeter assist air and the appropriate effective diameter to use in the calculation of NHV
                    <E T="52">dil</E>
                    , if it is retained, particularly for devices with multiple burner tips within the enclosed combustion device.
                </P>
                <P>
                    Regarding petitioner GPA's statement that 40 CFR 60.5417b(d)(8)(iii)(H) appears to not allow alternative test methods to continuously monitor NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                    , we note that the provisions at 40 CFR 60.5417b(d)(8)(iii) are specific to the 14-day alternative performance test (sampling demonstration) option and do not apply to continuous monitoring. We did not include provisions for a 14-day demonstration using continuous monitoring of NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     because assist rates could be changed and alter the control device's performance. Continuous monitoring using alternative test methods is expressly provided for in 40 CFR 60.5412b(d) and 60.5415b(f)(1)(xi). Additionally, we propose to clarify in 40 CFR 60.5417b(d)(8)(vi) that continuous monitoring of NHV
                    <E T="52">cz</E>
                     and, if applicable, NHV
                    <E T="52">dil</E>
                     using an approved alternative method as provided under 40 CFR 60.5412b(d)(1)(i) and (ii) is allowed and that, when using this alternative test method, you are not required to monitor NHV of the vent gas as specified in paragraph (d)(8)(ii) of this section or monitor flow rates as specified in paragraph (d)(8)(vi) of this section provided you can demonstrate that the maximum flow rate to the flare cannot cause the flare tip velocity to exceed 18.3 meter/second (60 feet/second). The EPA requests comment on the proposed clarifications when using the alternative test method to demonstrate continuous compliance and requests comment on whether and how such monitoring could be used as part of the 14-day sampling demonstration.
                </P>
                <P>
                    With respect to the monitoring requirements for NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     for air- and steam-assisted flares at new sources, the EPA acknowledges the petitioners' concerns but is not proposing significant changes to this requirement for new sources subject to NSPS subpart OOOOb. However, in reviewing these requirements we note that the requirements in 40 CFR 60.1547b(d)(8)(vi) reference NHV determinations using the lowest NHV result of the sampling demonstration in 40 CFR 60.1547b(d)(8)(iii), but 40 CFR 60.1547b(d)(8)(iii) did not have provisions for steam-assisted nor for certain air-assisted flares or enclosed combustion devices. Therefore, we are proposing to clarify that 40 CFR 60.1547b(d)(8)(iii) can be used for any steam- or air-assisted flare or enclosed combustion device, and that the effective vent gas NHV to allow the use of the demonstration is 300 Btu/scf when using continuous 14-day sampling or 360 Btu/scf when using the 14-day grab sampling approach. This revision in 40 CFR 60.1547b(d)(8)(iii) is necessary considering the calculation provision in 40 CFR 60.1547b(d)(8)(vi) and corrects an unintended error in the March 2024 final rule. The EPA requests comment on the use of the proposed use of the 14-day sampling demonstration in 40 CFR 60.1547b(d)(8)(iii) for air- and steam-assisted flares, particularly those at new sources subject to NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     requirements.
                </P>
                <P>
                    With the alternative sampling provisions being proposed in 40 CFR 60.5417b(d)(8)(iii) and the assessments outlined in 40 CFR 60.5417b(d)(8)(iv), we expect few facilities will have to install continuous monitoring systems. Since monitoring is necessary to ensure proper operation of these flares at new sources, and considering the monitoring options provided by the proposed revisions will afford sources additional flexibility when compared to the March 2024 final rule, we are retaining the NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     requirements in NSPS subpart OOOOb.
                </P>
                <P>
                    A provision to conduct monitoring for NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     at existing sources was included in the March 2024 final rule subpart OOOOc model rule in error. The EPA did not conduct Refinery MACT cost level monitoring for existing sources, and stated in the preamble to the March 2024 final rule that monitoring of NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     was not recommended as part of the Emission Guidelines for existing sources due to concerns about retrofitting existing flares to meet the requirements.
                    <SU>44</SU>
                    <FTREF/>
                     The EPA is proposing to correct this inadvertent error by removing the language in the model rule to conduct monitoring of NHV
                    <E T="52">cz</E>
                     and NHV
                    <E T="52">dil</E>
                     at existing sources and specifying the model rule for these control systems is an NHV of 300 Btu/scf in the vent gas. The EPA is requesting comment on the appropriateness of using an NHV of 300 Btu/scf in the vent gas for air- and steam-assisted flares or enclosed combustion devices at existing sources for demonstrating compliance with the combustion efficiency requirements for these control devices.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         See 89 FR 16895 and 16967.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">e. Miscellaneous Other Changes</HD>
                <P>
                    In addition to the proposed changes described above, the EPA is proposing to clarify that for the purposes of determining the hourly average of the NHV for continuously sampled (
                    <E T="03">i.e.,</E>
                     sampled continuously for 14 consecutive days) inlet streams, the hourly average shall be determined on a block (and not a rolling) average. The 
                    <PRTPAGE P="3750"/>
                    EPA is proposing this clarifying edit to ensure that all owners and operators are using the same averaging timeframe and it is not left up to interpretation as to whether the average should be a block average or a rolling average. Block averages are required for other averaging time periods in the March 2024 final rule and we consider this change to be warranted for consistency and clarity. The EPA also is proposing to clarify that the 14-day period for the continuous monitoring option shall be consecutive operating days. However, for manual grab sampling, the EPA is proposing to allow for breaks for weekends and holidays which may occur during the 14-day representative grab sampling period, such that these do not have to be consecutive. Consecutive operating days are reasonable for continuous monitoring because these systems are present continuously. However, manual grab sample collection requires someone to be present at the site to collect samples each day, which, if required to be done on consecutive days, would require collection on weekends and potentially on holidays. The final requirements of the March 2024 final rule already allows for sampling beyond the 14 days if 28 samples cannot be collected during that time frame. Allowing additional flexibility for non-consecutive operating day sampling can lengthen the time needed to collect samples and delay the conclusion of the NHV determination, but it does not reduce the number of samples required nor the representativeness of those samples. As such, we consider it reasonable to provide some flexibility in the grab sampling approach to allow twice daily sampling to determine the average NHV of the gas stream for 14 operating days, with no sampling day to be spaced more than 3 operating days apart from the previous sampling day. Finally, the EPA is proposing to allow 60 days for conducting the continuous NHV monitoring required by one of the options in 40 CFR 60.5417b(d)(8)(ii)(A) through (D) if the results of the periodic (3 samples every 5 years) sampling indicate that the NHV is less than 1.2 times the applicable threshold NHV level in the rule. The EPA considers it necessary to specify a timeframe to install and operate the required continuous monitors to provide owners and operators with regulatory certainty for when this must occur. We consider 60 days to be an expedited time schedule for the installation of continuous monitoring systems, but we consider it a reasonable timeframe for installing necessary grab sampling systems to automatically collect samples at least once every 8 hours as provided in 40 CFR 60.5417b(d)(8)(ii)(D). Facilities would be required to collect grab samples every 8 hours until such time a continuous monitor can be installed, and installation of such a system requires more than 60 days. We request comment on the proposed 60-day compliance provision when a 5-year sampling event indicates the vent stream is not sufficiently above the required NHV.
                </P>
                <P>
                    The EPA also is proposing a similar change to address compliance timing pending the re-evaluation that must occur after a process change that potentially reduces the NHV of the gas sent to an enclosed combustion device or flare. For the same reasons as stated above (
                    <E T="03">i.e.,</E>
                     for continuous monitoring which must occur after the results of periodic monitoring indicate the vent stream is not sufficiently above the required NHV), the EPA is proposing that continuous monitoring should commence within 60 days after the re-evaluation indicates that the inlet gas stream does not meet the limits. The EPA also is proposing to clarify, for both periodic testing and re-evaluations which occur after a process change, that if the results of the grab sampling indicate that the vent stream is not sufficiently above the required NHV, continuous monitoring using a calorimeter, GC, MS, or continuous grab sampling (
                    <E T="03">i.e.,</E>
                     once every 8 hours) sampling must commence within the specified timeframe.
                </P>
                <P>
                    Finally, the EPA is proposing revisions to the provisions in 40 CFR 60.1547b(d)(8)(v), which include one-time assessments to be used in lieu of installing vent gas flow monitors and, in the case of assisted flares, assist gas flow monitors if certain provisions are met. While we finalized provisions to unassisted flares to conduct an initial determination to ensure the flare tip velocity is not exceeded under worst-case flow provisions, this requirement was not included in the March 2024 final rule for air-assisted flares, even though the velocity limits apply. Therefore, we are proposing to add this maximum velocity assessment to the existing provisions in 40 CFR 60.1547b(d)(8)(v)(D) and (E) for air-assisted flares. This provision is not applicable to enclosed combustion devices. In reviewing these provisions, we also noted that there was no corresponding provision for steam-assisted flares or enclosed combustion devices. This was an oversight in the March 2024 final rule and we are proposing new provisions at 40 CFR 60.1547b(d)(8)(v)(F) similar to those for air-assisted devices that are specific to steam-assisted flares or enclosed combustion devices. These revisions are not needed in NSPS subpart OOOOc because these provisions are specific to evaluations for flares complying with an NHV
                    <E T="52">cz</E>
                     or NHV
                    <E T="52">dil</E>
                     parameter. The EPA requests comment on these proposed provisions to ensure compliance with the velocity operating limit and whether, for those devices that have conducted NHV demonstrations, the velocity limit used in the assessment should be based on the allowable velocity at the lowest NHV result from the demonstration rather than being based on the default of 18.3 meters/second (60 feet/second).
                </P>
                <HD SOURCE="HD1">IV. How do these proposed amendments impact the implementation of EG OOOOc?</HD>
                <P>The EPA's proposed amendments discussed in section III (Summary and Rationale of Proposed Amendments to NSPS OOOOb and EG OOOOc) of this preamble in response to several petitions for reconsideration of aspects of the 2024 NSPS and EG final rule would not significantly impact the implementation of EG OOOOc or the State planning process. Based on the EPA's reconsideration, the EPA is proposing amendments that revise two narrow aspects of the EG's model rule: (1) The associated gas temporary flaring provisions for certain situations and (2) the NHV value continuous monitoring and alternative performance test (sampling demonstration) provisions for certain combustion control devices. The proposed amendments do not alter in any way the EPA's identified best system of emission reduction (BSER) in the EG, the EPA's identified degree of emissions limitation achievable via application of that BSER, the timeline for State plan submittal, or compliance timelines finalized under EG OOOOc. Any changes that a State or Tribe may make to their plan as a result of this proposed action will be minor such that the State or Tribe should be able to make such changes before their plans are required to be submitted for approval.</P>
                <P>
                    As indicated in section I.A (Does this action apply to me?) of this preamble, the issuance of the CAA section 111(d) final EG does not impose binding requirements directly on existing sources. The EG (codified in 40 CFR part 60, subpart OOOOc) applies to States in the development, submittal, and implementation of State plans to establish performance standards to reduce emissions of GHGs from designated facilities that are existing sources on or before December 6, 2022. Further, under the TAR, eligible Tribes 
                    <PRTPAGE P="3751"/>
                    may seek approval to implement a plan under CAA section 111(d) in a manner similar to a State, and Tribes are authorized under the TAR to develop and implement their own air quality programs, or portions thereof, under the CAA.
                </P>
                <HD SOURCE="HD1">V. Summary of Cost, Environmental, and Economic Impacts</HD>
                <P>
                    The proposed NSPS OOOOb and EG OOOOc discrete compliance requirement revisions included in this action and discussed in section III (Summary and Rationale of Proposed Amendments to NSPS OOOOb and EG OOOOc) of this preamble do not alter the substantive requirements of the final rule. The economic impacts and a qualitative discussion of the environmental impacts are presented in the memorandum titled 
                    <E T="03">Economic Impact Analysis for 2024 NSPS &amp; EG Reconsideration.</E>
                     There are no other quantifiable environmental (
                    <E T="03">e.g.,</E>
                     air quality, water, waste), energy, or benefits beyond those already presented in accompanying Regulatory Impact Analysis (RIA) for the March 8, 2024, 
                    <E T="03">Standards of Performance for New, Reconstructed, and Modified Sources and Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate Review</E>
                     final rule (89 FR 16820). As such, a new environmental justice (EJ) analysis was not conducted for this action.
                </P>
                <HD SOURCE="HD1">VI. Statutory and Executive Order Reviews</HD>
                <P>
                    Additional information about these statutes and Executive orders can be found at 
                    <E T="03">https://www.epa.gov/laws-regulations/laws-and-executive-orders.</E>
                </P>
                <HD SOURCE="HD2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review</HD>
                <P>
                    This action is a “significant regulatory action” as defined in Executive Order 12866, as amended by Executive Order 14094. Accordingly, the EPA submitted this action to the Office of Management and Budget (OMB) for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket for this action (see memorandum titled 
                    <E T="03">Economic Impact Analysis for 2024 NSPS &amp; EG Reconsideration</E>
                    ).
                </P>
                <HD SOURCE="HD2">B. Paperwork Reduction Act (PRA)</HD>
                <P>The information collection activities for NSPS OOOOb and EG OOOOc were previously approved by OMB under the PRA as of June 28, 2024.</P>
                <P>The EPA has revised the approved information collection request (ICR) to include small changes to incorporate EPA's proposed recordkeeping and reporting to indicate whether the flare or enclosed combustion device receives inert gases or other streams which may lower the NHV of the combined stream as proposed in section III.B of this preamble. The EPA estimates an average of 48 respondents will be affected by this proposed requirement over the three-year period (2023-2025). The average annual burden for the recordkeeping and reporting requirements for these owners and operators is estimated at 83 person-hours, with an average annual cost of $4,374 over the three-year period.</P>
                <P>The EPA also revised the approved ICR to include burden estimates for the maintenance of records that EPA is soliciting comment on. Specifically, the EPA includes burden estimates in the revised ICR for the records and annual reporting that would be required if EPA were to allow for the use of the associated gas extended flaring allowance under “exigent circumstances” as specified in section III.A of this preamble. The incremental increase in burden that would be associated with these recordkeeping and reporting requirements relative to the baseline is estimated at 2 hours per event annually over the three-year period (2024-2026) at an average annual cost of $120 per flaring event over the three-year period. The occurrence of flaring that could potentially be claimed due to “exigent circumstances” is unknown. However, we expect that a maximum of 16 percent of flaring events could potentially require an owner or operator to need to extend flaring beyond 48 hours due to “exigent circumstances”. The burden associated with the two proposed reconsideration items under this action minimally affect the ICR burden estimated for compliance with EG OOOOc. The annual burden for this proposed additional collection of information for the States would be less than 1 percent.</P>
                <P>The approved ICR document that the EPA prepared was assigned OMB Control No. 2060-0721 and EPA ICR No. 2523.07. You can find a copy of the previously submitted ICR in Docket EPA-HQ-OAR-2021-0317. The revised ICR document that the EPA prepared for this reconsideration proposal has been assigned OMB Control No. 2060-0721 and EPA ICR No. 2523.08. You can find a copy of the revised ICR in Docket EPA-HQ-OAR-2024-0358.</P>
                <HD SOURCE="HD2">C. Regulatory Flexibility Act (RFA)</HD>
                <P>
                    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the Agency is certifying that this rule will not have a significant economic impact on a substantial number of small entities because the rule has reduced net regulatory burden on the small entities subject to the rule. This action addresses two discrete compliance requirement aspects of NSPS OOOOb and the model rules within EG OOOOc based on petitions for reconsideration received on the March 2024 final rule requirements, providing additional flexibilities to entities subject to the NSPS requirements and to the model rules within EG OOOOc. We have therefore concluded that this action will have reduced net regulatory burden for all directly regulated small entities. For further details, see the document, 
                    <E T="03">Economic Impact Analysis for 2024 NSPS &amp; EG Reconsideration,</E>
                     in the docket.
                </P>
                <HD SOURCE="HD2">D. Unfunded Mandates Reform Act (UMRA)</HD>
                <P>This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any State, local or Tribal governments or the private sector. This action addresses two discrete compliance requirement aspects of NSPS OOOOb and the model rules within EG OOOOc based on petitions for reconsideration received on the March 2024 final rule requirements.</P>
                <HD SOURCE="HD2">E. Executive Order 13132: Federalism</HD>
                <P>
                    This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. However, the EPA recognizes that States will have a substantial interest in this action and any future revisions to associated requirements. This action addresses two discrete compliance requirement aspects of NSPS OOOOb and the model rules within EG OOOOc based on petitions for reconsideration received on the March 2024 final rule requirements.
                    <PRTPAGE P="3752"/>
                </P>
                <HD SOURCE="HD2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</HD>
                <P>This action does not have Tribal implications as specified in Executive Order 13175. This action addresses two discrete compliance requirement aspects of NSPS OOOOb and the model rules within EG OOOOc based on petitions for reconsideration received on the March 2024 final rule requirements. Thus, Executive Order 13175 does not apply to this action.</P>
                <HD SOURCE="HD2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</HD>
                <P>The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. The EPA believes that it is not practicable to assess whether an environmental health risk or safety risk affecting children may exist prior to this action. This action addresses two discrete compliance requirement aspects of NSPS OOOOb and the model rules within EG OOOOc based on petitions for reconsideration received on the March 2024 final rule requirements and does not result in any changes to the BSER of NSPS OOOOb or EG OOOOc. The EPA believes that the EPA's Policy on Children's Health also does not apply.</P>
                <HD SOURCE="HD2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</HD>
                <P>This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. Further, we have concluded that this action is not likely to have any adverse energy effects because this action addresses two discrete compliance requirement aspects of NSPS OOOOb and the model rules within EG OOOOc based on petitions for reconsideration received on the March 2024 final rule requirements and does not result in any changes to the BSER of NSPS OOOOb or EG OOOOc.</P>
                <HD SOURCE="HD2">I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR Part 51</HD>
                <P>This action does not involve any new technical standards. Therefore, the NTTAA does not apply.</P>
                <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All</HD>
                <P>
                    The EPA believes that it is not practicable to assess whether the human health or environmental conditions that exist prior to this action result in disproportionate and adverse effects on communities with EJ concerns. This action addresses two discrete compliance requirement aspects of NSPS OOOOb and the model rules within EG OOOOc based on petitions for reconsideration received on the March 2024 final rule requirements and does not result in any changes to the BSER of NSPS OOOOb or EG OOOOc. The EPA lacks specific and representative data on the frequency of temporary or emergency flaring, the number of sources flaring, or the length of time temporary flaring occurs. This data limitation prevents the EPA from estimating the impacts of an extension of allowed flaring. The March 2024 final rule describes how the rule will result in reductions in VOCs, which are an important precursor contributing to ground-level ozone formation in many regions of the country and reduce methane pollution that contributes to climate change, which itself has substantial and adverse impacts on EJ communities.
                    <SU>45</SU>
                    <FTREF/>
                     The information supporting this Executive Order review is contained in the docket for this action (see memorandum titled 
                    <E T="03">Economic Impact Analysis for 2024 NSPS &amp; EG Reconsideration</E>
                    ).
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         89 FR 17031.
                    </P>
                </FTNT>
                <SIG>
                    <NAME>Michael S. Regan,</NAME>
                    <TITLE>Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31227 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Administration for Children and Families</SUBAGY>
                <CFR>45 CFR Parts 301, 302, 303, 304, 305, 307, 308, 309, and 310</CFR>
                <RIN>RIN 0970-AC96</RIN>
                <SUBJECT>Parentage Establishment in the Child Support Services Program; Withdrawal</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Administration for Children and Families (ACF), HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule; withdrawal.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document withdraws a proposed rule that was published in the 
                        <E T="04">Federal Register</E>
                         on September 26, 2023. The proposed rule would have amended the Child Support Services Program to be inclusive of all family structures served by the child support services program.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Administration for Children and Families is withdrawing the proposed rule published September 26, 2023 (88 FR 65928) as of January 15, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kimberly Curtis, Division of Policy and Training, OCSS, telephone (202) 690-6614. Email inquiries to 
                        <E T="03">ocss.dpt@acf.hhs.gov.</E>
                         Telecommunications Relay users may dial 711 first.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Administration for Children and Families (ACF) published a notice of proposed rulemaking (NPRM) related to the administration of the Child Support Services Program in the 
                    <E T="04">Federal Register</E>
                     on September 26, 2023 (88 FR 65928). The Notice of Proposed Rulemaking (NPRM) proposed to define “parentage” to mean the establishment of the legal parent-child relationship in accordance with the laws and procedures of the state or tribe. The NPRM also proposed to replace the gender-specific term “paternity” with the gender-neutral term “parentage” throughout Title 45 Chapter III of the Code of Federal Regulations, to be inclusive of all family structures served by the child support program. These proposed changes to Chapter III of the child support regulations recognized developments in state law regarding parentage establishment, including state laws allowing for establishment of parentage for children with same-sex parents. The proposed rulemaking provided states and tribes the option to expand their parentage establishment laws and procedures to include establishment of parentage for children of same-sex parents, and it reinforced that such services are eligible for Title IV-D matching funds.
                </P>
                <P>
                    ACF does not intend to publish a final rule following the publication of this NPRM on September 26, 2023. In making this decision, we considered the complexity of the issues raised by some of the comments received and determined that, if the Department were to proceed with rulemaking on this topic, we would benefit from additional input from stakeholders to assure that assistance in obtaining support would be available under Title IV-D to all children for whom such assistance is requested, regardless of their family structure. Moreover, with the time 
                    <PRTPAGE P="3753"/>
                    remaining in this Administration, the Department is focused on several critical child support priorities, including the recently passed H.R. 9076 Supporting America's Children and Families Act, the recently published Final Rule on Employment and Training Services, recently issued sub-regulatory guidance on Systems Modernization, and other sub-regulatory guidance documents. The Department's reasons for withdrawing this NPRM are independently sufficient.
                </P>
                <P>Importantly, the Department continues to believe that the NPRM is authorized by the Secretary's longstanding and existing authority under the Act, as explained in the NPRM.</P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Xavier Becerra,</NAME>
                    <TITLE>Secretary, Department of Health and Human Services.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00638 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4184-41-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF DEFENSE</AGENCY>
                <AGENCY TYPE="O">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <AGENCY TYPE="O">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <CFR>48 CFR Parts 1, 7, 12, 16, 19, and 52</CFR>
                <DEPDOC>[FAR Case 2023-011, Docket No. FAR-2023-0011, Sequence No. 1]</DEPDOC>
                <RIN>RIN 9000-AO59</RIN>
                <SUBJECT>Federal Acquisition Regulation: Small Business Participation on Certain Multiple-Award Contracts</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to issue policy on small business participation on certain multiple-award contracts.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested parties should submit written comments to the Regulatory Secretariat Division at the address shown below on or before March 17, 2025, to be considered in the formation of the final rule.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit comments in response to FAR Case 2023-011 to the Federal eRulemaking portal at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for “FAR Case 2023-011”. Select the link “Comment Now” that corresponds with “FAR Case 2023-011”. Follow the instructions provided on the “Comment Now” screen. Please include your name, company name (if any), and “FAR Case 2023-011” on your attached document. If your comment cannot be submitted using 
                        <E T="03">https://www.regulations.gov,</E>
                         call or email the points of contact in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section of this document for alternate instructions.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         Please submit comments only and cite “FAR Case 2023-011” in all correspondence related to this case. Comments received generally will be posted without change to 
                        <E T="03">https://www.regulations.gov,</E>
                         including any personal and/or business confidential information provided. Public comments may be submitted as an individual, as an organization, or anonymously (see frequently asked questions at 
                        <E T="03">https://www.regulations.gov/faq</E>
                        ). To confirm receipt of your comment(s), please check 
                        <E T="03">https://www.regulations.gov,</E>
                         approximately two to three days after submission to verify posting.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For clarification of content, contact Ms. Carrie Moore, Procurement Analyst, at 571-300-5917 or by email at 
                        <E T="03">carrie.moore@gsa.gov.</E>
                         For information pertaining to status, publication schedules, or alternate instructions for submitting comments if 
                        <E T="03">https://www.regulations.gov</E>
                         cannot be used, contact the Regulatory Secretariat Division at 202-501-4755 or 
                        <E T="03">GSARegSec@gsa.gov.</E>
                         Please cite FAR Case 2023-011.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>DoD, GSA, and NASA are proposing to revise the FAR to issue policy to update market research, acquisition planning, small business specialist coordination, and the use of set-asides during the award of, and placement of orders against, certain multiple-award contracts. This proposed rule implements recommendations of the Office of Federal Procurement Policy (OFPP) in its memorandum entitled, Increasing Small Business Participation on Multiple Award Contracts, dated January 25, 2024.</P>
                <P>This policy would expand the use of small business set-asides for orders against multiple-award contracts; increase coordination with the cognizant small business specialist and the Small Business Administration (SBA) procurement center representative (PCR) during acquisition planning for multiple-award contracts and when placing orders against multiple-award contracts, and provide additional criteria to consider or address in documentation provided to the cognizant small business specialist and PCR. This proposed rule is being published in conjunction with an SBA proposed rule regarding, “Assuring a Fair Proportion of Government Purchases are Awarded to Small Business Concerns,” to help the public and the acquisition workforce better understand how the two rules will implement the policy. This proposed rule would impact both acquisition planning and order placement, as discussed below.</P>
                <HD SOURCE="HD2">A. Acquisition Planning</HD>
                <P>To increase small business opportunities when developing acquisition strategies for multiple-award contracts, this proposed rule would increase and enhance small business documentation requirements and facilitate greater coordination and communication between agencies and their cognizant small business specialists during the acquisition planning process. Currently, agencies coordinate acquisitions with their respective Office of Small and Disadvantaged Business Utilization (OSDBU), or the Office of Small Business Programs (OSBP), for recommendations as to whether the acquisition should be set aside or reserved for small business concerns, in accordance with agency procedures. This proposed rule is intended to increase OSDBU and OSBP insight into acquisition planning for multiple-award contracts by requiring agencies, when contemplating the issuance of such a contract, to consider totally or partially setting aside the acquisition for small business or including a small business reserve. If a set-aside or reserve for small business is not planned, the agency would be required to document the reason, including any pertinent market research, for this decision in its acquisition strategy or plan, and coordinate the reason with the agency's cognizant small business specialist. (See FAR 7.105(b)(1)(iii)(A)).</P>
                <P>
                    In addition, when an acquisition is anticipated to meet or exceed the dollar threshold for substantial bundling at FAR 7.107-4(a)(1), the acquisition planner is currently required at FAR 7.104(d) to coordinate the acquisition with the agency's cognizant small business specialist. This coordination provides the specialist with insight into any decision to not set aside the acquisition for small business concerns, as well as an opportunity to ensure the acquisition is structured to maximize small business competition and award opportunities. This proposed rule would incorporate a higher level of 
                    <PRTPAGE P="3754"/>
                    coordination into the current process by requiring the agency's cognizant small business specialist to notify the PCR, if the acquisition plan involves a multiple-award contract that meets or exceeds the agency's respective threshold for substantial bundling and the number of small business contract awardees is anticipated to be less than 30 percent of all contract awardees. This higher-level coordination is proposed to reinforce careful consideration of small business equities on multiple-award contracts and increase the probability of participation by small business.
                </P>
                <P>
                    Finally, this proposed rule would also require agencies to consider the use of on-ramps when planning for the award of a long-term, multiple-award contract. On-ramps are a tool used with multiple-award contracts to permit large and small businesses to be added as awardees during the period of performance of the contract. To encourage the continued participation of small business concerns on long-term (
                    <E T="03">i.e.,</E>
                     more than five years in duration, including options, see 19.301-2(a)) multiple-award contracts, this proposed rule would require acquisition planners to discuss the use of on-ramps for these contracts in the acquisition plan. (See 7.105 (b)(1)(iii)(B)). If no on-ramps are planned for the contract but small businesses are expected to enter the market after the award of the contract, and the work anticipated under the contract is sufficient to provide meaningful opportunities for additional contract awardees, the planner would be required to explain in the acquisition plan why on-ramps will not be included in the contract.
                </P>
                <HD SOURCE="HD2">B. Orders Against Multiple-Award Contracts</HD>
                <P>In accordance with 15 U.S.C. 644(r), contracting officers have the discretion to decide whether to set aside an order against a multiple-award contract. To increase small business opportunities and maximize their participation under multiple-award contracts, this proposed rule would require contracting officers to exercise their discretion to set aside an order for small business if the contracting officer determines that, under an applicable multiple-award contract, there is a reasonable expectation of obtaining offers from two or more responsible small business contract awardees that are competitive in terms of fair market price, quality, capability, ability to comply with the delivery or performance schedule, and past performance. (See FAR 16.505(b)(1)(i)(C).) This set-aside requirement for the contracting officer to exercise their discretion would not apply to orders against the Federal Supply Schedule (FSS), or when an exception to fair opportunity or an agency-specific exception applies to the order (See FAR 16.505(a)(14)).</P>
                <P>
                    This proposed rule would permit agencies to establish procedures for contracting officers to exercise agency-specific exceptions. However, agencies must coordinate their procedures for granting those exceptions with their OSDBU or OSBP, as well as SBA, and make the procedures publicly available. The establishment of these procedures and their coordination with SBA and the agency OSDU or OSBP is not a requirement for their review and approval, as approval remains entirely within the discretion of the agency establishing the procedures. This proposed rule would also clarify that the set-aside requirement applies to existing contracts only to the extent that doing so is consistent with the ordering procedures of the contract and there is adequate time remaining on the contract to permit a small business concern to fully perform or deliver under the contract (See FAR 16.505(b)(1)(i)(C)(
                    <E T="03">2</E>
                    )).
                </P>
                <P>If an order is not set aside when there is a reasonable expectation of obtaining competitive offers from two or more responsible small business contract awardees under the multiple-award contract, the contracting officer would be required to document the reason for that decision and coordinate it with the agency's cognizant small business specialist. This proposed rule would require the small business specialist to coordinate the decision with the PCR when the order exceeds a dollar value threshold negotiated between SBA and the agency.</P>
                <P>
                    Alternatively, when an order is to be placed against a multiple-award contract with only one or no small business contract awardees, this proposed rule at FAR 16.505(a)(13) would require contracting officers to document the reason for choosing the contract, coordinate it with the agency's cognizant small business specialist, and provide the specialist with a reasonable opportunity to respond. This would not be a requirement for approval from the cognizant small business specialist. The documentation would need to discuss the following: how the market research of small business contract awardees, including small businesses that are not contract awardees, on the multiple-award contract against which the order will be placed, and how mission needs informed the agency's reason for selecting the multiple-award contract to fulfill its needs; and the market research the agency conducted within the past 18 months to support the decision, which may include the market research supporting the strategy to establish a multiple-award contract or deciding to use another agency's multiple-award contract on a repetitive basis. This documentation and coordination requirement will would not apply when placing an order against the FSS, an exception to fair opportunity applies, or to repetitive orders, including orders placed using automated procedures, issued by that agency (
                    <E T="03">i.e.,</E>
                     when an order was issued by that agency under the same contract and that order was documented in accordance with FAR 16.505(a)(13) and coordinated within the prior 18 months).
                </P>
                <HD SOURCE="HD1">II. Discussion and Analysis</HD>
                <P>The proposed changes to the FAR and the rationale are summarized as follows:</P>
                <P>• Revise part 1 to emphasize that the small business community is part of the acquisition team;</P>
                <P>• Revise part 7 to: require agencies to document and coordinate the decision to not include a set-aside or reserve for small business when planning for the award of multiple-award contract; identify the agency cognizant small business specialist's responsibility for coordination when reviewing acquisition plans or strategies for certain multiple-award contracts; and specify the additional considerations the agency acquisition planner must make and document in an acquisition plan or strategy when contemplating the award of a long-term, multiple-award contract.</P>
                <P>• Revise part 12 to focus text that refers to the contracting officer's discretion to set aside orders.</P>
                <P>• Revise part 16 to: require contracting officers to use their discretionary authority to set aside orders against certain multiple-award contracts and to incorporate set-asides in the ordering procedures of any new multiple-award contracts; specify the criteria to be considered when making a set-aside determination and when the set-aside requirement may not apply; identify the documentation and coordination requirements when the order is not set aside, and when placing an order against certain multiple-award contracts that have only one or no small business contract awardees; discuss how the set-aside requirement will apply to existing contracts; and remove the contracting officer's discretion to set aside an order from the list of exceptions to fair opportunity.</P>
                <P>
                    • Revise part 19 to: reiterate the requirement to set aside orders for small business contract awardees against certain multiple-award contracts; remove the discretionary authority for set-asides from the list of exclusions to 
                    <PRTPAGE P="3755"/>
                    fair opportunity; clarify that the contracting officer may provide the PCR with a proposed acquisition package more than 30 days in advance of the solicitation, upon agreement between the PCR and the agency; and revise the prescriptions for applicable clauses to ensure proper incorporation into contracts as a result of this rule.
                </P>
                <HD SOURCE="HD1">III. Applicability to Contracts at or Below the Simplified Acquisition Threshold (SAT) and for Commercial Products (Including Commercially Available Off-the-Shelf (COTS) Items) or for Commercial Services</HD>
                <P>This rule proposes to amend the prescriptions at FAR 19.507(c), 19.507(e)(1), 19.507(h)(1), 19.1309(a), 19.1408(a), and 19.1508(a) and (b). This rule also proposes to amend the following clauses: 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services; 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award; 52.219-6, Notice of Total Small Business Set-Aside; 52.219-14, Limitations on Subcontracting; 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program; 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns; 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program; and 52.219-33, Nonmanufacturer Rule.</P>
                <P>However, this rule would not impose any new requirements on contracts at or below the SAT, for commercial products (including COTS items), or for commercial services. The clauses would continue to apply to acquisitions at or below the SAT, acquisitions for commercial products (including COTS items), and commercial services.</P>
                <HD SOURCE="HD1">IV. Expected Impact of the Rule</HD>
                <P>This proposed rule supports Governmentwide efforts to leverage the small business growth occurring in the nation's supply chains that support agency missions, reverse the decline of small business participation in the Federal supplier base, and increase contracting opportunities for small business concerns. In its January 25, 2024 memo, OFPP identified several actions to strengthen small business participation on multiple-award contracts, including: earlier involvement of SBA PCRs and the agency small business specialists in the development of multiple-award contracts; express consideration during acquisition planning of on-ramps and the relative proportion of anticipated small business contract awardees on multiple-award contracts; and new requirements for order set-asides against multiple-award contracts.</P>
                <HD SOURCE="HD2">A. Benefits</HD>
                <P>Competitive small businesses that can participate on multiple-award contracts may find it easier to compete for work under the reduced administrative burden and simpler evaluation procedures used to support order competitions rather than pursuing competitions on the open market. Additionally, this proposed rule may result in an increased number of multiple-award contracts being set aside exclusively for small business concerns, and since small business concerns often grow to become large businesses, this rule may result in an increase in competition in unrestricted multiple-award contracts and further build the economic strength of the country.</P>
                <HD SOURCE="HD2">B. Estimated Costs</HD>
                <HD SOURCE="HD3">1. Public Costs</HD>
                <P>This rule affects the internal operating procedures of the Government when performing acquisition planning. This rule does not directly impose any burden on the public. This proposed rule may result in a greater percentage of orders being awarded to small business contract awardees under certain multiple-award contracts. The costs and benefits of this rule have not been realized yet; therefore, there is no data with which to quantify these impacts. Instead, this proposed rule has the potential to impact existing and future contract awardees under certain multiple-award contracts, depending on several factors, including the following: the primary industry of the entity; the Government's future needs for supplies and services; the entity's submission of proposals and offers for multiple-award contracts and the orders to be placed under those contracts; and agency budget.</P>
                <HD SOURCE="HD3">2. Government Costs</HD>
                <P>The total estimated Government costs associated with this FAR proposed rule, if finalized, in millions, over a ten-year period, are as follows:</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s50,12,10">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Government cost</CHED>
                        <CHED H="1">Undiscounted</CHED>
                        <CHED H="1">2 Percent</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Present Value</ENT>
                        <ENT>$117</ENT>
                        <ENT>$105</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Annualized</ENT>
                        <ENT>11.7</ENT>
                        <ENT>10.5</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Undiscounted Government costs (in millions) by year over a ten-year period are summarized as follows:</P>
                <GPOTABLE COLS="10" OPTS="L2,tp0,p7,7/8,i1" CDEF="s8,8,8,8,8,8,8,8,8,8">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Year 1</CHED>
                        <CHED H="1">Year 2</CHED>
                        <CHED H="1">Year 3</CHED>
                        <CHED H="1">Year 4</CHED>
                        <CHED H="1">Year 5</CHED>
                        <CHED H="1">Year 6</CHED>
                        <CHED H="1">Year 7</CHED>
                        <CHED H="1">Year 8</CHED>
                        <CHED H="1">Year 9</CHED>
                        <CHED H="1">Year 10</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">$11.7</ENT>
                        <ENT>$11.7</ENT>
                        <ENT>$11.7</ENT>
                        <ENT>$11.7</ENT>
                        <ENT>$11.7</ENT>
                        <ENT>$11.7</ENT>
                        <ENT>$11.7</ENT>
                        <ENT>$11.7</ENT>
                        <ENT>$11.7</ENT>
                        <ENT>$11.7</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">i. Acquisition Planning.</E>
                     First, this rule proposes to require agencies to document the reason a set-aside or reserve for small business is not planned for in the solicitation of a new multiple-award contract at any dollar value. Agencies would also be required to coordinate the documentation with the agency's cognizant small business specialist. The cost accounts for the time it takes an acquisition planner to document the reason for not including a set-aside or reserve for small business in the solicitation and the results of small business market research to support that decision and discuss the documentation with the agency's cognizant small business specialist. According to data from the Federal Procurement Data System (FPDS) for Fiscal Years (FYs) 2021 to 2023, the Government awards an average of approximately 3,700 multiple-award contracts that do not contain a set-aside or reserve for small business concerns annually. The Government does not collect data on each solicitation issued and, therefore, assumes that an average of 3 contracts are awarded from a solicitation for a multiple-award contract. This accounts for an average of 1,233 solicitations (3,700 contracts/3 contracts awarded per solicitation) for multiple-award contracts issued by the Government each year. It is estimated that it will take one GS-14, step 5, Government employee, on average, 1.5 hours to document and coordinate the rationale. Based on the Office of Personnel Management (OPM) 2024 General Schedule (GS) 14/step 5 salary for the rest of the United States ($66.36 per hour), a fringe rate of 36.25 percent (OMB memorandum M-08-13 for use in public-private competition), and an overhead rate of 12% (A-76 revised supplemental handbook), the average loaded wage rate for a GS-14, step 5 
                    <PRTPAGE P="3756"/>
                    employee is $101 (rounded to the nearest dollar). As a result, the total annual estimated cost for the Government to document and coordinate the reason for not including a set-aside or reserve for small business in a multiple-award contract is $186,800 (1,233 solicitations * 1.5 hours * $101). The Government acknowledges that this cost could be slightly increased by those solicitations that are issued but cancelled prior to award, or slightly decreased when more than 3 contracts are awarded from a single solicitation.
                </P>
                <P>Second, this rule proposes to require the cognizant small business specialist to coordinate with the PCR, if an acquisition plan or strategy involves a multiple-award contract that meets or exceeds the thresholds for substantial bundling and the number of small business contract awardees is anticipated to be less than 30 percent of all contract awardees. The cost accounts for the time it takes the agency's cognizant small business specialist to contact and discuss the acquisition with the SBA PCR. According to data from FPDS for FYs 2021 to 2023, the Government awards an average of approximately 2,900 multiple-award contracts that exceed an agency's respective substantial bundling threshold, and do not contain a set-aside or reserve for small business concerns. The Government estimates that approximately 50 percent, or 1,450 (2,900 * .50), of these contracts anticipate the number of small business contract awardees to be less than 30 percent of all contract awardees. The Government further assumes that one solicitation yielded two multiple-award contracts meeting the respective substantial bundling threshold. This accounts for an average of 725 solicitations (1,450 contracts/2 contracts awarded per solicitation) for multiple-award contracts valued over the substantial bundling threshold issued by the Government each year. It is estimated that it would take one GS-14, step 5, Government employee, on average, 0.5 hour to coordinate and discuss the acquisition plan or strategy with the SBA PCR. Using the average loaded wage rate for a GS-14, step 5, employee, the total annual estimated cost for the Government to coordinate the acquisition plan or strategy with the PCR is $36,613 (725 solicitations * .5 hour * $101).</P>
                <P>Finally, this rule proposes to require acquisition planners to document the use of on-ramps in long-term, multiple-award contracts, or the rationale for not including on-ramps in such contracts when small businesses are expected to enter the market after the award of the contract and the work anticipated under the contract is sufficient to provide meaningful opportunities for additional contract awardees. The cost accounts for the time it takes an acquisition planner to research and document the rationale behind including or not including on-ramps in the acquisition. Based on the discussion above, the Government issues an average of 1,233 solicitations for multiple-award contracts each year. The Government estimates that approximately 5 percent, or 62, of those solicitations are for long-term contracts. It is estimated that it would take one GS-14, step 5, Government employee, on average, 1 hour to research and document the rationale. Using the average loaded wage rate for a GS-14, step 5, employee, the total annual estimated cost for the Government to document and coordinate the reason for not including an on-ramp in a multiple-award contract is $6,262 (62 solicitations * 1 hour * $101). The Government acknowledges that this cost could be slightly increased by those solicitations that are issued but cancelled prior to award, or slightly decreased when more than 3 contracts are awarded from a single solicitation.</P>
                <P>
                    <E T="03">ii. Orders against multiple-award contracts.</E>
                     First, this rule proposes to require contracting officers to set aside an order for small business if they determine that, under an applicable multiple-award contract, there is a reasonable expectation of obtaining offers from two or more responsible small business contract awardees that are competitive in terms of fair market price, quality, capability, ability to comply with the delivery or performance schedule, and past performance. The cost accounts for the time it takes a contracting officer to research the specific criteria for each small business contract awardee under the selected contract. According to data from FPDS for FYs 2021 to 2023, the Government awards an average of 63,700 task orders or delivery orders against multiple-award contracts, excluding FSS, that are awarded to two or more small businesses annually. It is estimated that it would take one GS-14, step 5, Government employee, on average, 1 hour to research and document the criteria for each small business contract awardee. Using the average loaded wage rate for a GS-14, step 5, employee, the total annual estimated cost for the Government to research and document the criteria for each small business contract awardee is $6,433,700 (63,700 orders * 1 hour * $101).
                </P>
                <P>Second, when an order is not set aside, this rule proposes to require the contracting officer to document the reason for such a decision and coordinate it with the agency's cognizant small business specialist. The cost accounts for the time it takes a contracting officer to document and coordinate the reason for not setting aside an order. Based on the discussion above, the Government awards approximately 63,700 task orders or delivery orders against multiple-award contracts, excluding FSS, awarded to two or more small businesses annually. Of those 63,700 task orders and delivery orders, approximately 14,900 of them are awarded to large businesses each year. It is estimated that approximately half, or 7,450 (14,900 task orders and delivery orders * .5), of these orders were competed amongst all contract awardees, although a set-aside may have been available. It is estimated that it will take one GS-14, step 5, Government employee, on average, 1.5 hours to document and coordinate the reason for not setting aside the order. Using the average loaded wage rate for a GS-14, step 5, employee, the total annual estimated cost for the Government to document and coordinate the reason for not setting aside an order is $1,128,675 (7,450 orders * 1.5 hours * $101).</P>
                <P>This proposed rule would also require that the small business specialist coordinate the decision with the PCR when the order exceeds a dollar value threshold negotiated between SBA and the agency. While these thresholds have not been negotiated, the Government assumes that 30 percent, or 2,235 (7,450 * .3), of the orders not set aside when a set-aside is available may need to be coordinated with the PCR. The cost accounts for the time it takes a small business specialist to coordinate and discuss the reason for not setting aside an order, when doing so is possible. It is estimated that it would take one GS-14, step 5, Government employee, on average, .5 hour to coordinate with the SBA PCR the reason for not setting aside the order. Using the average loaded wage rate for a GS-14, step 5, employee, the total annual estimated cost for the Government to coordinate the reason with the SBA PCR is $112,868 (2,235 orders * .5 hour * $101).</P>
                <P>
                    Finally, when an order is to be placed against a multiple-award contract with only one or no small business contract awardees, this rule proposes to require contracting officers to document the reason for choosing the contract, coordinate it with the agency's cognizant small business specialist, and provide the specialist with a reasonable opportunity to respond. The cost accounts for the time it takes a contracting officer to research and 
                    <PRTPAGE P="3757"/>
                    document the rationale behind choosing the contract and reach out and discuss the reason with the specialist. According to data from FPDS for FYs 2021 to 2023, the Government awards an average of 15,000 task orders or delivery orders against multiple-award contracts that were awarded to one or no small business awardees annually. It is estimated that it would take one GS-14, step 5, Government employee, on average, 2.5 hours to research, document, and coordinate the rationale. Using the average loaded wage rate for a GS-14, step 5, employee, the total annual estimated cost for the Government to document and coordinate the reason for choosing a multiple-award contract with only one or no small business contract awardees is $3,787,500 (15,000 solicitations * 2.5 hours * $101).
                </P>
                <HD SOURCE="HD2">C. Alternatives</HD>
                <P>Several alternatives were considered in the drafting of this proposed rule, including requiring set-asides for small business prior to selecting a contract vehicle, requiring set-asides for agencies that do not meet their annual small business contracting goals, and maintaining contracting officer discretion to set aside an order for a small business contract awardee. However, each of these alternatives misses some portion of the small business community that may be able to compete for such requirements and therefore, do not provide the maximum opportunity for small business participation under certain multiple-award contracts.</P>
                <HD SOURCE="HD1">V. Executive Orders 12866 and 13563</HD>
                <P>Executive Orders (E.O.s) 12866 (as amended by E.O. 14094) and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action under section 3(f)(1) of E.O. 12866 and, therefore, was subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.</P>
                <HD SOURCE="HD1">VI. Regulatory Flexibility Act</HD>
                <P>DoD, GSA, and NASA do not expect this proposed rule, if finalized, to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601-612. This rule only revises the internal operating procedures of the Government. However, an Initial Regulatory Flexibility Analysis (IRFA) has been performed and is summarized as follows:</P>
                <EXTRACT>
                    <P>DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to update and clarify policy on market research, acquisition planning, small business specialist coordination, and the use of set asides during the award of and orders placed against certain multiple-award contracts.</P>
                    <P>The objective of this rule is to support Governmentwide efforts to leverage the small business growth occurring in the nation's supply chains that support agency missions, reverse the decline of small business participation in the Federal supplier base, and increase contracting opportunities for small business concerns. Promulgation of FAR regulations is authorized by 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.</P>
                    <P>This proposed rule would impact small business contract awardees under certain existing multiple-award contracts, as well as small business concerns that anticipate becoming a contract awardee under certain multiple-award contracts. The impacts of this rule have not been realized yet; therefore, there is no data with which to accurately reflect the number of small entities to which this rule would apply. Instead, this rule has the potential to benefit any small entity looking to do business with the Government under certain multiple-award contracts. According to data from the System for Award Management (SAM), there are approximately 384,100 small entities currently registered in SAM to do business with the Government. This proposed rule has the potential to impact any number of these small entities, depending on several factors, including the following: the primary industry of the entity, the Government's future needs for products and services, and the entity's submission of proposals and offers for multiple-award contracts and the orders to be placed against those contracts.</P>
                    <P>The proposed rule would not impose any new reporting, recordkeeping, or other compliance requirements for small entities. The proposed rule does not duplicate, overlap, or conflict with any other Federal rules.</P>
                    <P>There are no known significant alternative approaches to the proposed rule that would accomplish the stated objectives of the rule and further minimize any significant economic impact of this proposed rule on small entities, as the economic impact is not anticipated to be significant.</P>
                </EXTRACT>
                <P>The Regulatory Secretariat Division has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat Division. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.</P>
                <P>DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2023-011), in correspondence.</P>
                <HD SOURCE="HD1">VII. Paperwork Reduction Act</HD>
                <P>This rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501-3521).</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 48 CFR Parts 1, 7, 12, 16, 19, and 52</HD>
                    <P>Government procurement.</P>
                </LSTSUB>
                <SIG>
                    <NAME>William F. Clark,</NAME>
                    <TITLE>Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.</TITLE>
                </SIG>
                <P>Therefore, DoD, GSA, and NASA propose amending 48 CFR parts 1, 7, 12, 16, 19, and 52 as set forth below:</P>
                <AMDPAR>1. The authority citation for 48 CFR parts 1, 7, 12, 16, 19, and 52 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P> 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.</P>
                </AUTH>
                <PART>
                    <HD SOURCE="HED">PART 1—FEDERAL ACQUISITION REGULATIONS SYSTEM</HD>
                    <SECTION>
                        <SECTNO>1.102 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                </PART>
                <AMDPAR>2. Amend section 1.102 in paragraph (c) by removing “and procurement” and adding “procurement, and small business” in its place.</AMDPAR>
                <PART>
                    <HD SOURCE="HED">PART 7—ACQUISITION PLANNING</HD>
                </PART>
                <AMDPAR>3. Amend section 7.104 by revising paragraph (d) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>7.104</SECTNO>
                    <SUBJECT> General procedures.</SUBJECT>
                    <STARS/>
                    <P>(d)(1) The planner shall coordinate the acquisition plan or strategy with the cognizant small business specialist when the strategy contemplates an acquisition meeting the thresholds in 7.107-4 for substantial bundling unless the contract or task order or delivery order is totally set aside for small business under part 19.</P>
                    <P>(2) The small business specialist shall notify—</P>
                    <P>
                        (i) The agency Office of Small and Disadvantaged Business Utilization or 
                        <PRTPAGE P="3758"/>
                        the Office of Small Business Programs if the strategy involves—
                    </P>
                    <P>(A) Bundling that is unnecessary or unjustified; or</P>
                    <P>(B) Bundled or consolidated requirements not identified as such by the agency (see 7.107); and</P>
                    <P>(ii) The Small Business Administration (SBA) procurement center representative (or if one is not assigned, see 19.402(a)), early in the acquisition process, if the strategy involves a multiple-award contract that meets the thresholds in 7.107-4 for substantial bundling, and the number of small business contract awardees is anticipated to be under 30 percent of all contract awardees.</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>4. Amend section 7.105 by adding paragraphs (b)(1)(iii)(A) and (B) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>7.105</SECTNO>
                    <SUBJECT> Contents of written acquisition plans.</SUBJECT>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>(1) * * *</P>
                    <P>(iii) * * *</P>
                    <P>(A) When a multiple-award contract will not be totally or partially set aside for small business concerns or will not include a small business reserve (see 19.501(a)), the agency shall document the reason for this decision, including a description of the market research conducted. The agency shall coordinate the acquisition plan or strategy with the cognizant small business specialist.</P>
                    <P>
                        (B) When contemplating the award of a multiple-award contract that is a long-term contract, as defined at 19.301-2(a), discuss the use of on-ramps during the period of performance of the contract (
                        <E T="03">i.e.,</E>
                         permitting small and large business concerns to become contract holders during the period of performance of the contract). If small businesses are expected to enter the market after the award of the contract, and the work anticipated to be performed under the contract is sufficient to provide meaningful opportunities for additional contract holders, the plan or strategy shall explain why on-ramps will not be included in the contract. If on-ramps are included in the contract, agencies are discouraged from using off-ramps to remove a contract awardee from a contract that was set aside for small business concerns because of a change in the awardee's size status, except where the awardee's size status changes because of a merger or acquisition.
                    </P>
                    <STARS/>
                </SECTION>
                <PART>
                    <HD SOURCE="HED">PART 12—ACQUISITION OF COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES</HD>
                </PART>
                <AMDPAR>5. Amend section 12.207 by revising paragraph (b)(1)(i)(C) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>12.207 </SECTNO>
                    <SUBJECT>Contract type.</SUBJECT>
                    <STARS/>
                    <P>(b)(1) * * *</P>
                    <P>(i) * * *</P>
                    <P>(C) The fair opportunity procedures in 16.505 (including small business set-asides under 16.505(b)(1)(i)(C)), if placing an order under a multiple-award delivery-order contract; and</P>
                    <STARS/>
                </SECTION>
                <PART>
                    <HD SOURCE="HED">PART 16—TYPES OF CONTRACTS</HD>
                </PART>
                <AMDPAR>6. Amend section 16.505 by—</AMDPAR>
                <AMDPAR>a. Adding paragraphs (a)(13) and (14);</AMDPAR>
                <AMDPAR>b. In paragraph (b)(1)(i)(A), removing “or”;</AMDPAR>
                <AMDPAR>c. In paragraph (b)(1)(i)(B), removing the period at the end of the sentence and adding “; or” in its place;</AMDPAR>
                <AMDPAR>d. Adding paragraph (b)(1)(i)(C);</AMDPAR>
                <AMDPAR>e. Revising paragraph (b)(1)(ii)(A);</AMDPAR>
                <AMDPAR>f. Removing paragraph (b)(2)(i)(F), and redesignating paragraph (b)(2)(i)(G) as paragraph (b)(2)(i)(F);</AMDPAR>
                <AMDPAR>
                    g. Revising paragraphs (b)(2)(ii) introductory text and (b)(2)(ii)(D)(
                    <E T="03">5</E>
                    ).
                </AMDPAR>
                <P>The additions and revisions read as follows:</P>
                <SECTION>
                    <SECTNO>16.505</SECTNO>
                    <SUBJECT> Ordering.</SUBJECT>
                    <P>(a) * * *</P>
                    <P>(13)(i) When placing an order against a multiple-award contract that has no or only one small business contract awardee, the contracting officer shall document—</P>
                    <P>
                        (A) How the market research of small business contract awardees and small businesses, that are not contract holders on the multiple-award contract against which the order would be placed, and mission needs (
                        <E T="03">e.g.,</E>
                         price, schedule, technical and/or past performance of potential sources) informed the agency's basis for selecting the multiple-award contract to fulfill its needs; and
                    </P>
                    <P>(B) The market research the agency conducted within the past 18 months, which may include the market research supporting the acquisition plan or strategy to establish a multiple-award contract or deciding to use another agency's multiple-award contract on a repetitive basis.</P>
                    <P>(ii) Contracting officers shall provide a copy of the documentation (see paragraph (a)(13)(i) of this section) to the cognizant small business specialist, in accordance with agency procedures, and ensure the specialist has a reasonable opportunity to respond.</P>
                    <P>(iii) The requirements of paragraph (a)(13) of this section do not apply—</P>
                    <P>(A) To orders under the Federal Supply Schedule;</P>
                    <P>(B) When an exception to fair opportunity applies;</P>
                    <P>(C) When an agency exception applies; or</P>
                    <P>
                        (D) To repetitive orders, including orders placed using automated procedures, issued by an agency (
                        <E T="03">i.e.,</E>
                         when an order was issued by that agency under the same contract and that order was documented and coordinated within the prior 18 months in accordance with paragraph (a)(13) of this section).
                    </P>
                    <P>(14) Agencies may establish procedures to allow contracting officers to exercise exceptions to paragraph (a)(13) or (b)(1)(i)(C) of this section. Agencies shall coordinate their procedures for granting exceptions with the Office of Small and Disadvantaged Business Utilization, or for the Department of Defense, the Director of the Office of Small Business Programs, and the Small Business Administration and make the procedures publicly available.</P>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>(1) * * *</P>
                    <P>(i) * * *</P>
                    <P>(C) In accordance with section 1331 of Public Law 111-240 (15 U.S.C. 644(r)), contracting officers may, at their discretion, set aside an order for any of the small business concerns identified in 19.000(a)(3). When exercising this discretion, the contracting officer shall determine if there is a reasonable expectation of obtaining offers from two or more responsible small business contract awardees under the multiple-award contract that are competitive in terms of fair market price, quality, capability, ability to comply with the delivery or performance schedule, and past performance. If the contracting officer determines at least two small business contract awardees meet the criteria in this paragraph, the contracting officer shall set aside the order, unless the contracting officer determines that an exception applies (see paragraphs (a)(14) and (b)(2)(i) of this section).</P>
                    <P>
                        (
                        <E T="03">1</E>
                        ) Unless an exception applies, contracting officers shall document the reason for not setting aside an order and provide it to the cognizant small business specialist in accordance with agency procedures. The small business specialist shall notify the SBA procurement center representative (PCR) (or if one is not assigned, see 19.402(a)) when the value of the order exceeds the dollar threshold negotiated between the agency and the PCR and reflected in agency procedures.
                        <PRTPAGE P="3759"/>
                    </P>
                    <P>
                        (
                        <E T="03">2</E>
                        ) Paragraph (b)(1)(i)(C) of this section shall also apply to existing multiple-award contracts awarded before [EFFECTIVE DATE OF FINAL RULE], to the extent that setting aside an order is consistent with the order placement procedures of the multiple-award contract and there is adequate time remaining on the multiple-award contract to permit small business contract awardees to fully perform or deliver under the contract.
                    </P>
                    <P>(ii) * * *</P>
                    <P>(A) Develop placement procedures that will—</P>
                    <P>
                        (
                        <E T="03">1</E>
                        ) Provide each awardee a fair opportunity to be considered for each order and that reflect the requirement and other aspects of the contracting environment; and
                    </P>
                    <P>
                        (
                        <E T="03">2</E>
                        ) Except for FSS contracts, allow for orders to be set aside for small business awardees when the conditions of paragraph (b)(1)(i)(C) of this section are met, (unless an exception applies in accordance with paragraph (a)(14) or (b)(2)(i) of this section).
                    </P>
                    <STARS/>
                    <P>(2) * * *</P>
                    <P>(ii) The justification for an exception to fair opportunity shall be in writing as specified in paragraph (b)(2)(ii)(A) or (B) of this section.</P>
                    <STARS/>
                    <P>(D) * * *</P>
                    <P>
                        (
                        <E T="03">5</E>
                        ) The posting requirement of this section does not apply when disclosure would compromise the national security (
                        <E T="03">e.g.,</E>
                         would result in disclosure of classified information) or create other security risks.
                    </P>
                    <STARS/>
                </SECTION>
                <PART>
                    <HD SOURCE="HED">PART 19—SMALL BUSINESS PROGRAMS</HD>
                </PART>
                <AMDPAR>7. Amend section 19.202-1 by revising paragraph (e)(1) introductory text to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>19.202-1</SECTNO>
                    <SUBJECT> Encouraging small business participation in acquisitions.</SUBJECT>
                    <STARS/>
                    <P>(e)(1) Provide a copy of the proposed acquisition package and other reasonably obtainable information related to the acquisition to the SBA PCR (or, if a PCR is not assigned, see 19.402(a)) at least 30 days (or earlier as agreed upon by the agency and the SBA PCR) prior to the issuance of the solicitation if—</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>8. Amend section 19.504 by revising paragraphs (a) introductory text and (a)(1) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>19.504</SECTNO>
                    <SUBJECT> Orders under multiple-award contracts.</SUBJECT>
                    <P>
                        (a) 
                        <E T="03">General.</E>
                         Contracting officers shall use their discretion under 15 U.S.C. 644(r) to set aside orders under multiple-award contracts for any of the small business concerns identified in 19.000(a)(3) when the circumstances at 16.505(b)(1)(i)(C) are met, except as provided in 8.405-5, when placing an order outside the United States and its outlying areas (19.000(b)(1)(ii)), or where an exception applies in accordance with 16.505(a)(14) or (b)(2)(i). In accordance with section 1331 of the Small Business Jobs Act of 2010 (15 U.S.C. 644(r)(2)), contracting officers may, at their discretion, set aside orders under the Federal Supply Schedule (see subpart 8.4) for any of the small business concerns identified in 19.000(a)(3).
                    </P>
                    <P>(1) The contracting officer shall state in the solicitation and resulting contract that order set-asides will be mandatory when the conditions in 19.502-2 and 16.505(b)(1)(i)(C) are met at the time of order set-aside, and the specific program eligibility requirements, as applicable, are also then met.</P>
                    <STARS/>
                </SECTION>
                <SECTION>
                    <SECTNO>19.505</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>9. Amend section 19.505 in paragraph (a)(2)(iii) by removing “and 16.505(b)(2)(i)(F)” and adding “and 16.505(b)(1)(i)(C)” in its place.</AMDPAR>
                <SECTION>
                    <SECTNO>19.506</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>10. Amend section 19.506 in paragraph (a)(2) by removing “been used” and adding “been used (see 7.105(b)(1)(iii)(A))” in its place.</AMDPAR>
                <AMDPAR>11. Amend section 19.507 by revising paragraphs (c) and (e)(1) and paragraph (h)(1) introductory text to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>19.507 </SECTNO>
                    <SUBJECT>Solicitation provisions and contract clauses.</SUBJECT>
                    <STARS/>
                    <P>(c) The contracting officer shall insert the clause at 52.219-6, Notice of Total Small Business Set-Aside, in solicitations and contracts involving total small business set-asides. This includes multiple-award contracts when orders will be set aside for contract awardees that are any of the small business concerns identified in 19.000(a)(3), as described in 16.505(b)(1)(i)(C), and when orders may be set aside as described in 8.405-5. Use the clause at 52.219-6 with its Alternate I when including FPI in the competition in accordance with 19.502-7.</P>
                    <STARS/>
                    <P>(e) * * *</P>
                    <P>(1) For supplies, services, and construction, if any portion of the requirement is to be set aside for small business and the contract amount is expected to exceed the simplified acquisition threshold, and in any solicitations and contracts that are set aside or awarded on a sole-source basis in accordance with subpart 19.8, 19.13, 19.14, or 19.15, regardless of dollar value. This includes multiple-award contracts when orders will be set aside for small business contract awardees, as described in 16.505(b)(1)(i)(C), and when orders may be set aside as described in 8.405-5, and when orders may be issued directly to a small business concern as described in 19.504(c)(1)(ii). For contracts that are set aside, the contracting officer shall indicate in paragraph (f) of the clause whether compliance with the limitations on subcontracting is required at the contract or order level;</P>
                    <STARS/>
                    <P>(h)(1) The contracting officer shall insert the clause at 52.219-33, Nonmanufacturer Rule, in solicitations and contracts, including multiple-award contracts, when orders will be set aside for small business contract awardees as described in 16.505(b)(1)(i)(C), and when orders may be set aside as described in 8.405-5, and when orders may be issued directly to a small business concern as described in 19.504(c)(1)(ii), when—</P>
                    <STARS/>
                </SECTION>
                <SECTION>
                    <SECTNO>19.1304 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>12. Amend section 19.1304 in paragraph (b) by removing “16.505(b)(2)(i)(F) for discretionary” and adding “16.505(b)(1)(i)(C) for” in its place.</AMDPAR>
                <AMDPAR>13. Amend section 19.1309 by revising paragraph (a) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>19.1309</SECTNO>
                    <SUBJECT> Contract clauses.</SUBJECT>
                    <P>(a) The contracting officer shall insert the clause at 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award, in solicitations and contracts for acquisitions that are set aside or awarded on a sole-source basis to, HUBZone small business concerns under 19.1305 or 19.1306. This includes multiple-award contracts when orders will be set aside for contract awardees that are HUBZone small business concerns as described in 16.505(b)(1)(i)(C), when orders may be set aside as described in 8.405-5, or when orders may be issued directly to one HUBZone small business concern in accordance with 19.504(c)(1)(ii).</P>
                    <STARS/>
                </SECTION>
                <SECTION>
                    <PRTPAGE P="3760"/>
                    <SECTNO>19.1404 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>14. Amend section 19.1404 in paragraph (b) by removing “16.505(b)(2)(i)(F) for discretionary” and adding “16.505(b)(1)(i)(C) for” in its place.</AMDPAR>
                <AMDPAR>15. Amend section 19.1408 by revising paragraph (a) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>19.1408</SECTNO>
                    <SUBJECT> Contract clauses.</SUBJECT>
                    <P>(a) The contracting officer shall insert the clause at 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program, in solicitations and contracts for acquisitions that are set aside or awarded on a sole-source basis to, service-disabled veteran-owned small business concerns under 19.1405 and 19.1406. This includes multiple-award contracts when orders will be set aside for contract awardees that are service-disabled veteran-owned small business concerns as described in 16.505(b)(1)(i)(C), when orders may be set aside as described in 8.405-5, or when orders may be issued directly to one service-disabled veteran-owned small business contractor in accordance with 19.504(c)(1)(ii).</P>
                    <STARS/>
                </SECTION>
                <SECTION>
                    <SECTNO>19.1504 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>16. Amend section 19.1504 in paragraph (c) by removing “16.505(b)(2)(i)(F) for discretionary” and adding “16.505(b)(1)(i)(C) for” in its place.</AMDPAR>
                <AMDPAR>17. Amend section 19.1508 by revising paragraphs (a) and (b) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>19.1508</SECTNO>
                    <SUBJECT> Contract clauses.</SUBJECT>
                    <P>(a) The contracting officer shall insert the clause at 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-owned Small Business Concerns, in solicitations and contracts for acquisitions that are set aside or awarded on a sole-source basis to, EDWOSB concerns under 19.1505(b) or 19.1506(a). This includes multiple-award contracts when orders will be set aside for contract awardees that are EDWOSB concerns as described in 16.505(b)(1)(i)(C), when orders may be set aside as described in 8.405-5, or when orders may be issued directly to one EDWOSB contractor in accordance with 19.504(c)(1)(ii).</P>
                    <P>(b) The contracting officer shall insert the clause at 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program, in solicitations and contracts for acquisitions that are set aside or awarded on a sole-source basis to WOSB concerns under 19.1505(c) or 19.1506(b). This includes multiple-award contracts when orders will be set aside for contract awardees that are WOSB concerns eligible under the WOSB Program as described in 16.505(b)(1)(i)(C), when orders may be set aside as described in 8.405-5, or when orders may be issued directly to one WOSB contractor in accordance with 19.504(c)(1)(ii).</P>
                    <STARS/>
                </SECTION>
                <PART>
                    <HD SOURCE="HED">PART 52—SOLICITATION PROVISIONS AND CONTRACT CLAUSES</HD>
                </PART>
                <AMDPAR>18. Amend section 52.212-5 by—</AMDPAR>
                <AMDPAR>a. Revising the date of the clause;</AMDPAR>
                <AMDPAR>b. Removing from paragraph (b)(15) “OCT 2022” and adding “DATE” in its place;</AMDPAR>
                <AMDPAR>c. Removing from paragraph (b)(18)(i) “NOV 2020” and adding “DATE” in its place;</AMDPAR>
                <AMDPAR>d. Removing from paragraph (b)(23) “OCT 2022” and adding “DATE” in its place;</AMDPAR>
                <AMDPAR>e. Removing from paragraph (b)(25) “FEB 2024” and adding “DATE” in its place;</AMDPAR>
                <AMDPAR>f. Removing from paragraphs (b)(27) and (28) “OCT 2022” and adding “DATE” in their places, respectively; and</AMDPAR>
                <AMDPAR>g. Removing from paragraph (b)(30) “SEP 2021” and adding “DATE” in its place.</AMDPAR>
                <P>The revision reads as follows:</P>
                <SECTION>
                    <SECTNO>52.212-5 </SECTNO>
                    <SUBJECT>Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services.</SUBJECT>
                    <STARS/>
                    <EXTRACT>
                        <HD SOURCE="HD1">Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (DATE)</HD>
                    </EXTRACT>
                    <STARS/>
                </SECTION>
                <AMDPAR>19. Amend section 52.219-3 by revising the date of the clause and paragraph (b)(3) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>52.219-3 </SECTNO>
                    <SUBJECT>Notice of HUBZone Set-Aside or Sole-Source Award.</SUBJECT>
                    <STARS/>
                    <EXTRACT>
                        <HD SOURCE="HD1">Notice of HUBZone Set-Aside or Sole-Source Award (DATE)</HD>
                    </EXTRACT>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>(3) Orders set aside for contract awardees that are HUBZone small business concerns under multiple-award contracts as described in 8.405-5 and 16.505(b)(1)(i)(C); and</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>20. Amend section 52.219-6 by revising the date of the clause and paragraph (b)(2) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>52.219-6 </SECTNO>
                    <SUBJECT>Notice of Total Small Business Set-Aside.</SUBJECT>
                    <STARS/>
                    <EXTRACT>
                        <HD SOURCE="HD1">Notice of Total Small Business Set-Aside (DATE)</HD>
                    </EXTRACT>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>(2) Orders set aside for contract awardees that are small business concerns under multiple-award contracts as described in 8.405-5 and 16.505(b)(1)(i)(C).</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>21. Amend section 52.219-14 by—</AMDPAR>
                <AMDPAR>a. Revising the date of the clause and paragraph (c)(4)(i); and</AMDPAR>
                <AMDPAR>b. In paragraph (c)(5)(i) removing “16.505(b)(2)(i)(F)” and adding “16.505(b)(1)(i)(C)” in its place.</AMDPAR>
                <P>The revisions read as follows:</P>
                <SECTION>
                    <SECTNO>52.219-14</SECTNO>
                    <SUBJECT> Limitations on Subcontracting.</SUBJECT>
                    <STARS/>
                    <EXTRACT>
                        <HD SOURCE="HD1">Limitations on Subcontracting (DATE)</HD>
                    </EXTRACT>
                    <STARS/>
                    <P>(c) * * *</P>
                    <P>(4) * * *</P>
                    <P>(i) Set aside for contract awardees that are small business concerns under multiple-award contracts, as described in 8.405-5 and 16.505(b)(1)(i)(C); or</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>22. Amend section 52.219-27 by revising the date of clause and paragraph (b)(3) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>52.219-27 </SECTNO>
                    <SUBJECT>Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program.</SUBJECT>
                    <STARS/>
                    <EXTRACT>
                        <HD SOURCE="HD1">Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (DATE)</HD>
                    </EXTRACT>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>(3) Orders set aside for contract awardees that are SDVOSB concerns eligible under the SDVOSB Program, under multiple-award contracts as described in 8.405-5 and 16.505(b)(1)(i)(C); and</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>23. Amend section 52.219-29 by revising the date of clause and paragraph (b)(3) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>52.219-29</SECTNO>
                    <SUBJECT> Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns.</SUBJECT>
                    <STARS/>
                    <EXTRACT>
                        <PRTPAGE P="3761"/>
                        <HD SOURCE="HD1">Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (DATE)</HD>
                    </EXTRACT>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>(3) Orders set aside for contract awardees that are EDWOSB concerns under multiple-award contracts as described in 8.405-5 and 16.505(b)(1)(i)(C); and</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>24. Amend section 52.219-30 by revising the date of clause and paragraph (b)(3) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>52.219-30</SECTNO>
                    <SUBJECT> Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program.</SUBJECT>
                    <STARS/>
                    <EXTRACT>
                        <HD SOURCE="HD1">Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (DATE)</HD>
                    </EXTRACT>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>(3) Orders set aside for contract awardees that are WOSB concerns eligible under the WOSB Program, under multiple-award contracts as described in 8.405-5 and 16.505(b)(1)(i)(C); and</P>
                    <STARS/>
                </SECTION>
                <AMDPAR>25. Amend section 52.219-33 by—</AMDPAR>
                <AMDPAR>a. Revising the date of the clause and paragraph (b)(2)(iii)(A); and</AMDPAR>
                <AMDPAR>b. In paragraph (b)(2)(iv)(A) removing “16.505(b)(2)(i)(F)” and adding “16.505(b)(1)(i)(C)” in its place.</AMDPAR>
                <P>The revisions read as follows:</P>
                <SECTION>
                    <SECTNO>52.219-33</SECTNO>
                    <SUBJECT> Nonmanufacturer Rule.</SUBJECT>
                    <STARS/>
                    <EXTRACT>
                        <HD SOURCE="HD1">Nonmanufacturer Rule (DATE)</HD>
                    </EXTRACT>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>(2) * * *</P>
                    <P>(iii) * * *</P>
                    <P>(A) Set aside for contract awardees that are small business concerns under multiple-award contracts, as described in 8.405-5 and 16.505(b)(1)(i)(C); or</P>
                    <STARS/>
                </SECTION>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00615 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-EP-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <AGENCY TYPE="O">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <AGENCY TYPE="O">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <CFR>48 CFR Part 16</CFR>
                <DEPDOC>[FAR Case 2024-007, Docket No. FAR-2024-0007, Sequence No. 1]</DEPDOC>
                <RIN>RIN 9000-AO76</RIN>
                <SUBJECT>Federal Acquisition Regulation: Protests of Orders Under Certain Multiple-Award Contracts</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to clarify protest rights for orders set aside under certain multiple-award contracts.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested parties should submit written comments to the Regulatory Secretariat Division at the address shown below on or before March 17, 2025, to be considered in the formation of the final rule.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit comments in response to FAR Case 2024-007 to the Federal eRulemaking portal at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for “FAR Case 2024-007”. Select the link “Comment Now” that corresponds with “FAR Case 2024-007”. Follow the instructions provided on the “Comment Now” screen. Please include your name, company name (if any), and “FAR Case 2024-007” on your attached document. If your comment cannot be submitted using 
                        <E T="03">https://www.regulations.gov,</E>
                         call or email the points of contact in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section of this document for alternate instructions.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         Please submit comments only and cite “FAR Case 2024-007” in all correspondence related to this case. Comments received generally will be posted without change to 
                        <E T="03">https://www.regulations.gov,</E>
                         including any personal and/or business confidential information provided. Public comments may be submitted as an individual, as an organization, or anonymously (see frequently asked questions at 
                        <E T="03">https://www.regulations.gov/faq</E>
                        ). To confirm receipt of your comment(s), please check 
                        <E T="03">https://www.regulations.gov,</E>
                         approximately two to three days after submission to verify posting.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For clarification of content, contact Ms. Carrie Moore, Procurement Analyst, at 571-300-5917 or by email at 
                        <E T="03">carrie.moore@gsa.gov.</E>
                         For information pertaining to status, publication schedules, or alternate instructions for submitting comments if 
                        <E T="03">https://www.regulations.gov</E>
                         cannot be used, contact the Regulatory Secretariat Division at 202-501-4755 or 
                        <E T="03">GSARegSec@gsa.gov.</E>
                         Please cite FAR Case 2024-007.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>DoD, GSA, and NASA are proposing to revise the FAR to clarify protest rights, in accordance with existing statute and regulations, when an order is or is not set aside. This includes whether the action was taken in accordance with the policy proposed in FAR Case 2023-011, Small Business Participation on Certain Multiple-Award Contracts, published at XX FR XXX, on January XX, 2025.</P>
                <P>To increase small business opportunities and maximize their participation on multiple-award contracts, FAR Case 2023-011 proposes guidance for contracting officers regarding how to exercise the statutory grant of discretion to set aside an order for a small business under a multiple-award contract. Under that proposed rule, if the contracting officer determines that there is a reasonable expectation of obtaining offers from two or more responsible small business awardees that are competitive in terms of various criteria under the applicable multiple-award contract, then the order should be set aside for small business. This proposed rule for FAR Case 2024-007 clarifies that the proposed rule for FAR Case 2023-011 does not alter the existing statutory grant of discretion to agencies as to whether or not to set aside an order. The proposed rule for FAR Case 2023-011, if finalized, cannot alter the existing protest rights in connection with the issuance or proposed issuance of an order under a multiple-award contract. (See FAR 16.505(a)(10), 41 U.S.C. 4106, and 10 U.S.C. 3406.)</P>
                <HD SOURCE="HD1">II. Discussion and Analysis</HD>
                <P>This proposed rule adds clarifying text to FAR part 16 to specify that a contracting officer's decision to set aside or not set aside an order under a multiple-award contract is not grounds for protest.</P>
                <P>
                    Specifically, under 15 U.S.C. 644(r), Federal agencies, and contracting officers acting on behalf of those agencies, are granted discretion as to whether to set aside an order under a multiple-award contract for small 
                    <PRTPAGE P="3762"/>
                    businesses. This statutory grant of discretion means that agencies are not required to set aside orders; it is a choice. To the extent a bid protest challenges an agency's decision to set aside or not set aside an order for small business, that protest challenges a discretionary act statutorily committed to agency decision-making, and therefore cannot form the basis for a protest seeking to compel an agency to make a different choice.
                </P>
                <P>
                    This issue has not been clearly understood and has been subject to litigation, which is why FAR Case 2023-011 proposes to clarify guidance for agencies and this FAR Case 2024-007 proposes to clarify protest rights. On the one hand, in a series of decisions, the U.S. Government Accountability Office (GAO) has determined that 15 U.S.C. 644(r) “clearly provides for granting agency officials discretion in deciding whether to set aside orders under multiple-award contracts.” 
                    <E T="03">Aldevra,</E>
                     B-411752 (Oct. 16, 2015), 2015 CPD ¶ 339. In a separate decision, GAO discussed 15 U.S.C. 644(r) and the regulations implementing that provision in the FAR and issued by the SBA, and concluded that, “we think it is beyond debate that these regulations, by their plain language, grant discretion to a contracting officer about whether to set aside for small business participation task orders placed under multiple-award contracts.” See FAR 19.502-4 and 16.505(b)(2)(i)(F). 
                    <E T="03">Edmond Scientific Co.,</E>
                     B-410179 (Nov. 12, 2014), 2014 CPD ¶ 336. On the other hand, the U.S. Court of Federal Claims, in 
                    <E T="03">Tolliver Group, Inc.</E>
                     v. 
                    <E T="03">United States,</E>
                     151 Fed. Cl. 70 (2020), held that an agency is required to apply the Rule of Two prior to deciding to utilize a given multiple-award contract, and that, if the Rule of Two is satisfied, the agency is required to set the contract aside for small business. The Court rejected the position that 15 U.S.C. 644(r) provides agencies with discretion to utilize a multiple-award contract and then decide whether to set the order aside for small business.
                </P>
                <P>
                    Through the proposed rule for FAR case 2023-011, as well as this proposed rule, DoD, GSA, and NASA seek to address the confusion and disagreement regarding the discretion that is provided to agencies by clarifying the guidance previously issued under 15 U.S.C. 644(r). DoD, GSA, and NASA agree with, and adopts, GAO's conclusion that “the statutory grant of discretion does not require application of the Rule of Two prior to issuing an order, unless the multiple-award contract or task order solicitation expressly anticipated the use of the Rule of Two.” 
                    <E T="03">ITility, LLC,</E>
                     B-419167 (Dec. 23, 2020), 2020 CPD ¶ 412. Furthermore, as GAO explained in this decision, the discretion provided by the statute necessarily means that an agency decision as to whether to set aside an order, or not to set it aside, under a multiple-award contract, is not a decision that can be challenged via a bid protest: “Where Congress has enunciated a clear policy granting contracting officials discretion, and the Executive Branch's regulatory implementation similarly emphasizes the statutory grant of discretion, our Office cannot substitute the parties' or our own judgments on the matter.” Id.
                </P>
                <HD SOURCE="HD1">III. Applicability to Contracts at or Below the Simplified Acquisition Threshold (SAT) and for Commercial Products (Including Commercially Available Off-the-Shelf (COTS) Items) or for Commercial Services</HD>
                <P>This proposed rule does not create new solicitation provisions or contract clauses or impact any existing provisions or clauses.</P>
                <HD SOURCE="HD1">IV. Expected Impact of the Rule</HD>
                <P>This proposed rule is expected to impact contractors and the Government by clarifying that the proposed policies of FAR Case 2023-011 and the existing statutory grant of discretion to agencies as to whether or not to set aside an order do not alter the existing protest rights in connection with the issuance or proposed issuance of an order under a multiple-award contract. As such, this clarification is expected to deter contractors from submitting protests of decisions to set aside or not set aside orders placed against multiple-award contracts, thereby saving contractors and the Government time and resources.</P>
                <P>This savings in time and resources is expected to expedite the award of such orders and preclude delays in meeting mission needs. This rule is also expected to provide clarity for all parties in the protest process.</P>
                <HD SOURCE="HD1">V. Executive Orders 12866 and 13563</HD>
                <P>Executive Orders (E.O.s) 12866 (as amended by E.O. 14094) and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action under section 3(f)(1) of E.O. 12866 and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.</P>
                <HD SOURCE="HD1">VI. Regulatory Flexibility Act</HD>
                <P>DoD, GSA, and NASA do not expect this proposed rule, if finalized, to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601-612, because this rule only clarifies protest statute and regulations for contractors and the Government. However, an Initial Regulatory Flexibility Analysis (IRFA) has been performed and is summarized as follows:</P>
                <EXTRACT>
                    <P>DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to specify that the policy of FAR Case 2023-011, which proposes guidance for contracting officers regarding how to exercise the existing statutory grant of discretion to agencies as to whether or not to set aside an order, does not alter the existing protest rights in connection with the issuance or proposed issuance of an order under a multiple-award contract.</P>
                    <P>The objective of this rule is to clarify protest regulations in the FAR regarding the set-aside of certain orders under multiple-award contracts. Promulgation of FAR regulations is authorized by 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.</P>
                    <P>This proposed rule will impact small business contract holders under certain multiple-award contracts. Specifically, small entities will have clear guidance regarding when an order under a multiple-award contract may be protested. The impacts of this rule cannot be quantified, as there is no reliable way to estimate the number of protests that would have occurred without this proposed rule; therefore, there is no data with which to accurately reflect the number of small entities to which this rule will apply. Instead, this rule has the potential to benefit any small entity looking to do business with the Government under certain multiple-award contracts. According to data from the System for Award Management (SAM), there are approximately 384,100 small entities currently registered in SAM to do business with the Government. This proposed rule has the potential to impact any number of these small entities, depending on several factors, including: the primary industry of the entity; the Government's future needs for products and services; and the entity's submission of proposals and offers for orders to be placed against multiple-award contracts.</P>
                    <P>
                        The proposed rule does not impose any new reporting, recordkeeping, or other compliance requirements for small entities. The proposed rule does not duplicate or conflict with any other Federal rules. This rule is related to and overlaps with the proposed rule for FAR Case 2023-011.
                        <PRTPAGE P="3763"/>
                    </P>
                    <P>There are no known significant alternative approaches to the proposed rule that would accomplish the stated objectives of the rule and further minimize any significant economic impact of this proposed rule on small entities, as the economic impact is not anticipated to be significant.</P>
                </EXTRACT>
                <P>The Regulatory Secretariat Division has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat Division. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.</P>
                <P>DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2024-007), in correspondence.</P>
                <HD SOURCE="HD1">VII. Paperwork Reduction Act</HD>
                <P>This rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501-3521).</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 48 CFR Part 16</HD>
                    <P>Government procurement.</P>
                </LSTSUB>
                <SIG>
                    <NAME>William F. Clark,</NAME>
                    <TITLE>Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.</TITLE>
                </SIG>
                <P>Therefore, DoD, GSA, and NASA propose amending 48 CFR part 16 as set forth below:</P>
                <PART>
                    <HD SOURCE="HED">PART 16—TYPES OF CONTRACTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for 48 CFR part 16 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P> 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.</P>
                </AUTH>
                <AMDPAR>2. Amend section 16.505 by adding paragraph (a)(10)(iv) to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>16.505</SECTNO>
                    <SUBJECT> Ordering.</SUBJECT>
                    <P>(a) * * *</P>
                    <P>(10) * * *</P>
                    <P>(iv) In accordance with 15 U.S.C. 644(r), a contracting officer's decision to set aside or not set aside an order for small business concerns is an exercise of discretion granted to agencies and not a basis for protest. However, this does not preclude the filing of a protest of such an order if such a protest would otherwise be authorized on a separate basis recognized in accordance with paragraph (a)(10)(i) of this section.</P>
                    <STARS/>
                </SECTION>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00616 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-EP-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <CFR>50 CFR Part 17</CFR>
                <DEPDOC>[Docket No. FWS-R6-ES-2022-0150; FF09E21000-256-FXES11130900000]</DEPDOC>
                <SUBJECT>Endangered and Threatened Wildlife and Plants; 12-Month Finding for the Greater Yellowstone Ecosystem of the Grizzly Bear in the Lower-48 States</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notification of finding.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to establish and delist a Greater Yellowstone Ecosystem (GYE) distinct population segment (DPS) of the grizzly bear (
                        <E T="03">Ursus arctos horribilis)</E>
                         in the lower-48 States. After a thorough review of the best scientific and commercial data available, we find that grizzly bears in the petitioned DPS do not, on their own, represent a valid DPS. Thus, we find that the petitioned action to establish and delist a GYE DPS is not warranted at this time.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The finding in this document was made on January 15, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The finding and the supporting information that we developed for this finding, including the species status assessment report and species assessment form, are available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         under Docket No. FWS-R6-ES-2022-0150. Please submit any new information, materials, comments, or questions concerning this finding to the appropriate person, as specified under 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Hilary Cooley, Grizzly Bear Recovery Coordinator, Grizzly Bear Recovery Office, telephone: 406-243-4903, email: 
                        <E T="03">hilary_cooley@fws.gov.</E>
                         Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Previous Federal Actions</HD>
                <P>
                    Under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 
                    <E T="03">et seq.;</E>
                     hereafter, “Act”), the grizzly bear (
                    <E T="03">Ursus arctos horribilis)</E>
                     is currently listed as threatened species in the lower-48 States (40 FR 31734, July 28, 1975). We detail the original rulemaking and our subsequent actions for the species in our species status assessment (SSA) report (Service 2024, pp. 74-76) and summarize the relevant actions for this finding below.
                </P>
                <P>On June 30, 2017, we finalized a rule to establish the Greater Yellowstone Ecosystem (GYE) distinct population segment (DPS) of the grizzly bear and remove it from the Federal List of Endangered and Threatened Wildlife (List) due to recovery (82 FR 30502). However, in 2018, the U.S. District Court for the District of Montana vacated and remanded the 2017 delisting rule, putting the GYE grizzly bear population back on the List (as threatened) as part of the lower-48 States listed entity. As a result, the List does not currently include an entry for a GYE DPS. On March 30, 2021, we completed a 5-year status review for the grizzly bear in the lower-48 States in which we concluded that the listed entity should retain its status as a threatened species under the Act (Service 2021, entire).</P>
                <P>On January 21, 2022, we received a petition from the State of Wyoming (petitioner) to revise the listed entity of grizzly bear under the Act. The petition requested that we: (1) establish a GYE DPS; and (2) remove it from the List (“delist”), asserting that the GYE DPS did not meet the definition of an endangered or threatened species. On February 6, 2023, we published a 90-day finding (88 FR 7658) that the petition contained substantial information indicating that establishing and delisting a GYE DPS may be warranted. This document and our supporting species assessment form constitutes our 12-month finding on the January 21, 2022, petition to establish and delist a GYE DPS of grizzly bear under the Act.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Under section 4(b)(3)(B) of the Act (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ), we are required to make a finding, within 12 months after receiving any petition that we have determined contains substantial scientific or commercial information indicating that the petitioned action may be warranted, as to whether the petitioned action is warranted, not 
                    <PRTPAGE P="3764"/>
                    warranted, or warranted but precluded by other pending proposals (known as a “12-month finding”). We must publish a notification of this 12-month finding in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>
                    This document announces the not-warranted finding on the petition for the GYE grizzly bear population in accordance with the regulations at 50 CFR 424.14(h)(2)(i). In this document, we have also elected to include a summary of the analysis on which this finding is based. This supporting information can be found on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     under Docket No. FWS-R6-ES-2022-0150 (see 
                    <E T="02">ADDRESSES</E>
                    , above). We provide the full analysis, including our rationale and the data on which the finding is based, in the decisional file for the petition and our subsequent findings. The species assessment form contains an explanation of why we determined that grizzly bears in the petitioned DPS do not, on their own, represent a valid listable entity such that the petitioned actions are not warranted at this time. The following is a summary of the documents containing this full analysis.
                </P>
                <HD SOURCE="HD1">Listable Entity Requirements</HD>
                <P>
                    Under the Act, the term “species” includes any subspecies of fish or wildlife or plants, and any distinct population segment of any vertebrate fish or wildlife which interbreeds when mature (16 U.S.C. 1532(16)). To interpret and implement the distinct population segment (DPS) provisions of the Act, the Service and the National Oceanic and Atmospheric Administration published in the 
                    <E T="04">Federal Register</E>
                     the Policy Regarding the Recognition of Distinct Vertebrate Population Segments Under the Endangered Species Act on February 7, 1996 (61 FR 4722) (DPS Policy). Under the DPS Policy, we consider three elements to determine whether to classify a population of a vertebrate species as a DPS: (1) the discreteness of the population segment in relation to the remainder of the species to which it belongs; (2) the significance of the population segment to the species to which it belongs; and (3) the population segment's conservation status in relation to the Act's standard for listing, delisting, or reclassification. The Policy requires that a population segment meet both the discreteness and significance elements to be considered a valid DPS (
                    <E T="03">i.e.,</E>
                     a valid listable entity) and only then may we consider whether the DPS warrants listing under the Act.
                </P>
                <HD SOURCE="HD1">Summary of Biological Information</HD>
                <P>The grizzly bear is a large, long-lived mammal that occurs in a variety of habitat types in portions of Idaho, Montana, Washington, and Wyoming. Grizzly bears are light brown to nearly black and are so named for their “grizzled” coats with silver or golden tips. Grizzly bears in the GYE population and the lower-48 States need access to large, intact blocks of land with limited human influence that provide cover, high-caloric foods, dens, and areas for dispersal. The specific quality and quantity of these resources influence the ability of individual grizzly bears to reproduce, grow, and survive at different life stages and for the GYE population to be resilient or to withstand stochastic events (Service 2024, pp. 99-101). Our SSA report provides our full account of the life history, ecology, range, and historical and current distribution for the grizzly bear in the GYE population and the lower-48 States (Service 2024, pp. 39-73).</P>
                <HD SOURCE="HD1">Summary of Information From the Petition</HD>
                <P>The petitioner requests that we establish a DPS for the GYE grizzly bear population (GYE DPS). Specifically, the petitioner requests that we establish a GYE DPS within the same geographic boundary that we established as a DPS in our June 30, 2017, final rule (82 FR 30502), which was subsequently vacated. The petitioner did not provide a new geographic delineation for the petitioned GYE DPS and instead referenced the boundary for the GYE DPS that we described in 2017 (hereafter, 2017 GYE DPS). In their arguments to support delisting, the petitioner indicates that the GYE grizzly bear population's range has expanded, including a four-fold increase in the occupied range since the time of listing in 1975. The species assessment form provides additional summary of the information presented in the petition, including a map of the petitioned 2017 GYE DPS.</P>
                <HD SOURCE="HD1">Summary of Finding</HD>
                <P>In determining whether to recognize the petitioned DPS as a valid listable entity under the Act, we must base our decision on the best scientific and commercial data available. Since 2017, the abundance, distribution, and dispersal of grizzly bears within and surrounding the GYE has increased. New information supports the petitioner's claim that the GYE population has increased in size and distribution, so much so that grizzly bears have dispersed and expanded beyond the western boundary of the 2017 GYE DPS. The occupied range of the grizzly bear in both the GYE and the Northern Continental Divide Ecosystem (NCDE) located to the north of the GYE, has steadily expanded over time. From 2016 to 2022, occupied range in the GYE increased by 4 percent (Dellinger et al. 2023, pp. 22-23) and the NCDE increased by 19 percent (Costello et al. 2023, p. 13). As a result, the distance between these occupied ranges has decreased and continues to shrink. Models indicate that the GYE and NCDE are currently only 98 kilometers (61 miles) apart, within grizzly bear dispersal distance (Service 2024, p. 54).</P>
                <P>In the June 30, 2017, final rule, we stated that the DPS Policy does not require absolute separation of one population from another and that occasional interchange does not undermine the discreteness of potential DPSs (82 FR 30502 at 30518). While we still agree with this statement, the 2022 estimated occupied range of the GYE population now extends beyond the 2017 GYE DPS western boundary. We expect this trend to increase over time.</P>
                <P>Additionally, as the populations expand, individual grizzly bears are dispersing into new areas outside the estimated occupied range. Since 2017, there have been 190 verified observations of grizzly bears outside of the current estimated occupied range of grizzly bear populations in the lower-48 States. Currently, genetic studies have confirmed that at least two grizzly bears originating from the GYE population have dispersed beyond the 2017 GYE DPS border (IGBST, unpublished data). We have also verified 86 observations of grizzly bears outside of the 2017 GYE DPS boundaries and within potential connectivity pathways to the NCDE (NCDE Management Zone 2 (NCDE Subcommittee 2020, entire)) and to the Bitterroot Ecosystem (Sells et al. 2023, p. 6).</P>
                <P>
                    These occurrences outside of areas considered occupied range are becoming increasingly common, particularly in areas immediately to the north and west of the 2017 GYE DPS. While in most cases the source population of such grizzly bears is unknown, a number of them likely originated from the GYE population, given their close proximity to the GYE. The locations of these verified observations reveal the leading edges of grizzly bear expansion within and between ecosystems (see Service 2024, Fig. 1) (Dellinger et al. 2023, pp. 22-23). With the increasing trends of population growth and expansion over the last 7 years, we anticipate range expansion 
                    <PRTPAGE P="3765"/>
                    and dispersal events to continue under current management, including the protections of the Act, such that natural connectivity between the NCDE population and GYE population will likely occur in the near future (Service 2024, p. 54).
                </P>
                <P>To summarize, information provided by the petitioner and the best scientific and commercial data available indicate that grizzly bear abundance, distribution, and dispersal have increased, and grizzly bears have expanded beyond the 2017 GYE DPS boundary. As a result, the petitioned DPS identified in 2017 is no longer based on the best scientific and commercial data available and is obsolete. As populations have grown and expanded, grizzly bears have dispersed beyond the 2017 GYE DPS boundary, often into areas considered to be previously unoccupied.</P>
                <P>Under our DPS Policy, a population segment of a vertebrate species may be considered discrete if it satisfies either of the following two conditions: (1) it is markedly separated from other populations of the same taxon as a consequence of physical, physiological, ecological, or behavioral factors (quantitative measures of genetic or morphological discontinuity may provide evidence of this separation); or (2) it is delimited by international governmental boundaries within which significant differences in control of exploitation, management of habitat, conservation status, or regulatory mechanisms exist that are significant in light of section 4(a)(1)(D) of the Act. In determining whether the test for discreteness has been met under the DPS policy, we allow but do not require genetic evidence to be used.</P>
                <P>Although the DPS Policy does not require absolute separation of one population from another, (82 FR 30502, June 30, 2017, p. 30518), the standard for discreteness must allow us to distinguish between the DPS and other members of the species for purposes of administering and enforcing the Act (61 FR 4722, February 7, 1996, p. 4724). As summarized above, the best scientific and commercial data available indicate that the estimated occupied range of the grizzly bear population in the GYE has expanded since 2017. The NCDE population has also expanded its range, and the two populations are increasingly closer in proximity. Due to this expansion, which is expected to continue in the future under current management, including the protections of the Act, we no longer consider the 2017 GYE DPS to be discrete, as grizzly bears have dispersed and expanded to such an extent that it is not markedly separate from other members of the taxon. Because grizzly bears within the boundaries of the 2017 GYE DPS described by the petitioner are not markedly separated from other populations of the taxon, it does not meet the discreteness element in the DPS Policy as a consequence of physical, physiological, ecological, or behavioral factors (61 FR 4722, February 7, 1996). Therefore, we find that grizzly bears in the 2017 GYE DPS do not, on their own, represent a valid DPS and we therefore do not consider the status of grizzly bears in this petitioned entity as a separately listable entity under the Act. Accordingly, we find that the petitioned action to establish and delist the GYE DPS is not warranted.</P>
                <P>We are in the process of fully evaluating the latest information regarding the status of the grizzly bear in the lower-48 States in a rulemaking expected by January 31, 2026. This rulemaking is pursuant to a settlement agreement associated with the State of Idaho's petition to delist the grizzly bear in the lower-48 States. That rulemaking, to either remove or revise the currently listed entity of the grizzly bear in the lower-48 States, will fully evaluate the best scientific and commercial data available, which could include potential DPSs, while considering potential population segment's conservation status and Congress's direction to exercise DPSs sparingly and only when the biological evidence indicates that such action is warranted. The trends of increasing distribution and dispersal point to the need for a broader, holistic evaluation at the rangewide level, which will be completed as part of the rulemaking already underway. Consistent with the DPS Policy, that analysis will require careful consideration of the extent to which formerly isolated populations are connected, or likely to be connected, and the need for connectivity to small or isolated populations and unoccupied recovery zones, given the best and most recent biological data available that support a durable recovered grizzly bear in the lower-48 States.</P>
                <HD SOURCE="HD1">Peer Review</HD>
                <P>
                    In accordance with our July 1, 1994, peer review policy (59 FR 34270; July 1, 1994) and the Service's August 22, 2016, Director's Memo on the Peer Review Process, we solicited independent scientific reviews of the information contained in the SSA report for the grizzly bear in the lower-48 States. Results of this structured peer review process can be found at 
                    <E T="03">https://www.regulations.gov.</E>
                     We incorporated the results of these reviews, as appropriate, into the SSA report, which is the scientific foundation for this finding.
                </P>
                <HD SOURCE="HD1">References Cited</HD>
                <P>
                    A list of the references cited in this petition finding is available in the species assessment form, which is available on the internet at 
                    <E T="03">http://www.regulations.gov</E>
                     under Docket No. FWS-R6-ES-2022-0150 (see 
                    <E T="02">ADDRESSES</E>
                    , above).
                </P>
                <HD SOURCE="HD1">Authors</HD>
                <P>The primary authors of this document are staff members of the Grizzly Bear Recovery Office, Ecological Services Program.</P>
                <HD SOURCE="HD1">Authority</HD>
                <P>
                    The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Martha Williams,</NAME>
                    <TITLE>Director, U.S. Fish and Wildlife Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00325 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <CFR>50 CFR Part 17</CFR>
                <DEPDOC>[Docket No. FWS-R8-ES-2024-0131; FXES1111090FEDR-256-FF09E21000]</DEPDOC>
                <RIN>RIN 1018-BH71</RIN>
                <SUBJECT>Endangered and Threatened Wildlife and Plants; Designation of Critical Habitat for the San Francisco Bay-Delta Distinct Population Segment of the Longfin Smelt</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        We, the U.S. Fish and Wildlife Service (Service), propose to designate critical habitat for the San Francisco Bay-Delta distinct population segment (DPS) of the longfin smelt (
                        <E T="03">Spirinchus thaleichthys</E>
                        ), a fish species from the San Francisco Bay estuary in California, under the Endangered Species Act of 1973, as amended (Act). In total, approximately 91,630 acres (37,082 hectares) in California fall within the boundaries of the proposed critical habitat designation. We also announce the availability of an economic analysis of the proposed designation of critical habitat for the species.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        We will accept comments received or postmarked on or before March 17, 2025. Comments submitted 
                        <PRTPAGE P="3766"/>
                        electronically using the Federal eRulemaking Portal (see 
                        <E T="02">ADDRESSES</E>
                        , below) must be received by 11:59 p.m. eastern time on the closing date. We must receive requests for a public hearing, in writing, at the address shown in 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         by March 3, 2025.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments by one of the following methods:</P>
                    <P>
                        (1) 
                        <E T="03">Electronically:</E>
                         Go to the Federal eRulemaking Portal: 
                        <E T="03">https://www.regulations.gov.</E>
                         In the Search box, enter FWS-R8-ES-2024-0131, which is the docket number for this rulemaking. Then, click on the Search button. On the resulting page, in the panel on the left side of the screen, under the Document Type heading, check the Proposed Rule box to locate this document. You may submit a comment by clicking on “Comment.”
                    </P>
                    <P>
                        (2) 
                        <E T="03">By hard copy:</E>
                         Submit by U.S. mail to: Public Comments Processing, Attn: FWS-R8-ES-2024-0131, U.S. Fish and Wildlife Service, MS: PRB/3W, 5275 Leesburg Pike, Falls Church, VA 22041-3803.
                    </P>
                    <P>
                        We request that you send comments only by the methods described above. We will post all comments on 
                        <E T="03">https://www.regulations.gov.</E>
                         This generally means that we will post any personal information you provide us (see Information Requested, below, for more information).
                    </P>
                    <P>
                        <E T="03">Availability of supporting materials:</E>
                         Supporting materials, such as the species status assessment report and 100-word summary of this proposed rule, are available at 
                        <E T="03">https://www.regulations.gov</E>
                         at Docket No. FWS-R8-ES-2024-0131. For the proposed critical habitat designation, the coordinates or plot points or both from which the maps are generated are included in the decision file for this critical habitat designation and are available at 
                        <E T="03">https://www.regulations.gov</E>
                         at Docket No. FWS-R8-ES-2024-0131.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Donald Ratcliff, Field Supervisor, U.S. Fish and Wildlife Service, San Francisco Bay-Delta Fish and Wildlife Office, 650 Capitol Mall Suite 8-300, Sacramento, CA 95814; telephone 916-930-5603. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. Please see Docket No. FWS-R8-ES-2024-0131 on 
                        <E T="03">https://www.regulations.gov</E>
                         for a document that summarizes this proposed rule.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Executive Summary</HD>
                <P>
                    <E T="03">Why we need to publish a rule.</E>
                     Under the Act, a determination that a species is endangered or threatened requires that we must designate the species' critical habitat to the maximum extent prudent and determinable. We published a final rule in the 
                    <E T="04">Federal Register</E>
                     listing the San Francisco Bay-Delta distinct population segment (DPS) of the longfin smelt (
                    <E T="03">Spirinchus thaleichthys</E>
                    ) (Bay-Delta longfin smelt) as an endangered species on July 30, 2024 (89 FR 61029). We are now proposing to designate its critical habitat. Making a critical habitat designation can be completed only by issuing a rule through the Administrative Procedure Act rulemaking process (5 U.S.C. 551 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <P>
                    <E T="03">What this document does.</E>
                     We propose to designate critical habitat for the San Francisco Bay-Delta DPS of the longfin smelt (
                    <E T="03">Spirinchus thaleichthys</E>
                    ).
                </P>
                <P>
                    <E T="03">The basis for our action.</E>
                     Section 4(a)(3) of the Act requires that the Secretary of the Interior (Secretary), to the maximum extent prudent and determinable, designate critical habitat for listed species. Section 3(5)(A) of the Act defines critical habitat as (i) the specific areas within the geographical area occupied by the species, at the time it is listed, on which are found those physical or biological features (I) essential to the conservation of the species and (II) which may require special management considerations or protections; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination by the Secretary that such areas are essential for the conservation of the species. Section 4(b)(2) of the Act states that the Secretary must make the designation on the basis of the best scientific data available and after taking into consideration the economic impact, the impact on national security, and any other relevant impacts of specifying any particular area as critical habitat.
                </P>
                <HD SOURCE="HD1">Information Requested</HD>
                <P>We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:</P>
                <P>(1) Specific information on:</P>
                <P>(a) Biological or ecological requirements of the Bay-Delta longfin smelt, including habitat requirements for feeding, breeding, rearing, and sheltering;</P>
                <P>(b) The amount and distribution of the Bay-Delta longfin smelt's habitat;</P>
                <P>
                    (c) Any additional areas occurring within the range of the species in the San Francisco Bay estuary (
                    <E T="03">e.g.,</E>
                     Petaluma River, South San Francisco Bay) and ocean areas outside the Golden Gate, that should be included in the designation because the areas (i) were occupied at the time of listing and contain the physical or biological features that are essential to the conservation of the species and that may require special management considerations or protection, or (ii) were unoccupied at the time of listing and are essential for the conservation of the species;
                </P>
                <P>(d) Special management considerations or protection that may be needed in critical habitat areas we are proposing, including managing for the potential effects of climate change.</P>
                <P>(2) Land use designations and current or planned activities in the subject areas and their possible impacts on proposed critical habitat.</P>
                <P>(3) Any probable economic, national security, or other relevant impacts of designating any area that may be included in the final designation, and the related benefits of including or excluding specific areas.</P>
                <P>(4) Information on the extent to which the description of probable economic impacts in the draft economic analysis is a reasonable estimate of the likely economic impacts and any additional information regarding probable economic impacts that we should consider.</P>
                <P>(5) Whether any specific areas we are proposing for critical habitat designation should be considered for exclusion under section 4(b)(2) of the Act, and whether the benefits of potentially excluding any specific area outweigh the benefits of including that area under section 4(b)(2) of the Act. If you think we should exclude any areas, please provide information supporting a benefit of exclusion.</P>
                <P>(6) Whether we could improve or modify our approach to designating critical habitat in any way to provide for greater public participation and understanding, or to better accommodate public concerns and comments.</P>
                <P>
                    Please include sufficient information with your submission (such as scientific 
                    <PRTPAGE P="3767"/>
                    journal articles or other publications) to allow us to verify any scientific or commercial information you include.
                </P>
                <P>Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, do not provide substantial information necessary to support a determination. Section 4(b)(2) of the Act directs that the Secretary shall designate critical habitat on the basis of the best scientific data available.</P>
                <P>
                    You may submit your comments and materials concerning this proposed rule by one of the methods listed in 
                    <E T="02">ADDRESSES</E>
                    . We request that you send comments only by the methods described in 
                    <E T="02">ADDRESSES</E>
                    .
                </P>
                <P>
                    If you submit information via 
                    <E T="03">https://www.regulations.gov,</E>
                     your entire submission—including any personal identifying information—will be posted on the website. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>
                    Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>Our final designation may differ from this proposal because we will consider all comments we receive during the comment period as well as any information that may become available after this proposal. Based on the new information we receive (and, if relevant, any comments on that new information), our final critical habitat designation may not include all areas proposed, may include some additional areas that meet the definition of critical habitat, or may exclude some areas if we find the benefits of exclusion outweigh the benefits of inclusion and exclusion will not result in the extinction of the species. In our final rule, we will clearly explain our rationale and the basis for our final decision, including why we made changes, if any, that differ from this proposal.</P>
                <HD SOURCE="HD2">Public Hearing</HD>
                <P>
                    Section 4(b)(5) of the Act provides for a public hearing on this proposal, if requested. Requests must be received by the date specified in 
                    <E T="02">DATES</E>
                    . Such requests must be sent to the address shown in 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    . We will schedule a public hearing on this proposal, if requested, and announce the date, time, and place of the hearing, as well as how to obtain reasonable accommodations, in the 
                    <E T="04">Federal Register</E>
                     and local newspapers at least 15 days before the hearing. We may hold the public hearing in person or virtually via webinar. We will announce any public hearing on our website, in addition to the 
                    <E T="04">Federal Register</E>
                    . The use of virtual public hearings is consistent with our regulations at 50 CFR 424.16(c)(3).
                </P>
                <HD SOURCE="HD1">Previous Federal Actions</HD>
                <P>
                    On October 7, 2022, we published in the 
                    <E T="04">Federal Register</E>
                     a proposed rule to list the Bay-Delta longfin smelt as endangered (87 FR 60957). On February 27, 2023, we reopened the comment period on the proposed rule for 30 days and announced an online public hearing, which took place March 14, 2023 (88 FR 12304). Our final rule determining endangered species status for the Bay-Delta longfin smelt was published in the 
                    <E T="04">Federal Register</E>
                     on July 30, 2024 (89 FR 61029). In our 2022 proposed listing rule, we stated that the designation of critical habitat was not determinable due to the lack of incremental economic impact information. We have since obtained the necessary economic information and are now proposing critical habitat. Please see the 2022 proposed listing rule and 2024 final listing rule (citations above in this paragraph) for additional information on previous Federal actions.
                </P>
                <HD SOURCE="HD1">Peer Review</HD>
                <P>A species status assessment (SSA) team prepared an SSA report for the Bay-Delta longfin smelt (Service 2024, entire). The SSA team was composed of Service biologists, in consultation with other species experts including those from the California Department of Fish and Wildlife (CDFW). The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the Bay-Delta longfin smelt, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species.</P>
                <P>
                    In accordance with our joint policy on peer review published in the 
                    <E T="04">Federal Register</E>
                     on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review in listing and recovery actions under the Act, we solicited independent scientific review of the information contained in the draft SSA report (Service 2021, entire). We sent the draft SSA report to five independent peer reviewers and received three responses. Results of this structured peer review process can be found at 
                    <E T="03">https://www.regulations.gov.</E>
                     A summary of the peer review comments and our response to those comments can be found in the final listing rule (see 89 FR 61029; July 30, 2024, Peer Review section). Prior to preparing the proposed and final listing rules, we incorporated the results of these reviews as well as comments and information received from public comment, as appropriate, into the current (2024) SSA report. The information within the 2024 SSA report forms the foundation for this proposed critical habitat rule.
                </P>
                <HD SOURCE="HD1">Critical Habitat</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>Critical habitat is defined in section 3 of the Act as:</P>
                <P>(1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features</P>
                <P>(a) Essential to the conservation of the species, and</P>
                <P>(b) Which may require special management considerations or protection; and</P>
                <P>(2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.</P>
                <P>
                    Our regulations at 50 CFR 424.02 define the geographical area occupied by the species as an area that may generally be delineated around species' occurrences, as determined by the Secretary (
                    <E T="03">i.e.,</E>
                     range). Such areas may include those areas used throughout all or part of the species' life cycle, even if not used on a regular basis (
                    <E T="03">e.g.,</E>
                     migratory corridors, seasonal habitats, and habitats used periodically, but not solely by vagrant individuals).
                </P>
                <P>Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.</P>
                <P>
                    Critical habitat receives protection under section 7 of the Act through the 
                    <PRTPAGE P="3768"/>
                    requirement that each Federal action agency ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of designated critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation also does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Rather, designation requires that, where a landowner requests Federal agency funding or authorization for an action that may affect an area designated as critical habitat, the Federal agency consult with the Service under section 7(a)(2) of the Act. If the action may affect the listed species itself (such as for occupied critical habitat), the Federal agency would have already been required to consult with the Service even absent the designation because of the requirement to ensure that the action is not likely to jeopardize the continued existence of the species. Even if the Service were to conclude after consultation that the proposed activity is likely to result in destruction or adverse modification of the critical habitat, the Federal action agency and the landowner are not required to abandon the proposed activity, or to restore or recover the species; instead, they must implement “reasonable and prudent alternatives” to avoid destruction or adverse modification of critical habitat.
                </P>
                <P>Under the first prong of the Act's definition of critical habitat, areas within the geographical area occupied by the species at the time it was listed are included in a critical habitat designation if they contain physical or biological features (1) which are essential to the conservation of the species and (2) which may require special management considerations or protection. For these areas, critical habitat designations identify, to the extent known using the best scientific data available, those physical or biological features that are essential to the conservation of the species (such as space, food, cover, and protected habitat).</P>
                <P>Under the second prong of the Act's definition of critical habitat, we can designate critical habitat in areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.</P>
                <P>
                    Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific data available. Further, our Policy on Information Standards Under the Endangered Species Act (published in the 
                    <E T="04">Federal Register</E>
                     on July 1, 1994 (59 FR 34271)), the Information Quality Act (section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658)), and our associated Information Quality Guidelines provide criteria, establish procedures, and provide guidance to ensure that our decisions are based on the best scientific data available. They require our biologists, to the extent consistent with the Act and with the use of the best scientific data available, to use primary and original sources of information as the basis for recommendations to designate critical habitat.
                </P>
                <P>When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information compiled in the SSA report and information developed during the listing process for the species. Additional information sources may include any generalized conservation strategy, criteria, or outline that may have been developed for the species; the recovery plan for the species; articles in peer-reviewed journals; conservation plans developed by States and counties; scientific status surveys and studies; biological assessments; other unpublished materials; or experts' opinions or personal knowledge.</P>
                <P>Habitat is dynamic, and species may move from one area to another over time. We recognize that critical habitat designated at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not be needed for recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will continue to be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act; (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species; and (3) the prohibitions found in section 9 of the Act. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. These protections and conservation tools will continue to contribute to recovery of the species. Similarly, critical habitat designations made on the basis of the best scientific data available at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans (HCPs), or other species conservation planning efforts if new information available at the time of those planning efforts calls for a different outcome.</P>
                <HD SOURCE="HD1">Physical or Biological Features Essential to the Conservation of the Species</HD>
                <P>
                    In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12(b), in determining which areas we will designate as critical habitat from within the geographical area occupied by the species at the time of listing, we consider the physical or biological features that are essential to the conservation of the species and which may require special management considerations or protection. The regulations at 50 CFR 424.02 define “physical or biological features essential to the conservation of the species” as the features that occur in specific areas and that are essential to support the life-history needs of the species, including, but not limited to, water characteristics, soil type, geological features, sites, prey, vegetation, symbiotic species, or other features. A feature may be a single habitat characteristic or a more complex combination of habitat characteristics. Features may include habitat characteristics that support ephemeral or dynamic habitat conditions. Features may also be expressed in terms relating to principles of conservation biology, such as patch size, distribution distances, and connectivity. For example, physical features essential to the conservation of the species might include gravel of a particular size required for spawning, alkaline soil for seed germination, protective cover for migration, or susceptibility to flooding or fire that maintains necessary early-successional habitat characteristics. Biological features might include prey species, forage grasses, specific kinds or ages of trees for roosting or nesting, symbiotic fungi, or absence of a particular level of nonnative species consistent with conservation needs of the listed species. The features may also be combinations of habitat characteristics and may encompass the relationship between characteristics or the necessary amount of a characteristic essential to support the life history of the species.
                    <PRTPAGE P="3769"/>
                </P>
                <P>In considering whether features are essential to the conservation of the species, we may consider an appropriate quality, quantity, and spatial and temporal arrangement of habitat characteristics in the context of the life-history needs, condition, and status of the species. These characteristics include, but are not limited to, space for individual and population growth and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction, or rearing (or development) of offspring; and habitats that are protected from disturbance.</P>
                <HD SOURCE="HD2">Bay-Delta Longfin Smelt Description, Distribution, and Habitat Requirements</HD>
                <P>Below is a summary of the description, distribution, and habitat requirements of the Bay-Delta longfin smelt. For a more thorough discussion of this information as well as information on the species' ecology, life history, and habitat needs, please see the SSA report (Service 2024, chapter 2, pp. 9-27).</P>
                <BILCOD>BILLING CODE 4333-15-P</BILCOD>
                <GPH SPAN="3" DEEP="354">
                    <GID>EP15JA25.000</GID>
                </GPH>
                <BILCOD>BILLING CODE 4333-15-C</BILCOD>
                <P>
                    The longfin smelt is a small fish 9 to 11 centimeters (cm) (3.5 to 4.3 inches (in)) in length with a relatively short lifespan of approximately 2 to 3 years. The longfin smelt, as a species, occurs in bays and estuaries from northern California north along the coast through Alaska. The Bay-Delta DPS of the longfin smelt occupies the entire San Francisco Bay estuary and areas of the Pacific Ocean outside the Golden Gate (see figure 1 above) depending on time of year and lifestage. The Bay-Delta longfin smelt does not occur outside of the San Francisco Bay estuary or the near ocean areas in large numbers, and there does not appear to be substitutable habitat outside of currently occupied areas (
                    <E T="03">e.g.,</E>
                     salinity, water temperature); therefore, we have determined that proposing critical habitat in unoccupied areas is unnecessary, as these areas likely would not represent suitable habitat nor contribute to conservation of the Bay-Delta longfin smelt.
                </P>
                <P>
                    The tidally influenced San Francisco Bay estuary includes the central and south San Francisco Bay, San Pablo Bay, and Suisun Bay (and their tributaries), the Sacramento and San Joaquin River Delta (Delta), and near-shore ocean waters outside the Golden Gate from the Marin headlands to the mouth of Tomales Bay into the Gulf of the Farallones (CDFW 2009, pp. 6-9). The San Francisco Bay estuary is a complex and dynamic system exhibiting a wide range of salinities, temperatures, and habitats. Tidal movement and freshwater inputs from the Sacramento River and San Joaquin River as well as local tributaries are two major drivers of estuary conditions. Incoming high-salinity tides and freshwater flows combine in creating a longitudinal and vertical salinity gradient. Water temperature is also influenced by tidal and freshwater inflow as well as wind, precipitation, and air temperatures. This salinity gradient and water temperature variability exert a strong physical and biological influence in the estuary and 
                    <PRTPAGE P="3770"/>
                    dictates habitat use by different life stages of Bay-Delta longfin smelt.
                </P>
                <P>The Bay-Delta longfin smelt is a facultatively anadromous species, meaning some older juveniles and adults may migrate to the ocean to seek cooler water temperatures, but adults return to less saline water for spawning activities to meet egg laying, hatching, larval development, and juvenile growth requirements.</P>
                <P>
                    <E T="03">Water Temperature Conditions:</E>
                     Bay-Delta longfin smelt most frequently occur in cold- and cool-water habitats within the San Francisco Bay estuary (Jeffries et al. 2016, p. 1712; Yanagitsuru et al. 2021, fig. 1, p. 5). Adults are thought to be limited by water temperature of approximately &gt;22 degrees Celsius (°C) (&gt;72 degrees Fahrenheit (°F)) during the summer and are likely to spend the majority of this time in cooler water habitats of the San Francisco Bay and near-shore ocean areas. In general, fish over a year in age inhabit lower temperature water than fish below a year in age, although both age classes inhabit water temperature between 16-18 °C (61-64 °F) in the summer and fall (Baxter 1999, fig. 8, p. 191). In the fall and early winter as water temperatures in the estuary decline, Bay-Delta longfin smelt return upstream to the estuary to seek appropriate spawning areas where water conditions are favorable for egg survival. These conditions vary by location depending on delta outflow, freshwater flow from tributaries, water salinity conditions, and other environmental conditions. See Spawning Conditions below for information on egg and larvae water temperature conditions.
                </P>
                <P>
                    <E T="03">Water Turbidity Conditions:</E>
                     Turbidity, or the amount of suspended particles in the water, is an important habitat characteristic for the Bay-Delta longfin smelt. Turbidity in aquatic environments is similar to fog in terrestrial environments in that the greater the distance an object is from an individual the more obscure it becomes (Utne-Palm 2002, p. 115; Pangle et al. 2012, pp. 10-11). Turbid waters assist fish such as the Bay-Delta longfin smelt by making it less visible to predators and making its prey (which are relatively translucent) more visible against the backdrop of the particles in the water (Utne-Palm 2002, pp. 122-123). In laboratory studies, Bay-Delta longfin smelt larvae had higher survival rates in more turbid water measured at 40 NTU (nephelometric turbidity units) and grew larger at 20 NTU and 40 NTU as opposed to 10 NTU (Yanagitsuru 2020, entire).
                </P>
                <P>
                    <E T="03">Water Salinity Conditions:</E>
                     Although spawning behavior of longfin smelt has not been observed in the San Francisco Bay estuary, it is believed that spawning behavior is similar to that of the Lake Washington population in Washington State, where adults make overnight runs into tributaries of the lake then return to the lake before dawn (Dryfoos 1965, p. 61; Moulton 1974, pp. 49-50). For the Bay-Delta longfin smelt this would entail adult longfin smelt making short runs upstream into fresh-water areas of the Delta, tributaries, or into areas of the San Francisco Bay (Suisun Bay, San Pablo Bay, or South Bay) that have low-salinity water and appropriate water temperature conditions (CDFW 2009, pp. 11-12; Rosenfield 2010, p. 8). One laboratory study has identified a salinity tolerance below 32 parts per thousand (ppt) with larvae surviving the longest and having the largest growth at lower salinity levels between 5 and 10 ppt (Yanagitsuru et al. 2022, p. 6). Another study identified that Bay-Delta longfin smelt can successfully spawn and rear in a range of low salinity (0.4-5 ppt), with fertilization being greatest at lower salinity levels (Rahman et al. 2023, pp. 7-8). Field studies have identified salinity levels between 2-4 ppt as having the greatest density of larvae (4-9 millimeter (mm) (0.16-0.35 in) in length) (Grimaldo et al. 2017, p. 8).
                </P>
                <P>
                    <E T="03">Spawning Conditions:</E>
                     Bay-Delta longfin smelt spawn only once in their lifetime but may have multiple spawning events during that single period depending on habitat conditions. Spawning, reproduction, and rearing occurs in low-salinity to freshwater habitats beginning in late fall/early winter and extends into the spring as water temperature and low-salinity conditions allow. The freshwater flow into the estuary as well as other environmental conditions and geomorphology greatly influence the habitat conditions, spawning success, and food availability for the Bay-Delta longfin smelt.
                </P>
                <P>Observations of yolk-sac staged larvae suggest spawning habitat extends from the tidal reaches of the Sacramento and San Joaquin Rivers to Suisun Bay and Suisun Marsh as well as tributaries to San Pablo Bay, and in the sloughs of Coyote Creek in the South Bay, although recruitment success in San Pablo Bay tributaries and the South Bay was confirmed only during wet years (Wang 1986, pp. 113-121; Meng and Matern 2001, p. 755; Grimaldo et al. 2017, p. 6; Lewis et al. 2019, p. 31; Lewis et al. 2020, p. 1). Spawning substrate is composed of sandy or gravel substrates, rocks, or aquatic plants (Wang 1986, p. 113; Moyle 2002, p. 236; CDFW 2009, pp. 12, 16). Laboratory studies have identified that Bay-Delta longfin smelt release more eggs onto sand (approximately 94 percent) as opposed to gravel (approximately 6 percent) (CDFW 2009, p. 11). In one study, high river flows during egg incubation were associated with poor recruitment, whereas increased river flows later in the season—during the hatching period—were associated with greater recruitment (Chigbu 2000, pp. 549-554).</P>
                <P>Spawning activity for Bay-Delta longfin smelt can begin as early as November and extends until late June, although spawning more typically occurs from December through April based on ripe females and when the presence of yolk-sac larvae have been observed in the environment (Radtke 1966, p. 116; Hieb and Baxter 1993, p. 110; Moyle 2002, p. 236; CDFW 2009, p. 10). Water temperature plays an important role in triggering spawning activity. Although spawning can start once water temperatures drop below 16 °C (60.8 °F) (CDFW 2009, p. 11), other information suggests lower water temperatures may be more ideal (Baxter 2016, entire; Tempel and Burns 2021, slide 12). Lab studies have identified a minimum spawning temperature of 5.6 °C (41 °F) (Wang 1986, pp. 6-9) and reduced size of larvae and decrease in reproduction success near or above 15 °C (59 °F) (Yanagitsuru et al. 2021, Figure 1 and 3a, pp. 5 and 7). Within the San Francisco Bay estuary, spawning occurs when water temperature drops below ~14 °C (57.2 °F) and becomes consistent when water temperatures remain 13 °C or lower (55.4 °F) (CDFW 2009, p. 11; Baxter 2016, entire; Grimaldo et al. 2017, p. 8).</P>
                <P>
                    <E T="03">Larval Habitat Use:</E>
                     The majority of larvae are affiliated with the estuary's major low salinity zone (LSZ) generated by the mixing of freshwater outflow from the Delta with the brackish waters of the estuary (Service 2024, section 2.3, p. 11, and p. 20). However, larvae can also be found in tributaries when flows from those tributaries are high enough and temperatures low enough to support egg survival and hatching (Lewis et al. 2019, p. 3). The spatial distribution of these larvae reflects the year-to-year variation in the geographic location of the LSZ (Dege and Brown 2004, fig. 3, p. 57; Grimaldo et al. 2020, fig. 6, p. 10).
                </P>
                <P>
                    <E T="03">Juvenile and Adult Habitat Use:</E>
                     Aggregated survey data have shown that juveniles (&gt;20 mm in length) have been detected at one time or another throughout the estuary and into some tributaries to the Delta above tidal influence and have been collected most frequently from deeper water habitats as opposed to shoals or shoreline areas (Rosenfield and Baxter 2007, p. 1586; Merz et al. 2013, fig. 2, p. 132). 
                    <PRTPAGE P="3771"/>
                    Regardless of where spawning takes place and embryos develop, the spatial distribution of juveniles and adults shows a distinct seaward migration as water temperatures warm in the late spring and early summer in the Delta and upstream portions of the San Francisco Bay estuary (Rosenfield and Baxter 2007, p. 1590). However, in any given month, survey data indicate that some fraction of the Bay-Delta longfin smelt population remains in the San Francisco Bay with an unknown fraction moving out to the ocean off the coast of San Francisco (Rosenfield and Baxter 2007, p. 1590; Merz et al. 2013, p. 142; Garwood 2017, pp. 98-104).
                </P>
                <P>
                    <E T="03">Food Resources:</E>
                     Larval Bay-Delta longfin smelt select strongly for the calanoid copepod 
                    <E T="03">Eurytemora affinis</E>
                     as prey; all other prey types combined account for only about 10 percent of their diet (Barros et al. 2022, fig. 6a and 6c, p. 10). When longfin smelt reach about 25 mm (1 in) in length, their diet switches and is nearly all mysids (small shrimp-like crustaceans) (Barros et al. 2022, fig. 6b, p. 10). This finding of a highly specified diet applies to fresh- and brackish-water habitats throughout the estuary (Barros et al. 2022, fig. 2. p. 2). Bay-Delta longfin smelt larvae and small juveniles appear to focus on only two prey taxa. Larvae less than about 25 mm (1 in) in length appear to primarily feed on the copepod 
                    <E T="03">Eurytemora affinis.</E>
                     The same is true for larvae and small juveniles larger than 25 mm in length, which appear to prey most often on mysids. Bay-Delta longfin smelt adults that return to Suisun Marsh also show a strong dietary preference for mysids while relying on other copepods and amphipods when mysids are less abundant (CDFW unpub. Diet Study Data; Feyrer et al. 2003, p. 281; Burdi 2022, entire).
                </P>
                <HD SOURCE="HD2">Summary of Essential Physical or Biological Features</HD>
                <P>
                    The ecological conditions within the water areas of the San Francisco Bay estuary are complex and dynamic and exhibit a wide range of salinities, temperatures, and habitats as the result of tidal movement of ocean water, freshwater inputs from the Sacramento and San Joaquin Rivers and local tributaries, wind conditions, and air temperature. We derive the specific physical or biological features essential to the conservation of the Bay-Delta longfin smelt from studies of the species' habitat, ecology, and life history as described above. We focused our designation on areas that contained the appropriate physical or biological features needed by the species for successful spawning and rearing and that provide larvae sufficient food resources to grow and mature as described in our conservation strategy for determining critical habitat for the Bay-Delta longfin smelt (see Criteria Used to Identify Critical Habitat below). Although areas outside the designation, such as the Pacific Ocean or areas within the Sacramento-San Joaquin Delta, are used by the species and are important in providing appropriate life history conditions for adults and may provide for limited reproduction in years with extreme freshwater inflow, the majority of appropriate spawning conditions, spawning, and larval development occurs within the area we have identified as critical habitat. Additional information can be found in the SSA report (Service 2024, entire; available on 
                    <E T="03">https://www.regulations.gov</E>
                     under Docket No. FWS-R8-ES-2022-0082). The physical or biological features (PBFs) essential to the conservation of the Bay-Delta longfin smelt are comprised of water temperature, salinity, turbidity, food resources, substrate, and hydrologic conditions capable of supporting Bay-Delta longfin smelt spawning and rearing as well as larval and juvenile development. Within the San Francisco Bay estuary, different areas of the critical habitat unit provide all of the physical or biological features essential to the conservation of Bay-Delta longfin smelt, but not all of the features occur in all portions of the unit at all times. During various times of the year, different areas of the estuary provide the following essential physical or biological features:
                </P>
                <P>
                    <E T="03">PBF 1, Water temperature requirements:</E>
                     Water temperature ranges to support reproduction, growth, and survival of the Bay-Delta longfin smelt at different life stages to include:
                </P>
                <P>(A) Estuary water temperatures below 13 °Celsius (°C) (55.4 °F (°F)) from December through May to initiate and support successful spawning;</P>
                <P>(B) Estuary water temperatures less than 15 °C (59.0 °F) from December through May for egg development, hatching success, and early larval development;</P>
                <P>(C) Estuary water temperatures less than 20 °C (60.0 °F) from February through June for larvae 40 days post hatch and older to support growth and avoid physiological stress; and</P>
                <P>(D) Estuary and nearshore ocean water temperatures less than 22 °C (71.6 °F) year-round for juveniles and adults to support growth and avoid physiological stress.</P>
                <P>
                    <E T="03">PBF 2, Water salinity requirements:</E>
                     Suitable salinity concentrations to support successful reproduction, growth, and recruitment; such ranges include:
                </P>
                <P>(A) Salinity conditions between 2-4 parts per thousand (ppt) from December through May to support average larval salinity requirements; and</P>
                <P>(B) Salinity conditions between 0.4-10 ppt from December through May to support diversity of egg and early larval rearing conditions.</P>
                <P>
                    <E T="03">PBF 3, Water turbidity requirements:</E>
                     Turbidity greater than 20 nephelometric turbidity units to optimize feeding and predator avoidance.
                </P>
                <P>
                    <E T="03">PBF 4, Food resource requirements:</E>
                     Food resources in abundances that support growth and recruitment of all life stages; these food resources include, but are not limited to:
                </P>
                <P>
                    (A) The copepod 
                    <E T="03">Eurytemora affinis,</E>
                     the primary prey item supporting larvae less than 25 mm (approximately 1 inch length);
                </P>
                <P>
                    (B) Mysids including 
                    <E T="03">Neomysis mercedis</E>
                     and 
                    <E T="03">Hyperacanthomysis longirostris,</E>
                     and other amphipods, the primary prey items supporting juveniles and larvae greater than 25 mm in length (approximately 1 inch length); and
                </P>
                <P>(C) Prey of various zooplankton species such as those identified in paragraphs (A) and (B) of this entry for juveniles and adults.</P>
                <P>
                    <E T="03">PBF 5, Substrate requirements:</E>
                     Substrate composed mostly of sandy habitat, although portions may include gravel substrates, rocks, or aquatic plants that provide suitable habitat for spawning, protection, cover, and development of eggs and larvae.
                </P>
                <P>
                    <E T="03">PBF 6, Hydrologic requirements:</E>
                     Contemporaneous with the appropriate seasonal needs by life stage of the species, inflow into the estuary of appropriate freshwater to provide the appropriate water salinity, temperature, and turbidity conditions as well as food resources set forth in PBFs 1-4 above.
                </P>
                <HD SOURCE="HD1">Special Management Considerations or Protection</HD>
                <P>
                    When designating critical habitat, we assess whether the specific areas within the geographical area occupied by the species at the time of listing contain features which are essential to the conservation of the species and which may require special management considerations or protection. The features essential to the conservation of the Bay-Delta longfin smelt may require special management considerations or protections to address: (1) habitat alteration within and adjacent to water areas; (2) changes to hydrology associated with reduced and altered freshwater flows and resulting increases in saline habitat conditions; (3) increased water temperatures associated 
                    <PRTPAGE P="3772"/>
                    with altered flow regimes or climate change conditions; (4) reduced food resource availability due to inappropriate water conditions or introduction of nonnative species; and (5) introduction of pollutants and other sources of contaminants that may degrade water quality conditions or impact food resources.
                </P>
                <P>Special management considerations or protection that could address these threats include, but are not limited to: (1) implement best management practices to reduce impacts associated with habitat alteration such as bank hardening, levee maintenance, and channel dredging or reduction of sand sources; (2) consider water management to mimic functional flow regimes (timing, intensity, and duration of flows), especially during periods of low flow or drought conditions; (3) consider water management to maintain appropriate water temperature conditions for all life stages of the Bay-Delta longfin smelt; (4) implement monitoring and other actions to prevent or limit introduction of nonnative species into the estuary that may reduce or alter food resources for the Bay-Delta longfin smelt; and (5) monitor and manage water quality to assist in reducing the amount of pollutants entering the estuary.</P>
                <HD SOURCE="HD1">Criteria Used To Identify Critical Habitat</HD>
                <P>
                    As required by section 4(b)(2) of the Act, we use the best scientific data available to designate critical habitat. In accordance with the Act and our implementing regulations at 50 CFR 424.12(b), we review available information pertaining to the habitat requirements of the species and identify specific areas within the geographical area occupied by the species at the time of listing and any specific areas outside the geographical area occupied by the species to be considered for designation as critical habitat. We are not currently proposing to designate any areas outside the geographical area occupied by the Bay-Delta longfin smelt because we have not identified any unoccupied areas that meet the definition of critical habitat. The range of the Bay-Delta longfin smelt is only a portion of the range occupied by the species. The Bay-Delta longfin smelt as a DPS currently occupies the full extent of its identified range within the San Francisco Bay estuary and ocean areas outside the Golden Gate to the Farallon Islands depending on the time of year, life stage, and environmental conditions (see figure 1 in 
                    <E T="03">Bay-Delta Longfin Smelt Description, Distribution, and Habitat Requirements</E>
                     above).
                </P>
                <P>The sources of data used to determine and delineate the critical habitat for the Bay-Delta longfin smelt included: (1) the SSA report and references therein pertaining to the habitat needs of the DPS (Service 2024, entire); (2) Bay-Delta longfin smelt spawning and rearing habitat utilized during the winter/spring, fresher water phase of the life cycle as determined by study of the LSZ based on published data; (3) U.S. Geological Survey (USGS) National Hydrography Dataset (NHD) for California for the San Francisco Bay estuary and associated river systems and shorelines; (4) USGS digital ortho-photo quarter-quadrangles base layer map using Universal Transverse Mercator (UTM) Zone 10N coordinates, which was used to delineate the critical habitat unit; and (5) Environmental Systems Research Institute's (ESRI's) Aeronautical Reconnaissance Coverage Geographical Information System (ArcGIS) online basemap aerial imagery, which was used to cross-check the base layer map. Land ownership or management information was obtained from digitized surface land management data managed by the Bureau of Land Management.</P>
                <P>In order to determine the specific areas within the geographical area occupied by the species at the time of listing on which are found those PBFs essential to the conservation of the species and delineating the critical habitat unit boundaries, we developed a conservation strategy. Below we summarize our strategy and criteria for this designation. Please see the full description of our strategy for additional information (Service 2023a, entire).</P>
                <P>The goal of our conservation strategy for this critical habitat designation is to identify the specific areas within the Bay-Delta longfin smelt's range that provide essential physical or biological features; without these areas, range-wide resiliency, redundancy, and representation could not be achieved. The strategy focuses on the fundamental parameters of the species' biology and ecology based on well-accepted conservation-biology and ecological principles for conserving species and their habitats, such as those described by Carroll et al. (1996, pp. 1-12); Meffe and Carroll (1997, pp. 347-383); Shaffer and Stein (2000, pp. 301-321); Natural Resources Conservation Service (NRCS) 2004 (entire); Tear et al. (2005, pp. 835-849); Groom et al. (2006, entire); and Wolf et al. (2015, pp. 200-207).</P>
                <P>In developing our conservation strategy, we focused on increasing the resiliency of Bay-Delta longfin smelt by improving the DPS's abundance. To this end, our conservation strategy and rule set for determining critical habitat for the Bay-Delta longfin smelt looked at conserving and maintaining those areas within the San Francisco Bay estuary that provide sufficient amount of high-quality spawning and rearing habitat with appropriate physical and hydrological characteristics to provide for recruitment over the long term. We considered the habitat and conditions necessary for successful recruitment of individuals to the different life stages of the species. The Bay-Delta longfin smelt relies on the San Francisco Bay estuary and the unique suite of environmental conditions it provides for spawning, larval rearing, juvenile growth, and maturation.</P>
                <P>Salinity and water temperature are two primary factors that determine the distribution of the Bay-Delta longfin smelt in the estuary and are especially important for spawning and rearing life stages. Both salinity and water temperature conditions are influenced by freshwater input, primarily from the San Joaquin and Sacramento Rivers. The species uses most of the estuary during its life cycle, focusing spawning and larval rearing in the more landward LSZ, and juvenile growth and maturation at greater salinities typical of the more seaward areas of the estuary. The location and extent of the LSZ and suitable spawning and rearing habitat varies annually depending on the magnitude, timing, and duration of freshwater inputs into the estuary. Numerous studies have shown a positive and persistent correlation between longfin smelt juvenile abundance indices and freshwater flow (Stevens and Miller 1983, pp. 431-432; Jassby et al. 1995, p. 285; Sommer et al. 2007, p. 274; Thomson et al. 2010, pp. 1439-1440; Kimmerer 2002, p. 47; Rosenfield and Baxter 2007, p. 1585; Kimmerer et al. 2009, p. 381; Mac Nally et al. 2010, p. 1422; Maunder et al. 2015, p. 108; Nobriga and Rosenfield 2016, p. 53; Kimmerer and Gross 2022, p. 2734).</P>
                <P>
                    While the overall pattern relating freshwater flows to abundance indices for the Bay-Delta longfin smelt is widely accepted, the mechanisms driving this correlation are not fully quantified or resolved. Potential mechanisms have been identified and include how freshwater may affect spawning locations, the duration of the spawning season, the transport of eggs and larvae downstream to favorable rearing habitats, the location of the LSZ and larval and young juvenile retention, entrainment of larvae and juveniles, prey availability for larvae and juveniles, prey delivery, and turbidity of the LSZ (for further information see SSA section 3.1.1.). These mechanisms likely 
                    <PRTPAGE P="3773"/>
                    act in concert and influence recruitment in a manner determined by prevailing freshwater conditions. Our critical habitat designation was informed by the relationship between these mechanisms and freshwater inputs into the estuary.
                </P>
                <P>With this information, we have determined that the specific areas occupied by the species that provide spawning and rearing habitat that is utilized by the Bay-Delta longfin smelt during the fresher-water phase of the life cycle in the winter/spring period are the focus of our critical habitat designation. Without appropriate areas for spawning and rearing of offspring, the Bay-Delta longfin smelt would not be able to sustain populations in the wild. Therefore, we initially follow the PBFs to predict distribution, using salinity at these key life stages, as the primary predictive factor. These areas were determined by using the best available scientific information on the approximation of the LSZ of the San Francisco Bay-Delta, using the 95 percent occurrence interval (actual observed values) of X2 values between January through May for water years stretching the last nine decades (Hutton et al. 2017a, entire; Hutton et al. 2017b, entire). X2 is defined as the location (in kilometers) along a linear axis stretching from the Golden Gate Bridge eastwards into the Sacramento/San Joaquin River Delta where salinity measures two practical salinity units. This representation is a static estimate of a very dynamic phenomenon, as outflow and tidal dynamics influence this metric such that the actual position of X2 fluctuates in space and time. We also included areas within the Napa River that contain those low salinity habitat areas that were contiguous with the data on LSZ for the San Francisco Bay-Delta. Additional information on our conservation strategy can be found in our PBF and conservation strategy document (Service 2023a, entire)</P>
                <P>
                    The area identified as critical habitat is occupied during the spawning and rearing life stage (~January through May) and contains those physical or biological features essential to the conservation of the Bay-Delta longfin smelt reflecting the habitat characteristics required by pre-spawning adults, eggs, larvae, and early juveniles of the Bay-Delta longfin smelt for survival and successful reproduction. The Bay-Delta longfin smelt does not occur outside of the San Francisco Bay estuary or the near ocean, and there does not appear to be substitutable habitat outside of currently occupied areas (
                    <E T="03">e.g.,</E>
                     salinity, water temperature); therefore, we have determined that proposing critical habitat in unoccupied areas is unnecessary, as these areas likely would not represent suitable habitat nor contribute to conservation of the Bay-Delta longfin smelt.
                </P>
                <P>When determining proposed critical habitat boundaries, we made every effort to avoid including developed areas such as lands covered by buildings, pavement, and other structures because such lands lack physical or biological features necessary for the Bay-Delta longfin smelt. Because the designation focuses on water areas, very little if any developed areas such as buildings or other structures are included in the designation. However, any such lands inadvertently left inside critical habitat boundaries shown on the maps of this proposed rule are excluded by text in the proposed rule and are not proposed for designation as critical habitat. Therefore, if the critical habitat is finalized as proposed, a Federal action involving these lands would not trigger section 7 consultation with respect to critical habitat and the requirement of no adverse modification unless the specific action would affect the physical or biological features in the adjacent critical habitat.</P>
                <P>
                    We propose to designate as critical habitat areas that we have determined are occupied at the time of listing (
                    <E T="03">i.e.,</E>
                     currently occupied) and contain one or more of the physical or biological features that are essential to support life-history processes of the Bay-Delta longfin smelt.
                </P>
                <P>The proposal includes one unit for designation based on one or more of the physical or biological features being present to support the Bay-Delta longfin smelt's life-history processes. This unit contains all of the identified physical or biological features and supports the Bay-Delta longfin smelt's particular use of that habitat.</P>
                <P>
                    The proposed critical habitat designation is defined by the map, as modified by any accompanying regulatory text, presented at the end of this document under Proposed Regulation Promulgation. We include more detailed information on the boundaries of the critical habitat designation in the preamble of this document. We will make the coordinates or plot points or both on which the map is based available to the public on 
                    <E T="03">https://www.regulations.gov</E>
                     at Docket No. FWS-R8-ES-2024-0131 and on our internet site at 
                    <E T="03">https://www.fws.gov/office/san-francisco-bay-delta-fish-and-wildlife/,</E>
                     and at the field office responsible for the designation (see 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    ).
                </P>
                <HD SOURCE="HD1">Proposed Critical Habitat Designation</HD>
                <P>We are proposing to designate one unit of approximately 91,630 ac (37,082 ha) as critical habitat for the Bay-Delta longfin smelt, identified as the San Francisco Bay-Delta Unit (see table below). The critical habitat area we describe below constitutes our current best assessment of areas that meet the definition of critical habitat for the Bay-Delta longfin smelt.</P>
                <GPOTABLE COLS="5" OPTS="L2,p1,8/9,i1" CDEF="s30,r60,12,12,xs45">
                    <TTITLE>Table 1—Proposed Critical Habitat Unit for the Bay-Delta Longfin Smelt</TTITLE>
                    <TDESC>[Area estimates reflect all water and land within the critical habitat unit boundary]</TDESC>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1"> </CHED>
                        <CHED H="1"> </CHED>
                        <CHED H="1"> </CHED>
                        <CHED H="1"> </CHED>
                    </BOXHD>
                    <ROW RUL="s">
                        <ENT I="25">Critical habitat unit</ENT>
                        <ENT>Land ownership by type</ENT>
                        <ENT A="01">Size of unit in acres/hectares</ENT>
                        <ENT>Occupied?</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">San Francisco Bay-Delta</ENT>
                        <ENT>Federal</ENT>
                        <ENT>20</ENT>
                        <ENT>8</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>State</ENT>
                        <ENT>257</ENT>
                        <ENT>104</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Local government</ENT>
                        <ENT>7</ENT>
                        <ENT>3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Non-profit/nongovernmental organization</ENT>
                        <ENT>49</ENT>
                        <ENT>20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Undetermined Shoreline</ENT>
                        <ENT>913</ENT>
                        <ENT>370</ENT>
                    </ROW>
                    <ROW RUL="n,n,s,s,n">
                        <ENT I="22"> </ENT>
                        <ENT>Undetermined waters</ENT>
                        <ENT>90,384</ENT>
                        <ENT>36,578</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT O="oi3">Total</ENT>
                        <ENT>91,630</ENT>
                        <ENT>37,082</ENT>
                    </ROW>
                    <TNOTE>
                        <E T="02">Note:</E>
                         Area sizes may not sum due to rounding.
                    </TNOTE>
                </GPOTABLE>
                <PRTPAGE P="3774"/>
                <P>We present a brief description of the unit, and reasons why it meets the definition of critical habitat for the Bay-Delta longfin smelt, below.</P>
                <HD SOURCE="HD2">San Francisco Bay-Delta Unit</HD>
                <P>The San Francisco Bay-Delta Unit consists of 91,630 ac (37,082 ha) in total and is made up of 1,246 ac (504 ha) of shoreline area and 90,384 ac (36,578 ha) of stream and estuary water area within the San Francisco Bay estuary within Contra Costa, Napa, Sacramento, Solano, and Sonoma Counties, California. The unit extends from the numerous tributaries flowing into the Suisun Bay near the confluence of the Sacramento and San Joaquin Rivers at Sherman Island downstream approximately 7 to 10 miles (mi) (10 to 16 kilometers (km)) into San Pablo Bay near Point Pinole (Contra Costa County) and Midshipman Point at Tubbs Island (Sonoma County).</P>
                <P>
                    Ownership of shoreline areas within the proposed designation includes the U.S. Fish and Wildlife Service (20 ac (8 ha)), California Department of Fish and Wildlife (181 ac (73 ha)), California State Parks (3 ac (1.1 ha)), California Department of Water Resources (45 ac (18 ha)), California State Lands Commission (29 ac (12 ha)), local government (7 ac (3 ha)), and nonprofit and nongovernmental organizations (49 ac (20 ha)). Additionally, the proposed designation includes water areas of the San Francisco Bay estuary totaling approximately 90,384 ac (36,578 ha) of undetermined ownership. We have exempted Department of Defense (DoD) areas owned, managed, and controlled by the U.S. Army Military Ocean Terminal Concord (MOTCO) totaling approximately 753 ac (304 ha) under section 4(a)(3)(B)(i) of the Act (see Exemptions 
                    <E T="03">Application of Section 4(a)(3) of the Act,</E>
                     below).
                </P>
                <P>The unit was occupied by the species at the time of listing and is still occupied. Seasonally, this unit contains all the identified PBFs essential to the conservation of the Bay-Delta longfin smelt. Particularly, those PBFs reflecting the habitat characteristics required by pre-spawning adults, eggs, larvae, and early juveniles for survival and successful reproduction are geographically associated with this area. The identified specific critical habitat areas may require special management considerations or protection to address activities that impact the PBFs identified for the Bay-Delta longfin smelt and may include those activities associated with habitat alteration (such as dredging, shoreline protection activities, or levee maintenance); changes to hydrology associated with reduced and altered freshwater flows and its resulting potential increases in saline habitat conditions; increased water temperatures; reduced food resource availability; and activities that introduce or increase pollutants and other contaminants into the estuary.</P>
                <HD SOURCE="HD1">Effects of Critical Habitat Designation</HD>
                <HD SOURCE="HD2">Section 7 Consultation</HD>
                <P>Section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of designated critical habitat of such species. In addition, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any agency action which is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of proposed critical habitat.</P>
                <P>Destruction or adverse modification means a direct or indirect alteration that appreciably diminishes the value of critical habitat as a whole for the conservation of a listed species (50 CFR 402.02).</P>
                <P>Compliance with the requirements of section 7(a)(2) is documented through our issuance of:</P>
                <P>(1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or</P>
                <P>(2) A biological opinion for Federal actions that may affect, and are likely to adversely affect, listed species or critical habitat.</P>
                <P>When we issue a biological opinion concluding that a project is likely to jeopardize the continued existence of a listed species and/or destroy or adversely modify critical habitat, we provide reasonable and prudent alternatives to the project, if any are identifiable, that would avoid the likelihood of jeopardy and/or destruction or adverse modification of critical habitat. We define “reasonable and prudent alternatives” (at 50 CFR 402.02) as alternative actions identified during formal consultation that:</P>
                <P>(1) Can be implemented in a manner consistent with the intended purpose of the action,</P>
                <P>(2) Can be implemented consistent with the scope of the Federal agency's legal authority and jurisdiction,</P>
                <P>(3) Are economically and technologically feasible, and</P>
                <P>(4) Would, in the Service Director's opinion, avoid the likelihood of jeopardizing the continued existence of the listed species or avoid the likelihood of destroying or adversely modifying critical habitat.</P>
                <P>Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.</P>
                <P>
                    Regulations at 50 CFR 402.16 set forth requirements for Federal agencies to reinitiate consultation. Reinitiation of consultation is required and shall be requested by the Federal agency, where discretionary Federal involvement or control over the action has been retained or is authorized by law and: (1) if the amount or extent of taking specified in the incidental take statement is exceeded; (2) if new information reveals effects of the action that may affect listed species or critical habitat in a manner or to an extent not previously considered; (3) if the identified action is subsequently modified in a manner that causes an effect to the listed species or critical habitat that was not considered in the biological opinion or written concurrence; or (4) if a new species is listed or critical habitat designated that may be affected by the identified action. As provided in 50 CFR 402.16, the requirement to reinitiate consultations for new species listings or critical habitat designation does not apply to certain agency actions (
                    <E T="03">e.g.,</E>
                     land management plans issued by the Bureau of Land Management in certain circumstances).
                </P>
                <HD SOURCE="HD2">Destruction or Adverse Modification of Critical Habitat</HD>
                <P>The key factor related to the destruction or adverse modification determination is whether implementation of the proposed Federal action directly or indirectly alters the designated critical habitat in a way that appreciably diminishes the value of the critical habitat for the conservation of the listed species. As discussed above, the role of critical habitat is to support physical or biological features essential to the conservation of a listed species and provide for the conservation of the species.</P>
                <P>
                    Section 4(b)(8) of the Act requires that our 
                    <E T="04">Federal Register</E>
                     documents “shall, to the maximum extent practicable, also include a brief description and evaluation of those activities (whether public or private) which, in the opinion of the Secretary, if undertaken may adversely modify such [critical] habitat, or may be affected by such designation.” Activities that may be affected by 
                    <PRTPAGE P="3775"/>
                    designation of critical habitat for the Bay-Delta longfin smelt include those that may affect the physical or biological features of the Bay-Delta longfin smelt's critical habitat. See the sections above on Physical or Biological Features Essential to the Conservation of the Species and Special Management Considerations or Protection for additional information.
                </P>
                <HD SOURCE="HD1">Exemptions</HD>
                <HD SOURCE="HD2">Application of Section 4(a)(3) of the Act</HD>
                <P>The Sikes Act Improvement Act of 1997 (Sikes Act) (16 U.S.C. 670a) required each military installation that includes land and water suitable for the conservation and management of natural resources to complete an integrated natural resources management plan (INRMP) by November 17, 2001. An INRMP integrates implementation of the military mission of the installation with stewardship of the natural resources found on the base. Each INRMP includes:</P>
                <P>(1) An assessment of the ecological needs on the installation, including the need to provide for the conservation of listed species;</P>
                <P>(2) A statement of goals and priorities;</P>
                <P>(3) A detailed description of management actions to be implemented to provide for these ecological needs; and</P>
                <P>(4) A monitoring and adaptive management plan.</P>
                <P>Among other things, each INRMP must, to the extent appropriate and applicable, provide for fish and wildlife management; fish and wildlife habitat enhancement or modification; wetland protection, enhancement, and restoration where necessary to support fish and wildlife; and enforcement of applicable natural resource laws.</P>
                <P>The National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 108-136) amended the Act to limit areas eligible for designation as critical habitat. Specifically, section 4(a)(3)(B)(i) of the Act (16 U.S.C. 1533(a)(3)(B)(i)) provides that the Secretary shall not designate as critical habitat any lands or other geographical areas owned or controlled by the Department of Defense, or designated for its use, that are subject to an integrated natural resources management plan prepared under section 101 of the Sikes Act (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species for which critical habitat is proposed for designation.</P>
                <P>We consult with the military on the development and implementation of INRMPs for installations with listed species. We analyzed INRMPs developed by military installations located within the range of the proposed critical habitat designation for the Bay-Delta longfin smelt to determine if they meet the criteria for exemption from critical habitat under section 4(a)(3) of the Act. The following areas are Department of Defense (DoD) lands with completed, Service-approved INRMPs within the areas preliminarily identified as meeting the definition of critical habitat.</P>
                <HD SOURCE="HD2">Approved INRMPs</HD>
                <P>U.S. Army Military Ocean Terminal Concord (MOTCO), Contra Costa and Solano Counties, California, 753 ac (304 ha).</P>
                <P>Within the areas preliminarily identified as meeting the definition of critical habitat for the Bay-Delta longfin smelt, we identified a portion of shoreline (50 ac (20 ha)) and water area (703 ac (284 ha)) (753 ac (304 ha) total) of the San Francisco Bay estuary owned, controlled, and managed by the U.S. Army Military Surface Deployment and Distribution Command's 834th Transportation Battalion, which manages and operates the U.S. Army Military Ocean Terminal Concord (MOTCO). MOTCO is the primary munitions trans-shipment facility for the DoD on the West Coast of the United States.</P>
                <P>The U.S. Army received full management authority for MOTCO on October 1, 2008, as a result of the 2005 Base Realignment and Closure process. Prior to this, MOTCO was a tenant command to Naval Weapon Station Seal Beach Detachment (NWSSBD) Concord, operating under the U.S. Navy. Military lands on MOTCO include a total of 6,641 ac (2,688 ha) of uplands, shoreline, and island areas adjacent to or within Suisun Bay in Contra Costa and Solano Counties, California. Other military lands formerly belonging to the NWSSBD have been declared surplus and have been operationally closed and transferred to the City of Concord.</P>
                <P>In August 2023, staff at MOTCO in coordination with the Service and U.S. Department of Commerce National Oceanic and Atmospheric Administration-Fisheries, West Coast Region (NOAA) finalized and signed the Final MOTCO Integrated Natural Resources Management Plan (INRMP) (U.S. Army Corps of Engineers 2023, entire).</P>
                <P>The INRMP provides the staff of MOTCO with an adaptive plan for managing natural resources to support and be consistent with the military mission while protecting and enhancing those natural resources for multiple use and ecological integrity. The INRMP is designed to meet statutory requirements of the Sikes Act as amended as well as manage and implement measures concerning conservation, protection, and management of fish and wildlife resources. The total area owned by the DoD at MOTCO includes inland areas (115 ac (47 ha)) and tidal areas (6,242 ac (2,526 ha)). The tidal area comprises a mainland operational portion and island areas that include approximately 5 miles (8 kilometers) of mainland shoreline; three ocean terminal piers and facilities for reception, staging, and loading of ammunition; railroad infrastructure; and the Los Medanos Hills. Approximately 703 ac (284 ha) of water area of the San Francisco Bay estuary are restricted use areas controlled by MOTCO that are used for docking and loading of vessels for military purposes. The offshore islands consist of approximately 2,045 ac (828 ha). The offshore islands and most of the marshlands within the tidal area at MOTCO are part of a wetland preserve area, established through a memorandum of understanding between the U.S. Navy and the Service (U.S. Navy and U.S. Fish and Wildlife Service 1984, entire). The islands are undeveloped, except for natural gas wells operated on the southern shore of Ryer Island operated by Chevron U.S.A. Inc. (California Department of Conservation 1982, pp. 1-11, 250). The mainland operational area is composed of old and new buildings, roads, and other developed infrastructure and landscaping.</P>
                <P>The overall goal of the MOTCO INRMP is to integrate natural resources stewardship and compliance responsibilities with operational requirements to sustain the military mission at MOTCO as well as develop, initiate, and maintain programs for the conservation, utilization, and rehabilitation of natural resources at MOTCO. The following measures, objectives, and management strategies that have been identified and implemented to further the goal include:</P>
                <P>• Ensure compliance with applicable Federal laws and regulations as they pertain to natural resources.</P>
                <P>• Maintain and enhance biodiversity within the constraints of the military mission.</P>
                <P>• Implement adaptive management strategies using flexible and responsive management techniques based upon scientific data gathered from monitoring programs, literature, and resource experts.</P>
                <P>
                    • Conserve the quality of habitat for Federal and State-listed endangered and threatened species.
                    <PRTPAGE P="3776"/>
                </P>
                <P>• Maintain sufficient natural resources support personnel to implement, oversee, and monitor the management strategies of the INRMP.</P>
                <P>• Provide for an institutional memory and Geographic Information System (GIS) based data inventory that may be used as a framework for future resources personnel to make installation management decisions.</P>
                <P>• Maintain the distributions of sensitive plant and animal species and native plant communities, as well as their relationships to tidal hydrology and landscape features, until they become progressively better understood.</P>
                <P>• Maintain or enhance levels of biodiversity and habitat quality on the installation.</P>
                <P>
                    • Maintain or enhance tidally influenced marsh habitats capable of supporting viable populations of the federally listed salt marsh harvest mouse (
                    <E T="03">Reithrodontomys raviventris</E>
                    ), California Ridgway's rail (
                    <E T="03">Rallus obsoletus obsoletus</E>
                    ), and State listed California black rail (
                    <E T="03">Laterallus jamaicensis coturniculus</E>
                    ).
                </P>
                <P>• Maintain landscape-scale native habitat diversity and species richness.</P>
                <P>
                    • Monitor, control, and eventually eliminate the spread of nonnative invasive aquatic and marsh species, such as Brazilian waterweed (
                    <E T="03">Egeria densa</E>
                    ) and perennial pepperweed (
                    <E T="03">Lepidium latifolium</E>
                    ), to enhance native aquatic and wetland communities.
                </P>
                <P>• Adaptively manage approximately 3,227 ac (1,306 ha) of tidal wetlands at MOTCO using an improved understanding of the installation's tidal hydrology and its effects on native species diversity and habitat quality, as well as maintain and improve wetland functions and values.</P>
                <P>• Continue management of the Wetland Preserve Area in collaboration with the Service and coordinate with other stakeholders on tidal wetland management issues.</P>
                <P>• Ensure hydrologic regimes and erosion rates reflect natural conditions on-site.</P>
                <P>MOTCO has shown a track record of implementing conservation actions related to their activities that protect and maintain habitat for sensitive species including reducing erosion and run-off into the estuary, protecting water quality, and managing, conserving, and protecting wetland and estuary habitat adjacent to the San Francisco Bay-Delta and areas occupied by the Bay-Delta longfin smelt. The conservation efforts identified in the INRMP and being implemented by MOTCO will provide a benefit to the Bay-Delta longfin smelt by reducing or eliminating negative water quality impacts from erosion, maintaining tidally influenced wetland habitat adjacent to the bay, providing better water conditions for the DPS's food resources, and adaptively managing tidal wetlands to maintain and improve wetland functions and values.</P>
                <P>Based on the above considerations, and in accordance with section 4(a)(3)(B)(i) of the Act, we have determined that the identified lands are subject to the MOTCO INRMP and that conservation efforts identified in the INRMP will provide a benefit to the Bay-Delta longfin smelt. Therefore, lands within this installation are exempt from critical habitat designation under section 4(a)(3) of the Act. We are not including approximately 753 ac (304 ha) of shoreline and water habitat used by the Bay-Delta longfin smelt in this proposed critical habitat designation because of this exemption.</P>
                <HD SOURCE="HD1">Consideration of Impacts Under Section 4(b)(2) of the Act</HD>
                <P>Section 4(b)(2) of the Act states that the Secretary shall designate and make revisions to critical habitat on the basis of the best available scientific data after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from designated critical habitat based on economic impacts, impacts on national security, or any other relevant impacts. Exclusion decisions are governed by the regulations at 50 CFR 424.19 and the Policy Regarding Implementation of Section 4(b)(2) of the Endangered Species Act (hereafter, the “2016 Policy”; 81 FR 7226, February 11, 2016), both of which were developed jointly with the National Marine Fisheries Service (NMFS). We also refer to a 2008 Department of the Interior Solicitor's opinion entitled “The Secretary's Authority to Exclude Areas from a Critical Habitat Designation under Section 4(b)(2) of the Endangered Species Act” (M-37016).</P>
                <P>In considering whether to exclude a particular area from the designation, we identify the benefits of including the area in the designation, identify the benefits of excluding the area from the designation, and evaluate whether the benefits of exclusion outweigh the benefits of inclusion. If the analysis indicates that the benefits of exclusion outweigh the benefits of inclusion, the Secretary may exercise discretion to exclude the area only if such exclusion would not result in the extinction of the species. In making the determination to exclude a particular area, the statute on its face, as well as the legislative history, are clear that the Secretary has broad discretion regarding which factor(s) to use and how much weight to give to any factor. In our final rules, we explain any decision to exclude areas, as well as decisions not to exclude, to make clear the rational basis for our decision. We describe below the process that we use for taking into consideration each category of impacts and any initial analyses of the relevant impacts.</P>
                <HD SOURCE="HD2">Consideration of Economic Impacts</HD>
                <P>Section 4(b)(2) of the Act and its implementing regulations require that we consider the economic impact that may result from a designation of critical habitat. To assess the probable economic impacts of a designation, we must first evaluate specific land uses or activities and projects that may occur in the area of the critical habitat. We then must evaluate the impacts that a specific critical habitat designation may have on restricting or modifying specific land uses or activities for the benefit of the species and its habitat within the areas proposed. We then identify which conservation efforts may be the result of the species being listed under the Act versus those attributed solely to the designation of critical habitat for this particular species. The probable economic impact of a proposed critical habitat designation is analyzed by comparing scenarios both “with critical habitat” and “without critical habitat.”</P>
                <P>
                    The “without critical habitat” scenario represents the baseline for the analysis, which includes the existing regulatory and socio-economic burden imposed on landowners, managers, or other resource users potentially affected by the designation of critical habitat (
                    <E T="03">e.g.,</E>
                     under the Federal listing as well as other Federal, State, and local regulations). Therefore, the baseline represents the costs of all efforts attributable to the listing of the species under the Act (
                    <E T="03">i.e.,</E>
                     conservation of the species and its habitat incurred regardless of whether critical habitat is designated). The “with critical habitat” scenario describes the incremental impacts associated specifically with the designation of critical habitat for the species. The incremental conservation efforts and associated impacts would not be expected without the designation of critical habitat for the species. In other words, the incremental costs are those attributable solely to the designation of critical habitat, above and beyond the baseline costs. These are the costs we use when evaluating the benefits of inclusion and exclusion of particular areas from the final designation of critical habitat should we 
                    <PRTPAGE P="3777"/>
                    choose to conduct a discretionary 4(b)(2) exclusion analysis.
                </P>
                <P>Executive Orders (E.O.s) 12866 and 13563 direct Federal agencies to assess the costs and benefits of available regulatory alternatives in quantitative (to the extent feasible) and qualitative terms. Consistent with these E.O. regulatory analysis requirements, our effects analysis under the Act may take into consideration impacts to both directly and indirectly affected entities, where practicable and reasonable. If sufficient data are available, we assess to the extent practicable the probable impacts to both directly and indirectly affected entities. To determine whether the designation of critical habitat may have an economic effect of $200 million or more in any given year (which would trigger section 3(f)(1) of E.O. 12866, as amended by E.O. 14094), we used a screening analysis to assess whether a designation of critical habitat for the Bay-Delta longfin smelt is likely to exceed this threshold.</P>
                <P>
                    For this particular designation, we developed an incremental effects memorandum (IEM) considering the probable incremental economic impacts that may result from this proposed designation of critical habitat (Service 2023b, entire). The information contained in our IEM was then used to develop a screening analysis of the probable effects of the designation of critical habitat for the Bay-Delta longfin smelt (Industrial Economic Inc. (IEc) 2024, entire). We began by conducting a screening analysis of the proposed designation of critical habitat in order to focus our analysis on the key factors that are likely to result in incremental economic impacts. The purpose of the screening analysis is to filter out particular geographical areas of critical habitat that are already subject to such protections and are, therefore, unlikely to incur incremental economic impacts. In particular, the screening analysis considers baseline costs (
                    <E T="03">i.e.,</E>
                     absent critical habitat designation) and includes any probable incremental economic impacts where land and water use may already be subject to conservation plans, land management plans, best management practices, or regulations that protect the habitat area as a result of the Federal listing status of the species. Ultimately, the screening analysis allows us to focus our analysis on evaluating the specific areas or sectors that may incur probable incremental economic impacts as a result of the designation.
                </P>
                <P>The presence of the listed species in occupied areas of critical habitat means that any destruction or adverse modification of those areas is also likely to jeopardize the continued existence of the species. Therefore, designating occupied areas as critical habitat typically causes little if any incremental impacts above and beyond the impacts of listing the species. As a result, we generally focus the screening analysis on areas of unoccupied critical habitat (unoccupied units or unoccupied areas within occupied units). Overall, the screening analysis assesses whether designation of critical habitat is likely to result in any additional management or conservation efforts that may incur incremental economic impacts. This screening analysis combined with the information contained in our IEM constitute what we consider to be our economic analysis of the proposed critical habitat designation for the Bay-Delta longfin smelt and is summarized in the narrative below.</P>
                <P>As part of our screening analysis, we considered the types of economic activities that are likely to occur within the areas likely affected by the critical habitat designation. In our evaluation of the probable incremental economic impacts that may result from the proposed designation of critical habitat for the Bay-Delta longfin smelt, first we identified, in the IEM dated December 29, 2023 (Service 2023b), probable incremental economic impacts associated with the following categories of activities: (1) dredging; (2) levee construction; (3) sand mining; (4) in-water construction; (5) aquatic weed control; (6) flood/sea level rise protection projects; (7) habitat restoration projects; and (8) scientific monitoring activities. Indirect upstream impacts associated with water management or water withdrawal activities associated with water infrastructure and agriculture or municipal water use may also occur but the impacts associated with these activities would be overshadowed by the effects of climate change and reduced precipitation and water flows into the estuary. We considered each industry or category individually. Additionally, we considered whether their activities have any Federal involvement. Critical habitat designation generally will not affect activities that do not have any Federal involvement; under the Act, designation of critical habitat affects only activities conducted, funded, permitted, or authorized by Federal agencies.</P>
                <P>In areas where the Bay-Delta longfin smelt is present, Federal agencies would be required to consult with the Service under section 7 of the Act on activities they authorize, fund, or carry out that may affect the species. If we finalize this critical habitat designation as proposed, Federal agencies would be required to consider the effects of their actions on the designated habitat, and if the Federal action may affect critical habitat, our consultations would include an evaluation of measures to avoid the destruction or adverse modification of critical habitat.</P>
                <P>
                    In our IEM, we attempted to clarify the distinction between the effects that would result from the species being listed and those attributable to the critical habitat designation (
                    <E T="03">i.e.,</E>
                     difference between the jeopardy and adverse modification standards) for the Bay-Delta longfin smelt's critical habitat. Because the designation of critical habitat for Bay-Delta longfin smelt is being proposed nearly concurrently with the listing, it has been our experience that it is more difficult to discern which conservation efforts are attributable to the species being listed and those which will result solely from the designation of critical habitat. However, the following specific circumstances in this case help to inform our evaluation: (1) The essential physical or biological features identified for critical habitat are the same features essential for the life requisites of the species, and (2) any actions that would likely adversely affect the essential physical or biological features of occupied critical habitat are also likely to adversely affect the Bay-Delta longfin smelt. The IEM outlines our rationale concerning this limited distinction between baseline conservation efforts and incremental impacts of the designation of critical habitat for this species. This evaluation of the incremental effects has been used as the basis to evaluate the probable incremental economic impacts of this proposed designation of critical habitat.
                </P>
                <P>
                    The proposed critical habitat designation for the Bay-Delta longfin smelt includes a single occupied unit, totaling approximately 91,630 ac (37,082 ha). The areas being considered are shoreline areas ((less than 1 percent of the proposed designation) that are Federal (2 percent), State (21 percent), local government (1 percent), private or other non-profit areas (4 percent), and other undetermined shoreline areas (73 percent)) and a water area of undetermined ownership (over 99 percent of the proposed designation) within the San Francisco Bay-Delta. In these areas, any actions that may affect the Bay-Delta longfin smelt or its habitat would also affect the proposed critical habitat, and it is unlikely that any additional conservation efforts would be recommended to address the adverse modification standard over and above those recommended as necessary to 
                    <PRTPAGE P="3778"/>
                    avoid jeopardizing the continued existence of Bay-Delta longfin smelt. The entities most likely to incur incremental costs are parties to section 7 consultations, including Federal action agencies (such as the Bureau of Reclamation, U.S. Army Corps of Engineers, Federal Highway Administration, U.S. Fish and Wildlife Service, and U.S. Department of Agriculture) and, in some cases, third parties, most frequently State agencies, local government entities, and private land-owners. While this additional analysis will require time and resources by both the Federal action agency and the Service, in most circumstances, these costs would be administrative in nature.
                </P>
                <P>The total number of formal consultations expected to occur is between 7 and 13 consultations annually and the number of informal consultations is 7 to 15 annually (IEc 2024, Table 2, p. 12). The total incremental costs for each technical assistance interaction and informal, formal, and programmatic section 7 consultation conducted is estimated to total $440, $2,700, $5,700, and $11,000, respectively, across all Federal and third party participants. These estimates assume that consultations would occur even in the absence of critical habitat due to the presence of the listed Bay-Delta longfin smelt, and the amount of administrative effort to address critical habitat during this process is relatively minor.</P>
                <P>Applying these incremental costs to the estimated future consultations forecast, we estimate the incremental annual administrative costs of consultations pursuant to the proposed critical habitat for the Bay-Delta longfin smelt is likely between $56,500 to $120,000 per year (2024 dollars), including approximately $38,000 to $76,000 for formal consultations, and $18,000 to $42,000 for informal consultations.</P>
                <P>We are soliciting data and comments from the public on the economic analysis discussed above. During the development of a final designation, we will consider the information presented in the economic analysis and any additional information on economic impacts we receive during the public comment period to determine whether any specific areas should be excluded from the final critical habitat designation under authority of section 4(b)(2), our implementing regulations at 50 CFR 424.19, and the 2016 Policy. We may exclude an area from critical habitat if we determine that the benefits of excluding the area outweigh the benefits of including the area, provided the exclusion will not result in the extinction of this species. The benefits of designating areas as critical habitat include identifying and informing landowners and the public of which specific areas are important to a species' conservation and recovery. Critical habitat designation also raises awareness of the habitat needs of imperiled species and focuses efforts of our conservation partners.</P>
                <HD SOURCE="HD2">Consideration of National Security Impacts</HD>
                <P>
                    Section 4(a)(3)(B)(i) of the Act may not cover all DoD lands or areas that pose potential national-security concerns (
                    <E T="03">e.g.,</E>
                     a DoD installation that is in the process of revising its INRMP for a newly listed species or a species previously not covered). If a particular area is not covered under section 4(a)(3)(B)(i), then national-security or homeland-security concerns are not a factor in the process of determining what areas meet the definition of “critical habitat.” However, we must still consider impacts on national security, including homeland security, on those lands or areas not covered by section 4(a)(3)(B)(i) because section 4(b)(2) requires us to consider those impacts whenever it designates critical habitat. Accordingly, if DoD, Department of Homeland Security (DHS), or another Federal agency has requested exclusion based on an assertion of national-security or homeland-security concerns, or we have otherwise identified national-security or homeland-security impacts from designating particular areas as critical habitat, we generally have reason to consider excluding those areas.
                </P>
                <P>However, we cannot automatically exclude requested areas. When DoD, DHS, or another Federal agency requests exclusion from critical habitat on the basis of national-security or homeland-security impacts, we must conduct an exclusion analysis if the Federal requester provides information, including a reasonably specific justification of an incremental impact on national security that would result from the designation of that specific area as critical habitat. That justification could include demonstration of probable impacts, such as impacts to ongoing border-security patrols and surveillance activities, or a delay in training or facility construction, as a result of compliance with section 7(a)(2) of the Act. If the agency requesting the exclusion does not provide us with a reasonably specific justification, we will contact the agency to recommend that it provide a specific justification or clarification of its concerns relative to the probable incremental impact that could result from the designation. If we conduct an exclusion analysis because the agency provides a reasonably specific justification or because we decide to exercise the discretion to conduct an exclusion analysis, we will defer to the expert judgment of DoD, DHS, or another Federal agency as to: (1) Whether activities on its lands or waters, or its activities on other lands or waters, have national-security or homeland-security implications; (2) the importance of those implications; and (3) the degree to which the cited implications would be adversely affected in the absence of an exclusion. In that circumstance, in conducting a discretionary section 4(b)(2) exclusion analysis, we will give great weight to national-security and homeland-security concerns in analyzing the benefits of exclusion.</P>
                <P>Under section 4(b)(2) of the Act, we also consider whether a national security or homeland security impact might exist on lands owned or managed by DoD or DHS. In preparing this proposal, we have determined that, other than the land exempted under section 4(a)(3)(B)(i) of the Act based upon the existence of an approved INRMP (see Exemptions, above), the lands and water area within the proposed designation of critical habitat for the Bay-Delta longfin smelt are not owned or managed by DoD or DHS. Therefore, we anticipate no impact on national security or homeland security.</P>
                <HD SOURCE="HD2">Consideration of Other Relevant Impacts</HD>
                <P>
                    Under section 4(b)(2) of the Act, we consider any other relevant impacts, in addition to economic impacts and impacts on national security discussed above. To identify other relevant impacts that may affect the exclusion analysis, we consider a number of factors, including whether there are approved and permitted conservation agreements or plans covering the species in the area—such as safe harbor agreements (SHAs), candidate conservation agreements with assurances (CCAAs) or “conservation benefit agreement” or “conservation agreement” (“CBAs”) (CBAs are a new type of agreement replacing SHAs and CCAAs in use after April 2024 (89 FR 26070; April 12, 2024)) or HCPs—or whether there are non-permitted conservation agreements and partnerships that may be impaired by designation of, or exclusion from, critical habitat. In addition, we look at whether Tribal conservation plans or partnerships, Tribal resources, or government-to-government 
                    <PRTPAGE P="3779"/>
                    relationships of the United States with Tribal entities may be affected by the designation. We also consider any State, local, social, or other impacts that might occur because of the designation.
                </P>
                <HD SOURCE="HD1">Summary of Exclusions Considered Under 4(b)(2) of the Act</HD>
                <P>In preparing this proposal, we have determined that no HCPs or other management plans for the Bay-Delta longfin smelt currently exist, and the proposed designation does not include any Tribal lands or trust resources or any lands for which designation would have any economic or national security impacts. Therefore, we anticipate no impact on Tribal lands, partnerships, or HCPs from this proposed critical habitat designation, and thus, as described above, we are not considering excluding any particular areas on the basis of the presence of conservation agreements or impacts to trust resources.</P>
                <P>However, if through the public comment period we receive information that we determine indicates that there are potential economic, national security, or other relevant impacts from designating particular areas as critical habitat, then as part of developing the final designation of critical habitat, we will evaluate that information and may conduct a discretionary exclusion analysis to determine whether to exclude those areas under authority of section 4(b)(2) and our implementing regulations at 50 CFR 424.19. If we receive a request for exclusion of a particular area and after evaluation of supporting information we do not exclude, we will fully describe our decision in the final rule for this action.</P>
                <HD SOURCE="HD1">Required Determinations</HD>
                <HD SOURCE="HD2">Clarity of the Rule</HD>
                <P>We are required by E.O.s 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:</P>
                <P>(1) Be logically organized;</P>
                <P>(2) Use the active voice to address readers directly;</P>
                <P>(3) Use clear language rather than jargon;</P>
                <P>(4) Be divided into short sections and sentences; and</P>
                <P>(5) Use lists and tables wherever possible.</P>
                <P>
                    If you feel that we have not met these requirements, send us comments by one of the methods listed in 
                    <E T="02">ADDRESSES</E>
                    . To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.
                </P>
                <HD SOURCE="HD2">Regulatory Planning and Review (Executive Orders 12866, 13563 and 14094)</HD>
                <P>Executive Order 14094 amends and reaffirms the principles of E.O. 12866 and E.O. 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and are consistent with E.O. 12866, and E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, shall recognize distributive impacts and equity, to the extent permitted by law. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this proposed rule in a manner consistent with these requirements.</P>
                <P>Executive Order 12866, as reaffirmed by E.O. 13563 and amended and reaffirmed by E.O. 14094, provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is significant.</P>
                <HD SOURCE="HD2">Regulatory Flexibility Act (5 U.S.C. 601 et seq.)</HD>
                <P>
                    Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA; title II of Pub. L. 104-121, March 29, 1996), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effects of the rule on small entities (
                    <E T="03">i.e.,</E>
                     small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the RFA to require Federal agencies to provide a certification statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities.
                </P>
                <P>According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine whether potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.</P>
                <P>
                    Under the RFA, as amended, and as understood in light of court decisions (
                    <E T="03">see, e.g., American Trucking Ass'ns</E>
                     v. 
                    <E T="03">U.S. Envtl. Protection Agency,</E>
                     175 F.3d 1027, 1044 (D.C. Cir. 1999)), Federal agencies are required to evaluate the potential incremental impacts of rulemaking on those entities directly regulated by the rulemaking itself; in other words, the RFA does not require agencies to evaluate the potential impacts to indirectly regulated entities. The regulatory mechanism through which critical habitat protections are realized is section 7 of the Act, which requires Federal agencies, in consultation with the Service, to ensure that any action authorized, funded, or carried out by the agency is not likely to destroy or adversely modify critical habitat. Therefore, under section 7, only Federal action agencies are directly subject to the specific regulatory requirement (avoiding destruction and adverse modification) imposed by critical habitat designation. Consequently, only Federal action agencies would be directly regulated if we adopt the proposed critical habitat designation. The RFA does not require evaluation of the potential impacts to entities not directly regulated. Moreover, Federal agencies are not small entities. Therefore, because no small entities would be directly regulated by this rulemaking, the Service certifies that, if made final as proposed, the critical habitat designation will not have a significant economic impact on a substantial number of small entities.
                    <PRTPAGE P="3780"/>
                </P>
                <P>In summary, we have considered whether the proposed designation would result in a significant economic impact on a substantial number of small entities. For the above reasons and based on currently available information, we certify that, if made final, the critical habitat designation would not have a significant economic impact on a substantial number of small business entities. Therefore, an initial regulatory flexibility analysis is not required.</P>
                <HD SOURCE="HD2">Energy Supply, Distribution, or Use—Executive Order 13211</HD>
                <P>Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare statements of energy effects “to the extent permitted by law” when undertaking actions identified as significant energy actions (66 FR 28355; May 22, 2001). E.O. 13211 defines a “significant energy action” as an action that (i) is a significant regulatory action under E.O. 12866 or any successor order; and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy. This proposed rule is a significant regulatory action under E.O. 12866, as amended by E.O. 14094 (88 FR 21879; April 11, 2023). In our economic analysis, we did not find that this proposed critical habitat designation would significantly affect energy supplies, distribution, or use. This is because the proposed critical habitat is limited to a portion of the water and shoreline area of the San Francisco Bay estuary which is not used for energy supply, distribution or use. Therefore, this action is not a significant energy action, and no statement of energy effects is required.</P>
                <HD SOURCE="HD2">
                    Unfunded Mandates Reform Act (2 U.S.C. 1501 
                    <E T="03">et seq.</E>
                    )
                </HD>
                <P>
                    In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 
                    <E T="03">et seq.</E>
                    ), we make the following finding:
                </P>
                <P>(1) This proposed rule would not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or Tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or Tribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and Tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or Tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; Aid to Families with Dependent Children work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”</P>
                <P>The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions are not likely to destroy or adversely modify critical habitat under section 7. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply, nor would critical habitat shift the costs of the large entitlement programs listed above onto State governments.</P>
                <P>(2) We do not believe that this proposed rule would significantly or uniquely affect small governments because the majority of area associated with the proposal is water area of the San Francisco Bay estuary and not owned or managed by small governments. Small governments will be affected only to the extent that any programs having Federal funds, permits, or other authorized activities must ensure that their actions will not be likely to result in destruction or adverse modification of the species' critical habitat. Therefore, a small government agency plan is not required.</P>
                <HD SOURCE="HD2">Takings—Executive Order 12630</HD>
                <P>In accordance with E.O. 12630 (Government Actions and Interference with Constitutionally Protected Private Property Rights), we have analyzed the potential takings implications of designating critical habitat for the Bay-Delta longfin smelt in a takings implications assessment. The Act does not authorize the Services to regulate private actions on private lands or confiscate private property as a result of critical habitat designation. Designation of critical habitat does not affect land ownership, or establish any closures, or restrictions on use of or access to the designated areas. Furthermore, the designation of critical habitat does not affect landowner actions that do not require Federal funding or permits, nor does it preclude development of habitat conservation programs or issuance of incidental take permits to permit actions that do require Federal funding or permits to go forward. However, Federal agencies are prohibited from carrying out, funding, or authorizing actions that would destroy or adversely modify critical habitat. A takings implications assessment has been completed for the proposed designation of critical habitat for the Bay-Delta longfin smelt, and it concludes that, if adopted, this designation of critical habitat does not pose significant takings implications for lands within or affected by the designation.</P>
                <HD SOURCE="HD2">Federalism—Executive Order 13132</HD>
                <P>
                    In accordance with E.O. 13132 (Federalism), this proposed rule does not have significant Federalism effects. A federalism summary impact statement is not required. In keeping with Department of the Interior and Department of Commerce policy, we requested information from, and coordinated development of this proposed critical habitat designation with, appropriate State resource agencies. From a federalism perspective, the designation of critical habitat directly affects only the responsibilities of Federal agencies. The Act imposes no other duties with respect to critical habitat, either for States and local governments, or for anyone else. As a result, the proposed rule does not have substantial direct effects either on the States, or on the relationship between the Federal government and the States, or on the distribution of powers and responsibilities among the various levels of government. The proposed 
                    <PRTPAGE P="3781"/>
                    designation may have some benefit to these governments because the areas that contain the features essential to the conservation of the species are more clearly defined, and the physical or biological features of the habitat necessary for the conservation of the species are specifically identified. This information does not alter where and what federally sponsored activities may occur. However, it may assist State and local governments in long-range planning because they no longer have to wait for case-by-case section 7 consultations to occur.
                </P>
                <P>Where State and local governments require approval or authorization from a Federal agency for actions that may affect critical habitat, consultation under section 7(a)(2) of the Act would be required. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency.</P>
                <HD SOURCE="HD2">Civil Justice Reform—Executive Order 12988</HD>
                <P>In accordance with E.O. 12988 (Civil Justice Reform), the Office of the Solicitor has determined that the proposed rule would not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of the Order. We have proposed designating critical habitat in accordance with the provisions of the Act. To assist the public in understanding the habitat needs of the species, this proposed rule identifies the physical or biological features essential to the conservation of the species. The proposed areas of critical habitat are presented on maps, and the proposed rule provides several options for the interested public to obtain more detailed location information, if desired.</P>
                <HD SOURCE="HD2">
                    Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    )
                </HD>
                <P>
                    This rule does not contain information collection requirements, and a submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ) is not required. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.
                </P>
                <HD SOURCE="HD2">
                    National Environmental Policy Act (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    )
                </HD>
                <P>
                    Regulations adopted pursuant to section 4(a) of the Act are exempt from the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ) and do not require an environmental analysis under NEPA. We published a notice outlining our reasons for this determination in the 
                    <E T="04">Federal Register</E>
                     on October 25, 1983 (48 FR 49244). This includes listing, delisting, and reclassification rules, as well as critical habitat designations. In a line of cases starting with 
                    <E T="03">Douglas County</E>
                     v. 
                    <E T="03">Babbitt,</E>
                     48 F.3d 1495 (9th Cir. 1995), the courts have upheld this position.
                </P>
                <HD SOURCE="HD2">Government-to-Government Relationship With Tribes</HD>
                <P>In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951, May 4, 1994), E.O. 13175 (Consultation and Coordination with Indian Tribal Governments), the President's memorandum of November 30, 2022 (Uniform Standards for Tribal Consultation; 87 FR 74479, December 5, 2022), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with federally recognized Tribes and Alaska Native Corporations (ANCs) on a government-to-government basis. In accordance with Secretary's Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We have determined that no Tribal lands fall within the boundaries of the proposed critical habitat for the Bay-Delta longfin smelt, so no Tribal lands would be affected by the proposed designation. Accordingly, we have concluded that this action does not have Tribal implications as specified in E.O. 13175 because it will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.</P>
                <HD SOURCE="HD1">References Cited</HD>
                <P>
                    A complete list of references cited in this rulemaking is available on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     and upon request from the San Francisco Bay-Delta Fish and Wildlife Office (see 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    ).
                </P>
                <HD SOURCE="HD1">Authors</HD>
                <P>The primary authors of this proposed rule are the staff members of the Fish and Wildlife Service's Species Status Assessment Team, which includes staff from the Region 8 Regional Office and the San Francisco Bay-Delta Fish and Wildlife Office.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 50 CFR Part 17</HD>
                    <P>Endangered and threatened species, Exports, Imports, Plants, Reporting and recordkeeping requirements, Transportation, Wildlife.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>Martha Williams, Director of the U.S. Fish and Wildlife Service, approved this action on December 11, 2024, for publication. On December 11, 2024, Martha Williams authorized the undersigned to sign the document electronically and submit it to the Office of the Federal Register for publication as an official document of the U.S. Fish and Wildlife Service.</P>
                <HD SOURCE="HD1">Proposed Regulation Promulgation</HD>
                <P>Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:</P>
                <PART>
                    <HD SOURCE="HED">PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 17 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.</P>
                </AUTH>
                <AMDPAR>2. In § 17.11, amend paragraph (h) in the List of Endangered and Threatened Wildlife under Fishes by revising the entry for “Smelt, longfin [San Francisco Bay-Delta DPS]” to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 17.11 </SECTNO>
                    <SUBJECT>Endangered and threatened wildlife.</SUBJECT>
                    <STARS/>
                    <P>
                        (h) * * *
                        <PRTPAGE P="3782"/>
                    </P>
                    <GPOTABLE COLS="5" OPTS="L1,nj,tp0,i1" CDEF="s50,r25,xs60,xls30,r50">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">Common name</CHED>
                            <CHED H="1">Scientific name</CHED>
                            <CHED H="1">Where listed</CHED>
                            <CHED H="1">Status</CHED>
                            <CHED H="1">
                                Listing citations and
                                <LI>applicable rules</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="28">*         *         *         *         *         *         *</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="04">Fishes</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="28">*         *         *         *         *         *         *</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Smelt, longfin [San Francisco Bay-Delta DPS]</ENT>
                            <ENT>
                                <E T="03">Spirinchus thaleichthys</E>
                            </ENT>
                            <ENT>U.S.A. (CA)</ENT>
                            <ENT>E</ENT>
                            <ENT>
                                89 FR 61029, 07/30/2024; 50 CFR 17.95(e).
                                <SU>CH</SU>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="28">*         *         *         *         *         *         *</ENT>
                        </ROW>
                    </GPOTABLE>
                </SECTION>
                <AMDPAR>
                    3. Amend §  17.95(e) by adding an entry for “San Francisco Bay-Delta Distinct Population Segment of the Longfin Smelt (
                    <E T="03">Spirinchus thaleichthys</E>
                    )” after the entry for “Delta Smelt (
                    <E T="03">Hypomesus transpacificus</E>
                    )” to read as follows:
                </AMDPAR>
                <SECTION>
                    <SECTNO>§ 17.95 </SECTNO>
                    <SUBJECT>Critical habitat—fish and wildlife.</SUBJECT>
                    <STARS/>
                    <P>
                        (e) 
                        <E T="03">Fishes.</E>
                    </P>
                    <STARS/>
                    <P>
                        San Francisco Bay-Delta Distinct Population Segment of the Longfin Smelt (
                        <E T="03">Spirinchus thaleichthys</E>
                        )
                    </P>
                    <P>(1) Critical habitat consists of one unit located in the San Francisco Bay estuary in Contra Costa, Napa, Sacramento, Solano, and Sonoma Counties, California, and is depicted on the map in this entry. The San Francisco Bay estuary is a complex and dynamic system exhibiting a wide range of salinities, temperatures, and habitats as the result of tidal movement of ocean water and freshwater inputs from the Sacramento and San Joaquin Rivers and local tributaries. This unit provides the unique suite of environmental conditions needed for spawning, larval rearing, juvenile growth, and maturation of the San Francisco Bay-Delta distinct population segment of the longfin smelt (Bay-Delta longfin smelt).</P>
                    <P>(2) The essential physical or biological features for the Bay-Delta longfin smelt consist of water and shoreline areas with the appropriate water temperature, salinity, turbidity, food resources, substrate, and hydrologic conditions capable of supporting spawning, rearing, and larval and juvenile development. Within the San Francisco Bay estuary, different areas of the critical habitat unit provide all of the physical or biological features essential to the conservation of Bay-Delta longfin smelt, but not all of the features occur in all portions of the unit at all times. During various times of the year, different areas of the estuary provide the following essential physical or biological features:</P>
                    <P>
                        (i) 
                        <E T="03">Water temperature requirements:</E>
                         Water temperature ranges to support reproduction, growth, and survival of the Bay-Delta longfin smelt at different life stages to include:
                    </P>
                    <P>(A) Estuary water temperatures below 13 °Celsius (°C) (55.4 °F (°F)) from December through May to initiate and support successful spawning;</P>
                    <P>(B) Estuary water temperatures less than 15 °C (59.0 °F) from December through May for egg development, hatching success, and early larval development;</P>
                    <P>(C) Estuary water temperatures less than 20 °C (60.0 °F) from February through June for larvae 40 days post hatch and older to support growth and avoid physiological stress; and</P>
                    <P>(D) Estuary and nearshore ocean water temperatures less than 22 °C (71.6 °F) year-round for juveniles and adults to support growth and avoid physiological stress.</P>
                    <P>
                        (ii) 
                        <E T="03">Water salinity requirements:</E>
                         Suitable salinity concentrations to support successful reproduction, growth, and recruitment; such ranges include:
                    </P>
                    <P>(A) Salinity conditions between 2-4 parts per thousand (ppt) from December through May to support average larval salinity requirements; and</P>
                    <P>(B) Salinity conditions between 0.4-10 ppt from December through May to support diversity of egg and early larval rearing conditions.</P>
                    <P>
                        (iii) 
                        <E T="03">Water turbidity requirements:</E>
                         Turbidity greater than 20 nephelometric turbidity units to optimize feeding and predator avoidance.
                    </P>
                    <P>
                        (iv) 
                        <E T="03">Food resource requirements:</E>
                         Food resources in abundances that support growth and recruitment of all life stages; these food resources include, but are not limited to:
                    </P>
                    <P>
                        (A) The copepod 
                        <E T="03">Eurytemora affinis,</E>
                         the primary prey item supporting larvae less than 25 mm (approximately 1 inch length);
                    </P>
                    <P>
                        (B) Mysids including 
                        <E T="03">Neomysis mercedis</E>
                         and 
                        <E T="03">Hyperacanthomysis longirostris,</E>
                         and other amphipods, the primary prey items supporting juveniles and larvae greater than 25 mm in length (approximately 1 inch length); and
                    </P>
                    <P>(C) Prey of various zooplankton species such as those identified in paragraphs (2)(iv)(A) and (B) of this entry for juveniles and adults.</P>
                    <P>
                        (v) 
                        <E T="03">Substrate requirements:</E>
                         Substrate composed mostly of sandy habitat, although portions may include gravel substrates, rocks, or aquatic plants that provide suitable habitat for spawning, protection, cover, and development of eggs and larvae.
                    </P>
                    <P>
                        (vi) 
                        <E T="03">Hydrologic requirements:</E>
                         Contemporaneous with the appropriate seasonal needs by life stage of the species, inflow into the estuary of appropriate freshwater to provide the conditions set forth in paragraphs (2)(i) through (iv) of this entry.
                    </P>
                    <P>(3) Critical habitat does not include manmade structures (such as buildings, aqueducts, runways, roads, and other paved areas) and the land on which they are located existing within the legal boundaries on the [EFFECTIVE DATE OF THE FINAL RULE].</P>
                    <P>
                        (4) Data layers defining the map unit were created on a base of U.S. Geological Survey digital ortho-photo quarter-quadrangles, and the critical habitat unit was then mapped using Universal Transverse Mercator (UTM) North American Datum of 1983 (NAD 83) Zone 10N projected coordinate system. The map in this entry, as modified by any accompanying regulatory text, establish the boundaries of the critical habitat designation. The coordinates or plot points or both on which the map is based are available to the public at the Service's internet site at 
                        <E T="03">https://www.fws.gov/office/san-francisco-bay-delta-fish-and-wildlife,</E>
                         at 
                        <E T="03">https://www.regulations.gov</E>
                         at Docket No. FWS-R8-ES-2024-0131, and at the field office responsible for this designation. You may obtain field office location information by contacting one of the Service regional offices, the addresses of which are listed at 50 CFR 2.2.
                    </P>
                    <P>
                        (5) San Francisco Bay-Delta Unit, Contra Costa, Napa, Sacramento, 
                        <PRTPAGE P="3783"/>
                        Solano, and Sonoma Counties, California.
                    </P>
                    <P>(i) The San Francisco Bay-Delta Unit consists of a total of 91,603 ac (37,082 ha) of water and shoreline areas in a portion of the San Francisco Bay estuary bordering Contra Costa, Napa, Sacramento, Solano, and Sonoma Counties, California, and is composed of Federal (20 ac (8 ha)), State (257 ac (104 ha)), local government (7 ac (3 ha)), private, and nonprofit or nongovernmental organization lands (49 ac (20 ha)), and other water and shoreline area of undetermined ownership (91,297 ac (36,947 ha)).</P>
                    <P>(ii) Map of the San Francisco Bay-Delta Unit follows:</P>
                    <BILCOD>BILLING CODE 4333-15-P</BILCOD>
                    <FP SOURCE="FP-1">
                        Figure 1 to San Francisco Bay-Delta longfin smelt (
                        <E T="03">Spirinchus thaleichthys</E>
                        ) paragraph (5)(ii)
                    </FP>
                    <GPH SPAN="3" DEEP="404">
                        <GID>EP15JA25.001</GID>
                    </GPH>
                    <STARS/>
                </SECTION>
                <SIG>
                    <NAME>Sara Prigan,</NAME>
                    <TITLE>Federal Register Liaison Officer, U.S. Fish and Wildlife Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-29641 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-C</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <CFR>50 CFR Part 17</CFR>
                <DEPDOC>[Docket No. FWS-R6-ES-2022-0150; FF09E21000-256-FXES11130900000]</DEPDOC>
                <SUBJECT>Endangered and Threatened Wildlife and Plants; 12-Month Finding for the Northern Continental Divide Ecosystem of the Grizzly Bear in the Lower-48 States</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notification of finding.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to establish and delist a Northern Continental Divide Ecosystem (NCDE) distinct population segment (DPS) of the grizzly bear (
                        <E T="03">Ursus arctos horribilis)</E>
                         in the lower-48 States. After a thorough review of the best scientific and commercial data available, we find that grizzly bears in the petitioned DPS do not, on their own, represent a valid DPS. Thus, we find that the petitioned action 
                        <PRTPAGE P="3784"/>
                        to establish and delist an NCDE DPS is not warranted at this time.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The finding in this document was made on January 15, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The finding and the supporting information that we developed for this finding, including the species status assessment report and species assessment form, are available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         under Docket No. FWS-R6-ES-2022-0150. Please submit any new information, materials, comments, or questions concerning this finding to the appropriate person, as specified under 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Hilary Cooley, Grizzly Bear Recovery Coordinator, Grizzly Bear Recovery Office, telephone: 406-243-4903, email: 
                        <E T="03">hilary_cooley@fws.gov.</E>
                         Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Previous Federal Actions</HD>
                <P>
                    Under the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 
                    <E T="03">et seq.;</E>
                     hereafter, “Act”), the grizzly bear (
                    <E T="03">Ursus arctos horribilis)</E>
                     is currently listed as a threatened species in the lower-48 States (40 FR 31734, July 28, 1975). We detail the original rulemaking and our subsequent actions for the species in our species status assessment (SSA) report (Service 2024, pp. 74-76) and summarize the relevant actions for this finding below.
                </P>
                <P>On March 30, 2021, we completed a 5-year status review for the grizzly bear in the lower-48 States in which we concluded that the listed entity should retain its status as a threatened species under the Endangered Species Act (Act) (Service 2021, entire). On December 17, 2021, we received a petition from the State of Montana (petitioner) to revise the listed entity of grizzly bear under the Act. The petition requested that we: (1) establish a NCDE DPS; and (2) remove it from the List (“delist”), asserting that the NCDE DPS did not meet the definition of an endangered or threatened species. On February 6, 2023, we published a 90-day finding (88 FR 7658) that the petition contained substantial information indicating that establishing and delisting a NCDE DPS may be warranted. This document and our supporting species assessment form constitutes our 12-month finding on the December 17, 2021, petition to establish and delist a NCDE DPS of grizzly bear under the Act.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Under section 4(b)(3)(B) of the Act (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ), we are required to make a finding, within 12 months after receiving any petition that we have determined contains substantial scientific or commercial information indicating that the petitioned action may be warranted, as to whether the petitioned action is warranted, not warranted, or warranted but precluded by other pending proposals (known as a “12-month finding”). We must publish a notification of this 12-month finding in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>
                    This document announces the not-warranted finding on the petition for the NCDE grizzly bear population in accordance with the regulations at 50 CFR 424.14(h)(2)(i). In this document, we have also elected to include a summary of the analysis on which this finding is based. This supporting information can be found on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     under Docket No. FWS-R6-ES-2022-0150 (see 
                    <E T="02">ADDRESSES</E>
                    , above). We provide the full analysis, including our rationale and the data on which the finding is based, in the decisional file for the petition and our subsequent finding. The species assessment form contains an explanation of why we determined that grizzly bears in the petitioned DPS do not, on their own, represent a valid listable entity such that the petitioned actions are not warranted at this time. The following is a summary of the documents containing this full analysis.
                </P>
                <HD SOURCE="HD1">Listable Entity Requirements</HD>
                <P>
                    Under the Act, the term “species” includes any subspecies of fish or wildlife or plants, and any distinct population segment of any vertebrate fish or wildlife which interbreeds when mature (16 U.S.C. 1532(16)). To interpret and implement the distinct population segment (DPS) provisions of the Act, the Service and the National Oceanic and Atmospheric Administration published in the 
                    <E T="04">Federal Register</E>
                     the Policy Regarding the Recognition of Distinct Vertebrate Population Segments Under the Endangered Species Act on February 7, 1996 (61 FR 4722) (DPS Policy). Under the DPS Policy, we consider three elements to determine whether to classify a population of a vertebrate species as a DPS: (1) the discreteness of the population segment in relation to the remainder of the species to which it belongs; (2) the significance of the population segment to the species to which it belongs; and (3) the population segment's conservation status in relation to the Act's standard for listing, delisting, or reclassification. The Policy requires that a population segment meet both the discreteness and significance elements to be considered a valid DPS (
                    <E T="03">i.e.,</E>
                     a valid listable entity) and only then may we consider whether the DPS warrants listing under the Act.
                </P>
                <HD SOURCE="HD1">Summary of Biological Information</HD>
                <P>The grizzly bear is a large, long-lived mammal that occurs in a variety of habitat types in portions of Idaho, Montana, Washington, and Wyoming. Grizzly bears are light brown to nearly black and are so named for their “grizzled” coats with silver or golden tips. Grizzly bears in the NCDE population and the lower-48 States need access to large, intact blocks of land with limited human influence that provide cover, high-caloric foods, dens, and areas for dispersal. The specific quality and quantity of these resources influence the ability of individual grizzly bears to reproduce, grow, and survive at different life stages and for the NCDE population to be resilient or to withstand stochastic events (Service 2024, pp. 99-101). Our SSA report provides our full account of the life history, ecology, range, and historical and current distribution for the grizzly bear in the NCDE population and the lower-48 States (Service 2024, pp. 39-73).</P>
                <HD SOURCE="HD1">Summary of Information From the Petition</HD>
                <P>The petitioner requests that we establish a DPS for the NCDE grizzly bear population (petitioned DPS) that occurs entirely within the State of Montana. In their arguments to support delisting, the petitioner indicates that the NCDE grizzly bear population's range has expanded, including a four-fold increase in the occupied range since the time of listing in 1975. The species assessment form provides additional summary of the information presented in the petition, including a map of the petitioned DPS.</P>
                <HD SOURCE="HD1">Summary of Finding</HD>
                <P>
                    In determining whether to recognize the petitioned DPS as a valid DPS (
                    <E T="03">e.g.,</E>
                     a listable entity under the Act), we must base our decision on the best scientific and commercial data available. Since the time of the original listing in 1975, the abundance, distribution, and dispersal of grizzly bears within and surrounding the NCDE has increased. 
                    <PRTPAGE P="3785"/>
                    New information supports the petitioner's claim that the NCDE population has increased in size and distribution, so much so that grizzly bears have dispersed and expanded their occupied range and verified outliers are occurring beyond the western and southern boundary of the petitioned DPS. From 2014 to 2022, estimated occupied range in the NCDE increased by 21 percent, averaging 5 percent every 2 years. As a result, the distance between the occupied range in the NCDE and that of other ecosystems has decreased and continues to shrink. Models indicate that the NCDE estimated occupied range overlaps with the Cabinet-Yaak Ecosystem (CYE), although no genetic or demographic connectivity has been documented. In addition, models indicate that the estimated occupied ranges of the NCDE and Greater Yellowstone Ecosystem (GYE) populations are currently only 98 kilometers (61 miles) apart, within grizzly bear dispersal distance.
                </P>
                <P>The 2022 estimated occupied range of the NCDE population of grizzly bear extends beyond the western and southern boundaries of the petitioned DPS (Service 2024, figure 1). From 2020 to 2022, occupied range in the NCDE increased by 11 percent (Costello et al. 2023, p. 13). We expect this trend to increase over time. Additionally, as the populations expand, individual grizzly bears are dispersing into new areas outside the estimated occupied range. Since 2014, there have been 213 verified observations of grizzly bears outside of current estimated occupied range in the lower-48 States. Currently, genetic studies have confirmed that at least 14 grizzly bears originating from the NCDE population have dispersed beyond the boundary of the petitioned DPS. Seven of these individuals are known to have emigrated from the NCDE to the CYE, however, no gene flow is known to have occurred as of 2022 (Kasworm et al. 2024, p. 34). These occurrences outside of areas considered occupied range are becoming increasingly common. While in most cases, the source population of such grizzly bears is unknown, a number of them likely originated from the NCDE population. The locations of these verified observations reveal the leading edges of grizzly bear range expansion within and between ecosystems (see Service 2024, figure 1) (Costello et al. 2023, pp. 13-17; Dellinger et al. 2023, pp. 22-23). With the increasing trend of population growth and expansion over the last several years, we anticipate range expansion and dispersal events to continue under current management, including the protections of the Act, such that natural connectivity between the NCDE population and other grizzly bear populations in the lower-48 States will likely occur in the near future (Service 2024, p. 54).</P>
                <P>Additionally, we anticipate that dispersing bears from the NCDE will re-establish a population in the Bitterroot Ecosystem (BE) in the next 15 to 20 years. The estimated occupied range for the NCDE grizzly bear population is less than 5 kilometers (3 miles) from the Bitterroot recovery zone and a subadult female dispersed to within 5 kilometers (3 miles) of the BE in 2022. This information indicates that the grizzly bear population has expanded beyond the boundary of the petitioned DPS and continues to expand.</P>
                <P>To summarize, information provided by the petitioner and the best scientific and commercial data available indicate that grizzly bear abundance, distribution, and dispersal have increased, and grizzly bears have expanded beyond the petitioned DPS boundary. As a result, the petitioned DPS is not based on the best scientific and commercial data available and is obsolete. As populations have grown and expanded, estimated occupied range has expanded beyond the petitioned DPS boundary. In addition, grizzly bears have dispersed beyond the petitioned DPS boundary, often into areas considered to be previously unoccupied.</P>
                <P>Under our DPS Policy, a population segment of a vertebrate species may be considered discrete if it satisfies either of the following two conditions: (1) it is markedly separated from other populations of the same taxon as a consequence of physical, physiological, ecological, or behavioral factors (quantitative measures of genetic or morphological discontinuity may provide evidence of this separation); or (2) it is delimited by international governmental boundaries within which significant differences in control of exploitation, management of habitat, conservation status, or regulatory mechanisms exist that are significant in light of section 4(a)(1)(D) of the Act. In determining whether the test for discreteness has been met under the DPS policy, we allow but do not require genetic evidence to be used.</P>
                <P>Although the DPS Policy does not require absolute separation of one population from another, (82 FR 30502, June 30, 2017, p. 30518), the standard for discreteness must allow us to distinguish between the DPS and other members of the species for purposes of administering and enforcing the Act (61 FR 4722, February 7, 1996, p. 4724). As summarized above, the best scientific and commercial data available indicate that the estimated occupied range of the grizzly bear population in the NCDE has expanded steadily in the past decade. The GYE and CYE populations have also expanded their range and these populations are increasingly closer in proximity to the NCDE population. Grizzly bears have dispersed beyond the boundaries of the petitioned DPS and the NCDE population has expanded to such an extent that it is not markedly separate from other populations of the taxon. Due to ongoing population growth and range expansion, which is expected to continue in the future under current management, including the protections of the Act, we do not consider the petitioned DPS to be discrete due to physical factors. Because grizzly bears within the boundaries of the petitioned DPS are not markedly separated from other populations of the taxon, the petitioned DPS does not meet the discreteness element in the DPS Policy. Therefore, we find that grizzly bears in the petitioned DPS do not, on their own, represent a valid DPS and we therefore do not consider the status of grizzly bears in this petitioned entity as a separately listable entity under the Act.</P>
                <P>
                    We are in the process of fully evaluating the latest information regarding the status of the grizzly bear in the lower-48 States in a rulemaking expected by January 31, 2026. This rulemaking is pursuant to a settlement agreement associated with the State of Idaho's petition to delist the grizzly bear in the lower-48 States. That rulemaking, to either remove or revise the currently listed entity of the grizzly bear in the lower-48 States, will fully evaluate the best scientific and commercial data available, which could include potential DPSs, while considering potential population segment's conservation status and Congress's direction to exercise DPSs sparingly and only when the biological evidence indicates that such action is warranted. The trends of increasing distribution and dispersal point to the need for a broader, holistic evaluation at the rangewide level, which will be completed as part of the rulemaking already underway. Consistent with the DPS Policy, that analysis will require careful consideration of the extent to which formerly isolated populations are connected, or likely to be connected, and the need for connectivity to small or isolated populations and unoccupied recovery zones, given the best and most recent biological data available that 
                    <PRTPAGE P="3786"/>
                    support a durable recovered grizzly bear in the lower-48 States.
                </P>
                <HD SOURCE="HD1">Peer Review</HD>
                <P>
                    In accordance with our July 1, 1994, peer review policy (59 FR 34270; July 1, 1994) and the Service's August 22, 2016, Director's Memo on the Peer Review Process, we solicited independent scientific reviews of the information contained in the SSA report for the grizzly bear in the lower-48 States. Results of this structured peer review process can be found at 
                    <E T="03">https://www.regulations.gov.</E>
                     We incorporated the results of these reviews, as appropriate, into the SSA report, which is the scientific foundation for this finding.
                </P>
                <HD SOURCE="HD1">References Cited</HD>
                <P>
                    A list of the references cited in this petition finding is available in the species assessment form, which is available on the internet at 
                    <E T="03">http://www.regulations.gov</E>
                     under Docket No. FWS-R6-ES-2022-0150 (see 
                    <E T="02">ADDRESSES</E>
                    , above).
                </P>
                <HD SOURCE="HD1">Authors</HD>
                <P>The primary authors of this document are staff members of the Grizzly Bear Recovery Office, Ecological Services Program.</P>
                <HD SOURCE="HD1">Authority</HD>
                <P>
                    The authority for these actions is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Martha Williams,</NAME>
                    <TITLE>Director, U.S. Fish and Wildlife Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00330 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-P</BILCOD>
        </PRORULE>
    </PRORULES>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NOTICES>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3787"/>
                <AGENCY TYPE="F">INTERNATIONAL BROADCASTING ADVISORY BOARD</AGENCY>
                <SUBJECT>Sunshine Act Meetings</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">TIME AND DATE: </HD>
                    <P>January 14, 2025, 2:00 p.m.-3:00 p.m. ET.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE: </HD>
                    <P>On January 14, 2025, the board will meet virtually.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS: </HD>
                    <P>This meeting will be closed to the public.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED: </HD>
                    <P>The International Broadcasting Advisory Board (Board) will conduct a meeting closed to the public at the date and time listed above. Board Members (membership includes Chair Kenneth Jarin, Luis Botello, Jamie Fly, Michelle Giuda, Kathleen Matthews, Under Secretary Lee Satterfield (Secretary of State's Representative)), Chief Executive Officer of the U.S. Agency for Global Media (USAGM), the USAGM General Counsel and Acting Board Secretary to the Board, the Secretariat to the Board, and recording secretaries will attend the closed meeting.</P>
                    <P>The USAGM General Counsel and Acting Board Secretary has certified that, in his opinion, exemptions set forth in the Government in the Sunshine Act, in particular 5 U.S.C. 552b(c)(2), (6), and (9)(B), permit closure of this meeting.</P>
                    <P>The entirety of the Board's membership approved the closing of this meeting.</P>
                    <P>The purpose for closing the meeting is so that the IBAB may deliberate on and, if necessary, vote on matters pursuant to its authority under 22 U.S.C. 6205. Publicizing these deliberations would frustrate the implementation of the very items they will be proposing. [This related to (2) and (9).]</P>
                    <P>
                        In the event that the time, date, or location of this meeting changes, IBAB will post an announcement of the change, along with the new time, date, and/or place of the meeting on its website at 
                        <E T="03">https://www.ibab.gov.</E>
                    </P>
                    <P>Although a separate federal entity, USAGM prepared this notice and will continue to support the Board in accordance with 22 U.S.C. 6205(g).</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION: </HD>
                    <P>Persons interested in obtaining more information should contact USAGM's Executive Director Oanh Tran at (202) 920-2583.</P>
                </PREAMHD>
                <EXTRACT>
                    <FP>(Authority: 5 U.S.C. 552b, 22 U.S.C. 6205(e)(3)(C).)</FP>
                </EXTRACT>
                <SIG>
                    <DATED> Dated: January 10, 2025.</DATED>
                    <NAME>Armanda Matthews,</NAME>
                    <TITLE>Program Support Specialist, USAGM.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00902 Filed 1-13-25; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 8610-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">COMMISSION ON CIVIL RIGHTS</AGENCY>
                <SUBJECT>Notice of Public Briefing of the Guam Advisory Committee to the U.S. Commission on Civil Rights</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Commission on Civil Rights.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Announcement of public briefing.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Guam Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a virtual, public briefing via Zoom at 9:30 a.m. ChST on Friday, February 7, 2025 (6:30 p.m. ET on Thursday, February 6, 2025). The purpose of this briefing is to hear testimony on the topic, 
                        <E T="03">Overrepresentation of FAS Members in the Criminal Justice System on Guam.</E>
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Friday, February 7, 2025, from 9:30 a.m.-11:00 a.m. ChST (Thursday, February 6, 2025, from 6:30 p.m.-9:00 p.m. ET).</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>The meeting will be held via Zoom Webinar.</P>
                    <P>
                        <E T="03">Registration Link (Audio/Visual): https://www.zoomgov.com/webinar/register/WN_6BZhCWEHQt-GeuRxCnySgw</E>
                        .
                    </P>
                    <P>
                        <E T="03">Join by Phone (Audio Only):</E>
                         (833) 435-1820 USA Toll Free; Meeting ID: 160 613 1468.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kayla Fajota, DFO, at 
                        <E T="03">kfajota@usccr.gov</E>
                         or (434) 515-2395.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available by selecting “CC” in the meeting platform. To request additional accommodations, please email 
                    <E T="03">lschiller@usccr.gov</E>
                     at least 10 business days prior to the meeting.
                </P>
                <P>
                    Members of the public are entitled to submit written comments; the comments must be received within 30 days following the meeting. Written comments may be emailed to Kayla Fajota at 
                    <E T="03">kfajota@usccr.gov.</E>
                     Persons who desire additional information may contact the Regional Programs Coordination Unit at (434) 515-2395.
                </P>
                <P>
                    Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit, as they become available, both before and after the meeting. Records of the meeting will be available via the file sharing website, 
                    <E T="03">www.box.com.</E>
                     Persons interested in the work of this Committee are directed to the Commission's website, 
                    <E T="03">www.usccr.gov,</E>
                     or may contact the Regional Programs Coordination Unit at the above phone number.
                </P>
                <HD SOURCE="HD1">Agenda</HD>
                <FP SOURCE="FP-2">I. Welcome &amp; Roll Call</FP>
                <FP SOURCE="FP-2">II. Panelist Presentations</FP>
                <FP SOURCE="FP-2">III. Committee Q&amp;A</FP>
                <FP SOURCE="FP-2">IV. Public Comment</FP>
                <FP SOURCE="FP-2">V. Project Planning</FP>
                <FP SOURCE="FP-2">VI. Adjournment</FP>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>David Mussatt,</NAME>
                    <TITLE>Supervisory Chief, Regional Programs Unit.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00697 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3788"/>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[C-351-865, C-533-935, C-552-848, C-570-185]</DEPDOC>
                <SUBJECT>Hard Empty Capsules From Brazil, the People's Republic of China, India, and the Socialist Republic of Vietnam: Postponement of Preliminary Determinations in the Countervailing Duty Investigations</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable January 15, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Robert Copyak at (202) 482-3542 (Brazil); Laura Delgado at (202) 482-1468 and John Conniff (202) 482-1009 (the People's Republic of China (China)); Gorden Struck at (202) 482-8151 (India), and Jonathan Schueler at (202) 482-9175 (the Socialist Republic of Vietnam (Vietnam)), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On November 13, 2024, the U.S. Department of Commerce (Commerce) initiated countervailing duty (CVD) investigations of imports of Hard Empty Capsules (capsules) from Brazil, China, India, and Vietnam.
                    <SU>1</SU>
                    <FTREF/>
                     Currently, the preliminary determinations are due no later than January 17, 2025.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Hard Empty Capsules from Brazil, the People's Republic of China, India, and the Socialist Republic of Vietnam: Initiation of Countervailing Duty Investigations,</E>
                         89 FR 91680 November 20, 2024) (
                        <E T="03">Initiation Notice</E>
                        ).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Postponement of Preliminary Determinations</HD>
                <P>Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a CVD investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination in a CVD investigation until no later than 130 days after the date on which Commerce initiated the investigation if: (A) the petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.</P>
                <P>
                    On December 16, 2024, the petitioner 
                    <SU>2</SU>
                    <FTREF/>
                     submitted a timely request that Commerce postpone the preliminary CVD determinations.
                    <SU>3</SU>
                    <FTREF/>
                     The petitioner stated that postponement of the preliminary determinations is necessary because the current schedule does not provide Commerce with adequate time to fully analyze the forthcoming questionnaire responses of the mandatory respondents and issue supplemental questionnaires, as necessary.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The petitioner is Lonza Greenwood LLC.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letter, “Lonza's Request for Postponement of the Department's Countervailing Duty Preliminary Determinations,” dated December 16, 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    In accordance with 19 CFR 351.205(e), the petitioner submitted its request for postponement of the preliminary determinations in these investigations 25 days or more before the scheduled date of the preliminary determinations and stated the reasons for its request. Commerce finds no compelling reason to deny the request. Therefore, in accordance with section 703(c)(1)(A) of the Act, Commerce is postponing the deadline for the preliminary determinations in these investigations to no later than 130 days after the date on which it initiated these investigations, 
                    <E T="03">i.e.,</E>
                     March, 24, 2025.
                    <SU>5</SU>
                    <FTREF/>
                     Pursuant to section 705(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determinations of these investigations will continue to be 75 days after the date of the preliminary determinations.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Because the deadline for these preliminary results falls on the weekend (
                        <E T="03">i.e.,</E>
                         March 23, 2025), the deadline became the next business day (
                        <E T="03">i.e.,</E>
                         March 24, 2025). 
                        <E T="03">See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended,</E>
                         70 FR 24533 (May 10, 2005).
                    </P>
                </FTNT>
                <P>This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).</P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Abdelali Elouaradia, </NAME>
                    <TITLE>Deputy Assistant Secretary   for Enforcement and Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00658 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[C-570-195]</DEPDOC>
                <SUBJECT>Active Anode Material From the People's Republic of China: Initiation of Countervailing Duty Investigation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable January 7, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Gorden Struck, Office II, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-8151.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">The Petition</HD>
                <P>
                    On December 18, 2024, the U.S. Department of Commerce (Commerce) received a countervailing duty (CVD) petition concerning imports of active anode material from the People's Republic of China (China) filed in proper form on behalf of the American Active Anode Material Producers (the petitioner),
                    <SU>1</SU>
                    <FTREF/>
                     an 
                    <E T="03">ad hoc</E>
                     trade association of domestic producers.
                    <SU>2</SU>
                    <FTREF/>
                     The CVD Petition was accompanied by an antidumping duty (AD) petition concerning imports of active anode material from China.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The members of the American Active Anode Material Producers are Anovion Technologies, Syrah Technologies LLC, NOVONIX Anode Materials LLC, Epsilon Advanced Materials, and SKI US, Inc.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letter, “Petition for the Imposition of Antidumping and Countervailing Duties,” dated December 18, 2024 (Petition).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    Between December 19, 2024, and January 2, 2025, Commerce requested supplemental information pertaining to certain aspects of the Petition in supplemental questionnaires.
                    <SU>4</SU>
                    <FTREF/>
                     On December 27, 2024, and January 3, 2025, the petitioner filed timely responses to these requests for additional information.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Commerce's Letters, “Supplemental Questions,” dated December 19, 2024; and “Supplemental Questions,” dated December 20, 2024 (General Issues Questionnaire); 
                        <E T="03">see also</E>
                         Memorandum, “Phone Call with Counsel to the Petitioner,” dated January 2, 2025 (January 2, 2025, Memorandum).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letters, “Response to Supplemental Questions Regarding Common Issues and Injury Volume I of the Petitions,” dated December 27, 2024 (First General Issues Supplement); “Response to Supplemental Questions Regarding Countervailing Duty Volume III of the Petitions,” dated December 27, 2024; and “Response to Supplemental Questions Regarding 
                        <PRTPAGE/>
                        Volume I of the Petitions,” dated January 3, 2025 (Second General Issues Supplement).
                    </P>
                </FTNT>
                <PRTPAGE P="3789"/>
                <P>In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that the Government of China (GOC) is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to producers of active anode material in China, and that imports of such products materially retard the establishment of an industry in the United States, or in the alternative, that such products are materially injuring, or threatening material injury to, the active anode material industry in the United States. Consistent with section 702(b)(1) of the Act and 19 CFR 351.202(b), for those alleged programs on which we are initiating a CVD investigation, the Petition was accompanied by information reasonably available to the petitioner supporting its allegations.</P>
                <P>
                    Commerce finds that the petitioner filed the Petition on behalf of the domestic industry, because the petitioner is an interested party, as defined in section 771(9)(F) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support with respect to the initiation of the requested CVD investigation.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         section on “Determination of Industry Support for the Petition,” 
                        <E T="03">infra.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Period of Investigation</HD>
                <P>
                    Because the Petition was filed on December 18, 2024, the period of investigation for the CVD investigation is January 1, 2023, through December 31, 2023.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.204(b)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Scope of the Investigation</HD>
                <P>
                    The product covered by this investigation is active anode material from China. For a full description of the scope of this investigation, 
                    <E T="03">see</E>
                     the appendix to this notice.
                </P>
                <HD SOURCE="HD1">Comments on the Scope of the Investigation</HD>
                <P>
                    On December 20, 2024 and January 2, 2025, Commerce requested information and clarification from the petitioner regarding the proposed scope to ensure that the scope language in the Petition is an accurate reflection of the products for which the domestic industry is seeking relief.
                    <SU>8</SU>
                    <FTREF/>
                     On December 27, 2024 and January 3, 2025, the petitioner provided clarifications and revised the scope.
                    <SU>9</SU>
                    <FTREF/>
                     The description of merchandise covered by this investigation, as described in the appendix to this notice, reflects these clarifications.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         General Issues Questionnaire; 
                        <E T="03">see also</E>
                         January 2, 2025, Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         First General Issues Supplement at 2-5; 
                        <E T="03">see also</E>
                         Second General Issues Supplement at 1-6 and Exhibits I-Supp2-1 through I-Supp2-3.
                    </P>
                </FTNT>
                <P>
                    As discussed in the 
                    <E T="03">Preamble</E>
                     to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (
                    <E T="03">i.e.,</E>
                     scope).
                    <SU>10</SU>
                    <FTREF/>
                     Commerce will consider all comments received from interested parties and, if necessary, will consult with interested parties prior to the issuance of the preliminary determination. If scope comments include factual information, all such factual information should be limited to public information.
                    <SU>11</SU>
                    <FTREF/>
                     To facilitate preparation of its questionnaires, Commerce requests that scope comments be submitted by 5:00 p.m. Eastern Time (ET) on January 27, 2025, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, which may include factual information, and should also be limited to public information, must be filed by 5:00 p.m. ET on February 6, 2025, which is 10 calendar days from the initial comment deadline.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See Antidumping Duties; Countervailing Duties; Final Rule,</E>
                         62 FR 27296, 27323 (May 19, 1997) (
                        <E T="03">Preamble</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.102(b)(21) (defining “factual information”).
                    </P>
                </FTNT>
                <P>Commerce requests that any factual information that parties consider relevant to the scope of the investigation be submitted during that time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party must contact Commerce and request permission to submit the additional information. All scope comments must be filed simultaneously on the records of the concurrent AD and CVD investigations.</P>
                <HD SOURCE="HD1">Filing Requirements</HD>
                <P>
                    All submissions to Commerce must be filed electronically via Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS), unless an exception applies.
                    <SU>12</SU>
                    <FTREF/>
                     An electronically filed document must be received successfully in its entirety by the time and date it is due.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures,</E>
                         76 FR 39263 (July 6, 2011); 
                        <E T="03">see also Enforcement and Compliance; Change of Electronic Filing System Name,</E>
                         79 FR 69046 (November 20, 2014), for details of Commerce's electronic filing requirements, effective August 5, 2011. Information on using ACCESS can be found at 
                        <E T="03">https://access.trade.gov/help.aspx</E>
                         and a handbook can be found at 
                        <E T="03">https://access.trade.gov/help/Handbook_on_Electronic_Filing_Procedures.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Consultations</HD>
                <P>
                    Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, Commerce notified the GOC of the receipt of the Petition and provided an opportunity for consultations with respect to the Petition.
                    <SU>13</SU>
                    <FTREF/>
                     The GOC did not request consultations.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         Commerce's Letter, “Invitation for Consultation to Discuss the Countervailing Duty Petition,” dated December 19, 2024.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Determination of Industry Support for the Petition</HD>
                <P>Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) at least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”</P>
                <P>
                    Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The U.S. International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC apply the same statutory definition regarding the domestic like product,
                    <SU>14</SU>
                    <FTREF/>
                     they do so for different purposes and pursuant to a separate and distinct authority. In addition, Commerce's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the 
                    <PRTPAGE P="3790"/>
                    decision of either agency contrary to law.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         section 771(10) of the Act.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See USEC, Inc.</E>
                         v. 
                        <E T="03">United States,</E>
                         132 F. Supp. 2d 1, 8 (CIT 2001) (citing 
                        <E T="03">Algoma Steel Corp., Ltd.</E>
                         v. 
                        <E T="03">United States,</E>
                         688 F. Supp. 639, 644 (CIT 1988), 
                        <E T="03">aff'd Algoma Steel Corp., Ltd.</E>
                         v. 
                        <E T="03">United States,</E>
                         865 F.2d 240 (Fed. Cir. 1989)).
                    </P>
                </FTNT>
                <P>
                    Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
                    <E T="03">i.e.,</E>
                     the class or kind of merchandise to be investigated, which normally will be the scope as defined in the petition).
                </P>
                <P>
                    With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation.
                    <SU>16</SU>
                    <FTREF/>
                     Based on our analysis of the information submitted on the record, we have determined that active anode material, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product.
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For a discussion of the domestic like product analysis as applied to this case and information regarding industry support, 
                        <E T="03">see</E>
                         Checklist, “Countervailing Duty Investigation Initiation Checklist: Active Anode Material from the People's Republic of China,” dated concurrently with, and hereby adopted by, this notice (China CVD Initiation Checklist), at Attachment II, Analysis of Industry Support for the Antidumping and Countervailing Duty Petitions Covering Active Anode Material from the People's Republic of China (Attachment II). This checklist is on file electronically via ACCESS.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Attachment II of the China CVD Initiation Checklist.
                    </P>
                </FTNT>
                <P>
                    In determining whether the petitioner has standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the appendix to this notice. To establish industry support, the petitioner provided the 2023 production of the domestic like product for the supporters of the Petition and compared this to total 2023 production for the U.S. active anode material industry.
                    <SU>18</SU>
                    <FTREF/>
                     We relied on data provided by the petitioner for purposes of measuring industry support.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         For further discussion, 
                        <E T="03">see</E>
                         Attachment II of the China CVD Initiation Checklist.
                    </P>
                </FTNT>
                <P>
                    On December 30, 2024, we received timely filed comments on industry support from Tesla, Inc. (Tesla), a U.S. importer of active anode material.
                    <SU>20</SU>
                    <FTREF/>
                     On January 2, 2025, the petitioner responded to the comments from Tesla in a timely filed rebuttal submission.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See</E>
                         Tesla's Letter, “Request to Reject the Petition or to Poll the Industry,” dated December 30, 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letter, “Rebuttal Industry Support Comments,” dated January 2, 2025 (Petitioner's Response).
                    </P>
                </FTNT>
                <P>
                    Our review of the data provided in the Petition, the First General Issues Supplement, the Second General Issues Supplement, the Petitioner's Response, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petition.
                    <SU>22</SU>
                    <FTREF/>
                     First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, Commerce is not required to take further action in order to evaluate industry support (
                    <E T="03">e.g.,</E>
                     polling).
                    <SU>23</SU>
                    <FTREF/>
                     Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product.
                    <SU>24</SU>
                    <FTREF/>
                     Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition.
                    <SU>25</SU>
                    <FTREF/>
                     Accordingly, Commerce determines that the Petition was filed on behalf of the domestic industry within the meaning of section 702(b)(1) of the Act.
                    <SU>26</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         Attachment II of the China CVD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">Id.; see also</E>
                         section 702(c)(4)(D) of the Act.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">See</E>
                         Attachment II of the China CVD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Injury Test</HD>
                <P>Because China is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from China materially injure, or threaten material injury to, a U.S. industry, or whether the establishment of a U.S. industry is materially retarded, by reason of imports of the subject merchandise from China.</P>
                <HD SOURCE="HD1">Allegations and Evidence of Material Injury and Causation</HD>
                <P>
                    Section 703(a)(1)(B) of the Act states that the ITC “shall determine . . . whether there is a reasonable indication that the establishment of an industry in the United States is materially retarded by reason of imports of the subject merchandise.” The petitioner alleges that imports of subject merchandise are benefiting from countervailable subsidies and that such imports are materially retarding the establishment of the U.S. industry producing active anode material.
                    <SU>27</SU>
                    <FTREF/>
                     The petitioner argues that its production has been “modest” and has not stabilized and, therefore, the U.S. industry producing active anode material has not been established.
                    <SU>28</SU>
                    <FTREF/>
                     To support its argument, the petitioner examined the five factors 
                    <SU>29</SU>
                    <FTREF/>
                     the ITC considers to determine if an industry is established, as set forth in the ITC's 
                    <E T="03">AD/CVD Handbook.</E>
                    <SU>30</SU>
                    <FTREF/>
                     If the ITC determines that an industry is not established, it then considers whether the performance of the industry reflects normal start-up difficulties or whether the imports of the subject merchandise have materially retarded the establishment of the industry.
                    <SU>31</SU>
                    <FTREF/>
                     The petitioner contends that the domestic industry has performed substantially worse than what could reasonably be expected during normal start-up conditions, thereby demonstrating that the establishment of the domestic industry has been materially retarded by subject imports.
                    <SU>32</SU>
                    <FTREF/>
                     The petitioner also alleges that, in the alternative, the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise benefitting from countervailable subsidies.
                    <SU>33</SU>
                    <FTREF/>
                     In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided under section 771(24)(A) of the Act.
                    <SU>34</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         For a discussion of the petitioner's injury allegation, 
                        <E T="03">see</E>
                         China CVD Initiation Checklist at Attachment III, Analysis of Allegations and Evidence of Material Retardation, Material Injury, and Causation for the Antidumping and Countervailing Duty Petitions Covering Active Anode Material from the People's Republic of China (Attachment III).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         For a discussion of the factors related to whether an industry is established, 
                        <E T="03">see</E>
                         Attachment III of the China CVD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         
                        <E T="03">See Antidumping and Countervailing Duty Handbook</E>
                         (14th Ed.), USITC Pub. 4540 (June 2015) (
                        <E T="03">AD/CVD Handbook</E>
                        ), at II-33.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         
                        <E T="03">See</E>
                         Attachment III of the China CVD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <PRTPAGE P="3791"/>
                <P>
                    The petitioner contends that the industry's materially retarded, or in the alternative, injured condition is illustrated by a significant volume of subject imports; significant market share of subject imports; lost sales and revenues; underselling; low levels of production; and negative impact on financial performance.
                    <SU>35</SU>
                    <FTREF/>
                     We assessed the allegations and supporting evidence regarding material retardation, material injury, threat of material injury, causation, as well as negligibility, and we have determined that these allegations are properly supported by adequate evidence, and meet the statutory requirements for initiation.
                    <SU>36</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Initiation of CVD Investigation</HD>
                <P>Based upon the examination of the Petition and supplemental responses, we find that they meet the requirements of section 702 of the Act. Therefore, we are initiating a CVD investigation to determine whether imports of active anode material from China benefit from countervailable subsidies conferred by the GOC. In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.</P>
                <P>
                    Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation on 34 of the 36 programs alleged by the petitioner. For a full discussion of the basis for our decision to initiate on each program, 
                    <E T="03">see</E>
                     the China CVD Initiation Checklist. A public version of the initiation checklist for this investigation is available on ACCESS.
                </P>
                <HD SOURCE="HD1">Respondent Selection</HD>
                <P>
                    In the Petition, the petitioner identified 30 companies in China as producers and/or exporters of active anode material.
                    <SU>37</SU>
                    <FTREF/>
                     Commerce intends to follow its standard practice in CVD investigations and calculate company-specific subsidy rates in this investigation. In the event that Commerce determines that the number of companies is large and it cannot individually examine each company based on Commerce's resources, Commerce normally selects mandatory respondents in CVD investigations using U.S. Customs and Border Protection (CBP) entry data for U.S. imports under the appropriate Harmonized Tariff Schedule of the United States (HTSUS) subheading(s) listed in the “Scope of the Investigation” in the appendix.
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         
                        <E T="03">See</E>
                         Petition at Volume I (pages 6-7 and Exhibit I-9); 
                        <E T="03">see also</E>
                         First General Issues Supplement at 1-2 and Exhibit I-Supp-1.
                    </P>
                </FTNT>
                <P>
                    On January 7, 2025, Commerce released CBP data on imports of active anode material from China under administrative protective order (APO) to all parties with access to information protected by APO and indicated that interested parties wishing to comment on CBP data and/or respondent selection must do so within three business days of the publication date of the notice of initiation of this investigation.
                    <SU>38</SU>
                    <FTREF/>
                     Comments must be filed electronically using ACCESS. An electronically-filed document must be received successfully in its entirety via ACCESS by 5:00 p.m. ET on the specified deadline. Commerce will not accept rebuttal comments regarding the CBP data or respondent selection.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Release of U.S. Customs and Border Protection Entry Data,” dated January 7, 2025.
                    </P>
                </FTNT>
                <P>
                    Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on Commerce's website at 
                    <E T="03">https://www.trade.gov/administrative-protective-orders.</E>
                </P>
                <HD SOURCE="HD1">Distribution of Copies of the Petition</HD>
                <P>In accordance with section 702(b)(4)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the GOC via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).</P>
                <HD SOURCE="HD1">ITC Notification</HD>
                <P>Commerce will notify the ITC of its initiation, as required by section 702(d) of the Act.</P>
                <HD SOURCE="HD1">Preliminary Determination by the ITC</HD>
                <P>
                    The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of active anode material from China materially retard the establishment of a U.S. industry, or that subject imports are materially injuring, or threatening material injury to, a U.S. industry.
                    <SU>39</SU>
                    <FTREF/>
                     A negative ITC determination will result in the investigation being terminated.
                    <SU>40</SU>
                    <FTREF/>
                     Otherwise, this CVD investigation will proceed according to statutory and regulatory time limits.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         
                        <E T="03">See</E>
                         section 703(a)(1) of the Act.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Submission of Factual Information</HD>
                <P>
                    Factual information is defined in 19 CFR 351.102(b)(21) as: (i) evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors of production under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Section 351.301(b) of Commerce's regulations requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted 
                    <SU>41</SU>
                    <FTREF/>
                     and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct.
                    <SU>42</SU>
                    <FTREF/>
                     Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Interested parties should review the regulations prior to submitting factual information in this investigation.
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.301(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.301(b)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Extensions of Time Limits</HD>
                <P>
                    Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by Commerce. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301, or as otherwise specified by Commerce.
                    <SU>43</SU>
                    <FTREF/>
                     For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in a letter or memorandum of the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, standalone submission; under limited circumstances we will grant untimely filed requests for the extension of time 
                    <PRTPAGE P="3792"/>
                    limits, where we determine, based on 19 CFR 351.302, that extraordinary circumstances exist. Parties should review Commerce's regulations concerning the extension of time limits and the 
                    <E T="03">Time Limits Final Rule</E>
                     prior to submitting factual information in this investigation.
                    <SU>44</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.302.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.301; 
                        <E T="03">see also Extension of Time Limits; Final Rule,</E>
                         78 FR 57790 (September 20, 2013) (
                        <E T="03">Time Limits Final Rule</E>
                        ), available at 
                        <E T="03">https://www.gpo.gov/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Certification Requirements</HD>
                <P>
                    Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
                    <SU>45</SU>
                    <FTREF/>
                     Parties must use the certification formats provided in 19 CFR 351.303(g).
                    <SU>46</SU>
                    <FTREF/>
                     Commerce intends to reject factual submissions if the submitting party does not comply with the applicable certification requirements.
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         section 782(b) of the Act.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         
                        <E T="03">See Certification of Factual Information to Import Administration During Antidumping and Countervailing Duty Proceedings,</E>
                         78 FR 42678 (July 17, 2013) (
                        <E T="03">Final Rule</E>
                        ); 
                        <E T="03">see also</E>
                         frequently asked questions regarding the 
                        <E T="03">Final Rule,</E>
                         available at 
                        <E T="03">https://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>
                    Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. Parties wishing to participate in this investigation should ensure that they meet the requirements of 19 CFR 351.103(d) (
                    <E T="03">e.g.,</E>
                     by filing the required letters of appearance). Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f).
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         
                        <E T="03">See Administrative Protective Order, Service, and Other Procedures in Antidumping and Countervailing Duty Proceedings,</E>
                         88 FR 67069 (September 29, 2023).
                    </P>
                </FTNT>
                <P>This notice is issued and published pursuant to sections 702 and 777(i) of the Act, and 19 CFR 351.203(c).</P>
                <SIG>
                    <DATED>Dated: January 7, 2025.</DATED>
                    <NAME>Steven Presing,</NAME>
                    <TITLE>Acting Deputy Assistant Secretary for Policy and Negotiations.</TITLE>
                </SIG>
                <APPENDIX>
                    <HD SOURCE="HED">Appendix—Scope of the Investigation</HD>
                    <P>The merchandise covered by this investigation is active anode material, which is an anode grade graphite material with a graphite minimum purity content of 90 percent carbon by weight, whether containing synthetic graphite, natural graphite, or a blend of synthetic and natural graphite; with or without coating. Subject merchandise may be in the form of powder, dry, liquid, or block form and is covered irrespective of the form in which it enters. Subject merchandise typically has a maximum size of 80 microns when in powder form. Subject merchandise has an energy density of 330 milliamp hours per gram or greater and a degree of graphitization of 80 percent or greater, where graphitization refers to the extent of the graphite crystal structure.</P>
                    <P>
                        Subject merchandise is covered regardless of whether it is mixed with silicon based active materials, 
                        <E T="03">e.g.,</E>
                         silicon-oxide (SiOx), silicon-carbon (SiC), or silicon, or additives such as carbon black or carbon nanotubes. Subject merchandise is covered regardless of the combination of compounds that comprise the graphite material. Subject merchandise is covered regardless of whether it is imported independently, as part of a compound, in a battery, as a component of an anode slurry, or in a subassembly of a battery such as an electrode. Only the anode grade graphite material is covered when entered as part of a mixture with silicon based active materials, as part of a compound, in a batter, as a component of an anode slurry, or in a subassembly of a battery such as an electrode.
                    </P>
                    <P>Active anode material subject to the investigation may be classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 2504.10.5000 and 3801.10.5000. Subject merchandise may also enter under HTSUS subheadings 2504.10.1000 and 3801.90.0000. The HTSUS subheadings are provided for convenience and customs purposes only. The written description of the scope of the investigation is dispositive.</P>
                </APPENDIX>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00657 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[A-570-194]</DEPDOC>
                <SUBJECT>Active Anode Material From the People's Republic of China: Initiation of Less-Than-Fair-Value Investigation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable January 7, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christopher Maciuba, Office II, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0413.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">The Petition</HD>
                <P>
                    On December 18, 2024, the U.S. Department of Commerce (Commerce) received an antidumping duty (AD) petition concerning imports of active anode material from the People's Republic of China (China) filed in proper form on behalf of the American Active Anode Material Producers (the petitioner),
                    <SU>1</SU>
                    <FTREF/>
                     an 
                    <E T="03">ad hoc</E>
                     trade association of domestic producers.
                    <SU>2</SU>
                    <FTREF/>
                     The AD Petition was accompanied by a countervailing duty (CVD) petition concerning imports of active anode material from China.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The members of the American Active Anode Material Producers are Anovion Technologies, Syrah Technologies LLC, NOVONIX Anode Materials LLC, Epsilon Advanced Materials, and SKI US, Inc.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letter, “Petition for the Imposition of Antidumping and Countervailing Duties,” dated December 18, 2024 (Petition).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    On December 20, 2024 and January 2, 2025, Commerce requested supplemental information pertaining to certain aspects of the Petition in supplemental questionnaires.
                    <SU>4</SU>
                    <FTREF/>
                     On December 27, 2024 and January 3, 2025, the petitioner filed timely responses to these requests for additional information.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Commerce's Letters, “Supplemental Questions,” dated December 20, 2024 (General Issues Questionnaire); and “Supplemental Questions,” dated December 20, 2024; 
                        <E T="03">see also</E>
                         Memorandum, “Phone Call with Counsel to the Petitioner,” dated January 2, 2025.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letters, “Response to Supplemental Questions Regarding Common Issues and Injury Volume I of the Petitions,” dated December 27, 2024 (First General Issues Supplement); “Response to Supplemental Petition Questionnaire,” dated December 27, 2024; and “Response to Supplemental Questions Regarding Volume I of the Petitions,” dated January 3, 2025 (Second General Issues Supplement).
                    </P>
                </FTNT>
                <P>In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of active anode material from China are being, or are likely to be, sold in the United States at less than fair value (LTFV) within the meaning of section 731 of the Act, and that imports of such products materially retard the establishment of an industry in the United States, or in the alternative, that such products are materially injuring, or threaten material injury to, the active anode material industry in the United States. Consistent with section 732(b)(1) of the Act, the Petition was accompanied by information reasonably available to the petitioner supporting its allegations.</P>
                <P>
                    Commerce finds that the petitioner filed the Petition on behalf of the domestic industry, because the petitioner is an interested party, as defined in section 771(9)(F) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support for the initiation of the requested LTFV investigation.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         section on “Determination of Industry Support for the Petition,” 
                        <E T="03">infra</E>
                        .
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Period of Investigation</HD>
                <P>
                    Because the Petition was filed on December 18, 2024, and because China 
                    <PRTPAGE P="3793"/>
                    is a non-market economy (NME) country, pursuant to 19 CFR 351.204(b)(1), the period of investigation (POI) for the LTFV investigation is April 1, 2024, through September 30, 2024.
                </P>
                <HD SOURCE="HD1">Scope of the Investigation</HD>
                <P>
                    The product covered by this investigation is active anode material from China. For a full description of the scope of this investigation, 
                    <E T="03">see</E>
                     the appendix to this notice.
                </P>
                <HD SOURCE="HD1">Comments on the Scope of the Investigation</HD>
                <P>
                    On December 20, 2024, and January 2, 2025, Commerce requested information and clarification from the petitioner regarding the proposed scope to ensure that the scope language in the Petition is an accurate reflection of the products for which the domestic industry is seeking relief.
                    <SU>7</SU>
                    <FTREF/>
                     On December 27, 2024, and January 3, 2025, the petitioner provided clarifications and revised the scope.
                    <SU>8</SU>
                    <FTREF/>
                     The description of merchandise covered by this investigation, as described in the appendix to this notice, reflects these clarifications.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         General Issues Questionnaire; 
                        <E T="03">see also</E>
                         January 3, 2025, Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         First General Issues Supplement at 2-5; 
                        <E T="03">see also</E>
                         Second General Issues Supplement at 1-6 and Exhibits I-Supp2-1 through I-Supp2-3.
                    </P>
                </FTNT>
                <P>
                    As discussed in the 
                    <E T="03">Preamble</E>
                     to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (
                    <E T="03">i.e.,</E>
                     scope).
                    <SU>9</SU>
                    <FTREF/>
                     Commerce will consider all scope comments received from interested parties and, if necessary, will consult with interested parties prior to the issuance of the preliminary determination. If scope comments include factual information,
                    <SU>10</SU>
                    <FTREF/>
                     all such factual information should be limited to public information. To facilitate preparation of its questionnaires, Commerce requests that scope comments be submitted by 5:00 p.m. Eastern Time (ET) on January 27, 2025, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, which may include factual information, and should also be limited to public information, must be filed by 5:00 p.m. ET on February 6, 2025, which is 10 calendar days from the initial comment deadline.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See Antidumping Duties; Countervailing Duties, Final Rule,</E>
                         62 FR 27296, 27323 (May 19, 1997) (
                        <E T="03">Preamble</E>
                        ); 
                        <E T="03">see also</E>
                         19 CFR 351.312.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.102(b)(21) (defining “factual information”).
                    </P>
                </FTNT>
                <P>Commerce requests that any factual information that parties consider relevant to the scope of this investigation be submitted during that period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party must contact Commerce and request permission to submit the additional information. All scope comments must be filed simultaneously on the records of the concurrent LTFV and CVD investigations.</P>
                <HD SOURCE="HD1">Filing Requirements</HD>
                <P>
                    All submissions to Commerce must be filed electronically via Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS), unless an exception applies.
                    <SU>11</SU>
                    <FTREF/>
                     An electronically filed document must be received successfully in its entirety by the time and date it is due.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures,</E>
                         76 FR 39263 (July 6, 2011); 
                        <E T="03">see also Enforcement and Compliance: Change of Electronic Filing System Name,</E>
                         79 FR 69046 (November 20, 2014) for details of Commerce's electronic filing requirements, effective August 5, 2011. Information on using ACCESS can be found at 
                        <E T="03">https://access.trade.gov/help.aspx</E>
                         and a handbook can be found at 
                        <E T="03">https://access.trade.gov/help/Handbook_on_Electronic_Filing_Procedures.pdf</E>
                        .
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Comments on Product Characteristics</HD>
                <P>Commerce is providing interested parties an opportunity to comment on the appropriate physical characteristics of active anode material to be reported in response to Commerce's AD questionnaires. This information will be used to identify the key physical characteristics of the subject merchandise in order to report the relevant factors of production (FOPs) accurately, as well as to develop appropriate product comparison criteria.</P>
                <P>Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. In order to consider the suggestions of interested parties in developing and issuing the AD questionnaires, all product characteristics comments must be filed by 5:00 p.m. ET on January 27, 2025, which is 20 calendar days from the signature date of this notice. Any rebuttal comments must be filed by 5:00 p.m. ET on February 6, 2025, which is 10 calendar days from the initial comment deadline. All comments and submissions to Commerce must be filed electronically using ACCESS, as explained above, on the record of the LTFV investigation.</P>
                <HD SOURCE="HD1">Determination of Industry Support for the Petition</HD>
                <P>Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) at least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”</P>
                <P>
                    Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The U.S. International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC apply the same statutory definition regarding the domestic like product,
                    <SU>12</SU>
                    <FTREF/>
                     they do so for different purposes and pursuant to a separate and distinct authority. In addition, Commerce's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         section 771(10) of the Act.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See USEC, Inc.</E>
                         v. 
                        <E T="03">United States,</E>
                         132 F. Supp. 2d 1, 8 (CIT 2001) (citing 
                        <E T="03">Algoma Steel Corp., Ltd.</E>
                         v. 
                        <E T="03">United States,</E>
                         688 F. Supp. 639, 644 (CIT 1988), 
                        <E T="03">aff'd Algoma Steel Corp., Ltd.</E>
                         v. 
                        <E T="03">United States,</E>
                         865 F.2d 240 (Fed. Cir. 1989)).
                    </P>
                </FTNT>
                <P>
                    Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is 
                    <PRTPAGE P="3794"/>
                    “the article subject to an investigation” (
                    <E T="03">i.e.,</E>
                     the class or kind of merchandise to be investigated, which normally will be the scope as defined in the petition).
                </P>
                <P>
                    With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation.
                    <SU>14</SU>
                    <FTREF/>
                     Based on our analysis of the information submitted on the record, we have determined that active anode material, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         For a discussion of the domestic like product analysis as applied to this case and information regarding industry support, 
                        <E T="03">see</E>
                         Checklist, “Antidumping Duty Investigation Initiation Checklist: Active Anode Material from the People's Republic of China,” dated concurrently with, and hereby adopted by, this notice (China AD Initiation Checklist), at Attachment II, Analysis of Industry Support for the Antidumping and Countervailing Duty Petitions Covering Active Anode Material from the People's Republic of China (Attachment II). This checklist is on file electronically via ACCESS.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Attachment II of the China AD Initiation Checklist.
                    </P>
                </FTNT>
                <P>
                    In determining whether the petitioner has standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the appendix to this notice. To establish industry support, the petitioner provided the 2023 production of the domestic like product for the supporters of the Petition and compared this to total 2023 production for the U.S. active anode material industry.
                    <SU>16</SU>
                    <FTREF/>
                     We relied on data provided by the petitioner for purposes of measuring industry support.
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         For further discussion, 
                        <E T="03">see</E>
                         Attachment II of the China AD Initiation Checklist.
                    </P>
                </FTNT>
                <P>
                    On December 30, 2024, we received timely filed comments on industry support from Tesla, Inc. (Tesla), a U.S. importer of active anode material.
                    <SU>18</SU>
                    <FTREF/>
                     On January 2, 2025, the petitioner responded to the comments from Tesla in a timely filed rebuttal submission.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         Tesla's Letter, “Request to Reject the Petition or to Poll the Industry,” dated December 30, 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letter, “Rebuttal Industry Support Comments,” dated January 2, 2025 (Petitioner's Response).
                    </P>
                </FTNT>
                <P>
                    Our review of the data provided in the Petition, the First General Issues Supplement, the Second General Issues Supplement, the Petitioner's Response, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petition.
                    <SU>20</SU>
                    <FTREF/>
                     First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, Commerce is not required to take further action in order to evaluate industry support (
                    <E T="03">e.g.,</E>
                     polling).
                    <SU>21</SU>
                    <FTREF/>
                     Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product.
                    <SU>22</SU>
                    <FTREF/>
                     Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition.
                    <SU>23</SU>
                    <FTREF/>
                     Accordingly, Commerce determines that the Petition was filed on behalf of the domestic industry within the meaning of section 732(b)(1) of the Act.
                    <SU>24</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See</E>
                         Attachment II of the China AD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">Id.; see also</E>
                         section 732(c)(4)(D) of the Act.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         Attachment II of the China AD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Allegations and Evidence of Material Injury and Causation</HD>
                <P>
                    Section 773(a)(1)(B) of the Act states that the ITC “shall determine . . . whether there is a reasonable indication that the establishment of an industry in the United States is materially retarded by reason of imports of the subject merchandise.” The petitioner alleges that imports of subject merchandise sold at LTFV from China have materially retarded the establishment of the U.S. industry producing active anode material.
                    <SU>25</SU>
                    <FTREF/>
                     The petitioner argues that that its production has been “modest” and has not stabilized and, therefore, the U.S. industry producing active anode material has not been established.
                    <SU>26</SU>
                    <FTREF/>
                     To support its argument, the Petitioner examines the five factors 
                    <SU>27</SU>
                    <FTREF/>
                     considered by the ITC to determine if an industry is established,
                    <SU>28</SU>
                    <FTREF/>
                     as set forth in the ITC's 
                    <E T="03">AD/CVD Handbook.</E>
                    <SU>29</SU>
                    <FTREF/>
                     If the ITC determines that an industry is not established, it then considers whether the performance of the industry reflects normal start-up difficulties or whether the imports of the subject merchandise have materially retarded the establishment of the industry.
                    <SU>30</SU>
                    <FTREF/>
                     The petitioner contends that the domestic industry has performed substantially worse than what could reasonably be expected during normal start-up conditions, thereby demonstrating that the establishment of the domestic industry has been materially retarded by subject imports.
                    <SU>31</SU>
                    <FTREF/>
                     The petitioner also alleges that, in the alternative, the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than LTFV.
                    <SU>32</SU>
                    <FTREF/>
                     In addition, the petitioner alleges that subject imports from China exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         For a discussion of the material retardation allegation, 
                        <E T="03">see</E>
                         China AD Initiation Checklist at Attachment III, Analysis of Allegations and Evidence of Material Retardation, Material Injury, and Causation for the Antidumping and Countervailing Duty Petitions Covering Active Anode Material from the People's Republic of China (Attachment III).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         Attachment III of the China AD Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         For a discussion of the factors related to whether an industry is established, 
                        <E T="03">see</E>
                         Attachment III of the China AD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         
                        <E T="03">See Antidumping and Countervailing Duty Handbook</E>
                         (14th Ed.), USITC Pub. 4540 (June 2015) at II-33.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         
                        <E T="03">See</E>
                         Attachment III of the China AD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    The petitioner contends that the industry is materially retarded, or in the alternative, its injured condition is illustrated by a significant volume of subject imports; significant market share of subject imports; lost sales and revenues; underselling; low levels of production; and negative impact on financial performance.
                    <SU>34</SU>
                    <FTREF/>
                     We assessed the allegations and supporting evidence regarding material retardation, or in the alternative, material injury, threat of material injury, causation, as well as negligibility, and we have determined that these allegations are properly supported by adequate evidence and meet the statutory requirements for initiation.
                    <SU>35</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Allegations of Sales at LTFV</HD>
                <P>
                    The following is a description of the allegations of sales at LTFV upon which Commerce based its decision to initiate a LTFV investigation of imports of active anode material from China. The sources of data for the deductions and adjustments relating to U.S. price and 
                    <PRTPAGE P="3795"/>
                    normal value (NV) are discussed in greater detail in the China AD Initiation Checklist.
                </P>
                <HD SOURCE="HD1">U.S. Price</HD>
                <P>
                    The petitioner based export price (EP) on pricing information for the sale, or offer for sale, of active anode material produced in and exported from China.
                    <SU>36</SU>
                    <FTREF/>
                     The petitioner did not make any adjustments to U.S. price to calculate a net ex-factory U.S. price.
                    <SU>37</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See</E>
                         China AD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Normal Value</HD>
                <P>
                    Commerce considers China to be an NME country.
                    <SU>38</SU>
                    <FTREF/>
                     In accordance with section 771(18)(C)(i) of the Act, any determination that a foreign country is an NME country shall remain in effect until revoked by Commerce. Therefore, we continue to treat China as an NME country for purposes of the initiation of this LTFV investigation. Accordingly, we base NV on FOPs valued in a surrogate market economy country in accordance with section 773(c) of the Act.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See, e.g.,</E>
                          
                        <E T="03">Certain Freight Rail Couplers and Parts Thereof from the People's Republic of China: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Preliminary Affirmative Determination of Critical Circumstances,</E>
                         88 FR 15372 (March 13, 2023), and accompanying Preliminary Decision Memorandum at 5, unchanged in 
                        <E T="03">Certain Freight Rail Couplers and Parts Thereof from the People's Republic of China: Final Affirmative Determination of Sales at Less-Than-Fair Value and Final Affirmative Determination of Critical Circumstances,</E>
                         88 FR 34485 (May 30, 2023).
                    </P>
                </FTNT>
                <P>
                    The petitioner claims that Malaysia is an appropriate surrogate country for China because it is a market economy that is at a level of economic development comparable to that of China and is a significant producer of comparable merchandise.
                    <SU>39</SU>
                    <FTREF/>
                     The petitioner provided publicly available information from Malaysia to value all FOPs except labor.
                    <SU>40</SU>
                    <FTREF/>
                     Consistent with Commerce's recent practice in cases involving Malaysia as a surrogate country,
                    <SU>41</SU>
                    <FTREF/>
                     to value labor, the petitioner provided data from another surrogate country, Mexico.
                    <SU>42</SU>
                    <FTREF/>
                     Based on the information provided by the petitioner, we believe it is appropriate to use Malaysia as a surrogate country for China to value all FOPs except labor and Mexico to value labor for initiation purposes.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         
                        <E T="03">See</E>
                         China AD Initiation Checklist.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See, e.g.,</E>
                          
                        <E T="03">Certain Collated Steel Staples from the People's Republic of China: Final Results of Antidumping Duty Administrative Review; and Final Determination of No Shipments; 2021-2022,</E>
                         88 FR 85242 (December 7, 2023), and accompanying Issues and Decision Memorandum (IDM) at Comment 2; and 
                        <E T="03">Light-Walled Rectangular Pipe and Tube from the People's Republic of China: Final Results of Antidumping Duty Administrative Review,</E>
                         88 FR 15671 (March 14, 2023), and accompanying IDM at Comment 2.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         China AD Initiation Checklist.
                    </P>
                </FTNT>
                <P>Interested parties will have the opportunity to submit comments regarding surrogate country selection and, pursuant to 19 CFR 351.301(c)(3)(i), will be provided an opportunity to submit publicly available information to value FOPs within 30 days before the scheduled date of the preliminary determination.</P>
                <HD SOURCE="HD1">Factors of Production</HD>
                <P>
                    Because information regarding the volume of inputs consumed by Chinese producers/exporters was not reasonably available, the petitioner used product-specific consumption rates from a U.S. producer of active anode material as a surrogate to value Chinese manufacturers' FOPs.
                    <SU>43</SU>
                    <FTREF/>
                     Additionally, the petitioner calculated factory overhead, selling, general, and administrative expenses, and profit based on the experience of a Malaysian producer of comparable merchandise.
                    <SU>44</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Fair Value Comparisons</HD>
                <P>
                    Based on the data provided by the petitioner, there is reason to believe that imports of active anode material from China are being, or are likely to be, sold in the United States at LTFV. Based on comparisons of EP to NV in accordance with sections 772 and 773 of the Act, the estimated dumping margins for active anode material from China covered by this initiation range from 823.40 to 915.74 percent.
                    <SU>45</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Initiation of LTFV Investigation</HD>
                <P>Based upon the examination of the Petition and supplemental responses, we find that they meet the requirements of section 732 of the Act. Therefore, we are initiating a LTFV investigation to determine whether imports of active anode material are being, or are likely to be, sold in the United States at LTFV. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 140 days after the date of this initiation.</P>
                <HD SOURCE="HD1">Respondent Selection</HD>
                <P>
                    In the Petition, the petitioner identified 30 companies in China as producers and/or exporters of active anode material.
                    <SU>46</SU>
                    <FTREF/>
                     Our standard practice for respondent selection in AD investigations involving NME countries is to select respondents based on quantity and value (Q&amp;V) questionnaires in cases where Commerce has determined that the number of companies is large, and it cannot individually examine each company based upon its resources. Therefore, considering the number of producers and/or exporters identified in the Petition, Commerce will solicit Q&amp;V information that can serve as a basis for selecting exporters for individual examination in the event that Commerce determines that the number is large and decides to limit the number of respondents individually examined pursuant to section 777A(c)(2) of the Act. Because there are 30 Chinese producers and/or exporters identified in the Petition, Commerce has determined that it will issue Q&amp;V questionnaires to the largest producers and/or exporters in China that are identified in the U.S. Customs and Border Protection POI entry data for which there is complete address information on the record.
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         
                        <E T="03">See</E>
                         Petition at Volume I (page 6 and Exhibit I-9); 
                        <E T="03">see also</E>
                         First General Issues Supplement at 1-2 and Exhibit I-Supp-1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Release of U.S. Customs and Border Protection Entry Data,” dated January 7, 2025.
                    </P>
                </FTNT>
                <P>
                    Commerce will post the Q&amp;V questionnaires along with filing instructions on Commerce's website at 
                    <E T="03">https://www.trade.gov/ec-adcvd-case-announcements.</E>
                     Producers/exporters of active anode material from China that do not receive Q&amp;V questionnaires may still submit a response to the Q&amp;V questionnaire and can obtain a copy of the Q&amp;V questionnaire from Commerce's website. Responses to the Q&amp;V questionnaire must be submitted by the relevant Chinese producers/exporters no later than 5:00 p.m. ET on January 21, 2025, which is two weeks from the signature date of this notice. All Q&amp;V questionnaire responses must be filed electronically via ACCESS. An electronically filed document must be received successfully, in its entirety, by ACCESS no later than 5:00 p.m. ET on the deadline noted above.
                </P>
                <P>
                    Interested parties must submit applications for disclosure under administrative protective order (APO) in accordance with 19 CFR 351.305(b). As stated above, instructions for filing such applications may be found on Commerce's website at 
                    <E T="03">https://www.trade.gov/administrative-protective-orders.</E>
                </P>
                <HD SOURCE="HD1">Separate Rates</HD>
                <P>
                    In order to obtain separate rate status in an NME investigation, exporters and producers must submit a separate rate application. The specific requirements for submitting a separate rate 
                    <PRTPAGE P="3796"/>
                    application in an NME investigation are outlined in detail in the application itself, which is available on Commerce's website at 
                    <E T="03">https://access.trade.gov/Resources/nme/nme-sep-rate.html.</E>
                     The separate rate application will be due 30 days after publication of this initiation notice. Exporters and producers must file a timely separate rate application if they want to be considered for individual examination. Exporters and producers who submit a separate rate application and have been selected as mandatory respondents will be eligible for consideration for separate rate status only if they respond to all parts of Commerce's AD questionnaire as mandatory respondents. Commerce requires that companies from China submit a response both to the Q&amp;V questionnaire and to the separate rate application by the respective deadlines to receive consideration for separate rate status. Companies not filing a timely Q&amp;V questionnaire response will not receive separate rate consideration.
                </P>
                <HD SOURCE="HD1">Use of Combination Rates</HD>
                <P>Commerce will calculate combination rates for certain respondents that are eligible for a separate rate in an NME investigation. The Separate Rates and Combination Rates Bulletin states:</P>
                <EXTRACT>
                    <FP>
                        {w}hile continuing the practice of assigning separate rates only to exporters, all separate rates that {Commerce} will now assign in its NME investigation will be specific to those producers that supplied the exporter during the period of investigation. Note, however, that one rate is calculated for the exporter and all of the producers which supplied subject merchandise to it during the period of investigation. This practice applies both to mandatory respondents receiving an individually calculated separate rate as well as the pool of non-investigated firms receiving the {weighted average} of the individually calculated rates. This practice is referred to as the application of “combination rates” because such rates apply to specific combinations of exporters and one or more producers. The cash-deposit rate assigned to an exporter will apply only to merchandise both exported by the firm in question 
                        <E T="03">and</E>
                         produced by a firm that supplied the exporter during the period of investigation.
                        <SU>48</SU>
                        <FTREF/>
                    </FP>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             
                            <E T="03">See</E>
                             Enforcement and Compliance's Policy Bulletin No. 05.1, regarding, “Separate-Rates Practice and Application of Combination Rates in Antidumping Investigation involving NME Countries,” (April 5, 2005), at 6 (emphasis added), available on Commerce's website at 
                            <E T="03">https://access.trade.gov/Resources/policy/bull05-1.pdf.</E>
                        </P>
                    </FTNT>
                </EXTRACT>
                <HD SOURCE="HD1">Distribution of Copies of the Petition</HD>
                <P>In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), copies of the public version of the Petition have been provided to the Government of China via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).</P>
                <HD SOURCE="HD1">ITC Notification</HD>
                <P>Commerce will notify the ITC of our initiation, as required by section 732(d) of the Act.</P>
                <HD SOURCE="HD1">Preliminary Determination by the ITC</HD>
                <P>
                    The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of active anode material from China materially retard the establishment of a U.S. industry, or that such imports are materially injuring, or threatening material injury to, a U.S. industry.
                    <SU>49</SU>
                    <FTREF/>
                     A negative ITC determination will result in the investigation being terminated.
                    <SU>50</SU>
                    <FTREF/>
                     Otherwise, this LTFV investigation will proceed according to statutory and regulatory time limits.
                </P>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         
                        <E T="03">See</E>
                         section 733(a) of the Act.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Submission of Factual Information</HD>
                <P>
                    Factual information is defined in 19 CFR 351.102(b)(21) as: (i) evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Section 351.301(b) of Commerce's regulations requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted 
                    <SU>51</SU>
                    <FTREF/>
                     and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct.
                    <SU>52</SU>
                    <FTREF/>
                     Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Interested parties should review the regulations prior to submitting factual information in this investigation.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.301(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.301(b)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Extensions of Time Limits</HD>
                <P>
                    Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by Commerce. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301, or as otherwise specified by Commerce.
                    <SU>53</SU>
                    <FTREF/>
                     For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in a letter or memorandum of the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, standalone submission; under limited circumstances we will grant untimely filed requests for the extension of time limits, where we determine, based on 19 CFR 351.302, that extraordinary circumstances exist. Parties should review Commerce's regulations concerning the extension of time limits and the 
                    <E T="03">Time Limits Final Rule</E>
                     prior to submitting factual information in this investigation.
                    <SU>54</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.301; 
                        <E T="03">see also Extension of Time Limits; Final Rule,</E>
                         78 FR 57790 (September 20, 2013) (
                        <E T="03">Time Limits Final Rule</E>
                        ), available at 
                        <E T="03">https://www.gpo.gov/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.302; 
                        <E T="03">see also, e.g., Time Limits Final Rule.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Certification Requirements</HD>
                <P>
                    Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
                    <SU>55</SU>
                    <FTREF/>
                     Parties must use the certification formats provided in 19 CFR 351.303(g).
                    <SU>56</SU>
                    <FTREF/>
                     Commerce intends to reject factual submissions if the submitting party does not comply with the applicable certification requirements.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         section 782(b) of the Act.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         
                        <E T="03">See Certification of Factual Information to Import Administration During Antidumping and Countervailing Duty Proceedings,</E>
                         78 FR 42678 (July 17, 2013) (
                        <E T="03">Final Rule</E>
                        ). Additional information regarding the 
                        <E T="03">Final Rule</E>
                         is available at 
                        <E T="03">https://access.trade.gov/Resources/filing/index.html.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>
                    Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. Parties wishing to participate in this investigation should ensure that they meet the requirements of 19 CFR 351.103(d) (
                    <E T="03">e.g.,</E>
                     by filing the required 
                    <PRTPAGE P="3797"/>
                    letter of appearance). Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f).
                    <SU>57</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         
                        <E T="03">See Administrative Protective Order, Service, and Other Procedures in Antidumping and Countervailing Duty Proceedings,</E>
                         88 FR 67069 (September 29, 2023).
                    </P>
                </FTNT>
                <P>This notice is issued and published pursuant to sections 732(c)(2) and 777(i) of the Act, and 19 CFR 351.203(c).</P>
                <SIG>
                    <DATED>Dated: January 7, 2025.</DATED>
                    <NAME>Steven Presing,</NAME>
                    <TITLE>Acting Deputy Assistant Secretary for Policy and Negotiations.</TITLE>
                </SIG>
                <APPENDIX>
                    <HD SOURCE="HED">Appendix—Scope of the Investigation</HD>
                    <P>The merchandise covered by this investigation is active anode material, which is an anode grade graphite material with a graphite minimum purity content of 90 percent carbon by weight, whether containing synthetic graphite, natural graphite, or a blend of synthetic and natural graphite; with or without coating. Subject merchandise may be in the form of powder, dry, liquid, or block form and is covered irrespective of the form in which it enters. Subject merchandise typically has a maximum size of 80 microns when in powder form. Subject merchandise has an energy density of 330 milliamp hours per gram or greater and a degree of graphitization of 80 percent or greater, where graphitization refers to the extent of the graphite crystal structure.</P>
                    <P>
                        Subject merchandise is covered regardless of whether it is mixed with silicon based active materials, 
                        <E T="03">e.g.,</E>
                         silicon-oxide (SiOx), silicon-carbon (SiC), or silicon, or additives such as carbon black or carbon nanotubes. Subject merchandise is covered regardless of the combination of compounds that comprise the graphite material. Subject merchandise is covered regardless of whether it is imported independently, as part of a compound, in a battery, as a component of an anode slurry, or in a subassembly of a battery such as an electrode. Only the anode grade graphite material is covered when entered as part of a mixture with silicon based active materials, as part of a compound, in a batter, as a component of an anode slurry, or in a subassembly of a battery such as an electrode.
                    </P>
                    <P>Active anode material subject to the investigation may be classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 2504.10.5000 and 3801.10.5000. Subject merchandise may also enter under HTSUS subheadings 2504.10.1000 and 3801.90.0000. The HTSUS subheadings are provided for convenience and customs purposes only. The written description of the scope of the investigation is dispositive.</P>
                </APPENDIX>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00656 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[A-580-881]</DEPDOC>
                <SUBJECT>Certain Cold-Rolled Steel Flat Products From the Republic of Korea: Final Results of Antidumping Duty Administrative Review; 2022-2023</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Commerce (Commerce) determines that certain cold-rolled steel flat products (cold-rolled steel) from the Republic of Korea (Korea) was not sold in the United States at less than normal value during the period of review (POR) September 1, 2022, through August 31, 2023.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable January 15, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Caroline Carroll, AD/CVD Operations, Office IX, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4948.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On October 10, 2024, Commerce published the 
                    <E T="03">Preliminary Results</E>
                     in the 
                    <E T="04">Federal Register</E>
                    .
                    <SU>1</SU>
                    <FTREF/>
                     We invited interested parties to comment on the 
                    <E T="03">Preliminary Results;</E>
                     
                    <SU>2</SU>
                    <FTREF/>
                     however, no interested party submitted comments. Accordingly, the final results remain unchanged from the 
                    <E T="03">Preliminary Results</E>
                     and, thus, there are no memoranda accompanying this 
                    <E T="04">Federal Register</E>
                     notice. On December 9, 2024, Commerce tolled the deadline to issue the final results in this administrative review by 90 days.
                    <SU>3</SU>
                    <FTREF/>
                     Accordingly, the deadline for these final results is now May 8, 2025. Commerce conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Certain Cold-Rolled Steel Flat Products from the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2022-2023,</E>
                         89 FR 82218 (October 10, 2024) (
                        <E T="03">Preliminary Results</E>
                        ), and accompanying Preliminary Decision Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">Id.,</E>
                         89 FR at 82219.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Tolling of Deadlines for Antidumping and Countervailing Duty Proceedings,” dated December 9, 2024.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">
                    Scope of the Order 
                    <E T="51">4</E>
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See Certain Cold-Rolled Steel Flat Products from Brazil, India, the Republic of Korea, and the United Kingdom: Amended Final Affirmative Antidumping Determinations for Brazil and the United Kingdom and Antidumping Duty Orders,</E>
                         81 FR 64432 (September 20, 2016) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    The product covered by the 
                    <E T="03">Order</E>
                     is cold-rolled steel from Korea. For a complete description of the scope of the 
                    <E T="03">Order, see</E>
                     the 
                    <E T="03">Preliminary Results.</E>
                </P>
                <HD SOURCE="HD1">Rate for Non-Examined Company</HD>
                <P>
                    Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a less-than-fair-value (LTFV) investigation, for guidance when determining the weighted-average dumping margin for respondents that were not individually examined in an administrative review. Section 735(c)(5)(A) of the Act provides that the all-others rate should normally be calculated by weight averaging the weighted-average dumping margins determined for individually examined respondents, excluding rates that are zero, 
                    <E T="03">de minimis,</E>
                     or based entirely on facts available.
                </P>
                <P>
                    In this review, we calculated dumping margins of zero percent for the two mandatory respondents, Hyundai Steel Company (Hyundai) and POSCO/POSCO International Corporation (POSCO). Consistent with the U.S. Court of Appeals for the Federal Circuit's decision in 
                    <E T="03">Albemarle,</E>
                    <SU>5</SU>
                    <FTREF/>
                     and Commerce's practice,
                    <SU>6</SU>
                    <FTREF/>
                     we assigned the sole non-selected company under review, KG Dongbu Steel Co., Ltd. (KG Dongbu), a margin of zero percent, based on the rates calculated for Hyundai and POSCO, pursuant to section 735(c)(5)(B) of the Act.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See Albemarle Corp.</E>
                         v. 
                        <E T="03">United States,</E>
                         821 F.3d 1345 (Fed. Cir. 2016) (
                        <E T="03">Albemarle</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See Certain Cold-Rolled Steel Flat Products from the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2020-2021,</E>
                         87 FR 60989 (October 7, 2022).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Final Results of Review</HD>
                <P>We determine that the following estimated weighted-average dumping margins exist for the period of September 1, 2022, through August 31, 2023:</P>
                <GPOTABLE COLS="2" OPTS="L2,nj,tp0,i1" CDEF="s25,9">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Producer/exporter</CHED>
                        <CHED H="1">
                            Weighted- 
                            <LI>average </LI>
                            <LI>dumping </LI>
                            <LI>margin </LI>
                            <LI>(percent)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Hyundai Steel Company</ENT>
                        <ENT>0.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">POSCO/POSCO International Corporation</ENT>
                        <ENT>0.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">KG Dongbu Steel Co., Ltd</ENT>
                        <ENT>0.00</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Disclosure</HD>
                <P>
                    Normally, Commerce discloses to interested parties the calculations performed in connection with the final results of review within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of final results in the 
                    <E T="04">Federal Register</E>
                    , 
                    <PRTPAGE P="3798"/>
                    in accordance with 19 CFR 351.224(b). However, because Commerce made no changes from the 
                    <E T="03">Preliminary Results,</E>
                     there are no new calculations to disclose.
                </P>
                <HD SOURCE="HD1">Assessment Rates</HD>
                <P>Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Because the weighted-average dumping margins calculated for Hyundai and POSCO are zero, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.</P>
                <P>
                    Commerce's “automatic assessment” practice will apply to entries of subject merchandise during the POR produced by Hyundai or POSCO for which the reviewed companies did not know that the merchandise they sold to the intermediary (
                    <E T="03">e.g.,</E>
                     a reseller, trading company, or exporter) was destined for the United States. In such instances, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See Order,</E>
                         81 FR at 64434.
                    </P>
                </FTNT>
                <P>For KG Dongbu, the company that was not selected for individual examination, we will also assign a zero assessment rate as noted in the “Rate for Non-Examined Company” section, above.</P>
                <P>
                    Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of these final results of review in the 
                    <E T="04">Federal Register</E>
                    . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired (
                    <E T="03">i.e.,</E>
                     within 90 days of publication).
                </P>
                <HD SOURCE="HD1">Cash Deposit Requirements</HD>
                <P>
                    The following cash deposit requirements will be effective upon publication in the 
                    <E T="04">Federal Register</E>
                     of these final results of administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies listed above will be zero, as established in the final results of this review; (2) for previously investigated or reviewed companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review, or the LTFV investigation, but the producer is, then the cash deposit rate will be the cash deposit rate established for the most recently completed segment for the producer of the subject merchandise; and (4) the cash deposit rate for all other producers and exporters will continue to be 20.33 percent, the all-others rate established in the LTFV investigation.
                    <SU>8</SU>
                    <FTREF/>
                     These cash deposit requirements, when imposed, shall remain in effect until further notice.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Notification to Importers</HD>
                <P>This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.</P>
                <HD SOURCE="HD1">Administrative Protective Order (APO)</HD>
                <P>This notice serves as the only reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5).</P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Steven Presing,</NAME>
                    <TITLE>Acting Deputy Assistant Secretary for Policy and Negotiations.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00815 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Institute of Standards and Technology</SUBAGY>
                <DEPDOC>[Docket Number: 250108-0011]</DEPDOC>
                <RIN>XRIN: 0693-XC137</RIN>
                <SUBJECT>Request for Comments on AISI's Draft Document: Managing Misuse Risk for Dual-Use Foundation Models, Pursuant to Executive Order 14110 (Section 4.1(a)(ii) and Section4.1(a)(ii)(A)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Artificial Intelligence Safety Institute (AISI), National Institute of Standards and Technology (NIST), U.S. Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The U.S. Artificial Intelligence Safety Institute (AISI), housed within NIST at the Department of Commerce, requests comments on an updated draft document responsive to Section 4.1(a)(ii) and Section 4.1(a)(ii)(A) of Executive Order 14110 on Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI) issued on October 30, 2023 (E.O. 14110). This draft document, NIST AI 800-1, Managing Misuse Risk for Dual-Use Foundation Models, can be found at 
                        <E T="03">https://nvlpubs.nist.gov/nistpubs/ai/NIST.AI.800-1.ipd2.pdf.</E>
                         This document is an update to an initial public draft and includes changes based on the previous round of public comment, as well as two new appendices that apply these guidelines to (1) chemical and biological misuse risk and (2) cyber misuse risk.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments containing information in response to this notice must be received on or before March 15, 2025, at 11:59 p.m. Eastern Time. Submissions received after that date may not be considered.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The draft of NIST AI 800-1, Managing Misuse Risk for Dual-Use Foundation Models is available for review and comment on the U.S. AI Safety Institute website at 
                        <E T="03">https://nvlpubs.nist.gov/nistpubs/ai/NIST.AI.800-1.ipd2.pdf</E>
                         and at 
                        <E T="03">www.regulations.gov</E>
                         under docket number NIST-2025-0001.
                    </P>
                    <P>Comments may be submitted:</P>
                    <P>
                        <E T="03">By email:</E>
                    </P>
                    <P>
                        • Comments on NIST AI 800-1 may be sent electronically to 
                        <E T="03">NISTAI800-1@nist.gov</E>
                         with “NIST AI 800-1, Managing the Risk of Misuse for Dual-Use Foundation Models” in the subject line. Electronic submissions may be sent as an attachment in any of the following unlocked formats: HTML; ASCII; Word; RTF; or PDF.
                    </P>
                    <P>
                        <E T="03">Via</E>
                          
                        <E T="03">www.regulations.gov:</E>
                        <PRTPAGE P="3799"/>
                    </P>
                    <P>• To submit electronic public comments via the Federal eRulemaking Portal.</P>
                    <P>
                        1. Go to 
                        <E T="03">www.regulations.gov</E>
                         and enter NIST-2025-0001 in the search field,
                    </P>
                    <P>2. Click the “Comment Now!” icon, complete the required fields, including the relevant document number and title in the subject field, and</P>
                    <P>3. Enter or attach your comments.</P>
                    <P>• Written comments may also be submitted by mail to Information Technology Laboratory, ATTN: AI E.O. Document Comments, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 8900, Gaithersburg, MD 20899-8900.</P>
                    <P>Comments containing references, studies, research, and other empirical data that are not widely published should include copies of the referenced materials. All submissions, including attachments and other supporting materials, will become part of the public record and subject to public disclosure.</P>
                    <P>AISI will not accept comments accompanied by a request that part or all of the material be treated confidentially because of its business proprietary nature or for any other reason. Therefore, do not submit confidential business information or otherwise sensitive, protected, or personal information, such as account numbers, Social Security numbers, or names of other individuals.</P>
                    <P>
                        All relevant comments received by the deadline will be posted at 
                        <E T="03">https://www.regulations.gov</E>
                         under docket number NIST-2025-0001 and at 
                        <E T="03">https://www.nist.gov/artificial-intelligence/executive-order-safe-secure-and-trustworthy-artificial-intelligence.</E>
                         Attachments and other supporting materials may become part of the public record and may be subject to public disclosure.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For questions about this request for comments contact: Christina Knight, U.S. Department of Commerce, 1401 Constitution Ave. NW, Washington, DC, ((240) 961-8688). Direct media inquiries to NIST's Office of Public Affairs at (301) 975-2762. Users of telecommunication devices for the deaf, or a text telephone may call the Federal Relay Service toll free at 1-800-877-8339. Accessible Format: NIST will make the request for comments available in alternate formats, such as Braille or large print, upon request by persons with disabilities.</P>
                    <P>
                        <E T="03">Authority:</E>
                         Executive Order 14110 of Oct. 30, 2023; 15 U.S.C. 272.
                    </P>
                    <SIG>
                        <NAME>Alicia Chambers,</NAME>
                        <TITLE>NIST Executive Secretariat.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00698 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE605]</DEPDOC>
                <SUBJECT>North Pacific Fishery Management Council; Public Meetings</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of hybrid conference meetings of the North Pacific Fishery Management Council and its advisory committees.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The North Pacific Fishery Management Council (Council) and its advisory committees will meet February 3, 2025 through February 11, 2025.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Council's Scientific and Statistical Committee (SSC) will begin at 8 a.m. on Monday, February 3, 2025, and continue through Wednesday, February 5, 2025. The Council's Advisory Panel (AP) will begin at 8 a.m. on Tuesday, February 4, 2025, and continue through Saturday, February 8, 2025. The Council will begin at 8 a.m. on Thursday, February 6, 2025, and continue through Tuesday, February 11, 2025. All meetings scheduled from 8 a.m. to 5 p.m., but depending on volume of public testimony, meetings may go late. All times listed are Alaska Time.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meetings will be a hybrid conference. The in-person component of the meeting will be held at the Egan Center, 555 W 5th Ave., Anchorage, AK 99501, or join the meeting online through the links at 
                        <E T="03">https://www.npfmc.org/current-or-next-council-meeting/.</E>
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         North Pacific Fishery Management Council, 1007 W 3rd Ave., Suite 400, Anchorage, AK 99501-2252; telephone: (907) 271-2809. Instructions for attending the meeting via web conference are given under Connection Information, below.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Diana Evans, Council staff; email: 
                        <E T="03">diana.evans@noaa.gov;</E>
                         telephone: (907) 271-2809. For technical support, please contact our Council administrative staff, email: 
                        <E T="03">npfmc.admin@noaa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Agenda</HD>
                <HD SOURCE="HD2">Monday, February 3, 2025 Through Wednesday, February 5, 2025</HD>
                <P>The SSC agenda will include the following issues:</P>
                <FP SOURCE="FP-2">1. Administrative Issues</FP>
                <FP SOURCE="FP-2">2. Cook Inlet salmon harvest specifications—review report</FP>
                <FP SOURCE="FP-2">3. Salmon bycatch—Scientific and methodological second review Chum salmon bycatch initial review analysis</FP>
                <P>
                    The agenda is subject to change, and the latest version will be posted at 
                    <E T="03">https://meetings.npfmc.org/Meeting/Details/3070</E>
                     prior to the meeting, along with meeting materials.
                </P>
                <P>In addition to providing ongoing scientific advice for fishery management decisions, the SSC functions as the Council's primary peer review panel for scientific information, as described by the Magnuson-Stevens Act section 302(g)(1)(e), and the National Standard 2 guidelines (78 FR 43066). The peer-review process is also deemed to satisfy the requirements of the Information Quality Act, including the OMB Peer Review Bulletin guidelines.</P>
                <HD SOURCE="HD2">Tuesday, February 4, 2025 Through Saturday, February 8, 2025</HD>
                <P>The Advisory Panel agenda will include the following issues:</P>
                <FP SOURCE="FP-2">1. Administrative Issues</FP>
                <FP SOURCE="FP-2">2. Salmon bycatch—second review Chum salmon bycatch initial review analysis</FP>
                <HD SOURCE="HD2">Thursday, February 6, 2025 Through Tuesday, February 11, 2025</HD>
                <P>The Council agenda will include the following issues. The Council may take appropriate action on any of the issues identified.</P>
                <FP SOURCE="FP-2">1. Administrative Issues</FP>
                <FP SOURCE="FP-2">2. Cook Inlet salmon harvest specifications—review report</FP>
                <FP SOURCE="FP-2">3. Salmon bycatch—second review Chum salmon bycatch initial review analysis</FP>
                <P>
                    <E T="03">The agenda is subject to change, and the latest version will be posted at https://meetings.npfmc.org/Meeting/Details/3071 prior to the meeting, along with meeting materials</E>
                    .
                </P>
                <HD SOURCE="HD1">Connection Information</HD>
                <P>
                    You can attend the meeting online using a computer, tablet, or smart phone; or by phone only. Connection information will be posted online at: 
                    <E T="03">https://www.npfmc.org/upcoming-council-meetings.</E>
                     For technical support, please contact our administrative staff, email: 
                    <E T="03">npfmc.admin@noaa.gov.</E>
                </P>
                <P>
                    If you are attending the meeting in-person, please refer to the COVID 
                    <PRTPAGE P="3800"/>
                    avoidance protocols on our website, 
                    <E T="03">https://www.npfmc.org/current-or-next-council-meeting/.</E>
                </P>
                <HD SOURCE="HD1">Public Comment</HD>
                <P>
                    Public comment letters will be accepted and should be submitted electronically through the links at 
                    <E T="03">https://www.npfmc.org/current-or-next-council-meeting/.</E>
                     The Council strongly encourages written public comment for this meeting, to avoid any potential for technical difficulties to compromise oral testimony. The written comment period is open from December 20, 2024, and closes at 12 p.m. Alaska Time on Friday, January 31, 2025.
                </P>
                <P>Although other non-emergency issues not on the agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.</P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00758 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Licensing of Private Remote-Sensing Space Systems</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Oceanic &amp; Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection, request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>To ensure consideration, comments regarding this proposed information collection must be received on or before March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Interested persons are invited to submit written comments to Adrienne Thomas, NOAA PRA Officer, at 
                        <E T="03">NOAA.PRA@noaa.gov.</E>
                         Please reference OMB Control Number 0648-0174 in the subject line of your comments. Do not submit Confidential Business Information or otherwise sensitive or protected information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Requests for additional information or specific questions related to collection activities should be directed to Dr. Sarah Brothers, Director, Commercial Remote Sensing Regulatory Affairs, 1401 Constitution Avenue NW, Room 31027, Washington, DC 20230; (771) 216-4112; 
                        <E T="03">sarah.brothers@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Abstract</HD>
                <P>This is a request for revision and extension to an approved information collection.</P>
                <P>
                    The Department of Commerce (DOC), through the National Oceanic and Atmospheric Administration (NOAA) Office of Space Commerce (OSC) Commercial Remote Sensing Regulatory Affairs (CRSRA), has the authority to regulate private space-based remote sensing under the Land Remote Sensing Policy Act of 1992, 51 U.S.C. 60101 
                    <E T="03">et seq.</E>
                     (the Act) and regulations at 15 CFR part 960. The regulations facilitate the development of the U.S. private remote sensing industry and thus promote the collection and widespread availability of remote sensing data while preserving essential U.S. national security interests and observing international obligations.
                </P>
                <P>The proposed revisions in this notice are primarily tied to the development of a new, online platform to manage license actions called the Commerce Licensing and Compliance System for Space (CLCSS). CLCSS is intended to streamline the process for communications with CRSRA regarding applications, notices, modification requests, and annual compliance certifications. CRSRA is committed to improving the user experience and providing a simplified license application and management process for all licensees. The forms discussed below and their integration with CLCSS will streamline, clarify, and expedite paperwork submissions required to support regulation of the private space-based remote sensing industry.</P>
                <P>
                    Applications are made in response to the requirements in the Act, as amended. At present, CRSRA sends the applicant an Application Guide, which repeats the application questions and criteria listed in Appendix A to 15 CFR part 960 with an additional explanatory text. In the future, the CLCSS system will incorporate these questions and response criteria in a fillable, online form format. The application information received is used to determine if the applicant meets the legal criteria for issuance of a license to operate a private remote sensing space system, 
                    <E T="03">i.e.,</E>
                     the proposed system will be operated in accordance with the Act, U.S. national security concerns and international obligations. Application information includes information about the applicant (such as corporate information), the launch dates of any components going to space, and technical specifications of all components of the remote sensing system. CRSRA has observed that relying on both the Appendix and the Application Guide creates confusion and has led to the submission of incomplete applications. CRSRA anticipates the fillable format, which combines both the Application Guide and criteria in Appendix A, will help any new applicant accurately provide the necessary information.   If a licensee wishes to modify its license, either to reflect changes in its business practices or technical changes to its system, or to request different license conditions, it may submit such a request to CRSRA and explain why the change is sought. CRSRA needs this information to be able to keep licenses accurate and to respond to the regulated community's needs. CRSRA is incorporating a new form called the License Modification Form with a standard set of questions licensees can provide for the modification request to be processed. Licensees will identify the relevant license provisions, the requested changes to those provisions, and the date upon which the requested change will take effect. CRSRA anticipates this will expedite how quickly the requests are processed and remove a moderate amount of paperwork by clarifying what to include with a modification request.
                </P>
                <P>
                    Licensees are required to notify CRSRA when a spacecraft launches or deploys; upon disposal of an on-orbit component of the licensed system; upon detection of an anomaly; and upon the licensee's financial insolvency or dissolution. The existing information collection already allows for the collection of this information through the Licensee Notification Form (LNF). 
                    <PRTPAGE P="3801"/>
                    The approved LNF can already ease the burden on licensees when reporting this already-required information. This information is critical to fulfilling one of the United States' key international obligations, which is to authorize and continually supervise U.S. nationals' activities in space. CRSRA, therefore, must be notified when spacecraft are deployed and disposed of so that CRSRA can supervise the space activities of U.S. nationals. Similarly, anomalies may indicate loss of control of a spacecraft, so CRSRA must monitor any anomalies to meaningfully supervise the activities of U.S. nationals in space. Finally, the financial insolvency or dissolution of a licensee may indicate that a change in control of the spacecraft will follow, because an insolvent licensee may go through a bankruptcy process that might put the licensed system's ownership in question. It is critical that CRSRA be able to intervene as early as possible in this process so that a sensitive system does not pass into the ownership of an entity who might jeopardize national security or international obligations. The LNF ensures that only required information is submitted, thereby reducing unnecessary paperwork and/or follow-up correspondence. The LNF will be integrated into CLCSS to clarify content, make the LNF more accessible, and further reduce the paperwork burden.
                </P>
                <P>Pursuant to the regulations, CRSRA requires licensees to submit an annual compliance certification. In the certification, licensees verify that all facts in the license remain true. Facts that must be verified in this certification include the technical specifications of the system and other foundational facts that CRSRA relies upon in reviewing license applications. This information is critical to ensuring that only those entities who are legally fit to obtain a license do so. In order to integrate this process with CLCSS, CRSRA will turn the standard verification requirement into a form. There will be no substantive change in what information needs to be provided by licensees.</P>
                <P>
                    CRSRA will renew the optional Initial Contact Form (ICF) that includes contact information and general remote sensing system information with a few changes for clarity that include rephrasing a few questions and removing one or two. The ICF may be submitted electronically through the NOAA website prior to the submission of a full application and will also be integrated into CLCSS. The ICF information received is used to determine if the applicant is required to submit a full application for the issuance of a license to operate a private remote sensing space system, 
                    <E T="03">i.e.,</E>
                     the proposed system falls under the authority defined in the Act and the regulations. If NOAA determines after reviewing the ICF that an application is not required, the potential applicant will save 40-50 hours of paperwork by not submitting the application.
                </P>
                <P>Finally, CRSRA is renewing the optional Data Availability Notification (DAN) which includes contact information and general data availability information. The DAN may be submitted electronically through the NOAA website during the application process, while an applicant holds a license, or by any interested party. The DAN will be integrated with CLCSS as well. The DAN information received is used to help determine the availability of unenhanced data from a foreign or domestic remote sensing system, which may then be compared to unenhanced data produced by an applicant's system for the purpose of adjusting the conditions and/or restrictions in a license. The DAN form ensures that only required information is submitted, thereby reducing unnecessary paperwork and/or follow-up correspondence.</P>
                <HD SOURCE="HD1">II. Method of Collection</HD>
                <P>Information is collected electronically through the NOAA website and through the coming online platform Commerce Licensing and Compliance System for Space (CLCSS).</P>
                <HD SOURCE="HD1">III. Data</HD>
                <P>
                    <E T="03">OMB Control Number:</E>
                     0648-0174.
                </P>
                <P>
                    <E T="03">Form Number(s):</E>
                     None.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular (revision and extension of a current information collection).
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     100.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     25 hours for the submission of a license application (one time for the entire license); 1 hour for the submission of a license amendment; 30 minutes each for a notification of disposal of on-orbit component, notification of detection of anomaly, and notification of financial insolvency or dissolution using the Licensee Notification Form; 30 minutes each for notification of launch or deployment of spacecraft; 3 hours for the annual compliance certification; and 20 minutes for the Initial Contact Form; and 10 minutes for the Data Availability Notification.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     100 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Cost to Public:</E>
                     $0.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Mandatory. The ICF and DAN are voluntary.
                </P>
                <P>
                    <E T="03">Legal Authority:</E>
                     Land Remote Sensing Policy Act of 1992, 51 U.S.C. 60101 
                    <E T="03">et seq;</E>
                     and 15 CFR part 960—Licensing of Private Remote Sensing Space Systems.
                </P>
                <HD SOURCE="HD1">IV. Request for Comments</HD>
                <P>We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.</P>
                <P>Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <SIG>
                    <NAME>Sheleen Dumas,</NAME>
                    <TITLE>Departmental PRA Clearance Officer, Office of the Under Secretary for Economic Affairs, Commerce Department.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00741 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-HR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE572]</DEPDOC>
                <SUBJECT>South Atlantic Fishery Management Council; Public Meetings</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The South Atlantic Fishery Management Council (Council) will 
                        <PRTPAGE P="3802"/>
                        hold a meeting of the Law Enforcement Advisory Panel (AP) in February.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Law Enforcement AP meeting will be held via webinar on February 5, 2025. The meeting will be held from 1 p.m. until 5 p.m., EST.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Meeting address:</E>
                         The meeting will be held via webinar. The webinar is open to members of the public. Registration is required. Webinar registration, an online public comment form, and briefing book materials will be available two weeks prior to the meeting at: 
                        <E T="03">https://safmc.net/advisory-panel-meetings/.</E>
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N Charleston, SC 29405.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Myra Brouwer, Deputy Director for Management, SAFMC; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email: 
                        <E T="03">myra.brouwer@safmc.net.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Law Enforcement Advisory Panel will discuss modifications to the Law Enforcement Officer of the Year award process, background check practices for state agency appointments to advisory groups, potential actions to improve the Southeast For-Hire Integrated Electronic Reporting Program, and other enforcement issues as needed.</P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>
                    The meeting is physically accessible to people with disabilities. Requests for auxiliary aid should be directed to the Council office (see 
                    <E T="02">ADDRESSES</E>
                    ) 10 days prior to the meeting.
                </P>
                <P>
                    <E T="03">Note:</E>
                     The times and sequence specified in this agenda are subject to change.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00654 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE571]</DEPDOC>
                <SUBJECT>South Atlantic Fishery Management Council; Public Meetings</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The South Atlantic Fishery Management Council (Council) will hold a meeting of the 
                        <E T="03">Ad Hoc</E>
                         For-Hire Reporting Advisory Panel in January.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The 
                        <E T="03">Ad Hoc</E>
                         For-Hire Reporting Advisory Panel meeting will be held via webinar on January 29, 2025. The meeting will be held from 1 p.m. until 5 p.m., EST.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Meeting address:</E>
                         The meeting will be held via webinar. The webinar is open to members of the public. Registration is required. Webinar registration, an online public comment form, and briefing book materials will be available two weeks prior to the meeting at: 
                        <E T="03">https://safmc.net/advisory-panel-meetings/.</E>
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N Charleston, SC 29405.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Myra Brouwer, Deputy Director for Management, SAFMC; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email: 
                        <E T="03">myra.brouwer@safmc.net.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The 
                    <E T="03">Ad Hoc</E>
                     For-Hire Reporting Advisory Panel will discuss potential actions to improve the Southeast For-Hire Integrated Electronic Reporting (SEFHIER) Program.
                </P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>
                    The meeting is physically accessible to people with disabilities. Requests for auxiliary aid should be directed to the Council office (see 
                    <E T="02">ADDRESSES</E>
                    ) 10 days prior to the meeting.
                </P>
                <P>
                    <E T="03">Note:</E>
                     The times and sequence specified in this agenda are subject to change.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00652 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE608]</DEPDOC>
                <SUBJECT>Marine Mammals and Endangered Species</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; issuance of permits, permit amendments, and permit modifications.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given that permits, permit amendments, and permit modifications have been issued to the following entities under the Marine Mammal Protection Act (MMPA) and the Endangered Species Act (ESA), as applicable.</P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The permits and related documents are available for review upon written request via email to 
                        <E T="03">NMFS.Pr1Comments@noaa.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Erin Markin, Ph.D., (File Nos. 21467 and 28294); Carrie Hubard (File No. 28082); Courtney Smith, Ph.D. (File No. 27984), and Sara Young (File No. 22677); at (301) 427-8401.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Notices were published in the 
                    <E T="04">Federal Register</E>
                     on the dates listed below that requests for a permit, permit amendment, or permit modification had been submitted by the below-named applicants. To locate the 
                    <E T="04">Federal Register</E>
                     notice that announced our receipt of the application and a complete description of the activities, go to 
                    <E T="03">https://www.federalregister.gov</E>
                     and search on the file number provided in table 1 below.
                </P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="xs48,12,r30,r75,r50,r50">
                    <TTITLE>Table 1—Issued Permits, Permit Amendments, and Permit Modifications</TTITLE>
                    <BOXHD>
                        <CHED H="1">File No.</CHED>
                        <CHED H="1">Version No.</CHED>
                        <CHED H="1">RTID</CHED>
                        <CHED H="1">Applicant</CHED>
                        <CHED H="1">
                            Previous 
                            <E T="02">Federal</E>
                            <LI>
                                <E T="02">Register</E>
                                 notice
                            </LI>
                        </CHED>
                        <CHED H="1">Issuance date</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">21467</ENT>
                        <ENT>03</ENT>
                        <ENT>0648-XE413</ENT>
                        <ENT>Karen Holloway-Adkins, Ph.D., East Coast Biologists, Inc., P.O. Box 33715, Indialantic, FL 32903</ENT>
                        <ENT>89 FR 85518, October 28, 2024</ENT>
                        <ENT>December 17, 2024.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="3803"/>
                        <ENT I="01">22677</ENT>
                        <ENT>01</ENT>
                        <ENT>0648-XR039</ENT>
                        <ENT>NMFS Pacific Islands Fisheries Science Center, 1845 Wasp Boulevard, Building 176, Honolulu, HI 96818 (Responsible Party: Charles Littnan, Ph.D.)</ENT>
                        <ENT>85 FR 1805, January 13, 2020</ENT>
                        <ENT>December 12, 2024.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">27984</ENT>
                        <ENT>N/A</ENT>
                        <ENT>0648-XE291</ENT>
                        <ENT>Jooke Robbins, Ph.D., Center for Coastal Studies, 5 Holway Avenue, Provincetown, MA 02657</ENT>
                        <ENT>89 FR 86319, October 30, 2024</ENT>
                        <ENT>December 20, 2024.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">28082</ENT>
                        <ENT>N/A</ENT>
                        <ENT>0648-XD959</ENT>
                        <ENT>Pioneer Studios, 2511 Ashton Village Drive, San Antonio, TX 78248 (Responsible Party: Ben Hamilton)</ENT>
                        <ENT>89 FR 42854, May 16, 2024</ENT>
                        <ENT>December 20, 2024.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">28294</ENT>
                        <ENT>N/A</ENT>
                        <ENT>0648-XE457</ENT>
                        <ENT>Matthew Fisher, Normandeau Associates Inc., 2233 Spring Street, West Lawn, PA 19609</ENT>
                        <ENT>89 FR 85517, October 28, 2024</ENT>
                        <ENT>December 11, 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ), a final determination has been made that the activities proposed for File Nos. 21467, 27984, 28082, and 28294 are categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.
                </P>
                <P>For File No. 22677, NMFS determined that the activities proposed are consistent with the Preferred Alternative in the Final Hawaiian Monk Seal Recovery Actions Programmatic Environmental Impact Statement (NMFS 2014), and that issuance of the permit amendment would not have a significant adverse impact on the human environment.</P>
                <P>As required by the ESA, as applicable, issuance of these permit was based on a finding that such permits: (1) were applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) are consistent with the purposes and policies set forth in section 2 of the ESA.</P>
                <P>
                    <E T="03">Authority:</E>
                     The requested permits have been issued under the MMPA of 1972, as amended (16 U.S.C. 1361 
                    <E T="03">et seq.</E>
                    ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the ESA of 1973, as amended (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ), and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), as applicable.
                </P>
                <SIG>
                    <DATED>Dated: January 9, 2025.</DATED>
                    <NAME>Julia M. Harrison,</NAME>
                    <TITLE>Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00717 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID0648-XE598]</DEPDOC>
                <SUBJECT>Fisheries of the South Atlantic, Gulf of Mexico, and Caribbean; Southeast Data, Assessment, and Review (SEDAR); Public Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of the SEDAR Steering Committee meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The SEDAR Steering Committee will meet to discuss the SEDAR stock assessment process and assessment schedule. See 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        .
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The SEDAR Steering Committee will be held Tuesday, February 4, 2025, from 1 p.m. until 6 p.m., Eastern and from 9 a.m. until 3 p.m., Eastern on Wednesday, February 5, 2025. The established times may be adjusted as necessary to accommodate the timely completion of discussion relevant to the SEDAR process. Such adjustments may result in the meeting being extended from or completed prior to the time established by this notice.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Meeting address:</E>
                         The SEDAR Steering Committee meeting will be held at the Doubletree by Hilton, 5264 International Blvd., North Charleston, SC 29418; phone: (843) 576-0300.
                    </P>
                    <P>
                        <E T="03">SEDAR address:</E>
                         4055 Faber Place Drive, Suite 201, N Charleston, SC 29405; 
                        <E T="03">www.sedarweb.org.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Julie A. Neer, SEDAR Program Manager, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email: 
                        <E T="03">Julie.neer@safmc.net.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The SEDAR Steering Committee provides guidance and oversight of the SEDAR stock assessment program and manages assessment scheduling.</P>
                <P>The items of discussion for this meeting are as follows: SEDAR Projects Update; SEDAR Projects Schedule; SEDAR Process Review and Discussions; and other business.</P>
                <P>Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.</P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>
                    This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SEDAR office (see 
                    <E T="02">ADDRESSES</E>
                    ) at least 5 business days prior to the meeting.
                </P>
                <P>
                    <E T="03">Note:</E>
                     The times and sequence specified in this agenda are subject to change.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00655 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3804"/>
                <AGENCY TYPE="N">CONSUMER FINANCIAL PROTECTION BUREAU</AGENCY>
                <DEPDOC>[Docket No.: CFPB-2025-0005]</DEPDOC>
                <SUBJECT>Request for Information Regarding the Collection, Use, and Monetization of Consumer Payment and Other Personal Financial Data</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Consumer Financial Protection Bureau.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and request for information.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Consumer Financial Protection Bureau (CFPB) is seeking comments from the public to better understand how companies that offer or provide consumer financial products or services collect, use, share, and protect consumers' personal financial data, such as data harvested from consumer payments. The submissions in response to this request for information will serve to assist the CFPB and policymakers in further understanding the current state of the business practices at these companies and the concerns of consumers as the CFPB exercises its enforcement, supervision, regulatory, and other authorities.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before April 11, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by Docket No. CFPB-2025-0005, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Email: PrivacyRFI@cfpb.gov.</E>
                         Include the document title and Docket No. CFPB-2025-0005 in the subject line of the message.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail/Hand Delivery/Courier:</E>
                         Comment Intake, Request for Information Regarding Financial Company Consumer Data, Consumer Financial Protection Bureau, c/o Legal Division Docket Manager, 1700 G Street NW, Washington, DC 20552. Because paper mail in the Washington, DC area and at the CFPB is subject to delay, commenters are encouraged to submit comments electronically.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         The CFPB encourages the early submission of comments. All submissions should include the agency name and docket number for this request for information. Please note the number of the topic on which you are commenting at the top of each response (you do not need to address all topics). In general, all comments received will be posted without change to 
                        <E T="03">https://www.regulations.gov.</E>
                         All comments, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. Proprietary or sensitive personal information, such as account numbers or Social Security numbers, or the names of other individuals should not be included. Comments will not be edited to remove any identifying or contact information or other information that you would ordinarily not make public.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        George Karithanom, Regulatory Implementation and Guidance Program Analyst, Office of Regulations, at 202-435-7700 or at: 
                        <E T="03">https://reginquiries.consumerfinance.gov/.</E>
                         If you require this document in an alternative electronic format, please contact 
                        <E T="03">CFPB_Accessibility@cfpb.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <HD SOURCE="HD2">A. Recent CFPB Efforts on Payment Privacy</HD>
                <P>
                    Over the last decade, Americans have increasingly adopted new ways to make payments, particularly through digital payment services and applications operating adjacent to, but outside of, the traditional banking system. Since 2021, the CFPB has conducted extensive research into the changing landscape of consumer payments, which included information obtained through market monitoring orders issued to large technology companies offering digital payment apps. For example, in 2022, the CFPB published a report about the convergence of payments with other commercial activities in the United States and abroad.
                    <SU>1</SU>
                    <FTREF/>
                     The report noted some of the types of data captured in these “super apps,” including apps that are ubiquitous in China. As part of its development of the Personal Financial Data Rights Rule required by section 1033 of the Consumer Financial Protection Act, the CFPB closely studied ways in which financial data can be protected in the context of data portability and “open banking.” 
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         CFPB, 
                        <E T="03">The Convergence of Payments and Commerce</E>
                         (Aug. 2022), 
                        <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_convergence-payments-commerce-implications-consumers_report_2022-08.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Required Rulemaking on Personal Financial Data Rights, 89 FR 90838 (Nov. 18, 2024).
                    </P>
                </FTNT>
                <P>Across these efforts, the CFPB has observed that actual business practices show significant deviation from longstanding consumer expectations when it comes to the collection, use, and monetization of data harvested from payment transactions. Americans may think that their financial information is kept private just because it is sensitive. However, the CFPB's monitoring of the market suggests that companies operating payment systems and apps are able to connect payments data with a broad range of other data. The CFPB also notes that there have been significant advances in the capabilities of physical devices and hardware, giving these companies the technical capability to collect biometric information (including certain vital signs and the voices of individuals proximate to the primary user), geographic location, social networking habits, and more. The commingling of this data with personal financial data raises heightened concerns about privacy, given the significant value companies derive from that data. For example, such information could be used to develop dynamic pricing algorithms that tailor prices to a particular individual, where the seller is aided by knowledge about the consumer's purchase history.</P>
                <HD SOURCE="HD2">B. The Gramm-Leach-Bliley Act and Regulation P</HD>
                <P>
                    In 1999, Congress enacted the Gramm-Leach-Bliley Act (GLBA),
                    <SU>3</SU>
                    <FTREF/>
                     which authorized bank holding companies and financial holding companies to engage, directly and through their affiliates, in a wide variety of “financial activities” that extended far beyond traditional banking.
                    <SU>4</SU>
                    <FTREF/>
                     At the same time, Congress sought to protect consumers by imposing restrictions on how financial institutions share the information they receive about consumers with nonaffiliated third parties. These privacy provisions apply to “financial institution[s],” which Congress broadly defined to include most companies in “the business of . . . engaging in financial activities.” 
                    <SU>5</SU>
                    <FTREF/>
                     For example, banks, credit card issuers, credit bureaus, mortgage originators and servicers, student loan servicers, debt collectors, and payday lenders generally qualify as financial institutions subject to the GLBA.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Gramm-Leach-Bliley Act, Public Law 106-102, 113 Stat. 1338 (Nov. 12, 1999).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         12 U.S.C. 1843(k).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         15 U.S.C. 6809(3).
                    </P>
                </FTNT>
                <P>
                    The privacy provisions of the GLBA protect consumers' “nonpublic personal information”—a term that the GLBA defines broadly.
                    <SU>6</SU>
                    <FTREF/>
                     The GLBA limits the extent to which financial institutions can disclose nonpublic personal information to nonaffiliated third parties,
                    <SU>7</SU>
                    <FTREF/>
                     and also restricts how downstream recipients of such 
                    <PRTPAGE P="3805"/>
                    consumer data can use or further disclose that data.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         15 U.S.C. 6802(a)-(b); 
                        <E T="03">see also</E>
                         15 U.S.C. 6809(4) (defining “nonpublic personal information”); 12 CFR 1016.3(p)-(q) (defining “nonpublic personal information” and “personally identifiable financial information”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         15 U.S.C. 6802(b), (e); 12 CFR 1016.13-15.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         15 U.S.C. 6802(c); 12 CFR 1016.11.
                    </P>
                </FTNT>
                <P>
                    Initially, the GLBA gave rulemaking authority to several agencies, which then issued regulations to implement the GLBA.
                    <SU>9</SU>
                    <FTREF/>
                     On a few occasions, Congress amended the GLBA and the agencies updated their regulations in response.
                    <SU>10</SU>
                    <FTREF/>
                     With the passage of the Consumer Financial Protection Act (CFPA), Congress amended the GLBA's rulemaking provision, granting rulemaking authority for the privacy provisions of the GLBA to the CFPB.
                    <SU>11</SU>
                    <FTREF/>
                     The CFPA also gave the CFPB authority to enforce the GLBA's privacy provisions, along with other Federal regulators.
                    <SU>12</SU>
                    <FTREF/>
                     Additionally, the CFPB has used its authority to address unfair or deceptive acts or practices related to the handling of consumer data.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         section 504, Public Law 106-102, 113 Stat. 1439-40; 
                        <E T="03">e.g.,</E>
                         65 FR 35162 (June 1, 2000) (codified at 12 CFR parts 40, 216, 332, 573) (final rule implemented by the Office of the Comptroller of the Currency, the Federal Reserve System, the Federal Deposit Insurance Corporation, and the Office of Thrift Supervision); 65 FR 33646 (May 24, 2000) (codified at 12 CFR part 313) (final rule implemented by the Federal Trade Commission).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">E.g.,</E>
                         section 75001, Public Law 114-94, 129 Stat. 1312, 1787 (2015); section 728, Public Law 109-351, 120 Stat. 1966, 2003-04 (2006).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         section 1093, Public Law 111-203, 124 Stat. 1376, 2095 (July 21, 2010). The CFPB does not have rulemaking authority with respect to the GLBA's data security standards. 
                        <E T="03">See</E>
                         15 U.S.C. 6804(a). The Securities and Exchange Commission, Commodity Futures Trading Commission, and Federal Trade Commission also have rulemaking authority within their respective jurisdictions. 
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         15 U.S.C. 6805.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Consumer Financial Protection Circular 2022-04, 
                        <E T="03">Insufficient data protection or security for sensitive consumer information, https://www.consumerfinance.gov/compliance/circulars/circular-2022-04-insufficient-data-protection-or-security-for-sensitive-consumer-information/;</E>
                         Compl., 
                        <E T="03">Bureau of Consumer Fin. Prot.</E>
                         v. 
                        <E T="03">Equifax Inc.,</E>
                         No. 1:19-cv-03300-TWT (N.D. Ga. July 22, 2019), 
                        <E T="03">https://files.consumerfinance.gov/f/documents/cfpb_equifax-inc_complaint_2019-07.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    In 2011, the CFPB restated the prior agencies' regulations as Regulation P with certain ministerial changes to reflect the CFPB's role under the GLBA.
                    <SU>14</SU>
                    <FTREF/>
                     Since then, the CFPB has only modified Regulation P twice. As part of a streamlining initiative to reduce the burden of regulations it inherited from other agencies, the CFPB approved simplifications in the process for providing certain annual privacy notices.
                    <SU>15</SU>
                    <FTREF/>
                     Subsequently, in parallel with other agencies, the CFPB implemented congressional amendments to the GLBA that adjusted the annual notice requirement where certain conditions are met.
                    <SU>16</SU>
                    <FTREF/>
                     In most other respects, Regulation P continues to align with the regulations the predecessor agencies first issued to implement the GLBA following its enactment. For example, the CFPB has not revised the model form the predecessor agencies developed in 2009.
                    <SU>17</SU>
                    <FTREF/>
                     Given recent changes in the consumer data landscape, the CFPB has determined that it is appropriate to gather available evidence to inform how the CFPB uses its authorities to address privacy concerns with respect to companies that offer or provide consumer financial products or services, including (if warranted) any potential updates to Regulation P. The CFPB has previously sought information from the public on the consumer data practices of data brokers,
                    <SU>18</SU>
                    <FTREF/>
                     and in December 2024 published a proposed rule under the Fair Credit Reporting Act that would subject many data brokers that sell consumers' sensitive personal and financial information to the statute.
                    <SU>19</SU>
                    <FTREF/>
                     This request for information is another step in a series of efforts to examine data collection, use, and monetization, and to gather information from the public to determine whether additional actions are warranted to protect consumer privacy.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         12 CFR pt. 1016; 76 FR 79025 (Dec. 21, 2011).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         79 FR 64057 (Oct. 28, 2014).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         83 FR 40945 (Aug. 17, 2018).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         Model Privacy Form, appendix to part 1016, 12 CFR pt. 1016; 
                        <E T="03">Final Model Privacy Form Under the Gramm-Leach-Bliley Act,</E>
                         74 FR 62890 (Dec. 1, 2009).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">Request for Information Regarding Data Brokers and Other Business Practices Involving the Collection and Sale of Consumer Information,</E>
                         88 FR 16951 (Mar. 21, 2023).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">Protecting Americans From Harmful Data Broker Practices (Regulation V),</E>
                         89 FR 101402 (Dec. 13, 2024).
                    </P>
                </FTNT>
                  
                <P>
                    A study by the Government Accountability Office (GAO) also identified consumers' concerns over the privacy of their data, and the potential need for a reassessment of Regulation P and its model form.
                    <SU>20</SU>
                    <FTREF/>
                     The GAO observed that “[f]inancial institutions collect extensive amounts of personal information about consumers,” including but not limited to “the consumer's Social Security number, annual income, . . . outstanding debt, . . . account balance, payment history, and credit card transactions.” 
                    <SU>21</SU>
                    <FTREF/>
                     Notably, according to the GAO, financial institutions may also collect a consumer's social media activity and browsing activity “to compile a customer profile that can later be used for marketing purposes.” 
                    <SU>22</SU>
                    <FTREF/>
                     Although there has been an “increase in awareness and concern among consumers about their privacy,” “the consumer opt-out rate is generally low.” 
                    <SU>23</SU>
                    <FTREF/>
                     In particular, the GAO indicated that “[c]onsumers may be largely unaware of how fintech apps use their personal information and the privacy risks that such usage poses.” 
                    <SU>24</SU>
                    <FTREF/>
                     Although “the model privacy form is voluntary,” the GAO noted that “it has been widely adopted within the industry.” 
                    <SU>25</SU>
                    <FTREF/>
                     The GAO stated that “the model form provides consumers with limited insight into the specific information that [financial institutions] collect and with whom they share it.” 
                    <SU>26</SU>
                    <FTREF/>
                     The GAO indicated that “the continued proliferation of consumer data sharing suggests the form may be out of date and may not accurately represent the increased and varied ways financial institutions share information compared to when the form was implemented over 10 years ago.” 
                    <SU>27</SU>
                    <FTREF/>
                     The GAO ultimately concluded its report with a recommendation that the CFPB consider updating the model privacy forms.
                    <SU>28</SU>
                    <FTREF/>
                     This Request for Information is issued, in part, in response to that GAO recommendation.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         U.S. Gov't Accountability Office, 
                        <E T="03">Consumer Privacy: Better Disclosures Needed on Information Sharing by Banks and Credit Unions</E>
                         (Oct. 2020), 
                        <E T="03">https://www.gao.gov/assets/d2136.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">Id.</E>
                         at 1, 5.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">Id.</E>
                         at 11, 13.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">Id.</E>
                         at 25, 29.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">Id.</E>
                         at 18.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         
                        <E T="03">Id.</E>
                         at 23.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">Id.</E>
                         at 21.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">Id.</E>
                         at 23.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">Id.</E>
                         at 37.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Overview</HD>
                <HD SOURCE="HD2">A. General Expectations From Consumers Regarding Privacy and Data Protection</HD>
                <P>
                    Consumers place a high value on their financial data and are particularly concerned about maintaining the privacy of that data.
                    <SU>29</SU>
                    <FTREF/>
                     For example, in a 2021 survey, 89 percent of respondents expressed the belief that it should be illegal “for [their] current bank or credit union to give other companies access to personal data about [them] unless [consumers tell the bank to provide it],” and 94 percent of respondents stated that they would not like their “current bank or credit union to give other companies access to 
                    <PRTPAGE P="3806"/>
                    personal data” so those other companies could “market products and services to [those consumers].” 
                    <SU>30</SU>
                    <FTREF/>
                     Similarly, a 2016 survey suggested that Americans are more concerned about the security of their financial data than even their medical records.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Consumer Reports, 
                        <E T="03">American Experiences Survey, December 2023 Omnibus Results,</E>
                         at 18-19 (Jan. 2024), 
                        <E T="03">https://article.images.consumerreports.org/image/upload/v1704482298/prod/content/dam/surveys/Consumer_Reports_AES_December-2023.pdf</E>
                         (more than 75 percent of respondents said it was “very important” to them that they know “exactly which companies can access [their] banking data” and that their permission be required before banking data can be shared with another company; while 69 percent felt it was “very important” to “limit[ ] the purposes for which banks can share [their] banking data, for example, for financial services but not for advertising”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         Dan Murphy 
                        <E T="03">et al., Financial Data: The Consumer Perspective,</E>
                         at 10 (June 30, 2021), 
                        <E T="03">https://finhealthnetwork.org/wp-content/uploads/2021/04/Consumer-Data-Rights-Report_FINAL.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Centrify, Consumer Trust Survey, 
                        <E T="03">The Corporate Cost of Compromised Credentials</E>
                         (2016), 
                        <E T="03">https://web.archive.org/web/20170430003505/https:/www.centrify.com/resources/centrify-2016-thought-leadership-survey/</E>
                         (while 78 percent of Americans ranked “credit card or bank statements” as their top fear of being compromised by hacking or a data breach, only 46 percent ranked “health and medical records” so highly).
                    </P>
                </FTNT>
                <P>
                    At the same time, consumers are also increasingly gravitating toward the use of digital tools across their financial lives, from accessing banking services via mobile apps to making payments through products offered by tech companies.
                    <SU>32</SU>
                    <FTREF/>
                     Mobile banking became much more widely adopted as a result of the pandemic, reaching 95percent of consumers age 18-25, 90 percent of consumers under 40, 85 percent of consumers in their 40s, and 60 percent of consumers age 56-75.
                    <SU>33</SU>
                    <FTREF/>
                     Similarly, the Federal Reserve Bank of Atlanta found that, in 2023, 70 percent of consumers had made at least one payment via mobile phone or tablet, and 72 percent had adopted online or mobile payment services such as PayPal, Venmo, or Cash App.
                    <SU>34</SU>
                    <FTREF/>
                     Another survey found that more than two-thirds of consumers have linked a financial application to their checking account.
                    <SU>35</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         
                        <E T="03">See, e.g., id.</E>
                         at 12; Ron Shevlin, 
                        <E T="03">Mobile Banking Adoption in the United States Has Skyrocketed (But So Have Fraud Concerns),</E>
                         Forbes (July 29, 2021), 
                        <E T="03">https://www.forbes.com/sites/ronshevlin/2021/07/29/mobile-banking-adoption-has-skyrocketed-but-so-have-fraud-concerns-what-can-banks-do/.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         Shevlin, 
                        <E T="03">supra.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         Fed. Res. Bank of Atlanta, Research Data Report, 
                        <E T="03">2023 Survey and Diary of Consumer Payment Choice,</E>
                         at 4, 7, 16 (June 3, 2024), 
                        <E T="03">https://www.atlantafed.org/-/media/documents/banking/consumer-payments/survey-diary-consumer-payment-choice/2023/sdcpc_2023_report.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         Murphy, 
                        <E T="03">supra</E>
                         at 12.
                    </P>
                </FTNT>
                <P>
                    A variety of stakeholders, including consumer advocates and Members of Congress, have raised concerns about how information collected by companies that offer or provide consumer financial products or services is used. These companies are increasingly sharing purportedly deidentified individual information with advertisers, and seeking to hire from companies experienced in leveraging data.
                    <SU>36</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Iain Withers &amp; Lawrence White, 
                        <E T="03">Dollars in the detail; banks pan for gold in `data lakes',</E>
                         Reuters (June 21, 2019), 
                        <E T="03">https://www.reuters.com/article/us-banks-data/dollars-in-the-detail-banks-pan-for-gold-in-data-lakes-idUSKCN1TM0JG/.</E>
                    </P>
                </FTNT>
                <P>
                    It is not clear if consumers realize how many financial companies are currently undertaking these practices. Consumers may not be aware of all the ways that financial companies are collecting their data, or that it can be sold. For example, just 20 percent of respondents to a 2021 survey reported being aware that fintech apps use third-party providers to gather consumers' financial data, and only 24 percent knew that fintech apps could sell consumers' personal financial data.
                    <SU>37</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Clearinghouse, 
                        <E T="03">2021 Consumer Survey: Data Privacy and Financial App Usage,</E>
                         at 6 (Dec. 2021), 
                        <E T="03">https://www.theclearinghouse.org/-/media/New/TCH/Documents/Data-Privacy/2021-TCH-ConsumerSurveyReport_Final.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Observations From the CFPB's Inquiry Into Payment Platforms Operated by Big Tech and Other Large Technology Firms</HD>
                <P>
                    The CFPB launched an inquiry into payment platforms, issuing orders in 2021 and 2023 that sought to collect information on the business practices of six technology firms that offer consumer payment products. These orders were issued to two financial technology firms (Block and PayPal), and four large technology “Big Tech” firms whose initial product offerings did not involve payments, but eventually entered the payments market (Alphabet, Amazon, Apple, and Meta). The CFPB's questions related to the firms' respective payment products, and included requests for basic information about each data field 
                    <SU>38</SU>
                    <FTREF/>
                     each firm collected and maintained as a result of consumers' use of these products, and how the data is used.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         A data field or data element, at a high level, is the name of the data type being collected, similar to the name of a column in a spreadsheet. More formally, a data field or data element can be defined as, “[a] basic unit of information that has a unique meaning and subcategories (data items) of distinct value. Examples of data elements include gender, race, and geographic location.” 
                        <E T="03">Data Element,</E>
                         NIST Computer Security Resource Center (last visited Jan. 7, 2025), 
                        <E T="03">https://csrc.nist.gov/glossary/term/data_element.</E>
                    </P>
                </FTNT>
                <P>Preliminary findings from these inquiries identified potential risks to consumers. First, these firms collect an immense amount of data through their payment products, including data that goes far beyond what is necessary to facilitate a transaction. Specifically, it is common for these payment products to collect and maintain over one thousand data fields, and one of the products collects tens of thousands of data fields. This data and the predictions derived from it can be quite invasive. For example, the companies' data fields include items that appear to:</P>
                <P>(1) Predict a consumer's income, wealth, and propensity to spend money or engage in a transaction;</P>
                <P>(2) Estimate a consumer's likelihood of contacting customer service, and apparently use that prediction to prioritize access to a live customer service agent;</P>
                <P>
                    (3) “Fingerprint” a consumer's device (
                    <E T="03">e.g.,</E>
                     using details like phone carrier and model number to identify a specific phone) and what the consumer does on their device (
                    <E T="03">e.g.,</E>
                     identifying the name of a consumer's primary social media platform and screen recording a consumer's interaction on the company's app or website);
                </P>
                <P>(4) Use access to a consumer's contacts to collect not just the name and phone number or email address of each contact, but also potentially capture all details contained in the contact such as their birthday, and even the exchangeable image file format, or EXIF, metadata associated with a contact's picture thumbnail, which can include geolocation data; and</P>
                <P>
                    (5) Collect not just the vendor and transaction amount, but the stock keeping unit, or SKU, of what was purchased—
                    <E T="03">i.e.,</E>
                     the actual item purchased.  
                </P>
                <P>Regardless of the stated purpose for such immense data collection, the firms' access to this data may lead them to use this information for other purposes in the future as the incentives or opportunities to monetize it evolve.</P>
                <P>Even to the extent that privacy policies make commitments about data collection and use, the policies may still present challenges for consumers. First, many companies frequently update their privacy policies, and consumers may find it burdensome to stay abreast of and understand the implications of such changes. Second, consumers may have grown reliant on or feel “locked into” a product or service. Such consumers may therefore feel compelled to accept changes that they would not have agreed to when they initially began using the product or service. Third, some companies cross-reference “general” and other privacy policies within their product-specific policies, requiring consumers to stitch together a network of documents that makes it more difficult for consumers to form a complete understanding of how their data is being collected and used.</P>
                <P>
                    Finally, several of the firms' data governance practices appear to be so deficient that they were unable or unwilling to provide basic information about much of the sensitive consumer data they collect and maintain, such as the name of the data fields and a description of what data they capture. 
                    <PRTPAGE P="3807"/>
                    These companies, for example, generally lack systemic documentation of the immense consumer data they collect and maintain, and how they use this data. These data governance deficiencies raise substantial questions regarding the firms' ability to meaningfully protect consumers' sensitive data.
                </P>
                <HD SOURCE="HD2">C. Critiques of Regulation P</HD>
                <P>
                    Meanwhile, scholars and others have noted that Regulation P has limits. Since Regulation P envisions that financial institutions might combine required disclosures with other information, there may be an “incentive for sellers to bury the disclosures in other consumer correspondence,” 
                    <SU>39</SU>
                    <FTREF/>
                     even though the regulation requires privacy notices to be clear and conspicuous.
                    <SU>40</SU>
                    <FTREF/>
                     Research suggests consumers often do not understand how companies will use their behavioral or transactional data, even when consumers have purportedly consented to such use.
                    <SU>41</SU>
                    <FTREF/>
                     Some scholars propose placing affirmative duties on the companies that consumers trust with their data.
                    <SU>42</SU>
                    <FTREF/>
                     Others even propose moving away from the “notice and choice” approach of the GLBA altogether.
                    <SU>43</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         
                        <E T="03">E.g.,</E>
                         Kent H. Barnett, 
                        <E T="03">Some Kind of Hearing Officer,</E>
                         94 Wash. L. Rev. 515, 570 n.237 (2019) (citing 12 CFR 1016.3(b)(2)(ii)(E)).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1016.4(a), 1016.5(a)(1), 1016.8(a)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See</E>
                         Ramy El-Dardiry 
                        <E T="03">et al., Brave New Data: Policy Pathways for the Data Economy in an Imperfect World,</E>
                         CPB Netherlands Bureau for Econ. Policy Analysis, at 10 (July 2021), 
                        <E T="03">https://www.cpb.nl/sites/default/files/omnidownload/CPB-uk-Policy-Brief-Brave-new-data.pdf</E>
                         (“Consumers cannot see what companies are doing with their data, nor can they read all of the data terms of use or oversee the consequences.”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">E.g.,</E>
                         Bryce Clayton Newell 
                        <E T="03">et al., Regulating the Data Market: The Material Scope of American Consumer Data Privacy Law,</E>
                         45 U. Pa. J. Int'l L. 1055, 1140 &amp; n.493 (2024) (collecting publications discussing possible fiduciary duties); Neil Richards &amp; Woodrow Hartzog, 
                        <E T="03">A Duty of Loyalty for Privacy Law,</E>
                         99 Wash. Univ. L. Rev. 961 (2021) (describing a potential duty of loyalty).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         
                        <E T="03">E.g.,</E>
                         John A. Rothchild, 
                        <E T="03">Against Notice and Choice: The Manifest Failure of the Proceduralist Paradigm to Protect Privacy Online (or Anywhere Else),</E>
                         66 Cleveland State L. Rev. 559 (2018); Daniel J. Solove &amp; Woodrow Hartzog, 
                        <E T="03">Kafka in the Age of AI and the Futility of Privacy as Control,</E>
                         104 Boston Univ. L. Rev. 1021 (2024).
                    </P>
                </FTNT>
                <P>While observers have documented the increasing role of financial companies in amassing, processing, and selling consumer data, there is still relatively limited public understanding of the data-related operations of companies that offer or provide consumer financial products and services, and the costs and benefits and larger societal impact of those operations. Further, additional, more recent, or broader studies, surveys, and research beyond those summarized above could help to ensure the CFPB is fully informed about companies' current practices and consumers' preferences as the CFPB exercises its authorities.</P>
                <HD SOURCE="HD1">III. Request for Information</HD>
                <P>This request for information seeks comments from the public on how companies that offer or provide consumer financial products or services collect, use, process, transmit, share, store, aggregate, sell, or otherwise generate insights from or act upon consumer data, as well as potential proposals to revise or reform Regulation P. The CFPB is particularly interested in hearing from individuals, social services organizations, consumer rights and advocacy organizations, legal aid attorneys, academics and researchers, small businesses, financial institutions, and State and local government officials.</P>
                <P>The CFPB welcomes stakeholders to submit data and information about the ways companies that offer or provide consumer financial products or services collect, use, and share consumer data, including those companies subject to the GLBA and Regulation P. To assist commenters in developing responses, the CFPB has crafted the below questions that commenters may answer. However, the CFPB is interested in receiving any comments relating to the consumer data that financial companies collect.</P>
                <HD SOURCE="HD3">Public Inquiries</HD>
                <P>1. Are there studies, surveys, research, or other evidence about the incentives for companies to collect more data than is necessary to provide the consumer financial product or service, including to complete a transaction or payment?</P>
                <P>2. Are there studies, surveys, research, or other evidence about the effectiveness of Regulation P?</P>
                <P>3. Are there studies, surveys, research, or other evidence about the effectiveness of the privacy policy notices and opt-out notices that financial companies provide consumers?</P>
                <P>
                    a. How effective is the Regulation P model form 
                    <SU>44</SU>
                    <FTREF/>
                     in informing consumers about privacy policies, and enabling easy comparisons among different financial institutions? Are there any shortcomings of the model form in this regard?
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         
                        <E T="03">See</E>
                         Model Privacy Form, appendix to part 1016, 12 CFR pt. 1016.
                    </P>
                </FTNT>
                <P>
                    b. How effective are the Regulation P opt-out notices 
                    <SU>45</SU>
                    <FTREF/>
                     in describing how consumers can limit the sharing of their information, and explaining how consumers can exercise any opt-out rights they have at a particular company?
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1016.7.
                    </P>
                </FTNT>
                <P>c. Considering the privacy and opt-out notices required under Regulation P, how could companies more clearly explain what information they share with whom, and the choices consumers have to limit that sharing?</P>
                <P>d. What tools do regulators need or what actions can regulators take to ensure that financial companies are transparent in how they process, protect, and disclose data about consumers?  </P>
                <P>
                    e. How prevalent are retroactive changes to privacy policies that implicate previously collected data, 
                    <E T="03">i.e.,</E>
                     changes that purport to apply to previously collected data?
                </P>
                <P>f. How could companies more clearly explain changes in the scope of the data they collect, how it will be used, and what (if any) limitations are placed on future use of that data?</P>
                <P>4. Would it be beneficial to separate the privacy notice required by Regulation P from the opt-out notice required by Regulation P?</P>
                <P>5. With respect to providing consumers the opportunity to limit sharing, what proportion of consumers in fact opt out?</P>
                <P>a. What statistical analyses, surveys, studies, or other reports have sought to quantify the proportion of consumers who opt out?</P>
                <P>b. What analyses, surveys, studies, or other reports have examined why consumers opt out?</P>
                <P>c. What studies, research, or other sources of recommendations have proposed ways to make the opt-out process easier to use?</P>
                <P>6. Are there circumstances in which companies share nonpublic personal information with nonaffiliated third parties before consumers have a reasonable opportunity to opt out of the disclosure?</P>
                <P>7. What restrictions, conditions, obstacles, website/app designs, or dark patterns do companies place in the way of consumers who wish to opt out of information sharing?</P>
                <P>a. Are there acts or practices that unreasonably impede consumers from exercising the opt-out right the GLBA and Regulation P provide?</P>
                <P>b. What barriers, if any, impede consumers who wish to opt out from directing a company not to disclose the consumers' nonpublic personal information?</P>
                <P>
                    c. If a company is unable to determine how it uses or shares data, how would the company be able to accurately describe the categories of consumer data it shares with which categories of 
                    <PRTPAGE P="3808"/>
                    nonaffiliated third parties in an opt-out disclosure?
                </P>
                <P>8. What are the current shortcomings, if any, of Regulation P in protecting consumers' personally identifiable financial information?</P>
                <P>
                    9. What questions do financial companies' data collection and use practices raise regarding compliance with the prohibition against unfair, deceptive, and abusive 
                    <SU>46</SU>
                    <FTREF/>
                     acts and practices under the Consumer Financial Protection Act?
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         An abusive act or practice: (1) materially interferes with the ability of a consumer to understand a term or condition of a consumer financial product or service; or (2) takes unreasonable advantage of:
                    </P>
                    <P>—a lack of understanding on the part of the consumer of the material risks, costs, or conditions of the product or service; </P>
                    <P>—the inability of the consumer to protect the interests of the consumer in selecting or using a consumer financial product or service; or</P>
                    <P>—the reasonable reliance by the consumer on a covered person to act in the interests of the consumer. </P>
                    <P>12 U.S.C. 5531(d).</P>
                </FTNT>
                <P>
                    10. Are any revisions to Regulation P warranted to address the exceptions financial institutions use to share nonpublic personal information with nonaffiliated third parties? 
                    <SU>47</SU>
                    <FTREF/>
                     Would any of the exceptions benefit from clarification or adjustment?
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1016.13-15
                    </P>
                </FTNT>
                <P>11. What are the opportunities:</P>
                <P>a. To strengthen protections for consumers regarding data about them, including to give consumers more choice about what data is collected and how it is used?</P>
                <P>b. To protect data subject to secondary use, such as to ensure that secondary uses comply with the direction given by the consumer?</P>
                <P>c. To track, control, and protect data in the hands of downstream recipients, such as to require downstream recipients to disclose the use, sale, or sharing of consumer nonpublic personal information to the consumers whose data they possess?</P>
                <P>d. To address the aggregation of data that includes data about consumers that originated with financial companies or was collected digitally, to ensure that the data consumers entrusted to companies that offer or provide consumer financial products or services remains protected even in large databases?</P>
                <P>e. To improve the opt-out process under the GLBA and Regulation P?</P>
                <P>f. To ensure that consumers and financial data enjoy consistent protections, whether they use financial or payment products produced by big tech firms or traditional consumer finance firms?</P>
                <P>g. To ensure that all companies are “playing by the same rules” with respect to consumer data when engaging in the same markets?</P>
                <P>12. What types of information should the CFPB regularly collect and publish about how financial companies, especially big tech firms, treat data in payment and financial products? Should the CFPB publish more information about the activities of the nonaffiliated third parties that are part of this ecosystem?</P>
                <P>13. Are there studies, surveys, research, or other evidence about how the previous collection of consumer data by financial companies, especially large financial institutions and big tech firms, presents a barrier to entry against others wishing to offer competing consumer financial products or services?</P>
                <P>14. What harms, if any, result from current business practices that leverage consumer data originating with financial companies or collected digitally through a financial company? What benefits, if any, do consumers currently enjoy because companies share consumers' nonpublic personal information?</P>
                <P>15. What additional tools should regulators use to support potential whistleblowers to report corporate conduct that violates consumers' data protection rights?</P>
                <SIG>
                    <NAME>Rohit Chopra,</NAME>
                    <TITLE>Director, Consumer Financial Protection Bureau.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00811 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-AM-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DELAWARE RIVER BASIN COMMISSION</AGENCY>
                <SUBJECT>Notice of Public Hearing and Business Meeting, February 5, 2025 and March 12, 2025</SUBJECT>
                <P>Notice is hereby given that the Delaware River Basin Commission will hold a public hearing on Wednesday, February 5, 2025. A business meeting will be held the following month on Wednesday, March 12, 2025. Both the hearing and the business meeting are open to the public, and both will be conducted virtually.</P>
                <P>
                    <E T="03">Public Hearing.</E>
                     The Commission will conduct the public hearing virtually on February 5, 2025, commencing at 1:30 p.m. Hearing items will include draft dockets for withdrawals, discharges, and other projects that could have a substantial effect on the basin's water resources. A list of the projects scheduled for hearing, including project descriptions, along with links to draft dockets, will be posted on the Commission's website, 
                    <E T="03">www.drbc.gov,</E>
                     in a long form of this notice at least ten days before the hearing date.
                </P>
                <P>Written comments on matters scheduled for hearing on February 5, 2025, will be accepted through 5:00 p.m. on Monday, February 10, 2025.</P>
                <P>The public is advised to check the Commission's website periodically during the ten days prior to the hearing date, as items scheduled for hearing may be postponed if additional time is needed to complete the Commission's review. Items also may be added up to ten days prior to the hearing date. In reviewing docket descriptions, the public is asked to be aware that the details of projects may change during the Commission's review, which is ongoing.</P>
                <P>
                    <E T="03">Business Meeting.</E>
                     The business meeting on March 12, 2025 will be held virtually commencing at 10:30 a.m. and will include: adoption of the Minutes of the Commission's December 5, 2024 business meeting; announcements of upcoming meetings and events; a report on hydrologic conditions; reports by the Executive Director and the Commission's General Counsel; and consideration of any items for which a hearing has been completed or is not required. The agenda is expected to include consideration of the draft dockets for withdrawals, discharges, and other projects that are subjects of the public hearing on February 5, 2025.
                </P>
                <P>After all scheduled business has been completed and as time allows, the business meeting will be followed by up to one hour of Open Public Comment, an opportunity to address the Commission off the record on any topic concerning management of the Basin's water resources outside the context of a duly noticed, on-the-record public hearing.</P>
                <P>
                    There will be no opportunity for additional public comment for the record at the March 12, 2025 business meeting on items for which a hearing was completed on February 5, 2025 or a previous date. Commission consideration on March 12, 2025 of items for which the public hearing is closed may result in approval of the item as proposed, approval with changes, denial, or deferral. When the Commissioners defer an action, they may announce an additional period for written comment on the item, with or without an additional hearing date, or they may take additional time to consider the input they have already received without requesting further public input. Any deferred items will be considered for action at a public 
                    <PRTPAGE P="3809"/>
                    meeting of the Commission on a future date.
                </P>
                <P>
                    <E T="03">Advance Registration and Sign-Up for Oral Comment.</E>
                     Links for registration to attend the virtual public hearing and business meeting, respectively, will be posted at 
                    <E T="03">www.drbc.gov</E>
                     at least ten days before each meeting date. Registrants who wish to comment on the record during the public hearing on February 5, 2025 or to address the Commissioners informally during the Open Public Comment session following the meeting on March 12, 2025 as time allows, will be asked to so indicate when registering. The Commission's public hearing, business meeting, and Open Public Comment session will also be livestreamed on YouTube at 
                    <E T="03">https://www.youtube.com/@DRBC_1961.</E>
                     For assistance, please contact Ms. Patricia Hausler of the Commission staff, at 
                    <E T="03">patricia.hausler@drbc.gov.</E>
                </P>
                <P>
                    <E T="03">Addresses for Written Comment.</E>
                     Written comment on items scheduled for hearing may be made through the Commission's web-based comment system, a link to which is provided at 
                    <E T="03">www.drbc.gov.</E>
                     Use of the web-based system ensures that all submissions are captured in a single location and their receipt is acknowledged. Exceptions to the use of this system are available based on need, by writing to the attention of the Commission Secretary, DRBC, P.O. Box 7360, 25 Cosey Road, West Trenton, NJ 08628-0360. For assistance, please contact Patricia Hausler at 
                    <E T="03">patricia.hausler@drbc.gov.</E>
                </P>
                <P>
                    <E T="03">Accommodation for Special Needs.</E>
                     Closed captioning will be available on both webinar and live-stream internet platforms. Those with limited internet access may listen and speak at virtual public meetings of the DRBC using any of several toll-free phone numbers that will be provided to all virtual meeting registrants.
                </P>
                <P>Other individuals in need of an accommodation as provided for in the Americans with Disabilities Act who wish to attend the virtual hearing or meeting should contact the Commission Secretary directly at 609-883-9500 ext. 203 or through the Telecommunications Relay Services (TRS) at 711 to discuss how we can accommodate your needs.</P>
                <P>
                    <E T="03">Additional Information, Contacts.</E>
                     Additional public records relating to hearing items may be examined at the Commission's offices by appointment by contacting Donna Woolf, 609-477-7222. For other questions concerning hearing items, please contact David Kovach, Project Review Section Manager, at 609-477-7264.
                </P>
                <P>
                    <E T="03">Authority.</E>
                     Delaware River Basin Compact, Public Law 87-328, Approved September 27, 1961, 75 Statutes at Large, 688, sec. 14.4.
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Pamela M. Bush,</NAME>
                    <TITLE>Commission Secretary and Assistant General Counsel.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00740 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <SUBJECT>Applications for New Awards; Technical Assistance and Dissemination To Improve Services and Results for Children With Disabilities and Demonstration and Training Programs—National Technical Assistance Center on Transition for Students and Youth With Disabilities</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Special Education and Rehabilitative Services, Department of Education.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Education (Department) is issuing a notice inviting applications for new awards for fiscal year (FY) 2025 for National Technical Assistance Center on Transition for Students and Youth With Disabilities.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Applications Available:</E>
                         January 15, 2025.
                    </P>
                    <P>
                        <E T="03">Deadline for Transmittal of Applications:</E>
                         March 17, 2025.
                    </P>
                    <P>
                        <E T="03">Deadline for Intergovernmental Review:</E>
                         May 15, 2025.
                    </P>
                    <P>
                        <E T="03">Pre-Application Webinar Information:</E>
                         No later than January 21, 2025, the Office of Special Education Programs (OSEP) and Rehabilitative Services (OSERS) will post details on pre-recorded informational webinars designed to provide technical assistance (TA) to interested applicants. Links to the webinars may be found at 
                        <E T="03">www.ed.gov/about/ed-offices/osers/osep/new-osep-grant-competitions</E>
                        .
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        For the addresses for obtaining and submitting an application, please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the 
                        <E T="04">Federal Register</E>
                         on December 23, 2024 (89 FR 104528) and available at 
                        <E T="03">https://www.federalregister.gov/documents/2024/12/23/2024-30488/common-instructions-for-applicants-to-department-of-education-discretionary-grant-programs</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Selete Avoke, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202-5076. Telephone: (202) 245-7260. Email: 
                        <E T="03">Selete.Avoke@ed.gov</E>
                         or Tara Jordan, Department of Education, 400 Maryland Avenue SW, Washington, DC 20202-5076. Email: 
                        <E T="03">Tara.Jordan@ed.gov</E>
                        .
                    </P>
                    <P>If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Full Text of Announcement</HD>
                <HD SOURCE="HD1">I. Funding Opportunity Description</HD>
                <P>
                    <E T="03">Purpose of Program:</E>
                     The purpose of the Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities program is to promote academic achievement and to improve results for children with disabilities by providing TA, supporting model demonstration projects, disseminating useful information, and implementing activities that are supported by scientifically based research. The purpose of the Demonstration and Training program is to provide competitive grants, including cooperative agreements, to, or enter into contracts with, eligible entities to expand and improve the provision of vocational rehabilitation (VR) and other services authorized under the Rehabilitation Act of 1973 (Rehabilitation Act), or to further the purposes and policies in sections 2(b) and (c) of the Rehabilitation Act by supporting activities that increase the provision, extent, availability, scope, and quality of rehabilitation services under the Rehabilitation Act, including related research and evaluation activities.
                </P>
                <P>
                    <E T="03">Assistance Listing Number (ALN):</E>
                     84.326E.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1820-0028.
                </P>
                <P>
                    <E T="03">Priorities:</E>
                     This competition includes two absolute priorities. In accordance with 34 CFR 75.105(b)(2)(v), Absolute Priority 1 is from allowable activities specified in the statute (see sections 663 and 681(d) of the Individuals with Disabilities Education Act (IDEA); 20 U.S.C. 1463 and 1481(d)). In accordance with 34 CFR 75.105(b)(2)(iv), Absolute Priority 2 is from section 303 of the Rehabilitation Act of 1973; 29 U.S.C. 773.
                </P>
                <P>
                    <E T="03">Absolute Priorities:</E>
                     For FY 2025 and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are absolute priorities. Under 34 CFR 75.105(c)(3), we consider only applications that meet both of these priorities.
                </P>
                <P>
                    <E T="03">Background:</E>
                </P>
                <P>
                    While overall high school graduation rates for students with disabilities have 
                    <PRTPAGE P="3810"/>
                    increased in recent years, students with disabilities still lag behind their peers without disabilities by 16 percent (NCES, 2024a). A recent report indicates that in 2021, the dropout rate for students without a disability was 4.8 percent, while the rate for students with disabilities was more than double that at 10.1 percent (NCES, 2024b). High-quality secondary transition planning is critical to reducing the likelihood of dropout and increasing graduation rates for students with disabilities (National Technical Assistance Center on Transition: The Collaborative, 2022). To ensure effective secondary transition planning for, and active participation in decision making by, students with disabilities, members of the planning team should be well informed about the student's abilities, needs, and available services.
                </P>
                <P>Under 34 CFR 300.320(b), an individualized education program (IEP) team develops a student's IEP and updates it annually. Any IEP in effect when the student turns 16, or younger, if determined appropriate by the IEP team, must include appropriate measurable postsecondary goals based upon age-appropriate transition assessments related to training, education, employment, and, where appropriate, independent living skills and the services (including courses of study) needed to assist the child in reaching those goals. For any IEP team meeting where transition services are to be discussed, the school/IEP team must invite the student and, with the prior consent of the parent or the student if the student has reached the age of majority, any participating agency representative.</P>
                <P>While IDEA has requirements for transition services, local educational agencies (LEAs) face challenges in providing age-appropriate transition assessments, work experiences, and transition services, and obtaining the necessary collaborating partners to attend IEP meetings (Rowe et al., 2020). IDEA requires States to report data through their IDEA Part B State Performance Plan/Annual Performance Report (SPP/APR) on Indicator 13, which measures the percentage of youth ages 16 and above with IEPs that meet the transition requirements under IDEA. State SPP/APR data for FY 2022 for Indicator B13 showed that only 14 States reported 100 percent compliance.</P>
                <P>VR agencies also struggled to implement transition services, including pre-employment transition services (pre-ETS). Under the Rehabilitation Act, VR agencies must reserve and expend not less than 15 percent of the Federal VR grant award for the provision of pre-ETS to all students and youth with disabilities in need of such services who are eligible or potentially eligible for services under the VR program. The Rehabilitation Services Administration's (RSA's) most recent monitoring reports identified 38 VR agencies that still need considerable support regarding the use of funds and strategies to implement pre-ETS. Those reports identified information sharing, coaching, strategic planning, navigating regulations, and strengthening partnerships with State educational agencies (SEAs), LEAs, and families to effectively deliver pre-ETS as areas of greatest need. Even in States that have a history of collaboration among SEAs, LEAs, and VR agencies, the depth of collaboration and implementation required to define responsibilities and align services is a continuing challenge.</P>
                <P>
                    According to the Case Service Report (RSA-911), 120,119 students and youth with disabilities were referred for VR services in program year 2023 (July 1, 2023—June 30, 2024). During this period, 78 percent were referred by educational institutions, while 22 percent were referred by other referral sources (
                    <E T="03">e.g.,</E>
                     self-referrals, family and friends, employers). As there were 2,414,034 students ages 14 to 21 who received services under IDEA in school year 2022-23, the number of referrals for VR services represents only a small fraction of those students and youth with disabilities who were potentially eligible or eligible for VR services.
                </P>
                <P>Throughout 2023 and 2024, OSERS, as part of its transition initiative “Expect, Engage and Empower: Successful Transitions for All!”, gathered input from faculty, teachers, service providers, families, and individuals with disabilities across the country. The feedback consistently revealed that planning for a student's exit from high school when they reached the age of 16, or even 14 in some States, was far too late, especially for those with significant disabilities. In addition to starting earlier and maintaining high expectations for students and youth with disabilities, many constituents noted the need for ongoing TA to support the implementation of effective transition planning and services by education personnel and VR providers at State and local levels who may be inexperienced or otherwise face challenges due to shortages and turnover.</P>
                <P>Consistent with IDEA and the Rehabilitation Act, OSEP and RSA will jointly fund a center to provide support to SEAs, LEAs, and VR agencies to improve postsecondary outcomes for students and youth with disabilities, including strengthening efforts to more deeply collaborate and provide seamless and robust transition services.</P>
                <P>These priorities are:</P>
                <P>
                    <E T="03">Absolute Priority 1: National Technical Assistance Center on Transition for Students and Youth with Disabilities.</E>
                </P>
                <P>The purpose of this priority is to fund a cooperative agreement to establish and operate a National Technical Assistance Center on Transition for Students and Youth with Disabilities (Center). The Center will assist SEAs, LEAs, and VR agencies, including those located in rural areas, to implement practices and strategies that will promote collaboration among agency personnel to help ensure students and youth with disabilities graduate from high school with the knowledge, skills, and supports needed for credential attainment, postsecondary education, competitive integrated employment (CIE), and independent living.</P>
                <P>The Center must achieve, at a minimum, the following expected outcomes:</P>
                <P>
                    (a) Increased SEA and VR agency capacity to collect valid and reliable data (
                    <E T="03">i.e.,</E>
                     absentee rates, SPP/APR indicators B-1 (graduation rates), B2 (dropout rates), B13 (compliance with IDEA IEP transition requirements), and B14 (post-school outcomes), and RSA-911 (Case Service Reports)) for decision making and program improvement at State and local levels, and improvements in their ability to share these data across agencies and with diverse constituents, including OSERS-funded parent centers, career and technical education (CTE) providers, and correctional education entities;
                </P>
                <P>(b) Increased SEA and VR agency capacity to deliver professional development and TA to LEAs to reduce student absenteeism and drop out, and improve access to CTE, credential attainment, high school completion, postsecondary education, CIE, and independent living for students and youth with disabilities;</P>
                <P>
                    (c) Increased SEA, LEA, and VR agency capacity to deliver culturally and linguistically responsive transition services including pre-ETS and VR services for underserved students 
                    <SU>1</SU>
                    <FTREF/>
                     and youth with disabilities;
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         For the purposes of this priority, “underserved student” means a student in one or more of the following subgroups: Living in poverty or served by schools with high concentrations of students living in poverty, a student of color, a member of a federally recognized Indian Tribe, an English learner, disconnected, technologically unconnected, a migrant, experiencing homelessness or housing insecurity, lesbian, gay, bisexual, transgender, queer or questioning, or intersex (LGBTQI+), in foster care, without documentation of immigration status, 
                        <PRTPAGE/>
                        pregnant, parenting, or caregiving, impacted by the justice system including formerly incarcerated, the first in their family to attend postsecondary education, performing significantly below grade level, and military- or veteran-connected.
                    </P>
                </FTNT>
                <PRTPAGE P="3811"/>
                <P>(d) Increased levels of collaboration between SEAs and VR agencies and their partners at the State and local levels, including LEAs, to implement transition services including pre-ETS and VR transition services;</P>
                <P>(e) Improved SEA and VR agency methods and strategies for engaging students and youth with disabilities and their families at the local levels, including with LEAs, as collaborative partners to improve the delivery of transition services including pre-ETS and VR transition services; and</P>
                <P>(f) Increased SEA, LEA, and VR agency capacity to implement career pathways including work-based learning experiences, internships, and pre-apprenticeship and apprenticeship activities for students and youth with disabilities.</P>
                <P>In addition, to be considered for funding under this priority, applicants must meet the following requirements:</P>
                <P>(a) Describe, in the narrative section of the application under “Significance,” how the proposed project will—</P>
                <P>(1) Address current training and information needs, gaps, or weaknesses of SEAs, LEAs, and VR agencies, including those located in rural areas, in promoting collaboration among agency personnel to better serve students and youth with disabilities. To meet this requirement, the applicant must—</P>
                <P>(i) Demonstrate knowledge of new and emerging issues and TA needs related to reducing student absenteeism and drop out, and improving access to CTE, credential attainment, high school completion, postsecondary education, CIE, and independent living for students and youth with disabilities;</P>
                <P>(ii) Demonstrate knowledge of exemplary career pathway models, including work-based learning experiences, internships, and pre-apprenticeship and apprenticeship activities, that will assist SEAs, LEAs, and VR agencies in improving post-school outcomes for students and youth with disabilities;</P>
                <P>(iii) Demonstrate knowledge of VR agencies' current efforts to improve engagement and promote collaboration with secondary schools, charter schools, youth programs, and other programs that provide services to students and youth with disabilities for the purpose of providing pre-ETS; and</P>
                <P>(iv) Present applicable national and State data demonstrating the training needs of SEAs, LEAs, and VR agencies related to implementing exemplary practices and strategies and promoting collaboration to reduce student absenteeism and drop out, and improving access to CTE, credential attainment, high school completion, postsecondary education, CIE, and independent living for students and youth with disabilities;</P>
                <P>(2) Demonstrate understanding of the need for and value of secondary transition planning, self-determination, and self-advocacy skills at an early age, and the types of support needed by elementary and secondary general and special education and related services personnel, CTE providers, and families to support secondary transition planning, self-determination, and self-advocacy skills; and</P>
                <P>(3) Demonstrate knowledge of strategies for reaching and meeting the needs of underserved students.</P>
                <P>(b) Describe, in the narrative section of the application under “Quality of project services,” how the proposed project will—</P>
                <P>(1) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—</P>
                <P>(i) Measurable intended project outcomes; and</P>
                <P>(ii) In Appendix A, the logic model (as defined in 34 CFR 77.1) by which the proposed project will achieve its intended outcomes that depicts, at a minimum, the goals, activities, outputs, and intended outcomes of the proposed project;</P>
                <P>(2) Use a conceptual framework (and provide a copy in Appendix A) to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;</P>
                <P>
                    <E T="03">Note:</E>
                     The following website provides more information on logic models and conceptual frameworks: 
                    <E T="03">https://ies.ed.gov/ncee/rel/Products/Region/central/Resource/100644.</E>
                </P>
                <P>
                    (3) Be based on current research and make use of evidence-based 
                    <SU>2</SU>
                    <FTREF/>
                     practices (EBPs). To meet this requirement, the applicant must describe—
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         For the purposes of this priority, “evidence-based” means, at a minimum, evidence that demonstrates a rationale (as defined in 34 CFR 77.1), where a key project component included in the project's logic model is informed by research or evaluation findings that suggest the project component is likely to improve relevant outcomes.
                    </P>
                </FTNT>
                <P>(i) The current research on the most effective ways to prepare students and youth with disabilities to engage in transition services including pre-ETS and VR services, CTE, credential attainment, high school completion, postsecondary school, CIE, and independent living;</P>
                <P>(ii) The current research about adult learning principles and implementation science that will inform the proposed TA; and</P>
                <P>(iii) How the proposed project will incorporate current research and EBPs in the development and delivery of its products and services;</P>
                <P>(4) Develop products and provide services that are of high quality and sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this requirement, the applicant must describe—</P>
                <P>(i) How it proposes to further the knowledge base on the most effective ways to prepare students and youth with disabilities to engage in transition services including pre-ETS and VR services, CTE, credential attainment, high school completion, postsecondary school, CIE, and independent living;</P>
                <P>
                    (ii) The proposed approach to universal, general TA,
                    <SU>3</SU>
                    <FTREF/>
                     which must describe—
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         “Universal, general TA” means TA and information provided to independent users through their own initiative, resulting in minimal interaction with TA project staff and including one-time, invited or offered conference presentations by TA project staff. This category of TA also includes information or products, such as newsletters, guidebooks, or research syntheses, downloaded from the TA project's website by independent users. Brief communications by TA project staff with recipients, either by telephone or email, are also considered universal, general TA.
                    </P>
                </FTNT>
                <P>(A) The intended recipients, including the type and number of recipients, that will receive the products and services;</P>
                <P>(B) The products and services that the project proposes to make available;</P>
                <P>(C) The development and maintenance of a high-quality website, with an easy-to-navigate design, that meets or exceeds government- or industry-recognized standards for accessibility; and</P>
                <P>(D) The expected reach and impact of universal, general TA;</P>
                <P>
                    (iii) The proposed approach to targeted, specialized TA,
                    <SU>4</SU>
                    <FTREF/>
                     which must describe—
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         “Targeted, specialized TA” means TA services based on needs common to multiple recipients and not extensively individualized. A relationship is established between the TA recipient and one or more TA project staff. This category of TA includes one-time, labor-intensive events, such as facilitating strategic planning or hosting regional or national conferences. It can also include episodic, less labor-intensive events that extend over a period of time, such as facilitating a series of conference calls on single or multiple topics that are designed around the needs of the recipients. Facilitating communities of practice can also be considered targeted, specialized TA.
                    </P>
                </FTNT>
                <PRTPAGE P="3812"/>
                <P>(A) The intended recipients, including the type and number of recipients, that will receive the products and services;</P>
                <P>(B) The products and services that the project proposes to make available;</P>
                <P>(C) The proposed approach to measure the readiness of potential TA recipients to work with the project, including, at a minimum, an assessment of potential recipients' current infrastructure, available resources, and ability to build capacity at the local level; and</P>
                <P>(D) The expected impact of targeted, specialized TA;</P>
                <P>
                    (iv) The proposed approach to intensive, sustained TA,
                    <SU>5</SU>
                    <FTREF/>
                     which must describe—
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         “Intensive, sustained TA” means TA services often provided on-site and requiring a stable, ongoing relationship between the TA project staff and the TA recipient. “TA services” are defined as negotiated series of activities designed to reach a valued outcome. This category of TA should result in changes to policy, program, practice, or operations that support increased recipient capacity or improved outcomes at one or more systems levels.
                    </P>
                </FTNT>
                <P>(A) The intended recipients, including the type and number of recipients from a variety of settings and geographic distribution, that will receive the products and services designed to improve post-school outcomes;</P>
                <P>(B) The proposed approach to measure the readiness of SEAs, LEAs, and VR agencies to work with the project, including their commitment to the initiative, alignment of the initiative to their needs, and ability to build capacity, and implement and sustain TA at the local, district, or State level; and</P>
                <P>(C) The expected impact of intensive, sustained TA; and</P>
                <P>
                    (v) How the proposed project will intentionally engage families of children with disabilities and individuals with disabilities—including underserved families 
                    <SU>6</SU>
                    <FTREF/>
                     and individuals—in the development, implementation, and evaluation of its products and services across all levels of TA;
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         For the purposes of this priority, “underserved families” refers to foster, kinship, migrant, technologically unconnected, and military- or veteran-connected families; and families of color, living in poverty, without documentation of immigration status, experiencing homelessness or housing insecurity, or impacted by the justice system, including the juvenile justice system. Underserved families also refers to families that include: members of a federally or State recognized Indian Tribe; English learners; adults who experience a disability; members who are lesbian, gay, bisexual, transgender, queer or questioning, or intersex (LGBTQI+); adults in need of improving their basic skills or with limited literacy; and disconnected adults.
                    </P>
                </FTNT>
                <P>(5) Develop products and implement services that maximize efficiency. To address this requirement, the applicant must describe—</P>
                <P>(i) How the proposed project will use technology to achieve the intended project outcomes;</P>
                <P>(ii) With whom the proposed project will collaborate, including the Parent Training and Information centers and Community Parent Resource centers funded under sections 671, 672, and 681(d) of IDEA and the regional Parent Information and Training (PTI) centers and a national PTI Center funded under section 303(c) of the Rehabilitation Act, as well as other Department-funded projects and those supported by other Federal agencies, including those funded by the Department of Health and Human Services' Administration on Community Living, and the Department of Labor's Office of Disability Employment Policy, as appropriate, and the intended outcomes of this collaboration; and</P>
                <P>(iii) How the proposed project will use non-project resources, such as non-Federal funds and in-kind contributions, to achieve the intended project outcomes; and</P>
                <P>(6) Systematically disseminate information, products, and services to varied intended audiences. To address this requirement the applicant must describe—</P>
                <P>(i) The variety of dissemination strategies the project will use throughout the five years of the project to promote awareness and use of its products and services;</P>
                <P>(ii) How the project will tailor dissemination strategies across all planned levels of TA to ensure that products and services reach intended recipients, and those recipients can access and use those products and services;</P>
                <P>(iii) How the project's dissemination plan is connected to the proposed outcomes of the project; and</P>
                <P>(iv) How the project will evaluate and correct all digital products and external communications to ensure they meet or exceed government or industry-recognized standards for accessibility.</P>
                <P>(c) In the narrative section of the application under “Quality of the project evaluation or other evidence-building,” include an evaluation plan for the project as described in the following paragraphs. The evaluation plan must describe: measures of progress in implementation, including the criteria for determining the extent to which the project's products and services have met the goals for reaching its target population; measures of intended outcomes or results of the project's activities in order to evaluate those activities; and how the project will determine whether the goals or objectives of the proposed project, as described in its logic model, have been met.</P>
                <P>In the evaluation plan, the applicant must—</P>
                <P>
                    (1) Designate, with the approval of the OSEP project officers, a project liaison with sufficient dedicated time, experience in evaluation, and knowledge of the project to work in collaboration with the Center to Improve Program and Project Performance (CIPP),
                    <SU>7</SU>
                    <FTREF/>
                     the project director, and the OSEP project officer on the following tasks:
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The major tasks of CIPP are to guide, coordinate, and oversee the design of formative evaluations for every large discretionary investment (
                        <E T="03">i.e.,</E>
                         those awarded $500,000 or more per year and required to participate in the 3+2 process) in OSEP's Technical Assistance and Dissemination; Personnel Development; Parent Training and Information Centers; and Educational Technology, Media, and Materials programs. The efforts of CIPP are expected to enhance individual project evaluation plans by providing expert and unbiased TA in designing the evaluations with due consideration of the project's budget. CIPP does not function as a third-party evaluator.
                    </P>
                </FTNT>
                <P>(i) Revise the logic model submitted in the application to provide for a more comprehensive measurement of implementation and outcomes and to reflect any changes or clarifications to the model discussed at the kick-off meeting;</P>
                <P>
                    (ii) Refine the evaluation design and instrumentation proposed in the application consistent with the revised logic model and using the most rigorous design suitable (
                    <E T="03">e.g.,</E>
                     prepare evaluation questions about significant program processes and outcomes; develop quantitative or qualitative data collections that permit both the collection of progress data, including fidelity of implementation, as appropriate, and the assessment of project outcomes; and identify analytic strategies); and
                </P>
                <P>(iii) Revise the evaluation plan submitted in the application such that it clearly—</P>
                <P>(A) Specifies the evaluation questions, measures, and associated instruments or sources for data appropriate to answer these questions, suggests analytic strategies for those data, provides a timeline for conducting the evaluation, and includes staff assignments for completing the evaluation activities;</P>
                <P>
                    (B) Delineates the data expected to be available by the end of the second project year for use during the project's evaluation (3+2 review) for continued funding described under the heading 
                    <E T="03">Fourth and Fifth Years of the Project</E>
                    ; and
                </P>
                <P>
                    (C) Assists the project director and the OSEP project officer, with the assistance 
                    <PRTPAGE P="3813"/>
                    of CIPP, as needed, in specifying the project performance measures to be addressed in the project's annual performance report;
                </P>
                <P>
                    (2) Dedicate sufficient staff time and other resources during the first six months of the project to collaborate with CIPP staff, including regular meetings (
                    <E T="03">e.g.,</E>
                     weekly, biweekly, monthly) with CIPP and the OSEP and RSA project officers, to accomplish the tasks described in paragraph (C)(1) of this section; and
                </P>
                <P>(3) Dedicate sufficient funds in each budget year to carry out the tasks described in paragraphs (C)(1) and (2) of this section and revise and implement the evaluation plan. Please note in your budget narrative the funds dedicated for this activity.</P>
                <P>(d) Describe, in the narrative section of the application under “Adequacy of resources and quality of the project personnel,” how—</P>
                <P>(1) The proposed project will encourage applications for employment from persons who are members of groups that have traditionally been underrepresented, as appropriate;</P>
                <P>(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to carry out the proposed activities and achieve the project's intended outcomes;</P>
                <P>(3) The applicant and any key partners have adequate resources to carry out the proposed activities;</P>
                <P>
                    (4) The proposed project will have processes, resources, and funds in place to provide equitable access for project staff, contractors, and partners, who require digital accessibility accommodations; 
                    <SU>8</SU>
                    <FTREF/>
                     and
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         For information about digital accessibility and accessibility standards, visit 
                        <E T="03">https://sites.ed.gov/idea/topic-areas/#Accessibility-Creating-Content</E>
                         and 
                        <E T="03">https://www.ed.gov/laws-and-policy/civil-rights-laws/disability-discrimination/disability-discrimination-key-issues/disability-discrimination-technology-accessibility</E>
                        . Starting in either April 2026 or April 2027 (depending on the size of the school district), Title II of the Americans with Disabilities Act will require that public entities, including public schools, ensure that web content and mobile apps made available by the public entities are accessible in compliance with the Web Content Accessibility Guidelines (WCAG) 2.1, level AA. For New Rule on the Accessibility of Web Content and Mobile Apps Provided by State and Local Governments, visit 
                        <E T="03">https://www.ada.gov/resources/2024-03-08-web-rule/</E>
                         (
                        <E T="03">ada.gov</E>
                        ).
                    </P>
                </FTNT>
                <P>(5) The proposed costs are reasonable in relation to the anticipated results and benefits, and funds will be spent in a way that increases their efficiency and cost-effectiveness.</P>
                <P>(e) Describe, in the narrative section of the application under “Quality of the management plan,” how—</P>
                <P>(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—</P>
                <P>(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and</P>
                <P>(ii) Timelines and milestones for accomplishing the project tasks;</P>
                <P>(2) Key project personnel and any consultants and subcontractors will be allocated to the project and how these allocations are appropriate and adequate to achieve the project's intended outcomes;</P>
                <P>(3) The proposed management plan will ensure that the products and services provided are of high quality, relevant, and useful to recipients; and</P>
                <P>(4) The proposed project will benefit from a diversity of perspectives, including those of families, educators, TA providers, researchers, and policy makers, among others, in its development and operation.</P>
                <P>(f) Address the following application requirements. The applicant must—</P>
                <P>(1) Include, in Appendix A, personnel-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;</P>
                <P>(2) Include, in the budget, attendance at the following:</P>
                <P>(i) A one and one-half day kick-off meeting in Washington, DC, after receipt of the award, and an annual one and one-half day planning meeting in Washington, DC, with the OSEP project officer, RSA project officer, and other relevant staff during each subsequent year of the project period.</P>
                <P>
                    <E T="03">Note:</E>
                     Within 30 days of receipt of the award, a post-award teleconference must be held between the OSEP project officer, the RSA project officer, and the grantee's project director or other authorized representative;
                </P>
                <P>(ii) A two and one-half day project directors' conference in Washington, DC, during each year of the project period;</P>
                <P>(iii) Two annual two-day trips to attend Department briefings, Department-sponsored conferences, and other meetings, as requested by OSEP; and</P>
                <P>(iv) A one-day virtual 3+2 review meeting during the second year of the project period;</P>
                <P>(3) Provide an assurance that the project will reallocate unused travel funds no later than the end of the third quarter if the kick-off or planning meetings are conducted virtually;</P>
                <P>(4) Include, in the budget, a line item for an annual set-aside of 5 percent of the grant amount to support emerging needs that are consistent with the proposed project's intended outcomes, as those needs are identified in consultation with, and approved by, the OSEP project officer. With approval from the OSEP project officer, the project must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period;</P>
                <P>(5) Describe how it will engage doctoral students or post-doctoral fellows, including those who are multilingual and racially, ethnically, and culturally diverse, and those with disabilities, in the project to increase the number of future leaders in the field who are knowledgeable about exemplary practices and strategies that will reduce student absenteeism and drop out, and improve access to CTE, credential attainment, high school completion, postsecondary education, CIE, and independent living for students and youth with disabilities;</P>
                <P>(6) Describe how it will ensure that annual project progress toward meeting project goals is posted on the project website; and</P>
                <P>(7) Include, in Appendix A, an assurance to assist OSEP with the transfer of pertinent resources and products and to maintain the continuity of services to States during the transition to a new award at the end of this award period, as appropriate.</P>
                <P>
                    <E T="03">Fourth and Fifth Years of the Project:</E>
                </P>
                <P>In deciding whether to continue funding the project for the fourth and fifth years, the Secretary will consider the requirements of 34 CFR 75.253(a), including—</P>
                <P>(a) The recommendations of a 3+2 review team consisting of experts with knowledge and experience in IDEA transition services, VR services including pre-ETS, CTE participation, and underserved students and youth with disabilities. This review will be conducted during a one-day intensive meeting that will be held during the last half of the second year of the project period;</P>
                <P>(b) The timeliness with which, and how well, the requirements of the negotiated cooperative agreement have been or are being met by the project; and</P>
                <P>(c) The quality, relevance, and usefulness of the project's products and services and the extent to which the project's products and services are aligned with the project's objectives and likely to result in the project achieving its intended outcomes.</P>
                <P>
                    Under 34 CFR 75.253, the Secretary may reduce continuation awards or discontinue awards in any year of the project period for excessive carryover balances, a failure to make substantial progress, or a failure to maintain 
                    <PRTPAGE P="3814"/>
                    financial and administrative management systems that meet the requirements in 2 CFR 200.302, Financial management, and 200.303, Internal controls. The Department intends to closely monitor unobligated balances and substantial progress under this program and may reduce or discontinue funding accordingly.
                </P>
                <P>
                    <E T="03">Absolute Priority 2: National Technical Assistance Center on Transition for Students and Youth with Disabilities—Vocational Rehabilitation Demonstration and Training Program.</E>
                </P>
                <P>Projects that are designed to include initiatives focused on improving transition from education, including postsecondary education, to employment, particularly in competitive integrated employment, for youth who are individuals with significant disabilities and address the needs of underserved populations, unserved and underserved areas, individuals with significant disabilities, low-incidence disability population or individuals residing in federally designated empowerment zones and enterprise communities.</P>
                <HD SOURCE="HD1">References:</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        National Center for Education Statistics (NCES). (2024a). 
                        <E T="03">High school graduation rates. Condition of education</E>
                        . U.S. Department of Education, Institute of Education Sciences. 
                        <E T="03">https://nces.ed.gov/programs/coe/indicator/coi</E>
                        .
                    </FP>
                    <FP SOURCE="FP-2">
                        National Center for Education Statistics (NCES). (2024b). 
                        <E T="03">Status dropout rates. Condition of education</E>
                        . U.S. Department of Education, Institute of Education Sciences. 
                        <E T="03">https://nces.ed.gov/programs/coe/indicator/coj</E>
                        .
                    </FP>
                    <FP SOURCE="FP-2">
                        National Technical Assistance Center on Transition: The Collaborative. (2022). 
                        <E T="03">Effective practices in secondary transition: Operational definitions</E>
                        . Authors: D. Rowe, C.Y. Alverson, S. Kwiatek, C.H. Fowler, J.N. Vicchio, J.G. Rousey, &amp; V.L. Mazzotti. 
                        <E T="03">https://transitionta.org/wp-content/uploads/docs/Updated_EBP_Definitions_June_2022.pdf</E>
                        .
                    </FP>
                    <FP SOURCE="FP-2">
                        Office of Special Education and Rehabilitative Services. (2022). 
                        <E T="03">Rehabilitation Services Administration report for fiscal year 2017-2020: Report on Federal action under the Rehabilitation Act of 1973</E>
                        . 
                        <E T="03">https://rsa.ed.gov/sites/default/files/publications/ARC%20to%20Congress/RSA%20Report%20for%20FFY%202017_2020%20(May%2019%2C%202022).pdf</E>
                        .
                    </FP>
                    <FP SOURCE="FP-2">
                        Rowe, D.A., Carter, E., Gajjar, S., Maves, E.A., &amp; Wall, J. C. (2020). Supporting strong transitions remotely: Considerations and complexities for rural communities during COVID-19. 
                        <E T="03">Rural Special Education Quarterly, 39</E>
                        (4), 220-232. 
                        <E T="03">https://doi.org/10.1177/8756870520958199</E>
                        .
                    </FP>
                </EXTRACT>
                <P>
                    <E T="03">Waiver of Proposed Rulemaking:</E>
                     Under the Administrative Procedure Act (APA) (5 U.S.C. 553) the Department generally offers interested parties the opportunity to comment on proposed priorities. Section 681(d) of IDEA, however, makes the public comment requirements of the APA inapplicable to Absolute Priority 1; Absolute Priority 2 is from the program statute.
                </P>
                <P>
                    <E T="03">Program Authority:</E>
                     20 U.S.C. 1463 and 1481; 29 U.S.C. 709(c) and 773(b).
                </P>
                <P>
                    <E T="03">Note:</E>
                     Projects will be awarded and must be operated in a manner consistent with the nondiscrimination requirements contained in Federal civil rights laws.
                </P>
                <P>
                    <E T="03">Applicable Regulations:</E>
                     (a) The Education Department General Administrative Regulations in 34 CFR parts 75, 77, 79, 81, 82, 84, 86, 97, 98, and 99. (b) The Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Guidance for Federal Financial Assistance in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474.
                </P>
                <P>
                    <E T="03">Note:</E>
                     As of October 1, 2024, grant applicants must follow the provisions stated in the OMB Guidance for Federal Financial Assistance (89 FR 30046, April 22, 2024) when preparing an application. For more information about these regulations please visit: 
                    <E T="03">www.cfo.gov/resources-coffa/uniform-guidance/</E>
                    .
                </P>
                <P>
                    <E T="03">Note:</E>
                     The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian Tribes.
                </P>
                <P>
                    <E T="03">Note:</E>
                     The regulations in 34 CFR part 86 apply to institutions of higher education (IHEs) only.
                </P>
                <HD SOURCE="HD1">II. Award Information</HD>
                <P>
                    <E T="03">Type of Award:</E>
                     Cooperative agreement.
                </P>
                <P>
                    <E T="03">Estimated Available Funds:</E>
                     $4,099,988.
                </P>
                <P>The Administration has requested $39,345,000 for the Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities program for FY 2025, of which we intend to use an estimated $2,099,988 for this competition. The actual level of funding, if any, depends on final congressional action. However, we are inviting applications to allow enough time to complete the grant process if Congress appropriates funds for this program.</P>
                <P>The Administration has requested $11,796,000 for the RSA Demonstration and Training program for FY 2025, of which we intend to use an estimated $2,000,000 for this competition. The actual level of funding, if any, depends on final congressional action. However, we are inviting applications to allow enough time to complete the grant process if Congress appropriates funds for this program.</P>
                <P>Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2026 from the list of unfunded applications from this competition.</P>
                <P>
                    <E T="03">Maximum Award:</E>
                     We will not make an award exceeding $4,099,998 for a single budget period of 12 months.
                </P>
                <P>
                    <E T="03">Estimated Number of Awards:</E>
                     1.
                </P>
                <P>
                    <E T="03">Note:</E>
                     The Department is not bound by any estimates in this notice.
                </P>
                <P>
                    <E T="03">Project Period:</E>
                     Up to 60 months.
                </P>
                <HD SOURCE="HD1">III. Eligibility Information</HD>
                <P>
                    1. 
                    <E T="03">Eligible Applicants:</E>
                     SEAs; State lead agencies under Part C of the IDEA; LEAs, including public charter schools that are considered LEAs under State law; IHEs; other public agencies; private nonprofit organizations; freely associated States and outlying areas; Indian Tribes or Tribal organizations; and for-profit organizations.
                </P>
                <P>
                    2. a. 
                    <E T="03">Cost Sharing or Matching:</E>
                     This competition does not require cost sharing or matching.
                </P>
                <P>
                    b. 
                    <E T="03">Indirect Cost Rate Information:</E>
                     This program uses an unrestricted indirect cost rate. For more information regarding indirect costs, or to obtain a negotiated indirect cost rate, please see 
                    <E T="03">www.ed.gov/about/ed-offices/ofo#Indirect-Cost-Division.</E>
                </P>
                <P>
                    c. 
                    <E T="03">Administrative Cost Limitation:</E>
                     This program does not include any program-specific limitation on administrative expenses. All administrative expenses must be reasonable and necessary and conform to Cost Principles described in 2 CFR part 200 subpart E of the Guidance for Federal Financial Assistance.
                </P>
                <P>
                    3. 
                    <E T="03">Subgrantees:</E>
                     Under 34 CFR 75.708(b) and (c), a grantee under this competition may award subgrants—to directly carry out project activities described in its application under Absolute Priority 1—to the following types of entities: IHEs, nonprofit organizations suitable to carry out the activities proposed in the application, and other public agencies. The grantee may award subgrants to entities it has identified in an approved application or that it selects through a competition under procedures established by the grantee, consistent with 34 CFR 75.708(b)(2).
                </P>
                <P>
                    A grantee may not make a subgrant to carry out project activities described in 
                    <PRTPAGE P="3815"/>
                    its application under Absolute Priority 2. However, a grantee may contract for supplies, equipment, and other services, in accordance with 2 CFR part 200 (Guidance for Federal Financial Assistance) as adopted at 2 CFR part 3474, consistent with 34 CFR 373.23(b).
                </P>
                <P>
                    4. 
                    <E T="03">Other General Requirements:</E>
                </P>
                <P>(a) Recipients of funding under this competition must make positive efforts to employ and advance in employment qualified individuals with disabilities (see section 606 of IDEA).</P>
                <P>(b) Applicants for, and recipients of, funding must, with respect to the aspects of their proposed project relating to Absolute Priority 1, involve individuals with disabilities, or parents of individuals with disabilities ages birth through 26, in planning, implementing, and evaluating the project (see section 682(a)(1)(A) of IDEA).</P>
                <P>(c) Recipients of funding must, with respect to the aspects of their proposed project relating to Absolute Priority 2, (1) ensure equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disabilities; (2) encourage applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disabilities; (3) advise individuals with disabilities who are applicants for or recipients of the services, or the applicants' representatives or the individuals' representatives, of the availability and purposes of the Client Assistance Program, including information on means of seeking assistance under that program; and (4) provide, through a careful appraisal and study, an assessment and evaluation of the project that indicates the significance or worth of processes, methodologies, and practices implemented by the project. (34 CFR 373.23(a)).</P>
                <HD SOURCE="HD1">IV. Application and Submission Information</HD>
                <P>
                    1. 
                    <E T="03">Application Submission Instructions:</E>
                     Applicants are required to follow the Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the 
                    <E T="04">Federal Register</E>
                     on December 23, 2024 (89 FR 104528), and available at 
                    <E T="03">https://www.federalregister.gov/documents/2024/12/23/2024-30488/common-instructions-for-applicants-to-department-of-education-discretionary-grant-programs.</E>
                </P>
                <P>
                    2. 
                    <E T="03">Intergovernmental Review:</E>
                     This competition is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition.
                </P>
                <P>
                    3. 
                    <E T="03">Funding Restrictions:</E>
                     We reference regulations outlining funding restrictions in the 
                    <E T="03">Applicable Regulations</E>
                     section of this notice.
                </P>
                <P>
                    4. 
                    <E T="03">Recommended Page Limit:</E>
                     The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. We recommend that you (1) limit the application narrative to no more than 70 pages and (2) use the following standards:
                </P>
                <P>• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.</P>
                <P>• Double-space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, reference citations, and captions, as well as all text in charts, tables, figures, graphs, and screen shots.</P>
                <P>• Use a font that is 12 point or larger.</P>
                <P>• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.</P>
                <P>The recommended page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the abstract (follow the guidance provided in the application package for completing the abstract), the table of contents, the list of priority requirements, the resumes, the reference list, the letters of support, or the appendices. However, the recommended page limit does apply to all of the application narrative, including all text in charts, tables, figures, graphs, and screen shots.</P>
                <HD SOURCE="HD1">V. Application Review Information</HD>
                <P>
                    1. 
                    <E T="03">Selection Criteria:</E>
                     The selection criteria for this competition are from 34 CFR 75.210 and are as follows:
                </P>
                <P>
                    (a) 
                    <E T="03">Significance (10 points).</E>
                </P>
                <P>(1) The Secretary considers the significance of the proposed project.</P>
                <P>(2) In determining the significance of the proposed project, the Secretary considers the following factors:</P>
                <P>(i) The significance of the problem or issue as it affects educational access and opportunity, including the underlying or related challenges for underserved populations.</P>
                <P>(ii) The extent to which the proposed project is likely to build local, State, regional, or national capacity to provide, improve, sustain, or expand training or services that address the needs of underserved populations.</P>
                <P>(iii) The importance or magnitude of the results or outcomes likely to be attained by the proposed project, especially contributions toward improving teaching practice and student learning and achievement.</P>
                <P>(iv) The potential contribution of the proposed project to improve the provision of rehabilitative services, increase the number or quality of rehabilitation counselors, or develop and implement effective strategies for providing VR services to individuals with disabilities.</P>
                <P>
                    (b) 
                    <E T="03">Quality of project services (35 points).</E>
                </P>
                <P>(1) The Secretary considers the quality of the services to be provided by the proposed project.</P>
                <P>(2) In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equitable and adequate access and participation for project participants who experience barriers based on one or more of the following: economic disadvantage; gender; race; ethnicity; color; national origin; disability; age; language; migration; living in a rural location; experiencing homelessness or housing insecurity; involvement with the justice system; pregnancy, parenting, or caregiver status; and sexual orientation. This determination includes the steps developed and described in the form Equity For Students, Teachers, And Other Program Beneficiaries (OMB Control No. 1894-0005) (section 427 of the General Education Provisions Act (20 U.S.C. 1228a)).</P>
                <P>(3) In addition, the Secretary considers the following factors:</P>
                <P>(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified, measurable, and ambitious yet achievable within the project period, and aligned with the purposes of the grant program.</P>
                <P>(ii) The extent to which the services to be provided by the proposed project were determined with input from the community to be served to ensure that they are appropriate and responsive to the needs of the intended recipients or beneficiaries, including underserved populations, of those services.</P>
                <P>(iii) The extent to which the services to be provided by the proposed project reflect up-to-date knowledge and an evidence-based project component.</P>
                <P>
                    (iv) The extent to which the training or professional development services to be provided by the proposed project are of sufficient quality, intensity, and 
                    <PRTPAGE P="3816"/>
                    duration to build recipient and project capacity in ways that lead to improvements in practice among the recipients of those services.
                </P>
                <P>(v) The extent to which the services to be provided by the proposed project involve the use of efficient strategies, including the use of technology, as appropriate, and the leveraging of non-project resources.</P>
                <P>
                    (c) 
                    <E T="03">Quality of the project evaluation or other evidence-building (20 points).</E>
                </P>
                <P>(1) The Secretary considers the quality of the evaluation or other evidence-building of the proposed project.</P>
                <P>(2) In determining the quality of the evaluation or other evidence-building, the Secretary considers the following factors:</P>
                <P>(i) The extent to which the methods of evaluation or other evidence-building are thorough, feasible, relevant, and appropriate to the goals, objectives, and outcomes of the proposed project.</P>
                <P>(ii) The extent to which the methods of evaluation or other evidence-building are appropriate to the context within which the project operates and the target population of the proposed project.</P>
                <P>(iii) The extent to which the methods of evaluation or other evidence-building will provide performance feedback and provide formative, diagnostic, or interim data that is a periodic assessment of progress toward achieving intended outcomes.</P>
                <P>(iv) The extent to which the methods of evaluation or other evidence-building include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quality data that are quantitative and qualitative.</P>
                <P>
                    (d) 
                    <E T="03">Adequacy of resources and quality of the project personnel (15 points).</E>
                </P>
                <P>(1) The Secretary considers the adequacy of resources for the proposed project and the quality of the personnel who will carry out the proposed project.</P>
                <P>(2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant demonstrates that it has project personnel or a plan for hiring of personnel who are members of groups that have historically encountered barriers, or who have professional or personal experiences with barriers, based on one or more of the following: economic disadvantage; gender; race; ethnicity; color; national origin; disability; age; language; migration; living in a rural location; experiencing homelessness or housing insecurity; involvement with the justice system; pregnancy, parenting, or caregiver status; and sexual orientation.</P>
                <P>(3) In addition, the Secretary considers the following factors:</P>
                <P>(i) The extent to which the project director or principal investigator, when hired, has the qualifications required for the project, including formal training or work experience in fields related to the objectives of the project and experience in designing, managing, or implementing similar projects for the target population to be served by the project.</P>
                <P>(ii) The extent to which the key personnel in the project, when hired, have the qualifications required for the proposed project, including formal training or work experience in fields related to the objectives of the project, and represent or have lived experiences of the target population.</P>
                <P>(iii) The qualifications, including relevant training and experience, of project consultants or subcontractors.</P>
                <P>(iv) The extent to which the evaluator has the qualifications, including the relevant training, experience, and independence, required to conduct an evaluation of the proposed project, including experience conducting evaluations of similar methodology as proposed and with evaluations for the proposed population and setting.</P>
                <P>(v) The adequacy of support for the project, including facilities, equipment, supplies, and other resources, from the applicant organization or the lead applicant organization.</P>
                <P>(vi) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project.</P>
                <P>(vii) The extent to which the budget is adequate to support the proposed project and the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project.</P>
                <P>(viii) The extent to which the budget is adequate to support the proposed project and the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project.</P>
                <P>
                    (e) 
                    <E T="03">Quality of the management plan (20 points).</E>
                </P>
                <P>(1) The Secretary considers the quality of the management plan for the proposed project.</P>
                <P>(2) In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:</P>
                <P>(i) The feasibility of the management plan to achieve project objectives and goals on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.</P>
                <P>(ii) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.</P>
                <P>(iii) The adequacy of mechanisms for ensuring high-quality and accessible products and services from the proposed project for the target population.</P>
                <P>(iv) How the applicant will ensure that a diversity of perspectives, including those from underserved populations, are brought to bear in the design, implementation, operation, evaluation, and improvement of the proposed project, including those of parents, educators, community-based organizations, civil rights organizations, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate.</P>
                <P>
                    2. 
                    <E T="03">Review and Selection Process:</E>
                     We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.
                </P>
                <P>In addition, in making a competitive grant award, the Secretary requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).</P>
                <P>
                    In the event there are two or more applications with the same final score, and there are insufficient funds to fully support each of these applications, the scores under selection criterion (b) 
                    <E T="03">Quality of project services</E>
                     will be used as a tiebreaker. If the scores remain tied, then the scores under selection criterion (d) 
                    <E T="03">Adequacy of resources and quality of the project personnel</E>
                     will be used to break the tie.
                </P>
                <P>
                    3. 
                    <E T="03">Additional Review and Selection Process Factors:</E>
                     In the past, the Department has had difficulty finding peer reviewers for certain competitions because so many individuals who are eligible to serve as peer reviewers have conflicts of interest. The standing panel requirements under section 682(b) of IDEA also have placed additional constraints on the availability of reviewers. Therefore, the Department 
                    <PRTPAGE P="3817"/>
                    has determined that for some discretionary grant competitions, applications may be separated into two or more groups and ranked and selected for funding within specific groups. This procedure will make it easier for the Department to find peer reviewers by ensuring that greater numbers of individuals who are eligible to serve as reviewers for any particular group of applicants will not have conflicts of interest. It also will increase the quality, independence, and fairness of the review process, while permitting panel members to review applications under discretionary grant competitions for which they also have submitted applications.
                </P>
                <P>
                    4. 
                    <E T="03">Risk Assessment and Specific Conditions:</E>
                     Consistent with 2 CFR 200.206, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 200.208, the Secretary may impose specific conditions and, under 2 CFR 3474.10, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.
                </P>
                <P>
                    5. 
                    <E T="03">Integrity and Performance System:</E>
                     If you are selected under this competition to receive an award that over the course of the project period may exceed the simplified acquisition threshold (currently $250,000), under 2 CFR 200.206(a)(2) we must make a judgment about your integrity, business ethics, and record of performance under Federal awards—that is, the risk posed by you as an applicant—before we make an award. In doing so, we must consider any information about you that is in the integrity and performance system (currently referred to as the Federal Awardee Performance and Integrity Information System (FAPIIS)), accessible through the System for Award Management. You may review and comment on any information about yourself that a Federal agency previously entered and that is currently in FAPIIS.
                </P>
                <P>Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.</P>
                <HD SOURCE="HD1">VI. Award Administration Information</HD>
                <P>
                    1. 
                    <E T="03">Award Notices:</E>
                     If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN), or we may send you an email containing a link to access an electronic version of your GAN. We also may notify you informally.
                </P>
                <P>If your application is not evaluated or not selected for funding, we notify you.</P>
                <P>
                    2. 
                    <E T="03">Administrative and National Policy Requirements:</E>
                     We identify administrative and national policy requirements in the application package and reference these and other requirements in the 
                    <E T="03">Applicable Regulations</E>
                     section of this notice.
                </P>
                <P>
                    We reference the regulations outlining the terms and conditions of an award in the 
                    <E T="03">Applicable Regulations</E>
                     section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.
                </P>
                <P>
                    3. 
                    <E T="03">Open Licensing Requirements:</E>
                     Unless an exception applies, if you are awarded a grant under this competition, you will be required to openly license to the public grant deliverables created in whole, or in part, with Department grant funds. When the deliverable consists of modifications to pre-existing works, the license extends only to those modifications that can be separately identified and only to the extent that open licensing is permitted under the terms of any licenses or other legal restrictions on the use of pre-existing works. Additionally, a grantee that is awarded competitive grant funds must have a plan to disseminate these public grant deliverables. This dissemination plan can be developed and submitted after your application has been reviewed and selected for funding. For additional information on the open licensing requirements please refer to 2 CFR 3474.20.
                </P>
                <P>
                    4. 
                    <E T="03">Reporting:</E>
                     (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).
                </P>
                <P>
                    (b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to 
                    <E T="03">www.ed.gov/fund/grant/apply/appforms/appforms.html.</E>
                </P>
                <P>
                    5. 
                    <E T="03">Performance Measures:</E>
                     For the purposes of Department reporting under 34 CFR 75.110, the Department has established a set of performance measures including long-term measures that are designed to yield information on various aspects of the effectiveness and quality of the Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities program. These measures are:
                </P>
                <P>• Program Performance Measure #1: The percentage of Technical Assistance and Dissemination products and services deemed to be of high quality by an independent review panel of experts qualified to review the substantive content of the products and services.</P>
                <P>• Program Performance Measure #2: The percentage of Technical Assistance and Dissemination products and services deemed by an independent review panel of qualified experts to be of high relevance to educational and early intervention policy or practice.</P>
                <P>• Program Performance Measure #3: The percentage of all Technical Assistance and Dissemination products and services deemed by an independent review panel of qualified experts to be useful in improving educational or early intervention policy or practice.</P>
                <P>• Program Performance Measure #4: The cost efficiency of the Technical Assistance and Dissemination Program includes the percentage of milestones achieved in the current annual performance report period and the percentage of funds spent during the current fiscal year.</P>
                <P>• Long-term Program Performance Measure (applies to Absolute Priority 1 only): The percentage of States receiving Special Education Technical Assistance and Dissemination services regarding scientifically or evidence-based practices for infants, toddlers, children, and youth with disabilities that successfully promote the implementation of those practices in school districts and service agencies.</P>
                <P>The measures apply to projects funded under this competition, and grantees are required to submit data on these measures as directed by OSEP and RSA.</P>
                <P>
                    Grantees will be required to report information on their project's performance in annual and final 
                    <PRTPAGE P="3818"/>
                    performance reports to the Department (34 CFR 75.590).
                </P>
                <P>The Department will also closely monitor the extent to which the products and services provided by the project meet needs identified by stakeholders and may require the project to report on such alignment in its annual and final performance reports.</P>
                <P>
                    6. 
                    <E T="03">Continuation Awards:</E>
                     In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, whether the grantee has made substantial progress in achieving the performance targets in the grantee's approved application.
                </P>
                <P>In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).</P>
                <HD SOURCE="HD1">VII. Other Information</HD>
                <P>
                    <E T="03">Accessible Format:</E>
                     On request to the program contact persons listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    , individuals with disabilities can obtain this document and a copy of the application package in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, compact disc, or other accessible format.
                </P>
                <P>
                    <E T="03">Electronic Access to This Document:</E>
                     The official version of this document is the document published in the 
                    <E T="04">Federal Register</E>
                    . You may access the official edition of the 
                    <E T="04">Federal Register</E>
                     and the Code of Federal Regulations at 
                    <E T="03">www.govinfo.gov.</E>
                     At this site you can view this document, as well as all other Department documents published in the 
                    <E T="04">Federal Register</E>
                    , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.
                </P>
                <P>
                    You may also access Department documents published in the 
                    <E T="04">Federal Register</E>
                     by using the article search feature at 
                    <E T="03">www.federalregister.gov.</E>
                     Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
                </P>
                <SIG>
                    <NAME>Glenna Wright-Gallo,</NAME>
                    <TITLE>Assistant Secretary for the Office of Special Education and Rehabilitative Services.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00691 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF EDUCATION</AGENCY>
                <DEPDOC>[Docket No.: ED-2025-SCC-0004]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Comment Request; Best Interest Determination—Prison Education Program</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Student Aid (FSA), Department of Education (ED).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a new information collection request (ICR).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To access and review all the documents related to the information collection listed in this notice, please use 
                        <E T="03">http://www.regulations.gov</E>
                         by searching the Docket ID number ED-2025-SCC-0004. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at 
                        <E T="03">http://www.regulations.gov</E>
                         by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. If the 
                        <E T="03">regulations.gov</E>
                         site is not available to the public for any reason, the Department will temporarily accept comments at 
                        <E T="03">ICDocketMgr@ed.gov.</E>
                         Please include the docket ID number and the title of the information collection request when requesting documents or submitting comments. Please note that comments submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Manager of the Strategic Collections and Clearance Governance and Strategy Division, U.S. Department of Education, 400 Maryland Ave. SW, LBJ, Room 4C210, Washington, DC 20202-1200.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For specific questions related to collection activities, please contact Beth Grebeldinger, 202-570-8414.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.</P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Best Interest Determination—Prison Education Program.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1845-NEW.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     A new ICR.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     Private Sector; State, Local, and Tribal Governments.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     1,000.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     6,000.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The Prison Education Program (PEP) is authorized under section 484(t) of the Higher Education Act of 1965, as amended (HEA) with the requirements for participation outlined in 34 CFR 668, subpart P, effective July 1, 2023. The regulatory requirements are for a school to offer a PEP to confined or incarcerated individuals. This is a request for a new information collection to develop a form for Oversight Entities to have a mechanism to report the Best Interest Determination for every PEP under their jurisdiction as required under 34 CFR 668.241. This is an optional form which includes the required elements and is being offered for ease of reporting by the appropriate Oversight Entities. Oversight Entities include the appropriate State department of corrections or other entity responsible for overseeing correctional facilities or the Federal Bureau of Prisons. Once completed by the Oversight Entities, the report is 
                    <PRTPAGE P="3819"/>
                    forwarded to the institution which in turn will file the report with the Department of Education.
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Kun Mullan,</NAME>
                    <TITLE>PRA Coordinator, Strategic Collections and Clearance, Governance and Strategy Division, Office of Chief Data Officer, Office of Planning, Evaluation and Policy Development.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00705 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF EDUCATION</AGENCY>
                <DEPDOC>[Docket No.: ED-2024-SCC-0137]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Student Assistance General Provisions—Annual Fire Safety Report</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Student Aid (FSA), Department of Education (ED).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link 
                        <E T="03">www.reginfo.gov/public/do/PRAMain</E>
                         to access the site. Find this information collection request (ICR) by selecting “Department of Education” under “Currently Under Review,” then check the “Only Show ICR for Public Comment” checkbox. 
                        <E T="03">Reginfo.gov</E>
                         provides two links to view documents related to this information collection request. Information collection forms and instructions may be found by clicking on the “View Information Collection (IC) List” link. Supporting statements and other supporting documentation may be found by clicking on the “View Supporting Statement and Other Documents” link.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For specific questions related to collection activities, please contact Beth Grebeldinger, (202) 570-8414.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.</P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Student Assistance General Provisions—Annual Fire Safety Report
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1845-0097.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension without change of a currently approved ICR.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     Private Sector; State, Local, and Tribal Governments 
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     4,310.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     4,313.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The Department of Education regulations at 34 CFR 668.49 require institutions to collect statistics on fires occurring in on-campus student housing facilities, including the number and cause of each fire, the number of injuries related to each fire that required treatment at a medical facility, the number of deaths related to each fire, and the value of property damage caused by each fire. Institutions must also publish an annual fire safety report containing the institution's policies regarding fire safety and the fire statistics information. Further institutions are required to maintain a fire log that records the date, time, nature, and general location of each fire in on-campus student housing facilities.
                </P>
                <P>This is a request for extension without change of the current information collection 1845-0114. There has been no change to the regulations since the previous information collection filing. The collection requirements in the regulations are necessary to meet institutional information reporting to students and staff as well as for reporting to Congress through the Secretary.</P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Kun Mullan,</NAME>
                    <TITLE>PRA Coordinator, Strategic Collections and Clearance, Governance and Strategy Division, Office of Chief Data Officer, Office of Planning, Evaluation and Policy Development.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00682 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF EDUCATION</AGENCY>
                <DEPDOC>[Docket No.: ED-2025-SCC-0005]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Comment Request; School Pulse Panel 2025-26 Data Collection Activities</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Center for Education Statistics (NCES), Department of Education (ED).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before MARCH 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To access and review all the documents related to the information collection listed in this notice, please use 
                        <E T="03">http://www.regulations.gov</E>
                         by searching the Docket ID number ED-2025-SCC-0005. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at 
                        <E T="03">http://www.regulations.gov</E>
                         by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. If the regulations.gov site is not available to the public for any reason, the Department will temporarily accept comments at 
                        <E T="03">ICDocketMgr@ed.gov.</E>
                         Please include the docket ID number and the title of the information collection request when requesting documents or submitting comments. Please note that comments submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Manager of the Strategic Collections and Clearance Governance and Strategy Division, U.S. Department of Education, 400 Maryland Ave. SW, LBJ, Room 4C210, Washington, DC 20202-1200.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For specific questions related to collection activities, please contact Carrie Clarady, 202-245-6347.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the 
                    <PRTPAGE P="3820"/>
                    Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     School Pulse Panel 2025-26 Data Collection Activities.
                </P>
                <P>
                    <E T="03">OMB Control No.:</E>
                     1850-0975.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     A revision of a currently approved ICR.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     State, Local, and Tribal Governments. 
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     53,955.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     10,175.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The School Pulse Panel (SPP) is a data collection that was originally designed to collect voluntary responses from a nationally representative sample of public schools to better understand how schools, students, and educators were responding to the ongoing stressors of the coronavirus pandemic. The School Pulse Panel is conducted by the National Center for Education Statistics (NCES), part of the Institute of Education Sciences (IES), within the United States Department of Education. Initially, the purpose of the study was to collect extensive data on issues brought to light by the COVID-19 pandemic, as well as other important education-related issues that could inform data-driven policy decisions, in U.S. public schools. Due to the immediate need to collect pandemic-era information from schools as described in Executive Order 14000, an emergency clearance was issued to develop and field the first several monthly collections of the SPP in 2021 and a full review of the SPP data collection was performed in 2022 (OMB# 1850-0969). SPP's innovative design and timely dissemination of findings have been used and cited frequently among Department of Education senior leadership, the White House Domestic Policy Council, the USDA's Food and Nutrition Service, the Centers for Disease Control and Prevention, Congressional deliberations, and the media. The growing interest from stakeholders resulted in a request for funding to create an established NCES quick-turnaround data collection vehicle to become a mainstay for NCES. Funding for a mainstay collection was approved in late 2022, and NCES conducted a new collection during the 2023-24 and 2024-25 school years.
                </P>
                <P>The School Pulse Panel study is one of the few reliable, nationally representative, quick-turnaround studies that produces data on U.S. public schools. The sample design for the 2025-26 collection will roughly be the same as the 2023-24 and 2024-25 collections with 4,000 public schools randomly selected to an initial sample and 4,000 in a reserve sample. It is expected these schools will come from roughly 3,000 districts. The goal is national representation from about 1,200 responding schools each month in order to report out national estimates. School staff will be asked to provide requested data monthly during the 2025-26 school year. This approach provides the ability to collect detailed information on various topics while also assessing changes over time for items that are repeated from year to year. Given the demand for data collection, the content of the survey is expected to change monthly. For the 2025-26 school year, the survey may ask school staff about a wide range of topics, including but not limited to staffing; learning recovery; absenteeism; usage of federal funds; facilities; transportation; technology; and overall principal and staff experiences.</P>
                <P>This submission will undergo a 60-day public comment period, followed by an additional 30-day public comment period. We continue to make revisions to the communication materials (Appendix A) and will present final versions for the 30-day comment period. Items in the Item Bank (Appendix B) that have not already been approved are consider draft and will undergo cognitive testing and revision before final administration. Final instruments for the August, September, and October 2025 surveys (Appendix C1) will be added to this package during the 30-day public comment, to be posted in spring 2025. Final items will be submitted to OMB through a change request. Subsequent quarterly instruments will also be posted for 30-day comment in the months immediately preceding their administration, potentially followed by change requests to allow for small changes in items as deemed necessary by cognitive testing. Materials for SPP are cleared under two OMB Number sequences. Materials for SPP 2022 and SPP 2024-25 were cleared under OMB# 1850-0969, while SPP 2023-24 and now SPP 2025-26 are cleared under OMB# 1850-0975.</P>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Stephanie Valentine,</NAME>
                    <TITLE>PRA Coordinator, Strategic Collections and Clearance, Governance and Strategy Division, Office of Chief Data Officer, Office of Planning, Evaluation and Policy Development.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00781 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <SUBJECT>Combined Notice of Filings</SUBJECT>
                <P>Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:</P>
                <HD SOURCE="HD1">Filings Instituting Proceedings</HD>
                <P>
                    <E T="03">Docket Numbers:</E>
                     AC25-44-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Columbia Gulf Transmission, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Columbia Gulf Transmission, LLC submits request for approval of accounting treatment for deferred taxes associated with sale and purchase re a transaction with Global Infrastructure Partners, LP on 10/04/2023.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/8/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250108-5096.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/29/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     AC25-45-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Columbia Gas Transmission, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Columbia Gas Transmission, LLC submits request for approval of accounting treatment for deferred taxes associated with sale and purchase re a transaction with Global Infrastructure Partners, LP on 10/04/2023.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/8/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250108-5097.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/29/25.
                </P>
                <P>Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.</P>
                <P>
                    The filings are accessible in the Commission's eLibrary system (
                    <E T="03">
                        https://elibrary.ferc.gov/idmws/search/
                        <PRTPAGE P="3821"/>
                        fercgensearch.asp
                    </E>
                    ) by querying the docket number.
                </P>
                <P>
                    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: 
                    <E T="03">http://www.ferc.gov/docs-filing/efiling/filing-req.pdf.</E>
                     For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00766 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <SUBJECT>Privacy Act of 1974; System of Records</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Energy Regulatory Commission (FERC), Department of Energy (DOE).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Rescindment of system of records notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Pursuant to the Privacy Act of 1974 and Office of Management and Budget (OMB) Circular No. A-108, the Federal Energy Regulatory Commission (Commission or FERC) proposes to rescind two existing systems of records notices (SORNs). The Rescindment of System of Records Notice identifies the systems of records and explains why each is being rescinded.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        Comments on this rescindment notice must be received no later than 30 days after the date of publication in the 
                        <E T="04">Federal Register</E>
                        . If no public comment is received during the period allowed for comment or unless otherwise published in the 
                        <E T="04">Federal Register</E>
                         by FERC, the rescindment will become effective a minimum of 30 days after the date of publication in the 
                        <E T="04">Federal Register</E>
                        . If FERC receives public comments, FERC shall review the comments to determine whether any changes to the notice are necessary.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted in writing to Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, or electronically to 
                        <E T="03">privacy@ferc.gov.</E>
                         Comments should indicate that they are submitted in response to “Management, Administrative, and Payroll System (MAPS) (FERC-36)” and “Commission Employee Assistance Program Records (FERC-54)”.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Michelle Lipinski, Director, Human Resources Division, Office of the Executive Director, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, (202) 502-6852.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Two (2) systems of records were identified for rescindment from the FERC's Privacy Act systems of records inventory. Those two systems of records were identified for rescindment because: (1) the records will be maintained as part of a modified system of records; or (2) the records are no longer maintained by FERC.</P>
                <P>1. OMB requires that each agency provide assurance that systems of records do not duplicate any existing agency or government-wide systems of records (Appendix I, OMB Circular A-130). Management, Administrative, and Payroll System (MAPS) (FERC-36) was identified for rescindment because FERC is no longer using the Management, Administrative, and Payroll System (MAPS) and is instead using Federal Personnel Payroll System (FPPS) which is covered by Federal Personnel and Payroll Records (FERC-57) and PeopleSoft Financials which is covered by Financial Management Records (FERC-56).</P>
                <P>2. Commission Employee Assistance Program Records (FERC-54) was identified for rescindment because FERC no longer keeps records on employees who have been counseled or referred to the Employee Assistance Program for problems relating to alcoholism, drug abuse, job stress, chronic illness, family or relationship concerns, emotional and other similar issues. Instead, records of employees who sought assistance through that program are maintained by the Federal Occupational Health Program which is part of the Department of Health and Human Services.</P>
                <PRIACT>
                    <HD SOURCE="HD2">SYSTEM NAME(S) AND NUMBER(S):</HD>
                    <P>Management, Administrative, and Payroll System (MAPS) (FERC-36)</P>
                    <P>Commission Employee Assistance Program Records (FERC-54)</P>
                    <HD SOURCE="HD2">HISTORY:</HD>
                </PRIACT>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="xs48,r100">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">System No.</CHED>
                        <CHED H="1">
                            <E T="02">Federal Register</E>
                            <LI>No. and publication date</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">FERC-36</ENT>
                        <ENT>65 FR 21753 (April 24, 2000).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FERC-54</ENT>
                        <ENT>65 FR 21763 (April 24, 2000).</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <DATED>Issued: January 8, 2025.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00839 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket No. CP25-37-000]</DEPDOC>
                <SUBJECT>Transwestern Pipeline Company, LLC; Notice of Application and Establishing Intervention Deadline</SUBJECT>
                <P>Take notice that on December 20, 2024, Transwestern Pipeline Company, LLC (Transwestern), 1300 Main Street, Houston, Texas, 77002, filed an application under section 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's regulations requesting authorization for its WT-0 Compressor Station Project (Project). The Project involves the construction of a new WT-0 Compressor Station including one new Solar Mars 90 natural gas turbine-driven compressor unit providing 13,220 horsepower in Chaves County, New Mexico. The Project will enable Transwestern to deliver up to 80,000 million British thermal units per day of new firm transportation capacity of natural gas to be utilized by ETC Marketing, Ltd. Transwestern estimates the total cost of the Project to be $51,990,551 and proposes a negotiated rate with service provided under Rate Schedule FTS-1 for the cost recovery, all as more fully set forth in the application which is on file with the Commission and open for public inspection.</P>
                <P>
                    In addition to publishing the full text of this document in the 
                    <E T="04">Federal Register</E>
                    , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the internet through the Commission's Home Page (
                    <E T="03">http://www.ferc.gov</E>
                    ). From the Commission's Home Page on the internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three 
                    <PRTPAGE P="3822"/>
                    digits of this document in the docket number field.
                </P>
                <P>
                    User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email at 
                    <E T="03">ferconlinesupport@ferc.gov,</E>
                     or the Public Reference Room at (202) 502-8371, TTY (202) 502-8659. Email the Public Reference Room at 
                    <E T="03">public.referenceroom@ferc.gov.</E>
                </P>
                <P>
                    Any questions regarding the proposed project should be directed to Blair Lichtenwalter, Senior Director of Certificates, Transwestern Pipeline Company, LLC, 1300 Main Street, Houston, Texas 77002, by phone at (713) 989-2605, or by email at 
                    <E T="03">blairlichtenwalter@energytransfer.com.</E>
                </P>
                <P>
                    Pursuant to section 157.9 of the Commission's Rules of Practice and Procedure,
                    <SU>1</SU>
                    <FTREF/>
                     within 90 days of this Notice the Commission staff will either: complete its environmental review and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or environmental assessment (EA) for this proposal. The filing of an EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         18 CFR 157.9.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Public Participation</HD>
                <P>There are three ways to become involved in the Commission's review of this project: you can file comments on the project, you can protest the filing, and you can file a motion to intervene in the proceeding. There is no fee or cost for filing comments or intervening. The deadline for filing a motion to intervene is 5:00 p.m. Eastern Time on January 29, 2025. How to file protests, motions to intervene, and comments is explained below.</P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <HD SOURCE="HD1">Comments</HD>
                <P>Any person wishing to comment on the project may do so. Comments may include statements of support or objections, to the project as a whole or specific aspects of the project. The more specific your comments, the more useful they will be.</P>
                <HD SOURCE="HD1">Protests  </HD>
                <P>
                    Pursuant to sections 157.10(a)(4) 
                    <SU>2</SU>
                    <FTREF/>
                     and 385.211 
                    <SU>3</SU>
                    <FTREF/>
                     of the Commission's regulations under the NGA, any person 
                    <SU>4</SU>
                    <FTREF/>
                     may file a protest to the application. Protests must comply with the requirements specified in section 385.2001 
                    <SU>5</SU>
                    <FTREF/>
                     of the Commission's regulations. A protest may also serve as a motion to intervene so long as the protestor states it also seeks to be an intervenor.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         18 CFR 157.10(a)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         18 CFR 385.211.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Persons include individuals, organizations, businesses, municipalities, and other entities. 18 CFR 385.102(d).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         18 CFR 385.2001.
                    </P>
                </FTNT>
                <P>To ensure that your comments or protests are timely and properly recorded, please submit your comments on or before January 29, 2025.</P>
                <P>There are three methods you can use to submit your comments or protests to the Commission. In all instances, please reference the Project docket number CP25-37-000 in your submission.</P>
                <P>
                    (1) You may file your comments electronically by using the eComment feature, which is located on the Commission's website at 
                    <E T="03">www.ferc.gov</E>
                     under the link to Documents and Filings. Using eComment is an easy method for interested persons to submit brief, text-only comments on a project;
                </P>
                <P>
                    (2) You may file your comments or protests electronically by using the eFiling feature, which is located on the Commission's website (
                    <E T="03">www.ferc.gov</E>
                    ) under the link to Documents and Filings. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on “eRegister.” You will be asked to select the type of filing you are making; first select “General” and then select “Comment on a Filing”; or
                </P>
                <P>(3) You can file a paper copy of your comments or protests by mailing them to the following address below. Your written comments must reference the Project docket number (CP25-37-000).</P>
                <FP SOURCE="FP-1">
                    <E T="03">To file via USPS:</E>
                     Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">To file via any other courier:</E>
                     Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852
                </FP>
                <P>
                    The Commission encourages electronic filing of comments (options 1 and 2 above) and has eFiling staff available to assist you at (202) 502-8258 or 
                    <E T="03">FercOnlineSupport@ferc.gov.</E>
                </P>
                <P>Persons who comment on the environmental review of this project will be placed on the Commission's environmental mailing list, and will receive notification when the environmental documents (EA or EIS) are issued for this project and will be notified of meetings associated with the Commission's environmental review process.</P>
                <P>The Commission considers all comments received about the project in determining the appropriate action to be taken. However, the filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding. For instructions on how to intervene, see below.</P>
                <HD SOURCE="HD1">Interventions</HD>
                <P>
                    Any person, which includes individuals, organizations, businesses, municipalities, and other entities,
                    <SU>6</SU>
                    <FTREF/>
                     has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         18 CFR 385.102(d).
                    </P>
                </FTNT>
                <P>
                    To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure 
                    <SU>7</SU>
                    <FTREF/>
                     and the regulations under the NGA 
                    <SU>8</SU>
                    <FTREF/>
                     by the intervention deadline for the project, which is January 29, 2025. As described further in Rule 214, your motion to intervene must state, to the extent known, your position regarding the proceeding, as well as your interest in the proceeding. For an individual, this could include your status as a landowner, ratepayer, resident of an impacted community, or recreationist. You do not need to have property directly impacted by the 
                    <PRTPAGE P="3823"/>
                    project in order to intervene. For more information about motions to intervene, refer to the FERC website at 
                    <E T="03">https://www.ferc.gov/resources/guides/how-to/intervene.asp.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         18 CFR 385.214.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         18 CFR 157.10.
                    </P>
                </FTNT>
                <P>There are two ways to submit your motion to intervene. In both instances, please reference the Project docket number CP25-37-000 in your submission.</P>
                <P>
                    (1) You may file your motion to intervene by using the Commission's eFiling feature, which is located on the Commission's website (
                    <E T="03">www.ferc.gov</E>
                    ) under the link to Documents and Filings. New eFiling users must first create an account by clicking on “eRegister.” You will be asked to select the type of filing you are making; first select “General” and then select “Intervention.” The eFiling feature includes a document-less intervention option; for more information, visit 
                    <E T="03">https://www.ferc.gov/docs-filing/efiling/document-less-intervention.pdf.;</E>
                     or
                </P>
                <P>(2) You can file a paper copy of your motion to intervene, along with three copies, by mailing the documents to the address below. Your motion to intervene must reference the Project docket number CP25-37-000.</P>
                <FP SOURCE="FP-1">
                    <E T="03">To file via USPS:</E>
                     Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426
                </FP>
                <FP SOURCE="FP-1">To file via any other courier: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852</FP>
                <P>
                    The Commission encourages electronic filing of motions to intervene (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or 
                    <E T="03">FercOnlineSupport@ferc.gov.</E>
                </P>
                <P>
                    Protests and motions to intervene must be served on the applicant either by mail at: Blair Lichtenwalter, Senior Director of Certificates, 1300 Main Street, Houston, Texas 77002, or by email (with a link to the document) at 
                    <E T="03">blairlichtenwalter@energytransfer.com.</E>
                     Any subsequent submissions by an intervenor must be served on the applicant and all other parties to the proceeding. Contact information for parties can be downloaded from the service list at the eService link on FERC Online. Service can be via email with a link to the document.
                </P>
                <P>
                    All timely, unopposed 
                    <SU>9</SU>
                    <FTREF/>
                     motions to intervene are automatically granted by operation of Rule 214(c)(1).
                    <SU>10</SU>
                    <FTREF/>
                     Motions to intervene that are filed after the intervention deadline are untimely, and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations.
                    <SU>11</SU>
                    <FTREF/>
                     A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         The applicant has 15 days from the submittal of a motion to intervene to file a written objection to the intervention.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         18 CFR 385.214(c)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         18 CFR 385.214(b)(3) and (d).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Tracking the Proceeding</HD>
                <P>
                    Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at 
                    <E T="03">www.ferc.gov</E>
                     using the “eLibrary” link as described above. The eLibrary link also provides access to the texts of all formal documents issued by the Commission, such as orders, notices, and rulemakings.
                </P>
                <P>
                    In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to 
                    <E T="03">www.ferc.gov/docs-filing/esubscription.asp.</E>
                </P>
                <P>
                    <E T="03">Intervention Deadline:</E>
                     5:00 p.m. Eastern Time on January 29, 2025.
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00833 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project Nos. 2942-057; 2984-128]</DEPDOC>
                <SUBJECT>Presumpscot Hydro LLC and Dichotomy Power Maine LLC; Notice of Intent To Prepare an Environmental Assessment</SUBJECT>
                <P>
                    On June 20, 2023, and supplemented October 31, 2023, Presumpscot Hydro LLC, and Dichotomy Power Maine LLC 
                    <SU>1</SU>
                    <FTREF/>
                     (co-licensees) filed a Non-capacity Amendment of License for the Dundee Project No. 2942 and Eel Weir Project No. 2984. The Dundee Project is located on the Presumpscot River in Cumberland County, Maine, and the Eel Weir Project is located at the outlet of Sebago Lake on the Presumpscot River in Cumberland County, Maine. The projects do not occupy federal lands.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         On July 8, 2024, and November 14, 2024, the licensee filed a notice that its name changed to Relevate Power Maine LLC.
                    </P>
                </FTNT>
                <P>The co-licensees propose to upgrade two generating units and to construct a new transformer at the Eel Weir Project. The unit upgrades would increase the authorized installed capacity from 1.80 megawatts (MW) to 1.99 MW and decrease the total hydraulic capacity of the powerhouse from 822 to 796 cubic feet per second. The co-licensees also propose modifications to the transmission lines at both the Dundee and the Eel Weir projects. Specifically, the co-licensees propose to remove the 3.5-mile-long, 11-kV primary transmission line from Eel Weir Station to Dundee Station from the Eel Weir project boundary, and construct a new transformer at the Eel Weir Station and a new 12.5-kV primary transmission line using an existing 0.62-mile-long right-of-way along the power canal, to tie into the North Windham Substation on Route 35. At the Dundee Project, the co-licensees propose to remove the 10-mile-long, 11-kV North and South Feeder Lines from the Dundee Station to Westbrook from the project boundary, and instead transmit power from the Dundee Station to the new transformer at the Eel Weir Station using the existing 3.5-mile-long, 11-kV transmission line from Dundee to Eel Weir. On December 7, 2023, the Commission issued a public notice for the proposed amendment. The notice established January 8, 2024, for filing responses to the notice. No comments or motions to intervene were received.</P>
                <P>
                    This notice identifies Commission staff's intention to prepare an environmental assessment (EA) for the project.
                    <SU>2</SU>
                    <FTREF/>
                     Commission staff plans to issue an EA by May 5, 2025. Revisions to the schedule may be made as appropriate. The EA will be issued for a 30-day comment period. All comments filed on the EA will be reviewed by staff and considered in the Commission's final decision on the proceeding.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         In accordance with the Council on Environmental Quality's regulations, the unique identification number for documents relating to this environmental review is EAXX-019-20-000-1734683238. 40 CFR 1501.5(c)(4) (2024).
                    </P>
                </FTNT>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members, and 
                    <PRTPAGE P="3824"/>
                    others to access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    Any questions regarding this notice may be directed to Jeremy Jessup at (202) 502-6779 or 
                    <E T="03">Jeremy.Jessup@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00838 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket No. CP25-5-000]</DEPDOC>
                <SUBJECT>Columbia Gas Transmission, LLC; Notice of Schedule for the Preparation of an Environmental Assessment for the Line 4010 Abandonment Project</SUBJECT>
                <P>On October 10, 2024, Columbia Gas Transmission, LLC filed an application in Docket No. CP25-5-000 requesting authorization pursuant to section 7(b) of the Natural Gas Act to abandon certain natural gas pipeline facilities. The proposed project is known as the Line 4010 Abandonment Project (Project) and would abandon in place and by removal 13.2 miles of the Line 4010 pipeline and all related appurtenances in Jefferson and Clarion Counties, Pennsylvania.</P>
                <P>
                    On October 24, 2024, the Federal Energy Regulatory Commission (Commission or FERC) issued its 
                    <E T="03">Notice of Application and Establishing Intervention Deadline</E>
                     (Notice of Application) for the Project. Among other things, that notice alerted agencies issuing Federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a Federal authorization within 90 days of the date of issuance of the Commission staff's environmental document for the Project.
                </P>
                <P>
                    This notice identifies Commission staff's intention to prepare an environmental assessment (EA) for the Project and the planned schedule for the completion of the environmental review.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         In accordance with the Council on Environmental Quality's regulations, the unique identification number for documents relating to this environmental review is EAXX-019-20-000-1731407889. 40 CFR 1501.5(c)(4) (2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Schedule for Environmental Review</HD>
                <FP SOURCE="FP-1">Issuance of EA—May 16, 2025 </FP>
                <FP SOURCE="FP-1">
                    90-day Federal Authorization Decision Deadline 
                    <SU>2</SU>
                    <FTREF/>
                    —August 14, 2025
                </FP>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The Commission's deadline applies to the decisions of other Federal agencies, and state agencies acting under federally delegated authority, that are responsible for Federal authorizations, permits, and other approvals necessary for proposed projects under the Natural Gas Act. Per 18 CFR 157.22(a), the Commission's deadline for other agency's decisions applies unless a schedule is otherwise established by Federal law.
                    </P>
                </FTNT>
                <P>If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.</P>
                <HD SOURCE="HD1">Project Description</HD>
                <P>The Line 4010 Abandonment Project would abandon about 13.7 miles of 6-inch-diameter pipeline in Jefferson and Clarion Counties, Pennsylvania and abandon above ground facilities, including ten meter-stations, five mainline valves, and related appurtenances along Line 4010, also in Jefferson and Clarion Counties. The proposed Project would allow Columbia to comply with an order issued on April 22, 2022, by the United States Department of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) in response to an operating incident on Line 4010. Columbia determined that abandoning Line 4010 is the most prudent response given the pipeline's age, condition, and the PHMSA order.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On November 19, 2024, the Commission issued a “Notice of Scoping Period Requesting Comments on Environmental Issues for the Proposed Line 4010 Abandonment Project and Notice of Public Scoping Session
                    <E T="03">”</E>
                     (Notice of Scoping). The Notice of Scoping was sent to affected landowners; Federal, State, and local government agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. In response to the Notice of Scoping, the Commission received comments from U.S. Environmental Protection Agency, Region 3. Region 3 did not have any comments at this time regarding the Project. All substantive comments will be addressed in the EA.
                </P>
                <HD SOURCE="HD1">Additional Information</HD>
                <P>
                    In order to receive notification of the issuance of the EA and to keep track of formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This service provides automatic notification of filings made to subscribed dockets, document summaries, and direct links to the documents. Go to 
                    <E T="03">https://www.ferc.gov/ferc-online/overview</E>
                     to register for eSubscription.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
                    <E T="03">www.ferc.gov</E>
                    ). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (
                    <E T="03">i.e.,</E>
                     CP25-5), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at 
                    <E T="03">FERCOnlineSupport@ferc.gov.</E>
                     The eLibrary link on the FERC website also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00837 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 2716-051]</DEPDOC>
                <SUBJECT>Virginia Electric and Power Company d/b/a Dominion Energy Virginia, Allegheny Generating Company, and Bath County Energy, LLC; Notice of Application Tendered for Filing With the Commission and Establishing Procedural Schedule for Licensing and Deadline for Submission of Final Amendments</SUBJECT>
                <P>
                    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
                    <PRTPAGE P="3825"/>
                </P>
                <P>
                    a. 
                    <E T="03">Type of Application:</E>
                     New Major License.
                </P>
                <P>
                    b. 
                    <E T="03">Project No.:</E>
                     2716-051.
                </P>
                <P>
                    c. 
                    <E T="03">Date Filed:</E>
                     December 30, 2024.
                </P>
                <P>
                    d. 
                    <E T="03">Applicant:</E>
                     Virginia Electric and Power Company d/b/a Dominion Energy Virginia, Allegheny Generating Company, and Bath County Energy, LLC (Dominion).
                </P>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     Bath County Pumped Storage Project (Bath County Project).
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     On Back Creek and Little Back Creek in Bath, Highland, Augusta, and Rockbridge counties, Virginia. The current project boundary encompasses 3,451 acres of land, including 1,122 acres of Federal land in the George Washington and Jefferson National Forests administered by the U.S. Forest Service.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     Federal Power Act, 16 U.S.C. 791(a)-825(r).
                </P>
                <P>
                    h. 
                    <E T="03">Applicant Contact:</E>
                     Mr. Corwin D. Chamberlain, Relicensing Project Manager, Dominion Energy, 600 Canal Place, Richmond, VA 23219-3852; (804) 273-2948; 
                    <E T="03">corwin.d.chamberlain@dominionenergy.com.</E>
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     Andy Bernick at (202) 502-8660 or email at 
                    <E T="03">andrew.bernick@ferc.gov.</E>
                </P>
                <P>j. The application is not ready for environmental analysis at this time.</P>
                <P>k. The Bath County Project consists of the following existing facilities: (1) an upper reservoir with a surface area of 278 acres and a gross storage capacity of 37,910 acre-feet (with an usable storage capacity of 23,300 acre-feet—power pool) at a normal maximum surface elevation of 3,321 feet National Geodetic Vertical Datum of 1929 (NGVD29), created by a 2,250-foot-long, 460-foot-high, earth and rock-fill dam across Little Back Creek with a crest elevation of 3,331 feet NGVD29; (2) water conduits composed of: (a) three intake structures in the upper reservoir; (b) two 10.75-foot by 28.6-foot wheel gates at each of the three intakes; (c) three concrete-lined power tunnels, 28.5 feet in diameter with an approximately 3,300 to 3,400-foot-long upper horizontal section, a 980-foot-long vertical section, and an approximately 3,267 to 3,686-foot-long lower horizontal section, connecting each upper intake to two steel-lined 1,185 to 1,510-foot-long, 18.0 to 19.5-foot-diameter underground penstocks; and (d) a single-shaft surge tank, approximately 44 feet in diameter, for each of the power tunnels; (3) a 509-foot-long, 145-foot-wide, and 203-foot-high reinforced concrete, primarily underground powerhouse with six 65-foot-wide bays for generation/pumping equipment and one erection bay, located on the west side of the lower reservoir, housing six Francis reversible pump-turbines each rated at 414 megawatts (MW) with a maximum hydraulic capacity of 4,600 cubic feet per second (cfs) in pumping mode and 5,000 cfs in generation mode, and a total installed capacity of 2,484 MW; (4) a lower reservoir with a surface area of 555 acres and a gross storage capacity of 27,300 acre-feet (with an usable storage capacity of 25,620 acre-feet composed of a 22,570 acre-foot power pool and 3,050 acre-foot conservation pool) at a normal maximum surface elevation 2,118 feet NGVD29, created by a 2,100-foot-long, 135-foot-high, earth and rock-fill dam across Back Creek with a crest elevation of 2,136 feet NGVD29; (5) a project switchyard on top of the powerhouse containing transformers to step-up the generator voltage to 500 kilovolts (kV), the transmission line voltage; (6) two 500-kV transmission lines, approximately 51 miles (Valley Line) and 35 miles long (Lexington Line), which interconnect at substations located in Augusta County, near Bridgewater, Virginia, and Rockbridge County, near Lexington, Virginia, respectively; and (7) appurtenant facilities.</P>
                <P>The average annual energy generation (2014 to 2023) is 3,708,814 megawatt-hours (MWh), and the average annual pumping consumption (2000 to 2020) is 4,599,899 MWh.</P>
                <P>Dominion manages three sediment ponds with a combined storage of about 103.5 acre-feet, located downstream of the upper reservoir on Little Back Creek outside of the current project boundary. The ponds were originally constructed to trap and limit sediment input to Little Back Creek following project construction in 1985, and Dominion continues to manage the ponds: (1) as a safety feature to protect Little Back Creek from excessive sediment deposition and flooding in the event of an emergency drawdown of the upper reservoir; (2) to regulate flows from upstream sources including the upper reservoir; (3) to supplement downstream flow; and (4) to provide recreational fishing opportunities. Dominion proposes to include the sediment ponds within the project boundary to protect Little Back Creek by trapping sediment in the unlikely event of an emergency drawdown of the upper reservoir as well as provide recreational access to the ponds over the new license term.</P>
                <P>The project also includes an existing project recreation area, located downstream of the lower reservoir dam near Back Creek, that consists of: (1) a 49-acre upper recreation pond with a one-lane concrete boat ramp for electric motorized and non-motorized boats, a fishing pier/dock, a walking trail, two tent-only campsites, and a parking area for 22 vehicles; (2) a 26-acre lower recreation pond with a swimming beach, a recreational field for soccer or baseball, a volleyball court, a walking trail, three picnic areas with a total of 18 picnic tables, a pavilion with restrooms, a bathhouse with restrooms and showers, and a parking area for 65 vehicles; and (3) a campground with 30 recreational vehicle campsites (each with a gravel pad, fire ring, and picnic table), trash cans, a comfort station with restrooms and showers, and a check-in station.</P>
                <P>Dominion proposes to continue to operate the Bath County Project as required by the current license. Downstream flow releases are maintained in compliance with the Virginia Water Protection Permit. As required by the permit, under normal operating conditions: (1) the daily average release from the lower reservoir shall be no less than the difference between 15 cfs and the daily average release from the upper reservoir; (2) at no time shall the instantaneous release from the lower reservoir be less than 10 cfs; and (3) the instantaneous release from the upper reservoir shall be no less than 2 cfs.</P>
                <P>
                    Dominion proposes to upgrade the turbine-generator units (
                    <E T="03">i.e.,</E>
                     replacement of turbine runners), including associated appurtenant facilities. No other structural or operational changes to the Bath County Project are proposed by Dominion at this time.
                </P>
                <P>
                    l. In addition to publishing this notice in the 
                    <E T="04">Federal Register</E>
                    , the Commission provides all interested persons an opportunity to view and/or print the contents of this notice, as well as other documents in the proceeding (
                    <E T="03">e.g.,</E>
                     license application) via the internet through the Commission's Home Page (
                    <E T="03">http://www.ferc.gov</E>
                    ), using the “eLibrary” link. Enter the docket number, excluding the last three digits in the docket number field to access the document (P-2716). For assistance, contact FERC at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). You may also register online at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
                </P>
                <P>
                    m. The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including 
                    <PRTPAGE P="3826"/>
                    landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595, or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    n. 
                    <E T="03">Procedural Schedule:</E>
                     The application will be processed according to the following preliminary schedule. Revisions to the schedule will be made as appropriate.
                </P>
                <P>Deficiency Letter (if necessary)—January 2025</P>
                <P>Additional Information Request (if necessary)—February 2025</P>
                <P>Notice of Acceptance—June 2025</P>
                <P>Issue Notice of Ready for Environmental Analysis—June 2025</P>
                <P>o. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.</P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00836 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission </SUBAGY>
                <SUBJECT>Combined Notice of Filings #1</SUBJECT>
                <P>Take notice that the Commission received the following electric rate filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER10-566-005; ER11-3917-005; ER24-2897-001; ER24-2898-001; ER10-2774-007.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Arizona Solar One LLC, Mordor ES2 LLC, Mordor ES1 LLC, Mojave Solar LLC, Coso Geothermal Power Holdings, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Triennial Market Power Analysis for the Southwest Region of Coso Geothermal Power Holdings, LLC, et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/31/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241231-5474.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 3/3/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER10-2042-055; ER23-944-011; ER10-1942-046; ER17-696-034; ER10-1941-023; ER19-1127-013; ER10-1938-049; ER13-1407-018; ER10-1934-048; ER10-1893-048; ER10-3051-053; ER10-2985-052; ER10-3049-053; ER10-1888-023; ER10-1885-023; ER10-1884-023; ER10-1883-023; ER10-1878-023; ER20-1699-011; ER10-1876-024; ER10-1875-023; ER10-1873-023; ER11-4369-033; ER16-2218-034; ER24-15-003; ER12-1987-021; ER10-1947-024; ER12-2645-016; ER10-1862-048; ER12-2261-022; ER10-1865-021.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     South Point Energy Center, LLC, Russell City Energy Company, LLC, Power Contract Financing, L.L.C. Pastoria Energy Facility L.L.C., Otay Mesa Energy Center, LLC, O.L.S. Energy-Agnews, Inc., Nova Power, LLC, North American Power Business, LLC, North American Power and Gas, LLC, Metcalf Energy Center, LLC, Los Medanos Energy Center LLC, Los Esteros Critical Energy Facility, LLC, Johanna Energy Center, LLC, Goose Haven Energy Center, LLC, Gilroy Energy Center, LLC, Geysers Power Company, LLC, Delta Energy Center, LLC, Creed Energy Center, LLC, Champion Energy Services, LLC, Champion Energy Marketing LLC, Champion Energy, LLC, CES Marketing X, LLC, CES Marketing IX, LLC, CCFC Sutter Energy, LLC, Calpine Power America—CA, LLC, Calpine King City Cogen, LLC, Calpine Gilroy Cogen, L.P., Calpine Energy Solutions, LLC, Calpine Construction Finance Co., L.P., Calpine Community Energy, LLC, Calpine Energy Services, L.P.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Triennial Market Power Analysis for the Southwest Power Pool Inc. Region of Calpine Energy Services, L.P. et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/31/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241231-5471.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 3/3/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER12-1470-017; ER16-1833-012; ER10-3026-015.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Termoelectrica U.S., LLC, Sempra Gas &amp; Power Marketing, LLC, Energia Sierra Juarez U.S., LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Triennial Market Power Analysis for the Southwest Region of Energia Sierra Juarez U.S., LLC et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/31/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241231-5476.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 3/3/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER20-59-007; ER15-632-017; ER15-634-017; ER13-291-008; ER19-2287-008; ER10-2756-013; ER14-2939-015; ER15-2728-017; ER10-2201-009; ER19-2294-008; ER16-711-014; ER14-2466-018; ER14-2465-018; ER19-2305-008.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Valencia Power, LLC, RE Columbia Two LLC, RE Camelot LLC, Pio Pico Energy Center, LLC, Mesquite Power, LLC, Marina Energy, LLC, Maricopa West Solar PV, LLC, Imperial Valley Solar Company (IVSC) 2, LLC, Griffith Energy LLC, Goal Line L.P., EnergyMark, LLC, Cottonwood Solar, LLC, CID Solar, LLC, AZ Solar 1, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Triennial Market Power Analysis for the Southwest Region of AZ Solar 1, LLC et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/31/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241231-5478.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 3/3/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-124-001.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Illinois Winds LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Notice of Non-Material Change in Status of Illinois Winds LLC.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/31/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241231-5473.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/21/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-875-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     California Independent System Operator Corporation.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: 2025-01-07 Cert. of Concurrence—CAISO, SCE, Coso, &amp; Mordor ES2-Coso Navy 2 to be effective 11/15/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/7/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250107-5148.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/28/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-876-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southwest Power Pool, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: 2829R6 Midwest Energy/Evergy Kansas Central Meter Ag Cancellation to be effective 1/1/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/8/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250108-5037.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/29/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-877-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Amendment to WMPA, SA No. 6980; Queue No. AF2-060 to be effective 3/10/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/8/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250108-5055.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/29/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-878-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southern California Edison Company.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: LGIA, Sienna Solar 2 (TOT1046-SA 329) to be effective 1/9/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/8/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250108-5071.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/29/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-879-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Midcontinent Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: 2025-01-08_MSCPA Addition to Zone 13 Schedule 7, 8, 9 to be effective 3/10/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/8/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250108-5078.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/29/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-880-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Amendment to WMPA, SA No. 6022; Queue No. AB1-176 (amend) to be effective 3/10/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/8/25.
                    <PRTPAGE P="3827"/>
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250108-5080.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/29/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-881-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Duke Energy Carolinas, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: DEC-PMPA Revised NITSA SA No. 355 to be effective 1/1/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/8/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250108-5106.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/29/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-882-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Original GIA Service Agreement No. 7457; Project Identifier No. AF2-014 to be effective 12/10/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/8/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250108-5163.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/29/25.
                </P>
                <P>Take notice that the Commission received the following electric reliability filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RD25-5-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     North American Electric Reliability Corporation.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Petition of the North American Electric Reliability Corporation for Approval of Proposed Reliability Standards BAL-007-1 and TOP-003-7.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     1/6/25.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20250106-5245.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 2/5/25.
                </P>
                <P>
                    The filings are accessible in the Commission's eLibrary system (
                    <E T="03">https://elibrary.ferc.gov/idmws/search/fercgensearch.asp</E>
                    ) by querying the docket number.
                </P>
                <P>Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.</P>
                <P>
                    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: 
                    <E T="03">http://www.ferc.gov/docs-filing/efiling/filing-req.pdf.</E>
                     For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00765 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OAR-2024-0591; FRL-9448-04-OAR]</DEPDOC>
                <SUBJECT>Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2023</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of document availability and request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Draft Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2023 report is available for public review. Sectoral chapters within the report and cross-cutting summary and trends chapters will be posted to the identified docket on a rolling basis between January 15 and February 13, 2025. The Environmental Protection Agency (EPA) requests recommendations for improving the overall quality of the inventory report to be finalized in April 2025, as well as subsequent inventory reports.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>To ensure your comments are considered for the final version of the document, please submit your comments by February 14, 2025. However, comments received after that date will still be welcomed and considered for the next edition of this report.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2024-0591, to the Federal eRulemaking Portal: 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. Do not submit electronically any information you consider to be Confidential Business Information (CBI). Comments can also be submitted in hardcopy to GHG Inventory at: Environmental Protection Agency, Climate Change Division (6207A), 1200 Pennsylvania Ave. NW, Washington, DC 20460, Fax: (202) 343-2342. You are welcome and encouraged to send an email with your comments to 
                        <E T="03">GHGInventory@epa.gov.</E>
                         EPA may publish any comment received to its public docket, submitted in hardcopy or sent via email. For additional submission methods, the full EPA public comment policy, information about CBI, and general guidance on making effective comments, please visit 
                        <E T="03">http://www2.epa.gov/dockets/commenting-epa-dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Mausami Desai, Environmental Protection Agency, Office of Air and Radiation, Office of Atmospheric Protection, Climate Change Division, (202) 343-9381, 
                        <E T="03">GHGInventory@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Annual U.S. emissions for the period of time from 1990 through 2023 are summarized and presented by sector, including source and sink categories. The inventory contains estimates of carbon dioxide (CO
                    <E T="52">2</E>
                    ), methane (CH
                    <E T="52">4</E>
                    ), nitrous oxide (N
                    <E T="52">2</E>
                    O), hydrofluorocarbons (HFC), perfluorocarbons (PFC), sulfur hexafluoride (SF
                    <E T="52">6</E>
                    ), and nitrogen trifluoride (NF
                    <E T="52">3</E>
                    ) emissions. The technical approach used in this report to estimate emissions and sinks for greenhouse gases is consistent with the methodologies recommended by the Intergovernmental Panel on Climate Change (IPCC) and reported in a format consistent with the Paris Agreement and United Nations Framework Convention on Climate Change (UNFCCC) reporting guidelines. The Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2023 is the latest in a series of annual, policy-neutral U.S. submissions to the UNFCCC. EPA requests recommendations for improving the overall quality of the inventory report to be finalized in April 2025, as well as subsequent annual inventory reports.
                </P>
                <SIG>
                    <NAME>Paul M. Gunning,</NAME>
                    <TITLE>Director, Office of Atmospheric Protection.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31058 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OW-2024-0454; FRL 12023-03-OW]</DEPDOC>
                <SUBJECT>Draft National Recommended Ambient Water Quality Criteria for the Protection of Human Health for Perfluorooctanoic Acid, Perfluorooctane Sulfonic Acid, and Perfluorobutane Sulfonic Acid; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <PRTPAGE P="3828"/>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; correction.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Environmental Protection Agency (EPA) is making a correction to a notice that appeared in the 
                        <E T="04">Federal Register</E>
                         on December 26, 2024. The notice of availability contained an incorrect value in Table 1, which is corrected below.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before February 24, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Brandi Echols, Health and Ecological Criteria Division, Office of Water (4304T), Environmental Protection Agency, 1301 Constitution Ave. NW, Washington, DC 20460; telephone number: (202) 566-2717; email address: 
                        <E T="03">Echols.Brandi@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    EPA published a notice of availability in the 
                    <E T="04">Federal Register</E>
                     at 89 FR 105041, December 26, 2024. This document corrects an error in Table 1, third column, second row, by correcting the PFOA Organism Only HHC value of 0.00036 ng/L to 0.0036 ng/L. This notice for correction corrects that error.
                </P>
                <HD SOURCE="HD1">Correction</HD>
                <P>
                    In the 
                    <E T="04">Federal Register</E>
                     of December 26, 2024, in FR Doc. 2024-30637, on page 105042, correct “Table 1” to read:
                </P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s75,25,25">
                    <TTITLE>Table 1—Draft Human Health Criteria (HHC) for PFOA, PFOS, and PFBS</TTITLE>
                    <BOXHD>
                        <CHED H="1">PFAS</CHED>
                        <CHED H="1">
                            Water + organism HHC 
                            <LI>(ng/L)</LI>
                        </CHED>
                        <CHED H="1">
                            Organism only HHC 
                            <LI>(ng/L)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">PFOA</ENT>
                        <ENT>0.0009</ENT>
                        <ENT>0.0036</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PFOS</ENT>
                        <ENT>0.06</ENT>
                        <ENT>0.07</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PFBS</ENT>
                        <ENT>400</ENT>
                        <ENT>500</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <NAME>Tanya Hodge Mottley,</NAME>
                    <TITLE>Acting Director, Office of Science and Technology, Office of Water.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00710 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPPT-2018-0436; FRL-8806-04-OCSPP]</DEPDOC>
                <SUBJECT>Diisononyl Phthalate (DINP); Risk Evaluation Under the Toxic Substances Control Act; Notice of Availability</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA or Agency) is announcing the availability of the final risk evaluation under the Toxic Substances Control Act (TSCA) for diisononyl phthalate (DINP) (1,2-Benzene- dicarboxylic acid, 1,2- diisononyl ester) (CASRN 28553-12-0). The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, and without consideration of costs or non-risk factors. EPA used the best available science to prepare this final risk evaluation and determined, based on the weight of scientific evidence, that DINP poses unreasonable risk to human health. Under TSCA, EPA must initiate risk management actions to address the unreasonable risk.</P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0436, is available online at 
                        <E T="03">https://www.regulations.gov.</E>
                         Additional information about dockets generally, along with instructions for visiting the docket in-person, is available at 
                        <E T="03">https://www.epa.gov/dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">For technical information:</E>
                         Todd Coleman, Existing Chemical Risk Management Division (7404M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-1208; email address: 
                        <E T="03">coleman.todd@epa.gov.</E>
                    </P>
                    <P>
                        <E T="03">For general information:</E>
                         The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: 
                        <E T="03">TSCA-Hotline@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Executive Summary</HD>
                <HD SOURCE="HD2">A. Does this action apply to me?</HD>
                <P>
                    This action is directed to the public in general and may be of particular interest to those involved in the manufacture (defined under TSCA section 3(9) to include import), processing, distribution, use, and disposal of DINP, related industry trade organizations, non-governmental organizations with an interest in human and environmental health, State and local governments, Tribal Nations, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA. As such, the Agency has not attempted to describe all the specific entities that this action might apply to. If you need help determining applicability, consult the technical contact listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD>
                <P>
                    The Agency conducted this risk evaluation under TSCA section 6, 15 U.S.C. 2605, which requires that EPA conduct risk evaluations on chemical substances and identifies the minimum components EPA must include in all chemical substance risk evaluations. Each risk evaluation must be conducted consistent with the best available science, be based on the weight of the scientific evidence, and consider reasonably available information. 15 U.S.C. 2625(h), (i), and (k). See also the implementing procedural regulations at 40 CFR part 702 and for more information about the TSCA risk evaluation process for existing chemicals, go to 
                    <E T="03">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.</E>
                </P>
                <HD SOURCE="HD2">C. What action is the Agency taking?</HD>
                <P>
                    EPA is announcing the availability of the final risk evaluation under TSCA for DINP. The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, and without consideration of costs or non-risk factors. EPA has used the best available science to prepare this final risk evaluation and, based on the weight of scientific evidence, determined that DINP poses unreasonable risk to human health. Upon a determination of unreasonable risk, EPA must initiate risk management action as required 
                    <PRTPAGE P="3829"/>
                    pursuant to TSCA section 6(a), 15 U.S.C 2605(a), to address the unreasonable risk.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <HD SOURCE="HD2">A. What is DINP?</HD>
                <P>DINP is a common chemical name for the category of chemical substances that includes the following substances: Di-isononyl phthalate (DINP) (1,2-Benzene- dicarboxylic acid, 1,2- diisononyl ester) (CASRN 28553-12-0 and 68515-48-0). Both CASRNs contain mainly C9 dialkyl phthalate esters. DINP is manufactured (including imported), processed, distributed, and disposed as part of industrial, commercial, and consumer conditions of use. DINP is used primarily as a plasticizer to make flexible polyvinyl chloride (PVC). It is also used to make building and construction materials; automotive articles; and other commercial and consumer products including adhesives and sealants, paints and coatings, and electrical and electronic products. DINP production volumes are available through the TSCA Chemical Data Reporting (CDR) rule under two associated CAS Registry Numbers (CASRNs): 1) The production volume for CASRN 28553-12-0 in 2015 was between 100 to 250 million pounds (lb.) and decreased to 50 to 100 million lb. in 2019 based on the latest 2020 CDR data; and 2) The production volume for CASRN 68515-48-0 in 2015 ranged between 100 to 250 million lb. and changed to between 100 million and 1 billion lb. in 2019 based on the latest 2020 CDR data.</P>
                <HD SOURCE="HD2">B. Summary of Activities for the Risk Evaluation of DINP</HD>
                <P>In May 2019, EPA received a request to conduct a risk evaluation for DINP from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, through the American Chemistry Council's High Phthalates Panel (ACC HPP). In December 2019, EPA notified ACC HPP that the Agency had granted the manufacturer requested risk evaluation (Ref. 1). In November 2020, EPA released the draft scope of the DINP risk evaluation (Ref. 2), and, after receiving public comments, issued the problem formulation in August 2021 (Ref. 3). In May 2024, the Environmental Hazard and Human Health Hazard technical support documents for DINP were released for public comment and peer review by the Science Advisory Committee on Chemicals (SACC) (Ref. 4). In September 2024, EPA released a full draft risk evaluation for public comment (Ref. 5). The draft documents and public comments are in docket ID number EPA-HQ-OPPT-2024-0436.</P>
                <P>The docket also includes a response to comments document (Ref. 6), a non-technical summary of the final risk evaluation (Ref. 7), and the final risk evaluation (Ref. 8).</P>
                <HD SOURCE="HD1">III. Unreasonable Risk Determination</HD>
                <P>EPA has determined that DINP presents an unreasonable risk of injury to human health under the COUs. EPA did not identify risk of injury to the environment that would contribute to the unreasonable risk determination for DINP. EPA has determined that the unreasonable risk to human health presented by DINP is due to the following: (1) Non-cancer effects (developmental toxicity) in female workers of reproductive age from acute inhalation exposures; (2) Non-cancer effects (liver effects) in female workers of reproductive age from chronic aggregate exposures; and (3) Non-cancer effects (liver effects) in workers from chronic and aggregate exposures. This unreasonable risk determination is based on the information in the risk evaluation, the appendices, and technical support documents of the risk evaluation in accordance with TSCA section 6(b). It is also based on TSCA's best available science (TSCA section 26(h)), weight of scientific evidence standards (TSCA section 26(i)), and relevant implementing regulations in 40 CFR part 702.</P>
                <P>The COUs that EPA identified as significantly contributing to the unreasonable risk from DINP include those that lead to exposures to average adult workers, including female workers of reproductive age, in scenarios in which unprotected workers used spray adhesives and sealants or paints and coatings that contain DINP, because doing so could create high concentrations of DINP in mist that an unprotected worker could inhale.</P>
                <P>Between release of the draft risk evaluation and finalization of the DINP risk evaluation, EPA updated the risk determination to find that four conditions of use (COUs) significantly contribute to the unreasonable risk of DINP. These updates were based on new information identified by EPA, information provided by public commenters, and recommendations of the Science Advisory Committee on Chemicals (SACC). These changes stem from consideration of (1) multiple factors impacting occupational exposure during spray application; and (2) determination that the liver effects associated with chronic exposure are relevant to adult works, adult consumers, and adult members of the general population, but not infants and children.</P>
                <HD SOURCE="HD1">IV. Next Step Is Risk Management</HD>
                <P>
                    Consistent with TSCA section 6(a), EPA will propose a risk management regulatory action to the extent necessary so that DINP no longer presents an unreasonable risk. EPA expects to focus its risk management action on the COUs that significantly contribute to the unreasonable risk. However, it should be noted that, under TSCA section 6(a), EPA is not limited to regulating the specific activities found to drive unreasonable risk and may select from among a suite of risk management requirements in TSCA section 6(a) related to manufacture (including import), processing, distribution in commerce, commercial use, and disposal as part of its regulatory options to address the unreasonable risk. As a general example, EPA may regulate upstream activities (
                    <E T="03">e.g.,</E>
                     processing, distribution in commerce) to address downstream activities (
                    <E T="03">e.g.,</E>
                     consumer uses) driving unreasonable risk, even if the upstream activities do not drive the unreasonable risk. Like the prioritization and risk evaluation processes, there is an opportunity for public comment on any proposed risk management actions.
                </P>
                <HD SOURCE="HD1">V. References</HD>
                <P>
                    The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <EXTRACT>
                    <P>
                        1. EPA. Di-isononyl Phthalate (DINP); Manufacturer Request for Risk Evaluation Under the Toxic Substances Control Act (TSCA). 
                        <E T="04">Federal Register</E>
                        . 84 FR 42912, August 19, 2019 (FRL-9998-25-OCSPP).
                    </P>
                    <P>
                        2. EPA. Di-isononyl Phthalate (DINP); Draft Scope of the Risk Evaluation To Be Conducted Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comments. 
                        <E T="04">Federal Register</E>
                        . 85 FR 76072, November 27, 2020 (FRL-10017-15-OSCPP).
                    </P>
                    <P>
                        3. EPA. Di-isononyl Phthalate (DINP); Final Scope of the Risk Evaluation To Be Conducted Under the Toxic Substances Control Act (TSCA); Notice of Availability. 
                        <E T="04">Federal Register</E>
                        . 86 FR 48693, August 31, 2021 (FRL- 8806-01-OSCPP).
                    </P>
                    <P>
                        4. EPA. Di-isodecyl Phthalate (DIDP) and Di-isononyl Phthalate (DINP); Science Advisory Committee on Chemicals (SACC) Peer Review of Draft Documents; Notice of 
                        <PRTPAGE P="3830"/>
                        SACC Meeting; Availability; and Request for Comment. 
                        <E T="04">Federal Register</E>
                        . 89 FR 43847, May 20, 2024 (FRL-11760-02-OCSPP).
                    </P>
                    <P>
                        5. EPA. Di-isononyl phthalate (DINP); Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability, Webinar and Request for Comment. 
                        <E T="04">Federal Register</E>
                        . 89 FR 71270, September 3, 2024 (FRL-8806-02-OCSPP).
                    </P>
                    <P>6. EPA. Comment Summary and Responses for Di-isodecyl Phthalate (DIDP) and Diisononyl Phthalate (DINP). December 2024.</P>
                    <P>7. EPA. Nontechnical Summary of the TSCA Risk Evaluation for Di-isononyl Phthalate (DINP). December 2024. (EPA Publication ID No. EPA-740-S-25-001).</P>
                    <P>8. EPA. TSCA Risk Evaluation for Di-isononyl Phthalate (DINP). December 2024. (EPA Publication ID No. EPA-740-R-25-001).</P>
                </EXTRACT>
                <P>
                    <E T="03">Authority:</E>
                     15 U.S.C. 2601 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 7, 2025.</DATED>
                    <NAME>Michal Freedhoff,</NAME>
                    <TITLE>Assistant Administrator, Office of Chemical Safety and Pollution Prevention.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00730 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OW-2024-0456; FRL-10774-01-OW]</DEPDOC>
                <SUBJECT>Announcement of Preliminary Regulatory Determinations for Contaminants on the Fifth Drinking Water Contaminant Candidate List</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Safe Drinking Water Act (SDWA), as amended in 1996, requires that the U.S. Environmental Protection Agency (EPA) determine whether to regulate at least five unregulated contaminants every five years. The decision to regulate or not to regulate a contaminant is known as a regulatory determination. In most cases, the contaminants chosen for regulatory determination are selected from the most recent Contaminant Candidate List (CCL), which the SDWA requires the EPA to publish every five years. This document presents the preliminary regulatory determinations and supporting rationale for contaminants listed on the EPA's fifth CCL (CCL 5). Since the fourth round of regulatory determinations was published in March 2021, the EPA has made determinations to regulate per- and polyfluoroalkyl substances (PFAS), including individual determinations for three PFAS: perfluorononanoic acid (PFNA), perfluorohexanesulfonic acid (PFHxS), hexafluoropropylene oxide dimer acid and its ammonium salt (HFPO-DA, also known as GenX or GenX chemicals); and mixtures including two or more of these three PFAS and perfluorobutanesulfonic acid (PFBS). In April 2024, the agency issued a final National Primary Drinking Water Regulation that includes these four PFAS as well as perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). In this 
                        <E T="04">Federal Register</E>
                         Notice (FRN), the EPA is making preliminary determinations not to regulate nine additional contaminants from CCL 5: 2-aminotoluene, cylindrospermopsin, ethoprop, microcystins, molybdenum, permethrin, profenofos, tebuconazole and tribufos. The EPA requests public comment on these preliminary determinations and other aspects of this FRN. The EPA also presents updates on additional contaminants from CCL 5, as well as on some of those that have been considered in previous rounds of regulatory determinations and for which the EPA has not yet made a regulatory determination. The agency is also presenting and requesting comment on the process and analyses used for this round of regulatory determinations (
                        <E T="03">i.e.,</E>
                         RD 5), the supporting information, and the rationale used to make these preliminary decisions.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, identified by Docket ID No. EPA-HQ-OW-2024-0456, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov/</E>
                         (our preferred method). Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Water Docket, Environmental Protection Agency, Mail Code: [28221T], 1200 Pennsylvania Ave. NW, Washington, DC 20460.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         EPA Docket Center, [EPA/DC] EPA West, Room 3334, 1301 Constitution Ave. NW, Washington DC. Such deliveries are only accepted during the Docket's normal hours of operation and special arrangements should be made for deliveries of boxed information.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to 
                        <E T="03">https://www.regulations.gov/,</E>
                         including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the “Written Comments” heading of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section of this document.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        George Gardenier, Standards and Risk Management Division, Office of Ground Water and Drinking Water, MC: 4607M, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-3333; email address: 
                        <E T="03">gardenier.george@epa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. General Information</HD>
                <HD SOURCE="HD2">A. Written Comments</HD>
                <P>
                    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2024-0456, at 
                    <E T="03">https://www.regulations.gov</E>
                     (our preferred method), or the other methods identified in the 
                    <E T="02">ADDRESSES</E>
                     section. Once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
                    <E T="03">i.e.,</E>
                     on the web, cloud or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                    <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets</E>
                    .
                </P>
                <P>When submitting comments, remember to:</P>
                <P>
                    • Identify the rulemaking by docket number and other identifying information (subject heading, 
                    <E T="04">Federal Register</E>
                     date and page number).
                </P>
                <P>• Explain why you agree or disagree and suggest alternatives.</P>
                <P>• Describe any assumptions and provide any technical information and data that you used.</P>
                <P>• Provide specific examples to illustrate your concerns and suggest alternatives.</P>
                <P>• Explain your views as clearly as possible.</P>
                <PRTPAGE P="3831"/>
                <P>• Make sure to submit your comments by the comment period deadline identified.</P>
                <HD SOURCE="HD2">B. Does this action apply to me?</HD>
                <P>Neither these preliminary regulatory determinations nor the final regulatory determinations, when published, impose any requirements on anyone. Instead, this action notifies interested parties of the EPA's preliminary regulatory determinations for nine unregulated contaminants for comment.</P>
                <HD SOURCE="HD1">Abbreviations Used in This Document</HD>
                <GPOTABLE COLS="02" OPTS="L2,nj,i1" CDEF="xs60,r100">
                    <BOXHD>
                        <CHED H="1">Abbreviation</CHED>
                        <CHED H="1">Meaning</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">AChE</ENT>
                        <ENT>Acetylcholinesterase.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ADAF</ENT>
                        <ENT>Age Dependent Adjustment Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AM</ENT>
                        <ENT>Assessment Monitoring.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ATSDR</ENT>
                        <ENT>Agency for Toxic Substances and Disease Registry.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ATSDR MRL</ENT>
                        <ENT>ATSDR Minimal Risk Level.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AWIA</ENT>
                        <ENT>America's Water Infrastructure Act.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BAT</ENT>
                        <ENT>Best Available Technology.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BMD</ENT>
                        <ENT>Benchmark Dose.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            BMDL
                            <E T="0732">10</E>
                        </ENT>
                        <ENT>Lower 95% Confidence Limit on the Benchmark Dose Level Associated with a 10% Response.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            BMDL
                            <E T="0732">1SD</E>
                        </ENT>
                        <ENT>Lower 95% Confidence Limit on the Benchmark Dose Level Associated with a Difference of One Standard Deviation from Controls.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BW</ENT>
                        <ENT>Body Weight.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CBI</ENT>
                        <ENT>Confidential Business Information.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CCL</ENT>
                        <ENT>Contaminant Candidate List.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CCL 1</ENT>
                        <ENT>First Contaminant Candidate List.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CCL 2</ENT>
                        <ENT>Second Contaminant Candidate List.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CCL 3</ENT>
                        <ENT>Third Contaminant Candidate List.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CCL 4</ENT>
                        <ENT>Fourth Contaminant Candidate List.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CCL 5</ENT>
                        <ENT>Fifth Contaminant Candidate List.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CCR</ENT>
                        <ENT>Consumer Confidence Report.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CDR</ENT>
                        <ENT>Chemical Data Reporting.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ChE</ENT>
                        <ENT>Cholinesterase.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CRL</ENT>
                        <ENT>Cancer Risk Level.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CSF</ENT>
                        <ENT>Cancer Slope Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CWA</ENT>
                        <ENT>Clean Water Act.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CWS</ENT>
                        <ENT>Community Water System.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CWSS</ENT>
                        <ENT>Community Water System Survey.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DBP</ENT>
                        <ENT>Disinfection Byproduct.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DDE</ENT>
                        <ENT>1,1-Dichloro-2,2-bis(p-chlorophenyl)ethylene.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DWI</ENT>
                        <ENT>Drinking Water Intake.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">DWI-BW</ENT>
                        <ENT>Drinking Water Intake Adjusted for Body Weight.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EF</ENT>
                        <ENT>Exposure Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EPA</ENT>
                        <ENT>U. S. Environmental Protection Agency.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EPTC</ENT>
                        <ENT>S-Ethyl dipropylthiocarbamate.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FIFRA</ENT>
                        <ENT>Federal Insecticide, Fungicide and Rodenticide Act.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FQPA</ENT>
                        <ENT>Food Quality Protection Act.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FR</ENT>
                        <ENT>
                            <E T="02">Federal Register</E>
                            .
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FRN</ENT>
                        <ENT>
                            <E T="02">Federal Register</E>
                             Notice.
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Gen X</ENT>
                        <ENT>
                            Gen X Chemicals (
                            <E T="03">i.e.,</E>
                             HFPO dimer acid and its ammonium salt), also known as (2,3,3,3-tetrafluoro-2-(1,1,2,2,3,3,3-heptafluoropropoxy)propanoic acid (CASRN 13252-13-6) or hexafluoropropylene oxide (HFPO) dimer acid (HFPO-DA) and 2,3,3,3-tetrafluoro-2-(1,1,2,2,3,3,3-heptafluoropropoxy)propanoate (CASRN 62037-80-3) or HFPO-DA dimer acid and its ammonium salt).
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GWUDI</ENT>
                        <ENT>Groundwater Under the Direct Influence of Surface Water.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HA</ENT>
                        <ENT>Health Advisory.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HAA5</ENT>
                        <ENT>Sum of Five Haloacetic Acids.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HAB</ENT>
                        <ENT>Harmful Algal Bloom.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HCl</ENT>
                        <ENT>Hydrochloride.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HED</ENT>
                        <ENT>Health Effects Division.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HESD</ENT>
                        <ENT>Health Effects Support Document.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HFPO-DA</ENT>
                        <ENT>Hexafluoropropylene Oxide Dimer Acid.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HHRA</ENT>
                        <ENT>Human Health Risk Assessment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HRL</ENT>
                        <ENT>Health Reference Level.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HRRCA</ENT>
                        <ENT>Health Risk Reduction Cost Analysis.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">IUR</ENT>
                        <ENT>Inventory Update Reporting.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            K
                            <E T="0732">oc</E>
                        </ENT>
                        <ENT>Organic Carbon Partitioning Coefficient.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            K
                            <E T="0732">ow</E>
                        </ENT>
                        <ENT>Octanol-Water Partitioning Coefficient.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LOAEL</ENT>
                        <ENT>Lowest Observed Adverse Effect Level.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MAC</ENT>
                        <ENT>Maximum Acceptable Concentration.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MCL</ENT>
                        <ENT>Maximum Contaminant Level.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MCLG</ENT>
                        <ENT>Maximum Contaminant Level Goal.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MOA</ENT>
                        <ENT>Mode of Action.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MRL</ENT>
                        <ENT>Minimum Reporting Level.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NAS</ENT>
                        <ENT>National Academy of Sciences.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NAWQA</ENT>
                        <ENT>National Water-Quality Assessment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDBA</ENT>
                        <ENT>N-Nitrosodi-n-butylamine.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDEA</ENT>
                        <ENT>N-Nitrosodiethylamine.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDMA</ENT>
                        <ENT>N-Nitrosodimethylamine.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="3832"/>
                        <ENT I="01">NDPA</ENT>
                        <ENT>N-Nitroso-di-n-propylamine.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NPYR</ENT>
                        <ENT>N-Nitrosopyrrolidine.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDWAC</ENT>
                        <ENT>National Drinking Water Advisory Council.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NIRS</ENT>
                        <ENT>National Inorganics and Radionuclides Survey.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NOAEL</ENT>
                        <ENT>No Observed Adverse Effect Level.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NPDWR</ENT>
                        <ENT>National Primary Drinking Water Regulation.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NRC</ENT>
                        <ENT>National Research Council.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NRDC</ENT>
                        <ENT>Natural Resources Defense Council.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NWIS</ENT>
                        <ENT>National Water Information System.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">OPP</ENT>
                        <ENT>Office of Pesticides Program.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">OW</ENT>
                        <ENT>Office of Water.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PAD</ENT>
                        <ENT>Population-Adjusted Dose.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PCCL</ENT>
                        <ENT>Preliminary Contaminant Candidate List.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PDP</ENT>
                        <ENT>Pesticide Data Program.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PFAS</ENT>
                        <ENT>Per- and Polyfluoroalkyl Substances.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PFBA</ENT>
                        <ENT>Perfluorobutanoic acid.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PFBS</ENT>
                        <ENT>Perfluorobutanesulfonic acid.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PFHxS</ENT>
                        <ENT>Perfluorohexanesulfonic acid.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PFNA</ENT>
                        <ENT>Perfluorononanoic acid.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PFOA</ENT>
                        <ENT>Perfluorooctanoic acid.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PFOS</ENT>
                        <ENT>Perfluorooctanesulfonic acid.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PMP</ENT>
                        <ENT>Pilot Monitoring Program.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PND</ENT>
                        <ENT>Postnatal Day.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">POD</ENT>
                        <ENT>Point of Departure.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PPRTV</ENT>
                        <ENT>Provisional Peer-Reviewed Toxicity Value.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PST</ENT>
                        <ENT>Pre-Screen Testing.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PWS</ENT>
                        <ENT>Public Water System.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RBC</ENT>
                        <ENT>Red Blood Cell.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RD 1</ENT>
                        <ENT>Regulatory Determination 1.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RD 2</ENT>
                        <ENT>Regulatory Determination 2.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RD 3</ENT>
                        <ENT>Regulatory Determination 3.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RD 4</ENT>
                        <ENT>Regulatory Determination 4.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RD 5</ENT>
                        <ENT>Regulatory Determination 5.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RDX</ENT>
                        <ENT>Royal Demolition eXplosive.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RED</ENT>
                        <ENT>Reregistration Eligibility Decision.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RfD</ENT>
                        <ENT>Reference Dose.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RSC</ENT>
                        <ENT>Relative Source Contribution.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RUP</ENT>
                        <ENT>Restricted Use Pesticide.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SDWA</ENT>
                        <ENT>Safe Drinking Water Act.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SS</ENT>
                        <ENT>Screening Survey.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SSCT</ENT>
                        <ENT>Small System Compliance Technology.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">STORET</ENT>
                        <ENT>Storage and Retrieval Data System.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TCP</ENT>
                        <ENT>Trichloropropane.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TDI</ENT>
                        <ENT>Tolerable Daily Intake.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TRI</ENT>
                        <ENT>Toxics Release Inventory.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TSCA</ENT>
                        <ENT>Toxic Substances Control Act.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TT</ENT>
                        <ENT>Treatment Technique.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TTHM</ENT>
                        <ENT>Total Trihalomethanes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UA</ENT>
                        <ENT>Unit Adjustment Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UCM</ENT>
                        <ENT>Unregulated Contaminant Monitoring.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UCMR</ENT>
                        <ENT>Unregulated Contaminant Monitoring Rule.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UCMR 1</ENT>
                        <ENT>First Unregulated Contaminant Monitoring Rule.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UCMR 2</ENT>
                        <ENT>Second Unregulated Contaminant Monitoring Rule.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UCMR 3</ENT>
                        <ENT>Third Unregulated Contaminant Monitoring Rule.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UCMR 4</ENT>
                        <ENT>Fourth Unregulated Contaminant Monitoring Rule.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UCMR 5</ENT>
                        <ENT>Fifth Unregulated Contaminant Monitoring Rule.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UF</ENT>
                        <ENT>Uncertainty Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            UF
                            <E T="0732">A</E>
                        </ENT>
                        <ENT>Interspecies Uncertainty Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            UF
                            <E T="0732">D</E>
                        </ENT>
                        <ENT>Database Uncertainty Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            UF
                            <E T="0732">H</E>
                        </ENT>
                        <ENT>Intraspecies Uncertainty Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            UF
                            <E T="0732">L</E>
                        </ENT>
                        <ENT>LOAEL-to-NOAEL Extrapolation Uncertainty Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            UF
                            <E T="0732">S</E>
                        </ENT>
                        <ENT>Subchronic-to Chronic Exposure Duration Uncertainty Factor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">USDA</ENT>
                        <ENT>United States Department of Agriculture.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">USEPA</ENT>
                        <ENT>United States Environmental Protection Agency.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">USGS</ENT>
                        <ENT>United States Geological Survey.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WQP</ENT>
                        <ENT>Water Quality Portal.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">WQX</ENT>
                        <ENT>Water Quality Exchange.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. General Information</FP>
                    <FP SOURCE="FP1-2">A. Written Comments</FP>
                    <FP SOURCE="FP1-2">B. Does this action apply to me?</FP>
                    <FP SOURCE="FP-2">II. Purpose and Background</FP>
                    <FP SOURCE="FP1-2">A. What is the purpose of this action?</FP>
                    <FP SOURCE="FP1-2">B. Background on the CCL and Regulatory Determinations</FP>
                    <FP SOURCE="FP1-2">
                        1. Statutory Requirements for CCL and Regulatory Determinations
                        <PRTPAGE P="3833"/>
                    </FP>
                    <FP SOURCE="FP1-2">2. The First Contaminant Candidate List (CCL 1) and Regulatory Determination (RD 1)</FP>
                    <FP SOURCE="FP1-2">3. The Second Contaminant Candidate List (CCL 2) and Regulatory Determination (RD 2)</FP>
                    <FP SOURCE="FP1-2">4. The Third Contaminant Candidate List (CCL 3) and Regulatory Determination (RD 3)</FP>
                    <FP SOURCE="FP1-2">5. The Fourth Contaminant Candidate List (CCL 4) and Regulatory Determination (RD 4)</FP>
                    <FP SOURCE="FP1-2">6. The Fifth Contaminant Candidate List (CCL 5)</FP>
                    <FP SOURCE="FP-2">III. Approach and Overall Outcomes for RD 5</FP>
                    <FP SOURCE="FP1-2">A. Summary of the Approach and Overall Outcomes for RD 5</FP>
                    <FP SOURCE="FP1-2">1. Phase 1 (Data Availability Phase)</FP>
                    <FP SOURCE="FP1-2">2. Phase 2 (Data Evaluation Phase)</FP>
                    <FP SOURCE="FP1-2">3. Phase 3 (Regulatory Determination Assessment Phase)</FP>
                    <FP SOURCE="FP1-2">B. Supporting Documentation for the EPA's Preliminary Determination</FP>
                    <FP SOURCE="FP1-2">C. Analyses Used To Support the Preliminary Regulatory Determinations</FP>
                    <FP SOURCE="FP1-2">1. Evaluation of Contaminant Occurrence and Exposure</FP>
                    <FP SOURCE="FP-2">IV. Contaminant-Specific Discussions for the RD 5 Preliminary Determination</FP>
                    <FP SOURCE="FP1-2">A. Summary of the Preliminary Regulatory Determinations</FP>
                    <FP SOURCE="FP1-2">B. Contaminant Profiles</FP>
                    <FP SOURCE="FP1-2">1. 2-Aminotoluene</FP>
                    <FP SOURCE="FP1-2">2. Cylindrospermopsin</FP>
                    <FP SOURCE="FP1-2">3. Ethoprop</FP>
                    <FP SOURCE="FP1-2">4. Microcystins</FP>
                    <FP SOURCE="FP1-2">5. Molybdenum</FP>
                    <FP SOURCE="FP1-2">6. Permethrin</FP>
                    <FP SOURCE="FP1-2">7. Profenofos</FP>
                    <FP SOURCE="FP1-2">8. Tebuconazole</FP>
                    <FP SOURCE="FP1-2">9. Tribufos</FP>
                    <FP SOURCE="FP-2">V. Status of the Agency's Evaluation of 1,2,3-Trichloropropane, 1,4-Dioxane, Manganese, Quinoline and Strontium</FP>
                    <FP SOURCE="FP1-2">A. Ongoing Evaluation of Additional Phase 3 Contaminants</FP>
                    <FP SOURCE="FP1-2">B. Phase 3 Contaminant Updates</FP>
                    <FP SOURCE="FP1-2">1. 1,2,3-Trichloropropane</FP>
                    <FP SOURCE="FP1-2">2. 1,4-Dioxane</FP>
                    <FP SOURCE="FP1-2">3. Manganese</FP>
                    <FP SOURCE="FP1-2">4. Quinoline</FP>
                    <FP SOURCE="FP1-2">5. Strontium</FP>
                    <FP SOURCE="FP-2">VI. The EPA's Request for Comments and Next Steps</FP>
                    <FP SOURCE="FP-2">VII. References</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Purpose and Background</HD>
                <HD SOURCE="HD2">A. What is the purpose of this action?</HD>
                <P>
                    The purpose of this action is to request comment on the EPA's preliminary determinations not to regulate the following nine contaminants under the Safe Drinking Water Act: 2-aminotoluene, cylindrospermopsin, ethoprop, microcystins, molybdenum, permethrin, profenofos, tebuconazole and tribufos. As required by the SDWA, the EPA is seeking comment on these preliminary determinations. The agency is also presenting and requesting comment on the process and analyses used for this round of regulatory determinations (
                    <E T="03">i.e.,</E>
                     RD 5), the supporting information, and the rationale used to make these preliminary decisions. It should be noted that the analyses associated with a regulatory determination are distinct from the more detailed analyses required to develop a National Primary Drinking Water Regulation (NPDWR).
                </P>
                <HD SOURCE="HD2">B. Background on the CCL and Regulatory Determinations</HD>
                <HD SOURCE="HD3">1. Statutory Requirements for CCL and Regulatory Determinations</HD>
                <P>Section 1412(b)(1)(B)(i) of the SDWA requires the EPA to publish the CCL every five years after public notice and an opportunity to comment. The CCL is a list of contaminants which are not subject to any proposed or promulgated NPDWRs but are known or anticipated to occur in public water systems (PWSs) and may require regulation under the SDWA. SDWA section 1412(b)(1)(B)(ii) directs the EPA to determine, whether to regulate at least five contaminants from the CCL every five years. Under section 1412(b)(1)(A) of SDWA, the EPA may regulate a contaminant in drinking water if the Administrator determines that:</P>
                <P>(i) the contaminant may have an adverse effect on the health of persons;</P>
                <P>(ii) the contaminant is known to occur or there is substantial likelihood that the contaminant will occur in PWSs with a frequency and at levels of public health concern; and</P>
                <P>(iii) in the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by PWSs.</P>
                <P>SDWA 1412(b)(1)(C) requires that the Administrator prioritize selection of contaminants that present the greatest public health concern. The Administrator, in making such selections, shall take into consideration, among other factors of public health concern, the effect of such contaminants upon subgroups that comprise a meaningful portion of the general population (such as infants, children, pregnant women, the elderly, individuals with a history of serious illness or other subpopulations) that are identifiable as being at greater risk of adverse health effects due to exposure to contaminants in drinking water than the general population.</P>
                <P>
                    If the EPA determines that these three statutory criteria are met and makes a final determination to regulate a contaminant (
                    <E T="03">i.e.,</E>
                     a positive determination), the agency must publish a proposed Maximum Contaminant Level Goal (MCLG) 
                    <SU>1</SU>
                    <FTREF/>
                     and NPDWR 
                    <SU>2</SU>
                    <FTREF/>
                     within 24 months. After a proposal, the agency must publish a final MCLG and promulgate a final NPDWR (SDWA section 1412(b)(1)(E)) within 18 months.
                    <SU>3</SU>
                    <FTREF/>
                     The EPA may also develop regulatory determinations and associated rulemakings outside of the SDWA mandated process.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         An MCLG is the maximum level of a contaminant in drinking water at which no known or anticipated adverse effect on the health of persons would occur, and which allows an adequate margin of safety. MCLGs are non-enforceable health goals. (40 CFR 141.2; 42 U.S.C. 300g-1)
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         An NPDWR is a legally enforceable standard that applies to public water systems. An NPDWR sets a legal limit (called a maximum contaminant level or MCL) or specifies a certain treatment technique (TT) for public water systems for a specific contaminant or group of contaminants. The MCL is the highest level of a contaminant that is allowed in drinking water and is set as close to the MCLG as feasible using the best available treatment technology and taking cost into consideration.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The statute authorizes a nine-month extension of this promulgation date.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. The First Contaminant Candidate List (CCL 1) and Regulatory Determination (RD 1)</HD>
                <P>
                    The EPA published the final CCL 1, which contained 60 chemical and microbiological contaminants, in the 
                    <E T="04">Federal Register</E>
                     (FR) on March 2, 1998 (63 FR 10273; USEPA, 1998). The agency published the final regulatory determinations for nine of the 60 CCL 1 contaminants in the FR on July 18, 2003 (68 FR 42898; USEPA, 2003). The agency determined not to regulate the following nine contaminants with NPDWRs: 
                    <E T="03">Acanthamoeba,</E>
                     aldrin, dieldrin, hexachlorobutadiene, manganese, metribuzin, naphthalene, sodium and sulfate. The agency posted information about 
                    <E T="03">Acanthamoeba</E>
                     
                    <SU>4</SU>
                    <FTREF/>
                     on the EPA's website and issued health advisories (HAs) 
                    <SU>5</SU>
                    <FTREF/>
                     for manganese, sodium and sulfate.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Consumer information about 
                        <E T="03">Acanthamoeba</E>
                         for people who wear contact lenses can be found at 
                        <E T="03">http://water.epa.gov/action/advisories/acanthamoeba/index.cfm</E>
                        .
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Health advisories provide information on contaminants that can cause human health effects and are known or anticipated to occur in drinking water. The EPA's health advisories are non-enforceable and provide technical guidance to states agencies and other public health officials on health effects, analytical methodologies and treatment technologies associated with drinking water contamination. Health advisories can be found at 
                        <E T="03">http://water.epa.gov/drink/standards/hascience.cfm</E>
                        . See also SDWA Section 1412(b)(1)(F).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. The Second Contaminant Candidate List (CCL 2) and Regulatory Determination (RD 2)</HD>
                <P>
                    The agency published the final CCL 2 in the FR on February 24, 2005 (70 FR 9071; USEPA, 2005a) and carried 
                    <PRTPAGE P="3834"/>
                    forward the 51 remaining chemical and microbial contaminants listed on CCL 1. The agency published the final regulatory determinations for 11 of the 51 CCL 2 contaminants in the FR on July 30, 2008 (73 FR 44251; USEPA, 2008a). The agency determined not to regulate the following 11 contaminants: boron, the dacthal mono- and di-acid degradates, 1,1-dichloro-2,2-bis(
                    <E T="03">p</E>
                    -chlorophenyl)ethylene (DDE), 1,3-dichloropropene (Telone), 2,4-dinitrotoluene, 2,6-dinitrotoluene, 
                    <E T="03">S</E>
                    -ethyl dipropylthiocarbamate (EPTC), fonofos, terbacil and 1,1,2,2-tetrachloroethane. The agency issued new or updated HAs for boron, dacthal degradates, 2,4-dinitrotoluene, 2,6-dinitrotoluene and 1,1,2,2-tetrachloroethane.
                </P>
                <HD SOURCE="HD3">4. The Third Contaminant Candidate List (CCL 3) and Regulatory Determination (RD 3)</HD>
                <P>The agency published the final CCL 3, which listed 116 contaminants, in the FR on October 8, 2009 (74 FR 51850; USEPA, 2009a). In developing CCL 3, the EPA improved and built upon the process that was used for CCL 1 and CCL 2. The CCL 3 process was based on substantial expert input and recommendations from the National Academy of Sciences' (NAS) National Research Council (NRC) and the National Drinking Water Advisory Council (NDWAC) as well as input from the public. Based on these consultations and input, the EPA developed a multi-step process to select candidates for a final CCL, which included the following key steps:</P>
                <P>(a) Building a broad universe;</P>
                <P>(b) Screening the universe to select a Preliminary CCL (PCCL); and</P>
                <P>(c) Classification of PCCL chemicals to select a CCL.</P>
                <P>The agency published its preliminary regulatory determinations for contaminants listed on the CCL 3 in the FR on October 20, 2014 (79 FR 62715; USEPA, 2014). In that notice, the EPA made preliminary determinations for five of the 116 contaminants listed on the CCL 3, including a preliminary positive determination for strontium and preliminary negative determinations for dimethoate, 1,3-dinitrobenzene, terbufos and terbufos sulfone. On January 4, 2016 (81 FR 13; USEPA, 2016a), the EPA finalized the negative determinations for dimethoate, 1,3-dinitrobenzene, terbufos and terbufos sulfone. The EPA announced a delay in issuing a final regulatory determination on strontium in order to consider additional data. Additional discussion on strontium is provided in section V of this document.</P>
                <P>The EPA also published an off-cycle final determination to regulate one CCL 3 contaminant, perchlorate, on February 11, 2011 (76 FR 7762; USEPA, 2011) during the RD 3 cycle (bringing the total number of final determinations to five).</P>
                <HD SOURCE="HD3">5. The Fourth Contaminant Candidate List (CCL 4) and Regulatory Determination (RD 4)</HD>
                <P>The final CCL 4 was published on November 17, 2016 (81 FR 81099; USEPA, 2016b). The final CCL 4 consisted of 97 chemicals or chemical groups and 12 microbiological contaminants. Most CCL 4 contaminants were carried over from CCL 3. The EPA added two contaminants (manganese and nonylphenol) to the CCL 4 list based on nominations. The EPA removed from the list those CCL 3 contaminants that had been subject to recent preliminary or final regulatory determinations (perchlorate, dimethoate, 1,3-dinitrobenzene, terbufos, terbufos sulfone and strontium) and three pesticides with cancelled registrations (disulfoton, fenamiphos and molinate).</P>
                <P>
                    The EPA published its preliminary determinations for the fourth CCL in the 
                    <E T="04">Federal Register</E>
                     on March 10, 2020 (85 FR 14098; USEPA, 2020a). In that notice, the EPA made determinations for eight of the 109 contaminants on the CCL 4. The EPA determined to regulate two PFAS, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), and determined not to regulate six additional contaminants: 1,1-dichloroethane, acetochlor, methyl bromide, metolachlor, nitrobenzene and Royal Demolition eXplosive (RDX). The EPA published its final regulatory determinations for these contaminants on March 3, 2021 (86 FR 12272; USEPA, 2021a).
                </P>
                <HD SOURCE="HD3">6. The Fifth Contaminant Candidate List (CCL 5)</HD>
                <P>The final CCL 5 was published on November 14, 2022 (87 FR 68060; USEPA, 2022a). The final CCL 5 consists of 66 chemicals, 3 chemical groups (cyanotoxins, disinfection byproducts (DBPs) and PFAS) and 12 microbial contaminants. The CCL 5 was developed based on the existing framework used for CCL 3 and CCL 4. For CCL 5, the EPA updated the CCL process to consider a larger number of contaminants, enhance transparency in the data evaluation, and improve efficiency of information transfer to other SDWA processes, such as regulatory determinations.</P>
                <HD SOURCE="HD1">III. Approach and Overall Outcomes for RD 5</HD>
                <P>This section describes (a) the approach the EPA used to identify and evaluate contaminants for RD 5 along with the overall outcome of applying this approach, (b) the supporting RD 5 documentation and (c) the technical analyses and sources of health and occurrence information.</P>
                <HD SOURCE="HD2">A. Summary of the Approach and Overall Outcomes for RD 5</HD>
                <P>
                    The approach taken under RD 5 is similar to that used in previous rounds of regulatory determination and formalized in a written protocol under RD 3. The Regulatory Determination 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b), like the RD 3 and RD 4 Protocols, describes a three-phase process. The three phases are: (1) the Data Availability Phase, (2) the Data Evaluation Phase and (3) the Regulatory Determination Assessment Phase. Figure 1 provides an overview of the process the EPA uses to identify which CCL 5 contaminants are candidates for regulatory determinations and the SDWA statutory criteria considered in making the regulatory determinations. For more detailed information on the three phases of the RD 5 process, refer to the RD 5 Protocol in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b). 
                </P>
                <BILCOD>BILLING CODE 6560-50-P</BILCOD>
                <GPH SPAN="3" DEEP="364">
                    <PRTPAGE P="3835"/>
                    <GID>EN15JA25.049</GID>
                </GPH>
                <HD SOURCE="HD3">1. Phase 1 (Data Availability Phase)</HD>
                <P>In Phase 1, the Data Availability Phase, the agency identifies contaminants that have sufficient health and occurrence data to proceed to Phase 2 and be included on a “short list” for further evaluation. SDWA 1412(b)(1)(B)(ii)(II) requires that the EPA consider the best available public health information in making the regulatory determination.</P>
                <P>
                    To identify contaminant health effects data that are sufficient to make a regulatory determination regarding potential adverse health effect(s), the agency considers whether an EPA health assessment or an externally peer-reviewed health assessment from another agency is available, from which a health reference level (HRL) 
                    <SU>6</SU>
                    <FTREF/>
                     sufficient to inform a regulatory determination can be derived. See section III.C.1 of this document for information about how HRLs are derived. To identify “qualifying” health assessments, the EPA conducted a systematic search in January 2023 for the EPA and other authoritative sources of human health effects assessments for each drinking water chemical contaminant on CCL 5. Health assessments are considered qualifying if they (1) derived one or more toxicity values (
                    <E T="03">e.g.,</E>
                     oral reference value or oral cancer slope factor [CSF]) based on the best available science; (2) underwent a documented peer-review process; (3) are publicly available and final; (4) were developed using human health risk assessments methods that are comparable to current EPA human health risk assessment principles and approaches (
                    <E T="03">e.g.,</E>
                     a weight of evidence approach); and (5) are produced from an authoritative source that routinely develops health assessments (
                    <E T="03">e.g.,</E>
                     Agency for Toxic Substances and Disease Registry [ATSDR]). If a qualifying health assessment is not available for a contaminant, the contaminant will not proceed to Phase 2. See section B.5.1.1 in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for a list of sources of Health Effects Assessments (USEPA, 2024b).
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         A health reference level (HRL) is a health-based concentration against which the agency evaluates occurrence data when making decisions about preliminary regulatory determinations. An HRL is not a final determination on establishing a protective level of a contaminant in drinking water for a particular population; it is derived prior to development of a complete health and exposure assessment.
                    </P>
                </FTNT>
                <P>
                    After identifying the qualifying peer-reviewed health assessments for a chemical, the EPA followed a structured and transparent process to select the assessment(s) for both cancer and noncancer HRL derivation. The process included expert evaluations applying specific criteria. These criteria are designed to identify the assessment relevant to drinking water that was developed using comparable approaches to the EPA human health risk assessment methods and based on the best available science. The EPA used the results from the expert evaluations to select the health assessment used to derive the HRL for the chemical. In addition, the EPA applied expert judgement when evaluating a set of assessments for a given contaminant because certain health assessments and chemicals can present unique challenges. See section B.5.1.2 in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for 
                    <PRTPAGE P="3836"/>
                    the decision-logic that was applied for all RD 5 chemicals (USEPA, 2024b).
                </P>
                <P>
                    To identify contaminant occurrence data that are sufficient to evaluate with respect to the frequency and level of occurrence in PWSs, the agency considers nationally representative finished drinking water data (samples collected after the water undergoes treatment) when available for making regulatory determinations. The following sources, administered or overseen by the EPA, include finished drinking water occurrence data that are considered nationally representative: (a) the fourth Unregulated Contaminant Monitoring Rule (UCMR 4); (b) the third Unregulated Contaminant Monitoring Rule (UCMR 3); (c) the second Unregulated Contaminant Monitoring Rule (UCMR 2); (d) the first Unregulated Contaminant Monitoring Rule (UCMR 1); (e) the Unregulated Contaminant Monitoring (UCM) program; and (f) the National Inorganics and Radionuclides Survey (NIRS).
                    <SU>7</SU>
                    <FTREF/>
                     If a contaminant has occurrence data from a nationally representative source, it passes the Occurrence Data Availability Assessment.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Specific types of UCMR monitoring (
                        <E T="03">e.g.,</E>
                         assessment monitoring and sometimes the screening survey) are considered nationally representative. These are described further in Section III.C.2.a.1 of this notice.
                    </P>
                </FTNT>
                <P>
                    If nationally representative drinking water data are not available, the EPA identifies and evaluates other sources of finished water data, which may include other national assessments, regional data, state data and more localized finished water assessments. For more information on sources of occurrence that may be evaluated during the regulatory determination process, please refer to Chapter 2 of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b).
                </P>
                <P>
                    In Phase 1, the agency assesses whether the non-nationally representative finished water occurrence data show at least one detection at levels &gt;
                    <FR>1/2</FR>
                     the HRL 
                    <SU>8</SU>
                    <FTREF/>
                     for the critical endpoint. If a contaminant without nationally representative finished water occurrence data has non-nationally representative finished water occurrence data showing at least one detection &gt; 
                    <FR>1/2</FR>
                     HRL, the contaminant passes the Occurrence Data Availability Assessment. While there may be robust non-national data available for certain contaminants which can demonstrate substantial likelihood of occurrence at a frequency and level of public health concern (
                    <E T="03">e.g.,</E>
                     see PFAS 
                    <E T="04">Federal Register</E>
                     Notice section III.C), the EPA does not rely on non-national data alone to determine that there is no or low potential for occurrence in the nation's PWSs because these data tend to be limited in scope and do not provide a sufficiently accurate picture of occurrence to support a negative determination.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Note that the 
                        <FR>1/2</FR>
                         HRL threshold is based on a recommendation from the NDWAC working grouping that provided recommendations on the first regulatory determination effort (USEPA, 2000a).
                    </P>
                </FTNT>
                <P>If a widely available analytical method does not exist for monitoring occurrence of a contaminant in water, the contaminant will not be a viable candidate for regulation with a Maximum Contaminant Level (MCL). In certain limited cases, a contaminant's occurrence data may have been gathered using a specialized or experimental method that is not in general use. In the Analytical Methods Availability Assessment, the EPA determines for each contaminant whether a widely available analytical method for monitoring, which employs technology that is commonly in use at numerous drinking water laboratories, exists. If a widely available analytical method exists, the contaminant passes the Analytical Methods Availability Assessment. If a widely available analytical method does not exist, the EPA may still advance the contaminant to Phase 2 if the agency determines that indicator or surrogate monitoring, or use of a treatment technique (TT), could allow for effective regulation and there is evidence of occurrence.</P>
                <P>
                    The EPA also may consider issuing a regulatory determination for contaminant groups and/or mixtures that are a contaminant. The EPA has made final regulatory determinations for contaminant mixtures and regulated certain contaminants in drinking water collectively. For example, the EPA made a determination to regulate mixture combinations. containing two or more of the following PFAS: PFHxS PFNA, HFPO-DA (GenX chemicals), and PFBS. Additionally, the EPA has also established NPDWRs for groups of contaminants (
                    <E T="03">e.g.,</E>
                     DBPs; for total trihalomethanes [TTHMs] and the sum of five haloacetic acids [HAA5], as well as radionuclides). After conducting the health and occurrence data availability assessments, the agency identifies those contaminants and contaminant groups that meet the following Phase 1 data availability criteria:
                </P>
                <P>(a) An EPA health assessment or an externally peer-reviewed health assessment from another agency that conforms with the current EPA guidelines is available, from which an HRL can be derived;</P>
                <P>
                    (b) Either nationally representative finished drinking water occurrence data are available or other finished water occurrence data show occurrence at levels &gt;
                    <FR>1/2</FR>
                     the HRL; and
                </P>
                <P>(c) A widely available analytical method for monitoring is available.</P>
                <P>If a contaminant or group meets these three criteria, it is placed on a “short list” and proceeds to Phase 2. After evaluating the 81 CCL 5 contaminants/groups of contaminants and strontium in Phase 1, the agency identified 35 contaminants to evaluate further in Phase 2 (contaminants listed in Table 1 of this document). PFHxS, PFNA and HFPO-DA received final positive regulatory determinations in conjunction with the development of the PFAS NPDWR and therefore are not included in the contaminants considered here as part of the preliminary RD 5. For RD 5, the EPA set January 31, 2023 as a cutoff date for selection of health assessments. Health assessments published after this date were not considered in RD 5.</P>
                <GPOTABLE COLS="1" OPTS="L2,nj,p1,8/9,i1" CDEF="s100">
                    <TTITLE>Table 1—Contaminants Proceeding From Phase 1 to Phase 2</TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1,2,3-Trichloropropane.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">1,2,4-Trimethylbenzene.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">1,4-Dioxane.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            2-Aminotoluene (
                            <E T="03">o</E>
                            -Toluidine).
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">alpha-Hexachlorocyclohexane.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Boron.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Carbaryl.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Chlorate.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cobalt.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cylindrospermopsin.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Dieldrin.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Dimethoate.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Diuron.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ethoprop.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">Legionella pneumophila</E>
                            .
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Lithium.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Manganese.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Methomyl.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Microcystins.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Molybdenum.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">N-Nitrosodi-n-butylamine (NDBA).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">N-Nitrosodiethylamine (NDEA).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">N-Nitrosodimethylamine (NDMA).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">N-Nitroso-di-n-propylamine (NDPA).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">N-Nitrosopyrrolidine (NPYR).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Perfluorobutanoic acid (PFBA).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Permethrin.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Profenofos.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Propachlor.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quinoline.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Strontium.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tebuconazole.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Terbufos.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tribufos.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Vanadium.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    The remaining CCL 5 contaminants listed in Chapter 2 of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b) did not meet one or 
                    <PRTPAGE P="3837"/>
                    more of the Phase 1 data availability criteria described earlier in this section and were not considered further for RD 5.
                </P>
                <HD SOURCE="HD3">2. Phase 2 (Data Evaluation Phase)</HD>
                <HD SOURCE="HD3">(a) Evaluation of Adverse Health Effects</HD>
                <P>This section describes the approach for deriving the HRL for the contaminants under consideration for regulatory determinations. HRLs are health-based drinking water concentrations against which the EPA evaluates occurrence data to determine if contaminants occur at levels of potential public health concern in drinking water. HRLs are not final values for establishing a protective level of a contaminant in drinking water for any particular population and are derived prior to the development of a complete health and exposure assessment for regulatory determination. More specific information about the potential for adverse health effects for each contaminant is presented in section IV.B of this action.</P>
                <HD SOURCE="HD3">(i) Derivation of an HRL</HD>
                <P>
                    There are two general approaches to the derivation of an HRL. One approach is used for chemicals with a threshold dose-response. For noncancer effects and non-linear carcinogens, HRLs are obtained by dividing the reference dose (RfD) (or equivalent, such as an ATSDR minimal risk level) by an exposure factor (EF) (
                    <E T="03">i.e.,</E>
                     drinking water intake rate adjusted for body weight [DWI-BW]) relevant to the target population and critical effect (USEPA, 2019a) and multiplying by a 20% relative source contribution (RSC) (USEPA, 2000a). Consistent with HRL development for previous regulatory determinations, HRLs derived for RD 5 are rounded to one significant figure. The RSC is used to account for exposure via non-drinking water routes in deriving health-based drinking water concentrations for contaminants with threshold effects (noncarcinogens and nonlinear carcinogens). A 20% RSC is used for all RD 5 contaminants, consistent with other regulatory determination cycles (USEPA, 2021a), to derive the noncancer HRL because (1) HRLs are developed prior to completing the exposure assessment; and (2) a 20% RSC is the lowest that is applied for deriving health-based drinking water concentrations, therefore resulting in the most health protective HRL (USEPA, 2000a). Should a contaminant proceed to a NPDWR, a full exposure analysis is conducted and an RSC is derived following the Exposure Decision Tree approach described in the 
                    <E T="03">Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health</E>
                     (USEPA, 2000a).
                </P>
                <P>HRLs for contaminants with a threshold dose-response (non-cancer and nonlinear cancer endpoints) are calculated as follows:</P>
                <GPH SPAN="1" DEEP="25">
                    <GID>EN15JA25.050</GID>
                </GPH>
                <P>
                    The second general approach is used for chemicals that exhibit a linear, non-threshold response to dose as is typical of carcinogens. For this approach, the HRL is calculated for one-in-a-million (10
                    <E T="51">−6</E>
                    ) cancer risk expressed as a drinking water concentration. HRLs for contaminants with a linear dose-response (typically cancer endpoints) are calculated as follows:
                </P>
                <GPH SPAN="1" DEEP="25">
                    <GID>EN15JA25.051</GID>
                </GPH>
                <P>In this second approach, when a carcinogen with a linear dose-response has a known mutagenic mode of action (MOA), the EPA follows the Cancer Guidelines (USEPA, 2005b) when deriving HRLs (USEPA, 2024b). For carcinogens with a MOA, the 2005 Cancer Guidelines recommend consideration of increased risk due to early-life exposure. When chemical-specific data to quantify the increased risk from developmental exposure are lacking, Age Dependent Adjustment Factors (ADAFs) are applied. The recommended ADAFs are a 10-fold adjustment for exposure during the interval from birth to &lt;2 years (infant and toddler); a 3-fold adjustment for exposure from 2 to &lt;16 years (childhood and adolescence); and no additional adjustment for exposures for 16 years to 70 years of age. In cases where the MOA cannot be determined, the default low-dose linear extrapolation approach without ADAFs (described earlier in this section) is used.</P>
                <P>HRLs for carcinogenic contaminants with a known mutagenic MOA are calculated as follows:</P>
                <GPH SPAN="3" DEEP="28">
                    <GID>EN15JA25.052</GID>
                </GPH>
                <P>The following terms are used in these questions:</P>
                <EXTRACT>
                    <P>
                        <E T="03">HRL</E>
                         = Health Reference Level (mg/L), a non-regulatory health-based drinking water concentration levels of a specific contaminant at or below which is not anticipated to lead to adverse human health effects.
                    </P>
                    <P>
                        <E T="03">RfD</E>
                         = Reference Dose (mg/kg/day)—an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily oral exposure of the human population to a substance that is likely to be without an appreciable risk of deleterious effects during a lifetime. The value of this parameter is derived in the selected qualifying health assessment and is based on the critical effect and study identified in that assessment. An RfD is considered an oral reference value for RD 5 and can also refer to the maximum acceptable concentration (MAC), ATSDR minimal risk level, point of departure (POD)/uncertainty factor (UF), population-adjusted dose (PAD) or tolerable daily intake (TDI).
                    </P>
                    <P>
                        <E T="03">DWI-BW</E>
                        <E T="54">i</E>
                         = Drinking water intake (DWI), adjusted for body weight (BW), in units of liter per kilogram BW per day (L/kg/day) for each age group (i).
                    </P>
                    <P>
                        <E T="03">RSC</E>
                         = Relative Source Contribution—the percentage of the total exposure attributed to drinking water sources (USEPA, 2000a) where the remainder of the exposure is allocated to other routes or sources.
                    </P>
                    <P>
                        <E T="03">CSF</E>
                         = Cancer Slope Factor (mg/kg/day)
                        <E T="51">−1</E>
                        ,—an upper-bound estimate of risk per increment of dose that can be used to estimate cancer risk probabilities for different exposure levels (USEPA, 2005b).
                    </P>
                    <P>
                        <E T="03">CRL</E>
                         = Cancer risk level,—the target incidence used to establish lifetime exposure limits for carcinogens, set at one excess cancer case in a population of one million (1 × 10
                        <E T="51">−6</E>
                        ).
                    </P>
                    <P>
                        <E T="03">ADAF</E>
                        <E T="54">i</E>
                         = the age dependent adjustment factor for each age group (i), used when calculating cancer risk concentrations for carcinogens that act via a mutagenic MOA; by default, ADAF = 10 from birth to two years of age; ADAF = 3 from two to sixteen years of age; and ADAF = 1 from 16 to 70 years of age (USEPA, 2005b).
                    </P>
                    <P>
                        <E T="03">UA</E>
                         = Unit adjustment factor to convert the dose (
                        <E T="03">i.e.,</E>
                         CSF) from mg of a chemical to µg of the chemical—ensures the ADAF-adjusted Unit Risk is in µg/L. This unit adjustment is not needed if the CSF is presented in (ug/kg/day)
                        <E T="51">−1</E>
                         or if the desired units of the ADAF-adjusted concentration (
                        <E T="03">i.e.,</E>
                         HRL) is mg/L. A different adjustment factor is needed for other units.
                    </P>
                    <P>
                        <E T="03">F</E>
                        <E T="54">i</E>
                         = the fraction of life spent in each age group (i), used when calculating cancer risk concentrations for mutagens (USEPA, 2005b).
                    </P>
                </EXTRACT>
                <P>
                    In some cases, the health assessments identified for HRL derivation provided both cancer and non-cancer toxicity values (
                    <E T="03">e.g.,</E>
                     an oral reference value and oral CSF). When this situation occurred, the EPA selected the health assessments 
                    <PRTPAGE P="3838"/>
                    according to the criteria explained earlier in this section, derived a noncancer HRL and a cancer HRL based on noncancer and cancer health effects information, respectively, and then selected the most health protective (
                    <E T="03">i.e.,</E>
                     lowest value) to serve as the final HRL (USEPA, 2000a).
                </P>
                <HD SOURCE="HD3">(ii) Exposure Factor Selection Process for HRL Derivation</HD>
                <P>
                    In prioritizing the contaminants of greatest public health concern for regulatory determination, section 1412(b)(1)(C) of SDWA requires the agency to consider “among other factors of public health concern, the effect of such contaminants upon subgroups that comprise a meaningful portion of the general population (such as infants, children, pregnant women, the elderly or other subpopulations) that are identifiable as being at greater risk of adverse health effects due to exposure to contaminants in drinking water compared to the general population.” It is also the EPA's policy to “protect children from environmental exposures by consistently and explicitly considering early life exposures and lifelong health in human health decisions” (USEPA, 2021b). One way that the EPA considers potentially sensitive populations or life stages (
                    <E T="03">i.e.,</E>
                     populations or life stages that may be more susceptible or sensitive to a chemical exposure) is during the selection of EFs for the development of HRLs.
                </P>
                <P>
                    DWI-BW is the EF used to derive HRLs for RD 5 (USEPA, 2019a). EFs are input values intended to protect the general population including sensitive populations or life stages from adverse effects resulting from exposure to a contaminant. The agency selects an appropriate DWI-BW for each chemical by reviewing the critical effect and study used for HRL derivation and identifying the interval of exposure (for examples, see USEPA, 2022b; USEPA, 2022c). The critical effect used as the basis for the oral reference value or oral CSF typically represents the health outcome at the lowest dose from the critical study among the best available studies. Since the critical effect typically represents the most sensitive adverse effect observed based on the available published data for a given chemical, it is reasonable to assume that the interval of exposure in the critical study could inform the selection of a DWI-BW protective of sensitive populations. Therefore, the EPA uses the interval of exposure in the critical study to identify potentially sensitive life stages as the basis for EF selection. When multiple potentially sensitive populations or life stages are identified based on the interval of exposure in the study used for HRL derivation, the EPA selects the population or life stage with the highest DWI-BW because it is the most health protective. See section B.6.1.2 in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more information regarding the EPA's EF selection process (USEPA, 2024b).
                </P>
                <HD SOURCE="HD3">(b) Occurrence Data Evaluation</HD>
                <P>In Phase 2, the agency collects additional data on occurrence (including finished drinking water data; ambient water data; data on use, production and release; and information on environmental fate and transport) and more thoroughly evaluates this information (based on factors enumerated in the following paragraphs) to identify contaminants that should proceed to Phase 3.</P>
                <P>In Phase 2, the agency focuses its efforts on identifying those contaminants or contaminant groups that are occurring or have substantial likelihood to occur at levels and frequencies of public health concern in drinking water. As noted in section III.A, SDWA 1412(b)(1)(C) requires that the Administrator select contaminants that present the greatest public health concern. To identify such contaminants, the agency considers the following information:</P>
                <P>
                    (a) How many samples (number and percentage) have detections &gt; HRL and 
                    <FR>1/2</FR>
                     HRL in the nationally representative and other finished water occurrence data?
                </P>
                <P>
                    (b) How many systems (number and percentage) have detections &gt; HRL and 
                    <FR>1/2</FR>
                     HRL in the nationally representative and other finished water occurrence data?
                </P>
                <P>
                    (c) Are there uncertainties or limitations with the data or analyses, such as the age of the dataset, the reporting threshold (
                    <E T="03">i.e.,</E>
                     minimum reporting level [MRL 
                    <SU>9</SU>
                    <FTREF/>
                    ] &gt; HRL), or representativeness of the data (
                    <E T="03">e.g.,</E>
                     limited to a specific region), that may cause over- or underestimation of occurrence in finished water at levels and frequency of public health concern?
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         The MRL is the minimum concentration that is required to be reported quantitatively in a study. The MRL is set at a value that takes into account typical laboratory capabilities to reliably and cost-effectively detect and quantify a compound.
                    </P>
                </FTNT>
                <P>After identifying contaminants that are occurring at levels and frequencies of public health concern in drinking water to proceed to Phase 3 for a potential positive determination, the agency evaluates the remaining contaminants on the “short list” to determine which contaminants have no or low occurrence at levels of health concern that should proceed to Phase 3 for a potential negative determination. The agency considers the following information in selecting contaminants of no or low potential for public health concern to proceed to Phase 3:</P>
                <P>(a) Does the contaminant have nationally representative finished drinking water data showing no or a low number or percent of detections &gt; HRL?</P>
                <P>
                    (b) If a contaminant has other finished water data in addition to nationally representative finished water data, do these data suggest that there is no or low potential for occurrence in drinking water? 
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Note that other finished water data (
                        <E T="03">i.e.,</E>
                         non-nationally-representative occurrence data) tend to be limited in scope and the EPA does not use these data alone to support a determination that the contaminant is not substantially likely to “occur in PWSs with a frequency and at levels of public health concern,” which would therefore be a decision “not to regulate” (
                        <E T="03">i.e.,</E>
                         negative determination).
                    </P>
                </FTNT>
                <P>(c) Does additional high-quality occurrence information support the conclusion that there is low or no occurrence or potential for occurrence in drinking water? For example, is the occurrence in ambient/source water at levels below the HRL? How are releases to the environment or use/production changing over time?</P>
                <P>(d) Are critical gaps in health and occurrence information/data minimal?</P>
                <P>After evaluating the “short list” contaminants (listed in Table 1 of this document), the agency identified 14 CCL 5 contaminants to proceed to Phase 3 (listed in Table 2 of this document). The contaminants are within one of the following Phase 2 data evaluation categories:</P>
                <P>(a) A contaminant or part of a contaminant group occurring or likely to occur at levels and frequencies of public health concern, or</P>
                <P>(b) A contaminant not occurring or not likely to occur at levels and frequencies of public health concern and no data gaps.</P>
                <PRTPAGE P="3839"/>
                <GPOTABLE COLS="2" OPTS="L2,nj,p1,8/9,i1" CDEF="xl100,r100">
                    <TTITLE>Table 2—Contaminants Proceeding From Phase 2 to Phase 3</TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1"> </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1,2,3-Trichloropropane.</ENT>
                        <ENT>Molybdenum.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">1,4-Dioxane.</ENT>
                        <ENT>Permethrin.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            2-Aminotoluene (
                            <E T="03">o</E>
                            -Toluidine).
                        </ENT>
                        <ENT>Profenofos.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cylindrospermopsin.</ENT>
                        <ENT>Quinoline.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ethoprop.</ENT>
                        <ENT>Strontium.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Manganese.</ENT>
                        <ENT>Tebuconazole.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Microcystins.</ENT>
                        <ENT>Tribufos.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Note that the agency does not have a threshold for occurrence in drinking water that triggers whether a contaminant is occurring with a frequency and at levels of public health concern. An evaluation of this statutory criterion requires consideration of a number of factors, some of which include the health effect(s), the potency of the contaminant, the level at which the contaminant is found in drinking water, the frequency at which the contaminant is found, the geographic distribution (national, regional or local occurrence), other possible sources of exposure, and potential impacts on sensitive populations or lifestages. Given the many possible combinations of factors, a simple threshold is not viable.</P>
                <P>The remaining CCL 5 contaminants did not proceed to Phase 3 and were not considered for RD 5 for reasons that may include of one or more of the following reasons:</P>
                <P>(a) An updated health assessment completed by January 31, 2023 was not identified;</P>
                <P>
                    (b) Critical health effects gap (
                    <E T="03">e.g.,</E>
                     lack of data to support quantification for the oral route of exposure);
                </P>
                <P>(c) Lack of nationally representative finished water occurrence data and lack of sufficient other data to demonstrate occurrence at levels and frequencies of public health concern;</P>
                <P>
                    (d) Critical occurrence data limitation or gap (
                    <E T="03">e.g.,</E>
                     inconsistent results or trends in occurrence data requiring further research; significant uncertainty in occurrence analyses or data);
                </P>
                <P>or</P>
                <P>(e) The contaminant is being evaluated in other actions by the agency.</P>
                <P>The agency continues to conduct research and collect information to fill the data and information gaps identified for these contaminants. Three contaminants that had previously received negative regulatory determinations have been re-listed on CCL 5 based on new health or occurrence information or a reevaluation of existing information. The EPA made determinations not to regulate dieldrin and manganese in RD 1 and dimethoate in RD 3. These contaminants were considered in RD 5. Based on preliminary RD 5 evaluations of dieldrin and dimethoate, the EPA is not proposing a change to its previous negative regulatory determinations for these two contaminants at this time. Manganese is further discussed in section V. Additionally, all 29 PFAS contaminants that have approved analytical methods are being monitored under the fifth Unregulated Contaminant Monitoring Rule (UCMR 5). The UCMR 5 occurrence data collection began in 2023 and ends in 2025.</P>
                <HD SOURCE="HD3">3. Phase 3 (Regulatory Determination Assessment Phase)</HD>
                <P>Phase 3, the Regulatory Determination Assessment Phase, involves a complete evaluation of the statutory criteria for each contaminant or group of contaminants that proceed from Phase 2 and have sufficient information and data for making a regulatory determination. To meet the statutory requirement of making at least five regulatory determinations, in this phase, the agency evaluates the remaining contaminants against the following statutory criteria (SDWA 1412(b)(1)(A)):</P>
                <P>(a) Statutory Criterion 1—“The contaminant may have an adverse effect on the health of persons.” To evaluate the first criterion, the EPA evaluates whether a contaminant has an EPA health assessment, or an externally peer-reviewed health assessment from another agency that is publicly available and conforms with current EPA guidelines, from which an HRL can be derived. The HRL derived in or from the health assessment takes into account the MOA, the critical health effect(s), the dose-response relationship for critical health effect(s) and impacts on sensitive population(s) or lifestages.</P>
                <P>If an acceptable health assessment that demonstrates adverse health effects is available, the agency answers “yes” to the first statutory criterion. Otherwise, the agency answers “no” to the first statutory criterion. (In practice, it is expected that any contaminant that reaches Phase 3 would receive a “yes” to the first criterion.)</P>
                <P>
                    (b) Statutory Criterion 2—“The contaminant is known to occur or there is a substantial likelihood that the contaminant will occur in PWSs with a frequency and at levels of public health concern.” The EPA compares the occurrence data for each contaminant to the HRL to determine if the contaminant occurs at a frequency and levels of public health concern. The types of occurrence data used at this stage are described in section III.C.1, Evaluation of Contaminant Occurrence and Exposure, and in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b). The agency may consider the multiple factors when identifying contaminants or contaminant groups that are occurring at frequencies and levels of public health concern, including:
                </P>
                <P>• How many samples (number and percentage) have detections &gt; HRL in the nationally representative and other finished water occurrence data?</P>
                <P>• How many systems (number and percentage) have detections &gt; HRL in the nationally representative and other finished water occurrence data, and, in addition to the number of systems, what type of systems does the contaminant occur in? Does the contaminant occur in large or small systems? Does the contaminant occur in surface or groundwater systems?</P>
                <P>• Is the geographic distribution of the contaminant occurrence national, regional or localized?</P>
                <P>
                    • Are there significant uncertainties or limitations with the data or analyses, such as the age of the dataset, the MRL (
                    <E T="03">i.e.,</E>
                     MRL &gt; HRL), or representativeness of the data (
                    <E T="03">e.g.,</E>
                     limited in scope to a specific region)?
                </P>
                <P>
                    (c) Statutory Criterion 3—“In the sole judgment of the Administrator, regulation of the contaminant presents a meaningful opportunity for health risk reduction for persons served by public water systems.” The EPA evaluates the population exposed at the health level of concern along with several other factors to determine if regulation presents a meaningful opportunity for health risk reduction. Among other things, the EPA may consider the following factors in evaluating statutory criterion 3:
                    <PRTPAGE P="3840"/>
                </P>
                <P>• What is the nature of the health effect(s) identified in statutory criterion 1?</P>
                <P>
                    • Are there sensitive populations that may be affected (evaluated either qualitatively or quantitatively 
                    <SU>11</SU>
                    <FTREF/>
                    )?
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         If appropriate and available, the agency considers quantitative exposure data applicable to sensitive populations or lifestages when deriving HRLs for regulatory determinations. When data are not available on sensitive populations, the derivation of the RfD typically includes an uncertainty factor to account for the limitation in the database. Additionally, the EPA will use exposure factors relevant to the sensitive population in deriving the HRL. See Section III.C.1. Sensitive populations are also qualitatively considered by providing national prevalence estimates for a particular sensitive population, if available.
                    </P>
                </FTNT>
                <P>
                    • Based on the occurrence information for statutory criterion 2, including the number of systems potentially affected, what is the national population exposed or served by systems with levels &gt; HRL and &gt;
                    <FR>1/2</FR>
                     HRL?
                </P>
                <P>
                    • For non-carcinogens, are there other sources of exposure that should be considered (
                    <E T="03">i.e.,</E>
                     what is the RSC from drinking water)?
                </P>
                <P>
                    • What is the geographic distribution of occurrence (
                    <E T="03">e.g.,</E>
                     local, regional, national)?
                </P>
                <P>• Are there any uncertainties or limitations in the health and occurrence information or analyses that should be considered?</P>
                <P>
                    • Are there any limiting considerations related to technology (
                    <E T="03">e.g.,</E>
                     lack of available treatment or analytical methods)?
                </P>
                <P>If the Administrator, in their sole judgement, determines that there is a meaningful opportunity to reduce risk by regulating the contaminant in drinking water, then the agency answers “yes” to the third statutory criterion.</P>
                <P>The agency may make a positive preliminary determination if the agency answers “yes” to all three statutory criteria in Phase 3 for a particular contaminant. Additionally, after identifying compounds occurring at frequencies and levels of public health concern, if any, the agency may initiate a systematic literature review to identify new studies that may influence the derivation of an RfD or CSF. The list of potentially relevant health effect studies that could affect the derivation of an RfD or CSF identified through the systematic review process would then be placed in the docket at the time of the preliminary determination for public comment (discussed further in section IV of this document).</P>
                <P>
                    If, after considering public comment on the preliminary regulatory determination, the agency again answers “yes” to all three statutory criteria, the agency then may make a positive final determination that regulation is appropriate and proceed to develop an MCLG and NPDWR. If a final positive determination is made, the agency has 24 months to publish a proposed MCLG and NPDWR and an additional 18 months to publish a final MCLG and promulgate a final NPDWR.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         The statute authorizes a nine-month extension of this promulgation date.
                    </P>
                </FTNT>
                <P>It should be noted that the analyses associated with a regulatory determination process are distinct from the more detailed analyses needed to develop an NPDWR. The development and promulgation of an NPDWR is a multi-step process, which includes deriving a proposed MCLG as well as conducting a statutorily required health risk reduction cost analysis (HRRCA) and conducting other analyses required to propose an MCL or a TT approach to reduce contaminant levels in water systems. As part of the proposal, the agency must identify best available technologies (BATs), small system compliance technologies (SSCTs) and approved analytical methods if it proposes an enforceable MCL. Alternatively, if the EPA proposes a TT instead of an MCL, the agency must identify the TT. The EPA must also prepare a HRRCA which includes an extensive evaluation of the treatment costs and monitoring costs at a system level and aggregated at the national level. Thus, a decision to regulate is the beginning of the agency's regulatory development process, not the end.</P>
                <P>If a contaminant has sufficient information and the agency answers “no” to any of the three statutory criteria based on the available data, then the agency considers making a negative determination that an NPDWR is not appropriate for that contaminant at that time. A final determination not to regulate a contaminant is, by statute, a final agency action and is subject to judicial review. While a negative determination is considered a final agency action under SDWA for a round of regulatory determinations, the contaminant may be relisted on a future CCL based on newly available health or occurrence information.</P>
                <P>
                    If a negative determination or no determination is made for a contaminant, the agency may decide to develop an HA, which provides non-regulatory concentration values for drinking water contaminants at which adverse health effects are not anticipated to occur over specific exposure durations (
                    <E T="03">e.g.,</E>
                     one day, ten days, or a lifetime). The EPA's HAs are non-enforceable and non-regulatory and provide technical information to states' agencies and other public health officials on health effects, analytical methodologies and treatment technologies associated with drinking water contamination. See SDWA section 1412(b)(1)(F).
                </P>
                <P>After evaluating the CCL 5 contaminants in Table 3 of this document against the three SDWA criteria and considering the factors listed for each, the agency is making preliminary negative regulatory determinations for nine CCL 5 contaminants. Table 5 of this documentprovides a summary of the 14 contaminants evaluated for Phase 3 and the preliminary regulatory determination outcome for each contaminant. The agency seeks comment on the preliminary determination not to regulate nine contaminants (2-aminotoluene, cylindrospermopsin, ethoprop, microcystins, molybdenum, permethrin, profenofos, tebuconazole and tribufos). Section IV.B of this document provides a more detailed summary of the information and the rationale used by the agency to reach its preliminary decisions for these contaminants. At this time, the agency is not making preliminary regulatory determinations for five of the 14 contaminants that proceeded to Phase 3, namely1,2,3-trichloropropane (1,2,3-TCP), 1,4-dioxane, manganese, quinoline and strontium (see section V of this document for more information).</P>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="xs50,r100,r100">
                    <TTITLE>Table 3—Contaminants Evaluated in Phase 3 and the Regulatory Determination Outcome</TTITLE>
                    <BOXHD>
                        <CHED H="1">Number</CHED>
                        <CHED H="1">Contaminant</CHED>
                        <CHED H="1">Preliminary determination outcome</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            <E T="03">1</E>
                        </ENT>
                        <ENT>
                            2-Aminotoluene (
                            <E T="03">o</E>
                            -Toluidine)
                        </ENT>
                        <ENT>Negative Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">2</E>
                        </ENT>
                        <ENT>1,2,3-Trichloropropane</ENT>
                        <ENT>No Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">3</E>
                        </ENT>
                        <ENT>1,4-Dioxane</ENT>
                        <ENT>No Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">4</E>
                        </ENT>
                        <ENT>Cylindrospermopsin</ENT>
                        <ENT>Negative Determination.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="3841"/>
                        <ENT I="01">
                            <E T="03">5</E>
                        </ENT>
                        <ENT>Ethoprop</ENT>
                        <ENT>Negative Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">6</E>
                        </ENT>
                        <ENT>Manganese</ENT>
                        <ENT>No Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">7</E>
                        </ENT>
                        <ENT>Microcystins</ENT>
                        <ENT>Negative Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">8</E>
                        </ENT>
                        <ENT>Molybdenum</ENT>
                        <ENT>Negative Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">9</E>
                        </ENT>
                        <ENT>Permethrin</ENT>
                        <ENT>Negative Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">10</E>
                        </ENT>
                        <ENT>Profenofos</ENT>
                        <ENT>Negative Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">11</E>
                        </ENT>
                        <ENT>Quinoline</ENT>
                        <ENT>No Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">12</E>
                        </ENT>
                        <ENT>Strontium</ENT>
                        <ENT>No Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">13</E>
                        </ENT>
                        <ENT>Tebuconazole</ENT>
                        <ENT>Negative Determination.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">14</E>
                        </ENT>
                        <ENT>Tribufos</ENT>
                        <ENT>Negative Determination.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    In 
                    <E T="03">National Resources Defense Council</E>
                     v. 
                    <E T="03">Michael S. Regan, Administrator, U.S. Environmental Protection Agency and Environmental Protection Agency (NRDC</E>
                     v. 
                    <E T="03">EPA),</E>
                     67 F.4th 397 (D.C. Cir., 2023), the D.C. Circuit Court of Appeals ruled that when the EPA finalizes a positive regulatory determination for a contaminant under the SDWA, the EPA must then promulgate a regulation and the EPA does not have the ability to withdraw a final positive determination during the development of the proposed rule. This ruling presents a change to the EPA's understanding of the flexibilities afforded to the agency under the SDWA. Prior to this ruling, the EPA had understood that the agency could withdraw a positive determination if, during the more-detailed analyses conducted during the development of the proposed rule, for example, in the HRRCA, the EPA determined that the potential for health-risk reduction was less beneficial than initially predicted. Following the 
                    <E T="03">NRDC</E>
                     v. 
                    <E T="03">EPA</E>
                     ruling and the understanding now of the EPA's authorities under the SDWA, the agency will need to be more certain of the potential for health-risk reduction through regulation before making a determination to regulate a contaminant. As a result, the EPA will need to consider preliminary health benefits analysis information to support the finding that a positive determination would provide a meaningful opportunity for health risk reduction if the agency decides to regulate a contaminant under the SDWA. Therefore, the EPA is not making a regulatory determination for these five contaminants at this time, in order to gain an understanding of the potential for health-risk reduction by conducting additional analyses of the potential benefits and treatment feasibility prior to making positive determinations.
                </P>
                <HD SOURCE="HD2">B. Supporting Documentation for the EPA's Preliminary Determination</HD>
                <P>For this action, the EPA prepared several supporting documents that are available for review and comment in the EPA Water Docket. These support documents include:</P>
                <P>
                    • The comprehensive regulatory support document, 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b), summarizes the information and data evaluated by the EPA on the physical and chemical properties, uses and environmental release, environmental fate, potential health effects, occurrence and exposure estimates, analytical methods, treatment technologies and preliminary determinations. Additionally, Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     describes the approach implemented by the agency to evaluate the CCL 5 contaminants in a three-phase process and select the contaminants for preliminary determinations for RD 5.
                </P>
                <P>
                    • A comprehensive technical occurrence support document for UCMR 4, 
                    <E T="03">Occurrence Data from the Fourth Unregulated Contaminant Monitoring Rule (UCMR 4)</E>
                     (USEPA, 2024c). This occurrence support document includes more detailed information about UCMR 4, how the EPA assessed the data quality, completeness and representativeness, and how the data were used to generate estimates of drinking water contaminant occurrence in support of these regulatory determinations.
                </P>
                <HD SOURCE="HD2">C. Analyses Used To Support the Preliminary Regulatory Determinations</HD>
                <HD SOURCE="HD3">1. Evaluation of Contaminant Occurrence and Exposure</HD>
                <P>The EPA uses data from many sources to evaluate occurrence and exposure from drinking water contaminants. The discussion in this section focuses mainly on the following sources of finished drinking water occurrence data:</P>
                <P>• Unregulated Contaminant Monitoring Rules (UCMR 1, 2, 3 and 4);</P>
                <P>• UCM-State Program Rounds 1 and 2; and,</P>
                <P>• Data collected by states.</P>
                <P>Several of the primary sources of finished water occurrence data are designed to be statistically representative of the nation. These data sources include Assessment Monitoring (AM) data collected under UCMR 1-4 and Screening Survey (SS) data collected under UCMR 2 and 3.</P>
                <P>
                    The agency also evaluates supplemental sources of information on occurrence in drinking water, information on occurrence in ambient and source water and information on contaminant production and release to augment and complement these primary sources of drinking water occurrence data. section III.C.1.a of this action provides a brief summary of the primary sources of finished water occurrence data and sections III.C.1.b and III.C.1.c provide brief summary descriptions of some of the supplemental sources of occurrence information and data. These descriptions do not cover all the sources that the EPA reviews and evaluates. For individual contaminants, the EPA reviews additional published reports and peer-reviewed studies that may provide the results of monitoring efforts in limited geographic areas. A summary of the occurrence data and the results or findings for each of the contaminants considered for regulatory determination is presented in section IV.B, the contaminant profiles section, and the data are described in further detail in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b).
                </P>
                <HD SOURCE="HD3">(a) Primary Sources of Finished Drinking Water Occurrence Data</HD>
                <P>
                    The following section provides a brief summary of the finished water occurrence data sources used in RD 5. Table 4 in section IV of this document lists the primary data source/finding used to evaluate each of the nine contaminants for which the EPA is making preliminary determinations in this 
                    <E T="04">Federal Register</E>
                     Notice. The 
                    <PRTPAGE P="3842"/>
                    contaminant-specific discussions in section IV of this document, provide more detailed information about the primary data source findings as well as any supplemental occurrence information.
                </P>
                <P>Section V of this document provides more information about the five Phase 3 contaminants for which the EPA is not making a preliminary regulatory determination at this time: 1,4-dioxane, 1,2,3-TCP, manganese, quinoline and strontium.</P>
                <HD SOURCE="HD3">• The Unregulated Contaminant Monitoring Rules (UCMR 1, UCMR 2, UCMR 3 and UCMR 4)</HD>
                <P>
                    The UCMR program is the EPA's primary vehicle for collecting monitoring data on the occurrence of unregulated contaminants in PWSs. SDWA section 1412 (b)(1)(B)(ii)(II) requires that the EPA include consideration of the data collected by the UCMR program in making regulatory determinations. The UCMR program is designed to collect nationally representative occurrence data in coordination with the CCL and regulatory determination processes. The UCMR sampling is limited by statute to no more than 30 contaminants every five years (SDWA section 1445(a)(2)). However, the National Defense Authorization Act for Fiscal Year 2020 provided a one-time exception to this limit by stating that PFAS monitored under UCMR 5 do not count toward the limit of 30 contaminants. The EPA published the lists and requirements for UCMR 1 on September 17, 1999 (64 FR 50556; USEPA, 1999), and the monitoring was conducted primarily during 2001-2005. The requirements for UCMR 2 were published on January 4, 2007 (72 FR 367; USEPA, 2007) with monitoring conducted primarily during 2008-2010. Requirements for UCMR 3 were published on May 2, 2012 (77 FR 26072; USEPA, 2012a); with monitoring conducted primarily during 2013-2015. Requirements for UCMR 4 were published on December 20, 2016 (81 FR 92666; USEPA, 2016c) with monitoring conducted primarily during 2018-2020. (The complete contaminant lists are available at: 
                    <E T="03">https://www.epa.gov/dwucmr.</E>
                    ) On December 27, 2021, the EPA published UCMR 5, requiring certain PWSs to collect national occurrence data for 29 PFAS and lithium from 2023 through 2025 (86 FR 73131; USEPA, 2021c). The final UCMR 5 dataset is not complete at the time of these RD 5 preliminary determinations and will not conclude until December 31, 2026.
                </P>
                <P>
                    The UCMR program is designed as a three-tiered approach for monitoring contaminants related to the availability and complexity of analytical methods, laboratory capacity, sampling frequency, relevant PWSs based on contaminants and other considerations (
                    <E T="03">e.g.,</E>
                     cost/burden). AM is the primary tier and the largest in scope. The AM generally relies on analytical methods that use more common techniques and are expected to be widely available. SS monitoring is smaller in scope than the AM and generally pertains to monitoring with less established analytical techniques, such that laboratory capacity or cost may be a concern. A Pre-Screen Testing (PST) tier can be customized to meet specific monitoring objectives for a specific group of PWSs.
                </P>
                <P>
                    The EPA designed the AM sampling frame to ensure that sample results would support a high level of confidence and a low margin of error (see USEPA, 1999 and 2001a, for UCMR design details). The AM program includes PWSs from all 50 states, the District of Columbia, all five U.S. territories and Tribal lands across the EPA regions. The AM is required for all large and very large PWSs, those serving between 10,001 and 100,000 people and serving more than 100,000 people, respectively (
                    <E T="03">i.e.,</E>
                     a census of all large and very large systems) and a national statistically representative sample of 800 small PWSs, those serving 10,000 or fewer people.
                    <SU>13</SU>
                    <FTREF/>
                     The small system sample is stratified and population-weighted and includes some other sampling adjustments such as allocating a selection of at least two systems from each state for spatial coverage. The design meets the data quality objective for overall exposure estimates (99% confidence level with ±1% error tolerance, at 1% exposure) while providing more precise occurrence estimates for categories of small systems. The AM, the primary tier, has been used for all or a subset of contaminants in each UCMR cycle. With contaminant monitoring data from all large PWSs and a statistical, nationally representative sample of small PWSs, AM provides a robust dataset for evaluating national drinking water contaminant occurrence.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Section 1445 of the Safe Drinking Water Act was recently amended by Public Law 115-270, America's Water Infrastructure Act of 2018 (AWIA), and now specifies that, effective October 23, 2021, subject to the availability of appropriations for such purpose and appropriate laboratory capacity, the EPA must require all systems serving between 3,300 and 10,000 persons to monitor and ensure that only a representative sample of systems serving fewer than 3,300 persons are required to monitor.
                    </P>
                </FTNT>
                <P>
                    Each system conducts monitoring for 12 consecutive months during the three-year monitoring period. The rules typically require quarterly monitoring for surface water and groundwater under the direct influence of surface water (GWUDI) systems and twice-a-year, six-month-interval monitoring for groundwater systems, and include flexibilities for specialized sampling (
                    <E T="03">e.g.,</E>
                     eight sample events for cyanotoxins in UCMR 4). Samples may be collected at different sampling points or locations within the PWS depending on the specific contaminant (
                    <E T="03">e.g.,</E>
                     entry point to the distribution system). A brief outline of the structure of the UCMR efforts is provided in the paragraphs that follow.
                </P>
                <P>UCMR 1 included both the AM and SS tiers. UCMR1 a.m. was conducted by approximately 3,100 large systems and approximately 800 small systems and resulted in over 33,900 sample results for each contaminant. The UCMR 1 SS design included approximately 640 UCMR1 SS PWSs randomly selected from those PWSs required to conduct AM and was designed to determine if additional monitoring would be needed. Samples from the 639 PWSs from throughout the nation provided over 2,300 results for each contaminant. While the statistical design of the SS is national in scope, the uncertainty in the results for contaminants that have low occurrence is relatively high. Therefore, the EPA looked for additional data to supplement the SS data for regulatory determinations in RD 2. After UCMR 1, the SS design was adapted to include more PWSs and to be representative of national occurrence.</P>
                <P>UCMR 2 also included the AM and SS tiers. The UCMR 2 a.m. was conducted by approximately3,300 large systems and 800 small systems and resulted in over 32,000 sample results for each contaminant. For the UCMR 2 SS, the EPA improved the design to include a census of all systems serving more than 100,000 people, a nationally representative, statistically selected sample of 320 PWSs serving between 10,001 and 100,000 people, and a nationally representative sample including approximately 480 small PWSs serving 10,000 or fewer people (72 FR 367, January 4, 2007, USEPA, 2007). With a total of approximately 1,200 systems participating in the SS, sufficient data were generated to provide a confident national estimate of contaminant occurrence and population exposure. The UCMR 2 SS PWSs provided between 11,100 to 18,100 sample results per contaminant (depending on the specific sampling design for the contaminant).</P>
                <P>
                    UCMR 3 included the AM, SS and PST tiers. The UCMR 3 a.m. was conducted by approximately 4,100 large 
                    <PRTPAGE P="3843"/>
                    systems and approximately 800 small systems and resulted in between 36,800 and 63,000 sample results for each contaminant (depending on the specific sampling design for the contaminant). The UCMR 3 SS monitoring was conducted by all large systems serving more than 100,000 people, a nationally representative sample of 320 large systems serving 10,001 to 100,000 people and a nationally representative sample of approximately 480 small water systems serving 10,000 or fewer people for a total of approximately 1,200 PWSs. The UCMR 3 SS PWSs provided over 11,700 sample result per contaminant. The UCMR 3 PST monitoring was conducted by approximately 800 PWSs including, transient noncommunity water systems that purchase all their finished water from another. See USEPA (2012a) and USEPA (2019b) for more information on the UCMR 3 study design and data analysis.
                </P>
                <P>UCMR 4 involved only AM and did not include any SS or PST efforts. The UCMR 4 a.m. was conducted by approximately 4,200 large systems and two separate nationally representative statistical samples of approximately 800 small PWSs. One set of 800 small systems monitored for cyanotoxins, while the second set of 800 small systems monitored for the remaining UCMR 4 contaminants.</P>
                <P>Systems with surface water or GWUDI monitored for cyanotoxins and conducted eight sampling events over a period of four consecutive months. Cyanotoxin sampling was conducted during the period of March through November, when harmful algal bloom (HAB) events are more likely to occur in the Northern Hemisphere. Groundwater systems were excluded from cyanotoxin monitoring (USEPA, 2016c). Overall, the UCMR 4 a.m. resulted in approximately 35,000 to 63,000 sample results per contaminant (depending on the specific sampling design for the contaminant). (81 FR 92666; USEPA, 2016c)</P>
                <P>
                    The details of the occurrence data and the results or findings for each of the contaminants considered for regulatory determination are presented in section IV.B of this document, the contaminant profiles section, and are described in further detail in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b). The national design, the statistical sampling frame, any new analytical methods and the data analysis approach for the UCMR program have been peer-reviewed at different stages of development (see USEPA, 2001b, 2008b, 2015a, 2019b).
                </P>
                <P>The fifth UCMR (UCMR 5) FRN, published December 2021, requires sample collection and analysis for 29 PFAS, including PFOA, PFOS, PFHxS, PFNA, HFPO-DA and PFBS, to occur between January 2023 and December 2025 using drinking water analytical methods developed by the EPA. Section 2021 of America's Water Infrastructure Act of 2018 (AWIA) (Pub. L. 115-270) amended SDWA and specifies that, subject to the availability of EPA appropriations for such purpose and sufficient laboratory capacity, the EPA must require all PWSs serving between 3,300 and 10,000 people to monitor and ensure that a nationally representative sample of systems serving fewer than 3,300 people monitor for the contaminants in UCMR 5 and future UCMR cycles. All large water systems continue to be required to participate in the UCMR program. As data under the UCMR 5 are being collected concurrently with the RD 5 evaluation process, the complete UCMR 5 dataset is not available to inform the regulatory determinations in this preliminary RD 5 FRN. The EPA intends to evaluate the full UCMR 5 dataset when it is available and to consider making regulatory determinations for the included contaminants in the future.</P>
                <P>
                    The UCMR program serves as the primary occurrence data source for all nine preliminary determinations included in this FRN. Other examples of occurrence data sources considered to be nationally representative for RD 5 are listed here. These are described in more detail in Chapter 2 of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b).
                </P>
                <FP SOURCE="FP-1">• National Inorganics and Radionuclides Survey (NIRS)</FP>
                <FP SOURCE="FP-1">• Unregulated Contaminant Monitoring (UCM) Program Rounds 1 and 2</FP>
                <HD SOURCE="HD3">(b) Supplemental Sources of Finished Drinking and Ambient Water Occurrence Data</HD>
                <P>
                    The agency evaluates several sources of supplemental information related to contaminant occurrence in finished water and ambient and source waters to augment the primary drinking water occurrence data. Some of these sources were part of other agency information gathering efforts or submitted to the agency in public comment or suggested by stakeholders during previous CCL and regulatory determination efforts. These supplemental data are useful to evaluate the likelihood of contaminant occurrence in drinking water, to more fully characterize a contaminant's presence in the environment and potentially in source water and to evaluate any possible trends or spatial patterns that may need further review. In cases where there is a sufficient amount of non-national data to illustrate contaminant occurrence at a national level, the EPA may use non-national data as the basis for a regulatory determination. The descriptions that follow do not cover all the sources that the EPA used. For individual contaminants, the EPA reviewed additional published reports and peer-reviewed studies that may have provided the results of monitoring efforts in limited geographic areas. A more detailed discussion of the supplemental sources of information/data that the EPA evaluated and the occurrence data for each contaminant can be found in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b).
                </P>
                <P>
                    Occurrence data were collected from other sources for consideration in RD 5 as well. Non-national occurrence data sources are also discussed in detail in Chapter 2 of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     and include:
                </P>
                <FP SOURCE="FP-1">• Individual states' data</FP>
                <FP SOURCE="FP-1">• Community Water System Survey (CWSS) Data</FP>
                <FP SOURCE="FP-1">• United States Department of Agriculture (USDA) Pesticide Data Program (PDP)</FP>
                <FP SOURCE="FP-1">• United States Geological Survey (USGS) Pilot Monitoring Program (PMP)</FP>
                <FP SOURCE="FP-1">• USGS National Water Quality Assessment (NAWQA)</FP>
                <FP SOURCE="FP-1">• National Water Information System (NWIS)</FP>
                <FP SOURCE="FP-1">• Water Quality Exchange (WQX)/Water Quality Portal (WQP) Data System (Formerly the Storage and Retrieval Data System [STORET])</FP>
                <HD SOURCE="HD3">(c) Supplemental Production, Use and Release Data</HD>
                <P>
                    The agency reviews various sources of information to assess if there are changes or trends in a contaminant's production, use and release that may affect its presence in the environment and potential occurrence in drinking water. The cancellation of a pesticide or a clear increase in production and use of a contaminant are trends that can inform the regulatory determination process. Examples of such sources are listed here. A more detailed discussion of the supplemental sources of information/data that the EPA evaluated and the occurrence data for each contaminant can be found in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b).
                </P>
                <FP SOURCE="FP-1">
                    • Inventory Update Reporting (IUR) and Chemical Data Reporting (CDR) Program (
                    <E T="03">https://www.epa.gov/chemical-data-reporting</E>
                    )
                    <PRTPAGE P="3844"/>
                </FP>
                <FP SOURCE="FP-1">
                    • Toxics Release Inventory (TRI) (
                    <E T="03">https://www.epa.gov/toxics-release-inventory-tri-program</E>
                    )
                </FP>
                <FP SOURCE="FP-1">
                    • Pesticide Usage Estimates (
                    <E T="03">https://www.epa.gov/pesticides/pesticides-industry-sales-and-usage-2008-2012-market-estimates</E>
                    )
                </FP>
                <HD SOURCE="HD1">IV. Contaminant-Specific Discussions for the RD 5 Preliminary Determinations</HD>
                <HD SOURCE="HD2">A. Summary of the Preliminary Regulatory Determinations</HD>
                <P>Based on the EPA's evaluation of the three SDWA criteria (discussed in section II.B.1 of this document), the agency is making preliminary determinations not to regulate nine contaminants. For each of the nine contaminants discussed in this section of this Document, Table 4 of this document summarizes information about the qualifying health assessment that was selected, the critical study, the critical effect and the associated oral reference value or oral CSF used to derive an HRL. Following Table 4, Table 5 of this document summarizes the primary occurrence information used to make these preliminary regulatory determinations. Section IV.B of this document provides a more detailed summary of the information and the rationale used by the agency to reach its preliminary decisions for these nine contaminants. For more information about the five Phase 3 contaminants that are not receiving a preliminary regulatory determination, see section Vof this document.</P>
                <GPOTABLE COLS="7" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,r50,r50,r100,12,10,10">
                    <TTITLE>Table 4—Health Effects Information for Contaminants Discussed in Section IV</TTITLE>
                    <BOXHD>
                        <CHED H="1">RD 5 contaminant</CHED>
                        <CHED H="1">Qualifying health assessment selected</CHED>
                        <CHED H="1">Critical study</CHED>
                        <CHED H="1">Critical effect</CHED>
                        <CHED H="1">
                            Oral
                            <LI>reference</LI>
                            <LI>value for</LI>
                            <LI>noncancer</LI>
                            <LI>effects, in</LI>
                            <LI>mg/kg/day</LI>
                        </CHED>
                        <CHED H="1">
                            Oral CSF, in
                            <LI>
                                (mg/kg/day) 
                                <E T="0731">−</E>
                                <SU>1</SU>
                            </LI>
                        </CHED>
                        <CHED H="1">
                            HRL, in
                            <LI>µg/L</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">2-Aminotoluene</ENT>
                        <ENT>EPA PPRTV, 2012</ENT>
                        <ENT>Weisburger et al., 1978</ENT>
                        <ENT>Subcutaneous fibromas and fibrosarcomas in male rats and mice</ENT>
                        <ENT>n/a</ENT>
                        <ENT>0.016</ENT>
                        <ENT>2</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cylindrospermopsin</ENT>
                        <ENT>EPA OW HESD, 2015</ENT>
                        <ENT>Humpage and Falconer, 2002; Humpage and Falconer, 2003</ENT>
                        <ENT>Increased relative kidney weight in male mice</ENT>
                        <ENT>0.0001</ENT>
                        <ENT>n/a</ENT>
                        <ENT>0.6</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ethoprop</ENT>
                        <ENT>EPA OPP HHRA, 2015</ENT>
                        <ENT>Chartier et al., 2005</ENT>
                        <ENT>Inhibition of red blood cell (RBC) cholinesterase (ChE) in postnatal day (PND) 11 rat pups</ENT>
                        <ENT>
                            6.5 × 10
                            <E T="51">−</E>
                            <SU>5</SU>
                        </ENT>
                        <ENT>n/a</ENT>
                        <ENT>0.09</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Microcystins *</ENT>
                        <ENT>EPA OW HESD, 2015</ENT>
                        <ENT>Heinze, 1999</ENT>
                        <ENT>Liver effects (increased liver weight, slight to moderate liver necrosis lesions and increased enzyme levels) in rats</ENT>
                        <ENT>
                            5 × 10
                            <E T="51">−</E>
                            <SU>5</SU>
                        </ENT>
                        <ENT>n/a</ENT>
                        <ENT>0.3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Molybdenum</ENT>
                        <ENT>ATSDR, 2020</ENT>
                        <ENT>Murray et al., 2014</ENT>
                        <ENT>Renal proximal tubule hyperplasia</ENT>
                        <ENT>0.06</ENT>
                        <ENT>n/a</ENT>
                        <ENT>100</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Permethrin</ENT>
                        <ENT>EPA OPP HHRA, 2020</ENT>
                        <ENT>Wolansky et al., 2006</ENT>
                        <ENT>Decreased motor activity in adult male rats</ENT>
                        <ENT>0.44</ENT>
                        <ENT>n/a</ENT>
                        <ENT>3,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Profenofos</ENT>
                        <ENT>EPA OPP HHRA, 2015</ENT>
                        <ENT>Burdock et al., 1981</ENT>
                        <ENT>Inhibition of RBC acetylcholinesterase (AChE) in adult rats</ENT>
                        <ENT>0.00012</ENT>
                        <ENT>n/a</ENT>
                        <ENT>0.7</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tebuconzole</ENT>
                        <ENT>EPA OPP HHRA, 2021</ENT>
                        <ENT>Becker and Biedermann, 1995</ENT>
                        <ENT>Increased incidence of skull/neural tube defects including abnormalities of the eyes, head and skull</ENT>
                        <ENT>0.03</ENT>
                        <ENT>n/a</ENT>
                        <ENT>200</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tribufos</ENT>
                        <ENT>EPA OPP HHRA, 2015</ENT>
                        <ENT>Sheets and Gilmore, 2001</ENT>
                        <ENT>Inhibition of RBC ChE in adult female rats</ENT>
                        <ENT>0.0002</ENT>
                        <ENT>n/a</ENT>
                        <ENT>1</ENT>
                    </ROW>
                    <TNOTE>* Microcystin LR was used as a surrogate for deriving an oral reference value for all microcystin congeners.</TNOTE>
                </GPOTABLE>
                <GPOTABLE COLS="7" OPTS="L2,nj,p7,7/8,i1" CDEF="s75,10,r25,r40,r40,r40,r40">
                    <TTITLE>Table 5—Occurrence Findings From Primary Data Sources</TTITLE>
                    <BOXHD>
                        <CHED H="1">RD 5 contaminant</CHED>
                        <CHED H="1">HRL, µg/L</CHED>
                        <CHED H="1">Primary database</CHED>
                        <CHED H="1">
                            PWSs with at least 1 detection &gt;
                            <FR>1/2</FR>
                             HRL
                        </CHED>
                        <CHED H="1">
                            Population served by PWSs with at least 1 detection &gt;
                            <FR>1/2</FR>
                             HRL
                        </CHED>
                        <CHED H="1">PWSs with at least 1 detection &gt; HRL</CHED>
                        <CHED H="1">Population served by PWSs with at least 1 detection &gt; HRL</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">2-Aminotoluene</ENT>
                        <ENT>2</ENT>
                        <ENT>UCMR 4 AM</ENT>
                        <ENT>0/5,030 (0.00%)</ENT>
                        <ENT>0/249 M (0.00%)</ENT>
                        <ENT>0/5,030 (0.00%)</ENT>
                        <ENT>0/249 M (0.00%).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cylindrospermopsin</ENT>
                        <ENT>0.6</ENT>
                        <ENT>UCMR 4 AM</ENT>
                        <ENT>3/3,484 (0.09%)</ENT>
                        <ENT>30,829/195 M (0.02%)</ENT>
                        <ENT>1/3,484 (0.03%)</ENT>
                        <ENT>10,174/195 M (0.01%).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ethoprop</ENT>
                        <ENT>0.09</ENT>
                        <ENT>UCMR 4 AM</ENT>
                        <ENT>3/5,028 (0.06%)</ENT>
                        <ENT>75,032/249 M (0.03%)</ENT>
                        <ENT>1/5,028 (0.02%)</ENT>
                        <ENT>14,999/249 M (0.01%).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Microcystins</ENT>
                        <ENT>0.3</ENT>
                        <ENT>UCMR 4 AM</ENT>
                        <ENT>7/3,485 (0.20%)</ENT>
                        <ENT>119,725/195 M (0.06%)</ENT>
                        <ENT>7/3,485 (0.20%)</ENT>
                        <ENT>119,725/195 M (0.06%).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Molybdenum</ENT>
                        <ENT>100</ENT>
                        <ENT>UCMR 3 AM</ENT>
                        <ENT>29/4,922 (0.59%)</ENT>
                        <ENT>600,187/241 M (0.25%)</ENT>
                        <ENT>7/4,922 (0.14%)</ENT>
                        <ENT>148,678/241 M (0.06%).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Permethrin</ENT>
                        <ENT>3000</ENT>
                        <ENT>UCMR 4 AM</ENT>
                        <ENT>0/5,028 (0.00%)</ENT>
                        <ENT>0/249 M (0.00%)</ENT>
                        <ENT>0/5,028 (0.00%)</ENT>
                        <ENT>0/249 M (0.00%).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Profenofos</ENT>
                        <ENT>0.7</ENT>
                        <ENT>UCMR 4 AM</ENT>
                        <ENT>4/5,028 (0.08%)</ENT>
                        <ENT>85,728/249 M (0.03%)</ENT>
                        <ENT>1/5,028 (0.02%)</ENT>
                        <ENT>14,999/249 M (0.01%).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tebuconazole</ENT>
                        <ENT>200</ENT>
                        <ENT>UCMR 4 AM</ENT>
                        <ENT>0/5,028 (0.00%)</ENT>
                        <ENT>0/249 M (0.00%)</ENT>
                        <ENT>0/5,028 (0.00%)</ENT>
                        <ENT>0/249 M (0.00%).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tribufos</ENT>
                        <ENT>1</ENT>
                        <ENT>UCMR 4 AM</ENT>
                        <ENT>0/5,027 (0.00%)</ENT>
                        <ENT>0/249 M (0.00%)</ENT>
                        <ENT>0/5027 (0.00%)</ENT>
                        <ENT>0/249 M (0.00%).</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD2">B. Contaminant Profiles</HD>
                <HD SOURCE="HD3">1. 2-Aminotoluene</HD>
                <HD SOURCE="HD3">(a) Background</HD>
                <P>
                    2-Aminotoluene (also referred to as 
                    <E T="03">o</E>
                    -toluidine or 2-methylaniline) is a synthetic aromatic amine and occurs as a colorless or light-yellow liquid. It is used in the manufacture of dyes, rubber vulcanization accelerators, pharmaceuticals and pesticides.
                </P>
                <P>
                    Production data for 2-aminotoluene are available from the EPA's IUR and CDR programs. Annual production and importation of 2-aminotoluene was last reported by IUR for 2005 to be in the range of 10 to &lt;50 million pounds. From 2012 to 2019, annual production was in the range of 50 to 100 million pounds as reported under CDR. Industrial release data from TRI indicate that on-
                    <PRTPAGE P="3845"/>
                    site surface water discharges have been at just under 200 pounds per year since 2009, with no more than six states reporting surface water discharges in a given year.
                </P>
                <P>An overall removal half-life for 2-aminotoluene in Rhine River water was estimated to be approximately 1 day (IPCS, 1998). Volatilization from water surfaces is expected to be an important fate process. Based on these physical and chemical properties, 2-aminotoluene is unlikely to be environmentally persistent in surface water.</P>
                <HD SOURCE="HD3">(b) Statutory Criterion 1 (Adverse Health Effects)</HD>
                <P>The EPA proposes to find that 2-aminotoluene meets the first SDWA statutory criterion for regulatory determinations: exposure to 2-aminotoluene may have an adverse effect on the health of persons. The health assessment selected for RD 5 is the 2012 EPA Provisional Peer-Reviewed Toxicity Value (PPRTV) (USEPA, 2012b) because it is the only qualifying peer-reviewed health assessment identified for 2-aminotoluene that derives an oral CSF based on the best available science. In this health assessment, the EPA determined that 2-aminotoluene is “likely to be carcinogenic to humans” by following the process described in the EPA's 2005 Guidelines for Carcinogen Risk Assessment (USEPA, 2005b; USEPA, 2012b).</P>
                <P>
                    In the 2012 EPA PPRTV (USEPA, 2012b), the EPA selected a chronic carcinogenicity diet study in mice and rats (Weisburger et al., 1978) as the critical study to derive an oral CSF for 2-aminotoluene (see section 3.3 of Chapter 3 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more details about the critical study). Increased subcutaneous fibromas and fibrosarcomas in male rats was the critical effect selected for derivation of an oral CSF because it provided the most sensitive cancer endpoint (USEPA, 2012b). Because the Weisburger et al. (1978) study exposed experimental animals to 
                    <E T="03">o</E>
                    -toluidine hydrochloride (HCl), the EPA converted the oral CSF of 0.02 (mg/kg-day)
                    <E T="51">−1</E>
                      
                    <E T="03">o</E>
                    -toluidine HCl to account for the molecular weight difference of 
                    <E T="03">o</E>
                    -toluidine, resulting in a computed oral CSF of 0.016 (mg/kg-day)
                    <E T="51">−1</E>
                     for o-toluidine (2-aminotoluene) (USEPA, 2012b).
                </P>
                <P>
                    Because exposure began during postnatal development (
                    <E T="03">i.e.,</E>
                     at six to eight weeks of age) in the critical study (Weisburger et al., 1978), the EPA used the DWI-BW representing the 90th percentile consumers-only, two-day average, direct and indirect community water consumption for children (birth to &lt;21 years) of 0.0343 L/kg/day (USEPA, 2019a) to derive the HRL for 2-aminotoluene (see decision logic provided in section B.6.1.2 of the RD 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ).
                </P>
                <P>
                    Following HRL derivation practices, the EPA derived an HRL for 2-aminotoluene of 2 µg/L after rounding to one significant figure, based on a one-in-a-million (10
                    <E T="51">−6</E>
                    ) CRL, an oral CSF of 0.016 (mg/kg/day)
                    <E T="51">−1</E>
                     (USEPA, 2012b) and a DWI-BW of 0.0343 L/kg/day (USEPA, 2019a).
                </P>
                <P>These analyses formed the basis for the EPA's finding that 2-aminotoluene may have adverse effect on the health of persons and therefore that Statutory Criterion 1 is met.</P>
                <HD SOURCE="HD3">(c) Statutory Criterion 2 (Occurrence)</HD>
                <P>The EPA proposes to find that 2-aminotoluene does not occur with a frequency and at levels of public health concern in PWSs based on the EPA's evaluation of the following occurrence information.</P>
                <P>
                    The primary occurrence data for 2-aminotoluene are nationally representative drinking water monitoring data from the UCMR 4 program (2018-2020). Under UCMR 4 a.m., 37,517 samples collected from 5,030 PWSs were analyzed for 2-aminotoluene. Of these systems, 86 (1.71%) reported detections at or above the MRL of 0.007 µg/L. There were no detections greater than the HRL (2 µg/L) or the 
                    <FR>1/2</FR>
                     HRL threshold (1 µg/L) (USEPA, 2024b). This comprehensive dataset suggests that 2-aminotoluene is not present in public water systems at concentrations that would pose a risk to human health.
                </P>
                <P>Occurrence data for 2-aminotoluene in ambient water are available from the NWIS database and STORET. NWIS data show no detections of 2-aminotoluene in any of the 145 samples at 67 sites. The STORET data set had no detections of 2-aminotoluene out of 3 samples collected at 3 sites in 2021-2022.</P>
                <P>Based on the evaluation of these data sources, the EPA finds that 2-aminotoluene does not occur and is not likely to occur in PWSs with a frequency and at levels of public health concern. Therefore, the EPA finds that Statutory Criterion 2 is not met.</P>
                <HD SOURCE="HD3">(d) Statutory Criterion 3 (Meaningful Opportunity)</HD>
                <P>Regulating 2-Aminotoluene under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed population, including sensitive populations. UCMR 4 data indicate that the estimated population exposed to 2-aminotoluene at levels of public health concern is 0%. As a result, the agency finds that an NPDWR for 2-aminotoluene does not present a meaningful opportunity for health risk reduction.</P>
                <HD SOURCE="HD3">(e) Preliminary Regulatory Determination for 2-Aminotoluene</HD>
                <P>The agency is making a preliminary determination not to regulate 2-aminotoluene with an NPDWR after evaluating health, occurrence and other related information against the three SDWA statutory criteria. While data indicate that 2-aminotoluene may have an adverse effect on human health, the occurrence data indicate that 2-aminotoluene does not occur, nor is it likely to occur in PWSs with a frequency and at levels of public health concern.</P>
                <P>
                    Therefore, the agency has determined that regulating 2-aminotoluene with an NPDWR would not present a meaningful opportunity to reduce health risk for persons served by PWSs. The 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b) and the 
                    <E T="03">Occurrence Data from the Fourth Unregulated Contaminant Monitoring Rule (UCMR 4)</E>
                     (USEPA, 2024c) present additional information and analyses supporting the agency's evaluation of 2-aminotoluene.
                </P>
                <HD SOURCE="HD3">2. Cylindrospermopsin</HD>
                <HD SOURCE="HD3">(a) Background</HD>
                <P>Cylindrospermopsin is a toxin naturally produced and released by cyanobacteria. Cyanobacteria, sometimes referred to as blue-green algae, are photosynthetic bacteria that are nearly ubiquitous in freshwater and marine environments. HABs of cyanobacteria in freshwater environments can release quantities of cyanotoxins, including cylindrospermopsin.</P>
                <P>
                    Cylindrospermopsin is a tricyclic alkaloid (USEPA, 2015b). Cylindrospermopsin is naturally produced in the environment by cyanobacteria genera including the cylindrospermopsin-producing species 
                    <E T="03">Aphanizomenon, Dolichospermum</E>
                     (previously 
                    <E T="03">Anabaena</E>
                    ), 
                    <E T="03">Lyngbya, Raphidiopsis</E>
                     (previously 
                    <E T="03">Cylindrosperopsis</E>
                    ) and 
                    <E T="03">Umezakia</E>
                     (USEPA, 2022d). Cyanotoxin production is influenced by environmental conditions that favor the growth of particular cyanobacterial species and strains. Factors that affect 
                    <PRTPAGE P="3846"/>
                    cyanobacterial growth, cyanobacteria population dynamics and the development of blooms include nutrient concentrations, light intensity, water turbidity, temperature, competing bacteria and phytoplankton, pH and turbulence (mixing). The concentrations of cyanotoxins released from a bloom will depend on the composition of the bloom and environmental and ecosystem influences on bloom dynamics (USEPA, 2015b).
                </P>
                <P>Cylindrospermopsin may readily leach or be released from intact cyanobacterial cells into surrounding water. Field studies have found that from 24% to 100% of cylindrospermopsin can be extracellular (Chorus and Welker, 2021). Cylindrospermopsin is highly water-soluble (WHO, 2020a). Its ability to partition from water to sediments is affected by the type of sediment, with some adsorption to organic carbon sediments and little adsorption to sandy and silt sediments. Bioaccumulation of cylindrospermopsin in freshwater organisms has been documented (Kinnear, 2010).</P>
                <HD SOURCE="HD3">(b) Statutory Criterion 1 (Adverse Health Effects)</HD>
                <P>Exposure to cylindrospermopsin may have an adverse effect on the health of persons as supported by the health assessments identified for RD 5 (USEPA, 2015b; WHO, 2020a). The health assessment selected to derive an HRL for cylindrospermopsin is the 2015 EPA Office of Water (OW) Health Effects Support Document (HESD) (USEPA, 2015b) because it is an EPA peer-reviewed health assessment that derives an oral toxicity value and it uses the best available science in its evaluation of noncancer risk for cylindrospermopsin.</P>
                <P>
                    In the 2015 EPA OW HESD (USEPA, 2015b), the EPA selected an 11-week drinking water toxicity study in mice (Humpage and Falconer, 2002; Humpage and Falconer, 2003) as the critical study to derive an oral reference value (see section 4.3 of Chapter 4 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more details about the critical study). A No Observed Adverse Effect Level (NOAEL) of 30 mg/kg/day for increased relative kidney weight in mice was the critical effect and point of departure (POD) selected to derive an oral reference value because this was the most sensitive endpoint assessed in the critical study (USEPA, 2015b). A total UF of 300 was applied to the POD: an interspecies UF (UF
                    <E T="52">A</E>
                    ) of 10, an intraspecies UF (UF
                    <E T="52">H</E>
                    ) of 10 and a database UF (UF
                    <E T="52">D</E>
                    ) of 3. After applying the total UF of 300 (details can be found in section 4.3 of Chapter 4 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ), the oral reference value was calculated to be 0.0001 mg/kg/day (USEPA, 2015b) and the EPA selected this oral reference value to derive an HRL for RD 5.
                </P>
                <P>
                    The critical study does not report how old the mice were at the onset of exposure; however, it does report that mice weighed 20 to 25 grams at the beginning of the experiment (Humpage and Falconer, 2002; Humpage and Falconer, 2003). The EPA extrapolated the body weight of the rodents to their approximate age to determine the most sensitive lifestage exposed (Jackson Labs, 2023). Because exposure was estimated to have begun during postnatal development (
                    <E T="03">i.e.,</E>
                     at approximately six to eight weeks of age), the EPA used the DWI-BW representing the 90th percentile consumers-only, two-day average, direct and indirect community water consumption for children (birth to &lt;21 years) of 0.0343 L/kg/day (USEPA, 2019a) to derive the to derive the HRL for cylindrospermopsin (see decision logic provided in section B.6.1.2 of the RD 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ).
                </P>
                <P>Following HRL derivation practices, the EPA derived an HRL for cylindrospermopsin of 0.6 µg/L after rounding to one significant figure, based on an oral reference value of 0.0001 mg/kg/day (USEPA, 2015b), a DWI-BW of 0.0343 L/kg/day (USEPA, 2019a) and a 20% RSC (USEPA, 2000a). Note that this value differs from the 10-day HA for bottle-fed infants and young children (0.7 µg/L) and the 10-day HA for school-age children through adults (3 µg/L). These HA values are considered protective of non-carcinogenic adverse health effects over a ten-day exposure to cylindrospermopsin in drinking water.</P>
                <P>Based on these analyses, the EPA finds that cylindrospermopsin may have an adverse effect on the health of persons and therefore that Statutory Criterion 1 is met.</P>
                <HD SOURCE="HD3">(c) Statutory Criterion 2 (Occurrence)</HD>
                <P>The EPA proposes to find that cylindrospermopsin does not occur with a frequency and at levels of public health concern in PWSs based on the EPA's evaluation of the following occurrence information.</P>
                <P>Occurrence data for cylindrospermopsin in ambient water are available from the USGS NAWQA program, the USGS NWIS database, the EPA's legacy STORET Data System and several published studies. Additionally, a total of 18 states voluntarily adopted use of the One Health Harmful Algal Bloom System and entered 421 reports during 2016-2018 (Roberts et al., 2020). The majority of HAB events occurred during May-October (98%) and in freshwater bodies (90%). Cylindrospermopsin was reported as present in 4 (1%) of the 421 HAB events.</P>
                <P>The primary occurrence data for cylindrospermopsin are nationally representative drinking water monitoring data from the UCMR 4 program (2018-2020). Under UCMR 4 a.m., 35,425 samples collected from 3,484 PWSs were analyzed for cylindrospermopsin via EPA Method 545. Monitoring consisted of sampling finished drinking water in PWSs that use surface water or GWUDI. Groundwater systems were excluded from cyanotoxin monitoring. Monitoring occurred twice a month for four consecutive months during the period from March through November (for a total of eight sampling events). Sampling was conducted at entry points to the distribution system.</P>
                <P>In addition to analytical sample results, UCMR 4 required systems to provide information related to source water conditions and cyanobacteria/cyanotoxin occurrence and treatment, including bloom occurrence, possible bloom treatment and details on changes in source water quality conditions.</P>
                <P>
                    Reported UCMR 4 cylindrospermopsin concentrations ranged from 0.09 µg/L (the MRL) to 0.877 µg/L. Of these sampled systems, 12 (0.34% of systems, serving 0.23% of the PWS-served population) reported at least one detection of cylindrospermopsin. Three systems serving nearly 31,000 people reported at least one detection of cylindrospermopsin greater than the 
                    <FR>1/2</FR>
                     HRL threshold of 0.3 µg/L and 1 system serving 10,174 people reported at least one detection of cylindrospermopsin greater than the HRL of 0.6 µg/L. Extrapolating these findings from the population served by the PWSs participating in UCMR 4 to the national PWS-served population suggests that an estimated 34 PWSs serving around 488,000 people nationally have at least one detection of cylindrospermopsin while an estimated 14 PWSs serving 40,900 people nationally have at least one detection of cylindrospermopsin greater than the 
                    <FR>1/2</FR>
                     HRL threshold and only 1 PWS, serving 10,200 people, has at least one detection greater than the HRL.
                </P>
                <P>
                    Based on the evaluation of these data sources, the EPA finds that cylindrospermopsin does not occur in PWSs with a frequency and at levels of 
                    <PRTPAGE P="3847"/>
                    public health concern. Therefore, the EPA finds that Statutory Criterion 2 is not met.
                </P>
                <HD SOURCE="HD3">(d) Statutory Criterion 3 (Meaningful Opportunity)</HD>
                <P>Regulating cylindrospermopsin under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed population, including sensitive populations. The estimated PWS-served population exposed to cylindrospermopsin at levels of public health concern is 0.01% based on UCMR 4 finished water data.</P>
                <P>Conventional water treatment (consisting of coagulation, sedimentation, filtration and chlorination) can generally remove intact cyanobacterial cells and low levels of cyanotoxins from source waters. However, water systems may face challenges in providing drinking water during a severe bloom event when there are high levels of cyanobacteria and cyanotoxins in source waters. With proactive planning, diligent operations and maintenance and active management, PWSs can reduce the risks of cyanotoxins breaking through the treatment process and occurring in finished drinking water. Because these non-regulatory efforts to manage cyanotoxins are effective, the agency finds that an NPDWR for cylindrospermopsin does not present a meaningful opportunity for health risk reduction.</P>
                <HD SOURCE="HD3">(e) Preliminary Regulatory Determination for Cylindrospermopsin</HD>
                <P>The EPA is making a preliminary determination not to regulate cylindrospermopsin with an NPDWR after evaluating health, occurrence and other related information against the three SDWA statutory criteria. While data suggest that cylindrospermopsin may have an adverse effect on human health, the occurrence data indicate that cylindrospermopsin is not occurring or not likely to occur in PWSs with a frequency and at levels of public health concern. Additionally, because conventional water treatment and continued efforts by water systems to manage cyanotoxins have proven effective, an NPDWR for cylindrospermopsin does not present a meaningful opportunity for health risk reduction.</P>
                <HD SOURCE="HD3">2. Ethoprop</HD>
                <HD SOURCE="HD3">(a) Background</HD>
                <P>Ethoprop is an organophosphate (phosphorodithioate) pesticide and is used as an insecticide and nematicide. Ethoprop was first registered in the U.S. in 1967 (USEPA, 2006a) and is used on vegetables, fruits and other plants, including potatoes, sweet potatoes, beans, cucumbers, cabbage, pineapples, bananas, plantains, tobacco and ornamentals. Environmental fate assessments with organic carbon partitioning coefficient (Koc) values of 70-120 L/kg suggest ethoprop is mobile in soil and water (NCBI, 2023a).</P>
                <P>USGS estimates the usage of ethoprop has unevenly declined from 1992 to 2019, with less than 1 million pounds of ethoprop used per year since 2012 in the United States. According to USGS, ethoprop usage has been limited geographically in recent years, mainly to the Pacific Northwest and California.</P>
                <HD SOURCE="HD3">(b) Statutory Criterion 1 (Adverse Health Effects)</HD>
                <P>Exposure to ethoprop may have an adverse effect on the health of persons as supported by the health assessment identified for RD 5 (USEPA, 2015c; USEPA, 2015d). For pesticide chemicals currently registered under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), including ethoprop, toxicity information from the EPA's Office of Pesticide Programs (OPP) Human Health Risk Assessments (HHRAs) was used as the basis for HRL derivation (USEPA, 2024b).</P>
                <P>
                    The health assessment selected to derive an HRL for ethoprop is the 2015 EPA OPP HHRA (USEPA, 2015c; USEPA, 2015d), which provided both cancer and noncancer toxicity values (
                    <E T="03">i.e.,</E>
                     an oral reference value and oral CSF) for ethoprop. In 2023, OPP conducted exposure assessments for ethoprop to estimate human health risks resulting from registered uses (USEPA, 2023a). The cancer classification had then changed from “Likely to be Carcinogenic to Humans” to “Suggestive Evidence of Carcinogenic Potential” based on the presence of thyroid C-cell tumors in male F344 rats (USEPA, 2005b; 2023a). Although the critical study showed suggestive cancer effects from exposure to ethoprop, there were no concerns for mutagenicity. As a result, OPP recommended using a non-linear (
                    <E T="03">i.e.,</E>
                     RfD) approach as a protective measure of carcinogenic risk and did not conduct a new cancer assessment (USEPA, 2023a). Therefore, for RD 5 the EPA derived a noncancer HRL based on the oral reference value provided in the 2015 EPA OPP HHRA (USEPA, 2015c).
                </P>
                <P>
                    In the 2015 EPA OPP HHRA, the EPA selected a repeat-dosing gavage study in rats (Chartier et al., 2005) as the critical study to derive the oral reference value (see section 5.3 of Chapter 5 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more details about the critical study). Benchmark dose (BMD) modeling was used to determine the lower 95% confidence limit on the BMD level associated with a 10% response (BMDL
                    <E T="52">10</E>
                    ), the response in this case being inhibition of cholinesterase (ChE) activity (USEPA, 2015c). Inhibition of red blood cell (RBC) acetylcholinesterase (AChE) activity in postnatal day (PND) 11 males was the critical effect selected for derivation of the oral reference value because it was the most sensitive endpoint modeled (USEPA, 2015c). Therefore, the corresponding BMDL
                    <E T="52">10</E>
                     of 0.0653 mg/kg/day was selected as the POD for ethoprop (USEPA, 2015c). A total uncertainty factor (UF) of 1,000 was applied to the POD: an interspecies UF (UF
                    <E T="52">A</E>
                    ) of 10, an intraspecies UF (UF
                    <E T="52">H</E>
                    ) of 10, and a Food Quality Protection Act (FQPA) safety factor of 10 to account for uncertainty in the human dose-response relationship for neurodevelopmental effects (USEPA, 2015c). After applying the total UF (for more details about the selected UF, see section 5.3 of Chapter 5 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ), the oral reference value was calculated to be 0.000065 mg/kg/day and the EPA selected this oral reference value to derive an HRL for ethoprop.
                </P>
                <P>
                    Because exposure began during early postnatal development (
                    <E T="03">i.e.,</E>
                     11 days of age) in the critical study (Chartier et al., 2005), the EPA used the DWI-BW representing the 90th percentile consumers-only, two-day average, of direct and indirect community water consumption for infants (birth to &lt;1 year) of 0.143 L/kg/day (USEPA, 2019a) to derive the HRL for ethoprop (see decision logic provided in section B.6.1.2 of the RD 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ).
                </P>
                <P>Following HRL derivation practices, the EPA derived an HRL for ethoprop of 0.09 µg/L after rounding to one significant figure, based on an oral reference value of 0.000065 mg/kg/day (USEPA, 2015c), a DWI-BW of 0.143 L/kg/day (USEPA, 2019a) and a 20% RSC (USEPA, 2000a).</P>
                <P>Based on these analyses, the EPA finds that ethoprop may have an adverse effect on the health of persons and therefore that Statutory Criterion 1 is met.</P>
                <HD SOURCE="HD3">(c) Statutory Criterion 2 (Occurrence)</HD>
                <P>
                    The EPA proposes to find that ethoprop does not occur with a frequency and at levels of public health concern in PWSs based on the EPA's evaluation of occurrence information.
                    <PRTPAGE P="3848"/>
                </P>
                <P>
                    The primary occurrence data for ethoprop are nationally representative drinking water monitoring data from UCMR 4 (2018-2020). Ethoprop was found in 0.1% of systems (5 of 5,028) monitored in UCMR 4 a.m. Of systems that reported results for ethoprop, three systems, or 0.06%, reported results above the 
                    <FR>1/2</FR>
                     HRL threshold of 0.045 µg/L, and one system (0.02%) reported a result above the HRL (0.09 µg/L). Extrapolating the UCMR 4 data suggests that less than 0.01% of the national PWS-served population may be exposed to ethoprop in drinking water at levels above the HRL.
                </P>
                <P>Based on the evaluation of these data sources, the EPA finds that ethoprop does not occur and is not likely to occur in PWSs with a frequency and at levels of public health concern. Therefore, the EPA finds that Statutory Criterion 2 is not met.</P>
                <HD SOURCE="HD3">(d) Statutory Criterion 3 (Meaningful Opportunity)</HD>
                <P>The EPA proposes to find that ethoprop does not occur with a frequency and at levels of public health concern in PWSs based on the EPA's evaluation of the occurrence information. Therefore, regulation of ethoprop under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by PWSs.</P>
                <HD SOURCE="HD3">(e) Preliminary Regulatory Determination for Ethoprop</HD>
                <P>
                    The agency is making a preliminary determination not to regulate ethoprop with an NPDWR after evaluating health, occurrence and other related information against the three SDWA statutory criteria. While data suggest that ethoprop may have an adverse effect on human health, the occurrence data indicate that ethoprop is not occurring or not likely to occur in PWSs with a frequency and at levels of public health concern. The 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b) and the 
                    <E T="03">Occurrence Data from the Fourth Unregulated Contaminant Monitoring Rule (UCMR 4</E>
                    ) (USEPA, 2024c) present additional information and analyses supporting the agency's evaluation of ethoprop.
                </P>
                <HD SOURCE="HD3">3. Microcystins</HD>
                <HD SOURCE="HD3">(a) Background</HD>
                <P>Microcystins are toxins naturally produced and released by cyanobacteria. Cyanobacteria, sometimes referred to as blue-green algae, are photosynthetic bacteria that are nearly ubiquitous in freshwater and marine environments. HABs of cyanobacteria in freshwater environments can release quantities of cyanotoxins, including microcystins.</P>
                <P>Microcystins exist in multiple forms (congeners), based on variations in amino acid composition; there are approximately 100 known microcystin congeners (USEPA, 2015e). Microcystins are generally distinguished using letters that refer to the two variable amino acids. Microcystin-LR, which includes leucine (L) and arginine (R) amino acids, is the most common congener and also the most intensively studied (USEPA, 2015e). Synonyms for microcystin-LR include cyanoginosin LR (NCBI, 2022).</P>
                <P>
                    The cyanobacteria genera 
                    <E T="03">Anabaena, Fischerella, Gloeotrichia, Microcystis, Nodularia, Nostoc, Oscillatoria</E>
                     and 
                    <E T="03">Planktothrix</E>
                     are known to include microcystin-producing species (USEPA, 2015e). Microcystins are the most common cyanotoxins found worldwide and they have been reported in surface waters in most of the U.S. (Funari and Testai, 2008 as cited in USEPA, 2015e). For the most part, microcystins are not released into surrounding waters by healthy living cyanobacterial cells. Release of microcystins generally results from senescence or lysis. Cyanotoxin production is influenced by environmental conditions that favor the growth of particular cyanobacterial species and strains. Factors that affect cyanobacterial growth, cyanobacteria population dynamics and the development of blooms include nutrient concentrations, light intensity, water turbidity, temperature, competing bacteria and phytoplankton, pH and turbulence (mixing). The concentrations of cyanotoxins released from a bloom will depend on the composition of the bloom and environmental and ecosystem influences on bloom dynamics (USEPA, 2015f). Microcystins have the potential for bioconcentration and bioaccumulation in tissue (Machado et al., 2017).
                </P>
                <HD SOURCE="HD3">(b) Statutory Criterion 1 (Adverse Health Effects)</HD>
                <P>Exposure to microcystin congeners microcystin-LA, microcystin-LW, microcystin-RR, microcystin-YR and microcystin-LR, referred to collectively throughout this document as “microcystins,” may have an adverse effect on the health of persons as supported by the multiple health assessments identified for RD 5 (USEPA, 2015e; HC, 2017; WHO, 2020b). The health assessment selected for RD 5 is the 2015 EPA OW HESD (USEPA, 2015e) because it is an EPA peer-reviewed health assessment that derives an oral toxicity value and uses the best available science in its evaluation of noncancer risk.</P>
                <P>
                    In the 2015 EPA OW HESD (USEPA, 2015e), the EPA selected a 28-day drinking water study in 11-week-old male rats (Heinze, 1999) as the critical study to derive an oral reference value (see section 6.3 of Chapter 6 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more details about the critical study). A Lowest Observed Adverse Effect Limit (LOAEL) of 50 mg/kg/day for liver effects in rats orally exposed to microcystin-LR was identified as the critical effect and used to derive an oral reference value because this was considered the “most appropriate basis for quantitation as it was a common finding among oral toxicology studies” (USEPA, 2015e). Since microcystin-LR is one of the most potent microcystin congeners and the majority of microcystin toxicity data comes from studying this congener, microcystin-LR was used as a surrogate for deriving an oral reference value for all microcystins (USEPA, 2015e). A total UF of 1000 was applied to the POD: a UF
                    <E T="52">A</E>
                     of 10, a UF
                    <E T="52">H</E>
                     of 10, a LOAEL-to-NOAEL extrapolation UF (UF
                    <E T="52">L</E>
                    ) of 3 and a UF
                    <E T="52">D</E>
                     of 3. After applying the total UF of 1000, the oral reference value was calculated to be 0.00005 mg/kg/day (USEPA, 2015e) and the EPA selected this oral reference value to derive an HRL for microcystins.
                </P>
                <P>
                    Because exposure in the critical study started post-adolescence (
                    <E T="03">i.e.,</E>
                     at 11 weeks of age), the EPA used the DWI-BW EF representing the 90th percentile consumers-only, two-day average, direct and indirect community water consumption for adults (21 years and older) of 0.0336 L/kg/day (USEPA, 2019a) to derive the HRL for microcystins (see decision logic provided in section B.6.1.2 of the RD 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ).
                </P>
                <P>Following HRL derivation practices, the EPA derived an HRL for microcystins of 0.3 µg/L after rounding to one significant figure, based on an oral reference value of 0.00005 mg/kg/day (USEPA, 2015e), a DWI-BW of 0.0336 L/kg/day (USEPA, 2019a) and a 20% RSC (USEPA, 2000a).</P>
                <P>Based on these analyses, the EPA finds that microcystins may have an adverse effect on the health of persons and therefore that Statutory Criterion 1 is met.</P>
                <HD SOURCE="HD3">(c) Statutory Criterion 2 (Occurrence)</HD>
                <P>
                    The EPA proposes to find that microcystins do not occur with a frequency and at levels of public health concern in PWSs based on the EPA's 
                    <PRTPAGE P="3849"/>
                    evaluation of the following occurrence information.
                </P>
                <P>Occurrence data for microcystins in ambient water are available from the USGS NAWQA program, the USGS NWIS database, the EPA's legacy STORET Data System and several published studies. Additionally, a total of 18 states voluntarily adopted use of the One Health Harmful Algal Bloom System and entered 421 reports during 2016-2018 (Roberts et al., 2020). The majority of HAB events occurred during May-October (98%) and in freshwater bodies (90%). Microcystins were reported as present in 291 of the 421 HABs. Of the 35 HABs where multiple cyanotoxins were found, microcystins were present in 33. Ambient water occurrence data are also available in the National Lakes Assessment. According to the 2017 report (USEPA, 2022e), microcystin was found in 21% of lakes. The minimum detection level was 0.1 µg/L. The EPA's recreational criterion (8 µg/L) was exceeded in 2% of lakes (4,400 lakes).</P>
                <P>
                    The primary occurrence data for microcystins are nationally representative drinking water monitoring data from the UCMR 4 program (2018-2020). Under UCMR 4 a.m., 35,000 samples were collected from 3,485 PWSs and analyzed for total microcystins via EPA Method 546.
                    <SU>14</SU>
                    <FTREF/>
                     Monitoring consisted of sampling finished drinking water in PWSs that use surface water or groundwater under the influence of surface water (GWUDI. Groundwater systems were excluded from cyanotoxin monitoring. Monitoring occurred twice a month for four consecutive months from March through November (for a total of eight sampling events). Sampling was conducted at entry points to the distribution system.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Using EPA Method 546, UCMR 4 systems were required to report total microcystins values at or above the EPA-defined MRL of 0.3 μg/L. If a reporting threshold of 0.3 μg/L for total microcystins using EPA Method 546 was exceeded, systems were required to report values for the six included microcystin congeners at or above the EPA-defined MRLs for each individual congener using EPA Method 544. For more details, see USEPA (2024c).
                    </P>
                </FTNT>
                <P>In addition to analytical sample results, UCMR 4 required systems to provide information related to source water conditions and cyanobacteria/cyanotoxin occurrence and treatment, including bloom occurrence, possible bloom treatment and details on changes in source water quality conditions.</P>
                <P>Reported UCMR 4 total microcystins concentrations ranged from 0.32 µg/L to 0.83 µg/L. Seven systems (0.20% of systems, serving 0.06% of the PWS-served population) reported at least one result at or above the MRL for total microcystins. Extrapolating these findings suggests that an estimated 29 PWSs serving 0.06% of the PWS-served population nationally may have detectable levels of total microcystins. While all reported results were above the HRL (0.3 µg/L), only eight of the 35,000 samples collected during UCMR 4 contained reportable concentrations of microcystins.</P>
                <P>Based on the evaluation of these data sources, the EPA finds that microcystins do not occur and are not likely to occur in PWSs with a frequency and at levels of public health concern. Therefore, the EPA finds that Statutory Criterion 2 is not met.</P>
                <HD SOURCE="HD3">(d) Statutory Criterion 3 (Meaningful Opportunity)</HD>
                <P>Regulating microcystins under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed population, including sensitive populations. The estimated population exposed to microcystins at levels of public health concern is 0.06% based on UCMR 4 finished water data.</P>
                <P>Conventional water treatment (consisting of coagulation, sedimentation, filtration and chlorination) can generally remove intact cyanobacterial cells and low levels of cyanotoxins from source waters. However, water systems may face challenges in providing drinking water during a severe bloom event when there are high levels of cyanobacteria and cyanotoxins in source waters. With proactive planning, diligent operations and maintenance and active management, PWSs can reduce the risks of cyanotoxins breaking through the treatment process and occurring in finished drinking water. Because these non-regulatory efforts are effective, the agency finds that an NPDWR for microcystins does not present a meaningful opportunity for health risk reduction.</P>
                <HD SOURCE="HD3">(e) Preliminary Regulatory Determination for Microcystins</HD>
                <P>The agency is making a preliminary determination to not regulate microcystins with an NPDWR after evaluating health, occurrence and other related information against the three SDWA statutory criteria. While data suggest that microcystins may have an adverse effect on human health, the occurrence data indicate that microcystins are not occurring or not likely to occur in PWSs with a frequency and at levels of public health concern. Additionally, because conventional water treatment and continued efforts by water systems to manage cyanotoxins have proven effective, an NPDWR for microcystins does not present a meaningful opportunity for health risk reduction.</P>
                <HD SOURCE="HD3">5. Molybdenum</HD>
                <HD SOURCE="HD3">(a) Background</HD>
                <P>Molybdenum is a naturally occurring element, which, especially in the form of molybdenum trioxide, is commonly used in metallurgy, including in alloys with cast iron, steel and superalloys. Molybdenum compounds are also used in catalysts, lubricants and pigments.</P>
                <P>Molybdenum is naturally present in soils and additional molybdenum may be added by weathering and atmospheric deposition and by direct human activity such as application of molybdenum and phosphate fertilizers (Wong et al., 2021; Smedley and Kinniburgh, 2017). Anthropogenic sources of molybdenum in water include effluents from molybdenum, uranium and copper mining and milling operations, oil production and oil refining operations, and coal-fired power plants. Molybdenum is generally more mobile in water under alkaline conditions, with a greater potential for bioavailability through water exposure (ATSDR, 2020).</P>
                <HD SOURCE="HD3">(b) Statutory Criterion 1 (Adverse Health Effects)</HD>
                <P>Exposure to molybdenum may have an adverse effect on the health of persons as supported by the health assessments identified for RD 5 (USEPA, 1992; WHO, 2011; ATSDR, 2020). The health assessment selected for RD 5 is the 2020 ATSDR Toxicological Profile (ATSDR, 2020) because it is the most recent peer-reviewed health assessment identified for molybdenum that derives an oral toxicity value, it uses the best available science in its evaluation of noncancer risk, and its toxicity value is based on a more recent critical study (Murray et al., 2014) than those of previous health assessments (USEPA, 1992; WHO, 2011).</P>
                <P>
                    In the 2020 ATSDR Toxicological Profile (ATSDR, 2020), ATSDR selected a 90-day dietary toxicity study in rats (Murray et al. 2014) as the critical study to derive an intermediate-duration oral reference value (see section 7.3 of Chapter 7 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more details about the critical study). A NOAEL of 17 mg/kg/day for renal effects in female rats was identified as the critical effect to derive an oral reference value because this was the most sensitive endpoint identified (ATSDR, 
                    <PRTPAGE P="3850"/>
                    2020). After applying the total UF of 100 and a modifying factor of 3, the intermediate-duration oral reference value was calculated to be 0.06 mg/kg/day. Because ATSDR did not derive a chronic-duration oral reference value, and the EPA's definition of chronic exposure is repeated exposure (oral, dermal or inhalation) for 
                    <E T="03">more</E>
                     than approximately 90 days to 2 years (USEPA, 2023b), the EPA applied a UF for extrapolation from subchronic-to chronic exposure duration (UF
                    <E T="52">S</E>
                    ) of 3, per agency guidelines (USEPA, 2002), to the intermediate-duration oral reference value that was derived using the 90-day study. Therefore, the resulting oral reference value used to derive the HRL for molybdenum was calculated to be 0.02 mg/kg/day.
                </P>
                <P>
                    Because exposure began during postnatal development (approximately nine weeks of age), the EPA used the DWI-BW representing the 90th percentile consumers-only, two-day average, direct and indirect community water consumption for children (birth to &lt;21 years) of 0.0343 L/kg/day (USEPA, 2019a) to derive the HRL for molybdenum (see decision logic provided in section B.6.1.2 of the RD 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ).
                </P>
                <P>
                    Following HRL derivation practices, the EPA derived an HRL for molybdenum of 100 µg/L after rounding to one significant figure, based on an oral reference value of 0.06 mg/kg/day (ATSDR, 2020), with an additional UF
                    <E T="52">S</E>
                     of 3, a DWI-BW of 0.0343 L/kg/day (USEPA, 2019a) and a 20% RSC (USEPA, 2000a).
                </P>
                <P>Based on these analyses, the EPA finds that molybdenum may have an adverse effect on the health of persons and therefore that Statutory Criterion 1 is met.</P>
                <HD SOURCE="HD3">(c) Statutory Criterion 2 (Occurrence)</HD>
                <P>The EPA proposes to find that molybdenum does not occur with a frequency and at levels of public health concern in PWSs based on the EPA's evaluation of the following occurrence information.</P>
                <P>
                    The primary occurrence data for molybdenum are nationally representative drinking water monitoring data from the UCMR 3 program (2013-2015). Under UCMR 3 a.m., 62,986 samples were collected from 4,922 PWSs and analyzed for molybdenum. Of these systems, 52% reported results at or above the MRL of 1 µg/L. Seven systems (0.14%) reported results above the HRL of 100 µg/L and 29 systems (0.59%) reported results above the 
                    <FR>1/2</FR>
                     HRL threshold of 50 µg/L. Based on the UCMR 3 occurrence data set, a national estimate of 216 systems and 0.06% of the PWS-served population may be exposed to molybdenum in drinking water at levels exceeding the HRL.
                </P>
                <P>
                    Occurrence data for molybdenum in ambient water are available from the NAWQA program and NWIS database. Across the three cycles of NAWQA, molybdenum was detected in 45% to 100% of samples. The HRL was exceeded in a single surface water sample (in Cycle 1) and in 0.12% to 0.26% of groundwater samples across the three cycles. Non-NAWQA NWIS data for molybdenum include 47 finished water samples from 29 sites. The highest reported finished water concentration (52.5 µg/L) exceeds the 
                    <FR>1/2</FR>
                     HRL threshold but not the HRL. The median concentration of NWIS detections was 1.64 µg/L.
                </P>
                <P>
                    For additional information on occurrence data available for molybdenum in drinking water please see section 7.4 of Chapter 7 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b).
                </P>
                <P>Based on the evaluation of these data sources, the EPA finds that molybdenum does not occur and is not likely to occur in PWSs with a frequency and at levels of public health concern. Therefore, the EPA finds that Statutory Criterion 2 is not met.</P>
                <HD SOURCE="HD3">(d) Statutory Criterion 3 (Meaningful Opportunity)</HD>
                <P>Regulating molybdenum under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed population, including sensitive populations. UCMR 3 data indicate that the estimated population exposed to molybdenum above the HRL is 0.08%. As a result of the low occurrence above the HRL, the agency finds that an NPDWR for molybdenum does not present a meaningful opportunity for health risk reduction.</P>
                <HD SOURCE="HD3">(e) Preliminary Regulatory Determination for Molybdenum</HD>
                <P>
                    The agency is making a preliminary determination not to regulate molybdenum with an NPDWR after evaluating health, occurrence and other related information against the three SDWA statutory criteria. While data suggest that molybdenum may have an adverse effect on human health, the occurrence data indicate that molybdenum is not occurring or not likely to occur in PWSs with a frequency and at levels of public health concern. The 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b) and the 
                    <E T="03">Occurrence Data from the Third Unregulated Contaminant Monitoring Rule (UCMR 3)</E>
                     (USEPA, 2019b) present additional information and analyses supporting the agency's evaluation of molybdenum.
                </P>
                <HD SOURCE="HD3">7. Permethrin</HD>
                <HD SOURCE="HD3">(a) Background</HD>
                <P>Permethrin is a pyrethroid pesticide primarily used as an insecticide, with various synonyms including ambush and corsair. It was first registered in the U.S. in 1979.</P>
                <P>Sources of permethrin include agricultural usage and industrial activities. TRI provides insight into industrial releases of permethrin. There have been no reported surface water discharges since 2005. Permethrin usage in agriculture has been estimated by USGS to have peaked in 1995 with 1.4 million pounds, with a gradual decrease to steady usage between around 600,000 and 800,000 pounds annually throughout 2001-2019.</P>
                <P>
                    The EPA's assessments of permethrin include its chemical and physical properties, such as very low solubility in water (0.006 mg/L) and K
                    <E T="52">oc</E>
                     values of 10,471-86,000 L/kg, which suggest that permethrin will be of low mobility in soil and less likely to partition to water. Biodegradation is expected to be rapid in various environmental conditions, since the half-life of permethrin in sediment/seawater is &lt;2.5 days, while the half-life of permethrin in a model ecosystem at 15-19 degrees Celsius and a pH of 7.7 was 1.1-3.6 days.
                </P>
                <HD SOURCE="HD3">(b) Statutory Criterion 1 (Adverse Health Effects)</HD>
                <P>Exposure to permethrin may have an adverse effect on the health of persons as supported by the health assessment identified for RD 5 (USEPA, 2020b; USEPA, 2020c). For pesticide chemicals currently registered under FIFRA, including permethrin, toxicity information from EPA's OPP HED HHRAs was used as the basis for HRL derivation (USEPA, 2023c).</P>
                <P>
                    The health assessment selected to derive an HRL for permethrin is the 2020 EPA OPP HHRA (USEPA, 2020ba; USEPA, 2020c). Following the approach described in the EPA's 
                    <E T="03">Guidelines for Carcinogen Risk Assessment</E>
                     (USEPA, 2005b), permethrin was classified in the health assessment as having “Suggestive Evidence of Carcinogenic Potential” based on lung adenomas in female mice. However, due to the lack of increased hazard from repeated/chronic exposure to permethrin, the acute risk estimate derived from the non-linear approach is 
                    <PRTPAGE P="3851"/>
                    protective of chronic toxicity, including carcinogenicity, that could result from permethrin exposure (USEPA, 2020c). Therefore, the EPA selected an acute gavage study in rats (Wolansky et al., 2006) as the critical study to derive an oral reference value (see section 8.3 of Chapter 8 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more details about the critical study). BMD modeling was performed to derive a lower 95% confidence limit on the BMD level associated with a difference of one standard deviation from controls (BMDL
                    <E T="52">1SD</E>
                    ) for decreased motor activity (Wolansky et al., 2006), which was identified as the critical effect for dietary exposure, as this was the most sensitive endpoint measured (USEPA, 2020c). The BMDL
                    <E T="52">1SD</E>
                     was calculated to be 44 mg/kg. A total UF of 100 was applied to the POD: a UF
                    <E T="52">H</E>
                     of 10 and a UF
                    <E T="52">A</E>
                     of 10. After applying the total UF of 100, the oral reference value was calculated to be 0.44 mg/kg/day (USEPA, 2020c) and the EPA selected this oral reference value to derive an HRL for permethrin.
                </P>
                <P>
                    Because exposure began during postnatal development (
                    <E T="03">i.e.,</E>
                     at approximately nine weeks of age) in the critical study (Wolansky et al., 2006), the EPA used the DWI-BW representing the 90th percentile consumers-only, two-day average, direct and indirect community water consumption for children (birth to &lt;21 years) of 0.0343 L/kg/day (USEPA, 2019a) to derive the HRL for permethrin (see decision logic provided in section B.6.1.2 of the RD 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document,</E>
                     USEPA, 2024b).
                </P>
                <P>Following HRL derivation practices, the EPA derived an HRL for permethrin of 3,000 µg/L after rounding to one significant figure, based on an oral reference value of 0.44 mg/kg/day (USEPA, 2020b; USEPA, 2020c), a DWI-BW of 0.0343 L/kg/day (USEPA, 2019a) and a 20% RSC (USEPA, 2000a).</P>
                <P>Based on these analyses, the EPA finds that permethrin may have an adverse effect on the health of persons and therefore that Statutory Criterion 1 is met.</P>
                <HD SOURCE="HD3">(c) Statutory Criterion 2 (Occurrence)</HD>
                <P>The EPA proposes to find that permethrin does not occur with a frequency and at levels of public health concern in PWSs based on the EPA's evaluation of occurrence information.</P>
                <P>
                    The primary occurrence data for permethrin are nationally representative drinking water monitoring data from the UCMR 4 program (2018-2020). Under UCMR 4 a.m., 37,291 samples collected from 5,028 PWSs were analyzed for permethrin. Permethrin was detected in 0.26% of systems at or above the MRL of 0.04 µg/L. There were no reported results above the HRL of 3,000 µg/L or above the 
                    <FR>1/2</FR>
                     HRL threshold. This comprehensive dataset suggests that permethrin is not present in public water systems at concentrations that would pose a risk to human health.
                </P>
                <P>To supplement the data obtained from UCMR 4, the EPA also reviewed ambient water data from the USGS NAWQA program. NAWQA Cycle 2 showed no detections of permethrin. NAWQA Cycle 3 showed detections of permethrin in 2 of 11 sites (18%) with no results above the HRL.</P>
                <P>Based on the evaluation of these data sources, the EPA finds that permethrin does not occur and is not likely to occur in PWSs with a frequency and at levels of public health concern. Therefore, the EPA finds that Statutory Criterion 2 is not met.</P>
                <HD SOURCE="HD3">(d) Statutory Criterion 3 (Meaningful Opportunity)</HD>
                <P>Regulating permethrin under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed population, including sensitive populations. UCMR 4 findings indicate the estimated population exposed to permethrin at levels of public health concern is 0%.</P>
                <HD SOURCE="HD3">(e) Preliminary Regulatory Determination for Permethrin</HD>
                <P>The agency is making a preliminary determination to not regulate permethrin with an NPDWR after evaluating health, occurrence and other related information against the three SDWA statutory criteria. While data suggest that permethrin may have an adverse effect on human health, the occurrence data indicate that permethrin is not occurring or not likely to occur in PWSs with a frequency and at levels of public health concern.</P>
                <P>
                    Therefore, the agency has made the preliminary determination that an NPDWR for permethrin would not present a meaningful opportunity to reduce health risk for persons served by PWSs. The 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b) presents additional information and analyses supporting the agency's evaluation of permethrin.
                </P>
                <HD SOURCE="HD3">7. Profenofos</HD>
                <HD SOURCE="HD3">(a) Background</HD>
                <P>Profenofos is an organophosphate pesticide that is applied as an insecticide. Synonyms for profenofos include curacron and selecron (NCBI, 2023b). Profenofos was first registered in the U.S. in 1982 (USEPA, 2008c). Profenofos registration was canceled in 2018 and it currently has no active labels in the EPA's Pesticide Product and Label System database (USEPA, 2023c). USGS Pesticide Use Maps show cotton is the sole crop to which profenofos was applied in the years before cancellation; usage diminished since the mid-1990s and ceased around 2011 according to these records.</P>
                <P>
                    Environmental fate assessments indicate that low to slight mobility in soil and transport to water is expected based on K
                    <E T="52">oc</E>
                     values. Volatilization from water is not expected to occur based on the contaminant's Henry's Law Constant; thus it will remain once present in water (NCBI, 2023b). In soil and water, biodegradation may occur, but profenofos is stable to photolysis in these media and is not likely to degrade with exposure to sunlight.
                </P>
                <HD SOURCE="HD3">(b) Statutory Criterion 1 (Adverse Health Effects)</HD>
                <P>Exposure to profenofos may have an adverse effect on the health of persons as supported by the health assessment identified for RD 5 (USEPA, 2015d; USEPA, 2015g). For pesticide chemicals currently registered under FIFRA, including profenofos, toxicity information from EPA OPP HED HHRAs was used as the basis for HRL derivation (USEPA, 2024b).</P>
                <P>
                    The health assessment selected to derive an HRL for profenofos is the 2015 EPA OPP HHRA (USEPA, 2015d; USEPA, 2015g). The EPA selected a chronic toxicity and carcinogenicity study in rats (Burdock et al., 1981) as the critical study to derive an oral reference value for profenofos (see section 9.3 of Chapter 9 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more details about the critical study). A BMDL
                    <E T="52">10</E>
                     of 0.12 mg/kg/day based on RBC AChE inhibition was identified as the critical effect and POD for dietary exposure, as this was the most sensitive endpoint measured (USEPA, 2015g). After applying the total UF of 1,000, the oral reference value was calculated to be 0.00012 mg/kg/day (USEPA, 2015g) and the EPA selected this oral reference value to derive an HRL for profenofos.
                </P>
                <P>
                    The EPA extrapolated the body weight of the rodents to their approximate age at the onset of exposure in the critical study (Burdock et al., 1981) to determine the most sensitive lifestage exposed. Because exposure was estimated to have begun during postnatal development (
                    <E T="03">i.e.,</E>
                     at approximately seven to eight weeks of age), the EPA used the DWI-BW representing the 90th percentile 
                    <PRTPAGE P="3852"/>
                    consumers-only, two-day average, direct and indirect community water consumption for children (birth to &lt;21 years) of 0.0343 L/kg/day (USEPA, 2019a) to derive the HRL for profenofos (see decision logic provided in section B.6.1.2 of the RD 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ).
                </P>
                <P>Following HRL derivation practices, the EPA derived an HRL for profenofos of 0.7 µg/L after rounding to one significant figure, based on an oral reference value of 0.00012 mg/kg/day (USEPA, 2015d; USEPA, 2015g), a DWI-BW of 0.0343 L/kg/day (USEPA, 2019a) and a 20% RSC (USEPA, 2000a).</P>
                <P>Based on these analyses, the EPA finds that profenofos may have an adverse effect on the health of persons and therefore that Statutory Criterion 1 is met.</P>
                <HD SOURCE="HD3">(c) Statutory Criterion 2 (Occurrence)</HD>
                <P>The EPA proposes to find that profenofos does not occur with a frequency and at levels of public health concern in PWSs after evaluation of information from the following sources: UCMR 4, Consumer Confidence Reports (CCRs) from PWSs, USDA PDP, USGS PMP.</P>
                <P>The primary occurrence data for profenofos are nationally representative drinking water monitoring data from the UCMR 4 program (2018-2020). The MRL for profenofos was 0.3 µg/L. Under UCMR AM, 37,287 samples collected from 5,028 PWSs were analyzed for profenofos and profenofos was detected in only four systems (0.08%). One system reported a result above the HRL of 0.7 µg/L. This comprehensive dataset suggests that profenofos is not present in public water systems at concentrations that would pose a risk to human health.</P>
                <P>
                    Ambient water data from the USGS NAWQA program and NWIS database were evaluated. In NAWQA Cycle 1, profenofos was not detected in any samples at any sites. In Cycle 2, profenofos was detected only once, in surface water, and the detection was below the HRL. In Cycle 3, profenofos was detected in 0.06% of both groundwater and surface water samples. The highest concentration observed in surface water is less than the 
                    <FR>1/2</FR>
                     HRL threshold. In NWIS, profenofos was detected in a single surface water sample representing 0.2% of surface water sites. There were no detections in groundwater. The single surface water detection had a profenofos concentration of 0.00019 µg/L, which is less than the 
                    <FR>1/2</FR>
                     HRL threshold.
                </P>
                <P>Based on the evaluation of these data sources, the EPA finds that profenofos does not occur and is not likely to occur in PWSs with a frequency and at levels of public health concern. Therefore, the EPA finds that Statutory Criterion 2 is not met.</P>
                <HD SOURCE="HD3">(d) Statutory Criterion 3 (Meaningful Opportunity)</HD>
                <P>Regulating profenofos under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed population. The estimated population exposed to profenofos at levels of public health concern in drinking water is less than 0.005%.</P>
                <HD SOURCE="HD3">(e) Preliminary Regulatory Determination for Profenofos</HD>
                <P>The agency is making a preliminary determination not to regulate profenofos with an NPDWR after evaluating health, occurrence and other related information against the three SDWA statutory criteria. While data suggest that profenofos may have an adverse effect on human health, occurrence data indicate that profenofos is not occurring or not likely to occur in PWSs with a frequency and at levels of public health concern.</P>
                <P>
                    Therefore, the agency has determined that an NPDWR for profenofos would not present a meaningful opportunity to reduce health risk for persons served by PWSs. The 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b) presents additional information and analyses supporting the agency's evaluation of profenofos.
                </P>
                <HD SOURCE="HD3">8. Tebuconazole</HD>
                <HD SOURCE="HD3">(a) Background</HD>
                <P>Tebuconazole is a monochlorobenzene, triazole and tertiary alcohol that is used as a fungicide. It was first registered by the EPA in 1983 (USEPA, 2023d). Synonyms for tebuconazole include folicur, terbutrazole, ethyltrianol and fenetrazole (NCBI, 2023c).</P>
                <P>The USGS provides estimates for annual usage of U.S. pesticides, including tebuconazole. The USGS pesticide use data show that there has been an increase in tebuconazole use over the past few decades, peaking in 2015 at over 2.5 million pounds and then remaining steady at around 2.0 million pounds per year from 2016 to 2019 (USGS, 2023).</P>
                <P>Tebuconazole is expected to have a high likelihood of partitioning to water based on its Henry's Law Constant, and volatilization from water is not expected (NCBI, 2023c). Tebuconazole is expected to be persistent in soils and water based on the soil aerobic metabolism half-life of approximately 800 days, as well as resistance to photolysis in water and soil (USEPA, 2000b; NCBI, 2023c).</P>
                <HD SOURCE="HD3">(b) Statutory Criterion 1 (Adverse Health Effects)</HD>
                <P>Exposure to tebuconazole may have an adverse effect on the health of persons as supported by the health assessment identified for RD 5 (USEPA, 2021d; USEPA, 2021e). For pesticide chemicals currently registered under the FIFRA, including tebuconazole, toxicity information from EPA OPP HED HHRAs was used as the basis for HRL derivation (USEPA, 2024b).</P>
                <P>
                    The health assessment selected to derive an HRL for tebuconazole is the 2021 EPA OPP HHRA (USEPA, 2021d; USEPA, 2021e). The EPA selected a developmental toxicity study in mice (Becker and Biedermann, 1995) as the critical study to derive the oral reference value (see section 10.3 of Chapter 10 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more details about the critical study). A NOAEL of 3 mg/kg/day for increased incidence of fetal skull and neural tube defects was identified as the critical effect and POD, as this was the most sensitive endpoint measured after gestational exposure to tebuconazole via gavage (USEPA, 2021d). A total UF of 100 was applied to the POD: a UF
                    <E T="52">A</E>
                     of 10 and a UF
                    <E T="52">H</E>
                     of 10 (USEPA, 2021d). After applying the total UF of 100, the oral reference value was calculated to be 0.03 mg/kg/day and the EPA selected this oral reference value to derive an HRL for tebuconazole.
                </P>
                <P>
                    Because the mice in the critical study (Becker and Biedermann, 1995) were exposed to tebuconazole during gestation only (
                    <E T="03">i.e.,</E>
                     gestation days 6 through 15), the EPA determined that the critical effect in the fetus corresponds with gestational exposure in humans. The EPA used the DWI-BW representing the 90th percentile consumers-only, two-day average, direct and indirect community water consumption for females of reproductive age (13 to &lt;50 years) of 0.0354 L/kg/day (USEPA, 2019a) to derive the HRL for tebuconazole, as it is more health protective (
                    <E T="03">i.e.,</E>
                     greater) than the DWI-BW for pregnant women (0.0333 L/kg/day) (USEPA, 2019a) (see decision logic provided in section B.6.1.2 of the RD 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ).
                </P>
                <P>
                    Following HRL derivation practices, the EPA derived an HRL for tebuconazole of 200 µg/L after rounding to one significant figure, based on an oral reference value of 0.03 mg/kg/day 
                    <PRTPAGE P="3853"/>
                    (USEPA, 2021d; USEPA, 2021e), a DWI-BW of 0.0354 L/kg/day (USEPA, 2019a) and a 20% RSC (USEPA, 2000a).
                </P>
                <P>Based on these analyses, the EPA finds that tebuconazole may have an adverse effect on the health of persons and therefore that Statutory Criterion 1 is met.</P>
                <HD SOURCE="HD3">(c) Statutory Criterion 2 (Occurrence)</HD>
                <P>The EPA proposes to find that tebuconazole does not occur with a frequency and at levels of public health concern in PWSs based on the EPA's evaluation of the following occurrence information.</P>
                <P>
                    The primary occurrence data for tebuconazole are nationally representative drinking water monitoring data from the UCMR 4 program (2018-2020). Under UCMR 4 a.m., 37,286 samples collected from 5,028 PWSs were analyzed for tebuconazole. Tebuconazole was found at or above the MRL of 0.2 µg/L in three of the 5,028 systems, or 0.06%. However, there were no exceedances of the HRL (200 µg/L) or the 
                    <FR>1/2</FR>
                     HRL threshold (USEPA, 2024b). Reported results ranged from 0.21 to 1.96 µg/L. This comprehensive dataset suggests that tebuconazole is not present in public water systems at concentrations that would pose a risk to human health.
                </P>
                <P>
                    To understand the impact of tebuconazole use post UCMR 4, the EPA assessed ambient water and limited finished water data collected after 2020. Sources of such data include CCRs from Community Water Systems (CWSs), PWSs, USDA PDP, the NAWQA program, the NWIS database, STORET and several published studies. Data on tebuconazole were available from CCRs prepared by five CWSs from 2018 to 2021; tebuconazole was not detected in any system. Tebuconazole was included in the USDA PDP from 2001 to 2013, where it was detected in 2.11% of 2,656 raw water samples and 2.18% of 3,575 finished water samples, but no detected concentrations exceeded the 
                    <FR>1/2</FR>
                     HRL threshold or the HRL (USDA, 2022). Cycle 2 and Cycle 3 of the NAWQA program found tebuconazole in surface water (17.97% to 26.48% of samples) and groundwater (0% to 0.11% of samples), but no concentrations exceeded the 
                    <FR>1/2</FR>
                     HRL threshold or the HRL (WQP, 2023). Non-NAWQA NWIS data (1991-023) show no detected concentration greater than the 
                    <FR>1/2</FR>
                     HRL threshold or the HRL in ambient water (WQP, 2023). Analysis of STORET data from 2003 to 2016 shows that in 2,021 samples tested for tebuconazole there were no detectable concentrations (WQP, 2023).
                </P>
                <P>Based on the evaluation of these data sources, the EPA finds that tebuconazole does not occur and is not likely to occur in PWSs with a frequency and at levels of public health concern. Therefore, the EPA finds that Statutory Criterion 2 is not met.</P>
                <HD SOURCE="HD3">(d) Statutory Criterion 3 (Meaningful Opportunity)</HD>
                <P>Regulating tebuconazole under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed population, including sensitive populations. The estimated population exposed to tebuconazole at levels of public health concern is 0%, based on UCMR 4 finished water data from 2018-2020.</P>
                <HD SOURCE="HD3">(e) Preliminary Regulatory Determination for Tebuconazole</HD>
                <P>
                    The agency is making a preliminary determination not to regulate tebuconazole with an NPDWR after evaluating health, occurrence and other related information against the three SDWA statutory criteria. While data suggest that tebuconazole may have an adverse effect on human health, the occurrence data indicate that tebuconazole is not occurring or not likely to occur in PWSs with a frequency and at levels of public health concern and that regulation of such contaminant does not present a meaningful opportunity for health risk reduction served by PWSs. The 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b) and the 
                    <E T="03">Occurrence Data from the Fourth Unregulated Contaminant Monitoring Rule (UCMR 4)</E>
                     (USEPA, 2024c) present additional information and analyses supporting the agency's evaluation of tebuconazole.
                </P>
                <HD SOURCE="HD3">9. Tribufos</HD>
                <HD SOURCE="HD3">(a) Background</HD>
                <P>Tribufos is a thiophosphate pesticide that is used as an insecticide and cotton defoliant. It was first registered for use in the United States in 1961 (USEPA, 2009b). The EPA conducted a Reregistration Eligibility Decision (RED) for tribufos in July 2006, which included a comprehensive review of the available data on its environmental and human health effects (USEPA, 2006b). Tribufos is not listed on the EPA's most recent list of Restricted Use Pesticides (RUP) (USEPA, 2022f). Synonyms for tribufos include butifos, butiphos, butyl phosphorotrithioate and tribuphos (NCBI, 2023d).</P>
                <P>According to TRI data for tribufos from the years 1995-2022, on-site surface water discharges peaked in 1999 at 161 pounds and no discharges have been reported since 2007, with specific usage data indicating fluctuations based on agricultural demand and cotton acreage with an overall reduction in usage since 1999. The reports highlight the targeted and seasonal application of tribufos, reflecting its specific role in cotton production rather than widespread use throughout the year (USEPA, 2024b).</P>
                <P>
                    Environmental fate assessments with organic carbon partitioning coefficient (K
                    <E T="52">oc</E>
                    ) values of 4,870-12,684 L/kg suggest that tribufos will have little to no mobility in soil (NCBI, 2023d). Its strong adsorption to soil organic matter suggests limited mobility in soil, minimizing leaching into water. Tribufos is less mobile in soil and tends to remain near the application site. Persistence depends on various factors, including degradation and environmental conditions (USEPA, 2024b).
                </P>
                <HD SOURCE="HD3">(b) Statutory Criterion 1 (Adverse Health Effects)</HD>
                <P>Exposure to tribufos may have an adverse effect on the health of persons as supported by the health assessment identified for RD 5 (USEPA, 2015h; USEPA, 2015i). For pesticide chemicals currently registered under FIFRA, including tribufos, toxicity information from EPA OPP HED HHRAs was used as the basis for HRL derivation (USEPA, 2024b).</P>
                <P>
                    The health assessment selected to derive an HRL for tribufos is the 2015 EPA OPP HHRA (USEPA, 2015h; USEPA, 2015i). The EPA selected a subchronic oral neurotoxicity study in rats (Sheets and Gilmore, 2001) as the critical study to derive an oral reference value for tribufos (see section 11.3 of Chapter 11 in the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     for more details about the critical study). BMD modeling was performed to determine a BMDL
                    <E T="52">10</E>
                     for inhibition of RBC ChE in adult female rats. The BMDL
                    <E T="52">10</E>
                     of 0.19 mg/kg/day was identified as the critical effect and POD, as this was the most sensitive endpoint measured (USEPA, 2015h). A total UF of 1,000 was applied to the POD: a UF
                    <E T="52">A</E>
                     of 10, a UF
                    <E T="52">H</E>
                     of 10 and an FQPA safety factor of 10 to account for uncertainty in the human dose-response relationship for neurodevelopmental effects. After applying the total UF of 1,000, the oral reference value was calculated to be 0.0002 mg/kg/day (USEPA, 2015h) and the EPA selected this oral reference value to derive an HRL for tribufos.
                </P>
                <P>
                    Because exposure began during postnatal development (
                    <E T="03">i.e.,</E>
                     at eight weeks of age) in the critical study 
                    <PRTPAGE P="3854"/>
                    (Sheets and Gilmore, 2001), the EPA used the DWI-BW representing the 90th percentile consumers-only, two-day average, direct and indirect community water consumption for children (birth to &lt;21 years) of 0.0343 L/kg/day (USEPA, 2019a) to derive the HRL for tribufos (see decision logic provided in section B.6.1.2 of the RD 5 Protocol, found in Appendix B of the 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                    ).
                </P>
                <P>Following HRL derivation practices, the EPA derived an HRL for tribufos of 1 µg/L after rounding to one significant figure, based on an oral reference value of 0.0002 mg/kg/day (USEPA, 2015h; USEPA, 2015i), a DWI-BW of 0.0343 L/kg/day (USEPA, 2019a) and a 20% RSC (USEPA, 2000a).</P>
                <P>Based on these analyses, the EPA finds that tribufos may have an adverse effect on the health of persons and therefore that Statutory Criterion 1 is met.</P>
                <HD SOURCE="HD3">(c) Statutory Criterion 2 (Occurrence)</HD>
                <P>The EPA proposes to find that tribufos does not occur with a frequency and at levels of public health concern in PWSs based on the EPA's evaluation of the following occurrence information.</P>
                <P>
                    The primary occurrence data for tribufos are nationally representative drinking water monitoring data from the UCMR 4 program (2018-2020). Tribufos was found at or above the MRL of 0.07 µg/L in 3 (0.008%) of the 37,269 a.m. samples analyzed during this monitoring period. The estimated population exposed to tribufos at levels of public health concern is 0%. Detected concentrations ranged from 0.0742 µg/L to 0.4 µg/L. These detections were found at three large systems, representing 0.06% of systems participating in the monitoring program. There were no exceedances of the HRL or the 
                    <FR>1/2</FR>
                     HRL threshold. This comprehensive dataset suggests that tribufos is not present in PWSs at concentrations that would pose a risk to human health.
                </P>
                <P>Based on the evaluation of the available data, the EPA finds that tribufos does not occur and is not likely to occur in PWSs with a frequency and at levels of public health concern. Therefore, the EPA finds that Statutory Criterion 2 is not met.</P>
                <HD SOURCE="HD3">(d) Statutory Criterion 3 (Meaningful Opportunity)</HD>
                <P>Regulating tribufos under the SDWA does not present a meaningful opportunity for health risk reduction for persons served by PWSs based on the estimated exposed population, including sensitive populations. The agency finds that an NPDWR for tribufos does not present a meaningful opportunity for health risk reduction.</P>
                <P>The assessment also took into consideration the use patterns and regulatory actions related to tribufos, which have led to a decrease in its application and potential release into the environment. These factors, combined with the lack of detection in the UCMR 4 program, support the conclusion that tribufos does not currently represent a risk to public health for persons served by PWSs.</P>
                <HD SOURCE="HD3">(e) Preliminary Regulatory Determination for Tribufos</HD>
                <P>
                    The agency is making a preliminary determination to not regulate tribufos after evaluating health, occurrence and other related information against the three SDWA statutory criteria. While data suggest that tribufos may have an adverse effect on human health, the occurrence data indicate that tribufos is not occurring or not likely to occur in PWSs with a frequency and at levels of public health concern. Therefore, the agency has determined that an NPDWR for tribufos would not present a meaningful opportunity to reduce health risk for persons served by PWSs. The 
                    <E T="03">Regulatory Determination 5 Support Document</E>
                     (USEPA, 2024b) presents additional information and analyses supporting the agency's evaluation of tribufos.
                </P>
                <HD SOURCE="HD1">V. Status of the Agency's Evaluation of 1,2,3-Trichloropropane, 1,4-Dioxane, Manganese, Quinoline and Strontium</HD>
                <HD SOURCE="HD2">A. Ongoing Evaluation of Additional Phase 3 Contaminants</HD>
                <P>In addition to the nine contaminants discussed in section IV of this document for which the EPA is making preliminary negative determinations, there are five additional contaminants that were evaluated according to the RD 5 Protocol and proceeded to Phase 3 based on the robust available health effects and occurrence data for finished drinking water: 1,2,3-TCP, 1,4-dioxane, manganese, quinoline and strontium. As discussed earlier in section III.A.3 of this document, in order to make a positive determination, the EPA must show that a contaminant meets all three statutory criteria relating to health effects, occurrence and meaningful opportunity for health risk reduction, while the agency makes a negative determination if any one of the criteria is not met.</P>
                <P>
                    The EPA is continuing to analyze the available health and occurrence data for these contaminants to evaluate whether they occur at levels of public health concern in finished drinking water and to characterize the potential meaningful opportunity for health risk reduction if they were to be regulated under the SDWA. Therefore, the EPA is not making preliminary determinations for these five contaminants at this time. As noted in section III.A.3 of this document, the 2023 panel ruling from the D.C. Circuit Court of Appeals in 
                    <E T="03">NRDC</E>
                     v. 
                    <E T="03">EPA</E>
                     (D.C. Cir., 2023) established that the agency cannot withdraw a positive determination even if evidence identified during the rulemaking would change the EPA's conclusion of the potential for meaningful opportunity for health risk reduction by regulating a contaminant. Prior to this ruling, formal evaluation of the potential health benefits and analysis of the availability and feasibility of treatment options were conducted during the rule development process as part of the HRRCA. Because of the 2023 ruling, however, the EPA now has concluded that while the SDWA does not require a full HRRCA as part of regulatory determination prior to rule development, the agency will need to conduct preliminary benefits analyses, treatment feasibility analyses or both prior to making determinations for contaminants that may warrant regulation under the SDWA. The EPA will evaluate for each contaminant the population exposed at the health level of concern along with several other factors to determine if regulation presents a meaningful opportunity for health risk reduction. Therefore, the EPA intends to conduct such analyses for each of these five contaminants prior to making regulatory determinations, in order to better understand whether there would be a meaningful opportunity for health risk reduction for persons served by PWSs if the contaminant were to be regulated.
                </P>
                <HD SOURCE="HD2">B. Phase 3 Contaminant Updates</HD>
                <HD SOURCE="HD3">1. 1,2,3-Trichloropropane</HD>
                <P>1,2,3-Trichloropropane (1,2,3-TCP) is a synthetic chemical used as an industrial solvent, a cleaning and degreasing agent and a synthesis intermediate.</P>
                <P>
                    Since the EPA last provided an update on the evaluation of 1,2,3-TCP in the RD 4 FRN (USEPA, 2021a), the EPA has continued work on the evaluation of this contaminant. Work has focused on addressing issues related to the analytical method MRL being substantially higher than the level of public health concern which presents uncertainty in assessing the potential contaminant concentrations and exposure analysis. The fact that the MRL is much higher than the HRL 
                    <PRTPAGE P="3855"/>
                    suggests that there may be a substantial amount of occurrence of 1,2,3-TCP at levels of public health concern in water systems that would not show up in the occurrence data, as any measurement results below the MRL would not be reported. The EPA did not make a regulatory determination for 1,2,3-TCP during RD 4 due to this analytical method limitation, and the agency needs lower-level occurrence information prior to making a preliminary regulatory determination for 1,2,3-TCP. Method development work is underway to lower the MRL for 1,2,3-TCP under Method 524.3, which would enable reporting of concentrations closer to levels of public health concern. The EPA intends to consider new information related to the improved analytical method in future regulatory determination efforts to assess whether there would be a meaningful opportunity for health risk reduction if the EPA were to regulate 1,2,3-TCP in drinking water.
                </P>
                <HD SOURCE="HD3">2. 1,4-Dioxane</HD>
                <P>1,4-Dioxane is a cyclic aliphatic ether that is used as a solvent and a solvent stabilizer. As a solvent it is used in such products as inks, coatings, adhesives, oils, resins, waxes, and dyes (USEPA, 2024b). The EPA is continuing its efforts to evaluate 1,4-dioxane to determine in what manner to regulate this contaminant under SDWA and under the Toxic Substances Control Act (TSCA). The EPA evaluated 1,4-dioxane in RD 4 but did not make a regulatory determination at that time (USEPA, 2021a), referencing the status of the TSCA risk evaluation and the Health Canada health effects assessment, which had not been finalized at that time (Health Canada, 2018). During the timeframe of preliminary RD 5 evaluation, the EPA finalized the 2024 Supplement to the 2020 Risk Evaluation and a revised Risk Determination for 1,4-dioxane under the TSCA program. In the TSCA Risk Evaluation, which covers all conditions of use of 1,4-dioxane, the EPA found that 1,4-dioxane presents risk to the general population via drinking water sourced from surface water contaminated both by industrial discharges of 1,4-dioxane and down-the-drain releases of products that contain 1,4-dioxane (generated as an unintentional byproduct). Under section 6 of TSCA, if at the end of the TSCA risk evaluation process, the EPA determines that a chemical presents an unreasonable risk to health or the environment, the agency must immediately start the risk management process to reduce or eliminate these risks. TSCA directs the EPA to coordinate actions taken under TSCA with actions taken under other federal laws administered by the EPA, such as the Clean Water Act (CWA) and the SDWA. TSCA section 9 also provides that, if the EPA Administrator determines that a risk to health or the environment associated with a chemical substance could be eliminated or reduced to a sufficient extent by actions taken under those other Federal laws, the EPA must use those other laws unless the Administrator determines, in the Administrator's discretion, that it is in the public interest to protect against such risk by actions taken under TSCA. Input from all stakeholders is critical to the risk management process under TSCA. The EPA is committed to developing risk management actions for chemicals in a way that is transparent and includes proactive, meaningful outreach and education with the public and other stakeholders. The EPA is working collaboratively across programs to address the unreasonable risk identified under TSCA and has determined that the risk to human health associated with 1,4-dioxane exposure via drinking water sourced from surface water contaminated with both industrial discharges and down-the-drain releases of products containing 1,4-dioxane is best managed by coordinating actions under both TSCA and SDWA.</P>
                <P>As described in the EPA Administrator's memorandum “Coordinated Risk Management Action on 1,4-Dioxane under section 9(b) of the Toxic Substances Control Act” released alongside the TSCA's program's final 2024 Supplement to the 2020 Risk Evaluation and the revised Risk Determination for 1,4-dioxane, after the agency's regulatory action to address this risk under TSCA is implemented, the EPA will re-evaluate under SDWA whether there is any remaining risk that presents a meaningful opportunity for health risk reduction by regulating 1,4-dioxane in drinking water.</P>
                <HD SOURCE="HD3">3. Manganese</HD>
                <P>Manganese is a naturally occurring element and is ubiquitous in the environment as a component of over 100 minerals (ATSDR, 2012). Manganese compounds are used in a variety of industrial production processes and applications—production data from 2011 to 2019 from the EPA's CDR Program shows that fifteen manganese substances were produced or imported in quantities greater than one million pounds in at least one year and that elemental manganese was produced in quantities greater than 500 million pounds in 2018 (USEPA, 2024b).</P>
                <P>
                    The EPA made a negative regulatory determination for manganese in RD 1 (USEPA, 2003). Since then, new health effects information developed for the 2021 World Health Organization's (WHO) 
                    <E T="03">Guidelines for Drinking Water Quality</E>
                     indicates exposure to elevated levels of manganese in drinking water contributes to increased risk for adverse neurological effects, such as behavioral and sensorimotor effects (WHO, 2021). Nationally representative occurrence data in finished drinking water were collected for manganese in UCMR 4 (USEPA, 2024c). The EPA continues to evaluate the health effects and occurrence data for manganese and will conduct preliminary benefits analysis and treatment feasibility analysis to inform the potential meaningful opportunity for health risk reduction if manganese were to be regulated under the SDWA in the future.
                </P>
                <HD SOURCE="HD3">4. Quinoline</HD>
                <P>Quinoline is an aromatic heterocyclic amine used to make paints, dyes and other chemicals. Quinoline is also used as a solvent, anatomical specimen preservative, corrosion inhibitor, antimalarial drug and flavoring agent.</P>
                <P>Nationally representative finished water occurrence data for quinoline was collected under UCMR4. The analytical method MRL for quinoline is greater than the level of public health concern thus there is uncertainty regarding the frequency at which quinoline occurs at levels of public health concern in PWSs. Therefore, the EPA needs more information prior to making a preliminary regulatory determination for quinoline.</P>
                <P>The EPA continues to evaluate the health effects and occurrence data for quinoline and plans to conduct additional analyses of health benefits and possible treatment feasibility to inform whether regulating quinoline under SDWA would present a meaningful opportunity for health risk reduction to persons served by PWSs.</P>
                <HD SOURCE="HD3">5. Strontium</HD>
                <P>Strontium is a naturally occurring element, an alkaline earth metal typically found in the form of mineral compounds. Stable strontium tends to dissolve in water, and therefore water in contact with strontium-laden soils may also contain strontium.</P>
                <P>
                    Since the RD 4 FRN was published in 2021, (USEPA, 2021a) the EPA has continued to conduct additional work to evaluate the health risks and the potential for health risk reduction if strontium were to be regulated with an NPDWR. For the preliminary RD 5 evaluation, the EPA identified the 2019 
                    <PRTPAGE P="3856"/>
                    <E T="03">Health Canada Guidelines for Drinking Water Quality</E>
                     (HC, 2019), because it is the most recent health assessment identified for strontium and uses the best available science in its evaluation of noncancer risk. The EPA continues to evaluate the UCMR 3 occurrence data in light of the newer health effects information to determine whether there would be a meaningful opportunity for health risk reduction if strontium were to be regulated under the SDWA. In addition, the EPA understands that strontium may co-occur with beneficial calcium in some drinking water systems and treatment technologies that remove strontium may also remove calcium. The agency is evaluating the effectiveness of treatment technologies under different water conditions, including calcium concentrations.
                </P>
                <P>The EPA continues to evaluate the health effects and occurrence data for strontium and plans to conduct additional analyses of health benefits and possible treatment feasibility to inform whether regulating strontium under SDWA would present a meaningful opportunity for health risk reduction to persons served by PWSs.</P>
                <P>
                    In summary, the EPA is not making regulatory determinations at this time for these five contaminants in this document. In light of the decision announced in 
                    <E T="03">NRDC</E>
                     v. 
                    <E T="03">EPA</E>
                     (D.C. Cir., 2023), the EPA plans to conduct preliminary health benefits analyses to inform whether there would be a potential meaningful opportunity for health risk reduction through regulation of a contaminant with an NPDWR. In addition, the EPA continues to evaluate the effectiveness and feasibility of treatment methods to lower concentrations of these contaminants from drinking water systems.
                </P>
                <HD SOURCE="HD1">VI. The EPA's Request for Comments and Next Steps</HD>
                <P>The EPA invites commenters to submit any relevant data or information pertaining to the preliminary regulatory determinations identified in this document, as well as other relevant comments. The EPA will consider the public comments and any new, relevant data submitted for the contaminants discussed in this document and in the supporting rationale.</P>
                <P>The data and information requested by the EPA include peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices, and data collected by accepted methods or best available methods (if the reliability of the method and the nature of the review justifies use of the data).</P>
                <P>
                    Peer-reviewed data are studies/analyses that have been reviewed by qualified individuals (or organizations) who are independent of those who performed the work, but who are collectively equivalent in technical expertise (
                    <E T="03">i.e.,</E>
                     peers) to those who performed the original work. A peer review is an in-depth assessment of the assumptions, calculations, extrapolations, alternate interpretations, methodology, acceptance criteria and conclusions pertaining to the specific major scientific or technical work products and the documentation that supports them (USEPA, 2015j).
                </P>
                <P>Specifically, the EPA is requesting comment and information related to the following aspects:</P>
                <P>• The health effects information considered by the agency in making the preliminary determinations described in this Document. The EPA requests commenters identify any additional peer reviewed studies that could inform the final regulatory determination.</P>
                <P>• Drinking water occurrence information considered by the agency in making the preliminary determinations described in this document. The EPA requests commenters identify any additional data and studies on the occurrence of these contaminants in drinking water.</P>
                <P>
                    The EPA intends to evaluate the public comments received on the nine preliminary determinations and issue final regulatory determinations. If the agency makes a final determination to regulate any of the contaminants, the EPA intends to propose an NPDWR within 24 months and promulgate a final NPDWR within 18 months following the proposal.
                    <SU>15</SU>
                    <FTREF/>
                     In addition, the EPA will also consider information provided in public comment about the five contaminants discussed in section V of this document to inform potential future regulatory determinations.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         The statute authorizes a nine-month extension of this promulgation date.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">VII. References</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        Agency for Toxic Substances and Disease Registry (ATSDR). 2012. 
                        <E T="03">Toxicological Profile for Manganese.</E>
                         U.S. Department of Health and Human Services, Public Health Service. 
                        <E T="03">https://wwwn.cdc.gov/TSP/ToxProfiles/ToxProfiles.aspx?id=102&amp;tid=23.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        ATSDR. 2020. 
                        <E T="03">Toxicological Profile for Molybdenum.</E>
                         U.S. Department of Health and Human Services, Public Health Service. 
                        <E T="03">https://www.atsdr.cdc.gov/ToxProfiles/tp212.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">Becker, H., and Biedermann, K. 1995. HWG 1608 Technical (c.n. Tebuconazole): Embryotoxicity Study (Including Teratogenicity) and Supplementary Embryotoxicity Study (Including Teratogenicity) in the Mouse: Lab Project Number: 106899: 319443: 353294. Unpublished study prepared by RCC, Research and Consulting Co., Ltd. and RCC Umweltchemie AG. 921 p.</FP>
                    <FP SOURCE="FP-2">Burdock, G.A., L.E. Dudeck, R.D. Alsacker, D. Suchmann-Purvis, and S. Fieser. 1981. Two-Year Chronic Oral Toxicity Study in Albino Rats with Technical CGA 15324.Unpublished report No. 483-134 from Hazleton, Inc., Vienna, Virginia, USA. Submitted to WHO by Syngenta Crop Protection, Greensboro, North Carolina, USA.</FP>
                    <FP SOURCE="FP-2">
                        Chartier, SW, L.P. Sheets, and B.S. Gilmore. 2005. 
                        <E T="03">Cholinesterase Inhibition in Young Adult and Preweanling Wistar Rats Treated by Gavage for Eleven Days with Ethoprophos.</E>
                         Bayer Global Report Number 201317. 
                        <E T="03">https://www.bayer.com/en/agriculture/cholinesterase-inhibition-in-young-adult-and-preweanling-wistar-rats-treated-by-gavage.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Chorus, I. and M. Welker, ed. 2021. 
                        <E T="03">Toxic Cyanobacteria in Water: A Guide to Their Public Health Consequences, Monitoring and Management, 2nd edition.</E>
                         CRC Press and World Health Organization. 
                        <E T="03">https://www.taylorfrancis.com/books/oa-edit/10.1201/9781003081449/toxic-cyanobacteria-water-ingrid-chorus-martin-welker.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        D.C. Circuit Court (D.C. Cir.). 2023. 
                        <E T="03">National Resources Defense Council</E>
                         v. 
                        <E T="03">Michael S. Regan, Administrator, U.S. Environmental Protection Agency and Environmental Protection Agency,</E>
                         67 F.4th 397. 
                        <E T="03">https://casetext.com/case/nat-res-def-council-v-regan-1.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Funari, E. and E. Testai. 2008. Human Health Risk Assessment Related to Cyanotoxins Exposure. 
                        <E T="03">Critical Reviews in Toxicology,</E>
                         38(2): 97-125. 
                        <E T="03">https://doi.org/10.1080/10408440701749454.</E>
                         (As cited in USEPA 2015e.)
                    </FP>
                    <FP SOURCE="FP-2">
                        Health Canada (HC). 2017. 
                        <E T="03">Guideline Technical Document for Canadian Drinking Water Quality: Cyanobacterial Toxins.</E>
                         ISBN: 978-0-660-07494-8. 
                        <E T="03">https://www.canada.ca/en/health-canada/services/publications/healthy-living/guidelines-canadian-drinking-water-quality-guideline-technical-document-cyanobacterial-toxins.html.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        HC. 2018. 
                        <E T="03">1,4-Dioxane in Drinking Water: Guideline Technical Document for Public Consultation.</E>
                         August. 
                        <E T="03">https://www.canada.ca/content/dam/hc-sc/documents/programs/consultation-1-4-dioxane-drinking-water/pub-eng.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        HC. 2019. 
                        <E T="03">Guideline Technical Document—Strontium. Guidelines for Canadian Drinking Water Quality.</E>
                         Water and Air Quality Bureau, Healthy Environments and Consumer Safety Branch. H144-13/14-2019E-PDF. 
                        <E T="03">https://publications.gc.ca/collections/collection_2019/sc-hc/H144-13-14-2019-eng.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Heinze, R. 1999. Toxicity of the Cyanobacterial Toxin Microcystin-LR to Rats After 28 Days Intake with the Drinking Water. 
                        <E T="03">Environmental Toxicology,</E>
                         14(1): 57-60. 
                        <E T="03">
                            https://doi.org/10.1002/(SICI)1522-
                            <PRTPAGE P="3857"/>
                            7278(199902)14:1%3C57::AID-TOX9%3E3.0.CO;2-J.
                        </E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Humpage, A.R. and I.R. Falconer. 2002. 
                        <E T="03">Oral Toxicity of Cylindrospermopsin: No Observed Adverse Effect Level Determination in Male Swiss Albino Mice.</E>
                         Research Report 13. Salisbury, South Australia: Cooperative Research Centre for Water Quality and Treatment. ISBN 1876616156.
                    </FP>
                    <FP SOURCE="FP-2">
                        Humpage, A.R. and I.R. Falconer. 2003. Oral Toxicity of Cyanobacterial Toxin Cylindrospermopsin in Male Swiss Albino Mice: Determination of No Observed Adverse Effect Level for Deriving a Drinking Water Guideline Value. 
                        <E T="03">Environmental Toxicology,</E>
                         18(2): 94-103. 
                        <E T="03">https://doi.org/10.1002/tox.10104.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        International Programme on Chemical Safety (IPCS). 1998. Concise International Chemical Assessment Document (CICAD) No. 7: 
                        <E T="03">o</E>
                        -Toluidine. 
                        <E T="03">https://www.inchem.org/documents/cicads/cicads/cicad07.htm.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Jackson Labs. 2023. Body Weight Information for C57BL/6J (000664). The Jackson Laboratory, Bar Harbor, ME. 
                        <E T="03">https://www.jax.org/jax-mice-and-services/strain-data-sheet-pages/body-weight-chart-000664.</E>
                         Accessed July 2023.
                    </FP>
                    <FP SOURCE="FP-2">
                        Kinnear, S. 2010. Cylindrospermopsin: A Decade of Progress on Bioaccumulation Research. 
                        <E T="03">Marine Drugs,</E>
                         8(3): 542-564. 
                        <E T="03">https://doi.org/10.3390%2Fmd8030542.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Machado, J., A. Campos, V. Vasconcelos, and M. Freitas. 2017. Effects of Microcystin-LR and Cylindrospermopsin on Plant-Soil Systems: A Review of Their Relevance for Agricultural Plant Quality and Public Health. 
                        <E T="03">Environmental Research,</E>
                         153: 191-204. 
                        <E T="03">https://doi.org/10.1016/j.envres.2016.09.015.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Marie, P.J., M.T. Garba, M. Hott, and L. Miravet. 1985. Effect of Low Doses of Stable Sr on Bone Metabolism in Rats. 
                        <E T="03">Mineral and Electrolyte Metabolism,</E>
                         11(1): 5-13. 
                        <E T="03">https://pubmed.ncbi.nlm.nih.gov/3974537/.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Murray F.J., F.M. Sullivan, A.K. Tiwary, and S. Carey. 2014. 90-Day Subchronic Toxicity Study of Sodium Molybdate Dihydrate in Rats. 
                        <E T="03">Regulatory Toxicology and Pharmacology,</E>
                         70(3): 579-88. 
                        <E T="03">https://doi.org/10.1016/j.yrtph.2013.09.003.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        National Center for Biotechnology Information (NCBI). 2022. PubChem Compound Summary for CID 445434, Microcystin-LR. 
                        <E T="03">https://pubchem.ncbi.nlm.nih.gov/compound/Microcystin-LR.</E>
                         Accessed September 9, 2022.
                    </FP>
                    <FP SOURCE="FP-2">
                        NCBI. 2023b. PubChem Compound Summary for CID 38779, Profenofos. 
                        <E T="03">https://pubchem.ncbi.nlm.nih.gov/compound/Profenofos.</E>
                         Accessed December 8, 2023.
                    </FP>
                    <FP SOURCE="FP-2">
                        NCBI. 2023c. PubChem Compound Summary for CID 86102, Tebuconazole. 
                        <E T="03">https://pubchem.ncbi.nlm.nih.gov/compound/Tebuconazole.</E>
                         Accessed December 11, 2023.
                    </FP>
                    <FP SOURCE="FP-2">
                        NCBI. 2023d. PubChem Compound Summary for CID 5125, Tribufos. Accessed December 11, 2023. 
                        <E T="03">https://pubchem.ncbi.nlm.nih.gov/compound/Tribufos.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Roberts, V.A., M. Vigar, L. Backer, G.E. Veytsel, E.D. Hilborn, E.I. Hamelin, K.L. Vanden Esschert, J.Y. Lively, J.R. Cope, M.C. Hlavsa, and J.S. Yoder. 2020. Surveillance for Harmful Algal Bloom Events and Associated Human and Animal Illnesses: One Health Harmful Algal Bloom System, United States, 2016-2018. 
                        <E T="03">CDC MMWR Weekly,</E>
                         69(50): 1889-1894. 
                        <E T="03">https://doi.org/10.15585/mmwr.mm6950a2.</E>
                    </FP>
                    <FP SOURCE="FP-2">Sheets, L.P. and R.G. Gilmore. 2001. A Subchronic Neurotoxicity Screening Study with Technical Grade Tribufos (DEF®) in Wistar Rats. Bayer Corporation, Agriculture Division, Toxicology, 17745 South Metcalf Ave., Stilwell, Kansas, 66085-9104. Laboratory report number 110242; March 26, 2001. MRID 45369101. Unpublished.</FP>
                    <FP SOURCE="FP-2">
                        Smedley, P.L. and D.G. Kinniburgh. 2017. Molybdenum in Natural Waters: A Review of Occurrence, Distributions and Controls. 
                        <E T="03">Applied Geochemistry,</E>
                         84: 387-432. 
                        <E T="03">https://doi.org/10.1016/j.apgeochem.2017.05.008.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        United States Department of Agriculture (USDA). 2022. Pesticide Data Program Annual Summary Reports. 
                        <E T="03">https://www.ams.usda.gov/reports/pdp-annual-summary-reports.</E>
                         Published December 21, 2022. Accessed from 
                        <E T="03">https://www.ams.usda.gov/datasets/pdp/pdpdata.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        United States Environmental Protection Agency (USEPA). 1992. Molybdenum; CASRN 7439-98-7. National Center for Environmental Assessment, Integrated Risk Information System, Chemical Assessment Summary. 
                        <E T="03">https://iris.epa.gov/static/pdfs/0425_summary.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 1998. Announcement of the Drinking Water Contaminant Candidate List. 
                        <E T="04">Federal Register</E>
                        , 63(40): 10273, March 2, 1998. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-1998-03-02/pdf/98-5313.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 1999. Revisions to the Unregulated Contaminant Monitoring Regulation for Public Water Systems; Final Rule. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         64(180): 50556, September 17, 1999. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-1999-09-17/pdf/99-23030.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2000a. 
                        <E T="03">Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000).</E>
                         Office of Water, Office of Science and Technology. EPA/822/B-00/004. October. 
                        <E T="03">https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2000b. Section 18—Use of Tebuconazole on Hazelnuts in Oregon. February 29, 2000, memo from Office of Prevention, Pesticides and Toxic Substances. 
                        <E T="03">https://www3.epa.gov/pesticides/chem_search/cleared_reviews/csr_PC-128997_29-Feb-00_a.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2001a. 
                        <E T="03">Statistical Design and Sample Selection for the Unregulated Contaminant Monitoring Regulation (1999).</E>
                         Office of Water. EPA-815-R-01-004. August. 
                        <E T="03">https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=20001YZH.txt.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2001b. 
                        <E T="03">Reference Guide for the Unregulated Contaminant Monitoring Regulation.</E>
                         Office of Water. EPA 815-R-01-023. October. 
                        <E T="03">https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=20001ZBP.TXT.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2002. 
                        <E T="03">A Review of the Reference Dose and Reference Concentration Process.</E>
                         Risk Assessment Forum. EPA/630/P-02/002F. December. 
                        <E T="03">https://www.epa.gov/sites/default/files/2014-12/documents/rfd-final.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2003. Announcement of Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         68(138): 42898, July 18, 2003. 
                        <E T="03">https://federalregister.gov/a/03-18151.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2005a. Drinking Water Contaminant Candidate List 2; Final Notice. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         70(36): 9071, February 24, 2005. 
                        <E T="03">https://federalregister.gov/a/05-3527.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2005b. 
                        <E T="03">Guidelines for Carcinogen Risk Assessment.</E>
                         Risk Assessment Forum. EPA/630/P-03/001F. March. 
                        <E T="03">https://www.epa.gov/sites/default/files/2013-09/documents/cancer_guidelines_final_3-25-05.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2006a. 
                        <E T="03">Reregistration Eligibility Decision for Ethoprop.</E>
                         Includes July 31, 2006, finalization memo and EPA 738-R-06-018. Office of Prevention, Pesticides, and Toxic Substances. 
                        <E T="03">https://archive.epa.gov/pesticides/reregistration/web/pdf/ethoprop_red.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2006b. 
                        <E T="03">Reregistration Eligibility Decision for Tribufos.</E>
                         Includes July 31, 2006, finalization memo and EPA 738-R-00-022. Office of Prevention, Pesticides, and Toxic Substances. 
                        <E T="03">https://www3.epa.gov/pesticides/chem_search/reg_actions/reregistration/red_PC-074801_31-Jul-06.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2007. Unregulated Contaminant Monitoring Regulation (UCMR) for Public Water Systems Revisions. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         72(2): 367, January 4, 2007. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2007-01-04/pdf/E6-22123.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2008a. Drinking Water: Regulatory Determinations Regarding Contaminants on the Second Drinking Water Contaminant Candidate List. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         73(147): 44251, July 30, 2008. 
                        <E T="03">https://federalregister.gov/a/E8-17463.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2008b. 
                        <E T="03">The Analysis of Occurrence Data from the First Unregulated Contaminant Monitoring Regulation (UCMR 1) in Support of Regulatory Determinations for the Second Drinking Water Contaminant Candidate List (CCL 2).</E>
                         EPA 815-R-08-013. 
                        <E T="03">https://www.epa.gov/sites/default/files/2014-09/documents/the_analysis_of_occurrence_data_from_ucmr1_in_support_of_rd2.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2008c. 
                        <E T="03">Profenofos Summary Document, Registration Review: Initial Docket, June 2008. https://www.regulations.gov/document/EPA-HQ-OPP-2008-0345-0002.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2009a. Drinking Water Contaminant Candidate List 3—Final. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         74(194): 51850, October 8, 
                        <PRTPAGE P="3858"/>
                        2009. 
                        <E T="03">https://federalregister.gov/a/E9-24287.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2009b. 
                        <E T="03">Tribufos Summary Document, Registration Review: Initial Docket, March 2009. https://www.regulations.gov/document/EPA-HQ-OPP-2008-0883-0004.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2011. Drinking Water: Regulatory Determination on Perchlorate. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         76(29): 7762, February 11, 2011. 
                        <E T="03">https://federalregister.gov/a/2011-2603.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2012a. Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR 3) for Public Water Systems. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         77(85): 26071, May 2, 2012. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2012-05-02/pdf/2012-9978.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2012b. Provisional Peer-Reviewed Toxicity Values for o-Toluidine (CASRN 95-53-4). Office of Research and Development's National Center for Environmental Assessment, Superfund Health Risk Technical Support Center. EPA/690/R-12/032F. December. 
                        <E T="03">https://cfpub.epa.gov/ncea/pprtv/documents/ToluidineoMethylaniline2.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2014. Announcement of Preliminary Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         79(202): 62716, October 20, 2014. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2014-10-20/pdf/2014-24582.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015a. 
                        <E T="03">Occurrence Data from the Second Unregulated Contaminant Monitoring Regulation (UCMR 2).</E>
                         Office of Water. EPA-815-R-15-013. December. 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OW-2012-0155-0030.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015b. 
                        <E T="03">Health Effects Support Document for the Cyanobacterial Toxin Cylindrospermopsin.</E>
                         Office of Water, Health and Ecological Criteria Division. EPA-820R15103. June. 
                        <E T="03">https://www.epa.gov/sites/default/files/2017-06/documents/cylindrospermopsin-support-report-2015.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015c. Ethoprop: Draft Human Health Risk Assessment for Registration Review. September 15, 2015, memo from Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs, Health Effects Division. DP D410028. 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0560-0028.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015d. Pesticide Registration: Draft Human Health and Ecological Risk Assessments for Sulfonylureas and Certain Other Pesticides. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         80(186): 57812-57816, Sept 25, 2015. 
                        <E T="03">https://www.federalregister.gov/documents/2015/09/25/2015-24452/pesticide-registration-review-draft-human-health-and-ecological-risk-assessments-for-sulfonylureas.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015e. 
                        <E T="03">Health Effects Support Document for the Cyanobacterial Toxin Microcystins.</E>
                         EPA-820R15102. June. 
                        <E T="03">https://www.epa.gov/sites/default/files/2017-06/documents/microcystins-support-report-2015.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015f. 
                        <E T="03">Drinking Water Health Advisory for the Cyanobacterial Microcystin Toxins.</E>
                         EPA-820R15100. June. 
                        <E T="03">https://www.epa.gov/sites/default/files/2017-06/documents/microcystins-report-2015.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015g. Profenofos: Human Health Draft Risk Assessment (DRA) for Registration Review. September 15, 2015 memo from Office of Chemical Safety and Pollution Prevention. DP D414150. 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0345-0024.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015h. Tribufos: Human Health Draft Risk Assessment for Registration Review. September 15, 2015, memo from Office of Chemical Safety and Pollution Prevention. DP D357537. 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0883-0011.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015i. Pesticide Registration Review; Draft Human Health and Ecological Risk Assessments for Certain Organophosphates; Extension of Comment Period. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         80(246): 79888-79889, December 23, 2015. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-12-23/pdf/2015-32326.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2015j. 
                        <E T="03">Peer Review Handbook, 4th Edition.</E>
                         Science and Technology Policy Council. EPA 100-B-15-001. October. 
                        <E T="03">https://www.epa.gov/osa/peer-review-handbook-4th-edition-2015.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2016a. Announcement of Final Regulatory Determinations for Contaminants on the Third Drinking Water Contaminant Candidate List. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         81(1): 13, January 4, 2016. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2016-01-04/pdf/2015-32760.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2016b. Drinking Water Contaminant Candidate List 4—Final. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         81(222): 81099, November 17, 2016. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2016-11-17/pdf/2016-27667.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2016c. Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 4) for Public Water Systems and Announcement of Public Meeting. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         81(224): 92666, December 20, 2016. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2016-12-20/pdf/2016-30469.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2019a. 
                        <E T="03">Exposure Factors Handbook Chapter 3 (Update): Ingestion of Water and Other Select Liquids.</E>
                         Office of Research and Development. EPA/600/R-8/259F. 
                        <E T="03">https://cfpub.epa.gov/ncea/efp/recordisplay.cfm?deid=343661.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2019b. 
                        <E T="03">Occurrence Data from the Third Unregulated Contaminant Monitoring Rule (UCMR 3).</E>
                         EPA 815-R-19-007. 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OW-2019-0583-0005.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2020a. Announcement of Preliminary Regulatory Determinations for Contaminants on the Fourth Drinking Water Contaminant Candidate List. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         85(47): 14098, March 10, 2020. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2020-03-10/pdf/2020-04145.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2020b. Pesticide Registration Review: Interim Decisions for Several Pesticides. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         85(206): 67538-67540, Oct 23, 2020. 
                        <E T="03">https://www.federalregister.gov/documents/2020/10/23/2020-23504/pesticide-registration-review-interim-decisions-for-several-pesticides-notice-of-availability.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2020c. Permethrin: Human Health Risk Assessment for New Use on “Fruit, Small, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-07F”; Multiple Crop Group Conversions/Expansions; and the Establishment of a Tolerance without a U.S. Registration for Tea, and the Revised Draft Risk Assessment (DRA) for Registration Review. March 17, 2020, memo from Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs, Health Effects Division. DPs D449288, D455545. 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2011-0039-0130.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2021a. Announcement of Final Regulatory Determinations for Contaminants on the Fourth Drinking Water Contaminant Candidate List. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         86(40): 12272, March 3, 2021. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2021-03-03/pdf/2021-04184.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2021b. 2021 Policy on Children's Health. October 5, 2021, memo from Administrator Michael S. Regan. 
                        <E T="03">https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2021c. Revisions to the Unregulated Contaminant Monitoring Rule (UCMR 5) for Public Water Systems and Announcement of Public Meetings. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         86(245): 73131, December 27, 2021. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2021-12-27/pdf/2021-27858.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2021d. Registration Review Draft Risk Assessment for the Antimicrobial Uses of Tebuconazole. March 24, 2021, memo from Office of Chemical Safety and Pollution Prevention. DP 455145. 
                        <E T="03">https://downloads.regulations.gov/EPA-HQ-OPP-2015-0378-0020/content.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2021e. Pesticide Registration Review; Draft Human Health and/or Ecological Risk Assessments for Several Pesticides; Notice of Availability. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         86(97): 27593-27594, May 21, 2021. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2021-05-21/pdf/2021-10715.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2022a. Drinking Water Contaminant Candidate List 5—Final. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         87(218): 68060, November 14, 2022. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2022-11-14/pdf/2022-23963.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2022b. 
                        <E T="03">Drinking Water Health Advisory: Hexafluoropropylene Oxide (HFPO) Dimer Acid (CASRN 13252-13-6) and HFPO Dimer Acid Ammonium Salt (CASRN 62037-80-3), Also Known as “GenX Chemicals.”</E>
                         Office of Water, Office of Science and Technology. EPA/822/R-22/005. June. 
                        <E T="03">https://www.epa.gov/system/files/documents/2022-06/drinking-water-genx-2022.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2022c. 
                        <E T="03">Drinking Water Health Advisory: Perfluorobutane Sulfonic Acid (CASRN 375-73-5) and Related Compound Potassium Perfluorobutane Sulfonate (CASRN 29420-49-3).</E>
                         Office of Water, Office of Science and Technology. EPA/822/R-22/006. June. 
                        <E T="03">
                            https://www.epa.gov/system/files/documents/2022-06/drinking-water-pfbs-
                            <PRTPAGE P="3859"/>
                            2022.pdf.
                        </E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2022d. Learn about Cyanobacteria and Cyanotoxins. 
                        <E T="03">https://www.epa.gov/cyanohabs/learn-about-cyanobacteria-and-cyanotoxins.</E>
                         Accessed September 8, 2022.
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2022e. National Lakes Assessment 2017 Web Report. 
                        <E T="03">https://www.epa.gov/national-aquatic-resource-surveys/reports-and-data-national-lakes-assessment-2017.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2022f. 
                        <E T="03">Restricted Use Product Summary Report (October 31, 2022). https://www.epa.gov/system/files/documents/2022-11/RUP-Report-10-31-2022.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2023a. Ethoprop. Updated Occupational and Non-Occupational Spray Drift Assessment for Registration Review. February 17, 2023, memo from Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs. 
                        <E T="03">https://www.regulations.gov/document/EPA-HQ-OPP-2008-0560-0058.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2023b. Entry for “Chronic Exposure” in the Integrated Risk Information System (IRIS) Glossary. 
                        <E T="03">https://www.epa.gov/iris/iris-glossary.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2023c. Pesticide Product and Label System Database. 
                        <E T="03">https://ordspub.epa.gov/ords/pesticides/f?p=PPLS:1.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2023d. Pesticide Chemical Search for tebuconazole: 
                        <E T="03">https://ordspub.epa.gov/ords/pesticides/f?p=CHEMICALSEARCH:3::::21,3,31,7,12,25:P3_XCHEMICAL_ID:3984.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2024a. PFAS National Primary Drinking Water Regulation: Final Rule. 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         89(82): 32532, April 26, 2024. 
                        <E T="03">https://www.govinfo.gov/content/pkg/FR-2024-04-26/pdf/2024-07773.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2024b. 
                        <E T="03">Regulatory Determination 5 Support Document.</E>
                         EPA 815-B-24-017.
                    </FP>
                    <FP SOURCE="FP-2">
                        USEPA. 2024c. 
                        <E T="03">Occurrence Data from the Fourth Unregulated Contaminant Monitoring Rule (UCMR 4).</E>
                         EPA 815-B-24-016.
                    </FP>
                    <FP SOURCE="FP-2">
                        United States Geological Survey (USGS). 2023. Estimated Annual Agricultural Pesticide Use. 
                        <E T="03">https://water.usgs.gov/nawqa/pnsp/usage/maps/index.php.</E>
                         Last updated June 14, 2023.
                    </FP>
                    <FP SOURCE="FP-2">
                        Water Quality Portal (WQP). 2023. Water Quality Portal Data Warehouse. 
                        <E T="03">https://www.waterqualitydata.us/.</E>
                         Data Warehouse consulted September 2023.
                    </FP>
                    <FP SOURCE="FP-2">
                        Weisburger, E.K., A.B. Russfield, F. Homburger, F., J.H. Weisburger, E. Boger, C.G. Van Dongen, and K.C. Chu. 1978. Testing of Twenty-One Environmental Aromatic Amines or Derivatives for Long-Term Toxicity or Carcinogenicity. 
                        <E T="03">Journal of Environmental Pathology and Toxicology,</E>
                         2(2): 325-356. 
                        <E T="03">https://doi.org/10.1097/00043764-197911000-00017.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        WHO. 2011. 
                        <E T="03">Molybdenum in Drinking-Water. Background Document for Development of WHO Guidelines for Drinking-Water Quality.</E>
                         WHO/SDE/WSH/03.04/11/Rev/1. 
                        <E T="03">https://cdn.who.int/media/docs/default-source/wash-documents/wash-chemicals/molybdenum.pdf?sfvrsn=d01920eb_4.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        WHO. 2020a. 
                        <E T="03">Cyanobacterial Toxins: Cylindrospermopsins. Background Document for Development of WHO Guidelines for Drinking-Water Quality and Guidelines for Safe Recreational Water Environments.</E>
                         WHO/HEP/ECH/WSH/2020.4. 
                        <E T="03">https://apps.who.int/iris/bitstream/handle/10665/338063/WHO-HEP-ECH-WSH-2020.4-eng.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        WHO. 2020b. 
                        <E T="03">Cyanobacterial Toxins: Microcystins. Background Document for Development of WHO Guidelines for Drinking-Water Quality and Guidelines for Safe Recreational Water Environments.</E>
                         WHO/HEP/ECH/WSH/2020.6.
                    </FP>
                    <FP SOURCE="FP-2">https://cdn.who.int/media/docs/default-source/wash-documents/wash-chemicals/microcystins-background-201223.pdf.</FP>
                    <FP SOURCE="FP-2">
                        WHO. 2021. 
                        <E T="03">Manganese in Drinking-Water. Background Document for Development of WHO Guidelines for Drinking-Water Quality.</E>
                         WHO/HEP/ECH/WSH/2021.5. 
                        <E T="03">https://iris.who.int/bitstream/handle/10665/350933/WHO-HEP-ECH-WSH-2021.5-eng.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Wolansky, M.J., C. Gennings, K.M. Crofton. 2006. Relative Potencies for Acute Effects of Pyrethroids on Motor Function in Rats. 
                        <E T="03">Toxicological Sciences,</E>
                         89(1): 271-277. 
                        <E T="03">https://doi.org/10.1093/toxsci/kfj020.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        Wong, M.Y., S.D. Rathod, R. Marino, L. Li, R.W. Howarth, A. Alastuey, et al. 2021. Anthropogenic Perturbations to the Atmospheric Molybdenum Cycle. 
                        <E T="03">Global Biogeochemical Cycles,</E>
                         35(2): e2020GB006787. 
                        <E T="03">https://doi.org/10.1029/2020GB006787.</E>
                    </FP>
                </EXTRACT>
                <SIG>
                    <NAME>Jane Nishida,</NAME>
                    <TITLE>Acting Administrator. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00133 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OW-2024-0504; FRL 12451-01-OW]</DEPDOC>
                <SUBJECT>Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        As part of the Environmental Protection Agency's (EPA's) commitment to safeguarding the environment from per- and polyfluoroalkyl substances (PFAS), the agency is announcing the availability of the “Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS)” for a 60-day public comment period. This draft risk assessment reflects the agency's latest scientific understanding of the potential risks to human health and the environment posed by the presence of PFOA and PFOS in sewage sludge that is land applied as a soil conditioner or fertilizer (on agricultural, forested, and other lands), surface disposed, or incinerated. The draft risk assessment focuses on those living on or near impacted sites or those that rely primarily on their products (
                        <E T="03">e.g.,</E>
                         food crops, animal products, drinking water); the draft risk assessment does not model risks for the general public. This draft risk assessment underwent independent external peer review, and the EPA revised the document accordingly. Once finalized, the risk assessment will provide information on risk from use or disposal of sewage sludge and will inform the EPA's potential future regulatory actions under the Clean Water Act (CWA).
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>The EPA has established a docket for the “Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS)” action under Docket ID No EPA-HQ-OW-2024-0504. You may send comments, identified by Docket ID No. EPA-HQ-OW-2024-0504, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                          
                        <E T="03">https://www.regulations.gov/</E>
                         (our preferred method). Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Environmental Protection Agency, EPA Docket Center, Office of Water Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery or Courier:</E>
                         EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operations are 8:30 a.m. to 4:30 p.m., Monday through Friday (except Federal Holidays).
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to 
                        <E T="03">https://www.regulations.gov/,</E>
                         including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the “Public Participation—Written comments” heading of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section of this document.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Tobias, Health and Ecological Criteria Division, Office of Science and Technology, Office of Water, Environmental Protection Agency; email address: 
                        <E T="03">biosolidsprogram@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <PRTPAGE P="3860"/>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>This notice of availability is organized as follows:</P>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Public Participation—Written Comments</FP>
                    <FP SOURCE="FP-2">II. Background</FP>
                    <FP SOURCE="FP1-2">A. Clean Water Act Authorities</FP>
                    <FP SOURCE="FP1-2">B. What is the purpose of this action?</FP>
                    <FP SOURCE="FP1-2">C. What is sewage sludge?</FP>
                    <FP SOURCE="FP1-2">D. What are PFOA and PFOS?</FP>
                    <FP SOURCE="FP1-2">E. What are the potential sources of PFOA and PFOS to sewage sludge?</FP>
                    <FP SOURCE="FP1-2">F. What is a risk assessment?</FP>
                    <FP SOURCE="FP-2">III. Description and Preliminary Findings of the EPA's Draft Risk Assessment</FP>
                    <FP SOURCE="FP1-2">A. Scope of the Draft Risk Assessment</FP>
                    <FP SOURCE="FP1-2">B. Modeling Approaches</FP>
                    <FP SOURCE="FP1-2">C. Preliminary Findings of the Central Tendency Modeling</FP>
                    <FP SOURCE="FP-2">IV. Next Steps</FP>
                    <FP SOURCE="FP1-2">A. Risk Reduction</FP>
                    <FP SOURCE="FP1-2">B. Related Actions</FP>
                    <FP SOURCE="FP1-2">C. Final Risk Assessment and Potential Future Actions</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Public Participation—Written Comments</HD>
                <P>
                    The EPA is seeking comments, particularly on scientific and technical issues, on its “Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS).” Submit your comments, identified by Docket ID No. EPA-HQ-OW-2024-0504, on the draft sewage sludge risk assessment at 
                    <E T="03">https://www.regulations.gov</E>
                     (our preferred method), or the other methods identified in the 
                    <E T="02">ADDRESSES</E>
                     section. Once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. Do not submit any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
                    <E T="03">i.e.,</E>
                     on the web, cloud, or other file sharing system). For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                    <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <HD SOURCE="HD2">A. Clean Water Act Authorities</HD>
                <P>
                    Consistent with CWA section 405(d)(2), 33 U.S.C. 1345(d)(2), the EPA periodically reviews its existing regulations for the purpose of identifying additional toxic pollutants that may be present in sewage sludge and assesses whether those pollutants may adversely affect public health or the environment based on their toxicity, persistence, concentration, mobility, and potential for exposure. In December 2022, the EPA completed its latest review of the sewage sludge regulations as published in the EPA's 
                    <E T="03">Biennial Review of 40 CFR part 503 To Fulfill Clean Water Act Section 405(d)(2)(C), Biosolids Biennial Report No. 9</E>
                     (
                    <E T="03">see https://www.epa.gov/biosolids/biennial-report-no-9-reporting-period-2020-2021</E>
                    ). This notice of availability for the draft risk assessment is in accordance with CWA section 405(g)(1), 33 U.S.C. 1345(g)(1), which authorizes the EPA to conduct scientific studies and provide public information to promote the safe and beneficial management or use of sewage sludge.
                </P>
                <HD SOURCE="HD2">B. What is the purpose of this action?</HD>
                <P>
                    The purpose of this action is to request public comments, particularly regarding scientific and technical aspects, on the EPA's “Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS).” The EPA is most interested in receiving comments regarding the draft risk assessment modeling (
                    <E T="03">e.g.,</E>
                     the scenarios, sewage sludge application rates, environmental fate and transport parameters, human exposure assumptions). The draft risk assessment reflects the agency's latest scientific understanding of the risks to human health and the environment posed by the presence of PFOA and PFOS in sewage sludge that is land applied as a soil conditioner or fertilizer (on agricultural, forested, and other lands), surface disposed (
                    <E T="03">e.g.,</E>
                     placed in a sewage sludge-only landfill called a monofill), or incinerated. The draft risk assessment focuses on those living on or near impacted properties where sewage sludge has been used or disposed. The intent of the draft risk assessment is to evaluate whether there may be risks to human health or the environment for the wide range of possible sewage sludge use and disposal scenarios. Not all the scenarios described in the draft risk assessment may be common practice or applicable to the general public. The EPA uses sewage sludge risk assessments to help evaluate whether risk reduction actions, including regulation, are warranted to protect those who may experience elevated risks from sewage sludge use or disposal. The draft risk assessment reflects external peer review and incorporates revisions from the peer review process. The EPA will consider public comments and prepare a final risk assessment for publication. The EPA will announce the availability of the final risk assessment in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD2">C. What is sewage sludge?</HD>
                <P>
                    When domestic sewage is transported and conveyed to a wastewater treatment plant (WWTP), it is treated to separate liquids from the solids, which produces a semi-solid, nutrient-rich product known as sewage sludge. In some instances, industrial wastewater is also conveyed to a WWTP and combined with domestic sewage. The terms “biosolids” and “sewage sludge” are often used interchangeably by the public; however, the EPA typically uses the term “biosolids” to mean sewage sludge that has been treated to meet the requirements in the EPA's regulation entitled, “Standards for the Use or Disposal of Sewage Sludge,” promulgated at 40 CFR part 503, and intended to be applied to land as a soil conditioner or fertilizer. In the U.S., there are generally three options for use or disposal of sewage sludge. Based on available data, (1) approximately 56 percent of the nation's sewage sludge is land applied as a soil conditioner or fertilizer (roughly 31 percent is applied to agricultural land and 25 percent is applied to other lands, such as reclamation sites, home lawns and gardens, or golf courses), (2) approximately 27 percent is disposed of in a sewage sludge monofill or municipal solid waste (MSW) landfill, and (3) approximately 16 percent is incinerated.
                    <SU>1</SU>
                    <FTREF/>
                     Land application of sewage sludge can have environmental benefits including improved soil health, carbon sequestration, and reduced demand on non-renewable resources like phosphorus. Land application also generates reduced emissions of greenhouse gases compared to other management practices.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         An additional 1 percent of sewage sludge is disposed of using other management practices (
                        <E T="03">e.g.,</E>
                         deep-well injection).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. What are PFOA and PFOS?</HD>
                <P>
                    PFOA and PFOS are two chemicals in a large class of synthetic chemicals called PFAS. PFOA and PFOS persist in the environment for long periods of time and have been linked to a variety of adverse human health effects. In 2024, the EPA classified both PFOA and PFOS as 
                    <E T="03">likely to be carcinogenic to humans</E>
                     and concluded that these chemicals are also likely to cause a range of non-cancer effects in humans, including hepatic, immunological, cardiovascular, and developmental effects, depending 
                    <PRTPAGE P="3861"/>
                    on exposure conditions (
                    <E T="03">see</E>
                     the EPA's 
                    <E T="03">Final Human Health Toxicity Assessment for Perfluorooctanoic Acid (PFOA) and Related Salts,</E>
                     available at: 
                    <E T="03">https://www.epa.gov/sdwa/human-health-toxicity-assessment-perfluorooctanoic-acid-pfoa,</E>
                     and 
                    <E T="03">Final Human Health Toxicity Assessment for Perfluorooctane Sulfonic Acid (PFOS) and Related Salts,</E>
                     available at: 
                    <E T="03">https://www.epa.gov/sdwa/human-health-toxicity-assessment-perfluorooctane-sulfonic-acid-pfos</E>
                    ).
                </P>
                <P>
                    PFAS have been manufactured and used by a broad range of industries since the 1940s, and there are estimated to be thousands of PFAS present in the global marketplace that are used in many consumer, commercial, and industrial products. PFOA and PFOS have been widely studied, and they were once high production volume chemicals within the PFAS chemical class. PFAS manufacturers voluntarily phased out domestic manufacturing of PFOS by 2002 and of PFOA by 2015, and the EPA restricted their uses by Significant New Use Rules (SNURs) issued under section 5(a)(2) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2604(a)(2) (
                    <E T="03">see https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-and-polyfluoroalkyl-substances-pfas</E>
                    ).
                </P>
                <HD SOURCE="HD2">E. What are the potential sources of PFOA and PFOS to sewage sludge?</HD>
                <P>
                    Although domestic manufacturing of PFOA and PFOS have been phased out and their uses restricted, multiple activities still result in PFOA, PFOS, and their precursors being released to WWTPs. Current and historical activities include industrial releases (
                    <E T="03">e.g.,</E>
                     aqueous film-forming foam, pulp and paper plants), commercial releases (
                    <E T="03">e.g.,</E>
                     car washes, industrial launderers), and down-the-drain releases from homes (
                    <E T="03">e.g.,</E>
                     use of consumer products like after-market water resistant sprays, ski wax, floor finishes, and laundering of stain or water-resistant textiles with PFOA or PFOS coatings) (
                    <E T="03">see</E>
                     the 
                    <E T="03">Preliminary Effluent Guidelines Program Plan 16,</E>
                     available at 
                    <E T="03">https://www.epa.gov/eg/preliminary-effluent-guidelines-program-plan,</E>
                     and the 
                    <E T="03">Multi-Industry Per- and Polyfluoroalkyl Substances (PFAS) Study—2021 Preliminary Report,</E>
                     available at 
                    <E T="03">https://www.epa.gov/system/files/documents/2021-09/multi-industry-pfas-study_preliminary-2021-report_508_2021.09.08.pdf</E>
                    ). If products containing PFOA or PFOS are disposed of at a lined MSW landfill, because the most common off-site management practice for landfill leachate is to transfer it to a WWTP, then that landfill's leachate could be a source of PFOA and PFOS to a WWTP. At different WWTPs across the country, any of these release mechanisms may play a role in PFOA or PFOS entering the plant and contaminating the sewage sludge.
                </P>
                <P>
                    Statewide surveys have found PFOA and PFOS in sewage sludge originating from industrial and non-industrial sources that are discharging to WWTPs. Traditional wastewater treatment technology does not remove or destroy PFOA or PFOS, and these chemicals typically accumulate in the sewage sludge. Appropriate pretreatment solutions at industrial dischargers exist, are cost-effective, and have been shown to be effective in reducing high concentrations of PFOA and PFOS; however, studies have found that PFOA and PFOS are consistently detected at varying levels in sewage sludge even at WWTPs that do not receive wastewater from industrial users of the chemicals (
                    <E T="03">i.e.,</E>
                     they only receive wastewater from residential and commercial users).
                </P>
                <HD SOURCE="HD2">F. What is a risk assessment?</HD>
                <P>
                    Risk assessment is a scientific process that is used to characterize the nature and magnitude of health risks to humans (
                    <E T="03">i.e.,</E>
                     children and adults) and ecological receptors (
                    <E T="03">i.e.,</E>
                     aquatic and terrestrial plants and wildlife) from pollutants (
                    <E T="03">see https://www.epa.gov/risk/about-risk-assessment#whatisrisk</E>
                    ). An environmental risk assessment considers three primary factors: (1) presence (
                    <E T="03">i.e.,</E>
                     how much of a pollutant is present in the environment), (2) exposure (
                    <E T="03">i.e.,</E>
                     how much contact humans or wildlife have with the pollutant), and (3) the toxicity of the pollutant (
                    <E T="03">i.e.,</E>
                     the health effects the pollutant causes in humans or wildlife).
                </P>
                <P>The concentration of pollutants found in sewage sludge varies across space and time, depending on industrial and other inputs to individual WWTPs. The presence of a pollutant in sewage sludge alone does not necessarily mean that there is risk to human health or the environment from its use or disposal. The EPA estimates potential exposures to humans and environmental receptors by modeling the fate and transport of a pollutant through the environment, taking into account different environmental conditions and exposure scenarios, and then estimates risk by comparing those potential exposures to toxicity values.</P>
                <HD SOURCE="HD1">III. Description and Preliminary Findings of the EPA's Draft Risk Assessment</HD>
                <HD SOURCE="HD2">A. Scope of the Draft Risk Assessment</HD>
                <P>The EPA's draft risk assessment describes the potential human health and environmental risks associated with land application, surface disposal, and incineration of sewage sludge containing PFOA or PFOS, which are the use and disposal practices regulated under CWA section 405(d) and the EPA's accompanying regulation at 40 CFR part 503, Standards for the Use or Disposal of Sewage Sludge. The draft risk assessment does not assess human health or environmental risks associated with sewage sludge disposal in MSW landfills, a common management practice for disposal of sewage sludge, because that practice is regulated under the Resource Conservation and Recovery Act (RCRA) and the EPA's accompanying regulations at 40 CFR part 258, Criteria for Municipal Solid Waste Landfills.</P>
                <P>
                    The draft risk assessment is scoped to model risks to human populations because available data indicate that humans are more sensitive to PFOA and PFOS exposures than aquatic or terrestrial wildlife or livestock. For the land application scenarios, the EPA modeled potential PFOA and PFOS exposures and estimated human health risks to those living on or near impacted properties under three hypothetical scenarios: (1) application to a farm raising dairy cows, beef cattle, or chickens (pasture farm scenario), (2) application to a farm growing fruits or vegetables (food crop farm scenario),
                    <SU>2</SU>
                    <FTREF/>
                     and (3) application to reclaim damaged soils such as an overgrazed pasture (reclamation scenario). For the surface disposal scenarios, the EPA modeled potential PFOA or PFOS exposures via groundwater to those living near a lined or unlined surface disposal site (
                    <E T="03">e.g.,</E>
                     sewage sludge monofill). For the incineration scenario, the EPA provides a qualitative description of the potential risks to communities living near a sewage sludge incinerator (SSI). The draft risk assessment does not provide quantitative risk estimates for the incineration scenario due to significant data gaps related to the extent to which 
                    <PRTPAGE P="3862"/>
                    incineration in an SSI destroys PFOA and PFOS and the health effects of exposure to products of incomplete combustion.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The EPA acknowledges that the majority of food crops grown in the United States do not use sewage sludge as a soil conditioner or fertilizer and some states have restricted the land application of sewage sludge to food crops. However, this practice is not consistent across all states. Furthermore, because of the extreme persistence of PFOA and PFOS in soils, a property with previous sewage sludge land application that has been repurposed as a food or feed crop farm could still have multiple relevant human exposure pathways.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Based on currently available information, sewage sludge incinerators may not operate at high enough temperatures and long enough residence times to fully destroy PFOA and PFOS in sewage sludge (
                        <E T="03">see</E>
                         the 
                        <E T="03">Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances—Version 2 (2024),</E>
                         available at: 
                        <E T="03">https://www.epa.gov/pfas/interim-guidance-destruction-and-disposal-pfas-and-materials-containing-pfas</E>
                        ).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Modeling Approaches</HD>
                <P>
                    The EPA first performed a screening-level risk analysis for PFOA and PFOS in sewage sludge using a high-end deterministic exposure model for a hypothetical farm. This screening approach assumed high starting concentrations of PFOA and PFOS in sewage sludge (approximating a 95th percentile concentration based on available data), high-end consumption rates for each exposure pathway (
                    <E T="03">e.g.,</E>
                     90th percentile consumption rates for drinking water intake, milk consumption), and other high-end factors. The high-end screening model resulted in risks exceeding the EPA's acceptable thresholds for every individual human exposure pathway (
                    <E T="03">e.g.,</E>
                     drinking water, consumption of fish, milk, beef, vegetables). Given that the risk estimates greatly exceeded the agency's acceptable thresholds in the screening-level assessment, the EPA next moved on to a refined risk assessment. In this assessment, the EPA refined the modeling approach and assessed risks under median (
                    <E T="03">i.e.,</E>
                     central tendency, 50th percentile), rather than high-end exposure conditions, to better understand the potential scope and magnitude of risks under different use and disposal scenarios. To complete the central tendency deterministic modeling steps of the refined risk assessment, the EPA (1) identified available fate and transport models to select the best models for assessing PFOA and PFOS, and (2) parameterized the models with inputs and exposure factors to reflect median U.S. conditions and consumption behaviors. For example, when calculating risks from egg consumption in the central tendency approach, the model assumes that an adult living on a farm consumes, on average, 1 egg per day from the impacted property for ten years, which represents the median egg consumption rate reported in the EPA's 
                    <E T="03">Exposure Factors Handbook</E>
                     for households who farm (
                    <E T="03">see https://www.epa.gov/expobox/about-exposure-factors-handbook, Table 13-40</E>
                    ). The model further assumes that when the adult lives on the impacted farm, they have no sources of PFOA or PFOS exposure other than the contaminated eggs and that for the remainder of the adult's life, they have no exposure to PFOA or PFOS through any pathway.
                </P>
                <HD SOURCE="HD2">C. Preliminary Findings of the Central Tendency Modeling</HD>
                <P>
                    The findings summarized here and presented in the draft risk assessment are preliminary. The EPA expects to publish a final risk assessment after reviewing public comments and revising the draft risk assessment accordingly. Based on the modeling results of the refined risk assessment for the central tendency (median) exposure scenarios, the EPA has found that draft risk estimates exceed the agency's acceptable human health risk thresholds 
                    <SU>4</SU>
                    <FTREF/>
                     for some pasture farm, food crop farm, and reclamation scenarios when assuming that the land-applied sewage sludge contains 1 part per billion (ppb) 
                    <SU>5</SU>
                    <FTREF/>
                     of PFOA or PFOS. The EPA also finds that there are human health risks associated with drinking contaminated groundwater sourced near a surface disposal site when sewage sludge containing 1 ppb of PFOA or sewage sludge containing 4 to 5 ppb of PFOS is disposed in an unlined or clay-lined surface disposal unit.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         The risk threshold for non-cancer human health effects is a hazard quotient equal to one, 
                        <E T="03">i.e.,</E>
                         when the exposure is equal to the reference dose (RfD). The threshold for cancer effects is a lifetime excess cancer risk of 1 × 10
                        <E T="51">−6</E>
                        , 
                        <E T="03">i.e.,</E>
                         when the lifetime average daily dose results in one extra cancer case per million people above the background cancer incidence.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Though EPA Method 1633 recommends that laboratories develop their own limit of quantification (LOQ) and method detection limit (MDL) when measuring PFAS in sewage sludge, most laboratories running this method achieve LOQs and MDLs of 1 ppb or lower for PFOA and PFOS (
                        <E T="03">see</E>
                          
                        <E T="03">https://www.epa.gov/cwa-methods/cwa-analytical-methods-and-polyfluorinated-alkyl-substances-pfas</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    Not all farms or disposal sites where sewage sludge containing PFOA or PFOS have been used or disposed of are expected to pose a risk to human health. For example, human health risks are expected to be lower when sewage sludge is applied to areas with protected groundwater, sites that are distant from surface waters used for fishing or as a drinking water source, and when applied to non-food crops, such as grain, fuel, or fiber crops. However, the EPA's modeling results from the draft risk assessment suggest that under certain scenarios and conditions, land-applying or disposing of sewage sludge containing a detectable level (
                    <E T="03">i.e.,</E>
                     1 ppb or more) of PFOA or PFOS could result in human health risks exceeding the agency's acceptable thresholds for cancer and non-cancer effects. At this low level (1 ppb) of PFOA or PFOS in sewage sludge, the EPA modeled land application scenarios for either a single application at a rate of 50 dry metric tons (dmt) per hectare (reclamation scenario) or 40 annual applications at a rate of 10 dmt per hectare (approximately the median application rate of U.S. sewage sludge; used for pasture and food crop farm scenarios). Each of these modeled scenarios resulted in exceedances of risk thresholds for several exposure pathways (
                    <E T="03">e.g.,</E>
                     consumption of drinking water, fish, beef, milk, eggs, certain fruits and vegetables). The EPA's modeling indicates that, for a subset of the modeled scenarios and pathways, there may be potential risks exceeding acceptable levels following a single application of sewage sludge contaminated with 1 ppb of PFOA or PFOS, applied at a rate of 10 dmt per hectare (median rate).
                </P>
                <P>
                    The presence and magnitude of human health risks from sewage sludge use and disposal to those living on or near impacted properties or primarily relying on their products is expected to vary across regions and among properties depending on the concentration of PFOA and PFOS in sewage sludge; the number of land applications; the volume of sewage sludge land applied; the climate, geology, and hydrology at the use or disposal site; agronomic practices; human behavioral patterns (
                    <E T="03">e.g.,</E>
                     drinking water ingestion rates, consumption rate of impacted products); and many other site-specific factors.
                </P>
                <P>
                    Draft risk estimates for the modeled scenarios are presented in the risk assessment as cancer risk levels and hazard quotients (HQs). Cancer risk levels represent the number of expected excess lifetime cancer cases due to exposure to the carcinogenic pollutant in a given population size. For example, a cancer risk level of 1 in 1,000 indicates that lifetime exposure to the carcinogenic pollutant would be expected to cause one additional case of cancer for every one thousand people in the exposed population. Risk for non-cancer effects are expressed as HQs that represent the ratio of the potential exposure to a pollutant to the level below which adverse non-cancer effects are not expected. In other words, an HQ of less than 1 means adverse non-cancer health effects are unlikely and thus risk can be considered negligible; an HQ greater than 1 means adverse non-cancer 
                    <PRTPAGE P="3863"/>
                    effects are possible and thus risk is indicated.
                </P>
                <P>
                    Modeling for land application scenarios suggests that, when the majority of the consumer's dietary intake of a product comes from a property impacted by the land application of sewage sludge contaminated with PFOA or PFOS, the highest risk pathways include (1) drinking milk from pasture-raised cows consuming contaminated forage, soil, and water, (2) drinking water sourced from contaminated surface or groundwater on or adjacent to the impacted property, (3) eating fish from a lake impacted by runoff from the impacted property, and (4) eating beef or eggs from majority pasture-raised hens or cattle where the pasture has received impacted sewage sludge. The risk calculations assume each of these farm products (
                    <E T="03">e.g.,</E>
                     milk, beef, eggs) or drinking water consumed comes from the impacted property but does not combine risks from each of these products. The EPA did not estimate risk associated with occasionally consuming products or drinking water impacted by land application of contaminated sewage sludge nor foods that come from a variety of sources (
                    <E T="03">e.g.,</E>
                     milk from a grocery store that is sourced from many farms and mixed together before being bottled). Additionally, the majority of food produced in the U.S. is not grown on fields where sewage sludge is land applied.
                </P>
                <P>
                    Risk estimates for the highest risk pathways can exceed the EPA's acceptable thresholds by several orders of magnitude. For example, for the land application scenarios, cancer risk levels associated with drinking the modeled amount of contaminated milk (
                    <E T="03">i.e.,</E>
                     32 ounces per day for adults) can exceed 1 in 1,000, and HQs for non-cancer effects associated with eating the modeled amount of contaminated fish (
                    <E T="03">i.e.,</E>
                     1 to 2 servings per week for adults) can reach up to 45. For the food crop farm scenario, there are limited scientific studies available regarding the uptake of PFOA and PFOS from sewage sludge-amended soils into certain fruits and vegetables; however, the draft risk assessment suggests that cancer risks from consuming the modeled amount of these contaminated foods (
                    <E T="03">e.g.,</E>
                     1 serving per day for adults for certain categories of fruits and vegetables) can exceed 1 in 100,000 for PFOA. Because the draft risk assessment indicates risks associated with individual exposure pathways, there may be potential risks to populations beyond the farm family (
                    <E T="03">e.g.,</E>
                     people living near a use or disposal site who use contaminated groundwater as a source of drinking water or people who primarily consume produce, dairy, or meat from a farm that has applied contaminated sewage sludge under the modeled conditions).
                </P>
                <P>For the surface disposal sites, there are no exceedances of the EPA's risk thresholds for PFOA or PFOS in drinking water sourced from groundwater near composite-lined surface disposal sites. However, for unlined and clay-lined surface disposal sites, there can be exceedances of the risk thresholds for the drinking water pathway; for unlined sites, the cancer risk levels can exceed 1 in 1,000 and HQs are as high as 12; for clay-lined sites, the cancer risk levels can exceed 1 in 1,000 and HQs are up to 9. As mentioned above, the draft risk assessment does not include quantitative risk estimates for incineration due to data limitations.</P>
                <P>
                    The draft risk calculations are not conservative estimates because they (1) model risks associated with sludge containing 1 ppb of PFOA or PFOS, which is on the low end of measured U.S. sewage sludge concentrations, (2) reflect median exposure conditions (
                    <E T="03">e.g.,</E>
                     50th percentile drinking water intake rates) rather than high exposure conditions, (3) do not include non-sewage sludge exposures to PFOA or PFOS (
                    <E T="03">e.g.,</E>
                     consumer products, other dietary sources), (4) do not account for the combined risk of PFOA and PFOS together, and (5) do not account for exposures from the transformation of PFOA or PFOS precursors. As such, risk estimates that account for multiple dietary exposures (
                    <E T="03">e.g.,</E>
                     consuming impacted milk, water, and eggs), multiple sources of exposure (
                    <E T="03">e.g.,</E>
                     exposure to PFOA or PFOS-containing consumer products), or exposure to other PFAS would be greater than those presented in this draft risk assessment. Further, the EPA's draft risk assessment relies on models where risks scale linearly with the starting concentration of PFOA or PFOS in sewage sludge. As such, sewage sludge containing ten times more PFOA or PFOS (
                    <E T="03">i.e.,</E>
                     10 ppb) would yield risk estimates that are ten times greater than those presented in the draft risk assessment, assuming all other factors are constant.
                </P>
                <P>
                    The EPA did not complete Monte Carlo probabilistic modeling because risks exceeding acceptable thresholds were identified in multiple scenarios and pathways in the central tendency deterministic modeling results. Further refinement of the draft risk assessment from the central tendency deterministic models to Monte Carlo probabilistic models would result in an increased risk finding because the EPA's goal for a probabilistic assessment is to identify a high-end (
                    <E T="03">e.g.,</E>
                     95th percentile) threshold protective of the impacted population (
                    <E T="03">e.g.,</E>
                     farm families), while a central tendency approach, which the EPA used in this case, models a person at the 50th percentile exposure level of the impacted population. Since risk is indicated under this central tendency scenario, Monte Carlo probabilistic modeling, which would examine the entire distribution of potential exposures to PFOA or PFOS and report the 95th percentile of the risk distribution, is not warranted at this time. For this reason, the EPA is focused on the central tendency modeling results and identifying actions that could be taken to mitigate risks.
                </P>
                <HD SOURCE="HD1">IV. Next Steps</HD>
                <HD SOURCE="HD2">A. Risk Reduction</HD>
                <P>
                    The draft risk assessment indicates that there are potential risks to human health to those living on or near impacted properties or primarily relying on their products from land application and surface disposal of sewage sludge containing detectable levels of PFOA or PFOS. That risk is dependent on (1) the concentration of PFOA and PFOS in sewage sludge, (2) the specific type of management practice (
                    <E T="03">e.g.,</E>
                     type of farm or presence of a liner in a monofill), (3) the local environmental and geological conditions (
                    <E T="03">e.g.,</E>
                     climate and distance to groundwater), (4) the share of each product (
                    <E T="03">e.g.,</E>
                     food crop, drinking water) that is sourced exclusively from the impacted property, and other factors noted above. Risks are possible, though not quantified due to data limitations, from the incineration of PFOA and PFOS-containing sewage sludge. Site-specific factors should be considered when identifying risk mitigation and management practices to reduce human exposures associated with PFOA and PFOS in sewage sludge.
                </P>
                <P>
                    Regardless of the management practice to use or dispose of sewage sludge, exposure and risk reduction is possible through pretreatment at industrial facilities discharging to a WWTP. By monitoring sewage sludge for PFOA and PFOS, WWTPs can identify likely discharges of PFOA and PFOS from industrial contributors, require pretreatment, and achieve significant reductions in PFOA and PFOS concentrations in their sewage sludge. In some state programs, WWTPs with industrial sources have achieved a 98 percent reduction in PFOS sewage sludge concentrations through industrial pretreatment initiatives. The EPA recommends that states, Tribes, and WWTPs monitor sewage sludge for PFAS contamination, identify likely 
                    <PRTPAGE P="3864"/>
                    industrial discharges of PFAS, and implement industrial pretreatment requirements, where appropriate. Doing so will help reduce downstream PFAS contamination and lower the concentration of PFOA and PFOS in sewage sludge (
                    <E T="03">see</E>
                     Section C of the EPA's December 2022 memorandum 
                    <E T="03">Addressing PFAS Discharges in NPDES Permits and Through the Pretreatment Program and Monitoring Programs,</E>
                     available at: 
                    <E T="03">https://www.epa.gov/newsreleases/epa-issues-guidance-states-reduce-harmful-pfas-pollution</E>
                    ).
                </P>
                <HD SOURCE="HD2">B. Related Actions</HD>
                <P>
                    The EPA is planning to conduct the next National Sewage Sludge Survey (NSSS) in collaboration with the publicly owned treatment works (POTW) Influent PFAS Study (
                    <E T="03">see https://www.epa.gov/biosolids/sewage-sludge-surveys</E>
                    ). This NSSS will focus on obtaining current national occurrence and concentration data on PFAS in sewage sludge. The data generated by the NSSS will help inform future risk assessments and risk management actions for sewage sludge.
                </P>
                <P>
                    Additionally, the EPA continues to evaluate opportunities to limit PFAS discharges from multiple industrial categories through the Effluent Guidelines Program. The specific actions include revising the Organic Chemicals, Plastics, and Synthetic Fibers Effluent Limitations Guidelines (ELGs) to address wastewater discharge from PFAS manufacturing facilities; revising the Metal Finishing and Electroplating ELGs to address wastewater discharge from metal finishing and electroplating operations focusing on facilities using PFAS-based fume suppressants and wetting agents; and revising the Landfills ELGs to address PFAS discharges from landfill leachate. The upcoming POTW Influent PFAS Study will also help the agency prioritize industrial point source categories for future study and, as appropriate, ELGs (
                    <E T="03">see https://www.epa.gov/eg/study-pfas-influent-potws</E>
                    ).
                </P>
                <HD SOURCE="HD2">C. Final Risk Assessment and Potential Future Actions</HD>
                <P>
                    After the public comment period has closed, the EPA will consider the comments received, revise the draft risk assessment as appropriate, and prepare a final risk assessment. The EPA will announce the availability of the final risk assessment in the 
                    <E T="04">Federal Register</E>
                    . If the final risk assessment indicates that there are risks above acceptable thresholds when using or disposing of sewage sludge, the EPA expects to propose a regulation under CWA section 405 to manage PFOA and/or PFOS in sewage sludge to protect public health and the environment. The EPA may also consider developing regulations under other statutory authorities to further reduce PFAS discharged to WWTPs. During the risk management deliberation process, the results of the final risk assessment may be integrated with other considerations, such as economic costs and treatment feasibility, to reach decisions regarding the need for and practicability of implementing various risk reduction activities. If the EPA proposes regulatory standards for PFOA and/or PFOS in sewage sludge, the public will have an opportunity to provide comment.
                </P>
                <SIG>
                    <NAME>Bruno Pigott,</NAME>
                    <TITLE>Principal Deputy Assistant Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00734 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <DEPDOC>[OMB 3060-0392; FR ID 272605]</DEPDOC>
                <SUBJECT>Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.</P>
                    <P>The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written PRA comments should be submitted on or before March 17, 2025. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Direct all PRA comments to Nicole Ongele, FCC, via email 
                        <E T="03">PRA@fcc.gov</E>
                         and to 
                        <E T="03">nicole.ongele@fcc.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For additional information about the information collection, contact Nicole Ongele, (202) 418-2991.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">OMB Control Number:</E>
                     3060-0392.
                </P>
                <P>
                    <E T="03">Title:</E>
                     47 CFR 1 Subpart J—Pole Attachment Complaint Procedures.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     N/A.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Businesses or other for-profit.
                </P>
                <P>
                    <E T="03">Number of Respondents and Responses:</E>
                     1,760 respondents; 1,760 responses.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     0.50 hours (30 minutes)-75 hours.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On occasion reporting requirements.
                </P>
                <P>
                    <E T="03">Obligation to Respond:</E>
                     Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 224.
                </P>
                <P>
                    <E T="03">Total Annual Burden:</E>
                     2,759 hours.
                </P>
                <P>
                    <E T="03">Total Annual Cost:</E>
                     $15,000.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     Currently, OMB Collection No. 3060-0392, tracks the burdens associated with requests for access to a utility's poles, notifications between utility pole owners and attachers needed for the shared use of utility poles, as well as the filing of complaints and petitions for stay against the actions of said utilities. The Commission will use the information collected to assess whether the petition or complaint can proceed as a docketed case.
                </P>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Marlene Dortch,</NAME>
                    <TITLE>Secretary, Office of the Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00645 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3865"/>
                <AGENCY TYPE="N">FEDERAL HOUSING FINANCE AGENCY</AGENCY>
                <DEPDOC>[No. 2025-N-2]</DEPDOC>
                <SUBJECT>Notice of Annual Adjustment of the Cap on Average Total Assets That Defines Community Financial Institutions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Housing Finance Agency.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Housing Finance Agency (FHFA) has adjusted the cap on average total assets that is used in determining whether a Federal Home Loan Bank (Bank) member qualifies as a “community financial institution” (CFI) to $1,500,000,000, based on the annual percentage increase in the Consumer Price Index for all urban consumers (CPI-U), as published by the Department of Labor (DOL). This change is effective as of January 1, 2025.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Janna Bruce, Senior Financial Analyst, Division of Federal Home Loan Bank Regulation, (202) 649-3202, 
                        <E T="03">Janna.Bruce@fhfa.gov;</E>
                         or RG Yamba, Honors Counsel, Office of General Counsel, (202) 649-3399, 
                        <E T="03">RG.Yamba@fhfa.gov,</E>
                         (these are not toll-free numbers), Federal Housing Finance Agency, Constitution Center, 400 Seventh Street SW, Washington, DC 20219. For TTY/TRS users with hearing and speech disabilities, dial 711 and ask to be connected to any of the contact numbers above.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Statutory and Regulatory Background</HD>
                <P>
                    The Federal Home Loan Bank Act (Bank Act) confers upon insured depository institutions that meet the statutory definition of a CFI certain advantages over non-CFI insured depository institutions in qualifying for Bank membership, and in the purposes for which they may receive long-term advances and the collateral they may pledge to secure advances.
                    <SU>1</SU>
                    <FTREF/>
                     Section 2(10)(A) of the Bank Act and § 1263.1 of FHFA's regulations define a CFI as any Bank member the deposits of which are insured by the Federal Deposit Insurance Corporation and that has average total assets below the statutory cap.
                    <SU>2</SU>
                    <FTREF/>
                     The Bank Act was amended in 2008 to set the statutory cap at $1 billion and to require FHFA to adjust the cap annually to reflect the percentage increase in the CPI-U, as published by the DOL.
                    <SU>3</SU>
                    <FTREF/>
                     For 2024, FHFA set the CFI asset cap at $1,461,000,000, which reflected a 3.1 percent increase over 2023, based upon the increase in the CPI-U between 2022 and 2023.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 1424(a), 1430(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 1422(10)(A); 12 CFR 1263.1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 1422(10)(B); 12 CFR 1263.1 (defining the term “CFI asset cap”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         89 FR 2225 (Jan. 12, 2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. The CFI Asset Cap for 2025</HD>
                <P>As of January 1, 2025, FHFA will increase the CFI asset cap to $1,500,000,000, which reflects a 2.7 percent increase in the unadjusted CPI-U from November 2023 to November 2024. Consistent with the practice of other Federal agencies required to calculate and make annual adjustments based on CPI-U changes, FHFA bases the annual adjustment to the CFI asset cap on the percentage increase in the CPI-U from November of the year prior to the preceding calendar year to November of the preceding calendar year. The November figures represent the most recent available data as of January 1st of the current calendar year. FHFA determined the new CFI asset cap by applying the percentage increase in the CPI-U to the unrounded amount for the preceding year and rounding to the nearest million, as has been FHFA's practice for all previous adjustments.</P>
                <P>
                    In calculating the CFI asset cap, FHFA uses CPI-U data that have not been seasonally adjusted (
                    <E T="03">i.e.,</E>
                     the data have not been adjusted to remove the estimated effect of price changes that normally occur at the same time and in about the same magnitude every year). The DOL encourages use of unadjusted CPI-U data in applying “escalation” provisions such as that governing the CFI asset cap, because the factors that are used to seasonally adjust the data are amended annually, and seasonally adjusted data that are published earlier are subject to revision for up to five years following their original release. Unadjusted data are not routinely subject to revision, and previously published unadjusted data are only corrected when significant calculation errors are discovered.
                </P>
                <SIG>
                    <NAME>Joshua R. Stallings,</NAME>
                    <TITLE>Deputy Director, Division of Federal Home Loan Bank Regulation, Federal Housing Finance Agency. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00720 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8070-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL HOUSING FINANCE AGENCY</AGENCY>
                <DEPDOC>[No. 2025-N-1]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Housing Finance Agency.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day notice of submission of information collection for approval from the Office of Management and Budget.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the Federal Housing Finance Agency (FHFA or the Agency) is seeking public comments concerning an information collection called the “Minimum Requirements for Appraisal Management Companies,” which has been assigned control number 2590-0013 by the Office of Management and Budget (OMB). FHFA intends to submit the information collection to OMB for review and approval of a three-year extension of the control number, which is due to expire on March 31, 2025.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons may submit comments on or before March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit comments to FHFA, identified by “Proposed Collection; Comment Request: Minimum Requirements for Appraisal Management Companies, (No. 2025-N-1)” by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Agency Website: https://www.fhfa.gov/regulation/federal-register?comments=open.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail/Hand Delivery:</E>
                         Federal Housing Finance Agency, Fourth Floor, 400 Seventh Street SW, Washington, DC 20219, ATTENTION: Proposed Collection; Comment Request: “Minimum Requirements for Appraisal Management Companies, (No. 2025-N-1).” Please note that all mail sent to FHFA via the U.S. Postal Service is routed through a national irradiation facility, a process that may delay delivery by approximately two weeks. For any time-sensitive correspondence, please plan accordingly.
                    </P>
                    <P>
                        FHFA will post all public comments on the FHFA public website at 
                        <E T="03">http://www.fhfa.gov,</E>
                         except as described below. Commenters should submit only information that the commenter wishes to make available publicly. FHFA may post only a single representative example of identical or substantially identical comments, and in such cases will generally identify the number of identical or substantially identical 
                        <PRTPAGE P="3866"/>
                        comments represented by the posted example. FHFA may, in its discretion, redact or refrain from posting all or any portion of any comment that contains content that is obscene, vulgar, profane, or threatens harm. All comments, including those that are redacted or not posted, will be retained in their original form in FHFA's internal file and considered as required by all applicable laws. Commenters that would like FHFA to consider any portion of their comment exempt from disclosure on the basis that it contains trade secrets, or financial, confidential or proprietary data or information, should follow the procedures in section IV.D. of FHFA's 
                        <E T="03">Policy on Communications with Outside Parties in Connection with FHFA Rulemakings, see https://www.fhfa.gov/sites/default/files/documents/Ex-Parte-Communications-Public-Policy_3-5-19.pdf.</E>
                         FHFA cannot guarantee that such data or information, or the identity of the commenter, will remain confidential if disclosure is sought pursuant to an applicable statute or regulation. 
                        <E T="03">See</E>
                         12 CFR 1202.8, 12 CFR 1214.2, and the FHFA 
                        <E T="03">FOIA Reference Guide</E>
                         at 
                        <E T="03">https://www.fhfa.gov/about/foia-reference-guide</E>
                         for additional information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Angela Supervielle, Senior Counsel, 
                        <E T="03">Angela.Supervielle@fhfa.gov,</E>
                         (202) 649-3973 (these are not toll-free numbers); Federal Housing Finance Agency, 400 Seventh Street SW, Washington, DC 20219. For TTY/TRS users with hearing and speech disabilities, dial 711 and ask to be connected to any of the contact numbers above.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">A. Need for and Use of the Information Collection</HD>
                <P>
                    In 2015, FHFA, the Federal Deposit Insurance Corporation (FDIC), the Office of the Comptroller of the Currency (OCC), and the Board of Governors of the Federal Reserve System (Board) (collectively, the Agencies) jointly issued regulations 
                    <SU>1</SU>
                    <FTREF/>
                     to implement minimum statutory requirements to be applied by states in the registration and supervision of appraisal management companies (AMCs).
                    <SU>2</SU>
                    <FTREF/>
                     These minimum requirements apply to states that have elected to establish an appraiser certifying and licensing agency with authority to register and supervise AMCs (participating states).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The National Credit Union Administration and the Bureau of Consumer Financial Protection also participated in the joint rulemaking but, by agreement, the responsibility for clearance under the PRA of information collections contained in the joint regulations is shared only by the FDIC, OCC, Board, and FHFA.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 3353(a). An AMC is an entity that serves as an intermediary for, and provides certain services to, appraisers and lenders.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         12 U.S.C. 3346.
                    </P>
                </FTNT>
                <P>
                    The regulations also implement the statutory requirement that states report to the Appraisal Subcommittee (ASC) of the Federal Financial Institutions Examination Council (FFIEC) the information required by the ASC to administer the national registry of AMCs (AMC National Registry or Registry).
                    <SU>4</SU>
                    <FTREF/>
                     The AMC National Registry includes AMCs that are either: (1) subsidiaries owned and controlled by an insured depository institution (as defined in 12 U.S.C. 1813) and regulated by either the FDIC, OCC, or Board (federally regulated AMCs); 
                    <SU>5</SU>
                    <FTREF/>
                     or (2) registered with, and subject to supervision of, a state appraiser certifying and licensing agency.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 3353(e).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1222.21(k) (defining “Federally regulated AMC”).
                    </P>
                </FTNT>
                <P>FHFA's AMC regulation, located at Subpart B of 12 CFR part 1222, is substantively identical to the AMC regulations of the FDIC, OCC, and Board and contains the recordkeeping and reporting requirements described below.</P>
                <HD SOURCE="HD2">1. Written Notice of Appraiser Removal From Network or Panel (IC #1, Formerly #3)</HD>
                <P>
                    An entity meets the definition of an AMC that is subject to the requirements of the AMC regulation if, among other things, it oversees an appraiser panel of more than 15 state-certified or state-licensed appraisers in a state, or 25 or more state-certified or state-licensed appraisers in two or more states, within a given 12-month period.
                    <SU>6</SU>
                    <FTREF/>
                     For purposes of determining whether a company qualifies as an AMC under that definition, the regulation provides that an appraiser in an AMC's network or panel is deemed to remain on the network or panel until: (i) the AMC sends a written notice to the appraiser removing the appraiser with an explanation; or (ii) receives a written notice from the appraiser asking to be removed or receives a notice of the death or incapacity of the appraiser.
                    <SU>7</SU>
                    <FTREF/>
                     The AMC would retain these notices in its files.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1222.21(c)(1)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1222.22(b).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">2. State Recordkeeping Requirements (IC #2, Formerly IC #1)</HD>
                <P>
                    States seeking to register AMCs must have an AMC registration and supervision program. The regulation requires each participating state to establish and maintain within its appraiser certifying and licensing agency a registration and supervision program with the legal authority and mechanisms to: (i) review and approve or deny an application for initial registration; (ii) periodically review and renew, or deny renewal of, an AMC's registration; (iii) examine an AMC's books and records and require the submission of reports, information, and documents; (iv) verify an AMC's panel members' certifications or licenses; (v) investigate and assess potential violations of laws, regulations, or orders; (vi) discipline, suspend, terminate, or deny registration renewals of, AMCs that violate laws, regulations, or orders; and (vii) report violations of appraisal-related laws, regulations, or orders, and disciplinary and enforcement actions to the ASC.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1222.23(a).
                    </P>
                </FTNT>
                <P>
                    The regulation requires each participating state to impose requirements on AMCs that are not federally regulated (non-federally regulated AMCs) to: (i) register with and be subject to supervision by a state appraiser certifying and licensing agency in each state in which the AMC operates; (ii) use only state-certified or state-licensed appraisers for federally regulated transactions in conformity with any federally regulated transaction regulations; (iii) establish and comply with processes and controls reasonably designed to ensure that the AMC, in engaging an appraiser, selects an appraiser who is independent of the transaction and who has the requisite education, expertise, and experience necessary to competently complete the appraisal assignment for the particular market and property type; (iv) direct the appraiser to perform the assignment in accordance with the Uniform Standards of Professional Appraisal Practice; and (v) establish and comply with processes and controls reasonably designed to ensure that the AMC conducts its appraisal management services in accordance with sections 129E(a) through (i) of the Truth-in-Lending Act.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1222.23(b). Sections 129E(a) through (i) of the Truth-in-Lending Act are located at 15 U.S.C. 1639e(a)-(i).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">3. AMC Disclosure Requirements (State-Regulated AMCs) (IC #3, Formerly #2)</HD>
                <P>
                    The regulation provides that an AMC may not be registered by a state or included on the AMC National Registry if the company is owned, directly or indirectly, by any person who has had an appraiser license or certificate refused, denied, cancelled, surrendered in lieu of revocation, or revoked in any state for a substantive cause.
                    <SU>10</SU>
                    <FTREF/>
                     The 
                    <PRTPAGE P="3867"/>
                    regulation also provides that an AMC may not be registered by a state if any person that owns 10 percent or more of the AMC fails to submit to a background investigation carried out by the state appraiser certifying and licensing agency.
                    <SU>11</SU>
                    <FTREF/>
                     Thus, each AMC registering with a state must provide information to the state on compliance with those ownership restrictions.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1222.24(a), 1222.25(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         12 CFR 1222.24(b).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">B. Burden Estimate</HD>
                <P>For the information collections described above, the general methodology is to compute the industry wide burden hours for participating states and AMCs and then assign a share of the burden hours to each of the Agencies for each information collection.</P>
                <P>As noted above, each of the Agencies' AMC regulations contains reporting and recordkeeping requirements applying to participating states and to both federally regulated and non-federally regulated AMCs. Unlike the insured depository institutions regulated by the OCC, FDIC, and Board, none of FHFA's regulated entities owns or controls an AMC or, by law, could ever own or control an AMC. Accordingly, the Agencies have agreed that responsibility for the burdens arising from reporting and recordkeeping requirements imposed upon federally regulated AMCs are to be split evenly among the OCC, FDIC, and Board and that FHFA will not include those burdens in its totals.</P>
                <P>The four Agencies have agreed to split the total burdens imposed upon participating states and upon non-federally regulated AMCs among them. For IC #1 and #3, which relates to disclosure requirements imposed upon state regulated AMCs the OCC, FDIC, and the Board are each responsible for 30 percent of the total burden, while FHFA is responsible only for 10 percent of the total burden. For IC #2, which relates to reporting and recordkeeping requirements imposed upon participating states, each agency is responsible for 25 percent of the total estimated burden.</P>
                <P>The Agencies estimate the total annualized hour burden placed on respondents by the information collection in the joint AMC regulations to be 6,651 hours. FHFA estimates its share of the hour burden to be 678 hours. The calculations on which those estimations are based are described below.</P>
                <HD SOURCE="HD2">1. Written Notice of Appraiser Removal From Network or Panel (IC #1, Formerly #3)</HD>
                <P>State-regulated AMCs disclose written notices sent or received regarding appraiser removal from the AMC's network or panel. The Agencies estimate that the total number of annual respondents for this information collection is 28,270, with one notice sent per respondent. The estimated number of respondents per year allocated to each of the four agencies (FDIC, FRB, OCC, and FHFA) is calculated by splitting the total estimated number of respondents using a ratio of 3:3:3:1. Thus, the estimated number of annual respondents attributable to FHFA for this IC is 2,827 (28,270 notices × 10% = 2,827). FHFA estimates an average of 5 minutes per response. The total hour burden attributable to FHFA is 236 (2,827 notices × 5 minutes = 236, after rounding up).</P>
                <HD SOURCE="HD2">2. State Recordkeeping Requirements (IC #2, Formerly IC #1)</HD>
                <P>States without a current AMC certifying and licensing program that elect to establish such a program as a result of the rule maintain records related to the rule's substantive requirements. According to the ASC, there are 5 states that do not have an AMC program. The estimated number of respondents is split evenly among the four agencies, which amounts to one respondent each, after rounding up to a whole number. FHFA estimates 40 hours per recordkeeping activity, which is unchanged from the previous ICR. The total hour burden attributable to FHFA is 40 (40 hours × 1 respondent = 40).</P>
                <HD SOURCE="HD2">3. AMC Disclosure Requirements (IC #3, Formerly #2)</HD>
                <P>State-regulated AMCs disclose to states information necessary to determine whether any person that owns more than 10 percent of the AMC has had an appraiser license or certificate refused, denied, cancelled, surrendered in lieu of revocation, or revoked in any state. The Agencies estimate the number of state-regulated AMCs for the next three years as 4,020, with an average of one report per AMC and one hour preparation time per report. The estimated number of respondents per year allocated to each of the four agencies (FDIC, FRB, OCC, and FHFA) is calculated by splitting the total estimated number of respondents using a ratio of 3:3:3:1. Thus, the estimated number of annual respondents attributable to FHFA for this IC is 402 (4,020 respondents × 10% = 402).</P>
                <HD SOURCE="HD1">C. Comments Request</HD>
                <P>FHFA requests written comments on the following: (1) Whether the collection of information is necessary for the proper performance of FHFA functions, including whether the information has practical utility; (2) the accuracy of FHFA's estimates of the burdens of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.</P>
                <SIG>
                    <NAME>Shawn Bucholtz,</NAME>
                    <TITLE>Chief Data Officer, Federal Housing Finance Agency.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00729 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8070-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL MARITIME COMMISSION</AGENCY>
                <DEPDOC>[Docket No. 25-02]</DEPDOC>
                <SUBJECT> Nielsen &amp; Bainbridge, LLC, Complainant v. Ocean Network Express Pte. Ltd.; Orient Overseas Container Line Limited; OOCL (Europe) Limited; Evergreen Line Joint Service Agreement (FMC Agreement No. 011982); Evergreen Marine Corporation (Taiwan) Ltd.; Evergreen Marine (UK) Limited, Italia Marittima SpA; Evergreen Marine (Hong Kong) Ltd.; Evergreen Marine (Singapore) Pte. Ltd.; And Yang Ming Marine Transport Corporation, Respondents; Notice of Filing of Complaint and Assignment</SUBJECT>
                <DATE>Served: January 8, 2025.</DATE>
                <P>
                    Notice is given that a complaint has been filed with the Federal Maritime Commission (the “Commission”) by Nielsen &amp; Bainbridge, LLC (the “Complainant”) against Ocean Network Express Pte. Ltd.; Orient Overseas Container Line Limited; OOCL (Europe) Limited; Evergreen Line Joint Service Agreement (FMC Agreement No.011982); Evergreen Marine Corporation (Taiwan) Ltd.; Evergreen Marine (UK) Limited; Italia Marittima SpA; Evergreen Marine (Hong Kong) Ltd.; Evergreen Marine (Singapore) Pte. Ltd.; and Yang Ming Marine Transport Corporation (collectively, the “Respondents”). Complainant states that the Commission has subject-matter jurisdiction over this Complaint pursuant to the Shipping Act of 1984, as amended, 46 U.S.C. 40101 
                    <E T="03">et seq.</E>
                     and personal jurisdiction over each of the 
                    <PRTPAGE P="3868"/>
                    Respondents as ocean common carriers, as defined in 46 U.S.C. 40102(18), that has entered into a service contract, as defined in 46 U.S.C. 40102(21), with Complainant.
                </P>
                <P>Complainant is a limited liability company existing under the laws of Delaware with a mailing address in New Rochelle, New York that formerly conducted business as “NBG Home.”</P>
                <P>Complainant identifies Respondent Ocean Network Express Pte. Ltd. as a company existing under the laws of Singapore with its principal place of business located in Singapore whose agent in the United States is Ocean Network Express (North America) Inc. with its principal place of business located in Richmond, Virginia.</P>
                <P>Complainant identifies Respondent Orient Overseas Container Line Limited as a company existing under the laws of Hong Kong with its principal place of business located in Wanchai, Hong Kong whose agent in the United States is OOCL (USA) Inc. with its principal place of business located in South Jordan, Utah.</P>
                <P>Complainant identifies Respondent OOCL (Europe) Limited as a company existing under the laws of the United Kingdom with its principal place of business located in Levington Suffolk, United Kingdom whose agent in the United States is OOCL (USA) Inc. with its principal place of business located in South Jordan, Utah.</P>
                <P>Complainant identifies Respondent Evergreen Marine Corporation (Taiwan) Ltd. as a company existing under the laws of Taiwan with its principal place of business located in Taipei City, Taiwan.</P>
                <P>Complainant identifies Respondent Evergreen Marine (UK) Limited as a company existing under the laws of the United Kingdom with its principal place of business located in London, United Kingdom.</P>
                <P>Complainant identifies Respondent Italia Marittima SpA as a company existing under the laws of Italy with its principal place of business located in Trieste, Italy.</P>
                <P>Complainant identifies Respondent Evergreen Marine (Hong Kong) Ltd. as a company existing under the laws of Hong Kong with its principal place of business located in Wan Chai, Hong Kong.</P>
                <P>Complainant identifies Respondent Evergreen Marine (Singapore) Pte. Ltd. as a company existing under the laws of Singapore with its principal place of business in Southpoint, Singapore.</P>
                <P>Complainant identifies Respondent Evergreen Line Joint Service Agreement (FMC Agreement No. 011982) as a vessel-operating ocean common carrier consisting of Evergreen Marine Corporation (Taiwan) Ltd., Evergreen Marine (UK) Limited, Italia Marittima SpA, Evergreen Marine (Hong Kong) Ltd., Evergreen Marine (Singapore) Pte. Ltd., and non-party, Evergreen Marine (Asia) Pte. Ltd.</P>
                <P>Complainant identifies Respondent Yang Ming Marine Transport Corporation as a company existing under the laws of Taiwan with its principal place of business located in Keelung City, Taiwan whose agent in the United States is Yang Ming (America) Corp. with its principal place of business located in Newark, New Jersey.</P>
                <P>Complainant alleges that Respondents violated 46 U.S.C. 41102(c), 41104(a)(2), 41104(a)(10); and 46 CFR 545.5. Complainant alleges these violations arose from a practice of systematically failing to meet service commitments, the use of coercion to require payment of extracontractual surcharges prior to performance of service commitments and to require amendments to service contracts, an unreasonable assessment of demurrage and detention charges, and other acts or omissions of the Respondents.</P>
                <P>An answer to the complaint must be filed with the Commission within 25 days after the date of service.</P>
                <P>
                    The full text of the complaint can be found in the Commission's electronic Reading Room at 
                    <E T="03">https://www2.fmc.gov/readingroom/proceeding/25-02/.</E>
                     This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding judge shall be issued by January 8, 2026, and the final decision of the Commission shall be issued by July 22, 2026.
                </P>
                <SIG>
                    <NAME>David Eng,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00784 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL MARITIME COMMISSION</AGENCY>
                <DEPDOC>[Docket No. 25-03]</DEPDOC>
                <SUBJECT>Euromarket Designs, Inc., Complainant v. MSC Mediterranean Shipping Company SA; Ocean Network Express Pte. Ltd.; Evergreen Line Joint Service Agreement (FMC Agreement No. 011982); Evergreen Marine Corp. (Taiwan) Ltd., Evergreen Marine (UK) Limited; Italia Marittima SpA; Evergreen Marine (Hong Kong) Ltd.; Evergreen Marine (Singapore) Pte. Ltd.; HMM Company Limited; Maersk A/S; CMA CGM S.A.; Apex Maritime Co., Inc.; China United Transport, Inc.; Cosco Shipping Lines Co., Ltd.; And Wan Hai Lines Ltd., Respondents; Notice of Filing of Complaint and Assignment</SUBJECT>
                <DATE>Served: January 8, 2025.</DATE>
                <P>
                    Notice is given that a complaint has been filed with the Federal Maritime Commission (the “Commission”) by Euromarket Designs, Inc. (the “Complainant”) against MSC Mediterranean Shipping Company SA; Ocean Network Express Pte. Ltd.; Evergreen Line Joint Service Agreement (FMC Agreement No. 011982); Evergreen Marine Corp. (Taiwan) Ltd., Evergreen Marine (UK) Limited; Italia Marittima SpA; Evergreen Marine (Hong Kong) Ltd.; Evergreen Marine (Singapore) Pte. Ltd.; HMM Company Limited; Maersk A/S; CMA CGM S.A.; Apex Maritime Co., Inc.; China United Transport, Inc.; COSCO SHIPPING Lines Co., Ltd.; and Wan Hai Lines Ltd. (collectively, the “Respondents”). Complainant states that the Commission has subject-matter jurisdiction over this Complaint pursuant to the Shipping Act of 1984, as amended, 46 U.S.C. 40101 
                    <E T="03">et seq.</E>
                     (the “Shipping Act”). Complainant states that the Commission has personal jurisdiction over some of the Respondents as ocean common carriers, as defined in 46 U.S.C. 40102(18), that entered into a service contract, as defined in 46 U.S.C. 40102(21), with Complainant, and others as vessel-operating ocean common carriers, as defined in 46 U.S.C. 40102(18), and non-vessel-operating common carriers, as defined in 46 U.S.C. 40102(17).
                </P>
                <P>Complainant is a corporation existing under the laws of Illinois with a mailing address in Northbrook, Illinois.</P>
                <P>Complainant identifies Respondent MSC Mediterranean Shipping Company SA as a company existing under the laws of Switzerland with its principal place of business located in Geneva, Switzerland.</P>
                <P>
                    Complainant identifies Respondent Ocean Network Express Pte. Ltd. as a 
                    <PRTPAGE P="3869"/>
                    company existing under the laws of Singapore with its principal place of business located in Singapore whose agent in the United States is Ocean Network Express (North America) Inc. with its principal place of business located in Richmond, Virginia.
                </P>
                <P>Complainant identifies Respondent Evergreen Marine Corp. (Taiwan) Ltd. as a company existing under the laws of Taiwan with its principal place of business located in Taipei City, Taiwan whose agent in the United States is Evergreen Shipping Agency (America) Corp. with its principal place of business located in Jersey City, New Jersey.</P>
                <P>Complainant identifies Respondent Evergreen Marine (UK) Limited as a company existing under the laws of the United Kingdom with its principal place of business located in London, England.</P>
                <P>Complainant identifies Respondent Italia Marittima SpA as a company existing under the laws of Italy with its principal place of business located in Trieste, Italy.</P>
                <P>Complainant identifies Respondent Evergreen Marine (Hong Kong) Ltd. as a company existing under the laws of Hong Kong with its principal place of business located in Wan Chai, Hong Kong.</P>
                <P>Complainant identifies Respondent Evergreen Marine (Singapore) Pte. Ltd. as a company existing under the laws of Singapore with its principal place of business in Southpoint, Singapore.</P>
                <P>Complainant identifies Respondent Evergreen Line Joint Service Agreement (FMC Agreement No. 011982) as a vessel-operating ocean common carrier consisting of Evergreen Marine Corporation (Taiwan) Ltd., Evergreen Marine (UK) Limited, Italia Marittima SpA, Evergreen Marine (Hong Kong) Ltd., Evergreen Marine (Singapore) Pte. Ltd., and non-party, Evergreen Marine (Asia) Pte. Ltd.</P>
                <P>Complainant identifies Respondent HMM Company Limited as a company existing under the laws of the Republic of Korea with its principal place of business located in Seoul, Korea whose agent in the United States is HMM (America) Inc. with its principal place of business located in Irving, Texas.</P>
                <P>Complainant identifies Respondent Maersk A/S as a company existing under the laws of Denmark with its principal place of business located in Copenhagen, Denmark whose agent in the United States is Maersk Agency U.S.A., Inc. with its principal place of business located in Florham Park, New Jersey.</P>
                <P>Complainant identifies Respondent CMA CGM S.A. as a company existing under the laws of France with its principal place of business located in Marseilles, France whose agent in the United States is CMA CGM (America) LLC with its principal place of business located in Norfolk, Virginia.</P>
                <P>Complainant identifies Respondent Apex Maritime Co., Inc. as a company existing under the laws of California with its principal place of business located in Burlingame, California.</P>
                <P>Complainant identifies Respondent China United Transport, Inc. as a company existing under the laws of the People's Republic of China with its principal place of business located in Shanghai, China.</P>
                <P>Complainant identifies Respondent COSCO SHIPPING Lines Co., Ltd. as a company existing under the laws of the People's Republic of China with its principal place of business located in Shanghai, China whose agent in the United States is COSCO SHIPPING Lines (North America) Inc. with its principal place of business located in Secaucus, New Jersey.</P>
                <P>Complainant identifies Respondent Wan Hai Lines Ltd. as a company existing under the laws of Taiwan with its principal place of business located in Taipei, Taiwan whose agent in the United States is Wan Hai Lines (USA) Ltd. with its principal place of business located in Long Beach, California.</P>
                <P>Complainant alleges that all Respondents violated 46 U.S.C. 41102(c), 41104(a)(2), 41104(a)(10); and 46 CFR 545.5. Complainant alleges these violations arose from the assessment of demurrage and detention charges during periods of time in which the charges were not just or reasonable because of circumstances outside the control of the Complainant, the assessment of these charges under non-compliant bills of lading, and other acts or omissions of the Respondents.</P>
                <P>Complainant alleges that the Respondents that entered into a service contract with Complainant violated 46 U.S.C. 41102(c) and 41104(a)(2). Complainant alleges these violations arose from a practice of systematically failing to meet service commitments, the use of coercion to require payment of extracontractual surcharges prior to performance of service commitments and to require amendments to service contracts, and other acts or omissions of these Respondents.</P>
                <P>An answer to the complaint must be filed with the Commission within 25 days after the date of service.</P>
                <P>
                    The full text of the complaint can be found in the Commission's electronic Reading Room at 
                    <E T="03">https://www2.fmc.gov/readingroom/proceeding/25-03/.</E>
                     This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding judge shall be issued by January 8, 2026, and the final decision of the Commission shall be issued by July 22, 2026.
                </P>
                <SIG>
                    <NAME>David Eng,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00780 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL MARITIME COMMISSION</AGENCY>
                <DEPDOC>[Docket No. 25-01]</DEPDOC>
                <SUBJECT>20230930-DK-Butterfly-1, INC., Complainant v. BAL Container Line Co., Limited, Respondent. Notice of Filing of Complaint and Assignment</SUBJECT>
                <DATE>Served: January 8, 2025.</DATE>
                <P>
                    Notice is given that a complaint has been filed with the Federal Maritime Commission (the “Commission”) by 20230930-DK-Butterfly-1, Inc. (the “Complainant”) against BAL Container Line Co., Limited (the “Respondent”). Complainant states that the Commission has subject matter jurisdiction over the complaint pursuant to the Shipping Act of 1984, as amended, 46 U.S.C. 40101 
                    <E T="03">et seq.</E>
                     and personal jurisdiction over Respondent as an ocean common carrier, as defined in 46 U.S.C. 40102(18).
                </P>
                <P>Complainant is a corporation existing under the laws of New York with a mailing address in Union, New Jersey, that was formerly known as Bed Bath &amp; Beyond, Inc.</P>
                <P>Complainant identifies Respondent as a company existing under the laws of the Hong Kong Special Administrative Region of the People's Republic of China with its principal place of business located in Sheung Wan, Hong Kong.</P>
                <P>Complainant alleges that Respondent violated 46 U.S.C. 41102(c) and 41104(a)(10), and 46 CFR 545.5. Complainant alleges these violations arose from the assessment of detention and demurrage charges during periods of time in which the charges were not just or reasonable because of circumstances outside the control of Complainant and its agents and service providers, and the acts or omissions of Respondent that led to the assessment of such charges.</P>
                <P>An answer to the complaint must be filed with the Commission within 25 days after the date of service.</P>
                <P>
                    The full text of the complaint can be found in the Commission's electronic Reading Room at 
                    <E T="03">https://www2.fmc.gov/readingroom/proceeding/25-01/</E>
                    . This proceeding has been assigned to the Office of Administrative Law Judges. 
                    <PRTPAGE P="3870"/>
                    The initial decision of the presiding judge shall be issued by January 8, 2026, and the final decision of the Commission shall be issued by July 22, 2026.
                </P>
                <SIG>
                    <NAME>David Eng,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00779 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL MARITIME COMMISSION</AGENCY>
                <SUBJECT>Notice of Agreements Filed</SUBJECT>
                <P>
                    The Commission hereby gives notice of filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments, relevant information, or documents regarding the agreement to the Secretary by email at 
                    <E T="03">Secretary@fmc.gov,</E>
                     or by mail, Federal Maritime Commission, 800 North Capitol Street, Washington, DC 20573. Comments will be most helpful to the Commission if received within 12 days of the date this notice appears in the 
                    <E T="04">Federal Register</E>
                    , and the Commission requests that comments be submitted within 7 days on agreements that request expedited review. Copies of these agreements are available through the Commission's website (
                    <E T="03">www.fmc.gov</E>
                    ) or by contacting the Office of Agreements at (202)-523-5793 or 
                    <E T="03">tradeanalysis@fmc.gov.</E>
                </P>
                <P>
                    <E T="03">Agreement No.:</E>
                     201444.
                </P>
                <P>
                    <E T="03">Agreement Name:</E>
                     ONE to HMM AL5 Space Charter Agreement.
                </P>
                <P>
                    <E T="03">Parties:</E>
                     HMM Co. Ltd.; Ocean Network Express Pte. Ltd.
                </P>
                <P>
                    <E T="03">Filing Party:</E>
                     Joshua Stein, Cozen O'Connor.
                </P>
                <P>
                    <E T="03">Synopsis:</E>
                     The Agreement authorizes ONE to charter space to HMM in the trade between ports on the U.S. East Coast/Gulf and the U.S. West Coast on the one hand and ports in the United Kingdom, Germany, France, The Netherlands, Belgium, Colombia, and Dominican Republic on the other hand.
                </P>
                <P>
                    <E T="03">Proposed Effective Date:</E>
                     01/08/2025.
                </P>
                <P>
                    <E T="03">Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/88590.</E>
                </P>
                <P>
                    <E T="03">Agreement No.:</E>
                     201445.
                </P>
                <P>
                    <E T="03">Agreement Name:</E>
                     ONE to YML AL5 Slot Charter Agreement.
                </P>
                <P>
                    <E T="03">Parties:</E>
                     Ocean Network Express Pte. Ltd.; Yang Ming Joint Service Agreement (“YML”).
                </P>
                <P>
                    <E T="03">Filing Party:</E>
                     Joshua Stein, Cozen O'Connor.
                </P>
                <P>
                    <E T="03">Synopsis:</E>
                     The Agreement authorizes ONE to charter space to YML in the trade between ports on the U.S. East Coast/Gulf and the U.S. West Coast on the one hand and ports in the United Kingdom, Germany, France, The Netherlands, Belgium, Colombia, and Dominican Republic on the other hand.
                </P>
                <P>
                    <E T="03">Proposed Effective Date:</E>
                     01/08/2025.
                </P>
                <P>
                    <E T="03">Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/88591.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Jennifer Everling,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00777 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6730-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL RESERVE SYSTEM</AGENCY>
                <SUBJECT>Formations of, Acquisitions by, and Mergers of Bank Holding Companies;</SUBJECT>
                <HD SOURCE="HD1">Correction</HD>
                <P>
                    In the 
                    <E T="04">Federal Register</E>
                     of December 26, 2024, FR Doc. 2024-30728, the notice “Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities” by the Federal Reserve Bank of Chicago, 
                    <E T="03">Marathon MHC, Wausau, Wisconsin;</E>
                     is corrected to read “Formations of, Acquisitions by, and Mergers of Bank Holding Companies”, and that the company listed applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 
                    <E T="03">et seq.</E>
                    ), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations, to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company. In addition, the notice is corrected to read that the entities listed as savings and loan holding companies are bank holding companies. The comment period continues to end on January 27, 2025. Interested persons may continue to view the notice and submit comments as provided in 89 FR 105048 (December 26, 2024) no later than January 27, 2025.
                </P>
                <SIG>
                    <P>Board of Governors of the Federal Reserve System.</P>
                    <NAME>Michele Taylor Fennell,</NAME>
                    <TITLE>Associate Secretary of the Board.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00832 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Agency for Toxic Substances and Disease Registry</SUBAGY>
                <DEPDOC>[Docket No. ATSDR-2024-0004]</DEPDOC>
                <SUBJECT>Availability of Five Draft Toxicological Profiles; Extension of Comment Period</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Extension of comment period.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On November 8, 2024, the Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announced the opening of a docket to obtain comments on drafts of five updated toxicological profiles. This notice extends the comment period to February 13, 2025.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The comment period for the notice published November 8, 2024, at 89 FR 88772 is extended. Written comments must be received on or before February 13, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by Docket No. ATSDR-2024-0004 by either of the methods listed below. Do not submit comments by email. ATSDR does not accept comments by email.</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Agency for Toxic Substances and Disease Registry, Office of Innovation and Analytics, 4770 Buford Highway, Mail Stop S106-5, Atlanta, GA 30341-3717. Attn: Docket No. ATSDR-2024-0004.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to 
                        <E T="03">http://www.regulations.gov,</E>
                         including any personal information provided. For access to the docket to read background documents or comments received, go to 
                        <E T="03">http://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Farhana Rahman, Agency for Toxic Substances and Disease Registry, Office of Innovation and Analytics, 4770 Buford Highway, Mail Stop S106-5, Atlanta, GA 30341-3717; Email: 
                        <E T="03">ATSDRToxProfileFRNs@cdc.gov;</E>
                         Phone: 1-800-232-4636.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In the “Availability of Five Draft Toxicological Profiles” notice that appeared in the November 8, 2024 
                    <E T="04">Federal Register</E>
                     (89 FR 88772), we solicited public comments on drafts of five updated 
                    <PRTPAGE P="3871"/>
                    toxicological profiles: benzene, carbon disulfide, cyanide, thallium, and chlorinated dibenzo-
                    <E T="03">p</E>
                    -dioxins. This action is necessary as this is the opportunity for members of the public and organizations to submit comments on drafts of the profiles. The intended effect of this action is to ensure that the public can note any pertinent additional information or reports on studies about the health effects caused by exposure to the substances covered in these five profiles for review.
                </P>
                <P>We have received requests from interested parties to extend the comment period. Therefore, we are extending the comment period for an additional seven days.</P>
                <SIG>
                    <NAME>Donata Green,</NAME>
                    <TITLE>Associate Director, Office of Policy, Planning and Partnerships, Agency for Toxic Substances and Disease Registry.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00827 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4163-70-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                <DEPDOC>[Document Identifiers: CMS-10330 and CMS-10416]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Medicare &amp; Medicaid Services, Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Centers for Medicare &amp; Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the 
                        <E T="04">Federal Register</E>
                         concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:</P>
                    <P>
                        1. 
                        <E T="03">Electronically.</E>
                         You may send your comments electronically to 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.
                    </P>
                    <P>
                        2. 
                        <E T="03">By regular mail.</E>
                         You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
                    </P>
                    <P>
                        To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: 
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>William N. Parham at (410) 786-4669.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Contents</HD>
                <P>
                    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see 
                    <E T="02">ADDRESSES</E>
                    ).
                </P>
                <FP SOURCE="FP-1">CMS-10330 Notice of Rescission of Coverage and Disclosure Requirements for Patient Protection under the Affordable Care Act</FP>
                <FP SOURCE="FP-1">CMS-10416 Blueprint for Approval of State-based Exchange</FP>
                <P>
                    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the 
                    <E T="04">Federal Register</E>
                     concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.
                </P>
                <HD SOURCE="HD1">Information Collections</HD>
                <P>
                    1. 
                    <E T="03">Type of Information Collection Request:</E>
                     Extension of a currently approved collection; 
                    <E T="03">Title of Information Collection:</E>
                     Notice of Rescission of Coverage and Disclosure Requirements for Patient Protection under the Affordable Care Act; 
                    <E T="03">Use:</E>
                     Section 2712 of the Public Health Service Act (PHS Act), as added by the Affordable Care Act, contains a rescission notice. The No Surprises Act, enacted as part of the Consolidated Appropriations Act, 2021, sunset the patient protections related to choice of health care professional under section 2719A of the PHS Act and recodified these patient protections in newly added section 9822 of the Internal Revenue Code, section 722 of the Employee Retirement Income Security Act, and section 2799A-7 of the PHS Act and extended the applicability of these provisions to grandfathered health plans for plan years beginning on or after January 1, 2022. The rescission notice will be used by health plans and issuers to provide advance notice to certain individuals that their coverage may be rescinded as a result of fraud or intentional misrepresentation of material fact. The patient protection notification will be used by certain health plans and issuers to inform individuals of their right to choose a primary care provider or pediatrician and to use obstetrical/gynecological services without prior authorization. The related provisions are finalized in the 2015 final regulations titled “Final Rules under the Affordable Care Act for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections” (80 FR 72192, November 18, 2015) and 2021 interim final regulations titled “Requirements Related to Surprise Billing; Part I” (86 FR 36872, July 13, 2021). 
                    <E T="03">Form Number:</E>
                     CMS-10330 (OMB control number 0938-1094); Annually; 
                    <E T="03">Affected Public:</E>
                     State, Local, or Tribal Governments, Private Sector; 
                    <E T="03">Number of Respondents:</E>
                     82,638; 
                    <E T="03">Total Annual Responses:</E>
                     13,741,303; 
                    <E T="03">Total Annual Hours:</E>
                     10. (For policy questions regarding this 
                    <PRTPAGE P="3872"/>
                    collection, contact Adam Pellillo at 667-290-9621.)
                </P>
                <P>
                    2. 
                    <E T="03">Type of Information Collection Request:</E>
                     Revision of a currently approved collection; 
                    <E T="03">Title of Information Collection:</E>
                     Blueprint for Approval of State-based Exchange; 
                    <E T="03">Use:</E>
                     The Patient Protection and Affordable Care Act (ACA) and its implementing regulations provide states with flexibility in the design and operation of Exchanges to ensure states are implementing Exchanges that best meet the needs of their consumers. States can choose to establish and operate a State-based Exchange (SBE) or a State-based Exchange on the Federal Platform (SBE-FP). To ensure a state can operate a successful and compliant SBE or SBE-FP, it is critical that states provide CMS with a complete and thorough Exchange Blueprint Application, Declaration of Intent Letter, and attest to demonstrate operational readiness. The information collected from states will be used by CMS, IRS, SSA and reviewed by other Federal agencies to determine if a state can implement a complete and fully operational Exchange. 
                    <E T="03">Form Number:</E>
                     CMS-10416 (OMB control number: 0938-1172); 
                    <E T="03">Frequency:</E>
                     Annually; 
                    <E T="03">Affected Public:</E>
                     State, Local, or Tribal governments; 
                    <E T="03">Number of Respondents:</E>
                     2; 
                    <E T="03">Total Annual Responses:</E>
                     21; 
                    <E T="03">Total Annual Hours:</E>
                     106. (For policy questions regarding this collection contact Tiffany Y. Animashaun at 
                    <E T="03">Tiffany.Animashaun@cms.hhs.gov.</E>
                    )
                </P>
                <SIG>
                    <NAME>William N. Parham, III,</NAME>
                    <TITLE>Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00695 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4120-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                <DEPDOC>[Document Identifier: CMS-R-71 and CMS-855B]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Submission for OMB Review; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Medicare &amp; Medicaid Services, Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Centers for Medicare &amp; Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the 
                        <E T="04">Federal Register</E>
                         concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments on the collection(s) of information must be received by the OMB desk officer by February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain</E>
                        . Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                    <P>
                        To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: 
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>William Parham at (410) 786-4669.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the 
                    <E T="04">Federal Register</E>
                     concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:
                </P>
                <P>
                    1. 
                    <E T="03">Type of Information Collection Request:</E>
                     Extension of a currently approved collection; 
                    <E T="03">Title of Information Collection:</E>
                     Quality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations; 
                    <E T="03">Use:</E>
                     The Peer Review Improvement Act of 1982 amended Title XI of the Social Security Act to create the Utilization and Quality Control Peer Review Organization (PRO) program which replaces the Professional Standards Review Organization (PSRO) program and streamlines peer review activities. The term PRO has been renamed Quality Improvement Organization (QIO). This information collection describes the review functions to be performed by the QIO. It outlines relationships among QIOs, providers, practitioners, beneficiaries, intermediaries, and carriers. 
                    <E T="03">Form Number:</E>
                     CMS-R-71 (OMB control number: 0938-0445); 
                    <E T="03">Frequency:</E>
                     Yearly; 
                    <E T="03">Affected Public:</E>
                     Business or other for-profit and Not-for-profit institutions; 
                    <E T="03">Number of Respondents:</E>
                     6,120; 
                    <E T="03">Total Annual Responses:</E>
                     502,246; 
                    <E T="03">Total Annual Hours:</E>
                     1,091,597. (For policy questions regarding this collection contact Cheryl Lehane at 617-461-4888.)
                </P>
                <P>
                    2. 
                    <E T="03">Type of Information Collection Request:</E>
                     Reinstatement with change of a previously approved collection; 
                    <E T="03">Title of Information Collection:</E>
                     Medicare Enrollment Application for Clinics/Group Practices and Other Suppliers; 
                    <E T="03">Use:</E>
                     Various sections of the Act, the United States Code (U.S.C.), Internal Revenue Service (IRS) Code, and the CFR require providers and suppliers to furnish information concerning the amounts due and the identification of individuals or entities that furnish medical services to beneficiaries before payment can be made. The Form CMS-855B application is submitted when the applicant first requests Medicare enrollment. The application is used by the MACs to collect data to ensure the applicant has the necessary credentials to provide the health care services for which they intend to bill Medicare; this includes data that allows the Medicare contractor to correctly price, process, and pay the applicant's claims. It also gathers information that enables MACs to ensure that the supplier is neither excluded from the Medicare program nor debarred, suspended, or excluded from any other Federal agency or program. The application is also used by 
                    <PRTPAGE P="3873"/>
                    enrolled suppliers when they are reporting a change in their ownership, a change in their current Medicare enrollment information, or are revalidating or reactivating their Medicare enrollment. 
                    <E T="03">Form Number:</E>
                     CMS-855B (OMB control number: 0938-1377); 
                    <E T="03">Frequency:</E>
                     Occasionally; 
                    <E T="03">Affected Public:</E>
                     Private Sector; Business or other for-profits, and Not-for Profits; 
                    <E T="03">Number of Respondents:</E>
                     132,800; 
                    <E T="03">Number of Responses:</E>
                     132,800; 
                    <E T="03">Total Annual Hours:</E>
                     155,884. (For questions regarding this collection, contact Frank Whalen at 410-786-1302 or 
                    <E T="03">Frank.Whelan@cms.hhs.gov.</E>
                    )
                </P>
                <SIG>
                    <NAME>William N. Parham, III,</NAME>
                    <TITLE>Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00696 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4120-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2021-P-0168]</DEPDOC>
                <SUBJECT>Growing, Harvesting, Processing, and Distribution of Poppy Seeds—Industry Practices Related to Opiate Alkaloids; Request for Information</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for information.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA or we) is requesting information on industry practices related to poppy seeds, such as information about growing, harvesting, processing, and distribution of poppy seeds, including industry practices to reduce the opiate alkaloid content of poppy seeds. We are taking this action, in part, because we have received reports of adverse events related to the use of some poppy seed products. We intend to use the information to help determine what type(s) of actions, if any, we should take to help ensure that poppy seed products do not pose a health risk when consumed.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Either electronic or written comments on the notice must be submitted by April 15, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments and information as follows. Please note that late, untimely filed comments will not be considered. The 
                        <E T="03">https://www.regulations.gov</E>
                         electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 15, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
                    </P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    <E T="03">https://www.regulations.gov</E>
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</P>
                <HD SOURCE="HD2">Written/Paper Submissions</HD>
                <P>Submit written/paper submissions as follows:</P>
                <P>
                    • 
                    <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E>
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <P>• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</P>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the Docket No. FDA-2021-P-0168 for “Growing, Harvesting, Processing, and Distribution of Poppy Seeds—Industry Practices related to Opiate Alkaloids; Request for Information.” Received comments, those filed in a timely manner (see 
                    <E T="02">ADDRESSES</E>
                    ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    <E T="03">https://www.regulations.gov</E>
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
                </P>
                <P>
                    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</E>
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Jesse Lunzer, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2879, or Holli Kubicki, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    FDA is requesting information on industry practices related to poppy seeds, such as information about growing, harvesting, processing, and distribution of poppy seeds, including industry practices to reduce the opiate alkaloid content of poppy seeds. The opium poppy (
                    <E T="03">Papaver somniferum</E>
                    ), or the “poppy plant,” is cultivated for food use, decorative use, ornamental use, and 
                    <PRTPAGE P="3874"/>
                    medicinal purposes. In the poppy plant, seeds grow inside an enclosed round fruit that is often referred to as a “capsule” or “seed capsule.” The poppy plant produces substances, including alkaloids, to maintain the biological processes needed to grow and reproduce. Morphine, codeine, and thebaine are alkaloids produced by poppy plants and are referred to as opiate alkaloids.
                </P>
                <P>The scientific literature and FDA's preliminary surveillance sampling show that poppy seeds may have varying amounts of opiate alkaloids and that opiate alkaloids may be present on poppy seeds or in poppy seed-containing foods. Opiate alkaloid exposure may cause a range of side effects, including unusual dizziness or lightheadedness, sedation, extreme sleepiness, slowed or difficult breathing, unresponsiveness, respiratory arrest, and, in some cases, death. Reports of adverse events associated with poppy seed consumption have also garnered concern among citizens and consumer groups such as the Center for Science in the Public Interest (Ref. 1).</P>
                <P>FDA is aware that some consumers have used poppy seeds to produce a “poppy seed tea” that has been linked to serious adverse events, including death. “Tea” is a misnomer, as the beverage is a solution that results from rinsing the opiate alkaloid-containing latex residue from the outer hull of the poppy seeds using cold water, and not an infusion created by steeping the seeds in hot water. To date, FDA has received nine reports of deaths purportedly associated with the consumption of homemade poppy seed tea. The cause of death for eight cases was morphine intoxication, often with codeine from poppy seeds and other substances (prescription opioids, benzodiazepines, anticonvulsants, mitragynine (kratom), and cannabis) also involved.</P>
                <P>FDA's efforts to expand our understanding of opiate alkaloids on poppy seeds and consumer behaviors related to poppy seed consumption include surveillance sampling and testing poppy seeds from marketed products to determine their opiate alkaloid content. Twenty-one samples taken from poppy seeds purchased online showed morphine levels between 1 milligram per kilogram (mg/kg) and 520 mg/kg (median 70 mg/kg; mean 120.4 mg/kg) and codeine levels between 0.8 mg/kg and 255 mg/kg (median 85 mg/kg; mean 113.1 mg/kg). We also have been examining agricultural and manufacturing practices related to poppy seeds and are interested in learning whether there are agricultural or manufacturing practices that might reduce the presence of the opiate alkaloids on poppy seeds.</P>
                <P>
                    Our current understanding is that most opiate alkaloids on poppy seeds are deposited on the seeds by means of contact with liquid or dried latex that may occur through pod/capsule damage and/or particulate latex-derived dust through growing, harvesting, and processing practices (Refs. 2-4). Because these practices may vary depending on the grower or manufacturer and the intended use of the poppy plant (
                    <E T="03">e.g.,</E>
                     whether it is grown for food or pharmaceutical purposes), we would like more detailed information about the specific practices and processes from growth of the poppy plant and harvesting of poppy seeds to the processing and manufacturing of poppy seeds and poppy seed food products in the marketplace.
                </P>
                <P>Accordingly, we are seeking additional information on industry practices, such as information about the poppy seed supply chain and harvesting, handling, and testing practices, as well as manufacturing, processing, or other practices available and in use by industry to reduce or otherwise affect the opiate alkaloid content of poppy seeds. This information would help FDA understand existing industry practices and determine what type(s) of actions, if any, we should take to help to ensure that poppy seed products do not pose a health risk when consumed.</P>
                <HD SOURCE="HD1">II. Issues for Consideration and Request for Information  </HD>
                <P>
                    We invite comment in response to the questions below. Please explain your answers and provide references and data, if possible. Including contextual information about your role(s) in the poppy seed industry (
                    <E T="03">e.g.,</E>
                     grower, importer, retailer) would also be helpful.
                </P>
                <HD SOURCE="HD2">A. Questions About Growing, Harvesting, and Post-Harvest Processes of Poppy Plant Crops and Poppy Seeds</HD>
                <P>As background, a poppy plant's production of opiate alkaloids varies based on certain environmental, biological, and inter-cultivar genetic variation. In addition, we are aware that agricultural practices that occur during poppy plant growth may impact opportunities for opiate alkaloid-containing latex to be deposited on seeds (Refs. 2-5 and 9).</P>
                <P>Dried mature poppy plants are commonly harvested by using mechanized harvesting machinery that cuts and removes the above-ground plants after the plants have died and dried out in the field (Refs. 6-9). We want to learn about the types of harvesting practices and machinery used, because harvesting dried plants can result in the production of opiate alkaloid-containing dust or particulate plant tissue that may be deposited on the seeds (Ref. 9).</P>
                <P>We also are aware of some practices that are used to separate seeds from the seed capsules. For example, firms might use threshing machines, which crush the capsules and release the seeds. Other practices involve use of sieves, gravity tables, or other cleaning machines intended to separate the seeds from debris (such as small fragments of capsules, stems, or rocks) by shaking or blowing air through a permeable surface and separating plant material by size (Ref. 8). Opiate alkaloids might be transferred to the outer surface of poppy seeds during various harvesting and post-harvesting steps.</P>
                <P>
                    <E T="03">Question 1:</E>
                     Please tell us about the growing, harvesting, and post-harvest processes used to produce poppy plant crops and seeds and what types of equipment are used for these processes. What, if any, are the different processes used for different geographic areas where the plant(s) are grown and why are the different processes used? We are particularly interested in information about good agricultural practices, scoring or nicking pods, harvesting procedures, cleaning and separation of plant parts, opiate alkaloid testing method and frequency, thermal treatments (
                    <E T="03">e.g.,</E>
                     to degrade opiate alkaloids), packaging, cleaning of equipment, frequency of cleaning, and storage.
                </P>
                <P>
                    <E T="03">Question 2:</E>
                     Do buyers of poppy plants request specific varieties or cultivars based on the amount of opiate alkaloid produced by the variety or cultivar? If so, what are the specific varieties or cultivars and, if known, what are the preferred uses for these varieties or cultivars, and why are those varieties or cultivars preferred?
                </P>
                <P>
                    <E T="03">Question 3:</E>
                     What types of equipment (
                    <E T="03">e.g.,</E>
                     agricultural threshers, combines, cultivators, other equipment) are used for harvesting poppy plants? FDA is aware that machine harvesting can result in opiate alkaloids being deposited on poppy seeds (Ref. 9). Please elaborate on style, model, settings, etc.
                </P>
                <P>
                    <E T="03">Question 4:</E>
                     What practices are used to monitor, control, reduce, or otherwise affect poppy seed opiate alkaloid content, such as opiate alkaloid testing or poppy seed heat treatments (Refs. 10-12)? We are particularly interested in information on the types of practices to reduce opiate alkaloids and frequency of 
                    <PRTPAGE P="3875"/>
                    use of the practices, as well as any evidence of their impact on the opiate alkaloid content of poppy seeds and the quality of the seeds.
                </P>
                <HD SOURCE="HD2">B. Questions About Poppy Seed Supply Chain</HD>
                <P>We also seek information about distribution chains of poppy seeds and activities conducted during distribution (for example, opioid alkaloid testing and poppy seed heat treatment). Poppy seeds might be sourced from poppy plants that are grown solely for food use. In addition, seeds from poppy plants that are grown for pharmaceutical purposes might be sold for human food consumption (Refs. 4 and 6). Thus, FDA also wants to better understand the practices of companies that sell poppy capsules and seeds from plants grown for pharmaceutical purposes to entities involved in food manufacturing and distribution, at all points in time from the growth of poppy plants to the sale of poppy seeds. Cultivars grown for pharmaceutical purposes may produce higher opiate alkaloids compared to cultivars grown solely for food use, which may result in higher opiate alkaloid content on seeds. These cultivars and their seeds might be more affected by the practices involved in growing, harvesting, processing, and distribution.</P>
                <P>
                    <E T="03">Question 5:</E>
                     What are the various intermediaries and processes that are part of the supply chain for poppy seeds? Please include information about what intermediaries (such as brokers, exporters, importers, consolidators, manufacturers, and retailers) and processes (such as opiate alkaloid testing, testing frequency, packing, sale, and transportation) might be involved at various stages throughout the poppy seed supply chain.
                </P>
                <P>
                    <E T="03">Question 6:</E>
                     What activities are performed in the distribution chains of poppy seeds? For example, do distributors or wholesalers engage in opioid alkaloid testing and heat treatments of poppy seeds? If so, what types of testing, treatments, or other activities are performed and how frequently are such activities performed?
                </P>
                <P>
                    <E T="03">Question 7:</E>
                     Describe the role of any brokers or other intermediary distributors that sell poppy seeds between pharmaceutical companies (or poppy plants grown for pharmaceutical use) and food manufacturers. Do brokers or other intermediary distributors request poppy seeds from specific cultivars of poppy plants? If so, what are these specific cultivars?
                </P>
                <P>
                    <E T="03">Question 8:</E>
                     Do brokers or other intermediary distributors typically sell poppy seeds direct to retailers or individual consumers? What additional precautions or steps are taken when selling directly to retailers or consumers?
                </P>
                <HD SOURCE="HD2">C. Questions About Processing and Manufacturing From Poppy Plants to Poppy Seeds</HD>
                <P>We want additional information about other post-harvest practices conducted by manufacturers to control or reduce, or that may otherwise affect, poppy seed opiate alkaloid content, such as if opiate alkaloid testing (at any point) or poppy seed heat treatments are performed (Refs. 10-12). More information on the types of practices to reduce opiate alkaloids and frequency of the practices, as well as any evidence on their impact on the opiate alkaloid content of poppy seeds and the quality of the seeds, would be useful.  </P>
                <P>
                    <E T="03">Question 9:</E>
                     What manufacturing processes are used to manufacture poppy seed food products and what processes are applied to reduce poppy seeds' opiate alkaloid content? Information about any processes, such as initial inspection, cleaning or separation of plant parts, mixing, crushing, blending, treatments such as heating or washing, drying, cleaning of equipment, cleaning frequency, packaging, testing, testing type, and transportation, used to process poppy seeds and manufacture poppy seed products would be useful.
                </P>
                <P>
                    <E T="03">Question 10:</E>
                     When using contract growers or otherwise procuring seeds, what specific varieties, cultivars, characteristics (
                    <E T="03">e.g.,</E>
                     color, aroma, opiate alkaloid levels), or other specifications are typically required for food use?
                </P>
                <P>
                    <E T="03">Question 11:</E>
                     If you are a manufacturer of poppy seeds or poppy seed products, what types of customers (
                    <E T="03">e.g.,</E>
                     manufacturers of other products, retailers, individual customers) do you sell to? What additional precautions or steps, if any, are taken when selling to various customers?
                </P>
                <P>
                    <E T="03">Question 12:</E>
                     If you are a manufacturer of poppy seeds or poppy seed products, what types of sellers (
                    <E T="03">e.g.,</E>
                     manufacturers of other products, growers, other sources) do you buy poppy seeds from? What additional precautions or steps, if any, are taken when buying from various sellers?
                </P>
                <HD SOURCE="HD1">III. References</HD>
                <P>
                    The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see 
                    <E T="02">ADDRESSES</E>
                    ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at 
                    <E T="03">https://www.regulations.gov.</E>
                     References without asterisks are not on public display at 
                    <E T="03">https://www.regulations.gov</E>
                     because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the 
                    <E T="04">Federal Register</E>
                    , but websites are subject to change over time.
                </P>
                <EXTRACT>
                    <FP SOURCE="FP-2">*1. Center for Science in the Public Interest Citizen Petition, February 5, 2021, Docket No. FDA-2021-P-0168).</FP>
                    <FP SOURCE="FP-2">
                        *2. BfR (Bundesinstitut für Risikobewertung—Federal Institute for Risk Assessment), 2005. “BfR Recommends Provisional Daily Upper Intake Level and a Guidance Value for Morphine in Poppy Seeds.” BfR Health Assessment No. 012/2006, 27 December 2005. Available at 
                        <E T="03">http://www.bfr.bund.de/cm/245/bfr_recommends_provisional_daily_upper_intake_level_and_a_guidance_value_for_morphine_in_poppy_seeds.pdf</E>
                         (accessed September 13, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        *3. European Food Safety Authority (EFSA) Panel on Contaminants in the Food Chain (CONTAM). “Scientific Opinion on the Risks for Public Health Related to the Presence of Opium Alkaloids in Poppy Seeds.” 
                        <E T="03">EFSA Journal,</E>
                         9(11):2405, 2011. Available at 
                        <E T="03">https://doi.org/10.2903/j.efsa.2011.2405</E>
                         (accessed September 13, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        *4. EFSA Panel on Contaminants in the Food Chain (CONTAM), et al. “Update of the Scientific Opinion on Opium Alkaloids in Poppy Seeds.” 
                        <E T="03">EFSA Journal,</E>
                         16(5):e05243, 2018. Available at 
                        <E T="03">https://doi.org/10.2903/j.efsa.2018.5243</E>
                         (accessed September 13, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        *5. European Union “Commission Recommendation of 10 September 2014 on Good Practices to Prevent and to Reduce the Presence of Opium Alkaloids in Poppy Seeds and Poppy Seed Products.” 2014/662/EU. Official Journal of the European Union, L271/96. Available at 
                        <E T="03">https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2014.271.01.0096.01.ENG&amp;toc=OJ%3AL%3A2014%3A271%3ATOC</E>
                         (accessed September 13, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        *6. Fist, A.J. “The Tasmanian Poppy Industry: A Case Study of the Application of Science and Technology.” 
                        <E T="03">Proceedings of the Australian Agronomy Conference.</E>
                         2001. Available at 
                        <E T="03">https://nla.gov.au/nla.obj-1382338968/view</E>
                         (accessed September 13, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        7. Martinov, M. and M. Konstantinovic. “Chapter 2: Harvesting,” in 
                        <E T="03">Medicinal and Aromatic Crops: Harvesting, Drying, and Processing.</E>
                         Öztekin, S., Martino, M., The Hawthorn Press, Inc. 2007.
                    </FP>
                    <FP SOURCE="FP-2">
                        8. Fejér, J. and I. Salamon. “Agro-Technology of the Poppy: Large-Scale Cultivation in Slovakia.” 
                        <E T="03">
                            International Symposium on 
                            <PRTPAGE P="3876"/>
                            Papaver 1036.
                        </E>
                         2014.
                    </FP>
                    <FP SOURCE="FP-2">
                        9. Montgomery, M.T., X.A. Conlan, A.G. Theakstone, et al. “Extraction and Determination of Morphine Present on the Surface of Australian Food Grade Poppy Seeds Using Acidic Potassium Permanganate Chemiluminescence Detection.” 
                        <E T="03">Food Analytical Methods,</E>
                         13(5):1159-1165, 2020. Available at 
                        <E T="03">https://doi.org/10.1007/s12161-020-01729-z</E>
                         (accessed December 8, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        10. Lo, D. and T. Chua. “Poppy Seeds: Implications of Consumption.” 
                        <E T="03">Medicine, Science and the Law,</E>
                         32(4):296-302, 1992. Available at 
                        <E T="03">https://doi.org/10.1177/002580249203200403</E>
                         (accessed December 8, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        11. Sproll, C., R.C. Perz, R. Buschmann, et al. “Guidelines for Reduction of Morphine in Poppy Seed Intended for Food Purposes.” 
                        <E T="03">European Food Research and Technology,</E>
                         226(1):307-310, 2007. Available at 
                        <E T="03">https://doi.org/10.1007/s00217-006-0522-7</E>
                         (accessed December. 8, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        12. Shetge, S.A., M.P. Dzakovich, J.L. Cooperstone, et al. “Concentrations of the Opium Alkaloids Morphine, Codeine, and Thebaine in Poppy Seeds are Reduced After Thermal and Washing Treatments But Are Not Affected When Incorporated in a Model Baked Product.” 
                        <E T="03">Journal of Agricultural and Food Chemistry,</E>
                         68(18):5241-5248, 2020. Available at 
                        <E T="03">https://doi.org/10.1021/acs.jafc.0c01681</E>
                         (accessed December 8, 2024).
                    </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>P. Ritu Nalubola,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00757 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2024-N-5964]</DEPDOC>
                <SUBJECT>Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Approval is withdrawn as of February 14, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 301-796-3471, 
                        <E T="03">Martha.Nguyen@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.</P>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="xs60,r100,r100">
                    <TTITLE>Table 1—ANDAs for Which Approval Is Withdrawn</TTITLE>
                    <BOXHD>
                        <CHED H="1">Application No.</CHED>
                        <CHED H="1">Drug</CHED>
                        <CHED H="1">Applicant</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">ANDA 040454</ENT>
                        <ENT>Promethazine Hydrochloride (HCl) injectable, 25 milligrams (mg)/milliliters (mL) and 50 mg/mL</ENT>
                        <ENT>Teva Pharmaceuticals USA, Inc., 400 Interpace Parkway, Bldg. A, Parsippany, NJ 07054.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 040593</ENT>
                        <ENT>Promethazine HCl injectable, 25 mg/mL and 50 mg/mL</ENT>
                        <ENT>Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 064042</ENT>
                        <ENT>Nystatin suspension, 100,000 units/mL</ENT>
                        <ENT>PAI Holdings, LLC, dba Pharmaceutical Associates, Inc., and dba PAI Pharma, 1700 Perimeter Rd., Greenville, SC 29605.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 074811</ENT>
                        <ENT>Haloperidol Decanoate injectable, Equivalent to (EQ) 50 mg base/mL</ENT>
                        <ENT>Hikma Pharmaceuticals USA Inc., 2 Esterbrook Lane, Cherry Hill, NJ 08003.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 076061</ENT>
                        <ENT>Pergolide Mesylate tablet, EQ 0.05 mg base, EQ 0.25 mg base, and EQ 1 mg base</ENT>
                        <ENT>Strides Pharma Inc., U.S. Agent for Strides Pharma Global Pte Ltd., 2 Tower Center Blvd., Suite 1102, East Brunswick, NJ 08816.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 079075</ENT>
                        <ENT>Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base</ENT>
                        <ENT>Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Parkway, Bldg. A, Parsippany, NJ 07054.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 079240</ENT>
                        <ENT>Sumatriptan Succinate injectable, EQ 6 mg base/0.5 mL (EQ 12 mg base/mL) and EQ 4 mg base/0.5 mL (EQ 8 mg base/mL)</ENT>
                        <ENT>Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 084591</ENT>
                        <ENT>Promethazine HCl injectable, 25 mg/mL</ENT>
                        <ENT>Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 090016</ENT>
                        <ENT>Irinotecan HCl injectable, 40 mg/2mL (20 mg/mL) and 100 mg/5 mL (20 mg/mL)</ENT>
                        <ENT>Hisun Pharmaceuticals USA Inc., U.S. Agent for Hisun Pharmaceutical (Hangzhou) Co., Ltd., 200 Crossing Blvd., 2nd Floor, Bridgewater, NJ 08807.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 200536</ENT>
                        <ENT>Ranitidine HCl tablet, EQ 150 mg base</ENT>
                        <ENT>Strides Pharma Inc., U.S. Agent for Strides Pharma Global Pte Ltd.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 201745</ENT>
                        <ENT>Ranitidine HCl tablet, EQ 75 mg base</ENT>
                        <ENT>Do.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 204991</ENT>
                        <ENT>Atorvastatin Calcium tablet, EQ 10 mg base, EQ 20 mg base, EQ 40 mg base, and EQ 80 mg base</ENT>
                        <ENT>Lupin Pharmaceuticals, Inc., U.S. Agent for Lupin Ltd., Harborplace Tower, 111 South Calvert St., 21st Floor, Baltimore, MD 21202.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 205512</ENT>
                        <ENT>Ranitidine HCl tablet, EQ 150 mg base and EQ 300 mg base</ENT>
                        <ENT>Strides Pharma Inc., U.S. Agent for Strides Pharma Global Pte Ltd.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 206155</ENT>
                        <ENT>Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg</ENT>
                        <ENT>RegCon Solutions, LLC, U.S. Agent for Indoco Remedies Ltd., 9920 Pacific Heights Blvd., Suite 250, San Diego, CA 92121.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 206204</ENT>
                        <ENT>Piperacillin and Tazobactam injectable, EQ 12 grams (g) base/vial; EQ 1.5 g base/vial</ENT>
                        <ENT>Fresenius Kabi USA, LLC.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 207338</ENT>
                        <ENT>Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, EQ 0.3 mg base, EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base</ENT>
                        <ENT>Actavis Laboratories FL, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA Inc.), 400 Interpace Parkway, Bldg. A, Parsippany, NJ 07054.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="3877"/>
                        <ENT I="01">ANDA 207919</ENT>
                        <ENT>Acyclovir Sodium injectable, EQ 50 mg base/mL</ENT>
                        <ENT>Dr. Reddy's Laboratories Inc., 107 College Rd. East, Princeton, NJ 08540.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 209325</ENT>
                        <ENT>Miglustat capsule, 100 mg</ENT>
                        <ENT>Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 201, Berlin, CT 06037.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 209708</ENT>
                        <ENT>Mivacurium Chloride solution, EQ 10 mg base/5 mL (EQ 2 mg base/mL) and EQ 20 mg base/10 mL (EQ 2 mg base/mL)</ENT>
                        <ENT>Woodward Pharma Services, LLC, 47220 Cartier Dr., Suite A, Wixom, MI 48393.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 211893</ENT>
                        <ENT>Ranitidine HCl capsule, EQ 150 mg base and EQ 300 mg base</ENT>
                        <ENT>Appco Pharma LLC, 262 Old New Brunswick Rd., Suite M, N, B-1, F, Piscataway, NJ 08854.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 214428</ENT>
                        <ENT>Niacin extended-release tablet, 500 mg and 1 g</ENT>
                        <ENT>Sciecure Pharma Inc., U.S. Agent for Beijing Sciecure Pharmaceutical Co., Ltd., 138 Glendale Ave., Edison, NJ 08817.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 215908</ENT>
                        <ENT>Nitisinone capsule, 2 mg, 5 mg, 10 mg, and 20 mg</ENT>
                        <ENT>Torrent Pharma Inc., 106 Allen Rd., Suite 305, Basking Ridge, NJ 07920.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ANDA 217094</ENT>
                        <ENT>Fluphenazine HCl tablet, 1 mg, 2.5 mg, 5 mg, and 10 mg</ENT>
                        <ENT>Torrent Pharma Inc., U.S. Agent for Torrent Pharmaceuticals Ltd., 106 Allen Rd., Suite 305, Basking Ridge, NJ 07920.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of February 14, 2025. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved new drug application or ANDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in table 1 that are in inventory on February 14, 2025 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.</P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>P. Ritu Nalubola,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00742 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2024-N-5851]</DEPDOC>
                <SUBJECT>Teva Branded Pharmaceutical Products R&amp;D, Inc., et al.; Withdrawal of Approval of 12 New Drug Applications</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Approval is withdrawn as of February 14, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137, 
                        <E T="03">Kimberly.Lehrfeld@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The applicants listed in table 1 have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.</P>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="xs68,r100,r100">
                    <TTITLE>Table 1—NDAs for Which Approval Is Withdrawn</TTITLE>
                    <BOXHD>
                        <CHED H="1">Application No.</CHED>
                        <CHED H="1">Drug</CHED>
                        <CHED H="1">Applicant</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">NDA 009388</ENT>
                        <ENT>Diamox IV (acetazolamide) Injectable, Equivalent to (EQ) 500 milligrams (mg) base per vial</ENT>
                        <ENT>Teva Branded Pharmaceutical Products R&amp;D, Inc., 145 Brandywine Parkway, West Chester, PA 19380.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 012836</ENT>
                        <ENT>Persantine (dipyridamole) Tablets, 25mg, 50mg, and 75mg</ENT>
                        <ENT>Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, P.O. Box 368, Ridgefield, CT 06877.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 018817</ENT>
                        <ENT>Calan (verapamil hydrochloride (HCl)) Tablets, 40 mg, 80 mg, 120 mg, and 160 mg</ENT>
                        <ENT>Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 021743</ENT>
                        <ENT>Tarceva (erlotinib HCl) Tablets, EQ 25 mg base, EQ 100 mg base, and EQ 150 mg base</ENT>
                        <ENT>OSI Pharmaceuticals, LLC, 2375 Waterview Dr., Northbrook, IL 60062.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 021785</ENT>
                        <ENT>Invirase (saquinavir mesylate) Tablets, EQ 500 mg base</ENT>
                        <ENT>Hoffmann-La Roche, Inc. c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 021937</ENT>
                        <ENT>Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) Tablets, 600 mg/200 mg/300 mg</ENT>
                        <ENT>Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 022383</ENT>
                        <ENT>Arcapta Neohaler (indacaterol maleate) Powder for Inhalation, EQ 75 micrograms base</ENT>
                        <ENT>Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 204412</ENT>
                        <ENT>Delzicol (mesalamine), Delayed-Release Capsules, 400 mg</ENT>
                        <ENT>AbbVie Inc., 1 N. Waukegan Rd., North Chicago, IL 60064.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 210875</ENT>
                        <ENT>Kynmobi (apomorphine HCl) Sublingual Film, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg</ENT>
                        <ENT>Sumitomo Pharma America, Inc., 84 Waterford Dr., Marlborough, MA 01752.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="3878"/>
                        <ENT I="01">NDA 211172</ENT>
                        <ENT>Tegsedi (inotersen sodium) Solution for Injection, EQ 284 mg base/1.5 mL</ENT>
                        <ENT>Akcea Therapeutics, Inc., 2850 Gazelle Ct., Carlsbad, CA 92010.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 212640</ENT>
                        <ENT>Exservan (riluzole) Oral Film, 50 mg</ENT>
                        <ENT>Aquestive Therapeutics, 30 Technology Dr., Warren, NJ 07059.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">NDA 213426</ENT>
                        <ENT>Seglentis (celecoxib and tramadol HCl) 56 mg; 44 mg</ENT>
                        <ENT>Kowa Pharmaceuticals America, Inc., 530 Industrial Park Blvd., Montgomery, AL 36117.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of February 14, 2025. Approval of each entire application is withdrawn, including any strengths and dosage forms included in the application but inadvertently missing from table 1. Introduction or delivery for introduction into interstate commerce of products listed in table 1 without an approved NDA violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in table 1 that are in inventory on February 14, 2025 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.</P>
                <SIG>
                    <DATED>Dated: January 6, 2025.</DATED>
                    <NAME>P. Ritu Nalubola,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00743 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2024-N-5716]</DEPDOC>
                <SUBJECT>High-Protein Yogurt; Request for Information</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for information.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA or we) is requesting information and data about the manufacturing processes and ingredients used to make certain dairy products referred to as high-protein yogurt, Greek yogurt, or Greek-style yogurt in this document. We are taking this action, in part, because the yogurt standard of identity may not align with certain manufacturing processes and ingredients used to concentrate protein to manufacture these products. We intend to use the information and data to help determine what type(s) of actions, if any, should be taken.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Either electronic or written comments on the notice must be submitted by April 15, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments and information as follows. Please note that late, untimely filed comments will not be considered. The 
                        <E T="03">https://www.regulations.gov</E>
                         electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 15, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
                    </P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    <E T="03">https://www.regulations.gov</E>
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</P>
                <HD SOURCE="HD2">Written/Paper Submissions</HD>
                <P>Submit written/paper submissions as follows:</P>
                <P>
                    • 
                    <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E>
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <P>• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</P>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the Docket No. FDA-2024-N-5716 for “High-Protein Yogurt; Request for Information.” Received comments, those filed in a timely manner (see 
                    <E T="02">ADDRESSES</E>
                    ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    <E T="03">https://www.regulations.gov</E>
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
                </P>
                <P>
                    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">
                        https://
                        <PRTPAGE P="3879"/>
                        www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
                    </E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</E>
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Yan Peng, Office of Nutrition and Food Labeling, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371, or Holli Kubicki, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>The Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) gives FDA the authority to establish definitions and standards of identity (SOIs) for foods whenever such action would promote honesty and fair dealing in the interest of consumers (see section 401 of the FD&amp;C Act (21 U.S.C. 341)). SOIs specify the ingredients, both mandatory and optional, of a standardized food, and sometimes describe the amount or proportion of each ingredient. Many SOIs also prescribe a method of production.</P>
                <P>
                    The yogurt SOI is stated at 21 CFR 131.200. There is not a separate SOI for high-protein yogurt, Greek yogurt, or Greek-style yogurt. For purposes of this document, high-protein yogurt, Greek yogurt, or Greek-style yogurt (collectively referred to in this document as “high-protein yogurt”) generally refers to a dairy product cultured with, at minimum, 
                    <E T="03">Lactobacillus delbrueckii,</E>
                     subspecies 
                    <E T="03">bulgaricus,</E>
                     and 
                    <E T="03">Streptococcus thermophilus,</E>
                     which has undergone a manufacturing method to increase the protein level.
                </P>
                <P>In recent years, the yogurt industry has raised concerns that the existing, single yogurt SOI does not accommodate the current practices or technologies to manufacture high-protein yogurt. Specifically, FDA received comments from the yogurt industry during the FDA 2019 Public Meeting on Horizontal Approaches to Food Standards of Identity Modernization (84 FR 45497, August 29, 2019 (Docket No. FDA-2018-N-2381)), and after the reopening of comments on the FDA 2005 proposed rule titled Food Standards; General Principles and Food Standards Modernization (85 FR 10107, February 21, 2020 (Docket No. FDA-1995-N-0062)), advocating for an additional SOI for strained, high-protein yogurt (which some comments referred to as Greek yogurt). The comments stated that a new SOI for strained, high-protein yogurt should include language that describes the authentic straining process, the characteristics of the product, and the distinguishing compositional nutritional elements of the product.</P>
                <P>We understand that since high-protein yogurt was introduced to the U.S. market, this category continues to expand substantially in product availability and variety, along with innovations in formulations and manufacturing processes.</P>
                <P>We also understand that there are different methods used by industry to increase the protein level of yogurt, some of which may not be consistent with the yogurt SOI. One method is to concentrate yogurt after culturing to remove liquid whey by a straining process (Refs. 1 and 2). The straining process can be done in a traditional way using cheesecloth, but is more commonly done commercially using a centrifugal separator (Refs. 1 and 2). Many yogurt manufacturers that use the straining process to make high-protein yogurt add cream after culturing and straining to achieve the desired fat content specified for the product. These manufacturers state that cream must be added after culturing and straining due to a variety of challenges that occur if cream is added before culturing, including reduced production efficiency due to clogging of centrifugal separators by fat, loss of fat in acid whey, and reduced ability to recycle acid whey with high fat content.</P>
                <P>Another method is the addition of milk-protein ingredients to milk prior to culturing (Refs. 1 and 2). This method is also known as the protein-fortified method, which allows for the production of high-protein yogurt on the same processing equipment used for yogurt not fortified with milk-protein ingredients, without the need for liquid whey removal after culturing (Refs. 1 and 2).</P>
                <P>
                    Yet another method is to concentrate protein in milk before or after culturing (
                    <E T="03">e.g.,</E>
                     membrane ultrafiltration (Refs. 1 and 2)). (We note that FDA granted a temporary permit to Chobani to market test certain yogurt products deviating from the yogurt SOI by using ultrafiltered nonfat milk as a basic dairy ingredient before culturing (88 FR 18322, March 28, 2023).
                </P>
                <HD SOURCE="HD1">II. Issues for Consideration and Request for Information</HD>
                <P>FDA is issuing this request for information to better understand the current marketplace for high-protein yogurt products. In particular, FDA is interested in information that would help us determine whether there is a need for updating an existing, or establishing a new standard of identity for these products to promote honesty and fair dealing in the interest of consumers. We also request information and data about the various manufacturing processes and ingredients used to make high-protein yogurt. We specifically invite comment in response to the questions below. Please explain your answers and provide references and data, if possible.</P>
                <P>1. We seek input from all interested parties related to consumers' understanding and expectations of high-protein yogurt, and the current industry practices and innovations. We are also interested in data and other information regarding usage of the various names for high-protein yogurt.</P>
                <P>
                    2. If pasteurized cream is added after culturing, please specify the point at which cream is added during the manufacturing process (
                    <E T="03">e.g.,</E>
                     time, temperature, pH). What are the typical amount and the effects of adding pasteurized cream after culturing on yogurt attributes that are required by the SOI (
                    <E T="03">e.g.,</E>
                     pH, milk solids not fat level, level of live cultures, including 
                    <E T="03">Lactobacillus delbrueckii subsp. bulgaricus</E>
                     and 
                    <E T="03">Streptococcus thermophilus</E>
                    )? Please specify with data. What adjustments are needed, if any, to meet the levels required by the yogurt SOI?
                </P>
                <P>
                    3. How are the characteristics of yogurt impacted by the point at which cream is added during the manufacturing process relative to culturing (
                    <E T="03">i.e.,</E>
                     adding cream to milk before culturing compared to adding cream after culturing)? Please explain and provide data (
                    <E T="03">e.g.,</E>
                     pH, sensory properties, compositions, levels of live cultures) to compare the yogurt made by adding cream before culturing versus adding cream after culturing.
                </P>
                <P>
                    4. There are different ways to achieve high-protein content in high-protein yogurt, such as membrane concentration of milk protein before culturing, straining of cultured yogurt after culturing, membrane separation of yogurt after culturing, or milk protein fortification. How do the high-protein yogurts made with these different processes differ in characteristics (
                    <E T="03">e.g.,</E>
                     pH, sensory properties, compositions, levels of live cultures, nutrient profile)? 
                    <PRTPAGE P="3880"/>
                    Please explain and specify which characteristics differ.
                </P>
                <P>
                    4.a. Membrane filtration (often ultrafiltration) can be used to concentrate milk prior to culturing. What are the specifications of the ultrafiltered milk (
                    <E T="03">e.g.,</E>
                     concentration factors; filtered milk pH; compositions, such as total solids, protein, lactose, fat, minerals, vitamins; other pertinent information) used to manufacture high-protein yogurt?
                </P>
                <P>
                    4.b. Straining after culturing removes a portion of the liquid whey from the cultured yogurt to increase protein content in the finished yogurt product. What is the concentration factor or weight ratio of liquid whey versus concentrated yogurt after straining? What are important processing parameters, such as temperature, during the straining process? What are the characteristics of the liquid whey from the yogurt straining process and the concentrated yogurt (
                    <E T="03">e.g.,</E>
                     pH; levels of live cultures; compositions, including total solids, total protein, whey protein, casein, lactose, fat, minerals, vitamins; other pertinent information)?
                </P>
                <P>
                    4.c. Membrane filtration of yogurt after culturing removes liquid whey to concentrate yogurt. What is the typical concentration factor or weight ratio of permeate (liquid whey) versus retentate (concentrated yogurt) after membrane filtration? What are important processing parameters, such as temperature, during the membrane filtration process? What are the characteristics of the liquid whey and concentrated yogurt after membrane filtration (
                    <E T="03">e.g.,</E>
                     pH; levels of live cultures; compositions, including total solids, total protein, whey protein, casein, lactose, fat, minerals, vitamins; other pertinent information)?
                </P>
                <P>
                    4.d. Dairy protein fortification can also be used to increase the protein level in yogurt. Please describe the types of protein ingredient(s) (
                    <E T="03">e.g.,</E>
                     whey protein, casein protein, milk protein, caseinate) added during the manufacturing process to increase the protein level in yogurt. How are the dairy protein ingredients added (
                    <E T="03">e.g.,</E>
                     timing of the addition during processing, amounts added)? How are the characteristics of yogurts impacted by fortifying with different types of protein ingredients? Please explain and provide data (
                    <E T="03">e.g.,</E>
                     pH, sensory properties, levels of live cultures, composition) to compare the yogurts made by fortifying with different types of protein ingredients.
                </P>
                <P>
                    5. As indicated earlier in this document, high-protein yogurt is also known as or referred to under different names, such as Greek yogurt and Greek-style yogurt. Please provide relevant data and information regarding usage of the various names for high-protein yogurt (
                    <E T="03">e.g.,</E>
                     Greek yogurt and Greek-style yogurt). Please also provide relevant data and information regarding the inclusion of the manufacturing process in the names for high-protein yogurt (
                    <E T="03">e.g.,</E>
                     “strained yogurt,” “strained Greek yogurt,” “ultrafiltered yogurt”). Examples of relevant data and information may include specific firm practices, trade conventions, and consumer studies.
                </P>
                <HD SOURCE="HD1">III. References</HD>
                <P>
                    The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see 
                    <E T="02">ADDRESSES</E>
                    ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at 
                    <E T="03">https://www.regulations.gov.</E>
                     References without asterisks are not on public display at 
                    <E T="03">https://www.regulations.gov</E>
                     because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.
                </P>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        1. Chandan, R.C. and A. Kilara, editors, 2013, Manufacturing Yogurt and Fermented Milks, Second Edition, John Wiley &amp; Sons, Inc. Available at 
                        <E T="03">https://doi.org/10.1002/9781118481301.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        2. *Jørgensen, C.E., R.K. Abrahamsen, E. Rukke, et al. “Processing High-Protein Yoghurt—A Review,” 
                        <E T="03">International Dairy Journal,</E>
                         88: 42-59, 2019. Available at 
                        <E T="03">https://doi.org/10.1016/j.idairyj.2018.08.002.</E>
                    </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>P. Ritu Nalubola,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00754 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2020-N-0026]</DEPDOC>
                <SUBJECT>Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ALHEMO (concizumab-mtci), approved on December 20, 2024, manufactured by Novo Nordisk, Inc., meets the criteria for a priority review voucher.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Cathryn Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&amp;C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that ALHEMO (concizumab-mtci), manufactured by Novo Nordisk, Inc., meets the criteria for a priority review voucher. ALHEMO (concizumab-mtci) injection is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and hemophilia B (congenital factor IX deficiency) with FIX inhibitors.</P>
                <P>
                    For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&amp;C Act, go to 
                    <E T="03">https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm.</E>
                     For further information about ALHEMO (concizumab-mtci), go to the “
                    <E T="03">Drugs@FDA</E>
                    ” website at 
                    <E T="03">https://www.accessdata.fda.gov/scripts/cder/daf/</E>
                    .
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>P. Ritu Nalubola,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00750 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3881"/>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Health Resources and Services Administration</SUBAGY>
                <SUBJECT>Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; 340B Drug Pricing Program; Initiation of the Administrative Dispute Resolution Process</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Health Resources and Services Administration (HRSA), Department of Health and Human Services.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments on this ICR should be received no later than February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request a copy of the clearance requests submitted to OMB for review, email Joella Roland, the HRSA Information Collection Clearance Officer, at 
                        <E T="03">paperwork@hrsa.gov</E>
                         or call (301) 443-3983.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Information Collection Request Title:</E>
                     340B Drug Pricing Program; Initiation of the Administrative Dispute Resolution Process, OMB No. 0906-xxxx—New.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, created the 340B Drug Pricing Program in section 340B of the Public Health Service (PHS) Act. Eligible covered entity types are defined in section 340B(a)(4) of the PHS Act, as amended. Section 340B(a)(1) of the PHS Act instructs HHS to enter into pharmaceutical pricing agreements with manufacturers of covered outpatient drugs. Under section 1927(a)(5)(A) of the Social Security Act, a manufacturer must enter into an agreement with the Secretary that complies with section 340B of the PHS Act to receive payments from Medicaid or Medicare Part B for the manufacturer's covered outpatient drugs. When a manufacturer signs a pharmaceutical pricing agreement, it agrees that the prices charged for covered outpatient drugs to covered entities will not exceed statutorily defined 340B ceiling prices. Such prices are based on quarterly pricing reports that manufacturers must provide to the Secretary, which are calculated and verified by HRSA.
                </P>
                <P>Section 340B(d)(3) to the PHS Act requires HHS to promulgate regulations establishing and implementing a binding 340B Administrative Dispute Resolution (ADR) process for certain disputes arising under the 340B Drug Pricing Program. Pursuant to the statute, the 340B ADR process is intended to resolve (1) claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit as authorized by section 340B(a)(5)(C) of the PHS Act, that a covered entity has violated the prohibition on diversion or duplicate discounts.</P>
                <P>
                    On April 19, 2024, HRSA published the 340B Drug Pricing Program; Administrative Dispute Resolution Regulation Final Rule (340B ADR Final Rule) (89 FR 28,643 (Apr. 19, 2024) (to be codified at 42 CFR part 10)). The 340B ADR Final Rule provides the requirements for filing a 340B ADR claim. The 340B ADR Final Rule requires the submission of a 340B ADR claim within 3 years of the date of the alleged violation and specifies that it is a remedy open to all manufacturers and covered entities that participate in the 340B Drug Pricing Program. To initiate the 340B ADR process, a petitioner will email HRSA's Office of Pharmacy Affairs' (OPA) designated mailbox with its 340B ID or Labeler code and contact information, the 340B ID or Labeler code and contact information of the opposing party, and a brief description of the claim. Once a petition is filed, OPA reviews the petition to make sure the claim meets the requirements for the 340B ADR process, including whether: (1) the claim alleges a violation of an overcharge, duplicate discount, or diversion; (2) the claim has been filed within 3 years of the alleged violation; and (3) the petitioner has engaged in good faith efforts to resolve the claim. Both the petitioner and opposing party will be required to upload certain documentation to a secure 340B ADR workspace in the 340B OPA Information System to substantiate the claim. After an initial review of the claim and any supporting documentation, OPA staff will determine whether the requirements for filing a claim have been met, and if the claim is deemed complete, OPA will notify the parties. If the claim is deemed complete and all filing requirements are met, the claim will be assigned to a 340B ADR Panel. If the claim does not meet the filing requirements, the claim will not move forward for a 340B ADR Panel's review. Specific details concerning the 340B ADR Panel and requirements for filing a claim are outlined in the 340B ADR Final Rule and can be reviewed at 
                    <E T="03">https://www.hrsa.gov/opa/340b-administrative-dispute-resolution.</E>
                </P>
                <P>This information collection request is limited to the initiation of the 340B ADR process and the uploading of the related documents. Filing a claim though the 340B ADR process is a remedy open to all manufacturers and covered entities that participate in the 340B Drug Pricing Program, which can constitute a standardized federal information collection. Once the claim is assigned to a 340B ADR Panel for review, these subsequent steps, which encompass the 340B ADR process itself and ensuing correspondence with the parties involved in the process, are exempt from Paperwork Reduction Act requirements, pursuant to the Paperwork Reduction Act exception listed at 44 U.S.C. 3518(c), which exempts administrative actions or investigations involving an agency against specific individuals or entities.</P>
                <P>The only substantive change to the information collection request for this 30-day notice is that HRSA adjusted the estimated number of respondents based on the number of ADR requests received thus far. HRSA increased the estimate from 10 requests to 15 over the next three years.</P>
                <P>
                    A 60-day notice published in the 
                    <E T="04">Federal Register</E>
                     on August 7, 2024, 89 FR 64468 and 64469. HRSA received five public comments.
                </P>
                <P>
                    Three commenters representing pharmaceutical manufacturers explained that HRSA's estimate of 2.5 hours per response underestimates the significant burden manufacturers incur to access the ADR process. Some manufacturers noted that under the statute a manufacturer can only access the ADR process after it has completed an audit of a covered entity and argued HRSA's manufacturer audit guidelines impose significant burdens on manufacturers' ability to audit. HRSA notes that manufacturer audits of 
                    <PRTPAGE P="3882"/>
                    covered entities are a separate, pre-existing process and are not subject to this information request. This information collection request is limited specifically to the initiation of the 340B ADR process under the 2024 340B ADR Final Rule and the uploading of the related documents at the initial phase of the 340B ADR process.
                </P>
                <P>One commenter requested that HRSA require manufacturers to present specific types of documentation and evidence to initiate a dispute. Another commenter requested that HRSA specify what “sufficient documentation” consists of for submitting an ADR claim. Under the 340B ADR Final Rule, petitioners have discretion regarding the documentation they submit as part of their initial submission to support their claims.</P>
                <P>Other comments discussed elements of the ADR Final Rule, including defining what good faith efforts entail, how child site eligibility relates to diversion and what the definition of an overcharge should include, that are outside of the scope of this information collection request. After detailed analysis of the comments received, HRSA plans to maintain the burden hours as proposed in the 60-day notice.  </P>
                <P>
                    <E T="03">Need and Proposed Use of the Information:</E>
                     HRSA is requesting approval for the initiation of the 340B ADR process and uploading of the related documents outlined in the 340B ADR Final Rule. The 340B ADR process is conducted pursuant to the requirements under section 340B(d)(3) of the PHS Act, which requires the establishment and implementation of the 340B ADR process for certain disputes arising under the 340B Drug Pricing Program. HRSA uses the information gathered in the 340B ADR initiation process to determine if the claim submitted meets the statutory requirements for filing a 340B claim and accessing the 340B ADR process.
                </P>
                <P>
                    <E T="03">Likely Respondents:</E>
                     Covered entities (or their membership organizations or associations) and manufacturers.
                </P>
                <P>
                    <E T="03">Burden Statement:</E>
                     Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.
                </P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,12,12,12,12,12">
                    <TTITLE>Total Estimated Annualized Burden Hours</TTITLE>
                    <BOXHD>
                        <CHED H="1">Form name</CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>responses per</LI>
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Total
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>burden per</LI>
                            <LI>response</LI>
                            <LI>(in hours)</LI>
                        </CHED>
                        <CHED H="1">Total burden hours</CHED>
                    </BOXHD>
                    <ROW RUL="n,s">
                        <ENT I="01">340B Claim Submission</ENT>
                        <ENT>15</ENT>
                        <ENT>1</ENT>
                        <ENT>15</ENT>
                        <ENT>2.5</ENT>
                        <ENT>37.5</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>15</ENT>
                        <ENT/>
                        <ENT>15</ENT>
                        <ENT/>
                        <ENT>37.5</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <NAME>Maria G. Button,</NAME>
                    <TITLE>Director, Executive Secretariat.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00831 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4165-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Health Resources and Services Administration</SUBAGY>
                <SUBJECT>Meeting of the National Advisory Council on the National Health Service Corps</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Health Resources and Services Administration (HRSA), Department of Health and Human Services.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on the National Health Service Corps (NACNHSC) will hold public meetings for the 2025 calendar year (CY). Information about NACNHSC, agendas, and materials for these meetings can be found on the NACNHSC website at: 
                        <E T="03">https://www.hrsa.gov/advisory-committees/national-health-service-corps.</E>
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>NACNHSC meetings will be held on March 18, 2025, 10:00 a.m. Eastern Time (ET)-4:30 p.m. ET and March 19, 2025, 10 a.m. ET-3:30 p.m. ET; June 24, 2025, 9 a.m. ET-4:30 p.m. ET and June 25, 2025, 8:30 a.m. ET-2 p.m. ET; and November 18, 2025, 10 a.m. ET-4:30 p.m. ET and November 19, 2025, 10 a.m. ET-3:30 p.m. ET.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Meetings may be held in-person, by teleconference, and/or video conference. For updates on how the meeting will be held, visit the NACNHSC website 30 business days before the date of the meeting, where instructions for joining meetings either in-person or remotely will also be posted. In-person NACNHSC meetings will be held at 5600 Fishers Lane, Rockville, Maryland 20857. For meeting information updates, go to the NACNHSC website meeting page at: 
                        <E T="03">https://www.hrsa.gov/advisory-committees/national-health-service-corps/meetings.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Diane Fabiyi-King, Designated Federal Official, Division of National Health Service Corps, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 
                        <E T="03">NHSCAdvisoryCouncil@hrsa.gov</E>
                         or (301) 443-3609.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>NACNHSC provides advice and recommendations to the Secretary of Health and Human Services on policy, program development, and other matters of significance concerning the activities under subpart II, part D of title III of the Public Health Service Act. NACNHSC members are experts in the issues that communities with a shortage of primary care professionals face in meeting their healthcare needs.</P>
                <P>
                    Since priorities dictate meeting times, be advised that start times, end times, and agenda items are subject to change. For CY 2025 meetings, agenda items may include, but are not limited to: the identification of NHSC priorities for future program issues and concerns; proposed policy changes by using the varying levels of expertise represented on NACNHSC to advise on specific program areas; updates from clinician workforce experts; and education and practice improvement in the training development of primary care clinicians. More general items may include presentations and discussions on the 
                    <PRTPAGE P="3883"/>
                    current and emerging needs of the health workforce, public health priorities, health care access and evaluation; NHSC-approved sites; HRSA priorities; and other Federal health workforce and education programs that impact the NHSC. Refer to the NACNHSC website listed above for all current and updated information concerning the CY 2025 NACNHSC meetings, including draft agendas and meeting materials that will be posted 30 calendar days before the meeting.
                </P>
                <P>Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting(s). Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to submit a written statement or make oral comments to the NACNHSC should be sent to Diane Fabiyi-King using the contact information above at least 5 business days before the meeting date(s).</P>
                <P>Individuals who need special assistance or another reasonable accommodation should notify Diane Fabiyi-King using the contact information listed above at least 10 business days before the meeting(s) they wish to attend. Since all in person meetings will occur in a Federal Government building, attendees must go through a security check to enter the building. Non-U.S. citizen attendees must notify HRSA of their planned attendance at least 20 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry.</P>
                <SIG>
                    <NAME>Maria G. Button,</NAME>
                    <TITLE>Director, Executive Secretariat.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30715 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4165-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBJECT>Center for Indigenous Innovation and Health Equity Tribal Advisory Committee; Solicitation of Nominations for Delegates</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Minority Health, Office of the Secretary, Department of Health and Human Services.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; correcting amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        On January 8, 2025, we published a 
                        <E T="04">Federal Register</E>
                         Notice requesting nomination letters for the CIIHE TAC delegates. This correcting amendment corrects two errors: the submission deadline and the notification timeframe for nominee selection.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Tribal leaders are encouraged to submit their nomination letters for CIIHE TAC delegates by February 18, 2025, at the address listed below. The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) will continue to receive nominations until all CIIHE TAC primary and alternate delegate positions are filled.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        All nominations should be emailed to 
                        <E T="03">minorityhealth@hhs.gov.</E>
                         Please use the subject line “CIIHE TAC Nomination.”
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For information and guidance about the nomination process for CIIHE TAC delegates, please contact Rochelle Rollins, Senior Policy Advisor, at 
                        <E T="03">Rochelle.Rollins@hhs.gov.</E>
                         Sample CIIHE TAC nomination letters are available on the OMH website: 
                        <E T="03">https://minorityhealth.hhs.gov/ciihe-tribal-advisory-committee-tac.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Authorized under Section 1707 of the Public Health Service Act, 42 U.S.C. 300u-6, as amended, the mission of OMH is to improve the health of racial and ethnic minority and American Indian and Alaska Native (AI/AN) populations through the development of health policies and programs that help eliminate health disparities. OMH awards and other activities are intended to support the identification of effective policies, programs, and practices that improve health outcomes and to promote the sustainability and dissemination of these approaches.</P>
                <HD SOURCE="HD1">Summary of Errors</HD>
                <P>Tribal leaders are encouraged to submit their nomination letters for CIIHE TAC delegates by February 18, 2025. Nominees will be notified of the delegate selection status in March 2025.</P>
                <SIG>
                    <NAME>Tarsha Cavanaugh,</NAME>
                    <TITLE>Capt, Principal Deputy Director, Office of Minority Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00701 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4150-29-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBJECT>Request for Public Comments on Reports on Alcoholic Beverages and Health To Inform the Dietary Guidelines for Americans, 2025-2030</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Health (OASH), Office of Disease Prevention and Health Promotion; U.S. Department of Agriculture (USDA), Food, Nutrition, and Consumer Services (FNCS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>
                        Notice and request public comments on two reports on alcoholic beverages and health to inform the 
                        <E T="03">Dietary Guidelines for Americans, 2025-2030 (Dietary Guidelines).</E>
                    </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>HHS and USDA invite the public to provide written comments on two reports: The Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD) Alcohol Intake and Health (AIH) draft report and The National Academies of Sciences, Engineering, and Medicine's (NASEM) Review of Evidence on Alcohol and Health report.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        Written comments will be accepted for 30 days. This public comment period closes on the 30th calendar day at 11:59 p.m. ET. Specific dates will be announced at 
                        <E T="03">www.DietaryGuidelines.gov.</E>
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Links to both reports, along with additional information about each report, are available at 
                        <E T="03">www.DietaryGuidelines.gov/alcohol/info.</E>
                         You may submit comments as follows:
                    </P>
                    <P>
                        • 
                        <E T="03">Online (preferred method):</E>
                         Follow the instructions for submitting comments at 
                        <E T="03">www.regulations.gov.</E>
                         Comments submitted electronically, including attachments, will be posted to Docket HHS-OASH-2024-0019. HHS-OASH-2024-0019
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Mail/courier to Janet M. de Jesus, MS, RD, HHS/OASH/ODPHP, 1101 Wootton Parkway, Suite 420S, Rockville, MD 20852. For written/paper submissions, ODPHP will post your comment, and any attachments, to 
                        <E T="03">www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Janet M. de Jesus, MS, RD; Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Suite 420, Rockville, MD 20852; Phone: 240-453-8266; Email 
                        <E T="03">DietaryGuidelines@hhs.gov.</E>
                         Additional information is available at 
                        <E T="03">www.DietaryGuidelines.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Authority and Purpose:</E>
                     Under Section 301 of Public Law 101-445 (7 U.S.C. 5341, the National Nutrition Monitoring and Related Research Act of 1990, Title III), the Secretaries of HHS and USDA are directed to publish the 
                    <E T="03">Dietary Guidelines</E>
                     jointly at least every five years. Guidance on the consumption of alcoholic beverages has been included in each edition of the 
                    <E T="03">Dietary Guidelines</E>
                     since the first edition in 1980. In the process of updating the 
                    <E T="03">
                        Dietary 
                        <PRTPAGE P="3884"/>
                        Guidelines,
                    </E>
                     HHS and USDA determined the topic of alcoholic beverages and health required a comprehensive review with significant, specific expertise. ICCPUD and NASEM conducted separate, complementary scientific reviews on adult alcohol consumption and health. Each scientific review resulted in a report with findings, not recommendations, on alcohol consumption. HHS and USDA will consider these findings to help inform guidance on alcoholic beverage consumption in the 
                    <E T="03">Dietary Guidelines.</E>
                </P>
                <P>
                    <E T="03">Public Comments:</E>
                     HHS and USDA request comments on both reports. Specifically, HHS and USDA request comments on considerations for the Departments as they use the reports to inform guidance on alcoholic beverage consumption in the 
                    <E T="03">Dietary Guidelines.</E>
                     Additionally, ICCPUD will consider public comments on its draft report to ensure the findings in its report are clearly presented and may make adjustments based on public input. Specific questions to consider when commenting on the ICCPUD draft report are available at: 
                    <E T="03">https://www.stopalcoholabuse.gov/research-resources/alcohol-intake-health.aspx.</E>
                </P>
                <P>
                    <E T="03">Additional Information:</E>
                     Additional information about each scientific review and the resulting reports is available at 
                    <E T="03">www.DietaryGuidelines.gov/alcohol/info.</E>
                </P>
                <SIG>
                    <NAME>Brandon L. Taylor,</NAME>
                    <TITLE>Deputy Assistant Secretary for Health, Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00416 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4150-32-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Proposed Collection; 60-Day Comment Request; NIH Division of Police Law Enforcement Forms (Office of the Director)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Institutes of Health, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) Office of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Peter “Rocky” Whitesell, PRA Liaison, DQMP/OAM/OD/ORS/OM/OD/NIH, 31 Center Drive, Bethesda, MD 20892-2140 or call the non-toll-free number 240-541-1165 or email your request, including your address to: 
                        <E T="03">peter.whitesell@nih.gov.</E>
                         Formal requests for additional plans and instruments must be requested in writing.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize
                    <E T="7601">s</E>
                     the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
                </P>
                <P>
                    <E T="03">Proposed Collection Title:</E>
                     NIH Division of Police Law Enforcement Forms, 0925-NEW, Office of Security and Emergency Response (OSER), Office of the Director (OD), National Institutes of Health (NIH).
                </P>
                <P>
                    <E T="03">Need and Use of Information Collection:</E>
                     The purpose of the submitted forms is to enable the continued operation of normal NIH Division of Police functions. The first form is for collecting statements and affidavits relating to incidents on campus, 
                    <E T="03">i.e.,</E>
                     chronology of events, perspectives, etc. from witnessing parties. The second form is a police warning issued on campus by officers, to be signed by the person warned for different infractions, and potentially a recognition they are banned from campus. The third form is an authorization for release of information given out to potential hires with the NIH Division of Police, so that suitability for hiring can be determined with a normal background check. The fourth, fifth, and sixth forms are for collecting application information for extended visitor access on campus, for patients, non-patient professionals (such as researchers or those conducting business), and non-patient non-professionals (such as patient visitors) respectively who have a need to more easily access campus for some period of time. These three forms allow an alternative to acquiring temporary access badges repeatedly.
                </P>
                <P>OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 3,209.</P>
                <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="s50,xs66,10,12,12,12">
                    <TTITLE>Estimated Annualized Burden Hours</TTITLE>
                    <BOXHD>
                        <CHED H="1">Form name</CHED>
                        <CHED H="1">
                            Type of
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>responses per</LI>
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>burden per</LI>
                            <LI>response</LI>
                            <LI>(in hours)</LI>
                        </CHED>
                        <CHED H="1">
                            Total
                            <LI>annual</LI>
                            <LI>burden</LI>
                            <LI>(in hours)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1—NIH Police Statement and Affidavit</ENT>
                        <ENT>Individuals</ENT>
                        <ENT>20</ENT>
                        <ENT>1</ENT>
                        <ENT>10/60</ENT>
                        <ENT>3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">2—NIH Police Warning Notice</ENT>
                        <ENT>Individuals</ENT>
                        <ENT>258</ENT>
                        <ENT>1</ENT>
                        <ENT>10/60</ENT>
                        <ENT>43</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3—NIH Police Authorization for Release of Information</ENT>
                        <ENT>Individuals</ENT>
                        <ENT>15</ENT>
                        <ENT>1</ENT>
                        <ENT>10/60</ENT>
                        <ENT>3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">4—NIH Police Officer Candidate Application</ENT>
                        <ENT>Individuals</ENT>
                        <ENT>15</ENT>
                        <ENT>1</ENT>
                        <ENT>8</ENT>
                        <ENT>120</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">5—NIH Extended Visitor Form (Patient)</ENT>
                        <ENT>Individuals</ENT>
                        <ENT>11,180</ENT>
                        <ENT>1</ENT>
                        <ENT>10/60</ENT>
                        <ENT>1,863</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">6—NIH Extended Visitor Form (Non-Patient)</ENT>
                        <ENT>Individuals</ENT>
                        <ENT>4,560</ENT>
                        <ENT>1</ENT>
                        <ENT>10/60</ENT>
                        <ENT>760</ENT>
                    </ROW>
                    <ROW RUL="n,n,s">
                        <PRTPAGE P="3885"/>
                        <ENT I="01">7—NIH Extended Visitor Form (Generic)</ENT>
                        <ENT>Individuals</ENT>
                        <ENT>2,500</ENT>
                        <ENT>1</ENT>
                        <ENT>10/60</ENT>
                        <ENT>417</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Totals</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>18,548</ENT>
                        <ENT/>
                        <ENT>3,209</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <DATED>Dated: January 3, 2025.</DATED>
                    <NAME>Lawrence A. Tabak,</NAME>
                    <TITLE>Principal Deputy Director, National Institutes of Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00650 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) and NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 12, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         11:00 a.m. to 2:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G13A, Rockville, MD 20892 (Video Assisted Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Mairi Noverr, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G13A, Rockville, MD 20892, (240) 747-7530, 
                        <E T="03">mairi.noverr@nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Lauren A. Fleck,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00851 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Heart, Lung, and Blood Institute; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Heart, Lung, and Blood Initial Review Group; NHLBI Mentored Clinical and Basic Science Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 27-28, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge I, 6705 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Manoj Kumar Valiyaveettil, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 208-R, Bethesda, MD 20817, (301) 402-1616, email: 
                        <E T="03">manoj.valiyaveettil@nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Bruce A. George, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00688 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Aging Research.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 21, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 12:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Anita T. Tandle, Ph.D., Scientific Review Officer, National Institute on Aging, National Institutes of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892, (240) 204-0329, 
                        <E T="03">tandlea@mail.nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Lauren A. Fleck,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00849 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3886"/>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Microphysiological Aging Systems.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 24, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         11:00 a.m. to 5:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant proposals.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Kaitlyn Noel Lewis Hardell, Ph.D., MPH, Scientific Review Officer, National Institute on Aging, National Institutes of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892, (301) 594-7945, 
                        <E T="03">kaitlyn.hardell@nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Lauren A. Fleck,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00842 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Heart, Lung, and Blood Institute; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Heart, Lung, and Blood Initial Review Group; NHLBI Mentored Patient-Oriented Research Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 20-21, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 12:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge I, 6705 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Fungai Chanetsa, MPH, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Room 206-B, Bethesda, MD 20817, (301) 402-9394, email: 
                        <E T="03">fungai.chanetsa@nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Bruce A. George, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00687 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Center for Scientific Review; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.</P>
                <P>The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Applied Therapeutics for Cancer Integrated Review Group; Radiation Therapeutics and Biology Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 10-11, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8:30 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Bo Hong, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6194, MSC 7804, Bethesda, MD 20892, 301-996-6208, 
                        <E T="03">hongb@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Auditory System Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 10-11, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8:30 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Brian H. Scott, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-827-7490, 
                        <E T="03">brianscott@mail.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Social and Community Influences on Health Integrated Review Group; Health Promotion in Communities Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 11-12, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                          
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892. 
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Helena Eryam Dagadu, MPH, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3137, Bethesda, MD 20892, (301) 435-1266, 
                        <E T="03">dagaduhe@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Cell Biology Integrated Review Group; Cell Structure and Function 1 Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 11-12, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Jessica Smith, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 402-3717, 
                        <E T="03">jessica.smith6@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Population Sciences and Epidemiology Integrated Review Group; Social and Environmental Determinants of Health Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 12-13, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Ananya Paria, MPH, MS, DHSC, Scientific Review Officer, Center for Scientific Review, National Institutes of 
                        <PRTPAGE P="3887"/>
                        Health, 6701 Rockledge Drive, Room 1007H, Bethesda, MD 20892, (301) 827-6513, 
                        <E T="03">pariaa@mail.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Bioengineering Sciences &amp; Technologies Integrated Review Group; Innovations in Nanosystems and Nanotechnology Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 12-13, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Yingli Fu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-0840, 
                        <E T="03">yingli.fu@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Digestive, Kidney and Urological Systems Integrated Review Group; Kidney and Urological Systems Function and Dysfunction Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 12-13, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Santanu Banerjee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2106, Bethesda, MD 20892, (301) 435-5947, 
                        <E T="03">banerjees5@mail.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 7, 2025.</DATED>
                    <NAME>Victoria E. Townsend, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00660 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; R13 Conference Grant Applications.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 27, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 12:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, NIDDK Democracy II, Suite 7000A, 6707 Democracy Boulevard, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Jian Yang, Ph.D., Scientific Review Officer, National Institute of Diabetes and Digestive and Kidney, National Institute of Health, 6707 Democracy Boulevard, Rm. 7011, Bethesda, MD 20892-5452, (301) 594-7799,
                        <E T="03">yangj@extra.niddk.nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Lauren A. Fleck,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00850 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Office of the Director, National Institutes of Health; Notice of Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Council of Councils.</P>
                <P>
                    The meeting will be held as a virtual meeting and is open to the public as indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations, to view the meeting should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting website (
                    <E T="03">http://videocast.nih.gov/</E>
                    ).
                </P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Council of Councils.
                    </P>
                    <P>
                        <E T="03">Open:</E>
                         February 06, 2025, 10:15 a.m. to 12:45 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Welcome and Opening Remarks; Announcements, and NIH Program Updates.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Building 1, 1 Center Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 06, 2025
                    </P>
                    <P>
                        <E T="03">Closed:</E>
                         February 06, 2025, 12:45 p.m. to 01:45 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Review of Grant Applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Building 1, 1 Center Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Open:</E>
                         February 06, 2025, 01:45 p.m. to 05:15 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Presentations; and Other Business of the Committee.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Building 1, 1 Center Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Open:</E>
                         February 07, 2025, 10:00 a.m. to 2:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Welcome; Announcements; Presentations; and Other Business of the Committee.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Building 1, 1 Center Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Franziska Grieder, D.V.M., Ph.D., Executive Secretary, Council of Councils, Director, Office of Research Infrastructure Programs, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, 6701 Democracy Boulevard, Room 948, Bethesda, MD 20892, 
                        <E T="03">email:GriederF@mail.nih.gov,</E>
                         301-435-0744.
                    </P>
                </EXTRACT>
                <P>Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.</P>
                <P>
                    Information is also available on the Council of Council's home page at 
                    <E T="03">http://dpcpsi.nih.gov/council/</E>
                     where an agenda and any additional information for the meeting will be posted when available.
                </P>
                <EXTRACT>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <PRTPAGE P="3888"/>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Bruce A. George,</NAME>
                    <TITLE>Program Analyst, Office of Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00690 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Center for Scientific Review; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.</P>
                <P>The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Emerging Technologies and Training Neurosciences Integrated Review Group; Imaging Technology for Neuroscience Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 6-7, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Rachel A. Kane, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr., Bethesda, MD 20892, (301) 496-0221, email: 
                        <E T="03">kanera@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; PAR Panel: Academic-Industrial Partnerships for Translation of Technologies.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 11-12, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8:00 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         The Watergate, 2650 Virginia Avenue NW, Washington, DC 20037.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Jennifer Ann Sanders, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 496-3553, email: 
                        <E T="03">jennifer.sanders@nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Applied Immunology and Disease Control Integrated Review Group; Transmission of Vector-Borne and Zoonotic Diseases Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 11-12, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Haruhiko Murata, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594-3245, email: 
                        <E T="03">muratah@csr.nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Bruce A. George,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00845 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Mental Health; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Mental Health Initial Review Group; Mental Health Services Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 24-25, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         11:00 a.m. to 5:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Aileen Schulte, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Bethesda, MD 20852, 301-443-1225, email: 
                        <E T="03">aschulte@mail.nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Bruce A. George,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00843 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Cancer Institute; Amended Notice of Meeting</SUBJECT>
                <P>
                    Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, TEP-5B: SBIR Review Meeting, March 04, 2025, 11:00 a.m. to 04:00 p.m., National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W534, Rockville, Maryland, 20850 which was published in the 
                    <E T="04">Federal Register</E>
                     on December 26, 2024, FR Doc 2024-30711, 89 FR 105062.
                </P>
                <P>This notice is being amended to change the virtual meeting date from March 04, 2025, 11:00 a.m. to 04:00 p.m. to March 03, 2025, 11:00 a.m. to 04:00 p.m. The meeting times, format, and location will stay the same. The meeting is closed to the public.</P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Supervisory Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00739 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Frontotemporal Lobar Degeneration.
                        <PRTPAGE P="3889"/>
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 7, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 5:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Nijaguna Prasad, Ph.D., Scientific Review Officer, National Institute on Aging, National Institutes of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892, (301) 496-9667, 
                        <E T="03">prasadnb@nia.nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Lauren A. Fleck,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00846 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.</P>
                <P>The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant and cooperative agreement applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant and cooperative agreement applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Neurological Sciences Training Initial Review Group; NST-4 Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 6-7, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Steven G. Britt, MD, Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, NINDS/NIH/DHHS, NSC, 6001 Executive Boulevard, Rockville, MD 20852, 301-480-1953, 
                        <E T="03">steve.britt@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Neurological Disorders and Stroke Special Emphasis Panel; HEAL—Pain Therapeutics Development Review.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         March 6, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 4:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate cooperative agreement applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         W. Ernest Lyons, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, NINDS/NIH/DHHS, NSC, 6001 Executive Boulevard, Rockville, MD 20852, 301-496-4056, 
                        <E T="03">lyonse@ninds.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>David W. Freeman, </NAME>
                    <TITLE>Supervisory Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00738 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Dental &amp; Craniofacial Research; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute of Dental and Craniofacial Research; Special Grants Review Committee.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 25-26, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 5:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute of Dental &amp; Craniofacial Research, 31 Center Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Aiwu Cheng, Ph.D., Scientific Review Officer, National Institute of Dental and Craniofacial Research, National Institutes of Health, 31 Center Drive, Bethesda, MD 20892, (301) 594-4859, email: 
                        <E T="03">chengai@mail.nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program No. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Bruce A. George,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00844 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Pepper Centers Review.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 18-19, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 2:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Sandhya Sanghi, Ph.D., Scientific Review Officer, National Institute on Aging, National Institutes of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892, (301) 496-2879, 
                        <E T="03">sandhya.sanghi@nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Lauren A. Fleck,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00841 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3890"/>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Center for Scientific Review; Notice of Closed Meetings</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.</P>
                <P>The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Brain Disorders and Clinical Neuroscience Integrated Review Group; Pathophysiology of Eye Disease—1 Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 6-7, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8:30 a.m. to 7:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Afia Sultana, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4189, Bethesda, MD 20892, (301) 827-7083, email: 
                        <E T="03">sultanaa@mail.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; Translational Investigations of Pulmonary and Immunological Diseases.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 11-12, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting,
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Imoh S. Okon, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20817, 301-347-8881, 
                        <E T="03">imoh.okon@nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Cardiovascular and Respiratory Sciences Integrated Review Group; Pulmonary Injury, Repair, and Remodeling Study Section (PIRR).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 13-14, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Ghenima Dirami, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4122, MSC 7814, Bethesda, MD 20892, 240-498-7546, email: 
                        <E T="03">diramig@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Digestive, Kidney and Urological Systems Integrated Review Group; Digestive and Nutrient Physiology and Diseases Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 13-14, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         8:30 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         In Person and Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Aster Juan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20817, 301-435-5000, 
                        <E T="03">juana2@mail.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Center for Scientific Review Special Emphasis Panel; Glia in Health and Disease.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 13, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health. Rockledge II. 6701 Rockledge Drive. Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Sung-Wook Jang, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 812P, Bethesda, MD 20892, (301) 435-1042, 
                        <E T="03">jangs2@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Imaging Guided Interventions and Surgery Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 13-14, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Ella Fung Jones, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 496-0777, email: 
                        <E T="03">ella.jones@nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Imaging Probes and Contrast Agents Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 13-14, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Donald Scott Wright, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7854, Bethesda, MD 20892, (301) 435-8363, email:
                        <E T="03">wrightds@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Integrative, Functional and Cognitive Neuroscience Integrated Review Group; Neuroscience of Interoception and Chemosensation Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 13-14, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Myongsoo Matthew Oh, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1011F, Bethesda, MD 20892, (301) 435-1042, email: 
                        <E T="03">ohmm@csr.nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Genes, Genomes, and Genetics Integrated Review Group; Molecular Genetics Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 13-14, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Altaf Ahmad Dar, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 827-2680, email: 
                        <E T="03">altaf.dar@nih.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Skin and Connective Tissue Sciences Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 13-14, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Robert Gersch, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 800K, Bethesda, MD 20817, (301) 867-5309, email: 
                        <E T="03">robert.gersch@nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Bruce A. George, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00689 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3891"/>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Federal Emergency Management Agency</SUBAGY>
                <SUBJECT>National Flood Insurance Program (NFIP); Assistance to Private Sector Property Insurers, Notice of FY 2026 Arrangement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Emergency Management Agency, Department of Homeland Security.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Emergency Management Agency announces the Fiscal Year 2026 Financial Assistance/Subsidy Arrangement for private property insurers interested in participating in the National Flood Insurance Program's Write Your Own Program.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested insurers must submit intent to subscribe or re-subscribe to the Arrangement by May 15, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Karolyn Kiss, Federal Insurance Directorate (FID), Resilience FEMA, 400 C St. SW, Washington, DC 20472 (mail); (202) 646-3140 (phone); or 
                        <E T="03">karolyn.kiss@fema.dhs.gov</E>
                         (email).
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    The National Flood Insurance Act of 1968 (NFIA) (42 U.S.C. 4001 
                    <E T="03">et seq.</E>
                    ) authorizes the Administrator of the Federal Emergency Management Agency (FEMA) to establish and carry out a National Flood Insurance Program (NFIP) to enable interested persons to purchase flood insurance. 
                    <E T="03">See</E>
                     42 U.S.C. 4011(a). Under the NFIA, FEMA may use insurance companies and other insurers, insurance agents and brokers, and insurance adjustment organizations as fiscal agents of the United States to help it carry out the NFIP. 
                    <E T="03">See</E>
                     42 U.S.C. 4071. To this end, FEMA may “enter into any contracts, agreements, or other appropriate arrangements” with private insurance companies to use their facilities and services in administering the NFIP on such terms and conditions as they agree upon. 
                    <E T="03">See</E>
                     42 U.S.C. 4081(a).
                </P>
                <P>
                    Pursuant to this authority, FEMA enters into a standard Financial Assistance/Subsidy Arrangement (Arrangement) with private sector property insurers, also known as Write Your Own (WYO) companies, to sell NFIP flood insurance policies under their own names and adjust and pay claims arising under the Standard Flood Insurance Policy (SFIP). Each Arrangement entered into by a WYO company must be in the form and substance of the standard Arrangement, a copy of which is published in the 
                    <E T="04">Federal Register</E>
                     annually, at least 6 months prior to becoming effective. 
                    <E T="03">See</E>
                     44 CFR 62.23(a). To learn more about FEMA's WYO Program, please visit 
                    <E T="03">https://nfipservices.floodsmart.gov/write-your-own-program.</E>
                </P>
                <HD SOURCE="HD1">II. Notice of Availability</HD>
                <P>
                    Insurers interested in participating in the WYO Program for Fiscal Year 2026 must contact Karolyn Kiss at 
                    <E T="03">karolyn.kiss@fema.dhs.gov</E>
                     by May 15, 2025.
                </P>
                <P>Prior participation in the WYO Program does not guarantee FEMA will approve continued participation. FEMA will evaluate requests to participate in light of publicly available information, industry performance data, and other criteria listed in 44 CFR 62.24 and the FY 2026 Arrangement, copied below. FEMA encourages private insurance companies to supplement this information with customer satisfaction surveys, industry awards or recognition, or other objective performance data. In addition, private insurance companies should work with their vendors and other service providers involved in servicing and delivering their insurance lines to ensure FEMA receives the information necessary to effectively evaluate the criteria set forth in its regulations.</P>
                <P>
                    FEMA will send a copy of the offer for the FY 2026 Arrangement, together with related materials and submission instructions, to all private insurance companies successfully evaluated by the NFIP. If FEMA, after conducting its evaluation, chooses not to renew a Company's participation, FEMA, at its option, may require the continued performance of all or selected elements of the FY 2025 Arrangement for a period required for orderly transfer or cessation of the business and settlement of accounts, not to exceed forty-eight (48) months. 
                    <E T="03">See</E>
                     FY 2025 Arrangement, Article II.D. All evaluations, whether successful or unsuccessful, will inform both an overall assessment of the WYO Program and any potential changes FEMA may consider regarding the Arrangement in future fiscal years.
                </P>
                <P>
                    Any private insurance company with questions may contact FEMA at: Karolyn Kiss, Federal Insurance Directorate, Resilience, FEMA, 400 C St. SW, Washington, DC 20472 (mail); (202) 646-3140 (phone); or 
                    <E T="03">karolyn.kiss@fema.dhs.gov</E>
                     (email).
                </P>
                <HD SOURCE="HD1">III. Fiscal Year 2026 Arrangement</HD>
                <P>Pursuant to 44 CFR 62.23(a), FEMA must publish the Arrangement at least six months prior to the Arrangement becoming effective. The FY 2026 Arrangement provided below is substantially similar to the previous year's Arrangement, but includes the following changes:</P>
                <P>
                    1. For clarity, throughout the Arrangement, FEMA is making minor changes by adding “insurance” before “agents” to clarify the type of “agent” when referring to licensed insurance professionals that sell property and flood insurance and have an agency contract with the Company, distinguishing the term from other types of “agents” referred to in the Arrangement (
                    <E T="03">e.g.,</E>
                     “fiscal agent,” “customer service agents” and “direct servicing agent”).
                </P>
                <P>2. For clarity, throughout the Arrangement, FEMA is substituting all references to “the Act” with the “NFIA,” as abbreviated in Article I.C.</P>
                <P>3. In Article I.A, FEMA is deleting “(as defined at III.N)” because a definition section is proposed in new Article I.D.</P>
                <P>4. In new Article I.D, FEMA is adding definitions for the terms “Service Provider,” “Vendor” and “Contractor,” as they are used throughout the Arrangement.</P>
                <P>5. In Article II.D.4.c, FEMA is deleting “[i]n the event of a transfer of services provided” for clarity, because it is repetitive and could cause confusion. The first paragraph in Article II.D.4 already states that it is regarding a required transfer of activities.</P>
                <P>6. In Article II.D.6, FEMA is making a minor grammatical change by deleting the word “other” and, in Article II.D.6.b, it is clarifying that the Company must provide the dates for the renewal or transfer of policies in its detailed transfer plan.</P>
                <P>7. In Article III.A.1.g, FEMA is clarifying that the Company is responsible for the payment of insurance brokers' commissions, as well as insurance agents', in alignment with Article IV.A and Article IV.B.2.</P>
                <P>8. For clarity, in Article III.A.3.a, FEMA is making a minor, non-substantive change by substituting “as much as possible” with “to the extent possible.”</P>
                <P>9. In new Article III.A.5.b, FEMA is adding a new provision in the Arrangement requiring a Vendor Oversight Plan to be included in the Operations Plan describing the Company's oversight of its Vendors, pursuant to 44 CFR 62.24(d).</P>
                <P>10. FEMA is redesignating the remaining subparagraphs in Article III.A.5 as III.A.5.c through III.A.5.j.</P>
                <P>
                    11. In newly-redesignated Article III.A.5.f, FEMA is requiring WYO 
                    <PRTPAGE P="3892"/>
                    Companies to include in their distribution plan the average rate of commissions they pay insurance agents and brokers “for new business and renewals,” and substituting “producers” with “insurance agents and brokers.”
                </P>
                <P>12. In newly-redesignated Article III.A.5.g.iii, FEMA is adding “independent adjusters” to the list of stakeholders the Company has to consider when providing key messaging during catastrophic events.</P>
                <P>13. For clarity and alignment with the definition in new Article I.D, in newly-redesignated Article III.A.5.i, FEMA is substituting “vendors or contractors” with “Service Providers.”</P>
                <P>14. In newly-redesignated Article III.A.5.j.i and in Article III.M, subparagraphs III.M.1, III.M.2.a.ii and III.M.2.b, FEMA is updating the reference to the system security requirements specified by the National Institute of Standards and Technology, “Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations,” to the latest version, Revision 3 (May 2024). FEMA is also updating the redesignated citation in Article III.M.2.b.</P>
                <P>15. For clarity and alignment, in newly-redesignated Article III.A.5.j.ii, FEMA is adding “pursuant to Article III.M” at the end of the subparagraph.</P>
                <P>16. For clarity, in Article III.F.2.a, FEMA is making a minor, non-substantive change by substituting “Program” with “FEMA.”</P>
                <P>17. For clarity, in Article III.H.4, FEMA is making minor, non-substantive changes by deleting “notify agents of flood insurance” and adding “and.”</P>
                <P>18. In Article III.I.5, FEMA is adding “[t]he Company must:” and making minor, non-substantive grammatical changes.</P>
                <P>19. In Article III.N, FEMA is clarifying that the Company must ensure its Service Providers act consistently with the NFIA and written standards and procedures issued by FEMA, in addition to the Arrangement and FEMA's regulations and guidance.</P>
                <P>20. In Article IV.A, FEMA is making a minor, non-substantive change to clarify that the Company is liable for insurance broker commissions, as well as insurance agents', in alignment with Article III.A.1.g and Article IV.B.2.</P>
                <P>21. In Article IV.B.1, FEMA is changing the reference to the source used to obtain the data for the property/casualty industry, from A.M. Best to the National Association of Insurance Commissioners (NAIC). A.M. Best's data is derived from the NAIC. This will enable FEMA to use the latest available data gathered directly from the primary source. FEMA is also making a minor, non-substantive change by substituting “`Other Act.,' `Gen. Exp.' And `Taxes'” and spelling it out as “`Other Acquisition,' `General Expenses' and `Taxes.'”</P>
                <P>22. In Article IV.B.3, FEMA is making a non-substantive change by substituting the term “Growth Bonus” with “Growth and Retention Bonus,” without any material change to the provision, to acknowledge the current practice that bonuses are paid for both growth and retention potential.</P>
                <P>23. In Article IV.E.3.a, FEMA added “and broker” to clarify that it will not reimburse the Company for awards or judgements for damages and costs to defend litigation involving issues of broker negligence, errors or omissions, pursuant to 42 U.S.C. 4081(c).</P>
                <P>24. FEMA is adding two new subparagraphs to Article IV.E.3, subparagraphs IV.E.3.g and IV.E.3.h, to clarify that FEMA will not reimburse the Company for awards, judgments and costs to defend litigation when a default is entered against it, or the Company fails to remove a case filed in State court to Federal court in a timely manner.</P>
                <P>25. In Article V.A.3, FEMA is making a minor, non-substantive change by deleting “Allocated and unallocated” and leaving the more general term “Loss Adjustment Expenses,” to better align with the language in Article IV.C.</P>
                <P>26. In the last Article, FEMA is making a minor correction in numbering, from “Article XV” to “Article XIV.” The previous WYO Arrangement had a non-substantive error in numbering and FEMA is clarifying it.</P>
                <P>The Fiscal Year 2026 Arrangement reads as follows:</P>
                <HD SOURCE="HD2">Financial Assistance/Subsidy Arrangement</HD>
                <HD SOURCE="HD3">Article I. General Provisions</HD>
                <P>A. Parties. The parties to the Financial Assistance/Subsidy Arrangement are the Federal Emergency Management Agency (FEMA) and the Company. This Arrangement is solely between FEMA and the Company, and in no instance shall any of the Company's Service Providers have any rights under this Arrangement.</P>
                <P>B. Purpose. The purpose of this Financial Assistance/Subsidy Arrangement is to authorize the Company to sell and service flood insurance policies made available through the National Flood Insurance Program (NFIP) and adjust and pay claims arising under such policies as fiscal agents of the Federal Government.</P>
                <P>
                    C. Authority. This Financial Assistance/Subsidy Arrangement is authorized under the National Flood Insurance Act of 1968 (NFIA) (42 U.S.C. 4001 
                    <E T="03">et seq.</E>
                    ), and in particular, section 1345(a) of the NFIA (42 U.S.C. 4081(a)), as implemented by 44 CFR 62.23 and 62.24.
                </P>
                <P>D. Definitions.</P>
                <P>
                    1. 
                    <E T="03">Service Provider</E>
                     means Vendors, Contractors, and independent adjusters working on behalf of the Company.
                </P>
                <P>
                    2. 
                    <E T="03">Vendor</E>
                     means any entity hired by the Company to carry out administrative and operational responsibilities of the Company under the Arrangement, including, but not limited to, issuing and renewing policies, policy management, rating, collecting premiums and making refunds, claims handling, customer service, reporting and compliance requirements. In this context, 
                    <E T="03">Vendor</E>
                     does not include adjusters, insurance agents or brokers, or Company employees.
                </P>
                <P>
                    3. 
                    <E T="03">Contractor</E>
                     means any other third-party Service Provider that does not meet the definition of Vendor. In this context, 
                    <E T="03">Contractor</E>
                     does not include adjusters, insurance agents or brokers, or Company employees.
                </P>
                <HD SOURCE="HD3">Article II. Commencement and Termination</HD>
                <P>A. The effective period of this Arrangement begins on October 1, 2025, and terminates no earlier than September 30, 2026, subject to extension pursuant to Articles II.D and II.I. FEMA may provide financial assistance only for policy applications, renewals, and endorsements accepted by the Company during this period pursuant to the Program's effective date, underwriting, and eligibility rules.</P>
                <P>
                    B. Pursuant to 44 CFR 62.23(a), FEMA will publish the Arrangement and the terms for subscription or re-subscription for Fiscal Year 2027 in the 
                    <E T="04">Federal Register</E>
                     no later than April 1, 2026. Within ninety (90) calendar days of such publication, the Company must notify FEMA of its intent to re-subscribe to the WYO Program for the following term.
                </P>
                <P>C. Requesting Participation in WYO Program. Insurers interested in participating in the WYO Program, that have never participated or are returning to the Program after a period of non-participation, must submit a written request to participate.</P>
                <P>1. Participation is then contingent on submission of both:</P>
                <P>a. A completed application package, the requirements and contents of which FEMA will outline in its written response to the request to participate.</P>
                <P>
                    b. A completed operations plan, whose requirements and contents are 
                    <PRTPAGE P="3893"/>
                    outlined at Article III.A.5 of this Arrangement.
                </P>
                <P>2. Insurers that are already participating in the Program must submit their operations plan within ninety (90) calendar days as outlined in Article III.A.5 of this Arrangement.</P>
                <P>D. Uninterrupted Service to Policyholders and Transfer of Data and Records.</P>
                <P>
                    1. To ensure uninterrupted service to policyholders, the Company must notify FEMA within thirty (30) calendar days from when the Company elects not to re-subscribe to the WYO Program during the term of this Arrangement, but no later than ninety (90) calendar days from the publication in the 
                    <E T="04">Federal Register</E>
                     of the Fiscal Year 2027 Arrangement.
                </P>
                <P>2. The Company must notify FEMA as soon as possible, but no later than thirty (30) calendar days from when the Company elects to no longer sell or renew NFIP policies in a community as defined in 44 CFR 59.1.</P>
                <P>3. If so notified under Article II.D.1 or II.D.2, or if FEMA chooses not to renew the Company's participation, FEMA, at its option, may require the continued performance of all or selected elements of this Arrangement for the period required for orderly transfer or cessation of business and settlement of accounts, not to exceed forty-eight (48) months after the end of this Arrangement (September 30, 2026), and may either require transfer of activities, in whole or in part, to FEMA under Article II.D.4 or allow transfer of activities, in whole or in part, to another WYO company under Article II.D.6.</P>
                <P>4. FEMA may require the Company to transfer all activities under this Arrangement to FEMA. Within thirty (30) calendar days of FEMA's election of this option, the Company must deliver to FEMA the following:</P>
                <P>a. A plan for the orderly transfer to FEMA of any continuing responsibilities in administering the policies issued by the Company under the Program including provisions for coordination assistance.</P>
                <P>b. All data received, produced, and maintained through the life of the Company's participation in the Program, including certain data, as determined by FEMA, in a standard format and medium.</P>
                <P>c. All claims and policy files, including those pertaining to receipts and disbursements that have occurred during the life of each policy. The Company must provide FEMA with a report showing, on a policy basis, any amounts due from or payable to policyholders, insurance agents, brokers, and others as of the transition date.</P>
                <P>d. All funds in its possession with respect to any policies transferred to FEMA for administration and the unearned expenses retained by the Company.</P>
                <P>e. A point of contact within the Company responsible for addressing issues that may arise from the Company's previous participation under the WYO Program.</P>
                <P>5. Within ninety (90) calendar days of FEMA receiving the Company's data and supporting documentation, FEMA will notify the Company of the date that FEMA will complete the transfer.</P>
                <P>6. FEMA may allow the Company to transfer all activities under this Arrangement to one or more WYO companies. Prior to commencing such transfer, the Company must submit, and FEMA must approve, a formal request. Such request must include the following:</P>
                <P>a. An assurance of uninterrupted service to policyholders.</P>
                <P>b. A detailed transfer plan providing for either: (1) the renewal of the Company's NFIP policies by one or more WYO companies and the date such transfer of NFIP policy renewals will be effective; or (2) the transfer of the Company's NFIP policies to one or more WYO companies and the date of the transfer of policies.</P>
                <P>c. A description of who the responsible party will be for liabilities relating to losses incurred by the Company in this or preceding Arrangement years.</P>
                <P>d. A point of contact within the Company responsible for addressing issues that may arise from the Company's previous participation under the WYO Program.</P>
                <P>7. FEMA will not reimburse the Company for costs associated with the transfer of activities under this Arrangement to FEMA or another WYO Company.</P>
                <P>8. Failure to timely transfer data. The Company agrees to hold FEMA harmless for all costs, liabilities, and expenses, including litigation expenses, incurred due to the Company's failure to timely transfer the data and information requested by FEMA or another WYO Company.</P>
                <P>E. Cancellation by FEMA.</P>
                <P>1. FEMA may cancel financial assistance and this Arrangement upon thirty (30) calendar days written notice to the Company stating one or more of the following reasons for such cancellation:</P>
                <P>a. Fraud or misrepresentation by the Company subsequent to the inception of the Arrangement.</P>
                <P>b. Nonpayment to FEMA of any amount due.</P>
                <P>c. Material failure to comply with the requirements of this Arrangement or with the written standards, procedures, or guidance issued by FEMA relating to the NFIP and applicable to the Company.</P>
                <P>d. Failure to maintain compliance with WYO company participation criteria at 44 CFR 62.24.</P>
                <P>e. Any other cause so serious or compelling a nature that affects the Company's present responsibility.</P>
                <P>2. If FEMA cancels this Arrangement pursuant to Article II.E.1, FEMA may require the transfer of administrative responsibilities, and the transfer of data and records as provided in Article II.D.4 and Article II.D.7-8. If transfer is required, the Company must remit to FEMA the unearned expenses retained by the Company. In such event, FEMA will assume all obligations and liabilities owed to policyholders under such policies, arising before and after the date of transfer.</P>
                <P>3. As an alternative to the transfer of the policies to FEMA pursuant to Article II.E.2, FEMA will consider a proposal, if it is made by the Company, for the assumption of responsibilities by another WYO company as provided in Article II.D.6 and Article II.D.7-8.</P>
                <P>F. The Company shall notify FEMA, immediately, if:</P>
                <P>1. An independent financial rating company downgrades its financial strength during its period of performance under this Arrangement; or</P>
                <P>
                    2. It receives an order or directive making it unable to carry out its obligations under this Arrangement by the insurance industry regulatory body of any jurisdiction (
                    <E T="03">e.g.,</E>
                     Department of Insurance or Commissioner or Superintendent of Insurance) or court of law to which the Company is subject, including but not limited to being placed in receivership or run-off status by a State insurance regulatory body.
                </P>
                <P>G. In the event that the Company is unable or otherwise fails to carry out its obligations under this Arrangement for reasons set out in Article II.F.2:</P>
                <P>
                    1. The Company agrees to transfer, and FEMA will accept, any and all WYO policies issued by the Company and in force as of the date of such inability or failure to perform. In such event FEMA will assume all obligations and liabilities within the scope of the Arrangement owed to policyholders arising before and after the date of transfer, and the Company will immediately transfer to FEMA all needed records and data, pursuant to Article II.D.4 and Article II.D.7-8, and all funds in its possession with respect 
                    <PRTPAGE P="3894"/>
                    to all such policies transferred and the unearned expenses retained by the Company. As an alternative to the transfer of the policies to FEMA, FEMA will consider a proposal, if it is made by the Company, for the assumption of responsibilities under this Arrangement by another WYO company as provided by Article II.D.6 and Article II.D.7-8.
                </P>
                <P>2. If there is ongoing litigation, the Company must file a motion to stay the proceedings on any and all pending litigation within the scope of the Arrangement, and FEMA or, if approved by FEMA, another WYO company, will assume full litigation responsibility.</P>
                <P>H. In the event the NFIA is amended, repealed, expires, or if FEMA is otherwise without authority to continue the Program, FEMA may cancel financial assistance under this Arrangement for any new or renewal business, but the Arrangement will continue for policies in force that shall be allowed to run their term under the Arrangement.</P>
                <P>
                    I. If FEMA does not publish the Fiscal Year 2027 Arrangement in the 
                    <E T="04">Federal Register</E>
                     on or before April 1, 2026, then FEMA may require the continued performance of all or selected elements of this Arrangement through December 31, 2027, but such extension may not exceed the expiration of the six (6) month period following publication of the Fiscal Year 2027 Arrangement in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD3">Article III. Undertakings of the Company</HD>
                <P>A. Responsibilities of the Company.</P>
                <P>1. Policy Issuance and Maintenance. The Company must meet all requirements of the Financial Control Plan and any guidance issued by FEMA. The Company is responsible for the following:</P>
                <P>a. Compliance with Rating Procedures.</P>
                <P>b. Eligibility Determinations.</P>
                <P>c. Policy Issuances.</P>
                <P>d. Policy Endorsements.</P>
                <P>e. Policy Cancellations.</P>
                <P>f. Policy Correspondence.</P>
                <P>g. Payment of Insurance Agents' and Brokers' Commissions.</P>
                <P>h. Fund management, including the receipt, recording, disbursement, and timely deposit of NFIP funds.</P>
                <P>2. The Company must provide a live customer service agent that (1) is accessible to all policyholders via telephone during business days, and (2) can resolve commonplace customer service issues.</P>
                <P>3. Claims Processing.</P>
                <P>a. In general. The Company must process all claims consistent with the Standard Flood Insurance Policy, Financial Control Plan, Claims Manual, other guidance adopted by FEMA, and to the extent possible, with the Company's standard business practices for its non-NFIP policies.</P>
                <P>b. Adjuster registration. The Company may not use an independent adjuster to adjust a claim unless the independent adjuster:</P>
                <P>i. Holds a valid Flood Control Number issued by FEMA; or</P>
                <P>ii. Participates in the Flood Adjuster Capacity Program.</P>
                <P>c. Claim reinspections. The Company must cooperate with any claim reinspection by FEMA.</P>
                <P>4. Reports. The Company must certify its business under the WYO Program through monthly financial reports in accordance with the requirements of the Pivot Use Procedures. The Company must follow the Financial Control Plan and the WYO Accounting Procedures Manual. FEMA will validate and audit, in detail, these data and compare the results against Company reports.</P>
                <P>5. Operations Plan. Within ninety (90) calendar days of the commencement of this Arrangement, the Company must submit a written Operations Plan to FEMA describing its efforts to perform under this Arrangement. The plan must include the following:</P>
                <P>a. Private Flood Insurance Separation Plan. If applicable, a description of the Company's policies, procedures, and practices separating their NFIP flood insurance lines of business from their non-NFIP flood insurance lines of business, including its implementation of Article III.F.</P>
                <P>b. Vendor Oversight Plan. If the Company uses a Vendor to carry out any of its responsibilities under this Arrangement, the Company shall submit to FEMA a Vendor Oversight Plan, and this Plan must:</P>
                <P>i. Identify the activities and responsibilities that will be carried out by the Vendor.</P>
                <P>ii. Include a description of the oversight measures the Company will perform of its Vendor to ensure compliance with the NFIA, this Arrangement, regulations, written standards, procedures, and guidance issued by FEMA.</P>
                <P>c. Marketing Plan. A marketing plan describing the Company's forecasted growth, efforts to achieve that growth, and ability to comply with any marketing guidelines provided by FEMA.</P>
                <P>d. Policy Retention Plan. A retention plan describing the Company's efforts to retain and renew policies and methods of communicating with policyholders on renewals.</P>
                <P>e. Customer Service Plan. A description of overall customer service practices, including ongoing and planned improvement efforts.</P>
                <P>f. Distribution Plan. A description of the Company's NFIP flood insurance distribution network, including anticipated number of insurance agents, efforts to train those insurance agents, and the average rate of commissions for new business and renewals paid to insurance agents and brokers by State.</P>
                <P>g. Catastrophic Claims Handling Plan. A catastrophic claims handling plan describing how the Company will respond and maintain service standards in catastrophic flood events, including:</P>
                <P>i. Deploying mobile or temporary claims centers to provide immediate policyholder assistance, including submission of notice of loss and claim status information.</P>
                <P>ii. Preparing people, processes, and tools for claims processing in remote work scenarios.</P>
                <P>
                    iii. Preparing communications in advance for readiness throughout the year including a suite of printed and digital materials (
                    <E T="03">e.g.,</E>
                     advertisements, educational materials, social media messaging, website blogs and announcements) that provide key messaging to stakeholders, including policyholders, insurance agents, independent adjusters and the public following a catastrophic flood event.
                </P>
                <P>iv. Identifying the core areas of information technology that need to be scaled pre-event or are scalable post-event.</P>
                <P>v. Ensuring the availability of sufficient adjusters and examiners to handle sudden surge in claims filings and handling.</P>
                <P>h. Business Continuity Plan. A business continuity plan identifying threats and risks facing the Company's NFIP-related operations and how the Company will maintain operations in the event of a disaster affecting its operational capabilities.</P>
                <P>i. Privacy Protection Plan. A privacy protection plan that describes the Company's standards and required procedures for using and maintaining personally identifiable information, in its possession and control or in the possession or control of its Service Providers.</P>
                <P>
                    j. System Security Plan. A system security plan that describes system boundaries, system environments of operation, how security requirements are implemented, and the relationships with or connections to other systems, including plans of action that describe how unimplemented security requirements will be met and how any planned mitigations will be 
                    <PRTPAGE P="3895"/>
                    implemented, prepared in accordance with either:
                </P>
                <P>
                    i. National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171 “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations,” Revision 3, 
                    <E T="03">https://csrc.nist.gov/pubs/sp/800/171/r3/final;</E>
                     or
                </P>
                <P>ii. Another comparable standard deemed acceptable by FEMA, pursuant to Article III.M.</P>
                <P>B. Time Standards. WYO companies must meet the time standards provided below. Time will be measured from the date of receipt through the date the task is completed. In addition to the standards set forth below, all functions performed by the Company must be in accordance with the highest reasonably attainable quality standards generally used in the insurance and data processing field. Applicable time standards are:</P>
                <P>1. Application Processing—fifteen (15) business days (Note: if the policy cannot be sent due to insufficient or erroneous information or insufficient funds, the Company must send a request for correction or added moneys within ten (10) business days).</P>
                <P>2. Renewal processing—seven (7) business days.</P>
                <P>3. Endorsement processing—fifteen (15) business days.</P>
                <P>4. Cancellation processing—fifteen (15) business days.</P>
                <P>5. File examination—seven (7) business days from the day the Company receives the final report.</P>
                <P>6. Claims draft processing—seven (7) business days from completion of file examination.</P>
                <P>7. Claims adjustment—forty-five (45) calendar days average from the receipt of Notice of Loss (or equivalent) through completion of examination.</P>
                <P>8. Upload transactions to Pivot—one (1) business day.</P>
                <P>C. Policy Issuance.</P>
                <P>1. The flood insurance subject to this Arrangement must be only that insurance written by the Company in its own name pursuant to the NFIA.</P>
                <P>2. The Company must issue policies under the regulations prescribed by FEMA, in accordance with the NFIA, on a form approved by FEMA.</P>
                <P>3. The Company must issue all policies in consideration of such premiums and upon such terms and conditions and in such States or areas or subdivisions thereof as may be designated by FEMA and only where the Company is licensed by State law to engage in the property insurance business.</P>
                <P>D. Installment Plans for Premium Payments. During the term of the Arrangement, FEMA may require the Company to offer a monthly premium installment payment option.</P>
                <P>E. Lapse of Authority or Appropriation. FEMA may require the Company to discontinue issuing policies subject to this Arrangement immediately in the event Congressional authorization or appropriation for the NFIP lapses.</P>
                <P>F. Separation of Finances and Other Lines of Flood Insurance.</P>
                <P>1. The Company must separate Federal flood insurance funds from all other Company accounts, at a bank or banks of its choosing for the collection, retention and disbursement of Federal funds relating to its obligation under this Arrangement, less the Company's expenses as set forth in Article IV. The Company must remit all funds not required to meet current expenditures to the United States Treasury, in accordance with the provisions of the WYO Accounting Procedures Manual.</P>
                <P>2. Other Undertakings of the Company.</P>
                <P>a. Clear communication. If the Company also offers insurance policies covering the peril of flood outside of the NFIP in any geographic area in which FEMA authorizes the purchase of flood insurance, the Company must ensure that all public communications (whether written, recorded, electronic, or other) regarding non-NFIP insurance lines would not lead a reasonable person to believe that the NFIP, FEMA, or the Federal Government in any way endorses, sponsors, oversees, regulates, or otherwise has any connection with the non-NFIP insurance line. The Company may assure compliance with this requirement by prominently including in such communications the following statement: “This insurance product is not affiliated with the National Flood Insurance Program.”</P>
                <P>b. Data protection. The Company may not use non-public data, information, or resources obtained in course of executing this Arrangement to further or support any activities outside the scope of this Arrangement.</P>
                <P>G. Claims. The Company must investigate, adjust, settle, and defend all claims or losses arising from policies issued under this Arrangement. Payment of flood insurance claims by the Company bind FEMA, subject to appeal.</P>
                <P>H. Compliance with Agency Standards and Guidelines.</P>
                <P>1. The Company must comply with the NFIA, regulations, written standards, procedures, and guidance issued by FEMA relating to the NFIP and applicable to the Company, including, but not limited to the following:</P>
                <P>a. WYO Program Financial Control Plan.</P>
                <P>b. Pivot Use Procedures.</P>
                <P>c. NFIP Flood Insurance Manual.</P>
                <P>d. NFIP Claims Manual.</P>
                <P>e. NFIP Litigation Manual.</P>
                <P>f. WYO Accounting Procedures Manual.</P>
                <P>g. WYO Company Bulletins.</P>
                <P>2. The Company must market flood insurance policies in a manner consistent with marketing guidelines established by FEMA.</P>
                <P>3. FEMA may require the Company to collect customer service information to monitor and improve its program delivery.</P>
                <P>4. The Company must notify its insurance agents of the requirement to comply with State regulations regarding flood insurance agent education and training opportunities, and assist FEMA in periodic assessment of insurance agent training needs.</P>
                <P>I. Compliance with Appeals Process.</P>
                <P>1. In general. FEMA will notify the Company when a policyholder files an appeal. After notification, the Company must provide FEMA the following information:</P>
                <P>a. All records created or maintained pursuant to this Arrangement requested by FEMA.</P>
                <P>b. A comprehensive claim file synopsis, redacted of personally identifiable information, that includes a summary of the appeal issues, the Company's position on each issue, and any additional relevant information. If, in the process of writing the synopsis, the Company determines that it can address the issue raised by the policyholder on appeal without further direction, it must notify FEMA. The Company will then work directly with the policyholder to achieve resolution and update FEMA upon completion. The Company may have a claims examiner review the file who is independent from the original decision and who possesses the authority to overturn the original decision if the facts support it.</P>
                <P>2. Cooperation. The Company must cooperate with FEMA throughout the appeal process until final resolution. This includes adhering to any written appeals guidance issued by FEMA.</P>
                <P>3. Resolution of Appeals. FEMA will close an appeal when:</P>
                <P>a. FEMA upholds the denial by the Company.</P>
                <P>b. FEMA overturns the denial by the Company and all necessary actions that follow are completed.</P>
                <P>
                    c. The Company independently resolves the issue raised by the policyholder without further direction.
                    <PRTPAGE P="3896"/>
                </P>
                <P>d. The policyholder voluntarily withdraws the appeal.</P>
                <P>e. The policyholder files litigation.</P>
                <P>4. Processing of Additional Payments from Appeal. The Company must follow established NFIP adjusting practices and claim handling procedures for appeals that result in additional payment to a policyholder when FEMA does not explicitly direct such payment during the review of the appeal.</P>
                <P>5. Time Standards. The Company must:</P>
                <P>a. Provide FEMA with requested files pursuant to Article III.I.1.a—ten (10) business days after request.</P>
                <P>b. Provide FEMA with a comprehensive claim file synopsis pursuant to Article III.I.1.b—ten (10) business days after request.</P>
                <P>c. Respond to inquiries from FEMA regarding an appeal—ten (10) business days after inquiry.</P>
                <P>d. Inform FEMA of any litigation filed by a policyholder with a current appeal—ten (10) business days of notice.</P>
                <P>J. Subrogation.</P>
                <P>1. In general. Consistent with Federal law and guidance, the Company must use its customary business practices when pursuing subrogation.</P>
                <P>2. Referral to FEMA. Pursuant to 44 CFR 62.23(i)(8), in lieu of the Company pursuing a subrogation claim, WYO companies may refer such claims to FEMA.</P>
                <P>3. Notification. No more than ten (10) calendar days after either the Company identifies a possible subrogation claim or FEMA notifies the Company of a possible subrogation claim, the Company must notify FEMA of its intent to pursue the claim or refer the claim to FEMA.</P>
                <P>4. Cooperation. Pursuant to 44 CFR 62.23(i)(11), the Company must extend reasonable cooperation to FEMA's Office of the Chief Counsel on matters related to subrogation.</P>
                <P>K. Access to Records. The Company must furnish to FEMA such summaries and analysis of information including claim file information and property address, location, and/or site information in its records as may be necessary to carry out the purposes of the NFIA, in such form as FEMA, in cooperation with the Company, will prescribe.</P>
                <P>L. System for Award Management (SAM). The Company must be registered in the System for Award Management. Such registration must have an active status during the period of performance under this Arrangement. The Company must ensure that its SAM registration is accurate and up to date.</P>
                <P>M. Cybersecurity.</P>
                <P>
                    1. In general. Unless the Company uses a compliance alternative pursuant to Article III.M.2, the Company must implement the security requirements specified by National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171 “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations”, Revision 3 (
                    <E T="03">https://csrc.nist.gov/pubs/sp/800/171/r3/final</E>
                    ) for any system that processes, stores, or transmits information that requires safeguarding or dissemination controls pursuant to and consistent with law, regulations, this Arrangement, or other applicable requirements, including information protected pursuant to Article XII.C and personally identifiable information of NFIP applicants and policyholders. Such implementation must be validated by a third-party assessment organization.
                </P>
                <P>2. Compliance alternatives. In lieu of compliance with Article III.M.1, the Company may either:</P>
                <P>a. Provide FEMA with documentation that the Company is securing the systems subject to the requirements of Article III.M.1 with either:</P>
                <P>
                    i. ISO/IEC 27001, 
                    <E T="03">https://www.iso.org/isoiec-27001-information-security.html</E>
                </P>
                <P>
                    ii. NIST Cybersecurity Framework, 
                    <E T="03">https://csrc.nist.gov/pubs/sp/800/171/r3/final;</E>
                </P>
                <P>
                    iii. Cybersecurity Maturity Model Certification (CMMC 2.0), 
                    <E T="03">https://dodcio.defense.gov/CMMC/;</E>
                </P>
                <P>
                    iv. Service and Organization Controls (SOC) 2, 
                    <E T="03">https://www.aicpa.org/interestareas/frc/assuranceadvisoryservices/sorhome.html;</E>
                     or
                </P>
                <P>v. Another comparable standard deemed acceptable by FEMA.</P>
                <P>
                    b. Provide a plan of action that describes how unimplemented security requirements of NIST SP 800-171, rev. 3, (
                    <E T="03">https://csrc.nist.gov/pubs/sp/800/171/r3/final</E>
                    ) will be met and how any planned mitigations will be implemented as part of the system security plan required under Article III.A.5.j.
                </P>
                <P>N. Company's Service Providers. The Company is required to ensure its Service Providers are acting consistently with the NFIA, this Arrangement, and regulations, written standards, procedures, and guidance issued by FEMA.</P>
                <HD SOURCE="HD3">Article IV. Loss Costs, Expenses, Expense Reimbursement, and Premium Refunds</HD>
                <P>A. The Company is liable for operating, administrative, and production expenses, including any State premium taxes, dividends, insurance agents' and brokers' commissions or any other expense of whatever nature incurred by the Company in the performance of its obligations under this Arrangement but excluding other taxes or fees, such as municipal or county premium taxes, surcharges on flood insurance premium, and guaranty fund assessments.</P>
                <P>B. Payment for Selling and Servicing Policies.</P>
                <P>1. Operating and Administrative Expenses. The Company may withhold, as operating and administrative expenses, other than insurance agents' or brokers' commissions, an amount from the Company's written premium on the policies covered by this Arrangement in reimbursement of all of the Company's marketing, operating, and administrative expenses, except for allocated and unallocated loss adjustment expenses described in Article IV.C. This amount will equal the sum of the average industry expenses ratios for “Other Acquisition”, “General Expenses” and “Taxes” calculated by aggregating premiums and expense amounts for each of five property coverages using direct premium and expense information to derive weighted average expense ratios. For this purpose, FEMA will use the latest available data for the property/casualty industry for the prior Arrangement year, from the National Association of Insurance Commissioners (NAIC) annual statement in Part III of the Insurance Expense Exhibit for the following five property coverages: Fire, Allied Lines, Farmowners Multiple Peril, Homeowners Multiple Peril, and Commercial Multiple Peril (non-liability portion).</P>
                <P>2. Insurance Agent and Broker Compensation. The Company may retain fifteen (15) percent of the Company's written premium on the policies covered by this Arrangement as the commission allowance to meet the commissions or salaries of insurance agents, brokers, or other entities producing qualified flood insurance applications and other related expenses.</P>
                <P>
                    3. Growth and Retention Bonus. FEMA may increase the amount of expense allowance retained by the Company depending on the extent to which the Company meets the marketing goals for the Arrangement year contained in marketing guidelines established pursuant to Article III.H.2. The total growth and retention bonuses paid to companies pursuant to this Arrangement may not exceed two (2) percent of the aggregate net written premium collected by all WYO companies. FEMA will pay the Company the amount of any increase after the end of the Arrangement year.
                    <PRTPAGE P="3897"/>
                </P>
                <P>C. FEMA will reimburse Loss Adjustment Expenses as follows:</P>
                <P>1. FEMA will reimburse unallocated loss adjustment expenses to the Company pursuant to a “ULAE Schedule” coordinated with the Company and provided by FEMA.</P>
                <P>2. FEMA will reimburse allocated loss adjustment expenses to the Company pursuant to a “Fee Schedule” coordinated with the Company and provided by FEMA. To ensure the availability of qualified insurance adjusters during catastrophic flood events, FEMA may, in its sole discretion, temporarily authorize the use of an alternative Fee Schedule with increased amounts during the term of this Arrangement for losses incurred during a time frame established by FEMA.</P>
                <P>3. FEMA will reimburse special allocated loss expenses under 44 CFR 62.23(i)(9) and subrogation expenses reimbursable under 44 CFR 62.23(i)(8) to the Company in accordance with guidelines issued by FEMA.</P>
                <P>D. Loss Payments.</P>
                <P>1. The Company must make loss payments for flood insurance policies from Federal funds retained in the bank account(s) established under Article III.F.1 and, if such funds are depleted, from Federal funds withdrawn from the National Flood Insurance Fund pursuant to Article V.</P>
                <P>2. Loss payments include payments because of awards, judgments for damages or settlements that arise under the scope of this Arrangement, and the Authorities set forth herein. All such loss payments and related expenses must meet the documentation requirements of the Financial Control Plan and of this Arrangement, and the Company must comply with the litigation documentation and notification requirements established by FEMA. Failure to meet these requirements may result in FEMA's decision not to provide reimbursement.</P>
                <P>E. Litigation Oversight and Reimbursable Litigation Expenses.</P>
                <P>1. Any litigation resulting from, related to, or arising from the Company's compliance with the written standards, procedures, and guidance issued by FEMA arises under the NFIA or regulations, and such legal issues raise a Federal question.</P>
                <P>2. The Company must conduct and oversee litigation arising out of the Company's participation in the NFIP in accordance with the National Flood Insurance Program Litigation Manual. When a specific issue is not addressed by the National Flood Insurance Program Litigation Manual, the Company must consult with FEMA's WYO Oversight Team.</P>
                <P>3. Limitation on Reimbursement and Payment of Litigation Expenses and Payment of Judgment and Award. FEMA will not reimburse the Company, in whole or part, for any award or judgment for damages, and any costs to defend litigation:</P>
                <P>a. Involving issues of insurance agent and broker negligence, errors or omissions;</P>
                <P>b. Grounded in actions by the Company that are significantly outside the scope of this Arrangement, including, but not limited to, reckless disregard of the Company's duties under the Arrangement, regulations or FEMA's written standards, procedures or guidance relating to the NFIP;</P>
                <P>c. Involving the submittal of inaccurate, false or fraudulent requests for litigation expense reimbursement;</P>
                <P>d. Where the Company failed to comply with the requirements of the NFIP Litigation Manual;</P>
                <P>e. Incurred after the Company became unable or otherwise failed to carry out its obligations under this Arrangement for the reasons contained in Article II.F.2, except that FEMA will reimburse the Company for reasonable costs of filing motions to stay proceedings;</P>
                <P>f. When FEMA and the Company's interests diverge, including positions on litigation strategy and settlement;</P>
                <P>g. When a Company fails to respond to a lawsuit and a default is entered; or</P>
                <P>h. When a Company fails to remove a case filed in State court to Federal court in a timely manner.</P>
                <P>F. Refunds. The Company must make premium refunds required by FEMA to applicants and policyholders from Federal flood insurance funds referred to in Article III.F.1, and, if such funds are depleted, from funds derived by withdrawing from the National Flood Insurance Fund pursuant to Article V. The Company may not refund any premium from Federal flood insurance funds to applicants or policyholders in any manner other than as specified by FEMA since flood insurance premiums are funds of the Federal Government.</P>
                <P>G. Suspension and Debarment.</P>
                <P>1. In general. The Company may not contract with or employ any person who is suspended or debarred from participating in Federal transactions pursuant to 2 CFR part 180 (covering Federal nonprocurement transactions) or 48 CFR part 9, subpart 9.4 (covering Federal procurement transactions) in relation to this Arrangement.</P>
                <P>2. Reimbursement. FEMA will not reimburse the company for any expenses incurred in violation of Article IV.G.1.</P>
                <P>3. Compliance. The Company may ensure compliance with Article IV.G.1 by:</P>
                <P>
                    a. Checking the System for Awards Management at 
                    <E T="03">sam.gov;</E>
                </P>
                <P>b. Collecting a certification from that person; or</P>
                <P>c. Adding a clause or condition to the transaction with that person.</P>
                <HD SOURCE="HD3">Article V. Undertakings of the Government</HD>
                <P>A. FEMA must enable the Company to withdraw funds from the National Flood Insurance Fund daily, if needed, pursuant to prescribed procedures implemented by FEMA. FEMA will increase the amounts of the authorizations as necessary to meet the obligations of the Company under Article IV.C-F. The Company may only request funds when net premium income has been depleted. The timing and amount of cash advances must be as close as is administratively feasible to the actual disbursements by the recipient organization for allowable expenses. Request for payment may not ordinarily be drawn more frequently than daily. The Company may withdraw funds from the National Flood Insurance Fund for any of the following reasons:</P>
                <P>1. Payment of claims, as described in Article IV.D.</P>
                <P>2. Refunds to applicants and policyholders for insurance premium overpayment, or if the application for insurance is rejected or when cancellation or endorsement of a policy results in a premium refund, as described in Article IV.F.</P>
                <P>3. Loss Adjustment Expenses, as described in Article IV.C.</P>
                <P>B. FEMA must provide technical assistance to the Company as follows:</P>
                <P>1. NFIP policy and history.</P>
                <P>2. Clarification of underwriting, coverage, and claims handling.</P>
                <P>3. Other assistance as needed.</P>
                <P>C. FEMA must provide the Company with a copy of all formal written appeal decisions conducted in accordance with Section 205 of the Bunning-Bereuter-Blumenauer Flood Insurance Reform Act of 2004, Public Law 108-264 and 44 CFR 62.20.</P>
                <P>
                    D. Prior to the end of the Arrangement period, FEMA may provide the Company a statistical summary of their performance during the signed Arrangement period. This summary will detail the Company's performance individually, as well as compare the Company's performance to the aggregate performance of all WYO companies and the NFIP Direct Servicing Agent.
                    <PRTPAGE P="3898"/>
                </P>
                <HD SOURCE="HD3">Article VI. Cash Management and Accounting</HD>
                <P>A. FEMA must make available to the Company during the entire term of this Arrangement the ability to withdraw funds from the National Flood Insurance Fund provided for in Article V. The Company may withdraw funds from the National Flood Insurance Fund for reimbursement of its expenses as set forth in Article V.A that exceed net written premiums collected by the Company from the effective date of this Arrangement or continuation period to the date of the draw. In the event that adequate funding is not available to meet current Company obligations for flood policy claim payments issued, FEMA must direct the Company to immediately suspend the issuance of loss payments until such time as adequate funds are available. The Company is not required to pay claims from their own funds in the event of such suspension.</P>
                <P>B. The Company must remit all funds, including interest, not required to meet current expenditures to the United States Treasury, in accordance with the provisions of the WYO Accounting Procedures Manual or procedures approved in writing by FEMA.</P>
                <P>C. In the event the Company elects not to participate in the Program in this or any subsequent fiscal year, or is otherwise unable or not permitted to participate, the Company and FEMA must make a provisional settlement of all amounts due or owing within three (3) months of the expiration or termination of this Arrangement. This settlement must include net premiums collected, funds withdrawn from the National Flood Insurance Fund, and reserves for outstanding claims. The Company and FEMA agree to make a final settlement of accounts for all obligations arising from this Arrangement within forty-eight (48) months, which may be extended for good cause and subject to audit, of its expiration or termination, except for contingent liabilities that must be listed by the Company. At the time of final settlement, the balance, if any, due FEMA or the Company must be remitted by the other immediately and the operating year under this Arrangement must be closed.</P>
                <P>D. Upon FEMA's request, the Company must provide FEMA with a true and correct copy of the Company's Fire and Casualty Annual Statement, and Insurance Expense Exhibit or amendments thereof as filed with the State Insurance Authority of the Company's domiciliary State.</P>
                <P>E. The Company must comply with the requirements of the False Claims Act (41 U.S.C. 3729-3733), which prohibits submission of false or fraudulent claims for payment to the Federal Government.</P>
                <HD SOURCE="HD3">Article VII. Arbitration</HD>
                <P>If any misunderstanding or dispute arises between the Company and FEMA with reference to any factual issue under any provisions of this Arrangement or with respect to FEMA's nonrenewal of the Company's participation, other than as to legal liability under or interpretation of the Standard Flood Insurance Policy, such misunderstanding or dispute may be submitted to arbitration for a determination that will be binding upon approval by FEMA. The Company and FEMA may agree on and appoint an arbitrator who will investigate the subject of the misunderstanding or dispute and make a determination. If the Company and FEMA cannot agree on the appointment of an arbitrator, then two arbitrators will be appointed, one to be chosen by the Company and one by FEMA.</P>
                <P>The two arbitrators so chosen, if they are unable to reach an agreement, must select a third arbitrator who must act as umpire, and such umpire's determination will become final only upon approval by FEMA. The Company and FEMA shall bear in equal shares all expenses of the arbitration. Findings, proposed awards, and determinations resulting from arbitration proceedings carried out under this section, upon objection by FEMA or the Company, shall be inadmissible as evidence in any subsequent proceedings in any court of competent jurisdiction.</P>
                <P>This Article shall indefinitely succeed the term of this Arrangement.</P>
                <HD SOURCE="HD3">Article VIII. Errors and Omissions</HD>
                <P>A. In the event of negligence by the Company that has not resulted in litigation but has resulted in a claim against the Company, FEMA will not consider reimbursement of the Company for costs incurred due to that negligence unless the Company takes all reasonable actions to rectify the negligence and to mitigate any such costs as soon as possible after discovery of the negligence. The Company may choose not to seek reimbursement from FEMA.</P>
                <P>B. If the Company has made a claim payment to an insured without including a mortgagee (or trustee) of which the Company had actual notice prior to making payment, and subsequently determines that the mortgagee (or trustee) is also entitled to any part of said claim payment, any additional payment may not be paid by the Company from any portion of the premium and any funds derived from any Federal funds deposited in the bank account described in Article III.F.1. In addition, the Company agrees to hold the Federal Government harmless against any claim asserted against the Federal Government by any such mortgagee (or trustee), as described in the preceding sentence, by reason of any claim payment made to any insured under the circumstances described above.</P>
                <HD SOURCE="HD3">Article IX. Officials Not to Benefit</HD>
                <P>No Member or Delegate to Congress, or Resident Commissioner, may be admitted to any share or part of this Arrangement, or to any benefit that may arise therefrom; but this provision may not be construed to extend to this Arrangement if made with a corporation for its general benefit.</P>
                <HD SOURCE="HD3">Article X. Offset</HD>
                <P>At the settlement of accounts, the Company and FEMA have, and may exercise, the right to offset any balance or balances, whether on account of premiums, commissions, losses, loss adjustment expenses, salvage, or otherwise due one party to the other, its successors or assigns, hereunder or under any other Arrangements heretofore or hereafter entered into between the Company and FEMA. This right of offset shall not be affected or diminished because of insolvency of the Company.</P>
                <P>All debts or credits of the same class, whether liquidated or unliquidated, in favor of or against either party to this Arrangement on the date of entry, or any order of conservation, receivership, or liquidation, shall be deemed to be mutual debts and credits and shall be offset with the balance only to be allowed or paid. No offset shall be allowed where a conservator, receiver, or liquidator has been appointed and where an obligation was purchased by or transferred to a party hereunder to be used as an offset.</P>
                <P>Although a claim on the part of either party against the other may be unliquidated or undetermined in amount on the date of the entry of the order, such claim will be regarded as being in existence as of the date of such order and any credits or claims of the same class then in existence and held by the other party may be offset against it.</P>
                <HD SOURCE="HD3">Article XI. Equal Opportunity</HD>
                <P>
                    A. Age Discrimination Act of 1975. The Company must comply with the requirements of the Age Discrimination Act of 1975, Public Law 94-135 (42 
                    <PRTPAGE P="3899"/>
                    U.S.C. 6101 
                    <E T="03">et seq.</E>
                    ) which prohibits discrimination on the basis of age in any program or activity receiving Federal financial assistance.
                </P>
                <P>B. Americans with Disabilities Act. The Company must comply with the requirements of Titles I, II, and III of the Americans with Disabilities Act, Public Law 101-336 (42 U.S.C. 12101-12213), which prohibits recipients from discriminating on the basis of disability in the operation of public entities, public and rivate transportation systems, places of public accommodation, and certain testing entities.</P>
                <P>
                    C. Civil Rights Act of 1964-Title VI. The Company must comply with the requirements of Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d 
                    <E T="03">et seq.</E>
                    ), which provides that no person in the United States will, on the grounds of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. Department of Homeland Security implementing regulations for the Act are found at 6 CFR part 21 and 44 CFR part 7.
                </P>
                <P>D. Civil Rights Act of 1968. The Company must comply with Title VIII of the Civil Rights Act of 1968, which prohibits recipients from discriminating in the sale, rental, financing, and advertising of dwellings, or in the provision of services in connection therewith, on the basis of race, color, national origin, religion, disability, familial status, and sex as implemented by the U.S. Department of Housing and Urban Development at 24 CFR part 100.</P>
                <P>E. Rehabilitation Act of 1973. The Company must comply with the requirements of Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), which provides that no otherwise qualified handicapped individuals in the United States will, solely by reason of the handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.</P>
                <HD SOURCE="HD3">Article XII. Access to Books and Records</HD>
                <P>A. FEMA, the Department of Homeland Security, and the Comptroller General of the United States, or their duly authorized representatives, for the purpose of investigation, audit, examination, and to enable FEMA to carry out the NFIP shall have access to any books, documents, papers and records of the Company that are pertinent to this Arrangement. The Company shall keep records that fully disclose all matters pertinent to this Arrangement, including premiums and claims paid or payable under policies issued pursuant to this Arrangement. Records of accounts and records relating to financial assistance shall be retained and available for three (3) years after final settlement of accounts, and to financial assistance, three (3) years after final adjustment of such claims. FEMA shall have access to policyholder and claim records at all times for purposes of the review, defense, examination, adjustment, or investigation of any claim under a flood insurance policy subject to this Arrangement.</P>
                <P>B. Nondisclosure by FEMA. FEMA, to the extent permitted by law and regulation, will safeguard and treat information submitted or made available by the Company pursuant to this Arrangement as confidential where the information has been marked “confidential” by the Company and the Company customarily keeps such information private or closely held. To the extent permitted by law and regulation, FEMA will not release such information to the public pursuant to a Freedom of Information Act (FOIA) request, 5 U.S.C. 552, without prior notification to the Company. FEMA may transfer documents provided by the Company to any department or agency within the Executive Branch or to either house of Congress if the information relates to matters within the organization's jurisdiction. FEMA may also release the information submitted pursuant to a judicial order from a court of competent jurisdiction.</P>
                <P>C. Nondisclosure by Company.</P>
                <P>1. In general. The Company, to the extent permitted by law, must safeguard and treat information submitted or made available by FEMA pursuant to this Arrangement as confidential where the information has been marked or identified as “confidential” by FEMA and FEMA customarily keeps such information private or closely held. The Company may not disclose such confidential information to a third-party without the express written consent of FEMA or as otherwise required by law.</P>
                <P>2. Other protections. Article XII.C.1 shall not be construed as to limit the effect of any other requirement on the Company to protect information from disclosure, including a joint defense agreement or under the Privacy Act.</P>
                <HD SOURCE="HD3">Article XIII. Compliance With the NFIA and Regulations</HD>
                <P>This Arrangement and all policies of insurance issued pursuant thereto are subject to Federal law and regulations.</P>
                <HD SOURCE="HD3">Article XIV. Relationship Between the Parties and the Insured</HD>
                <P>Inasmuch as the Federal Government is a guarantor hereunder, the primary relationship between the Company and the Federal Government is one of a fiduciary nature, that is, to ensure that any taxpayer funds are accounted for and appropriately expended. The Company is a fiscal agent of the Federal Government, but is not a general agent of the Federal Government. The Company is solely responsible for its obligations to its insured under any policy issued pursuant hereto, such that the Federal Government is not a proper party to any lawsuit arising out of such policies.</P>
                <P>
                    <E T="03">Authority:</E>
                     42 U.S.C. 4071, 4081; 44 CFR 62.23.
                </P>
                <SIG>
                    <NAME>Jeffrey Jackson,</NAME>
                    <TITLE>Assistant Administrator (A) for Federal Insurance Directorate, Resilience Federal Emergency Management Agency.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00511 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9111-52-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBJECT>Notice Regarding the Uyghur Forced Labor Prevention Act Entity List</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Homeland Security.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The U.S. Department of Homeland Security (DHS), as the Chair of the Forced Labor Enforcement Task Force (FLETF), announces the publication and availability of the updated Uyghur Forced Labor Prevention Act (UFLPA) Entity List, a consolidated register of the four lists required to be developed and maintained pursuant to the UFLPA, on the DHS UFLPA website. The updated UFLPA Entity List is also published as an appendix to this notice. This update adds three entities to the section 2(d)(2)(B)(ii) list of the UFLPA and thirty-five entities to the section 2(d)(2)(B)(v) list of the UFLPA. This update adds one entity to both the 2(d)(2)(B)(ii) list and section 2(d)(2)(B)(v) of the UFLPA. This update also includes a technical correction to the name of an entity listed in section 2(d)(2)(B)(ii) of the UFLPA. Details related to the process for revising the UFLPA Entity List are included in this 
                        <E T="04">Federal Register</E>
                         notice.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        This notice announces the publication and availability of the UFLPA Entity List updated as of January 
                        <PRTPAGE P="3900"/>
                        15, 2025, included as an appendix to this notice.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Persons seeking additional information on the UFLPA Entity List should email the FLETF at 
                        <E T="03">FLETF.UFLPA.EntityList@hq.dhs.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        LeRoy Potts, Director, Entity List Office, Trade and Economic Security, Office of Strategy, Policy, and Plans, DHS. Phone: (202) 891-2331, Email: 
                        <E T="03">FLETF.UFLPA.EntityList@hq.dhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The U.S. Department of Homeland Security (DHS), on behalf of the Forced Labor Enforcement Task Force (FLETF), is announcing the publication of the updated UFLPA Entity List, a consolidated register of the four lists required to be developed and maintained pursuant to section 2(d)(2)(B) of the Uyghur Forced Labor Prevention Act (Pub. L. 117-78) (UFLPA), to 
                    <E T="03">https://www.dhs.gov/uflpa-entity-list.</E>
                     The UFLPA Entity List is available as an appendix to this notice. This update adds three entities to the 2(d)(2)(B)(ii) list of the UFLPA, which identifies entities working with the government of the Xinjiang Uyghur Autonomous Region to recruit, transport, transfer, harbor or receive forced labor or Uyghurs, Kazakhs, Kyrgyz, or members of other persecuted groups out of the Xinjiang Uyghur Autonomous Region. This update also adds thirty-five entities to the section 2(d)(2)(B)(v) list of the UFLPA, which identifies facilities and entities that source material from the Xinjiang Uyghur Autonomous Region or from persons working with the government of Xinjiang or the Xinjiang Production and Construction Corps for purposes of the “poverty alleviation” program or the “pairing-assistance” program or any other government labor scheme that uses forced labor. This update also adds one entity to both the section 2(d)(2)(B)(ii) list and the section 2(d)(2)(B)(v) list of the UFLPA Entity List. This update also includes a technical correction to the name of an entity listed in section 2(d)(2)(B)(ii) of the UFLPA. Future revisions to the UFLPA Entity List, which may include additions, removals or technical corrections, will be published to 
                    <E T="03">https://www.dhs.gov/uflpa-entitylist</E>
                     and in the appendices of future 
                    <E T="04">Federal Register</E>
                     notices. 
                    <E T="03">See</E>
                     appendix 1.
                </P>
                <P>
                    Beginning on June 21, 2022, the UFLPA requires the Commissioner of U.S. Customs and Border Protection to apply a rebuttable presumption that goods mined, produced, or manufactured by entities on the UFLPA Entity List are made with forced labor, and therefore, prohibited from importation into the United States under 19 U.S.C. 1307. 
                    <E T="03">See</E>
                     section 3(a) of the UFLPA. As the FLETF revises the UFLPA Entity List, including by making additions, removals, or technical corrections, DHS, on its behalf, will post such revisions to the DHS UFLPA website (
                    <E T="03">https://www.dhs.gov/uflpa-entity-list</E>
                    ) and also publish the revised UFLPA Entity List as an appendix to a 
                    <E T="04">Federal Register</E>
                     notice.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <HD SOURCE="HD2">A. The Forced Labor Enforcement Task Force</HD>
                <P>
                    Section 741 of the United States-Mexico-Canada Agreement Implementation Act established the FLETF to monitor United States enforcement of the prohibition under section 307 of the Tariff Act of 1930, as amended (19 U.S.C. 1307). 
                    <E T="03">See</E>
                     19 U.S.C. 4681. Pursuant to DHS Delegation Order No. 23034, the DHS Under Secretary for Strategy, Policy, and Plans serves as Chair of the FLETF, an interagency task force that includes the Department of Homeland Security, the Office of the U.S. Trade Representative, and the Departments of Labor, State, Justice, the Treasury, and Commerce (member agencies).
                    <SU>1</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     19 U.S.C. 4681; Executive Order 13923 (May 15, 2020). In addition, the FLETF includes six observer agencies: the Departments of Energy and Agriculture, the U.S. Agency for International Development, the National Security Council, U.S. Customs and Border Protection, and U.S. Immigration and Customs Enforcement Homeland Security Investigations.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The U.S. Department of Homeland Security, as the FLETF Chair, has the authority to invite representatives from other executive departments and agencies, as appropriate. 
                        <E T="03">See</E>
                         Executive Order 13923 (May 15, 2020). The U.S. Department of Commerce is a member of the FLETF as invited by the Chair.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. The Uyghur Forced Labor Prevention Act: Preventing Goods Made With Forced Labor in the People's Republic of China From Being Imported Into the United States</HD>
                <P>
                    The UFLPA requires, among other things, that the FLETF, in consultation with the Secretary of Commerce and the Director of National Intelligence, develop a strategy (UFLPA section 2(c)) for supporting enforcement of section 307 of the Tariff Act of 1930, to prevent the importation into the United States of goods, wares, articles, and merchandise mined, produced, or manufactured wholly or in part with forced labor in the People's Republic of China. As required by the UFLPA, the 
                    <E T="03">Strategy to Prevent the Importation of Goods Mined, Produced, or Manufactured with Forced Labor in the People's Republic of China,</E>
                     which was published on the DHS website on June 17, 2022 (
                    <E T="03">see https://www.dhs.gov/uflpa-strategy</E>
                    ), includes the initial UFLPA Entity List, a consolidated register of the four lists required to be developed and maintained pursuant to the UFLPA. 
                    <E T="03">See</E>
                     UFLPA Section 2(d)(2)(B).
                </P>
                <HD SOURCE="HD2">C. UFLPA Entity List</HD>
                <P>The UFLPA Entity List addresses distinct requirements set forth in clauses (i), (ii), (iv), and (v) of section 2(d)(2)(B) of the UFLPA that the FLETF identify and publish the following four lists:</P>
                <P>(1) a list of entities in the Xinjiang Uyghur Autonomous Region that mine, produce, or manufacture wholly or in part any goods, wares, articles, and merchandise with forced labor;</P>
                <P>(2) a list of entities working with the government of the Xinjiang Uyghur Autonomous Region to recruit, transport, transfer, harbor or receive forced labor or Uyghurs, Kazakhs, Kyrgyz, or members of other persecuted groups out of the Xinjiang Uyghur Autonomous Region;</P>
                <P>(3) a list of entities that exported products made by entities in lists 1 and 2 from the People's Republic of China into the United States; and</P>
                <P>(4) a list of facilities and entities, including the Xinjiang Production and Construction Corps, that source material from the Xinjiang Uyghur Autonomous Region or from persons working with the government of Xinjiang or the Xinjiang Production and Construction Corps for purposes of the “poverty alleviation” program or the “pairing-assistance” program or any other government-labor scheme that uses forced labor.</P>
                <P>The UFLPA Entity List is a consolidated register of the above four lists. In accordance with section 3(e) of the UFLPA, effective June 21, 2022, entities on the UFLPA Entity List (listed entities) are subject to the UFLPA's rebuttable presumption that products they produce, wholly or in part, are prohibited from entry into the United States under 19 U.S.C. 1307. The UFLPA Entity List is described in appendix 1 to this notice. The UFLPA Entity List should not be interpreted as an exhaustive list of entities engaged in the practices described in clauses (i), (ii), (iv), or (v) of section 2(d)(2)(B) of the UFLPA.</P>
                <P>
                    Revisions to the UFLPA Entity List, including all additions, removals, and technical corrections, will be published on the DHS UFLPA website (
                    <E T="03">https://www.dhs.gov/uflpa-entity-list</E>
                    ) and as an 
                    <PRTPAGE P="3901"/>
                    appendix to a notice that will be published in the 
                    <E T="04">Federal Register</E>
                    . 
                    <E T="03">See</E>
                     appendix 1. The FLETF will consider future additions to, or removals from, the UFLPA Entity List based on criteria described in clauses (i), (ii), (iv), or (v) of Section 2(d)(2)(B) of the UFLPA. Any FLETF member agency may submit a recommendation(s) to add, remove or make technical corrections to an entry on the UFLPA Entity List. FLETF member agencies will review and vote on revisions to the UFLPA Entity List accordingly.
                </P>
                <HD SOURCE="HD3">Additions to the Entity List</HD>
                <P>The FLETF will consider future additions to the UFLPA Entity List based on the criteria described in clauses (i), (ii), (iv), or (v) of section 2(d)(2)(B) of the UFLPA. Any FLETF member agency may submit a recommendation to the FLETF Chair to add an entity to the UFLPA Entity List. Following review of the recommendation by the FLETF member agencies, the decision to add an entity to the UFLPA Entity List will be made by majority vote of the FLETF member agencies.  </P>
                <HD SOURCE="HD3">Requests for Removal From the Entity List</HD>
                <P>
                    Any listed entity may submit a request for removal (removal request) from the UFLPA Entity List along with supporting information to the FLETF Chair at 
                    <E T="03">FLETF.UFLPA.EntityList@hq.dhs.gov.</E>
                     In the removal request, the entity (or its designated representative) should provide information that demonstrates that the entity no longer meets or does not meet the criteria described in the applicable clause ((i), (ii), (iv), or (v)) of section 2(d)(2)(B) of the UFLPA. The FLETF Chair will refer all such removal requests and supporting information to FLETF member agencies. Upon receipt of the removal request, the FLETF Chair or the Chair's designated representative may contact the entity on behalf of the FLETF regarding questions on the removal request and may request additional information. Following review of the removal request by the FLETF member agencies, the decision to remove an entity from the UFLPA Entity List will be made by majority vote of the FLETF member agencies.
                </P>
                <P>
                    Listed entities may request a meeting with the FLETF after submitting a removal request in writing to the FLETF Chair at 
                    <E T="03">FLETF.UFLPA.EntityList@hq.dhs.gov.</E>
                     Following its review of a removal request, the FLETF may accept the meeting request at the conclusion of the review period and, if accepted, will hold the meeting prior to voting on the entity's removal request. The FLETF Chair will advise the entity in writing of the FLETF's decision on its removal request. While the FLETF's decision on a removal request is not appealable, the FLETF will consider new removal requests if accompanied by new information.
                </P>
                <SIG>
                    <NAME>Robert Paschall,</NAME>
                    <TITLE>Acting Under Secretary, Office of Strategy, Policy, and Plans, U.S. Department of Homeland Security.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Appendix 1</HD>
                <EXTRACT>
                    <P>
                        This notice supersedes the UFLPA Entity List published in the 
                        <E T="04">Federal Register</E>
                         on November 25, 2024 (89 FR 92953). The UFLPA Entity List as of January 15, 2025 is available in this appendix and is published on 
                        <E T="03">https://www.dhs.gov/uflpa-entity-list.</E>
                         This update adds three entities to the section 2(d)(2)(B)(ii) list of the UFLPA, which identifies entities working with the government of the Xinjiang Uyghur Autonomous Region to recruit, transport, transfer, harbor or receive forced labor or Uyghurs, Kazakhs, Kyrgyz, or members of other persecuted groups out of the Xinjiang Uyghur Autonomous Region:
                    </P>
                    <P>• Xinjiang Energy (Group) Co., Ltd.</P>
                    <P>• Xinjiang Energy (Group) Real Estate Co., Ltd.</P>
                    <P>• Xinjiang Jinbao Mining Co., Ltd.</P>
                    <P>This update also adds thirty-five entities to the section 2(d)(2)(B)(v) list of the UFLPA, which identifies facilities and entities that source material from the Xinjiang Uyghur Autonomous Region or from persons working with the government of Xinjiang or the Xinjiang Production and Construction Corps for purposes of the “poverty alleviation” program or the “pairing-assistance” program or any other government labor scheme that uses forced labor:</P>
                    <P>• Aksu Biaoxin Fiber Co., Ltd. (formerly known as Aksu Shangheng Fiber Co., Ltd.)</P>
                    <P>• Aksu Huafu Color Spinning Co., Ltd. (also known as Aksu Huafu Textiles Co., Ltd.; Akesu Huafu; Aksu Huafu Dyed Melange Yarn; and Akesu Huafu Melange Yarn Co., Ltd.)</P>
                    <P>• Awati Huafu Textile Co., Ltd.</P>
                    <P>• Baotou Meike Silicon Energy Co., Ltd.</P>
                    <P>• Donghai JA Solar Technology Co., Ltd.</P>
                    <P>• Hongyuan Green Energy Co., Ltd. (also known as HY Solar; and Hoyuan Green Energy Co. Ltd. and formerly known as Wuxi Shangji CNC Co., Ltd.; Wuxi Shangji Automation Co., Ltd.; and Wuxi Shangji Grinding Machine Co., Ltd.)</P>
                    <P>• Hongyuan New Materials (Baotou) Co., Ltd.</P>
                    <P>• Huafu Fashion Co., Ltd.</P>
                    <P>• Huyanghe Huafu Hongsheng Cotton Industry Co., Ltd.</P>
                    <P>• Jiangsu Meike Solar Technology Co., Ltd. (also known as Meike Co. and formerly known as Jiangsu Gaozhao New Energy Development Co., Ltd.)</P>
                    <P>• Kuche Zongheng Cotton Industry Co., Ltd.</P>
                    <P>• Kuitun Jinfu Textile Co., Ltd.</P>
                    <P>• Ningbo Huafu Donghao Industrial Co., Ltd.</P>
                    <P>• Ninghai Huafu Textile Co., Ltd.</P>
                    <P>• Shaya Yinhua Cotton Industry Co., Ltd.</P>
                    <P>• Shihezi Huafu Hongfeng Cotton Industry Co., Ltd.</P>
                    <P>• Shihezi Huafu Hongsheng Cotton Industry Co., Ltd.</P>
                    <P>• Shihezi Standard Fiber Co., Ltd.</P>
                    <P>• Shuangliang Silicon Materials (Baotou) Co., Ltd.</P>
                    <P>• Xinjiang Cotton Industry Group Jiashi Cotton Industry Co., Ltd.</P>
                    <P>• Xinjiang Cotton Industry Group Yuepu Lake Cotton Industry Co., Ltd.</P>
                    <P>• Xinjiang Habahe Ashele Copper Co., Ltd. (also known as Ashele Copper)</P>
                    <P>• Xinjiang Huafu Color Spinning Group Co., Ltd.</P>
                    <P>• Xinjiang Huafu Cotton Industry Group Co., Ltd.</P>
                    <P>• Xinjiang Huafu Hengfeng Cotton Industry Co., Ltd.</P>
                    <P>• Xinjiang Huafu Hongfeng Agricultural Development Co., Ltd.</P>
                    <P>• Xinjiang Huafu Textile Co., Ltd.</P>
                    <P>• Xinjiang Liufu Textile Industrial Park Co., Ltd.</P>
                    <P>• Xinjiang Shengfu Cotton Industry Co., Ltd.</P>
                    <P>• Xinjiang Tianfu Cotton Supply Chain Co., Ltd.</P>
                    <P>• Xinjiang Tianhong Xinba Cotton Industry Co., Ltd. (also known as Xinjiang Tianhong New Eight Cotton Industry Co., Ltd.)</P>
                    <P>• Xinjiang Zefu Cotton Co., Ltd.</P>
                    <P>• Xinjiang Zijin Nonferrous Metals Co., Ltd.</P>
                    <P>• Zhejiang Weixin Trading Co., Ltd.</P>
                    <P>• Zijin Mining Group Co., Ltd.</P>
                    <P>This update also adds one entity to both the section 2(d)(2)(B)(ii) list and the section 2(d)(2)(B)(v) list of the UFLPA:</P>
                    <P>• Xinjiang Zijin Zinc Industry Co., Ltd.</P>
                    <P>This update also modifies the name for a listing for one entity on the section 2(d)(2)(B)(ii) list of the UFLPA:</P>
                    <P>• Aksu Huafu Textiles Co. (including two aliases: Akesu Huafu and Aksu Huafu Dyed Melange Yarn) is changed to Aksu Huafu Color Spinning Co., Ltd. (also known as Aksu Huafu Textiles Co., Ltd.; Akesu Huafu; Aksu Huafu Dyed Melange Yarn; and Akesu Huafu Melange Yarn Co., Ltd.)</P>
                    <P>Xinjiang Energy (Group) Co., Ltd. is a state owned enterprise based in Urumqi, Xinjiang Uyghur Autonomous Region that is principally engaged in the development and utilization of coal, wind, photovoltaic, oil, gas, and other resources. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Energy (Group) Co., Ltd. works with the government of the Xinjiang Uyghur Autonomous Region to recruit, transport, transfer, harbor or receive Uyghurs, Kazakhs, Kyrgyz, or members of other persecuted groups out of the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Energy (Group) Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(ii).</P>
                    <P>
                        Xinjiang Energy (Group) Real Estate Co., Ltd. is a subsidiary of a state-owned enterprise based in Urumqi, Xinjiang Uyghur Autonomous Region that is principally 
                        <PRTPAGE P="3902"/>
                        engaged in real estate development and property management. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Energy (Group) Real Estate Co., Ltd. works with the government of the Xinjiang Uyghur Autonomous Region to recruit, transport, transfer, harbor or receive Uyghurs, Kazakhs, Kyrgyz, or members of other persecuted groups out of the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Energy (Group) Real Estate Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(ii).
                    </P>
                    <P>Xinjiang Jinbao Mining Co., Ltd. is a mine operator based in Altay Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in iron mining. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Jinbao Mining Co., Ltd. works with the government of the Xinjiang Uyghur Autonomous Region to recruit, transport, transfer, harbor or receive Uyghurs, Kazakhs, Kyrgyz, or members of other persecuted groups out of the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Jinbao Mining Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(ii).  </P>
                    <P>Xinjiang Zijin Zinc Industry Co., Ltd. is a mining company based in Kizilsu Kirgiz Autonomous Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in mining and producing zinc. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Zijin Zinc Industry Co., Ltd. works with the government of the Xinjiang Uyghur Autonomous Region to recruit, transport, transfer, harbor or receive Uyghurs, Kazakhs, Kyrgyz, or members of other persecuted groups out of the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Zijin Zinc Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(ii).</P>
                    <P>Aksu Biaoxin Fiber Co., Ltd. (formerly known as Aksu Shangheng Fiber Co., Ltd.) is a textile manufacturer located in Aksu Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton processing, fabric printing and dyeing, spinning and fabric textile processing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Aksu Biaoxin Fiber Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Aksu Biaoxin Fiber Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Aksu Huafu Color Spinning Co., Ltd. (also known as Aksu Huafu Textiles Co., Ltd. Akesu Huafu, Aksu Huafu Dyed Melange Yarn, and Akesu Huafu Melange Yarn Co., Ltd.) is a textile manufacturer located in Aksu Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in spinning processing, manufacturing of industrial textile products, and selling cotton and linen. The United States Government has reasonable cause to believe, based on specific and articulable information, that Aksu Huafu Color Spinning Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Aksu Huafu Color Spinning Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Awati Huafu Textile Co., Ltd. is a textile manufacturer located in Aksu Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in the production and sale of cotton yarn and textile manufacturing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Awati Huafu Textile Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Awati Huafu Textile Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Baotou Meike Silicon Energy Co., Ltd. is a company located in Baotou City in the Inner Mongolia Autonomous Region of China, that manufactures silicon rods and wafers. The United States Government has reasonable cause to believe, based on specific and articulable information, that Baotou Meike Silicon Energy Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Baotou Meike Silicon Energy Co., Ltd satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Donghai JA Solar Technology Co., Ltd. is a solar energy technology company located in Jiangsu Province, China, that focuses on the research and development of solar energy products and the production of silicon rods, wafers, ingots, and solar cell modules. Donghai JA Solar Technology Co., Ltd. also imports and exports various commodities and technologies. The United States Government has reasonable cause to believe, based on specific and articulable information, that Donghai JA Solar Technology Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Donghai JA Solar Technology Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Hongyuan Green Energy Co., Ltd. (also known as HY Solar; and Hoyuan Green Energy Co. Ltd. and formerly known as Wuxi Shangji CNC Co., Ltd.; Wuxi Shangji Automation Co., Ltd.; and Wuxi Shangji Grinding Machine Co., Ltd.) is a vertically integrated green energy manufacturing company located in Jiangsu Province, China, with several major business segments that include high-end equipment manufacturing, new energy power stations, and the production of industrial and crystalline silicon, silicon wafers, batteries, and modules. The United States Government has reasonable cause to believe, based on specific and articulable information, that Hongyuan Green Energy Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Hongyuan Green Energy Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Hongyuan New Materials (Baotou) Co., Ltd. is a company located in Baotou City, Inner Mongolia Autonomous Region of China, that produces photovoltaic monocrystalline silicon. The United States Government has reasonable cause to believe, based on specific and articulable information, that Hongyuan New Materials (Baotou) Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Hongyuan New Materials (Baotou) Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Huafu Fashion Co., Ltd. is a company based in Anhui Province, China that is vertically integrated from cotton planting and processing to yarn spinning to textiles manufacturing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Huafu Fashion Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Huafu Fashion Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Huyanghe Huafu Hongsheng Cotton Industry Co., Ltd. is a textile manufacturer located in Huyanghe City, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton processing and sales of cotton and textile products, among other activities. The United States Government has reasonable cause to believe, based on specific and articulable information, that Huyanghe Huafu Hongsheng Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Huyanghe Huafu Hongsheng Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Jiangsu Meike Solar Technology Co., Ltd. (also known as Meike Co. and formerly known as Jiangsu Gaozhao New Energy Development Co., Ltd.) is a company located in Jiangsu Province, China, that manufactures silicon rods and wafers. The United States Government has reasonable cause to believe, based on specific and articulable information, that Jiangsu Meike Solar Technology Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Jiangsu Meike Solar Technology Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).  </P>
                    <P>
                        Kuche Zongheng Cotton Industry Co., Ltd. is a material trading company located in Aksu Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton planting and processing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Kuche Zongheng Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Kuche 
                        <PRTPAGE P="3903"/>
                        Zongheng Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).
                    </P>
                    <P>Kuitun Jinfu Textile Co., Ltd. is a textile manufacturer located in Yili Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in fabric textile processing, the purchase of cotton, and fabric printing and dyeing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Kuitun Jinfu Textile Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Kuitun Jinfu Textile Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Ningbo Huafu Donghao Industrial Co., Ltd. is a materials trading company located in Ningbo City, Zhejiang Province that is principally engaged in trading colored spinning yarn and high-tech gray yarn. The United States Government has reasonable cause to believe, based on specific and articulable information, that Ningbo Huafu Donghao Industrial Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Ningbo Huafu Donghao Industrial Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Ninghai Huafu Textile Co., Ltd. is a textile manufacturer located in Ningbo City, Zhejiang Province that is principally engaged in the production of color-spun yarn. The United States Government has reasonable cause to believe, based on specific and articulable information, that Ninghai Huafu Textile Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Ninghai Huafu Textile Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Shaya Yinhua Cotton Industry Co., Ltd. is a materials trading company located in Aksu Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in seed cotton purchase processing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Shaya Yinhua Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Shaya Yinhua Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Shihezi Huafu Hongfeng Cotton Industry Co., Ltd. is a textile manufacturer located in Shihezi City, Xinjiang Uyghur Autonomous Region that is principally engaged in the purchase of cotton and sale of textile products. The United States Government has reasonable cause to believe, based on specific and articulable information, that Shihezi Huafu Hongfeng Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Shihezi Huafu Hongfeng Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Shihezi Huafu Hongsheng Cotton Industry Co., Ltd. is a textile manufacturer located in Shihezi City, Xinjiang Uyghur Autonomous Region that is principally engaged in processing and selling cotton. The United States Government has reasonable cause to believe, based on specific and articulable information, that Shihezi Huafu Hongsheng Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Shihezi Huafu Hongsheng Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Shihezi Standard Fiber Co., Ltd. is a textile manufacturer located in Shihezi City, Xinjiang Uyghur Autonomous Region that is principally engaged in dyeing and cotton processing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Shihezi Standard Fiber Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Shihezi Standard Fiber Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Shuangliang Silicon Materials (Baotou) Co., Ltd. is a company located in Baotou City, in the Inner Mongolia Autonomous Region of China, that researches, develops, processes, manufactures, and sells single crystal silicon rods and wafers. The United States Government has reasonable cause to believe, based on specific and articulable information, that Shuangliang Silicon Materials (Baotou) Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Shuangliang Silicon Materials (Baotou) Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Cotton Industry Group Jiashi Cotton Industry Co., Ltd. is a textile manufacturer located in Kashgar Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in processing and purchasing cotton seed. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Cotton Industry Group Jiashi Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Cotton Industry Group Jiashi Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Cotton Industry Group Yuepu Lake Cotton Industry Co., Ltd. is a textile manufacturer located in Kashgar Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in seed cotton purchasing and processing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Cotton Industry Group Yuepu Lake Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Cotton Industry Group Yuepu Lake Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Habahe Ashele Copper Co., Ltd. (also known as Ashele Copper) is a mine operator based in Altay Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in mining and producing copper, zinc, and silver. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Habahe Ashele Copper Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Habahe Ashele Copper Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Huafu Color Spinning Group Co., Ltd. is a textile manufacturer located in Urumqi City, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton planting, and cotton textile printing and dyeing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Huafu Color Spinning Group Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Huafu Color Spinning Group Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Huafu Cotton Industry Group Co., Ltd. is a textile manufacturer located in Urumqi City, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton processing, cotton planting, and cotton and linen sales. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Huafu Cotton Industry Group Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Huafu Cotton Industry Group Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Huafu Hengfeng Cotton Industry Co., Ltd. is a textile manufacturer located in Aksu Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton and cotton by-product processing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Huafu Hengfeng Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Huafu Hengfeng Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).  </P>
                    <P>
                        Xinjiang Huafu Hongfeng Agricultural Development Co., Ltd. is a materials trading company located in Aksu Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton planting and processing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Huafu Hongfeng Agricultural Development Co., Ltd. sources material from 
                        <PRTPAGE P="3904"/>
                        the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Huafu Hongfeng Agricultural Development Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).
                    </P>
                    <P>Xinjiang Huafu Textile Co., Ltd. is a textile manufacturer located in Aksu Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton processing and cotton purchasing. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Huafu Textile Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Huafu Textile Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Liufu Textile Industrial Park Co., Ltd. is a textile manufacturer located in Wujiaqu City, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton processing and cotton sales. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Liufu Textile Industrial Park Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Liufu Textile Industrial Park Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Shengfu Cotton Industry Co., Ltd. is a textile manufacturer located in Kashgar Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton purchasing, processing, and sales. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Shengfu Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Shengfu Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Tianfu Cotton Supply Chain Co., Ltd. is a material trading company located in Kashgar Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton planting and sales. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Tianfu Cotton Supply Chain Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Tianfu Cotton Supply Chain Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Tianhong Xinba Cotton Industry Co., Ltd. (also known as Xinjiang Tianhong New Eight Cotton Industry Co., Ltd.) is a textile manufacturer located in Shihezi City, Xinjiang Uyghur Autonomous Region that is principally engaged in spinning, weaving, and producing textiles. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Tianhong Xinba Cotton Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Tianhong Xinba Cotton Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Zefu Cotton Co., Ltd. is a textile manufacturer located in Kashgar Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in cotton purchasing, processing, and sales. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Zefu Cotton Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Zefu Cotton Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Zijin Nonferrous Metals Co., Ltd. is a smelter operator based in Kizilsu Kirgiz Autonomous Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in smelting and producing refined zinc and sulfuric acid. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Zijin Nonferrous Metals Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Zijin Nonferrous Metals Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Xinjiang Zijin Zinc Industry Co., Ltd. is a mining company based in Kizilsu Kirgiz Autonomous Prefecture, Xinjiang Uyghur Autonomous Region that is principally engaged in mining and producing zinc. The United States Government has reasonable cause to believe, based on specific and articulable information, that Xinjiang Zijin Zinc Industry Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Xinjiang Zijin Zinc Industry Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Zhejiang Weixin Trading Co., Ltd. is a materials trading company located in Ningbo City, Zhejiang Province that is principally engaged in the sale of cotton. The United States Government has reasonable cause to believe, based on specific and articulable information, that Zhejiang Weixin Trading Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Zhejiang Weixin Trading Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).</P>
                    <P>Zijin Mining Group Co., Ltd. is a global mining company based in Shanghang County, Fujian that is principally engaged in the exploration and extraction of metals, including zinc, copper, lead, silver, gold, iron ore, and sulfuric acid. The United States Government has reasonable cause to believe, based on specific and articulable information, that Zijin Mining Group Co., Ltd. sources material from the Xinjiang Uyghur Autonomous Region. The FLETF therefore determined that the activities of Zijin Mining Group Co., Ltd. satisfy the criteria for addition to the UFLPA Entity List described in section 2(d)(2)(B)(v).  </P>
                    <P>In June 2022, the FLETF added Aksu Huafu Textiles Co. (including two aliases: Akesu Huafu and Aksu Huafu Dyed Melange Yarn) to the UFLPA Entity List under section 2(d)(2)(B)(ii) of the UFLPA. Information reviewed by the FLETF indicates that the correct name and aliases of the entity is Aksu Huafu Color Spinning Co., Ltd. (also known as Aksu Huafu Textiles Co., Ltd.; Akesu Huafu; Aksu Huafu Dyed Melange Yarn; and Akesu Huafu Melange Yarn Co., Ltd.). Therefore, the FLETF has determined to make a technical correction to change the name of the entity as it appears on the UFLPA Entity List described in section 2(d)(2)(B)(ii) to “Aksu Huafu Color Spinning Co., Ltd. (also known as Aksu Huafu Textiles Co., Ltd.; Akesu Huafu; Aksu Huafu Dyed Melange Yarn; and Akesu Huafu Melange Yarn Co., Ltd.),”</P>
                    <P>No removal requests are being made to the UFLPA Entity List at this time.</P>
                    <P>
                        The UFLPA Entity List is a consolidated register of the four lists that are required to be developed and maintained pursuant to section 2(d)(2)(B) of the UFLPA. One hundred and forty-four entities that meet the criteria set forth in the four required lists (
                        <E T="03">see</E>
                         sections 2(d)(2)(B)(i), (ii), (iv), and (v) of the UFLPA) are specified on the UFLPA Entity List.
                    </P>
                    <HD SOURCE="HD1">UFLPA Entity List January 15, 2025</HD>
                    <HD SOURCE="HD1">UFLPA Section 2(d)(2)(B)(i) A List of Entities in Xinjiang That Mine, Produce, or Manufacture Wholly or in Part Any Goods, Wares, Articles, and Merchandise With Forced Labor</HD>
                    <FP SOURCE="FP-1">Baoding LYSZD Trade and Business Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Hetian Haolin Hair Accessories Co. Ltd. (and two aliases: Hotan Haolin Hair Accessories; and Hollin Hair Accessories)</FP>
                    <FP SOURCE="FP-1">Hetian Taida Apparel Co., Ltd. (and one alias: Hetian TEDA Garment)</FP>
                    <FP SOURCE="FP-1">Hoshine Silicon Industry (Shanshan) Co., Ltd. (including one alias: Hesheng Silicon Industry (Shanshan) Co.) and subsidiaries</FP>
                    <FP SOURCE="FP-1">Xinjiang Daqo New Energy, Co. Ltd. (including three aliases: Xinjiang Great New Energy Co., Ltd.; Xinjiang Daxin Energy Co., Ltd.; and Xinjiang Daqin Energy Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Xinjiang East Hope Nonferrous Metals Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang GCL New Energy Material Technology, Co. Ltd. (including one alias: Xinjiang GCL New Energy Materials Technology Co.)</FP>
                    <FP SOURCE="FP-1">Xinjiang Junggar Cotton and Linen Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Production and Construction Corps (including three aliases: XPCC; Xinjiang Corps; and Bingtuan) and its subordinate and affiliated entities</FP>
                    <HD SOURCE="HD1">UFLPA Section 2(d)(2)(B)(ii) A List of Entities Working With the Government of Xinjiang To Recruit, Transport, Transfer, Harbor or Receive Forced Labor or Uyghurs, Kazakhs, Kyrgyz, or Members of Other Persecuted Groups Out of Xinjiang</HD>
                    <FP SOURCE="FP-1">
                        Aksu Huafu Color Spinning Co., Ltd. (also known as Aksu Huafu Textiles Co., Ltd.; Akesu Huafu; Aksu Huafu Dyed Melange 
                        <PRTPAGE P="3905"/>
                        Yarn; and Akesu Huafu Melange Yarn Co., Ltd.)
                    </FP>
                    <FP SOURCE="FP-1">Anhui Xinya New Materials Co., Ltd. (formerly known as Chaohu Youngor Color Spinning Technology Co., Ltd.; and Chaohu Xinya Color Spinning Technology Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Baowu Group Xinjiang Bayi Iron and Steel Co., Ltd. (also known as Xinjiang Bayi Iron and Steel Co. Ltd.; Baosteel Group Xinjiang Bayi Iron and Steel Co., Ltd.; and Bayi Iron and Steel)</FP>
                    <FP SOURCE="FP-1">Camel Group Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Changhong Meiling Co., Ltd. (formerly known as Hefei Meiling Co., Ltd.; and Hefei Meiling Group Holdings Limited)</FP>
                    <FP SOURCE="FP-1">COFCO Sugar Holdings Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Dongguan Oasis Shoes Co., Ltd. (also known as Dongguan Oasis Shoe Industry Co. Ltd.; Dongguan Luzhou Shoes Co., Ltd.; and Dongguan Lvzhou Shoes Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Geehy Semiconductor Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Hefei Bitland Information Technology Co., Ltd. (including three aliases: Anhui Hefei Baolongda Information Technology; Hefei Baolongda Information Technology Co., Ltd.; and Hefei Bitland Optoelectronic Technology Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Kashgar Construction Engineering (Group) Co., Ltd.</FP>
                    <FP SOURCE="FP-1">KTK Group (including three aliases: Jiangsu Jinchuang Group; Jiangsu Jinchuang Holding Group; and KTK Holding)</FP>
                    <FP SOURCE="FP-1">Lop County Hair Product Industrial Park</FP>
                    <FP SOURCE="FP-1">Lop County Meixin Hair Products Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Nanjing Synergy Textiles Co., Ltd. (including two aliases: Nanjing Xinyi Cotton Textile Printing and Dyeing; and Nanjing Xinyi Cotton Textile).</FP>
                    <FP SOURCE="FP-1">Ninestar Corporation</FP>
                    <FP SOURCE="FP-1">No. 4 Vocation Skills Education Training Center (VSETC)</FP>
                    <FP SOURCE="FP-1">Shandong Meijia Group Co., Ltd. (also known as Rizhao Meijia Group)</FP>
                    <FP SOURCE="FP-1">Sichuan Jingweida Technology Group Co., Ltd. (also known as Sichuan Mianyang Jingweida Technology Co., Ltd. and JWD Technology; and formerly known as Mianyang High-tech Zone Jingweida Technology Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Tanyuan Technology Co. Ltd. (including five aliases: Carbon Yuan Technology; Changzhou Carbon Yuan Technology Development; Carbon Element Technology; Jiangsu Carbon Element Technology; and Tanyuan Technology Development).</FP>
                    <FP SOURCE="FP-1">Western Gold Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Western Gold Hami Gold Mine Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Western Gold Karamay Hatu Gold Mine Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Energy (Group) Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Energy (Group) Real Estate Co., Ltd</FP>
                    <FP SOURCE="FP-1">Xinjiang Habahe Ashele Copper Co., Ltd. (also known as Ashele Copper)</FP>
                    <FP SOURCE="FP-1">Xinjiang Jinbao Mining Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Nonferrous Metals Industry Group Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Production and Construction Corps (XPCC) and its subordinate and affiliated entities</FP>
                    <FP SOURCE="FP-1">Xinjiang Shenhuo Coal and Electricity Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Tengxiang Magnesium Products Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Tianmian Foundation Textile Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Tianshan Wool Textile Co. Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Zhonghe Co., Ltd. (also known as Xinjiang Joinworld Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Xinjiang Zhongtai Chemical Co. Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Zhongtai Group Co. Ltd</FP>
                    <FP SOURCE="FP-1">Xinjiang Zijin Zinc Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Zhuhai Apex Microelectronics Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Zhuhai G&amp;G Digital Technology Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Zhuhai Ninestar Information Technology Co. Ltd.</FP>
                    <FP SOURCE="FP-1">Zhuhai Ninestar Management Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Zhuhai Pantum Electronics Co. Ltd.</FP>
                    <FP SOURCE="FP-1">Zhuhai Pu-Tech Industrial Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Zhuhai Seine Printing Technology Co., Ltd.</FP>
                    <HD SOURCE="HD1">UFLPA Section 2(d)(2)(B)(iv) A List of Entities That Exported Products Described in Clause (iii) From the People's Republic of China Into the United States</HD>
                    <P>Entities identified in sections (i) and (ii) above may serve as both manufacturers and exporters. The FLETF has not identified additional exporters at this time but will continue to investigate and gather information about additional entities that meet the specified criteria.  </P>
                    <HD SOURCE="HD1">UFLPA Section 2(d)(2)(B)(v) A List of Facilities and Entities, Including the Xinjiang Production and Construction Corps, That Source Material From Xinjiang or From Persons Working With the Government of Xinjiang or the Xinjiang Production and Construction Corps for Purposes of the “Poverty Alleviation” Program or the “Pairing-Assistance” Program or Any Other Government Labor Scheme That Uses Forced Labor</HD>
                    <FP SOURCE="FP-1">Aksu Biaoxin Fiber Co., Ltd. (formerly known as Aksu Shangheng Fiber Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Aksu Huafu Color Spinning Co., Ltd. (also known as Aksu Huafu Textiles Co., Ltd.; Akesu Huafu; Aksu Huafu Dyed Melange Yarn; and Akesu Huafu Melange Yarn Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Anhui Yaozhiyuan Biotechnology Development Co., Ltd. (also known as Anhui Yaozhiyuan Chinese Herbal Medicine Co., Ltd.; Anhui Yaozhiyuan Chinese Medicinal Materials Co., Ltd.; and Anhui Yaozhiyuan Biological Technology Development Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Annan Canned Food Co., Ltd. (also known as Nanling County Annan Canned Food Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Awati Huafu Textile Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Baoding LYSZD Trade and Business Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Baotou Meike Silicon Energy Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Binzhou Chinatex Yintai Industrial Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Century Sunshine Group Holdings, Ltd.</FP>
                    <FP SOURCE="FP-1">Changji Esquel Textile Co., Ltd. (also known as Changji Yida Textile Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Changzhou Guanghui Food Ingredients Co., Ltd. (also known as GSweet; Changzhou Guanghui Food Additive Co., Ltd.; and Changzhou Guanghui Food Technology Co., Ltd.; and formerly known as Changzhou Guanghui Biotechnology Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Chenguang Biotech Group Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Chenguang Biotechnology Group Yanqi Co. Ltd.</FP>
                    <FP SOURCE="FP-1">China Cotton Group Henan Logistics Park Co., Ltd., Xinye Branch</FP>
                    <FP SOURCE="FP-1">China Cotton Group Nangong Hongtai Cotton Co., Ltd.</FP>
                    <FP SOURCE="FP-1">China Cotton Group Shandong Logistics Park Co., Ltd.</FP>
                    <FP SOURCE="FP-1">China Cotton Group Xinjiang Cotton Co.</FP>
                    <FP SOURCE="FP-1">Dalian Sunspeed Foods Co., Ltd. (also known as Dalian Shengchi International Trade Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Donghai JA Solar Technology Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Esquel Group (also known as Esquel China Holdings Limited)</FP>
                    <FP SOURCE="FP-1">Fujian Minlong Warehousing Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Gansu Yasheng International Trading Co., Ltd. (also known as Gansu Yasheng International Trade Co., Ltd.; and Yasheng International Trade; and formerly known as Gansu Yasheng International Trade Group Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Guangdong Esquel Textile Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Hangzhou Union Biotechnology Co., Ltd. (also known as Hangzhou Youer Biotechnology Co., Ltd.; Youer Biotech; and Union Biotech)</FP>
                    <FP SOURCE="FP-1">Hebei Suguo International Trade Co., Ltd. (also known as Suguo International)</FP>
                    <FP SOURCE="FP-1">Hebei Tomato Industry Co., Ltd. (also known as Hebei Temeite Industrial Group Co., Ltd.; and formerly known as Hebei Temeite International Trade Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Hefei Bitland Information Technology Co. Ltd.</FP>
                    <FP SOURCE="FP-1">Henan Yumian Group Industrial Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Henan Yumian Logistics Co., Ltd. (formerly known as 841 Cotton Transfer Warehouse)</FP>
                    <FP SOURCE="FP-1">Hengshui Cotton and Linen Corporation Reserve Library</FP>
                    <FP SOURCE="FP-1">Hetian Haolin Hair Accessories Co. Ltd.</FP>
                    <FP SOURCE="FP-1">Hetian Taida Apparel Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Heze Cotton and Linen Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Heze Cotton and Linen Economic and Trade Development Corporation (also known as Heze Cotton and Linen Trading Development General Company)</FP>
                    <FP SOURCE="FP-1">Hongyuan Green Energy Co., Ltd. (also known as HY Solar; and Hoyuan Green Energy Co. Ltd. and formerly known as Wuxi Shangji CNC Co., Ltd.; Wuxi Shangji Automation Co., Ltd.; and Wuxi Shangji Grinding Machine Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Hongyuan New Materials (Baotou) Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Hoshine Silicon Industry (Shanshan) Co., Ltd., and Subsidiaries</FP>
                    <FP SOURCE="FP-1">Huafu Fashion Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Huangmei Xiaochi Yinfeng Cotton (formerly known as Hubei Provincial Cotton Corporation's Xiaochi Transfer Reserve)</FP>
                    <FP SOURCE="FP-1">Hubei Jingtian Cotton Industry Group Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Hubei Qirun Investment Development Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Hubei Yinfeng Cotton Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Hubei Yinfeng Warehousing and Logistics Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Hunan Nanmo Biotechnology Co., Ltd. (also known as Hunan Nanmomo Technology Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Huyanghe Huafu Hongsheng Cotton Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Inner Mongolia Qileyuan Food Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Inner Mongolia Xuanda Food Co., Ltd. (also known as Xuanda Food; and formerly known as Wuyuan County Xuanda Cereals, Oils and Foods Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Jiangsu Meike Solar Technology Co., Ltd. (also known as Meike Co. and formerly known as Jiangsu Gaozhao New Energy Development Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">
                        Jiangsu Yinhai Nongjiale Storage Co., Ltd.
                        <PRTPAGE P="3906"/>
                    </FP>
                    <FP SOURCE="FP-1">Jiangsu Yinlong Warehousing and Logistics Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Jiangyin Lianyun Co. Ltd. (also known as Jiangyin Intermodal Transport Co. and Jiangyin United Transport Co.)</FP>
                    <FP SOURCE="FP-1">Jiangyin Xiefeng Cotton and Linen Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Jinan Haihong International Trade Co., Ltd. (formerly known as Jinan Haifang Trading Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Jining Pengjie Trading Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Junan Jinsheng Import &amp; Export Co., Ltd. (also known as Junan County Jinsheng Import and Export Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Juye Cotton and Linen Station of the Heze Cotton and Linen Corporation</FP>
                    <FP SOURCE="FP-1">Kingherbs Limited (also known as Changsha Jincao Biotechnology Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Kuche Zongheng Cotton Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Kuitun Jinfu Textile Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Lanxi Huachu Logistics Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Linxi County Fangpei Cotton Buying and Selling Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Lop County Hair Product Industrial Park</FP>
                    <FP SOURCE="FP-1">Lop County Meixin Hair Products Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Nanyang Hongmian Logistics Co., Ltd. (also known as Nanyang Red Cotton Logistics Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Ningbo Huafu Donghao Industrial Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Ninghai Huafu Textile Co., Ltd.</FP>
                    <FP SOURCE="FP-1">No. 4 Vocation Skills Education Training Center (VSETC)</FP>
                    <FP SOURCE="FP-1">Qingdao Vital Nutraceutical Ingredients BioScience Co., Ltd. (also known as Qingdao Weiyikang Biotechnology Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Rare Earth Magnesium Technology Group Holdings, Ltd.</FP>
                    <FP SOURCE="FP-1">Shanghai JUMP Machinery &amp; Technology Co., Ltd. (also known as Shanghai Jiapai Machinery Technology Co., Ltd.; and formerly known as Shanghai Chituma Food Machinery Technology Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Shaya Yinhua Cotton Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Shihezi Huafu Hongfeng Cotton Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Shihezi Huafu Hongsheng Cotton Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Shihezi Standard Fiber Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Shuangliang Silicon Materials (Baotou) Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Sichuan Yuan'an Pharmaceutical Co., Ltd. (also known as Sichuan Yuanan Pharmaceutical Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Taiyuan Weishan International Economic Business Co., Ltd. (also known as Taiyuan Weishan International Trade Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">The TNN Development Limited (also known as Dehui (Dalian) International Trade Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Tianjin Dunhe International Trade Co., Ltd. (also known as Dunhe Foods)</FP>
                    <FP SOURCE="FP-1">Tianjin Kunyu International Co., Ltd. (also known as China Kunyu Industrial Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Tianjin Tianwei Food Co., Ltd. (formerly known as Tianjin Sanhe Fruit and Vegetable Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Turpan Esquel Textile Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Weifang Alice Food Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Wugang Zhongchang Logistics Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Cotton Industry Group Jiashi Cotton Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Cotton Industry Group Yuepu Lake Cotton Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Daqo New Energy Co., Ltd. (also known as Xinjiang Great New Energy Co., Ltd.; Xinjiang Daxin Energy Co., Ltd.; and Xinjiang Daqin Energy Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Xinjiang Habahe Ashele Copper Co., Ltd. (also known as Ashele Copper)</FP>
                    <FP SOURCE="FP-1">Xinjiang Huafu Color Spinning Group Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Huafu Cotton Industry Group Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Huafu Hengfeng Cotton Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Huafu Hongfeng Agricultural Development Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Huafu Textile Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Junggar Cotton and Linen Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Liufu Textile Industrial Park Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Production and Construction Corps (XPCC) and its subordinate and affiliated entities</FP>
                    <FP SOURCE="FP-1">Xinjiang Shengfu Cotton Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Tengxiang Magnesium Products Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Tianfu Cotton Supply Chain Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Tianhong Xinba Cotton Industry Co., Ltd. (also known as Xinjiang Tianhong New Eight Cotton Industry Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Xinjiang Yinlong Agricultural International Cooperation Co.</FP>
                    <FP SOURCE="FP-1">Xinjiang Zefu Cotton Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Zijin Nonferrous Metals Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Xinjiang Zijin Zinc Industry Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Yili Zhuowan Garment Manufacturing Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Zhangzhou Hang Fat Import &amp; Export Co., Ltd. (also known as Zhangzhou Hengfa Import and Export Co., Ltd.)</FP>
                    <FP SOURCE="FP-1">Zhejiang Weixin Trading Co., Ltd.</FP>
                    <FP SOURCE="FP-1">Zijin Mining Group Co., Ltd.</FP>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00901 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-9M-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Indian Affairs</SUBAGY>
                <DEPDOC>[256A2100DD/AAKC001030/A0A501010.999900]</DEPDOC>
                <SUBJECT>Land Acquisitions; Scotts Valley Band of Pomo Indians, Vallejo Site, Solano County, California</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Indian Affairs, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Principal Deputy Assistant Secretary—Indian Affairs, exercising authority by delegation of the Assistant Secretary—Indian Affairs, made a final agency determination to acquire in trust 160.333 acres, more or less, of land known as the Vallejo Site in Solano County, California, for the Scotts Valley Band of Pomo Indians for gaming and other purposes.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final determination was made on January 10, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, 
                        <E T="03">IndianGaming@bia.gov;</E>
                         (202) 219-4066.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Principal Deputy Assistant Secretary—Indian Affairs, exercising authority by delegation of the Assistant Secretary—Indian Affairs, took this action under the authority of the Indian Reorganization Act of June 18, 1934, 25 U.S.C. 5108.</P>
                <P>The Principal Deputy Assistant Secretary—Indian Affairs, exercising authority by delegation of the Assistant Secretary—Indian Affairs, on behalf of the Secretary of the Interior, will immediately acquire the title to the site in the name of the United States of America in trust for the Scotts Valley Band of Pomo Indians upon fulfillment of all Departmental requirements. The 160.333 acres, more or less, are described as follows:</P>
                <HD SOURCE="HD1">Legal Description of Property</HD>
                <HD SOURCE="HD1">GRANT DEED RECORDED MARCH 15, 2016, DOCUMENT NO. 2016-00020200</HD>
                <P>THE LAND REFERRED TO HEREIN BELOW IS SITUATED IN THE CITY OF VALLEJO, COUNTY OF SOLANO, STATE OF CALIFORNIA AND IS DESCRIBED AS FOLLOWS:</P>
                <P>THAT CERTAIN PARCEL OF LAND DELINEATED ON THE MAP ENTITLED “RECORD OF SURVEY OF A PARCEL OF LAND EAST OF U.S. 40 AND NORTH OF COLUMBUS PARKWAY, VALLEJO, CALIFORNIA”, MADE BY EDWARD F. SCHWAFEL, ENGINEER, INC., FILED IN THE OFFICE OF THE COUNTY RECORDER OF SOLANO COUNTY, CALIFORNIA, ON JULY 28, 1965, IN BOOK 9 OF SURVEYS, AT PAGE 61.</P>
                <P>EXCEPTING THEREFROM AN UNDIVIDED 11/24 INTEREST IN AND TO ALL OIL, GAS, ASPHALTUM, HYDROCARBONS, MINERALS AND KINDRED SUBSTANCES IN AND UNDER SAID LAND BELOW THE DEPTH OF 500 FEET FROM THE SURFACE THEREOF, BUT WITHOUT THE RIGHT OF ENTRY UPON OR THROUGH THE SURFACE OF SAID LANDS AS RESERVED IN THE DEED DATED NOVEMBER 1, 1965, RECORDED NOVEMBER 12, 1965, IN BOOK 1368 OF OFFICIAL RECORDS, PAGE 280, INSTRUMENT NO. 31220, EXECUTED BY HENRY SHAPRIO, ET AL, TO ROBERT LANRER, ET UX.</P>
                <P>
                    ALSO EXCEPTING THEREFROM UNDIVIDED 13/24 INTEREST IN AND TO ALL OIL, GAS, ASPHALTUM, HYDROCARBONS, MINERALS AND KINDRED SUBSTANCES IN AND UNDER SAID LAND BELOW A DEPTH OF 500 FEET FROM THE SURFACE 
                    <PRTPAGE P="3907"/>
                    THEREOF BUT WITHOUT THE RIGHT OF ENTRY UPON OR THROUGH THE SURFACE OF SAID LANDS AS RESERVED IN THE DEED EXECUTED BY ROBERT LARNER AND BEVERLY LARNER, HIS WIFE, DATED DECEMBER 31, 1968 AND RECORDED DECEMBER 31, 1968, IN BOOK 1542 OF OFFICIAL RECORDS, PAGE 397, INSTRUMENT NO. 23899.
                </P>
                <P>ALSO EXCEPTING THEREFROM THE PARCEL OF LAND DESCRIBED AS PARCEL 10A IN THE FINAL ORDER OF CONDEMNATION HAD ON APRIL 14, 1972 IN THE SUPERIOR COURT, SOLANO COUNTY, CASE NO. 50096, A CERTIFIED COPY OF WHICH WAS RECORDED APRIL 14, 1972, IN BOOK 1744 OF OFFICIAL RECORDS, AT PAGE 151, INSTRUMENT NO. 8056.</P>
                <P>ALSO EXCEPTING THEREFROM THE PARCEL OF LAND DESCRIBED IN THE GRANT DEED FROM CHARLES G. MOYER AND DIANE E. MOYER, HUSBAND AND WIFE, TO THE STATE OF CALIFORNIA, DATED SEPTEMBER 22, 1980 AND RECORDED DECEMBER 4, 1980, INSTRUMENT NO. 53746, PAGE 88104, SOLANO COUNTY RECORDS.</P>
                <FP SOURCE="FP-1">APN: 0182-010-010</FP>
                <HD SOURCE="HD1">QUITCLAIM DEED RECORDED January 11, 2024, Instrument No. 202400001365</HD>
                <P>THE LAND DESCRIBED HEREIN IS SITUATED IN THE STATE OF CALIFORNIA, COUNTY OF SOLANO, CITY OF VALLEJO, DESCRIBED AS FOLLOWS:</P>
                <HD SOURCE="HD2">PARCEL ONE</HD>
                <P>BEGINNING AT THE POINT OF INTERSECTION OF THE NORTHERLY LINE OF COLUMBUS PARKWAY (COUNTY ROAD NO. 233) WITH THE WESTERLY LINE OF PARCEL 1 OF THE RECORD OF SURVEY OF THE UPPER AND MIDDLE HUNTER RANCHES, FILED FOR RECORD 17 MARCH, 1965 IN BOOK 9 OF SURVEYS AT PAGE 42, SOLANO COUNTY RECORDS; THENCE 650 FEET EASTERLY, ALONG THE NORTHERLY LINE OF COLUMBUS PARKWAY TO THE SOUTHWEST CORNER OF PARCEL A; THENCE; THENCE NORTHERLY 650.00 FEET ALONG THE WESTERLY LINE OF PARCEL A; THENCE WESTERLY AT 90° TO THE PROCEEDING COURSE 629.29 FEET TO THE WESTERLY LINE OF SAID PARCEL 1; THENCE SOUTH 12°02′48″ WEST, 651.32 FEET TO THE POINT OF BEGINNING.</P>
                <HD SOURCE="HD2">PARCEL TWO</HD>
                <P>COMMENCING AT THE POINT OF INTERSECTION OF THE NORTHERLY LINE OF COLUMBUS PARKWAY (COUNTY ROAD NO. 233), WITH THE WESTERLY LINE OF PARCEL 1 OF THE RECORD OF SURVEY OF THE UPPER &amp; MIDDLE HUNTER RANCHES, FILED FOR RECORD 17 MARCH, 1965, IN BOOK 9 OF SURVEYS AT PAGE 42, SOLANO COUNTY RECORDS; THENCE 650 FEET EASTERLY ALONG THE NORTHERLY LINE OF COLUMBUS PARKWAY TO THE TRUE POINT OF BEGINNING; THENCE NORTHERLY AT RIGHT ANGLES TO THE NORTHERLY RIGHT-OF-WAY LINE OF COLUMBUS PARKWAY, 950 FEET; THENCE EASTERLY, 950 FEET; THENCE SOUTHERLY, 950 FEET TO THE NORTHERLY LINE OF COLUMBUS PARKWAY; THENCE WESTERLY 950 FEET TO THE TRUE POINT OF BEGINNING.</P>
                <P>EXCEPTING THEREFROM:</P>
                <P>THAT PORTION OF THE HEREIN DESCRIBED PROPERTY AS DESCRIBED IN THE AMENDED FINAL JUDGEMENT IN CONDEMNATION PURSUANT TO STIPULATION SUPERIOR COURT CASE NO. 48484, RECORDED SEPTEMBER 7, 1970, IN BOOK 1643 OF OFFICIAL RECORDS, AT PAGE 112, AS INSTRUMENT NO. 16338.</P>
                <HD SOURCE="HD2">PARCEL THREE</HD>
                <P>THAT PORTION OF THE PARCEL OF LAND SHOWN AS 301.669 +/− ACRES LYING NORTH OF THE CENTERLINE ST. JOHN'S MINE ROAD IN BOOK 15 OF SURVEYS AT PAGE 18, SOLANO COUNTY RECORDS DESCRIBED AS FOLLOWS:</P>
                <P>BEGINNING AT THE NORTHWESTERLY CORNER OF PARCEL A SHOWN AS “N.D.S DEV. CORP., BOOK 1796 O.R. PAGE 333 S.C.R.” IN BOOK 15 OF SURVEYS AT PAGE 18, SOLANO COUNTY RECORDS; THENCE NORTH 57°28′48″ WEST, 280.54 FEET; THENCE NORTH 88°25′41″ WEST, 464.40 FEET; THENCE SOUTH 17°42′05″ EAST, 224.00 FEET; THENCE SOUTH 12°02′48″ WEST, 159.71 FEET; THENCE SOUTH 81°42′05″ EAST, 629.29 FEET; THENCE NORTH 8°17′55″ EAST, 300.00 FEET TO THE POINT OF BEGINNING.</P>
                <FP SOURCE="FP-1">APN: 0182-020-010 (AFFECTS PARCEL ONE), 0182-020-020 (AFFECTS PARCEL TWO), 0182-020-080 (AFFECTS PARCEL THREE)</FP>
                <P>
                    <E T="03">Authority:</E>
                     This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by part 209 Departmental Manual 8.1. This notice is published to comply with the requirements of 25 CFR 151.13 (c)(2)(ii) that notice of the decision to acquire land in trust be promptly provided in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Wizipan Garriott,</NAME>
                    <TITLE>Principal Deputy Assistant Secretary—Indian Affairs, Exercising by Delegation the Authority of the Assistant Secretary—Indian Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00744 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4337-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Indian Affairs</SUBAGY>
                <DEPDOC>[256A2100DD/AAKE200000/A0A501010.000000]</DEPDOC>
                <SUBJECT>Land Acquisitions; Coquille Indian Tribe, Medford Site, City of Medford, Jackson County, Oregon</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Indian Affairs, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Assistant Secretary—Indian Affairs made a final agency determination to acquire in trust 2.42 acres, more or less, of land known as the Medford Site in the City of Medford, Jackson County, Oregon, for gaming and other purposes.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final determination was made on January 10, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, 
                        <E T="03">IndianGaming@bia.gov;</E>
                         (202) 219-4066.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On the date listed in the 
                    <E T="02">DATES</E>
                     section of this notice, the Assistant Secretary—Indian Affairs made a final agency determination to acquire the Medford Site, consisting of 2.42 acres, more or less, in trust for the Coquille Indian Tribe under the authority of the Indian Reorganization Act of 1934 and the Coquille Restoration Act of June 28, 1989, (Pub. L. 101-42, 103 Stat. 92).
                </P>
                <P>The Assistant Secretary—Indian Affairs, on behalf of the Secretary of the Interior, will immediately acquire title to the Medford Site in the name of the United States of America in trust for Coquille Indian Tribe upon fulfillment of all Departmental requirements. The 2.42 acres, more or less, are described as follows:</P>
                <HD SOURCE="HD1">Legal Description of Property</HD>
                <EXTRACT>
                    <P>
                        Beginning at the Northeast Corner of Donation Land Claim No. 46, Township 37 South, Range 1 West, Willamette Meridian, Jackson County, Oregon; thence South 00°02′40″ East along the East line of said Donation Land Claim line 1163.22 feet {record South 1163.80 feet); thence South 
                        <PRTPAGE P="3908"/>
                        51″15′00″ West,1338.47 feet to a 
                        <FR>5/8</FR>
                         inch iron pin at the Point of Beginning; thence continue South 51″15′00″ West 468.33 feet to Intersect the Northeasterly Right of Way line of U.S. Highway No. 99 at a 
                        <FR>5/8</FR>
                         inch iron pin; thence along said Highway Right of Way line on a spiral curve to the left (the long chord to which bears North 39″58′20″ West, 33.73 feet) to a 
                        <FR>5/8</FR>
                         inch iron pin, said pin being a Point of Spiral Curve {P.S.C.), Station 490+28.72 of said Highway; thence 177.14 feet along said Highway line on an arc of a 5761.16 foot radius curve to the left (the long chord to which bears North 41″03′50″ West 177.14 feet) to a 
                        <FR>5/8</FR>
                         inch iron pin, said point being a P.S.C., Station 492+4.90 of said Highway; thence along said Highway Right of Way Line on a spiral curve to the left {the long chord to which bears North 42°00′ West 12.00 feet) to a 
                        <FR>5/8</FR>
                         inch iron pin; thence leaving said Right of Way Line North 51°15′00″ East, 477.40 feet to a 
                        <FR>5/8</FR>
                         inch iron pin; thence South 38°36′27″ East, 222.70 feet to the Point of Beginning.
                    </P>
                    <P>Containing 2.42 acres, more or less.</P>
                </EXTRACT>
                <P>
                    <E T="03">Authority:</E>
                     This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by the Departmental Manual part 209, chapter 8, paragraph 8.1, and is published to comply with the requirements of 25 CFR 151.12(c)(2)(ii) that notice of the decision to acquire land in trust be promptly provided in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Bryan Newland,</NAME>
                    <TITLE>Assistant Secretary—Indian Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00761 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4337-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Indian Affairs</SUBAGY>
                <DEPDOC>[256A2100DD/AAKC001030/A0A501010.999900]</DEPDOC>
                <SUBJECT>Indian Gaming; Approval of the Fifth Amendment to the Tribal-State Class III Gaming Compact Amendment Between Stillaguamish Tribe of Indians of Washington and the State of Washington</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Indian Affairs, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Assistant Secretary for Indian Affairs approves the fifth amendment to the Tribal-State compact for class III gaming between the Stillaguamish Tribe of Indians of Washington and the State of Washington governing the operation and regulation of class III gaming activities. The amendment allows for the operation of electronic table games and removes provisions related to revenue sharing for smoking cessation purposes.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The amendment takes effect on January 15, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, 
                        <E T="03">IndianGaming@bia.gov;</E>
                         (202) 219-4066.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Indian Gaming Regulatory Act of 1988, 25 U.S.C. 2701 
                    <E T="03">et seq.,</E>
                     (IGRA) provides the Secretary of the Interior (Secretary) with 45 days to review and approve or disapprove the Tribal-State compact governing the conduct of class III gaming activity on the Tribe's Indian lands. 
                    <E T="03">See</E>
                     25 U.S.C. 2710(d)(8). If the Secretary does not approve or disapprove a Tribal-State compact within the 45 days, IGRA provides the Tribal-State compact is considered to have been approved by the Secretary, but only to the extent the compact is consistent with IGRA. 
                    <E T="03">See</E>
                     25 U.S.C. 2710(d)(8)(D). The IGRA also requires the Secretary to publish in the 
                    <E T="04">Federal Register</E>
                     notice of the approved Tribal-State compacts for the purpose of engaging in class III gaming activities on Indian lands. 
                    <E T="03">See</E>
                     25 U.S.C. (d)(8)(D). As required by 25 CFR 293.4, all compacts and amendments are subject to review and approval by the Secretary. The Amendment changes the scope of gaming to include electronic table games and creates regulations for those games. The Amendment is approved.
                </P>
                <SIG>
                    <NAME>Bryan Newland,</NAME>
                    <TITLE>Assistant Secretary—Indian Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00772 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4337-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <DEPDOC>[MO 4500183156]</DEPDOC>
                <SUBJECT>Notice of Adoption of Categorical Exclusions Under Section 109 of the National Environmental Policy Act</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Secretary, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of the Interior is notifying the public and documenting the adoption of two U.S. Forest Service, one National Park Service, and three U.S. Fish and Wildlife Service categorical exclusions (CXs) by the Bureau of Land Management (BLM), under section 109 of the National Environmental Policy Act (NEPA). In accordance with section 109, this notice identifies the types of actions to which the BLM will apply the CXs, the considerations that the BLM will use in determining the applicability of the CXs, and the consultation between the agencies on the use of the CXs, including application of extraordinary circumstances.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The adoption is effective January 15, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Amelia Savage, Senior Planning and Environmental Analyst, Division of Support, Planning and NEPA, 
                        <E T="03">alsavage@blm.gov,</E>
                         telephone (480) 307-8665.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <HD SOURCE="HD2">Program Backgrounds</HD>
                <HD SOURCE="HD3">1. Visitor Use</HD>
                <P>The Federal Land Policy and Management Act (FLPMA) (43 U.S.C. 1701-1787) establishes the BLM's multiple use and sustained yield mandate. In managing the public lands in accordance with FLPMA, the BLM occasionally issues temporary closure and restriction orders under 43 CFR 8364.1 to protect persons, property, public lands, and resources. The need to temporarily close or restrict the use of public land arises in various situations, for example where a recreation site requires routine maintenance or where construction or heavy visitor use is causing erosion or the creation of unauthorized trails, or when an unforeseen event warrants agency action. As resource uses and demands for access to public lands have increased, the need for the BLM to issue temporary closure and restriction orders to protect persons, property, and the public lands and their resources has also increased.</P>
                <HD SOURCE="HD3">2. Aquatic Resources</HD>
                <P>
                    Riparian and wetland areas, lakes, streams, and aquifers on public lands managed by the BLM are among the most important, productive, and diverse resources in the Nation, providing sustained value to the American public. They provide habitat for myriad species of plants, fish, and wildlife; provide ecosystem services such as drinking water, pollination, and nutrient cycling; attenuate effects of wildfires, floods, and drought; and are key to the vitality of local economies and communities. BLM-managed lands include approximately 4,600 square miles of lakes and reservoirs, over 155,000 miles of streams and rivers, and over 20,000 square miles of wetlands and riparian areas. The BLM Aquatic Resources Program protects and restores water 
                    <PRTPAGE P="3909"/>
                    resources, riparian and wetland areas, and aquatic habitats to provide functioning ecosystems for a combination of balanced and diverse uses, including fish and wildlife and the long-term needs of future generations. The Aquatic Resources Program restores the physical and ecological processes associated with healthy ecosystems to ensure that public land management based on multiple use and sustained yield principles provides healthy and productive habitat for fish and wildlife.
                </P>
                <HD SOURCE="HD3">3. Land Acquisitions</HD>
                <P>The BLM may purchase or acquire land and interests in land from a willing seller (including access easements, conservation easements, mineral or water rights) if funding is available, acquisition is supported in a land use plan, and there are no title defects, hazardous materials, or other local issues that might limit such acquisition. Acquiring land through purchase can enhance recreation opportunities, preserve open space, strengthen resource protection, and provide an alternative for transferring ownership to the BLM when a land exchange or other options are not available. The BLM may accept donations of land as a gift to the United States if the lands are contiguous to, and “block-up” with, existing public lands.</P>
                <HD SOURCE="HD3">4. Rights-of-Way</HD>
                <P>The BLM Realty Program processes applications for rights-of-way or other land use authorizations for specific use of parcels of public land for a specified period that facilitate commercial, non-commercial, recreational, and conservation activities to ensure that the public lands are working landscapes managed for the use and enjoyment of current and future generations, including for communication sites, transmission lines, fiber optic infrastructure, and renewable energy. The BLM has discretion to grant rights-of-way when doing so is in the public interest.</P>
                <HD SOURCE="HD2">National Environmental Policy Act and Categorical Exclusions</HD>
                <P>NEPA as amended, at 42 U.S.C. 4321-4347, requires all Federal agencies to consider the environmental impact of their proposed actions before deciding whether and how to proceed. 42 U.S.C. 4321, 4332. NEPA's aims are to ensure agencies consider the environmental effects of their proposed actions in their decision-making processes and inform and involve the public in that process. 42 U.S.C. 4331. NEPA created the Council on Environmental Quality (CEQ), which promulgated NEPA implementing regulations, 40 CFR parts 1500 through 1508 (CEQ regulations).</P>
                <P>Under NEPA and the CEQ's NEPA implementing regulations, a Federal agency establishes categorical exclusions (CX)s—categories of actions that normally do not have a significant effect on the human environment, individually or in the aggregate, and therefore do not require preparation of an environmental assessment (EA) or an environmental impact statement (EIS)—in their agency NEPA procedures. 42 U.S.C. 4336e(1); 40 CFR 1501.4, 1507.3, 1508.1(e). If an agency determines that a CX covers a proposed action, it then evaluates the proposed action for extraordinary circumstances in which a normally excluded action may have a significant effect. 40 CFR 1501.4(b); 43 CFR 46.205(c). If no extraordinary circumstances are present or if further analysis determines that the extraordinary circumstances do not involve the potential for significant environmental impacts, the agency may apply the CX to the proposed action without preparing an EA or EIS. 42 U.S.C. 4336(a)(2), 40 CFR 1501.4.</P>
                <P>Section 109 of NEPA, enacted as part of the Fiscal Responsibility Act of 2023, allows a Federal agency to adopt another agency's CX for a category of proposed agency actions. 42 U.S.C. 4336c. To rely on another agency's CX under Section 109, the adopting agency must identify the relevant CX listed in another agency's (“establishing agency”) NEPA procedures that cover the adopting agency's category of proposed actions or related actions; consult with the establishing agency to ensure that the proposed adoption of the CX for a category of actions is appropriate; identify to the public the CX that the adopting agency plans to use for its proposed actions; and document adoption of the CX. 42 U.S.C. 4336c. The BLM has prepared this notice to describe how it has met applicable statutory requirements for the adoption of six CXs, 36 CFR 220.6(e)(7), 36 CFR 220.6(e)(18), 516 DM 8.5 (A)4, 516 DM 8.5 (B)3, 516 DM 8.5 (C)4 and 516 DM 12.5 (D)2, and to notify the public.  </P>
                <P>The Department of the Interior (Department)'s NEPA procedures are codified at 43 CFR part 46. These procedures address compliance with NEPA. The Department's protocol for application of CXs is at 43 CFR 46.205. The Department's CXs available to all bureaus within the Department are listed in 43 CFR 46.210. Additional Department-wide NEPA policy is found in the Department's Departmental Manual (DM), in chapters 1 through 4 of part 516. Supplementary NEPA procedures for the Department's bureaus are published in additional chapters in part 516 of the DM. Chapter 11 of the 516 DM covers the BLM's NEPA procedures and the BLM CXs are listed in 516 DM 11.9.</P>
                <HD SOURCE="HD1">Categorical Exclusions That Are Adopted</HD>
                <P>The BLM has identified the U.S. Forest Service (USFS) CX, found at 36 CFR 220.6(e)(7) regarding modification or maintenance of stream or lake aquatic habitat improvement structures using native materials or normal practices for adoption. The BLM will rely on this CX to approve projects that modify or maintain existing habitat improvement structures to restore streams or lake aquatic habitat. Examples of BLM's intended uses include those described in the USFS CX, and are also inclusive of, but are not limited to, modifying or maintaining existing habitat improvement structures that mimic or promote natural processes using natural materials, and modifying or maintaining fish screens. Consistent with the terms of the CX, the BLM will not rely on this CX to support approval of projects that include installation of new structures or improvements where no structure or improvement has been installed before.</P>
                <P>The BLM has identified the USFS CX, found at 36 CFR 220.6(e)(18), regarding restoring wetlands, streams, riparian areas or other water bodies, for adoption. The BLM intends to rely on this CX for projects that remove, replace, or modify existing water control structures to restore streams or other water bodies; wetlands, including wet meadows; and riparian areas to improve water quality, habitat for native species, and overall ecosystem function, and to remove barriers to habitat connectivity. Examples of BLM's intended uses include those described in the USFS CX, and are also inclusive of, but not limited to, removing, replacing, repairing, or modifying existing structures—such as fish screens, legacy rip-rap, and protective enclosures—with wildlife-friendly fencing. Consistent with the terms of the CX, the BLM will not rely on this CX to support approval of projects that include installation of new structures or improvements where no structure or improvement has been installed before.</P>
                <P>
                    Per 36 CFR 220.6(e), the USFS, when relying on these CXs, develops a supporting record and a decision memo. Under CEQ NEPA regulations, at 40 CFR 1501.4(e)(5), agencies publish documentation of the application of an adopted CX. Therefore, the documentation the BLM develops for each reliance on this adopted CX will be similar to USFS documentation, and the 
                    <PRTPAGE P="3910"/>
                    BLM will publish the documentation on its publicly available National NEPA Register (
                    <E T="03">https://eplanning.blm.gov/eplanning-ui/home</E>
                    ).
                </P>
                <P>
                    The BLM has identified the U.S. Fish and Wildlife Service (FWS) CX, found at 516 DM 8.5 (A)4, regarding acquisition of real property obtained either through discretionary acts or when acquired by law, whether by way of condemnation, donation, escheat, right-of-entry, escrow, exchange, lapses, purchase, or transfer, that will be under the jurisdiction or control of the United States, for adoption. Examples of how the BLM would rely on this CX include, but are not limited to, acquisition of lands from a willing seller through exchange, sale, escheat, right-of-entry, escrow, lapses, donation of access easements, conservation easements, mineral or water rights under the exchange provisions of Section 206 of the FLPMA, or through acquisition under FLPMA Section 205 as allowable under a land use plan. This includes acquisitions consistent with the Uniform Relocation Act, the Land and Water Conservation Fund Act, and the Federal Land Transaction Facilitation Act. The CX language requires that acquisitions be in accordance with 602 DM 2 and the Service's procedures. As the BLM and FWS are bureaus within the Department, both are required to follow the process set forth in Departmental policy at 602 DM 2, 
                    <E T="03">Real Property Pre-Acquisition Environmental Sites Assessments.</E>
                     FWS-specific policy and procedures are found in the FWS Manual (
                    <E T="03">www.fws.gov/policy-library/manuals</E>
                    ). The BLM evaluated FWS's real property management and land acquisition procedures found in parts 340 through 343 and compared them to BLM Acquisition Handbook (H-2100-1). These policies outline how each agency is required to complete the acquisition processes, including, appraisals, survey property boundaries, and title curative and conveyance actions. While the FWS's land acquisition procedures incorporate FWS-specific land acquisition authorities, the policies and procedures are similar to those of the BLM.
                </P>
                <P>The BLM has identified FWS CX, found at 516 DM 8.5(B)3, regarding the construction of new, or the addition of, small structures or improvements, including structures and improvements for the restoration of wetland, riparian, instream, or native habitats, for adoption. The BLM intends to rely on this CX to approve projects that construct new, or add to, small structures or improvements to restore streams or other water bodies, wetlands, including wet meadows, riparian areas, and native habitats. Examples of the BLM's intended uses include those examples described in the FWS CX, and are also inclusive of, but are not limited to, installation of small permeable structures that mimic, promote, and sustain natural processes; installation of wildlife friendly fences, including drift fences and protective enclosures; development of limited access for routine maintenance of habitat structures and improvements; and habitat restoration for both terrestrial and aquatic habitats.</P>
                <P>The BLM has identified FWS CX, found at 516 DM 8.5(C)4, regarding the issuance or reissuance of permits for limited additional use of an existing right-of-way for underground or above ground power, telephone, or pipelines, for adoption. The BLM intends to use this CX for the realty program, primarily to support “permitting a new right-of-way, where no or negligible environmental disturbances are anticipated.” Examples include, but are not limited to, installation of single power poles, authorizing a right-of-way for existing roads without existing rights-of-way, installation of fiber optic cable on existing structures, and authorizing development of a domestic water source with negligible environmental disturbances.</P>
                <P>The BLM has identified the National Park Service (NPS) CX, found at 516 DM 12.5(D)2, regarding minor changes in amounts or types of visitor use for the purpose of ensuring visitor safety or resource protection, for adoption. The BLM intends to use this CX to support approval of temporary closures or restrictions on the use of designated public lands, including roads, trails, waterways or specific areas; to protect persons, property, public lands, or resources; and avoid conflict among public land users.</P>
                <HD SOURCE="HD1">Consultation With USFS, FWS, and NPS and Determination of Appropriateness</HD>
                <P>The BLM consulted with USFS, FWS, and NPS on the appropriateness of the adoption of these CXs for BLM's use in April 2024, October 2024, and October 2024, respectively. The consultation included a review of USFS, FWS, and NPS experience developing and applying the CXs, as well as the types of actions for which the BLM plans to utilize the CXs. The BLM actions are similar in type and scope to the actions that the USFS, FWS, and NPS conduct and therefore the effects of BLM's actions are expected to be similar to the effects of USFS, FWS, and NPS actions, which are not significant, absent the presence of extraordinary circumstances that could involve potentially significant effects. Therefore, the Department has determined that adoption of the CXs for the BLM's use as described in this notice is appropriate.</P>
                <HD SOURCE="HD1">Consideration of Extraordinary Circumstances</HD>
                <P>
                    In consultation with the USFS, FWS, and NPS, the BLM evaluated the extraordinary circumstances to be considered when applying these CXs. When applying these CXs, Responsible Officials (43 CFR 46.30) within the BLM will evaluate proposed actions covered by the CXs to determine whether any extraordinary circumstances are present. The Department's extraordinary circumstances are listed at 43 CFR 46.215 and include, in part, consideration of impacts on public health and safety; natural resources and unique geographic characteristics; historic or cultural resources; park, recreation, or refuge lands; wilderness areas; wild or scenic rivers; national natural landmarks, sole or principal drinking water aquifers; prime farmlands; wetlands; floodplains; national monuments; migratory birds; other ecologically significant or critical areas; unresolved conflicts concerning alternative uses of available resources; unique or unknown environmental risks; precedent for future decision-making; historic properties; listed species or critical habitat; low income or minority populations; access by Indian religious practitioners to, and for ceremonial use of, Indian sacred sites and the physical integrity of those sites; and contribution to the introduction, continued existence, or spread of invasive weeds or non-native invasive species. The Department's list of extraordinary circumstances addresses issues also identified by the USFS and found at 36 CFR 220.6; therefore, Responsible Officials in the BLM intending to rely on these CXs will review whether the proposed action has the potential to result in significant effects as described in the Department's extraordinary circumstances. Since the BLM, FWS, and NPS are bureaus within the Department, the same extraordinary circumstances are used for all three bureaus. The Responsible Official will assess whether an extraordinary circumstance is present. If the Responsible Official cannot rely on a CX to support a decision to authorize or take a particular proposed action due to extraordinary circumstances, the proposed action must be analyzed in an EA or EIS before doing so, consistent with 40 CFR 1501.4(b)(2) and 43 CFR 46.205(c).
                    <PRTPAGE P="3911"/>
                </P>
                <HD SOURCE="HD1">Notice to the Public and Documentation of Adoption</HD>
                <P>
                    This notice identifies to the public the BLM's adoption of the USFS, FWS, and NPS CXs for the BLM's use. The notice identifies the types of actions to which the BLM would apply the CXs. The documentation of the adoption will also be available at 
                    <E T="03">http://www.blm.gov/programs/planning-and-nepa/what-informs-our-plans/nepa</E>
                     and at 
                    <E T="03">https://www.doi.gov/oepc/nepa/categorical-exclusions.</E>
                     The BLM will add the adopted CXs to the BLM's NEPA DM Chapter in 516 DM 11.
                </P>
                <HD SOURCE="HD1">Authorities</HD>
                <P>
                    National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Stephen G. Tryon,</NAME>
                    <TITLE>Director, Office of Environmental Policy and Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00452 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-27-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[PO #4820000251; NVNV106696478]</DEPDOC>
                <SUBJECT>Proposed Withdrawal and Opportunity for Public Meeting for the Sloan Utility and Transportation Corridor; Clark County, NV</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed withdrawal.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>At the request of the Bureau of Land Management (BLM), the Secretary of the Interior proposes to withdraw approximately 1,043.57 acres of public lands located in Clark County, Nevada, from location and entry under the United States mining laws and from leasing under the mineral and geothermal leasing laws, but not from the disposal of mineral materials under the mineral materials disposal laws, for 20 years, subject to valid existing rights. The purpose of the proposed withdrawal is to establish protection for a utility and transportation corridor to facilitate the orderly development of future infrastructure and public services while preventing conflicting land uses. Publication of this notice segregates these lands for up to 2 years from location and entry under the United States mining laws and from leasing under the mineral and geothermal leasing laws, but not from the disposal of mineral materials under the mineral materials disposal laws, subject to valid existing rights. This notice initiates a 90-day public comment period and announces an opportunity to request a public meeting.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments and requests for a public meeting must be received by April 15, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        All comments should be sent to the BLM, Las Vegas Field Office, Attn: Proposed Sloan Utility and Transportation Corridor Withdrawal, 4701 N Torrey Pines Dr., Las Vegas, NV 89130, or via email at 
                        <E T="03">blm_nv_lvfo_landtenureteam@blm.gov.</E>
                         The BLM will not consider comments submitted via telephone calls.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Eric Benavides, Realty Specialist, BLM Las Vegas Field Office, at (702) 515-5144, email: 
                        <E T="03">ebenavides@blm.gov.</E>
                         Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or Tele Braille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The purpose of the proposed withdrawal is to support the development of future infrastructure projects and public services by ensuring the land in the designated utility and transportation corridor remains available for these uses and by preventing activities or land uses that could interfere with or hinder such developments. The proposed withdrawal would allow for the disposal of mineral resources through lease, license, or permit if excess mineral materials are generated during development activities.</P>
                <P>The BLM filed a petition/application requesting that the Secretary withdraw the following described public lands located in Clark County, Nevada, for a 20-year term:</P>
                <EXTRACT>
                    <HD SOURCE="HD1">Federal Lands</HD>
                    <HD SOURCE="HD2">Mount Diablo Meridian, Nevada</HD>
                    <FP SOURCE="FP-2">T. 23 S., R. 60 E.,</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 24, SW
                        <FR>1/4</FR>
                        NE
                        <FR>1/4</FR>
                        NE
                        <FR>1/4</FR>
                        , S
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        NE
                        <FR>1/4</FR>
                        , S
                        <FR>1/2</FR>
                        NE
                        <FR>1/4</FR>
                        , S
                        <FR>1/2</FR>
                        NE
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        , NW
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        , S
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        , and S
                        <FR>1/2</FR>
                        ;
                    </FP>
                    <FP SOURCE="FP1-2">
                        Sec. 25, N
                        <FR>1/2</FR>
                        .
                    </FP>
                    <FP SOURCE="FP-2">T. 23 S., R. 61 E.,</FP>
                    <FP SOURCE="FP1-2">Sec. 19, lots 9 thru 13, and 15 thru 19;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 30, lots 6 thru 10, NE
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        , N
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        , NE
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        , and N
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        , those portions lying northwesterly of the westerly right-of-way of U.S. Highway 15.
                    </FP>
                    <P>The area described contains 1,015 acres, more or less, according to the BLM National PLSS CadNSDI, and the official plats of the surveys of the said land, on file with the BLM.</P>
                    <HD SOURCE="HD1">Non-Federal Surface Federal Mineral</HD>
                    <HD SOURCE="HD2">Mount Diablo Meridian, Nevada</HD>
                    <FP SOURCE="FP-2">T. 23 S., R. 61 E.,</FP>
                    <FP SOURCE="FP1-2">Sec. 19, lots 14 and 20;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 30, lot 5, NE
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        , and S
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        .
                    </FP>
                    <P>The area described contains 28.57 acres, according to the official plats of the surveys of the said land, on file with the BLM.</P>
                    <P>The total areas described, including both Federal and non-Federal surface/Federal mineral lands, aggregate approximately 1,043.57 acres, more or less.</P>
                </EXTRACT>
                <P>The Secretary of the Interior approved the BLM's petition. Therefore, the petition/application constitutes a withdrawal proposal by the Secretary of the Interior (43 CFR 2310.1-3(e)).</P>
                <P>The use of a right-of-way, interagency, or cooperative agreement would not provide adequate protection for the area.</P>
                <P>No additional water rights would be needed to fulfill the purpose of this proposed withdrawal.</P>
                <P>Neither a right-of-way nor a cooperative agreement would adequately provide for the proposed uses because this area is a designated transportation corridor specifically established for compatible rights-of-way and the purpose of the withdrawal is to protect this corridor from conflicting uses. Relocating the proposed withdrawal outside this corridor would fail to realize its intended purpose of consolidating infrastructure to minimize environmental impacts and supporting the orderly development of future infrastructure projects and public services.</P>
                <P>Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>
                    Notice is hereby given that an opportunity for a public meeting is afforded in connection with the withdrawal proposal. All interested persons who desire a public meeting for the purpose of being heard on the proposed withdrawal must submit a written request to the BLM Nevada State Director at the BLM address listed above no later than April 15, 2025. If the authorized officer determines that a public meeting will be held, a notice of the time, date, and location will be published in the 
                    <E T="04">Federal Register</E>
                     and a local newspaper at least 30 days before the scheduled date of the meeting.
                    <PRTPAGE P="3912"/>
                </P>
                <P>For a period until January 15, 2027, the public lands described earlier will be segregated from location and entry under the United States mining laws and from leasing under the mineral and geothermal leasing laws, but not from the disposal of mineral materials under the mineral materials disposal laws, subject to valid existing rights, unless the application is denied or canceled, or the withdrawal is approved prior to that date. Licenses, permits, cooperative agreements, or discretionary land use authorizations of a temporary nature may be allowed on a case-by-case basis during the temporary segregation period if they would comply with the applicable BLM land use plans for the described public lands located within the boundary of the proposed withdrawal.</P>
                <P>This application will be processed in accordance with the regulations set forth in 43 CFR part 2300.</P>
                <EXTRACT>
                    <FP>(Authority: 43 U.S.C. 1714)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Kimberly Prill,</NAME>
                    <TITLE>Acting State Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00814 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-21-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[PO #4820000251]</DEPDOC>
                <SUBJECT>BLM Director's Response to the Appeals by the Governors of California and Utah of the BLM State Director's Governor's Consistency Review Determination for Utility-Scale Solar Energy Development Resource Management Plan Amendments, Also Known as the Updated Western Solar Plan</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of response.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Bureau of Land Management (BLM) is publishing this notice of the reasons for the BLM Principal Deputy Director's determination to reject the recommendations of the Governors of California and Utah regarding the Utility-Scale Solar Energy Development Resource Management Plan Amendments (RMPAs).</P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        A copy of the Record of Decision (ROD) and RMPAs for Utility-Scale Solar Energy Development are available on the BLM website at: 
                        <E T="03">https://eplanning.blm.gov/public_projects/2022371/200538533/20125356/251025336/Solar%20PEIS%20ROD_Vol%201_Final%2012.19.2024.pdf.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Heather Bernier, Division Chief for Decision Support, Planning, and National Environmental Policy Act; telephone 303-239-3635; address P.O. Box 151029, Lakewood, CO 80215; email 
                        <E T="03">hbernier@blm.gov.</E>
                         Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services for contacting Ms. Bernier. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>On August 30, 2024, the BLM released the Final Programmatic Environmental Impact Statement (PEIS) and Proposed Resource Management Plan Amendments (RMPAs) for Utility-Scale Solar Energy Development (89 FR 70660). In accordance with the regulations at 43 CFR 1610.3-2(e), the BLM submitted the Proposed RMPAs for Utility-Scale Solar Energy Development to the Governors of Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, and Wyoming for a 60-day review to identify any inconsistencies with State or local plans, policies, or programs.</P>
                <P>The Governors of California, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, and Wyoming submitted a response regarding the Proposed RMPAs for Utility-Scale Solar Energy Development to the relevant BLM State Directors. After careful consideration of the concerns raised by the Governors, the relevant State Directors decided not to adopt the recommendations made by the Governors and sent a written response to each respective Governor.</P>
                <P>The applicable regulations at 43 CFR 1610.3-2(e) provide these Governors with the opportunity to appeal the State Director's decision to not accept the recommendations made in the respective consistency review letters. The Governors of California and Utah appealed the respective State Director's decisions to the BLM Director. In reviewing these appeals, the regulations at 43 CFR 1610.3-2(e) state that “[t]he Director shall accept the [consistency] recommendations of the Governor(s) if he/she determines they provide for a reasonable balance between the national interest and the State's interest.”</P>
                <P>On December 19, 2024, the BLM Principal Deputy Director issued a response to each Governor detailing the reasons that the recommendations did not meet this standard. Each appeal response letter provides the basis for the BLM's determination on the respective Governor's appeal (pursuant to 43 CFR 1610.3-2(e)). The appeal responses are being published verbatim.</P>
                <HD SOURCE="HD1">California</HD>
                <P>On August 30, 2024, the Bureau of Land Management (BLM) released the Final Programmatic Environmental Impact Statement and Proposed Resource Management Plan Amendments (RMPA) for Utility-Scale Solar Energy Development. In accordance with the regulations at 43 CFR 1610.3-2(e), the BLM submitted the Proposed RMPAs for Utility-Scale Solar Energy Development to the Governors of Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, and Wyoming for a 60-day review to identify any inconsistencies with State or local plans, policies, or programs.</P>
                <P>A representative from the California Governor's Office of Land Use and Climate Innovation submitted a response regarding the Proposed RMPAs for Utility-Scale Solar Energy Development to the BLM California State Director. After careful consideration of the concerns you raised, the BLM California State Director Joseph Stout decided not to adopt the recommendations you made and sent you a written response detailing why.</P>
                <P>The applicable regulations at 43 CFR 161-3-2(e) provide you with the opportunity to appeal the State Director's decision to not accept the recommendations you made in your consistency review letter. These regulations also guide my review of the appeal, in which I must consider whether you have raised actual inconsistencies with State or local plans, polices, and or programs. To the extent inconsistencies are raised, I then consider whether your recommendations address the inconsistencies and provide for a reasonable balance between the national interest and your State's interest. In reviewing your appeal, the regulations at 43 CFR 1610.3-2(e) state that “[t]he Director shall accept the [consistency] recommendations of the Governor(s) if he/she determines they provide for a reasonable balance between the national interest and the State's interest.”</P>
                <P>
                    This letter addresses your appeal of the response provided by the BLM California State Director regarding your consistency review of the Proposed RMPAs for Utility-Scale Solar Energy Development. The Governor's consistency review is an important part of the BLM land use planning process, and we appreciate the significant time 
                    <PRTPAGE P="3913"/>
                    and attention that you and your staff have committed to this effort.
                </P>
                <P>I have completed my review of your appeal and determined that the recommendations you have provided do not meet the standard described above for the following reasons.</P>
                <P>In your appeal, you raise a concern that the reduction in public land available for solar development in southern Nevada will reduce the potential for solar generation and transmission development that the State of California has planned on to meet its energy needs. You suggest that if the BLM approves the proposed RMPAs, certain transmission upgrades may become stranded assets and the California Public Utilities Commission (CPUC) would need to update its assumptions about administration of public lands in the area because the CPUC's integrated resource planning process has traditionally assumed the availability of land in southern Nevada consistent with the BLM's 2012 Western Solar Plan. You recommend that BLM reconsider the exclusion criterion for habitat for species protected under the Endangered Species Act, which applies in some areas in southern Nevada.</P>
                <P>Although the BLM California State Director responded to the concerns in your consistency letter to clarify aspects of the proposed RMPAs, I find that you have not identified a specific inconsistency with an approved or adopted State or local plan, policy, or program. While you express concern that the proposed RMPAs could harm solar development, you do not identify specific elements of State plans or policies that conflict with the proposed RMPAs and potential effects are speculative. To the extent you are concerned about the continued viability of solar projects that are already under construction or where applications are under review by the BLM, the proposed RMPAs include provisions designed to reduce disruption during the transition between plans by limiting the effect of the proposed RMPAs on some pending applications. Therefore, the potential impact of the proposed RMPAs on California's energy planning process is speculative, and the present appeal does not identify a specific inconsistency.</P>
                <P>In your appeal you recommend that the BLM remove the exclusion for certain habitat for species protected under the Endangered Species Act from the proposed RMPAs, at least as it applies in southern Nevada. You recommend that the BLM instead protect habitat through the consultation process under Section 7 of the Endangered Species Act on an individual project basis. While you did not make this recommendation in your original consistency letter, the BLM State Director's response explained the BLM's rationale for the habitat exclusion. The BLM conducted programmatic consultations with the U.S. Fish and Wildlife Service and National Marine Fisheries Service to evaluate the potential impacts of the proposed RMPAs on species protected under the Endangered Species Act, and the habitat exclusion areas were developed as part of that consultation. The BLM agrees that Section 7 consultation will be required on a project-specific basis, but there is a Federal interest—and obligation under the Endangered Species Act—to consider impacts to species at the planning level. I find that eliminating the habitat exclusion in southern Nevada is not a reasonable balance of the national interest in protecting species habitat and the State's interest in facilitating solar projects. Exclusion based on the criteria identified in the proposed RMPAs promotes balance between renewable energy development and protection of important ecological, cultural, and other resources in accordance with the Federal Land Policy and Management Act's direction to manage the public lands under principles of multiple use and sustained yield.</P>
                <P>I have found that no changes to the proposed updated Western Solar Plan are necessary in response to your appeal as it does not identify inconsistencies with any approved or adopted State or local plans, policies, or programs and does not provide for a reasonable balance between the State's interest and the national interest (43 CFR 1610.3-2(e)).</P>
                <HD SOURCE="HD1">Utah</HD>
                <P>On August 30, 2024, the Bureau of Land Management (BLM) released the Final Programmatic Environmental Impact Statement and Proposed Resource Management Plan Amendments (RMPA) for Utility-Scale Solar Energy Development. In accordance with the regulations at 43 CFR 1610.3-2(e), the BLM submitted the Proposed RMPAs for Utility-Scale Solar Energy Development to the Governors of Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, and Wyoming for a 60-day review to identify and inconsistencies with State or local plans, polices, or programs.</P>
                <P>You submitted a response regarding the Proposed RMPAs for Utility-Scale Solar Energy Development to the BLM Utah State Director. After careful consideration of the concerns you raised, the BLM Acting Utah State Director Matthew Preston decided not to adopt the recommendations you made and sent you a written response detailing why.</P>
                <P>The applicable regulations at 43 CFR 1610.3-2(e) provide you with the opportunity to appeal the State Director's decision to not accept the recommendations you made in your consistency review letter. These regulations also guide my review of the appeal, in which I must consider whether you have raised actual inconsistencies with State or local plans, policies, and or programs. To the extent inconsistencies are raised, I then consider whether your recommendations address the inconsistencies and provide for a reasonable balance between the national interest and your State's interest. In reviewing your appeal, the regulations at 43 CFR 161-.3-2(e) state the “[t]he Director shall accept the [consistency] recommendations of the Governor(s) if he/she determines they provide for a reasonable balance between the national interest and the State's interest.”</P>
                <P>This letter addresses your appeal of the response provided by the BLM Acting Utah State Director regarding your consistency review of the Proposed RMPAs for Utility-Scale Solar Energy Development. The Governor's consistency review is an important part of the BLM land use planning process, and we appreciate the significant time and attention that you and your staff have committed to this effort.</P>
                <P>I have completed my review of your appeal and determined that the recommendations you have provided do not meet the standards described above for the following reasons.</P>
                <P>In your appeal, you identify the following three issues: (1) the potential for conflicts between solar and geothermal energy development; (2) concern about the extent of available areas relative to the BLM's reasonably foreseeable development scenario; and (3) alleged conflicts between solar energy development and the treatment of livestock grazing under Utah's and Beaver County's Resource Management Plans. To address these issues and alleged inconsistencies, it is your recommendation that the BLM withdraw and reconsider the proposed updated Western Solar Plan.</P>
                <HD SOURCE="HD2">Potential Conflicts Between Solar and Geothermal Energy Development</HD>
                <P>
                    I have considered your concerns about potential conflicts between solar and geothermal energy development but find that you have not identified an inconsistency with any approved or 
                    <PRTPAGE P="3914"/>
                    adopted State or local plan, policy, or program. You explain in your appeal that the Utah Energy Policy emphasizes a diverse energy portfolio. The proposed updated Western Solar Plan appropriately balances the potential for development from both solar and geothermal sources of energy. First of all, where a current geothermal lease already exists, no solar right-of-way (ROW) may be issued that would interfere with the grantee's use of the public lands consistent with the terms and conditions of the geothermal lease. Where a solar project is proposed in an area with geothermal potential but no existing ROW, the BLM will assess the best use of the land subject to the proposal. In evaluating solar project applications, the BLM will consider and address the impacts of utility-scale solar development on the ability to exploit geothermal resources. I decline to adopt your recommendation that the BLM include a separate planning-level exclusion of lands with potential geothermal resources in the proposed RMPAs because it does not address an identified inconsistency with a Utah plan, and it is not prudent or necessary in light of the presence of further review at the implementation stage.
                </P>
                <HD SOURCE="HD2">Extent of Lands Available</HD>
                <P>I have considered your concerns about the extent of lands available under the proposed updated Western Solar Plan but find that you have not identified an inconsistency with any approved or adopted State or local plan, policy, or program. Further, the BLM is proposing to identify an appropriate number of acres of public lands as available, both in Utah and the broader planning area for this effort. It is true that the scope of available areas goes well beyond the acreage that the BLM anticipates will be developed in fact based on the reasonably foreseeable development scenario (RFDS), but that approach to land allocation and management is appropriate. The proposed updated Western Solar Plan identifies over 5 million acres in Utah as available for future solar projects, whereas the RFDS estimates that slightly less than 40,000 acres of development is expected to occur in Utah by 2045. It is appropriate for broad-scale planning efforts to make orders-of-magnitude more lands available for a given use than the RFDS estimates would be put to that use. Complexity and controversy involved in navigating technical challenges, environmental concerns, community interests, and other potential uncertainties involved in the deliberative permitting process make that approach prudent. Making significantly more acres available than the BLM estimates will be developed will help to ensure solar projects are not only sited for feasibility and legal compliance but also in a way that is environmentally responsible and works for local communities. The fact that more lands are allocated as available than the RFDS suggests will be developed in fact does not represent an inconsistency with the Utah plans identified in your appeal, and I therefore decline to adopt your recommendation to make the proposed RMPAs commensurate with the RFDS.</P>
                <HD SOURCE="HD2">Alleged Inconsistency With Treatment of Livestock Grazing Under State and County Plans</HD>
                <P>The proposed updated Western Solar Plan appropriately balances use of the public lands for solar energy development and use of the public lands for livestock grazing, in keeping with the BLM's obligation to manage the public lands under principles of multiple use and sustained yield. As your appeal recognizes, the proposed updated Western Solar Plan would not approve any solar project or result in the reduction of authorized unit months (AUM) associated with public land livestock grazing permits or leases in Utah. A future decision to issue a ROW for solar development within a grazing allotment would be subject to project-specific review and would need to comply with the applicable grazing regulations and the design features included as part of the proposed updated Western Solar Plan, including those, such as design feature LG-1, designed to minimize conflicts between solar development and grazing. To the extent that the potential for future reductions in AUMs resulting from solar ROW grants represents an inconsistency with the Utah or Beaver County Resource Management Plan, I considered your recommendation to add an exclusion criteria and additional design features related to livestock grazing. This recommendation does not provide for a reasonable balance between the national interest and the State's interest because the BLM has determined that the national interest in supporting use of public land for solar development is incompatible with an exclusion that would make all lands within grazing allotments unavailable.</P>
                <HD SOURCE="HD2">Conclusion</HD>
                <P>I have found that no changes to the proposed updated Western Solar Plan are necessary in response to the issues raised in your appeal as they either do not identify inconsistencies with any approved or adopted State or local plans, policies, or programs or do not provide for a reasonable balance between the State's interest and the national interest (43 CFR 1610.3-2(e)).</P>
                <SIG>
                    <NAME>Nada Wolff Culver,</NAME>
                    <TITLE>Principal Deputy Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00753 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-27-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[BLM_NV_FRN_MO4540000292; NVNV106391927]</DEPDOC>
                <SUBJECT>Proposed Withdrawal and Public Meeting for the Amargosa Valley, Nevada</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed withdrawal.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary of the Interior proposes to withdraw 308,890 acres of Federal lands located in Nye County, Nevada, from location and entry under the United States mining laws, and from leasing under the mineral and geothermal leasing laws, for 20 years, subject to valid existing rights. The area also includes approximately 40,000 acres, more or less, of non-Federal lands that would be subject to the withdrawal if they are subsequently acquired by the United States. The purpose of the proposed withdrawal is to protect the cultural, recreational, and biological resources of these lands. Publication of this notice temporarily segregates the lands for up to 2 years from location and entry under the United States mining laws and leasing under the mineral and geothermal leasing laws, subject to valid existing rights. The lands will remain open to disposal under the mineral materials laws. This notice initiates a 90-day public comment period and announces a public meeting on the proposed withdrawal, including input related to ongoing mining activities for sepiolite, saponite, and bentonite within the study area related to projected development of valid existing rights.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All Comments must be received by April 15, 2025.</P>
                    <P>The BLM will hold a Public Meeting on the withdrawal proposal on February 27, 2025, at 5:30 p.m. Pacific time at the Amargosa Community Center located at 1640 E. Amargosa Farm Road, Amargosa Valley, NV 89020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        All comments should be submitted to the BLM Pahrump Field Manager, Bureau of Land Management, Pahrump Field Office, Attn: Amargosa 
                        <PRTPAGE P="3915"/>
                        Withdrawal, 4701 North Torrey Pines Drive, Las Vegas, NV 89130, or via email at 
                        <E T="03">blm_nv_sndo_amargosa@blm.gov.</E>
                         The BLM will not consider comments via telephone calls.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Nicholas B. Pay, Field Manager, Pahrump Field Office at (702) 515-5042, or you may contact the BLM office at the address listed in the 
                        <E T="02">ADDRESSES</E>
                         section. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. You will receive a reply during normal business hours.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The purpose of the proposed withdrawal is to protect the cultural, recreational, and biological resources of the lands proposed for withdrawal. The proposed withdrawal includes the federal lands within the area described below in Nye County, Nevada:</P>
                <EXTRACT>
                    <HD SOURCE="HD1">Mount Diablo Meridian, Nevada</HD>
                    <FP SOURCE="FP-2">Tps. 14 thru 17 S., R. 48 E., partly unsurveyed, those portions lying southwesterly of the centerline of U.S. Highway No. 95.</FP>
                    <FP SOURCE="FP-2">Tps. 15 thru 18 S., Rs. 49 and 50 E., those portions lying southwesterly of the centerline of U.S. Highway No. 95.</FP>
                    <FP SOURCE="FP-2">T. 19 S., R. 50 E.</FP>
                    <FP SOURCE="FP-2">Tps. 15 thru 18 S., R. 51 E., partly unsurveyed, those portions lying southwesterly of the centerline of U.S. Highway No. 95.</FP>
                    <FP SOURCE="FP-2">T. 19 S., R. 51 E.,</FP>
                    <FP SOURCE="FP1-2">Secs. 1 thru 18.</FP>
                    <FP SOURCE="FP-2">T. 16 S., R. 52 E.,</FP>
                    <FP SOURCE="FP1-2">Secs. 7 thru 10, secs. 15 thru 22, and secs 27 thru 34, those portions lying southwesterly of the centerline of U.S. Highway No. 95.</FP>
                    <FP SOURCE="FP-2">T. 17 S., R. 52 E.,</FP>
                    <FP SOURCE="FP1-2">Secs. 3 thru 10, secs. 15 thru 22, and secs. 26 thru 35.</FP>
                    <FP SOURCE="FP-2">T. 18 S., R. 52 E.,</FP>
                    <FP SOURCE="FP1-2">Secs. 2 thru 10, secs 15 thru 21, and secs. 29 thru 32.</FP>
                    <FP SOURCE="FP-2">T. 19 S., R. 52 E.,</FP>
                    <FP SOURCE="FP1-2">Secs. 5 thru 8 and secs. 17 and 18.</FP>
                    <HD SOURCE="HD1">San Bernadino Meridian, Nevada</HD>
                    <FP SOURCE="FP-2">T. 25 N., R. 7 E.,</FP>
                    <FP SOURCE="FP1-2">Secs. 4, 5, and 6.</FP>
                    <FP SOURCE="FP-2">T. 26 N., R. 7 E.,</FP>
                    <FP SOURCE="FP1-2">Sec. 31.</FP>
                </EXTRACT>
                <P>The area described, including both Federal and non-Federal land, contains 308,890 acres, more or less, as derived from Bureau of Land Management GIS data. No part of this description shall be construed to impact surface rights to non-Federal land or existing valid claims to Federal subsurface mineral estate.</P>
                <P>Non-Federal lands included in the description above would be subject to the proposed withdrawal only if they are subsequently acquired by the United States.</P>
                <P>The Secretary of the Interior approved the BLM's petition. Therefore, the petition/application constitutes a withdrawal proposal of the Secretary of the Interior (43 CFR 2310.1-3(e)).</P>
                <P>The use of a right-of-way, interagency agreement, or cooperative agreement would not adequately constrain non-discretionary uses and would not provide adequate protection for the cultural, recreational, and biological resources in this area.</P>
                <P>No additional water rights would be needed to fulfill the purpose of the proposed withdrawal.</P>
                <P>There are no suitable alternative sites as the described lands contain the resource values to be protected.</P>
                <P>Records relating to the withdrawal proposal may be examined by contacting the BLM at the address and phone number provided above in this notice.</P>
                <P>
                    For a 90-day period from the date of publication of this notice in the 
                    <E T="04">Federal Register</E>
                    , all persons who wish to submit comments in connection with the proposed withdrawal may present their views in writing to the address or email above, including comments or input related to on-going mining activities for sepiolite, saponite, and bentonite within the proposed withdrawal area related to projected development of valid existing rights. Information regarding the proposed withdrawal will be available for public review at the BLM's Southern Nevada District Office, during regular business hours, 8:00 a.m. to 4:30 p.m. Monday through Friday, except federal holidays.
                </P>
                <P>Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. All submissions from organizations or businesses, and from individuals identifying themselves as representatives of officials of organizations or businesses, will be made available for public inspection in their entirety.</P>
                <P>Notice is hereby given that the BLM will hold a Public Meeting on February 27, 2025, at 5:30 p.m. Pacific time at the Amargosa Community Center located at 1640 East Amargosa Farm Road, Amargosa Valley, Nevada 89020.</P>
                <P>For a period until January 15, 2027, the Federal lands described in this notice will be segregated from location and entry under the United States mining laws and from leasing under the mineral or geothermal leasing laws, subject to valid existing rights, unless the application is denied or canceled, or the withdrawal is approved prior to that date.</P>
                <P>Licenses, permits, cooperative agreements, or discretionary land use authorizations of a temporary nature that will not significantly impact the values to be protected by the proposed withdrawal may be allowed with the approval of the authorized officer of the BLM during the temporary segregation period.</P>
                <P>The withdrawal proposal will be processed in accordance with the regulations set forth in 43 CFR 2300.</P>
                <EXTRACT>
                    <FP>(Authority: 43 U.S.C. 1714)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Jon K. Raby,</NAME>
                    <TITLE>State Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00700 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-21-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR </AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[PO #4820000251]</DEPDOC>
                <SUBJECT>Record of Decision and Approved Resource Management Plan for the North Dakota Resource Management Plan/Environmental Impact Statement, North Dakota</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) and Approved Resource Management Plan (RMP) for North Dakota. The Principal Deputy Assistant Secretary for Land and Minerals Management signed the ROD on January 8, 2025, which constitutes the decision of the BLM and makes the Approved RMP effective immediately.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Principal Deputy Assistant Secretary for Land and Minerals Management signed the ROD/Approved RMP on January 8, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The ROD/Approved RMP is available online at the BLM National Environmental Policy Act Register at 
                        <E T="03">https://eplanning.blm.gov/eplanning-ui/project/1505069/570.</E>
                         A printed copy of the ROD/Approved RMP will also be 
                        <PRTPAGE P="3916"/>
                        available for public inspection within weeks of publication of this notice at the following location: BLM North Dakota Field Office, 99 23rd Ave. West, Dickinson, ND 58601, telephone: (701) 227-7725. A limited number of printed copies will also be available upon request by contacting the BLM North Dakota Field Office listed above.
                    </P>
                    <P>
                        A copy of the Protest Resolution Report is available at: 
                        <E T="03">https://www.blm.gov/programs/planning-and-nepa/public-participation/protest-resolution-reports.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kristine Braun, North Dakota Field Office; telephone: (701) 227-7725, email: 
                        <E T="03">kebraun@blm.gov.</E>
                         Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Approved RMP replaces the 1988 North Dakota RMP as amended. The Approved RMP provides guidance for managing approximately 58,500 acres of BLM-administered surface and 4.1 million acres of BLM-administered mineral estate, mostly split estate, across North Dakota.</P>
                <P>The Approved RMP will guide management of these public lands for the next 15 to 20 years for the benefit of current and future generations as part of the BLM's multiple-use mission. This planning effort is updating management decisions for public land uses and resources, including mineral leasing and development.</P>
                <P>The North Dakota Proposed RMP/Final EIS evaluated four full alternatives and one sub-alternative for managing the planning area. Alternatives B (preferred alternative from the Draft RMP/EIS), B.1, C, and D were developed using input from the public, Tribes, stakeholders, and cooperating agencies. Alternative D is the BLM's Approved RMP. This alternative was developed after considering public comments on the Draft RMP/EIS, internal BLM discussions, government-to-government consultation, and cooperating agency input.</P>
                <P>
                    The Approved RMP designates one Area of Critical Environmental Concern, encompassing approximately 960 acres (see Appendix A of the Approved RMP). The BLM provided the Proposed RMP/Final EIS for a 30-day public protest period starting on August 9, 2024, and received six letters containing valid protest issues. The BLM addressed the protests and issued a Protest Resolution Report (see 
                    <E T="02">ADDRESSES</E>
                    ); no changes to the North Dakota Proposed RMP/Final EIS were necessary.
                </P>
                <P>
                    The BLM provided the Proposed RMP/Final EIS to the Governor of North Dakota for a 60-day Governor's consistency review on August 9, 2024. The Governor's Office identified concerns and potential inconsistencies between the Proposed RMP/Final EIS and State and local plans, policies, and programs. The BLM considered the concerns and potential inconsistencies and responded to the Governor's Office on November 8, 2024. The BLM concluded that the Proposed RMP does not conflict with existing State plans. On December 12, 2024, the Governor of North Dakota appealed the State Director's decision not to accept the State's recommendations to the BLM Director. After careful review and consideration, the Principal Deputy Assistant Secretary for Land and Minerals Management determined that the State Director properly considered all applicable State and local plans, policies, and programs in the North Dakota planning effort, and that no changes are necessary to provide for a reasonable balance between the national interest and the State's interest. The Principal Deputy Assistant Secretary for Land and Minerals Management response to the State of North Dakota's Appeal was signed on January 7, 2025, and transmitted to State Officials on January 8, 2025, prior to approval of the ROD. Consistent with the BLM regulations at 43 CFR 1610.3-2 the Principal Deputy Assistant Secretary for Land and Minerals Management Response will also be published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <EXTRACT>
                    <FP>(Authority: 40 CFR 1506.6, 43 CFR 1610.2)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Sonya Germann,</NAME>
                    <TITLE>State Director, Montana/Dakotas.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00840 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-20-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[PO #4820000251]</DEPDOC>
                <SUBJECT>Public Land Order No. 7958; Extension of Public Land Order No. 6597, as Extended; for White Mountain Petroglyphs Site, Wyoming</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Public Land Order.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This order extends the duration of the withdrawal created by Public Land Order (PLO) No. 6597, as extended by PLO No. 7621, for an additional 20-year period. PLO No. 6597, as extended, withdrew 20 acres of public land administered by the Bureau of Land Management (BLM) in Sweetwater County, Wyoming from settlement, sale, location, or entry under the general land laws, including the United States mining laws, but not from leasing under the mineral leasing laws, for 20 years, subject to valid existing rights, to protect the White Mountain Petroglyphs Site. Extension of the withdrawal is necessary to protect the Native American, cultural resource, wildlife, scenic, and educational values of, as well as the capital investment in, the White Mountain Petroglyphs Site.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This PLO takes effect on January 15, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sarah Naranjo, Realty Specialist, at (307) 775-6189, Bureau of Land Management, Wyoming State Office, 5353 Yellowstone Rd., Cheyenne, Wyoming 82009. Individuals in the United States who are deaf, blind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. The service is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The extension of PLO No. 6597, as extended by PLO No. 7621, is required to continue the protection of Native American cultural resources; wildlife, scenic, and educational values; as well as the capital investment of the White Mountain Petroglyphs Site.</P>
                <HD SOURCE="HD1">Order</HD>
                <P>By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, it is ordered as follows:</P>
                <P>
                    1. PLO No. 6597 (50 FR 11865 (1985)), as extended by PLO No. 7621 (70 FR 1466 (2005)), which withdrew 20 acres of public land from settlement, sale, location, or entry under the general land laws, including the United States mining laws, but not from leasing under the mineral leasing laws, subject to existing rights, to protect the White Mountain Petroglyphs Site, is hereby 
                    <PRTPAGE P="3917"/>
                    extended for an additional 20-year period. The lands are described as follows:
                </P>
                <EXTRACT>
                    <HD SOURCE="HD1">Sixth Principal Meridian, Wyoming</HD>
                    <FP SOURCE="FP-2">T. 22 N., R. 105 W.,</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 11, NE
                        <FR>1/4</FR>
                        SE1
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        , N
                        <FR>1/2</FR>
                        SW
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        ;
                    </FP>
                    <FP SOURCE="FP1-2">
                        Sec. 12, W
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        .
                    </FP>
                </EXTRACT>
                <P>The areas described aggregate 20 acres, according to the official plat of survey of the said lands, on file with the BLM.</P>
                <P>2. This withdrawal will expire 20 years from the effective date of this Order unless, as a result of a review conducted prior to the expiration date pursuant to section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f), the Secretary determines that the withdrawal shall be further extended.</P>
                <EXTRACT>
                    <FP>(Authority: 43 U.S.C. 1714)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Robert T. Anderson,</NAME>
                    <TITLE>Solicitor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00776 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-26-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Ocean Energy Management</SUBAGY>
                <DEPDOC>[Docket No. BOEM 2025-0002]</DEPDOC>
                <SUBJECT>Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Vineyard Mid-Atlantic Project on the U.S. Outer Continental Shelf Offshore New York</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Ocean Energy Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of intent to prepare an environmental impact statement; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Bureau of Ocean Energy Management (BOEM) announces its intent to prepare an environmental impact statement (EIS) (Unique Identification Number DOI-BOEM-OREP-2025-0001-EIS) for a construction and operations plan (COP) of an offshore wind energy facility submitted by Vineyard Mid-Atlantic, LLC (hereinafter referred to as Vineyard Mid-Atlantic or Proponent). This notice of intent (NOI) initiates the public scoping and comment process under the National Environmental Policy Act (NEPA) and under section 106 of the National Historic Preservation Act (NHPA). Vineyard Mid-Atlantic proposes to construct and operate the facility in Renewable Energy Lease Area OCS-A 0544 (Lease Area), which is approximately 43,056 acres and located approximately 24 statute miles (mi) offshore, south of Fire Island, New York, and approximately 60 statute mi offshore New Jersey. Vineyard Mid-Atlantic proposes to develop the entire Lease Area.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Your comments must be received by BOEM no later than March 3, 2025 for timely consideration. BOEM will hold three virtual public scoping meetings at the following dates and times (eastern time):</P>
                    <P>• Thursday, February 6, 5:00 p.m.—ending;</P>
                    <P>• Tuesday, February 11, 5:00 p.m.—ending; and</P>
                    <P>• Wednesday, February 19, 1:00 p.m.—ending.</P>
                    <P>
                        Registration for the virtual public meetings may be completed here: 
                        <E T="03">https://www.boem.gov/renewable-energy/state-activities/vineyard-mid-atlantic-ocs-0544</E>
                         or by calling (888) 788-0099 (toll free). The meetings are open to the public and free to attend.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Written comments can be submitted in any of the following ways:</P>
                    <P>• Delivered by U.S. mail or other delivery service, enclosed in an envelope labeled “Vineyard Mid-Atlantic EIS” and addressed to Lindy Nelson, NEPA Coordinator, Environmental Branch for Renewable Energy, Bureau of Ocean Energy Management, 45600 Woodland Road, VAM-OREP, Sterling, Virginia 20166; or</P>
                    <P>
                        • 
                        <E T="03">Through the regulations.gov web portal:</E>
                         Navigate to 
                        <E T="03">www.regulations.gov</E>
                         and search for Docket No. BOEM-2025-0002. Select the document in the search results on which you want to comment, click on the “Comment” button, and follow the online instructions for submitting your comment. A commenter's checklist is available on the comment web page. Enter your information and comment, then click “Submit.”
                    </P>
                    <P>
                        For more information about submitting comments, please see the “Public Participation” heading under 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        .
                    </P>
                    <P>
                        Detailed information about the proposed Project, including the COP and instructions for making written comments, can be found on BOEM's website at: 
                        <E T="03">https://www.boem.gov/renewable-energy/state-activities/vineyard-mid-atlantic-ocs-0544.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Lindy Nelson, Office of Renewable Energy Programs, Bureau of Ocean Energy Management, 45600 Woodland Road, Sterling, Virginia 20166, telephone (703) 787-1460, or email 
                        <E T="03">Lindy.Nelson@boem.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Purpose of and Need for the Proposed Action</HD>
                <P>In Executive Order 14008, “Tackling the Climate Crisis at Home and Abroad,” issued on January 27, 2021, President Joseph R. Biden stated that the policy of his administration is “to organize and deploy the full capacity of its agencies to combat the climate crisis to implement a government-wide approach that reduces climate pollution in every sector of the economy; increases resilience to the impacts of climate change; protects public health; conserves our lands, waters, and biodiversity; delivers environmental justice; and spurs well-paying union jobs and economic growth, especially through innovation, commercialization, and deployment of clean energy technologies and infrastructure.”</P>
                <P>Through a competitive leasing process conducted under 30 CFR 585.211, BOEM awarded Commercial Lease OCS-A 0544 to Vineyard Mid-Atlantic, covering an area offshore New York. BOEM approved an assignment of 100 percent interest in the lease to Vineyard Mid-Atlantic in April 2022. Vineyard Mid-Atlantic has the exclusive right to submit a COP for activities within the Lease Area. Vineyard Mid-Atlantic submitted a COP to BOEM proposing the construction, operation, maintenance, and conceptual decommissioning of an offshore wind energy facility consisting of up to two commercial-scale offshore wind energy projects in Lease Area OCS-A 0544, referred to collectively as the Vineyard Mid-Atlantic Offshore Wind Project (the Project).</P>
                <P>Vineyard Mid-Atlantic's goal is to develop up to two commercial-scale offshore wind energy project(s) in the Lease Area to provide renewable energy to the State of New York. New York State's Climate Leadership and Community Protection Act mandates that at least 70% of the State's electricity come from renewable energy sources by 2030, calls for the development of 9 gigawatts (GW) of offshore wind energy by 2035, and mandates that greenhouse gas (GHG) emissions be reduced 85% below 1990 levels by 2050. Vineyard Mid-Atlantic's ability to deliver ~2 GW of power is needed to meet the State's clean energy goals. The Project will help further diversify New York State's electricity supply, increase energy reliability, and reduce GHG emissions. Vineyard Mid-Atlantic is actively seeking one or more offshore renewable energy certificate or power purchase agreement awards.</P>
                <P>
                    Vineyard Mid-Atlantic proposes to use up to 118 positions in the Lease 
                    <PRTPAGE P="3918"/>
                    Area to be occupied by up to 117 wind turbine generators (WTGs) and up to 2 electrical service platforms (ESPs). In accordance with the lease stipulations, the WTGs and ESP(s) would be oriented in west-northwest to east-southeast rows and north to south columns with 0.68 nautical mile (nm) (1.3 kilometer [km]) spacing between positions. Inter-array cables would transmit power from groups of WTGs to the ESP(s). If two ESPs are used, they may be connected with inter-link cables. Up to six high voltage alternating current (HVAC) cables, two high voltage direct current (HVDC) cable bundles, or a combination of up to four HVAC cables/HVDC cable bundles would be installed within an Offshore Export Cable Corridor (OECC) to transmit to shore the electricity collected at the ESP(s).
                </P>
                <P>The OECC extends from the northern end of the Lease Area, continues west along the boundary of neighboring Lease Area OCS-A 0512, and then proceeds northwest across the Ambrose to Nantucket and Nantucket to Ambrose Traffic Lanes towards the southern shore of Long Island, New York. As the OECC approaches shore, it splits into three variations to connect to three potential landfall site(s) (of which, up to two would be used): the Rockaway Beach Landfall Site, the Atlantic Beach Landfall Site, and the Jones Beach Landfall Site. Vineyard Mid-Atlantic has also identified a “Western Landfall Sites OECC Variant” that may be used for routing offshore export cables to the Rockaway Beach and Atlantic Beach Landfall Sites.</P>
                <P>Onshore export cables would connect up to two of the three potential landfall site(s) to two new onshore substations in Nassau County and/or Suffolk County, New York. If HVAC cables are used, an onshore reactive compensation station may be located along each onshore export cable route to manage the export cables' reactive power (unusable electricity), increase the transmission system's operational efficiency, reduce conduction losses, and minimize excess heating. Grid interconnection cables would connect the new onshore substations to up to two of the existing East Garden City Substation (Uniondale) Point of Interconnection (POI) in Uniondale, New York, the Ruland Road Substation POI in Melville, New York, or the proposed Eastern Queens Substation POI in Queens, New York.</P>
                <P>
                    Based on BOEM's authority under the Outer Continental Shelf Lands Act (OCSLA) to authorize renewable energy activities on the OCS; Executive Order 14008; the shared goals of the Federal agencies to deploy 30 GW of offshore wind in the United States by 2030, while protecting biodiversity and promoting ocean co-use; 
                    <SU>1</SU>
                    <FTREF/>
                     and in consideration of the Proponent's goals; the purpose of BOEM's action is to determine whether to approve, approve with conditions, or disapprove Vineyard Mid-Atlantic's COP. BOEM will make its determination after weighing the factors in subsection 8(p)(4) of OCSLA that are applicable to plan decisions and in consideration of the above goals. BOEM's action is needed to fulfill its duties under the lease, which require BOEM to make a decision on the lessee's plan to construct and operate a commercial-scale, offshore wind energy facility(ies) in the Lease Area, in accordance with the relevant regulations in 30 CFR part 585.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         FACT SHEET: Biden Administration Jumpstarts Offshore Wind Energy Projects to Create Jobs | Interior, Energy, Commerce, and Transportation Departments Announce New Leasing, Funding, and Development Goals to Accelerate and Deploy Offshore Wind Energy and Jobs | The White House 
                        <E T="03">https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/29/fact-sheet-biden-administration-jumpstarts-offshore-wind-energy-projects-to-create-jobs/.</E>
                    </P>
                </FTNT>
                <P>
                    In addition, the National Oceanic and Atmospheric Administration's National Marine Fisheries Service (NMFS) anticipates one or more requests for authorization under the Marine Mammal Protection Act (MMPA) (16 U.S.C. 1361 
                    <E T="03">et seq.</E>
                    ) to take marine mammals incidental to construction activities related to the Project. NMFS' issuance of an MMPA incidental take authorization would be a major Federal action connected to BOEM's action (40 CFR 1501.3(b)). The purpose of the NMFS action—which is a direct outcome of Vineyard Mid-Atlantic's request for authorization to take marine mammals incidental to specified activities associated with the Project (
                    <E T="03">e.g.,</E>
                     pile driving)—is to evaluate Vineyard Mid-Atlantic's request pursuant to specific requirements of the MMPA and its implementing regulations administered by NMFS, considering impacts of the Vineyard Mid-Atlantic Offshore Wind Project's activities on relevant resources and, if appropriate, to issue the permit or authorization. NMFS needs to render a decision regarding the request for authorization due to NMFS's responsibilities under the MMPA (16 U.S.C. 1371(a)(5)(A)&amp;(D)) and its implementing regulations. If NMFS makes the findings necessary to issue the requested authorization, NMFS intends to adopt, after independent review, BOEM's EIS to support that decision and fulfill its NEPA requirements.
                </P>
                <P>The U.S. Army Corps of Engineers (USACE) New York District anticipates requests for authorizing a permit action to be undertaken through authority delegated to the district engineer by 33 CFR 325.8, under section 10 of the Rivers and Harbors Act of 1899 (RHA) (33 U.S.C. 403), and section 404 of the Clean Water Act (CWA) (33 U.S.C. 1344). In addition, it is anticipated that a section 408 permission will be required pursuant to section 14 of the RHA (33 U.S.C. 408), for any proposed alterations that have the potential to alter, occupy, or use any existing federally authorized civil works projects.</P>
                <P>The USACE considers issuance of permits and permissions under these three delegated authorities a major Federal action connected to BOEM's action (40 CFR 1501.9(e)(1)). The need for the Project, as provided by the Proponent in Volume 1, Section 1.2 of the COP and reviewed by USACE for NEPA purposes, is to provide a commercially viable offshore wind energy project within the Lease Area to supply electricity in support of renewable and offshore wind energy goals established by the State of New York.</P>
                <P>The basic Project purpose, as determined by USACE for section 404(b)(1) guidelines evaluation, is offshore wind energy generation. The overall project purpose for section 404(b)(1) guidelines evaluation, as determined by USACE, is the construction and operation of a commercial-scale, offshore wind energy project for renewable energy generation in Lease Area OCS-A 0544 offshore New York and transmission to the New York energy grid.</P>
                <P>The purpose of USACE section 408 action as determined by Engineer Circular 1165-2-220 is to evaluate the Proponent's request and determine whether the proposed alterations are injurious to the public interest or impair the usefulness of the USACE project. The USACE section 408 permission is needed to ensure that congressionally authorized projects continue to provide their intended benefits to the public.</P>
                <P>
                    USACE intends to adopt BOEM's EIS to support its decision on any permits or permissions requested under section 10 of the RHA, section 404 of the CWA, and section 408 of the RHA. The USACE would adopt the EIS per 40 CFR 1506.3 if, after its independent review of the document, it concludes that the EIS appropriately addresses the USACE's comments and recommendations. Based on its participation as a cooperating agency and its consideration of BOEM's EIS, USACE intends to issue a record of 
                    <PRTPAGE P="3919"/>
                    decision (ROD) to formally document its decision on the Proposed Action.
                </P>
                <P>The U.S. Environmental Protection Agency (EPA) Region 2 anticipates requests under section 402 of the CWA for an individual National Pollutants Discharge Elimination System (NPDES) permit to authorize discharges to surface waters from operation of an HVDC ESP. EPA intends to rely on the final EIS to support its decision on NPDES permit issuance. EPA will also rely on certain components of the Final EIS and ROD to support its Clean Air Act Outer Continental Shelf air permitting decision.</P>
                <HD SOURCE="HD1">Proposed Action and Preliminary Alternatives</HD>
                <P>Vineyard Mid-Atlantic proposes to construct and operate an offshore wind energy facility consisting of up to two commercial-scale offshore wind energy projects within Lease Area OCS-A-0544, with up to 118 total foundation locations. Offshore components for the Vineyard Mid-Atlantic Project include up to 117 WTGs and up to 2 ESPs, foundations and associated scour protection for WTGs and ESPs, associated inter-array cables, and up to two OECCs for HVAC and/or HVDC submarine export cables and cable protection. Two to six offshore export cables are proposed to transmit electricity from the Lease Areas to shore.</P>
                <P>Vineyard Mid-Atlantic is proposing monopile foundations to support the WTGs, and monopile or piled jacket foundations to support the ESPs. The WTGs, ESPs, foundations, and inter-array cables would be located entirely within the Lease Area. Additional details on the OECC and onshore facilities are described under the Purpose and Need section of this NOI.</P>
                <P>BOEM will evaluate reasonable alternatives to the Proposed Action that are identified during the scoping period and included in the draft EIS, including a no action alternative. Under the no action alternative, BOEM would disapprove Vineyard Mid-Atlantic's COP, and the proposed wind energy facility described in the COP would not be built within the Lease Area.</P>
                <P>
                    In addition to the Proposed Action and the no action alternative (
                    <E T="03">i.e.,</E>
                     disapproval of the COP), potential alternatives that the draft EIS could analyze include the following preliminary alternatives:
                </P>
                <P>
                    • 
                    <E T="03">Visual Minimization Alternative:</E>
                     BOEM intends to examine design parameters to reduce visual impacts.
                </P>
                <P>
                    • 
                    <E T="03">Habitat and Fisheries Impact Minimization Alternatives:</E>
                     BOEM intends to examine alternatives that would reduce impacts to habitat and fisheries.
                </P>
                <P>All preliminary alternatives would consider avoidance and minimization of impacts to Waters of the U.S. and federal projects such as federal navigation channels and flood protection projects. After completing the EIS and associated consultations, BOEM will decide through a record of decision (ROD) whether to approve, approve with conditions, or disapprove the Vineyard Mid-Atlantic Offshore Wind Project COP. If BOEM approves the COP, Vineyard Mid-Atlantic must comply with all conditions of its approval.</P>
                <HD SOURCE="HD1">Summary of Potential Impacts</HD>
                <P>The draft EIS will identify and describe the potential effects of the Proposed Action and the alternatives on the human environment. Those potential effects must be reasonably foreseeable and must have a reasonably close causal relationship to the Proposed Action and the alternatives. Such effects include those that occur at the same time and place as the Proposed Action and alternatives and those that are later in time or occur in a different place. Potential effects include, but are not limited to, impacts (whether beneficial or adverse) on air quality; water quality; bats; benthic habitat; essential fish habitat; invertebrates; finfish; birds; marine mammals; terrestrial and coastal habitats and fauna; sea turtles; wetlands and other Waters of the United States; commercial fisheries and for-hire recreational fishing; cultural resources; Tribal issues of concern; demographics; employment; economics; environmental justice; land use and coastal infrastructure; navigation and vessel traffic; other marine uses; recreation and tourism; and visual resources. These potential effects will be analyzed in the draft and final EIS.</P>
                <P>
                    Based on a preliminary evaluation of the resources listed in the preceding paragraph, BOEM expects potential impacts on sea turtles and marine mammals from underwater noise caused by construction and from collision risks with Project-related vessel traffic. Structures installed by the Project could permanently change benthic and fish habitats (
                    <E T="03">e.g.,</E>
                     creation of artificial reefs). Commercial fisheries and for-hire recreational fishing could be impacted. Project structures above the water could affect the visual character defining historic properties and recreational and tourism areas. Project structures also would pose an allision and height hazard to vessels passing close by, and vessels would, in turn, pose a hazard to the structures. Additionally, the Project might cause conflicts with military activities, air traffic, land-based radar services, cables and pipelines, and scientific surveys. The EIS will analyze all significant impacts, as well as potential measures that would avoid, minimize, or mitigate identified non-beneficial impacts.
                </P>
                <P>Beneficial impacts are also expected by facilitating achievement of State renewable energy goals, increasing job opportunities, improving air quality, and addressing climate change.</P>
                <HD SOURCE="HD1">Anticipated Permits and Authorizations</HD>
                <P>
                    In addition to the requested COP approval, various other Federal, State, and local authorizations will be required for the Project. Applicable Federal laws include the Endangered Species Act, Magnuson‐Stevens Fishery Conservation and Management Act, MMPA, RHA, CWA, Clean Air Act section 328, and the Coastal Zone Management Act. BOEM will also conduct government-to-government Tribal consultations. For a detailed listing of regulatory requirements applicable to the Project, please see the COP, volume I, available at 
                    <E T="03">https://www.boem.gov/renewable-energy/state-activities/vineyard-mid-atlantic-ocs-0544.</E>
                </P>
                <P>BOEM has chosen to use the NEPA process to fulfill its obligations under NHPA. While BOEM's obligations under NHPA and NEPA are independent, regulations implementing section 106 of NHPA at 36 CFR 800.8(c) allow the NEPA process and documentation to substitute for various aspects of the NHPA review. This process is intended to improve efficiency, promote transparency and accountability, and support a broadened discussion of potential effects that the Project could have on the human environment. During preparation of the EIS, BOEM will ensure that the NEPA process will fully meet all NHPA obligations.</P>
                <HD SOURCE="HD1">Schedule for the Decision-Making Process</HD>
                <P>
                    After the draft EIS is completed, BOEM will publish a notice of availability (NOA) and request public comments on the draft EIS. BOEM currently expects to issue the NOA for the draft EIS in June 2026. After the public comment period ends, BOEM will review and respond to comments received and will develop the final EIS. BOEM currently expects to make the final EIS available to the public in April 2027. As permitted under 40 CFR 1501.10(b)(2), BOEM extended the schedule for completion of the EIS beyond the 2-year deadline in 
                    <PRTPAGE P="3920"/>
                    consultation with the Proponent. A ROD will be completed no sooner than 30 days after the final EIS is released, in accordance with 40 CFR 1506.11.
                </P>
                <P>
                    This Project is a “covered project” under section 41 of the Fixing America's Surface Transportation Act (FAST-41). FAST-41 provides increased transparency and predictability by requiring Federal agencies to publish comprehensive permitting timetables for all covered projects. FAST-41 also provides procedures for modifying permitting timetables to address the unpredictability inherent in the environmental review and permitting process for significant infrastructure projects. To view the FAST-41 Permitting Dashboard for the Project, visit: 
                    <E T="03">https://www.boem.gov/renewable-energy/state-activities/vineyard-mid-atlantic-ocs-0544.</E>
                </P>
                <HD SOURCE="HD1">Scoping Process</HD>
                <P>
                    This NOI commences the public scoping process to identify issues and potential alternatives for consideration in the Vineyard Mid-Atlantic EIS. BOEM will hold three virtual public scoping meetings at the times and dates described above under the 
                    <E T="02">DATES</E>
                     heading. Throughout the scoping process, Federal agencies, Tribes, State and local governments, and the public will have the opportunity to help BOEM identify significant resources and issues, impact-producing factors, reasonable alternatives (
                    <E T="03">e.g.,</E>
                     size, geographic, seasonal, or other restrictions on construction and siting of facilities and activities), and potential mitigation measures to be analyzed in the EIS, as well as to provide additional information.
                </P>
                <P>As noted above, BOEM will use the NEPA process to comply with NHPA. BOEM will consider all written requests from individuals and organizations to participate as consulting parties under NHPA and, as discussed below, will determine who among those parties will be a consulting party in accordance with NHPA regulations.</P>
                <HD SOURCE="HD1">NEPA Cooperating Agencies</HD>
                <P>BOEM has invited Federal agencies and State and local governments to consider becoming cooperating agencies and has invited federally recognized Tribes to become cooperating Tribal governments in the preparation of this EIS. The Council on Environmental Quality (CEQ) NEPA regulations specify that cooperating agencies and governments are those with “jurisdiction by law or special expertise.” Potential cooperating agencies should consider their authority and capacity to assume the responsibilities of a cooperating agency and should be aware that an agency's role in the environmental analysis neither enlarges nor diminishes the final decision-making authority of any other agency involved in the NEPA process.</P>
                <P>
                    BOEM has provided potential cooperating agencies with a written summary of expectations for cooperating agencies, including schedules, milestones, responsibilities, scope and detail of cooperating agencies' expected contributions, and availability of pre-decisional information. BOEM anticipates this summary will form the basis for a memorandum of agreement between BOEM and any non-Department of the Interior cooperating agency. Agencies should also consider the factors for determining cooperating agency status in the CEQ memorandum entitled “Cooperating Agencies in Implementing the Procedural Requirements of the National Environmental Policy Act,” dated January 30, 2002. This document is available on the internet at: 
                    <E T="03">https://www.energy.gov/nepa/articles/cooperating-agencies-implementing-procedural-requirements-national-environmental.</E>
                     BOEM, as the lead agency, does not provide financial assistance to cooperating agencies.
                </P>
                <P>Governmental entities that are not cooperating agencies will have opportunities to provide information and comments to BOEM during the public input stages of the NEPA process.</P>
                <HD SOURCE="HD1">NHPA Consulting Parties</HD>
                <P>Individuals and organizations with a demonstrated interest in the Project can request to participate as NHPA consulting parties under 36 CFR 800.2(c)(5) based on their legal or economic stake in historic properties affected by the Project.</P>
                <P>Before issuing this NOI, BOEM compiled a list of potential consulting parties and invited them to become consulting parties. To become a consulting party, those invited must respond in writing by the requested response date.</P>
                <P>
                    Interested individuals and organizations that did not receive a written invitation can request to be consulting parties by writing to the staff NHPA contact at ICF International, Inc., the third-party EIS contractor supporting BOEM in its administration of this review. ICF's NHPA contact for this review is Jean Stoll at 
                    <E T="03">VineyardMidAtlantic-Section106@icf.com.</E>
                     BOEM will determine which interested parties should be consulting parties.
                </P>
                <HD SOURCE="HD1">Public Participation</HD>
                <P>Federal agencies, Tribes, State and local governments, interested parties, and the public are requested to comment on the scope of this EIS, significant issues that should be addressed, and alternatives that should be considered.</P>
                <HD SOURCE="HD2">Information on Submitting Comments</HD>
                <HD SOURCE="HD3">a. Freedom of Information Act</HD>
                <P>BOEM will protect privileged or confidential information that you submit when required by the Freedom of Information Act (FOIA). Exemption 4 of FOIA applies to trade secrets and commercial or financial information that is privileged or confidential. If you wish to protect the confidentiality of such information, clearly label it and request that BOEM treat it as confidential. BOEM will not disclose such information if BOEM determines under 30 CFR 585.114(b) that it qualifies for exemption from disclosure under FOIA. Please label privileged or confidential information “Contains Confidential Information” and consider submitting such information as a separate attachment. Information that is not labeled as privileged or confidential may be regarded by BOEM as suitable for public release.</P>
                <P>BOEM will not treat as confidential any aggregate summaries of such information or comments not containing such privileged or confidential information.</P>
                <HD SOURCE="HD3">b. Personally Identifiable Information (PII)</HD>
                <P>BOEM discourages anonymous comments. Please include your name and address as part of your comment. You should be aware that your entire comment, including your name, address, and any other personally identifiable information included in your comment, may be made publicly available. All comments from individuals, businesses, and organizations will be available for public viewing on regulations.gov.</P>
                <P>
                    For BOEM to consider withholding your PII from disclosure, you must identify any information contained in your comments that, if released, would constitute a clearly unwarranted invasion of your personal privacy. You must also briefly describe any possible harmful consequences of the disclosure of information, such as embarrassment, injury, or other harm. Even if BOEM withholds your information in the context of this notice, your submission is subject to FOIA. If your submission is requested under FOIA, your information will only be withheld if a determination 
                    <PRTPAGE P="3921"/>
                    is made that one of FOIA's exemptions to disclosure applies. Such a determination will be made in accordance with the Department of the Interior's FOIA regulations and applicable law.
                </P>
                <HD SOURCE="HD3">c. Section 304 of the NHPA (54 U.S.C. 307103(a))</HD>
                <P>After consultation with the Secretary, BOEM is required to withhold the location, character, or ownership of historic resources if it determines that disclosure may, among other things, risk harm to the historic resources or impede the use of a traditional religious site by practitioners. Tribal entities should designate information that falls under section 304 of the NHPA as confidential.</P>
                <HD SOURCE="HD1">Request for Identification of Potential Alternatives, Information, and Analyses Relevant to the Proposed Action</HD>
                <P>BOEM requests data, comments, views, information, analysis, alternatives, or suggestions relevant to the proposed action from: the public; affected Federal, Tribal, State, and local governments, agencies, and offices; the scientific community; industry; or any other interested party. Specifically, BOEM requests information on the following topics:</P>
                <P>1. Potential effects on biological resources, including bats, birds, coastal fauna, finfish, invertebrates, essential fish habitat, marine mammals, and sea turtles.</P>
                <P>2. Potential effects on physical resources and conditions including air quality, water quality, wetlands, and other waters of the United States.</P>
                <P>3. Potential effects on socioeconomic and cultural resources, including commercial fisheries and for-hire recreational fishing, demographics, employment, economics, environmental justice, land use and coastal infrastructure, navigation and vessel traffic, other uses (marine minerals, military use, aviation), recreation and tourism, and scenic and visual resources.</P>
                <P>4. Other possible reasonable alternatives to the proposed action that BOEM should consider, including additional or alternative avoidance, minimization, and mitigation measures.</P>
                <P>
                    5. As part of its compliance with NHPA section 106 and its implementing regulations (36 CFR part 800), BOEM seeks comment and input from the public and consulting parties regarding the identification of historic properties within the proposed action's area of potential effects, the potential effects on those historic properties from the activities proposed in the COP, and any information that supports identification of historic properties under NHPA. BOEM also solicits proposed measures to avoid, minimize, or mitigate any adverse effects on historic properties. BOEM will present available information regarding known historic properties during the public scoping period at 
                    <E T="03">https://www.boem.gov/renewable-energy/state-activities/vineyard-mid-atlantic-ocs-0544.</E>
                     BOEM's effects analysis for historic properties will be available for public and consulting party comment with the draft EIS.
                </P>
                <P>6. Information on other current or planned activities in, or in the vicinity of, the Project, their possible impacts on the Project, and the Project's possible impacts on those activities.</P>
                <P>7. Other information relevant to the proposed action and its impacts on the human environment.</P>
                <P>To promote informed decision-making, comments should be as specific as possible and should provide as much detail as necessary to meaningfully and fully inform BOEM of the commenter's position. Comments should explain why the issues raised are important to the consideration of potential environmental impacts and possible alternatives to the proposed action, as well as economic, employment, and other impacts affecting the quality of the human environment.</P>
                <P>The draft EIS will include a summary of all alternatives, information, and analyses submitted during the scoping process for consideration by BOEM and the cooperating agencies.</P>
                <P>
                    <E T="03">Authority:</E>
                     42 U.S.C. 4321 
                    <E T="03">et seq.,</E>
                     and 40 CFR 1501.9.
                </P>
                <SIG>
                    <NAME>Walter D. Cruickshank,</NAME>
                    <TITLE>Deputy Director,  Bureau of Ocean Energy Management.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00733 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4340-98-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation No. 332-606]</DEPDOC>
                <SUBJECT>Caribbean Basin Economic Recovery Act: Impact on U.S. Industries and Consumers and on Beneficiary Countries</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States International Trade Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of preparation of 2025 biennial report and scheduling of a public hearing.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Commission has begun preparation of its 2025 report, as required by section 215 of the Caribbean Basin Economic Recovery Act, and has scheduled a public hearing for February 20, 2025, in connection with the report. The report will cover trade during calendar years 2023 and 2024.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">February 5, 2025:</E>
                         Deadline for filing requests to appear at the public hearing.
                    </P>
                    <P>
                        <E T="03">February 7:</E>
                         Deadline for filing prehearing briefs and statements.
                    </P>
                    <P>
                        <E T="03">February 12:</E>
                         Deadline for filing electronic copies of public hearing oral statements.
                    </P>
                    <P>
                        <E T="03">February 20:</E>
                         Public hearing.
                    </P>
                    <P>
                        <E T="03">March 6:</E>
                         Deadline for filing posthearing briefs and statements.
                    </P>
                    <P>
                        <E T="03">March 13:</E>
                         Deadline for filing all other written submissions related to this investigation.
                    </P>
                    <P>
                        <E T="03">September 30:</E>
                         Deadline for transmittal of Commission report to Congress and the President.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>All Commission offices, including the Commission's hearing rooms, are located in the U.S. International Trade Commission Building, 500 E Street SW, Washington, DC. All written submissions must be submitted electronically and addressed to the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. The Commission cannot accept paper copies at this time.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Project Leader Alan Fox (202-205-3267 or 
                        <E T="03">alan.fox@usitc.gov</E>
                        ) or Deputy Project Leader Chang Hong (202-205-2791 or 
                        <E T="03">chang.hong@usitc.gov</E>
                        ) for information specific to this investigation. For information on the legal aspects of this investigation, contact Brian Allen (
                        <E T="03">brian.allen@usitc.gov</E>
                         or 202-205-3034) or William Gearhart (202-205-3091 or 
                        <E T="03">william.gearhart@usitc.gov</E>
                        ) of the Commission's Office of the General Counsel. The media should contact Claire Huber, Office of External Relations (202-205-1819 or 
                        <E T="03">claire.huber@usitc.gov</E>
                        ).
                    </P>
                    <P>
                        The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at 
                        <E T="03">https://edis.usitc.gov.</E>
                         General information concerning the Commission may be obtained by accessing its internet address (
                        <E T="03">https://www.usitc.gov</E>
                        ). Hearing-impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Background:</E>
                     The report is required by section 215 of the Caribbean Economic Recovery Act (19 U.S.C. 2704). The Act requires the Commission to submit to Congress and the President biennial 
                    <PRTPAGE P="3922"/>
                    reports, by September 30 of each reporting year, regarding the economic impact of the Act on United States industries and consumers and on the economy of the beneficiary countries.
                </P>
                <P>The Commission is required to provide an assessment of the effect, during the period covered by the report, on the United States economy generally as well as on those specific domestic industries which produce articles that are like, or directly competitive with, articles being imported into the United States from beneficiary countries; and the probable future effect the Act will have on the United States economy generally, as well as on such domestic industries.</P>
                <P>
                    <E T="03">Public hearing:</E>
                     A public hearing in connection with this investigation will be held in-person beginning at 9:30 a.m. on February 20, 2025, in the Main Hearing Room of the U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. The hearing can also be accessed remotely using the WebEx videoconference platform. A link to the hearing will be posted on the Commission's website at 
                    <E T="03">https://www.usitc.gov/calendarpad/calendar.html.</E>
                </P>
                <P>Requests to appear at the hearing should be filed with the Secretary no later than 5:15 p.m., February 5, 2025, in accordance with the requirements in the “Written Submissions” section below. Any requests to appear as a witness via videoconference must be included with your request to appear. Requests to appear as a witness via videoconference must include a statement explaining why the witness cannot appear in person; the Chair, or other person designated to conduct the investigation, may at their discretion for good cause shown, grant such requests. Requests to appear as a witness via videoconference due to illness or a positive COVID-19 test result may be submitted by 3 p.m. the business day prior to the hearing.</P>
                <P>All prehearing briefs and statements should be filed not later than 5:15 p.m., February 7, 2025. To facilitate the hearing, including the preparation of an accurate written transcript of the hearing, oral testimony to be presented at the hearing must be submitted to the Commission electronically no later than noon, February 12, 2025. All posthearing briefs and statements should be filed no later than 5:15 p.m., March 6, 2025. Posthearing briefs and statements should address matters raised at the hearing. For a description of the different types of written briefs and statements, see the “Definitions” section below.</P>
                <P>In the event that, as of the close of business on February 5, 2025, no witnesses are scheduled to appear at the hearing, the hearing will be canceled. Any person interested in attending the hearing as an observer or nonparticipant should check the Commission website as indicated above for information concerning whether the hearing will be held.</P>
                <P>
                    <E T="03">Written submissions:</E>
                     In lieu of or in addition to participating in the hearing, interested persons are invited to file written submissions concerning this investigation. All written submissions should be addressed to the Secretary, and should be received no later than 5:15 p.m., March 13, 2025. All written submissions must conform to the provisions of section 201.8 of the Commission's 
                    <E T="03">Rules of Practice and Procedure</E>
                     (19 CFR 201.8), as temporarily amended by 85 FR 15798 (March 19, 2020). Under that rule waiver, the Office of the Secretary will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS, 
                    <E T="03">https://edis.usitc.gov</E>
                    ). No in-person, paper-based filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding electronic filing should contact the Office of the Secretary, Docket Services Division (202-205-1802), or consult the Commission's 
                    <E T="03">Handbook on Filing Procedures.</E>
                </P>
                <P>
                    <E T="03">Definitions of types of documents that may be filed; Requirements:</E>
                     In addition to requests to appear at the hearing, this notice provides for the possible filing of four types of documents: prehearing briefs, hearing oral statements, posthearing briefs, and other written submissions.
                </P>
                <P>
                    (1) 
                    <E T="03">Prehearing briefs</E>
                     refers to written materials relevant to the investigation and submitted in advance of the hearing, and includes written views on matters that are the subject of the investigation, supporting materials, and any other written materials that you consider will help the Commission in understanding your views. You should file a prehearing brief particularly if you plan to testify at the hearing on behalf of an industry group, company, or other organization, and wish to provide detailed views or information that will support or supplement your testimony.
                </P>
                <P>
                    (2) 
                    <E T="03">Hearing oral statements (testimony)</E>
                     refers to the actual oral statement that you intend to present at the hearing. Do not include any confidential business information (CBI) in that statement. If you plan to testify, you must file a copy of your oral statement by the date specified in this notice. This statement will allow Commissioners to understand your position in advance of the hearing and will also assist the court reporter in preparing an accurate transcript of the hearing (
                    <E T="03">e.g.,</E>
                     names spelled correctly).
                </P>
                <P>
                    (3) 
                    <E T="03">Posthearing briefs</E>
                     refers to submissions filed after the hearing by persons who appeared at the hearing. Such briefs: (a) should be limited to matters that arose during the hearing; (b)should respond to any Commissioner and staff questions addressed to you at the hearing; (c)should clarify, amplify, or correct any statements you made at the hearing; and (d) may, at your option, address or rebut statements made by other participants in the hearing.
                </P>
                <P>
                    (4) 
                    <E T="03">Other written submissions</E>
                     refers to any other written submissions that interested persons wish to make, regardless of whether they appeared at the hearing or filed a prehearing or posthearing brief, and may include new information or updates of information previously provided.
                </P>
                <P>
                    In accordance with the provisions of section 201.8 of the Commission's 
                    <E T="03">Rules of Practice and Procedure</E>
                     (19 CFR 201.8), the document must identify on its cover (1) the investigation number and title and the type of document filed (
                    <E T="03">i.e.,</E>
                     prehearing brief, oral statement of (name), posthearing brief, or written submission), (2) the name and signature of the person filing it, (3)the name of the organization that the submission is filed on behalf of, and (4) whether it contains CBI. If it contains CBI, it must comply with the marking and other requirements set out below in this notice relating to CBI. Submitters of written documents (other than oral statements) are encouraged to include a short summary of their position or interest at the beginning of the document, and a table of contents when the document addresses multiple issues.
                </P>
                <P>
                    <E T="03">Confidential business information:</E>
                     Any submissions that contain CBI must also comply with the requirements and procedures of section 201.6 of the Commission's 
                    <E T="03">Rules of Practice and Procedure</E>
                     (19 CFR 201.6). Among other things, section 201.6 of the rules requires that the cover of the document and the individual pages be clearly marked as to whether they are the “confidential” or “nonconfidential” version, and that the CBI is clearly identified by means of brackets. All written submissions, except for CBI, will be made available for inspection by interested persons.
                </P>
                <P>
                    The Commission will not include any CBI in its report. However, all information, including CBI, submitted in this investigation may be disclosed to and used: (i) by the Commission, its 
                    <PRTPAGE P="3923"/>
                    employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission, including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel for cybersecurity purposes. The Commission will not otherwise disclose any CBI in a way that would reveal the operations of the firm supplying the information.
                </P>
                <P>
                    <E T="03">Summaries of views of interested persons:</E>
                     Interested persons wishing to have a summary of their views included in the report should include a summary with a written submission on or before March 13, 2025, and must use the Commission template, which can be downloaded from 
                    <E T="03">https://www.usitc.gov/docket_services/documents/firm_or_organization_summary_word_limit.pdf.</E>
                     The Commission template must be uploaded as a separate attachment with the written submission, which is filed on EDIS under the document type “Briefs and Written Submissions.” The summary may not exceed 500 words and should not include any CBI. The summary will be published as provided only if it utilizes the Commission-provided template, meets these requirements, and is germane to the subject matter of the investigation. The Commission will list the name of the organization furnishing the summary and will include a link where the written submission can be found.
                </P>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: January 8, 2025.</DATED>
                    <NAME>Susan Orndoff,</NAME>
                    <TITLE>Supervisory Attorney, Docket Services Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00677 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBJECT>Notice of Lodging of Proposed Modifcation to a Stipulated Order Under the Clean Water Act and Safe Drinking Water Act</SUBJECT>
                <P>
                    On January 8, 2025, the Department of Justice lodged a proposed modification to Stipulated Order No. 1 that was entered in 2009 by the United States District Court for the Northern Mariana Islands in the lawsuit entitled 
                    <E T="03">United States</E>
                     v. 
                    <E T="03">Commonwealth Utilities Corp. et al.,</E>
                     Civil Action No. 08-cv-0051 (dkt. No. 14).
                </P>
                <P>
                    Stipulated Order No. 1 requires the Commonwealth Utilities Corporation (CUC) to undertake certain measures to address violations of the Clean Water Act (CWA), 33 U.S.C. 1311 
                    <E T="03">et seq.</E>
                     and Safe Drinking Water Act (SDWA), 42 U.S.C. 300f. 
                    <E T="03">et seq.</E>
                     with respect to its wastewater treatment and drinking water systems. An EPA inspection in December of 2023 found deficiencies in CUC's operation and maintenance of its drinking water system. The proposed modification requires CUC to correct these deficiencies and undertake certain measures to ensure future compliance with the CWA and SDWA.
                </P>
                <P>
                    The publication of this notice opens a period for public comment on the proposed modification. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to 
                    <E T="03">United States</E>
                     v. 
                    <E T="03">Commonwealth Utilities Corp.</E>
                     D.J. Ref. No. 90-5-1-1-08471. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail:
                </P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="xs50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1" O="L">
                            <E T="03">To submit comments:</E>
                        </CHED>
                        <CHED H="1" O="L">
                            <E T="03">Send them to:</E>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">By email</ENT>
                        <ENT>
                            <E T="03">pubcomment-ees.enrd@usdoj.gov</E>
                            .
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">By mail</ENT>
                        <ENT>Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    Any comments submitted in writing may be filed in whole or in part on the public court docket without further notice to the commenter. During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website: 
                    <E T="03">https://www.justice.gov/enrd/consent-decrees.</E>
                     If you require assistance accessing Consent Decree, you may request assistance by email or by mail to the addresses provided above for submitting comments.
                </P>
                <SIG>
                    <NAME>Scott Bauer,</NAME>
                    <TITLE>Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00686 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employee Benefits Security Administration</SUBAGY>
                <DEPDOC>[Prohibited Transaction Exemption 2025-04; Exemption Application No. L-12069]</DEPDOC>
                <SUBJECT>Exemption From Certain Prohibited Transaction Restrictions Involving Boilermakers Western States Apprenticeship Fund, Located in Page, Arizona</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Employee Benefits Security Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of exemption.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This document gives notice of an individual exemption from certain prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA). The exemption permits the purchase of a parcel of improved real property (the Property) by the Boilermakers Western States Apprenticeship Fund (the Plan or Applicant) from the “Navajo Nation” Lodge 4 of the International Brotherhood of Boilermakers, Iron Ship Builders, Blacksmith, Forgers, and Helpers (Lodge 4) whose members may be participants in the Plan.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Exemption Date: This exemption is in effect as of January 15, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Mr. Frank Gonzalez, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor, (202) 693-8553. (This is not a toll-free number).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Plan requested an exemption pursuant to ERISA section 408(a) and supplemented the request with certain additional information (that is collectively, referred to as the “Application”).
                    <SU>1</SU>
                    <FTREF/>
                     On November 4, 2024, the Department of Labor (the Department) published a notice of proposed exemption in the 
                    <E T="04">Federal Register</E>
                     (the Proposed Exemption).
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The procedures for requesting an exemption are set forth in 29 CFR part 2570, subpart B (76 FR 66637, 66644, October 27, 2011).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         89 FR 87600.
                    </P>
                </FTNT>
                <P>Based on the Applicant's representations contained in the Application and the administrative record, the Department has determined to grant the Proposed Exemption. This exemption provides only the relief specified herein and does not provide relief from violations of any law other than the prohibited transaction provisions of ERISA.</P>
                <P>
                    <E T="03">Benefits of the Exemption:</E>
                     The Department is granting the exemption based in part on the Applicant's representations that, among other 
                    <PRTPAGE P="3924"/>
                    things, the Plan's purchase of the Property would avoid significant time and cost of relocating the Plan's training program to an alternative location (as the property has already been modified at the Plan's own expense for its particular training purposes). The transaction will be subject to further protection because an independent fiduciary will be responsible for ensuring that the Plan does not pay more than fair market value to purchase the Property.
                </P>
                <P>As discussed below, the Department makes the requisite findings under ERISA section 408(a) based on the Applicant's adherence to all the exemption's conditions at all times. Accordingly, affected parties should be aware that the Applicant's adherence to all conditions incorporated in this exemption is necessary for the Department to grant the relief that the Applicant requested. Absent these conditions, the Department would not have granted this exemption.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>1. As discussed in the Proposed Exemption, the Plan is an apprenticeship program trust fund created to provide training benefits to individuals engaged in the boilermaker construction trade.</P>
                <P>
                    2. The Plan was created pursuant to collective bargaining agreements (under the Taft-Hartley Act of 1947) 
                    <SU>3</SU>
                    <FTREF/>
                     between signatory contractors/employers (the Employers) and the International Brotherhood of Boilermakers, Iron Ship Builders, Blacksmiths, Forgers, and Helpers (the Boilermakers Union). As of December 31, 2023, the approximate aggregate fair market value of the Plan's total assets was $12,611,589. As of May 17, 2024, there are 369 apprentices currently active in the Plan's apprenticeship program. The program graduated 84 apprentices in 2022, 65 in 2023, and 51 as of May 17, 2024. The Plan admits apprentices on a rolling basis. There have been 1,233 apprentices participating in the Plan's training from May 13, 2019, through May 13, 2024.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The Department notes that the Taft-Hartley Act is commonly known as the Labor Management Relations Act of 1947; 
                        <E T="03">see</E>
                         29 U.S.C. 141.
                    </P>
                </FTNT>
                <P>3. The Plan provides training and education to eligible participants located in the following states: Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, and Wyoming (the Western States Area).</P>
                <P>
                    4. The Plan is sponsored by the Boilermakers National Apprenticeship Program (the BNAP).
                    <SU>4</SU>
                    <FTREF/>
                     The BNAP sponsors apprenticeship programs in four different geographical areas, including the Western States Area.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         ERISA Section 3(16)(B) defines the term Plan Sponsor to mean in pertinent part . . . (ii) the employee organization in the case of a plan established or maintained by an employee organization, (iii) in the case of a plan established or maintained by two or more employers or jointly by one or more employers and one or more employee organizations, the association, committee, joint board of trustees, or other similar group of representatives of the parties who establish or maintain the plan. . . .”
                    </P>
                </FTNT>
                <P>5. A board of trustees—the Boilermakers National Apprenticeship Board—administers the Plan (the Board of Trustees). The Board of Trustees consists of equal representation from locals of the Boilermakers Union (the Union Trustees) and signatory contractors/employers (the Employer Trustees). The Board of Trustees has discretion over the Plan's assets, including over the investment of such assets.</P>
                <P>6. The Plan receives funding through collectively bargained contributions from contributing employers and grants, among other income sources provided under the Plan's governing documents. According to the Plan's governing documents, the Plan's assets may be used to provide apprenticeship and training benefits and to finance the operation and administration of such apprenticeship and training benefits within the Western States Area. As described in the Proposed Exemption, the Plan provides benefits in two ways: through a regional training center, the JG Cooksey Training Center in Salt Lake City, Utah; and through subsidizing apprenticeship and training programs maintained by locals of the Boilermakers Union within the Western States Area.</P>
                <P>
                    7. During a five-year period ending on February 11, 2022, the Plan nearly doubled its apprentice numbers, and the participation rate continued to increase as of May 17, 2024, as the demand for boilermakers in the Western States Area continues to rise. Accordingly, the Plan is interested in opening a new regional training center and is seeking to purchase an improved real estate parcel (the Property) from Lodge 4, a labor union, located in Page, Arizona, that is affiliated with the Boilermakers Union. Lodge 4 is a separate legal entity from both the Boilermakers Union and the other lodges of the Boilermakers Union. The Board of Trustees does not currently have any Union Trustees who were appointed by Lodge 4. Rather, the Union Trustees serving on the Plan's Board of Trustees are appointed either by the Boilermakers Union or other lodges of the Boilermakers Union (
                    <E T="03">e.g.,</E>
                     Boilermakers Lodge 502).  
                </P>
                <P>
                    8. 
                    <E T="03">The Property.</E>
                     The Property is an improved real estate parcel located at 294 Cowboy Ray Road, Page, Arizona. The Property's site is 1.678 acres, with two office/warehouse buildings totaling 5,000 square feet in usable space. As discussed further below, the Plan's apprentices currently use the Property's buildings as training facilities (the Training Facility). The Applicant represents that this use of the Training Facility is essential for the Plan to fulfill its purpose of providing education and training opportunities to its apprentices. As described in the Proposed Exemption, Lodge 4 has decided to move and no longer desires to operate the Training Facility.
                </P>
                <P>
                    9. The Applicant represents that the Property has been modified to carry out the purposes of the Plan and is ideally situated to be a regional training facility for boilermaker apprentices and journeypersons and suited for the Plan's purposes. The Property also has administrative space for the Plan's headquarters.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The Plan maintains an administrative office in Page, Arizona, three miles away from the Property, that it began leasing from Marquis Realty LLC, an unrelated party to the Plan, on July 1, 2014 (the Leased Office).
                    </P>
                </FTNT>
                <P>
                    10. The Union Trustees recused themselves from voting with respect to the Plan's decision to enter into the Transaction, and the Plan's Employer Trustees 
                    <SU>6</SU>
                    <FTREF/>
                     determined it would be in the interest of the Plan to purchase the Property because: (a) the Training Facility is already suited for the needs of the Plan; (b) the purchase of the Property would allow the Plan to maintain the Training Program at the Training Facility notwithstanding Lodge 4's decision to terminate operating the Training Facility; (c) using the Property to create a regional training facility would meet the increasing demand for the training of participants, including apprentices within the Western States Area; (d) the purchase of the Property from Lodge 4 would allow the Plan to pay the Property's fair market value without incurring any commission costs or other expenses in connection with the purchase; and (e) the Plan's continued use of the Property for training purposes would provide additional benefits to participants and provide other financial benefits to the Plan.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         The Applicant represents that the Union Trustees recused themselves from the vote to enter into the Proposed Transaction with Lodge 4 on behalf of the Plan. The recusal is described in more detail below.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The Department understands that the Plan would financially benefit from the Transaction (and 
                        <PRTPAGE/>
                        indirectly benefit the Plan's participants and beneficiaries), because it (1) would not need to pay for the removal of the Plan's specialized air venting system from the Training Facility (the venting system is explained further below) and (2) could relocate its administrative office to the Property instead of paying for the Leased Office . The Applicant also stated that participants would benefit by having the ability to visit the Plan's administration office and training facilities at the same location after the office is moved from the Leased Office to the Property.
                    </P>
                </FTNT>
                <PRTPAGE P="3925"/>
                <P>11. On January 20, 2022, the Employer Trustees gave their approval for the Plan to proceed with the purchase of the Property (the Transaction), subject to the Department's grant of this exemption. The Plan intends to purchase the Property from Lodge 4 within ninety (90) days following the Department's grant of this exemption. The Applicant represents that the Plan considered other possible locations and properties for a regional center, but after consulting with various service providers, it ultimately determined that purchasing the Property was the most appropriate given the Plan's goals, as explained below.</P>
                <P>12. In connection with the Transaction, the Plan would pay the lesser of: (i) the Property's fair market value of $920,000 identified in the appraisal conducted on April 1, 2021; and (ii) the updated appraised fair market value of the Property as determined by the qualified independent appraiser on the purchase date. The Plan may finance its purchase of the Property. In this regard, the exemption prohibits the Plan from financing the acquisition of the Property with any bank that has any pecuniary interest in, or that is owned, managed, or controlled in any manner by a party in interest with respect to the Plan as defined in ERISA section 3(14).</P>
                <P>
                    13. Lodge 4 and the Plan will each pay half of the costs associated with this exemption, including but not limited to fees for qualified independent fiduciary services, qualified independent appraiser services, and legal fees for preparing the Plan's application to the Department requesting the Exemption.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Matters pertaining to services being provided by the independent fiduciary and independent appraiser with respect to the Transaction, including their qualifications and independence, are explained further below.
                    </P>
                </FTNT>
                <P>
                    14. 
                    <E T="03">ERISA Prohibited Transaction Analysis.</E>
                     Lodge 4 is an employee organization whose members are covered by the Plan; therefore, it is a party in interest to the Plan pursuant to ERISA section 3(14)(D).
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         ERISA section 3(14)(D) defines, in part, the term party in interest to an employee benefit plan as “an employee organization any of whose members are covered by such plan.”
                    </P>
                </FTNT>
                <P>15. ERISA section 406(a)(1)(A) prohibits a plan fiduciary from causing the sale or exchange, or leasing, of property between a plan and a party in interest. ERISA section 406(a)(1)(D) provides that a plan fiduciary shall not cause the plan to engage in a transaction if (1) that fiduciary knows or should know that such transaction constitutes a direct or indirect transfer of any of the plan's assets to a party in interest or (2) would result in the plan's assets being used by or for the benefit of a party in interest.</P>
                <P>16. The Plan's purchase of the Property from Lodge 4 in exchange for the Plan's funds would constitute a prohibited sale and transfer of Plan assets in violation of ERISA sections 406(a)(1)(A) and (D), respectively.</P>
                <P>17. Additionally, ERISA Section 406(b)(1) prohibits a plan fiduciary from dealing with a plan's assets “. . . in his own interest or for his own account.” ERISA Section 406(b)(2) prohibits a plan fiduciary “in his individual or in any other capacity [from acting] in any transaction involving the plan on behalf of a party (or represent a party) whose interests are adverse to the interests of the plan or the interests of its participants or beneficiaries.”</P>
                <P>
                    18. The Union Trustees may have an interest in benefitting Lodge 4, a party in interest to the Plan, because Lodge 4 is also a Boilermakers Union lodge, and as such, it is affiliated with the Boilermakers Union. Although the Applicant represents that the Union Trustees “recused” themselves from voting on the Plan's decision to enter into the Transaction, whether the Union Trustees' recusal from any aspects of the Transaction negates a violation of ERISA section 406(b)(1) or (2), involves an inherently factual determination that is beyond the scope of this exemption. Therefore, the Department cannot determine from the record whether the Union Trustees sufficiently recused themselves from engaging in the deliberations regarding of the Transaction or using their positions to influence the Employer Trustees' decision to approve the Transaction in order to determine definitively that there was no violation of ERISA section 406(b)(1) or (b)(2). To the extent the Union Trustees exercised any authority, control, or responsibility that make them a fiduciary to cause the Plan to engage in the Transaction, they would have violated ERISA Section 406(b)(1) and (b)(2), because the Transaction would benefit Lodge 4, an entity in which the Union Trustees have an interest and involve Union Trustees acting on behalf of both the Plan and Lodge 4.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         The Department notes that “the prohibitions of section 406(b) supplement the other prohibitions of section 406(a) of [ERISA] by imposing on parties in interest who are fiduciaries a duty of undivided loyalty to the plans for which they act. These prohibitions are imposed upon fiduciaries to deter them from exercising the authority, control, or responsibility which makes such persons fiduciaries when they have interests which may conflict with the interests of the plans for which they act. In such cases, the fiduciaries have interests in the transaction which may affect the exercise of their best judgment as fiduciaries.” See 29 CFR 2550.408b-2(e)(1).
                    </P>
                </FTNT>
                <P>
                    19. 
                    <E T="03">Applicant's Representations Regarding the Merits of the Transaction.</E>
                     The Applicant represents that the Transaction would benefit the Plan because the Training Facility is currently operated by Lodge 4 to conduct trainings and the Plan would not have to make any improvements or modifications to continue using it.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         The Applicant explains that a reimbursement policy between the Plan and Lodge 4 govern the Plan's reimbursement of Lodge 4 for the direct costs that Lodge 4 incurs in conducting training (the Reimbursement Policy) in accordance with ERISA section 408(b)(2). Whether the Reimbursement Policy complies with the requirements of ERISA section 408(b)(2) is an inherently factual inquiry that is beyond the scope of this exemption and with respect to which the Department offers no opinion.
                    </P>
                </FTNT>
                  
                <P>
                    20. The Applicant represents that the Plan has also invested nearly $600,000 in equipment at the Training Facility to equip 24 welding stations, including installing a $250,000 custom ventilation system designed to remove noxious fumes that are produced by the welding machines. The Applicant states that the Plan still owns this equipment, which is only used in connection with the training of participants by Lodge 4 in connection with the provision of services to the Plan, described in more detail below.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         The costs for these pieces of equipment are not included as part of the Property's value appraisal.
                    </P>
                </FTNT>
                <P>21. The Applicant represents that the Transaction would benefit the Plan because Lodge 4 intends to terminate its involvement with the Training Facility. If Lodge 4 no longer runs the Training Facility, the Plan could no longer provide training there. Furthermore, the Training Facility is currently equipped with Plan-purchased equipment that is used to provide training for participants. If Lodge 4 terminates its involvement with the Training Facility and/or sells the Property, the Plan would need to remove and relocate the equipment at significant time and expense.</P>
                <P>
                    22. The Applicant represents that the Plan wants to create a regional training center on the Property due to the transient nature of the boilermaker trade and industry. The Property is centrally located in the Southern portion of the Western States Area with convenient 
                    <PRTPAGE P="3926"/>
                    access from New Mexico, Arizona, Southern Nevada, and Southern California. The Property also is located on the edge of the Navajo Nation reservation, which has traditionally been a large source of apprenticeship participants in that area, making the Property a convenient location to a segment of current and future apprenticeship participants.
                </P>
                <P>23. The Applicant represents further that the Transaction would benefit the Plan, because the Property will become the site for the Plan's administrative headquarters. If the Plan moves its administrative headquarters to the Property, the Leased Office will no longer be needed. Additionally, co-locating the Plan's administrative offices at the Training Facility will facilitate the Plan staff's ability to monitor the Training Facility and interact with apprenticeship and journeyperson participants.</P>
                <P>24. The Applicant represents that the Plan would also benefit from the Transaction because the Property provides flexibility for expansion as the number of Boilermaker apprentices continues to grow and significant space for: (a) large training sessions where there are numerous vehicles and recreational vehicles utilized by participants; (b) outdoor training components such as training involving a rigging tower; and (c) expansion of training facilities and/or demonstrations.</P>
                <P>
                    25. 
                    <E T="03">The Property's Appraisal.</E>
                     The Property was appraised at $920,000 by an independent appraiser (Qualified Independent Appraiser).
                    <SU>13</SU>
                    <FTREF/>
                     The exemption's conditions for relief require the appraisal to be updated by the Qualified Independent Appraiser to reflect the fair market value of the Property on the Transaction's closing date. The Plan does not expect that the cost to update the appraisal will exceed $3,750.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         See Paragraphs 29-32 of the Proposed Exemption for information regarding the independent appraiser retained by the Plan, at 89 FR 87604.
                    </P>
                </FTNT>
                <P>
                    26. 
                    <E T="03">The Independent Fiduciary.</E>
                     Wagner Law Group was retained by the Plan to serve as the Plan's independent fiduciary with respect to the Proposed Transaction (Wagner).
                    <SU>14</SU>
                    <FTREF/>
                     The Proposed Exemption describes Wagner's conclusions regarding the Proposed Transaction. In this regard, Wagner opined that the Proposed Transaction for a price of the lesser of $920,000 or the Property's appraised value on the date of sale, under the terms and conditions required by the exemption, would be in the best interest and protective of the rights of the Plan's participants and beneficiaries.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         See Paragraphs 33-36 of the Proposed Exemption for information regarding the selection of Wagner as the Plan's independent fiduciary, at 89 FR 87604.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         Wagner's conclusions are described in Paragraphs 37-43 of the Proposed Exemption at 89 FR 87604-05. Among other things, Wagner noted that the Plan already owns the training equipment currently housed at the Training Facility, and removing and relocating this equipment to another location would be extremely costly. Because of this, the Plan will receive significant cost savings by purchasing the Property as compared to purchasing a comparable facility and having to pay to relocate this equipment or purchase new equipment to furnish the new facility.
                    </P>
                </FTNT>
                <P>
                    27. 
                    <E T="03">Protective Conditions.</E>
                     In addition to the conditions mentioned above, this exemption requires the parties' adherence to the protective conditions that are summarized below.
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         The Department notes that this is a summary of the conditions intended for the convenience of a reader; however, the governing conditions for the transaction are those reflected in Section III of the exemption.
                    </P>
                </FTNT>
                <P>28. The Transaction must be a one-time transaction in which the Plan pays the lesser of the Property's fair market value of $920,000 or an updated appraised value to be determined on the date of purchase, subject to cost sharing allocations regarding the cost for this exemption. The updated appraisal must be provided to the Department and will be made a part of the administrative record for this exemption's application.</P>
                <P>29. Acting as the Plan's independent fiduciary, Wagner must:</P>
                <P>(a) Determine that the Transaction is in the interest of and protective of the rights of the Plan and its participants and beneficiaries;</P>
                <P>(b) Determine whether it is prudent for the Plan to proceed with the Transaction;</P>
                <P>(c) Review, negotiate, and approve the terms and conditions of the Transaction;</P>
                <P>(d) Represent the Plan's interests in connection with the Transaction, including monitoring the parties' compliance with terms of the contract of sale and the closing contract, enforcing the Plan's rights under the contract of sale and the closing contract, and ensuring the satisfaction of all preconditions for the Plan's purchase of the Property, including the terms of the financing from an unrelated third-party bank;</P>
                <P>(e) Monitor the Transaction to ensure that all conditions in the exemption are met and take whatever actions are necessary to protect the rights of the Plan and its participants and beneficiaries in the Transaction;</P>
                <P>(f) Review the Appraisal Report and confirm that the underlying methodology is reasonable and accurate such that the valuation of the Property was reasonably derived;</P>
                <P>(g) Ensure that the Appraisal Report is based on complete, current, and accurate information; the appraiser was prudently selected; the methodology used by the Qualified Independent Appraiser is consistent with sound valuation principles; and that it is reasonable under the circumstances to rely upon the Appraisal Report, as updated, to determine the fair market value of the Property as of the date of the transaction; and</P>
                <P>
                    (h) Not have entered into, or must not enter into, any agreement or instrument that violates either ERISA Section 410, or the Department's Regulations codified at 29 CFR 2509.75-4; 
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         ERISA section 410 provides, in part, that “except as provided in ERISA sections 405(b)(1) and 405(d), any provision in an agreement or instrument which purports to relieve a fiduciary from responsibility or liability for any responsibility, obligation, or duty under this part [meaning Part 4 of Title I of ERISA] shall be void as against public policy.”
                    </P>
                </FTNT>
                <P>30. Furthermore, Wagner must not have entered into, and must not enter into, any agreement, arrangement, or understanding that includes any provision that provides for the direct or indirect indemnification or reimbursement of Wagner by the Plan or other party for any failure to adhere to its contractual obligations or to state or Federal laws applicable to Wagner's work; or waives any rights, claims, or remedies of the Plan under ERISA, state, or Federal law against Wagner with respect to the Transaction;  </P>
                <P>31. The Qualified Independent Appraiser must not have entered into, and must not enter into, any agreement, arrangement, or understanding that includes any provision that provides for the direct or indirect indemnification or reimbursement of the Qualified Independent Appraiser by the Plan or any other party for any failure to adhere to its contractual obligations or to state or Federal laws applicable to the Qualified Independent Appraiser's work. The Plan also must not waive any rights, claims or remedies of the Plan or its participants and beneficiaries under ERISA, the Code, or other Federal and state laws against the Qualified Independent Appraiser with respect to the Transaction.</P>
                <P>32. The Employer Trustees but not the Union Trustees must determine that the Transaction is prudent and in the Plan's interest to proceed with the Transaction; the Union Trustees cannot participate or in any way influence the Employer Trustees' determination.</P>
                <P>
                    33. The terms and conditions of the Transaction must be at least as favorable 
                    <PRTPAGE P="3927"/>
                    to the Plan as the terms and conditions the Plan would have received in an arm's length transaction between unrelated and independent parties. The Transaction must not be part of an agreement, arrangement, or understanding designed to benefit Lodge 4.
                </P>
                <P>34. The conditions for relief also require that any mortgage loan secured by the Plan to purchase the Property must be approved by the Qualified Independent Fiduciary, and its monthly payments must not exceed $10,000. Further, the collateral for such loan must be limited to a first mortgage lien and assignment of lease and rents on the Property. Finally, the Plan may not obtain a mortgage loan from a bank that has any pecuniary interest in, or is owned, managed, or controlled in any degree by any party in interest with respect to the Plan as defined in ERISA section 3(14).</P>
                <P>35. The Plan must not pay any commissions, costs, or other expenses in connection with the Transaction, and Lodge 4 must pay half of the costs associated with the exemption including but not limited to fees for Wagner's services, fees for Qualified Independent Appraiser services, and fees for preparing the Plan's application to the Department requesting this exemption (but not including the actual purchase price of the Property).</P>
                <P>36. No later than 30 days after the Transaction is completed, Wagner must submit to the Department a written certification that all of the conditions of the exemption have been met. Wagner must also provide a statement of its determination that the Transaction is in the interests of the Plan and of its participants and beneficiaries explaining the reasons on which its determination is based.</P>
                <P>37. This relief under this exemption is also subject to a recordkeeping requirement, and a requirement for all the material facts and representations set forth in the Summary of Facts and Representations to be true and accurate at all times.</P>
                <HD SOURCE="HD1">Written Comments Received Regarding the Proposed Exemption</HD>
                <P>38. In the Proposed Exemption, the Department invited all interested persons to submit written comments and/or requests for a public hearing with respect to such notice, which comment period ended on December 19, 2024. The Department did not receive any comments and it did not receive any hearing requests.</P>
                <P>39. The complete application file (L-12069) is available for public inspection in the Public Disclosure Room of the Employee Benefits Security Administration, Room N-1515, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC, 20210, reachable by telephone at (202) 693-8673. For a more complete statement of the facts and representations supporting the Department's decision to grant this exemption, please refer to the notice of proposed exemption published on November 4, 2024, at 89 FR 87600.</P>
                <P>General Information</P>
                <P>The attention of interested persons is directed to the following:</P>
                <P>(1) The fact that a transaction is the subject of an exemption under ERISA section 408(a) does not relieve a fiduciary or other party in interest from certain requirements of other ERISA provisions, including but not limited to any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of ERISA section 404, which, among other things, require a fiduciary to discharge their duties respecting the plan solely in the interest of the plan's participants and beneficiaries and in a prudent fashion in accordance with ERISA section 404(a)(1)(B).</P>
                <P>(2) As required by ERISA section 408(a), the Department hereby finds that the exemption is: (a) administratively feasible for the Department; (b) in the interests of the Plan and the Plan's participants and beneficiaries; and (c) protective of the rights of the Plan and the Plan's participants and beneficiaries.</P>
                <P>(3) This exemption is supplemental to, and not in derogation of, any other ERISA provisions, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive for determining whether the transaction is in fact a prohibited transaction.</P>
                <P>(4) The availability of this exemption is subject to the express condition that the material facts and representations contained in the application accurately describe all material terms of the transactions that are the subject of the exemption and are true at all times.</P>
                <P>Accordingly, after considering the entire record developed in connection with the Applicant's exemption application, the Department has determined to grant the following exemption under the authority of ERISA section 408(a) in accordance with the Department's exemption procedures set forth in 29 CFR part 2570, subpart B at 76 FR 66637, 66644 (October 27, 2011).</P>
                <HD SOURCE="HD2">Exemption</HD>
                <HD SOURCE="HD3">Section I. Definitions</HD>
                <P>(a) The term “Qualified Independent Fiduciary” means the Wagner Law Group, and any of its employees that provide any fiduciary service to the Plan in respect to this exemption; or such other “qualified independent fiduciary” as defined under 29 CFR part 2570, subpart B, as updated from time to time.</P>
                <P>(b) The term “Qualified Independent Appraiser” means Accurity Morley &amp; McConkie, LC, and any of its employees that provide any appraisal related service to the Plan in connection with this exemption.</P>
                <P>(c) The term “Mortgage Loan” means a mortgage loan from an independent, third-party bank consisting of a five-year term with payments based on 20-year amortization, ballooning at maturity, or such other mortgage loan prudently entered into by the Independent Fiduciary on behalf of the Plan.</P>
                <HD SOURCE="HD3">Section II. Transactions</HD>
                <P>The restrictions of ERISA Sections 406(a)(1)(A), (D), and 406(b)(1) and (2) shall not apply to the purchase of the improved real property located at 294 Cowboy Ray Road, Page, Arizona (the Property), by the Boilermakers Western States Apprenticeship Fund's (the Plan) from the “Navajo Nation” Lodge 4 of the International Brotherhood of Boilermakers, Iron Ship Builders, Blacksmith, Forgers, and Helpers (Lodge 4), a party in interest with respect to the Plan (the Purchase); provided that the conditions in Section III are satisfied.</P>
                <HD SOURCE="HD3">Section III. Conditions</HD>
                <P>(a) The Purchase is a one-time transaction for the lesser of $920,000 in cash or an updated appraised value to be determined by the Qualified Independent Appraiser as of the Purchase's closing date (the Price). The updated report from the Qualified Independent Appraiser must be submitted to the Department within 30 days before the date the Purchase is completed for inclusion in the record for this exemption's application;</P>
                <P>
                    (b) Approval of the Purchase must be made solely by Plan trustees that are not, and were not, appointed by a labor union that is affiliated with the International Brotherhood of Boilermakers, and such Plan trustees must prudently determine in a writing that the Purchase is in the Plan's best interest. Such non-union appointed Plan trustees must have considered other possible locations and properties that were unrelated to Lodge 4 prior to determining that the Purchase is the most appropriate given the Plan's goals. 
                    <PRTPAGE P="3928"/>
                    Any trustee appointed by a labor union that is affiliated with the International Brotherhood of Boilermakers cannot participate or in any way influence a non-union appointed Plan trustee;
                </P>
                <P>(c) The Plan must retain the services of a Qualified Independent Fiduciary and the Qualified Independent Fiduciary must prudently:</P>
                <P>(1) Determine that the Purchase is in the interest of, and protective of, the Plan and the Plan's participants;</P>
                <P>(2) Determine whether it is prudent for the Plan to proceed with the Purchase;</P>
                <P>(3) Review, negotiate, and approve the terms and conditions of the Purchase;</P>
                <P>(4) Represent the Plan's interests in connection with the Purchase, including monitoring the parties' compliance with terms of the sales contract and the closing contract, enforcing the Plan's rights under the sale contract and closing contract, and ensuring the satisfaction of all conditions precedent to complete the Purchase, including the terms of the Mortgage Loan;</P>
                <P>(5) Monitor to ensure that all of the conditions in this exemption are met and take whatever actions are necessary to protect the rights of the Plan and its participants and beneficiaries with respect to the Purchase;</P>
                <P>(6) Review the Qualified Independent Appraisal Report and confirm that the underlying methodology is reasonable and accurate and that the valuation of the Property was reasonably derived;</P>
                <P>(7) Ensure that the Qualified Independent Appraisal Report is based on complete, current, and accurate information; the Qualified Independent Appraiser was prudently selected; the methodology used by the Qualified Independent Appraiser is consistent with sound valuation principles; and that it is reasonable under the circumstances to rely upon the Qualified Independent Appraisal's report to determine the fair market value of the Property as of the date of the Purchase; and</P>
                <P>(8) Not have entered into, and must not enter into, any agreement or instrument that violates either ERISA section 410, or the Department's Regulations codified at 29 CFR 2509.75-4;</P>
                <P>(d) The terms and conditions of the Purchase must be at least as favorable to the Plan as the terms and conditions the Plan would have received in an arm's length transaction with an unrelated and independent party, each of which had full knowledge of the relevant facts, and neither of which were under any compulsion to buy or sell;  </P>
                <P>(e) The Purchase must not be part of an agreement, arrangement, or understanding designed to benefit Lodge 4 or the International Brotherhood of Boilermakers;</P>
                <P>(f) In the event the Purchase is financed with a Mortgage Loan, then the Mortgage Loan must be approved by the Qualified Independent Fiduciary, and its monthly payments must not exceed $10,000;</P>
                <P>(g) The Mortgage Loan collateral is limited to a first mortgage lien and assignment of lease and rents on the Property. The Plan may not obtain a Mortgage Loan from a bank that has any pecuniary interest in, or is owned, managed, or controlled in any degree by any party in interest with respect to the Plan as defined in ERISA section 3(14);</P>
                <P>(h) The Plan must not pay any commissions, costs, or other expenses in connection with the Purchase subject to the cost sharing allocations regarding the cost for this exemption as provided below in paragraph (i);</P>
                <P>(i) Lodge 4 and the Plan must each pay half of the costs associated with the exemption including but not limited to fees for Qualified Independent Fiduciary services, fees for Qualified Independent Appraiser services, and fees for preparing the Plan's application to the Department requesting this exemption, but not including the Price;</P>
                <P>(j) The Qualified Independent Fiduciary must not have entered into, and must not enter into, any agreement, arrangement, or understanding that includes any provision that provides for the direct or indirect indemnification or reimbursement of the Qualified Independent Fiduciary by the Plan or other party for any failure to adhere to its contractual obligations or to state or Federal laws applicable to the Qualified Independent Fiduciary's work; or that waives any rights, claims, or remedies of the Plan under ERISA, state, or Federal law against the Qualified Independent Fiduciary with respect to the Purchase;</P>
                <P>(k) The Qualified Independent Appraiser must not have entered into, and must not enter into, any agreement, arrangement, or understanding that includes any provision that provides for the direct or indirect indemnification or reimbursement of the Qualified Independent Appraiser by the Plan or any other party for any failure to adhere to its contractual obligations or to state or Federal laws applicable to the Qualified Independent Appraiser's work; or that waives any rights, claims or remedies of the Plan or its participants and beneficiaries under ERISA, the Code, or other Federal and state laws against the Qualified Independent Appraiser with respect to the Purchase;</P>
                <P>(l) The Plan's trustees and the Qualified Independent Fiduciary maintain for a period of six (6) years from the date of any transaction related to the Purchase, in a manner that is convenient and accessible for audit and examination, the records necessary to enable the persons described in paragraph (m)(1) below to determine whether conditions of this exemption have been met, except that (i) a prohibited transaction will not be considered to have occurred if, due to circumstances beyond the control of the Plan's trustees and/or the Qualified Independent Fiduciary, the records are lost or destroyed prior to the end of the six-year period, and (ii) no party in interest other than the Plan's trustees or the Qualified Independent Fiduciary shall be subject to the civil penalty that may be assessed under ERISA section 502(i) if the records are not maintained, or are not available for examination as required by paragraph (n) below; and</P>
                <P>(m)(1) Except as provided in section (2) of this paragraph and not withstanding any provisions of subsections (a)(2) and (b) of ERISA Section 504, the records referred to in paragraph (l) above shall be unconditionally available at their customary location during normal business hours to:</P>
                <P>(i) any duly authorized employee or representative of the Department or the Internal Revenue Service;</P>
                <P>(ii) the Plan's trustees or any duly authorized representative of the Plan's trustees;</P>
                <P>(iii) the Qualified Independent Fiduciary or any duly authorized representative of the Qualified Independent Fiduciary;</P>
                <P>(iv) any participant or beneficiary of the Plan, or any duly authorized representative of such participant or beneficiary;</P>
                <P>(2) Should Lodge 4 or any party refuse to disclose information to a person on the basis that such information is exempt from disclosure, such party shall provide a written notice advising that person of the reasons for the refusal and that the Department may request such information by the close of the thirtieth (30th) day following the request;</P>
                <P>
                    (n) Within 30 calendar days after the Property is purchased, the Qualified Independent Fiduciary must provide to the Department a written certification that all of this exemption's conditions have been met and must provide to the Department the Statement documenting its conclusion that the Proposed Transaction is in the Plan's best interest; and
                    <PRTPAGE P="3929"/>
                </P>
                <P>(o) All the material facts and representations set forth in the Proposed Exemption's Summary of Facts and Representations are true and accurate at all times.</P>
                <P>
                    <E T="03">Exemption Date:</E>
                     This exemption is in effect as of January 15, 2025.
                </P>
                <SIG>
                    <P>Signed at Washington, DC.</P>
                    <NAME>George Christopher Cosby,</NAME>
                    <TITLE>Director, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00810 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-29-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employee Benefits Security Administration</SUBAGY>
                <DEPDOC>[Prohibited Transaction Exemption 2025-03; Exemption Application No. D-12098]</DEPDOC>
                <SUBJECT>Exemption From Certain Prohibited Transaction Restrictions Involving UBS AG (UBS), Located in Zurich, Switzerland</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Employee Benefits Security Administration, Department of Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of exemption.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This exemption provides conditional prospective relief that allows current and future asset managers under the UBS corporate umbrella (UBS QPAMs) to continue to rely on PTE 84-14 for the five-year period from June 12, 2024, through June 11, 2029, notwithstanding four judgments of conviction involving entities within the UBS and CSAG (Credit Suisse AG) corporate umbrellas. The exemption also provides conditional retroactive relief to UBS QPAMs covering their reliance on PTE 84-14 during the one-year period from June 12, 2023, through June 11, 2024.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The exemption is in effect from June 12, 2023, through June 11, 2029.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Nicholas Schroth of the Department at (202) 693-8571 (this is not a toll-free number).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On June 11, 2024, the Department published a notice of proposed exemption in the 
                    <E T="04">Federal Register</E>
                    ,
                    <SU>1</SU>
                    <FTREF/>
                     (the Proposal) that would permit UBS' Affiliated QPAMs and/or the Related QPAMs (referred to herein individually or collectively as the UBS QPAMs) 
                    <SU>2</SU>
                    <FTREF/>
                     to continue to rely on the exemptive relief provided by PTE 84-14, notwithstanding several judgments of conviction involving entities within the UBS and CSAG corporate umbrellas that are described below.
                    <SU>3</SU>
                    <FTREF/>
                     The Department is hereby granting this exemption to ensure that participants and beneficiaries of ERISA-covered plans and Individual Retirement Accounts managed by UBS QPAMs (collectively referred to as Covered Plans) 
                    <SU>4</SU>
                    <FTREF/>
                     do not suffer harm that UBS represented would occur if the UBS QPAMs can no longer rely on PTE 84-14. This exemption provides only the relief expressly specified herein and does not provide relief from violations of any law other than the prohibited transaction provisions of Title I of the Employee Retirement Income Security Act of 1974, as amended (ERISA), and the Internal Revenue Code of 1986, as amended (the Code).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         88 FR 30785 (May 12, 2023).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         For purposes of this exemption, the term “Affiliated QPAM” and “Related QPAM” mean, respectively: (1) UBS Americas, UBS Hedge Fund Solutions LLC, Credit Suisse Asset Management, LLC, and any future separate legal entity within the Asset Management or the Global Wealth Management Americas U.S. divisions of UBS that qualifies as a “qualified professional asset manager” (as defined in Section VI(a) of PTE 84-14) and that relies on the relief provided by PTE 84-14, and with respect to which UBS is an “affiliate” (as defined in Part VI(d) of PTE 84-14) and (2) any current or future “qualified professional asset manager” (as defined in Section VI(a) of PTE 84-14) that relies on the relief provided by PTE 84-14, and with respect to which UBS owns a direct or indirect five (5) percent or more interest. The terms “Affiliated QPAM” and “Related QPAM” exclude any Misconduct Entity, and the term “Related QPAM” excludes any entity with respect to which a Misconduct Entity is an “affiliate” (as defined in section VI(d)(1) of PTE 84-14).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         89 FR 65, 23090 (April 3, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         The term “Covered Plan” means a plan subject to Part IV of Title I of ERISA (an ERISA-covered plan) or a plan subject to Code section 4975 (an IRA), in each case, with respect to which an Affiliated QPAM relies on PTE 84-14 or with respect to which an Affiliated QPAM (or any UBS affiliate) has expressly represented that the manager qualifies as a QPAM or relies on PTE 84-14. A Covered Plan does not include an ERISA-covered plan or IRA to the extent the Affiliated QPAM has expressly disclaimed reliance on QPAM status or PTE 84-14 in entering into a contract, arrangement, or agreement with the ERISA-covered plan or IRA. Notwithstanding the above, an Affiliated QPAM may disclaim reliance on QPAM status or PTE 84-14 in a written modification of a contract, arrangement, or agreement with an ERISA-covered plan or IRA, where: the modification is made in a bilateral document signed by the client; the client's attention is specifically directed toward the disclaimer; and the client is advised in writing that, with respect to any transaction involving the client's assets, the Affiliated QPAM will not represent that it is a QPAM, and will not rely on the relief described in PTE 84-14.
                    </P>
                </FTNT>
                <P>As discussed below, based on the administration record, the Department makes the requisite findings under ERISA section 408(a) that this exemption is: (1) administratively feasible, (2) in the interest of Covered Plans and their participants and beneficiaries, and (3) protective of the rights of the participants and beneficiaries of Covered Plans. Effective December 31, 1978, section 102 of the Reorganization Plan No. 4 of 1978, (5 U.S.C. App. 1 (1996)) transferred the authority of the Secretary of the Treasury to issue exemptions of the type requested to the Secretary of Labor. Accordingly, this final individual exemption is being issued solely by the Department. Affected parties should be aware that the exemption's conditions are, individually and collectively, necessary for the Department to grant the requested relief. Absent these conditions, the Department would not have granted this exemption.</P>
                <P>
                    <E T="03">Benefits of the Exemption:</E>
                </P>
                <P>The Department's objective in granting this exemption is to protect Covered Plans from the harms and costs UBS represents would be imposed on them if the UBS QPAMs no longer could rely on the relief provided in PTE 84-14. Among other important conditions, this exemption ensures that Covered Plans can terminate their relationships with one of the UBS QPAMs in an orderly and cost-effective fashion when the fiduciary of a Covered Plan determines that it is prudent to do so. This exemption promotes adherence to basic fiduciary standards and responsibilities required by Title I of ERISA and the Code by the UBS QPAMs and reinforces their obligation to act with a high degree of integrity on behalf of their Covered Plan clients as required by PTE 84-14.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>1. UBS is a Swiss-based global financial services company organized under the laws of Switzerland. On June 12, 2023, UBS acquired CSAG, another Swiss-based global financial services firm. This acquisition brought Credit Suisse Asset Management, LLC, a subsidiary of CSAG and a QPAM, under the UBS corporate umbrella. UBS represents that on May 1, 2024, Credit Suisse Asset Management, LLC was merged into UBS Asset Management (Americas) LLC. (UBS Americas), and UBS Americas is the surviving entity after the merger. As of November 5, 2024, UBS represents that UBS Americas is the only current Affiliated QPAM. </P>
                <HD SOURCE="HD2">PTE 84-14</HD>
                <P>
                    2. PTE 84-14 reflects the Department's conclusion that it could provide broad relief from the prohibited transaction provisions of ERISA section 406(a) and Code section 4975(c)(1) only if the commitments and the investments of plan assets and the negotiations leading thereto are the sole responsibility of an independent discretionary manager called a Qualified 
                    <PRTPAGE P="3930"/>
                    Plan Asset Manager or “QPAM” that meets the exemption's conditions.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         “Qualified Plan Asset Manager” or “QPAM” is defined in Section VI(a) of PTE 84-14. (See 89 FR 65, 23090, 23141 (April 3, 2024)).
                    </P>
                </FTNT>
                <P>
                    3. Section I(g) of PTE 84-14 provides that a QPAM becomes ineligible to rely on the relief provided by PTE 84-14 for ten years following: (1) a Criminal Conviction, as such term is defined in Section VI(s) of PTE 84-14, of the QPAM or an “affiliate” thereof,
                    <SU>6</SU>
                    <FTREF/>
                     or any direct or indirect owner of a five percent or more interest in the QPAM; or (2) on or after June 17, 2024, the date on which the QPAM, an “affiliate” thereof, or any direct or indirect owner of a five percent or more interest in the QPAM is found or determined in a final judgment or court-approved settlement by a Federal or State criminal or civil court to have engaged in Prohibited Misconduct, as such term is defined in Section VI(t) of amended PTE 84-14.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section VI(d) of PTE 84-14 defines the term “affiliate” for purposes of Section I(g) as “(1) Any person directly or indirectly through one or more intermediaries, controlling, controlled by, or under common control with the person, (2) Any director of, relative of, or partner in, any such person, (3) Any corporation, partnership, trust or unincorporated enterprise of which such person is an officer, director, or a five percent or more partner or owner, and (4) Any employee or officer of the person who—(A) is a highly compensated employee (as defined in Section 4975(e)(2)(H) of the Code) or officer (earning 10 percent or more of the yearly wages of such person), or (B) has direct or indirect authority, responsibility or control regarding the custody, management or disposition of plan assets.” (See 89 FR 23090, 23141 (April 3, 2024)).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The prohibited misconduct provision was effective on June 17, 2024 (89 FR 65, 23090 (April. 3, 2024)).
                    </P>
                </FTNT>
                <P>4. The Department included Section I(g) in PTE 84-14 based on its expectation that QPAMs will maintain a high standard of integrity in order to remain eligible to receive the broad prohibited transaction relief provided in PTE 84-14. This expectation extends not only to the QPAM itself, but also to those who may be in a position to influence the QPAM's policies. </P>
                <HD SOURCE="HD3">Relevant Convictions</HD>
                <P>
                    5. UBS-related entities are currently the subject of four criminal convictions that violate Section I(g) of PTE 84-14 (the Convictions). To protect Covered Plans from the costs and harms that UBS represents could arise if the UBS QPAMs suddenly lost their ability to engage in potentially beneficial transactions on behalf of their Covered Plan clients under PTE 84-14 due to these Convictions, the Department issued several temporary individual prohibited transaction exemptions over several years with protective conditions that are discussed below.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         In connection with the Credit Suisse-related convictions, the Department issued the following exemptions: PTE 2022-01 (87 FR 1186 (Jan. 10, 2022)); PTE 2019-07 (84 FR 61928 (Nov. 14, 2019)); PTE 2015-14 (80 FR 59817 (Oct. 2, 2015)); PTE 2014-11 (79 FR 68716 (Nov. 18, 2014)). In connection with the UBS-related convictions, the Department issued: PTE 2020-01 (85 FR 8020 (Feb. 12, 2020)); PTE 2019-01 (84 FR 6163 (Feb. 26, 2019)); PTE 2017-07 (82 FR 61903 (Dec. 29, 2017)); PTE 2016-17 (81 FR 94049 (Dec. 22, 2016)); PTE 2013-09 (78 FR 56740 (Sep. 13, 2013)).
                    </P>
                </FTNT>
                <P>
                    6. 
                    <E T="03">The 2017 UBS Conviction.</E>
                     In 2013, UBS Securities Japan Co. Ltd. (UBS Securities Japan) pled guilty to a crime arising out of its fraudulent submission of Yen London Interbank Offer (Yen LIBOR) rates between 2006 and 2009, and its participation in a scheme to defraud counterparties to interest rate derivatives trades executed on its behalf by secretly manipulating certain benchmark interest rates to which the profitability of those trades was tied (the 2013 UBS Conviction).
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         The UBS QPAMs received exemptive relief to continue to rely on PTE 84-14 notwithstanding the 2013 Conviction. However, the Section I(g) disqualification period for the 2013 Conviction expired on or about February 19, 2023; therefore, the UBS QPAMs no longer require exemptive relief from the Department to continue their reliance on PTE 84-14 with respect to the 2013 conviction.
                    </P>
                </FTNT>
                  
                <P>7. In connection with misconduct related to the 2013 UBS Conviction, UBS and the United States Department of Justice (DOJ) entered into a Non-Prosecution Agreement (the LIBOR NPA) wherein the DOJ agreed not to criminally prosecute UBS for any crimes related to UBS's misconduct involving its submission of Yen LIBOR rates and other benchmark rates between 2001 and 2010 (LIBOR Manipulation). A provision of DOJ's LIBOR NPA required UBS to avoid engaging in additional criminal activity for two years from the date of the LIBOR NPA.</P>
                <P>
                    8. Separately from the LIBOR Manipulation and after entering into the LIBOR NPA, UBS also was determined by DOJ to have participated in deceptive currency trading and sales practices with respect to certain foreign exchange (FX) market transactions and collusive conduct in certain FX markets (FX Misconduct). DOJ determined that by engaging in the FX Misconduct, UBS had breached the terms of the LIBOR NPA. As a result, UBS entered a guilty plea and was convicted on January 10, 2017 of engaging in the LIBOR Manipulation that was the subject of the LIBOR NPA. Specifically, UBS pled guilty to a scheme to defraud counterparties to interest rate derivatives transactions by secretly manipulating benchmark interest rates to which the profitability of those transactions was tied. This conviction is referred to as the “2017 UBS Conviction,” 
                    <SU>10</SU>
                    <FTREF/>
                     which disqualifies UBS-related QPAMs from relying on the relief set forth in PTE 84-14 for a ten-year period from January 10, 2017, through January 9, 2027.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         In PTE 2023-14, the Department erroneously referred to this conviction as the 2018 Conviction. The conviction actually occurred on January 10, 2017 (as described in PTE 2020-01, the prior UBS exemption).
                    </P>
                </FTNT>
                <P>
                    9. 
                    <E T="03">The 2014 CSAG Conviction.</E>
                     On May 19, 2014, the Tax Division of DOJ and the U.S. Attorney's Office for the Eastern District of Virginia filed a one-count criminal information in the District Court for the Eastern District of Virginia charging CSAG with a conspiracy to violate Code section 7206(2) in contravention of Title 18, United States Code, Section 371. According to the Statement of Facts, for decades before and through approximately 2009, CSAG operated an illegal cross-border banking business that knowingly and willfully aided and assisted thousands of U.S. clients in opening and maintaining undeclared accounts that concealed offshore assets and income from the Internal Revenue Service. On May 19, 2014, pursuant to a plea agreement (the Plea Agreement), CSAG pleaded guilty to a charge of assisting U.S. citizens in federal income tax evasion. The District Court entered a judgment of conviction against CSAG on November 21, 2014, which disqualified CSAG-related (and, thus, UBS-related QPAMs due to the merger) from the relief set forth in PTE 84-14 from November 21, 2014, through November 20, 2024.
                </P>
                <P>
                    10. 
                    <E T="03">The 2019 UBS France Conviction.</E>
                     In 2013, France opened an investigation into UBS, UBS France, and certain former employees of UBS France S.A. The investigation centered on the maintenance of foreign (“cross-border”) UBS bank accounts held for private citizens. Following a trial in the French First Instance Court, the French court convicted UBS and UBS France on February 20, 2019, of illegally soliciting clients from 2004 to 2012 and laundering the proceeds of tax fraud from 2004 to 2012. Based on this conviction, the UBS-related QPAMs were disqualified from relying on the relief provided in PTE 84-14 from February 20, 2019, through February 19, 2029.
                </P>
                <P>
                    11. 
                    <E T="03">The 2022 Credit Suisse Securities (Europe) Limited (CSSEL) Conviction.</E>
                </P>
                <P>
                    On October 19, 2021, DOJ's, Criminal Division, Money Laundering and Asset Recovery Section and Fraud Section and the United States Attorney's Office for the Eastern District of New York, filed a criminal information in the District Court for the Eastern District of New 
                    <PRTPAGE P="3931"/>
                    York charging CSSEL with one count of conspiracy to commit wire fraud in violation of 18 U.S.C. 1349. CSSEL agreed to resolve the action through a plea agreement presented to the New York District Court on October 19, 2021 (the CSSEL Plea Agreement). Under the CSSEL Plea Agreement, CSSEL agreed to enter a guilty plea to the charge set out in the CSSEL information (the CSSEL Plea).
                </P>
                <P>The District Court entered a judgment of conviction against CSSEL on July 22, 2022. Due to the judgement of conviction, the CSAG-related QPAMs (and, thus, UBS-related QPAMs due to the merger) are ineligible from relying on the relief set forth in PTE 84-14 from July 22, 2022 through July 21, 2032.</P>
                <HD SOURCE="HD1">Requests for Relief and Additional Information</HD>
                <P>
                    12. On April 17, 2023, UBS and CSAG (and their affiliated QPAMs) submitted an exemption application to the Department that requested modifications to their existing exemptions due to their imminent merger. On June 2, 2023, the Department published PTE 2023-14, which allowed UBS-related and Credit Suisse-related QPAMs to continue to rely on PTE 84-14, notwithstanding the Convictions, for one year following the date of the merger, which UBS represents occurred on June 12, 2023 (the Merger). PTE 2023-14 had an audit requirement tailored to the unique circumstances of the one-year exemption, which is referred to as the Stub Period Audit.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Before the merger of UBS and CSAG, PTE 2020-01 required that the UBS QPAMs submit to annual audits covering periods from March 20 through March 19 of the following year (the CS QPAMs were on a different audit schedule). Upon the merger of UBS and CSAG on June 12, 2023, a one-year temporary exemption provided in PTE 2023-14 became effective. PTE 2023-14 provided that the combined UBS-CSAG entity would resume audits on a unified schedule from June 12, 2023, through June 11, 2024. Thus, the last audit to occur under PTE 2020-01, originally scheduled from March 20, 2023 through March 19, 2024, was modified to run from March 20, 2023, through June 11, 2023 and became known as the Stub Period Audit.
                    </P>
                </FTNT>
                <P>
                    13. On February 22, 2024, UBS filed an exemption application with the Department that requested a five-year extension of PTE 2023-14 from June 12, 2024, through June 11, 2029. During the Department's review process for UBS' exemption application, the Department requested additional information from UBS regarding the auditor's findings for each audit that was performed before its application was submitted. In response, UBS' counsel notified the Department on May 3, 2024, that UBS failed to complete the Stub Period Audit report, and UBS did not submit the certified audit report to the Department until May 10, 2024.
                    <SU>12</SU>
                    <FTREF/>
                     In fact, the record currently before the Department indicates that UBS did not engage the independent auditor, Fiduciary Counselors Inc, to complete the Stub Period Audit until March 18, 2024, notwithstanding the fact that PTE 2023-14 required the audit to be completed by December 9, 2023, and for the audit report to be certified and submitted to the Department by January 23, 2024. The Department stated in the proposed exemption that UBS should have engaged an independent auditor well in advance of the dates set forth in Section III(j) of the exemption for the audit to be timely completed and for the audit report to be timely certified and submitted to the Department.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         In a supplemental letter to the Department dated May 29, 2024, UBS' counsel informed the Department that the auditor notified UBS about the failure to complete the stub audit in January 2024, and the auditor sent a draft of the engagement letter to perform the audit to UBS on February 12, 2024. These events occurred before the Department received UBS' exemption application on February 23, 2024, and UBS should have disclosed them in its exemption application.
                    </P>
                </FTNT>
                <P>
                    14. On June 11, 2024, the Department published a proposed exemption in the 
                    <E T="04">Federal Register</E>
                     with an effective period from June 12, 2024, through June 11, 2029. The Proposal alerted UBS that its failure to timely comply with the Stub Period Audit requirement violated an important condition of the relief the Department provided in PTE 2023-14. UBS itself pointed out the importance of the audit requirement in its exemption application where it stated that, “[t]he purpose of the independent audit is to give [Covered Plan] clients and the Department the confidence that the asset manager is complying with ERISA, and that continued exemptive relief is warranted.” In the Proposal, the Department reiterated this point by stating that it included the independent audit requirements in the exemption to ensure that the UBS QPAMs remain insulated from the convicted UBS and Credit Suisse entities and could be trusted to safeguard plan assets, notwithstanding the convictions.
                </P>
                <P>
                    15. Because the UBS QPAMs failed to comply with the audit conditions of the exemption, the Department determined that they were ineligible to rely on the relief provided by PTE 2023-14, and the Department indicated in the proposed exemption that it is considering whether it should grant retroactive relief extending back to June 12, 2023 as part of this exemption, which would otherwise provide relief only from June 12, 2024 through June 11, 2029. The Department requested comments from UBS, the public, and interested parties on whether retroactive relief is appropriately including in this exemption, which would extend exemptive coverage to include the period from June 12, 2023, through June 11, 2024, as well as June 12, 2024, through June 11, 2029. The Department also requested UBS provide a detailed statement regarding how a grant of retroactive relief would be consistent with the requirements for such relief set forth in the Department's exemption procedure regulation.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         29 CFR 2570.35(d).
                    </P>
                </FTNT>
                <P>16. In connection with the Department's request for comment on retroactive relief, in the Proposal, the Department also requested UBS to describe how Covered Plans were safeguarded in light of this failure to satisfy the Stub Audit condition and whether UBS acted in good faith despite its failure. UBS's comments and the Department's responses to those comments are discussed below.</P>
                <HD SOURCE="HD1">Retroactive Relief Periods</HD>
                <P>17. The exemption provides retroactive relief to UBS for two periods. The first period covers June 12, 2023, through June 11, 2024, and allows UBS QPAMs to rely on PTE 84-14 despite UBS' failure to comply with the Stub Period Audit requirement in Section III(j)(1) of PTE 2023-14. The second period of retroactive relief applies from June 12, 2024, through January 15, 2025, and is needed because UBS failed to submit a complete exemption application with sufficient information (including a description of its failure to meet the Stub Period Audit Requirement) and enough lead time for the Department to develop a complete administrative record, publish a proposed exemption with an adequate public notice and comment period, consider the public comments received, and publish this grant notice exemption before the relief provided under PTE 2023-14 expired.</P>
                <P>
                    <E T="03">Department's Note:</E>
                </P>
                <P>
                    18. The Department notes that this individual exemption would solely provide relief from the ineligibility under PTE 84-14 Section I(g) that occurred with respect to the four criminal convictions of entities within the UBS corporate family that are described above. The conditions of this exemption require the UBS QPAMs to adhere to every other specific condition for relief that is required under PTE 84-14, as amended, including the ineligibility provision in the amended version of PTE 84-14, which became effective on June 17, 2024. If any UBS-
                    <PRTPAGE P="3932"/>
                    Affiliated QPAMs violate any conditions of amended PTE 84-14 in the future, they would fail to comply with the requirements of the exemption, and the relief provided under this exemption would become unavailable.
                </P>
                <HD SOURCE="HD1">Written Comments</HD>
                <P>
                    19. In the Proposal, the Department invited all interested persons to submit written comments and/or requests for a public hearing with respect to the notice of the Proposal by July 29, 2024.
                    <SU>14</SU>
                    <FTREF/>
                     The Department received written comments from the following commenter: (1) UBS; (2) an anonymous commenter; (3) the ERISA Industry Committee; (4) SIFMA; and (5) a group of individuals referring to themselves as the “QPAM Coalition.” 
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         PTE 2024-03's original deadline for the comment period was July 15, 2024. The Department extended the comment period to July 29, 2024, based on two requests from commentors. (See 89 FR 137, 58189).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         The Department also received comments three months after the end of the comment period, as extended, which the Department did not consider.
                    </P>
                </FTNT>
                <P>
                    20. In granting this exemption, the Department has considered the public comments noted above, as well as representations by UBS. If any material statement or representation by UBS to the Department that is included in its application or its comment is not or has not remained completely and factually accurate, UBS must immediately alert the Department.
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         The representations stated herein that are attributable to UBS or any commenter do not reflect factual findings or opinions of the Department. The Department notes that the availability of this exemption is subject to the express condition that the material facts and representations contained in the are true and complete at all times, and accurately describe all material terms of the transactions covered by the exemption. If there is any material change in a transaction covered by the exemption, or in a material fact or representation described in the application, the exemption will cease to apply as of the date of the change.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Comments From UBS</HD>
                <HD SOURCE="HD3">Comment 1: Department's Request for Justification of Retroactive Relief for Failure To Perform Audit</HD>
                <P>21. As stated above, in the Proposal, the Department requested that UBS demonstrate whether retroactive relief is appropriate, and that the UBS QPAMs at a minimum: (a) ensured that appropriate safeguards were established during the period of exemptive relief provided under PTE 2023-14 from June 12, 2023 to June 11, 2024, to protect the interests of Covered Plan clients (the First Retroactive Period); (b) Covered Plan clients were not harmed by non-exempt transactions during the First Retroactive Period; (c) a responsible plan fiduciary acted in good faith and took appropriate steps that were necessary to protect the Covered Plans from abuse, loss, and risk during the First Retroactive Period; and (d) the UBS QPAMs have adjusted their policies and procedures in light of past failures to comply with PTE 2023-14 to ensure that such failures will not reoccur.</P>
                <P>
                    22. Comment #1(a): 
                    <E T="03">UBS Ensured and will ensure that appropriate safeguards were established during the First Retroactive Period to protect the interests of Covered Plan.</E>
                     UBS stated that appropriate safeguards were established during the First Retroactive Period despite its failure to properly perform the required audit. Specifically, UBS represents that the UBS official responsible for overseeing the audits failed to meet the deadline, in part, because they mistakenly believed that the Stub Period Audit's findings would be rolled into the following year's audit report. UBS represents that, upon realizing the mistake, it engaged an independent auditor who completed the Stub Period Audit. The Auditor concluded that it found no deficiencies on behalf of UBS or the UBS QPAMs during the Stub Audit period, and the Auditor provided no recommendations for improvement. In its comment letter, UBS asserted that the successful completion of the Stub Period Audit, albeit late, evidences that UBS established adequate safeguards to protect Covered Plans during the First Retroactive Period.
                </P>
                <P>
                    23. Comment #1(b): 
                    <E T="03">Covered Plan clients were not harmed by non-exempt transactions during the First Retroactive Period.</E>
                     UBS represented that Covered Plans were not harmed by non-exempt transactions. To make that determination, UBS reviewed all Client Plan transactions that UBS conducted from June 2023 to June 2024, which encompassed more than 16,000 transactions. UBS' review determined that there were, in fact, no non-exempt prohibited transactions. In this regard, UBS determined that potentially implicated Client Plan transactions for which UBS QPAMs would otherwise rely on PTE 84-14 were either (1) covered, in the alternative, by other prohibited transaction exemptions or (2) were not, in fact, prohibited transactions.
                </P>
                <P>
                    24. The transactions that UBS determined were not prohibited transactions in need of exemptive relief consisted of approximately three to four hundred loans held during the relevant period in which one component of the investment—a service fee paid to an administrative agent by the borrower, rather than the plan—was not covered by an alternative exemption and very likely involved a party in interest for many of the transactions. UBS confirmed to the Department, however, that the fee was not paid from plan assets. UBS provided that the fee was paid by the 
                    <E T="03">counterparty</E>
                     to the loans, not the plan or UBS, and the fee was not incorporated in the plan's payment for the loans' overarching investment because, as the 
                    <E T="03">lender,</E>
                     the plan's investment was in the form of lending money to the counterparty. UBS further stated that the borrower of these loans also selects the administrative agent on its own accord without direction from plans or UBS. Furthermore, the fees are usually negotiated between the administrative service agent and the borrower before the identity of the plan lender is even known.
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         The Department is not opining on UBS' determination as to whether the transactions it has described are prohibited transactions as that is outside the scope of this prohibited transaction exemption.
                    </P>
                </FTNT>
                <P>
                    25. Comment 1(c): 
                    <E T="03">A responsible plan fiduciary acted (and is acting) in good faith and took (and will take) appropriate steps that are necessary to protect the Covered Plans from abuse, loss, and risk during the Relief Period.</E>
                     UBS maintains that the UBS QPAMs acted in good faith to protect Covered Plans because they maintained extensive protocols to ensure it upheld its fiduciary responsibilities and no Covered Plans were harmed during the Relief Period. For example, UBS represents that its protocols required the UBS QPAMs to seek the best possible trade execution for each and every transaction regardless of the identity of the counterparty, and in accordance with each of the written investment guidelines approved by each Covered Plan. Further, UBS addressed the failure to perform the Stub Audit and proposed changes to its protocols, as discussed immediately below, to ensure that such a failure does not reoccur.
                </P>
                <P>
                    26. Comment 1(d): 
                    <E T="03">The UBS QPAMs have adjusted their policies and procedures in light of past failures to comply with PTE 2023-14 to ensure that such failures will not reoccur.</E>
                     To prevent the reoccurrence of a missed Stub Period Audit, UBS proposed to take the following steps: (1) designate a second Compliance Officer both to facilitate the timely completion of exemption reviews and audits and check to ensure that exemption deadlines are correctly identified and completed; (2) inform the Auditor in writing within 45 days after receiving the Auditor's engagement agreement of the target dates for the Auditor to send UBS the initial document requests and for UBS to respond to those requests; (3) 
                    <PRTPAGE P="3933"/>
                    require the Compliance Officers to provide the Auditor with the Exemption Report created pursuant to Section III(m)(4)(ii) of the exemption within seven days after the Exemption Report's completion; (4) allow the Department to receive audit updates from UBS and the Auditor upon request; and (5) provide the Department with a copy of the Auditor's engagement agreement within 15 days after its execution.
                </P>
                <P>27. The Department is persuaded that adding these conditions to the exemption's existing protective conditions will be beneficial to Covered Plans and has included them in this final exemption.</P>
                <HD SOURCE="HD3">Comment 2: UBS' Materiality Argument</HD>
                <P>28. UBS contends that failing to adhere to a condition of PTE 2023-14 relating to the due date of the Stub Period Audit should not cause it to forfeit the exemptive relief provided in PTE 2023-14 because its failure to comply with the condition was not a “material failure.”  </P>
                <P>29. The Department strongly disagrees with UBS's materiality argument. First, each condition in an exemption is material to the Department's findings and must be adhered to in order for an ERISA-covered plan, IRA, a party in interest, or disqualified person to rely on the exemption. Second, the independent audits required by PTE 2023-14 and similar exemptions are particularly vital to the Department's findings, because they help ensure that, among other things: the QPAMs adhere to their basic fiduciary obligations under ERISA; transactions prohibited under ERISA section 406 are implemented in accordance with the requirements of PTE 84-14 and monitored in a way that protects participants; the Policies and Training requirements of the exemption are maintained; and violations of the Policies and Training requirements are promptly reported and remedied. The purpose of the audit requirement is not merely to ascertain possible past violations, but rather to promote and encourage an ongoing culture of compliance for personnel subject to the audit. The latter goal is ill-served when the QPAMs disregard their obligation to perform timely audits, irrespective of whether any particular audit would have found serious past violations of the exemption's conditions. Lastly, in contradiction of UBS' contention that the failure to comply with the condition was not a “material failure,” UBS acknowledged the importance of the independent audit requirement in its exemption application, which stated that, “[t]he purpose of the independent audit is to give [Covered Plans] clients and the Department the confidence that the asset manager is complying with ERISA, and that continued exemptive relief is warranted.”</P>
                <HD SOURCE="HD3">Comment 3: Covered Plans Would Be Harmed Without an Exemption</HD>
                <P>
                    30. UBS asserts that Covered Plans would incur harm if relief is not granted, because Covered Plans would likely terminate their relationships with the UBS QPAMs and hire new asset managers. UBS contends that Covered Plans would switch because the Covered Plan's fiduciaries would be uncertain as to which transactions would have prohibited transaction relief, and as to the specific conditions and limitations that would be imposed upon those transactions. UBS argues that Covered Plans that switch asset managers would be harmed because they would lose access to UBS's unique services and strategies. Further, the Covered Plans would spend additional fees and incur lost opportunities costs as a result of an asset manager switch, and the additional fees would include costs incurred to solicit and hire a new asset manager. UBS estimates Covered Plans would incur $90 million in liquidation and reinvestment costs as a result of liquidating all of the Covered Plan positions.
                    <SU>18</SU>
                    <FTREF/>
                     In support of this estimate, UBS provided a report from an institutional investment consultant concluding that UBS' assumptions and methodology in calculating these liquidation costs were reasonable and the estimation of $90 million in liquidation costs was also reasonable.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         UBS submitted a report by an independent consultant in support of the estimated liquidation cost.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         The report was provided by John Minihan, Ph.D., a former Senior Lecturer of finance at MIT Sloan School of Management, a former associate editor of the Journal of Investing, and currently an investment management industry consultant with 30 years of experience in institutional investment consulting. Dr. Minahan provided, in summary, that UBS's estimates and assumptions were reasonable as expected values but with two minor caveats. First, asset managers can take several years to transition assets and if market conditions deteriorate during that time transitions could cause additional risk to ERISA clients. Second, new asset managers may decide that not all assets need to be liquidated and, if so, an assumption that all assets need to be liquidated would overstate transition costs. Dr. Minahan believes that these two caveats do not undermine the reasonableness of the estimated expected values “as long as they do not overwhelm each other.” He also provides that these caveats are difficult to quantify and work in opposite directions.
                    </P>
                </FTNT>
                <P>31. Department's Note: While the Department recognizes that Covered Plans may incur certain liquidation and reinvestment costs as a result of liquidating their positions, UBS QPAMs are cautioned that if UBS engages in future conduct prohibited by PTE 84-14, the Department may not be able to make its required findings in order to grant future exemptive relief. UBS QPAMs must take all prudent steps pursuant to its obligations under ERISA section 404 to mitigate risks of losses to, and to defray the reasonable expenses related to the investment of, Covered Plan assets if UBS engages in future conduct prohibited by PTE 84-14. The Department believes that the failure to take such basic steps, in the event that the UBS QPAMs become ineligible for their exemptive relief under PTE 84-14, would likely constitute a violation of the QPAMs' fiduciary duties to act in the best interest of their Covered Plan clients.</P>
                <HD SOURCE="HD3">Comment 4: Nonquantifiable Harms Should Be Considered</HD>
                <P>
                    32. UBS argues that the Department should include nonquantifiable harms in the Department's findings. UBS suggests that the Department has foreclosed including information about potential harms in its findings unless the harm is estimated in dollar amounts.
                    <SU>20</SU>
                    <FTREF/>
                     The Department has no objection to considering any nonquantifiable harms identified by UBS. However, information concerning the dollar value of harms, including the methodology and assumptions made in reaching such dollar values, are important to the Department's analysis. The Department will consider representations about nonquantifiable harm to Covered Plans to the extent the Department is able to determine that the information presented is relevant, reliable, and necessary to the Department's findings. The Department notes, however, that depending on context and the type of harm that the applicant represents may occur, the Department will request to see additional, quantifiable data in order appropriately consider such representations.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         In footnote 24 of the Proposal, “[t]he Department notes that UBS provided information not mentioned in this proposal regarding the potential losses to ERISA clients, but without clearly identifying the dollar amount of losses to plans in concrete terms. In such cases, the Department does not have enough information to include such representations in its findings. However, the information that UBS provided that the Department can rely on is described below.” 89 FR 49219 n.24
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Comment 5: Denying Exemptive Relief Would Negatively Impact the QPAM Program as a Whole  </HD>
                <P>
                    33. UBS argues that denying prospective or retroactive relief would result in wide-ranging consequences for all retirement accounts within the 
                    <PRTPAGE P="3934"/>
                    financial industry. UBS contends, for example, that denying relief would make it more difficult for counterparties to transact with any industry QPAMs because counterparties would be unsure if new convictions or later-discovered issues would result in crippling financial penalties for those counterparties. UBS argues that this increased risk would be priced into the market for all retirement plans, whether or not a QPAM is compliant with PTE 84-14 or an individual exemption with respect to a failure to comply with PTE 84-14 I(g).
                </P>
                <P>34. The Department agrees that a denial of UBS' exemption request could have consequences for Covered Plans. However, these consequences would be due to the widespread UBS-related criminal behavior that occurred over long periods of time, involved massive amounts of client assets, and UBS' inability to comply with the terms of PTE 2023-14 that are described above. The Department does not believe that UBS' history of criminal sanctions is representative of the industry as a whole, or is likely to result in the sorts of consequences suggested by UBS with respect to entities that have far different compliance histories.</P>
                <P>
                    35. Additionally, the Department notes that it is aware that UBS and/or its affiliates are the subject of additional investigations that could result in future violations of Section I(g) of PTE 84-14.
                    <SU>21</SU>
                    <FTREF/>
                     While the Department cannot opine on the likelihood that UBS asset managers will receive additional exemptive relief if it engages in additional violations of Section I(g) of PTE 84-14, the Department may take a proactive approach to protecting Covered Plans in light of the uncertainty created by these additional investigations. Especially given the history and extent of criminal conduct at issue, the Department is considering proposing an individual exemption that would, in certain circumstances, permit UBS asset managers to continue to engage in the same covered transactions described in Section I of PTE 84-14, if the UBS QPAMs become ineligible again to rely on PTE 84-14 due to another violation of Section I(g) of PTE 84-14.
                    <SU>22</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         See, for example, the following publicly available news articles describing inquiries into possible UBS/Credit Suisse-related misconduct: UBS's French unit placed under formal investigation at 
                        <E T="03">https://www.fnlondon.com/articles/ubs-french-division-placed-under-formal-investigation-20160304;</E>
                         Credit Suisse has violated US tax evasion deal, Senate Committee finds | The Business Standard, at 
                        <E T="03">https://www.tbsnews.net/world/global-economy/credit-suisse-has-violated-us-tax-evasion-deal-senate-committee-finds-607578.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         It is expected that a number of conditions would apply, including that no QPAM or its personnel were involved in the Prohibited Misconduct.
                    </P>
                </FTNT>
                <P>
                    36. As currently contemplated, the relief that would be provided in the individual exemption would not be linked to PTE 84-14, and the asset managers that rely on the individual exemption would not be referred to as QPAMs.
                    <SU>23</SU>
                    <FTREF/>
                     If the Department takes this approach, the proposed individual exemption would be subject to a full notice and comment period, and UBS, plan fiduciaries and plan counterparties would have ample opportunity to comment.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         The Department notes that, should UBS QPAMs become disqualified from the relief in this exemption due to additional UBS-related prohibited misconduct described in Section I(g) of PTE 84-14, Section I(i) of PTE 84-14 may permit UBS QPAMs to continue to rely on the class exemption for one year, if the terms and conditions of the class exemption are met. In that instance, the effective date of the above-described individual exemption, if granted, would begin following the period covered by Section I(i) of PTE 84-14.
                    </P>
                </FTNT>
                <P>37. The Department previously raised the possibility of this type of individual exemption in the preamble to the PTE 2023-14 proposal and requested comment from UBS. UBS responded that current QPAMs have existing contracts that expressly rely on the QPAM exemption or include representations that the asset manager is a QPAM, and those contracts do not account for an alternative individual exemption such as the one the Department described in the preamble to the proposal for PTE 2023-14. Moreover, UBS asserted that the QPAM exemption is widely accepted and understood by sophisticated clients; therefore, the Department's withdrawal of the availability of the relief provided in PTE 84-14 for a particular asset manager and substituting an alternative individual exemption would put that asset manager at a competitive disadvantage. UBS claimed that this result is directly contrary to the financial strength and stability that regulators intended to be achieved by the Merger, and that if the Department is interested in creating an alternative individual exemption to the QPAM exemption, it should make the alternative available to all asset managers concurrently with the QPAM exemption, so that the alternative can gain broad market adoption.</P>
                <P>38. The Department is not persuaded by UBS' response. The fact that UBS QPAMs may have existing contracts with the provisions and limitations described above, is not dispositive to the Department's determination whether UBS QPAMs should be permitted to continue to rely on PTE 84-14, especially considering UBS' multiple violations of Section I(g) of the class exemption that call its integrity and compliance culture into question. The Department is also skeptical of assertions that it should rely on the parties' contract provisions as a basis for disregarding exemption conditions or limiting the consequences of violating those provisions. A QPAM cannot simply contract with a client in a manner that ensures the QPAM will always be able to remain a QPAM, regardless of the QPAM's or its affiliates' behavior.</P>
                <P>39. Further, the fact that the QPAM exemption is widely accepted and understood by sophisticated clients suggests to the Department that these counterparties would not be confused by an individual exemption that clearly states it has the same scope of relief as Section I of PTE 84-14. UBS' “competitive disadvantage” arguments also do not support a finding under ERISA Section 408(a) that UBS QPAMs should be permitted to rely on PTE 84-14; particularly where to the Department's knowledge, none of UBS' “competitors” have as many disqualifying convictions as UBS.  </P>
                <P>40. Regarding UBS's suggestion that the Department should make the individual exemption approach “available to all asset managers concurrently with the QPAM exemption, so that the alternative can gain broad market adoption,” the Department notes that the scope, seriousness, and recurrent nature of UBS' prohibited misconduct are unique. Therefore, the Department is not persuaded that making such an individual exemption available for broad market adoption is presently warranted.</P>
                <HD SOURCE="HD3">Comment 6: Indemnification</HD>
                <P>
                    41. Section III(k) of PTE 2023-14 requires UBS to “indemnify and hold harmless the Covered Plans for any actual losses resulting directly from UBS QPAM's violation of fiduciary duties, prohibited transactions, breach of contract, or any claim arising out of the failure of such QPAM to qualify for the exemptive relief provided by PTE 84-14 as a result of violation of Section I(g) of PTE 84-14.” 
                    <SU>24</SU>
                    <FTREF/>
                     Given this 
                    <PRTPAGE P="3935"/>
                    requirement, the Department requested in the Proposal that UBS comment on why Covered Plans would incur the liquidation and other costs identified by UBS if the Department does not grant relief.
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         PTE 2023-14, Section III(k)(2) requires UBS QPAMs “[t]o indemnify and hold harmless the Covered Plan for any actual losses resulting directly from the QPAM's violation of ERISA's fiduciary duties, as applicable, and of the prohibited transaction provisions of ERISA and the Code, as applicable; a breach of contract by the QP AM; or 
                        <PRTPAGE/>
                        any claim arising out of the failure of such QPAM to qualify for the exemptive relief provided by PTE 84-14 as a result of a violation of Section I(g) of PTE 84-14, other than a Conviction covered under this exemption. This condition applies only to actual losses caused by the QPAM's violations.”
                    </P>
                </FTNT>
                <P>42. In its response, UBS argues that liquidation and additional costs do not result “directly” from UBS's criminal convictions and failures to comply with exemptive conditions. UBS argues instead that a Covered Plan fiduciary and new asset manager's decision to liquidate and reinvest plan assets is an intervening decision by a separate agent, which is inconsistent with one of many definitions of “directly” contained in the Oxford Dictionary.</P>
                <P>43. The Department disagrees with UBS's analysis. The condition requires indemnification for costs that result “directly” from, among other things, “the failure of such QPAM to qualify for the exemptive relief provided by PTE 84-14 as a result of violation of Section I(g) of PTE 84-14.” As UBS itself noted in a letter to the Department, dated July 29, 2024, “[i]n fact, Dr. Minahan, an expert in the field of ERISA plan transitions, projects that if the Department does not grant UBS a new exemption, “then most, and likely all, UBS ERISA Clients would feel forced to replace UBS as their asset manager.” Certainly, to the extent Covered Plans “feel forced” to transition to new asset managers because the UBS QPAMs could no longer rely on PTE 84-14, the liquidation and additional costs arising from the transition constitute actual losses resulting directly from the failure of such QPAM to qualify for the exemptive relief provided by PTE 84-14 as a result of violation of Section I(g) of PTE 84-14. If a plan's fiduciary is compelled to replace a UBS asset manager as a result of a violation of Section I(g) and the asset manager's loss of QPAM status, the affected plan is entitled to indemnification of its associated losses, including the transitional expenses necessary to effectuate the switch to a qualified QPAM.</P>
                <HD SOURCE="HD3">Comment 7. Violation Notice</HD>
                <P>44. Section III(t) of the Proposal includes a condition that would require UBS to send a Violation Notice, as defined therein, to Covered Plans if UBS fails to comply with an exemption condition. UBS commented that this proposed condition would be too difficult to administer and would not materially increase protection for Covered Plans.</P>
                <P>45. The Department disagrees. Providing timely information to Covered Plans will allow their fiduciaries to take prudent and timely steps, as necessary to protect themselves from loss of the exemption's protections. This Violation Notice is particularly relevant to UBS due to its history of recidivism.</P>
                <P>46. However, the Department understands UBS' position that certain aspects of the Violation Notice requirement may be difficult to administer. In particular, UBS raised concerns regarding the difficulty it would confront to determine whether a Violation Notice must be issued. In response to this concern, and as a recognition that UBS may need more time to make its required determination that sending a violations notice is required, the Department has revised the deadline in Section III to extend the time a Violation Notice must be provided to Covered Plans as a result of a breach of an exemption condition, from 14 to 30 days after the violation is discovered. In situations where the auditor discovers a violation that the UBS QPAM had not previously detected, the UBS QPAM may comply with the Violation Notice condition by sending the Violation Notice to all affected Covered Plans and the Department within 30-days after the completion of the audit, if the notice includes an addendum describing the reason for the UBS QPAM's failure to send the Violation Notice. This last provision is not a substitute for UBS' own responsibility to take reasonable steps to determine whether a violation has occurred.</P>
                <HD SOURCE="HD3">Comment 8: Written Processes Related to Indemnification</HD>
                <P>47. Section III(v) of the Proposal would require all UBS QPAMs to develop written processes that clearly describe: (a) how the QPAM identifies and quantifies “actual losses” for purposes of Section III(j)(2) of the exemption; and (b) how Covered Plans may recover or avoid incurring the losses that the UBS QPAM must indemnify or hold Covered Plans harmless from incurring pursuant to Section III(j)(2) of the exemption. UBS commented that losses are too specific to each Covered Plan for it to develop an effective written indemnification process. Additionally, UBS asserted that it would be unable to develop written processes for indemnification because the party seeking indemnification would have to identify the specific covered losses or expenses.</P>
                <P>
                    48. The Department disagrees with UBS' interpretation of this condition. The condition simply requires UBS to establish a process that would apply when Covered Plans submit indemnification claims, not to identify all the specific losses or expenses that could conceivably be covered in advance of violation. The process should, at a minimum, inform Covered Plans of how to initiate a claim for indemnification with a UBS QPAM (including a description of the information required to be submitted) and provide reasonable time frames for the resolution of claims. The process should also ensure that substantially similar claims are treated alike, and Covered Plans are equitably treated based on the merits of the claim rather than type or size of client. The process also should require the UBS QPAM to fully and fairly notify Covered Plans of the indemnification requirement and inform them that they can submit questions relating to the final indemnification provision to the Department's email inbox (
                    <E T="03">e-oed@dol.gov</E>
                    ). The Department believes that these clarifications address the concerns raised by UBS.
                </P>
                <P>49. Further, the Department has revised the provision in the final exemption to require each UBS QPAM to complete the development of the indemnification claims process and deliver a copy of the process to each Covered Plan within 90 days after January 15, 2025, rather than within 30 days as originally proposed. The extended timelines give the UBS QPAMs enough time to specify appropriate processes and make any required internal changes to operationalize such processes. The exemption requires the UBS QPAMs to notify Covered Plans of any subsequent material changes to the processes within 30 days after the effective date of such changes.</P>
                <HD SOURCE="HD3">Comment 9: Seconded Employee Definition  </HD>
                <P>
                    50. UBS commented that it has no fundamental objection to the Department's proposed definition of “UBS Seconded Employee” in Section I(l) of the Proposal.
                    <SU>25</SU>
                    <FTREF/>
                     However, UBS 
                    <PRTPAGE P="3936"/>
                    believes that the definition should reflect the language in the recent Deutsche Bank exemption (PTE 2024-02), which does not contain this new definition of Seconded Employee, to promote greater consistency across individual QPAM exemptions.
                    <SU>26</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         The Proposal added a new definition of the term “UBS Seconded Employee” that means, an individual nominally employed by a Misconduct Entity who performs work on behalf of a qualified UBS QPAM, provided that such UBS QPAM is solely responsible for the management and control of the employee's job activities performed on behalf of such QPAM. The UBS QPAM must be solely responsible for the establishment of the employee's job duties and terms of employment (including compensation, promotions, and benefits), and must 
                        <PRTPAGE/>
                        have supervisory responsibility with respect to, among other things, the employee's performance, training, and disciplinary actions. The definition of UBS Seconded Employee is used in Sections III(d) to clarify that an employee of a Misconduct Entity may provide services to a UBS QPAM, as long as the individual is a “Seconded Employee.” Sections III(a) and (b) require that Seconded Employees did not participate in the conduct underlying the Criminal Activity or receive compensation in connection therewith.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         See 89 FR 76, 27789 (April 18, 2024).
                    </P>
                </FTNT>
                <P>
                    51. The Department has decided to retain the proposed language in the final exemption. Conditions in the Department's individual exemptions may evolve over time as it becomes clear that additional clarity or substantive improvements are appropriate. The Department notes that prior QPAM Section I(g) exemptions relied on the term “seconded employee” to permit certain employees to perform services for QPAMs notwithstanding the fact that such employees were nominally employed by a corporate entity that had been involved in misconduct.
                    <SU>27</SU>
                    <FTREF/>
                     In the recent Deutsche Bank exemption, PTE 2024-02, that the Applicant points out, the Department declined to use the term “seconded employee” and instead included a description of the type of employees permitted to perform services under these circumstances.
                    <SU>28</SU>
                    <FTREF/>
                     In the Proposal, the Department created a defined term “UBS Seconded Employee” in order to further streamline the operative language of the exemption. The defined term also slightly modified the language from that which was in the Deutsche Bank exemption to more clearly set forth the requirement that the QPAMs have control over the seconded employee. For example, the term “oversight” was changed to “control” and the term “day to day activities” was changed to “job activities.”
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         These employees were required not to have participated in, been aware of, and received compensation in respect of, any of the misconduct.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Section III(g) of PTE 2024-02 provides that, “Other than with respect to employee benefit plans maintained or sponsored for its own employees or the employees of an affiliate, DB Group Services will not act as a fiduciary within the meaning of ERISA Sections 3(21)(A)(i) or (iii) or Code Sections 4975(e)(3)(A) and (C) with respect to ERISA-covered plan and IRA assets; provided, however, that DB Group Services will not be treated as violating the conditions of this exemption solely because . . . . (2) DB Group Services' employees perform work on behalf of a DB QPAM that is solely responsible for the management and oversight of the DB Group Services' employee's day to day activities performed on behalf of such QPAM, including the employee's performance, training, and terms of employment (including compensation, promotions, and benefits), including any such employees acting in a discretionary fiduciary capacity with respect to the DB QPAM.” See also 89 FR 76, 27795-96.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Comment 10: Other Edits</HD>
                <P>52. UBS requested that the Department make the following edits to the Proposal's operative text, which it characterizes as clarification of facts or technical corrections:</P>
                <P>(a) The definition of “CSAG” in Section I(a)(1) should be revised to clarify that CSAG merged into UBS AG on May 31, 2024, with UBS AG as the surviving entity.</P>
                <P>
                    <E T="03">Department Response:</E>
                     The Department concurs and has made the change.
                </P>
                <P>(b) The definition of “UBS Americas” in Section I(a)(5) should be revised to reflect that UBS AM Americas no longer is wholly owned by UBS Americas, Inc.</P>
                <P>
                    <E T="03">Department Response:</E>
                     The Department concurs and has revised Section I(a)(5) to reflect that UBS AM is 
                    <E T="03">majority</E>
                    -owned by UBS Americas, Inc.
                </P>
                <P>(c) The definition of “UBS Hedge Fund Solutions LLC” in Section I(a)(7) should be deleted because UBS Hedge Fund Solutions LLC merged with UBS Asset Management (Americas) LLC, on April 1, 2024.</P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department has not made the requested change, because the definition in the Proposal provides clarity that the retroactive relief covers the subject entity as well.
                </P>
                <P>(d) The definition of “Affiliated QPAM” should be modified to reflect that UBS AM Americas is the only current UBS QPAM, and a future additional QPAM may sit within a successor of the Asset Management or Global Wealth Management Americas U.S. divisions of UBS.</P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department has not made UBS' requested changes, because the retrospective nature of this exemption warrants defining the term “Affiliated QPAM” consistent with PTE 2023-14, and UBS' requested change would allow an entity to qualify as an Affiliated QPAM notwithstanding that it also fits within the definition of Misconduct Entity.
                </P>
                <P>
                    (e) The footnote in Section I(b) should be deleted.
                    <SU>29</SU>
                    <FTREF/>
                     This footnote is unnecessary. Moreover, UBS O'Connor LLC no longer exists; it merged with UBS AM Americas on April 1, 2024, with UBS AM Americas as the surviving entity.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                          This footnote states that “UBS represents that UBS O'Connor LLC and UBS Realty Investors LLC are entities under the UBS corporate umbrella that currently offer investment products which are accessible by ERISA-covered plans, but do not currently rely on Class PTE 84-14 when managing those products.”
                    </P>
                </FTNT>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department concurs and has made the change.
                </P>
                <P>(f) The definition of “Misconduct Entity” in Section I(i) should be revised to remove “CSAG,” as CSAG no longer exists.</P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department has not made the requested change, because the proposed definition provides clarity that retroactive relief covers periods of time that CSAG existed.
                </P>
                <P>
                    (g) The reference to “CS Affiliated QPAM[s]” in the footnote in Section III(h)(1) should be deleted.
                    <SU>30</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         The referenced footnote states that “[t]he exemption does not preclude the UBSQPAMs and CS Affiliated QPAM from maintaining separate Policies provided that the Policies comply with this exemption.”
                    </P>
                </FTNT>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department concurs and has made the change.
                </P>
                <P>
                    (h) Section III(i) should be revised to require provision of a copy of the audit report to the Risk Committee of 
                    <E T="03">UBS Group AG's</E>
                     Board of Directors and to a senior executive officer of 
                    <E T="03">UBS Group AG's</E>
                     Compliance and Operational Risk Control function.
                </P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department concurs and has made the requested change.
                </P>
                <P>(i) The phrase “one-year exemption” should be revised to “five-year exemption” in Sections III(i)(3) and III(k).</P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department concurs that the operative language in Sections III(i)(3) and III(k) should not read “one-year exemption” and has modified the provisions to read “exemption.”
                </P>
                <P>
                    (j) Section III(m)(1)(ii) should be revised to require that the compliance officer (or officers) have a direct reporting line to either the highest-ranking corporate officer in charge of compliance for the applicable Affiliated QPAM 
                    <E T="03">or the highest-ranking corporate officer in charge of the applicable Affiliated QPAM.</E>
                     This would allow the QPAM to designate the highest-ranking corporate compliance officer as a “compliance officer” under the exemption.
                </P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department concurs and has made the requested change.
                </P>
                <P>
                    (k) Section III(l) should be included in the list in the first clause of Section III(s), and the reference in the second clause of Section III(s) should be to Section III(i)(10), not Section III(i)(11).  
                    <PRTPAGE P="3937"/>
                </P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department concurs and has made UBS' requested changes, although due to changes to Section III(i) described above, the latter change was made to Section III(i)(12) not Section III(i)(11).
                </P>
                <P>
                    (l) The phrase “at all times” should be deleted from Section III(u),
                    <SU>31</SU>
                    <FTREF/>
                     because that phrase is inconsistent with the Proposed Exemption's statement that only “material change[s]” in “material fact[s] or representation[s]” would affect the status of the exemption.
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Section III(u) provides that, “All the material facts and representations set forth in the Summary of Facts and Representations are true and accurate at all times.”
                    </P>
                </FTNT>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department disagrees with this revision. If, at any time, a material representation UBS made to the Department is no longer accurate, UBS must immediately inform the Department. If UBS has questions regarding the materiality of a representation, it should contact the Office of Exemption Determinations immediately.
                </P>
                <HD SOURCE="HD3">Industry Comments</HD>
                <HD SOURCE="HD3">SIFMA (Securities Industry and Financial Markets Association) and the ERISA Industry Committee (ERIC)</HD>
                <P>53. SIFMA and ERIC's comment letters argue that if the Department does not grant UBS retroactive relief, it will cause wide ranging disruption to the securities markets.</P>
                <P>54. The Department notes that it has addressed these broad concerns in its response to Comment 5, above. The Department reiterates that it must make the findings required by ERISA section 408(a) in order to grant an exemption with respect to the particular applicant seeking relief and for the transactions described in the application. If a QPAM or related party's behavior precludes such a finding, any wide-ranging disruption to the securities markets that results would be solely attributable to behavior of such QPAM or related party. As such, many of the concerns raised in SIFMA and ERIC's comments are outside the scope of this exemption.</P>
                <HD SOURCE="HD3">Anonymous</HD>
                <P>55. An anonymous commenter stated without specificity that the Department should not grant the proposed exemption in order to better protect the financial industry from corruption. Since the comment offered no further reasoning or substance, the Department cannot respond with specificity to this comment. This exemption, however, has taken the commenter's position into account by ensuring that Covered Plans are insulated from UBS' malfeasance.</P>
                <HD SOURCE="HD3">The QPAM Coalition Comment 1: Hearing Request</HD>
                <P>
                    56. A commenter entitled the “QPAM Coalition,” is comprised of, at various times, Mr. James S. Henry; Mr. John Christensen; Dr. Paul J. Morganoff; Mr. Ralph Nader; Mr. Khadija Sharife; Mr. Ke Francis Karugu; and Mr. and Mrs. Andreas and Dagmar Frank. The coalition made two separate submissions during the comment period, which are considered together for purposes of this granted notice. As a preliminary matter, the QPAM Coalition requested a public hearing to provide a “more thorough examination and interrogation.” In the view of the QPAM Coalition, the Application omitted critical data required by the Department's exemption procedure regulation, and a public hearing is needed to fully air the universe of relevant lawsuits and criminal investigations concerning UBS' and Credit Suisse's conduct as a fiduciary . . . .
                    <SU>32</SU>
                    <FTREF/>
                     The QPAM Coalition states that “extraordinary new details about UBS/CS misconduct [discussed below] really do deserve to be aired in public.” The QPAM Coalition states that its members “would be available to present even more [i]mportant evidence directly related to the question of whether UBS/CS deserve to have their (collectively) 14th QPAM Exemption since 1994, despite serial criminal convictions.”
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         29 CFR 2570.35(a)(5). The QPAM Coalition also takes issue with UBS' representation that the “number of plans and IRAs to which the exemption will apply are too numerous to identify.”
                    </P>
                </FTNT>
                <P>57. The Department notes that most of the exemptions identified by the QPAM Coalition were either extensions of existing exemptions or necessitated by the merger of UBS and Credit Suisse. Such extensions do not involve new instances of misconduct, and it is inappropriate to treat them as if they were the result of new, distinct, and separate violations of exemption conditions. To the contrary, the grants of extensions generally reflected the Department's view that the QPAMs had complied with the conditions of the initial exemptions. Similarly, it is inappropriate to penalize the UBS QPAMs solely because they received exemptions (including this one) that arose from the merger of Credit Suisse and UBS; particularly when considering that these exemptions did not arise from any additional criminal misconduct or failure to supervise by UBS or its affiliates.</P>
                <P>
                    58. As the Department notes in its exemption procedure regulation (the Procedures),
                    <SU>33</SU>
                    <FTREF/>
                     “[t]he Department will grant a request for a hearing . . . where a hearing is necessary to fully explore material factual issues identified by the person requesting the hearing.” 
                    <SU>34</SU>
                    <FTREF/>
                     The QPAM Coalition provided an expansive and detailed description of the “extraordinary new details” that needed to be discussed at a public hearing in their comment letter. Although the QPAM Coalition suggests that it could provide more evidence at a hearing, the Department's regulations provide that it may decline to hold a hearing if, among other things, “the factual issues identified can be fully explored through the submission of evidence in written (including electronic) form.” 
                    <SU>35</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         29 CFR part 2570 (76 FR 66637 (Oct. 27, 2011)).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         See Section 2570.46(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         See Section 2570.46(b)(3).
                    </P>
                </FTNT>
                <P>
                    59. In the Department's view, the “factual issues” identified by the QPAM Coalition could be and have been fully explored through the submission of its written and electronically provided evidence. The Department also notes that its Procedures provide that hearing requestors must state, among other things, “the nature of the person's interest in the exemption and the manner in which the person would be adversely affected by the exemption.” 
                    <SU>36</SU>
                    <FTREF/>
                     The QPAM Coalition did not state in their comment letters how they would be “materially affected by the exemption.”
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         See Section 2570.46(a)(2).
                    </P>
                </FTNT>
                <P>
                    60. The Department notes that in processing UBS' exemption request, it thoroughly reviewed UBS' application. The Department relied on public comments and a robust exchange of information with UBS and external stakeholders to fill in factual gaps in the public record. The QPAM Coalition's own comment provided information concerning a number of past and current investigations and prosecutions that form part of the public record that the Department has reviewed in making its requisite findings under ERISA section 408(a) Among other materials provided in their comments, the QPAM Coalition provided the text of a decision of the French Court of Cassation, Criminal Division, dated November 15, 2023 dealing with UBS' participation in a cross-border tax evasion via French and Swiss branches of UBS; a copy of the criminal complaint filed by the U.S. Department of Justice against UBS Securities LLC, et al. on November 08, 2018 in Case No. 1:18-cv-06369-RPK-PK; a comment letter describing additional lawsuits and criminal trials that they believe should be taken into 
                    <PRTPAGE P="3938"/>
                    consideration by the Department; 
                    <SU>37</SU>
                    <FTREF/>
                     copies of letters written by members of the QPAM Coalition to the UBS General Counsel 
                    <SU>38</SU>
                    <FTREF/>
                     describing shortcomings in the compliance and controls of Credit Suisse' banking systems and generally detailing efforts to inform UBS and Credit Suisse of “entrenched criminal structures” within Credit Suisse; a transcript of comments at the Department's November 2022 hearing regarding amendments to the QPAM Exemption; and a copy of a letter to the Department 
                    <SU>39</SU>
                    <FTREF/>
                     advocating for the denial of Credit Suisse's exemption application No. D-11819.
                    <SU>40</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         The comment letter provides information about: 
                        <E T="03">United States</E>
                         v. 
                        <E T="03">UBS Securities, LLC, et al.</E>
                         (generally, UBS' conduct in the mortgage crisis); 
                        <E T="03">Murray</E>
                         v. 
                        <E T="03">UBS Securities, LLC</E>
                         601 U.S. 23 (2024) (regarding an employee's claim that UBS forced him to fraudulently certify his analyst reports); 
                        <E T="03">U.S.</E>
                         v. 
                        <E T="03">Birkenfeld</E>
                        , Case No. 08-60099-CR-ZLOCH (concerning offshore bank accounts and suppression of whistleblower activity); and links to various French and German tax fraud matters involving UBS.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         Letter from Dr. Paul Morjanoff, Financial Recovery and Consulting Services Pty Ltd to Ms. Barbara Levi, UBS Group General Counsel, dated July 11, 2023.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         Letter from Dr. Paul Morjanoff, Financial Recovery and Consulting Services Pty Ltd to Thomas Perez, U.S. Secretary of Labor, dated June 23, 2014.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         Credit Suisse was granted PTE 2014-11 on November 18, 2014 (79 FR 68716).
                    </P>
                </FTNT>
                  
                <P>61. The QPAM Coalition's comment further supplemented the record with articles written by its members that describe, among other things: the role of Swiss banks in money laundering and corrupt banking practices in Kenya; how, in the QPAM Coalition's view, Swiss bank secrecy laws facilitate participation by UBS and Credit Suisse in various criminal and political activities, including Swiss banks' past involvement in South Africa's “apartheid machinery”; political activities in Yemen, the Democratic Republic of Congo, and Mozambique; circumvention of European Union sanctions on various governments; the facilitation of corrupt finance and banking activities in various developing countries; and UBS' leveraging of the British Channel Island's legal jurisdiction to avoid criminal prosecution for various acts.</P>
                <P>62. Finally, the QPAM Coalition submitted a brief article advocating for an “institutional grey list” similar to ones established by various inter-governmental organizations, such as the Organization for Economic Co-operation and Development, that would assist the Department in evaluating financial institutions that repeatedly find themselves in violation of applicable law. Even though the information provided by the QPAM Coalition does not lead the Department to conclude that a hearing is necessary to further explore any of the issues presented in its comment, the information provided by the QPAM Coalition validates the importance of one of the exemption's critical conditions: an in-depth annual audit of each UBS QPAM by a qualified, independent auditor. In this regard, the scope of ongoing investigations and potential misconduct identified by the QPAM Coalition in its comments illustrates the need for an independent audit to verify on an annual basis that the UBS QPAMs continue to adhere to applicable fiduciary provisions and the terms of this exemption and maintain a strong culture of compliance.</P>
                <P>63. Based on the record developed by the Department, it does not appear to the Department that UBS QPAM personnel participated in the conduct described by the QPAM Coalition. In fact, the Department is able to make its findings that the UBS QPAMs may continue to rely on PTE 84-14 in part because the QPAMs and their personnel are insulated from the corporate management and business activities of UBS entities that were involved in criminal activity described above. In this regard, the independent auditor must continue to validate, among other things, that the asset management decisions of the QPAM are conducted independently of the corporate and management and business activities of each Misconduct Entity, and any failures of the QPAMs to maintain or follow the Policies must be corrected and reported to the QPAM's head of compliance and general counsel.</P>
                <HD SOURCE="HD3">The QPAM Coalition Comment 2: Rebutting UBS</HD>
                <P>
                    64. The QPAM Coalition's comment focuses on rebutting UBS' five “principal reasons” justifying the Department's grant of a five-year exemption. As described by the QPAM Coalition, UBS argues that (1) the convictions and the pending French charge do not relate to the UBS QPAMs, which are operated as separate businesses from the entities involved in the underlying conduct; (2) the disqualifying conduct described in the convictions and the pending French charge is historical in nature; (3) the UBS QPAMs have documented proof that ERISA plan assets have been safeguarded, as evidenced by their ERISA audit results for many years; (4) it is in the best interest of plans and their participants and beneficiaries for plan fiduciaries, well versed in their obligations to protect plan assets, to be able to select the asset managers they judge best, particularly when DOL-supervised audits confirm the managers' capability; and (5) UBS and the UBS QPAMs should not be punished, in effect, for the acquisition of Credit Suisse AG by UBS Group AG at the strong encouragement of the Swiss government.
                    <SU>41</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See</E>
                         UBS Exemption Application, dated February 22, 2024, pp. 1-2.
                    </P>
                </FTNT>
                <P>65. In response to these arguments, the QPAM Coalition states that (1) is irrelevant because the QPAM Exemption's required standard of integrity relates to the “corporate family's culture of compliance,” and the exemption is a privilege to execute transactions which would otherwise be illegal; (2) is irrelevant because “UBS and Credit Suisse repeatedly engaged in stonewalling and obstruction of investigations, as well as legal tactics of interminable delays, even when they knew of their own guilt;” (3) the UBS and Credit Suisse audit reports are not “proof” because they did not assess all relevant factors, “including if financial instruments were being illegitimately laundered through pension funds;” (4) UBS and Credit Suisse should have taken its responsibility more seriously before engaging in criminal activity; moreover, according to the QPAM Coalition, the UBS entities are still engaging in some of these behaviors; and (5) UBS benefitted greatly from taking over Credit Suisse AG. The QPAM Coalition also points out in their comment that the UBS QPAMs violated various conditions of the exemption, including the requirement for the stub audit.</P>
                <P>66. The Department has considered and rejected the QPAM Coalition's request to deny the UBS QPAMs' exemption application. The QPAM Coalition's points are addressed in turn:</P>
                <P>
                    (1) The Department agrees with the principle that the required standard of integrity in PTE 84-14 relates not just to the QPAM's compliance culture, but also to its “corporate family's culture of compliance.” Therefore, an important aspect of the Proposal is that the UBS QPAMs are operated separately from the parts of the UBS organization that engaged in criminal misconduct underlying the Convictions (Criminal Misconduct). The record in this case demonstrates that the UBS QPAMs have been insulated from UBS' corporate and business decisions, and from the parts of UBS that were involved in the Criminal Misconduct. Furthermore, the Department designed the Proposal's first six conditions for relief to ensure that the UBS QPAMs: (1) had no involvement with the Criminal 
                    <PRTPAGE P="3939"/>
                    Misconduct; and (2) continue to have no relationship with any entity or individual that was involved in the Criminal Misconduct. In order to further support the UBS QPAMs' insulation from the rest of UBS and to strengthen their own culture of compliance, the Department included other conditions in the Proposal that would require the UBS QPAMs to maintain their own policies, procedures, and training program, perform internal compliance reporting, and submit to a publicly available independent audit;
                </P>
                <P>(2) The Department agrees that it is important that the Department consider the Criminal Misconduct irrespective of the applicant's suggestion that it is “historical in nature,” and the Department has, accordingly, considered all the Criminal Misconduct in connection with this exemption. The Department considered the numerous convictions, and the extent of UBS' cooperation (or non-cooperation) with investigators, as well as the information provided by UBS, commenters (including the QPAM Coalition), and other internal and external stakeholders, in formulating the conditions for relief described in this exemption and making its findings under ERISA section 408(a);</P>
                <P>
                    (3) The Department notes that the independent audits are meant to verify that the assets of Covered Plans are managed in accordance with the requirements of Title I of ERISA and the Code, as applicable, and that the requirements of the individual exemptions from Section I(g) of PTE 84-14 are met. The Department determined in this exemption and in others that an independent audit with the requirements described herein, provides a sufficient mechanism for the Department to make its findings that the Proposal is protective of the rights of participants and beneficiaries of Covered Plans; 
                    <SU>42</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         The Department notes that the record does not contain any information that the UBS QPAMs illegally laundered financial instruments through pension plans, and this has not been a specific target of the independent audits required by the Department in numerous individual exemptions. If the QPAM Coalition or any other commenter has evidence demonstrating that the UBS QPAMs had used or permitted money laundering through pension funds, this would be of great import to the Department, and likely also to a number of other Federal and international regulators.
                    </P>
                </FTNT>
                <P>(4) The QPAM Coalition is not clear which responsibilities it is referring to in its statement that UBS should have taken its responsibilities more seriously before engaging in criminal activity. In this regard, the Department notes that the Proposal is focused on the actions of the UBS QPAMS and is not aware that the UBS QPAMs failed to take their responsibilities under ERISA seriously prior to the criminal activity engaged in by other UBS entities. However, the conditions for relief in this grant notice require the UBS QPAMs to adhere to Policies and Training designed to promote adherence to basic fiduciary standards under Title I of ERISA and the Code and reinforce their obligation to act with a high degree of integrity on behalf of their Covered Plan clients as required by PTE 84-14. The Department acknowledges the QPAM Coalition's statement that certain UBS entities continue to be investigated for their participation in various forms of misconduct, but it has not seen evidence of wrongdoing sufficient to warrant a different approach to the exemption than that taken by the Department. Also, when considering past and continuing Criminal Misconduct by other corporate entities, the Department must consider the potential harms to Covered Plans that may result from a denial of the exemption. The final exemption reflects the Department's primary focus on protecting Covered Plans and their participants and beneficiaries from the costs that they may incur if the UBS QPAMs become ineligible to rely on PTE 84-14, subject to the QPAMs' adherence to protective conditions that insulate UBS QPAMs, and by extension Covered Plans, from potential concerns based on the compliance culture in other parts of the organization; and  </P>
                <P>(5) Lastly, the QPAM Coalition states that UBS benefitted greatly from taking over Credit Suisse, thus undercutting the Applicant's argument that UBS should not be punished, in effect for acquiring Credit Suisse AG at the behest of the Swiss government. The Department notes that its primary concern is to ensure that an exemption is in the interest and protective of the rights of Covered Plans and their participants and beneficiaries—not whether UBS benefitted from the acquisition of Credit Suisse AG.</P>
                <P>67. In sum, in response to the QPAM Coalition's rebuttal of UBS, the Department acknowledges the severity of the misconduct at issue, but also notes that none of the specific entities responsible for the wrongdoing are granted relief under the terms of this exemption. In addition to considering past misconduct, the Department must consider the potential harms to Covered Plans that may result from a denial of the exemption. Based on the written administrative record for this exemption, the Department has concluded that the exemption's conditions will appropriately ensure that Covered Plans are protected from future violations, and insulated from the injury they could experience from denial of the requested exemption. The Department also has determined that a hearing is not necessary to further explore the issues raised in the commenter's written submission.</P>
                <HD SOURCE="HD3">The QPAM Coalition Comment 3: Request for Changes to the Exemption</HD>
                <P>68. The QPAM Coalition made a series of requests if the Department determines to grant exemptive relief for the UBS QPAMs. Generally, the QPAM Coalition requested that the Department: (1) require UBS to provide additional information regarding the plans for which it provides services; prohibit UBS from managing plan assets due to a self-perception that it is “above the law”; (2) limit the exemption's effective period to two-years; (3) require UBS to pay monetary penalties (presumably in order to rely on the QPAM Exemption); implement a regime for monitoring UBS compliance with the exemption's conditions that includes a panel of independent auditors; (4) establish a public registry for all financial actors involved in working with QPAMs; and (5)collaborate with financial regulators from around the world in making its determinations regarding UBS' exemption request, and other financial entities that on the relief provided in PTE 84-14.</P>
                <P>69. The Department carefully considered the QPAM Coalition's comments and determined not to make their requested changes for the following reasons. First, the Department does not have the authority to make some of the requested changes. For example, in connection with the exemption process, the Department does not have the authority to prohibit the UBS QPAMs from managing plan assets if the UBS QPAMs rely on other available prohibited transaction exemptions or to require the UBS QPAMs to pay additional monetary penalties based on the Covered Convictions.</P>
                <P>
                    70. Second, in the Department's view, several of the QPAM Coalition's recommendations would not provide meaningful protections to Covered Plans. For example, limiting relief in the exemption to two years as suggested by coalition would not provide much additional protection to Covered Plans especially considering the exemption condition requiring the UBS QPAMs to undergo an in-depth annual audit by an independent auditor. The audit reports are publicly available and could form the basis for the Department to revise or revoke this exemption, if warranted or lead to a referral of the UBS QPAMs to 
                    <PRTPAGE P="3940"/>
                    EBSA's Office of Enforcement in the event that violations of ERISA were revealed through the audit. UBS QPAMs are well aware of these potential consequences, which makes the audit an effective means to ensure compliance with the provisions of Title I of ERISA and the terms of this exemption. The Department also is not persuaded that a panel of auditors would provide significant additional protection to Covered Plans as compared to a single independent auditor experienced and knowledgeable about ERISA and the terms of this exemption.
                    <SU>43</SU>
                    <FTREF/>
                     The Department reviews each audit and is empowered to seek additional information from the auditor if the audit appears lacking in any respect. The Department notes that Covered Plans already receive a copy of the proposed exemption, the final exemption, the Summary and the Statement. Further, the annual independent audit is available to all Covered Plan fiduciaries through EBSA's Public Disclosure Room (see above). This final exemption also adds two additional disclosure requirements (the Violation Notice, and disclosure of the QPAMs' indemnification procedures). The Department is skeptical that, under the circumstances, more disclosure of the kind suggested by the QPAM Coalition 
                    <SU>44</SU>
                    <FTREF/>
                     will benefit Covered Plans, and the QPAM Commenters Coalition has not made a showing to the contrary.
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         The ERISA Coalition also failed to provide any detail regarding how the “panel of auditors” could be operationalized as a condition for relief. Important unanswered questions include how a panel of auditors would be chosen, how they would coordinate their audit findings, and how any conflicts in their findings would be resolved.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         The QPAM Coalition, suggests, among other things, that “foreign banks should provide information on why they wish to open branches in the E.U. financial market, including submission of all possible convictions, deferred prosecution agreements, and equivalent measures, transparently and publicly.”
                    </P>
                </FTNT>
                <P>71. Regarding the comment that the Department should coordinate with regulators around the world, the Department notes that it has communicated with other regulators in the past during its consideration of exemption requests and will continue to do so in the future when appropriate to protect affected plans.</P>
                <P>The conditions of this exemption are not intended to punish UBS or burden the UBS QPAMs in a manner that will not provide meaningful protections to Covered Plans. Instead, the Department's objective in granting this exemption is to (i) insulate UBS QPAMs from the business and corporate decision making of UBS and its affiliates and any Criminal Misconduct or potential future misconduct of UBS and its affiliates; (ii) allow Covered Plans to terminate their relationship with the UBS QPAMs with minimal disruption to the Covered Plans; (iii) create an annual reliable and independent public record that documents the UBS QPAMs' level of compliance with the terms of this exemption and adherence to their basic fiduciary duties; and (iv) provide the Department with the flexibility to revise or revoke the relief in this exemption in a manner most protective of Covered Plans if UBS engages in future criminal activity.</P>
                <HD SOURCE="HD3">Modifications to the Proposal the Department Is Making on Its Own Motion</HD>
                <P>72. The Department has decided to make several minor changes to the Proposal in the final exemption to correct scrivener's errors in the operative text, renumber sections of the operative text, and make certain updates to the factual record.</P>
                <P>
                    73. The Department also revised Section III(l) of the Proposal by replacing text referencing the exemption's termination if a UBS entity is 
                    <E T="03">convicted of a crime</E>
                     described in Section I(g) of PTE 84-14 and replacing this text with the exemption's termination if a UBS entity engages in 
                    <E T="03">conduct prohibited</E>
                     by Section I(g) of PTE 84-14 (see Section III (l) in this exemption). The Department made this modification to ensure consistency with the ineligibility requirements of the recently amended PTE 84-14.
                </P>
                <P>
                    74. Section III(o) of the Proposal reads: “Relief in this exemption will terminate on the date that is six months following the date that a U.S. regulatory authority makes a final decision that UBS or an affiliate of either failed to comply in all material respects with any requirement imposed by such regulatory authority in connection with the Covered Convictions.” The Department inadvertently omitted the words “or CSAG” following “UBS.” Further, the Department has determined to extend the relief period to one year to make the provision consistent with the one-year transition period requirement in Section I(i) of amended PTE 84-14. After these edits, Condition (o) of this final exemption reads: “this exemption will terminate on the date that is one year following the date that a U.S. regulatory authority makes a final decision that UBS 
                    <E T="03">or CSAG</E>
                     or an affiliate of either failed to comply in all material respects with any requirement imposed by such regulatory authority in connection with the Covered Convictions [emphasis added].”
                </P>
                <P>75. Finally, the Department modified Section III(s) of the Proposal by adding language that an Affiliated QPAM will not fail to meet the terms of this exemption if a different Affiliated QPAM failed to provide Covered Plans with a Violation Notice required by Section III(t) of this exemption. The Department is making this revision because it did not intend for a QPAM to lose exemptive relief under the exemption solely when a different QPAM fails to provide a Violation Notice.  </P>
                <P>
                    <E T="03">Publicly Available Information:</E>
                </P>
                <P>76. The complete application file (D-12098) is available for public inspection in the Public Disclosure Room of the Employee Benefits Security Administration, Room N-1515, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, reachable by phone at (202) 693-8673. For a more complete statement of the facts and representations supporting the Department's decision to grant this exemption, please refer to the notice of proposed exemption published on June 11, 2024 (89 FR 49213).</P>
                <HD SOURCE="HD1">General Information</HD>
                <P>The attention of interested persons is directed to the following:</P>
                <P>(1) The fact that a transaction is the subject of an exemption under ERISA section 408(a) and/or Code section 4975(c)(2) does not relieve a fiduciary or other party in interest from certain requirements of other provisions of ERISA or the Code, including but not limited to any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of ERISA section 404, which, among other things, require a fiduciary to discharge their duties respecting the plan solely in the interest of the plan's participants and beneficiaries and in a prudent fashion in accordance with ERISA section 404(a)(1)(B); nor does it affect the requirement of Code section 401(a) that the plan must operate for the exclusive benefit of the employees of the employer maintaining the plan and their beneficiaries.</P>
                <P>(2) As required by ERISA section 408(a) and/or Code section 4975(c)(2), the Department finds that the exemption is: (a) administratively feasible for the Department; (b) in the interests of Covered Plans and their participants and beneficiaries; and (c) protective of the rights of the Covered Plan's participants and beneficiaries.</P>
                <P>
                    (3) This exemption is supplemental to and not in derogation of any other provisions of ERISA and/or the Code, including statutory or administrative 
                    <PRTPAGE P="3941"/>
                    exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive for determining whether the transaction is in fact a prohibited transaction.
                </P>
                <P>(4) The availability of this exemption is subject to the express condition that the facts and representations contained in the application accurately describe all material terms of the transactions that are the subject of the exemption and are true at all times.</P>
                <P>
                    Accordingly, after considering the entire record developed in connection with UBS's exemption application, the Department has determined to grant the following exemption under the authority of ERISA section 408(a) and Code section 4975(c)(2) and in accordance with the Department's exemption procedures set forth in 29 CFR part 2570, subpart B.
                    <SU>45</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         76 FR 66637, 66644, October 27, 2011.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Exemption</HD>
                <HD SOURCE="HD1">Section I. Definitions</HD>
                <P>(a) Names of Certain Corporate Entities:</P>
                <P>(1) The term “CSAG” means Credit Suisse AG, which was 100% owned by Credit Suisse Group AG, before UBS acquired Credit Suisse Group AG on June 12, 2024, and became the sole surviving entity.</P>
                <P>(2) The term “CSAM LLC” means Credit Suisse Asset Management, LLC. On May 1, 2024, CSAM LLC was merged into UBS Americas, with UBS Americas as the surviving entity.</P>
                <P>(3) The term “CSSEL” means Credit Suisse Securities (Europe) Limited an indirectly a wholly owned subsidiary of UBS Group AG.</P>
                <P>(4) The term “UBS” means UBS AG which is a wholly owned subsidiary of UBS Group AG.</P>
                <P>(5) The term “UBS Americas” means UBS Asset Management (Americas) LLC, which is majority owned by UBS Americas, Inc., a wholly owned subsidiary of UBS AG.</P>
                <P>(6) The term “UBS Europe” means UBS Europe SE. UBS Europe is the successor to UBS (France) S.A. UBS (France) S.A. was a wholly owned subsidiary of UBS under the laws of France until 2023. In July of 2023, UBS France S.A. merged into UBS Europe and set up a branch in France called UBS Europe SE France Branch.</P>
                <P>(7) The term “UBS Hedge Fund Solutions LLC” was formerly known as UBS Alternative and Quantitative Investments, LLC and is wholly owned by UBS Americas Holding LLC, a wholly owned subsidiary of UBS. UBS Hedge Fund Solutions merged into UBS Americas on April 1, 2024.</P>
                <P>(8) The term “UBS Securities Japan” means UBS Securities Japan Co. Ltd, a wholly owned subsidiary of UBS incorporated under the laws of Japan.</P>
                <P>(b) The term “Affiliated QPAM” means: UBS Americas, UBS Hedge Fund Solutions LLC, Credit Suisse Asset Management, LLC, and any future separate legal entity within the Asset Management or the Global Wealth Management Americas U.S. divisions of UBS that qualifies as a “qualified professional asset manager” (as defined in Section VI(a) of PTE 84-14) and that relies on the relief provided by PTE 84-14, and with respect to which UBS is an “affiliate” (as defined in Part VI(d) of PTE 84-14). The term Affiliated QPAM excludes a Misconduct Entity.</P>
                <P>(c) The term “Criminal Activity” means the Covered Convictions, the 2013 UBS Conviction, and the FX Misconduct.</P>
                <P>(d) The term “Covered Convictions” means (1) the judgment of conviction against CSAG for one count of conspiracy to violate section 7206(2) of the Internal Revenue Code in violation of Title 18, United States Code, Section 371, that was entered in the District Court for the Eastern District of Virginia in Case Number 1:14-cr-188-RBS, on November 21, 2014 (the “2014 CSAG Conviction”); (2) the judgment of conviction against CSSEL in Case Number 1:21-cr-00520-WFK (the “2022 CSSEL Conviction”); (3) the judgment of conviction against UBS in case number 3:15-cr-00076-RNC in the U.S. District Court for the District of Connecticut for one count of wire fraud in violation of Title 18, United States Code, Sections 1343 and 2 in connection with UBS's submission of Yen London Interbank Offered Rates and other benchmark interest rates between 2001 and 2010; and (4) the judgment of conviction on February 20, 2019, against UBS and UBS France in case Number 1105592033 in the French First Instance Court (the “2019 UBS France Conviction”).</P>
                <P>(e) The term “2013 UBS Conviction” means the judgment of conviction against UBS Securities Japan Co. Ltd. in case number 3:12 cr 00268 RNC in the U.S. District Court of the District of Connecticut for one count of wire fraud in violation of Title 18, United States Code, sections 1343 and 2 in connection with submission of YEN London Interbank Offered Rates and other benchmark interest rates.</P>
                <P>(f) The term “FX Misconduct” means the conduct engaged in by UBS personnel described in Exhibit 1 of the Plea Agreement (Factual Basis for Breach) entered into between UBS and the Department of Justice Criminal Division, on May 20, 2015, in connection with Case Number 3:15-cr-00076-RNC filed in the US District Court for the District of Connecticut.</P>
                <P>(g) The term “Covered Plan” means a plan subject to Part IV of Title I of ERISA (an “ERISA-covered plan”) or a plan subject to Code section 4975 (an “IRA”), in each case, with respect to which an Affiliated QPAM relies on PTE 84-14, or with respect to which an Affiliated QPAM (or any UBS affiliate) has expressly represented that the manager qualifies as a QPAM or relies on PTE 84-14. A Covered Plan does not include an ERISA-covered plan or IRA to the extent the Affiliated QPAM has expressly disclaimed reliance on QPAM status or PTE 84-14 in entering into a contract, arrangement, or agreement with the ERISA-covered plan or IRA. Notwithstanding the above, an Affiliated QPAM may disclaim reliance on QPAM status or PTE 84-14 in a written modification of a contract, arrangement, or agreement with an ERISA-covered plan or IRA, where: the modification is made in a bilateral document signed by the client; the client's attention is specifically directed toward the disclaimer; and the client is advised in writing that, with respect to any transaction involving the client's assets, the Affiliated QPAM will not represent that it is a QPAM, and will not rely on the relief described in PTE 84-14.</P>
                <P>(h) The term “Exemption Period” means the period beginning on June 12, 2024, and ending on June 11, 2029.</P>
                <P>
                    (i) The term “Misconduct Entity” means any one of the following: an entity subject to one of the Covered Convictions, 
                    <E T="03">i.e.,</E>
                     UBS, UBS France (recently merged into UBS Europe), CSAG and CSSEL; the entity subject to the 2013 UBS Conviction, 
                    <E T="03">i.e.,</E>
                     UBS Securities Japan; or an entity that was the subject of the FX Misconduct, 
                    <E T="03">i.e.,</E>
                     UBS.
                </P>
                <P>(j) The term “Related QPAM” means any current or future “qualified professional asset manager” (as defined in Section VI(a) of PTE 84-14) that relies on the relief provided by PTE 84-14, and with respect to which UBS owns a direct or indirect five (5) percent or more interest, but with respect to which a Misconduct Entity is not an “affiliate” (as defined in section VI(d)(1) of PTE 84-14). The term “Related QPAM” excludes a Misconduct Entity.  </P>
                <P>
                    (k) The term “best knowledge,” “to the best of one's knowledge,” “best knowledge at that time,” and other similar “best knowledge” terms shall include matters that are known to the 
                    <PRTPAGE P="3942"/>
                    applicable individual or should be known to such individual upon the exercise of such individual's due diligence required under the circumstances, and, with respect to an entity other than a natural person, such term includes matters that are known to the directors and officers of the entity or should be known to such individuals upon the exercise of such individuals' due diligence required under the circumstances.
                </P>
                <P>(l) The term “UBS Seconded Employee” means, an individual nominally employed by a Misconduct Entity who performs work on behalf of a UBS QPAM; provided that such UBS QPAM is solely responsible for the management and control of the employee's job activities performed on behalf of such QPAM. Notwithstanding the preceding sentence, the UBS QPAM must be solely responsible for the establishment of the employee's job duties and terms of employment (including compensation, promotions, and benefits); and must have supervisory responsibility with respect to, among other things, the employee's performance, training, and disciplinary actions.</P>
                <P>(m) The term “UBS QPAMs” means, individually or collectively, the Affiliated QPAMs and/or the Related QPAMs.</P>
                <P>(n) The “conduct” of any person or entity that is the “subject of” the Criminal Activity encompasses any misconduct of CSAG, CSSEL, UBS, UBS France (later merged with UBS Europe), UBS Securities Japan, and/or their personnel: (i) that is described in Exhibit 3 to the Plea Agreement entered into between UBS and the Department of Justice Criminal Division, on May 20, 2015, in connection with case number 3:15-cr-00076-RNC; (ii) that is described in Exhibits 3 and 4 to the Plea Agreement entered into between UBS Securities Japan and the Department of Justice Criminal Division, on December 19, 2012, in connection with case number 3:12-cr-00268-RNC; (iii) that is described in Exhibit 1 of the Plea Agreement (Factual Basis for Breach) entered into between UBS and the Department of Justice Criminal Division, on May 20, 2015, in connection with Case Number 3:15-cr-00076-RNC filed in the US District Court for the District of Connecticut; (iv) that is the basis of the 2019 UBS France Conviction; and (v) that is the subject of the 2014 CSAG Conviction and the 2022 CSSEL Conviction described in Section I(c)(1) and (c)(2).</P>
                <P>(o) The term “participate in” when used to describe an individual or entity's participation in the Criminal Activity refers not only to active participation in the Criminal Activity but also includes an individual or entity's knowledge or approval of the Criminal Activity, without taking active steps to prohibit such conduct, such as reporting the conduct to the individual's supervisors, and to the Board of Directors.</P>
                <HD SOURCE="HD1">Section II. Covered Transactions</HD>
                <P>
                    (a) UBS QPAMs are not precluded from relying on the exemptive relief provided by Prohibited Transaction Exemption 84-14 (PTE 84-14) 
                    <SU>46</SU>
                    <FTREF/>
                     during the Exemption Period, notwithstanding the “Covered Convictions,” provided that the definitions in Section I and the conditions in Section III are satisfied.
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         49 FR 9494 (March 13, 1984), as corrected at 50 FR 41430, (Oct. 10, 1985), as amended at 70 FR 49305 (Aug. 23, 2005), as amended at 75 FR 38837 (July 6, 2010), and as amended at 89 FR 23090 (April 3, 2024).
                    </P>
                </FTNT>
                <P>(b) UBS QPAMS are not precluded from relying on the exemptive relief provided by PTE 84-14 during the period from June 12, 2023, to June 11, 2024, notwithstanding UBS's failure to comply with Section III(j)(1) of PTE 2023-14.</P>
                <HD SOURCE="HD1">Section III. Conditions</HD>
                <P>(a) The UBS QPAMs (including their officers, directors, agents other than the Misconduct Entities, employees of such QPAMs, and UBS Seconded Employees) did not know nor have reason to know of and did not participate in the conduct underlying the Criminal Activity. Further, any other party engaged on behalf of the UBS QPAMs who had responsibility for, or exercised authority in connection with, the management of plan assets did not know or have reason to know of and did not participate in the criminal conduct underlying the Criminal Activity.</P>
                <P>(b) The UBS QPAMs (including their officers, directors, agents other than the Misconduct Entities, employees of such QPAMs, and UBS Seconded Employees) did not receive direct compensation, or knowingly receive indirect compensation, in connection with the criminal conduct that is the subject of the Criminal Activity. Further, any other party engaged on behalf of the UBS QPAMs who had responsibility for, or exercised authority in connection with the management of plan assets did not receive direct compensation, or knowingly receive indirect compensation, in connection with the Criminal Activity.</P>
                <P>(c) The Affiliated QPAMs do not currently and will not in the future employ or knowingly engage any of the individuals who participated in the criminal conduct underlying the Criminal Activity.</P>
                <P>(d) At all times during the Exemption Period, no Affiliated QPAM will use its authority or influence to direct an “investment fund” (as defined in Section VI(b) of PTE 84-14) that is subject to ERISA or the Code and managed by such Affiliated QPAM with respect to one or more Covered Plans, to enter into any transaction with a Misconduct Entity or to engage a Misconduct Entity to provide any service to such investment fund, for a direct or indirect fee borne by such investment fund, regardless of whether such transaction or service may otherwise be within the scope of relief provided by an administrative or statutory exemption. An Affiliated QPAM will not fail this condition solely because:</P>
                <P>(1) A UBS (or successor) affiliate serves as a local sub-custodian that is selected by an unaffiliated global custodian that, in turn, is selected by someone other than a UBS QPAM; or</P>
                <P>(2) Services are provided by UBS Seconded Employees.</P>
                <P>(e) Any failure of an Affiliated QPAM to satisfy Section I(g) of PTE 84-14 arose solely from the Covered Convictions.</P>
                <P>(f) A UBS QPAM did not exercise authority over the assets of any plan subject to Part 4 of Title I of ERISA (an “ERISA-covered plan”) or Code section 4975 (an “IRA”) in a manner that it knew or should have known would further the criminal conduct underlying the Criminal Activity; or cause the UBS QPAM or its affiliates to directly or indirectly profit from the criminal conduct underlying the Criminal Activity.</P>
                <P>(g) No Misconduct Entity will act as a fiduciary within the meaning of ERISA section 3(21)(A)(i) or (iii) or Code section 4975(e)(3)(A) and (C) with respect to ERISA-covered Plan and IRA assets, except that each may act as such a fiduciary with respect to employee benefit plans sponsored for its own employees or employees of an affiliate. No Misconduct Entity will be treated as violating the conditions of the exemption solely because it acted as an investment advice fiduciary within the meaning of ERISA section 3(21)(A)(ii) or Code section 4975(e)(3)(B).</P>
                <P>(h)(1) Each Affiliated QPAM must maintain, adjust (to the extent necessary), implement, and follow the written policies and procedures described below (Policies). The Policies must require and must be reasonably designed to ensure that:</P>
                <P>
                    (i) The asset management decisions of the QPAM are conducted independently of the corporate and management and 
                    <PRTPAGE P="3943"/>
                    business activities of each Misconduct Entity, and without considering any fee a related local sub-custodian may receive from those decisions. This condition does not preclude an Affiliated QPAM, as defined in Section I(b)(1), from receiving publicly available research and other widely available information from a UBS affiliate;  
                </P>
                <P>(ii) The QPAM fully complies with ERISA's fiduciary duties, and with ERISA and the Code's prohibited transaction provisions, in each case as applicable with respect to each Covered Plan, and does not knowingly participate in any violation of these duties and provisions with respect to Covered Plans;</P>
                <P>(iii) The QPAM does not knowingly participate in any other person's violation of ERISA or the Code with respect to Covered Plans;</P>
                <P>(iv) Any filings or statements made by the QPAM to regulators, including but not limited to, the Department, the Department of the Treasury, the Department of Justice, and the Pension Benefit Guaranty Corporation, on behalf of or in relation to Covered Plans, are materially accurate and complete, to the best of such QPAM's knowledge at that time;</P>
                <P>(v) To the best of its knowledge at that time, the QPAM does not make material misrepresentations or omit material information in its communications with such regulators with respect to Covered Plans, or make material misrepresentations or omit material information in its communications with Covered Plans; and</P>
                <P>(vi) The QPAM complies with the terms of this exemption;</P>
                <P>(2) Any violation of or failure to comply with an item in subparagraphs (h)(1)(ii) through (vi) is corrected as soon as reasonably possible upon discovery, or as soon after the QPAM reasonably should have known of the noncompliance (whichever is earlier), and any such violation or compliance failure not so corrected is reported, upon the discovery of such failure to so correct, in writing. This report must be made to the head of compliance and the general counsel (or their functional equivalent) of the relevant UBS QPAM that engaged in the violation or failure and the independent auditor responsible for reviewing compliance with the Policies. A QPAM will not be treated as having failed to develop, implement, maintain, or follow the Policies, if it corrects any instance of noncompliance as soon as reasonably possible upon discovery, or as soon as reasonably possible after the QPAM reasonably should have known of the noncompliance (whichever is earlier), and provided that it adheres to the reporting requirements set forth in this subparagraph (2);</P>
                <P>
                    (3) Each Affiliated QPAM must maintain, adjust (to the extent necessary), and implement or continue a program of training during the Exemption Period (the Training) that is conducted at least annually for all relevant Affiliated QPAM asset/portfolio management, trading, legal, compliance, and internal audit personnel.
                    <SU>47</SU>
                    <FTREF/>
                     The Training must:
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         The exemption does not preclude an Affiliated QPAM from maintaining separate training programs provided each training program complies with this exemption.
                    </P>
                </FTNT>
                <P>(i) At a minimum, cover the Policies, ERISA and Code compliance (including applicable fiduciary duties and the prohibited transaction provisions), ethical conduct, the consequences for not complying with the conditions of this exemption (including any loss of exemptive relief provided herein), and the requirement for prompt reporting of any wrongdoing;</P>
                <P>(ii) Be conducted by a professional who has been prudently selected and who has appropriate technical training and proficiency with ERISA and the Code to perform the tasks required by this exemption; and</P>
                <P>(iii) Be conducted in-person, electronically, or via a website.</P>
                <P>(i)(1) Each Affiliated QPAM submits to an audit conducted by an independent auditor, who has been prudently selected and who has appropriate technical training and proficiency with ERISA and the Code, to evaluate the adequacy of, and each Affiliated QPAM's compliance with, the Policies and Training described above in Section (h). The audit requirement must be incorporated in the Policies.</P>
                <P>(2) UBS shall provide the Department a copy of the engagement agreement with the independent auditor within 15 days after its execution. Within 45 days after executing the engagement agreement with the independent auditor, and after consultation with the auditor, UBS must finalize and provide to the independent auditor a schedule for completion of the audit. The schedule must include target dates for the auditor to send initial information and document requests to UBS and for UBS to respond to those requests. The Department's receipt and incorporation of the engagement agreement into the record, with or without comment, should not be taken as an indication that the Department has approved of the engagement agreement.</P>
                <P>(3) The initial audit under this exemption must cover the period that begins on June 12, 2024, and ends on June 11, 2025, and the audit must be completed by Thursday, December 11, 2025. The second audit must cover the period that begins on June 12, 2025, and ends on June 11, 2026, and must be completed by Friday, December 11, 2026. The third audit must cover the period that begins on June 12, 2026, and ends on June 11, 2027, and must be completed by Monday, December 13, 2027. The fourth audit must cover the period that begins on June 12, 2027, and ends on June 11, 2028, and must be completed by Monday, December 11, 2028. The fifth audit must cover the period that begins on June 12, 2028, and ends on June 11, 2029, and must be completed by Tuesday, December 11, 2029. Notwithstanding the audit periods described above, the audit required under PTE 2023-14 must be completed for the prior period of June 12, 2023, through June 11, 2024 and delivered to the Department in accordance with the terms of that exemption. The prior exemption audit report(s) must be submitted in accordance with section III(i)(9) below;</P>
                <P>(4) Within the scope of the audit and to the extent necessary for the auditor, in its sole opinion, to complete its audit and comply with the conditions for relief described herein, and only to the extent such disclosure is not prevented by state or federal statute, or involves communications subject to attorney-client privilege, each Affiliated QPAM and, if applicable, UBS, must grant the auditor unconditional access to its business, including, but not limited to: its computer systems; business records; transactional data; workplace locations; training materials; and personnel. Such access is limited to information relevant to the auditor's objectives as specified by the terms of this exemption;</P>
                <P>(5) The auditor's engagement must specifically require the auditor to annually determine whether each Affiliated QPAM has developed, implemented, maintained, and followed the Policies in accordance with the conditions of this exemption, and has developed and implemented the Training, as required herein;</P>
                <P>
                    (6) The auditor's engagement must specifically require the auditor to test each Affiliated QPAM's operational compliance with the Policies and Training. In this regard, the auditor must test, for each Affiliated QPAM, a sample of such Affiliated QPAM's transactions involving Covered Plans, sufficient in size and nature to afford the auditor a reasonable basis to determine such Affiliated QPAM's operational compliance with the Policies and Training;
                    <PRTPAGE P="3944"/>
                </P>
                <P>(7) For the audit, on or before the end of the relevant period described in Section III(i)(1) for completing the audit, the auditor must issue a written report (the Audit Report) to UBS and the Affiliated QPAM to which the audit applies that describes the procedures performed by the auditor in connection with its examination. The auditor, at its discretion, may issue a single consolidated Audit Report that covers all the Affiliated QPAMs. The Audit Report must include the auditor's specific determinations regarding:</P>
                <P>(i) The adequacy of each Affiliated QPAM's Policies and Training; each Affiliated QPAM's compliance with the Policies and Training; the need, if any, to strengthen such Policies and Training; and any instance of the respective Affiliated QPAM's noncompliance with the written Policies and Training described in Section III(h) above. The Affiliated QPAM must promptly address any noncompliance and prepare a written plan of action to address any determination as to the adequacy of the Policies and Training and the auditor's recommendations (if any) with respect to strengthening the Policies and Training of the respective Affiliated QPAM. Any action taken or the plan of action to be taken by the respective Affiliated QPAM must be included in an addendum to the Audit Report (such addendum must be completed prior to the certification described in Section III(i)(7) below). In the event such a plan of action to address the auditor's recommendation regarding the adequacy of the Policies and Training is not completed by the time of submission of the Audit Report, the following period's Audit Report must state whether the plan was satisfactorily completed. Any determination by the auditor that an Affiliated QPAM has implemented, maintained, and followed sufficient Policies and Training must not be based solely or in substantial part on an absence of evidence indicating noncompliance. In this last regard, any finding that an Affiliated QPAM has complied with the requirements under this subparagraph must be based on evidence that each Affiliated QPAM has implemented, maintained, and followed the Policies and Training required by this exemption. Furthermore, the auditor must not solely rely on the Exemption Report created by the Compliance Officers, as described in Section III(m) below, as the basis for the auditor's conclusions in lieu of independent determinations and testing performed by the auditor as required by Section III(i)(3) and (4) above; and</P>
                <P>(ii) The adequacy of the Exemption Review described in Section III(m);  </P>
                <P>(8) The auditor must notify the respective Affiliated QPAM of any instance of noncompliance identified by the auditor within five (5) business days after such noncompliance is identified by the auditor, regardless of whether the audit has been completed as of that date;</P>
                <P>(9) With respect to the Audit Report, the General Counsel, or one of the three most senior executive officers of the Affiliated QPAM to which the Audit Report applies, must certify in writing, under penalty of perjury, that the officer has reviewed the Audit Report and this exemption; that, to the best of such officer's knowledge at the time, such Affiliated QPAM has addressed, corrected, and remedied any noncompliance and inadequacy or has an appropriate written plan to address any inadequacy regarding the Policies and Training identified in the Audit Report. Such certification must also include the signatory's determination that, to the best of such officer's knowledge at the time, the Policies and Training in effect at the time of signing are adequate to ensure compliance with the conditions of this exemption and with the applicable provisions of ERISA and the Code;</P>
                <P>(10) The Risk Committee of UBS's Group AG's Board of Directors is provided a copy of the Audit Report; and a senior executive officer of UBS Group AG's Compliance and Operational Risk Control function must review the Audit Report for each Affiliated QPAM and must certify in writing, under penalty of perjury, that such officer has reviewed the Audit Report;</P>
                <P>
                    (11) Each Affiliated QPAM provides its certified Audit Report, by regular mail to: Office of Exemption Determinations (OED), 200 Constitution Avenue NW, Washington, DC 20001; or via email to 
                    <E T="03">e-OED@dol.gov.</E>
                     This delivery must take place no later than 45 days following completion of the Audit Report. The Audit Reports will be made part of the public record regarding this exemption. Furthermore, each Affiliated QPAM must make its Audit Reports unconditionally available, electronically or otherwise, for examination upon request by any duly authorized employee or representative of the Department, other relevant regulators, and any fiduciary of a Covered Plan;
                </P>
                <P>(12) The auditor must provide the Department, upon request, for inspection and review, access to all the workpapers created and used in connection with the audit, provided such access and inspection is otherwise permitted by law;</P>
                <P>(13) UBS must notify the Department of Labor's Office of Exemption Determinations (OED) no later than 90 days after the Effective Date of this exemption, of the auditor selected to complete audits required by Section III(i)(1) above for the periods covering June 12, 2024, through June 11, 2029. Any engagement agreement with an auditor to perform the audit required by this exemption that is entered into subsequent to the effective date of this exemption must be submitted to OED no later than two months after the execution of such agreement;</P>
                <P>(14) At the Department's request, UBS and the Auditor shall provide the Department with updates about the progress of the audit. The Department's requests may be directed to UBS and/or the auditor;</P>
                <P>(15) For only the initial audit required by Section III(i)(1) above for the period covering June 12, 2024, through June 11, 2025, the auditor must consult with the auditors who performed the audits required pursuant to PTE 2023-14 for the period of June 12, 2023, through June 11, 2024, unless such auditor is the same auditor selected under paragraph 11 of this subsection. UBS must notify OED if for any reason the consultation required by this paragraph 12 cannot occur and must provide an explanation for why the consultation cannot occur. Such consultation may, but need not, occur for subsequent audits; and</P>
                <P>(16) UBS must notify the Department of a change in the independent auditor no later than two months after the engagement of a substitute or subsequent auditor and must provide an explanation for the substitution or change including a description of any material disputes between the terminated auditor and UBS.</P>
                <P>(j) As of the effective date of this exemption, with respect to any arrangement, agreement, or contract between an Affiliated QPAM and a Covered Plan, the QPAM agrees and warrants to Covered Plans:</P>
                <P>(1) To comply with ERISA and the Code, as applicable with respect to such Covered Plan; to refrain from engaging in prohibited transactions that are not otherwise exempt (and to promptly correct any prohibited transactions); and to comply with the standards of prudence and loyalty set forth in ERISA section 404 with respect to each such ERISA-covered plan and IRA to the extent that ERISA section 404 is applicable;</P>
                <P>
                    (2) To indemnify and hold harmless the Covered Plan for any actual losses resulting directly from the QPAM's 
                    <PRTPAGE P="3945"/>
                    violation of any conditions of this exemption, ERISA's fiduciary duties, as applicable, and of the prohibited transaction provisions of ERISA and the Code, as applicable; a breach of contract by the QPAM; or any claim arising out of the failure of such QPAM to qualify for the exemptive relief provided by PTE 84-14 as a result of a violation of Section I(g) of PTE 84-14, other than a Conviction covered under this exemption. The term “actual losses” includes, but is not limited to, losses and related costs arising from unwinding transactions with third parties and from transitioning Plan assets to an alternative asset manager as well as costs associated with any exposure to excise taxes under Code section 4975 as a result of a QPAM's inability to rely upon the relief in PTE 84-14;  
                </P>
                <P>(3) Not to require (or otherwise cause) the Covered Plan to waive, limit, or qualify the liability of the QPAM for violating ERISA or the Code for engaging in prohibited transactions;</P>
                <P>(4) Not to restrict the ability of the Covered Plan to terminate or withdraw from its arrangement with the QPAM, with respect to any investment in a separately-managed account or pooled fund subject to ERISA and managed by such QPAM, with the exception of reasonable restrictions, appropriately disclosed in advance, that are specifically designed to ensure equitable treatment of all investors in a pooled fund in the event such withdrawal or termination may have adverse consequences for all other investors. In connection with any such arrangement involving investments in pooled funds subject to ERISA entered into after the effective date of this exemption, the adverse consequences must relate to a lack of liquidity of the underlying assets, valuation issues, or regulatory reasons that prevent the fund from promptly redeeming an ERISA-covered plan's or IRA's investment, and such restrictions must be applicable to all such investors and be effective no longer than reasonably necessary to avoid the adverse consequences;</P>
                <P>(5) Not to impose any fees, penalties, or charges for such termination or withdrawal with the exception of reasonable fees, appropriately disclosed in advance, that are specifically designed to prevent generally-recognized abusive investment practices or specifically designed to ensure equitable treatment of all investors in a pooled fund in the event such withdrawal or termination may have adverse consequences for all other investors, provided that such fees are applied consistently and in a like manner to all such investors;</P>
                <P>(6) Not to include exculpatory provisions disclaiming or otherwise limiting liability of the QPAM for a violation of such agreement's terms. To the extent consistent with ERISA section 410, however, this provision does not prohibit disclaimers for liability caused by an error, misrepresentation, or misconduct of a plan fiduciary or other party hired by the plan fiduciary who is independent of UBS (and affiliates), or damages arising from acts outside the control of the Affiliated QPAM; and</P>
                <P>(7) Within 120 days after the effective date of this exemption, each QPAM must provide a notice of its obligations under this Section III(j) to each Covered Plan. For prospective Covered Plans that enter into a written asset or investment management agreement with a QPAM on or after a date that is 120 days after the effective date of this exemption, the QPAM must agree to its obligations under this Section III(j) in an updated investment management agreement between the QPAM and such clients or other written contractual agreement. Notwithstanding the above, a QPAM will not violate the condition solely because a Covered Plan refuses to sign an updated investment management agreement. For new Covered Plans that were provided an investment management agreement prior to the effective date of this exemption, returning it within 120 days after the effective date of this exemption, and that signed investment management agreement requires amendment to meet the terms of the exemption, the QPAM may provide the new Covered Plan with amendments that need not be signed with any documents required by this subsection (j) within ten (10) business days after receipt of the signed agreement.</P>
                <P>
                    (k) Within 60 days after the publication date of the notice of final exemption in the 
                    <E T="04">Federal Register</E>
                    , each Affiliated QPAM provides notice of the proposed and final exemption as published in the 
                    <E T="04">Federal Register</E>
                    , along with a summary describing the facts that led to the Covered Convictions (the Summary), which has been submitted to the Department, and a prominently displayed statement (the Statement) that the Covered Convictions result in a failure to meet a condition in PTE 84-14, to each sponsor and beneficial owner of a Covered Plan that has entered into a written asset or investment management agreement with an Affiliated QPAM, or the sponsor of an investment fund in any case where an Affiliated QPAM acts as a sub-adviser to the investment fund in which such ERISA-covered plan and IRA invests. The Summary will be submitted to OED before it is distributed by each Affiliated QPAM. All prospective Covered Plan clients that enter into a written asset or investment management agreement with an Affiliated QPAM after a date that is 60 days after the effective date of this exemption must receive a copy of the notice of the exemption, the Summary, and the Statement before, or contemporaneously with, the Covered Plan's receipt of a written asset or investment management agreement from the Affiliated QPAM. The notices may be delivered electronically (including by an email that has a link to the exemption).
                </P>
                <P>(l) The Affiliated QPAMs must comply with each condition of PTE 84-14, as amended, with the sole exception of the violation of Section I(g) of PTE 84-14 that is attributable to the Covered Convictions. If, during the Exemption Period, an entity within UBS's corporate structure engages in conduct prohibited by Section I(g) of PTE 84-14 (other than the Covered Convictions), relief in this exemption would terminate immediately.</P>
                <P>(m)(1) Within 60 days after the date of publication of the exemption, each Affiliated QPAM must designate two senior Compliance Officers (the Compliance Officers) who will be responsible for compliance with the Policies and Training requirements described herein. For purposes of this condition (m), each relevant line of business within an Affiliated QPAM may designate its own two Compliance Officers. Notwithstanding the above, the appointed Compliance Officers must not be a person who: (i) participated in the criminal conduct underlying the Criminal Activity, or knew of, or (ii) had reason to know of, the Criminal Activity without taking active documented steps to stop the misconduct.  </P>
                <P>
                    (2) The Compliance Officers must conduct a review of each twelve-month period of the Exemption Period (the Exemption Review), to determine the adequacy and effectiveness of the implementation of the Policies and Training.
                    <SU>48</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         Pursuant to PTE 2023-14, the Compliance Officer also must conduct and complete an exemption review within three months of June 11, 2024.
                    </P>
                </FTNT>
                <P>(3) With respect to the Compliance Officers, the following conditions must be met:</P>
                <P>
                    (i) Each Compliance Officer must be a professional who has extensive experience with, and knowledge of, the regulation of financial services and 
                    <PRTPAGE P="3946"/>
                    products, including under ERISA and the Code;
                </P>
                <P>(ii) Each Compliance Officer must have a direct reporting line to the highest-ranking corporate officer in charge of compliance for the applicable Affiliated QPAM or the highest-ranking corporate officer in charge of the applicable Affiliated QPAM and</P>
                <P>(iii) The Compliance Officers responsible for the Exemption Review must provide the Exemption Report described in Section III(m)(4)(ii) below to the Auditor within seven (7) days of completing the report.</P>
                <P>(4) With respect to the Exemption Review, the following conditions must be met:</P>
                <P>(i) The Annual Exemption Review includes a review of the Affiliated QPAM's compliance with and effectiveness of the Policies and Training and of the following: any compliance matter related to the Policies or Training that was identified by, or reported to, the Compliance Officers or others within the compliance and risk control function (or its equivalent) during the time period; the most recent Audit Report issued pursuant to this exemption or PTE 2023-14; any material change in the relevant business activities of the Affiliated QPAMs; and any change to ERISA, the Code, or regulations related to fiduciary duties and the prohibited transaction provisions that may be applicable to the activities of the Affiliated QPAMs;</P>
                <P>(ii) The Compliance Officers must prepare a written report for the Exemption Review (an Exemption Report) that (A) summarizes their material activities during the prior year; (B) sets forth any instance of noncompliance discovered during the prior year, and any related corrective action; (C) details any change to the Policies or Training to guard against any similar instance of noncompliance occurring again; and (D) makes recommendations, as necessary, for additional training, procedures, monitoring, or additional and/or changed processes or systems, and management's actions on such recommendations;</P>
                <P>(iii) In the Exemption Report, each Compliance Officer must certify in writing that to the best of his or her knowledge at the time: (A) the report is accurate; (B) the Policies and Training are working in a manner which is reasonably designed to ensure that the Policies and Training requirements described herein are met; (C) any known instance of noncompliance during the prior year and any related correction taken to date have been identified in the Exemption Report; and (D) the Affiliated QPAMs have complied with the Policies and Training, and/or corrected (or are correcting) any known instances of noncompliance in accordance with Section III(h) above;</P>
                <P>(iv) The Exemption Report must be provided to appropriate corporate officers of UBS and to each Affiliated QPAM to which such report relates, and to the head of compliance and the general counsel (or their functional equivalent) of UBS, and the relevant Affiliated QPAM. The Exemption Report must be made unconditionally available to the independent auditor described in Section III(i) above; and</P>
                <P>(v) The Exemption Review, including the Compliance Officers' written Annual Exemption Report, must cover the Exemption Period, and the Annual Review, including the Compliance Officers' written Report, must be completed within three (3) months following the end of the period to which it relates.</P>
                <P>(n) UBS imposes its internal procedures, controls, and protocols on each Misconduct Entity to reduce the likelihood of any recurrence of conduct that is the subject of the Criminal Activity.</P>
                <P>(o) Relief in this exemption will terminate on the date that is one year following the date that a U.S. regulatory authority makes a final decision that UBS or CSAG or an affiliate of either failed to comply in all material respects with any requirement imposed by such regulatory authority in connection with the Covered Convictions.</P>
                <P>(p) Each Affiliated QPAM will maintain records necessary to demonstrate that the conditions of this exemption have been met for six (6) years following the date of any transaction for which the Affiliated QPAM relies upon the relief in this exemption.</P>
                <P>
                    (q) During the Exemption Period, UBS must: (1) immediately disclose to the Department any Deferred Prosecution Agreement (a DPA) or Non-Prosecution Agreement (an NPA) with the U.S. Department of Justice, entered into by UBS or any of its affiliates (as defined in Section VI(d) of PTE 84-14) in connection with conduct described in Section I(g) of PTE 84-14 or section 411 of ERISA via email addressed to 
                    <E T="03">e-OED@dol.gov;</E>
                     and (2) immediately provide the Department with any information requested by the Department, as permitted by law, regarding the agreement and/or conduct and allegations that led to the agreement via email addressed to 
                    <E T="03">e-OED@dol.gov.</E>
                </P>
                <P>
                    (r) Within 60 days after the effective date of this exemption, each Affiliated QPAM, in its agreements with, or in other written disclosures provided to Covered Plans, will clearly and prominently inform Covered Plan clients of their right to obtain a copy of the Policies or a description (Summary Policies) which accurately summarizes key components of the QPAM's written Policies developed in connection with this exemption. If the Policies are thereafter changed, each Covered Plan client must receive a new disclosure within six (6) months following the end of the calendar year during which the Policies were changed.
                    <SU>49</SU>
                    <FTREF/>
                     With respect to this requirement, the description may be continuously maintained on a website, provided that such website link to the Policies or Summary Policies is clearly and prominently disclosed to each Covered Plan.
                </P>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         If the UBS meets this disclosure requirement through Summary Policies, changes to the Policies shall not result in the requirement for a new disclosure unless, as a result of changes to the Policies, the Summary Policies are no longer accurate.
                    </P>
                </FTNT>
                <P>(s) An Affiliated QPAM will not fail to meet the terms of this exemption solely because a different Affiliated QPAM fails to satisfy a condition for relief described in Section III(c), (d), (h), (i), (j), (k), (l), (m), (p), (r), or (t); or if the independent auditor described in Section III(i) fails to comply with a provision of the exemption other than the requirement described in Section III(i)(12), provided that such failure did not result from any actions or inactions of UBS or its affiliates;</P>
                <P>
                    (t) If the independent auditor or UBS or its affiliates learns of any material noncompliance with a condition of this exemption, UBS must send a notice (a “Violation Notice”) to all affected Covered Plans and the Department that prominently and conspicuously states or describes: (1) that UBS, or the UBS QPAM, as applicable, failed to meet the terms of this exemption (and describes the failure); (2) the extent to which UBS QPAMs have potentially been operating without an exemption due to the failure; (3) whether UBS plans to apply for retroactive relief from the Department for this failed condition; (4) any further transactions engaged in by the UBS QPAMs on behalf of Covered Plans that may be non-exempt prohibited transactions unless the Department grants retroactive relief for the period in which the transactions occurred; and (5) UBS must indemnify and hold harmless the Covered Plan for any actual losses resulting directly from the QPAM's failure to comply with any conditions of this exemption, ERISA's fiduciary duties and of the prohibited transaction provisions of ERISA and the Code, a 
                    <PRTPAGE P="3947"/>
                    breach of contract by the QPAM, or any claim arising out of the failure of such QPAM to qualify for the exemptive relief provided by PTE 84-14 as a result of a violation of PTE 84-14 Section I(g), other than a Conviction covered under the exemption. The Violation Notice must be sent to all affected Covered Plans and the Department within 30 days after the independent auditor becomes aware of the violation. If the Violation Notice is not sent within the 30-day period, the UBS QPAM may self-correct the failure by sending the Violation Notice to all affected Covered Plans and the Department with an addendum describing the failure within 30 days after the completion of next scheduled audit.
                </P>
                <P>(u) All the material facts and representations set forth in the Summary of Facts and Representations are true and accurate at all times.</P>
                <P>
                    (v) Each UBS QPAM must develop written processes that clearly describe: (1) how the QPAM identifies and quantifies “actual losses” for purposes of Section III(j)(2); and (2) how Covered Plans may recover or avoid incurring the losses that the UBS QPAM must indemnify or hold Covered Plans harmless from incurring pursuant to Section III(j)(2). Each UBS QPAM must develop these processes and deliver a copy of the processes to each Covered Plan within 90 days after the date the Department publishes a final exemption in the 
                    <E T="04">Federal Register</E>
                     and notify Covered Plans of any subsequent material changes to the processes within 30 days of the effective date of such changes. 
                    <E T="03">Applicability Date:</E>
                     This exemption will be in effect for the period beginning on June 12, 2024 and ending on June 11, 2029, as well as the period of June 12, 2023, through June 11, 2024.
                </P>
                <SIG>
                    <P>Signed at Washington, DC.</P>
                    <NAME>George Christopher Cosby,</NAME>
                    <TITLE>Director, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00812 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-29-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">EMPLOYEE BENEFITS SECURITY ADMINISTRATION</AGENCY>
                <DEPDOC>[Prohibited Transaction Exemption 2025-02; Exemption Application No. D-12073]</DEPDOC>
                <SUBJECT>Exemption From Certain Prohibited Transaction Restrictions Involving Memorial Sloan Kettering Cancer Center (MSKCC or the Applicant) Located in New York, New York</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Employee Benefits Security Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of exemption.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This document contains a notice of exemption issued by the Department of Labor (the Department) from certain prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). This exemption permits the reinsurance of risks and the receipt of a premium by MSK Employee Benefits IC (MSK EB or the Captive), a captive insurance and reinsurance subsidiary that is wholly-owned by MSKCC, in connection with a single premium group insurance contract sold by an unrelated fronting insurer (the Fronting Insurer or the Fronter) to provide pension annuities to participants and beneficiaries in the Memorial Sloan Kettering Cancer Center Pension Plan (the Plan). The relief provided in the exemption will only be available if the conditions in Section III are met in conformance with the definitions in Section I.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The exemption will be in effect on January 15, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Mr. Joseph Brennan of the Department at (202) 693-8456. (This is not a toll-free number.)</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Applicant submitted an exemption application requesting an individual exemption pursuant to ERISA section 408(a) in accordance with the Department's exemption procedures set forth in 29 CFR part 2570, subpart B.
                    <SU>1</SU>
                    <FTREF/>
                     On July 9, 2024, the Department published a notice of proposed exemption in the 
                    <E T="04">Federal Register</E>
                    .
                    <SU>2</SU>
                    <FTREF/>
                     Based on adherence to the conditions of this exemption by MSKCC, the Independent Fiduciary, and the IB 95-1 Independent Fiduciary (as defined below), the Department makes the requisite findings under ERISA section 408(a) that this exemption is: (1) administratively feasible for the Department, (2) in the interest of the participants and beneficiaries of the Plan, and (3) protective of the rights of the participants and beneficiaries of the Plan. Accordingly, affected parties should be aware that the conditions incorporated in this exemption are, individually and taken as a whole, necessary for the Department to grant the relief provided herein. The Department would not have granted this exemption without these conditions.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         76 FR 66637, 66644, (October 27, 2011).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         89 FR 56422 (July 9, 2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Background</HD>
                <HD SOURCE="HD2">Overview of the Exemption</HD>
                <P>
                    1. Under the exemption, the Plan will enter into a single premium group annuity insurance contract (the GAC) with an unrelated Fronting Insurer that will be selected by an IB 95-1 Fiduciary in compliance with the requirements of the Department's Interpretive Bulletin 95-1.
                    <SU>3</SU>
                    <FTREF/>
                     The Fronting Insurer will, in turn, enter into a reinsurance contract (the Reinsurance Arrangement) with the Captive. Under the Reinsurance Arrangement, the Captive will reinsure 100 percent of the Plan's risks under the GAC. Importantly, the Fronting Insurer will remain fully responsible for the benefits of participants and beneficiaries for the entire duration of the GAC and Reinsurance Arrangement if the Captive fails to fulfill its contractual obligations to the Fronting Insurer, without any caveats, contingencies, or conditions that would relieve or limit the Fronting Insurer's contractual obligation to pay benefits to the Plan's participants and beneficiaries.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         29 CFR 2509.95-1.
                    </P>
                </FTNT>
                <P>
                    In connection with the Reinsurance Arrangement, all Plan participants and beneficiaries will receive an increase to their monthly pension benefit that is currently expected to be 5.55 percent.
                    <SU>4</SU>
                    <FTREF/>
                     The Applicant expects that this benefit increase will provide $66,408,000 in additional benefits to the Plan's participants and beneficiaries. Importantly, this increase will remain in place for the entirety of Plan participants' and beneficiaries' lives and, as a condition of this exemption, 
                    <PRTPAGE P="3948"/>
                    MSKCC will not reduce any benefits that participants and beneficiaries receive from MSKCC, including benefits they receive from the Plan, as a result of the Reinsurance Arrangement. Absent this exemption, participants and beneficiaries would not receive this estimated 5.55 percent benefit increase.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         As discussed in more detail below, the exemption requires the Plan participants and beneficiaries to receive the majority of the benefits derived from the Reinsurance Arrangement. While, as noted above, it is “currently expected” that a 5.55% increase in Plan's participants' and beneficiaries' monthly pension benefits will achieve this objective, the exact percentage increase needed to ensure that Plan participants and beneficiaries receive the majority of the benefits derived from the proposed arrangement will not be known until the Plan actually enters into the GAC, which will occur after the Fronting Insurer is selected by the IB 95-1 Fiduciary. As described in further detail below, after the Plan enters into the GAC, Milliman, a second independent fiduciary acting solely on behalf of the Plan, must determine, based on objective data, that the Plan participants' and beneficiaries' monthly pension benefits have been increased by a percentage that ensures they will receive the majority of the benefits derived from the Reinsurance Arrangement. The methodology for making this calculation is discussed below. Milliman as independent fiduciary must, among other things, conclude, in a written report submitted to the Department, that Plan participants and beneficiaries received the appropriate percentage increase in their monthly pension benefits. The written report of the independent fiduciary will be available to the public by contacting EBSA's Public Disclosure Office and referencing Exemption Application D-12073.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">The Plan</HD>
                <P>
                    2. The Plan is a defined benefit pension plan that provides retirement and death benefits for eligible participants.
                    <SU>5</SU>
                    <FTREF/>
                     The Plan administrator and named fiduciary is the MSK Executive Benefits Committee and the Plan trustee is JPMorgan Chase. In 2012, MSKCC amended the Plan to close enrollment to employees hired on or after December 16, 2012. In 2020, MSKCC amended the Plan to freeze future benefit accruals effective December 20, 2020. As of December 31, 2023, the Plan covered 8,089 participants and held $1,384,897,170 in total assets.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Under the Plan, the normal form of payment for an unmarried participant is a single-life annuity, and the normal form of payment for a married participant is a joint and 50% survivor annuity.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">The Captive</HD>
                <P>3. MSK Insurance US, Inc. (MSK US) is MSKCC's wholly-owned captive insurance and reinsurance subsidiary. MSK US writes approximately $75 million in premiums and insures the property and equipment of MSKCC. The Captive (MSK EB) is a segregated cell within MSK US that will be used to reinsure the risks related to the Reinsurance Arrangement and this exemption. While MSK US will contract with the Fronting Insurer as part of the Reinsurance Arrangement, MSK EB will hold the reserves that will be used to pay benefits to the Plan's participants and beneficiaries under the GAC.</P>
                <HD SOURCE="HD2">The IB 95-1 Fiduciary and the Selection of the Fronting Insurer</HD>
                <P>
                    4. MSKCC has engaged Fiduciary Counselors Inc. (FCI) as the IB 95-1 Fiduciary that is responsible for selecting a Fronting Insurer based on a competitive bidding process. The Applicant represents that FCI will send requests for proposals to potential Fronting Insurers and will then select a Fronting Insurer in compliance with the Department's Interpretive Bulletin (IB) 95-1, which provides several factors that fiduciaries must consider to ensure they select the safest annuity available for a plan.
                    <SU>6</SU>
                    <FTREF/>
                     Within 30 days after the GAC has been executed, FCI must provide the Department with a written report that: (a) identifies the Fronting Insurer selected; (b) contains a detailed representation regarding the methodology used to make the selection and how that methodology determines that the selected Fronting Insurer and GAC met the requirements of IB 95-1; and (c) prudently concludes that it would have been consistent with IB 95-1 to select the Fronting Insurer as the insurer for a final termination buy-out annuity had MSKCC adopted that approach.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         29 CFR 2509-95-1. As stated in IB 95-1, when conducting a search, a fiduciary must evaluate a number of factors relating to a potential annuity provider's claims-paying ability and creditworthiness. Reliance solely on ratings provided by insurance rating services would not be sufficient to meet this requirement. In this regard, the types of factors a fiduciary should consider would include, among other things: (a) the quality and diversification of the annuity provider's investment portfolio; (b) the size of the insurer relative to the proposed contract; (c) the level of the insurer's capital and surplus; (d) the lines of business of the annuity provider and other indications of an insurer's exposure to liability; (e) the structure of the annuity contract and guarantees supporting the annuities, such as the use of separate accounts; and (f) the availability of additional protection through state guaranty associations and the extent of their guarantees.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Mechanics of the Reinsurance Arrangement</HD>
                <P>5. The Plan will purchase the GAC from the Fronting Insurer by using current Plan assets to pay a one-time premium to the Fronting Insurer. The Fronting Insurer will enter into an indemnity reinsurance contract with the Captive and will transfer the premium amount paid by the Plan to the Captive where it will be held in reserve. The GAC will cover all of the Plan's liabilities and have two phases that are described below.</P>
                <P>
                    <E T="03">Buy-In Phase:</E>
                     During the Buy-in Phase, the Plan will hold the GAC as a plan asset and the Plan will remain active. During this phase, the Fronting Insurer will send funds to the Plan Trustee (JPMorgan Chase) to make benefit payments to participants and beneficiaries and, every three months, the Fronting Insurer will submit payment requests to the Captive requesting reimbursement to cover participant and beneficiary distributions paid by the Fronting Insurer during the preceding three months. If the Fronting Insurer and Captive fail to pay benefits during the Buy-In Phase, MSKCC will still be required to fund the Plan, and the Plan will still be required to pay all benefits due to participants and beneficiaries.
                </P>
                <P>Following the purchase of the GAC, and while the Plan is still active, the Plan's fiduciaries will be obligated to manage all Plan assets, including those assets not used to purchase the GAC, solely in the interest of participants and beneficiaries and exclusively for their benefit. Any payments for Plan expenses that do not clearly and exclusively benefit participants and beneficiaries will be subject to additional scrutiny.</P>
                <P>
                    <E T="03">Buy-Out Phase:</E>
                     The GAC will contain a “conversion option” (the Conversion Option) that MSKCC can exercise (at any time) if and when it decides to terminate the Plan.
                    <SU>7</SU>
                    <FTREF/>
                     If exercised, the Conversion Option would transition the GAC from the Buy-in Phase to the Buy-Out Phase,
                    <SU>8</SU>
                    <FTREF/>
                     and the following events would occur: (a) the GAC will no longer be held by the Plan as a Plan asset; (b) MSKCC will replace the Plan as the holder of the GAC; (c) the Fronting Insurer will issue annuity certificates to all Plan participants and beneficiaries; and (d) the Fronting Insurer will take complete control of the administration of the GAC and make benefit payments directly to the former Plan participants and beneficiaries that have become annuitants.
                    <SU>9</SU>
                    <FTREF/>
                     During the Buy-Out Phase the Captive will continue to hold the reserves and the Fronting Insurer will continue to remit quarterly reimbursement payment requests to the Captive.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         This exemption would not relieve the Plan's fiduciaries from their express ERISA duties to manage the assets of the plan solely in the interest of the plan and its participants and beneficiaries, including when the fiduciaries are contemplating terminating the plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The effective date of the conversion would be aligned with the Plan's termination (
                        <E T="03">i.e.,</E>
                         the Conversion Option will be exercised only if and when the Plan terminates).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         As a condition of this exemption, after the Buy-In phase for the Reinsurance Arrangement is completed and MSKCC exercises the Conversion Option, MSKCC will terminate the Plan in compliance with all applicable Code and ERISA requirements.
                    </P>
                </FTNT>
                <P>The relationship between the Fronting Insurer and Captive will remain the same during both the Buy-In and Buy-Out Phases; therefore, the Fronting Insurer will assume full responsibility for benefit obligations to participants and beneficiaries, without conditions or caveats, and the Captive will assume the reinsurance risk. During both phases, the Captive is fully obligated to make payments to the Fronting Insurer under the Reinsurance Arrangement. This means that the Captive is fully obligated to satisfy the benefit obligations, but the mechanism of that obligation flows through the Fronting Insurer rather than directly to the Plan or to participants and beneficiaries.</P>
                <P>
                    As a condition of this exemption, the Fronting Insurer must have a direct contractual relationship with the Plan during the Buy-In phase of the GAC and with the Plan's participants and 
                    <PRTPAGE P="3949"/>
                    beneficiaries during the Buy-Out phase, without any caveats, contingencies, or conditions that would relieve or limit the Fronting Insurer's contractual obligation to pay benefits to the Plan's participants and beneficiaries.
                </P>
                <HD SOURCE="HD2">Collateral Under the Reinsurance Agreement</HD>
                <P>
                    6. As part of the Reinsurance Arrangement, the Captive will be collateralized by MSKCC. The Captive is expected to use the assets received as the reinsurance premium to collateralize its obligations under the Reinsurance Arrangement, in each case with such modifications as the Fronting Insurer's regulatory, accounting, or commercial considerations may require.
                    <SU>10</SU>
                    <FTREF/>
                     MSKCC will capitalize the Captive in accordance with the requirements of the State of Vermont and will provide a parental guarantee for the benefit of the Fronting Insurer with respect to the Captive's obligations. Parental guarantee assets will be separate and apart from the Plan assets used to purchase the GAC.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         The Fronting Insurer will be required to carry statutory reserves on its financial statements in such amounts as the insurance law in its state of domicile may require, and the collateral requirements will be based on those reserve requirements. The Fronting Insurer will have the right to access the collateral assets in accordance with the Reinsurance Arrangement. Collateral assets will back the Captive's reserves but will not be distinct from them.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Oversight by the Vermont DFR</HD>
                <P>7. Before MSKCC submitted its exemption request, the Captive requested and received formal approval from the Vermont Department of Financial Regulation (Vermont DFR) to enter into the Reinsurance Arrangement and operate the Captive to reinsure the Plan's pension benefits. The Vermont DFR issued formal approval after reviewing the Captive's Feasibility Report, which included, among other things, actuarial projections, an investment policy statement, and a business plan. The Captive will be required to submit independent audit and actuarial reports to the Vermont DFR annually and, at least once every five years, the Vermont DFR will conduct a thorough review of the Captive and issue an Exam Report.</P>
                <P>This exemption requires the Independent Fiduciary to obtain and review all independent audit and actuarial reports submitted by the Captive to the Vermont DFR as well as all Exam Reports issued to the Captive by the Vermont DFR, as long as the plan remains active. Further, the Independent Fiduciary must provide the Department with a detailed summary of each Exam Report in its annual Independent Fiduciary Report covering the year the Exam Report is issued. This exemption also requires the Captive to request a Certificate of Good Standing from the Vermont DFR every year and provide the Department with any Exam Reports it receives no later than 30 days after MSKCC receives such report.</P>
                <HD SOURCE="HD2">Financial Benefit to MSKCC</HD>
                <P>
                    8. The Applicant represents that purchasing the GAC in conjunction with the Reinsurance Arrangement will result in an estimated ten percent cost savings. For instance, if the single premium cost to purchase the GAC from the Fronting Insurer 
                    <E T="03">without</E>
                     the Captive would be $1.2 billion, the cost to purchase it 
                    <E T="03">with</E>
                     the Captive would be $1.08 billion. Since the financial benefit of this cost reduction would inure to MSKCC, this exemption requires MSKCC to provide the majority of the derived financial benefit to the Plan's participants and beneficiaries in the form of a permanent monthly annuity payment increase, as described below.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         The Applicant represents that because MSKCC is a non-profit entity, there will be no associated tax advantages flowing to MSKCC from the Reinsurance Arrangement.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">The Primary Benefits Test</HD>
                <P>9. This exemption requires the Plan to receive the majority of the financial benefits flowing from the Reinsurance Arrangement (the Primary Benefits Test). Under this exemption, the Independent Fiduciary must quantify all benefits derived from the Reinsurance Arrangement, including all benefits directly and indirectly received by MSKCC and any entity affiliated with MSKCC, and confirm that participants and beneficiaries receive at least 51 percent of all benefits derived from the arrangement. Throughout the Reinsurance Arrangement, while the Plan remains active, the Independent Fiduciary must continuously review and confirm that the Primary Benefits Test is being met.</P>
                <HD SOURCE="HD2">MSKCC-Provided Benefit Enhancement</HD>
                <P>
                    10. MSKCC will implement a one-time benefit increase sufficient to pass the Primary Benefits Test (the Benefit Enhancement). If the savings generated from using the Captive, as determined by the Independent Fiduciary, equals 10 percent, MSKCC will implement a Benefit Enhancement in the form of a permanent 5.37 percent 
                    <SU>12</SU>
                    <FTREF/>
                     increase to the monthly benefits of all participants and beneficiaries that will continue without reduction for the remainder of their lives. In addition, and as discussed below, MSKCC will add a second layer benefit enhancement of .18% for participants and beneficiaries—which is derived from the present value of the Independent Fiduciary's fees over the expected life of the GAC, post-plan termination.
                    <SU>13</SU>
                    <FTREF/>
                     Thus, if the savings from the Captive equals 10 percent, all plan participants and beneficiaries will receive a permanent pension benefit increase of 5.55 percent. Collectively, Plan participants and beneficiaries would receive increased pension benefit payments with a present value of $66,408,000 and, therefore, will receive the majority of the financial benefit derived from the Reinsurance Arrangement plus the present value of the Independent Fiduciary's fees over the expected life of the GAC.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         The formula underlying the 5.37 percent calculation is based on the actual percentage of savings in the annuity purchase, including the value of the pension benefit enhancement. All details regarding the formula used to calculate the Benefit Enhancement are included in the exemption application file and available to the public upon request.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         The Independent Fiduciary confirmed that the present value of its fees over the expected life of the GAC would be $1,968,000. As a condition of this exemption, MSKCC will add this entire amount into the GAC as a second-layer benefit enhancement which will result in an additional .18 percent permanent monthly pension increase for all participants and beneficiaries. Thus, the total benefit enhancement under this exemption is expected to be 5.55 percent.
                    </P>
                </FTNT>
                <P>As noted in the proposed exemption, MSKCC represents that: (a) apart from the conditions of this exemption, MSKCC otherwise had no preexisting obligation to provide a benefit increase to participants and beneficiaries; and (b) before its formal submission for exemptive relief, MSKCC had not considered or offered any increase to the current value of the benefits of the Plan's participants and beneficiaries.</P>
                <P>
                    <E T="03">Department's Note:</E>
                     The Department notes that the ratio of the benefit enhancement to MSKCC savings described in this exemption should not be relied upon as a precedent for future exemption applicants. If the Department receives applications for similar reinsurance exemptions in the future, it may require a higher ratio of participant and beneficiary benefit enhancements to plan sponsor savings, based upon the specific design of the transaction and financial circumstances of the plan and plan sponsor. In this regard, the Department's exemption procedure regulation provides that “[t]he existence of previously issued administrative exemptions is not determinative of whether the Department will propose future exemptions for applications with the same or similar facts, or whether a proposed exemption will contain the same conditions as a similar previously 
                    <PRTPAGE P="3950"/>
                    issued administrative exemption.” 
                    <SU>14</SU>
                    <FTREF/>
                     As the Department stated in the preamble to that regulation, “. . . this language reinforces the Department's existing policy that it has the sole discretionary authority to issues exemptions and is not bound by the facts or conditions of prior exemptions in making determinations with respect to an exemption application.”
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         29 CFR 2570.30(g).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Independent Fiduciary</HD>
                <P>11. Milliman will serve as the Plan's Independent Fiduciary with respect to the Reinsurance Arrangement and Kathleen E. Ely of Milliman will perform the functions required of the independent fiduciary on behalf of Milliman with respect to the requirements of this exemption. As the Plan's Independent Fiduciary, Milliman must represent the Plan in accordance with the obligations of prudence and loyalty under ERISA sections 404(a)(1)(A) and (B) and determine whether the Reinsurance Arrangement is in the interests of the Plan's participants and beneficiaries. In this regard, before the Plan purchases the GAC, Milliman must prudently and loyally confirm that the Benefit Enhancement is sufficient to meet the Primary Benefits Test.</P>
                <P>Further, not later than 30 days after the purchase of the GAC and consummation of the Reinsurance Arrangement, Milliman must confirm to the Department in writing that all terms and conditions of the exemption have been met. This confirmation must include copies of each document relied upon and the steps taken to make this determination. In this written determination, the Independent Fiduciary must confirm the actual cost savings associated with the Reinsurance Arrangement by obtaining documentation from the Fronting Insurer that compares the cost to purchase the GAC without the Captive in place to the cost to purchase the GAC with the Captive in place. The Independent Fiduciary must include this documentation from the Fronting Insurer with its written determination to the Department.</P>
                <P>The Independent Fiduciary must also monitor and ensure that any assets that remain in the Plan during the Buy-In phase of the Reinsurance Arrangement are managed and used exclusively to provide benefits to Plan participants and beneficiaries and to defray reasonable expenses of administering the Plan in compliance with ERISA sections 403(c)(1) and 404(a)(1)(A).</P>
                <P>Ms. Ely and Milliman represent that they are independent of all parties associated with the Reinsurance Arrangement, including the Plan, MSKCC, and the Captive. Milliman also represents that its gross income received from parties in interest to the Plan in connection with the Reinsurance Arrangement represents less than 0.1 percent of Milliman's gross annual income from all sources.</P>
                <P>Milliman will be required to continue monitoring, enforcing, and ensuring compliance with all conditions of this exemption until the plan is terminated, and report any instance of non-compliance immediately to the Department. As long as the plan is active, Milliman must submit written annual Independent Fiduciary Reports to the Department certifying under penalty of perjury whether each term and condition of the exemption has been met over the applicable period. In this regard, Milliman's final Independent Fiduciary Report will be due to the Department no later than six months after the Plan's termination date. Please see below for a discussion regarding the removal of the Independent Fiduciary after plan termination.</P>
                <P>In its final independent fiduciary report, Milliman must determine that the plan termination, transfer of assets, and new contractual arrangements accord with all conditions of this exemption at the time of termination, and that it remains the case that the primary benefits of this arrangement are expected to inure to the plan for the entire duration of the arrangement. The Independent Fiduciary must also represent that MSKCC has not managed plan assets in a way that results in MSKCC receiving a greater benefit from this arrangement than plan participants and beneficiaries.</P>
                <HD SOURCE="HD1">Written Comments</HD>
                <P>In the proposed exemption, the Department invited all interested persons to submit written comments and/or requests for a public hearing with respect to the notice of proposed exemption by August 23, 2024. The Department received written comments from the Applicant and Plan participants and beneficiaries and no requests for a public hearing.</P>
                <HD SOURCE="HD2">I. Comments From the Applicant</HD>
                <HD SOURCE="HD3">1. Removal of the Independent Fiduciary After Plan Termination</HD>
                <P>The proposed exemption requires an Independent Fiduciary to act on behalf of the Plan's participants and beneficiaries and provide oversight through the end of the Reinsurance Arrangement. Section III(h)(4) of the proposed exemption would require the Independent Fiduciary to: “Represent and protect the interests of the participants and beneficiaries of the Plan during both the Buy-In and Buy-Out Phases to ensure they receive everything that they are entitled to receive under this exemption, the terms of the Plan, and the GAC.” Further, Section III(i)(1) of the proposed exemption would require the Independent Fiduciary to submit annual Independent Fiduciary Reports to the Department until the end of the Reinsurance Arrangement. The proposed exemption also provides that the Independent Fiduciary must prudently and loyally confirm that the Primary Benefits Test is met throughout the Reinsurance Arrangement and continue to monitor, enforce, and ensure compliance with all conditions of the exemption throughout the Reinsurance Arrangement.</P>
                <P>MSKCC requests the Department remove the independent fiduciary requirement following the Plan's termination. MSKCC states that the phrases “throughout the Reinsurance Arrangement” and “throughout the duration of the Reinsurance Arrangement” should be modified, as they suggest that there is a Plan fiduciary obligation that extends beyond the termination of the Plan. MSKCC asserts that the Plan will terminate in connection with the Buy-Out conversion of the GAC and cease to exist, and once the Plan terminates, there will be no ongoing fiduciary obligations with respect to the Plan. MSKCC further asserts that at the time of the Plan's termination, Plan fiduciaries must ensure that the Plan's obligations are discharged, and that determination would include ensuring that the structure of the Reinsurance Arrangement complies with the exemption's conditions.</P>
                <P>Accordingly, MSKCC requests the Department to revise Section III(h)(4) of the proposed exemption to read as follows: “The Independent Fiduciary must . . . Represent and protect the interests of the participants and beneficiaries of the Plan unless and until the Plan is terminated to ensure they receive everything that they are entitled to receive under this exemption, the terms of the Plan, and the GAC.”</P>
                <P>
                    <E T="03">Department's Response:</E>
                     After considering this comment, the Department has determined to remove the requirement that the Independent Fiduciary perform duties beyond the date of a plan termination if the 
                    <PRTPAGE P="3951"/>
                    Independent Fiduciary calculates the present value of its expected fees over the expected life of the GAC and MSKCC adds that amount into the GAC as an additional benefit enhancement for participants and beneficiaries. Also, as noted above, the Independent Fiduciary has confirmed that the present value of its expected fees is $1,968,000. Therefore, as a condition of this exemption, MSK must add an additional $1,968,000 as a second-layer benefit increase into the GAC to permanently increase the pension benefits for participants and beneficiaries. This $1,968,000 second-layer benefit increase will add an additional .18 percent increase to the monthly annuity payable to participants and beneficiaries and thus increase the total monthly annuity payable to participants and beneficiaries from 5.37 percent to 5.55 percent.
                </P>
                <P>The Department's determination to allow the Independent Fiduciary to step aside after plan termination is based upon an understanding that the Vermont DFR will be performing substantial oversight over the Captive after the plan is terminated, and that this oversight is similar to the duties the Independent Fiduciary would have had to perform under the proposed exemption. The Department notes that under this exemption, the Captive must request a Certificate of Good Standing from the Vermont DFR every year, and that before issuing a Certificate, Vermont DFR will review the Captive, its reserves, and investments. If Vermont finds anything concerning, including risk, solvency, investments, or compliance issues, they will not issue the Certificate to the Captive. Also, during this review, the Vermont DFR will look into the financial health of MSKCC and the unrelated Fronting Insurer.</P>
                <P>Additionally, at least once every five years, the Vermont DFR will conduct a more thorough examination of the Captive and produce an Exam Report. Through its Exam Report process, the Vermont DFR will determine compliance with state insurance laws and regulations and evaluate the Captive's solvency. As part of this report, a team of examiners from Vermont DFR will conduct an in-depth review of the Captive's operations and balance sheet, and if they find something concerning, they will issue a Company Action Letter or a Regulatory Action Letter to the Captive. The Department notes that this exemption requires MSK to submit all Exam Reports to the Department.</P>
                <P>Moreover, the Fronting Insurer will have a strong interest in ensuring the Captive has sufficient reserves to pay benefit liabilities because the Fronter pays pension benefits to participants and beneficiaries from its own account. The Fronter's obligation to participants and beneficiaries is unconditional and will continue even if the Captive becomes insolvent, because the Fronter's arrangement with the Captive is an indemnity reinsurance arrangement. This means that the Captive reimburses the Fronter every three months for pension payments that the Fronter has already paid to participants and beneficiaries over the preceding three months. Under the reinsurance contract between the Fronter and the Captive, the Fronter monitors the investment of the Captive's reserves and also has the contractual right to draw on a collateral account that is funded by the Captive.</P>
                <P>Finally, the Department notes that after plan termination, all participants and beneficiaries become individual annuitants with the Fronter, and those annuities are regulated by the state in which the Fronter is domiciled. Under state insurance law, the Fronter is required to submit to an annual independent audit and file that report with their state regulator.</P>
                <P>Based on the foregoing, the Department has determined to remove the requirement that the Independent Fiduciary perform duties beyond the date of a plan termination because there will be sufficient oversight of the Captive after the plan terminates to ensure that participants and beneficiaries are protected and their benefits remain secure. Moreover, the second-layer benefit enhancement that will result from adding the additional $1,968,000 into the GAC is a meaningful additional benefit for participants and beneficiaries that will provide a more secure retirement for all participants and beneficiaries covered by the Plan.</P>
                <HD SOURCE="HD3">2. Timing of Identifying the Fronting Insurer</HD>
                <P>In paragraph 5 of the proposed exemption, the Department states that “given the importance of a highly rated Fronting Insurer to the security of the pension benefits provided to the Plan's participants and beneficiaries, Fiduciary Counselors must provide the Department with a written submission that identifies the Fronting Insurer selected along with a written representation detailing the methodology that it used to select the Fronting Insurer and how that methodology, and the Fronting Insurer selected, met the requirements of IB 95-1.” Section III(e)(1) of the proposed exemption states that this report must be provided to the Department “before this proposed exemption is granted.”</P>
                <P>MSKCC maintains in its comment letter, that it will not be practicable for the IB 95-1 Fiduciary to select the Fronting Insurer and provide the IB 95-1 Report to the Department before the exemption is granted. According to MSKCC, FCI would not be able to negotiate every term of the annuity purchase with the Fronter—including final pricing—until the terms of the final exemption are known and the timing of the annuity purchase is certain and imminent. And further, if the final exemption is conditioned upon the selection of a particular Fronting Insurer, MKSCC would lose leverage to negotiate final annuity purchase terms favorable to the Plan's participants and beneficiaries.</P>
                <P>
                    Instead, MSK requests that the Department revise the exemption to require the IB 95-1 Fiduciary to provide its written IB 95-1 Report and identify the Fronting Insurer 
                    <E T="03">after</E>
                     the exemption is granted. However, in their comment letter, MSKCC offers to provide the Department with a list of Fronting Insurers that FCI has determined should be considered and approached as part of the request for proposal (RFP) process before the Department issues the final exemption, but on a confidential basis to preserve the integrity of the RFP process. Further, if FCI subsequently decides not to select a Fronter from the list, they would provide the Department with 30 days advance notice before selecting the Fronter to provide the Department with an opportunity to comment or discuss with MSKCC before the Fronter is engaged.
                </P>
                <P>
                    <E T="03">Department's Response:</E>
                     After considering the applicant's request and rationale, the Department accepts the Applicant's request to remove the condition requiring Fiduciary Counselors to provide a written submission that identifies the Fronting Insurer selected along with detail on the methodology it used to select the Fronter and how that methodology, and the Fronter selected, met the requirements of IB 95-1 before the exemption is granted. The Department, instead, has revised the exemption to remove this requirement entirely. Therefore, Fiduciary Counselors will not be required to submit anything to the Department before the exemption is granted. In making this change, the Department emphasizes that Fiduciary Counselors must follow IB 95-1 and prudently and loyally select the safest available annuity for the plan participants and beneficiaries and submit a detailed written report to the Department regarding the methodology 
                    <PRTPAGE P="3952"/>
                    the IB 95-1 Fiduciary used to determine that the selected Fronting Insurer and GAC met the requirements of IB 95-1 no later than 30 days after the execution of the GAC.
                </P>
                <HD SOURCE="HD3">3. Use of Participant Data</HD>
                <P>Section III(j) of the proposed exemption states that “neither MSKCC nor any related entity may use participant or beneficiary-related data, or information generated by or derived from the Reinsurance Arrangement in a manner that benefits MSKCC or a related entity.” MSKCC contends that this condition is too broad and requests that it be changed to only prohibit MSKCC from using participant data “for purposes unrelated to the administration, funding, or security of retirement benefits (including obligations under the GAC and the Reinsurance Arrangement).” MSKCC states that the proposed condition is too broad because MSKCC benefits by providing retirement benefits to its employees and retirees and ensuring that benefits are secure and appropriately administered.</P>
                <P>
                    <E T="03">Department's Response:</E>
                     After considering this comment, the Department accepts MSKCC's requested revision with some modifications that narrow the scope of MSKCC's requested change. The Department is limiting the expanded permitted uses of participant data under this exemption to purposes related to the administration, funding, or security of 
                    <E T="03">the GAC, Reinsurance Arrangement, or Plan.</E>
                     Expanding the scope of permissible data use to administration, funding, and security of the GAC, Reinsurance Arrangement, or Plan is appropriate, but expanding permitted uses to purposes related to the administration, funding, or security of 
                    <E T="03">retirement benefits generally,</E>
                     as requested by MSKCC, is too broad. Therefore, Section III(j) of this exemption provides that “neither MSKCC nor any related entity may use participant or beneficiary-related data, or information generated by or derived from the Reinsurance Arrangement for purposes unrelated to the administration, funding, or security of the GAC, Reinsurance Arrangement, or Plan.”
                </P>
                <P>The Department notes that this exemption does not permit the use of participant and beneficiary data in a way that primarily benefits MSKCC, the Captive, or the Fronting Insurer. Under this exemption, prohibited uses of participant and beneficiary data include, but are not limited to, selling the data to third parties, using the data to cross-sell services, or using the data to target participants and beneficiaries to attempt to sell them new products or services. MSKCC did not explain why they would need to use information derived from the Reinsurance Arrangement for more general purposes. Because the security of participant data is critically important to the Department, the Plan and participants and beneficiaries, the Department has construed its permitted uses as narrowly as possible.</P>
                <HD SOURCE="HD3">4. Allow MSKCC To Take Dividends From the Captive</HD>
                <P>Section III(p) of the proposed exemption states that “MSKCC may not receive a dividend or any other form of distribution from the Captive at any point during the Reinsurance Arrangement.” In its comment letter, MSKCC requests a revision that would allow it to receive dividends and distributions from the Captive, provided that MSKCC would contribute the majority of each such dividend or distribution as a benefit enhancement to another MSKCC-sponsored employee benefit plan under the Primary Benefits Test.</P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department declines to make this requested change because there is no compelling reason to allow MSKCC to take distributions from the Captive. An essential purpose of this exemption is to ensure that Plan participants' and beneficiaries' pension benefits are as secure as possible. This objective is best achieved by ensuring that the assets formerly held in the Plan's trust that will be transferred to the Captive as part of the Reinsurance Arrangement remain in the Captive's reserves where they can be used to pay the retirement benefits of the participants and beneficiaries of 
                    <E T="03">this</E>
                     Plan. The Department notes that MSKCC does not provide any detail on the risk impact associated with allowing MSKCC to receive future distributions from the Captive. Furthermore, it is inappropriate for participants in another MSKCC-sponsored employee benefit plan to receive a portion of a dividend taken from the Captive before the Captive has satisfied all liabilities under the GAC.
                </P>
                <P>
                    The Department also notes that MSKCC has consistently represented that the Captive will be funded on a break-even basis and that no excess assets are anticipated at the end of the Reinsurance Arrangement. If this is the case, then all Plan assets used to fund participant and beneficiary liabilities should remain in the Captive where they can be used to pay benefits to the participants and beneficiaries of 
                    <E T="03">this</E>
                     Plan—rather than as distributions to MSKCC and contributions to another plan.
                </P>
                <HD SOURCE="HD3">5. Factual Accuracy</HD>
                <P>
                    Condition (k) of the proposed exemption provides that “all the facts and representations set forth in the Summary of Facts and Representations must be true and accurate at all times.” The Applicant requests that section (k) be modified to state, “All the material facts and representations set forth in the Summary of Facts and Representations (
                    <E T="03">as modified by the clarifications set forth in the comment letter submitted by the Applicant</E>
                    ) must be true and accurate at all times;”
                </P>
                <P>The Department accepts the Applicant's request to modify Section (k) in part. Instead of expanding section (k) to incorporate all modifications noted in the Applicant's comment letter, the Department will expand Section (k) to incorporate all modifications from the proposed exemption, as detailed in this final exemption. Section (k) now states: “All the material facts and representations set forth in the Background section of this exemption, including all modifications from the proposed exemption as detailed in this final exemption, must be true and accurate at all times[.]”</P>
                <HD SOURCE="HD3">6. Factual Clarifications</HD>
                <P>Paragraph 6 of the proposed exemption's Summary of Facts and Representations states, “the Plan would purchase the GAC from the Fronting Insurer by using current Plan assets (including an in-kind transfer) to pay a one-time premium amount to the Fronting Insurer... Subsequently, the Fronting Insurer would transfer the premium amount paid by the Plan to the Captive where it would be held in reserve within the captive cell (MSK EB) throughout the duration of the Reinsurance Arrangement.”</P>
                <P>MSKCC requests a clarification that the insurance premium and the reinsurance premium may be paid concurrently and that the Captive is expected to use the assets received as reinsurance premium to collateralize its obligations under the Reinsurance Arrangement, in each case with such modifications as the Fronting Insurer's regulatory, accounting or commercial considerations may require.</P>
                <P>
                    The Department accepts MSKCC's requested clarification but notes that in its application MSKCC stated that: “The Fronter will purchase the reinsurance contract from MSK Insurance through a transfer from the Fronter to MSK Insurance of cash and, through an in-kind transfer, assets 
                    <E T="03">previously</E>
                     transferred from the Pension Plan.”
                    <PRTPAGE P="3953"/>
                </P>
                <P>Paragraph 8 of the proposed exemption's Summary of Facts and Representations states that “as part of the Reinsurance Arrangement, the Captive would be collateralized by MSKCC, and all collateral will be separate and apart from the Plan assets used to purchase the GAC.” Further, the second sentence of paragraph 8 states that “collateral would be distinct from the reserves” and that “pursuant to the GAC, MSKCC would establish a collateral account that the Fronting Insurer can access: (1) in the event the Captive fails to make a required quarterly payment to the Fronting Insurer; or (2) to reduce the financial risk that would arise if, for example, the Captive is holding too large a portion of the reserves in illiquid investments.” Finally, the fourth sentence of paragraph 8 states that “the collateral requirements will be determined by the Fronting Insurer and will be based on the reserve requirements mandated by the State of Vermont.”</P>
                <P>MSKCC requests the following clarifications. First, to further support the Captive, MSKCC will capitalize the Captive in accordance with the requirements of the State of Vermont and will provide a guarantee for the benefit of the Fronting Insurer with respect to the Captive's obligations, and those assets will be separate and apart from the Plan assets used to purchase the GAC. Second, the Fronter will be required to carry statutory reserves on its financial statements in such amounts as the insurance law in its state of domicile may require, and the collateral requirements will be based on those reserve requirements. Third, the Fronting Insurer will have the right to access the collateral assets in accordance with the Reinsurance Arrangement. Collateral assets will back the Captive's reserves but will not be distinct from them. In addition, other assets of the Captive will support the Reinsurance Arrangement.</P>
                <P>Paragraph 6 of the proposed exemption states, “[t]he Fronting Insurer would assume full responsibility for benefit obligations to participants and beneficiaries, without conditions or caveats, and the Captive would assume the reinsurance risk.” However, paragraph 6 also states that “. . . both the Fronting Insurer and the Captive would assume full responsibility for making pension benefit payments to participants and beneficiaries . . . the Fronting Insurer and the Captive would remain 100 percent liable for making benefit payments to participants and beneficiaries.”</P>
                <P>The Applicant states that, while it is correct that both the Fronting Insurer and the Captive are fully obligated to satisfy the benefit obligations, paragraph 6 of the Summary requires a technical modification in its description of the mechanism of those obligations. In this regard, (a) during the Buy-In Phase, the Fronting Insurer makes payments to the Plan; and (b) during the Buy-Out Phase, the Fronting Insurer makes benefit payments directly to participants and beneficiaries. During both phases, the Captive is fully obligated to make payments to the Fronting Insurer under the Reinsurance Arrangement. The Captive, thus, is fully obligated to satisfy the benefit obligations, but the mechanism of that obligation flows through the Fronting Insurer, rather than directly to participants and beneficiaries of the Plan.</P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department accepts MSKCC's factual clarifications.
                </P>
                <HD SOURCE="HD3">7. Scope of Exemptive Relief</HD>
                <P>Section II of the proposed exemption would grant relief only under ERISA sections 406(a)(1)(D) and 406(b)(1), (2), and (3) and the parallel provisions in Code section 4975(c)(1)(D), (E), and (F). MSKCC states that it is plausible that certain aspects of the Reinsurance Arrangement could constitute a prohibited transaction under ERISA sections 406(a)(1)(A), (B), and (C) (and the parallel provisions under Code Sec. 4975). MSKCC requests that either (1) the exemption be expanded to provide relief under 406(a)(1)(A), (B), and (C), or (2) include an explanation from the Department that, in its view, the Reinsurance Arrangement (including the additional aspects to such arrangement described above) would not result in prohibited transactions under ERISA sections 406(a)(1)(A), (B), and (C) (and the parallel provisions under Code Sec. 4975), and thus no relief is needed for those sections.</P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department agrees with the Applicant's request to expand the scope of relief under the exemption. The exemption now provides relief under ERISA sections 406(a)(1)(A), (B), and (D) and 406(b)(1), (2), and (3) and the parallel provisions of the Code. However, with respect to ERISA section 406(a)(1)(C), the Department expects MSKCC and the Captive to comply with the statutory exemption codified in ERISA section 408(b)(2) (and the regulations thereunder) for the provision of services to the Plan.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         29 CFR 2550.408(b)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">II. Comments From Participants</HD>
                <HD SOURCE="HD3">1. Why are participants and beneficiaries not receiving more?</HD>
                <P>In their comment letters, several participants asked why they would not receive more than 51 percent of the savings MSKCC would realize through the Reinsurance Arrangement. One participant asked, “how was this number arrived at? Why couldn't or shouldn't the plan participants receive a higher percentage? Would MSKCC still pursue this plan if participants were to receive 90% of the benefit?”</P>
                <P>
                    <E T="03">Department's Response:</E>
                     The Department has crafted this exemption to ensure that: (1) plan participants and beneficiaries receive a greater financial benefit from the transaction than any financial savings or benefits accruing to MSKCC; and (2) the participants and beneficiaries are financially better off than they would have been in the absence of an exemption. The Department is granting this exemption, in large part, because the exemption meets these criteria. Moreover, the Department has no basis for believing that MSKCC would have agreed to give even greater benefits to the plan, its participants, and beneficiaries, much less 90 percent of all the cost savings associated with the captive arrangement.
                </P>
                <P>The Department continually requested that MSKCC increase the benefit enhancement provided under the exemption and the estimated 5.55 percent benefit increase represents a substantial benefit enhancement for the Plan's participants and beneficiaries that will provide an estimated 5.55 percent increase in their monthly retirement annuity for the rest of their lives. As noted above, this benefit increase will result in an estimated $66,408,000 of additional benefits for participants and beneficiaries which will strengthen retirement security for these individuals. The Department also notes that this estimated 5.55 percent increase is consistent with the Primary Benefits Test used by the Department in its welfare benefit plan captive reinsurance cases.</P>
                <P>
                    Moreover, the permanent 5.55 percent benefit increase is substantially more than MSKCC proposed to provide participants and beneficiaries when it submitted its exemption application to the Department. MSKCC initially proposed no benefit enhancements at all, arguing that the entirety of the financial benefit derived from using the Captive would inure to the Plan. The Department, however, pushed back on this position and argued that a discount on the purchase price of the GAC would 
                    <PRTPAGE P="3954"/>
                    financially benefit MSKCC, as the plan sponsor, and not the Plan because the participants' and beneficiaries,' whose monthly pension benefits are set according to the Plan's benefit formula and would not be increased as a result of a discount to the group annuity purchase price.
                </P>
                <P>MSKCC subsequently amended its application to provide for the following two benefit enhancements: (1) a retirement planning program available upon election for participants and beneficiaries that would cost MSKCC $300 per election; and (2) an additional $2,000 incidental death benefit under the plan. The Department told MSKCC that these enhancements were insufficient for the Department to make its finding under ERISA section 408(a) and that it would not move forward with the exemption application unless MSKCC agreed to provide participants and beneficiaries with the majority of the financial benefits derived from using the Captive.</P>
                <P>Finally, the Department notes that absent this exemption, participants and beneficiaries would not receive any benefit increase when MSKCC terminates the plan and purchases a group annuity.</P>
                <HD SOURCE="HD3">2. Can the Fronting Insurer sell the GAC to another insurer?</HD>
                <P>One participant asked whether the Fronting Insurer would be able to transfer or sell the GAC after the exemption is granted. The Department posed this question to MSKCC and received the following response: “The Fronting Insurer will commit irrevocably to provide the benefits under the terms of the contract and cannot sell the annuity to another insurance company. If the fronting insurer is itself bought by another insurance company or merges with another insurance company, the successor insurance company would also be bound by the contract's obligations.”</P>
                <P>As a new condition of this exemption, the group annuity contract between the Fronting Insurer and the Plan must include language that unequivocally prohibits the Fronting Insurer from selling or otherwise transferring the GAC to another insurer. The Department notes that the appointment of an independent IB 95-1 Fiduciary to prudently select the Fronting Insurer and GAC is an essential part of this exemption and allowing the Fronter to sell the GAC to another insurer after the Plan's acquisition of the GAC would not be protective of the participants and beneficiaries because the acquiring insurer might not meet the standards of IB 95-1.</P>
                <HD SOURCE="HD3">3. Will a lump sum distribution option be provided under the GAC?</HD>
                <P>Two participants asked whether MSKCC will retain the lump sum distribution option currently provided under the Plan in the GAC. The Department referred this question to MKSCC, and they confirmed that the lump sum distribution option will be retained in the GAC. To ensure this is the case, the Department has added a new condition to the exemption that requires the GAC to include a lump sum distribution option for all participants and beneficiaries who have the right to receive a lump sum distribution under the terms of the Plan.</P>
                <HD SOURCE="HD2">III. Final Independent Fiduciary Report</HD>
                <P>The Department has added a new Section III(i)(4) to provide specific requirements for the final Independent Fiduciary Report. In its final Independent Fiduciary Report, the Independent Fiduciary must determine that the plan termination, transfer of assets, and new contractual arrangements accord with all conditions of this exemption at the time of termination, and that it remains the case that the primary benefits of this arrangement are expected to go to the Plan's participants and beneficiaries for the entire duration of the arrangement. The Independent Fiduciary must also represent that MSKCC has not managed plan assets in a way that results in MSKCC receiving a greater benefit from this arrangement than plan participants and beneficiaries.</P>
                <P>The complete application file (D-12073) is available for public inspection in the Public Disclosure Room of the Employee Benefits Security Administration, Room N-1515, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210. For a more complete statement of the facts and representations supporting the Department's decision to grant this exemption, please refer to the notice of proposed exemption published on July 9, 2024, at 89 FR 56422.</P>
                <HD SOURCE="HD1">General Information</HD>
                <P>The attention of interested persons is directed to the following:</P>
                <P>(1) The fact that a transaction is the subject of an exemption under ERISA section 408(a) does not relieve a fiduciary or other party in interest from certain requirements of other ERISA provisions, including but not limited to any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of ERISA section 404, which, among other things, require a fiduciary to discharge their duties respecting the plan solely in the interest of the plan's participants and beneficiaries and in a prudent fashion in accordance with ERISA section 404(a)(1)(B).</P>
                <P>(2) As required by ERISA section 408(a), the Department hereby finds that the exemption is: (a) administratively feasible for the Department; (b) in the interests of the Plan and the Plan's participants and beneficiaries; and (c) protective of the rights of the Plan and the Plan's participants and beneficiaries.</P>
                <P>(3) This exemption is supplemental to, and not in derogation of, any other ERISA provisions, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive for determining whether the transaction is in fact a prohibited transaction.</P>
                <P>(4) The availability of this exemption is subject to the express condition that the material facts and representations contained in the application accurately describe all material terms of the transactions that are the subject of the exemption and are true at all times.</P>
                <P>
                    Accordingly, after considering the entire record developed in connection with the Applicant's exemption application, the Department has determined to grant the following exemption under the authority of ERISA section 408(a) in accordance with the Department's exemption procedures set forth in 29 CFR part 2570, subpart B: 
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         76 FR 66637, 66644 (October 27, 2011).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Exemption</HD>
                <HD SOURCE="HD2">Section I. Definitions</HD>
                <P>(a) An “affiliate” of MSKCC, MSK US, or MSK EB includes: (1) any person or entity who controls MSKCC, MSK US, or MSK EB or is controlled by or under common control with MSKCC, MSK US, or MSK EB; (2) any officer, director, employee, relative, or partner with respect to MSKCC, MSK US, or MSK EB; and (3) any corporation or partnership of which a person described in (2) above in this paragraph is an officer, director, partner, or employee;</P>
                <P>
                    (b) The term “Benefit Enhancement” means the benefit increase, as determined by the Independent Fiduciary based upon the Primary Benefits Test, that will be applied equally to all participants and beneficiaries across the Plan and last throughout the duration of the group annuity contract (the GAC) and Reinsurance Arrangement with no corresponding offsets or reductions;
                    <PRTPAGE P="3955"/>
                </P>
                <P>(c) The term “Captive” means MSK Employee Benefits IC, Inc., a segregated cell within MSK Insurance US, Inc., a captive insurance and reinsurance subsidiary that is wholly-owned by MSKCC and domiciled in the state of Vermont. MSK Employee Benefits IC, Inc. will be used to reinsure the risks related to the Reinsurance Arrangement;</P>
                <P>(d) The term “control” means the power to exercise a controlling influence over the management or policies of a person other than an individual; and</P>
                <P>(e) The term “Independent Fiduciary” means a person who:</P>
                <P>(1) Is not MSKCC or an affiliate of MSKCC, or the Captive and does not hold an ownership interest in MSKCC, the Captive, or their affiliates;</P>
                <P>(2) Was not a fiduciary with respect to the Plan before its appointment to serve as the Independent Fiduciary;</P>
                <P>(3) Has acknowledged in writing that:</P>
                <P>(i) It is a fiduciary and has agreed not to participate in any decision with respect to any transaction in which it has an interest that might affect its best judgment as a fiduciary; and</P>
                <P>(ii) Has appropriate technical training or experience to perform the services contemplated by this exemption;</P>
                <P>(4) For purposes of this definition, no organization or individual may serve as Independent Fiduciary for any fiscal year if the gross income received by such organization or individual from MSKCC, the Captive, or their affiliates for that fiscal year exceeds two percent of such organization's or individual's gross income from all sources for the prior fiscal year. This provision also applies to a partnership or corporation of which such organization or individual is an officer, director, or 10 percent or more partner or shareholder and includes as gross income amounts received as compensation for services provided as an independent fiduciary under any prohibited transaction exemption granted by the Department;</P>
                <P>(5) No organization or individual that is an Independent Fiduciary and no partnership or corporation of which such organization or individual is an officer, director, or ten percent or more partner or shareholder may acquire any property from, sell any property to, or borrow any funds from MSKCC, the Captive, or their affiliates while the individual serves as an Independent Fiduciary. This prohibition will continue for a period of six months after the party ceases to be an Independent Fiduciary and/or the Independent Fiduciary negotiates any transaction on behalf of the Plan during the period that the organization or individual serves as an Independent Fiduciary; and</P>
                <P>(6) In the event a successor Independent Fiduciary is appointed to represent the interests of the Plan with respect to the subject transaction, no time should elapse between the resignation or termination of the former Independent Fiduciary and the appointment of the successor Independent Fiduciary.</P>
                <HD SOURCE="HD2">Section II. Covered Transactions</HD>
                <P>This exemption provides relief from the prohibited transactions provisions of ERISA sections 406(a)(1)(A), (B), and (D), and 406(b)(1), (b)(2), and (b)(3), and the excise tax imposed by Code section 4975(a) and (b) (due to the operation of parallel prohibited transaction provisions contained in Code section 4975(c)(1) (A), (B), (D), (E), and (F)) with respect to: (1) the reinsurance of risks; and (2) the receipt of a premium by the Captive in connection with a single premium group insurance contract sold by an unrelated fronting insurer (the Fronting Insurer) to provide pension annuities to Plan participants and beneficiaries. To receive this relief, the conditions in Section III must be met in conformance with the definitions in Section I.</P>
                <HD SOURCE="HD2">Section III. Conditions</HD>
                <P>(a) MSKCC must amend the Plan document to provide a universal benefit increase to all participants and beneficiaries that will apply immediately once the GAC is purchased and will continue with no reduction or offsets for the remainder of the participants and beneficiaries' lives (the Benefit Enhancement). The additional benefit provided by the Benefit Enhancement to participants and beneficiaries must be greater than 51 percent of the total benefit, including cost savings, derived by MSKCC from the Reinsurance Arrangement (the Primary Benefits Test). In addition, MSKCC must include an additional $1,968,000 in the GAC as a second-layer benefit increase that will further permanently increase the monthly pension benefit of all participants and beneficiaries covered by the Plan. This second layer benefit enhancement represents the present value of the expected Independent Fiduciary's fees over the projected life of the GAC;</P>
                <P>(b) Following the Plan's purchase of the GAC from the Fronting Insurer and the consummation of the Reinsurance Arrangement between the Fronting Insurer and the Captive, the Independent Fiduciary must prudently and loyally determine the Primary Benefits Test has been met. The Independent Fiduciary must submit its determination in writing to the Department within 30 days after the GAC is entered into. In this written determination, the Independent Fiduciary must confirm the actual cost savings associated with the Reinsurance Arrangement by obtaining documentation from the Fronting Insurer that compares the cost to purchase the GAC without the Captive in place to the cost to purchase the GAC with the Captive in place. The Independent Fiduciary must include this documentation from the Fronting Insurer with its written determination to the Department;</P>
                <P>(c) The Captive or MSK US Insurance US, Inc. must:</P>
                <P>(1) Be a party in interest with respect to the Plan based on an affiliation with MSKCC that is described in ERISA section 3(14)(G);</P>
                <P>(2) Be licensed to sell insurance or conduct reinsurance operations in Vermont;</P>
                <P>(3) Have obtained a Certificate of Authority from the Insurance Commissioner of Vermont to transact business as a captive insurance company and such certificate must not have been revoked or suspended;</P>
                <P>(4) Have undergone a financial examination (within the meaning of the law of its domiciliary State, Vermont) by the Insurance Commissioner of Vermont within five years before the end of the year preceding the year in which the reinsurance transaction occurred;  </P>
                <P>(5) Have undergone, and continue to undergo, an examination by an independent certified public accountant for its last completed taxable year immediately before the taxable year of the Reinsurance Arrangement covered by this exemption; and</P>
                <P>(6) Be licensed to conduct reinsurance transactions by a state whose law requires an actuarial review of reserves to be conducted annually by an independent firm of actuaries and reported to the appropriate regulatory authority;</P>
                <P>(d) The Plan must pay no commissions with respect to the purchase of the GAC or the Reinsurance Arrangement;</P>
                <P>
                    (e)(1) The Fronting Insurer and GAC must be selected by Fiduciary Counselors, an independent fiduciary to the Plan, in compliance with the Department's Interpretive Bulletin 95-1 (29 CFR 2509-95-1). Within 30 days after the GAC is entered into, Fiduciary Counselors must submit a written report to the Department that identifies the Fronting Insurer selected, details the methodology used to select the Fronting Insurer, and explains how Fiduciary Counselors determined that the selected Fronting Insurer and GAC meet the 
                    <PRTPAGE P="3956"/>
                    requirements of IB 95-1. Fiduciary Counselors must also represent in writing to the Department that it would have been consistent with IB 95-1 to select the Fronting Insurer as the insurer for a final termination buy-out annuity had MSKCC adopted that approach. To meet its fiduciary responsibility owed to the Plan's participants and beneficiaries to select and purchase the “safest available annuity,” before selecting the Fronting Insurer, Fiduciary Counselors must evaluate such insurer's claims-paying ability and creditworthiness in full compliance with guidance provided in the Department's Interpretive Bulletin 95-1;
                </P>
                <P>(f) (1) The Reinsurance Arrangement between MSK US and the Fronting Insurer must be indemnity insurance only and must not relieve the Fronting Insurer from any responsibility or liability to the Plan's participants and beneficiaries, including any liability that would result if MSK US fails to meet any of its contractual obligations to the Fronting Insurer or any successor Fronting Insurer under the Reinsurance Arrangement;</P>
                <P>(2) The Fronting Insurer must have a direct contractual relationship with the Plan during the Buy-In phase of the GAC and with the Plan's participants and beneficiaries after MSKCC exercises the Conversion Option under the GAC when it terminates the Plan, without any caveats, contingencies, or conditions that would relieve or limit the Fronting Insurer's contractual obligation to pay benefits to the Plan's participants and beneficiaries in accordance with the Plan and the terms of this exemption;</P>
                <P>(g) MSKCC must not offset or reduce any benefits provided to Plan participants and beneficiaries in relation to its implementation of the Benefit Enhancement at any time. In this regard, MSKCC must not implement any benefit cuts or offsets of any kind to the benefits the Plan provides to any Plan participant or beneficiary;</P>
                <P>(h) The Independent Fiduciary must:</P>
                <P>(1) In compliance with its fiduciary obligations of prudence and loyalty under ERISA sections 404(a)(1)(A) and (B): (i) review the Reinsurance Arrangement and the terms of the exemption; (ii) obtain and review all current objective, reliable, third-party documentation necessary to make the determinations required of the Independent Fiduciary by the exemption; and (iii) confirm in writing that all of the exemption's terms and conditions have been met (or, due to timing requirements, can reasonably be expected to be met consistent with the terms of the exemption) and send this confirmation to the Department's Office of Exemption Determinations not later than 30 days after the Captive enters into the Reinsurance Arrangement. In this written report, the Independent Fiduciary must also confirm that the Fronting Insurer and GAC selected, and the methodology used by Fiduciary Counselors to make the selection, meet the requirements of IB 95-1 and that it would have been consistent with IB 95-1 to select the Fronting Insurer as the insurer for a final termination buy-out annuity had MSKCC adopted that approach;</P>
                <P>(2) Approve the Reinsurance Arrangement in advance and ensure that the Reinsurance Arrangement is in the interest of the Plan's participants and beneficiaries and protective of the Plan's participants and beneficiaries;</P>
                <P>(3) As long as the Plan remains active, monitor, enforce, and ensure compliance with all conditions of this exemption in accordance with its obligations of prudence and loyalty under ERISA sections 404(a)(1)(A) and (B), including all conditions and obligations imposed on any party dealing with the Plan, throughout the period during which the Captive's assets are directly or indirectly used in connection with a transaction covered by this exemption;</P>
                <P>(4) Represent and protect the interests of the participants and beneficiaries of the Plan when the plan is active during the Buy-In Phase to ensure they receive everything that they are entitled to receive under this exemption, the terms of the Plan, and the GAC;</P>
                <P>(5) Monitor and ensure that any assets that remain in the Plan during the Buy-In Phase of the Reinsurance Arrangement are managed and used exclusively to provide benefits to Plan participants and beneficiaries and to defray reasonable expenses of administering the Plan in compliance with ERISA sections 403(c)(1) and 404(a)(1)(A);</P>
                <P>(6) Report any instance of non-compliance immediately to the Department's Office of Exemption Determinations until the Plan is terminated;</P>
                <P>(7) Take all appropriate actions to safeguard the interests of the Plan and its participants and beneficiaries until the Plan is terminated; and</P>
                <P>(8) Review all contracts pertaining to the Reinsurance Arrangement, and any renewals of such contracts, to determine whether the requirements of this exemption and the terms of Benefit Enhancement continue to be satisfied until the Plan is terminated;</P>
                <P>(i)(1) The Independent Fiduciary must submit annual Independent Fiduciary Reports to the Department's Office of Exemption Determinations as long as the plan remains active, certifying under penalty of perjury whether each term and condition of the exemption has been met over the applicable period. Each Report must be completed within six months after the end of the twelve-month period to which it relates (the first twelve-month period would begin on the effective date of the exemption grant); and submitted to the Department's Office of Exemption Determinations within 60 days thereafter;</P>
                <P>(2) In preparing the Independent Fiduciary Report, the Independent Fiduciary must:</P>
                <P>(i) Review the Captive's annual audit and actuarial reports as submitted to the Vermont Department of Financial Regulation (Vermont DFR);</P>
                <P>(ii) Review any Certificate of Good Standing received by the Captive;</P>
                <P>(iii) Review any Exam Report completed by the Vermont DRF and include a detailed summary of the Exam Report;</P>
                <P>(iv) Confirm that MSKCC has not reduced or offset any benefits in relation to its implementation of the Benefit Enhancement; and</P>
                <P>(v) Confirm that MSKCC has not reduced the Benefit Enhancement amount at any point during the year covered.</P>
                <P>(3) The Independent Fiduciary must confirm in each Report that the Primary Benefits Test was met for the covered year. In this regard, the Independent Fiduciary must determine the value of the Benefit Enhancement and the total value of the Reinsurance Arrangement to MSKCC, including cost savings, and confirm that MSKCC has not received any additional financial benefit that the Independent Fiduciary did not account for when it previously used the Primary Benefits Test to derive the Benefit Enhancement amount;</P>
                <P>(4) In its final independent fiduciary report, the Independent Fiduciary must determine that the plan termination, transfer of assets, and new contractual arrangements accord with all conditions of this exemption at the time of termination, and that it remains the case that the primary benefits of this arrangement are expected to go to the plan for the entire duration of the arrangement. The Independent Fiduciary must also represent that MSKCC has not managed plan assets in a way that results in MSKCC receiving a greater benefit from this arrangement than plan participants and beneficiaries;</P>
                <P>
                    (j) Neither MSKCC nor any related entity may use participant or beneficiary-related data or information 
                    <PRTPAGE P="3957"/>
                    generated by or derived from the Reinsurance Arrangement for purposes unrelated to the administration, funding, or security of the GAC, Reinsurance Arrangement, or Plan;
                </P>
                <P>(k) All the material facts and representations set forth in the Background section of this exemption, including all modifications from the proposed exemption as detailed in this final exemption, must be true and accurate at all times;</P>
                <P>(l) No party related to this exemption request has or will indemnify the Independent Fiduciary or the IB 95-1 Independent Fiduciary, in whole or in part, for negligence and/or for any violation of state or federal law that may be attributable to the Independent Fiduciary's or IB 95-1 Independent Fiduciary's performance of its duties in connection with the Reinsurance Arrangement. In addition, no contract or instrument may purport to waive any liability under state or federal law for any such violations;</P>
                <P>(m) MSKCC must provide the Department's Office of Exemption Determinations with all Exam Reports issued by the State of Vermont throughout the duration of the Reinsurance Arrangement within 30 days after such Exam Report is received;  </P>
                <P>(n) The Captive must request a Certificate of Good Standing from the State of Vermont on an annual basis;</P>
                <P>(o) MSKCC must notify the Department's Office of Exemption Determinations if there is any change in the Captive's business plan, auditor, or the composition of its board of directors;</P>
                <P>(p) MSKCC may not receive a dividend or any other form of distribution from the Captive at any point during the Reinsurance Arrangement;</P>
                <P>(q) MSKCC and the Captive must maintain all the records necessary to demonstrate that the conditions of this exemption have been met for a period of six years from the date of each record. MSKCC must provide these records to the Department's Office of Exemption Determinations within 30 days from the date of a request by the Department;</P>
                <P>(r) MSKCC must provide a Parental Guarantee to the Captive and provide cash as needed if the Captive's general and separate account asset balances have been extinguished;</P>
                <P>(s) The Captive must invest the reserves in accordance with the regulations and under the supervision of the State of Vermont;</P>
                <P>(t) MSKCC must amend the Plan document to memorialize the Benefit Enhancement and provide a copy of the amended plan document to the Department's Office of Exemption Determinations no later than 30 days after the date the Captive enters into the Reinsurance Arrangement;</P>
                <P>(u) After the Buy-In phase for the Reinsurance Arrangement is completed and MSKCC exercises the Conversion Option, MSKCC will terminate the Plan in compliance with all applicable Code and ERISA requirements;</P>
                <P>(v) MSKCC must notify the Department of any change in the Independent Fiduciary no later than 30 days after the engagement of a substitute or subsequent Independent Fiduciary and must explain the substitution or change, including a description of any material disputes between the terminated Independent Fiduciary and MSKCC;</P>
                <P>(w) Once the Benefit Enhancement percentage amount is set (in conformity with the Primary Benefits Test), MSKCC may not reduce that Benefit Enhancement percentage amount at any point;</P>
                <P>(x) The GAC between the Fronting Insurer and the Plan must include language that unequivocally prohibits the Fronting Insurer from selling or otherwise transferring the GAC to another insurer; and</P>
                <P>(y) The GAC must include a lump sum distribution option for all participants and beneficiaries who have the right to receive a lump sum distribution under the Plan.</P>
                <P>
                    <E T="03">Effective Date:</E>
                     This exemption is in effect on January 15, 2025.
                </P>
                <SIG>
                    <P>Signed at Washington, DC.</P>
                    <NAME>George Christopher Cosby,</NAME>
                    <TITLE>Director, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00813 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-29-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employment and Training Administration</SUBAGY>
                <SUBJECT>Agency Information Collection Activities; Comment Request; Unemployment Insurance (UI) Data Validation (DV) Program</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor's (DOL) Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, “Unemployment Insurance (UI) Data Validation (DV) Program.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all written comments received by March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained free by contacting India Oliver by telephone at 202-693-3020 (this is not a toll-free number), or by email at 
                        <E T="03">OUI-PRA@dol.gov.</E>
                         For persons with a hearing or speech disability who need assistance to use the telephone system, please dial 711 to access telecommunications relay services.
                    </P>
                    <P>
                        Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training Administration, Office of Unemployment Insurance, Room S-4519, 200 Constitution Avenue NW, Washington, DC 20210; by email: 
                        <E T="03">OUI-PRA@dol.gov;</E>
                         or by fax 202-693-3975.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        India Oliver by telephone at 202-693-3020 (this is not a toll-free number) or by email at 
                        <E T="03">OUI-PRA@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.</P>
                <P>Section 303(a)(6) of the Social Security Act specifies that the Secretary of Labor will not certify State UI programs to receive administrative grants unless the State's law includes provisions for “making of such reports . . . as the Secretary of Labor may from time to time require, and compliance with such provisions as the Secretary may from time to time find necessary to assure the correctness and verification of such reports.” DOL considers DV to be one of those “provisions . . . necessary to assure the correctness and verification” of the reports submitted by states that authorizes this information collection.</P>
                <P>
                    The Government Performance and Results Act of 1993 (GPRA) requires 
                    <PRTPAGE P="3958"/>
                    Federal agencies to develop annual and strategic performance plans that establish performance goals, have concrete indicators of the extent that goals are achieved, and set performance targets. Each year, the agency is to issue a report that “evaluate[s] the performance plan for the current fiscal year relative to the performance achieved toward the performance goals in the fiscal year covered by the report.” DOL emphasizes the importance of complete and accurate information for program monitoring and improving program performance “. . . as a framework for agencies to communicate progress in achieving their missions.” (OMB Circular A-11, Section 15.5).
                </P>
                <P>The UI DV program employs a refined and automated approach to review 363 elements reported on 15 UI Benefits reports and 1 UI Tax report. DOL uses many of these elements for key performance measures and workload analysis. The validation process assesses the accuracy of the counts of transactions. Guided by a detailed handbook, the state UI agency first constructs extract files containing all pertinent individual transactions for the desired report period to be validated. These transactions are grouped into 16 UI Benefits and 5 UI Tax populations. Each transaction record contains the necessary characteristics or dimensions that enable it to be summed into an independent recount of what the state has already reported. DOL provides state agencies with software that edits the extract file (to identify and remove duplicate transactions and improperly built records, for example), then aggregates the transactions to produce an independent reconstruction or “validation count” of the reported figure. The reported count is considered valid by this “quantity” validation test if it is within plus or minus two percent of the validation count (plus or minus one percent for a GPRA-related element).</P>
                <P>The software also draws samples of most transaction types from the extract files. Guided by a state-specific handbook, the validators review these sample records against documentation in the state's management information system to determine whether the transactions in the extract file are supported by system documentation. This qualitative check determines whether the state management information system accurately reflects data elements of UI transactions. The UI Benefits extract files are considered to pass this “quality” review if random samples indicate that no more than five percent of the records contain errors. The UI Tax extract files are subjected to different “quality” tests. An extract file of a population is considered valid only if the reported count differs from the reconstructed (validation) count by no more than the appropriate criterion of plus or minus two percent or plus or minus one percent and the samples of transactions have satisfied all quality tests.</P>
                <P>For Federal fiscal years 2011 and beyond, all states are required to conduct a complete validation every three years. In the following three cases, the three-year rule does not apply and a re-validation must occur within one year: (1) groups of reported counts that are summed for purposes of making a Pass/Fail determination and do not pass validation by being within plus or minus two percent of the reconstructed counts or the extract file does not pass all quality tests; (2) the validation applies to the two UI Benefits populations and one UI Tax population used for GPRA measures; and (3) reports are produced by new reporting software following a state's information technology modernization effort. Every year, states must also certify that Module 3, the state specific validation manual of the UI Benefits and UI Tax information systems, are up to date. Section 303(a)(6) of the Social Security Act authorizes this information collection.</P>
                <P>
                    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. 
                    <E T="03">See</E>
                     5 CFR 1320.5(a) and 1320.6.
                </P>
                <P>
                    Interested parties are encouraged to provide comments to the contact shown in the 
                    <E T="02">ADDRESSES</E>
                     section. Comments must be written to receive consideration, and they will be summarized and included in the request for OMB approval of the final ICR. In order to help ensure appropriate consideration, comments should OMB Control No. 1205-0431.
                </P>
                <P>Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.</P>
                <P>DOL is particularly interested in comments that:</P>
                <P>• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;</P>
                <P>• Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</P>
                <P>• Enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, (
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses).
                </P>
                <P>
                    <E T="03">Agency:</E>
                     DOL-ETA.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension without changes.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Unemployment Insurance (UI) Data Validation (DV).
                </P>
                <P>
                    <E T="03">Form:</E>
                     ETA Handbooks 361.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1205-0431.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State Workforce Agencies.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     53.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Varies.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Responses:</E>
                     53.
                </P>
                <P>
                    <E T="03">Estimated Average Time per Response:</E>
                     Varies.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     23,644 hours.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Other Cost Burden:</E>
                     $0.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3506(c)(2)(A).
                </P>
                <SIG>
                    <NAME>José Javier Rodríguez,</NAME>
                    <TITLE>Assistant Secretary for Employment and Training, Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00807 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employment and Training Administration</SUBAGY>
                <SUBJECT>Agency Information Collection Activities; Comment Request; Nonmonetary Determination Activity Report</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Labor's (DOL) Employment and Training Administration (ETA) is soliciting comments concerning proposed 
                        <PRTPAGE P="3959"/>
                        revisions and extension for the authority to conduct the information collection request (ICR) titled, “Nonmonetary Determination Activities Report.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all written comments received by March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained free by contacting Kristen Santos by telephone at 617-788-0148 (this is not a toll-free number). For persons with a hearing or speech disability who need assistance to use the telephone system, please dial 711 to access telecommunications relay services.</P>
                    <P>
                        Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training Administration, Room S-4524, 200 Constitution Avenue NW, Washington, DC 20210; by email: 
                        <E T="03">OUI-PRA@dol.gov;</E>
                         or by fax: 202-693-3975.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Eric Congious by telephone at 202-693-0763 (this is not a toll-free number) or by email at 
                        <E T="03">OUI-PRA@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.</P>
                <P>The Secretary of Labor, under the Social Security Act, title III, section 302 (42 U.S.C. 502), funds the necessary cost of proper and efficient administration of each state Unemployment Insurance (UI) law. The ETA 207, Nonmonetary Determination Activities Report, contains State data on the number and types of adjudicated issues concerning UI benefits eligibility determined by the states. It also has data on the number of disqualifications that are issued for reasons associated with a claimant's separation from employment and reasons related to a claimant's continuing eligibility for benefits.</P>
                <P>These data are used by ETA's Office of Unemployment Insurance (OUI) to determine workload counts for the allocation of administrative funds, to analyze the ratio of disqualifications to determinations, and to examine and evaluate the program effect of nonmonetary activities.</P>
                <P>
                    DOL is proposing revisions to the ETA 207 Report and considers these proposed revisions to be “provisions . . . necessary to assure the correctness and verification” of the reports submitted by states. These proposed changes include creating new definitions (
                    <E T="03">e.g.,</E>
                     alien benefit year availability, work search), delineating issues previously grouped together (
                    <E T="03">e.g.,</E>
                     able and available, actively seeking work), delineating issues previously reported in the “Other” category (
                    <E T="03">e.g.,</E>
                     reasonable assurance, alien able and available, unemployment status, seasonal work, removal of all or part of a disqualification, etc.), and expanding terms and definitions to promote accuracy of and visibility into state adjudication reporting activities. Requiring states to report these issues in separate categories should have minimal additional impact as the information is already maintained and reported by the states per prior ICRs for the ETA 207 report.
                </P>
                <P>The revised 207 report also proposes the collection of demographic information on each determination issued, which includes the claimant's race or ethnicity, sex and/or gender, and level of educational attainment, following the definitions established in ETA 203 Report titled “Distributions of Characteristics of the Insured Unemployed” under OMB control number 1205-0009.</P>
                <P>Section 303(a)(6) of the Social Security Act specifies that for State UI programs to be certified to receive administrative funding, the State's law must include provisions for “making of such reports . . . as the Secretary of Labor may from time to time require, and compliance with such provisions as the Secretary may from time to time find necessary to assure the correctness and verification of such reports.” 42 U.S.C. 503(a)(6) of the Social Security Act authorizes this information collection.</P>
                <P>
                    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control. 
                    <E T="03">See</E>
                     5 CFR 1320.5(a) and 1320.6.
                </P>
                <P>
                    Interested parties are encouraged to provide comments to the contact shown in the 
                    <E T="02">ADDRESSES</E>
                     section. Comments must be written to receive consideration, and they will be summarized and included in the request for OMB approval of the final ICR. In order to help ensure appropriate consideration, comments should mention OMB 1205-0150.
                </P>
                <P>Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.</P>
                <P>DOL is particularly interested in comments that:</P>
                <P>• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;</P>
                <P>• Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</P>
                <P>• Enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, (
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses).
                </P>
                <P>
                    <E T="03">Agency:</E>
                     DOL—ETA.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Nonmonetary Determination Activities Report.
                </P>
                <P>
                    <E T="03">Forms:</E>
                     ETA 207, Regular and Extended Benefits reports.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1205-0150.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State Workforce Agencies.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     53.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Quarterly.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Responses:</E>
                     424.
                </P>
                <P>
                    <E T="03">Estimated Average Time per Response:</E>
                     4 hours per response.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     1,696.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Other Cost Burden:</E>
                     $0.
                    <PRTPAGE P="3960"/>
                </P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3506(c)(2)(A).
                </P>
                <SIG>
                    <NAME>José Javier Rodríguez,</NAME>
                    <TITLE>Assistant Secretary for Employment and Training, Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00662 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employment and Training Administration</SUBAGY>
                <SUBJECT>Agency Information Collection Activities; Comment Request; Work Application/Job Order Recordkeeping</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor's (DOL) Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, “Work Application/Job Order Recordkeeping.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all written comments received by March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained free by contacting Heather Fleck by telephone at 202-693-2956 (this is not a toll-free number) or email at 
                        <E T="03">fleck.heather@dol.gov.</E>
                         For persons with a hearing or speech disability who need assistance to use the telephone system, please dial 711 to access telecommunications relay services.
                    </P>
                    <P>
                        Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training Administration, Office of Workforce Investment; 200 Constitution Ave. NW, Room S-4209, Washington, DC 20210, Attn. Heather Fleck; or by email to 
                        <E T="03">fleck.heather.dol.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Heather Fleck by telephone at 202-693-2956 (this is not a toll-free number) or by email at 
                        <E T="03">fleck.heather@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.</P>
                <P>This ICR collects the required information for work applications and job order recordkeeping. The exact information collected is determined by the state. At a minimum, the information to be collected is that which enables the state to comply with regulations under 20 CFR 652 and the Wagner-Peyser Act.</P>
                <P>In October 2022, OMB approved the ICR, OMB control number 1205-0001, that allows the Department of Labor to collect information from states pertaining to work applications and job orders and their retention of that data. OMB granted approval for the ICR through October 31, 2025. 29 U.S.C. 49 (The Wagner-Peyser Act) authorizes this information collection.</P>
                <P>
                    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. 
                    <E T="03">See</E>
                     5 CFR 1320.5(a) and 1320.6.
                </P>
                <P>
                    Interested parties are encouraged to provide comments to the contact shown in the 
                    <E T="02">ADDRESSES</E>
                     section. Comments must be written to receive consideration, and they will be summarized and included in the request for OMB approval of the final ICR. In order to help ensure appropriate consideration, comments should mention OMB control number 1205-0001.
                </P>
                <P>Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.</P>
                <P>DOL is particularly interested in comments that:</P>
                <P>• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;</P>
                <P>• Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</P>
                <P>• Enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, (
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses).
                </P>
                <P>
                    <E T="03">Agency:</E>
                     DOL-ETA.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension without changes.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Work Application/Job Order Recordkeeping.
                </P>
                <P>
                    <E T="03">Form:</E>
                     N/A.
                </P>
                <P>
                    <E T="03">OMB Control No.:</E>
                     1205-0001.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State, Local, and Tribal Governments.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     52.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Annually.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Responses:</E>
                     52.
                </P>
                <P>
                    <E T="03">Estimated Average Time per Response:</E>
                     8 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     416 hours.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Other Cost Burden:</E>
                     $0.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3506(c)(2)(A).
                </P>
                <SIG>
                    <NAME>José Javier Rodrìguez,</NAME>
                    <TITLE>Assistant Secretary for Employment and Training, Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00808 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FN-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBJECT>Agency Information Collection Activities; Submission for OMB Review; Comment Request; Alien Claims Activity Report</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.</P>
                </SUM>
                <DATES>
                    <PRTPAGE P="3961"/>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The OMB will consider all written comments that the agency receives on or before February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Howell by telephone at 202-693-6782, or by email at 
                        <E T="03">DOL_PRA_PUBLIC@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The USCIS verification system, commonly called the Systematic Alien Verification for Entitlement (SAVE) Program, is currently available to and being utilized by the states. To comply with its responsibilities under the SSA, the Department of Labor (Department) must gather information from state agencies concerning alien claimant activities. The Alien Claimant Activity Report is the only source available for collecting this information.</P>
                <P>
                    The report allows the Department to determine the number of aliens filing for unemployment insurance (UI), the number of benefit issues detected and the denials resulting from the USCIS SAVE system. From these data, the Department can determine the extent to which state agencies use the system, and the overall effectiveness and cost efficiency of the USCIS SAVE verification system. For additional substantive information about this ICR, see the related notice published in the 
                    <E T="04">Federal Register</E>
                     on August 1, 2024 (89 FR 62792).
                </P>
                <P>Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.</P>
                <P>
                    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. 
                    <E T="03">See</E>
                     5 CFR 1320.5(a) and 1320.6.
                </P>
                <P>DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.</P>
                <P>
                    <E T="03">Agency:</E>
                     DOL-ETA.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Alien Claims Activity Report.
                </P>
                <P>
                    <E T="03">OMB Control No.:</E>
                     1205-0268.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State Workforce Agencies.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Respondents:</E>
                     53.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Responses:</E>
                     212.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Time Burden:</E>
                     212 hours.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Other Costs Burden:</E>
                     $0.
                </P>
                <EXTRACT>
                    <FP>(Authority: 44 U.S.C. 3507(a)(1)(D))</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Michael Howell,</NAME>
                    <TITLE>Senior Paperwork Reduction Act Analyst.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00809 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FN-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBJECT>Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guam Military Base Realignment Contractors Recruitment Standards</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The OMB will consider all written comments that the agency receives on or before February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Howell by telephone at 202-693-6782, or by email at 
                        <E T="03">DOL_PRA_PUBLIC@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The National Defense Authorization Act (NDAA) for Fiscal Year 2010 (Pub. L. 111.84, enacted October 28, 2009) requires an expanded effort to recruit U.S. and other eligible workers for employment on Guam military base realignment construction projects. This reporting structure features electronic posting of construction job opportunities on an internet job banks site with national coverage, posting job opportunities on several state workforce agency job banks, and documentation of worker recruitment results reports that will be submitted to the Guam Department of Labor (GDOL). All data collection and reporting will be done by military base construction contractors, and the data and recruitment results in a report that will be submitted to the GDOL. These recruitment requirements help fulfill the responsibilities assigned to the Secretary of Labor in the provisions of the NDAA of 2010 and increase employment opportunities for U.S. construction workers. For additional substantive information about this ICR, see the related notice published in the 
                    <E T="04">Federal Register</E>
                     on October 22, 2024 (89 FR 84398).
                </P>
                <P>Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.</P>
                <P>
                    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not 
                    <PRTPAGE P="3962"/>
                    display a valid OMB Control Number. 
                    <E T="03">See</E>
                     5 CFR 1320.5(a) and 1320.6.
                </P>
                <P>DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.</P>
                <P>
                    <E T="03">Agency:</E>
                     DOL-ETA.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Guam Military Base Realignment Contractors Recruitment Standards.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1205-0484.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Private sector (for-profit businesses and not-for-profit organizations).
                </P>
                <P>
                    <E T="03">Total Estimated Number of Respondents:</E>
                     62.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Responses:</E>
                     62.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Time Burden:</E>
                     93 hours.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Other Costs Burden:</E>
                     $3,401.
                </P>
                <EXTRACT>
                    <FP>(Authority: 44 U.S.C. 3507(a)(1)(D))</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Michael Howell,</NAME>
                    <TITLE>Senior Paperwork Reduction Act Analyst.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00653 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FN-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBJECT>Agency Information Collection Activities; Submission for OMB Review; Comment Request; Claims and Payment Activities</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The OMB will consider all written comments that the agency receives on or before February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Howell by telephone at 202-693-6782, or by email at 
                        <E T="03">DOL_PRA_PUBLIC@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Form ETA-5159 report provides important program information on claims taking and benefit payment activities under State/Federal unemployment insurance laws. These data are needed for budget preparation and control, program planning and evaluation, personnel assignment, actuarial and program research, and for accounting to Congress and the public. This collection is authorized under the Social Security Act, Title III, Section 303(a)(6) and Public Law 112-96. For additional substantive information about this ICR, see the related notice published in the 
                    <E T="04">Federal Register</E>
                     on July 8, 2024 (89 FR 55987).
                </P>
                <P>
                    <E T="03">Comments are invited on:</E>
                     (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
                </P>
                <P>
                    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. 
                    <E T="03">See</E>
                     5 CFR 1320.5(a) and 1320.6.
                </P>
                <P>DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.</P>
                <P>
                    <E T="03">Agency:</E>
                     DOL-ETA.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Claims and Payment Activities.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1205-0010.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State, Local, and Tribal Governments.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Respondents:</E>
                     53.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Responses:</E>
                     2,544.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Time Burden:</E>
                     7,314 hours.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Other Costs Burden:</E>
                     $0.
                </P>
                <EXTRACT>
                    <FP>(Authority: 44 U.S.C. 3507(a)(1)(D))</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Michael Howell,</NAME>
                    <TITLE>Senior Paperwork Reduction Act Analyst.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00661 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FN-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">LEGAL SERVICES CORPORATION</AGENCY>
                <SUBJECT>Sunshine Act Meetings</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">TIME AND DATE: </HD>
                    <P>The Operations and Regulations, Governance and Performance Review, and Institutional Advancement Committees, and the Communications Subcommittee of the Legal Services Corporation Board of Directors will meet virtually on January 21 and January 23, 2025. On January 21, the Operations and Regulations Committee meeting will begin at 2:00 p.m. ET and will continue until the conclusion of the Committee's agenda. The Governance and Performance Review Committee meeting will begin at 3:00 p.m. ET and will continue until the conclusion of the Committee's agenda. On January 23, the Institutional Advancement Committee meeting will begin at 3:00 p.m. ET and will continue until the conclusion of the Committee's agenda.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE: </HD>
                    <P>
                        <E T="03">Public Notice of Virtual Meeting</E>
                    </P>
                    <P>LSC will conduct the January 21 and January 23, 2025, meetings via Zoom.</P>
                    <P>
                        <E T="03">Public Observation:</E>
                         Unless otherwise noted herein, all committee and subcommittee meetings will be open to public observation via Zoom. Members of the public who wish to participate remotely in the public proceedings may do so by following the directions provided below.
                    </P>
                </PREAMHD>
                <HD SOURCE="HD1">Directions for Open Sessions</HD>
                <HD SOURCE="HD2">Tuesday, January 21, 2025</HD>
                <P>
                    • 
                    <E T="03">To join the Zoom meeting by computer, please use this link:</E>
                      
                    <E T="03">https://lsc-gov.zoom.us/j/81310387219?pwd=QThds1Z7zK7xmkYe0QUZACzliiSHzJ.1&amp;from=addon</E>
                    .
                </P>
                <P>
                    <E T="03">Meeting ID:</E>
                     813 1038 7219.
                </P>
                <P>
                    <E T="03">Passcode:</E>
                     12125.
                </P>
                <P>
                    • 
                    <E T="03">To join the Zoom meeting with one tap from your mobile phone, please dial:</E>
                </P>
                <FP SOURCE="FP-1">+16699006833,,81310387219# US (San Jose)</FP>
                <FP SOURCE="FP-1">+14086380968,,81310387219# US (San Jose)</FP>
                <PRTPAGE P="3963"/>
                <P>
                    • 
                    <E T="03">To join the Zoom meeting by telephone, please dial one of the following phone numbers:</E>
                </P>
                <FP SOURCE="FP-1">• +1 669 900 6833 US (San Jose)</FP>
                <FP SOURCE="FP-1">• +1 408 638 0968 US (San Jose)</FP>
                <FP SOURCE="FP-1">• +1 669 444 9171 US</FP>
                <FP SOURCE="FP-1">• +1 253 215 8782 US (Tacoma)</FP>
                <FP SOURCE="FP-1">• +1 346 248 7799 US (Houston)</FP>
                <FP SOURCE="FP-1">• +1 719 359 4580 US</FP>
                <FP SOURCE="FP-1">• +1 253 205 0468 US</FP>
                <FP SOURCE="FP-1">• +1 386 347 5053 US</FP>
                <FP SOURCE="FP-1">• +1 507 473 4847 US</FP>
                <FP SOURCE="FP-1">• +1 564 217 2000 US</FP>
                <FP SOURCE="FP-1">• +1 646 876 9923 US (New York)</FP>
                <FP SOURCE="FP-1">• +1 646 931 3860 US</FP>
                <FP SOURCE="FP-1">• +1 689 278 1000 US</FP>
                <FP SOURCE="FP-1">• +1 301 715 8592 US (Washington DC)</FP>
                <FP SOURCE="FP-1">• +1 305 224 1968 US</FP>
                <FP SOURCE="FP-1">• +1 309 205 3325 US</FP>
                <FP SOURCE="FP-1">• +1 312 626 6799 US (Chicago)</FP>
                <FP SOURCE="FP-1">• +1 360 209 5623 US</FP>
                <P>
                    <E T="03">Meeting ID:</E>
                     813 1038 7219.
                </P>
                <HD SOURCE="HD2">Thursday, January 23, 2025</HD>
                <P>
                    • 
                    <E T="03">To join the Zoom meeting by computer, please use this link:</E>
                      
                    <E T="03">https://lsc-gov.zoom.us/j/85376875347?pwd=9RWUAXgEMGIh5wbhV91nISN6MLRsbY.1&amp;from=addon</E>
                    .
                </P>
                <P>
                    <E T="03">Meeting ID:</E>
                     853 7687 5347.
                </P>
                <P>
                    <E T="03">Passcode:</E>
                     12325.
                </P>
                <P>
                    • 
                    <E T="03">To join the Zoom meeting with one tap from your mobile phone, please dial:</E>
                </P>
                <FP SOURCE="FP-1">+14086380968,,85376875347# US (San Jose)</FP>
                <FP SOURCE="FP-1">+16694449171,,85376875347# US</FP>
                <P>
                    • 
                    <E T="03">To join the Zoom meeting by telephone, please dial one of the following phone numbers:</E>
                </P>
                <FP SOURCE="FP-1">• +1 408 638 0968 US (San Jose)</FP>
                <FP SOURCE="FP-1">• +1 669 444 9171 US</FP>
                <FP SOURCE="FP-1">• +1 669 900 6833 US (San Jose)</FP>
                <FP SOURCE="FP-1">• +1 253 215 8782 US (Tacoma)</FP>
                <FP SOURCE="FP-1">• +1 346 248 7799 US (Houston)</FP>
                <FP SOURCE="FP-1">• +1 719 359 4580 US</FP>
                <FP SOURCE="FP-1">• +1 253 205 0468 US</FP>
                <FP SOURCE="FP-1">• +1 507 473 4847 US</FP>
                <FP SOURCE="FP-1">• +1 564 217 2000 US</FP>
                <FP SOURCE="FP-1">• +1 646 876 9923 US (New York)</FP>
                <FP SOURCE="FP-1">• +1 646 931 3860 US </FP>
                <FP SOURCE="FP-1">• +1 689 278 1000 US </FP>
                <FP SOURCE="FP-1">• +1 301 715 8592 US (Washington DC)</FP>
                <FP SOURCE="FP-1">• +1 305 224 1968 US</FP>
                <FP SOURCE="FP-1">• +1 309 205 3325 US</FP>
                <FP SOURCE="FP-1">• +1 312 626 6799 US (Chicago)</FP>
                <FP SOURCE="FP-1">• +1 360 209 5623 US</FP>
                <FP SOURCE="FP-1">• +1 386 347 5053 US</FP>
                <P>
                    <E T="03">Meeting ID:</E>
                     853 7687 5347.
                </P>
                <P>Once connected to Zoom, please immediately mute your computer or telephone. Members of the public are asked to keep their computers or telephones muted to eliminate background noise. To avoid disrupting the meetings, please refrain from placing the call on hold if doing so will trigger recorded music or other sound.</P>
                <P>From time to time, the Committee Chairs may solicit comments from the public. To participate in the meeting during public comment, use the `raise your hand' or `chat' functions in Zoom and wait to be recognized by the Chair before stating your questions and/or comments.</P>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS: </HD>
                    <P>Parts of this meeting will be open to the public. The rest of the meeting will be closed to the public.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED:</HD>
                    <P/>
                </PREAMHD>
                <HD SOURCE="HD1">Meeting Schedule</HD>
                <HD SOURCE="HD2">Tuesday, January 21, 2025</HD>
                <P>
                    <E T="03">Start Time:</E>
                     2:00 p.m. ET.
                </P>
                <P>Operations and Regulations Committee.</P>
                <PREAMHD>
                    <HD SOURCE="HED">PORTIONS OPEN TO THE PUBLIC: </HD>
                    <P>Matters to be discussed in open session include approval of the Committee's agenda; approval of the minutes of the Committee's October 7, 2024, meeting; the Committee's self-evaluation for 2024 and goals for 2025; Management's report on implementation of LSC's 2021-2025 strategic plan; and LSC's engagement with the Client Leaders Council around LSC's rules governing client grievance procedures and prohibition of discrimination on the basis of disability.</P>
                </PREAMHD>
                <HD SOURCE="HD2">Tuesday, January 21, 2025</HD>
                <P>
                    <E T="03">Start Time:</E>
                     3:00 p.m. ET.
                </P>
                <P>Governance and Performance Review Committee.</P>
                <PREAMHD>
                    <HD SOURCE="HED">PORTIONS OPEN TO THE PUBLIC: </HD>
                    <P>Matters to be discussed in open session include approval of the Committee's agenda; approval of the minutes of the Committee's October 8, 2024, meeting; Management's report on the 2024 annual Board and committee self-evaluation process; the Committee's self-evaluation for 2024 and goals for 2025; proposed Board handbook; activities of the Office of Access to Justice, Department of Justice, and the White House Legal Aid Interagency Roundtable; Presidential transition and legislative outreach plans; LSC President's self-evaluation; and the 2024 activities of the Office of Inspector General.</P>
                </PREAMHD>
                <HD SOURCE="HD2">Thursday, January 23, 2025</HD>
                <P>
                    <E T="03">Start Time:</E>
                     3:00 p.m. ET.
                </P>
                <P>Institutional Advancement Committee and Communications Subcommittee.</P>
                <PREAMHD>
                    <HD SOURCE="HED">PORTIONS OPEN TO THE PUBLIC: </HD>
                    <P>Matters to be discussed in open session include approval of the Committee's agenda; approval of the minutes of the Subcommittee's and Committee's October 7, 2024, and October 15, 2024 meetings, respectively; the Subcommittee's and Committee's self-evaluations for 2024 and goals for 2025; activities of the Leaders and Emerging Leaders Councils; development activities; the Civil Court Data Initiative; Veterans Task Force implementation activities; communications and social media update; and a preview of the dynamic strategic communication plan for 2025.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PORTIONS CLOSED TO THE PUBLIC: </HD>
                    <P>Matters to be discussed in closed session include approval of the minutes of the Committee's October 15, 2024, meeting; a confidential development report; and consideration of and action on nominations to the Leaders and Emerging Leaders Councils.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION: </HD>
                    <P>
                        Cheryl DuHart, Administrative Coordinator, at (202) 295-1621. Questions may also be sent by electronic mail to 
                        <E T="03">duhartc@lsc.gov.</E>
                    </P>
                    <P>
                        <E T="03">Non-Confidential Meeting Materials:</E>
                         Non-confidential meeting materials will be made available in electronic format at least 24 hours in advance of the meeting on the LSC website, at 
                        <E T="03">https://www.lsc.gov/about-lsc/board-meeting-materials.</E>
                    </P>
                </PREAMHD>
                <EXTRACT>
                    <FP>(Authority: 5 U.S.C. 552b).</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Stefanie Davis,</NAME>
                    <TITLE>Deputy General Counsel, Legal Services Corporation.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00944 Filed 1-13-25; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 7050-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">OFFICE OF MANAGEMENT AND BUDGET</AGENCY>
                <SUBJECT>Advancing the Domestic Manufacturing of Semiconductors in Commercial Information Technology</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Management and Budget.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for information: Advancing the Domestic Manufacturing of Semiconductors in Commercial Information Technology.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This request for information (RFI) seeks input on ways the Federal Government can build the resilience of domestic semiconductor manufacturing and maintain this essential capability through the procurement of commercial IT end products that include semiconductors fabricated in the United States. Specific feedback is sought on potential procurement approaches to minimize supply chain disruption and increase fabrication of semiconductors in the United States.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Responses to this request for information will be accepted for consideration until March 17, 2025.</P>
                </DATES>
                <ADD>
                    <PRTPAGE P="3964"/>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Responses must be submitted electronically through 
                        <E T="03">regulations.gov.</E>
                         Mailed paper submissions will not be accepted, and electronic submissions received after the deadline may not be considered.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         Federal eRulemaking Portal: Go to 
                        <E T="03">www.regulations.gov</E>
                         search “Commercial IT Procurement RFI” to submit your comments electronically. Information on how to use 
                        <E T="03">Regulations.gov,</E>
                         including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “FAQ” (
                        <E T="03">https://www.regulations.gov/faq</E>
                        ).
                    </P>
                    <P>
                        <E T="03">Privacy Act Statement:</E>
                         OMB is issuing this request for information (RFI) pursuant to its authorities under the Office of Federal Procurement Policy Act, 41 U.S.C. 1101 
                        <E T="03">et seq.,</E>
                         and consistent with Executive Order (E.O.) 14005 and sec. 70933(1) of the Infrastructure Investment and Jobs Act (IIJA), Public Law 117-58, which aim for every executive agency to maximize the use of goods, products, and materials produced in, and services offered in, the United States. Your response to this RFI and submission of comments is voluntary. OMB will use your feedback to inform sound decision-making on topics related to this RFI regarding potential government-wide actions to revitalize the domestic manufacturing base, create new opportunities for U.S. firms and workers, and position U.S. businesses to compete and lead globally in strategic industries. Please note that submissions received in response to this notice may be posted in the Federal eRulemaking Portal at 
                        <E T="03">www.regulations.gov</E>
                         or otherwise released in their entirety, including any personal and business confidential information provided. Do not include in your submissions any information of a confidential nature, such as personal or proprietary information, or any information you would not like to be made publicly available. The OMB Public Input System of Records, OMB/INPUT/01 at 
                        <E T="03">88 FR 20913</E>
                         (
                        <E T="03">https://www.federalregister.gov/documents/2023/04/07/2023-07452/privacy-act-of-1974-system-of-records</E>
                        ) includes a list of routine uses associated with the collection of this information.
                    </P>
                    <P>Comments containing references, studies, research, and other empirical data that are not widely published should include electronic links to the referenced materials, if they are available online.</P>
                    <P>Please note that the U.S. Government will not pay for response preparation, or for the use of any information contained in the response. A response to this RFI will not be viewed as a binding commitment to develop or pursue the project or ideas discussed.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Please direct questions regarding this Notice to Eddie Garcia, Procurement Analyst (telephone: 202-881-7508) or email the Made in America Office at 
                        <E T="03">MadeInAmerica@omb.eop.gov</E>
                         with “Commercial IT Procurement RFI” in the subject line.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The bipartisan CHIPS and Science Act of 2022, Public Law 117-167, made historic investments in American semiconductor manufacturing to strengthen U.S. supply chains and help address vulnerabilities identified in the Information and Communications Technology (ICT) review of critical sectors conducted pursuant to E.O. 14017, 
                    <E T="03">America's Supply Chains.</E>
                </P>
                <P>This RFI is part of a series of government-wide actions the Administration is taking to build an essential domestic manufacturing capability for semiconductors. This RFI complements related efforts to minimize risk to U.S. economic and national security, which includes potential rulemaking by the Federal Acquisition Regulatory Council to prohibit Federal agencies from procuring or obtaining semiconductors manufactured in certain countries.</P>
                <P>OMB's Made in America Office (MIAO) and Office of Federal Procurement Policy (OFPP) seek to understand how the Federal acquisition system can best leverage domestic sources for semiconductors to ensure a safe and secure supply chain for U.S. government procured commercial IT products and services (hereafter referred to as “commercial IT”). Market segments of interest include:</P>
                <FP SOURCE="FP-1">—Telecommunication infrastructure and services</FP>
                <FP SOURCE="FP-1">—Cloud/data center infrastructure and services</FP>
                <FP SOURCE="FP-1">
                    —ICT devices (
                    <E T="03">e.g.,</E>
                     mobile phones, laptops)
                </FP>
                <FP SOURCE="FP-1">—Transportation/vehicles</FP>
                <P>MIAO and OFPP are especially interested in obtaining your views regarding the impact of using contract requirements for dual sourcing, potential agency reliance on the industrial mobilization exception to full and open competition, or other contracting methods to create and preserve this essential capability, mitigate the risk posed by undue dependence on foreign manufacturing and help reduce costs currently associated with domestic fabrication, assembly, test, and packaging (hereafter referred to as “manufacturing”).</P>
                <P>
                    <E T="03">Dual sourcing.</E>
                     Dual sourcing refers to the supply chain management practice of requiring contractors to utilize at least two suppliers to provide a specific component, material, or product for the purpose of helping to build alternative sources of supply and reducing supply chain disruption risks associated with relying on a single source.
                </P>
                <P>
                    <E T="03">Industrial mobilization.</E>
                     Procurement law and regulations have long recognized exceptions to full and open competition for a period of time, including when an agency can demonstrate that an exception is necessary to award the contract to particular sources in order to (a) maintain a facility, producer, manufacturer, or other supplier available for furnishing supplies or services in case of a national emergency or to achieve industrial mobilization; or (b) establish or maintain an essential engineering, research, or development capability to be provided by an educational or other nonprofit institution or a Federally funded research and development center. 10 U.S.C. 2304(c)(3), 41 U.S.C. 3304(a)(3); FAR 6.302-3. Limiting competition to domestic sources for a period of time to create or maintain the required domestic capability for production of critical supplies has long been identified in the FAR as a recognized application of the industrial mobilization exception to full and competition and can help to address the cost differences between domestic and foreign production by building the competitiveness of the domestic market over time. For additional information on industrial mobilization, see OFPP &amp; MIAO, 
                    <E T="03">Strengthening Domestic Sourcing for Critical Items (Mar. 13, 2024).</E>
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">https://www.whitehouse.gov/wp-content/uploads/2024/03/Strengthening-Domestic-Sourcing-for-Critical-Items.pdf.</E>
                    </P>
                </FTNT>
                <P>To understand the potential impact of these or other strategies, OMB seeks feedback on the following questions. OMB is especially interested in feedback as it pertains to data centers, telecom, and other IT infrastructure and services, mobile devices, laptops, servers, and workstations, as well as automobiles and other vehicles, but welcomes feedback on any commercial IT that uses semiconductors.</P>
                <P>
                    For purposes of this RFI, the terms 
                    <E T="03">semiconductor</E>
                     and 
                    <E T="03">semiconductor manufacturing</E>
                     have the same meanings as set forth in National Institute of Standards and Technology regulations at 15 CFR 
                    <E T="03">231.115 and 231.116.</E>
                     Examples of semiconductors include 
                    <PRTPAGE P="3965"/>
                    memory chips, logic chips such as microprocessors and microcontrollers, complex systems-on-a-chip, and discrete, analog, and optoelectronic chips. The RFI encompasses in its scope leading-edge, current-generation, and mature-node semiconductors as defined in CHIPS Program Office Notice of Funding Opportunities for commercial fabrication facilities, Feb 28 2023]. For instance, leading-edge logic semiconductors are those requiring extreme ultraviolet (EUV) lithography tools for production (and equivalent performance spec for memory chips); current-generation semiconductors are those that are not leading-edge, up to 28 nanometer process technologies, and include logic, analog, radio frequency, and mixed-signal devices; mature-node semiconductors include sensors, optoelectronics, discrete devices, and logic and analog chips not based on FinFET, post-FinFET, or any other sub-28 nanometer transistor architectures.
                </P>
                <HD SOURCE="HD1">Questions</HD>
                <P>
                    1. If sufficient economic incentives existed, how quickly could you begin to use domestically manufactured semiconductors? In responding, please identify your market segment or segments (
                    <E T="03">e.g.,</E>
                     cloud services, cloud infrastructure, telecom services, telecom infrastructure, user devices, automobiles) and the type of chips you use most frequently.
                </P>
                <P>2. Once you have determined that there is sufficient domestic manufacturing of semiconductors, what factors, including economic incentives, would affect your willingness to take advantage of this supply? In responding, please identify your market segment.</P>
                <P>3. How much production is needed to constitute a sufficient domestic supply of semiconductors? In responding, please identify both your market segment and the any information regarding semiconductors that would be helpful to better understand your market segment needs.</P>
                <P>4. Last year, the Federal Government purchased approximately $10 billion on IT hardware, including approximately 1.5 million mobile devices and 1.3 million laptops, around $14 billion of cloud computing, including data centers, and $5.43 billion of telecom services.</P>
                <P>
                    a. What steps might agencies take that could effectively incentivize you to use domestically manufactured semiconductors in meeting this demand (
                    <E T="03">e.g.,</E>
                     agency competitions limited to offerors who use only domestically manufactured semiconductors; requirements that awardees must use two different sources for semiconductors and at least one source must provide domestically manufactured semiconductors; agency forecasts published well in advance of solicitation that inform interested sources of these competitions)? Please identify your market segment.
                </P>
                <P>b. Would you be willing to compete for an IT data center contract or a telecom contract that requires the service provider to use equipment with domestically manufactured semiconductors in the performance of the required service? If not, why not? Would your answer change if the statement of work required offerors to agree to use at least two different sources for semiconductors?</P>
                <P>
                    c. What opportunities or challenges do you see for your market segment if you were to use only domestically manufactured semiconductors? Are there steps that could make the requirement more manageable, such as with a phase-in (
                    <E T="03">e.g.,</E>
                     requiring a certain percentage of semi-conductors to be domestically manufactured)?
                </P>
                <P>d. Many state and local governments adopt Federal standards with respect to their own procurement regulations. Would your responses change to any of the above questions, if State and local governments adopted, through their own authorities, complementary actions?</P>
                <P>e. What percentage of your current offerings rely on domestically manufactured semiconductors? Please identify your market segment.</P>
                <P>f. Are there particular categories of semiconductors that would be easier to source domestically or ones that would be more difficult?</P>
                <P>g. Are there particular categories of semiconductors that would constitute a larger portion of your purchased components and would be better sourced domestically?</P>
                <P>5. How far in advance of manufacturing must a purchase order be secured from a semiconductor fabricator to support production, or infrastructure build-out?</P>
                <P>6. What, if any, significant domestic supply chain vulnerabilities surrounding semiconductors are you aware of and what could be done to reduce or eliminate those vulnerabilities? Are there other vulnerabilities of which we should be aware?</P>
                <P>7. To meet Federal sustainability purchasing requirements, should domestically-produced commercial IT products with domestic semiconductors include specifications, standards, or ecolabels recommended by the Environmental Protection Agency (EPA) for Federal purchasing or be capable of meeting EPA's Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing for future inclusion?</P>
                <HD SOURCE="HD1">Questions for Domestic Manufacturers of Semiconductors</HD>
                <P>8. What is the anticipated timeline for domestic production and anticipated capacity of various types of semiconductors, including but not limited to memory chips, logic chips such as microprocessors and microcontrollers, complex systems-on-a-chip, and discrete, analog, and optoelectronic chips?</P>
                <P>9. How much time do you need from the placement of an order from an IT hardware manufacturer to deliver the semiconductors?</P>
                <P>10. What is the anticipated timeline for domestic production and capacity of associated components, including, but not limited to, packaging of chips, mother boards, etc.?</P>
                <P>11. What raw materials used in semiconductor manufacturing are in limited or constrained supply and could prevent scale up of your domestic manufacturing operations?</P>
                <P>12. What manufacturing equipment do you use that are in limited or constrained supply and could prevent scale up of your domestic semiconductor manufacturing and operations?</P>
                <P>13. What, if any, factors (for example, workforce, permitting, access to high quality power/water, etc.) are causing significant delays in bringing domestic manufacturing facilities online?</P>
                <P>14. What types of innovations can help make the manufacturing market more efficient?</P>
                <HD SOURCE="HD1">Additional Questions for Interested Stakeholders</HD>
                <P>15. What actions should the Federal Government take to enable strong small business participation by resellers offering commercial IT with domestically fabricated semiconductors?</P>
                <P>
                    OMB intends to hold industry listening sessions in the coming months to discuss industry feedback. Listening sessions will be noticed through the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Christine J. Harada,</NAME>
                    <TITLE>Senior Advisor, Office of Federal Procurement Policy, Performing, by delegation, the duties of the Administrator for Federal Procurement Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00727 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3966"/>
                <AGENCY TYPE="N">MILLENNIUM CHALLENGE CORPORATION</AGENCY>
                <DEPDOC>[MCC FR 25-01]</DEPDOC>
                <SUBJECT>Report on the Selection of Eligible Countries for Fiscal Year 2025 (Albania)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Millennium Challenge Corporation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This report is provided in accordance with the Millennium Challenge Act of 2003, as amended. The report is set forth in full below.</P>
                </SUM>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Report on the Selection of Eligible Countries for Fiscal Year 2025 (Albania).</P>
                <HD SOURCE="HD1">Summary</HD>
                <P>This report is provided in accordance with section 608(d)(1) of the Millennium Challenge Act of 2003, as amended (the Act) (22 U.S.C. 7707(d)(1)). This is the second such report for fiscal year (FY) 2025 due to the enactment of the Millennium Challenge Corporation Candidate Country Reform Act on December 23, 2024.</P>
                <P>
                    The Act authorizes the provision of assistance under section 605 of the Act (22 U.S.C. 7704) to countries that enter into compacts with the United States to support policies and programs that advance the progress of such countries in achieving lasting poverty reduction through economic growth and are in furtherance of the Act. The Act requires the Millennium Challenge Corporation (MCC) to determine the countries that will be eligible to receive assistance for the fiscal year, based on their demonstrated commitment to just and democratic governance, economic freedom, and investing in their people, as well as on the opportunity to reduce poverty through economic growth in the country. The Act also requires the submission of reports to appropriate congressional committees and the publication of notices in the 
                    <E T="04">Federal Register</E>
                     that identify, among other things:
                </P>
                <P>1. The countries that are “candidate countries” for assistance for FY 2025 based on their per-capita income levels and their eligibility to receive assistance under U.S. law, and countries that would be candidate countries, but for specified legal prohibitions on assistance (section 608(a) of the Act (22 U.S.C. 7707(a)));</P>
                <P>2. The criteria and methodology that the Board of Directors of MCC (the Board) used to measure and evaluate the policy performance of the “candidate countries” consistent with the requirements of section 607 of the Act in order to determine “eligible countries” from among the “candidate countries” (section 608(b) of the Act (22 U.S.C. 7707(b))); and</P>
                <P>3. The list of countries determined by the Board to be “eligible countries” for FY 2025, with justification for eligibility determination and selection for compact negotiation, including with which of the eligible countries the Board will seek to enter into compacts (section 608(d) of the Act (22 U.S.C. 7707(d))).</P>
                <P>This is an additional report that fulfills the requirements under the third of the above-described reports by MCC for FY 2025. A prior report was sent to Congress on December 19, 2024. Both the prior report and this report identify countries determined by the Board to be eligible under section 607 of the Act (22 U.S.C. 7706) for FY 2025 with which MCC seeks to enter into compacts under section 609 of the Act (22 U.S.C. 7708), as well as the justification for such decisions. The prior report also identifies countries selected by the Board to receive assistance under MCC's threshold program pursuant to section 616 of the Act (22 U.S.C. 7715).</P>
                <HD SOURCE="HD1">Eligible Countries</HD>
                <P>The Board met on December 18, 2024, to select those eligible countries with which the United States, through MCC, will seek to enter into a Millennium Challenge Compact pursuant to section 607 of the Act (22 U.S.C. 7706). At the time, the Board selected Liberia as eligible to develop a compact, as noted in MCC's previous report.</P>
                <P>Following the passage of the MCC Candidate Country Reform Act, as part of the National Defense Authorization Act for Fiscal Year 2025, the Board considered additional eligible countries with which the United States, through MCC, will seek to enter into a Millennium Challenge Compact pursuant to section 607 of the Act (22 U.S.C. 7706). On January 7, 2025, the Board selected Albania for such assistance for FY 2025 via a written consent action in accordance with section 9 of MCC's bylaws. Albania is invited by MCC to develop a compact.</P>
                <HD SOURCE="HD1">Criteria</HD>
                <P>
                    In accordance with the Act and with the “Selection Criteria and Methodology Report for Fiscal Year 2025” formally submitted to Congress on September 20, 2024, selection was based primarily on a country's overall performance in three broad policy categories: 
                    <E T="03">Ruling Justly, Encouraging Economic Freedom,</E>
                     and 
                    <E T="03">Investing in People.</E>
                     The Board relied, to the fullest extent possible, upon transparent and independent indicators to assess countries' policy performance and demonstrated commitment in these three broad policy areas. The Board compared countries' performance on the indicators relative to their income-level peers, evaluating them in comparison to either the group of countries with a GNI per capita equal to or less than $2,165, the group with a GNI per capita between $2,166 and $4,515, or the group with a GNI per capita between $4,516 and $7,895.
                </P>
                <P>
                    The criteria and methodology used to assess countries, including the methodology for the annual scorecards, are outlined in the “Selection Criteria and Methodology Report for Fiscal Year 2025.” 
                    <SU>1</SU>
                    <FTREF/>
                     Scorecards reflecting each country's performance on the indicators are available on MCC's website at 
                    <E T="03">https://www.mcc.gov/who-we-select/scorecards.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Available at 
                        <E T="03">https://www.mcc.gov/resources/doc/report-selection-criteria-methodology-fy25</E>
                        .
                    </P>
                </FTNT>
                <P>
                    The Board also considered whether any adjustments should be made for data gaps, data lags, or recent events since the indicators were published, as well as strengths or weaknesses in particular indicators. Where appropriate, the Board considered additional quantitative and qualitative information, such as evidence of a country's commitment to fighting corruption, investments in human development outcomes, or poverty rates. MCC published a Guide to Supplemental Information 
                    <SU>2</SU>
                    <FTREF/>
                     to increase transparency about the type of supplemental information the Board uses to assess a country's policy performance. In keeping with statutory requirements, the Board also considered the opportunity to reduce poverty and promote economic growth in a country, in light of the overall information available, as well as the availability of appropriated funds.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Available at 
                        <E T="03">https://www.mcc.gov/resources/doc/guide-to-supplemental-information</E>
                        .
                    </P>
                </FTNT>
                <P>The Board sees the selection decision as an annual opportunity to determine where MCC funds can be most effectively used to support poverty reduction through economic growth in well-governed countries with demonstrated development need. The Board carefully considers the appropriate nature of each country partnership—on a case-by-case basis—based on factors related to poverty reduction through economic growth, the sustainability of MCC's investments, and the country's ability to attract and leverage public and private resources in support of development.</P>
                <P>
                    This is the first fiscal year in which the Board used its new authority under 
                    <PRTPAGE P="3967"/>
                    the MCC Candidate Country Reform Act to select from the additional group of countries newly included for consideration for MCC assistance. The new authority aligns the income threshold for a country to be an MCC candidate county with the World Bank threshold for initiating the International Bank for Reconstruction and Development graduation process ($7,895 gross national income per capita for fiscal year 2025). In considering any such new countries in MCC's candidate pool, the Board will continue to apply MCC's long-standing statutorily mandated eligibility criteria and selectivity model to all selections and will continue to prioritize the opportunity to reduce poverty through economic growth.
                </P>
                <HD SOURCE="HD1">Country Newly Selected for Compact Assistance</HD>
                <P>
                    Using the criteria described above, 
                    <E T="03">Albania,</E>
                     a candidate country under section 606(a) of the Act (22 U.S.C. 7705(a)), was newly selected as eligible for assistance under section 607 of the Act (22 U.S.C. 7706). Albania is invited by MCC to develop a compact.
                </P>
                <P>
                    <E T="03">Albania:</E>
                     A prior MCC threshold program partner, Albania performs well on the scorecard, passing 15 of 20 indicators overall. A stable democracy with a record of competitive elections, Albania is expected to hold parliamentary elections on May 11, 2025. In recent years, Albania has adopted critical anti-corruption and rule of law reforms amid efforts to join the European Union, which are reflected in its performance on the scorecard. Despite sound economic governance, Albania continues to face headwinds in its development path given its vulnerabilities to geopolitical and natural disaster-related shocks, which have disproportionately affected the poor in recent years; 14 percent of the population lives on less than $6.85 per day—the World Bank's poverty line for upper middle-income countries. MCC's Board selected Albania as eligible to develop a compact in recognition of Albania's democratic history, progress fighting corruption, and ongoing development needs.
                </P>
                <EXTRACT>
                    <FP>(Authority: 22 U.S.C. 7707(d)(2))</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Peter E. Jaffe,</NAME>
                    <TITLE>Vice President, General Counsel, and Corporate Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00899 Filed 1-13-25; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 9211-03-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <DEPDOC>[Notice: 25-002]</DEPDOC>
                <SUBJECT>Aerospace Safety Advisory Panel; Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel (ASAP). The ASAP will hold its First Quarterly Meeting for 2025. This discussion is pursuant to carrying out its statutory duties for which the Panel reviews, identifies, evaluates, and advises on those program activities, systems, procedures, and management activities that can contribute to program risk. Priority is given to those programs that involve the safety of human flight.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Thursday, January 30, 2025, 3:00 p.m. to 4:30 p.m., eastern time.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Public attendance will be virtual only. See dial-in information below under 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Lisa M. Hackley, ASAP Administrative Officer, NASA Headquarters, Washington, DC 20546, (202) 358-1947 or 
                        <E T="03">lisa.m.hackley@nasa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    As noted above, this meeting is only available telephonically. Any interested person must use a touch-tone phone to participate in this meeting. Any interested person may call the USA toll free conference call number 888-566-6133; passcode 8343253 and then the # sign. At the beginning of the meeting, members of the public may make a verbal presentation to the Panel limited to the subject of safety in NASA, not to exceed 5 minutes in length. To do so, members of the public must contact Ms. Lisa M. Hackley at 
                    <E T="03">lisa.m.hackley@nasa.gov</E>
                     or at (202) 358-1947 at least 48 hours in advance. Any member of the public is permitted to file a written statement with the Panel via electronic submission to Ms. Hackley at the email address previously noted. Written statements should be limited to the subject of safety in NASA.
                </P>
                <P>The agenda for the meeting includes the following topics:</P>
                <FP SOURCE="FP-1">—Updates on the Space Station Program</FP>
                <FP SOURCE="FP-1">—Updates on the Commercial Crew Program</FP>
                <FP SOURCE="FP-1">—Updates on the Moon to Mars Program</FP>
                <P>It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.</P>
                <SIG>
                    <NAME>Jamie M. Krauk,</NAME>
                    <TITLE>Advisory Committee Management Officer, National Aeronautics and Space Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00666 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7510-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                <DEPDOC>[NOTICE: 25-001]</DEPDOC>
                <SUBJECT>Notice of Intent To Grant an Exclusive, Co-Exclusive or Partially Exclusive Patent License</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Aeronautics and Space Administration (NASA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of intent to grant exclusive, co-exclusive or partially exclusive patent license.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        NASA hereby gives notice of its intent to grant an exclusive, co-exclusive or partially exclusive patent license to practice the inventions described and claimed in the patents and/or patent applications listed in 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         below.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The prospective exclusive, co-exclusive or partially exclusive license may be granted unless NASA receives written objections including evidence and argument, no later than January 30, 2025 that establish that the grant of the license would not be consistent with the requirements regarding the licensing of federally owned inventions as set forth in the Bayh-Dole Act and implementing regulations. Competing applications completed and received by NASA no later than January 30, 2025 will also be treated as objections to the grant of the contemplated exclusive, co-exclusive or partially exclusive license. Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act.</P>
                    <P>
                        <E T="03">Objections and Further Information:</E>
                         Written objections relating to the prospective license or requests for further information may be submitted to Agency Counsel for Intellectual Property, NASA Headquarters at Email: 
                        <E T="03">hq-patentoffice@mail.nasa.gov.</E>
                         Questions may be directed to Phone: (202) 358-0646.
                    </P>
                </DATES>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    NASA intends to grant an exclusive, co-exclusive, or partially exclusive patent license in the United States to practice the inventions described and claimed in 
                    <PRTPAGE P="3968"/>
                    U.S. Patent No. 10,767,058 entitled “Controlled Release Materials for Anti-Corrosion Agents,” issued on September 8, 2020, to SynMatter LLC, having its principal place of business in Orlando, Florida. The fields of use may be limited. NASA has not yet made a final determination to grant the requested license and may deny the requested license even if no objections are submitted within the comment period.
                </P>
                <P>This notice of intent to grant an exclusive, co-exclusive or partially exclusive patent license is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective license will comply with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.</P>
                <P>
                    Information about other NASA inventions available for licensing can be found online at 
                    <E T="03">http://technology.nasa.gov.</E>
                </P>
                <SIG>
                    <NAME>Trenton J. Roche,</NAME>
                    <TITLE>Agency Counsel for Intellectual Property, National Aeronautics and Space Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00669 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7510-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL ARCHIVES AND RECORDS ADMINISTRATION</AGENCY>
                <DEPDOC>[NARA-2025-013]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Submission for OMB Review; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Archives and Records Administration (NARA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>We have submitted a request to the Office of Management and Budget (OMB) for approval to continue to use three currently approved information collections. People use the first information collection to request permission to film, photograph, or videotape at a NARA facility for news purposes. People use the second information collection to request permission to use NARA facilities for events in the Washington, DC, area, at a Federal records center, or at a Presidential library. People use the third information collection to request their name be placed on a list of independent researchers who perform freelance research for hire in the Washington, DC, area. We invite you to comment on the proposed information collections.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>OMB must receive written comments on or before February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send any comments and recommendations on the proposed information collection in writing to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         You can find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kellie Shipley, Paperwork Reduction Act Officer, by email at 
                        <E T="03">kellie.shipley@nara.gov</E>
                         or by telephone at 301.837.0685 with any requests for additional information.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), we invite the public and other Federal agencies to comment on proposed information collections. We published a notice of proposed collection for these information collections on November 1, 2024 (89 FR 87427) and we received no comments. We are therefore submitting the described information collections to OMB for approval.</P>
                <P>If you have comments or suggestions, they should address one or more of the following points: (a) whether the proposed information collections are necessary for NARA to properly perform its functions; (b) our estimate of the burden of the proposed information collections and its accuracy; (c) ways we could enhance the quality, utility, and clarity of the information we collect; (d) ways we could minimize the burden on respondents of collecting the information, including through information technology; and (e) whether these collections affect small businesses.</P>
                <P>In this notice, we solicit comments concerning the following information collections:</P>
                <P>
                    1. 
                    <E T="03">Title:</E>
                     Request to film, photograph, or videotape at a NARA facility for news purposes.
                </P>
                <P>
                    <E T="03">OMB number:</E>
                     3095-0040.
                </P>
                <P>
                    <E T="03">Agency form number:</E>
                     NA Form 11010 (Use of Equipment Consent Waiver and Release).
                </P>
                <P>
                    <E T="03">Type of review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Affected public:</E>
                     Business or other for-profit, not-for-profit institutions.
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     350.
                </P>
                <P>
                    <E T="03">Estimated time per response:</E>
                     10 minutes.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     58.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The information collection is prescribed by 36 CFR 1280.48. The collection is prepared by organizations that wish to film, photograph, or videotape on NARA property for news purposes. We need the information to determine if the request complies with NARA regulations, to ensure protection of archival holdings, and to schedule the filming appointment.
                </P>
                <P>
                    2. 
                    <E T="03">Title:</E>
                     Request to use NARA facilities in the Washington, DC, area, public spaces at Federal records centers, or Presidential library and grounds, for events.
                </P>
                <P>
                    <E T="03">OMB number:</E>
                     3095-0043.
                </P>
                <P>
                    <E T="03">Agency form number:</E>
                     NA Form 16011 (Application and permit for use of space in Presidential library and grounds).
                </P>
                <P>
                    <E T="03">Type of review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Affected public:</E>
                     Not-for-profit institutions, individuals or households, business or other for-profit, private organizations, Federal Government.
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     300 for facilities in the Washington, DC, area and Federal records centers; 500 for Presidential library facilities and grounds.
                </P>
                <P>
                    <E T="03">Estimated time per response:</E>
                     30 minutes for facilities in the Washington, DC, area and Federal records centers; 20 minutes for Presidential library facilities and grounds.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     150 hours for facilities in the Washington, DC, area and Federal records centers; 165 hours for Presidential library facilities and grounds.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The information collection is prescribed by 36 CFR 1280.64. Requesters submit the information when they wish to use NARA public areas in the Washington, DC, area or public spaces at Federal records centers for an event, or they submit the application to request the use of space in a Presidential library for a privately sponsored activity. We use the information to determine whether or not we can accommodate the request and date, whether the requested use meets the criteria in 36 CFR 1280, and to ensure that the proposed event complies with NARA regulations.
                </P>
                <P>
                    3. 
                    <E T="03">Title:</E>
                     Independent Researcher Listing Application.
                </P>
                <P>
                    <E T="03">OMB number:</E>
                     3095-0054.
                </P>
                <P>
                    <E T="03">Agency form numbers:</E>
                     NA Form 14115 (Independent Researcher Listing Application).
                </P>
                <P>
                    <E T="03">Type of review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Affected public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     300.
                </P>
                <P>
                    <E T="03">Estimated time per response:</E>
                     10 minutes.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     50.
                    <PRTPAGE P="3969"/>
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     In the past, the National Archives has made use of various lists of independent researchers who perform freelance research for hire in the Washington, DC, area. We have sent these lists upon request to researchers who could not travel to the metropolitan area to conduct their own research. To better accommodate both the public and NARA staff, the Archival Operations division of the National Archives maintains a listing of independent researchers for the public. All interested independent researchers provide their contact information via this form. Collecting contact and other key information from each independent researcher and providing such information to the public when deemed appropriate will only increase business. This form is not a burden in any way to any independent researcher who voluntarily submits a completed form. Inclusion on the list will not be viewed or advertised as an endorsement by the National Archives and Records Administration (NARA). The listing is compiled and disseminated as a service to the public.
                </P>
                <SIG>
                    <NAME>Gulam Shakir,</NAME>
                    <TITLE>Acting Executive for Information Services/CIO.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00714 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7515-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES</AGENCY>
                <SUBAGY>National Endowment for the Arts</SUBAGY>
                <SUBJECT>Arts Advisory Panel Meetings</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Endowment for the Arts.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of meetings.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 4 meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference or videoconference.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        See the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section for individual meeting times and dates. All meetings are Eastern time and ending times are approximate:
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>National Endowment for the Arts, Constitution Center, 400 7th St. SW, Washington, DC 20506.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Further information with reference to these meetings can be obtained from David Travis, Office of Guidelines &amp; Panel Operations, National Endowment for the Arts, Washington, DC 20506; 
                        <E T="03">travisd@arts.gov,</E>
                         or call 202-682-5001.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chair of March 11, 2022, these sessions will be closed to the public pursuant to 5 U.S.C. 10.</P>
                <HD SOURCE="HD1">The Upcoming Meetings Are</HD>
                <P>
                    <E T="03">NEA Jazz Masters Fellowships Panel A (review of applications):</E>
                     This meeting will be closed.
                </P>
                <P>
                    <E T="03">Date and time:</E>
                     February 6, 2025; 2:00 p.m. to 4:00 p.m.
                </P>
                <P>
                    <E T="03">NEA Jazz Masters Fellowships Panel B (review of applications):</E>
                     This meeting will be closed.
                </P>
                <P>
                    <E T="03">Date and time:</E>
                     February 6, 2025; 2:00 p.m. to 4:00 p.m.
                </P>
                <P>
                    <E T="03">Arts Education Partnership Panel (review of applications):</E>
                     This meeting will be closed.
                </P>
                <P>
                    <E T="03">Date and time:</E>
                     February 12, 2025; 1:30 p.m. to 3:30 p.m.
                </P>
                <P>
                    <E T="03">International Activities Panel (review of applications):</E>
                     This meeting will be closed.
                </P>
                <P>
                    <E T="03">Date and time:</E>
                     March 4, 2024; 2:00 p.m. to 4:00 p.m.
                </P>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>David Travis, </NAME>
                    <TITLE>Specialist, National Endowment for the Arts.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00752 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7537-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL SCIENCE FOUNDATION</AGENCY>
                <SUBJECT>Agency Information Collection Activities: Comment Request; 2025 National Survey of College Graduates</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Center for Science and Engineering Statistics, National Science Foundation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Submission for OMB review; comment request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The National Center for Science and Engineering Statistics (NCSES) within the National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the 
                        <E T="04">Federal Register</E>
                         and two comments were received. NCSES is forwarding the proposed information collection to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice. The full submission may be found at: 
                        <E T="03">http://www.reginfo.gov/public/do/PRAMain.</E>
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAmain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314, or send email to 
                        <E T="03">splimpto@nsf.gov.</E>
                         Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339, which is accessible 24 hours a day, 7 days a week, 365 days a year (including federal holidays). Comments regarding this information collection are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling 703-292-7556.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Comments:</E>
                     Comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the NSF, including whether the information shall have practical utility; (b) the accuracy of the NSF's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, use, and clarity of the information on respondents; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to the points of contact in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <P>NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.</P>
                <P>
                    <E T="03">Comments:</E>
                     As required by 5 CFR 1320.8(d), comments on the information collection activities as part of this study 
                    <PRTPAGE P="3970"/>
                    were solicited through the publication of a 60-Day Notice in the 
                    <E T="04">Federal Register</E>
                     on September 4, 2024, at 89 FR 71938. We received four comments. The nature of each comment and our responses are summarized below.
                </P>
                <P>• The American Association for the Advancement of Science (AAAS) and the American Educational Research Association (AERA) provided a joint comment discussing the necessity of the NSCG data to provide critical insights into opportunities and gaps in the STEM workforce. The commentors also encouraged the incorporation of a sexual orientation question into the 2025 NSCG survey cycle.</P>
                <P>• The Council of Professional Associations on Federal Statistics (COPAFS) provided a comment encouraging the incorporation of a sexual orientation question into the 2025 NSCG survey cycle.</P>
                <P>• The Federation of Associations in Behavioral &amp; Brain Sciences (FABBS) provided a comment encouraging the incorporation of a sexual orientation question into the 2025 NSCG survey cycle.</P>
                <P>• An Associate Professor from Columbia University provided feedback on past sexual orientation and gender identity research conducted by NCSES and the Census Bureau. The commentor also encouraged the incorporation of a sexual orientation question into the 2025 NSCG survey cycle.</P>
                <P>
                    <E T="03">Response:</E>
                     NCSES thanked the commentors for their support of the NSCG, referenced the NCSES website that summarizes past research findings, and summarized the necessity of using the Census Bureau's American Community Survey sexual orientation research findings, when completed, to inform NCSES's future data collection plans.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     2025 National Survey of College Graduates.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     3145-0141.
                </P>
                <P>
                    <E T="03">Summary of Collection:</E>
                     The National Survey of College Graduates (NSCG) has been conducted biennially since the 1970s. The 2025 NSCG sample will be selected from the 2023 American Community Survey (ACS) and the 2023 NSCG. By selecting the sample from these two sources, the 2025 NSCG will provide coverage of the college graduate population residing in the United States. The purpose of this repeated cross-sectional survey is to collect data that will be used to provide national estimates on the science and engineering workforce and changes in their employment, education, and demographic characteristics.
                </P>
                <P>The National Science Foundation Act of 1950, as subsequently amended, includes a statutory charge to “. . . provide a central clearinghouse for the collection, interpretation, and analysis of data on scientific and engineering resources, and to provide a source of information for policy formulation by other agencies of the Federal Government.” The NSCG is designed to comply with these mandates by providing information on the supply and utilization of the nation's scientists and engineers.</P>
                <P>The U.S. Census Bureau will continue to serve as the NSCG data collection contractor for NCSES. The survey data collection is expected to begin in March 2025 and continue for approximately six months. Data will be collected using web and mail questionnaires. The individual's response to the survey is voluntary. The survey will be conducted in conformance with Census Bureau statistical quality standards and, as such, the NSCG data will be afforded confidentiality protection under the applicable Census Bureau confidentiality statutes.</P>
                <P>
                    <E T="03">Use of the Information:</E>
                     NCSES uses the information from the NSCG to prepare congressionally mandated reports such as 
                    <E T="03">Women, Minorities and Persons with Disabilities in Science and Engineering</E>
                     (
                    <E T="03">https://www.nsf.gov/statistics/women/</E>
                    ) and 
                    <E T="03">Science and Engineering Indicators</E>
                     (
                    <E T="03">https://ncses.nsf.gov/indicators</E>
                    ), 
                    <E T="03">both of which are available online.</E>
                     A public release file of collected data, designed to protect respondent confidentiality, will be made available on the internet and will be accessible through an online data tool (
                    <E T="03">https://ncsesdata.nsf.gov/ids/</E>
                    ).
                </P>
                <P>
                    <E T="03">Expected Respondents:</E>
                     A statistical sample of approximately 161,000 persons will be contacted in 2025. NCSES estimates the 2025 NSCG response rate to be 60 to 65 percent.
                </P>
                <P>
                    <E T="03">Estimate of Burden:</E>
                     The amount of time to complete the questionnaire may vary depending on an individual's circumstances; however, it is estimated that on average it will take approximately 23 minutes to complete the survey. NCSES estimates that the average annual burden for the 2025 NSCG over the course of the three-year OMB clearance period will be no more than 13,372 hours [(161,000 individuals × 65% response rate × 23 minutes)/3 years].
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Suzanne H. Plimpton,</NAME>
                    <TITLE>Reports Clearance Officer, National Science Foundation. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00683 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7555-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">OFFICE OF PERSONNEL MANAGEMENT</AGENCY>
                <DEPDOC>[Docket ID: OPM-2024-0022]</DEPDOC>
                <SUBJECT>Privacy Act of 1974; System of Records</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Workforce Policy and Innovation, Office of Personnel Management.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a new system of records.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Privacy Act of 1974, the Office of Personnel Management (OPM) proposes to establish a new system of records titled, “OPM/Internal—31, VA Recoupment and Reduction Appeals to OPM.” OPM will use this system to process appeals from current and former civil service Department of Veterans Affairs (VA) employees who received an order by the VA to recoup or reduce their awards, bonuses, relocation expenses, or retirement benefits, and chose to appeal that order to the Director of OPM.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        Submit comments on or before February 14, 2025. This new system is effective upon publication in the 
                        <E T="04">Federal Register</E>
                        , except for the routine uses, which are effective February 18, 2025.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit written comments using the Federal eRulemaking Portal at 
                        <E T="03">https://www.regulations.gov.</E>
                         All submissions received must include the agency name and docket number for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         without change, including any personal identifiers.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For general questions, please contact the Tim Curry, Employee Services, Accountability and Workforce Relations, Workforce Policy and Innovation, at (202) 606-2930 or 
                        <E T="03">employeeaccountability@opm.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Sections 721 and 723 of title 38, United States Code, permit the VA to order the recoupment of a VA employee's awards, bonuses, or relocation expenses if (a) the VA finds the individual engaged in misconduct, poor performance, fraud, or malfeasance and (b) if the VA had known about those actions prior to awarding the relevant benefit, it would have impacted the awarding of said benefit. Section 719 of title 38, United States Code, permits the VA to order the reduction of a VA employee's retirement 
                    <PRTPAGE P="3971"/>
                    benefits if they were convicted of certain crimes and removed for (or are in the process of being removed for) performance or misconduct. These statutes provide individuals who receive one of these orders the right to appeal that order to the Director of OPM. In accordance with 5 U.S.C. 552a(r), OPM has provided a report of this new system of records to the Office of Management and Budget and to Congress. This new system of records will be included in OPM's inventory of record systems.
                </P>
                <SIG>
                    <FP>Office of Personnel Management.</FP>
                    <NAME>Kayyonne Marston,</NAME>
                    <TITLE>Federal Register Liaison.</TITLE>
                </SIG>
                <PRIACT>
                    <HD SOURCE="HD2">SYSTEM NAME AND NUMBER:</HD>
                    <P>OPM/Internal—31, VA Recoupment and Reduction Appeals to OPM.</P>
                    <HD SOURCE="HD2">SECURITY CLASSIFICATION:</HD>
                    <P>Unclassified.</P>
                    <HD SOURCE="HD2">SYSTEM LOCATION:</HD>
                    <P>Records on recoupments are stored at: Workforce Policy and Innovation, Office of Personnel Management, 1900 E Street NW, Washington, DC 20415-0001.</P>
                    <P>Records on the reduction of retirement benefits are stored at: Retirement Services, Office of Personnel Management, 1900 E Street NW, Washington, DC 20415-0001.</P>
                    <HD SOURCE="HD2">SYSTEM MANAGER(S):</HD>
                    <P>Deputy Associate Director, Employee Services, Accountability and Workforce Relations, Workforce Policy and Innovation, Office of Personnel Management, 1900 E Street NW, Washington, DC 20415-0001.</P>
                    <HD SOURCE="HD2">AUTHORITY FOR MAINTENANCE OF THE SYSTEM:</HD>
                    <P>38 U.S.C. 719, Reduction of benefits of employees convicted of certain crimes; 38 U.S.C. 721, Recoupment of bonuses or awards paid to employees of Department; and 38 U.S.C. 723, Recoupment of relocation expenses paid on behalf of employees of Department.</P>
                    <HD SOURCE="HD2">PURPOSE(S) OF THE SYSTEM:</HD>
                    <P>The purpose of this system of records is to process appeals from current and former civil service Department of Veterans Affairs (VA) employees, who (a) received an order by the VA to recoup or reduce their awards, bonuses, relocation expenses, or retirement benefits and (b) appealed that order to the Director of the Office of Personnel Management (OPM).  </P>
                    <HD SOURCE="HD2">CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:</HD>
                    <P>This system of records will include information on current and former civil service VA employees (a) who received an order by the VA to recoup or reduce their awards, bonuses, relocation expenses, or retirement benefits and (b) appealed that order to the Director of OPM.</P>
                    <HD SOURCE="HD2">CATEGORIES OF RECORDS IN THE SYSTEM:</HD>
                    <P>This system of records will contain information related to an appeal of a VA order by a current or former civil service VA employee. This may include the following:</P>
                    <P>a. The notice of proposed order received;</P>
                    <P>b. The employee's response to the proposed order;</P>
                    <P>c. The order received;</P>
                    <P>d. A statement explaining why the employee believes the order received is in error;</P>
                    <P>e. The name, mailing address, telephone number, and email address of the employee and, if applicable, their authorized representative;</P>
                    <P>f. The name, mailing address, telephone number, and email address of the VA official who issued the order;</P>
                    <P>g. The evidence file relied upon in proposing and deciding the VA order; and</P>
                    <P>h. Any other evidence, information, and correspondence (between OPM, VA, and/or the current or former civil service VA employee) that is received, developed, or issued during the appeal.</P>
                    <HD SOURCE="HD2">RECORD SOURCE CATEGORIES:</HD>
                    <P>Information in this system of records may be provided by the current or former civil service VA employee (or their authorized representative). Information in this system of records may also be provided by OPM and VA staff who are involved in adjudicating the appeal or providing information related to the appeal.</P>
                    <HD SOURCE="HD2">ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND PURPOSES OF SUCH USES:</HD>
                    <P>In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, the records in this system may be disclosed outside OPM as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:</P>
                    <P>a. In an appropriate proceeding before a court, grand jury, or administrative or adjudicative body, when OPM or another agency representing OPM determines that the records are relevant and necessary to the proceeding; or in an appropriate proceeding before an administrative or adjudicative body when the adjudicator determines the records to be relevant to the proceeding.</P>
                    <P>b. To the Department of Justice when (a) OPM, or any component thereof; (b) any OPM employee in their official capacity; (c) any OPM employee in their individual capacity where the Department of Justice has agreed to represent the employee; or (d) the United States, where OPM determines that litigation is likely to affect OPM or any of its components, is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice is deemed by OPM to be relevant and necessary to the litigation.</P>
                    <P>c. Where a record, either alone or in conjunction with other information, indicates a violation or potential violation of law—criminal, civil, or regulatory in nature—the relevant records may be referred to the appropriate Federal, State, local, territorial, Tribal, or foreign law enforcement authority or other appropriate entity charged with the responsibility for investigating or prosecuting such violation or charged with enforcing or implementing such law.</P>
                    <P>d. To a member of Congress or staff acting upon the member's behalf, when the member or staff requests the information on behalf of, and at the request of, the individual to whom the record pertains.</P>
                    <P>e. To the National Archives and Records Administration (NARA) for records management inspections conducted under the authority of 44 U.S.C. 2904 and 2906.</P>
                    <P>f. To appropriate agencies, entities, and persons when (1) OPM suspects or has confirmed that there has been a breach of the system of records, (2) OPM has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, OPM (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with OPM's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.</P>
                    <P>
                        g. To another Federal agency or Federal entity, when OPM determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
                        <PRTPAGE P="3972"/>
                    </P>
                    <P>h. To contractors, grantees, experts, consultants, or volunteers performing or working on a contract, service, grant, cooperative agreement, or other assignment for OPM to the extent necessary to accomplish an agency function related to this system of records.</P>
                    <P>i. To the VA for their personnel and administrative records, and to the VA Office of the Inspector General for oversight purposes.</P>
                    <P>j. To external parties who OPM has reason to believe possess evidence relevant to the adjudication of the appeal, to the extent necessary to elicit such evidence.</P>
                    <P>k. To the Department of Defense, the Office of the Director of National Intelligence, and other Federal Government agencies responsible for conducting and adjudicating background investigations, continuous evaluation, and continuous vetting to provide them with information relevant to their inquiries and investigations.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR STORAGE OF RECORDS:</HD>
                    <P>The records in this system of records are stored electronically on servers operated by OPM or pursuant to an OPM contract, or on paper in locked file cabinets or locked offices. Access to the electronic systems or paper files is restricted to authorized users with a need to know.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:</HD>
                    <P>Records may be retrieved by name or other personal identifiers discussed in the categories of records section of this notice.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:</HD>
                    <P>A records retention schedule will be established with NARA for the records about covered individuals in this system of records and, until it is finalized, records will be treated as permanent. Once that schedule is established, the method(s) for disposing of records that are no longer eligible for retention will be established.</P>
                    <HD SOURCE="HD2">ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:</HD>
                    <P>Several administrative, technical, and physical security measures protect the records in this system from unauthorized access and misuse. These measures include encryption, limited access based on an individual's role, and assuring staff who are authorized to access the records have received the appropriate privacy and security training. All these measures comply with the Federal Information Security Modernization Act of 2002, as amended by the Federal Information Security Modernization Act of 2014, OMB policies, and standards and guidance from the National Institute of Standards and Technology (NIST). Any paper records in this system will be stored in locked file cabinets or locked offices with access restricted to those who have a need to know and the appropriate privacy and security training.</P>
                    <HD SOURCE="HD2">RECORD ACCESS PROCEDURES:</HD>
                    <P>
                        Individuals seeking access to their records in this system may email their request to 
                        <E T="03">foia@opm.gov</E>
                         or mail their request to the Office of Personnel Management, Office of the Executive Secretariat, Privacy, and Information Management—FOIA, 1900 E Street NW, OESPIM/FOIA, Room 5H35, Washington, DC 20415-0001. The email or letter should:
                    </P>
                    <P>1. Include the words “Privacy Act Records Access Request”,</P>
                    <P>2. State that the request relates to OPM/Internal—31, VA Recoupment and Reduction Appeals to OPM, and</P>
                    <P>3. Clearly describe the information requested.</P>
                    <P>The letter or email must also include the individual's:</P>
                    <P>1. Full name, and any former names,</P>
                    <P>2. Date of birth,</P>
                    <P>3. Preference for how they want to be contacted (home address, telephone number, and/or personal email), and</P>
                    <P>4. Signature.</P>
                    <P>Additional requirements regarding record access requests, including the rights of guardians and how records may be provided, may be found in 5 CFR part 297, Privacy Procedures for Personnel Records.</P>
                    <HD SOURCE="HD2">CONTESTING RECORD PROCEDURES:</HD>
                    <P>
                        Individuals wishing to request an amendment of records about them may email their request to 
                        <E T="03">foia@opm.gov</E>
                         or mail their request to the Office of Personnel Management, Office of the Executive Secretariat, Privacy, and Information Management—FOIA, 1900 E Street NW, OESPIM/FOIA, Room 5H35, Washington, DC 20415-0001. The email or letter should:
                    </P>
                    <P>1. Include the words “Privacy Act Amendment Request”,</P>
                    <P>2. State that the request relates to OPM/Internal—31, VA Recoupment and Reduction Appeals to OPM,</P>
                    <P>3. Clearly describe the records the individual wants to amend and why, and</P>
                    <P>4. Include any documents which could help substantiate the request.</P>
                    <P>The letter or email must also include the individual's:</P>
                    <P>1. Full name, and any former names,</P>
                    <P>2. Date of birth,</P>
                    <P>3. Preference for how they want to be contacted (home address, telephone number, and/or personal email), and</P>
                    <P>4. Signature.</P>
                    <P>Additional requirements regarding record access requests, including the rights of guardians and how records may be provided, may be found in 5 CFR part 297, Privacy Procedures for Personnel Records.</P>
                    <HD SOURCE="HD2">NOTIFICATION PROCEDURES:</HD>
                    <P>See “Record Access Procedures.”</P>
                    <HD SOURCE="HD2">EXEMPTIONS PROMULGATED FOR THE SYSTEM:</HD>
                    <P>None.</P>
                    <HD SOURCE="HD2">HISTORY:</HD>
                    <P>None.</P>
                </PRIACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00584 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6325-39-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket Nos. MC2025-1068; K2025-1067; MC2025-1069; K2025-1068; MC2025-1070; K2025-1069; MC2025-1071; K2025-1070; MC2025-1072; K2025-1071; MC2025-1073; K2025-1072; MC2025-1074; K2025-1073; MC2025-1075; K2025-1074; MC2025-1076; K2025-1075; MC2025-1077; K2025-1076; MC2025-1078; K2025-1077; MC2025-1079; K2025-1078; MC2025-1080; K2025-1079; MC2025-1081; K2025-1080]</DEPDOC>
                <SUBJECT>New Postal Products</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Postal Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments are due:</E>
                         January 16, 2025.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit comments electronically via the Commission's Filing Online system at 
                        <E T="03">https://www.prc.gov.</E>
                         Those who cannot submit comments electronically should contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section by telephone for advice on filing alternatives.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>David A. Trissell, General Counsel, at 202-789-6820.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Introduction</FP>
                    <FP SOURCE="FP-2">II. Public Proceeding(s)</FP>
                    <FP SOURCE="FP-2">III. Summary Proceeding(s)</FP>
                </EXTRACT>
                <PRTPAGE P="3973"/>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.</P>
                <P>
                    The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
                    <E T="03">http://www.prc.gov</E>
                    ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         Docket No. RM2018-3, Order Adopting Final Rules Relating to Non-Public Information, June 27, 2018, Attachment A at 19-22 (Order No. 4679).
                    </P>
                </FTNT>
                <P>Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). Section II also establishes comment deadline(s) pertaining to each such request.</P>
                <P>The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.</P>
                <P>
                    Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review. 
                    <E T="03">See</E>
                     39 CFR 3041.110(n); 39 CFR 3041.205(a). Such requests are reviewed in summary proceedings pursuant to 39 CFR 3041.325(c)(2) and 39 CFR 3041.505(f)(1). Pursuant to 39 CFR 3041.405(c)-(d), the Commission does not appoint a Public Representative or request public comment in proceedings to review such requests.
                </P>
                <HD SOURCE="HD1">II. Public Proceeding(s)</HD>
                <P>
                    1. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1068 and K2025-1067; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1250 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Almaroof Agoro; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    2. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1069 and K2025-1068; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1251 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Almaroof Agoro; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    3. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1070 and K2025-1069; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1252 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Maxine Bradley; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    4. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1071 and K2025-1070; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1253 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Maxine Bradley; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    5. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1072 and K2025-1071; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1254 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Maxine Bradley; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    6. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1073 and K2025-1072; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1255 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    7. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1074 and K2025-1073; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1256 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    8. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1075 and K2025-1074; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1257 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    9. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1076 and K2025-1075; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1258 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Elsie Lee-Robbins; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    10. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1077 and K2025-1076; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1259 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Almaroof Agoro; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    11. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1078 and K2025-1077; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail &amp; USPS Ground Advantage Contract 590 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">
                        Public 
                        <PRTPAGE P="3974"/>
                        Representative:
                    </E>
                     Jennaca Upperman; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    12. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1079 and K2025-1078; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1260 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Elsie Lee-Robbins; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    13. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1080 and K2025-1079; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1261 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Elsie Lee-Robbins; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <P>
                    14. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1081 and K2025-1080; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1262 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 7, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Elsie Lee-Robbins; 
                    <E T="03">Comments Due:</E>
                     January 16, 2025.
                </P>
                <HD SOURCE="HD1">III. Summary Proceeding(s)</HD>
                <P>
                    None. 
                    <E T="03">See</E>
                     Section II for public proceedings.
                </P>
                <P>
                    This Notice will be published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Erica A. Barker,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00702 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket Nos. K2025-157; MC2025-1082; K2025-1081; MC2025-1083; K2025-1082; MC2025-1084; K2025-1083; MC2025-1085; K2025-1084; MC2025-1086; K2025-1085; MC2025-1087; K2025-1086; MC2025-1088; K2025-1087; MC2025-1089; K2025-1088; MC2025-1090; K2025-1089; MC2025-1091; K2025-1090; MC2025-1092; K2025-1091; MC2025-1093; K2025-1092; MC2025-1094; K2025-1093; MC2025-1095; K2025-1094; MC2025-1096; K2025-1095; MC2025-1097; K2025-1096; MC2025-1098; K2025-1097; MC2025-1099; K2025-1098; MC2025-1100; K2025-1099; MC2025-1101; K2025-1100; MC2025-1102; K2025-1101]</DEPDOC>
                <SUBJECT>New Postal Products</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Postal Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments are due:</E>
                         January 17, 2025.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit comments electronically via the Commission's Filing Online system at 
                        <E T="03">https://www.prc.gov.</E>
                         Those who cannot submit comments electronically should contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section by telephone for advice on filing alternatives.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>David A. Trissell, General Counsel, at 202-789-6820.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Introduction</FP>
                    <FP SOURCE="FP-2">II. Public Proceeding(s)</FP>
                    <FP SOURCE="FP-2">III. Summary Proceeding(s)</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.</P>
                <P>
                    The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
                    <E T="03">http://www.prc.gov</E>
                    ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         Docket No. RM2018-3, Order Adopting Final Rules Relating to Non-Public Information, June 27, 2018, Attachment A at 19-22 (Order No. 4679).
                    </P>
                </FTNT>
                <P>Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). Section II also establishes comment deadline(s) pertaining to each such request.</P>
                <P>The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.</P>
                <P>
                    Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review. 
                    <E T="03">See</E>
                     39 CFR 3041.110(n); 39 CFR 3041.205(a). Such requests are reviewed in summary proceedings pursuant to 39 CFR 3041.325(c)(2) and 39 CFR 3041.505(f)(1). Pursuant to 39 CFR 3041.405(c)-(d), the Commission does not appoint a Public Representative or request public comment in proceedings to review such requests.
                </P>
                <HD SOURCE="HD1">II. Public Proceeding(s)</HD>
                <P>
                    1. 
                    <E T="03">Docket No(s).:</E>
                     K2025-157; 
                    <E T="03">Filing Title:</E>
                     USPS Request Concerning Amendment One to Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 536, with Materials Filed Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 CFR 3041.505; 
                    <E T="03">Public Representative:</E>
                     Jennaca Upperman; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    2. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1082 and K2025-1081; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1263 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Jennaca Upperman; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    3. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1083 and K2025-1082; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1264 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                      
                    <PRTPAGE P="3975"/>
                    39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Jennaca Upperman; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    4. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1084 and K2025-1083; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1265 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    5. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1085 and K2025-1084; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1266 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.  
                </P>
                <P>
                    6. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1086 and K2025-1085; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail &amp; USPS Ground Advantage Contract 591 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    7. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1087 and K2025-1086; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail &amp; USPS Ground Advantage Contract 592 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Maxine Bradley; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    8. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1088 and K2025-1087; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1267 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Maxine Bradley; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    9. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1089 and K2025-1088; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1268 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Maxine Bradley; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    10. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1090 and K2025-1089; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1269 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Katalin Clendenin; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    11. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1091 and K2025-1090; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1270 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Jana Slovinska; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    12. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1092 and K2025-1091; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1271 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Jennaca Upperman; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    13. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1093 and K2025-1092; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1272 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Jana Slovinska; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    14. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1094 and K2025-1093; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail &amp; USPS Ground Advantage Contract 593 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    15. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1095 and K2025-1094; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1273 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Katalin Clendenin; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    16. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1096 and K2025-1095; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1274 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Kenneth Moeller; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    17. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1097 and K2025-1096; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1275 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Katalin Clendenin; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    18. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1098 and K2025-1097; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1276 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Almaroof Agoro; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    19. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1099 and K2025-1098; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1277 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Jennaca Upperman; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    20. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1100 and K2025-1099; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1278 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Christopher Mohr; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    21. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1101 and K2025-1100; 
                    <E T="03">Filing Title:</E>
                     USPS Request 
                    <PRTPAGE P="3976"/>
                    to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage Contract 1279 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Katalin Clendenin; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <P>
                    22. 
                    <E T="03">Docket No(s).:</E>
                     MC2025-1102 and K2025-1101; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail &amp; USPS Ground Advantage Contract 594 to the Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     January 8, 2025; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; 
                    <E T="03">Public Representative:</E>
                     Christopher Mohr; 
                    <E T="03">Comments Due:</E>
                     January 17, 2025.
                </P>
                <HD SOURCE="HD1">III. Summary Proceeding(s)</HD>
                <P>
                    None. 
                    <E T="03">See</E>
                     Section II for public proceedings.
                </P>
                <P>
                    This Notice will be published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Erica A. Barker,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00817 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 586 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1046, K2025-1045.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00806 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 3, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1240 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1040, K2025-1039.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00799 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 3, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1239 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1039, K2025-1038.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00798 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1237 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1054, K2025-1053.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00796 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <PRTPAGE P="3977"/>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1229 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1042, K2025-1041.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00788 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1238 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1055, K2025-1054.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00797 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1241 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1056, K2025-1055.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00800 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 585 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1045, K2025-1044.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00805 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1233 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1050, K2025-1049.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00792 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">
                        USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 
                        <PRTPAGE P="3978"/>
                        1231 to Competitive Product List.
                    </E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1048, K2025-1047.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00790 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 584 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1044, K2025-1043.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00804 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1228 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1041, K2025-1040.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00787 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1232 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1049, K2025-1048.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00791 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1235 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1052, K2025-1051.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00794 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1234 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1051, K2025-1050.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00793 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="3979"/>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1242 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1057, K2025-1056.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00801 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 583 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1043, K2025-1042.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00803 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1243 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1058, K2025-1057.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00802 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1236 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1053, K2025-1052.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00795 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         January 15, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on January 6, 2025, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1230 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-1047, K2025-1046.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00789 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">RAILROAD RETIREMENT BOARD</AGENCY>
                <SUBJECT>Agency Forms Submitted for OMB Review, Request for Comments</SUBJECT>
                <P>
                    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory 
                    <PRTPAGE P="3980"/>
                    Affairs (OIRA), Office of Management and Budget (OMB). Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens.
                </P>
                <P>The RRB invites comments on the proposed collections of information to determine (1) the practical utility of the collections; (2) the accuracy of the estimated burden of the collections; (3) ways to enhance the quality, utility, and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to the RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if the RRB and OIRA receive them within 30 days of the publication date.</P>
                <P>
                    <E T="03">1. Title and purpose of information collection:</E>
                     Application for Employee Annuity Under the Railroad Retirement Ac; OMB 3220-0002.
                </P>
                <P>Section 2(a) of the Railroad Retirement Act (RRA) (45 U.S.C. 231a) provides for payments of age and service, disability, and supplemental annuities to qualified employees. An annuity cannot be paid until the employee stops working for a railroad employer. In addition, the age and service employee must relinquish any rights held to such jobs. A disabled employee does not need to relinquish employee rights until attaining Full Retirement Age, or if earlier, when their spouse is awarded a spouse annuity. Benefits become payable after the employee meets certain other requirements, which depend on the type of annuity payable. The requirements for obtaining the annuities are prescribed in 20 CFR 216 and 220.</P>
                <P>
                    To collect the information needed to help determine an applicant's entitlement to, and the amount of, an employee retirement annuity the RRB uses Forms AA-1, 
                    <E T="03">Application for Employee Annuity;</E>
                     AA-1d, 
                    <E T="03">Application for Determination of Employee Disability;</E>
                     G-204, 
                    <E T="03">Verification of Workers Compensation/Public Disability Benefit Information,</E>
                     and electronic Forms AA-1cert, 
                    <E T="03">Application Summary and Certification,</E>
                     and AA-1sum, 
                    <E T="03">Application Summary.</E>
                </P>
                <P>
                    The AA-1 application process obtains information from an applicant about their marital history, work history, military service, benefits from other governmental agencies, railroad pensions and Medicare entitlement for either an age and service or disability annuity. An RRB representative interviews the applicant either at a field office, an itinerant point, or by telephone. During the interview, the RRB representative enters the information obtained into an on-line information system. Upon completion of the interview, the on-line information system generates Form AA-1cert, 
                    <E T="03">Application Summary and Certification,</E>
                     or Form AA-1sum, 
                    <E T="03">Application Summary,</E>
                     a summary of the information that was provided for the applicant to review and approve. Form AA-1cert documents approval using the traditional pen and ink “wet” signature, and Form AA-1sum documents approval using the alternative signature method called Attestation. When the RRB representative is unable to contact the applicant in person or by telephone, for example, the applicant lives in another country, a manual version of Form AA-1 is used.
                </P>
                <P>
                    Form AA-1d, 
                    <E T="03">Application for Determination of Employee's Disability,</E>
                     is completed by an employee who is filing for a disability annuity under the RRA, or a disability freeze under the Social Security Act, for early Medicare based on a disability. Form G-204, 
                    <E T="03">Verification of Worker's Compensation/Public Disability Benefit Information,</E>
                     is used to obtain and verify information concerning a worker's compensation or a public disability benefit that is or will be paid by a public agency to a disabled railroad employee.
                </P>
                <P>One response is requested of each respondent. Completion of the forms is required to obtain/retain a benefit.</P>
                <P>
                    <E T="03">Previous Requests for Comments:</E>
                     The RRB has already published the initial 60-day notice (89 FR 88826 on November 8, 2024) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.
                </P>
                <HD SOURCE="HD1">Information Collection Request (ICR)</HD>
                <P>
                    <E T="03">Title:</E>
                     Application for Employee Annuity Under the Railroad Retirement Act.
                </P>
                <P>
                    <E T="03">OMB Control No.:</E>
                     3220-0002.
                </P>
                <P>
                    <E T="03">Form(s) submitted:</E>
                     AA-1, AA-1cert, AA-1d, AA-1sum and G-204.
                </P>
                <P>
                    <E T="03">Type of request:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected public:</E>
                     Individuals or Households.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The Railroad Retirement Act provides for payment of age, disability and supplemental annuities to qualified employees. The application and related forms obtain information about the applicant's family work history, military service, disability benefits from other government agencies and public or private pensions. The information is used to determine entitlement to and the amount of the annuity applied for.
                </P>
                <P>
                    <E T="03">Changes proposed:</E>
                     The RRB proposes no changes to Form AA-1, Form AA-1 (internet), Form AA-1cert, AA-1sum and Form G-204. The RRB proposes the following changes to Form AA-1d:
                </P>
                <P>• Section 1, General Instructions, the date is being updated to 06/06/24,</P>
                <P>• Section 6, Information About Your Daily Activities, add “Sleeping” to the activity list for question 34,</P>
                <P>• Section 6, Information about Your Daily Activities, add a question 35b, “Describe and explain if your condition affects your memory, concentration, or ability to understand and follow instructions. (Include when this change began.)”,</P>
                <P>• Section 7, Information About You Work and Earnings, question 43, update to 12-2024 in example,  </P>
                <P>• Section 11, Certification, question 63, remove the word “criminal” from the sentence to read “I know that if I am receiving a disability annuity and fail to report work and earnings promptly, I am committing a crime punishable by Federal law that may result in prosecution and/or penalty deductions in my annuity payments”,</P>
                <P>• Corrected the abbreviation word “Cont.” to “Continued” throughout form, and</P>
                <P>• Correct grammar, spacing, heading and other issues within the form for consistency.</P>
                <P>
                    <E T="03">The burden estimate for the ICR is as follows:</E>
                </P>
                <GPOTABLE COLS="4" OPTS="L2,nj,tp0,i1" CDEF="s50,12,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Form No.</CHED>
                        <CHED H="1">
                            Annual 
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">
                            Time 
                            <LI>(minutes)</LI>
                        </CHED>
                        <CHED H="1">
                            Burden 
                            <LI>(hours)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">AA-1 (without assistance)</ENT>
                        <ENT>30</ENT>
                        <ENT>62</ENT>
                        <ENT>31</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AA-1cert (with assistance)</ENT>
                        <ENT>5,425</ENT>
                        <ENT>30</ENT>
                        <ENT>2,712</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AA-1sum (with assistance)</ENT>
                        <ENT>2,750</ENT>
                        <ENT>29</ENT>
                        <ENT>1,329</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AA-1 (Internet) (without assistance)</ENT>
                        <ENT>0</ENT>
                        <ENT>45</ENT>
                        <ENT>0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AA-1d (with assistance)</ENT>
                        <ENT>2,600</ENT>
                        <ENT>60</ENT>
                        <ENT>2,817</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="3981"/>
                        <ENT I="01">AA-1d (without assistance)</ENT>
                        <ENT>5</ENT>
                        <ENT>90</ENT>
                        <ENT>8</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">G-204</ENT>
                        <ENT>20</ENT>
                        <ENT>15</ENT>
                        <ENT>5</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>10,830</ENT>
                        <ENT/>
                        <ENT>6,902</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    2. 
                    <E T="03">Title and purpose of information collection:</E>
                     Application for Survivor Insurance Annuities; OMB 3220-0030.
                </P>
                <P>Under section 2(d) of the Railroad Retirement Act (RRA) (45 U.S.C. 231a), monthly survivor annuities are payable to surviving widow(er)s, parents, unmarried children, and in certain cases, divorced spouses, mothers (fathers), remarried widow(er)s, and grandchildren of deceased railroad employees if there are no qualified survivors of the employee immediately eligible for an annuity. The requirements relating to the annuities are prescribed in 20 CFR 216, 217, 218, and 219.</P>
                <P>
                    To collect the information needed to help determine an applicant's entitlement to, and the amount of, a survivor annuity the RRB uses Forms AA-17, 
                    <E T="03">Application for Widow(er)'s Annuity;</E>
                     AA-17b, 
                    <E T="03">Applications for Determination of Widow(er)'s Disability;</E>
                     AA-18, 
                    <E T="03">Application for Mother's/Father's and Child's Annuity;</E>
                     AA-19, 
                    <E T="03">Application for Child's Annuity;</E>
                     AA-19a, 
                    <E T="03">Application for Determination of Child's Disability;</E>
                     AA-20, 
                    <E T="03">Application for Parent's Annuity,</E>
                     and electronic Forms AA-17cert, 
                    <E T="03">Application Summary and Certification</E>
                     and AA-17sum, 
                    <E T="03">Application Summary.</E>
                </P>
                <P>
                    The on-line automated survivor annuity application (Forms AA-17, AA-18, AA-19, and AA-20) process obtains information about an applicant's marital history, work history, benefits from other government agencies, and Medicare entitlement for a survivor annuity. An RRB representative interviews the applicant either at a field office (preferred), an itinerant point, or by telephone. During the interview, the RRB representative enters the information obtained into an on-line information system. Upon completion of the interview, the system generates, for the applicant's review, either Form AA-17cert or AA-17sum, which provides a summary of the information that the applicant provided or verified. Form AA-17cert, 
                    <E T="03">Application Summary and Certification,</E>
                     requires a tradition pen and ink “wet” signature. Form AA-17sum, 
                    <E T="03">Application Summary,</E>
                     documents the alternate signing method called “Attestation,” which is an action taken by the RRB representative to confirm and annotate in the RRB records (1) the applicant's intent to file an application; (2) the applicant's affirmation under penalty of perjury that the information provided is correct; and (3) the applicant's agreement to sign the application by proxy. When the RRB representative is unable to contact the applicant in person or by telephone, for example, the applicant lives in another country, a manual version of the appropriate form is used. One response is requested of each respondent. Completion of the forms is required to obtain a benefit.
                </P>
                <P>
                    <E T="03">Previous Requests for Comments:</E>
                     The RRB has already published the initial 60-day notice (89 FR 88827 on November 8, 2024) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.
                </P>
                <HD SOURCE="HD1">Information Collection Request (ICR)</HD>
                <P>
                    <E T="03">Title:</E>
                     Application for Survivor Insurance Annuities.
                </P>
                <P>
                    <E T="03">OMB Control No.:</E>
                     3220-0030.
                </P>
                <P>
                    <E T="03">Form(s) submitted:</E>
                     AA-17b, AA-17cert, AA-17sum, and AA-19a.
                </P>
                <P>
                    <E T="03">Type of request:</E>
                     Extension without change of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected public:</E>
                     Individuals or Households.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Under Section 2(d) of the Railroad Retirement Act, monthly survivor annuities are payable to surviving widow(er)s, parents, unmarried children, and in certain cases, divorced wives (husbands), mothers (fathers), remarried widow(er)s and grandchildren of deceased railroad employees. The collection obtains information needed by the RRB to determine entitlement to and the amount of the annuity applied for.
                </P>
                <P>
                    <E T="03">Changes proposed:</E>
                     The RRB proposes no changes to forms AA-17cert.
                </P>
                <P>The RRB proposes the following changes to Form AA-17b:</P>
                <P>• Section 1, General Instructions, the date is being updated to 12/13/24,</P>
                <P>• Section 6, Information About Your Daily Activities, remove the word “even” from question 33 in sentence “NOT AT ALL—I cannot do the activity even with or without assistance”,</P>
                <P>• Section 6, Information About Your Daily Activities, add “Sleeping” to the activity list for question 33,</P>
                <P>• Section 6, Information About Your Daily Activities, rename question 34 to be question 34a,</P>
                <P>• Section 6, Information about Your Daily Activities, add a question 34b, “Describe and explain if your condition affects your memory, concentration, or ability to understand and follow instructions. (Include when this change began.)”,</P>
                <P>• Section 7, Information About You Work and Earnings, question 46, update to 12-2024 in example,</P>
                <P>• Section 10, Certification, question 65, remove the word “criminal” from the sentence to read “I know that if I am receiving a disability annuity and fail to report work and earnings promptly, I am committing a crime punishable by Federal law that may result in prosecution and/or penalty deductions in my annuity payments”, and</P>
                <P>• Correct grammar, spacing, and heading issues within the form for consistency</P>
                <P>The RRB proposes the following changes to Form AA-19a:</P>
                <P>• Section 1, General Instructions, the date is being updated to 12/13/24  </P>
                <P>• Section 5, Information About Your Daily Activities, remove the word “even” from question 28 in sentence “NOT AT ALL—I cannot do the activity even with or without assistance”,</P>
                <P>• Section 5, Information About The Child's Daily Activities, add “Sleeping” to the activity list for question 28.</P>
                <P>• Section 5, Information About The Child's Daily Activities, rename question 29 to be question 29a.</P>
                <P>• Section 5, Information about Your Daily Activities, add a question 29b, “Describe and explain if your condition affects your memory, concentration, or ability to understand and follow instructions. (Include when this change began.)”</P>
                <P>• Section 7, Information About You Work and Earnings, question 74, update to 12-2024 in example.</P>
                <P>• Section 10, Certification, question 99, remove the word “criminal” from the sentence to read “I know that if I am receiving a disability annuity and fail to report work and earnings promptly, I am committing a crime punishable by Federal law that may result in prosecution and/or penalty deductions in my annuity payments”, and</P>
                <P>• Correct grammar, spacing, and heading issues within the form for consistency.</P>
                <P>
                    The RRB proposes minor changes to the Form AA-17sum:
                    <PRTPAGE P="3982"/>
                </P>
                <P>• Update the outdated office hours with a link to the RRB website and the toll-free number, and</P>
                <P>• Remove the date that the applicant would be notified of a decision in the application process.</P>
                <P>
                    <E T="03">The burden estimate for the ICR is as follows:</E>
                </P>
                <GPOTABLE COLS="4" OPTS="L2,nj,tp0,i1" CDEF="s50,12,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Form No.</CHED>
                        <CHED H="1">
                            Annual 
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">
                            Time 
                            <LI>(minutes)</LI>
                        </CHED>
                        <CHED H="1">
                            Burden 
                            <LI>(hours)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">AA-17 Application Process: </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">AA-17cert</ENT>
                        <ENT>900</ENT>
                        <ENT>20</ENT>
                        <ENT>300</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">AA-17sum</ENT>
                        <ENT>2,100</ENT>
                        <ENT>19</ENT>
                        <ENT>665</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">AA-17b:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">(With assistance)</ENT>
                        <ENT>175</ENT>
                        <ENT>50</ENT>
                        <ENT>146</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">(Without assistance)</ENT>
                        <ENT>20</ENT>
                        <ENT>60</ENT>
                        <ENT>18</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">AA-19a:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">(With assistance)</ENT>
                        <ENT>200</ENT>
                        <ENT>50</ENT>
                        <ENT>167</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="03">(Without assistance)</ENT>
                        <ENT>15</ENT>
                        <ENT>70</ENT>
                        <ENT>18</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="05">Total</ENT>
                        <ENT>3,410</ENT>
                        <ENT/>
                        <ENT>1,314</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">3. Title and purpose of information collection:</E>
                     Continuing Disability Report; OMB 3220-0187. Under section 2 of the Railroad Retirement Act (45 U.S.C. 231a), an annuity is not payable or is reduced for any month in which the annuitant works for a railroad or earns more than prescribed dollar amounts from either non-railroad employment or self-employment. Certain types of work may indicate an annuitant's recovery from disability. The provisions relating to the reduction or non-payment of an annuity by reason of work, and an annuitant's recovery from disability for work, are prescribed in 20 CFR 220.17-220.20. The RRB conducts continuing disability reviews (CDR) to determine whether an annuitant continues to meet the disability requirements of the law. Provisions relating to when and how often the RRB conducts CDR's are prescribed in 20 CFR 220.186.
                </P>
                <P>
                    Form G-254, 
                    <E T="03">Continuing Disability Report,</E>
                     is used by the RRB to develop information for a CDR determination, including a determination prompted by a report of work, return to railroad service, allegation of medical improvement, or a routine disability review call-up. Form G-254a, Continuing Disability Update Report, is used to help identify a disability annuitant whose work activity and/or recent medical history warrants completion of Form G-254 for a more extensive review.
                </P>
                <P>Completion is required to retain a benefit. One response is requested of each respondent to Forms G-254 and G-254a.</P>
                <P>
                    <E T="03">Previous Requests for Comments:</E>
                     The RRB has already published the initial 60-day notice (89 FR 88828 on November 8, 2024) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.
                </P>
                <HD SOURCE="HD1">Information Collection Request (ICR)</HD>
                <P>
                    <E T="03">Title:</E>
                     Continuing Disability Report.
                </P>
                <P>
                    <E T="03">OMB Control No.:</E>
                     3220-0187.
                </P>
                <P>
                    <E T="03">Forms submitted:</E>
                     G-254, G-254a, and RL-8a.
                </P>
                <P>
                    <E T="03">Type of request:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected public:</E>
                     Individuals or Households.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Under the Railroad Retirement Act, a disability annuity can be reduced or not paid, depending on the amount of earnings and type of work performed. The collection obtains information about a disabled annuitant's employment and earnings.
                </P>
                <P>
                    <E T="03">Changes proposed:</E>
                     The RRB proposes the following changes to Form G-254:
                </P>
                <P>• Section 5, Information about Your Condition before Full Retirement Age, remove the word “even” from question 31a in sentence “NOT AT ALL—I cannot do the activity even with or without assistance”,</P>
                <P>• Section 5, Information about Your Condition before Full Retirement Age, add “Sleeping” to the activity list for question 31a,</P>
                <P>• Section 5, Information about Your Condition before Full Retirement Age, add a question 31e, “Describe and explain if your condition affects your memory, concentration, or ability to understand and follow instructions. (Include when this change began.)”, and</P>
                <P>• Correct grammar, spacing, and heading issues within the form for consistency.</P>
                <P>
                    <E T="03">The burden estimate for the ICR is as follows:</E>
                </P>
                <GPOTABLE COLS="4" OPTS="L2,nj,tp0,i1" CDEF="s50,12,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Form No.</CHED>
                        <CHED H="1">
                            Annual 
                            <LI>responses</LI>
                        </CHED>
                        <CHED H="1">
                            Time 
                            <LI>(minutes)</LI>
                        </CHED>
                        <CHED H="1">
                            Burden 
                            <LI>(hours)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">G-254:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Annuitant</ENT>
                        <ENT>900</ENT>
                        <ENT>40</ENT>
                        <ENT>600</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Employer verification</ENT>
                        <ENT>100</ENT>
                        <ENT>5</ENT>
                        <ENT>8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Doctor, hospital, or clinic verification</ENT>
                        <ENT>100</ENT>
                        <ENT>5</ENT>
                        <ENT>8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Vocational, Rehabilitation Counselor verification)</ENT>
                        <ENT>100</ENT>
                        <ENT>5</ENT>
                        <ENT>8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Other governmental agency verification</ENT>
                        <ENT>100</ENT>
                        <ENT>5</ENT>
                        <ENT>8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">School verification</ENT>
                        <ENT>100</ENT>
                        <ENT>5</ENT>
                        <ENT>8</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">G-254a</ENT>
                        <ENT>1350</ENT>
                        <ENT>5</ENT>
                        <ENT>113</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="05">Total</ENT>
                        <ENT>2750</ENT>
                        <ENT/>
                        <ENT>753</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Additional Information or Comments:</E>
                     Copies of the forms and supporting documents or comments regarding the information collection should be addressed to Brian Foster, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611-1275 or emailed to 
                    <E T="03">Brian.Foster@rrb.gov.</E>
                </P>
                <P>
                    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                    <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                     Find this particular information collection by selecting 
                    <PRTPAGE P="3983"/>
                    “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                </P>
                <SIG>
                    <NAME>Brian Foster,</NAME>
                    <TITLE>Clearance Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00767 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7905-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[SEC File No. 270-101, OMB Control No. 3235-0082]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request; Extension: Form 11-K</SUBJECT>
                <FP SOURCE="FP-1">
                    <E T="03">Upon Written Request Copies Available From:</E>
                     Securities and Exchange Commission,  Office of FOIA Services, 100 F Street NE, Washington, DC 20549-2736.
                </FP>
                <P>
                    Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), the Securities and Exchange Commission (“Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget for extension and approval.
                </P>
                <P>
                    Form 11-K (17 CFR 249.311) is the annual report designed for use by employee stock purchase, savings, and similar plans to comply with the reporting requirements under Section 15(d) of the Securities and Exchange Act of 1934 (the “Exchange Act”) (15 U.S.C. 78o(d)). Section 15(d) establishes a periodic reporting obligation for every issuer of a class of securities registered under the Securities Act of 1933 (the “Securities Act”) (15 U.S.C. 77a 
                    <E T="03">et seq.</E>
                    ). Form 11-K provides employees of an issuer with financial information so that they can assess the performance of the investment vehicle or stock plan. We estimate that Form 11-K requires approximately internal 95.81 burden hours per response and that there is an average of approximately 941 Form 11-K filings annually for a total of 90,157 internal burden hours annually (95.81 hours per response × 941 responses). We also estimate that Form 11-K requires a cost of approximately $7,525 per response for a total annual cost burden of $7,081,025 ($7,525 per response × 941 responses).
                </P>
                <P>Written comments are invited on: (a) whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden imposed by the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication by March 17, 2025.</P>
                <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.</P>
                <P>
                    Please direct your written comment to Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Tanya Ruttenberg, 100 F Street NE, Washington, DC 20549 or send an email to: 
                    <E T="03">PRA_Mailbox@sec.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00665 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[SEC File No. 270-335, OMB Control No. 3235-0381]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request; Extension: Form 40-F</SUBJECT>
                <FP SOURCE="FP-1">
                    <E T="03">Upon Written Request Copies Available From:</E>
                     Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE, Washington, DC 20549-2736.
                </FP>
                <P>
                    Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), the Securities and Exchange Commission (“Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget for extension and approval.
                </P>
                <P>
                    Form 40-F (17 CFR 249.240f) is used by certain Canadian issuers to register a class of securities under Section 12 of the Securities Exchange Act of 1934 (“Exchange Act”) (15 U.S.C. 78
                    <E T="03">l</E>
                    ) or as an annual report pursuant to Section 13(a) or 15 (d) of the Exchange Act (15 U.S.C. 78m(a) or 78o(d)). The information required in the Form 40-F is used by investors in making investment decisions with respect to the securities of such Canadian companies. We estimate that Form 40-F takes approximately 431.42 hours per response and that there is an average of approximately 175 responses annually. We estimate that 25% of the 431.42 hours per response is prepared by the issuer for an internal burden of 18,875 hours ((0.25 × 431.42) hours per response × 175 responses).
                </P>
                <P>Written comments are invited on: (a) whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden imposed by the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication by March 17, 2025.</P>
                <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.</P>
                <P>
                    Please direct your written comment to Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Tanya Ruttenberg, 100 F Street NE, Washington, DC 20549 or send an e-mail to: 
                    <E T="03">PRA_Mailbox@sec.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00680 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[SEC File No. 270-489, OMB Control No. 3235-0541]</DEPDOC>
                <SUBJECT>Submission for OMB Review; Comment Request; Extension: Rule 606 of Regulation NMS</SUBJECT>
                <FP SOURCE="FP-1">
                    <E T="03">Upon Written Request, Copies Available From:</E>
                     Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE, Washington, DC 20549-2736
                </FP>
                <P>
                    Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
                    <E T="03"> et seq.</E>
                    ) (“PRA”), the Securities and Exchange Commission (“Commission”) has submitted to the Office of Management and Budget (“OMB”) a request for approval of extension on the previously approved 
                    <PRTPAGE P="3984"/>
                    collection of information provided for in Rule 606 of Regulation NMS (“Rule 606”) (17 CFR 242.606), under the Securities Exchange Act of 1934 (15 U.S.C. 78a 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <P>Rule 606 (formerly known as Rule 11Ac1-6) requires require disclosure by broker-dealers of, (1) pursuant to Rule 606(a)(1), a quarterly aggregated public report on the handling of orders in NMS stocks that are submitted on a held basis and orders in NMS securities that are option contracts with a market value less than $50,000; (2) pursuant to Rule 606(b)(1), a report, upon request of a customer, on the routing of that customer's orders in NMS stocks that are submitted on a held basis; orders in NMS stocks that are submitted on a not held basis and do not qualify for two de minimis exceptions; and orders in NMS securities that are option contracts, containing certain information on the broker-dealer's routing of such orders for that customer for the prior six months; and (3) pursuant to Rule 606(b)(3), a report, upon request of a customer that places with the broker-dealer, directly or indirectly, NMS stock orders of any size that are submitted on a not held basis (subject to two de minimis exceptions), containing certain information on the broker-dealer's handling of such orders for that customer for the prior six months.</P>
                <P>The Commission estimates that out of the currently 3,399 broker-dealers that are subject to the collection of information obligations of Rule 606(a)(1), clearing brokers bear a substantial portion of the burden of complying with the reporting and recordkeeping requirements of Rule 606 on behalf of small to mid-sized introducing firms. There currently are approximately 179 clearing brokers. In addition, there are approximately 61 introducing brokers that receive funds or securities from their customers. Because at least some of these firms also may have greater involvement in determining where customer orders are routed for execution, they have been included, along with clearing brokers, in estimating the total burden of Rule 606(a)(1).</P>
                <P>As described in more detail, below, the total annual time burden associated with rule 606 is approximately 183,000 hours per year and the total annual cost burden is approximately $1,300,000 per year.</P>
                <P>The Commission staff estimates that each firm significantly involved in order routing practices incurs an average burden of 40 hours to prepare and disseminate the quarterly report required by Rule 606(a)(1), or a burden of 160 hours per year. With an estimated 240 broker-dealers significantly involved in order routing practices, the total industry-wide burden per year to comply with the quarterly reporting requirement in Rule 606 is estimated to be 38,400 hours (160 × 240). Additionally, for each of the 240 broker-dealers subject to disclosure requirements of Rule 606(a)(1), the Commission estimates the annual burden under Rule 606(a)(1)(iv) to monitor payment for order flow and profit-sharing relationships and potential self-regulatory organization rule changes that could impact their order routing decisions and incorporate any new information into their reports to be 10 hours and the annual burden for each broker-dealers to describe and update any terms of payment for order flow arrangements and profit-sharing relationships with a Specified Venue that may influence their order routing decisions to be 15 hours, for a total annual burden of 6,000 hours (25 × 240). Therefore, the estimated total annual burden to comply with Rule 606(a)(1) is 44,400 hours.</P>
                <P>Clearing brokers generally bear the burden of responding to individual customer requests under Rule 606(b)(1) for order handling information. The Commission staff estimates that an average clearing broker incurs an annual burden of 400 hours (2000 responses x 0.2 hours/response) to prepare, disseminate, and retain responses to customers required by Rule 606. With an estimated 179 clearing brokers subject to Rule 606(b)(1), the total industry-wide burden per year to comply with the customer response requirement in Rule 606 is estimated to be 71,600 hours (179 × 400).</P>
                <P>The Commission estimates that approximately 200 broker-dealers are involved in routing orders subject to the disclosure requirements of Rule 606(b)(3). The Commission believes that some such broker-dealers will respond to requests for customer-specific reports in house, while others will engage a third-party service provider to do so. The Commission estimates that approximately 135 broker-dealers will respond in-house to individual customer requests for information on order handling under Rule 606(b)(3), and that for each, the individual annual burden will be 400 hours (200 responses × 2 hours/response), with a total annual burden of 54,000 hours (400 × 135).</P>
                <P>The Commission estimates that approximately 65 broker-dealers will engage a third party to respond to individual customer requests, and that for each, the individual annual burden will be 200 hours (200 responses × 1 hour/response), with a total annual burden of 13,000 hours (200 × 65). The total annual cost burden associated with engaging such third parties is approximately $1,300,000 (65 × 200 annual requests × $100 per request to engage a third-party service provider). Therefore, the estimated total annual burden to comply with Rule 606(b)(3) is 67,000 hours and $1,300,000.</P>
                <P>
                    The public may view and comment on this information collection request at: 
                    <E T="03">https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=</E>
                    202411-3235-001 or send an email comment to 
                    <E T="03">MBX.OMB.OIRA.SEC_desk_officer@omb.eop.gov</E>
                     within 30 days of the day after publication of this notice by February 18, 2025.
                </P>
                <SIG>
                    <DATED>Dated: January 8, 2025.</DATED>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00664 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-102138; File No. SR-ISE-2025-02]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Real-Time Depth of Market Raw Data Feed, Nasdaq ISE Order Feed, Nasdaq ISE Top Feed, Nasdaq ISE Spread Feed, and Nasdaq ISE Trade Feed Fees Based on the Rate of Inflation</SUBJECT>
                <DATE>January 8, 2025.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on January 6, 2025, Nasdaq ISE, LLC (“Exchange”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Item I below, which Item has been substantially prepared by the Exchange. The Exchange has designated this proposal for immediate effectiveness pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>3</SU>
                    <FTREF/>
                     and Rule 19b-4(f) thereunder.
                    <SU>4</SU>
                    <FTREF/>
                     The Commission is publishing this 
                    <PRTPAGE P="3985"/>
                    notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         17 CFR 240.19b-4(f). At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>The Exchange proposes to amend the fees of the following market data products based on the rate of inflation: (i) Real-time Depth of Market Raw Data Feed (internal and external distribution and associated fee caps); (ii) Nasdaq ISE Order Feed (internal and external distribution and associated fee caps); (iii) Nasdaq ISE Top Feed (internal and external distribution and associated fee caps); (iv) Nasdaq ISE Spread Feed (internal and external distribution and associated fee caps); and (v) Nasdaq ISE Trade Feed (internal and external distribution). Each fee will be adjusted for the inflation that has occurred since that specific fee was last changed</P>
                <P>
                    The proposed rule change, including the Exchange's statement of the purpose of, and statutory basis for, the proposed rule change, is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/ise/rules</E>
                     and on the Commission's website at 
                    <E T="03">https://www.sec.gov/rules-regulations/self-regulatory-organization-rulemaking/national-securities-exchanges?file_number=SR-ISE-2025-02.</E>
                </P>
                <HD SOURCE="HD1">II. Solicitation of Comments</HD>
                <P>
                    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act.
                    <SU>5</SU>
                    <FTREF/>
                     Comments may be submitted electronically by using the Commission's internet comment form (
                    <E T="03">https://www.sec.gov/rules-regulations/self-regulatory-organization-rulemaking/national-securities-exchanges?file_number=SR-ISE-2025-02</E>
                    ) or by sending an email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include file number SR-ISE-2025-02 on the subject line. Alternatively, paper comments may be sent to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090. All submissions should refer to file number SR-ISE-2025-02. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
                    <E T="03">https://www.sec.gov/rules-regulations/self-regulatory-organization-rulemaking/national-securities-exchanges?file_number=SR-ISE-2025-02</E>
                    ). Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection. All submissions should refer to file number SR-ISE-2025-02 and should be submitted on or before February 5, 2025.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange.
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00684 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <SUBJECT>Data Collection Available for Public Comments</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day notice and request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the 
                        <E T="04">Federal Register</E>
                         concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments on or before March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send all comments to Amy Garcia, Veterans Business Analyst, Office of Veterans Development, 
                        <E T="03">amy.garcia@sba.gov,</E>
                         Small Business Administration.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Amy Garcia, Veterans Business Analyst, Office of Veterans, 
                        <E T="03">amy.garcia@sba.gov</E>
                        , 202-205-7526, or Curtis B. Rich, Agency Clearance Officer, 202-205-7030, 
                        <E T="03">curtis.rich@sba.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This form facilitates online registration for the Boots to Business course for eligible service members and their spouses. The collected data will be used to report course statistics, manage course operations more efficiently, tailor individual classes based on the experience and interests of the participants, and ultimately contact Boots to Business alumni.</P>
                <HD SOURCE="HD1">Solicitation of Public Comments</HD>
                <P>Comments may be submitted on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.</P>
                <HD SOURCE="HD2">Summary of Information Collections</HD>
                <P>
                    <E T="03">OMB Control Number:</E>
                     3245-0384.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Boots to Business Course Registration.
                </P>
                <P>
                    <E T="03">Description of Respondents:</E>
                     Transitioning Service Members.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     2453.
                </P>
                <P>
                    <E T="03">Estimated Annual Respondents:</E>
                     24,000.
                </P>
                <P>
                    <E T="03">Estimated Annual Responses:</E>
                     24,000.
                </P>
                <P>
                    <E T="03">Estimated Annual Hour Burden:</E>
                     120,000.
                </P>
                <SIG>
                    <NAME>Curtis Rich,</NAME>
                    <TITLE>Agency Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00782 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8026-09-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <SUBJECT>Small Business Investment Company License Issuance</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Small Business Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of Small Business Investment Company (SBIC) licenses.</P>
                </ACT>
                <P>
                    Pursuant to the authority granted to the United States Small Business Administration under section 301(c) of the Small Business Investment Act of 1958, as amended, to grant Small Business Investment Company licenses under the Small Business Investment Company Program, this notice satisfies the requirement effective August 17, 2023 under 13 CFR 107.501(a) to publish in the 
                    <E T="04">Federal Register</E>
                     the names of SBICs with date of licensure and Total Intended Leverage Commitments. The following SBICs received SBIC licenses as of the date indicated below:
                    <PRTPAGE P="3986"/>
                </P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s100,16,15">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">SBIC fund name</CHED>
                        <CHED H="1">Date of licensure</CHED>
                        <CHED H="1">
                            Leverage tiers 
                            <SU>1</SU>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">DC Small Business Fund, L.P</ENT>
                        <ENT>12/31/2024</ENT>
                        <ENT>1.00x</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ridgeline Ventures Fund II-S, L.P</ENT>
                        <ENT>12/27/2024</ENT>
                        <ENT>1.25x</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Midwest Growth Partners IV, L.P</ENT>
                        <ENT>12/27/2024</ENT>
                        <ENT>1.50x</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BBK Ventures Fund I, L.P</ENT>
                        <ENT>12/27/2024</ENT>
                        <ENT>2.00x</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Strategic Equality Fund II, L.P</ENT>
                        <ENT>12/20/2024</ENT>
                        <ENT>2.00x</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GP Capital Partners II, L.P</ENT>
                        <ENT>12/19/2024</ENT>
                        <ENT>2.00x</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Escalate Capital V, L.P</ENT>
                        <ENT>12/9/2024</ENT>
                        <ENT>2.00x</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Charter Growth Capital Fund II, L.P</ENT>
                        <ENT>12/6/2024</ENT>
                        <ENT>1.00x</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Rochefort Ventures, L.P</ENT>
                        <ENT>12/6/2024</ENT>
                        <ENT>2.00x</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         Maximum amount of Leverage expressed as a multiple of Leverageable Capital pursuant to 13 CFR 107.1150. For all SBIC Licensees that submitted a Management Assessment Questionnaire after August 17, 2023, the Notice of SBIC Licenses will include the Total Intended Leverage Commitment at the time of Licensure.
                    </TNOTE>
                </GPOTABLE>
                <SIG>
                    <NAME>Bailey DeVries,</NAME>
                    <TITLE>Associate Administrator, Office of Investment and Innovation, U.S. Small Business Administration.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00759 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8026-09-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SOCIAL SECURITY ADMINISTRATION</AGENCY>
                <DEPDOC>[Docket No: SSA-2024-0057]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Proposed Request</SUBJECT>
                <P>The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes a revision of OMB-approved information collections.</P>
                <P>SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.</P>
                <FP SOURCE="FP-1">(OMB) Office of Management and Budget, Attn: Desk Officer for SSA</FP>
                <FP SOURCE="FP-1">
                    (SSA) Social Security Administration, OLCA, Attn: Reports Clearance Director, Mail Stop 3253 Altmeyer, 6401 Security Blvd., Baltimore, MD 21235, Fax: 833-410-1631, Email address: 
                    <E T="03">OR.Reports.Clearance@ssa.gov</E>
                </FP>
                <P>
                    Or you may submit your comments online through 
                    <E T="03">https://www.reginfo.gov/public/do/PRAmain</E>
                     by clicking on Currently under Review—Open for Public Comments and choosing to click on one of SSA's published items. Please reference Docket ID Number [SSA-2024-0057] in your submitted response.
                </P>
                <P>I. The information collection below is pending at SSA. SSA will submit it to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than March 17, 2025. Individuals can obtain copies of the collection instrument by writing to the above email address.</P>
                <P>
                    <E T="03">Social Security Benefits Application—20 CFR 404.310-404.311, 404.315-404.322, 404.330-404.333, 404.601-404.603, and 404.1501-404.1512—0960-0618.</E>
                     Title II of the Social Security Act provides retirement, survivors, and disability benefits to individuals who meet the eligibility criteria and file the appropriate application. This collection comprises the various application methods for each type of benefits. SSA uses the information we gather through the multiple information collection tools in this information collection request to determine applicants' eligibility for specific Social Security benefits, as well as the amount of the benefits. Individuals filing for disability benefits can, and in some instances SSA may require them to, file applications under both title II, Social Security disability benefits, and title XVI, SSI payments. We refer to disability applications filed under both titles as “concurrent applications.” This collection comprises the various application methods for each type of benefits. These methods include the following modalities: Paper forms (Forms SSA-1, SSA-2, and SSA-16); Modernized Claims System (MCS) screens for in-person interview applications; and internet-based iClaim application. SSA uses the information we collect through these modalities to determine: (1) the applicants' eligibility for the above-mentioned Social Security benefits, and (2) the amount of the benefits. The respondents are applicants for retirement, survivors, and disability benefits under title II of the Social Security Act, or their representative payees.
                </P>
                <GPOTABLE COLS="8" OPTS="L2,nj,tp0,p7,7/8,i1" CDEF="s30,10,9,10,9,11,12,15">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Modality of completion</CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Frequency
                            <LI>of</LI>
                            <LI>response</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>burden per</LI>
                            <LI>response</LI>
                            <LI>(minutes)</LI>
                        </CHED>
                        <CHED H="1">
                            Estimated
                            <LI>annual</LI>
                            <LI>burden</LI>
                            <LI>(hours)</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>theoretical</LI>
                            <LI>cost amount</LI>
                            <LI>dollars) *</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>wait time</LI>
                            <LI>in field office</LI>
                            <LI>(minutes) **</LI>
                        </CHED>
                        <CHED H="1">
                            Total annual
                            <LI>opportunity</LI>
                            <LI>cost</LI>
                            <LI>(dollars) ***</LI>
                        </CHED>
                    </BOXHD>
                    <ROW EXPSTB="07" RUL="s">
                        <ENT I="21">
                            <E T="02">SSA-1</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Paper version/SSA-1</ENT>
                        <ENT>2,346</ENT>
                        <ENT>1</ENT>
                        <ENT>11</ENT>
                        <ENT>430</ENT>
                        <ENT>* $31.48</ENT>
                        <ENT>** 24</ENT>
                        <ENT>*** $43,065</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Interview/MCS</ENT>
                        <ENT>1,925,180</ENT>
                        <ENT>1</ENT>
                        <ENT>10</ENT>
                        <ENT>320,863</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT>** 24</ENT>
                        <ENT>*** 34,342,634</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Internet/iClaim—Domestic Residence:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">First Party</ENT>
                        <ENT>1,470,043</ENT>
                        <ENT>1</ENT>
                        <ENT>15</ENT>
                        <ENT>367,511</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT/>
                        <ENT>*** 11,569,247</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Third party initiated (complete and submit)</ENT>
                        <ENT>25,706</ENT>
                        <ENT>1</ENT>
                        <ENT>15</ENT>
                        <ENT>6,427</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT/>
                        <ENT>*** 202,322</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Internet/iClaim—Foreign Residence:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">First Party</ENT>
                        <ENT>7,993</ENT>
                        <ENT>1</ENT>
                        <ENT>18</ENT>
                        <ENT>2,398</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT/>
                        <ENT>*** 75,489</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="03">Third party-initiated (complete and submit)</ENT>
                        <ENT>645</ENT>
                        <ENT>1</ENT>
                        <ENT>18</ENT>
                        <ENT>194</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT/>
                        <ENT>*** 6,107</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="05">Totals</ENT>
                        <ENT>3,431,913</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>697,823</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>*** 46,238,864</ENT>
                    </ROW>
                    <ROW EXPSTB="07" RUL="s">
                        <ENT I="21">
                            <E T="02">SSA-2</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Paper version/SSA-2</ENT>
                        <ENT>779</ENT>
                        <ENT>1</ENT>
                        <ENT>15</ENT>
                        <ENT>195</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT>** 24</ENT>
                        <ENT>*** 15,960</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="3987"/>
                        <ENT I="01">Interview/MCS</ENT>
                        <ENT>407,415</ENT>
                        <ENT>1</ENT>
                        <ENT>14</ENT>
                        <ENT>95,064</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT>** 24</ENT>
                        <ENT>*** 8,122,784</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">iClaim</ENT>
                        <ENT>124,499</ENT>
                        <ENT>1</ENT>
                        <ENT>15</ENT>
                        <ENT>31,125</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT/>
                        <ENT>*** 979,815</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="03">Totals</ENT>
                        <ENT>532,693</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>126,384</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>*** 9,118,559</ENT>
                    </ROW>
                    <ROW EXPSTB="07" RUL="s">
                        <ENT I="21">
                            <E T="02">SSA-16</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Paper version/SSA-16</ENT>
                        <ENT>29,485</ENT>
                        <ENT>1</ENT>
                        <ENT>20</ENT>
                        <ENT>9,828</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT>** 24</ENT>
                        <ENT>*** 680,661</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Interview/MCS</ENT>
                        <ENT>920,938</ENT>
                        <ENT>1</ENT>
                        <ENT>19</ENT>
                        <ENT>291,630</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT>** 24</ENT>
                        <ENT>*** 20,776,957</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Internet/iClaim—Domestic Residence:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">First Party</ENT>
                        <ENT>503,567</ENT>
                        <ENT>1</ENT>
                        <ENT>15</ENT>
                        <ENT>125,892</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT/>
                        <ENT>*** 3,963,080</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Third party initiated (complete and submit)</ENT>
                        <ENT>528,474</ENT>
                        <ENT>1</ENT>
                        <ENT>15</ENT>
                        <ENT>132,119</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT/>
                        <ENT>*** 4,159,106</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Internet/iClaim—Foreign Residence:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">First Party</ENT>
                        <ENT>781</ENT>
                        <ENT>1</ENT>
                        <ENT>18</ENT>
                        <ENT>234</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT/>
                        <ENT>*** 7,366</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="03">Third party-initiated (complete and submit)</ENT>
                        <ENT>123</ENT>
                        <ENT>1</ENT>
                        <ENT>18</ENT>
                        <ENT>37</ENT>
                        <ENT>* 31.48</ENT>
                        <ENT/>
                        <ENT>*** 1,165</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="05">Totals</ENT>
                        <ENT>1,983,368</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>559,740</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>*** 29,588,335</ENT>
                    </ROW>
                    <ROW EXPSTB="07" RUL="s">
                        <ENT I="21">
                            <E T="02">Grand Total</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Total</ENT>
                        <ENT>5,947,974</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>1,383,947</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>*** 84,945,758</ENT>
                    </ROW>
                    <TNOTE>
                        * We based this figure on the average hourly wage for all occupations in May 2024 as reported by the U.S. Bureau of Labor Statistics (
                        <E T="03">https://www.bls.gov/oes/current/oes_nat.htm#00-0000</E>
                        ).
                    </TNOTE>
                    <TNOTE>** We based this figure on the average FY 2024 wait times for field offices, based on SSA's current management information data.</TNOTE>
                    <TNOTE>*** This figure does not represent actual costs that SSA is imposing on recipients of Social Security payments to complete this application; rather, these are theoretical opportunity costs for the additional time respondents will spend to complete the application. There is no actual charge to respondents to complete the application.</TNOTE>
                </GPOTABLE>
                <SIG>
                    <P>Dated: January 8, 2025.</P>
                    <NAME>Naomi Sipple,</NAME>
                    <TITLE>Reports Clearance Officer, Social Security Administration.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00668 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4191-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF STATE</AGENCY>
                <DEPDOC>[Public Notice: 12628]</DEPDOC>
                <SUBJECT>Specially Designated Global Terrorist Designations of The Terrorgram Collective, Ciro Daniel Amorim Ferreira, Noah Licul, and Hendrik-Wahl Muller</SUBJECT>
                <P>Acting under the authority of and in accordance with section 1(a)(ii)(A) of Executive Order 13224, as amended (“E.O. 13224” or “Order”), the Secretary of State has determined that the person known as The Terrorgram Collective (also known as Terrorgram) is a foreign person that has committed or has attempted to commit, poses a significant risk of committing, or has participated in training to commit acts of terrorism that threaten the security of United States nationals or the national security, foreign policy, or economy of the United States.</P>
                <P>Additionally, acting under the authority of and in accordance with section 1(a)(ii)(B)(2) of E.O. 13224, the Secretary of State has determined that the persons known as Ciro Daniel Amorim Ferreira (also known as Ciro Daniel Ferreira), Noah Licul (also known as Noah Lycul), and Hendrik-Wahl Muller, are foreign persons who are leaders of The Terrorgram Collective, an entity whose property and interests in property are concurrently blocked pursuant to a determination by the Secretary of State pursuant to E.O. 13224.</P>
                <P>Consistent with the determination in section 10 of E.O. 13224 that prior notice to persons determined to be subject to the Order who might have a constitutional presence in the United States would render ineffectual the blocking and other measures authorized in the Order because of the ability to transfer funds instantaneously, the Secretary of State determines that no prior notice needs to be provided to any person subject to this determination who might have a constitutional presence in the United States, because to do so would render ineffectual the measures authorized in the Order.</P>
                <P>
                    This determination shall be published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Hillary Batjer Johnson,</NAME>
                    <TITLE>Deputy Coordinator, Bureau of Counterterrorism, Department of State.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00756 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4710-AD-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF STATE</AGENCY>
                <DEPDOC>[Delegation of Authority No. 568]</DEPDOC>
                <SUBJECT>Delegation of Authority—Authorities of the Under Secretary for Civilian Security, Democracy, and Human Rights</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Delegation of authority.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The State Department is publishing a Delegation of Authority signed by the Secretary of State on December 20, 2024.</P>
                </SUM>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Antony J. Blinken, Secretary of State, signed the following “Delegation of Authority—Authorities of the Under Secretary for Civilian Security, Democracy, and Human Rights” on December 20, 2024. The State Department maintains the original document.</P>
                <P>(Begin text.)</P>
                <HD SOURCE="HD1">Delegation of Authority—Authorities of the Under Secretary for Civilian Security, Democracy, and Human Rights</HD>
                <P>By virtue of the authority vested in the Secretary of State by the laws of the United States, including section 1(a)(4) of the State Department Basic Authorities Act (22 U.S.C. 2651a(a)(4)), I hereby delegate to Todd D. Robinson, to the extent authorized by law, all authorities vested in or delegated to the Under Secretary for Civilian Security, Democracy, and Human Rights by any act, order, determination, delegation of authority, regulation, or executive order, now or hereafter issued.</P>
                <P>The Secretary, Deputy Secretary, Deputy Secretary for Management and Resources, and the Under Secretary for Management may exercise any function or authority delegated herein. This delegation of authority does not modify any other delegation of authority currently in effect.</P>
                <P>
                    This delegation will be effective on January 10, 2025, and will expire upon 
                    <PRTPAGE P="3988"/>
                    the entry upon duty of a confirmed Under Secretary for Civilian Security, Democracy, and Human Rights unless sooner revoked, and shall be published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>(End text.)</P>
                <SIG>
                    <NAME>Zachary A. Parker,</NAME>
                    <TITLE>Director, Office of Organizational Policy, Department of State.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00679 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4710-10-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF STATE</AGENCY>
                <DEPDOC>[Delegation of Authority No. 567]</DEPDOC>
                <SUBJECT>Delegation of Authority—Authorities of the Under Secretary for Economic Growth, Energy, and the Environment</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Delegation of authority.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The State Department is publishing a Delegation of Authority signed by the Secretary of State on December 20, 2024.</P>
                </SUM>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Antony J. Blinken, Secretary of State, signed the following “Delegation of Authority—Authorities of the Under Secretary for Economic Growth, Energy, and the Environment” on December 20, 2024. The State Department maintains the original document.</P>
                <P>(Begin text.)</P>
                <HD SOURCE="HD1">Delegation of Authority—Authorities of the Under Secretary for Economic Growth, Energy, and the Environment</HD>
                <P>By virtue of the authority vested in the Secretary of State by the laws of the United States, including section 1(a)(4) of the State Department Basic Authorities Act (22 U.S.C. 2651a(a)(4)), I hereby delegate to Geoffrey R. Pyatt, to the extent authorized by law, all authorities vested in or delegated to the Under Secretary for Economic Growth, Energy, and the Environment by any act, order, determination, delegation of authority, regulation, or executive order, now or hereafter issued.</P>
                <P>The Secretary, Deputy Secretary, Deputy Secretary for Management and Resources, and the Under Secretary for Management may exercise any function or authority delegated herein. This delegation of authority does not modify any other delegation of authority currently in effect.</P>
                <P>
                    This delegation will be effective on January 10, 2025, and will expire upon the entry upon duty of a confirmed Under Secretary for Economic Growth Energy, and the Environment unless sooner revoked and shall be published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>(End text.)</P>
                <SIG>
                    <NAME>Zachary A. Parker,</NAME>
                    <TITLE>Director, Office of Organizational Policy, Department of State.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00678 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4710-10-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">TENNESSEE VALLEY AUTHORITY</AGENCY>
                <SUBJECT>Meeting of the Regional Energy Resource Council</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Tennessee Valley Authority (TVA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The TVA Regional Energy Resource Council (RERC) will hold a meeting on January 31, 2025, to receive an update on the draft 2025 Integrated Resource Plan (IRP). The IRP provides strategic direction on how TVA will continue to provide low-cost, reliable, resilient, and increasingly cleaner electricity to the 10 million residents of the Valley region.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The meeting will be held virtually, on Friday, January 31, 2025, from 10 a.m. to 12:30 p.m. ET. To view the webinar, the public must register for the webinar. The registration link and instructions to view the meeting will be posted on TVA's RERC website at 
                        <E T="03">www.tva.com/rerc.</E>
                         A one-hour public listening session for the public to present comments virtually will be held January 31, 2025, at 11:30 a.m. ET. Persons who wish to speak during the public listening session must pre-register by 5 p.m. ET Wednesday, January 29, 2025, by emailing 
                        <E T="03">bhaliti@tva.gov.</E>
                         Persons who are pre-registered to provide comments virtually will be called on during the public listening session to share their views for up to five minutes, depending on number of registrants. Written comments are also invited and may be emailed to 
                        <E T="03">bhaliti@tva.gov.</E>
                         Anyone needing special accommodations should email 
                        <E T="03">bhaliti@tva.gov</E>
                         at least one week in advance.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will be fully virtual, and the meeting link will be provided at 
                        <E T="03">www.tva.com/rerc</E>
                         prior to the meeting.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Bekim Haliti, 
                        <E T="03">bhaliti@tva.gov</E>
                         or 931-349-1894.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The RERC was established to advise TVA on its energy resource activities and the priorities among competing objectives and values. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. 10.</P>
                <P>The meeting agenda includes the following:</P>
                <HD SOURCE="HD1">January 31</HD>
                <FP SOURCE="FP-1">1. Welcome and Introductions</FP>
                <FP SOURCE="FP-1">2. IRP Process Update</FP>
                <FP SOURCE="FP-1">3. Recap of Draft IRP Public Comment Period</FP>
                <FP SOURCE="FP-1">4. IRP Sensitivities</FP>
                <FP SOURCE="FP-1">5. Forming the IRP Recommendations</FP>
                <FP SOURCE="FP-1">6. Public Listening Session</FP>
                <SIG>
                    <DATED>Dated: January 10, 2025.</DATED>
                    <NAME>Melanie Farrell,</NAME>
                    <TITLE>Vice President, Valley Engagement and Strategy, Tennessee Valley Authority.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00783 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8120-08-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <DEPDOC>[Docket No.: FAA-2023-0699; Summary Notice No.-2025-01]</DEPDOC>
                <SUBJECT>Petition for Exemption; Summary of Petition Received; Houff Corporation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion nor omission of information in the summary is intended to affect the legal status of the petition or its final disposition.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments on this petition must identify the petition docket number and must be received on or before February 4, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Send comments identified by docket number [FAA-2023-0699] using any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">http://www.regulations.gov</E>
                         and follow the online instructions for sending your comments electronically.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Send comments to Docket Operations, M-30; U.S. Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery or Courier:</E>
                         Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                        <PRTPAGE P="3989"/>
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         Fax comments to Docket Operations at (202) 493-2251.
                    </P>
                    <P>
                        <E T="03">Privacy:</E>
                         In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                        <E T="03">http://www.regulations.gov,</E>
                         as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
                        <E T="03">http://www.dot.gov/privacy.</E>
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         Background documents or comments received may be read at 
                        <E T="03">http://www.regulations.gov</E>
                         at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Jake Troutman, (202) 267-2928, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.</P>
                    <P>This notice is published pursuant to 14 CFR 11.85.</P>
                    <SIG>
                        <P>Issued in Washington, DC.</P>
                        <NAME>Dan A. Ngo,</NAME>
                        <TITLE>Manager, Part 11 Petitions Branch, Office of Rulemaking.</TITLE>
                    </SIG>
                    <HD SOURCE="HD1">Petition for Exemption</HD>
                    <P>
                        <E T="03">Docket No.:</E>
                         FAA-2023-0699.
                    </P>
                    <P>
                        <E T="03">Petitioner:</E>
                         Houff Corporation.
                    </P>
                    <P>
                        <E T="03">Section(s) of 14 CFR Affected:</E>
                         §§ 61.3(a)(1)(i), 91.7(a), 91.119(c), 91.121, 91.151(b), 91.403(b), 91.405(a), 91.407(a)(1), 91.409(a)(1), 91.409(a)(2), 91.417(a), 91.417(b), 137.19(c), 137.19(d), 137.19(e)(2)(ii), 137.19(e)(2)(iii), 137.19(e)(2)(v), 137.31, 137.33, 137.41(c), 137.42.
                    </P>
                    <P>
                        <E T="03">Description of Relief Sought:</E>
                         Houff Corporation requests an amendment to their current exemption to conduct commercial agricultural-related services without the need to request a Notice To Air Missions (NOTAM).
                    </P>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 2025-00699 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2024-0028]</DEPDOC>
                <SUBJECT>Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of final disposition.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>FMCSA announces its decision to exempt 13 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The exemptions were applicable on December 31, 2024. The exemptions expire on December 31, 2026.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001, 
                        <E T="03">fmcsamedical@dot.gov.</E>
                         Office hours are from 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Dockets Operations, (202) 366-9826.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <HD SOURCE="HD2">A. Viewing Comments</HD>
                <P>
                    To view comments go to 
                    <E T="03">www.regulations.gov.</E>
                     Insert the docket number, (FMCSA-2024-0028) in the keyword box and click “Search.” Next, sort the results by “Posted (Older-Newer),” choose the first notice listed, and click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                </P>
                <HD SOURCE="HD2">B. Privacy Act</HD>
                <P>
                    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov.</E>
                     As described in the system of records notice DOT/ALL 14 (Federal Docket Management System), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices,</E>
                     the comments are searchable by the name of the submitter.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>On November 26, 2024, FMCSA published a notice announcing receipt of applications from 13 individuals requesting an exemption from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and requested comments from the public (89 FR 93392). The public comment period ended on December 26, 2024, and no comments were received.</P>
                <P>FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(8).</P>
                <P>The physical qualification standard for drivers regarding epilepsy found in § 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.</P>
                <P>
                    In addition to the regulations, FMCSA has published advisory criteria 
                    <SU>1</SU>
                    <FTREF/>
                     to assist medical examiners (MEs) in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         These criteria may be found in APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. Epilepsy: § 391.41(b)(8), paragraphs 3, 4, and 5, which is available on the internet at 
                        <E T="03">https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Discussion of Comments</HD>
                <P>FMCSA received no comments in this proceeding.</P>
                <HD SOURCE="HD1">IV. Basis for Exemption Determination</HD>
                <P>
                    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be 
                    <PRTPAGE P="3990"/>
                    achieved absent such exemption. The statutes allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.
                </P>
                <P>
                    The Agency's decision regarding these exemption applications is based on the 2007 recommendations of the Agency's Medical Expert Panel. The Agency conducted an individualized assessment of each applicant's medical information, including the root cause of the respective seizure(s) and medical information about the applicant's seizure history, the length of time that has elapsed since the individual's last seizure, the stability of each individual's treatment regimen and the duration of time on or off of anti-seizure medication. In addition, the Agency reviewed the treating clinician's medical opinion related to the ability of the driver to safely operate a CMV with a seizure history and each certified driving record from their State Driver's Licensing Agency (SDLA). The information obtained from each applicant's driving record provides the Agency with details regarding any moving violations or reported crash data, which demonstrates whether the driver has a safe driving history and is an indicator of future driving performance. If the driving record revealed a crash, FMCSA requested and reviewed the related police reports and other relevant documents, such as the citation and conviction information. A summary of each applicant's seizure history was discussed in the November 26, 2024, 
                    <E T="04">Federal Register</E>
                     notice (89 FR 93392) and will not be repeated in this notice.
                </P>
                <P>These 13 applicants have been seizure-free over a range of 21 years while taking anti-seizure medication and maintained a stable medication treatment regimen for the last 2 years. In each case, the applicant's treating physician verified his or her seizure history and supports the ability to drive commercially.</P>
                <P>The Agency acknowledges the potential consequences of a driver experiencing a seizure while operating a CMV. However, the Agency believes the drivers granted this exemption have demonstrated that they are unlikely to have a seizure and their medical condition does not pose a risk to public safety.</P>
                <P>Consequently, FMCSA finds further that in each case exempting these applicants from the epilepsy and seizure disorder prohibition in § 391.41(b)(8) would likely achieve a level of safety equal to that existing without the exemption, consistent with the applicable standard in 49 U.S.C. 31315(b)(1).</P>
                <HD SOURCE="HD1">V. Terms and Conditions</HD>
                <P>The terms and conditions of the exemption are provided to the applicants in the exemption document and include the following: each driver must (1) remain seizure-free, maintain a stable treatment, and report to FMCSA within 24 hours if they experience a seizure during the 2-year exemption period; (2) submit to FMCSA annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) undergo an annual medical examination by a certified medical examiner, as defined by § 390.5T; (4) provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of their driver's qualification file if they are self-employed; (5) report to FMCSA the date, location, and time of any crashes as defined in § 390.5T within 7 days of the crash; (6) report to FMCSA any citations and convictions for disqualifying offenses under 49 CFR parts 383 and 391 within 7 days of the citations and convictions; and (7) submit to FMCSA annual certified driving records from their SDLA. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. In addition, the driver must meet all applicable commercial driver's license testing requirements.</P>
                <HD SOURCE="HD1">VI. Preemption</HD>
                <P>During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.</P>
                <HD SOURCE="HD1">VII. Conclusion</HD>
                <P>Based upon its evaluation of the 13 exemption applications, FMCSA exempts the following drivers from the epilepsy and seizure disorder prohibition in § 391.41(b)(8), subject to the requirements cited above:</P>
                <FP SOURCE="FP-1">Timothy Andersen (WI)</FP>
                <FP SOURCE="FP-1">Randson Burdette (OH)</FP>
                <FP SOURCE="FP-1">Giovanni Dale (MS)</FP>
                <FP SOURCE="FP-1">Robert Edwards (NV)</FP>
                <FP SOURCE="FP-1">Chad Johnson (IA)</FP>
                <FP SOURCE="FP-1">Austin Little (PA)</FP>
                <FP SOURCE="FP-1">Denton O'Conner (NY)</FP>
                <FP SOURCE="FP-1">Monroe Peterson (IA)</FP>
                <FP SOURCE="FP-1">Austin Rodriguez (CA)</FP>
                <FP SOURCE="FP-1">Wayne Scaggs (OH)</FP>
                <FP SOURCE="FP-1">Richard Sievers (WI)</FP>
                <FP SOURCE="FP-1">Beth Smith (MT)</FP>
                <FP SOURCE="FP-1">Brandon White (CA)</FP>
                <P>In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.</P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00748 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2024-0307]</DEPDOC>
                <SUBJECT>Commercial Driver's License: Bianco Trucking Services, LLC d.b.a. CDL and Operator Training; Application for Exemption</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of application for exemption; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Motor Carrier Safety Administration (FMCSA) requests public comment on the application from Bianco Trucking Services, LLC d.b.a. CDL and Operator Training (“Bianco”) for an exemption to allow drivers aged 18, 19, and 20 years with a Wisconsin State-issued commercial learners permit (CLP) and a “K” restriction on their CLP to attend its driver training facility in Michigan. Bianco is a registered entry-level driver training (ELDT) provider listed on the Agency's Training Provider Registry (TPR).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA-2024-0307 by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: www.regulations.gov.</E>
                         See the Public Participation and Request for Comments section below for further information.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Dockets Operations, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, 
                        <PRTPAGE P="3991"/>
                        Ground Floor, Washington, DC 20590-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery or Courier:</E>
                         West Building, Ground Floor, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m. E.T., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        Each submission must include the Agency name and the docket number (FMCSA-2024-0307) for this notice. Note that DOT posts all comments received without change to 
                        <E T="03">www.regulations.gov,</E>
                         including any personal information included in a comment. Please see the Privacy Act heading below.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         For access to the docket to read background documents or comments, go to 
                        <E T="03">www.regulations.gov</E>
                         at any time on the ground level of the West Building, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mr. Richard Clemente, Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards, FMCSA; (202) 366-2722; or 
                        <E T="03">richard.clemente@dot.gov.</E>
                    </P>
                    <P>If you have questions on viewing or submitting material to the docket, contact Dockets Operations at (202) 366-9826.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation and Request for Comments</HD>
                <P>FMCSA encourages you to participate by submitting comments and related materials.</P>
                <HD SOURCE="HD2">A. Submitting Comments</HD>
                <P>If you submit a comment, please include the docket number for this notice (FMCSA-2024-0307), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.</P>
                <P>
                    To submit your comment online, go to 
                    <E T="03">www.regulations.gov/docket/FMCSA-2024-0307,</E>
                     click on this notice, click “Comment,” and type your comment into the text box on the following screen.
                </P>
                <P>
                    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
                    <FR>1/2</FR>
                     by 11 inches, suitable for copying and electronic filing.
                </P>
                <P>FMCSA will consider all comments and material received during the comment period. Comments received after the comment closing date will be filed in the public docket and will be considered to the extent practicable.</P>
                <HD SOURCE="HD2">B. Confidential Business Information (CBI)</HD>
                <P>
                    CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to the notice contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to the notice, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission that constitutes CBI as “PROPIN” to indicate it contains proprietary information. FMCSA will treat such marked submissions as confidential under the Freedom of Information Act, and they will not be placed in the public docket of the notice. Submissions containing CBI should be sent to Brian Dahlin, Chief, Regulatory Evaluation Division, Office of Policy, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 or via email at 
                    <E T="03">brian.g.dahlin@dot.gov.</E>
                     At this time, you need not send a duplicate hardcopy of your electronic CBI submissions to FMCSA headquarters. Any comments FMCSA receives not specifically designated as CBI will be placed in the public docket for this notice.
                </P>
                <HD SOURCE="HD2">C. Viewing Comments and Documents</HD>
                <P>
                    To view comments, as well as any documents mentioned as being available in the docket, go to 
                    <E T="03">https://www.regulations.gov/docket/FMCSA-2024-0237/document</E>
                     and choose the document to review. To view comments, click this notice, then click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Docket Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m., ET Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                </P>
                <HD SOURCE="HD2">D. Privacy</HD>
                <P>
                    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its regulatory process. DOT posts these comments, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov,</E>
                     as described in the system of records notice DOT/ALL 14 (Federal Docket Management System (FDMS)), which can be reviewed under the “Department Wide System of Records Notices” at 
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices.</E>
                     The comments are posted without edit and are searchable by the name of the submitter.
                </P>
                <HD SOURCE="HD1">II. Legal Basis</HD>
                <P>
                    FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the 
                    <E T="04">Federal Register</E>
                     (49 CFR 381.315(a)). The Agency must provide the public an opportunity to inspect the information relevant to the application, including the applicant's safety analysis. The Agency must provide an opportunity for public comment on the request.
                </P>
                <P>
                    The Agency reviews safety analyses and public comments submitted and determines whether granting the exemption would likely maintain a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305(a)). The Agency must publish its decision in the 
                    <E T="04">Federal Register</E>
                     (49 CFR 381.315(b)). If granted, the notice will identify the regulatory provision from which the applicant will be exempt, the effective period, and all terms and conditions of the exemption (49 CFR 381.315(c)(1)). If the exemption is denied, the notice will explain the reason for the denial (49 CFR 381.315(c)(2)). The exemption may be renewed (49 CFR 381.300(b)).
                </P>
                <HD SOURCE="HD1">III. Current Regulatory Requirements</HD>
                <P>
                    Drivers of commercial motor vehicles (CMVs), as defined in 49 CFR 390.5T, operating in interstate commerce, must be at least 21 years of age (§ 391.11(b)(1)). An individual younger than age 21 may drive in intrastate commerce only in the driver's State of domicile. FMCSA's regulations at 49 CFR 383.153(b)(2)(ix)(G) require that CLPs issued to drivers limited to intrastate commerce be marked with a “K” restriction.
                    <PRTPAGE P="3992"/>
                </P>
                <HD SOURCE="HD1">IV. Applicant's Request</HD>
                <P>Bianco requests a 5-year exemption to allow drivers aged 18, 19, and 20 years, with a Wisconsin State-issued CLP and a “K” restriction on their CLP, to attend Bianco's driver training facility in Michigan. The applicant's driver training facility is listed on the Agency's Training Provider Registry. The applicant states that its facility is located approximately 29 miles from the Wisconsin border. Bianco states that several students located in Wisconsin have inquired about attending its training program because Bianco's training facility is their closest registered training provider. The applicant further adds that an option to attend a training program located within a reasonable driving distance would be invaluable to students who are working and attending school at the same time.</P>
                <P>Bianco indicates that drivers under this exemption will not operate a CMV without a licensed training provider in the vehicle, apart from range maneuvers on a training lot that is maintained and insured by the applicant. Bianco also requires pre-employment drug screens for all students prior to the start of its training class. The students are also required to complete all components of the ELDT as required under 49 CFR part 380. A copy of Bianco's application for exemption is available for review in the docket for this notice.</P>
                <HD SOURCE="HD1">V. Request for Comments</HD>
                <P>
                    In accordance with 49 U.S.C. 31315(b), FMCSA requests public comment from all interested persons on Bianco's application for an exemption. All comments received before the close of business on the comment closing date will be considered and will be available for examination in the docket at the location listed under the 
                    <E T="02">ADDRESSES</E>
                     section of this notice. Comments received after the comment closing date will be filed in the public docket and will be considered to the extent practicable. In addition to late comments, FMCSA will also continue to file, in the public docket, relevant information that becomes available after the comment closing date. Interested persons should continue to examine the public docket for new material.
                </P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00818 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2024-0017]</DEPDOC>
                <SUBJECT>Qualification of Drivers; Exemption Applications; Hearing</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of final disposition.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>FMCSA announces its decision to exempt 16 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The exemptions were applicable December 24, 2024. The exemptions expire December 24, 2026.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001, 
                        <E T="03">fmcsamedical@dot.gov.</E>
                         Office hours are from 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Dockets Operations, (202) 366-9826.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <HD SOURCE="HD2">A. Viewing Comments</HD>
                <P>
                    To view comments go to 
                    <E T="03">www.regulations.gov.</E>
                     Insert the docket number (FMCSA-2024-0017) in the keyword box and click “Search.” Next, sort the results by “Posted (Older-Newer),” choose the first notice listed, and click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations in on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                </P>
                <HD SOURCE="HD2">B. Privacy Act</HD>
                <P>
                    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov.</E>
                     As described in the system of records notice DOT/ALL 14 (Federal Docket Management System), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices,</E>
                     the comments are searchable by the name of the submitter.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>On November 19, 2024, FMCSA published a notice announcing receipt of applications from 16 individuals requesting an exemption from the hearing requirement in 49 CFR 391.41(b)(11) to operate a CMV in interstate commerce and requested comments from the public (89 FR 91474). The public comment period ended on December 19, 2024, and no comments were received.</P>
                <P>FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(11).</P>
                <P>The physical qualification standard for drivers regarding hearing found in § 391.41(b)(11) states that a person is physically qualified to drive a CMV if that person first perceives a forced whispered voice in the better ear at not less than 5 feet with or without the use of a hearing aid or, if tested by use of an audiometric device, does not have an average hearing loss in the better ear greater than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a hearing aid when the audiometric device is calibrated to American National Standard (formerly ASA Standard) Z24.5—1951.</P>
                <P>This standard was adopted in 1970 and was revised in 1971 to allow drivers to be qualified under this standard while wearing a hearing aid (35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971), respectively).</P>
                <HD SOURCE="HD1">III. Discussion of Comments</HD>
                <P>FMCSA received no comments in this proceeding.</P>
                <HD SOURCE="HD1">IV. Basis for Exemption Determination</HD>
                <P>
                    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. However, FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the 
                    <PRTPAGE P="3993"/>
                    maximum duration of a driver's medical certification.
                </P>
                <P>The Agency's decision regarding these exemption applications is based on relevant scientific information and literature, and the 2008 Evidence Report, “Executive Summary on Hearing, Vestibular Function and Commercial Motor Driving Safety.” The evidence report reached two conclusions regarding the matter of hearing loss and CMV driver safety: (1) no studies that examined the relationship between hearing loss and crash risk exclusively among CMV drivers were identified; and (2) evidence from studies of the private driver's license holder population does not support the contention that individuals with hearing impairment are at an increased risk for a crash. In addition, the Agency reviewed each applicant's certified driving record from their State Driver's Licensing Agency (SDLA). The information obtained from each applicant's driving record provides the Agency with details regarding any moving violations or reported crash data., which demonstrates whether the driver has a safe driving history and is used as an indicator of future driving performance. If the driving record revealed a crash, FMCSA requested and reviewed the related police reports and other relevant documents, such as the citation and conviction information. Each applicant's record demonstrated a safe driving history. Based on an individual assessment of each applicant that focused on whether an equal or greater level of safety would likely be achieved by permitting each of these drivers to drive in interstate commerce, the Agency finds the drivers granted this exemption have demonstrated that they do not pose a risk to public safety.</P>
                <P>Consequently, FMCSA finds further that in each case exempting these applicants from the hearing standard in § 391.41(b)(11) would likely achieve a level of safety equal to that existing without the exemption, consistent with the applicable standard in 49 U.S.C. 31315(b)(1).</P>
                <HD SOURCE="HD1">V. Terms and Conditions</HD>
                <P>The terms and conditions of the exemption are provided to the applicants in the exemption document and include the following: each driver (1) must report to FMCSA the date, location, and time of any crashes as defined in § 390.5T, within 7 days of the crash; (2) must report to FMCSA any citations and convictions for disqualifying offenses under 49 CFR parts 383 and 391 within 7 days of the citations and convictions; (3) must submit to FMCSA annual certified driving records from their SDLA; and (4) is prohibited from operating a motorcoach or bus with passengers in interstate commerce. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. In addition, the driver must meet all applicable commercial driver's license testing requirements.</P>
                <HD SOURCE="HD1">VI. Preemption</HD>
                <P>During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.</P>
                <HD SOURCE="HD1">VII. Conclusion</HD>
                <P>Based upon its evaluation of the 16 exemption applications, FMCSA exempts the following drivers from the hearing standard; in § 391.41(b)(11), subject to the requirements cited above:</P>
                <FP SOURCE="FP-1">Bryan Brignac (MS)</FP>
                <FP SOURCE="FP-1">Anthony Byrd (CA)</FP>
                <FP SOURCE="FP-1">Margarita Casas (TX)</FP>
                <FP SOURCE="FP-1">Dorsey Chany (TX)</FP>
                <FP SOURCE="FP-1">Ali Elmasri (TX)</FP>
                <FP SOURCE="FP-1">Aldin Erskine (TX)</FP>
                <FP SOURCE="FP-1">Austin Hughes (AL)</FP>
                <FP SOURCE="FP-1">Milton Hunt (CA)</FP>
                <FP SOURCE="FP-1">Irfan Kabir (CT)</FP>
                <FP SOURCE="FP-1">Raymond Lee (TX)</FP>
                <FP SOURCE="FP-1">Leon McClish (TX)</FP>
                <FP SOURCE="FP-1">Maisel Rodriguez (IL)</FP>
                <FP SOURCE="FP-1">Maino Salas (CA)</FP>
                <FP SOURCE="FP-1">Jasmine Smith (MS)</FP>
                <FP SOURCE="FP-1">Justin Soliz (TX)</FP>
                <FP SOURCE="FP-1">Carter Wyant (MI)</FP>
                <P>In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.</P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00745 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2014-0102; FMCSA-2014-0104; FMCSA-2014-0384; FMCSA-2017-0057; FMCSA-2017-0058; FMCSA-2018-0136; FMCSA-2022-0035; FMCSA-2022-0037]</DEPDOC>
                <SUBJECT>Qualification of Drivers; Exemption Applications; Hearing</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of final disposition.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>FMCSA announces its decision to renew exemptions for 13 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates provided below.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001, 
                        <E T="03">fmcsamedical@dot.gov.</E>
                         Office hours are 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Dockets Operations, (202) 366-9826.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <HD SOURCE="HD2">A. Viewing Comments</HD>
                <P>
                    To view comments go to 
                    <E T="03">www.regulations.gov.</E>
                     Insert the docket number (FMCSA-2014-0102, FMCSA-2014-0104, FMCSA-2014-0384, FMCSA-2017-0057, FMCSA-2017-0058, FMCSA-2018-0136, FMCSA-2022-0035, or FMCSA-2022-0037) in the keyword box and click “Search.” Next, sort the results by “Posted (Newer-Older),” choose the first notice listed, and click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To be 
                    <PRTPAGE P="3994"/>
                    sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                </P>
                <HD SOURCE="HD2">B. Privacy Act</HD>
                <P>
                    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov.</E>
                     As described in the system of records notice DOT/ALL 14 (Federal Docket Management System), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices,</E>
                     the comments are searchable by the name of the submitter.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>On November 26, 2024, FMCSA published a notice announcing its decision to renew exemptions for 13 individuals from the hearing standard in 49 CFR 391.41(b)(11) to operate a CMV in interstate commerce and requested comments from the public (89 FR 93394). The public comment period ended on December 26, 2024, and no comments were received.</P>
                <P>FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(11).</P>
                <P>The physical qualification standard for drivers regarding hearing found in § 391.41(b)(11) states that a person is physically qualified to drive a CMV if that person first perceives a forced whispered voice in the better ear at not less than 5 feet with or without the use of a hearing aid or, if tested by use of an audiometric device, does not have an average hearing loss in the better ear greater than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a hearing aid when the audiometric device is calibrated to American National Standard (formerly ASA Standard) Z24.5—1951.</P>
                <P>This standard was adopted in 1970 and was revised in 1971 to allow drivers to be qualified under this standard while wearing a hearing aid (35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971), respectively).</P>
                <HD SOURCE="HD1">III. Discussion of Comments</HD>
                <P>FMCSA received no comments in this proceeding.</P>
                <HD SOURCE="HD1">IV. Conclusion</HD>
                <P>Based upon its evaluation of the 13 renewal exemption applications and comments received, FMCSA announces its decision to exempt the following drivers from the hearing requirement in § 391.41 (b)(11).</P>
                <P>As of December 16, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following nine individuals have satisfied the renewal conditions for obtaining an exemption from the hearing requirement in the FMCSRs for interstate CMV drivers (89 FR 93394):</P>
                <FP SOURCE="FP-1">Blair Chappell (PA)</FP>
                <FP SOURCE="FP-1">James Dignan (IL)</FP>
                <FP SOURCE="FP-1">Ahmed Gabr (NC)</FP>
                <FP SOURCE="FP-1">Arnold Hatton (DE)</FP>
                <FP SOURCE="FP-1">Peter Mannella (WA)</FP>
                <FP SOURCE="FP-1">Keith Miller (PA)</FP>
                <FP SOURCE="FP-1">Scott Perdue (GA)</FP>
                <FP SOURCE="FP-1">Allen Whitener (TX)</FP>
                <FP SOURCE="FP-1">Eric Woods (MD)</FP>
                <P>The drivers were included in docket number FMCSA-2014-0102, FMCSA-2014-0104, FMCSA-2014-0384, FMCSA-2017-0057, FMCSA-2017-0058, FMCSA-2018-0136, or FMCSA-2022-0035. Their exemptions were applicable as of December 16, 2024 and will expire on December 16, 2026.</P>
                <P>As of December 22, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following two individuals have satisfied the renewal conditions for obtaining an exemption from the hearing requirement in the FMCSRs for interstate CMV drivers (89 FR 93394):</P>
                <P>Michael Clark (MD); and Michael Piirainen (ME).</P>
                <P>The drivers were included in docket number FMCSA-2022-0035. Their exemptions were applicable as of December 22, 2024 and will expire on December 22, 2026.</P>
                <P>As of December 30, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following two individuals have satisfied the renewal conditions for obtaining an exemption from the hearing requirement in the FMCSRs for interstate CMV drivers (89 FR 93394):</P>
                <P>Saranne Fewel (OK); and Jared Healan (CO).</P>
                <P>The drivers were included in docket number FMCSA-2022-0037. Their exemptions were applicable as of December 30, 2024 and will expire on December 30, 2026.</P>
                <P>In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the FMCSRs.</P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00746 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2013-0109; FMCSA-2013-0442; FMCSA-2022-0044]</DEPDOC>
                <SUBJECT>Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of final disposition.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>FMCSA announces its decision to renew exemptions for seven individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The exemptions were applicable on August 31, 2024. The exemptions expire on August 31, 2026.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001, 
                        <E T="03">fmcsamedical@dot.gov.</E>
                         Office hours are from 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Dockets Operations, (202) 366-9826.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <HD SOURCE="HD2">A. Viewing Comments</HD>
                <P>
                    To view comments go to 
                    <E T="03">www.regulations.gov.</E>
                     Insert the docket number (FMCSA-2013-0109, FMCSA-2013-0442, or FMCSA-2022-0044) in the keyword box and click “Search.” Next, sort the results by “Posted (Newer-Older),” choose the first notice listed, and click “Browse Comments.” If 
                    <PRTPAGE P="3995"/>
                    you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                </P>
                <HD SOURCE="HD2">B. Privacy Act</HD>
                <P>
                    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov.</E>
                     As described in the system of records notice DOT/ALL 14 (Federal Docket Management System), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices,</E>
                     the comments are searchable by the name of the submitter.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>On August 7, 2024, FMCSA published a notice announcing its decision to renew exemptions for seven individuals from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV in interstate commerce and requested comments from the public (89 FR 64532). The public comment period ended on September 6, 2024, and no comments were received. However, FMCSA reopened the comments to the public on November 14, 2024, to correct an error by indicating the complete docket number of FMCSA-2013-0442 for renewal applicant, Raymond Lobo (NJ) (89 FR 90212). The second public comment period ended on December 16, 2024, and no comments were received.</P>
                <P>FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(8).</P>
                <P>The physical qualification standard for drivers regarding epilepsy found in § 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.</P>
                <P>
                    In addition to the regulations, FMCSA has published advisory criteria 
                    <SU>1</SU>
                    <FTREF/>
                     to assist medical examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         These criteria may be found in APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. 
                        <E T="03">Epilepsy:</E>
                         § 391.41(b)(8), paragraphs 3, 4, and 5, which is available on the internet at 
                        <E T="03">https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Discussion of Comments</HD>
                <P>FMCSA received no comments in this proceeding.</P>
                <HD SOURCE="HD1">IV. Conclusion</HD>
                <P>Based on its evaluation of the seven renewal exemption applications and comments received, FMCSA announces its decision to exempt the following drivers from the epilepsy and seizure disorders prohibition in § 391.41(b)(8).</P>
                <P>As of August 31, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following seven individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers (89 FR 64532):</P>
                <FP SOURCE="FP-1">Cody Baker (IN)</FP>
                <FP SOURCE="FP-1">David P. Crowe (VA)</FP>
                <FP SOURCE="FP-1">Michael Curtis Gibson (SC)</FP>
                <FP SOURCE="FP-1">Raymond Lobo (NJ)</FP>
                <FP SOURCE="FP-1">Alexis Roldan (IL)</FP>
                <FP SOURCE="FP-1">William Smith (NC)</FP>
                <FP SOURCE="FP-1">Yoon Song (CA)</FP>
                <P>The drivers were included in docket number FMCSA-2013-0109, FMCSA-2013-044, or FMCSA-2022-0044. Their exemptions were applicable as of August 31, 2024 and will expire on August 31, 2026.</P>
                <P>In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).</P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00820 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2025-0003]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Renewal of an Approved Information Collection: Transportation of Household Goods; Consumer Protection</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval and invites public comment. FMCSA requests OMB's renewed approval of the ICR titled “Transportation of Household Goods; Consumer Protection,” which applies to household goods motor carriers who are procured by the public (household goods shippers) to transport their household goods. This renewal revises the previous information collection's number of respondents, total respondent hours, and cost burden.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments on this notice must be received on or before March 17, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket Number FMCSA-2025-0003 using any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Dockets Operations; U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor, Washington, DC 20590-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery or Courier:</E>
                         Dockets Operations, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor, Washington, DC 20590-0001 between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         1-202-493-2251.
                    </P>
                    <P>
                        To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section for instructions on submitting comments.
                    </P>
                </ADD>
                <FURINF>
                    <PRTPAGE P="3996"/>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Donnice Wagoner, Commercial Enforcement Division, DOT, FMCSA, West Building, 6th Floor, 1200 New Jersey Avenue SE, Washington, DC 20590-0001; (202) 366-8045; 
                        <E T="03">Donnice.Wagoner@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Instructions</HD>
                <P>
                    All submissions must include the Agency name and docket number. For detailed instructions on submitting comments, see the Public Participation heading below. Note that all comments received will be posted without change to 
                    <E T="03">https://www.regulations.gov,</E>
                     including any personal information provided. Please see the Privacy Act heading below.
                </P>
                <HD SOURCE="HD1">Public Participation and Request for Comments</HD>
                <P>If you submit a comment, please include the docket number for this notice (FMCSA-2025-0003), indicate the specific section of this document to which your comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so FMCSA can contact you if there are questions regarding your submission.</P>
                <P>
                    To submit your comment online, go to 
                    <E T="03">https://www.regulations.gov/docket/FMCSA-2025-0003/document,</E>
                     click on this notice, click “Comment,” and type your comment into the text box on the following screen.
                </P>
                <P>
                    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
                    <FR>1/2</FR>
                     by 11 inches, suitable for copying and electronic filing.
                </P>
                <P>Comments received after the comment closing date will be included in the docket and will be considered to the extent practicable.</P>
                <HD SOURCE="HD1">Privacy Act</HD>
                <P>
                    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its regulatory process. DOT posts these comments, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov</E>
                     as described in the system of records notice DOT/ALL 14 (Federal Docket Management System (FDMS)), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices.</E>
                     The comments are posted without edits and are searchable by the name of the submitter.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>On July 12, 2005, FMCSA published a final rule titled “Transportation of Household Goods; Consumer Protection Regulations,” (70 FR 39949), which specifies how motor carriers transporting household goods by motor vehicle in interstate commerce must assist their individual customers who ship household goods. The collected information encompasses that which is generated, maintained, and provided to, or for, the Agency under 49 CFR part 375.</P>
                <P>On August 10, 2005, the President signed into law the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users ((SAFETEA-LU), Pub. L. 109-59, 119 Stat. 1144, Aug. 10, 2005). The Agency consequently revised this ICR to address these statutory impacts in a final rule titled “Amendments to Implement Certain Provisions of the Safe, Accountable, Flexible, Efficient Transportation Act: A Legacy for Users (SAFETEA-LU)” (72 FR 36760, July 5, 2007). Section 4205 of SAFETEA-LU amended 49 U.S.C. 14104(b) by requiring the household goods motor carrier to conduct a physical survey of the household goods to be transported on behalf of the individual shipper. The carrier must then provide the shipper with a written estimate, based on the physical survey, of charges for the transportation and all related services.</P>
                <P>On July 16, 2012, FMCSA published a direct final rule titled “Transportation of Household Goods in Interstate Commerce; Consumer Protection Regulations: Household Goods Motor Carrier Record Retention Requirements” (77 FR 41699) that amended the regulations governing the period during which household goods motor carriers must retain documentation of an individual shipper's waiver of receipt of printed copies of consumer protection materials. In the rulemaking, FMCSA reduced the 3-year required retention period for those receipts to one year. This change harmonizes the retention period with other document retention requirements applicable to household goods motor carriers. FMCSA also amended the regulations to clarify that a household goods motor carrier is not required to retain waiver documentation from any individual shippers for whom the carrier does not actually provide services.</P>
                <P>On April 26, 2022, FMCSA updated the regulations at 49 CFR parts 371 and 375 in a final rule titled “Implementation of Household Goods Working Group Recommendations” (87 FR 24431). The final rule made various changes to the household goods regulations that the Household Goods Consumer Protection Working Group recommended to FMCSA. These changes include further revisions to streamline FMCSA's publication “Your Rights and Responsibilities When You Move,” which are incorporated in Appendix A of the regulations, requiring “Your Rights and Responsibilities When You Move” to be provided along with the estimate, requiring new binding or non-binding estimates when an individual shipper tenders more goods or requests additional service instead of a revised estimate as previously required, allowing a motor carrier to provide a virtual survey and removing the 50-mile radius for when a survey is required, removing the requirement for an order for service and incorporating that document into the bill of lading, as well as other minor updates to increase the clarity of the regulations. These changes are intended to reduce the paperwork burden on household goods motor carriers and reduce confusion for individual shippers.</P>
                <P>
                    The complete collection of information required by the referenced final rules assists household goods shippers in their business dealings with interstate household goods motor carriers. The information collected is used by prospective household goods shippers to make informed decisions about contracts and services ordered, executed, and settled. The household goods motor carrier is often the final contact for individual shippers and is in the best position to educate and assist household goods shippers during their move. This information collection is intended to combat deceptive business practices by requiring household goods motor carriers to conduct physical surveys of shippers' items to be transported unless waived in writing by the shipper. This information collection is intended to combat deceptive business practices by requiring the household goods motor carrier to prepare an inventory of the goods shipped and a bill of lading for each shipment. This information collection also requires motor carriers to obtain weight tickets for each shipment. This information collection requires household goods motor carriers to generate and maintain additional documents associated with the status of shipment delays and to furnish shippers, upon request, the records of contact regarding delays. This information collection requires 
                    <PRTPAGE P="3997"/>
                    household goods motor carriers to keep written or electronic records of all complaints received from shippers. This information collection helps enforcement personnel better protect consumers by verifying that shippers are receiving information as required by regulations.
                </P>
                <P>FMCSA revises the total annual burden to 3,722,704 hours. This is an increase of 14,609 annual burden hours from the currently approved 3,708,095 burden estimates. The increase is due to an increase in Agency estimates.</P>
                <P>
                    <E T="03">Title:</E>
                     Transportation of Household Goods; Consumer Protection.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2126-0025.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Renewal of a currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Household goods motor carriers.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     7,861.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     Varies.
                </P>
                <P>
                    <E T="03">Expiration Date:</E>
                     July 31, 2025.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden:</E>
                     3,722,704 hours. The estimated total annual burden was calculated using the hourly burden for each of the five Information Collections.
                </P>
                <P>
                    <E T="03">Public Comments Invited:</E>
                     You are asked to comment on any aspect of this information collection, including: (1) whether the proposed collection is necessary for the performance of FMCSA's functions; (2) the accuracy of the estimated burden; (3) ways for FMCSA to enhance the quality, usefulness, and clarity of the collected information; and (4) ways that the burden could be minimized without reducing the quality of the collected information. The Agency will summarize or include your comments in the request for OMB's clearance of this ICR.
                </P>
                <SIG>
                    <P>Issued under the authority of 49 CFR 1.87.</P>
                    <NAME>Thomas P. Keane,</NAME>
                    <TITLE>Associate Administrator, Office of Research and Registration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00819 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2024-0004]</DEPDOC>
                <SUBJECT>Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators (ICDs)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of applications for exemption; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>FMCSA announces receipt of applications from two individuals for an exemption from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against operation of a commercial motor vehicle (CMV) by persons with a current clinical diagnosis of myocardial infarction, angina pectoris, coronary insufficiency, thrombosis, or any other cardiovascular disease of a variety known to be accompanied by syncope (transient loss of consciousness), dyspnea (shortness of breath), collapse, or congestive heart failure. If granted, the exemptions would enable these individuals with ICDs to operate CMVs in interstate commerce.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2024-0004 using any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">www.regulations.gov/,</E>
                         insert the docket number (FMCSA-2024-0004) in the keyword box and click “Search.” Next, sort the results by “Posted (Newer-Older),” choose the first notice listed, and click on the “Comment” button. Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Dockets Operations; U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Washington, DC 20590-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         West Building Ground Floor, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal Holidays.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section for instructions on submitting comments.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001, 
                        <E T="03">fmcsamedical@dot.gov.</E>
                         Office hours are from 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Dockets Operations, (202) 366-9826.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <HD SOURCE="HD2">A. Submitting Comments</HD>
                <P>If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2024-0004), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.</P>
                <P>
                    To submit your comment online, go to 
                    <E T="03">www.regulations.gov/docket?D=FMCSA-2024-0004</E>
                    . Next, sort the results by “Posted (Newer-Older),” choose the first notice listed, click the “Comment” button, and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.
                </P>
                <P>
                    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
                    <FR>1/2</FR>
                     by 11 inches, suitable for copying and electronic filing. FMCSA will consider all comments and material received during the comment period.
                </P>
                <HD SOURCE="HD2">B. Viewing Comments</HD>
                <P>
                    To view comments go to 
                    <E T="03">www.regulations.gov.</E>
                     Insert the docket number (FMCSA-2024-0004) in the keyword box and click “Search.” Next, sort the results by “Posted (Newer-Older),” choose the first notice listed, and click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                </P>
                <HD SOURCE="HD2">C. Privacy Act</HD>
                <P>
                    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov.</E>
                     As described in the system of records notice DOT/ALL 14 (Federal Docket Management System), which can be reviewed at 
                    <PRTPAGE P="3998"/>
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices,</E>
                     the comments are searchable by the name of the submitter.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.</P>
                <P>The two individuals listed in this notice have requested an exemption from § 391.41(b)(4). Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.</P>
                <P>The physical qualification standard found in § 391.41(b)(4) states that a person is physically qualified to drive a CMV if that person has no current clinical diagnosis of myocardial infarction, angina pectoris, coronary insufficiency, thrombosis, or any other cardiovascular disease of a variety known to be accompanied by syncope, dyspnea, collapse, or congestive cardiac failure.</P>
                <P>
                    In addition to the regulations, FMCSA has published advisory criteria 
                    <SU>1</SU>
                    <FTREF/>
                     to assist medical examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. The advisory criteria states that ICDs are disqualifying due to risk of syncope.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         These criteria may be found in 49 CFR part 391, Appendix A to Part 391—Medical Advisory Criteria, Section D. Cardiovascular: § 391.41(b)(4), paragraph 4, which is available on the internet at 
                        <E T="03">https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Qualifications of Applicants</HD>
                <HD SOURCE="HD2">Micos Mims</HD>
                <P>Micos Mims is a class A commercial driver's license (CDL) holder in Alabama. An August 21, 2023 letter from Micos Mims' cardiologist reports that their ICD was implanted on March 6, 2023, due to heart failure. Micos Mims' cardiologist also reports no instances of the ICD deploying and has not experienced any symptoms concerning the device.</P>
                <HD SOURCE="HD2">Paul Siefker</HD>
                <P>Paul Siefker is a class D driver's license holder in Ohio. A November 26, 2024 letter from Paul Siefker's cardiologist reports that their ICD/pacemaker combination device was implanted on July 6, 2020, due to ventricular tachycardia, syncope, atrioventricular node dysfunction, history of coronary artery disease and percutaneous coronary intervention to the left main coronary artery. Paul Siefker's cardiologist also reports no shocks received or recorded, however, Paul Siefker has received three anti-tachycardia pacing therapies for three ventricular tachycardia episodes.</P>
                <HD SOURCE="HD1">IV. Request for Comments</HD>
                <P>
                    In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated under the 
                    <E T="02">DATES</E>
                     section of the notice.
                </P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00749 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2013-0444; FMCSA-2015-0323; FMCSA-2018-0052; FMCSA-2018-0054; FMCSA-2020-0050; FMCSA-2022-0045]</DEPDOC>
                <SUBJECT>Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of final disposition.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>FMCSA announces its decision to renew exemptions for eight individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates provided below.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001, 
                        <E T="03">fmcsamedical@dot.gov.</E>
                         Office hours are from 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Dockets Operations, (202) 366-9826.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <HD SOURCE="HD2">A. Viewing Comments</HD>
                <P>
                    To view comments go to 
                    <E T="03">www.regulations.gov.</E>
                     Insert the docket number (FMCSA-2013-0444, FMCSA-2015-0323, FMCSA-2018-0052, FMCSA-2018-0054, FMCSA-2020-0050, or FMCSA-2022-0045) in the keyword box and click “Search.” Next, sort the results by “Posted (Newer-Older),” choose the first notice listed, and click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                </P>
                <HD SOURCE="HD2">B. Privacy Act</HD>
                <P>
                    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov.</E>
                     As described in the system of records notice DOT/ALL 14 (Federal Docket Management System), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices,</E>
                     the comments are searchable by the name of the submitter.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>
                    On December 3, 2024, FMCSA published a notice announcing its decision to renew exemptions for eight individuals from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV in interstate commerce and requested comments from the public (89 FR 
                    <PRTPAGE P="3999"/>
                    95899). The public comment period ended on January 2, 2025, and no comments were received.
                </P>
                <P>FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved by complying with § 391.41(b)(8).</P>
                <P>The physical qualification standard for drivers regarding epilepsy found in § 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.</P>
                <P>
                    In addition to the regulations, FMCSA has published advisory criteria 
                    <SU>1</SU>
                    <FTREF/>
                     to assist medical examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         These criteria may be found in APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. 
                        <E T="03">Epilepsy:</E>
                         § 391.41(b)(8), paragraphs 3, 4, and 5, which is available on the internet at 
                        <E T="03">https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Discussion of Comments</HD>
                <P>FMCSA received no comments in this proceeding.</P>
                <HD SOURCE="HD1">IV. Conclusion</HD>
                <P>Based on its evaluation of the eight renewal exemption applications and comments received, FMCSA announces its decision to exempt the following drivers from the epilepsy and seizure disorders prohibition in § 391.41(b)(8). As of December 12, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following seven individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers (89 FR 95899):</P>
                <FP SOURCE="FP-1">Jesse Hansen (MN)</FP>
                <FP SOURCE="FP-1">Thomas Kline (PA)</FP>
                <FP SOURCE="FP-1">Jose Lara-Ramirez (NV)</FP>
                <FP SOURCE="FP-1">Domenick Panfile (NJ)</FP>
                <FP SOURCE="FP-1">Andrew Rieschick (NE)</FP>
                <FP SOURCE="FP-1">Stephen St. Marthe (NC)</FP>
                <FP SOURCE="FP-1">Carsten Thode (WA)</FP>
                <P>The drivers were included in docket number FMCSA-2013-0444, FMCSA-2018-0052, FMCSA-2018-0054, FMCSA-2020-0050, or FMCSA-2022-0045. Their exemptions were applicable as of December 12, 2024 and will expire on December 12, 2026.</P>
                <P>As of December 16, 2024, and in accordance with 49 U.S.C. 31136(e) and 31315(b), Kyle Loney (WA) has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers (89 FR 95899).</P>
                <P>This driver was included in docket number FMCSA- FMCSA-2015-0323. The exemption is applicable as of December 16, 2024, and will expire on December 16, 2026.</P>
                <P>In accordance with 49 U.S.C. 31315(b), each exemption will be valid for 2 years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).</P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00747 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <DEPDOC>[Docket No.: DOT-OST-2024-0129]</DEPDOC>
                <SUBJECT>Waiver of Buy America Requirements for the Pacific Island Territories and the Freely Associated States</SUBJECT>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Transportation (DOT) is finalizing a general applicability public interest waiver of the requirements of section 70914(a) of the Build America, Buy America Act (BABA) and related domestic preference statutes administered by DOT and its Operating Administrations (OAs) for federal financial assistance awarded for infrastructure projects located in the Commonwealth of Northern Mariana Islands (CNMI), Guam, and American Samoa, collectively referred to as the Pacific Island territories. The waiver would also apply to discretionary grant assistance provided by DOT to the Freely Associated States (the Republic of Palau, Republic of the Marshall Islands, and Federated States of Micronesia) in the Pacific that is subject to a domestic preference statute (which does not include BABA, as that statute only applies to the United States and its territories). The waiver will remain in effect for five years after the effective date of the final waiver. This action also terminates the previously issued temporary general applicability waiver for this region.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The waiver is applicable to awards that are obligated on or after January 10, 2025, until January 9, 2030.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For questions about this notice, please contact Elizabeth Fox, DOT Office of the Assistant Secretary for Transportation Policy, at 
                        <E T="03">elizabeth.fox@dot.gov</E>
                         or at 202-366-4540. For legal questions, please contact Jennifer Kirby-McLemore, DOT Office of the General Counsel, 405-446-6883, or via email at 
                        <E T="03">jennifer.mclemore@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The Buy America preferences set forth in section 70914(a) of BABA 
                    <SU>1</SU>
                    <FTREF/>
                     require that all iron, steel, manufactured products, and construction materials used for infrastructure projects in the United States under federal financial assistance awards be produced in the United States.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The Build America, Buy America Act was included as title XI, subtitle A of the Infrastructure Investment and Jobs Act (IIJA) (Pub. L. 117-58).
                    </P>
                </FTNT>
                <P>
                    Under section 70914(b) and in accordance with the Office of Management and Budget (OMB)'s Guidance Memorandum M-24-02, 
                    <E T="03">Implementation Guidance on Application of Buy America Preference in Federal Financial Assistance Programs for Infrastructure,</E>
                     DOT may waive the application of BABA requirements in any case in which it finds that: (i) applying the domestic content procurement preference would be inconsistent with the public interest; (ii) types of iron, steel, manufactured products, or construction materials are not produced in the U.S. in sufficient and reasonably available quantities or of a satisfactory quality; or (iii) the inclusion of iron, steel, manufactured products, or construction materials produced in the U.S. will increase the cost of the overall project by more than 25 percent.
                </P>
                <P>
                    BABA also provides that the preferences under section 70914 apply only to the extent that a domestic content procurement preference as described in section 70914 does not already apply to iron, steel, manufactured products, and construction materials. IIJA § 70917(a)-(b). Federal financial assistance programs administered by DOT's Operating Administrations (OAs) 
                    <SU>2</SU>
                    <FTREF/>
                     are 
                    <PRTPAGE P="4000"/>
                    subject to a variety of mode-specific statutes that apply particular Buy America 
                    <SU>3</SU>
                    <FTREF/>
                     requirements to iron, steel, and manufactured products, including 49 U.S.C. 50101(a) (FAA); 23 U.S.C. 313 (FHWA); 49 U.S.C. 5323(j) (FTA); and 46 U.S.C. 54101(d)(2) (MARAD). Recent annual appropriations acts have also required DOT to apply the Buy American Act (41 U.S.C. chapter 83) to funds appropriated under those acts,
                    <SU>4</SU>
                    <FTREF/>
                     where a mode-specific statute is not in place. These statutes also allow for waivers of the Buy America requirements to be issued when the Department determines that doing so is in the public interest.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         DOT OAs that provide or administer financial assistance covered under this waiver include the Federal Aviation Administration (FAA); Federal Highway Administration (FHWA); Federal Transit 
                        <PRTPAGE/>
                        Administration (FTA); and the Maritime Administration (MARAD).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         In this notice, references to “Buy America” include domestic preference laws referred to “Buy American” that apply to DOT financial assistance programs.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         For example, Section 409 of the Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2024 states that “no funds appropriated pursuant to this Act may be expended by an entity unless the entity agrees that in expending the assistance the entity will comply with sections 2 through 4 of the Act of March 3, 1933 (41 U.S.C. 8301-8305, popularly known as the `Buy American Act').”
                    </P>
                </FTNT>
                <P>DOT and its OAs provide financial assistance to the three Pacific Island territories of Guam, American Samoa, and CNMI through both discretionary grants and allocated programs, including assistance programs for highways and bridges, public transportation, airports, and port facilities. The Freely Associated States (the Republic of Palau, Republic of the Marshall Islands, and Federated States of Micronesia) in the Pacific region are also eligible recipients of discretionary grants under FAA's Airport Improvement Program (AIP).</P>
                <P>During FY 2024, DOT OAs provided more than $132.7 million in financial assistance for at least 20 capital projects in the Pacific Island territories under various programs where infrastructure is an eligible activity and may be subject to BABA or other DOT existing Buy America requirements. DOT also provided $47.6 million in AIP discretionary grants to the Freely Associated States in the Pacific region for 3 projects during that time.</P>
                <P>On April 29, 2024, DOT issued a temporary general applicability waiver of the requirements of Section 70914(a) of BABA and related domestic preference statutes administered by DOT and its OAs. The DOT waiver was part of an interagency effort, led by the OMB, to provide time for DOT and other infrastructure agencies to collect and analyze evidence to determine if a long-term waiver of these requirements is in the public interest and allow time for DOT and its OAs to offer technical assistance to potential assistance recipients in the remote communities in the Pacific Island territories and Freely Associated States.</P>
                <P>During the temporary general applicability waiver period, DOT has worked with OMB's Made in America Office (MIAO) and with other infrastructure agencies to better understand the local manufacturing environment, consider how to best balance the equities for residents of the Pacific Island territories and domestic suppliers, and explore ways to potentially ease supply chain challenges for infrastructure projects in those territories. The Pacific Islands are over 5,000 miles from the mainland United States and must import products via air or sea. These economies have few local heavy manufacturers and largely rely on regional supply chains from east Asia, Australia, and New Zealand. Most goods, equipment, materials, and supplies are imported and rely on shipping with extended timelines and unpredictable shipping cost fluctuations. Moreover, materials sourced from the mainland U.S. lead to additional shipping fees and longer lead times, thus significantly extending construction activity schedules.</P>
                <P>
                    Along with other Federal agencies, DOT has reviewed the U.S. International Trade Commission's 2023 report 
                    <E T="03">U.S.-Pacific Islands Trade and Investment: Impediments and Opportunities,</E>
                     which noted the geographic isolation, high costs of shipping, dependence on imports, regulatory barriers, limited economies of scale, and environmental challenges as persistent barriers that the Pacific Island territories face. Additionally, the lack of available land on the Pacific Island territories creates barriers for developing new manufacturing and assembly facilities. Those infrastructure products readily available and produced locally on the Pacific Islands, such as aggregates and cement products, are mostly statutorily exempt from BABA requirements. For these reasons, the DOT remains concerned that complying with the domestic sourcing requirements may increase already elevated project time and costs.
                </P>
                <P>In considering this waiver, DOT consulted with the relevant Federal assistance programs in the respective OAs, including the regional offices in those agencies that directly administer DOT funding programs in the Pacific Island territories and Freely Associated States. DOT also relied on other communications that it has received from stakeholders in those territories. For example, CNMI and Guam have cited their isolated location in the Western Pacific and reliance on ocean freight as the only mode of transporting commodities to the island as creating significant challenges in obtaining materials from domestic sources, with impacts on both project costs and delivery schedules. The two territories have also indicated that shipping construction materials from the continental United States raises shipping costs by approximately 30 percent above the cost to ship directly to the islands from Asia.</P>
                <P>In August 2024, the U.S. Department of the Interior (DOI) hosted the third Territorial Climate and Infrastructure Workshop in Honolulu, HI, which included many representatives from various territorial agencies and departments. During the workshop, DOI and DOT led a session on the Build America, Buy America Act, during which many participants described the structural challenges the territories face in complying with Buy America requirements and the desire for relief due to the significant cost increases and delays in project timelines that would ensue. In addition, in February 2023, DOI hosted the Interagency Group on Insular Areas, at which the governors of the Territories expressed concerns related to BABA implementation and potential project delays and requested that federal agencies be flexible in these requirements, including consideration of waivers.</P>
                <P>Additionally, representatives from American Samoa have indicated to the Federal Emergency Management Agency that “As a containerized community, our territories depend on goods, equipment, materials, and supplies to be imported.” They further stated that “we can purchase equipment from foreign countries closer to American Samoa and with reasonable prices and shorter shipping time.” American Samoa representatives also noted that availability of materials from nearby foreign countries such as New Zealand and Australia would result in a significant cost savings to the grantors.</P>
                <HD SOURCE="HD1">Issuance of Waiver and Discussion of Comments Received</HD>
                <P>
                    On December 16, 2024, DOT published a proposed Buy America waiver for projects located within Pacific Island territories of CNMI, Guam, or American Samoa and funded under DOT-administered financial assistance programs in the 
                    <E T="04">Federal Register</E>
                     (89 FR 101688). DOT received 12 comments on the proposed waiver from individuals and government representatives in both the Pacific 
                    <PRTPAGE P="4001"/>
                    Island territories and the Freely Associated States and from the general public, a steel manufacturer, and a trade organization. Ten of the comments received were supportive of the waiver as proposed, while two expressed opposition to the waiver.
                </P>
                <P>Supportive comments noted the difficulties in complying with domestic content requirements that the distance from the mainland US creates. Shipping materials from the U.S. mainland incurs additional costs and lengthy delays that, in turn, imperil project timelines and budgets, with one commenter citing cost increases of 50-100%. Supportive commenters also noted that the small size of the infrastructure projects can also create compliance issues noting difficulties contractors face in obtaining Buy America certifications from manufacturers for small orders. Additionally, the length of the waiver was supported by more than one commenter, noting that the time will help entice contractors to bid on their projects and ensure projects are completed on time and on budget.</P>
                <P>One commenter requested that the waiver cover specific types of vehicles and associated infrastructure. DOT appreciates this comment and notes that as the waiver would apply to both manufactured products and iron and steel, vehicles should be covered, regardless of which category they fall into. Another supportive commenter requested that the waiver apply standards to the items procured. DOT notes that the waiver only applies to the domestic content requirements, and that the materials procured must still meet the necessary performance criteria and be suitable for their intended applications, regardless of their manufacturing location.</P>
                <P>One commenter raised concerns that the proposed waiver would result in tax dollars being utilized for the sourcing of iron and steel, manufactured products, and construction materials produced in countries of concern or by entities of concern. The commenter also raised concerns that the proposed waiver would render the territories' projects less resilient because they could foster a reliance on regional, rather than allied trading partners. Though DOT acknowledges this concern, DOT is confident that, through the implementation of existing prohibitions and the exclusion of the specified list of items provided in the waiver, this concern is addressed to the fullest extent possible under available legal authorities. With respect to existing prohibitions, various DOT OAs have prohibitions against use of funds for rolling stock purchases from certain entities found at 49 U.S.C. 5323(u) and 49 U.S.C. 50101(d). This waiver does not impact such prohibitions. Furthermore, DOT notes that the waiver applies only to domestic sourcing requirements; thus, all other restrictions on the use of Federal funding must still be followed, including any funding specific restrictions on purchases outside the Buy American statutes, and any limitations on funding imposed by the notice of funding opportunity or grant agreements. Lastly, the list of products excluded from this waiver was crafted with this concern in mind; accordingly, DOT incorporated this list of excluded products in this waiver to protect against related national security concerns. Taken together, these safeguards will ensure that the Pacific Island territories are able to rely on nearby allied trading partners for their purchases of materials, thereby improving resilience for their critical infrastructure projects.</P>
                <P>One commenter questioned DOT's conclusion that the assessment required under OMB Memorandum M-24-02 regarding dumping or injuriously subsidized products is not applicable to this waiver. To mitigate this concern, DOT has added language noting that the cost considerations driving this public interest waiver are not due to the use of dumped steel, iron, or manufactured products or of injuriously subsidized steel, iron, or manufactured products but rather to the increased costs of shipping domestic items from the mainland U.S.</P>
                <P>
                    A commenter also questioned DOT's authority to issue a waiver for a “deficient program,” as defined in sections 70912 and 70913(c) of BABA. However, DOT notes the identification of a program as “deficient” under the BABA statute does not have any bearing on the agency's ability to issue new waivers of Buy America requirements under the respective statutes applicable to those programs.
                    <SU>5</SU>
                    <FTREF/>
                     The commenter also indicated that they were “unaware of any instance in which the 1933 BAA has been deemed applicable to federally assisted building and infrastructure construction.” DOT notes that provisions included in annual appropriations acts in recent fiscal years provide the basis for applying Buy American Act requirements to financial assistance programs administered by DOT.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         For more discussion of “deficient programs,” see 
                        <E T="03">DOT's Identification of Federal Financial Assistance Infrastructure Programs Subject to the Build America, Buy America Provisions of the Infrastructure Investment and Jobs Act,</E>
                         January 2022, available at 
                        <E T="03">https://www.transportation.gov/office-policy/transportation-policy/made-in-america/build-america-buy-america-60-day-report.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         See, for example, section 409 of the Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2024.
                    </P>
                </FTNT>
                <P>Some of the commenters, both supporting and opposing, either directly or indirectly referenced the temporary waiver issued by DOT on April 29, 2024, apparently viewing the proposed waiver as an extension of that waiver. In the Findings section below, DOT is clarifying that this is a new, longer-duration waiver with a different public interest basis and justification, and the temporary waiver issued April 29, 2024, is being terminated concurrent with issuance of this waiver.</P>
                <P>Finally, one commenter stated that the 15-day comment period on the proposed waiver was insufficient. DOT notes that the comment period provided for this waiver is consistent with the requirements of BABA and related statutes for new Buy America waivers.</P>
                <HD SOURCE="HD1">Finding on Waiver and Termination of Temporary Waiver</HD>
                <P>DOT is using its authority under Section 70914(b)(1) to waive the Act's Buy America preferences for iron and steel, manufactured products, and construction materials used in infrastructure projects located within the Pacific Island territories of CNMI, Guam, or American Samoa and funded under DOT-administered financial assistance programs, on the basis that doing so would be in the public interest. The waiver applies to all awards obligated after the effective date and, in the case of awards obligated prior to the effective date, the waiver applies to all expenditures for non-domestic iron, steel, manufactured products, and construction materials incurred after the effective date. The waiver does not apply to the following products that have been identified by OMB as critical supply chains that warrant special consideration:</P>
                <P>• Telecommunications infrastructure:</P>
                <P>
                    ○ Telecommunications equipment used to transmit and receive digital signals across constructed networks (
                    <E T="03">e.g.,</E>
                     vaults, cabinets, routers, switches, optical line terminals (OLTs), optical network terminals (ONTs), wi-fi capable customer equipment, and other electronic hardware used to connect the network). This includes:
                </P>
                <P>
                     Video surveillance equipment, including any equipment that is used in fixed and mobile networks that provides advanced communications service in the form of a video surveillance service, provided the equipment includes or uses electronic components. This 
                    <PRTPAGE P="4002"/>
                    encompasses any equipment that can be used in a fixed or mobile broadband network to enable users to originate and receive high quality voice, data, graphics, and video telecommunications using technology with connection speeds of at least 200 kbps in either direction.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">https://www.fcc.gov/laboratory-division/equipment-authorization-approval-guide/equipment-authorization-system#step2</E>
                        .
                    </P>
                </FTNT>
                <P>
                     Broadcasting equipment, including radio frequency devices contained in electronic-electrical products that are capable of emitting radio frequency energy by radiation, conduction, or other means. These products have the potential to cause interference to radio services operating in the radio frequency range of 9 kHz to 3000 GHz.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">https://www.fcc.gov/oet/ea/rfdevice</E>
                        .
                    </P>
                </FTNT>
                <P>
                    ○ Broadband equipment (
                    <E T="03">e.g.,</E>
                     fiber/coax cable, conduit, pedestals, handholes, tower structures, and other physical components used to connect to telecommunication equipment).
                </P>
                <P>• Grid-connected utility-scale energy generation and stationary storage (&gt;5MW).</P>
                <P>
                    • Cargo handling equipment, including cranes, that are manufactured by or contain any networks, operating systems, or software identified in U.S. Maritime Advisory 2024-0026 or successor advisories.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         2024-002—Worldwide-Foreign Adversarial Technological, Physical, and Cyber Influence 
                        <E T="03">https://www.maritime.dot.gov/msci/2024-002-worldwide-foreign-adversarial-technological-physical-and-cyber-influence</E>
                        .
                    </P>
                </FTNT>
                <P>While these items are excluded from this general waiver, DOT recognizes that purchases of these items from non-domestic sources as part of a federally-assisted project may be warranted in certain circumstances. For those individual projects, DOT and its OAs will consider requests for potential waivers of BABA or other Buy America requirements on a case-by-case basis, with special attention to any strategic security issues that may be associated with those purchases.</P>
                <P>
                    Separately, DOT also notes that the waiver does not waive the requirements of 49 U.S.C. 50101(d) or 49 U.S.C. 5323(u), or any other requirements for federal financial assistance. Because many DOT-administered financial assistance programs are also subject to program-specific domestic preference requirements, the waiver would also apply to those requirements. Specifically, the waiver would also be an exercise of DOT's authority to issue public interest waivers under 23 U.S.C. 313(b)(1), 49 U.S.C. 5323(j), 46 U.S.C. 54101(d)(2)(B)(i)(I), 49 U.S.C. 50101(b)(1), and 41 U.S.C. chapter 83. Under those DOT authorities, the waiver also applies to projects in the Freely Associated States (the Republic of Palau, Republic of the Marshall Islands, and Federated States of Micronesia).
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         The proposed waiver under section 70914(b)(1) of BABA excludes projects in the Freely Associated States because the requirements under section 70914(a) are applicable only to infrastructure projects “in the United States” and, therefore, the BABA requirements to not apply to projects in the Freely Associated States. However, airports located in the Freely Associated States are eligible recipients under FAA's Airport Improvement Program, and the Buy American requirements specific to that program would thus also apply to the Freely Associated States.
                    </P>
                </FTNT>
                <P>The duration of the waiver will be for five years, from its effective date of January 10, 2025, until January 9, 2030. The Department will periodically review this waiver to assess whether it remains necessary to the fulfillment of DOT's missions and goals and consistent with applicable legal authorities, such as the IIJA, Executive Order 14005, and OMB M-24-02. The Department may, based on the results of that review, terminate the waiver, or take action to develop a new waiver in consultation with the MIAO.</P>
                <P>This action is a new public interest waiver being issued on the basis of the unique circumstances and ongoing challenges faced by the Pacific Island territories and Freely Associated States due to their remote location. Accordingly, effective with the issuance of the new waiver on January 10, 2025, DOT is also terminating the existing temporary general applicability waiver for the Pacific Island Territories, which DOT issued on April 29, 2024, to provide time to collect and analyze evidence to determine if a more targeted waiver of these requirements would be in the public interest.</P>
                <P>Under OMB Memorandum M-24-02, agencies are expected to assess “whether a significant portion of any cost advantage of a foreign-sourced product is the result of the use of dumped steel, iron, or manufactured products or the use of injuriously subsidized steel, iron, or manufactured products” as appropriate before granting a public interest waiver. DOT's analysis has not found that the cost considerations driving this public interest waiver are due to the use of dumped steel, iron, or manufactured products or of injuriously subsidized steel, iron, or manufactured products but rather to the increased costs of shipping domestic items from the mainland U.S.</P>
                <P>Pursuant to Section 117 of the SAFETEA-LU Technical Corrections Act of 2008 (Pub. L. 110-244, 122 Stat. 1572), if FHWA makes a finding that a waiver is appropriate under 23 U.S.C. 313(b), FHWA will also invite public comment on this finding for an additional five days following the date of publication of the finding. Comments received during that period will be reviewed, but the finding will continue to remain valid. Those comments may influence DOT/FHWA's decision to terminate or modify a finding.</P>
                <SIG>
                    <DATED>Issued in Washington, DC, on January 8, 2025.</DATED>
                    <NAME>Polly E. Trottenberg,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00713 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-9X-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>Office of Foreign Assets Control</SUBAGY>
                <SUBJECT>Notice of OFAC Sanctions Action</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Foreign Assets Control, Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        This action was issued on January 10, 2025. See 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         for relevant dates.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        OFAC: Associate Director for Global Targeting, 202-622-2420; Assistant Director for Sanctions Compliance, 202-622-2490 or 
                        <E T="03">https://ofac.treasury.gov/contact-ofac.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Electronic Availability</HD>
                <P>
                    The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's website: 
                    <E T="03">https://ofac.treasury.gov.</E>
                </P>
                <HD SOURCE="HD1">Notice of OFAC Action</HD>
                <P>
                    On January 10, 2025, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
                    <PRTPAGE P="4003"/>
                </P>
                <HD SOURCE="HD1">Individuals</HD>
                <EXTRACT>
                    <P>1. VELASQUEZ ARAGUAYAN, Ramon Celestino, Venezuela; DOB 31 Aug 1971; POB Guanaguana, Venezuela; nationality Venezuela; Gender Male; Cedula No. V-11448109 (Venezuela) (individual) [VENEZUELA].</P>
                    <P>Designated pursuant to section 1(a)(ii)(C) of Executive Order 13692 of March 8, 2015, “Blocking Property and Suspending Entry of Certain Persons Contributing to the Situation in Venezuela,” 80 FR 12747, 3 CFR, 2015 Comp., p. 276 (March 11, 2015) (E.O. 13692), as amended by Executive Order 13857 of January 25, 2019, “Taking Additional Steps To Address the National Emergency With Respect to Venezuela,” 84 FR 509, 3 CFR, 2019 Comp., p. 251 (January 30, 2019) (E.O. 13857), for being a current or former official of the Government of Venezuela.</P>
                    <P>2. OSORIO GUZMAN, Felix Ramon, Venezuela; DOB 05 Oct 1969; POB Maracay, Venezuela; nationality Venezuela; Gender Male; Cedula No. V-9657088 (Venezuela) (individual) [VENEZUELA].</P>
                    <P>Designated pursuant to section 1(a)(ii)(C) of E.O. 13692, as amended by E.O. 13857, for being a current or former official of the Government of Venezuela.</P>
                    <P>3. FERRER SANDREA, Danny Ramon (a.k.a. SANDREA FERRER, Danny Ramon), Venezuela; DOB 23 Sep 1969; POB Caracas, Venezuela; nationality Venezuela; Gender Male; Cedula No. V-10509178 (individual) [VENEZUELA].</P>
                    <P>Designated pursuant to section 1(a)(ii)(C) of E.O. 13692, as amended by E.O. 13857, for being a current or former official of the Government of Venezuela.</P>
                    <P>4. OBREGON PEREZ, Hector Andres, Venezuela; DOB 29 Aug 1983; POB Venezuela; nationality Venezuela; Gender Male; Cedula No. V-17123100 (Venezuela) (individual) [VENEZUELA].</P>
                    <P>Designated pursuant to section 1(a)(ii)(C) of E.O. 13692, as amended by E.O. 13857, for being a current or former official of the Government of Venezuela.</P>
                    <P>5. RICO GONZALEZ, Douglas Arnoldo, Caracas, Venezuela; DOB 15 Jul 1965; alt. DOB 28 Sep 1969; POB Caracas, Venezuela; nationality Venezuela; Gender Male; Cedula No. V-6864238 (Venezuela) (individual) [VENEZUELA].</P>
                    <P>Designated pursuant to section 1(a)(ii)(C) of E.O. 13692, as amended by E.O. 13857, for being a current or former official of the Government of Venezuela.</P>
                    <P>6. SALAZAR BELLO, Jhonny Rafael, Caracas, Venezuela; DOB 13 Nov 1970; POB Carupano, Venezuela; nationality Venezuela; Gender Male; Cedula No. V-10882214 (Venezuela); Passport 077530031 (Venezuela) expires 19 Sep 2018 (individual) [VENEZUELA].</P>
                    <P>Designated pursuant to section 1(a)(ii)(C) of E.O. 13692, as amended by E.O. 13857, for being a current or former official of the Government of Venezuela.</P>
                    <P>7. CASTILLO RENGIFO, Manuel Enrique, Venezuela; DOB 24 Nov 1969; POB Bolivar, Venezuela; nationality Venezuela; Gender Male; Cedula No. V-10049604 (Venezuela) (individual) [VENEZUELA].</P>
                    <P>Designated pursuant to section 1(a)(ii)(C) of E.O. 13692, as amended by E.O. 13857, for being a current or former official of the Government of Venezuela.</P>
                    <P>8. FIGUERA VALDEZ, Jose Ramon, Caracas, Venezuela; DOB 13 Oct 1974; POB Maturin, Venezuela; nationality Venezuela; Gender Male; Cedula No. V-11344561 (Venezuela) (individual) [VENEZUELA].</P>
                    <P>Designated pursuant to section 1(a)(ii)(C) of E.O. 13692, as amended by E.O. 13857, for being a current or former official of the Government of Venezuela.</P>
                </EXTRACT>
                <SIG>
                    <NAME>Lisa M. Palluconi,</NAME>
                    <TITLE>Acting Director, Office of Foreign Assets Control.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00762 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-AL-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <DEPDOC>[OMB Control No. 2900-0208]</DEPDOC>
                <SUBJECT>Agency Information Collection Activity Under OMB Review: Architect-Engineer Fee Proposal and Contractor Production Report</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Procurement Policy and Warrant Management Service (PPS), Office of Procurement Policy, Systems and Oversight, Office of Acquisition and Logistics, Department of Veterans Affairs.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Procurement Policy and Warrant Management Service, Office of Procurement Policy, Systems and Oversight, Office of Acquisition and Logistics, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden, and it includes the actual data collection instrument.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments and recommendations for the proposed information collection should be sent by February 14, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To submit comments and recommendations for the proposed information collection, please type the following link into your browser: 
                        <E T="03">www.reginfo.gov/public/do/PRAMain,</E>
                         select “Currently under Review—Open for Public Comments”, then search the list for the information collection by Title or “OMB Control No. 2900-0208.”
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        VA PRA information: Maribel Aponte, 202-461-8900, 
                        <E T="03">vacopaperworkreduact@va.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title:</E>
                     VA Form 6298, Architect-Engineer Fee Proposal, and VA Form 10101, Contractor Production Report.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2900-0208 
                    <E T="03">https://www.reginfo.gov/public/do/PRASearch</E>
                    .
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     VA Form 6298, Architect-Engineer Fee Proposal—the use of this form is mandatory for obtaining the proposal and supporting cost or pricing data from the contractor and its subcontractor(s) for all architect-engineer (A-E) contracts and orders for design services when the total contract value is estimated to be $50,000 or more. It is also used in obtaining proposals and supporting cost or pricing data for architect engineer services for research study, seismic study, master planning study, construction management, and other related services contracts. VA Form 10101, Contractor Production Report—is used by VA Resident Engineers to monitor contractors' work and verify the work progress reported before payment can be made. The requirement for this information is contained in VA Acquisition Regulation Clause 852.236-79.
                </P>
                <P>
                    An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The 
                    <E T="04">Federal Register</E>
                     Notice with a 60-day comment period soliciting comments on this collection of information was published at 89FR87459, November 1, 2024.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or Households.
                </P>
                <P>
                    <E T="03">Estimated Annual Burden:</E>
                     11,810 hours.
                </P>
                <P>
                    <E T="03">Estimated Average Burden per Respondent:</E>
                     264 minutes.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     644.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <NAME>Maribel Aponte,</NAME>
                    <TITLE>VA PRA Clearance Officer, Office of Enterprise and Integration, Data Governance Analytics, Department of Veterans Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2025-00694 Filed 1-14-25; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
    </NOTICES>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4005"/>
            <PARTNO>Part II</PARTNO>
            <AGENCY TYPE="P"> Department of Treasury</AGENCY>
            <SUBAGY>Internal Revenue Service</SUBAGY>
            <HRULE/>
            <CFR>26 CFR Part 1</CFR>
            <TITLE>Section 45Y Clean Electricity Production Credit and Section 48E Clean Electricity Investment Credit; Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="4006"/>
                    <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
                    <SUBAGY>Internal Revenue Service</SUBAGY>
                    <CFR>26 CFR Part 1</CFR>
                    <DEPDOC>[TD 10024]</DEPDOC>
                    <RIN>RIN 1545-BR17</RIN>
                    <SUBJECT>Section 45Y Clean Electricity Production Credit and Section 48E Clean Electricity Investment Credit</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Internal Revenue Service (IRS), Treasury.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final regulations.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This document sets forth final regulations regarding the clean electricity production credit and the clean electricity investment credit established by the Inflation Reduction Act of 2022. These final regulations provide rules for determining greenhouse gas emissions rates resulting from the production of electricity; petitioning for provisional emissions rates; and determining eligibility for these credits in various circumstances. The final regulations affect all taxpayers that claim the clean electricity production credit with respect to a qualified facility or the clean electricity investment credit with respect to a qualified facility or energy storage technology, as applicable, that is placed in service after 2024.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P/>
                        <P>
                            <E T="03">Effective date:</E>
                             These regulations are effective on January 15, 2025.
                        </P>
                        <P>
                            <E T="03">Applicability dates:</E>
                             For dates of applicability, see §§ 1.45Y-1(e), 1.45Y-2(d), 1.45Y-3(d) 1.45Y-4(e), 1.45Y-5(j), 1.48E-1(e), 1.48E-2(h), 1.48E-3(f), 1.48E-4(j), and 1.48E-5(l).
                        </P>
                    </EFFDATE>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>Maksim Berger, John M. Deininger, Martha M. Garcia, Boris Kukso, Nathaniel Kupferman, and Alexander Scott at (202) 317-6853 (not a toll-free number).</P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">Authority</HD>
                    <P>This Treasury decision amends the Income Tax Regulations (26 CFR part 1) to implement the statutory provisions of sections 45Y and 48E of the Internal Revenue Code (Code). The regulations contained in this Treasury decision are issued by the Secretary of the Treasury or her delegate (Secretary) pursuant to the authority granted under sections 45Y(f), 48E(i) and 7805(a) of the Code (final regulations).</P>
                    <P>Section 45Y(f) provides an express delegation of authority to the Secretary to prescribe rules to implement section 45Y, “including calculation of greenhouse gas emissions rates for qualified facilities and determination of clean electricity production credits under section 45Y.” Section 48E(i) provides an express delegation of authority to prescribe rules “regarding implementation of [section 48E].”</P>
                    <P>Finally, section 7805(a) authorizes the Secretary “to prescribe all needful rules and regulations for the enforcement of [the Code], including all rules and regulations as may be necessary by reason of any alteration of law in relation to internal revenue.”</P>
                    <HD SOURCE="HD1">Background</HD>
                    <P>
                        On August 30, 2023, the Treasury Department and the IRS published a notice of proposed rulemaking and a notice of public hearing (REG-100908-23) in the 
                        <E T="04">Federal Register</E>
                         (88 FR 60018), 
                        <E T="03">corrected in</E>
                         88 FR 73807 (Oct. 27, 2023), and 89 FR 25550 (April 11, 2024), providing guidance on the Prevailing Wage and Apprenticeship (PWA) requirements under sections 30C, 45, 45L, 45Q, 45U, 45V, 45Y, 45Z, 48, 48C, 48E, and 179D (PWA proposed regulations).
                    </P>
                    <P>
                        On November 22, 2023, the Treasury Department and the IRS published a notice of proposed rulemaking and a notice of public hearing (REG-132569-17) in the 
                        <E T="04">Federal Register</E>
                         (88 FR 82188), 
                        <E T="03">corrected in</E>
                         89 FR 2182 (January 12, 2024), proposing rules that would provide guidance under section 48 (section 48 proposed regulations). On February 22, 2024, the Treasury Department and the IRS published a second correction to the proposed regulations in the 
                        <E T="04">Federal Register</E>
                         (89 FR 13293) that re-opened the comment period through March 25, 2024. Among other matters, the section 48 proposed regulations withdrew and reproposed § 1.48-13 of the PWA proposed regulations addressing the PWA requirements under section 48, the rules under section 48(a)(9)(B)(i) related to an energy project with a maximum net output of less than one megawatt of electrical (as measured in alternating current) or thermal energy (One Megawatt Exception), and the recapture rules under section 48(a)(10)(C) related to the prevailing wage requirements. Although the section 48 proposed regulations withdrew certain portions of the PWA proposed regulations, the section 48 proposed regulations incorporated the preamble to the PWA proposed regulations for generally applicable rules.
                    </P>
                    <P>
                        On June 3, 2024, a notice of proposed rulemaking (REG-119283-23) relating to the clean electricity production credit determined under section 45Y (section 45Y credit) and the clean electricity investment credit determined under section 48E (section 48E credit) was published in the 
                        <E T="04">Federal Register</E>
                         (89 FR 47792) proposing amendments to 26 CFR part 1 (proposed regulations). 
                        <E T="03">See</E>
                         the Background and Explanation of Provisions sections of the preamble to the proposed regulations, which is incorporated in this preamble to the extent consistent with the following Summary of Comments and Explanation of Revisions. Additionally, the Treasury Department and the IRS requested comments on the proposed definition of a qualified facility with a maximum net output of less than one megawatt (as measured in alternating current) for purposes of the One Megawatt Exception under section 45Y(a)(2)(B)(i). The proposed regulations incorporated the preamble to the PWA proposed regulations for generally applicable rules.
                    </P>
                    <P>
                        On June 25, 2024, the Treasury Department and the IRS published final regulations (T.D. 9998) in the 
                        <E T="04">Federal Register</E>
                         (89 FR 53184) adopting the PWA proposed regulations (PWA final regulations) with certain modifications and revisions in response to public comments on the PWA proposed regulations. Comments received on generally applicable rules in response to the PWA proposed regulations, including rules that merely referenced section 48 or 48E, are addressed in the PWA final regulations. The preamble to the PWA final regulations explained that comments received regarding the specific PWA requirements related to the One Megawatt Exception under sections 45Y, 48, and 48E, and the recapture rules in section 48(a)(10)(C), whether received in response to the PWA proposed regulations or the section 48 proposed regulations, would be addressed in future guidance. Because proposed § 1.48E-3 of the PWA proposed regulations generally incorporated the rules of proposed § 1.48-13, the PWA final regulations did not include final regulations under section 48E. Proposed § 1.48E-3 of the PWA proposed regulations and the provisions relating to section 48E of the proposed regulations would be addressed in future guidance.
                    </P>
                    <P>
                        On December 12, 2024, the Treasury Department and the IRS published final regulations (T.D. 10015) in the 
                        <E T="04">Federal Register</E>
                         (89 FR 100598) adopting the section 48 proposed regulations, including the rules for the PWA requirements in § 1.48-13 (section 48 final regulations). The Treasury Department and the IRS addressed the comments related to the PWA requirements with respect to section 48 including the One Megawatt Exception 
                        <PRTPAGE P="4007"/>
                        under section 48(a)(9)(B)(i), the recapture rules under section 48(a)(10)(C), and the definition of an energy project in the section 48 final regulations.
                    </P>
                    <P>As described in the Summary of Comments and Explanation of Revisions, this Treasury decision adopts the proposed regulations with certain modifications after full consideration of all comments received, including comments pertaining to the One Megawatt Exception under section 45Y(a)(2)(B)(i) and to issues related to the PWA requirements under section 48E and proposed § 1.48E-3.</P>
                    <HD SOURCE="HD1">Summary of Comments and Explanation of Revisions</HD>
                    <HD SOURCE="HD2">I. Overview</HD>
                    <P>
                        The Treasury Department and the IRS received over 1,800 written comments timely submitted by the August 2, 2024, comment submission deadline, in response to the proposed regulations, which are available for public inspection at 
                        <E T="03">https://www.regulations.gov</E>
                         or upon request. A public hearing was held in person on August 12, 2024, and telephonically on August 13, 2024, at which 36 speakers provided testimony over the two days. After careful consideration of the comments and testimony, the proposed regulations are adopted with modifications as described in this Summary of Comments and Explanation of Revisions.
                    </P>
                    <P>Comments summarizing the statute or the proposed regulations, recommending statutory revisions to sections 45Y and 48E or other statutes, or addressing issues that are outside the scope of this rulemaking (such as revising other Federal regulations and recommending changes to IRS forms) are generally not described in this Summary of Comments and Explanation of Revisions or adopted in these final regulations. In addition to modifications described in this Summary of Comments and Explanation of Revisions, the final regulations also include non-substantive grammatical or stylistic changes to the proposed regulations. Unless otherwise indicated in this Summary of Comments and Explanation of Revisions, provisions of the proposed regulations with respect to which no comments were received are adopted without substantive change.</P>
                    <P>The Treasury Department and the IRS consulted extensively with scientific and technical experts from across the Federal government, including personnel from the Department of Energy (DOE), the Environmental Protection Agency (EPA), and the Department of Agriculture (USDA), in developing and drafting these final regulations. The Treasury Department and the IRS had regular working group meetings with these experts from the time that sections 45Y and 48E were enacted by the Inflation Reduction Act (IRA) through the drafting and publication of the proposed and final regulations. These meetings included discussions on the full range of issues related to determining greenhouse gas emissions rates for the production of electricity, petitioning for provisional emissions rates, and determining eligibility for the section 45Y and 48E credits in various circumstances. These meetings also included comprehensive briefing and full consideration of the issues raised in the comments received on the proposed regulations and proposed § 1.48E-3 of the PWA proposed regulations. In addition, experts from the DOE, the EPA, and the USDA reviewed multiple drafts of the proposed and final regulations in their entirety. The conclusions reached in these final regulations and explained in this Summary of Comments and Explanation of Revisions were deeply informed by these working group meetings and the scientific and technical expertise that was shared in those meetings.</P>
                    <P>For purposes of this preamble, a provision of the proposed regulations, for example, § 1.45Y-1 of the proposed regulations, is referred to as “proposed § 1.45Y-1.”</P>
                    <HD SOURCE="HD2">II. Rules Specific to Section 45Y</HD>
                    <P>Proposed § 1.45Y-1 provided an overview of proposed §§ 1.45Y-1 through 1.45Y-5 and definitions of terms for purposes of proposed §§ 1.45Y-1 through 1.45Y-5, including the terms “combined heat and power system (CHP) property,” “metering device,” “related person,” “unrelated person,” and “qualified facility.”</P>
                    <HD SOURCE="HD3">A. Metering Device</HD>
                    <P>Proposed § 1.45Y-1(a)(5)(i) through (iii) defined, for purposes of section 45Y(a)(1)(A)(ii)(II), the term “metering device;” provided standards for maintaining and operating a metering device for purposes of section 45Y(a)(1)(A)(ii)(II) and proposed § 1.45Y-1(a)(5), including by providing that a metering device should meet certain standards and be properly calibrated, and provided rules related to monitoring and locating the metering device. Proposed § 1.45Y-1(a)(5)(iv) provided examples illustrating the rules provided by proposed § 1.45Y-1(a)(5).</P>
                    <P>Commenters provided feedback on the definition of “metering device.” Two commenters noted that the proposed regulations defined a “metering device” related to “energy revenue metering,” and asserted that metering devices typically measure energy production, not revenue. The commenters recommended revising the term “energy revenue metering” to “energy production metering” in the final regulations.</P>
                    <P>The Treasury Department and the IRS have determined that, because energy revenue metering encompasses energy production measurement as part of its function, the commenters' concern is addressed by the proposed regulations. Therefore, these final regulations adopt the definition of metering device as proposed.</P>
                    <P>Another commenter requested that the final regulations provide clarifications regarding third-party metering requirements. The commenter requested that the Treasury Department and the IRS clarify whether operation of the metering device by a third party could be fully remote, or if the meter owner must be granted access to the site. The commenter further requested that the final regulations clarify whether the meter can be located prior to energy delivery to storage, or whether it must be located at the point of interconnection. Finally, the commenter requested clarification regarding whether the section 45Y credit amount is determined at the point of sale or where the electricity is metered.</P>
                    <P>
                        Section 45Y(a)(1)(A) provides, in part, that the amount of the credit is the kilowatt hours of electricity produced by the taxpayer at a qualified facility and in the case of a qualified facility which is equipped with a metering device which is owned and operated by an unrelated person, sold, consumed or stored by the taxpayer during the taxable year. Proposed § 1.45Y-1(a)(5)(ii) required a metering device to meet the requirements of the American National Standards Institute C12.1-2022 standard, or subsequent revisions, be revenue grade with a +/−0.5% accuracy, and be properly calibrated and maintained in proper working order according to the instructions of its manufacturer. If a metering device satisfies the requirements in § 1.45Y-1(a)(5)(ii), the statutory language of section 45Y(a)(1)(A) would not prevent operation by a third party to be fully remote. As to whether the metering device can be located prior to energy delivery to storage or whether it must be located at the point of interconnection, the location of the meter should not matter provided the meter meets the requirements in § 1.45Y-1(a)(5)(ii). Accordingly, the final regulations adopt 
                        <PRTPAGE P="4008"/>
                        proposed § 1.45Y-1(a)(5) without change, and do not impose a specific location requirement for such metering device based on the lack of such a requirement in the statutory language.
                    </P>
                    <HD SOURCE="HD3">B. Related and Unrelated Persons</HD>
                    <P>Proposed § 1.45Y-1(a)(7) provided a definition of the term “related person” and special rules for the treatment of corporations that are members of a consolidated group (as defined in § 1.1502-1(h)).</P>
                    <P>Proposed § 1.45Y-1(a)(11) provided a definition of the term “unrelated person;” rules for the sales of electricity to individual consumers; and an example illustrating the application of these rules.</P>
                    <P>A commenter requested clarification regarding the sale to an unrelated person requirement. The commenter pointed to Notice 2008-60, 2008-30 I.R.B. 178, which provides guidance on the section 45 credit by clarifying that the requirement of a sale to an unrelated person will be treated as satisfied if the producer of electricity sells electricity to a related person for resale by the related person to a person that is not related to the producer. The commenter requested that the Treasury Department and the IRS likewise confirm that under section 45Y, a sale to a related person for the purposes of resale to an unrelated person will also be treated as a sale to an unrelated person if there is no metering device owned and operated by a third party.</P>
                    <P>The Treasury Department and the IRS disagree that the rule in Notice 2008-60 that is applicable to the section 45 credit, under which the sale of electricity to a related party with a subsequent sale to an unrelated party is treated as a sale to an unrelated party, should apply to the section 45Y credit. Section 45 does not include a provision similar to section 45Y(a)(1)(A)(ii), which provides that either (I) a taxpayer must sell the electricity to an unrelated party, or (II) the taxpayer's qualified facility must be equipped with a metering device owned and operated by an unrelated person, and the electricity must be sold, consumed or stored by the taxpayer during the taxable year. The inclusion of section 45Y(a)(1)(A)(ii) demonstrates that Congress intended to allow the section 45Y credit for related party sales only if the taxpayer produces electricity at a qualified facility that has a metering device owned and operated by an unrelated person. Congress did not carve out an exception for related party sales for purposes of resale to unrelated persons and the final regulations cannot create one. To allow taxpayers to apply the concepts provided in Notice 2008-60 to the section 45Y credit for sales to unrelated parties would undermine the metering obligation in section 45Y(a)(1)(A)(ii)(II). Accordingly, the Treasury Department and the IRS cannot adopt the commenter's recommendation and the rule will be adopted as proposed.</P>
                    <HD SOURCE="HD3">C. Credit Phase Out</HD>
                    <P>Proposed § 1.45Y-1(c) provided rules for calculating the amount of the credit under section 45Y(a) and the applicable phase-out percentages; defined the term “applicable year” and provided rules for determining the applicable year, including rules regarding the use of certain datasets in determining the applicable year. The definition of “applicable year” also applies for purposes of the section 48E credit phase-out rules. In the preamble to the proposed regulations, the Treasury Department and the IRS requested comments on which datasets are most appropriate to determine the applicable year and why.</P>
                    <P>Commenters generally agreed with the Treasury Department and the IRS that the Energy Information Administration's (EIA) Electric Power Annual and Monthly Energy Review, the EPA Inventory of U.S. Greenhouse Gas Emissions and Sinks (GHGI), the EPA Greenhouse Gas Reporting Program (GHGRP), and the Emissions and Generation Resource Integrated Database (eGrid) are suitable datasets to determine the applicable year and recommended the final rules adopt one or more of these dataset(s) as providing the timeliest assessment of emissions to minimize potential confusion. One commenter suggested using a single annually published government data source, and recommended the EIA Monthly Energy Review that delineates electricity sector greenhouse gas (GHG) emissions for 2022 and the following years.</P>
                    <P>Review of the comments confirmed that the EIA Electric Power Annual and the EPA GHGI are well-established data sources that are representative of the annual GHG emissions from the production of electricity in the United States. Moreover, the requirement in § 1.45Y-1(c)(4) that both the EIA Electric Power Annual and the EPA GHGI must be assessed separately increases certainty that emissions from the power sector meet the required levels.</P>
                    <P>Another commenter requested that the Treasury Department and the IRS consider whether a single year drop in GHG emissions of less than the applicable year threshold followed by GHG emissions increases in subsequent years should trigger the phase-out of the credits.</P>
                    <P>Section 45Y(d)(3) describes the term “applicable year” as the later of 2032, or the calendar year in which the Secretary determines that the annual GHG emissions from the production of electricity in the United States are equal to or less than 25 percent of the annual GHG emissions from the production of electricity in the United States for calendar year 2022. Section 45Y(d)(2) provides that the section 45Y credit phases out over a four-year period subsequent to the applicable year. The statutory language describes the applicable year as a single year, and the credit phase-out begins subsequent to the applicable year. Based on the statutory language, the phase-out period is a continual period. Therefore, the statutory language does not grant the Treasury Department and the IRS authority to reverse a determination that GHG emissions were at a sufficient level to meet the definition of the applicable year. For this reason, the comment is not adopted.</P>
                    <HD SOURCE="HD3">D. Qualified Facility</HD>
                    <P>The proposed regulations adopted the statutory definition of a “qualified facility.” Section 45Y(b)(1)(A) provides, in part, that a qualified facility is a facility for which the GHG emissions rate is not greater than zero. The GHG emissions rate is further defined in section 45Y(b)(2). Section 45Y(b)(1)(B) provides that a facility is only treated as a qualified facility during the 10-year period beginning on the date the facility was originally placed in service.</P>
                    <P>A commenter asked for clarification regarding changes to a facility that impact its GHG emissions rate from electricity generation and whether such changes impact a qualified facility's credit eligibility. The commenter requested confirmation that a facility that initially operates with greater than zero GHG emissions but later operates with not greater than zero GHG emissions can still be considered a qualified facility under section 45Y. The commenter suggested clarifying that in the case of such a facility, the 10-year credit period begins when the facility first becomes a “qualified facility” operating at commercial scale with not greater than zero GHG emissions. The commenter asserted that providing a different interpretation would disincentivize facilities that are built with the capacity to produce power with greater than zero GHG emissions from undertaking such investment.</P>
                    <P>
                        The Treasury Department and the IRS note that section 45Y(b)(1)(B) treats a facility as a qualified facility only 
                        <PRTPAGE P="4009"/>
                        during the 10-year period beginning on the date the facility was originally placed in service. Generally, a qualified facility is considered placed in service in the earlier of (i) the taxable year in which, under the taxpayer's deprecation practice, the period for depreciation with the respect to such property begins; or (ii) the taxable year in which the qualified facility is placed in a condition or state of readiness and availability to produce electricity, whether in a trade or business or in the production of income. Accordingly, a facility that initially operates with greater than zero GHG emissions may later be treated as a qualified facility if it meets the requirements under section 45Y(b) in a taxable year, but only during the 10-year period beginning on the date the facility was originally placed in service. For example, taxpayer places in service a facility in year 1 that has GHG emission that are greater than zero. In year 6, the facility has GHG emissions that are not greater than zero and is a qualified facility under section 45Y. If the facility continues to have not greater than zero GHG emissions, the facility continues to be a qualified facility under section 45Y and taxpayer may claim the section 45Y credit until year 10 (years 6 through 10), provided the facility continues to have not greater than zero GHG emissions for each of the remaining years. The Treasury Department and the IRS cannot adopt the commenter's recommendation and the rule will be adopted as proposed.
                    </P>
                    <P>
                        A commenter asserted that a facility qualifying for a section 45Y credit should not cease to be a qualified facility if, for a limited time or in a limited amount, it has a GHG emissions rate above zero (for example, as a result of a temporary change in fuel or feedstock). The commenter referenced Notice 2008-60, which it described as allowing the use of minimal fossil fuels for flame startup and stabilization in an open-loop biomass facility that qualifies under section 45. The commenter stated that zero-carbon fuels are not always available. The commenter emphasized that the proposed regulations under section 48E, in contrast to those under section 45Y, provide flexibility for purposes of recapture for those facilities that produce 10 grams of CO
                        <E T="52">2</E>
                        e per kWh. As a result, the commenter requested that the final regulations allow a facility to claim the section 45Y credit for the days or months of the year during which the facility produces electricity with a GHG emissions rate of zero. The commenter asserted that flexibility is needed for de minimis emissions or periods during the tax year.
                    </P>
                    <P>Section 45Y(b)(1)(A) defines a qualified facility as having a GHG emissions rate from the production of electricity of not greater than zero. The statute does not provide a de minimis exception and the final regulations cannot create one. Accordingly, a facility cannot qualify for the section 45Y credit in a taxable year during the 10-year credit period after such facility is originally placed in service if such facility has a GHG emissions rate from the production of electricity of greater than zero, even if for a limited time or in a limited amount. However, the Treasury Department and the IRS note that a facility's failure to qualify for the section 45Y credit in one or more taxable years does not prevent such facility from qualifying for the section 45Y credit in any other taxable years during the 10-year credit period after such facility is originally placed in service. The statute allows a facility a 10-year credit period from the date the facility is originally placed in service, and a facility can be considered a qualified facility for any taxable year during such 10-year credit period in which it satisfies the requirements of the section 45Y credit.</P>
                    <HD SOURCE="HD3">E. Combined Heat and Power (CHP) Property</HD>
                    <P>Proposed § 1.45Y-1(a)(2) defined “combined heat and power (CHP) property.” Proposed § 1.45Y-1(d) set forth the credit eligibility requirements for CHP property; provided rules for determining the energy efficiency percentage of CHP property and for calculating electricity produced by CHP property; and defined the term “heat rate” and provided rules for its calculation.</P>
                    <P>Section 45Y(g)(2) generally provides special rules for the calculation of the credit with respect to CHP property. Section 45Y(g)(2)(A)(i) states that “the kilowatt hours of electricity produced by a taxpayer at a qualified facility shall include any production in the form of useful thermal energy by any combined heat and power system property within such facility.” Section 45Y(g)(2)(A)(i) requires the thermal energy output from a CHP property to be included in determining the energy that qualifies for the credit in contrast to a non-CHP facility, for which only the electricity generation should be credited. For example, if a CHP property produces 1 kWh of electricity output and 1 kWh of thermal output, then the taxpayer that owns the CHP property may compute a credit based on production of 2 kWh of electricity.</P>
                    <P>Section 45Y(g)(2)(B) provides that the term “combined heat and power property” has the same meaning given such term by section 48(c)(3) (without regard to subparagraphs (A)(iv), (B), and (D) thereof). Section 48(c)(3)(C)(i) and proposed § 1.45Y-1(d)(2) define the energy efficiency percentage for purposes of a CHP property as a fraction—(I) the numerator of which is the total useful electrical, thermal, and mechanical power produced by the system at normal operating rates, and expected to be consumed in its normal application, and (II) the denominator of which is the lower heating value of the fuel sources for the system. Section 45Y(g)(2)(C)(ii) provides that the term “heat rate” means the amount of energy used by the qualified facility to generate 1 kilowatt hour of electricity, expressed as British thermal units per net kilowatt hour generated. Proposed § 1.45Y-1(d)(3)(ii) addressed how to determine the “heat rate” for a qualified facility that includes CHP property that uses combustion. In the preamble to the proposed regulations, the Treasury Department and the IRS requested comments regarding the application of the energy efficiency percentage requirements to CHP property for which there is no combustion and whether the statutory definition of “heat rate” for this property should be further clarified in the final regulations.</P>
                    <P>One commenter addressed the application of the energy efficiency percentage requirements to CHP property involving nuclear power and recommended the final regulations adopt the EIA's definition of “heat content” as a substitute for the lower heating value used to calculate the energy efficiency of a CHP property. The commenter emphasized that the lower heating value usually applies to combustion fuels, not fuels such as uranium that are non-combustible, and for non-combustion fuels the lower heating value should be the same as the heat content. Another commenter made a similar request that the final regulations permit the use of a nuclear reactor's maximum licensed thermal output to serve as the functional equivalent of the lower heating value of fuel sources, in recognition that nuclear fission does not involve combustion.</P>
                    <P>
                        A separate commenter requested the final regulations establish a methodology for taxpayers to determine the energy efficiency percentage for CHP property using non-combustible fuel sources for which there is no lower heating value. With respect to the definition of heat rate, the commenter asserted that the methodology in proposed § 1.45Y-1(d)(3)(ii)(B) to calculate heat rate does not take into account that there is no lower heating 
                        <PRTPAGE P="4010"/>
                        value for CHP property using non-combustible fuel sources. The commenter further questioned the accuracy of the formula for converting from BTU to kWh to calculate electricity produced by CHP property because the formula relies upon a definition of heat rate that does not account for CHP property using non-combustion fuel sources. The commenter recommended providing a conversion formula in the final regulations for CHP property using non-combustion fuel sources.
                    </P>
                    <P>The Treasury Department and the IRS recognize there is a gap in the current guidance regarding how to calculate the energy efficiency percentage and heat rate for fuels without lower heating values as referenced in section 48(c)(3)(C)(i)(II) and the proposed methodology in proposed § 1.45Y-1(d)(3)(ii)(B). The lower heating value is intended to provide a measure for the energy released when a fuel is combusted under certain conditions. Fuels that are not combusted will not have a lower heating value, but the amount of energy such fuels could release under certain conditions can still be measured.</P>
                    <P>The Treasury Department and the IRS agree with commenters that the final regulations should permit the use of a nuclear reactor's thermal output to serve as the functional equivalent of the lower heating value of fuel sources, in recognition that nuclear fission does not involve combustion. The final regulations are amended accordingly. With respect to other technologies, the Treasury Department and the IRS will continue to consult with experts in order to develop additional approaches that are either generally applicable or appropriate for other particular technologies. The final regulations are therefore also amended to reflect this continuing consideration and to provide flexibility to prescribe these additional approaches in guidance published in the Internal Revenue Bulletin. Section 1.45Y-1(d)(2) and (d)(3)(ii)(B) of the final regulations are revised accordingly.</P>
                    <P>In addition, for organizational purposes, the definition under proposed § 1.45Y-1(a)(2) of a unit of a qualified facility for purposes of CHP property, has been moved within the definition of a unit of a qualified facility under § 1.45Y-2(b)(2)(i).</P>
                    <HD SOURCE="HD3">F. 80/20 Rule</HD>
                    <P>The 80/20 Rule is designed to broaden the availability of investment and production tax credits by providing a new original placed in service date for a qualified facility that includes some components of property previously placed in service, rather than requiring the qualified facility to be composed entirely of new components of property. In the context of section 45Y, the 80/20 Rule applies at the qualified facility level to the components of property within the unit of qualified facility. Proposed § 1.45Y-4(d)(1) provided that for purposes of section 45Y(b)(1)(B), a facility may qualify as originally placed in service even if it contains some used components of property within the unit of qualified facility, provided the fair market value of the used components of the unit of qualified facility is not more than 20 percent of the total value of the unit of qualified facility (that is, the cost of the new components of property plus the fair market value of the used components of property within the unit of qualified facility).</P>
                    <P>Although this section focuses on the 80/20 Rule in the section 45Y context, section III.E. of this Summary of Comments and Explanation of Revisions describes some comments received on both sections 45Y and 48E. This includes discussion of the interaction between the rule for addition of a new unit or an addition of capacity (Incremental Production Rule) and the 80/20 Rule. As described in that section, the Treasury Department and the IRS agree that the statutory provisions allowing for new units and additions of capacity provided in sections 45Y(b)(1)(C) and 48E(b)(3)(B)(i) are separate and distinct from the 80/20 Rule. If a retrofitted facility satisfies the 80/20 Rule, the final regulations provide that the facility will be treated as newly placed in service even if the taxpayer also satisfies the provisions regarding new units and additions of capacity. These final regulations provide an additional example, in § 1.45Y-4(c)(5)(v) that specifically addresses decommissioned and restarted facilities. In response to a comment, the Treasury Department and the IRS removed the reference to a decommissioned nuclear facility in Example 3 in § 1.45Y-4(c)(6)(iii) to avoid referring to decommissioned and restarted nuclear facilities in the additions of capacity rule and the 80/20 Rule. Additionally, § 1.45Y-4(d)(1) is clarified to confirm that a qualified facility that meets the requirements of section 45Y(b)(1)(A) may claim the full section 45Y credit rather than the credit resulting from the addition of a new unit or an addition of capacity.</P>
                    <P>While commenters generally supported the need for the 80/20 Rule for the section 45Y credit, commenters also asked for clarity regarding the application of the 80/20 Rule. A commenter requested clarification that a facility that previously qualified for a credit under section 45 or 48 and is later retrofitted may be eligible for a section 45Y or 48E credit if it satisfies the 80/20 Rule. The Treasury Department and the IRS agree that if a qualified facility under section 45 or an energy property under section 48 is later retrofitted in a manner that satisfies the 80/20 Rule, it will be considered a new qualified facility and may be eligible for a section 45Y or 48E credit so long as the qualified facility meets all requirements of section 45Y or 48E.</P>
                    <P>Another commenter generally stated that under Notice 2018-59, 2018-28 I.R.B. 196, the 80/20 Rule applies at the property level and not the project or system level. The commenter requested that the 80/20 Rule similarly only apply at the property level for the section 45Y credit. In response to this comment, the Treasury Department and the IRS confirm that for purposes of the section 45Y credit, the 80/20 Rule does not apply to a project or system but instead to a qualified facility. Proposed § 1.45Y-4(d)(1) set forth the 80/20 Rule for purposes of the section 45Y credit and applies the rule to a retrofitted qualified facility. The 80/20 Rule applies at the qualified facility level to the components of property within the unit of qualified facility. The final regulations retain this application of the 80/20 Rule to the section 45Y credit.</P>
                    <P>
                        Another commenter requested clarification regarding how the 80/20 Rule is applied for purposes of section 45Y by comparing its application to section 48E. The commenter pointed out that proposed § 1.48E-4(c)(4) looked only to functionally interdependent components of property (and not integral property) to determine what is considered new components of the unit of qualified facility, while proposed § 1.45Y-4(d) did not. This commenter requested clarification regarding which components are included in the determination under the 80/20 Rule for purposes of the section 45Y credit. Similarly, another commenter recommended that the final regulations define a “unit of qualified facility” as the specific components necessary for the production of electricity and not the integral property essential to the completeness of that function. With respect to dam-based hydropower facilities, another commenter supported proposed § 1.45Y-4(d) permitting existing dam-based hydroelectric facilities to qualify for the 80/20 Rule. The commenter asked to confirm that the 80/20 Rule is applied on a turbine-by-turbine basis and not the whole facility, because individual turbines may be repowered separately. As noted 
                        <PRTPAGE P="4011"/>
                        earlier, the 80/20 Rule applies at the qualified facility level to the components of property within the unit of qualified facility and therefore in the context of a hydropower facility the 80/20 Rule cannot be applied on a turbine-by-turbine basis.
                    </P>
                    <P>The Treasury Department and the IRS decline to modify the proposed rule in response to these requests for specific applications to particular technologies. Proposed § 1.45Y-2(b)(2)(i) provided that for purposes of the section 45Y credit, the unit of qualified facility includes all functionally interdependent components of property (as defined in proposed § 1.45Y-2(b)(2)(ii)) owned by the taxpayer that are operated together and that can operate apart from other property to produce electricity.</P>
                    <P>Proposed §§ 1.45Y-4(d)(2) and 1.48E-4(c)(3) both provided that the cost of new components of the unit of qualified facility includes all costs properly included in the depreciable basis of the new components of property of the unit of qualified facility. Under both proposed §§ 1.45Y-2(b)(2) and 1.48E-2(b)(2), a unit of qualified facility only includes functionally interdependent components of property and not integral property. Thus, the Treasury Department and the IRS agree with the commenter that only functionally interdependent property is taken into account to determine whether a retrofitted qualified facility satisfies the 80/20 Rule for purposes of sections 45Y and 48E. Proposed § 1.48E-4(c)(4) provided a rule allowing costs for integral property to be included in determining the section 48E credit after it has been determined that the qualified facility has satisfied the 80/20 Rule. Because the section 45Y credit is a production tax credit calculated based on electricity produced and not the amount of investment in the qualified facility, there is no need for a rule similar to proposed § 1.48E-4(c)(4) in the final regulations under section 45Y.</P>
                    <HD SOURCE="HD2">III. Rules Specific to Section 48E</HD>
                    <P>
                        Proposed § 1.48E-1(b)(1) provided rules for determining the amount of the credit; defined the term “applicable percentage;” and explained how to determine the applicable percentage for a qualified facility. Proposed § 1.48E-1(c) provided the credit phase-out rules and proposed § 1.48E-1(c)(3) defined applicable year for purposes of the credit phase-out rules by reference to proposed § 1.45Y-1(c)(3). 
                        <E T="03">See</E>
                         section II.C. of this Summary of Comments and Explanation of Revisions for a discussion of those rules.
                    </P>
                    <HD SOURCE="HD3">A. Organization of Proposed § 1.48E-2</HD>
                    <P>Proposed § 1.48E-2(a) defined a qualified facility for purposes of section 48E. Proposed § 1.48E-2(b) described the property included in a qualified facility for purposes of section 48E, defined the terms “unit of qualified facility” as well as “functionally interdependent” and “integral part” (both as they apply to a qualified facility), and provided several examples to illustrate the rules. Proposed § 1.48E-2(c) provided rules for the coordination of the section 48E credit with certain other Federal income tax credits with respect to qualified facilities. Proposed § 1.48E-2(d) provided rules for determining the qualified investment with respect to a qualified facility. Proposed § 1.48E-2(e) defined the term “qualified property.” Proposed § 1.48E-2(f) defined certain terms related to requirements for qualified property, including “tangible personal property,” “other tangible property,” “construction, reconstruction, or erection of qualified property,” “acquisition of qualified property,” “original use of qualified property,” “depreciation allowable,” “placed in service” and “claim.” Proposed § 1.48E-2(g) provided rules for energy storage technology (EST).</P>
                    <P>The Treasury Department and the IRS determined that the organization of proposed § 1.48E-2, as it related to qualified facilities, did not adhere to the organization of section 48E. The final regulations reorganize § 1.48E-2 to more clearly follow the organization of section 48E. The Treasury Department and the IRS do not intend for the reorganization of § 1.48E-2 to create any substantive differences from the rules as they were provided in the proposed regulations.</P>
                    <P>As reorganized, § 1.48E-2(a) of these final regulations provides the rules for determining the qualified investment with respect to a qualified facility. Section 1.48E-2(b) defines the term “qualified facility” as it relates to section 48E, as well as the term “placed in service.” Section 1.48E-2(c) defines the term “qualified property.” Section 1.48E-2(d) provides the rules for property included in a qualified facility, including a description of “unit of qualified facility” and “integral part,” and provides examples illustrating these rules. Section 1.48E-2(e) provides definitions related to the requirements for qualified property. Section 1.48E-2(f) provides rules for the coordination of the section 48E credit with certain other Federal income tax credits with respect to qualified facilities and includes examples to illustrate those rules. Section 1.48E-2(g) provides rules relating to EST. Finally, the definition of the term “claim” for both a qualified facility and EST is moved to § 1.48E-1(a)(2) and is modified to also apply to the other Federal income tax credits described in section 48E(b)(3)(C).</P>
                    <HD SOURCE="HD3">B. Qualified Investment With Respect to a Qualified Facility and Qualified Property</HD>
                    <P>Proposed § 1.48E-2(d) described a qualified investment with respect to any qualified facility. Proposed § 1.48E-2(e) defined “qualified property” for purposes of proposed § 1.48E-2(a).</P>
                    <P>A commenter requested that the final regulations clarify that the qualified property included in a qualified investment in a qualified hydropower facility includes all the components and property identified as qualified property in prior guidance under section 48, up through and including the substation at which the electrical voltage is stepped up to transmission voltage. Similarly, another commenter asked whether the scope of qualified property under section 48E(b)(2) includes all property identified as energy property under section 48(a)(3), unless explicitly excluded under section 48E.</P>
                    <P>The Treasury Department and the IRS recognize that some technologies may be creditable under both sections 48 and 48E. Although the rules for eligibility differ between the two sections, they share many overlapping concepts (for example, functional interdependence and integral property). For those facilities that generate electricity and for EST that are eligible for both the section 48 and 48E credits, the Treasury Department and the IRS expect similar property to be eligible. However, the application of these concepts to a specific facility or EST is ultimately a fact-specific determination.</P>
                    <P>That said, unlike section 48, these final regulations are technology neutral, and the rules are meant to apply to all qualified facilities. A definitive response to these comments would require the Treasury Department and the IRS to conduct a complete factual analysis of the property in question, which may include information beyond that which was provided by the commenters. Because more information is needed to make the determinations requested by the commenters, the requested clarifications are not addressed in these final regulations.</P>
                    <HD SOURCE="HD3">C. Energy Storage Technology Overview</HD>
                    <HD SOURCE="HD3">1. In General</HD>
                    <P>
                        Proposed § 1.48E-2(g) provided rules defining a unit of EST. Section 48E(c)(2) 
                        <PRTPAGE P="4012"/>
                        defines the term “energy storage technology” by reference to section 48(c)(6) (noting that the beginning of construction requirement in section 48(c)(6)(D) does not apply). A commenter suggested clarifying that EST may include either “property . . . which receives, stores, and delivers energy for conversion,” or “thermal energy storage property,” by reading the “and” between sections 48(c)(6)(A)(i) and (ii) as disjunctive. The Treasury Department and the IRS confirm that the term “and” between sections 48(c)(6)(A)(i) and (ii) is disjunctive for purposes of section 48E(c)(2) and property described in section 48(c)(6)(A)(i) or (ii) are included as EST.
                    </P>
                    <HD SOURCE="HD3">2. Functionally Interdependent</HD>
                    <P>Proposed § 1.48E-2(g)(2)(i) provided that, for purposes of the section 48E credit, a unit of EST includes all functionally interdependent components of property (as defined in proposed § 1.48E-2(g)(2)(ii)) owned by the taxpayer that are operated together and that can operate apart from other property to perform the intended function of the EST. Proposed § 1.48E-2(g)(2)(ii) provided that components are functionally interdependent if the placing in service of each of the components is dependent upon the placing in service of each of the other components to perform the intended function of the EST.</P>
                    <P>A commenter requested that the Treasury Department and the IRS explicitly clarify that the section 48E credit can be claimed with respect to EST that is co-located and used in conjunction with electricity generation equipment for which the section 45 or 45Y credits are claimed, without regard to whether the EST would be considered a functionally interdependent component or an integral part of the electricity generation equipment under other rules or whether the EST and electricity generation equipment are owned by the same or different taxpayers.</P>
                    <P>
                        Section 48E(a) provides that the clean electricity investment credit is determined separately with respect to any qualified facility and any EST. This statutory text establishes an important categorical distinction between qualified facilities and ESTs. While integral property may be shared by a co-located qualified facility and an EST, a unit of qualified facility and a unit of EST cannot share components for purposes of section 48E. Further, the Treasury Department and the IRS confirm that an EST is eligible for the section 48E credit if it satisfies the requirements of section 48E, even if the EST is co-located with a qualified facility that has claimed the section 45 or 45Y credits. 
                        <E T="03">See</E>
                         section III.C.6. of this Summary of Comments and Explanation of Revisions for additional discussion of comments on co-located, or “hybrid,” projects that include an EST and qualified facility.
                    </P>
                    <HD SOURCE="HD3">3. Qualified Investment With Respect to Energy Storage Technology</HD>
                    <P>Proposed § 1.48E-2(g)(4) provided that the qualified investment with respect to any EST for a taxable year is the basis of any EST placed in service by the taxpayer during such taxable year. Commenters requested clarification that the entire cost basis of EST property that converts energy to electricity is eligible for the section 48E credit, even if some functionally interdependent property is used to produce heat. The commenters asserted that there is no statutory requirement that the energy stored be exclusively converted to electricity and that the Code is silent about any minimum percentage requirement of energy being converted to electricity.</P>
                    <P>Proposed § 1.48E-2(g)(6)(i) described electrical energy storage property as property (other than property primarily used in the transportation of goods or individuals and not for the production of electricity) that receives, stores, and delivers energy for conversion to electricity and has a nameplate capacity of not less than 5 kWh. This definition is adopted from section 48E(c)(2), which defines “energy storage technology” including electrical energy storage property by reference to section 48(c)(6). Because the purpose of an electrical energy storage property is to receive, store and deliver energy for conversion to electricity, not to produce thermal energy, components of property of an energy storage property used to produce thermal energy would be subject to the incremental cost rule discussed in section III.G. of this Summary of Comments and Explanation of Revisions.</P>
                    <HD SOURCE="HD3">4. Placed in Service</HD>
                    <P>Proposed § 1.48E-2(g)(5)(i) provided rules for determining when an EST has been placed in service for purposes of the section 48E credit. Notwithstanding the general rules provided in proposed § 1.48E-2(g)(5)(i), an EST with respect to which an election is made under section 50(d)(5) of the Code and § 1.48-4 to treat the lessee as having purchased such EST is considered placed in service by the lessor in the taxable year in which possession is transferred to such lessee.</P>
                    <P>Commenters suggested expanding the definition of placed in service for EST because “energy storage may charge and discharge prior to being ready for commercial operation.” Specifically, a commenter suggested that EST property should be treated as placed in service when (i) such property has all licenses, permits, and approval required to store and dispatch power, (ii) pre-operational testing is complete, (iii) the taxpayer has title to the property, and (iv) the property is available to store and discharge power on a regular, commercial basis.</P>
                    <P>Instead of providing specific indicia of when an EST is treated as being placed in service, the rule in proposed § 1.48E-2(g)(5)(ii) provided general principles for a taxpayer to determine when an EST has been placed in service that are broadly applicable to all types of EST. These principles are based upon the placed in service rules provided by § 1.48-9(b)(5), which generally adopt the placed in service rules of § 1.46-3(d)(1). The general principles under § 1.46-3(d)(1) have applied to the section 48 credit since its enactment. These principles are well-understood, general standards for determining when property is placed in service, and they are widely relied upon by industry. The Treasury Department and the IRS view the general principles provided by the proposed rule as adequate for determining when EST is placed in service, and as sufficiently broad to address these commenters' concerns. Therefore, the final regulations adopt the placed in service rules as proposed.</P>
                    <HD SOURCE="HD3">5. Electrical Energy Storage Property</HD>
                    <P>Proposed § 1.48E-2(g)(6)(i) described electrical energy storage property as property (other than property primarily used in the transportation of goods or individuals and not for the production of electricity) that receives, stores, and delivers energy for conversion to electricity and has a nameplate capacity of not less than 5 kWh. For example, subject to the exclusion for property primarily used in the transportation of goods or individuals, electrical energy storage property includes but is not limited to rechargeable electrochemical batteries of all types (such as lithium-ion, vanadium redox flow, sodium sulfur, and lead-acid); ultracapacitors; physical storage such as pumped storage hydropower, compressed air storage, and flywheels; as well as reversible fuel cells.</P>
                    <P>
                        Commenters asked for clarification regarding what constitutes property “primarily used” in the transportation of goods or individuals. One commenter suggested that the final regulations 
                        <PRTPAGE P="4013"/>
                        provide a bright line rule and clarify that property that receives, stores, and delivers energy for conversion to electricity and is intended to be used for less than 35 percent of its hours of use in a calendar year for transporting goods or individuals is not considered “primarily used in the transportation of goods or individuals.” In this commenter's view, property, including a school bus, that receives, stores, and delivers energy for conversion to electricity that is used less than 35 percent of its hours of use in a calendar year for transporting goods or individuals is not primarily used for transportation. However, the commenter clarified that if electric school buses paired with a bidirectional vehicle-to-grid (V2G) charger are permitted to qualify as EST, then the charger itself should not be considered part of the electrical energy storage property.
                    </P>
                    <P>The final regulations mirror the language of section 48E(c)(2), which adopts the definition of EST provided in section 48(c)(6)(A), and excludes property primarily used in the transportation of individuals or goods. The Treasury Department and the IRS consider school buses as primarily used in transportation because the primary reason for a taxpayer to acquire school buses is to transport individuals, not store energy, notwithstanding the overall amount of time buses are used to actually transport individuals. A “bright line” test requested by the commenter is not feasible because any given situation and determination is fact dependent.</P>
                    <P>
                        In addition, there are other IRA tax incentives intended to benefit some technologies for which these commenters seek section 48E credit eligibility. For instance, section 45W of the Code provides a tax credit for vehicles such as electric school buses. Furthermore, a notice of proposed rulemaking (REG-118269-23) published in the 
                        <E T="04">Federal Register</E>
                         (89 FR 76759) on September 19, 2024, regarding the section 30C alternative fuel vehicle refueling property credit (September 2024 proposed regulations) proposed a definition for property primarily used in the transportation of goods or individuals and not for the production of electricity for purposes of sections 48 and 48E. In particular, proposed § 1.48E-2 provided that energy storage property is primarily used in the transportation of goods or individuals and not for the production of electricity, and therefore is not EST eligible for the section 48E credit, if a credit is claimed under section 30C for such property. Comments regarding this proposed definition will be further addressed in the Treasury decision that finalizes the September 2024 proposed regulations. The Treasury Department and IRS note that energy storage property for which the section 30C credit is not claimed may be creditable as EST under sections 48 and 48E if that property meets the requirements of those tax credits.
                    </P>
                    <HD SOURCE="HD3">6. Hybrid Systems (Qualified Facility + EST)</HD>
                    <P>Several commenters addressed the treatment of qualified facilities, such as solar generation facilities, and EST that are co-located, or so-called “hybrid” projects. At least one commenter supported treating a qualified facility and EST as separate for purposes of the section 48E credit. The commenter emphasized that such an approach is critical for the long-term success of the section 45Y and 48E credits, and importantly, will align with the goal of the domestic content bonus credit amount to reshore clean energy supply chains.</P>
                    <P>Other commenters requested that taxpayers be able to elect a single section 48E credit for hybrid systems, consisting of a qualified facility and an EST, and sought clarification of whether property included in a unit of EST may be included in a unit of qualified facility. A commenter noted that for purposes of rooftop solar and storage hybrid systems, the EST and the solar energy property are dependent upon each being placed in service because both are essential to the completeness of the intended function of the hybrid system. Commenters asserted that including EST in the definition of “integral part” of a qualified facility and providing examples of dual eligibility for section 48 and 48E credits during the transition period would help maintain consistency and reduce administrative burdens. One commenter recommended modifying proposed § 1.48E-2(b) to clarify that EST may (but is not required to) be considered an integral part of a qualified facility. Commenters stated that such a clarification would align with current guidance for the domestic content bonus credit amount and the test for determining whether multiple energy properties will be considered an energy project under the section 48 proposed regulations. Another commenter stated that this approach would allow for increased technological flexibility for purposes of the section 48E credit and would allow residential solar energy developers to continue claiming a single credit for hybrid systems. A commenter claimed that adding EST as an integral part of a qualified facility would allow utility scale solar energy developers the option to claim separate credits for the EST and the qualified facility under the section 48E proposed regulations.</P>
                    <P>
                        Another commenter suggested permitting a taxpayer developing a hybrid system and claiming the section 48E credit on both the qualified facility and EST to elect to treat them as a single energy project. Other commenters requested that the final regulations clarify that even if qualified facilities and EST are separate categories under section 48E, a taxpayer developing a hybrid system that incorporates both may file a single Form 3468, 
                        <E T="03">Investment Credit,</E>
                         and register only once for purposes of section 6418 of the Code relating to transfer elections for eligible credits (section 6418 credit transfer elections).
                    </P>
                    <P>
                        As noted earlier in section III.C.2. of this Summary of Comments and Explanation of Revisions, the statutory framework of section 48E does not support treating a qualified facility and EST as a single creditable property. Instead, the text of section 48E repeatedly treats a qualified facility and EST as separately creditable properties. Accordingly, there is no statutory basis to allow taxpayers an option to claim a single credit for hybrid systems that include both qualified facilities and EST. In addition, although beyond the scope of these final regulations, the Treasury Department and the IRS note that, because a hybrid system would be considered two separate eligible credit properties, a taxpayer would need to register them separately for purposes of making section 6418 credit transfer elections. 
                        <E T="03">See</E>
                         §§ 1.6418-1(d) and 1.6418-4.
                    </P>
                    <P>
                        Some commenters also requested that the final regulations provide an option to claim a single credit for a hybrid system rather than two credits, one for the EST and one for the qualified facility, in part, because those commenters currently enter into a single leasing agreement with customers for both a solar qualified facility and an EST. These commenters expressed concern about whether, under the proposed regulations, they would need to enter into separate contracts for the solar qualified facility and the EST. These commenters noted that if they are able to use a single contract, the contract will need to have separate term lengths for the solar qualified facility and the EST to satisfy the leasing rules for tax purposes. These commenters raised the issue that since a solar qualified facility and an EST generally have different useful lives the leasing rules could not cover both the solar qualified facility and the EST if they claimed separate credits.
                        <PRTPAGE P="4014"/>
                    </P>
                    <P>The Treasury Department and the IRS are not aware of any case law or guidance related to leasing rules that would require a taxpayer to break up the scope of a lease into components before analyzing whether there is a true lease for tax purposes regardless of the useful life of different assets included in the lease. In order to claim section 48E credits for both the solar qualified facility and an EST that are part of a combined solar qualified facility and EST, a taxpayer must retain ownership of both at the time such property is placed in service. This is true regardless of whether there are separate credits or separate credit calculations required for a solar qualified facility and an EST. While the final regulations define a unit of property as a qualified facility or an EST for purposes of section 48E, the final regulations are not intended to apply more broadly to define what comprises a unit of property for any other purpose of the Code.</P>
                    <P>Another commenter requested that the section 48E credit be made available for pumped storage hydropower property, including if such property overlaps or shares property with a qualified hydropower facility that has claimed or will claim the credit under section 45 or 45Y, and that no allocation of costs is required with respect to such overlapping property.</P>
                    <P>The Treasury Department and the IRS confirm that an EST is eligible for a separate section 48E credit if it satisfies the requirements of section 48E and the section 48E regulations. A taxpayer that makes a qualified investment with respect to a qualified facility or an EST is eligible for the section 48E credit only to the extent of the taxpayer's eligible investment in the qualified facility or EST. As described in proposed § 1.48E-2(b)(3)(vi), multiple qualified facilities (whether owned by one or more taxpayers), including qualified facilities with respect to which a taxpayer has claimed a credit under section 48E, 45, or 45Y or another Federal income tax credit, may include shared property that may be considered part of a qualified investment for each qualified facility so long as the cost basis for the shared property is properly allocated to each qualified facility and the taxpayer only claims a section 48E credit with respect to the portion of the cost basis properly allocable to the qualified facility for which the taxpayer is claiming a section 48E credit. The proposed rule addresses the commenter's concerns and will be adopted as proposed.</P>
                    <HD SOURCE="HD3">7. Thermal Energy Storage Property</HD>
                    <P>Proposed § 1.48E-2(g)(6)(ii) defined thermal energy storage property as property comprising a system that is directly connected to a heating, ventilation, or air conditioning (HVAC) system; removes heat from, or adds heat to, a storage medium for subsequent use; and provides energy for the heating or cooling of the interior of a residential or commercial building. Thermal energy storage property includes equipment and materials, and parts related to the functioning of such equipment, to store thermal energy for later use to heat or cool, or to provide hot water for use in heating a residential or commercial building. Thermal energy storage property does not include a swimming pool, CHP property, or a building or its structural components.</P>
                    <P>Several commenters requested additional examples of thermal energy storage property and asked whether specific property would be considered part of thermal energy storage. For example, a commenter recommended including an example of thermal energy storage property that includes phase change materials operating as a battery in place of a refrigeration cycle to reduce energy consumption in cold storage. Several commenters requested an example allowing for solar thermal systems to be treated as thermal energy storage property and noted that solar thermal systems are explicitly eligible under the section 48 credit. A commenter specifically contended that solar thermal systems that collect energy from the sun to heat a storage medium (for example, water) and then provide energy through an HVAC system for a residential or commercial building should be treated as thermal energy storage systems under section 48E.</P>
                    <P>Another commenter suggested clarifying that energy storage technology includes property capable of discharging both heat and electricity regardless of how the facility's heat is utilized as long as the facility has an electrical nameplate capacity of at least 5 kWh and the taxpayer claims a section 48E credit only on the parts of the facility that are essential to receiving, storing, and delivering energy for the conversion to electricity (that is, excluding components related to discharging heat). A different commenter suggested clarifying that thermal energy storage property includes property directly connected to a refrigeration system given that refrigeration systems are a subset of HVAC systems. Another commenter requested clarifying that otherwise-qualifying property that operates squarely within an HVAC ecosystem, or directly in connection with such a system, and that directly impacts the temperature of air being conditioned by an HVAC system, is “directly connected” to such system within the meaning of section 48E (and section 48); and non-structural, energy-saving, portable products that are incorporated into building elements specifically because of their energy-saving properties are not themselves “a building or its structural components,” and remain non-structural even if integrated into a ceiling.</P>
                    <P>Another commenter suggested providing examples of thermal energy storage property that include thermal ice or chilled water storage systems that use electricity to run a refrigeration cycle to produce ice or chilled water that is later connected to the HVAC system as an exchange medium for air conditioning the building, heat pump systems that store thermal energy in an underground tank or borehole field to be extracted for later use for heating and/or cooling, and electric furnaces that use electricity to heat bricks to high temperatures and later use this stored energy to heat a building through the HVAC system. Similarly, a commenter recommended several modifications to the examples of thermal energy storage in proposed § 1.48E-2(g)(6)(ii): (i) replace the reference to “thermal ice storage systems” with “chilled water or ice storage systems,” (ii) acknowledge that tanks could be above or below ground, and (iii) include “electric boilers that use electricity to heat water and later use this stored energy to provide heat and/or domestic hot water to a building through the HVAC system.” Several other commenters suggested clarifying whether the phrase “directly connect to” in proposed § 1.48E-2(g)(6)(ii) means that thermal storage systems that function as self-contained heating or cooling systems qualify as thermal energy storage property.</P>
                    <P>
                        The Treasury Department and the IRS agree that the definition of thermal energy storage property requires clarification. Proposed § 1.48E-2(g)(6)(ii) defined thermal energy storage property, in part, as a system which “removes heat from, or adds heat to, a storage medium for subsequent use.” The Treasury Department and the IRS understand the phrase “adds heat to” as including equipment that is involved in adding, or transferring, already-existing heat from one medium to the storage medium, but not equipment involved in transforming other forms of energy into heat in the first instance. Equipment that just adds (or removes) heat includes technologies, like heat pumps, that draw heat from the ambient air or other stores of heat and adds that heat to a storage medium. 
                        <PRTPAGE P="4015"/>
                        By contrast, equipment that transforms other forms of energy into heat in the first instance, for example through combustion or electric resistance, is not property that “removes heat from, or adds heat to” a storage medium and is therefore not an eligible component of a thermal energy storage property. For example, a conventional gas boiler with an integrated storage tank would not generally be thermal energy storage property, as it would generate new heat in the first instance through combustion and subsequently add that heat to the storage medium, rather than merely adding existing heat to the storage medium. While the gas boiler elements would not be part of such property, the integrated storage tank, may be thermal energy storage property if it otherwise meets the thermal energy storage property definition. Further, an air-to-water heat pump with a thermal storage tank, for example, would generally be thermal energy storage property provided it otherwise meets the definition of thermal energy storage. This could be the case even if the heat pump also serves a purpose in the connected HVAC system's real-time heating or cooling of a building. In that case, the thermal storage tank would be thermal energy storage property and the heat pump may also qualify as part of the thermal energy storage property to the extent the taxpayer's costs exceed the cost of an HVAC system without thermal storage capacity that would meet the same functional heating or cooling needs as the heat pump system with a storage medium, other than time shifting of heating or cooling. 
                        <E T="03">See</E>
                         section III.G. of the Summary of Comments and Explanation of Revisions for discussion of the Incremental Cost Rule.
                    </P>
                    <P>Proposed § 1.48E-2(g)(6)(ii) included an example of electric furnaces that use electricity to heat bricks to high temperatures and later use this stored energy to heat a building through the HVAC system. The Treasury Department and the IRS acknowledge that this example needs to be refined to more precisely delineate the scope of eligible thermal energy storage property. Whereas the heated bricks and equipment that adds heat generated by the furnace to those bricks, or removes heat from the bricks, is eligible thermal energy storage property, the electric furnace equipment that transforms energy into the thermal energy via electrical resistance in the first instance is not. Section 1.48E-2(g)(6)(ii) of the final regulations provides that thermal energy storage property does not include property that transforms other forms of energy into heat in the first instance.</P>
                    <P>
                        With respect to subsequent use, the Treasury Department and the IRS also agree that additional clarity is warranted. The statute requires that thermal energy storage property must be able to perform certain functions, not simply perform heat transfer. Any heat transfer may take some amount of time and heat does not immediately dissipate even if no effort is made to store it. While some commenters asserted that such heat transfer is subsequent use, the Treasury Department and the IRS disagree. A plain reading of the statute supports the conclusion that thermal energy storage property does not include property that simply engages in heat transfer. The thermal energy storage property must be able to 
                        <E T="03">store</E>
                         the thermal energy. The Treasury Department and the IRS find that a minimum time interval for subsequent use provides certainty for taxpayers and sound tax administration.
                    </P>
                    <P>Accordingly, the final regulations clarify that property that “removes heat from, or adds heat to, a storage medium for subsequent use” is property that is designed with the particular purpose of substantially altering the time profile of when heat added to or removed from the thermal storage medium can be used to heat or cool the interior of a residential or commercial building. The final regulations also provide a safe harbor for thermal energy storage property. If the thermal energy storage property can store energy that is sufficient to provide heating or cooling of the interior of a residential or commercial building for a minimum of one hour, it is deemed to have the purpose of substantially altering the time profile of when heat added to or removed from the thermal storage medium can be used to heat or cool the interior of a residential or commercial building.</P>
                    <P>These final regulations also add that thermal energy storage property may store thermal energy in an artificial pit, an aqueous solution, or a solid-liquid phase change material, in addition to the underground tank or a borehole field already included in the proposed regulations, in order to be extracted for later use for heating and/or cooling. The final regulations clarify that sources of thermal energy that transform other forms of energy into heat, such as electric boilers, are not thermal energy storage property.</P>
                    <P>The Treasury Department and the IRS clarified the definition of thermal energy storage property and the examples in the final regulations to illustrate what constitutes thermal energy storage property. The final regulations provide revised examples of thermal energy storage property, and those examples are intended to be a non-exhaustive list. The Treasury Department and the IRS have also determined that the revised description of thermal energy storage property in § 1.48E-2(e)(6)(ii) provides taxpayers with a sufficient means to determine whether specific property qualifies as thermal energy storage property. To the extent that commenters asked whether additional systems, configurations, or technologies would qualify as thermal energy storage property, such a determination would require the Treasury Department and the IRS to conduct a complete factual analysis of the system, configuration, or technology, which may include information beyond that which was provided by the commenters. Because more information is needed to make any such determinations requested by the commenters, the final regulations do not provide such additional requested clarifications.</P>
                    <P>Several commenters recommended clarifying that thermal energy storage property includes property providing energy for the heating or cooling of the interior of an industrial building, or other types of buildings. A commenter asserted that a wide variety of buildings are served by thermal energy storage, such as city halls, libraries, and jails, and that the definition of thermal energy storage property should not be limited to residential or commercial settings. Commenters requested that property used to convey stored energy and deliver it to building spaces (such as pipes and pumps), used to distribute stored thermal energy for heating or cooling or to supply domestic hot water for consumption in a residential or commercial building, be included within the definition of thermal energy storage property. One commenter recommended defining thermal energy storage property to include equipment, including pipes and pumps, used to distribute stored thermal energy to and within buildings. The commenter noted that such a clarification would necessitate incorporation of a dual use rule consistent with § 1.48-14(b), because thermal energy storage may use pipes to distribute stored thermal energy to and within buildings that are also used by non-qualifying sources.</P>
                    <P>
                        One commenter requested clarifying whether thermal energy storage property includes liquid desiccant storage systems that use electricity to store energy in liquid desiccants that remove latent heat from the air for use in a connected HVAC system. Another 
                        <PRTPAGE P="4016"/>
                        commenter noted that most solar thermal systems are combination or hybrid systems that provide thermal storage in the form of water or another fluid for a variety of applications. Regarding such combination systems, other commenters recommended clarifying that thermal energy property includes water heating applications and providing an example of such applications.
                    </P>
                    <P>Section 48E(c)(2) defines EST as having the same meaning as under section 48(c)(6), and section 48(c)(6) defines EST to include thermal energy storage property. The statutory definition of thermal energy storage property under section 48(c)(6)(C) provides that such property is directly connected to a HVAC, removes heat from, or adds heat to, a storage medium for subsequent use, and provides energy for the heating or cooling of the interior of a residential or commercial building. To maintain consistency with the statutory text, the final regulations maintain the wording regarding eligible building applications set forth in section 48(c)(6)(C)(i)(III). With respect to property used to distribute stored thermal energy, such as pipes and pumps, the final regulations provide a function-oriented method to evaluate whether property is a functionally interdependent or an integral part of thermal energy storage property. Beyond the examples included in the proposed regulations and additional examples added here, commenters have described a number of additional innovative technologies that might qualify as thermal energy storage property. However, application of the functional definition of thermal energy storage property provided at section 48E(c)(2) (by reference to section 48(c)(6)) would be necessary to determine if these technologies are, in fact, examples of qualifying thermal energy storage property. Moreover, the examples contained in proposed § 1.48E-2(g)(6)(ii) are a non-exhaustive list. Therefore, the final regulations do not adopt all the recommended additional examples.</P>
                    <P>Because section 48E(c)(2) provides that the term “energy storage technology” has the meaning given such term in section 48(c)(6), the final regulations incorporate modifications made to the section 48 proposed regulations by the section 48 final regulations to clarify the definition of EST, including with respect to thermal energy property.</P>
                    <HD SOURCE="HD3">8. Hydrogen Energy Storage Property</HD>
                    <P>Proposed § 1.48E-2(g)(6)(iii) provided that hydrogen energy storage property is property (other than property primarily used in the transportation of goods or individuals and not for the production of electricity) that stores hydrogen and has a nameplate capacity of not less than 5 kWh, equivalent to 0.127 kg of hydrogen or 52.7 standard cubic feet (scf) of hydrogen. Proposed § 1.48E-2(g)(6)(iii) also provided that hydrogen energy storage property must store hydrogen that is solely used as energy and not for other purposes, such as for the production of end products (for example, fertilizer), and set forth examples of hydrogen energy storage property.</P>
                    <P>A commenter stated that property storing hydrogen should be at least 1 GWh in capacity (which is equivalent to 96,554 gallons of liquid hydrogen storage capacity or about 25.4 metric tons) in order to qualify as hydrogen energy storage property. The Treasury Department and the IRS note that section 48E(c)(2) defines “energy storage technology” as having the meaning given such term in section 48(c)(6) (without the application of the beginning of construction deadline). Section 48(c)(6) defines “energy storage technology” as, in part, having a nameplate capacity of not less than 5 kilowatt hours. Accordingly, the final regulations do not adopt the commenter's suggestion, as doing so would be inconsistent with the statute.</P>
                    <HD SOURCE="HD3">a. End Use Requirement</HD>
                    <P>Numerous commenters disagreed with the requirement that hydrogen energy storage property must store hydrogen that is solely used as energy and not for other purposes, which the commenters referred to as the “end use requirement.” Commenters noted that the end use requirement is not statutorily prescribed and asserted that it would be difficult, if not impossible, to implement. Commenters asserted that a single industrial customer may have multiple uses for hydrogen, sometimes for energy and sometimes for other purposes such as stripping pollutants from flue gas streams, and that customers are not generally willing to restrict their use in order to indemnify the hydrogen energy storage property against investment credit recapture risk. Commenters also pointed out that hydrogen storage projects may sell to intermediaries in which case the end use of hydrogen is not necessarily known, and ensuring that the end use requirement is respected by export markets would be impossible. A commenter contended that the limited number of examples and use cases offered in the proposed regulations raise several questions for taxpayers and hydrogen storage developers.</P>
                    <P>Some commenters also maintained that the end use requirement would be inconsistent with the Biden Administration's U.S. National Clean Hydrogen Roadmap. One of these commenters stated that a major build-out of hydrogen storage facilities targeting exclusively power sector end use makes little sense from a strategic perspective. A commenter asserted that the definition of EST in section 48(c)(6)(A)(i), which includes “hydrogen, which stores energy,” simply recognizes that hydrogen is inherently a form of energy itself. A commenter also claimed that section 48(c) only sets out affirmative requirements for EST and that, therefore, hydrogen storage property that is not primarily used in the transportation of goods or individuals should qualify for the section 48E credit regardless of where the stored hydrogen ends up. Commenters further noted that some energy uses may be indirect (for example, via intermediary molecules), further complicating application of an end use requirement.</P>
                    <P>Commenters also asserted that an end use requirement would bifurcate and adversely affect the hydrogen market, and that additional uses for hydrogen, such as feedstock for industrial processes, could present significant decarbonization opportunities. A commenter asserted that disallowing the section 48E credit for hydrogen storage from serving applications such as steel production and iron refining would be a significant disservice to America and delay or prevent massive reductions in carbon emissions while hindering U.S. manufacturing of essential construction materials. Commenters noted that a hydrogen end use requirement would disadvantage large-scale hydrogen storage facilities relative to smaller ones.</P>
                    <P>
                        Commenters expressed concern that hydrogen energy storage is being unfairly singled out for disadvantageous treatment as compared to other EST, noting that the proposed regulations do not place an end use restriction on electricity stored within and discharged from batteries or other storage technologies; noting that energy withdrawn from batteries may be used for any purpose without losing its eligibility status. Commenters contended that the end use requirement would unduly push potential customers towards using battery-focused solutions instead of letting batteries and hydrogen solutions compete on equal footing, or in cases in which no alternative exists, would continue to extend the use of 
                        <PRTPAGE P="4017"/>
                        existing technologies, fuels, and processes.
                    </P>
                    <P>Some commenters supported the principle of an energy-based end use requirement for hydrogen energy storage property. One commenter sought clarification that “energy” was not limited to electricity production. Another commenter supported the principle of an energy-based end use limitation by comparing the statutory text of section 48(c)(6) from three legislative bills, including the version ultimately enacted by Congress, but opposed the “solely” criteria and cited practical challenges including administrability. Commenters generally requested that if an end use requirement is maintained that it be clarified and altered, and safe harbors provided. For example, a commenter suggested providing a rebuttable presumption of meeting the end use requirement if a taxpayer can demonstrate that it stored hydrogen predominantly for energy use.</P>
                    <P>Commenters also suggested creating a safe harbor as long as the facility itself uses some of the stored hydrogen for energy or the facility is an open access facility. A commenter requested flexible rules for determining the end use of hydrogen, including permitting taxpayers to assign withdrawn hydrogen based on commercial sales arrangements, or, alternatively, being able to rely on a mass balance approach based on the inputs and outputs to the storage property during the year. Commenters also suggested that the end use requirement conclude with the end of the 5-year recapture period provided by section 50. Several commenters suggested inverting the end use requirement to only disqualify property used to store hydrogen that is solely used for non-energy end products, or to exempt common carrier infrastructure from the end use requirement. Another commenter recommended a rule under which a facility that uses “qualified clean hydrogen” as defined under section 45V of the Code is deemed to qualify under section 48E if such hydrogen is used to create electricity.</P>
                    <P>Several commenters recommended implementing a dual use safe harbor to permit a taxpayer to claim a reduced section 48E credit when a portion of stored hydrogen is used for a purpose other than energy. Commenters noted that a dual use safe harbor could apply if at least half of the hydrogen in hydrogen energy storage property is used for energy purposes. In contrast, other commenters were opposed to any dual use approach to the end use limitation and asserted that such an approach would be unworkable, requiring “unknowable, unprovable, unmonitorable, unauditable facts.”</P>
                    <P>Commenters asked for clarification regarding what constitutes energy use of stored hydrogen and what documentation is needed to demonstrate such energy use. Several commenters were opposed to any recordkeeping requirements related to the end use of hydrogen and contended that such requirements would be unduly burdensome to taxpayers given the fungibility of hydrogen. Another commenter noted that there are currently no recordkeeping or documentation precedents available for a taxpayer to efficiently demonstrate the final end use of hydrogen stored in such taxpayer's hydrogen energy storage property. The commenter asserted that, as there is no available documentation pathway for tracking hydrogen molecules through to their end use, it would be both impractical and prohibitively costly for a taxpayer to develop and implement such recordkeeping practices.</P>
                    <P>After consideration of the comments received, the Treasury Department and the IRS agree that section 48(c)(6)(A)(i) does not require that hydrogen energy storage property store hydrogen that will be used for the production of energy. The Treasury Department and the IRS recognize commenters' concerns regarding the administrative challenges the end use requirement could present for taxpayers and agree that it should be removed. The final regulations therefore do not adopt the requirement that hydrogen energy storage property store hydrogen that is solely used as energy and not for other purposes such as for the production of end products like fertilizer.</P>
                    <HD SOURCE="HD3">b. Hydrogen Storage Media</HD>
                    <P>Many commenters provided feedback regarding the qualifying types of hydrogen storage media. Specifically, a commenter requested expanding the definition of hydrogen energy storage to include storage of ammonia and electrolytic hydrogen derivative e-fuels. A commenter also requested that the Treasury Department and the IRS recognize and clarify that, unlike electricity, hydrogen is a chemical building block for other molecules that are capable of more efficiently carrying hydrogen. According to the commenter, this means that hydrogen can be stored as a physical material medium such as a metal hydride. The commenter also requested confirmation that the examples of hydrogen storage mediums provided in the preamble to the proposed regulations are non-exhaustive and that the type of storage medium is intentionally unlimited.</P>
                    <P>The Treasury Department and the IRS decline to adopt comments requesting that the final regulations provide that chemical storage (that is, equipment used to store hydrogen carriers (such as ammonia and methanol)) is hydrogen energy storage property. Section 48E(c)(2) provides that the term “energy storage technology” has the meaning given to such term in section 48(c)(6). Section 48(c)(6)(A)(i) defines “energy storage technology” as property (other than property primarily used in the transportation of goods or individuals and not for the production of electricity) which receives, stores, and delivers energy for conversion to electricity (or, in the case of hydrogen, which stores energy), and has a nameplate capacity of not less than 5 kilowatt hours. Section 48(c)(6)(A) references hydrogen, but not compounds containing hydrogen.</P>
                    <HD SOURCE="HD3">c. Hydrogen Storage Components and Equipment</HD>
                    <P>Several commenters requested clarifications regarding the components included in the definition of hydrogen energy storage. Commenters generally requested that the final regulations expand the list of integral and functionally interdependent equipment to be more inclusive of existing and future hydrogen energy storage property technologies. One commenter noted that while the functional interdependence test provided by the proposed regulations is helpful, specifying further what components are considered part of hydrogen energy storage is paramount. The commenter requested additional examples that address specific components including equipment needed to functionally store hydrogen, equipment used to change the phase of matter, equipment used to liquify hydrogen prior to storage, equipment used to convert stored hydrogen to ammonia to be used as a carrier of that stored hydrogen, equipment used to store electrolytic hydrogen derivative e-fuels, and any related and necessary pipelines. Similarly, commenters requested that additional components and equipment be specifically identified as eligible parts of hydrogen energy storage property, including hydrogen liquefaction and related equipment and other equipment required to operate underground hydrogen storage property.</P>
                    <P>
                        A commenter requested that the final regulations demarcate between equipment used for hydrogen production, conditioning, transportation, and storage. The commenter emphasized that a clear demarcation is necessary to prevent 
                        <PRTPAGE P="4018"/>
                        gaming the system if storage property would qualify for the section 48E credit under section 48(c)(6) and the production equipment will, in many or most cases, be associated with the production tax credit under section 45V. The commenter suggested that the proper demarcation between hydrogen production and conditioning, transportation, or storage equipment is the point at which any post-production conditioning to remove impurities or to put the hydrogen into a saleable form is completed. The commenter stated that, in distinguishing hydrogen production equipment from storage equipment, the associated conditioning equipment should include all equipment necessary to treat, process, compress, pump, or perform other physical action on hydrogen prior to its storage or delivery. The commenter noted that equipment used to convert hydrogen into ammonia, methanol, or another hydrogen carrier also should be associated with post-production processing of hydrogen and not eligible for the section 48E credit. Similarly, the commenter asserted that equipment, such as compressors, used to liquify hydrogen (liquefaction) to put it into a deliverable and salable form should not qualify as hydrogen energy storage property, including the equipment necessary for liquefaction, conversion to ammonia, methanol, or other hydrogen carrier, and dissociation or cracking equipment necessary to convert a hydrogen carrier back into hydrogen. The commenter emphasized that if compressors are used in direct connection with storage devices, rather than to change the form of the hydrogen (for example, from gas to liquid), compressors are integral to the storage equipment and should qualify for the section 48E credit. Another commenter stated that the definition of hydrogen storage property should be limited to tanks and caverns of scale, and the associated equipment necessary to fill or discharge hydrogen from those tanks or caverns.
                    </P>
                    <P>Commenters also requested further guidance on the eligibility of pipelines as hydrogen energy storage property noting that there are specific cases in which hydrogen pipelines that are directly connected to an energy storage facility can operate as hydrogen storage, by providing additional volumes that can adjust pressure in direct coordination with the storage facility compression system. One commenter requested clarification of the term “primarily” in the phrase “other than property primarily used in the transportation of goods or individuals” as applied to pipelines that can be used to store hydrogen. Another commenter suggested clarifying the scope of hydrogen storage property with respect to transportation, customer delivery, and use.</P>
                    <P>
                        One commenter that opposed the inclusion of pipelines, rail cars, and truck trailers in the definition of hydrogen storage property, noted that if hydrogen has been stored in qualified storage property, such as tanks or underground storage salt caverns, the energy storage property should end at the valve where the stored hydrogen is delivered into a pipeline system. Additional commenters recommended limiting the treatment of hydrogen pipelines as integral or interdependent to hydrogen storage property. Commenters pointed to Federal Energy Regulatory Commission (FERC) rulings and applicable case law, such as 
                        <E T="03">Hawaiian Independent Refinery, Inc.</E>
                         v. 
                        <E T="03">U.S.,</E>
                         697 F.2d 1063 (Fed. Cir. 1983), which delineate the circumstances under which pipeline systems would be considered part of the storage facility. One commenter recommended only including pipelines directly linked to storage facilities and further recommended that the final regulations more precisely define the boundary between storage and transportation infrastructure. This commenter's proposed guideline would define the boundary between storage and transportation infrastructure by only considering specific interconnected pipeline segments as part of the storage system: point-to-point lines starting from the storage facility and ending at the first intersection point with explicit compression equipment. Commenters also requested a safe harbor for interconnecting pipelines whereby the pipelines would be deemed integral or interdependent to a hydrogen storage facility if (i) the complex is conceived and designed concurrently, and all offsite interconnecting pipeline components are placed into service within twenty four months of the date on which the first such component is placed into service, and (ii) the offsite interconnecting components are within 100 miles of the storage facility or within the same State as the storage facility.
                    </P>
                    <P>Commenters proposed the inclusion of additional examples that would provide additional specific eligible components and provide capitalization rules; establish eligibility of pipelines connecting storage facilities if exclusive to use of those facilities; and establish eligibility of purification equipment intended to return the purity of hydrogen post-storage to its purity level upon entering storage.</P>
                    <P>A commenter suggested allowing tanks and associated equipment for the storage of ammonia when used as a hydrogen carrier to qualify for the section 48E credit but stated that equipment used to disassociate ammonia into hydrogen (referred to as cracking) is a separate function from hydrogen storage and should not be treated as hydrogen energy storage property.</P>
                    <P>The Treasury Department and the IRS agree that clarifying the definition of hydrogen energy storage property is warranted. Hydrogen liquefaction equipment may prepare hydrogen for storage in the hydrogen energy storage property, making such property an integral part of hydrogen energy storage property. The final regulations provide that property that is an integral part of hydrogen energy storage property includes, but is not limited to, hydrogen liquefaction equipment.</P>
                    <P>Section 48E(c)(2) generally defines “energy storage technology” as having the meaning given such term in section 48(c)(6). Section 48(c)(6)(A)(i) defines “energy storage technology” as excluding property primarily used in the transportation of goods or individuals and not for the production of electricity. In general, whether property is “primarily” used in the transportation of goods or individuals and not for the production of electricity, is dependent on the facts and circumstances. Pipelines, trailers, and railcars are property primarily used in the transportation of goods or individuals and not for the production of electricity. Accordingly, such property generally would not be considered part of hydrogen energy storage property for purposes of section 48E.</P>
                    <P>
                        The Treasury Department and the IRS recognize that there are specific cases in which hydrogen pipelines that are directly connected to an energy storage facility can operate as hydrogen storage. Hydrogen energy storage property may have hydrogen pipelines that are used as gathering and distribution lines to transport hydrogen within the hydrogen energy storage property, making such hydrogen pipelines an integral part of the hydrogen energy storage property. These gathering and distribution lines are not pipelines used to transport hydrogen outside of the hydrogen energy storage property. The final regulations clarify that property that is an integral part of hydrogen energy storage property includes, but is not limited to, gathering and distribution lines within a hydrogen energy storage property.
                        <PRTPAGE P="4019"/>
                    </P>
                    <P>The Treasury Department and the IRS decline to provide additional examples of integral equipment and functionally interdependent equipment in the context of hydrogen energy storage property. The final regulations provide a function-oriented method to determine whether a technology is EST that is broad enough to encompass nascent technologies without rendering the regulations quickly obsolete. It is impossible to enumerate every technology that may be eligible for the section 48E credit given the ever-changing nature of the industry and pace of technological development. Although these regulations do not list all technologies that may qualify for the section 48E credit, the final regulations provide adequate guidance and examples to illustrate the application of the rules for taxpayers to analyze a particular technology. The Treasury Department and the IRS, therefore, do not adopt commenters' requests concerning specific technologies.</P>
                    <HD SOURCE="HD3">9. Modification of Energy Storage Technology</HD>
                    <P>Proposed § 1.48E-2(g)(7) provided that with respect to electrical energy storage property and hydrogen energy storage property, modified as set forth in proposed § 1.48E-2(g)(7), such property will be treated as an electrical energy storage property (as described in proposed § 1.48E-2(g)(6)(i)) or a hydrogen energy storage property (as described in proposed § 1.48E-2(g)(6)(iii)), except that the basis of the existing electrical energy storage property or hydrogen energy storage property prior to such modification is not taken into account for purposes of proposed § 1.48E-2(g)(7) and section 48E.</P>
                    <P>Commenters noted that taxpayers often replace energy storage equipment to manage the natural degradation of storage assets over time and to prolong the useful life of these projects, even if such improvements do not meet a 5-kWh capacity threshold. One commenter therefore contended that references to nameplate capacity in section 48E are best read to disregard any degradation of the EST between when it is placed in service and when capacity is added. The same commenter contended that modifications to EST should be eligible for the section 48E credit if one of the 5kWh nameplate measurement tests under proposed § 1.48E-2(g)(7)(i) and (ii) are met, regardless of any degradation that has occurred to the EST's nameplate capacity since its original in-service date. The commenter requested clarifying that the nameplate capacity after a modification is the nameplate capacity of such property before the modification plus the capacity added by the modification. Another commenter suggested permitting a “modification that leads to a demonstrated increase in capacity (measured and recorded immediately before such modifications) of not less than 5kWh,” to be eligible for the section 48E credit.</P>
                    <P>Another commenter explained that nameplate capacity of EST is typically defined when initial interconnection is approved, meaning that taxpayers who wish to claim the estimated expenditures of storage augmentation under section 48E will need to modify the original interconnection agreement or oversize their assets before placing them into service. The commenter requested that the section 48E rules recognize the eligibility of storage augmentation beyond nameplate capacity and suggested that the estimated expenditures associated with augmentation of qualifying EST be fully eligible for the section 48E credit. Another commenter suggested clarifying that augmentation of EST over time is eligible for the section 48E credit, either by treating estimated future augmentation costs at the time the EST is originally placed in service as eligible, with recapture provisions if estimated costs are not realized, or by treating any costs related to augmentation that are incurred as part of the upfront investment to construct an energy storage site as eligible. The commenter described augmentation as the periodic upgrade to capacity over a project's lifetime by either adding new inverters and enclosures or recycling batteries to old enclosures and adding new batteries behind an existing inverter.</P>
                    <P>Section 48E(c)(2) defines EST by reference to section 48(c)(6). Proposed § 1.48E-2(g)(7)(i) and (ii) applied the rules for modification of EST described in section 48(c)(6)(A)(i). In defining EST, section 48(c)(6)(A)(i) uses the term “nameplate capacity.” Accordingly, the rules for modification of EST apply with respect to the nameplate capacity of EST, and do not take into account potential degradation of the EST prior to its modification. The final regulations clarify that for purposes of the modification rules, the increase in nameplate capacity is equal to the difference between nameplate capacity immediately after the modification and nameplate capacity immediately prior to the modification. To maintain consistency with the statute, the final regulations do not adopt commenters' suggestions to measure an increase in nameplate capacity in a different manner.</P>
                    <P>A commenter also suggested clarifying that a modification is taken into account whether the increase in capacity is within an existing enclosure, the existing enclosure is expanded, a new enclosure is added for the increased capacity, or a new enclosure is constructed to include both the existing capacity and the added capacity.</P>
                    <P>Section 48(a)(6)(B) defines modifications of EST without any reference to physical space limitations. Proposed § 1.48E-2(g)(7) also does not address limiting modifications of EST based on physical space. The Treasury Department and the IRS conclude that a modification of EST is not limited by the physical space occupied by the EST before or after the modification and adopt the proposed regulations without change.</P>
                    <HD SOURCE="HD3">D. Rules for Certain Lower-Output Qualified Facilities</HD>
                    <P>
                        Proposed § 1.48E-4(a)(1) provided rules for qualified facilities with a maximum net output of not greater than 5 megawatts to include qualified interconnection costs in the basis of an associated qualified facility. Proposed § 1.48E-4(a)(1) provided that the qualified investment for a qualified facility includes amounts paid or incurred by the taxpayer for qualified interconnection property in connection with the installation of a qualified facility that has a maximum net output of not greater than 5 MW (as measured in alternating current) (Five-Megawatt Limitation). Proposed § 1.48E-4(a)(1) also provided that the qualified interconnection property must provide for the transmission or distribution of the electricity produced by a qualified facility and must be properly chargeable to the capital account of the taxpayer as reduced by the rules in proposed § 1.48E-4(a)(6). Proposed § 1.48E-4(a)(2) defined the term “qualified interconnection property.” Proposed § 1.48E-4(a)(2) further provided that qualified interconnection property is not taken into account to determine if a qualified facility meets the requirements for the increase in credit rate for energy communities or domestic content because qualified interconnection property is not part of a qualified facility. Proposed § 1.48E-4(a)(3) described the Five-Megawatt Limitation as a measurement taken at the qualified facility level. Proposed § 1.48E-4(a)(3)(i) provided that the maximum net output of a qualified facility is measured only by the nameplate generating capacity of the unit of qualified facility, which does 
                        <PRTPAGE P="4020"/>
                        not include the nameplate capacity of any integral property, at the time that the qualified facility is placed in service. Proposed § 1.48E-4(a)(3)(i) additionally provided that the nameplate generating capacity of the unit of qualified facility is measured independently from any other qualified facilities that share the same integral property. Proposed § 1.48E-4(a)(3)(ii) provided how the nameplate capacity at a qualified facility is measured. Proposed § 1.48E-4(a)(4) defined the term “interconnection agreement” and proposed § 1.48E-4(a)(5) defined the term “utility.” Proposed § 1.48E-4(a)(6) provided that expenses paid or incurred for qualified interconnection property and amounts otherwise chargeable to capital account with respect to such expenses must be reduced under rules similar to the rules contained in section 50(c). Proposed § 1.48E-4(a)(6) provided that the taxpayer must pay or incur the interconnection property costs, and therefore, any reimbursement, including by a utility, must be accounted for by reducing the taxpayers' expenditure to determine eligible costs. The preamble to proposed § 1.48E-4(a)(6) explained that a taxpayer that is reimbursed for these costs may not include such reimbursed costs in the amount paid or incurred by the taxpayer for qualified interconnection property. In the case of a utility reimbursing a taxpayer for costs the taxpayer pays or incurs for qualified interconnection property, the utility should provide the taxpayer with information regarding such costs by the date on which the project is placed in service.
                    </P>
                    <P>The preamble to the proposed regulations explained that the Treasury Department and the IRS are aware of common situations in which a taxpayer could ultimately receive a payment, credit, or service from another entity, including a utility, related to the costs the taxpayer pays or incurs for qualified interconnection property. For example, one taxpayer may place in service a qualified facility and make payments to a utility with respect to qualified interconnection property involving the addition, modification, or upgrade to the utility's transmission system related to such qualified facility. Subsequently, a different taxpayer may, at a later date, place in service a qualified facility and make payments to the same utility related to the same additions, modifications, or upgrades to the utility's transmission system that were made in response to the first taxpayer's interconnection. The utility may pay, credit, or provide services to the first taxpayer in an amount related to the costs paid by the second taxpayer. The likely amount or timing of any such payment, credit, or service would be unknown at the time the first taxpayer interconnects to the utility's transmission system.</P>
                    <P>Additionally, in the preamble to the proposed regulations, the Treasury Department and the IRS requested comments on several issues related to reimbursements. The Treasury Department and the IRS requested comment on whether such payment, credit, or service received by the first taxpayer, as a result of subsequent payments made to a utility by other parties, should be treated as a reimbursement to the first taxpayer and impact the amount of the costs of qualified interconnection property that the first taxpayer may include in its basis for purposes of the section 48E credit. The Treasury Department and the IRS also requested comment on whether the costs paid by the second taxpayer should be treated as amounts paid or incurred for qualified interconnection property in connection with the installation of the second taxpayer's qualified facility. The Treasury Department and the IRS requested comment on industry practices relevant to the determination of costs paid or incurred for qualified interconnection property, including the accounting treatment of costs paid or incurred for qualified interconnection property. The Treasury Department and the IRS also requested comment on whether any clarifications are needed regarding the tax treatment of amounts paid or incurred for qualified interconnection property, including reimbursement of costs paid or incurred by a taxpayer for qualified interconnection costs.</P>
                    <P>In addition to updates discussed in Sections III.D.1 through 6, the final regulations clarify the definition of an interconnection agreement in § 1.48E-4(a)(4) by stating that in the case of the election provided under section 50(d)(5) (relating to certain leased property), the term includes an agreement regarding a qualified facility leased by such taxpayer.</P>
                    <HD SOURCE="HD3">1. Qualified Interconnection Property</HD>
                    <P>Some commenters requested clarification on whether certain costs are considered amounts paid or incurred for qualified interconnection property. A commenter requested that the final regulations confirm that equipment required to modify and upgrade transmission or distribution systems beyond the point of interconnection would be considered qualified interconnection property.</P>
                    <P>
                        Section 48E(b)(4) provides that the term “qualified interconnection property” has the meaning given such term in section 48(a)(8)(B). Section 48(a)(8)(B) defines, in relevant part, the term “qualified interconnection property” to mean, with respect to an energy project that is not a microgrid controller, any tangible property that is part of an addition, 
                        <E T="03">modification, or upgrade</E>
                         to a transmission or distribution system that is required at or beyond the point at which the energy project interconnects to such transmission or distribution system in order to accommodate such interconnection. Proposed § 1.48E-4(a)(2) adopted this definition. The Treasury Department and the IRS confirm that under this definition, tangible property required to modify and upgrade transmission or distribution systems beyond the point of interconnection would (provided the property satisfies the other requirements of section 48(a)(8)(B)) be considered qualified interconnection property and eligible for inclusion in basis for purposes of the section 48E credit.
                    </P>
                    <P>Another commenter requested that the final regulations expand the definition of qualified interconnection property to include grid-enhancing property. A definitive response to this comment would require the Treasury Department and the IRS to conduct a complete factual analysis of the property in question, which would include information beyond that which was provided by the commenter. Because more information is needed to make the determinations requested by the commenter, the requested clarifications are not addressed in these final regulations.</P>
                    <P>
                        A commenter requested that, in instances in which the taxpayer funds network upgrades and is then later reimbursed by the transmission owner, taxpayers not be required to account for any reimbursements of interconnection-related expenses paid in later years to the taxpayer. Another commenter requested that in such a scenario, the final regulations should disregard reimbursements to the extent that the reimbursement is includable in the taxpayer's gross income. The commenter also asserted that in circumstances in which the taxpayer receives a later payment from a customer utilizing the qualified interconnection property, the taxpayer be permitted to treat the payments as revenue, rather than reimbursement. One of the commenters also requested confirmation that taxpayers can include in their basis qualifying interconnection costs recovered through “Transmission 
                        <PRTPAGE P="4021"/>
                        Owner Initial Funding.” According to the commenters, in certain regional markets, the transmission owner funds the costs of interconnection upgrades for which a taxpayer is responsible, and the taxpayer then reimburses the transmission owner over a certain period, typically 20 years. The commenters requested that a taxpayer with such an arrangement be allowed to include the full amount of interconnection costs that it will ultimately pay over that period in calculating their section 48E credit for the taxable year that the qualified facility is placed in service.
                    </P>
                    <P>The Treasury Department and the IRS note that the statute limits qualified interconnection property to tangible property. In the case of a taxpayer that pays costs over 20 years, the commenters do not describe whether these amounts paid may include amounts that are not tangible property. To the extent commenters are asking generally about the inclusion of the full allocated cost of interconnection upgrades and, therefore, any amounts paid or incurred by the taxpayer for qualified interconnection property, the Treasury Department and the IRS recognize these payments could include a number of markups that the utility that builds and owns the relevant interconnection property might charge for that property (whether currently or over a later reimbursement period), such as the markup for a rate of return or other costs (for example, a tax gross-up). Whether specific costs are allowable would be a fact-specific inquiry related to, among other things, whether such costs are incurred with respect to eligible tangible property. Therefore, the final regulations do not adopt commenters' suggestion to provide that the full allocated cost of interconnection upgrades is always eligible, although in many cases it may be. However, the Treasury Department and the IRS clarify that it is not determinative whether such costs are charged upfront or over time.</P>
                    <P>The final regulations under § 1.48E-4(a)(2) also clarify that for purposes of determining the original use of interconnection property in the context of a sale-leaseback or lease transaction, the principles of section 50(d)(4) must be taken into account, as applicable, with such original use determined on the date of the sale-leaseback or lease.</P>
                    <HD SOURCE="HD3">2. Interaction With Other Bonus Credit Amounts</HD>
                    <P>Commenters requested that the final regulations clarify the interaction between the rules for qualified interconnection costs and the computation of the domestic content bonus credit amount and the increased credit amount for energy projects located in an energy community since this clarification was provided in section 48.</P>
                    <P>Section 48E(b)(4) provides that the term “qualified interconnection property” has the meaning given such term in section 48(a)(8)(B). Section 48(a)(8)(B) defines qualified interconnection property as distinct from the definition of “energy property” provided in section 48(a)(3). Additionally, section 48(a)(8)(A) includes amounts paid or incurred for qualified interconnection property meeting certain requirements for purposes of determining the credit under section 48(a). Similarly, section 48E(b)(1) includes expenditures paid or incurred by the taxpayer for qualified interconnection property meeting certain requirements for purposes of determining a qualified investment under section 48E(a) and defines qualified interconnection property discretely from a qualified facility eligible under section 48E(a)(1). Given that qualified interconnection property is not part of a qualified facility, § 1.48E-4(a)(2) provides that qualified interconnection property is not taken into account to determine if a qualified facility meets the requirements for the increase in credit rate for energy communities or domestic content. Therefore, no further clarification is needed in the final regulations.</P>
                    <P>Additionally, because the credit under section 48E(a) is calculated by multiplying the applicable percentage—which includes any domestic content bonus credit amount—by the basis of the qualified facility—which includes amounts paid or incurred by the taxpayer for qualified interconnection property, qualified interconnection costs are taken into account in calculating the domestic content bonus credit amount and the increased credit amounts for energy projects located in an energy community and for certain facilities placed in service in connection with low-income communities.</P>
                    <HD SOURCE="HD3">3. Basis Reduction</HD>
                    <P>For purposes of section 48E(b), the term “qualified interconnection property” has the meaning given such term in section 48(a)(8)(B). There are no additional references to section 48(a)(8) other than section 48(a)(8)(B). As a result, the basis reduction language in section 48(a)(8)(E), which provides that in the case of expenses paid or incurred for interconnection property, amounts otherwise chargeable to capital account with respect to such expenses are to be reduced under rules similar to the rules of section 50(c), is not explicitly incorporated. However, the Treasury Department and the IRS determined that the section 50(c) basis reduction rules apply because section 50(c) provides for basis adjustments to investment credit property generally. Section 50(c) has two basis adjustment rules that could apply to interconnection property, section 50(c)(1) or (3). Although interconnection property is not part of a qualified facility as provided in proposed § 1.48E-4(a)(2), qualified interconnection costs are included in the basis used to calculate the section 48E credit. Therefore, the Treasury Department and the IRS confirm the special rule in section 50(c)(3)(A), which provides for a basis reduction of 50 percent in the case of any section 48E credit, applies to qualified interconnection property that is properly chargeable to capital account of the taxpayer which is the amount included in the basis used to calculate the section 48E credit.</P>
                    <HD SOURCE="HD3">4. Reimbursements and Other Cost Reductions</HD>
                    <P>The proposed regulations requested comment on several issues related to reimbursement. Generally, the proposed regulations requested feedback on treatment of reimbursements in common situations in which a taxpayer could ultimately receive a payment, credit, or service from another entity, including a utility, related to the costs the taxpayer pays or incurs for qualified interconnection property. The proposed regulations also requested comments on the outcome when a different taxpayer makes payments to a utility for the same additions, modifications, or upgrades of another taxpayer. Comments were also requested on industry practices and tax implications of reimbursements. In response to these requests, a commenter requested the final regulations clarify that a taxpayer is not required to reduce its section 48E credit on account of any reimbursement of interconnection costs in the absence of a fixed right (that is specific in amount and time) to receive the reimbursement at the time the taxpayer incurs the interconnection costs. This commenter recommended that the final regulations include rules that are administrable and provide only a single credit on qualified interconnection costs (for example, a case in which another possible section 48E claimant reimburses directly or indirectly a first claimant).</P>
                    <P>
                        Other commenters requested clarification of the reimbursement rules under specific scenarios. One commenter suggested that for cases in 
                        <PRTPAGE P="4022"/>
                        which the taxpayer funds network upgrades and is later reimbursed by the transmission owner, the final regulations should avoid accounting for any reimbursements of interconnection-related expenses paid in later years to the taxpayer.
                    </P>
                    <P>
                        Another commenter suggested that including reimbursed interconnection costs in the credit basis should be based on whether the amounts are includible in gross income. The commenter stated that in circumstances in which a utility reimburses a qualified facility owner under a set schedule, the final rule should disregard the utility's reimbursements to the extent that the reimbursement is includable in a taxpayer's gross income. The commenter added that if a subsequent interconnection customer's use of the qualified interconnection property results in a later payment or credit to the taxpayer, the payment or credit should be treated as revenue rather than reimbursement. The commenter also requested clarification that in circumstances in which a qualified facility owner pays for qualified interconnection property 
                        <E T="03">without</E>
                         reimbursement, the owner should be able to utilize the full cost of those facilities in determining its investment tax credit.
                    </P>
                    <P>The Treasury Department and the IRS recognize that situations may arise in which the initial amount paid or incurred for qualified interconnection property is reduced after the taxable year in which the taxpayer claims the section 48E credit. The Treasury Department and the IRS also recognize that other complicated situations may arise in determining whether a taxpayer has paid or incurred qualified interconnection costs. The comments received confirmed that these questions are not unique to the reimbursement of qualified interconnection costs and may also arise in the context of other tax credits. Therefore, the determination of whether qualified interconnection costs have been paid or incurred by the taxpayer and whether such amounts are reduced by virtue of transactions with the utility or with a third party should be based on generally applicable Federal tax principles.</P>
                    <P>In consideration of the comments, the final regulations revise the rule under § 1.48E-4(a)(6) regarding reduction to amounts chargeable to capital account to reflect the application of Federal tax principles to such transactions in determining the amount a taxpayer paid or incurred for qualified interconnection costs. The final regulations at § 1.48E-4(a)(1) explain that if the costs borne by the taxpayer are reduced by utility or non-utility payments, Federal tax principles may require the taxpayer to reduce the amount treated as paid or incurred for qualified interconnection property to determine a section 48E credit. The final regulations at § 1.48E-4(a)(7) also include two additional examples related to reducing costs borne by the taxpayer.</P>
                    <HD SOURCE="HD3">5. Five-Megawatt Limitation</HD>
                    <P>Some commenters provided feedback on the measurement rule for the Five-Megawatt Limitation provided at proposed § 1.48E-4(a)(3). Two commenters suggested that the Five-Megawatt Limitation be modified to clarify the relevant measurement is performed at the point of output (that is, 5 MW AC at the inverter) rather than nameplate generation capacity to better align with section 48E(b)(1)(B). As described by one of the commenters, the text of section 48E(b)(1)(B) does not contain the words “nameplate” or “capacity” and instead it specifically refers to the 5 MW limit by reference to “output . . . measured in alternating current” which, for solar photovoltaic systems can only be read to refer to post-inverter measurement. Another commenter recommended that the final regulations refer only to output measured in alternating current, without presuming that the direct current nameplate capacity is identical. Additionally, this commenter requested that the final regulations specifically clarify that qualified facilities be defined at the inverter level for the limited purpose of evaluating if they meet the Five-Megawatt Limitation, as this is the source of any alternating current output.</P>
                    <P>Measuring output with accuracy and consistency must be done using a defined standard. The Treasury Department and the IRS conclude that nameplate generating capacity is the best and most practical measure of the maximum net output of a unit of qualified facility. Nameplate generating capacity is an objective and identifiable standard that can be accurately measured with consistency. Therefore, the Treasury Department and the IRS do not adopt the comment suggesting changes to the use of nameplate capacity. The final regulations at § 1.48E-4(a)(3)(ii) retain the rule that the determination of whether a qualified facility has a maximum net output of not greater than 5 MW (as measured in alternating current) is based on the nameplate capacity of the unit of qualified facility.</P>
                    <P>Regarding measurement of the Five-Megawatt Limitation in alternating or direct current, the Treasury Department and the IRS understand the commenter's concerns and agree that the rule provided in the proposed regulations should be revised. Section 48E(b)(1)(B)(i)(I) refers to a maximum net output of not greater than five megawatts (as measured in alternating current). Proposed § 1.48E-4(a)(3)(ii) provided for nameplate capacity in alternating current, without addressing types of qualified facilities, such as solar facilities, that generate electricity in direct current. Nameplate capacity for these types of qualified facilities is measured before the facility's output is converted to alternating current by an inverter. Because an inverter would be considered property that is an integral part of the qualified facility and not part of the unit of qualified facility itself, measuring the nameplate capacity of a qualified facility that generates electricity in direct current would be difficult under the proposed regulations.</P>
                    <P>However, in response to comments, the final regulations provide a method of measuring nameplate capacity for a qualified facility that generates electricity in direct current. The final regulations at § 1.48E-4(a)(3)(iii) provide that, for qualified facilities that generate electricity in direct current, the taxpayer determines whether a qualified facility has a maximum net output of not greater than 5 MW (in alternating current) by using the lesser of: (i) the sum of the nameplate generating capacities within the unit of qualified facility in direct current, which is deemed the nameplate generating capacity of the unit of qualified facility in alternating current; or (ii) the nameplate capacity of the first component of the qualified facility that inverts the direct current electricity generated into alternating current. This rule provides flexibility for taxpayers while ensuring that the maximum net output (in alternating current) of a qualified facility can be determined in an administrable and reasonably accurate manner for qualified facilities that generate electricity in direct current.</P>
                    <P>A few commenters suggested providing additional examples to illustrate output rules for interconnection property. Another commenter recommended finalizing Example 1 in proposed § 1.48E-4(a)(7)(i) which specified that two section 48E facilities, each with a maximum output of 5 MW AC, can share—and treat as qualified interconnection property—a step-up transformer, which is integral to both properties.</P>
                    <P>
                        In response to commenters that requested additional clarification of the Five-Megawatt Limitation, the final 
                        <PRTPAGE P="4023"/>
                        regulations add an additional example under § 1.48E-4(a)(7) as well as provide clarifications to the existing examples. These clarifications illustrate the revised method of measuring nameplate capacity for a qualified facility that generates electricity in direct current. The clarifications also demonstrate the application of the Five-Megawatt Limitation in cases in which the nameplate capacity differs from the maximum output provided in the interconnection agreement. Specifically, the newly added example describes the application of the Five-Megawatt Limitation to separate interconnection agreements for a single qualified facility made up of units of a qualified facility owned by a single taxpayer. In that example, although the taxpayer has interconnection agreements with the utility that each allow for a maximum output of 10 MW (as measured in alternating current), the taxpayer may include the costs taxpayer paid or incurred for qualified interconnection property, subject to the terms of the interconnection agreement, to calculate the taxpayer's section 48E credits for each of the qualified facilities because each has a maximum net output of not greater than 5 MW (alternating current).
                    </P>
                    <HD SOURCE="HD3">6. Energy Storage Technology</HD>
                    <P>Two commenters suggested that the final regulations permit interconnection costs for stand-alone EST. Both commenters explained that although sections 48E(b) and (c) do not mention eligible interconnection costs in the context of stand-alone EST, the term “qualified interconnection property” is defined by reference to section 48(a)(8). Therefore, according to the commenters, this result is supported because the statutory text of that section expressly includes “amounts paid or incurred by the taxpayer for qualified interconnection property . . . to provide for the transmission or distribution of the electricity produced or stored by such property.” These commenters also added that this result would reconcile sections 48 and 48E and would advance the IRA's express policy of encouraging storage deployment.</P>
                    <P>
                        Based on the explicit language of section 48E, the Treasury Department and the IRS disagree that including costs for qualified interconnection property for a standalone EST is supported by the statute. Section 48E(c)(1), which describes the qualified investment 
                        <E T="03">with respect to EST,</E>
                         does not refer to qualified interconnection property.
                    </P>
                    <P>Section 48E(b)(1) generally provides, in part, that the qualified investment with respect to any qualified facility for any taxable year includes the amount of any expenditures which are both paid or incurred by the taxpayer for qualified interconnection property in connection with a qualified facility which has a maximum net output of not greater than 5 megawatts (as measured in alternating current), and placed in service during the taxable year of the taxpayer. The amount of any expenditures which are paid or incurred by the taxpayer for qualified interconnection property must also be properly chargeable to capital account of the taxpayer. Section 48E(b)(4) defines qualified interconnection property by reference to section 48(a)(8)(B). While commenters are correct that the reference to qualified interconnection property in section 48(a)(8)(A) also refers to “electricity stored,” the cross-reference applicable for qualified facilities is to section 48(a)(8)(B) (the definition of qualified interconnection property) and there is no similar cross-reference in section 48E to support including the costs of qualified interconnection property for an EST. The overt omission of a reference to qualified interconnection property in section 48E(c), which provides rules for determining qualified investment with respect to an EST is instructive. The clear exclusion of qualified interconnection property for EST under section 48E(c)(1), particularly when compared to its inclusion in section 48E(b)(1)(B)(i)(I), demonstrates Congressional intent. Therefore, the final regulations do not adopt commenters' recommendation that expenditures paid or incurred by the taxpayer for qualified interconnection property are includible in the section 48E credit for EST.</P>
                    <P>
                        As discussed earlier, the Treasury Department and the IRS understand that some hybrid systems (such as those for a solar qualified facility and EST) operate under a single interconnection agreement.
                        <SU>1</SU>
                        <FTREF/>
                         In these situations, while expenditures paid or incurred by a taxpayer for qualified interconnection property are not includible in the section 48E credit for an EST, those expenditures paid or incurred for qualified interconnection property that are properly allocated to the qualified facility (for example, the solar qualified facility) may be included in the credit base for the qualified facility's qualified investment for the section 48E credit.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             In some configurations, the addition of EST to a qualified facility may have no or limited impact on the interconnection costs of that hybrid facility.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">E. 80/20 Rule</HD>
                    <P>As noted earlier, the 80/20 Rule is designed to broaden the availability of the investment credit by providing a new original placed in service date for a qualified facility that includes some components of property previously placed in service, rather than requiring the qualified facility to be composed entirely of new components of property. In the context of section 48E, the 80/20 Rule applies at the qualified facility level to the components of property within the unit of qualified facility or unit of EST.</P>
                    <P>Proposed § 1.48E-4(c)(1) provided that for purposes of section 48E(b)(3)(A)(ii), a facility may qualify as originally placed in service even if it contains some used components of property within the unit of qualified facility, provided that the fair market value of the used components of the unit of qualified facility is not more than 20 percent of the unit of qualified facility's total value (that is, the cost of the new components of property plus the value of the used components of property within the unit of qualified facility). In addition to providing a new placed in service date for a qualified facility that includes some components of property that have previously been placed in service, the 80/20 Rule also encourages investment in the retrofitting of existing facilities.</P>
                    <P>Although this section focuses on the 80/20 Rule in the section 48E context, section II.F. of this Summary of Comments and Explanation of Revisions describes comments received on both sections 45Y and 48E. As described in that section, the Treasury Department and the IRS confirm that if a qualified facility under section 45 or energy property or EST under section 48 is later retrofitted in a manner that satisfies the 80/20 Rule, it will be considered a new qualified facility or a new EST and may be eligible for a section 48E credit so long as the qualified facility or EST meets all requirements of section 48E. Additionally, the Treasury Department and the IRS confirm that section 48E does not refer to a project or system but in the case of section 48E to a qualified facility and an EST.</P>
                    <HD SOURCE="HD3">1. Relevance of Prior Section 48 Guidance</HD>
                    <P>
                        Prior guidance and regulations under section 48 are not binding for purposes of section 48E. However, several commenters stated that application of the 80/20 Rule as proposed violated longstanding precedent under section 48. These commenters stated that under section 48 as previously applied, 
                        <PRTPAGE P="4024"/>
                        taxpayers would be allowed to claim the section 48E credit for capital improvements as well as additions or modifications to existing property without regard to the 80/20 Rule. Further, some commenters suggested that the 80/20 Rule as originally applied in the section 48 context was only relevant for addressing the “original use requirement” for property and was not intended to prevent additions of new property from qualifying for a credit. These commenters pointed to Example 2 in § 1.48-2(b)(7) and Examples 4 and 5 in § 1.48-2(c), to illustrate that, in the context of the section 48 credit, the 80/20 Rule was intended to address the “original use requirement.” Consistent with this view, several commenters asserted that the prohibition against claiming the section 48E credit for additions that do not meet the 80/20 Rule (Excluded Costs Rule) is inconsistent with the statute and regulations and should be removed.
                    </P>
                    <P>One commenter, like many others that asserted that the application of the 80/20 Rule for purposes of section 48E is contrary to historical precedent, also focused on the negative economic impact. The commenter stated that the proposed regulations would negatively impact the economics of both existing and future development of clean energy projects and that existing project investments were based on reasonable reliance that future capital improvements would be eligible for the section 48E credit without regard to the 80/20 Rule. Similarly, another commenter stated it did not see a policy rationale for application of the 80/20 Rule in the manner provided in the proposed regulations, as it would lead to uneconomic decisions, such as favoring demolition and rebuilding instead of capital expenditures to modify an existing energy property and, like others, pointed to what they view as inconsistency with more than 60 years of prior investment tax credit (ITC) precedent.</P>
                    <P>The Treasury Department and the IRS understand the concerns raised by commenters. However, prior guidance and regulations based on section 48 are not binding for purposes of section 48E. Section 48E provides a credit only for a qualified investment with respect to a qualified facility or an EST and not for components of property within a qualified facility or an EST. For the reasons provided here, the Treasury Department and the IRS believe that the best interpretation of “qualified investment with respect to a qualified facility or an EST” is that if a taxpayer does not place in service a qualified facility or an EST, a taxpayer is not eligible for a credit. Therefore, the application of the 80/20 Rule to the section 48E credit in the proposed regulations benefits taxpayers by providing a path to access the section 48E credit when less than an entirely new qualified facility or EST is placed in service.</P>
                    <P>Section 48E contains several features that require the credit to be analyzed at the level of a qualified facility or an EST. The PWA requirements are applied to a qualified facility or an EST under section 48E(a)(2)(A) and (B). Likewise, determining whether the increased credit amounts for domestic content and energy communities also apply to a qualified facility or an EST. Finally, determining whether a taxpayer may include qualified interconnection property expenditures is tied to the maximum net output of a qualified facility. These determinations cannot be made with respect to individual components of property. This statutory construction clearly contemplates calculating the credit on the basis of an entire qualified facility or EST. Applying the 80/20 Rule for purposes of section 48E provides taxpayers with an opportunity for additions of property to an existing facility or an EST to be eligible for the section 48E credit if the rule is satisfied.</P>
                    <P>Other commenters pointed to what they describe as longstanding rules that otherwise ITC-eligible improvements made to existing energy property may qualify for the ITC. One commenter stated that the IRA did not change this rule in any way. According to this commenter, application of the 80/20 Rule has always uniquely been relevant for purposes of the production tax credit (PTC) and is simply not relevant for purposes of the ITC. The Treasury Department and the IRS affirm the role of the 80/20 Rule in the ITC context to allow for additions of new property to an existing facility or EST to be eligible for the section 48E credit if the rule is satisfied.</P>
                    <HD SOURCE="HD3">2. Excluded Costs</HD>
                    <P>Several commenters asserted that section 48E allows a credit for adding components or making capital additions to a qualified facility. One commenter concluded that capital improvements should not be penalized under the 80/20 Rule. According to the commenter, owners of a qualified facility, such as a solar qualified facility, should be allowed to upgrade or replace components and claim new section 48E credits. The commenter pointed to two examples in the existing Treasury Regulations under section 48 that the commenter stated illustrate the proper interpretation of the original use requirement in § 1.48-2(b)(7) and the difference between a reconditioned or rebuilt unit of property previously placed in service and/or the use of “some used parts,” on the one hand, and the addition of new property or capital improvements, on the other.</P>
                    <P>Another commenter stated that the excluded costs described in proposed § 1.48E-4(c)(5) are unclear because a taxpayer is always adding new components to used components, and it should be reworded to clarify that it does not imply that the taxpayer must exclude the cost of new components when a taxpayer adds them to used components.</P>
                    <P>Some of these commenters requested that the 80/20 Rule and the Excluded Costs Rule provided at proposed § 1.48E-4(c)(5) not apply for section 48E purposes to additions of otherwise eligible new components of property added to an existing qualified facility on which a PTC was not claimed. As an example, the commenter asserted that the owner of a solar qualified facility should be able to make capital improvements to upgrade or replace existing solar modules or inverters and claim a new section 48E credit without regard to the 80/20 Rule on such capital improvements. This commenter stated that the 80/20 Rule should only apply when a new category of components is added to an existing qualified facility comprised of different categories of components (such as wind being added to solar), then that new category of component should be treated as a separate “unit of qualified facility.” The commenter stated that this result is also consistent with the IRA generally, which does not prevent a taxpayer from claiming both a PTC with respect to the output of a qualified facility and an ITC with respect to any associated EST. The commenter stated that this is also consistent with Notice 2018-59.</P>
                    <P>
                        Another commenter explained that the 80/20 Rule has its origins under the section 48 credit and in the context of the section 48 regulations the phrase, “some used parts,” that has been the focus of the IRS's administrative practice for almost 60 years. According to the commenter, Rev. Rul. 68-111, 1968-1 C.B. 29, reflects the proper application of the 80/20 Rule albeit under a prior version of the section 48 credit. The commenter asserted that the Excluded Costs Rule in proposed § 1.48E-4(c)(5) distorts the 80/20 Rule by shifting the focus from the use of “used parts” at the time the unit of property is originally placed in service to “new” property and capital improvements that are added later.
                        <PRTPAGE P="4025"/>
                    </P>
                    <P>The Treasury Department and the IRS note that the application of the 80/20 Rule clarifies that expenditures for components of property that are not a unit of qualified facility can only qualify if the 80/20 Rule is satisfied, and thus any new property and capital improvements added later that are not a unit of qualified facility are ineligible for a section 48E credit unless the 80/20 Rule is satisfied. In response to the commenters that asserted that section 48E allows a credit for a component of property rather than a qualified facility, the Treasury Department and the IRS disagree with commenters' interpretation of the statutory language. The Treasury Department and the IRS also emphasize that existing regulations under § 1.48-2 do not reflect the current version of section 48 and are not applicable to section 48E. Additionally, a taxpayer who makes a capital improvement to an existing facility should consider the application of the Incremental Production Rule provided in § 1.45Y-4(d). Similarly, a taxpayer that makes modifications to an EST should consider the application of the rule provided at § 1.48E-2(g)(7).</P>
                    <P>Another commenter suggested that the purpose of the 80/20 Rule is to allow a facility that was placed in service prior to January 1, 2025, to nevertheless satisfy the requirement in section 48E(b)(3)(A)(ii) that a qualified facility be placed in service after December 31, 2024, if a substantial portion of the facility is reconstructed after 2024.</P>
                    <P>The Treasury Department and the IRS disagree that the 80/20 Rule is tied to a particular year. The 80/20 Rule allows a taxpayer to treat an existing facility as originally placed in service at a later date by adding new components of property that represent at least 80 percent of the value of the unit of qualified facility. A retrofitted qualified facility or EST will be eligible for the section 48E credit if it meets the requirements of the 80/20 Rule before the section 48E credit phases out.</P>
                    <HD SOURCE="HD3">3. Recapture</HD>
                    <P>A commenter stated that if the Treasury Department and the IRS retain the Excluded Costs Rule as written, the final regulations should further clarify that investment tax credit recapture rules will not apply to additions of property that do not satisfy the 80/20 Rule. Generally, recapture under section 48E is governed by section 50(a)(1)(A), which provides for recapture of the credit if property ceases to be investment credit property. Additions of property that do not satisfy the 80/20 Rule and that are thus subject to the Excluded Costs Rule are not included in the calculation of the section 48E credit. Accordingly, there is no credit to recapture with respect to such additions of property.</P>
                    <HD SOURCE="HD3">4. Original Use Requirement</HD>
                    <P>
                        Some commenters asserted that the original use requirement applies only to 
                        <E T="03">acquired</E>
                         property, and therefore, the 80/20 Rule is unnecessary for other types of property. These commenters pointed to section 48E(b)(2)(C), which provides, in part, that qualified property means property (i) the construction, reconstruction, or erection of which is completed by the taxpayer, or (ii) which is acquired by the taxpayer if the original use of such property commences with the taxpayer. This language was incorporated at proposed § 1.48E-2(f)(3) through (5). The commenters cited this language to support their view that the original use requirement applies only to acquired property. Therefore, according to the commenters, the “original use” requirement applies to property acquired by a taxpayer, but does not apply to property the construction, 
                        <E T="03">reconstruction,</E>
                         or erection of which is completed by the taxpayer. The commenters concluded that this statutory language supports the position that capital additions to an existing qualified facility or EST qualify for the section 48E credit.
                    </P>
                    <P>The Treasury Department and the IRS disagree with the commenters' interpretation of the statutory language and corresponding language in the proposed regulations. The commenters are correct that section 48E(b)(2)(C)(ii) requires original use for acquired property, whereas section 48E(b)(2)(C)(i) does not mention original use with respect to property that is constructed, reconstructed, or erected by or for the taxpayer, however, that is because an original use requirement is unnecessary in the latter context. The taxpayer that is claiming a credit for property that it constructed, reconstructed, or erected by or for such taxpayer will necessarily be the original user of such property. Although some commenters suggested the 80/20 Rule has historically been applied in the section 48 context with respect to the original use requirement, the Treasury Department and the IRS emphasize that the 80/20 Rule was first applied to the section 48 credit through guidance issued in the Internal Revenue Bulletin providing beginning of construction guidance. The Treasury Department and the IRS reiterate that for section 48E purposes, the 80/20 Rule allows a taxpayer that retrofits an existing facility to treat such facility as a new qualified facility or EST.</P>
                    <HD SOURCE="HD3">5. EST</HD>
                    <P>In the context of section 48E, the proposed regulations discussed the 80/20 Rule for purposes of retrofitting a qualified facility but did not specifically address the application of the 80/20 Rule to EST. Some commenters asked if the 80/20 Rule applied to EST. Commenters requested that the final regulations clarify that the 80/20 Rule also applies to EST, including battery energy storage systems and pumped storage hydropower. Another commenter stated that new component categories, like EST, added to existing facilities should be treated as separate units of qualifying facility and exempted from the 80/20 Rule.</P>
                    <P>In response to these comments, the Treasury Department and the IRS note that the 80/20 Rule applies to EST. The 80/20 Rule, as it is applied to EST, is a separate rule from the modification of EST provided by the section 48E(c)(2) reference incorporating section 48(c)(6)(B) (modifications of EST). The final regulations adopt the application of the 80/20 Rule for EST, and this Summary of Comments and Explanation of Revisions addresses EST in regard to the 80/20 Rule. With respect to the addition of EST to a site with an existing qualified facility, the Treasury Department and the IRS note that an EST is separate from a qualified facility as discussed in section III.C.2. of this Summary of Comments and Explanation of Revisions. As a result, merely adding an EST to a site with an existing qualified facility does not require application of the 80/20 Rule.</P>
                    <HD SOURCE="HD3">6. Specific Technologies</HD>
                    <P>Some commenters asked for specific clarifications regarding the 80/20 Rule and particular technologies. A commenter suggested that in the case of a hydropower facility combined with a pumped storage hydropower facility, each powerhouse generating unit (turbine or pump turbine, generator and controls) should be considered a unit of qualified facility for purposes of the final regulations. Additionally, this commenter asserted, that, in the case of a wind facility, the functionally interdependent components of a unit of qualified facility should be the turbine, tower, and foundation pad. In both cases, the commenter requested that the 80/20 Rule apply to the functionally interdependent components of the unit of qualified facility.</P>
                    <P>
                        For purposes of the section 45Y and section 48E credits, the unit of qualified facility includes all functionally interdependent components of property (as defined in proposed § 1.48E-
                        <PRTPAGE P="4026"/>
                        2(d)(2)(ii)) owned by the taxpayer that are operated together and that can operate apart from other property to produce electricity. The final regulations adopt these rules, which provide a function-oriented approach to determine if property is considered part of the qualified facility that generates electricity, to ensure that the final regulations are broad enough to encompass nascent technologies without rendering the regulations quickly obsolete. After consideration of the comments, an example of the application of the 80/20 Rule to a qualified hydropower production facility has been added to the final regulations under § 1.48E-4(c)(6)(v). Additionally, the Treasury Department and the IRS made revisions to Example 3 of § 1.48E-4(c)(6)(iii), similar to those made for § 1.45Y-4(d)(3)(iii), that removed the reference to a decommissioned nuclear facility to avoid referring to decommissioned and restarted nuclear facilities in the Incremental Production Rule and the 80/20 Rule.
                    </P>
                    <P>
                        Another commenter specifically asked that the 80/20 Rule be eliminated for certain types of facilities such as power generation, thermal generation, or CHP facilities upgraded to be carbon neutral. To support this request, the commenter noted that the 80/20 Rule discourages the use of existing infrastructure in CHP applications. While the Treasury Department and the IRS appreciate the concerns raised for particular technologies, as described in the preamble to the proposed regulations, a qualified facility generally does not include equipment that is an addition or modification to an existing qualified facility or EST. However, 
                        <E T="03">see</E>
                         § 1.48E-4(b) regarding the Incremental Production Rule.
                    </P>
                    <HD SOURCE="HD3">7. Interaction Between the Incremental Production Rule and the 80/20 Rule</HD>
                    <P>Some commenters were concerned about the interaction of the Incremental Production Rule and the 80/20 Rule and the provided at proposed §§ 1.45Y-4(c) and 1.48E-4(b). One commenter requested that the Treasury Department and the IRS make clear that the provision for retrofitted facilities is separate and distinct from the requirements for the Incremental Production Rule, and that if there is any overlap between the two, the 80/20 Rule should control. The commenter stated that a retrofitted facility that results in the addition of capacity should be treated as newly placed in service if it meets the 80/20 Rule (rather than requiring the retrofitted facility to follow the Incremental Production Rule).</P>
                    <P>Another commenter recommended clarifying when to apply one rule or the other in situations in which both the 80/20 and Incremental Production rules could apply. A commenter also asserted that the statutory text under sections 45Y(b)(1)(C) and 48E(b)(3)(B)(i), regarding the Incremental Production Rule, is without regard to the 80/20 Rule or the facility's original placed in service date, and that, therefore, Congress sought to incentivize investment in existing facilities without requiring taxpayers to meet the 80/20 Rule. Similarly, commenters recommended providing an example of a decommissioned facility without any reference to the 80/20 Rule, and to revise Example 3 in proposed § 1.45Y-4(d)(3)(iii), regarding the 80/20 Rule, to remove the reference to decommissioning.</P>
                    <P>The Treasury Department and the IRS agree that the Incremental Production Rule provided in sections 45Y(b)(1)(C) and 48E(b)(3)(B)(i) are separate and distinct from the 80/20 Rule. If a retrofitted facility satisfies the 80/20 Rule, the final regulations provide that the facility will be treated as newly placed in service even if the taxpayer also satisfies the Incremental Production Rule. Separately, these final regulations provide an additional example, in § 1.48E-4(b)(5), which specifically addresses decommissioned and restarted facilities. Additionally, § 1.48E-4(c)(1) is clarified to confirm that a qualified facility or EST may claim the full available credit rather than the credit resulting from an addition of capacity. Finally, Example 3 in § 1.45Y-4(d)(3)(iii) is modified to remove the reference to decommissioning.</P>
                    <P>Another commenter requested clarification that even if a facility placed in service before 2025 (pre-2025 facility) fails the 80/20 Rule, property that is added to the facility may still qualify for the section 48E credit under the Incremental Production Rule in section 48E(b)(3)(B)(i). Proposed § 1.48E-4(b)(1) provided, in part, that the term qualified facility includes either a new unit or an addition of capacity placed in service after December 31, 2024, in connection with a facility described in section 48E(b)(3)(A) (without regard to section 48E(b)(3)(A)(ii)), which was placed in service before January 1, 2025, but only to the extent of the increased amount of electricity produced at the facility by reason of such new unit or addition of capacity. Thus, a pre-2025 facility that fails the 80/20 Rule may still qualify for the section 48E credit under the Incremental Production Rule. Additionally, the Treasury Department and the IRS confirm that this rule will apply to a pre-2025 facility regardless of whether it satisfies the 80/20 Rule.</P>
                    <HD SOURCE="HD3">8. Other Comments</HD>
                    <P>While the majority of commenters that opposed the 80/20 Rule suggested eliminating it, particularly the Excluded Costs Rule, one commenter provided an additional recommendation. This commenter recommended that the proposed regulations be revised to permit taxpayers to elect either the 80/20 Rule or a rule based on the original cost of the qualified facility (Original Cost Rule). Under the Original Cost Rule as proposed by the commenter, a qualified facility would be treated as originally placed in service, even though it contains some used components of property, provided the cost of the new components of the unit of qualified facility is at least 50 percent of the original cost of the unit of qualified facility. Original cost would be defined as the unadjusted GAAP book basis at the time the qualified facility was originally placed in service. The commenter also explained that this new rule could be limited in its application and stated that outside of sections 45 and 48 an 80/20 Rule currently applies to determine eligibility for bonus depreciation under section 168(k)(7) and the carbon oxide sequestration credit under section 45Q of the Code. Therefore, the commenter requested that the final regulations adopt an optional Original Cost Rule limited to section 45Y and section 48E qualified facilities, which would limit the effect to the section 45Y and 48E credits and permit the 80/20 Rule adopted in other contexts to remain in place.</P>
                    <P>The Treasury Department and the IRS understand the commenter's desire for a less restrictive standard than what the proposed 80/20 Rule provides, but the Treasury Department and the IRS think the 80/20 Rule strikes the appropriate balance between allowing taxpayers flexibility and creating an incentive for new investment. Therefore, the final regulations do not adopt the commenter's proposal.</P>
                    <P>
                        After consideration of all comments expressing opposition to the 80/20 Rule in the context of section 48E, the Treasury Department and the IRS decline to modify or abandon the 80/20 Rule as requested. Section 48E(b)(1) provides that the section 48E credit is available for the qualified investment with respect to any qualified facility for any taxable year that includes the basis of any qualified property placed in service by the taxpayer during such 
                        <PRTPAGE P="4027"/>
                        taxable year which is part of a qualified facility. Section 48E(c)(1) provides that a credit for the qualified investment with respect to an EST for any taxable year is the basis of any EST placed in service by the taxpayer during such taxable year. The 80/20 Rule is designed to broaden the availability of the section 48E credit to provide a new original placed in service date for a qualified facility or EST that includes some components of a qualified facility or EST that have already been placed in service, rather than requiring the entire unit of qualified facility or EST to be composed of only new property. The 80/20 Rule also encourages retrofitting an existing qualified facility or EST provided there is sufficient new investment. As described earlier in this section on the 80/20 Rule, if a qualified facility under section 45 or energy property under section 48 is retrofitted in a manner that satisfies the 80/20 Rule, it will be considered a new qualified facility and may be eligible for the section 45Y or 48E credits if the qualified facility meets all of the sections 45Y and 48E requirements.
                    </P>
                    <P>Section 48E(c)(2) incorporates the lone express rule for modification of existing energy property that is found in section 48(c)(6)(B). This special rule is limited to modifications of existing EST. The inclusion of this specific provision suggests that modifications of existing EST that do not meet the 80/20 Rule or the Incremental Production Rule are ineligible for the section 45Y or 48E credits. Adopting the 80/20 Rule for the section 48E credit is favorable to taxpayers and encourages substantial additional investment in existing qualified facilities and EST.</P>
                    <P>As discussed in section IV.G. of this Summary of Comments and Explanation of Revisions, the ownership rules provided that the section 45Y and 48E credits are available for an entire unit of qualified facility or unit of EST and not for individual components of property. The 80/20 Rule is consistent with the ownership rules because it ensures that a qualified facility or EST that is retrofitted to a sufficient extent is considered a new qualified facility or EST, whereas the addition of mere components is not eligible for the section 48E credit.</P>
                    <HD SOURCE="HD3">F. Qualified Progress Expenditures</HD>
                    <P>Section 48E(d)(1) provides that rules similar to the rules of former section 46(c)(4) and (d) (as in effect on the day before the date of the enactment of the Revenue Reconciliation Act of 1990) apply for purposes of section 48E(a). Footnote 5 of the proposed regulations explained that the rules provided by § 1.46-5 related to qualified progress expenditures apply for purposes of section 48E(a).</P>
                    <P>Several commenters requested that the final regulations provide additional clarifications related to whether qualified progress expenditures are allowable for purposes of elective payment elections under section 6417 (section 6417 elective payment elections). Commenters requested clarifying the application of qualified progress expenditure payments to “applicable entities,” as defined in section 6417(d)(1), and confirming that progress expenditures permitted by section 48E are allowable for purposes of section 6417 elective payment elections. Commenters noted that, while section 6418(g)(4) provides an explicit statutory prohibition on using the section 6418 credit transfer election provisions for progress expenditures, a similar prohibition was not included for section 6417 elective payment elections and that, therefore, permitting applicable entities to use the section 48E credit for purposes of section 6417 elective payment elections is consistent with the statutory text of section 6417.</P>
                    <P>Given the statutory language under section 48E(d)(1), a taxpayer can make a qualified progress expenditure election, as provided in § 1.46-5, to increase its qualified investment with respect to a qualified facility or EST for the taxable year by any qualified expenditures made during such taxable year. Section 6417(b)(12) provides that the section 48E credit is an applicable credit for purposes of making an elective payment election. The statutory text of sections 48E(d)(1) and 6417(b)(12), when read in tandem, permit a taxpayer to make an elective payment election with respect to a section 48E credit determined pursuant to a qualified progress expenditure election. Therefore, the Treasury Department and the IRS confirm that for the section 48E credit, qualified progress expenditures are allowable for purposes of section 6417 elective payment elections but have determined that no change is necessary in the final regulations. The final regulations at § 1.48E-4(g) adopt language similar to footnote 5 from the proposed regulations, that the rules provided by § 1.46-5 related to qualified progress expenditures apply for purposes of section 48E(a).</P>
                    <HD SOURCE="HD3">G. Incremental Cost Rule</HD>
                    <P>One commenter requested that the final regulations “clarify the application of the `incremental cost'” concept to section 48E. Incremental cost is the excess of the total cost of equipment over the amount that would have been expended for the equipment if the equipment were not used for a qualifying purpose. The regulations under former § 1.48-9(k) provided the incremental cost rule. The preamble to the Treasury Decision (TD 7765, 46 FR 7291) that implemented this rule noted that in many instances one item of property can be used in part for a qualifying energy purpose and in part for non-qualifying functions. The preamble to TD 7765 explained that the Treasury Department and the IRS approached this situation by considering whether to deny the credit, provide partial credit, or allow a full credit. The preamble stated that simply denying the credit entirely would discourage investments, but that, on the other hand, property which incidentally serves an energy function should not receive the subsidy of a full energy credit. For these reasons, the Treasury Department and the IRS viewed the incremental cost rule as the most fair approach.</P>
                    <P>The Treasury Department and the IRS have determined that a similar approach should be taken in these final regulations. Section 1.48E-4(h)(1) provides that for purposes of section 48E, if a component of qualified property of a qualified facility or a component of property of an EST is also used for a purpose other than the intended function of the qualified facility or EST, only the incremental cost of such component is included in the basis of the qualified facility or EST. This section also defines the term “incremental cost” to mean the excess of the total cost of a component over the amount that would have been expended for the component if that component were used for a non-qualifying purpose. Section 1.48E-4(h)(2) provides an example to illustrate this rule.</P>
                    <HD SOURCE="HD3">H. Application of Normalization Opt-Out</HD>
                    <P>
                        Proposed § 1.48E-4(g)(4) referred taxpayers to section 50(d)(2) for application of the normalization rules to the section 48E credit in the case of certain regulated companies, including rules regarding the election not to apply the normalization rules to EST (as defined in section 48(c)(6) of the Code). Several commenters requested that the final regulations clarify that the normalization opt-out election provided in section 50(d)(2) is available for the section 48E credit claimed with respect to an EST, without regard to the date on which construction of such EST begins. After consideration of the comments, the requested clarification has been adopted in § 1.48E-4(i)(4).
                        <PRTPAGE P="4028"/>
                    </P>
                    <HD SOURCE="HD2">IV. Combined Qualified Facilities (Sections 45Y and 48E)</HD>
                    <P>This section covers issues that impact both sections 45Y and 48E and includes the topics: beginning of construction, property included in a qualified facility, qualified facilities and specific technologies, coordination with other credits, integral part, shared integral property, ownership, the Incremental Production Rule, and the dual use rule.</P>
                    <P>Proposed § 1.45Y-2(a) defined a “qualified facility” to mean a facility owned by the taxpayer that is used for the generation of electricity, is placed in service after December 31, 2024, and has a GHG emissions rate of not greater than zero (as determined under rules provided in proposed § 1.45Y-5).</P>
                    <P>Proposed § 1.48E-2(a) defined a “qualified facility” to mean a facility that is used for the generation of electricity, is placed in service by the taxpayer after December 31, 2024, and has a GHG emissions rate of not greater than zero (as determined under rules provided in § 1.45Y-5).</P>
                    <HD SOURCE="HD3">A. Beginning of Construction</HD>
                    <P>Notice 2022-61, 2022-52 I.R.B. 560, provides guidance regarding the prevailing wage and apprenticeship (PWA) requirements and provides guidance for determining the beginning of construction of a facility for the section 45Y and 48E credits. Section 5 of the Notice provides that, to determine when construction begins for purposes of sections 30C, 45V, 45Y, and 48E, principles similar to those under Notice 2013-29, 2013-20 I.R.B. 1085, regarding the Physical Work Test and Five Percent Safe Harbor apply, and taxpayers satisfying either test will be considered to have begun construction.</P>
                    <P>
                        Section 5 of Notice 2022-61 also provides that principles similar to those provided in certain IRS Notices 
                        <SU>2</SU>
                        <FTREF/>
                         regarding the Continuity Requirement for purposes of sections 30C, 45V, 45Y, and 48E apply. Section 5 further provides that whether a taxpayer meets the Continuity Requirement under either test is determined by the relevant facts and circumstances. Additionally, section 5 states that principles similar to those under section 3 of Notice 2016-31, 2013-44 I.R.B. 431, regarding the Continuity Safe Harbor also apply for purposes of sections 30C, 45V, 45Y, and 48E. Section 5 also provides that taxpayers may rely on the Continuity Safe Harbor provided the facility is placed in service no more than four calendar years after the calendar year during which construction began. For purposes of the section 45Y and 48E credits, Notice 2022-61 continues to apply.
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             Notice 2013-29, 2013-20 I.R.B. 1085; 
                            <E T="03">clarified by</E>
                             Notice 2013-60, 2013-44 I.R.B. 431; 
                            <E T="03">clarified and modified by</E>
                             Notice 2014-46, 2014-36 I.R.B. 520; 
                            <E T="03">updated by</E>
                             Notice 2015-25, 2015-13 I.R.B. 814; 
                            <E T="03">clarified and modified by</E>
                             Notice 2016-31, 2016-23 I.R.B. 1025; 
                            <E T="03">updated, clarified, and modified by</E>
                             Notice 2017-04, 2017-4 I.R.B. 541; Notice 2018-59, 2018-28 I.R.B. 196; 
                            <E T="03">modified by</E>
                             Notice 2019-43, 2019-31 I.R.B. 487; 
                            <E T="03">modified by</E>
                             Notice 2020-41, 2020-25 I.R.B. 954; 
                            <E T="03">clarified and modified by</E>
                             Notice 2021-5, 2021-3 I.R.B. 479; 
                            <E T="03">clarified and modified by</E>
                             Notice 2021-41, 2021-29 I.R.B. 17.
                        </P>
                    </FTNT>
                    <P>A commenter requested that final regulations clarify that projects failing to qualify for the section 45 or 48 credits due to a failure to satisfy continuity requirements may still qualify for the section 45Y or 48E credits, assuming all other requirements for the section 45Y or 48E credit are satisfied. The commenter contended that a taxpayer may meet the January 1, 2025, beginning of construction requirement to qualify for the section 45 and 48 credits, but may not be able to satisfy continuity requirements under existing IRS guidance by placing the facility in service within four years after construction began. The Treasury Department and the IRS confirm that a facility that fails to satisfy the requirements (including beginning of construction requirements) for the section 45 or 48 credit, is not disqualified from claiming either section 45Y or 48E so long as the facility meets all requirements under those Code sections.</P>
                    <P>The commenter also noted that sections 45Y and 48E employ a “start of construction” metric for purposes of determining whether a qualified facility is eligible for the increase in credit rates for satisfying the domestic content or energy communities bonus, and for assessing the applicable credit phaseout amounts. The commenter recommended resolving what they characterized as uncertainty related to application of beginning of construction rules under existing IRS guidance to sections 45Y and 48E by adopting modified continuity safe harbor requirements for determining the beginning of construction. One such modified safe harbor would permit a taxpayer to apply whatever rules were applicable to the “commence construction” year that corresponds to the earliest year that would still meet a continuity safe harbor based on when the facility was ultimately placed in service.</P>
                    <P>The Treasury Department and the IRS have determined that the existing Internal Revenue Bulletin guidance (referred to as the IRS Notices) adequately addresses the beginning of construction rules applicable to sections 45Y and 48E. Additionally, modifications to the beginning of construction guidance provided by the IRS Notices for sections 45 and 48 are beyond the scope of these final regulations.</P>
                    <HD SOURCE="HD3">B. Property Included in Qualified Facility</HD>
                    <P>Proposed § 1.45Y-2(b) provided a description of the property included in a qualified facility. Proposed § 1.45Y-2(b)(1) provided that a qualified facility includes a unit of qualified facility, defined in proposed § 1.45Y-2(b)(2)(i), and also includes qualified property owned by the taxpayer that is an integral part of a qualified facility, defined in proposed § 1.45Y-2(b)(3). Section 45Y is silent regarding the credit eligibility of components that are part of a qualified facility but located in different locations. Accordingly, proposed § 1.45Y-2(b)(1) clarified that any property that meets the requirements of a qualified facility described in proposed § 1.45Y-2(b) is part of a qualified facility, regardless of where such property is located.</P>
                    <P>Proposed § 1.48E-2(b) provided that a qualified facility includes a unit of qualified facility, defined in proposed § 1.48E-2(b)(2)(i), and also includes property owned by the taxpayer that is integral to the unit of qualified facility, which is defined in proposed § 1.48E-2(b)(3). For purposes of section 48E, a qualified facility does not include any electrical transmission equipment, such as transmission lines and towers, or any equipment beyond the electrical transmission stage, and generally does not include equipment that is an addition or modification to an existing qualified facility. However, the proposed regulations provided two specific exceptions to that rule: the Incremental Production Rule, and the 80/20 Rule.</P>
                    <P>
                        A commenter stated that there are inconsistencies between the definitions of a “property included in a qualified facility” in proposed § 1.45Y-2(b)(1) and “unit of qualified facility” in proposed § 1.45Y-2(b)(2). The commenter stated that the first definition provides that the qualified facility equals the “unit of qualified facility” plus the “integral property”, however, the second definition provides that a “unit of qualified facility” equates to “functionally interdependent components of property.” The commenter stated that proposed § 1.48E-2 had similar inconsistencies. The commenter suggested that the final regulations include an example to more clearly define a qualified facility. The commenter also referred to the coordination with other credits in 
                        <PRTPAGE P="4029"/>
                        proposed § 1.45Y-2(c) and stated that a taxpayer must assume that what constitutes a “qualified facility” under section 45Y, namely, all functionally interdependent components of property as well as any integral property, is the same with respect to all other Federal income tax credits that reference a qualified facility, but that this definition needs to be made consistent across all the other Code sections.
                    </P>
                    <P>The Treasury Department and the IRS do not agree that an ambiguity exists between the references to a qualified facility. For both sections 45Y and 48E, the unit of qualified facility is the narrower definition and includes only the functionally interdependent components of property. A qualified facility is this “unit of qualified facility” plus integral property. Multiple examples in the proposed regulations illustrate these concepts.</P>
                    <P>The Treasury Department and the IRS also do not agree that taxpayers must assume that the definition of a “qualified facility” under sections 45Y and 48E is the same in all other Federal income tax credits. Each Code section has its own unique definition of a facility that must be considered; addressing definitions in other Code sections is beyond the scope of these final regulations. In response to commenters' concerns, though, the final regulations add additional examples to illustrate the interaction of Federal income tax credits in §§ 1.45Y-2(c)(3) and 1.48E-2(f)(3). The final regulations at §§ 1.45Y-2(b)(3)(vii) and 1.48E-2(b)(3)(vii) also change the term “qualified property” in proposed § 1.45Y-2(b)(1) to “property” as “qualified property” is not a term used in section 45Y.</P>
                    <HD SOURCE="HD3">C. Qualified Facilities and Specific Technologies for Purposes of Sections 45Y and/or 48E</HD>
                    <HD SOURCE="HD3">1. Biogas</HD>
                    <P>Commenters stated that the energy feedstock production property comprising a feedstock processing and treatment system, when owned by the same taxpayer that owns the electric generation facility placed in service after December 31, 2024, is either a functionally interdependent component property operated together with the electric generation facility or an integral part of that facility. Commenters asserted that anaerobic digester and gas conditioning components are used directly in the intended function of the facility and that, without this feedstock treatment, the electricity production component would not be able to produce zero or negative GHG electricity. Accordingly, commenters requested that the final regulations recognize all components of an electricity production facility, including the anaerobic digester and gas conditioning equipment as part of a qualified facility. The final regulations do not adopt these comments because while the energy feedstock production property described is generally used to produce fuel that may be used by a qualified facility to generate electricity, it is not part of such qualified facility based on the definition of qualified facility for purposes of the section 45Y and 48E credits.</P>
                    <HD SOURCE="HD3">2. Solar</HD>
                    <P>A commenter encouraged the Treasury Department and the IRS to explicitly define solar photovoltaic panels used to generate electricity for an automated shading system as a qualified facility. The commenter noted that the example in proposed § 1.45Y-5(c)(1)(iii) already describes the GHG emissions rate for qualified facilities that produce electricity using solar photovoltaic properties as not greater than zero and that proposed § 1.45Y-5(c)(2)(iv) also describes solar photovoltaic power as a type of non-C&amp;G facility.</P>
                    <P>The Treasury Department and the IRS have determined that the example in proposed § 1.45Y-5(c)(1)(iii) and the list of non-C&amp;G facilities in proposed § 1.45Y-5(c)(2)(iv) are sufficient to address commenter's request as the rules adequately provide that facilities using solar photovoltaic property to produce electricity are eligible for the section 45Y and 48E credits assuming the taxpayer satisfies the other statutory requirements. Accordingly, the final regulations adopt the proposed rule without change.</P>
                    <HD SOURCE="HD3">3. Nuclear</HD>
                    <P>A commenter requested that the final regulations confirm that nuclear structures, components, and fuel are part of qualified property for purposes of section 48E. Similarly, another commenter requested confirmation that specific components, such as reactor cores, are included in the qualified investment in a qualified facility under section 48E. Another commenter suggested adding language to the definition of integral part with respect to buildings to specifically address a building used for nuclear fusion or fission. The commenter specifically requested the final regulations describe a structure or building that is integral to the intended function of a qualified facility because it is needed to comply with or maintain required radiological health and safety conditions as required by a qualified facility's regulator.</P>
                    <P>Section 48E(b)(1) generally provides that the section 48E credit is available for a taxpayer's qualified investment with respect to a qualified facility, which is the sum of the basis of any qualified property placed in service by the taxpayer during such taxable year that is part of such qualified facility and if applicable, qualified interconnection costs. Section 48E(b)(2)(A) provides, in relevant part, that qualified property is property which is tangible personal property or other tangible property (not including a building or its structural components), but only if such property is used as an integral part of the qualified facility. Therefore, tangible property, including structures (other than buildings or their structural components), components, and fuel, that meets the definition of qualified property may be included in the credit base of a qualified facility. As provided in § 1.48E-2(d)(3)(v), generally buildings are not integral parts of a qualified facility because they are not integral to the intended function of the qualified facility. Due to the exclusion of a building or its structural components, this would exclude, for example, buildings that house nuclear reactor control rooms.</P>
                    <P>
                        However, as the proposed regulations acknowledged, not all structures are considered “buildings” for the purpose of excluding buildings and their structural components. Proposed § 1.48E-2(b)(3)(v)(A) and (B) provided that a structure is not considered a building if it is essentially an item of machinery or equipment, or if it houses components of property that are integral to the intended function of the qualified facility and if the use of the structure is so closely related to the use of the housed components of property therein that the structure clearly can be expected to be replaced if the components of property it initially houses are replaced. The Treasury Department and the IRS confirm that nuclear containment structures fall within the exception provided in proposed § 1.48E-2(b)(3)(v)(A) and (B), which has been adopted and moved to § 1.48E-2(d)(3)(v)(A) and (B) of the final regulations. Like hydropower dams, but unlike control room buildings, nuclear containment structures are integral to the intended function of the qualified facility. Moreover, given their complexity, technical requirements, Nuclear Regulatory Commission-mandated testing requirements, severe limits on the time workers and other personnel can spend inside the structure, and purpose, nuclear 
                        <PRTPAGE P="4030"/>
                        containment structures are essentially pieces of specialized equipment. They ensure the fulfillment of several safety functions at a nuclear power plant, including: (i) confinement of radioactive substances in operational states and in accidental conditions; (ii) protection of the reactor against natural external events and human induced events; and (iii) radiation shielding in operational states and in accident conditions.
                    </P>
                    <HD SOURCE="HD3">4. Hydropower</HD>
                    <P>A commenter requested that the final regulations provide additional examples illustrating the scope of a “qualified investment credit facility” and “qualified property” with respect to hydropower. Another commenter asked that the final regulations confirm that components of project works as identified in FERC licenses (referred to by the commenter as physical structures of a project) are integral property to a hydropower facility and therefore eligible for the section 48E credit. Specifically, the commenter suggested adopting principles from the section 48 proposed regulations regarding qualified offshore wind facilities, whereby all FERC-licensed components of any kind, including remote islanded hydropower generation components, including the switchgear or substation housed in an onshore substation, are either functionally interdependent components of a unit of the qualified facility or integral parts of a qualified facility.</P>
                    <P>A definitive response to these comments would require the Treasury Department and the IRS to conduct a complete factual analysis of the hydropower property in question, which may include information beyond that which was provided by the commenters. Because more information is needed to make the determinations requested by the commenters, the final regulations do not provide these requested clarifications. However, further discussion of relevant components of hydropower facilities is provided in section IV.E. of this Summary of Comments and Explanation of Revisions.</P>
                    <HD SOURCE="HD3">5. Section 48 Energy Properties</HD>
                    <P>
                        A commenter suggested that, for purposes of the qualified investment calculation in section 48E(b), the final regulations should clarify that the term “qualified property” includes any energy property defined in section 48(a)(3), unless it is specifically excluded. The Treasury Department and the IRS reiterate that the determination of whether a qualified facility is eligible for the section 48E credit depends, in part, on the anticipated GHG emissions of the facility as determined under section 48E(b)(3)(B)(ii) and § 1.48E-5 of these regulations rather than the technology used. This is distinct from section 48(a)(3), which identified specific types of energy property that are eligible for the section 48 credit. 
                        <E T="03">See</E>
                         the discussion of qualified property for section 48E in section III.B. of this Summary of Comments and Explanation of Revisions. Accordingly, the Treasury Department and the IRS cannot adopt the commenter's recommendation and the rule will be adopted as proposed.
                    </P>
                    <HD SOURCE="HD3">6. Facilities That Are Not Used for the Generation of Electricity</HD>
                    <P>A commenter requested that the final regulations provide flexibility to ensure that the following thermal energy technologies would not be prohibited from qualifying for the section 45Y and 48E credits: alternative water thermal sourcing, heat recovery systems for ventilation air, simultaneous heat recovery, and air source heat pumps. Similarly, another commenter suggested that thermal production from non-waste energy recovery should be eligible for the section 45Y credit and provided sample regulatory language to that effect. Another commenter suggested that technologies such as air-source heat pumps and building efficiency retrofits should be eligible for the section 45Y and 48E credits. Other commenters stated that microgrid controllers, which are energy property under section 48, should be eligible for the section 48E credit.</P>
                    <P>Sections 45Y(b)(1)(A)(i) and 48E(b)(3)(A)(i) define a qualified facility as a facility which is used for the generation of electricity. A facility cannot be considered a qualified facility under either section 45Y or 48E if it does not meet this requirement. However, the Treasury Department and the IRS note that the section 48E credit applies to both qualified facilities and EST. Section III.C.1. of this Summary of Comments and Explanation of Revisions discusses the definition of EST for purposes of the section 48E credit.</P>
                    <P>Given the earlier-described comments, and a few comments on other topics that indirectly suggested that EST that are net consumers of electricity were nonetheless “used for the generation of electricity,” the Treasury Department and the IRS have determined that additional clarification of the phrase “used for the generation of electricity” is warranted. The final regulations at §§ 1.45Y-2(a)(1) and 1.48E-2(b)(1)(i) clarify that, for a facility to meet the requirements of sections 45Y(b)(1)(A)(i) and 48E(b)(3)(A)(i), the facility must be a net generator of electricity, taking into account any electricity consumed by the facility.</P>
                    <HD SOURCE="HD3">D. Coordination With Other Credits</HD>
                    <P>Proposed §§ 1.45Y-2(c) and 1.48E-2(c) provided rules for coordination of the section 45Y and 48E credits with other Federal income tax credits, including those determined under sections 45, 45J, 45Q, 45U, 48, and 48A. Proposed § 1.45Y-1(c)(1) provided, in part, that a taxpayer that owns a qualified facility that is eligible for both a section 45Y credit and another Federal income tax credit is eligible for the section 45Y credit only if the other Federal income tax credit was not allowed with respect to the qualified facility.</P>
                    <P>A commenter suggested clarifying that the reference in proposed § 1.45Y-2(c)(1) to “another Federal income tax credit” does not extend beyond those credits specifically listed in section 45Y(c)(1). The commenter stated that, although the reference to “another Federal income tax credit” follows a specific reference to specific sections of the Code, the general reference is ambiguous and may inadvertently preclude claiming the section 45Y or 48E credits when a taxpayer claims a non-energy credit such as the credit for increasing research activities under section 41 of the Code or the advanced manufacturing production credit under section 45X of the Code.</P>
                    <P>A commenter requested modifying § 1.45Y-2(c)(1) to permit a taxpayer to claim the section 45Y credit with respect to a qualified facility that is co-located with another facility for which a credit determined under section 45V or 45Z of the Code is allowed. Another commenter requested that the final regulations clarify that the carbon capture portion of a bioenergy and carbon sequestration facility is a section 45Q facility separate from the electricity generating portion of a qualified facility under section 45Y.</P>
                    <P>
                        A commenter asked whether the “anti-abuse provision” in the section 45V proposed regulations would bar a taxpayer from claiming the section 45V credit in addition to either the section 45Y or 48E credits. Similarly, commenters requested clarifying whether taxpayers claiming the section 48E credit in a taxable year would be unable to claim the section 45Q credit in any subsequent year. The commenters asserted that section 48E(b)(3)(C) only specifically prohibits a taxpayer from claiming a section 48E credit for a facility for which a section 45Q credit was claimed “for the taxable year or any prior taxable year,” but does 
                        <PRTPAGE P="4031"/>
                        not directly state that a taxpayer cannot claim a section 45Q credit for that facility in a future taxable year.
                    </P>
                    <P>Some commenters requested that the final regulations prevent taxpayers from claiming multiple Federal or State tax incentives based on the same investment in or for the production of clean energy. By contrast, another commenter requested confirmation that claiming the section 45Y and 48E credits would not impact a taxpayer's ability to qualify for other subsidies, grants, or loans from DOE's Loans Program Office.</P>
                    <P>In accordance with the statutory language under section 45Y(b)(1)(D), the Treasury Department and the IRS confirm that the phrases “another Federal income tax credit” and “other Federal income tax credit” in proposed § 1.45Y-2(c)(1) refer solely to the credits claimed under sections 45, 45J, 45Q, 45U, 48, 48A, and 48E. Similarly, in accordance with section 48E(b)(3)(C), the phrases “another Federal income tax credit” and “other Federal income tax credit” in proposed § 1.48E-2(c)(1) refer solely to those credits claimed under sections 45, 45J, 45Q, 45U, 45Y, 48, and 48A. Moreover, the provisions under sections 45Y(b)(1)(D) and 48E(b)(3)(C) do not impact the ability of a taxpayer to claim a credit for a qualified facility that is co-located with a facility for which a credit under any Code section is claimed. In general, a taxpayer may claim a section 45Y or 48E credit for a qualified facility that is co-located with another facility, irrespective of any credit that the co-located facility claimed.</P>
                    <P>The determination of what constitutes a qualified facility for purposes of section 45Q is addressed in regulations under section 45Q and thus is beyond the scope of these final regulations. However, as described earlier, a taxpayer may not claim the section 45Y credit and the section 45Q (or sections 45, 45J, 45U, 48, 48A, and 48E) credit with respect to the same qualified facility for the taxable year or any prior taxable year. Nor may a taxpayer claim the section 48E credit and the section 45Q (or sections 45, 45J, 45U, 45Y, 48, and 48A) credit with respect to the same qualified facility for the taxable year or any prior taxable year. An examination of the whether the regulations under section 45Q prohibit a taxpayer from claiming the section 45Q credit with respect to a qualified facility for which the taxpayer has claimed a section 45Y or section 48E credit in any prior taxable year is beyond the scope of these final regulations. Finally, an examination of the application of the anti-abuse provision in the section 45V proposed regulations, or an analysis of Federal or State tax incentives, including subsidies, grants, or loans from DOE's Loans Program Office, are also beyond the scope of these final regulations. The final regulations add examples to §§ 1.45Y-2(c)(3) and 1.48E-2(f)(3) to further illustrate the interaction of sections 45Y and 48E with other Federal income tax credits.</P>
                    <HD SOURCE="HD3">E. Integral Part</HD>
                    <P>Proposed § 1.45Y-2(b)(3)(i) provided that for purposes of the section 45Y credit, a component of property owned by a taxpayer is an integral part of a qualified facility if it is used directly in the intended function of the qualified facility and is essential to the completeness of such function. Property that is an integral part of a qualified facility is part of the qualified facility. Proposed § 1.45Y-2(b)(3)(ii) through (v) applied this rule to different types of property.</P>
                    <P>Proposed § 1.48E-2(b)(3)(i) similarly provided that for purposes of the section 48E credit, a component of property owned by a taxpayer is an integral part of a qualified facility if it is used directly in the intended function of the qualified facility and is essential to the completeness of the intended function. Property that is an integral part of a qualified facility is part of the qualified facility. A taxpayer may not claim the section 48E credit for any property that is an integral part of a qualified facility that is not owned by the taxpayer. Proposed § 1.48E-2(b)(3)(ii) through (v) applied this rule to different types of property.</P>
                    <P>Proposed § 1.48E-2(g)(3) provided that for purposes of the section 48E credit, property owned by a taxpayer is an integral part of EST owned by the same taxpayer if it is used directly in the intended function of the EST and is essential to the completeness of such function. Property that is an integral part of an EST is part of an EST. A taxpayer may not claim the section 48E credit for any property that is an integral part of an EST that is not owned by the taxpayer.</P>
                    <P>A commenter supported the facility-by-facility approach that section 48E uses and sought confirmation that taxpayers can determine section 48E credits on this basis, rather than under the “energy project” definition used in section 48 by which multiple energy properties would be treated as one energy project if, at any point during their construction, they are owned by a single taxpayer and meet two or more of seven factors set forth the in section 48 proposed regulations.</P>
                    <P>Section 48 was amended by the IRA to, among other things, provide a definition of the term “energy project” and provide increased credit amounts for energy property if that property is part of an energy project that satisfies specified conditions. While sections 45Y and 48E provide for similar increased credit amounts, the sections 45Y and 48E apply the increased credit amounts at the level of a qualified facility rather than an energy project. As a result, taxpayers can only determine section 48E credits on the facility-by-facility approach described in the statute and the proposed regulations.</P>
                    <P>Commenters requested expanding the scope of power conditioning equipment that is considered an integral part of a qualified facility to include software that optimizes or automates the function of power conditioning equipment. Commenters also requested that the final regulations clarify that software performing similar functions to other integral parts of the qualified facility, such as energy management systems, battery management systems, data acquisition systems, and optimization software, are all considered “power conditioning equipment.”</P>
                    <P>Section 48E(b)(2) defines qualified property, in part, as property that is tangible personal property, or other tangible property (not including a building or its structural components), but only if such property is used as an integral part of the qualified facility. Software is not tangible property and therefore cannot be integral property included in the qualified investment of a section 48E qualified facility. Because the statutory definition limits “qualified property” to tangible property, the final regulations modify the language in proposed § 1.48E-2(b)(3)(ii) to remove any reference to software. The same language regarding software that was included in proposed § 1.48E-2(b)(3)(ii) was also included in proposed § 1.45Y-2(b)(3)(ii). The Treasury Department and the IRS note that, while the inclusion or exclusion of software does not impact the calculation of the section 45Y credit, in order to provide uniform definitions that are consistent with the statutory structure governing both credits, the final regulations also remove the references to software in § 1.45Y-2(b)(3)(ii).</P>
                    <P>
                        Commenters requested retaining the treatment of offshore wind power conditioning and transfer equipment as an integral part of an offshore wind facility if it is owned by the same taxpayer that owns the unit of qualified facility. In addition, commenters stated that the examples in proposed § 1.48E-2(b)(3)(ii) were useful in illustrating the 
                        <PRTPAGE P="4032"/>
                        project components that are integral parts of an offshore wind facility. Commenters stated that full eligibility is critically important, as power conditioning and transfer equipment represents a significant portion (up to 40 percent) of the total cost of an offshore wind facility. The final regulations adopt the proposed rule without change.
                    </P>
                    <P>A commenter expressed concern that special-purpose buildings or building-like structures that have long been considered integral property under section 48 may be inadvertently excluded under the section 48E final regulations. For example, the commenter noted that the IRS previously issued revenue rulings (Rev. Rul. 72-223, 1972-1 C.B. 17; Rev. Rul. 72-96, 1972-1 C.B. 67; Rev. Rul. 84-40, 1984-12 I.R.B. 4) holding that special-purpose property such as hydroelectric power plant structures, reservoirs to be used with steam turbine generating plants, and dams were eligible for the section 48 credit as other tangible property rather than being considered buildings or their structural components. The commenter noted that in only one of the revenue rulings was the property not considered a building based on the idea that replacement of the turbine and support have to be undertaken at the same time. Similarly, commenters requested verification that the definition of integral property includes canopies for solar carports, racking structures specific to commercial and industrial solar projects, rooftop specialized battery housing structures, enclosures for densely populated urban environments, and similar components. In contrast, a commenter recommended clarifying that containers for utility-scale battery energy storage systems, inverter housing, and transformer housing are specifically considered buildings or equivalents.</P>
                    <P>As an alternative, some commenters suggested modifying the rule for buildings to generally include structures but exclude buildings of particular concern to the IRS (for example, housing or offices for maintenance equipment or regular operations staff). A commenter requested that, similar to proposed § 1.48E-2(b)(3)(v), the final regulations include a permanent building or structure as an integral part of an EST to the extent it can be demonstrated that (i) the construction of such building or structure would not have occurred but for placing the EST in service and (ii) the design and cost of such structure is consistent with the requirements of the EST. According to the commenter, such a rule would treat the portion of the building or structure used to house the EST as an integral part of the EST, whether or not permanent in nature. The commenter noted that in harsh environments, the taxpayer must construct a permanent structure for housing the EST and the applicable HVAC equipment needed to regulate the temperature of the structure so that the EST will function properly. The commenter also explicitly requested that HVAC equipment needed to regulate the temperature of the structure so that the EST will function properly be considered an integral part of the EST. Another commenter requested modifying proposed § 1.48E-2(b)(3)(v) to allow for structures or buildings integral to the intended function of the qualified facility if such building or structure is required to comply with or maintain required health and safety conditions required by the qualified facility's regulator.</P>
                    <P>Another commenter requested confirmation that devices used to manage load served by EST, such as critical loads panels or load controllers, are integral parts of EST. The commenter noted that backup batteries need load management devices to function correctly during grid failures or for off-grid power.</P>
                    <P>The definition of qualified property in section 48E(b)(2)(A)(ii) includes tangible property that is used as an integral part of a qualified facility, but explicitly excludes buildings or their structural components. Proposed § 1.48E-2(b)(3)(v) provides that while buildings are generally not integral parts of a qualified facility because they are not integral to the intended function of the qualified facility (to generate electricity), the following structures are not treated as buildings for this purpose: (A) a structure that is essentially an item of machinery or equipment; and (B) a structure that houses components of property that is integral to the intended function of the qualified facility if the use of the structure is so closely related to the use of the housed components of property therein that the structure clearly can be expected to be replaced if the components of property it initially houses are replaced.</P>
                    <P>Although the proposed regulations do not list particular buildings that may qualify as an integral part of a qualified facility, the Treasury Department and the IRS have concluded that the guidance and examples included are adequate to illustrate the intended application of the rules. The revenue rulings raised by a commenter with respect to special-purpose buildings or building-like structures involved specific situations arising under section 48. A definitive response regarding the situations in the revenue rulings or other specific situations described by the previous comments would require the Treasury Department and the IRS to conduct a complete factual analysis of the property in question, which may include information beyond that which was provided by the commenters. Because more information is needed to make the determinations requested by the commenters, the requested clarifications are not addressed in these final regulations.</P>
                    <P>In the case of hydropower facilities, a commenter stated that it is critical that final regulations confirm that costs incurred for new property with respect to a hydropower facility qualify for the section 48E credit even though certain portions of a hydropower project may be owned by Federal agencies. This commenter explained that in some cases, the U.S. Army Corps of Engineers may own all or a portion of the dam and associated property but asserted that this circumstance should not affect the credit eligibility of other qualified property (the electric-generating assets) within the qualified facility owned by the taxpayer.</P>
                    <P>While a taxpayer may not claim the section 48E credit for any property that is not owned by the taxpayer even if it is an integral part of a qualified facility, the inverse is not true. A taxpayer is not required to own all the other tangible property that is an integral part of a qualified facility to claim a credit for the qualified facility. In the case of a hydropower facility, the qualified facility consists of a unit of qualified facility including water intake, water isolation mechanisms, turbine, pump, motor, and generator. The associated impoundment (dam) and power conditioning equipment are integral property to the unit of qualified facility. Therefore, in response to the commenter's example, the final regulations incorporate a new example in §§ 1.45Y-2 and 1.48E-3 illustrating that property such as a dam being owned by a Federal agency would not prevent a taxpayer that owns the hydropower facility from qualifying for a section 45Y or 48E credit.</P>
                    <HD SOURCE="HD3">F. Shared Integral Property</HD>
                    <P>
                        Proposed § 1.45Y-2(b)(3)(vi) provided that multiple qualified facilities (whether owned directly by one or more taxpayers), including qualified facilities with respect to which a taxpayer has claimed a credit under section 48E or another Federal income tax credit, may include shared property that can be considered an integral part of each qualified facility. A component of property that is shared by a qualified 
                        <PRTPAGE P="4033"/>
                        facility as defined in section 45Y(b) (45Y Qualified Facility) and a qualified facility as defined in section 48E(b)(3) (48E Qualified Facility) that is an integral part of both qualified facilities will not affect the eligibility of the 45Y Qualified Facility for the section 45Y credit or the 48E Qualified Facility for the section 48E credit. Proposed § 1.45Y-2(b)(3)(vii) provides examples illustrating proposed § 1.45Y-2(b)(3).
                    </P>
                    <P>Proposed § 1.48E-2(b)(3)(vi) provided that multiple qualified facilities (whether owned by one or more taxpayers), including qualified facilities with respect to which a taxpayer has claimed a credit under section 48E or another Federal income tax credit, may include shared property that may be considered an integral part of each qualified facility so long as the cost basis for the shared property is properly allocated to each qualified facility and the taxpayer only claims a section 48E credit with respect to the portion of the cost basis properly allocable to a qualified facility for which the taxpayer is claiming a section 48E credit. The total cost basis of such shared property divided among qualified facilities may not exceed 100 percent of the cost of such shared property. Property that is shared by a 48E Qualified Facility and a 45Y Qualified Facility that is an integral part of both qualified facilities will not affect the eligibility of the 48E Qualified Facility to claim the section 48E credit or the 45Y Qualified Facility to claim the section 45Y credit. To better illustrate the treatment of shared integral property, these final regulations add an additional example to § 1.48E-4(d)(5) regarding related taxpayers.</P>
                    <P>A commenter expressed confusion with what is meant by “another facility” in proposed § 1.45Y-2(c)(1), in the context of defining a qualified facility co-located with another facility. Additionally, as explained in section IV.B. of this Summary of Comments and Explanation of Revisions, each Code section has its own unique definition of a facility that must be considered. Proposed § 1.45Y-2(c)(3) (Examples 1 and 2) involve fact patterns addressing the ability of one or more taxpayers to claim a section 45Y credit for a solar farm and a section 48E credit for a co-located EST. The Treasury Department and the IRS view these examples as adequately addressing this comment.</P>
                    <HD SOURCE="HD3">G. Ownership</HD>
                    <HD SOURCE="HD3">1. Qualified Facility</HD>
                    <P>Proposed § 1.48E-4(d) provided rules related to the ownership of a qualified facility or EST. In addition to the ownership rules in proposed § 1.48E-4(d), proposed § 1.48E-2(b)(3)(i) provided a taxpayer may not claim the section 48E credit for any property that is an integral part of the taxpayer's qualified facility that is not owned by the taxpayer.</P>
                    <P>Some commenters opposed the proposed rule that only the taxpayer that owns a unit of qualified facility is eligible for a section 48E credit with respect to property that is an integral part of that qualified facility. These commenters asserted that property that is treated as an integral part of a qualified facility should be eligible for the section 48E credit regardless of whether the taxpayer also owns any interest in the unit of qualified facility. As an example, one commenter described a qualified facility in which generation assets and transfer equipment are constructed together but owned by separate taxpayers and suggested that both taxpayers should be able to claim a section 48E credit on the basis of their respectively owned portions. This commenter similarly suggested that if a unit of qualified facility is constructed and placed in service by a taxpayer, and another taxpayer later constructs and places in service an integral part of such qualified facility, both taxpayers should be able to claim section 48E credits on their respective property.</P>
                    <P>A commenter opposed to the ownership requirement suggested that, under their reading of the proposed regulations and the existing section 48 regulations, different components treated as “integral parts” would still be energy property and, thus, should still qualify for the section 48E credit when separately owned. According to this commenter, under section 48 taxpayers have the flexibility to own and claim credit for separate “integral parts.” The commenter stated that this flexibility in ownership is essential for many projects because it may be impractical (if not impossible) for one taxpayer to own all components of a larger system. The commenter stated that the limitation in the proposed regulations that a taxpayer may not claim the section 48E credit for any property that is an integral part of a qualified facility that is not owned by the taxpayer is not found in the statutory text and could have an unnecessary chilling effect on investment.</P>
                    <P>Raised in the context of offshore wind, commenters requested that the final regulations eliminate the requirement that the generating facility and the integral power conditioning and transfer equipment be owned by the same taxpayer. In the commenters' view, this would allow owners of offshore wind power conditioning and transfer equipment that do not own an interest in the offshore turbines to claim the section 48E credit. A commenter stated that the ownership rules, as proposed, would result in the buildout of more equipment and cables at a greater total expense, be more disruptive of the environment, and cause more interference with coastal communities, while at the same time failing to achieve the desired resiliency, reliability, flexibility, and ability to plan for future expansion of offshore wind. A comment submitted jointly by seven states requested that the Treasury Department and the IRS reconsider the rule to require that the owner of integral power conditioning and transfer equipment to also own the offshore wind facility to claim the section 48E credit. This comment expressed similar concerns regarding potential impacts of the ownership rules.</P>
                    <P>A commenter proposed that the Treasury Department and the IRS revise the proposed rule to allow owners of integral property that do not own an interest in the associated unit of qualified facility to claim a section 48E credit if the integral property is used in the trade or business of furnishing or selling electrical energy and if a regulatory authority determines that ownership of integral property separate from ownership of the underlying unit of qualified facility is in the public interest.</P>
                    <P>
                        The Treasury Department and the IRS have determined that the ownership rules provided in the proposed regulations are appropriate. Although commenters asserted that property that is treated as an integral part of a qualified facility should be eligible for the credit regardless whether the taxpayer also owns any interest in the unit of qualified facility (as defined in proposed § 1.48E-2(b)(2)), such an approach would conflict with the statutory requirement that a credit only be available for a qualified facility, that is, a facility that generates electricity and for which the anticipated GHG emissions rate is not greater than zero. Integral property alone does not constitute a qualified facility. Adopting the commenters' recommendation that a taxpayer be able claim the section 48E credit for integral property alone would conflict with the application of several other provisions in the statute that apply to an entire qualified facility rather than individual components of property (including the PWA requirements, certain bonus credit amounts, and certain rules applicable to lower-output qualified facilities to 
                        <PRTPAGE P="4034"/>
                        include expenditures for qualified interconnection property).
                    </P>
                    <P>The Treasury Department and the IRS conclude that no section 48E credit may be determined with respect to a taxpayer's ownership of integral property which is a separate component of a qualified facility (or EST) if the same taxpayer does not own the components that constitute a unit of qualified facility (as defined in proposed § 1.48E-2(b)(2)) or unit of EST (as defined in proposed § 1.48E-2(g)(2)). Additionally, based on similar considerations, the Treasury Department and the IRS maintain that no section 48E credit may be allowed unless a taxpayer directly owns at least a fractional interest in the entire unit of qualified facility or unit of EST. Thus, in the case of an offshore wind farm, a taxpayer directly owning power conditioning and transfer equipment would only be able to claim a section 48E credit on that equipment if the same taxpayer also directly owned a fractional interest in at least one qualified facility (wind turbine, tower, and pad) for which such power conditioning and transfer equipment in is integral property.</P>
                    <P>In response to the comment that retaining the common ownership requirement will result in the buildout of more equipment and cables at a greater total expense, more disruption of the environment, and more interference with coastal communities, the Treasury Department and the IRS acknowledge the commenters' concerns. However, as explained later, retaining the rule is necessary based on legal and administrability concerns.</P>
                    <P>Section 48E provides an investment credit equal to a specified percentage of the taxpayer's qualified investment with respect to a qualified facility or EST. Section 48E(b)(1) defines a qualified investment with respect to a qualified facility as the sum of “the basis of any qualified property placed in service by the taxpayer during such taxable year which is part of a qualified facility, plus the amount of any expenditures which are paid or incurred by the taxpayer for qualified interconnection property . . .” Section 48E(b)(2) provides, in part, that the term qualified property means property which is tangible personal property or other tangible property (not including a building or its structural components) but only if such property is used as an integral part of the qualified facility.</P>
                    <P>While the language in section 48E(b)(1) and 48E(b)(2), on its own, could be read to suggest that a taxpayer may claim a section 48E credit with respect to any property that does not constitute a unit of qualified facility, section 48E must be read holistically to give effect to its provisions. The statute provides a credit with respect to a qualified facility, which is a facility that generates electricity and that has a GHG emissions rate not greater than zero. Only once it has been determined that a facility is a qualified facility that is eligible for a section 48E credit may the amount on which the credit will be calculated—the qualified investment in that qualified facility—be determined under section 48E(b)(1) and (2). Section 48E(b)(1) identifies what items comprise that qualified investment—the basis of any qualified property that is part of the qualified facility plus certain qualified interconnection costs. Section 48E(b)(2) specifies what types of property are considered qualified property—tangible personal property or, only if used as an integral part of the qualified facility, other tangible property (not including a building or its structural components). The term “integral part” specifically modifies the term “other tangible property.” It serves to include or exclude items like fencing that are not directly related to the function of the qualified facility. The statutory language thus provides that any property that does not meet the definition of “qualified property,” or any property that is not part of the qualified facility, is not part of the qualified investment.</P>
                    <P>Once the qualified investment has been determined, the credit rate by which that qualified investment will be multiplied to calculate the credit amount must be determined. The credit rate is the applicable percentage under section 48E(a)(2)(A), which is either 6 percent or 30 percent depending on whether the qualified facility satisfies any of the three tests for the alternative rate set forth in section 48E(2)(A)(ii). The requirements of section 48E apply to the qualified facility (rather than components of property comprising such qualified facility): a qualified facility is a facility that generates electricity and that has a GHG emissions rate not greater than zero; the applicable percentage depends on whether the qualified facility meets the various requirements for PWA, or the domestic content and energy communities bonus credit amounts. Within this statutory structure, section 48E(a)(1)(A) and (2)(A) operate to identify what is included and what is excluded from the credit base. Accordingly, the statute requires ownership of a qualified facility rather than mere components of property.</P>
                    <P>Section 48E provides a credit for an investment in a qualified facility that satisfies the definition of “qualified facility” provided at section 48E(b)(3). The statute defines a “qualified facility”, in part, by requiring that the facility be used for the generation of electricity and that the anticipated GHG emissions rate is not greater than zero. The Treasury Department and the IRS view the concepts of qualified investment and qualified property as inextricably tied to the statutory definition of a qualified facility. As discussed throughout this Summary of Comments and Explanation of Revisions, the section 48E credit is available for a qualified facility that generates electricity for which the anticipated GHG emissions rate is not greater than zero. Electricity can only be generated by, and GHG emissions can only be determined with respect to, a unit of qualified facility. Integral property, by itself, does not satisfy this statutory definition because integral property is not property used for the generation of electricity, nor can the GHG emissions of a qualified facility be determined solely on the basis of integral property.</P>
                    <P>
                        Furthermore, a taxpayer who owns only property that is an integral part of a qualified facility may not be able to establish the anticipated GHG emissions rate for the entire qualified facility. For the determination of the anticipated GHG emissions rate of a qualified facility, section 48E mandates rules similar to those in section 45Y(b)(2)(C)(ii), which requires that “[i]n the case of any facility for which an emissions rate has not been established by the Secretary, 
                        <E T="03">a taxpayer which owns such facility</E>
                         may file a petition with the Secretary for determination of the emissions rate with respect to such facility” (emphasis added). The statute does not appear to permit a taxpayer who does not own a unit of qualified facility, but instead only owns property that is integral to a unit of qualified facility, to petition for a determination of the emissions rate. This further bolsters the conclusion that ownership interest in a qualified facility, not in mere integral part, is required for the credit to operate.
                    </P>
                    <P>
                        Several other key provisions of section 48E are only applicable to a qualified facility: the placed in service date; the applicable percentage; application of the PWA requirements, eligibility for the domestic content and energy communities bonus credit amounts; and inclusion of qualified interconnection expenditures for lower-output qualified facilities. These provisions apply at the level of a qualified facility, not to components of property within such qualified facility or components of property that are an 
                        <PRTPAGE P="4035"/>
                        integral part of such qualified facility. For example, the owner of a component of property within a qualified facility cannot claim a domestic content bonus credit amount if another owner of components of property included within the unit of qualified facility does not satisfy the domestic content requirements with respect to its components. The determination requires an analysis of the entire qualified facility.
                    </P>
                    <P>Unless a taxpayer directly owns at least a fractional interest in the entire unit of qualified facility, the taxpayer cannot effectively claim the section 48E credit or the bonus or increase credit amounts. The availability of the section 48E credit for the taxpayer who owns only integral property would depend on whether another taxpayer's qualified facility meets the GHG emission requirements. The availability of any bonus or increased credit amounts for the taxpayer who owns only integral property would also depend on whether other taxpayers who invested in the qualified facility satisfy all the adder requirements. Similarly, in cases in which one taxpayer's tangible property ceases to be eligible for the credit, recapture under sections 48E(g) and 50(a) would implicate all other taxpayers who invest in the qualified facility. All these cases further support the conclusion that the statutory scheme applies at the level of a qualified facility, and that the owner of only integral property cannot effectively claim the credit or the bonus or increased credit amounts.</P>
                    <P>Finally, taxpayers would need access to information about all other property that is part of the qualified facility to properly determine whether the taxpayer's specific investment in integral property is eligible for a section 48E credit and to determine the amount of that credit. This would impose a high burden of information sharing on the taxpayers and increase uncertainty, as one taxpayer's choices would impact another taxpayer's eligibility for the credit and bonus or increased credit amounts. It would also create corresponding administrative problems for the IRS to effectively analyze and, if necessary, adjust multi-party credit claims.</P>
                    <P>
                        Some commenters pointed to Internal Revenue Bulletin guidance, caselaw, and other guidance to support their position that a taxpayer that owns property that is an integral part of a qualified facility should not be required to also own the qualified facility to be eligible for a section 48E credit. Commenters cited Rev. Rul. 78-268, 1978-2 C.B. 10, PLR 201536017, PLR 201208035, and FAQ 35 of guidance from the Treasury Department regarding payments under section 1603 of the American Recovery and Reinvestment Act of 2009 
                        <SU>3</SU>
                        <FTREF/>
                         (Section 1603 Grant Program) to support the premise that ownership of an entire qualified facility is not required to be eligible to claim a section 48E credit.
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             Payment for Specified Energy Property in Lieu of Tax Credits Under the American Recovery and Reinvestment Act of 2009, Frequently Asked Questions and Answers.
                        </P>
                    </FTNT>
                    <P>The commenters' reliance on Revenue Ruling 78-268, which addressed a prior version of the section 48 credit, is misplaced. In Revenue Ruling 78-268, four parties, two of which were tax-exempt, owned an electric generating facility through a tenancy in common. In other words, each taxpayer owned a fractional interest in the entire energy property. Revenue Ruling 78-268 held that the presence of the tax-exempt owners did not disqualify the other owners from claiming a section 48 credit because the fractional interests in the tenancy in common were treated as separate assets. Because the fractional ownership arrangement in Revenue Ruling 78-268 is consistent with the fractional ownership rule in proposed § 1.48E-4(d)(2), the Treasury Department and the IRS disagree with commenters that the holding of Revenue Ruling 78-268 supports their position.</P>
                    <P>
                        Commenters' reliance on PLR 201536017 is also misplaced. Private letter rulings (PLR) are not precedential and cannot be relied upon by a taxpayer other than the one addressed in the letter (
                        <E T="03">see</E>
                         section 6110(k)(3) of the Code). Furthermore, this PLR involved the section 25D credit, which, in relevant part, provides a credit for “qualified solar electric property expenditures,” rather than the section 48E credit. Regardless, like Revenue Ruling 78-268, the PLR involves credit eligibility through fractional ownership of an entire energy property, not ownership of just certain components. The PLR addresses a factual scenario in which a taxpayer purchased solar PV panels in an offsite array (that also contains other solar PV panels owned by other individuals) as well as a partial ownership in racking equipment, inverter equipment, and wiring and other equipment and installation services required for the integration of the panels in the array and the interconnection of the array to a local utility's electric distribution system. The PLR concludes that the taxpayer made a “qualified solar electric property expenditure” under section 25D(d)(2) and is eligible to claim a section 25D credit. To the extent this PLR provides any helpful analysis to a section 48E credit, it involves partial ownership in all the equipment necessary to integrate the solar PV panels into the array and interconnect the array to a local utility's electric distribution system. It does not apply the section 25D credit to just certain components of property. Like Revenue Ruling 78-268, the PLR involves credit eligibility through fractional ownership of a unit of property analogous to a qualified facility under section 48E rather than ownership of mere components of property.
                    </P>
                    <P>Similarly, commenters' reliance on PLR 201208035 for the proposition that taxpayers should be permitted to claim the section 48E credit on any portion of eligible property owned by such taxpayer is inapposite. The factual scenario in that PLR involved a taxpayer seeking to add energy storage property to an existing wind facility for which section 48 credits had been claimed with respect to certain phases of the facility and a Section 1603 Grant Program payment had been received with respect to another phase of the facility. Because the same taxpayer owned the existing wind facility and the later added energy storage property (which was treated as property integral to the wind facility under the relevant version of section 48), the cited PLR does not establish that a taxpayer who has no ownership of a unit of a qualified facility is entitled to the section 48E credit for ownership of integral parts only.</P>
                    <P>
                        Finally, commenters also relied on FAQ 35 of the Section 1603 Grant Program guidance to support their contention that ownership of an entire qualified facility is not required to claim the section 48E credit. Under the Section 1603 Grant Program, the Treasury Department made payments in lieu of section 45 and 48 credits to eligible applicants for specified energy property. FAQ 35 addressed the procedural requirements of the Section 1603 Grant Program in a situation in which an open-loop biomass facility was owned by one party that uses off-site feedstock conversion equipment owned by another party. FAQ 35 provided that the party that owns the conversion equipment and the party that owns the open-loop biomass facility must each submit an application in order to receive Section 1603 Grant Program payments. While the Section 1603 Grant Program guidance borrowed important concepts from the section 45 and 48 credits, it is not based on any specific income tax provisions and is 
                        <PRTPAGE P="4036"/>
                        not precedential for purposes of the section 48E credit.
                    </P>
                    <P>Moreover, FAQ 35 required the multiple parties that owned the different components of property to join in each separate application for the Section 1603 Grant Program payment and agree to the terms and conditions. The Treasury Department would then review those applications together and make any determination regarding eligibility for a Section 1603 Grant Program payment for the entire facility based on information provided with respect to the entire facility rather than each party's respective components. This is very different from the commenters' requests to allow taxpayers to claim and substantiate separate section 48E credits claimed by separate taxpayers on Federal income tax returns. This type of tax filing has significantly fewer guardrails than Treasury's advance review of Section 1603 Grant Program applications. And, as discussed earlier, the statute requires ownership of a qualified facility, rather than ownership of mere components of property to claim the credit.</P>
                    <P>
                        Other commenters cited 
                        <E T="03">Cooper</E>
                         v. 
                        <E T="03">Comm'r,</E>
                         88 T.C. 84 (1987), to support allowing a taxpayer to claim a section 48E credit with respect to components of property they own that are an integral part of a qualified facility owned by a different taxpayer. 
                        <E T="03">Cooper,</E>
                         which was decided under prior versions of sections 46 and 48 and the regulations thereunder, does not directly support the commenters' contention. In 
                        <E T="03">Cooper,</E>
                         the taxpayer asserted that owning specific components of solar water heating system was sufficient to claim the section 48 credit for solar energy property. Acknowledging that the taxpayer did not own the entire working solar water heating system, the Tax Court held that the definition of a solar energy property provided by the regulations under former section 48(l)(4) were sufficiently broad to provide a credit for component parts of a solar water heating system. In a subsequent case, the Tax Court distinguished 
                        <E T="03">Cooper,</E>
                         explaining that “the property in 
                        <E T="03">Cooper</E>
                         consisted of integrated water-heating systems that were ready for installation to discharge their designated function.” 
                        <E T="03">Olsen</E>
                         v. 
                        <E T="03">Commissioner,</E>
                         T.C. Memo 2021-41, *14, aff'd, 52 F.4th 1039 (10th Cir., 2022). Conversely, in the 
                        <E T="03">Olsen</E>
                         case, the taxpayer owned certain solar lenses that the Tax Court described as “mere components of a system” that were “intended to operate as part of a complicated solar energy system and were incapable of performing any useful function in isolation.” 
                        <E T="03">Id.</E>
                         at 13-14. The Tax Court held that the solar lenses “were not `placed in service' because the solar energy system as a whole was not `in a condition or state of readiness and availability for a specifically assigned function.'” 
                        <E T="03">Id.</E>
                         at 13. Thus, the taxpayer was not entitled to claim a section 48 credit.
                    </P>
                    <P>Finally, the IRS has no authority to compel taxpayers to coordinate tax credit claims or share tax return information with other taxpayers. Accordingly, the rules as provided in proposed §§ 1.48E-4(d) and 1.48E-2(b)(3)(i) that require a taxpayer to directly own at least a fractional interest in the entire unit of qualified facility or unit of EST and that deny a credit for owners of integral property alone are adopted and moved to § 1.48E-1(c) of the final regulations.</P>
                    <P>However, while the final regulations maintain the overall structure of the proposed ownership rules, after further consideration, the Treasury Department and the IRS have determined that certain modifications to proposed § 1.48E-2 are required to more closely reflect the statutory language. The final regulations adopt those modifications.</P>
                    <HD SOURCE="HD3">2. Ownership of EST</HD>
                    <P>A commenter requested clarification that the section 48E credit can be claimed with respect to an EST that is co-located and used in conjunction with a qualified facility for which the section 45 or 45Y credit is claimed even if the EST could be considered a functionally interdependent or an integral part of that qualified facility and whether the EST and the facility may be owned by different taxpayers. Proposed § 1.48E-2(g)(3) provides that a taxpayer may not claim the section 48E credit for any property that is an integral part of an EST that is not owned by the taxpayer. Commenters expressed concern that this rule prohibits the owner of an EST from claiming a section 48E credit if that EST is an integral part of a qualified facility that is owned by another taxpayer.</P>
                    <P>This commenter's concerns are misplaced. Section 48E(a) describes the clean electricity investment credit generally as determined separately with respect to any qualified facility and any EST. Accordingly, an EST cannot be included in a unit of qualified facility under either the integral part or functional interdependence rules for purposes of section 48E. Therefore, the Treasury Department and the IRS confirm that an EST is eligible for the section 48E credit if it satisfies the requirements of section 48E, even if the EST is co-located with a qualified facility that has claimed the section 45 or 45Y credits. Assuming all statutory and regulatory requirements are satisfied, a qualified facility owned by one taxpayer and an EST owned by another taxpayer may each be eligible for a separate section 48E credit. From the perspective of credit eligibility, EST is not an integral part of a qualified facility.</P>
                    <HD SOURCE="HD3">H. Incremental Production Rule</HD>
                    <P>Proposed § 1.45Y-4(c)(1) provided, solely for purposes of proposed § 1.45Y-4(c), that the term “qualified facility” includes either a new unit or an addition of capacity placed in service after December 31, 2024, in connection with a facility described in section 45Y(b)(1)(A) (without regard to clause (ii) of such paragraph), which was placed in service before January 1, 2025, but only to the extent of the increased amount of electricity produced at the facility by reason of such new unit or addition of capacity. Proposed § 1.45Y-4(c)(1) also provided that a new unit or an addition of capacity will be treated as a separate qualified facility. Proposed § 1.45Y-4(c)(1) provided, for purposes of proposed § 1.45Y-4(c), that a new unit or an addition of capacity requires the addition or replacement of components of property, including any new or replacement integral property, added to a facility necessary to increase capacity. Proposed § 1.45Y-4(c) provided that, if applicable, taxpayers must use modified or amended facility operating licenses or the International Standard Organization (ISO) conditions to measure the maximum electrical generating output of a facility to determine its nameplate capacity. Additionally, proposed § 1.45Y-4(c)(1) provided that for purposes of section 45Y(a)(2)(B)(i) (that is, the One Megawatt Exception), the capacity for a new unit or an addition of capacity is the sum of the nameplate capacity of the added qualified facility and the nameplate capacity of the facility to which the qualified facility was added.</P>
                    <P>
                        Proposed § 1.45Y-4(c)(2) provided that, solely for purposes of proposed § 1.45Y-4(c), a facility that is decommissioned or in the process of decommissioning and restarts can be considered to have increased capacity if certain conditions are met. Proposed § 1.45Y-4(c)(3) described how to compute the increased amount of electricity produced as a result of a new unit or an addition of capacity. Proposed § 1.45Y-4(c)(4) illustrated the application of these rules to determine the increased amount of electricity attributable to a new unit or an addition of capacity described in proposed § 1.45Y-4(c).
                        <PRTPAGE P="4037"/>
                    </P>
                    <P>Proposed § 1.48E-4(b)(1) provided, solely for purposes of proposed § 1.48E-4(b), that the term “qualified facility” includes either a new unit or an addition of capacity placed in service after December 31, 2024, in connection with a facility described in section 48E(b)(3)(A) (without regard to clause (ii) of such paragraph), which was placed in service before January 1, 2025, but only to the extent of the increased amount of electricity produced at the facility by reason of such new unit or addition of capacity. A new unit or an addition of capacity will be treated as a separate qualified facility. For purposes of proposed § 1.48E-4(b), a new unit or an addition of capacity requires the addition or replacement of qualified property (as defined in proposed § 1.48E-2(e)), including any new or replacement integral property added to a facility necessary to increase capacity. Proposed § 1.48E-4(b) provided that, if applicable, taxpayers must use modified or amended facility operating licenses or ISO conditions to measure the maximum electrical generating output of a facility to determine its nameplate capacity. Additionally, proposed § 1.48E-4(b)(1) provided that for purposes of section 48E(a)(2)(A)(ii)(I) (that is, the One Megawatt Exception), the capacity for a new unit or an addition of capacity is the sum of the nameplate capacity of the added qualified facility and the nameplate capacity of the facility to which the qualified facility was added.</P>
                    <P>Proposed § 1.48E-4(b)(2) provided that, solely for purposes of proposed § 1.48E-4(b), a facility that is decommissioned or in the process of decommissioning and restarts can be considered to have increased capacity if certain conditions are met. Proposed § 1.48E-4(b)(3) described how to compute the qualified investment for a new unit or an addition of capacity. Proposed § 1.48E-4(b)(4) illustrated the application of the rules described in proposed § 1.48E-4(b).</P>
                    <HD SOURCE="HD3">1. General Rules</HD>
                    <P>A commenter noted that proposed §§ 1.45Y-4(c)(1) and 1.48E-4(b)(3) both reference “components of property,” whereas proposed § 1.48E-4(b)(1) references “qualified property,” and requested that the final regulations use a consistent reference to property included in the qualified facility. The final regulations at § 1.48E-4(b)(4) change the term “components of property” in proposed § 1.48E-4(b)(3) to “components of qualified property” to align with the requirement of section 48E(b)(1)(A) that the qualified investment (as defined in proposed § 1.48E-1(a)(6)) in a qualified facility is the basis of any qualified property (as defined in proposed § 1.48E-2(e)) placed in service by the taxpayer which is part of a qualified facility. However, the term “components of property” in proposed § 1.45Y-4(c)(1) remains unchanged in these final regulations, because the term “qualified property” is not used in section 45Y.</P>
                    <P>
                        Several commenters recommended permitting modifications to a facility to qualify as an addition of capacity, and specifically requested that the final regulations define additions of capacity as “modifications to the facility, including any new or replacement integral property added to a facility necessary to increase the capacity of the facility 
                        <E T="03">by replacing or modifying,</E>
                         in whole or in part, the existing capacity of the facility. . .” (emphasis added). Several commenters also requested that the final regulations clarify whether such modifications could be to existing components, physical or digital, or whether existing components need to be replaced or new components added.
                    </P>
                    <P>Other commenters asked whether any uprate, upgrade, or efficiency improvement to an existing facility that results in an incremental increase in the electric-generating output based on the actual productive capacity of the facility would qualify as an addition of capacity. A commenter noted that sometimes components, including software, are modified or adjusted to increase electrical generating output. Another commenter stated that the example related to an addition of capacity in proposed § 1.45Y-4(c)(4)(ii) does not represent a typical fact pattern.</P>
                    <P>In response to these comments, the Treasury Department and the IRS confirm that the Incremental Production Rule is based on the increased amount of electricity produced at a facility as a result of a new unit or an addition to capacity. For purposes of the section 45Y credit, a new unit or an addition of capacity requires an addition or replacement of components of property, including any new or replacement integral property, added to a facility necessary to increase capacity. For purposes of the section 48E credit, a new unit or addition of capacity requires the addition or replacement of qualified property (as defined in § 1.48E-2(e)), including any new or replacement integral property, added to the facility necessary to increase capacity.</P>
                    <P>Several commenters asked whether there is a minimum capital expenditure necessary to qualify as a new unit or an addition of capacity. Additionally, a commenter suggested that the final regulations list the types of new units that would be considered to increase the amount of electricity produced. In response to these comments, the Treasury Department and the IRS note there is no minimum capital expenditure that would satisfy the Incremental Production Rule for either a new unit or an addition to capacity. Additionally, to provide greater clarity regarding what would qualify as a new unit or an addition to capacity, additional examples are included in proposed §§ 1.45Y-4(c)(4) and 1.48E-4(b)(4), and moved to §§ 1.45Y-4(c)(5) and 1.48E-4(b)(5), respectively, in the final regulations. These additional examples illustrate the range and diversity of types of investments that can result in an addition of capacity.</P>
                    <P>Another commenter requested that each stage of a multi-staged expansion be eligible for the section 45Y credit even if the larger, overall program for improvement and expansion has not yet been completed. A commenter requested permitting multiple additions of capacity or new units added to the same facility over time to separately qualify for the section 45Y credit. The commenter noted that, in this case, a taxpayer would measure the electricity production attributable to each new addition by reducing earlier additions' proportionate share of total energy production. Another commenter recommended that taxpayers should be permitted to aggregate all components added to a facility and placed in service in the same tax year as a single new unit or addition of capacity.</P>
                    <P>
                        In response to comments that taxpayers should be able to aggregate all components of property added to a facility and placed in service in the same tax year as a single new unit or addition of capacity, the Treasury Department and the IRS note that proposed §§ 1.45Y-4(c)(1) and 1.48E-4(b)(1) both provided, in part, that a new unit or an addition of capacity that meets the requirements of the Incremental Production Rule will be treated as a separate qualified facility. In response to the commenters' request that a series of additions to capacity should be eligible for the Incremental Production Rule, the Treasury Department and the IRS interpret section 45Y(b)(1)(C) (and by reference, section 48E(b)(3)(B)) to mean that if a single facility includes multiple new units or additions to capacity, the taxpayer must apply the Incremental Production Rule to each of the new units or additions to capacity to determine whether such property meets the Incremental Production Rule.
                        <PRTPAGE P="4038"/>
                    </P>
                    <P>A commenter also suggested treating new units as qualified facilities that are distinct and separate from the existing qualified facility to which they are added and clarifying that all energy produced by the new unit would qualify for the section 45Y credit. In response to this comment, the Treasury Department and the IRS confirm that the Incremental Production Rule is only applicable to additions of capacity and new units that would not otherwise qualify as a separate qualified facility as defined in section 45Y(b)(1)(A) (or by reference section 48E(b)(3)) and therefore clarify this in the final regulations at § 1.45Y-4(c)(1) and § 1.48E-4(b)(1).</P>
                    <HD SOURCE="HD3">2. Application to Hydropower Facilities</HD>
                    <P>Commenters noted that FERC guidance has described “additions of capacity” to mean any increase in generating capacity other than an addition resulting from an efficiency improvement or an addition resulting from an operational change. Commenters noted that FERC has provided guidance generally indicating that efficiency improvements encompass additional generation from existing equipment in the form of upgrades to generators or turbines. Commenters also noted that FERC guidance provides examples of efficiency improvements that include rewinding generators, replacing turbines with more efficient units, and computerizing control of turbines and generators to optimize regulation of flows for generation.</P>
                    <P>A commenter requested that the final regulations define an “addition of capacity” for purposes of a hydropower facility and referenced a FERC certification procedure required by section 45(c)(8), which provides a production tax credit for certain incremental hydropower production. While the commenter acknowledged that section 45(c)(8) does not define the term “additions of capacity,” the commenter noted that FERC has provided guidance related to certification required under section 45(c)(8) in which FERC describes “additions of capacity” as “any increase in generating capacity other than an addition resulting from an efficiency improvement or an addition resulting from an operational change.”</P>
                    <P>Commenters also requested that efficiency improvements and upgrades to a hydropower facility consisting of refurbished or modified existing components, but not the addition or replacement of existing components, may qualify as an addition of capacity. Commenters specifically noted that upgrades to generators or turbines, rewinding generators, replacing turbines with more efficient units, and computerizing control of turbines and generators to optimize regulation of flows for generation should be treated as efficiency improvements and upgrades that should qualify as additions of capacity.</P>
                    <P>Similarly, another commenter noted that the requirements for establishing incremental hydropower are well-established and well-understood, and provide precedent for modifications and changes to a hydropower facility that result in incremental hydropower production. The commenter asserted that the final regulations should take those precedents into account in establishing rules for determining an increase in capacity for purposes of sections 45Y and 48E.</P>
                    <P>The Treasury Department and the IRS acknowledge that section 45(c)(8) provides that incremental hydropower production attributable to “efficiency improvements” or “additions of capacity” are eligible for the section 45 credit. However, section 45(c)(8) does not define the terms “efficiency improvements” nor “additions of capacity.” While section 45(c)(8)(B) allows for a determination of incremental hydropower production at an existing facility attributable to the efficiency improvements or additions of capacity, section 45Y(b)(1)(C) (and by reference section 48E(b)(3)(B)(i)) provides a credit for a new unit or any additions of capacity, but only to the extent of the increased amount of electricity production at the facility. Notably, section 45Y(b)(1)(C) does not provide for a credit for efficiency improvements. As a result, the relevant determination is whether a facility's electrical generation capacity increased as a result of an addition or replacement of components or property (including any new or replacement integral property) to a facility necessary to increase capacity. Accordingly, these final regulations do not adopt the recommendation that any efficiency improvement could meet the requirements of the Incremental Production Rule. However, efficiency improvements that are an addition or replacement of components of property (including integral property) that result in an addition to capacity could meet the requirements of the Incremental Production Rule.</P>
                    <P>The final regulations add an additional example at §§ 1.45Y-4(c)(5) and 1.48E-4(b)(5) to illustrate the application of the Incremental Production Rule to a hydropower facility.</P>
                    <HD SOURCE="HD3">3. Method of Measuring Increased Amount of Electricity Produced at the Facility by Reason of New Units or Additions of Capacity</HD>
                    <P>
                        As noted earlier, the Incremental Production Rule is based on the increased amount of electricity produced at a facility as a result of a new unit or an addition to capacity. The Incremental Production Rule is focused on measuring the amount of the capacity increase. In response to commenters, the final regulations permit the measurement of increased capacity in several ways, including: (i) modified or amended facility operating licenses from the Federal Energy Regulatory Commission (FERC) or the Nuclear Regulatory Commission (NRC), or related reports prepared by FERC or NRC as part of the licensing process (as described in section IV.H.4. of this Summary of Comments and Explanation of Revisions); (ii) the ISO conditions to measure the nameplate capacity of the facility consistent with the definition of nameplate capacity provided in 40 CFR 96.202; or (iii) a measurement standard prescribed by the Secretary in guidance published in the Internal Revenue Bulletin (
                        <E T="03">see</E>
                         26 CFR 601.601). The final regulations also clarify that taxpayers able to use the measurement standard described in § 1.45Y-4(c)(2)(i) or § 1.48E-4(b)(2)(i) may not use the method described in § 1.45Y-4(c)(2)(ii) or § 1.48E-4(b)(2)(ii) (permitting use of the ISO conditions to measure the maximum electrical generating output of a facility to determine its nameplate capacity).
                    </P>
                    <P>A commenter asserted that all energy produced by a new unit should be eligible for the section 45Y credit regardless of the degree to which that new unit and its electricity replaced existing electricity production at that facility. The Treasury Department and the IRS disagree with this comment, as the statute limits the application of the Incremental Production Rule to the increased amount of electricity produced at the facility by reason of the new unit or an addition of capacity.</P>
                    <P>
                        As proposed, the Incremental Production Rule provided that if applicable, taxpayers must use modified or amended facility operating licenses or the ISO conditions to measure the maximum electrical generating output of a facility to determine its nameplate capacity. Several commenters supported the use of the ISO conditions to measure the maximum electrical generating output of a facility to determine nameplate capacity. Additionally, a commenter noted that the proposed regulations properly focus on measuring 
                        <PRTPAGE P="4039"/>
                        the maximum generating output, rather than measuring increases in annual generation that do not impact the maximum output.
                    </P>
                    <P>Conversely, several commenters expressed concern with the proposed rule requiring the use of nameplate capacity to measure the increased amount of electricity produced at a facility because section 45Y(b)(1)(C) does not mention the term “nameplate capacity” and only provides that the credit is available to the extent of the increased amount of electricity produced at a facility without additional elaboration. A commenter also raised the importance of consistency when referring to a facility's “electrical generating output,” “electrical generating capacity,” “nameplate capacity,” and “additions of capacity.” Several commenters contended that using nameplate capacity would not be an accurate way to measure additions of capacity and emphasized that not every addition of capacity results in a new nameplate issued by the manufacturer.</P>
                    <P>Additional commenters noted that manufacturer-stamped nameplate capacity is, by design, the maximum theoretical output of the facility and differs from a facility's actual electric generating capacity. The ISO conditions generally require that this measurement be done by the manufacturer and would normally occur when the facility is originally placed in service. As a result, several commenters noted that measurement of nameplate capacity using the ISO conditions would not take into account physical depreciation, degradation, and other factors that may significantly reduce the maximum generating output and safe operating conditions of the facility over time when compared to the facility's original nameplate capacity. The Treasury Department and the IRS acknowledge that using the ISO conditions to determine nameplate capacity may limit nameplate capacity to the nameplate capacity of the facility on the original placed in service date, or to a revised nameplate capacity of the facility based on major upgrades that would result in a revised nameplate capacity rating.</P>
                    <P>Commenters noted that the proposed regulations only define nameplate capacity by adopting the definition at 40 CFR 96.202 in reference to the Five-Megawatt Limitation while noting that the final regulations did not adopt the same definition for the Incremental Production Rule. In response, the Treasury Department and the IRS have modified the Incremental Production Rule at §§ 1.45Y-4(c)(2)(ii) and 1.48E-4(b)(2)(ii) to clarify that the definition of nameplate capacity for the Incremental Production Rule is consistent with the definition of nameplate capacity provided in 40 CFR 96.202.</P>
                    <P>A commenter requested additional flexibility in demonstrating incremental generation, including through the use of actual baseline generation data reported to government and quasi-government agencies such as independent system operators, regional transmission organizations, or other balancing authorities where the generator is connected. Additionally, several commenters stated that ISO standards are not widely used in the industry and that other standards more widely used by the industry would be more effective at determining true capacity additions. Several commenters that recommended other standards for measuring increased capacity noted that geothermal facilities, hydropower facilities, and other clean energy facilities would be disadvantaged by relying on nameplate capacity to satisfy the Incremental Production Rule. Several commenters provided options for alternative measurements standards, including the American Society of Mechanical Engineers (ASME) Performance Tests, IEC standards, and NERC procedures, and other comparable technical standard conditions. Additionally, a commenter suggested permitting taxpayers to use an accredited measurement method, such as the ASME Performance Test, suitable for the particular circumstances associated with the facility modification or addition, provided that the accredited method can be used to reasonably measure electrical generating capacity, can be consistently applied to measure electrical generation capacity before and after the modification or addition, and can be clearly documented by a third-party engineering report specific to the project.</P>
                    <P>Other commenters proposed measuring additional capacity based on changes in output compared to the facility's historical baseline output. A commenter proposed permitting taxpayers to measure by themselves the amount by which all components of property added to the facility in a taxable year increases the generating capacity of the facility, relative to a baseline in which the components of property are not added to the facility. Several commenters also noted that measurements should be adjusted as reasonably practicable to ensure a like-for-like comparison pre- and post-addition. Conversely, a commenter noted that additional capacity measurements should not rely on monthly or annual output of a facility prior to and after a project or modification because other factors, such as weather, demand, and outages will affect a facility's output from one period to another. The Treasury Department and the IRS have determined that increased capacity should not be based on a measurement methodology that simply compares electricity production before the increase in capacity to electricity production after the increase in capacity because such measurement methodologies involve seasonal or other fluctuations that are too easily manipulated to show a greater increase in capacity than the actual increase.</P>
                    <P>The Treasury Department and the IRS considered the comments regarding different methods for measuring increased capacity and found that many of the proposed measurement standards were not broadly applicable across technologies. Additionally, many were not sufficiently objective. The Treasury Department and the IRS recognize, though, that different methods may exist that are broadly applicable across technologies and sufficiently objective. The Treasury Department and the IRS will continue to consult with experts on potential additional measurement standards that could apply. The final regulations are amended to reflect this continuing consideration and to provide flexibility by permitting the Secretary to prescribe additional measurement standards in guidance published in the Internal Revenue Bulletin.</P>
                    <P>
                        The Treasury Department and the IRS recognize the limitations of measuring increased capacity with nameplate capacity. As a result, the Treasury and the IRS have provided additional measurement options in the final regulations. Measurement options in the final rule include: modified or amended facility operating licenses from FERC or NRC, or related reports prepared by FERC or NRC as part of the licensing process (as described in section IV.H.4. of this Summary of Comments and Explanation of Revisions); and any measurement standard prescribed by the Secretary in guidance published in the Internal Revenue Bulletin (
                        <E T="03">see</E>
                         26 CFR 601.601). The final regulations also clarify that taxpayers that are able to use the measurement standard described in § 1.45Y-4(c)(2)(i) or § 1.48E-4(b)(2)(i) may not use the method described in § 1.45Y-4(c)(2)(ii) or § 1.48E-4(b)(2)(ii) (permitting use of the ISO conditions to measure the maximum electrical generating output of a facility to determine its nameplate capacity). Additionally, the final regulations add an additional example at §§ 1.45Y-4(c)(5) and 1.48E-4(b)(5) to illustrate the application of the Incremental Production Rule to a geothermal facility.
                        <PRTPAGE P="4040"/>
                    </P>
                    <HD SOURCE="HD3">4. Documentation Used To Demonstrate Increased Capacity</HD>
                    <P>As proposed, the Incremental Production Rule allowed taxpayers to use modified or amended facility operating licenses to measure capacity and changes therein. Several commenters noted that nuclear facilities are unable to use modified or amended facility operating licenses to measure an addition of capacity, because a NRC operating license lists a reactor's maximum power level in megawatts thermal, rather than maximum electric generating capacity, and changes can be made to improve a plant's thermal efficiency (and thus electric generating capacity) without altering the reactor's thermal power or necessitating a modified or amended operating license. Nonetheless, the Treasury Department and the IRS understand that, under certain circumstances, FERC and NRC modified or amended licenses and reports related to those modified or amended licenses do report electrical capacity and changes therein.</P>
                    <P>For example, the NRC reports the electric capacity of nuclear power plants before and after uprates involving amendments to NRC licenses. Electric generating capacity is not typically included in NRC operating licenses, as operating licenses do not condition or limit the electric power output. However, electric capacity can be included in related NRC-authored safety evaluation reports, which are a required element of the license amendment process. These reports typically express power output in MW thermal but can also provide information related to capacity in MW electric. The final regulations at §§ 1.45Y-4(c)(2)(i) and 1.48E-4(b)(2)(i) allow taxpayers to use the electric capacity, and changes therein, presented in safety evaluation reports that are part of a modified or amended operating license to demonstrate an increased amount of electricity produced at the facility by reason of a new unit or addition of capacity, and to calculate the amount of that increase. Similarly, the final regulations at §§ 1.45Y-4(c)(2)(i) and 1.48E-4(b)(2)(i) also allow taxpayers to use electrical capacity and changes therein as reported in FERC modified or amended licenses, and reports related to those modified or amended licenses. The final regulations clarify, though, that taxpayers that are able to use the measurement standard described in § 1.45Y-4(c)(2)(i) or § 1.48E-4(b)(2)(i) may not use the method described in § 1.45Y-4(c)(2)(ii) or § 1.48E-4(b)(2)(ii) (permitting use of the International Standard Organization (ISO) conditions to measure the maximum electrical generating output of a facility to determine its nameplate capacity).</P>
                    <P>Several commenters proposed various additional methods for documenting an increase in capacity including the use of a third-party engineering report. The Treasury Department and the IRS determined that without a specific measurement standard and certification requirements, an independent third-party engineering report alone does not provide an adequate method to substantiate a facility's increased capacity.</P>
                    <HD SOURCE="HD3">5. Measurement of Eligible Basis for a New Unit or an Addition of Capacity Under Section 48E</HD>
                    <P>Several commenters recommended that the cost of any uprates, upgrades, efficiency, or other improvements that result in additional generation capacity at a facility be considered a qualified investment for purposes of the section 48E credit. Specifically, commenters asserted that the qualified investment with respect to a qualified facility should include the entire cost of a new unit or any additions of capacity, rather than a proportionate share of those costs reflective of the extent to which the electricity produced attributable to a new unit or addition of capacity increased (as opposed to replaced) the existing facility's production. Commenters supported this recommendation by noting a similar treatment of basis was used in the Section 1603 Grant Program for improvements to hydropower facilities.</P>
                    <P>Commenters also noted that the proposed regulations allow for the full basis of a qualified investment in a new unit to be eligible for the credit, but not for additions of capacity. A commenter emphasized that this approach creates challenges for administrability, and application of the rule based on measuring fractional additions of capacity. As an example, the commenter indicated that some replacement parts do not have a nameplate capacity but are essential to the total nameplate capacity of the overall facility. Several commenters recommended an alternative rule that prorates an investment between qualified and non-qualified property when the investment is a discretionary replacement of existing capacity but suggested that the entire amount of an investment should be treated as eligible for the credit if the investment would not have occurred but for increasing capacity.</P>
                    <P>In response to the comments, the Treasury Department and the IRS acknowledge that a qualified investment for an addition of capacity would not be paid or incurred but for the increase in electricity generation capacity and agree that the rules for computing the qualified investment for an addition of capacity should be modified. Therefore, the final regulations at § 1.48E-4(b)(4) are amended to make the rule for an addition of capacity equivalent to that of a new unit by providing that a taxpayer's qualified investment during the taxable year that resulted in an increased capacity of a facility by reason of a new unit or an addition of capacity is its total qualified investment in components of qualified property that result in the new unit or addition of capacity.</P>
                    <HD SOURCE="HD3">6. Special Rule for Restarted Facilities</HD>
                    <P>A few commenters requested further guidance specific to decommissioned facilities. These commenters suggested treating the capacity of decommissioned facilities before restarting as zero and clarifying that facilities meeting the special rule for restarted facilities under proposed §§ 1.45Y-4(c)(2) and 1.48E-4(b)(2) can treat their entire capacity as an addition of capacity. One commenter noted that a decommissioned facility ceases operations and is not legally permitted to produce electricity due to a lack of operating license. Another commenter requested that, instead of requiring a period without a valid operating license, the final regulations cover the typical situation for decommissioning a hydropower facility in which the licensee maintains an operating license that no longer authorizes the operation of the facility. Another commenter similarly asserted that a nuclear facility must maintain its operating license until decommissioning is concluded. The commenter stated that a nuclear facility's operating license (issued by the NRC) generally does not authorize operation and electricity production after the licensee submits a written certification to the NRC that they have determined to permanently cease operations and once fuel has been permanently removed from the reactor vessel. Accordingly, both commenters suggested revising proposed §§ 1.45Y-4(c)(2)(ii) and 1.48E-4(b)(2)(ii) to treat a facility that is decommissioned or in the process of decommissioning and restarts to have increased capacity if the facility shuts down for at least one calendar year, during which it was not authorized to operate by its respective Federal Agency or did not generate more than 0 megawatt-hours, while holding a license from the FERC or NRC.</P>
                    <P>
                        An additional commenter recommended expanding the special 
                        <PRTPAGE P="4041"/>
                        rule for restarted facilities to include continuous operation in the case of a facility that obtains a renewed operating license and enters an initial or subsequent period of extended operation under the renewed operating license after December 31, 2024. The commenter suggested treating such a scenario as an addition of capacity equal to the full capacity of the facility.
                    </P>
                    <P>In contrast, a commenter raised concerns regarding the special rule for restarted facilities, pointing to abuse by certain taxpayers and noting that the rule strays from the intention of the tax credits to deploy new resources. The commenter further highlighted a potential lack of readiness by implicated government agencies, noting specifically that the NRC does not have regulations governing license reinstatement. The commenter recommended removing the special rule for restarted facilities from the final regulations or, in the alternative, engaging in further fact finding before finalizing such a rule. If a special rule for restarted facilities is implemented, the commenter requested that additional requirements be incorporated to raise the bar to entry for decommissioned facilities to prevent abuse of loopholes.</P>
                    <P>
                        In response to these comments, the final regulations make four changes to proposed §§ 1.45Y-4(c)(2) and 1.48E-4(b)(2) and moved them to §§ 1.45Y-4(c)(3) and 48E-4(b)(3), respectively. First, the final regulations modify the language in proposed §§ 1.45Y-4(c)(2)(ii) and 1.48E-4(b)(2)(ii) to state that “[t]he existing facility must have a shutdown period of at least one calendar year during which it 
                        <E T="03">was not authorized to operate</E>
                         by its respective Federal regulatory authority (that is, the FERC or the NRC).” (Emphasis added.) Second, the final regulations modify the language in proposed §§ 1.45Y-4(c)(2)(iii) and 1.48E-4(b)(2)(iii) to state that the restarted facility must be eligible to restart based on an operating license issued by either FERC or NRC. Third, the final regulations are modified to reflect the Treasury Department and the IRS' agreement with the commenter's concerns regarding potential abuse by certain taxpayers related to the decommissioning and shutdown steps in the proposed regulations. In order to limit this potential abuse, the final regulations add an anti-abuse rule to §§ 1.45Y-4(c)(3) and 1.48E-4(b)(3) that provides that a facility may not cease operation for the purpose of qualifying for the special rule for restarted facilities. Finally, the final regulations reflect that the addition of capacity in the case of a restarted facility is the total capacity of the facility after it is restarted by modifying the language to state that a facility that is decommissioned or in the process of decommissioning and restarts can be considered to have increased capacity 
                        <E T="03">from a base of zero</E>
                         if certain conditions are met. The final regulations add an additional example at §§ 1.45Y-4(c)(5) and 1.48E-4(b)(5) to illustrate the application of the Incremental Production Rule to a restarted facility.
                    </P>
                    <HD SOURCE="HD3">I. Dual Use Rule</HD>
                    <P>A commenter requested clarifying the applicability of the “dual use” concept to sections 45Y and 48E. Specifically, the commenter suggested clarifying that the “75 percent cliff” for energy property with integrated storage does not apply. A previous version of § 1.48-9 included a Dual Use Rule, referred to as the “75-percent cliff,” which provided that a solar energy property, wind energy property, or geothermal equipment is eligible for the section 48 credit to the extent of the energy property's basis or cost allocable to its annual use of energy from a qualified source if the use of energy from “non-qualifying” sources does not exceed 25 percent of the total energy input of the energy property during an annual measuring period.</P>
                    <P>Historically, the Dual Use Rule was used in the section 48 regulations to address the treatment of energy storage property that stored energy from a qualified source and a non-qualified source. This was necessary because prior to the IRA amendments to section 48, energy storage property was only allowed for the section 48 credit as part of an energy property. After the IRA amendments, energy storage property became a separate type of energy property, referred to as “energy storage technology,” and the need for the Dual Use Rule changed. Similar to the treatment of EST in section 48, a separate credit is provided under section 48E. Accordingly, the Treasury Department and IRS clarify that the Dual Use Rule contained in a prior version of § 1.48-9 is not applicable to the section 45Y and 48E credits.</P>
                    <HD SOURCE="HD2">V. Rules Relating to the Increased Credit Amount for Satisfying Certain Prevailing Wage and Apprenticeship Requirements</HD>
                    <HD SOURCE="HD3">A. In General</HD>
                    <P>The PWA final regulations provide generally applicable rules on the PWA requirements. Comments on the general PWA requirements (including comments that referenced section 45Y or 48E but addressed the PWA requirements more generally) were addressed in the PWA final regulations. To the extent consistent with this Summary of Comments and Explanation of Revisions, the Explanation of Revisions described in the PWA final regulations is incorporated in these final regulations. Therefore, general comments addressed in the preamble to the PWA final regulations are not readdressed in this Summary of Comments and Explanation of Revisions.</P>
                    <P>Increased credit amounts are generally available under section 45Y(a)(2)(B) for qualified facilities and section 48E(a)(2)(A)(ii) for qualified facilities and EST if beginning of construction of the qualified facility or EST occurs before January 29, 2023 (BOC Exception). Under the relevant BOC Exception in sections 45Y and 48E, taxpayers may claim the amount of the increased credit without satisfying the PWA requirements if construction “begins prior to the date that is 60 days after the Secretary publishes guidance with respect to the [PWA requirements].” On November 30, 2022, the Treasury Department and the IRS published Notice 2022-61, 2022-52 I.R.B. 560, providing initial guidance with respect to the PWA requirements and starting the 60-day period described in those sections. To qualify for the BOC Exception, a taxpayer must begin construction before January 29, 2023.</P>
                    <P>Additionally, increased credit amounts are generally available under sections 45Y and 48E with respect to qualified facilities with a maximum net output (or capacity for EST under section 48E) of less than one megawatt (One Megawatt Exception). If a taxpayer satisfies the PWA requirements, meets the BOC Exception, or meets the One Megawatt Exception, the amount of section 45Y credit or section 48E credit determined is equal to the otherwise determined amounts multiplied by five.</P>
                    <HD SOURCE="HD3">B. Application of the PWA Requirements to Section 45Y</HD>
                    <P>Section 45Y(g)(9) provides that rules similar to the rules of section 45(b)(7) apply with respect to the prevailing wage requirements (Prevailing Wage Requirements). Section 45Y(g)(10) provides that rules similar to the rules of section 45(b)(8) apply with respect to the apprenticeship requirements (Apprenticeship Requirements). Section 1.45Y-3(b)(3) adopted by cross-reference the rules in the PWA final regulations promulgated under section 45(b)(7) and (8); specifically, §§ 1.45-7 (Prevailing Wage Requirements), 1.45-8 (Apprenticeship Requirements), and 1.45-12 (recordkeeping and reporting).</P>
                    <P>
                        As previously explained, the PWA final regulations addressed general 
                        <PRTPAGE P="4042"/>
                        application of the PWA requirements and provided the rules (except the One Megawatt Exception) applicable for section 45Y in § 1.45Y-3. To provide consistent descriptions and terminology, non-substantive, technical updates have been made to § 1.45Y-3 to reflect these final regulations. As revised, § 1.45Y-3 also includes a new applicability date. These final regulations make no substantive change regarding application of the general PWA requirements, notwithstanding the new applicability date, apart from the amendments made to address the One Megawatt Exception. Taxpayers that began construction after June 25, 2024, and taxpayers that begin construction after the publication of the final regulations continue to follow the same general rules with respect to the PWA requirements.
                    </P>
                    <P>Taxpayers also have the option to apply these final regulations to qualified facilities that began construction before the publication of the final regulations, provided that taxpayers follow these final regulations in their entirety and in a consistent manner. Likewise, taxpayers that choose to apply these final regulations must also follow the PWA final regulations, consistent with prior § 1.45Y-3. There are no changes to the application of the transition rules provided for in the PWA final regulations for taxpayers choosing to apply these final regulations for construction that began before the publication of the final regulations as the general PWA requirements did not change between prior § 1.45Y-3 in the PWA final regulations and § 1.45Y-3 in these final regulations.</P>
                    <P>The Treasury Department and the IRS understand that taxpayers may need additional time to comply with the amendments made by these final regulations to the One Megawatt Exception. Therefore, the amendments made to § 1.45Y-3 with respect to the One Megawatt Exception have a delayed applicability date that is 60 days after publication of the final regulations. Comments received regarding the One Megawatt Exception under section 45Y are addressed in these final regulations and explained in section V.D. of this Summary of Comments and Explanation of Revisions.</P>
                    <HD SOURCE="HD3">C. Application of the PWA Requirements to Section 48E</HD>
                    <HD SOURCE="HD3">1. In General</HD>
                    <P>The PWA requirements in section 48E cross-reference both sections 45 and 48 for operative rules. Section 48E(d)(3) provides that rules similar to the rules of section 48(a)(10) apply with respect to the prevailing wage requirements. Section 48(a)(10) provides rules with respect to the prevailing wage requirements under section 48, including the special recapture provision under section 48(a)(10)(C). Section 48(a)(10)(B) provides that the correction and penalty procedures under section 45(b)(7)(B) for a failure to satisfy the prevailing wage requirements generally apply prior to a recapture event under section 48(a)(10)(C). Section 48E(d)(4) provides that rules similar to the rules of section 45(b)(8) apply with respect to the apprenticeship requirements. Proposed § 1.48E-3 would adopt by cross-reference those rules in the section 48 final regulations promulgated under section 48(a)(10) and the PWA final regulations promulgated under section 45(b)(7) and (8); specifically, §§ 1.48-13(c) (Prevailing Wage Requirements), 1.45-8 (Apprenticeship Requirements), and 1.45-12 (recordkeeping and reporting). These rules are generally adopted by cross-reference in § 1.48E-3 with additional clarifications to reflect §§ 1.48-13, 1.45-8, and 1.45-12 and these final regulations.</P>
                    <P>At least one commenter requested that C&amp;G facilities fueled by woody biomass feedstocks be eligible to qualify for the domestic content bonus credit amount and increased credit amount for satisfying PWA requirements. As discussed in section IV.A. of this Summary of Comments and Explanation of Revisions, a facility that meets the definition of a qualified facility may qualify for the relevant section 45Y and 48E credits. Accordingly, a qualified facility may also qualify for an increased credit amount under sections 45Y and 48E provided that the facility satisfies the relevant domestic content bonus or PWA requirements.</P>
                    <P>A commenter praised the PWA final regulations for using restraint in incorporating elements of the Davis-Bacon Act and suggested that the Treasury Department and the IRS exercise the same restraint in drafting these regulations. The Treasury Department and the IRS generally agree with the commenter that the final regulations for section 48E should apply a similar approach as in the PWA final regulations in order to ensure consistency across different Code sections, provide taxpayer certainty, and further tax administration. These final regulations reflect such an approach.</P>
                    <HD SOURCE="HD3">2. Transition Rules</HD>
                    <P>As stated in the preamble to the PWA final regulations and reiterated in the preamble to the section 48 final regulations, the Treasury Department and the IRS have determined that given the complexity of the PWA requirements, the uncertainty regarding the potential retroactive effects of the PWA requirements, and the benefits to tax administration gained with consistency across the various Code sections containing PWA requirements, that a transition rule is appropriate. The PWA final regulations provide that any work performed before January 29, 2023 (that is, the date that is 60 days after the publication of Notice 2022-61) is not subject to the PWA requirements, regardless of whether there is an applicable BOC Exception. This transition rule also applies for taxpayers that may initially satisfy the BOC Exception, but later fail to meet the BOC Exception (for example, by failing to meet certain continuity requirements). These taxpayers must satisfy the PWA requirements for construction, alteration, or repair (as applicable) that occurs on or after January 29, 2023, but do not need to meet the PWA requirements for work that occurred prior to that date. For similar reasons, this transition rule also applies to the PWA requirements under section 48E and is incorporated by cross-reference to §§ 1.48-13 and 1.45-8 in these final regulations.</P>
                    <P>The section 48 final regulations (and as described in the PWA final regulations) also provide a limited transition waiver for the penalty payment with respect to the correction and penalty procedures described in section 45(b)(7)(B) for a failure to satisfy the Prevailing Wage Requirements. The PWA final regulations provide that the penalty payment is waived with respect to a laborer or mechanic who performed work in the construction, alteration, or repair of a qualified facility on or after January 29, 2023, and prior to June 25, 2024, if the taxpayer relied upon Notice 2022-61 or the PWA proposed regulations for determining when the obligation to pay prevailing wages began, provided the taxpayer makes the appropriate correction payments to the impacted workers within 180 days of June 25, 2024. These final regulations clarify that this limited transition waiver applies to section 48E (by incorporation of the cross-reference to section 48(a)(10)) provided the taxpayer makes the appropriate correction payments to the impacted workers within 180 days of the publication of these final regulations.</P>
                    <P>
                        Similarly, these final regulations also allow taxpayers to use Notice 2022-61 for determining when construction begins for purposes of the applicable percentage of labor hours performed by qualified apprentices required under 
                        <PRTPAGE P="4043"/>
                        section 45(b)(8) in satisfying the labor hours requirement described in § 1.45-8. These transition rules are further explained in the preamble to the PWA final regulations.
                    </P>
                    <HD SOURCE="HD3">3. Recapture</HD>
                    <P>The section 48 final regulations also addressed the recapture rules under section 48(a)(10)(C). The preamble to the section 48 final regulations contains detailed discussion of the recapture rules, and similar rules apply for purposes of the special recapture rule in section 48E(d)(3) (by reference to section 48(a)(10)). The recapture rules in § 1.48-13 are incorporated by cross-reference in § 1.48E-3. These final regulations do clarify that if there is no alteration or repair that occurs during the relevant year during the five-year recapture period, the taxpayer is deemed to satisfy the PWA requirements with respect to that year.</P>
                    <HD SOURCE="HD3">4. Interconnection Property</HD>
                    <P>Some commenters suggested clarifying that the PWA requirements do not apply to the construction, alteration, or repair of interconnection property. Section 48E(a)(2)(A)(ii) provides that the increased credit amount (for satisfying the PWA requirements) is determined in the case of a qualified facility. The qualified investment with respect to a qualified facility described in section 48E(b) is the sum of the basis of any qualified property placed in service by the taxpayer during such taxable year that is part of a qualified facility, plus the amount of expenditures that are paid or incurred by the taxpayer for qualified interconnection property. Therefore, interconnection property is eligible for the increased credit amount. However, consistent with section 48(a)(8), § 1.48E-4(a)(2) clarifies that interconnection property is not part of a qualified facility and therefore is not subject to the PWA requirements.</P>
                    <P>In addition to not being part of the qualified facility, as defined in section 48E(b)(3)(A), interconnection property generally is also not within the control of the taxpayer that owns the qualified facility because it generally is not owned by the same taxpayer. Instead, qualified interconnection property is generally owned by a utility and is part of an addition, modification, or upgrade to a transmission or distribution system that is required at or beyond the point at which the qualified facility interconnects to such transmission or distribution system. It would therefore be difficult or impossible in such a case for the taxpayer to control or monitor whether the construction of the interconnection property complies with the PWA requirements. This may explain why the statute permits the increased credit amount for amounts paid or incurred for qualified interconnection property, without subjecting the construction of that property to the PWA requirements.</P>
                    <P>With respect to EST, section 48E(c)(1) describes the qualified investment with respect to EST without reference to interconnection property. This differing treatment of interconnection property between qualified facilities under section 48E(b) and EST under section 48E(c) is further supported by section 48E(b)(4), which solely defines interconnection property “[f]or purposes of this paragraph [(b)(4)].” Accordingly, the qualified investment with respect to any EST does not include qualified interconnection costs and qualified interconnection property is not subject to PWA requirements. Interconnection property with respect to EST is further discussed in section III.D.6. of this Summary of Comments and Explanation of Revisions.</P>
                    <HD SOURCE="HD3">D. One Megawatt Exception Under Section 45Y</HD>
                    <P>The preamble to the PWA final regulations explained that the One Megawatt Exception for purposes of section 45Y would be addressed in these final regulations. Comments pertaining to the technical aspects of measuring output for the purposes of the One Megawatt Exception under 45Y were limited. Commenters stated that some technologies, such as solar, generate electricity in direct current not alternating current, so it is unclear how to measure such technologies.</P>
                    <P>The Treasury Department and the IRS agree that the One Megawatt Exception under section 45Y(a)(2)(B)(i) requires clarification. The final regulations under § 1.45Y-3(c)(1) provide that the determination of whether a qualified facility has a maximum net output of less than one megawatt of electricity (as measured in alternating current) is based on the nameplate capacity of the qualified facility. The nameplate capacity for purposes of the One Megawatt Exception is the maximum electrical generating output in megawatts that a qualified facility is capable of producing on a steady state basis and during continuous operation under standard conditions, as measured by the manufacturer and consistent with the definition of nameplate capacity provided in 40 CFR 96.202. If applicable, taxpayers must use the ISO conditions to measure the maximum electrical generating output of a qualified facility. For qualified facilities that generate electrical output in direct current, the final regulations under § 1.45Y-3(c)(2) provide an alternative nameplate capacity measurement. For qualified facilities that generate electricity in direct current, the taxpayer may choose to determine the maximum net output (in alternating current) of each qualified facility for purposes of the One Megawatt Exception by using the lesser of: (i) the sum of the nameplate generating capacities within the unit of qualified facility in direct current, which is deemed the nameplate generating capacity of the unit of qualified facility in alternating current; or (ii) the nameplate capacity of the first component of property that inverts the direct current electricity into alternating current.</P>
                    <P>When evaluating whether the One Megawatt Exception under section 45Y applies, the Treasury Department and the IRS have determined that a consistent approach should apply for purposes of sections 48E and 45Y. A plain reading of the statutory exception for facilities with a maximum net output of less than one megawatt demonstrates Congress's intent to have only lower output, small facilities excepted from the PWA requirements and still be eligible for the increased credit amount. For purposes of determining whether a qualified facility must satisfy the PWA requirements to obtain an increased credit amount, the output of any qualified facility must be evaluated consistent with its operations. These final regulations provide, in part, that the unit of qualified facility includes all functionally interdependent components of property owned by the taxpayer that are operated together and that can operate apart from other property to produce electricity. The Treasury Department and the IRS intended for the term “operated together” to be given effect when considering whether the One Megawatt Exception applies to the PWA requirements.</P>
                    <P>
                        When measuring nameplate capacity for the purposes of the One Megawatt Exception under section 45Y, these final regulations provide parity with the rules for section 48E and include the same special rule that if the qualified facility has 
                        <E T="03">integrated operations</E>
                         with one or more other qualified facilities, then the aggregate nameplate capacity of the qualified facilities is used for purposes of determining whether the One Megawatt Exception applies to the qualified facility. Solely for the purposes of the One Megawatt Exception, these final regulations provide that a qualified facility is treated as having 
                        <E T="03">integrated operations</E>
                         with any other qualified facility of the 
                        <PRTPAGE P="4044"/>
                        same technology type if the facilities are: (i) owned by the same or related taxpayers; (ii) placed in service in the same taxable year; and (iii) transmit electricity generated by the facilities through the same point of interconnection or, if the facilities are not grid-connected or are delivering electricity directly to an end user behind a utility meter, are able to support the same end user. The final regulations also provide a definition for related taxpayers. For purposes of the One Megawatt Exception, the term 
                        <E T="03">related taxpayers</E>
                         means members of a group of trades or businesses that are under common control (as defined in § 1.52-1(b)). Related taxpayers are treated as one taxpayer in determining whether a qualified facility has integrated operations.
                    </P>
                    <P>The Treasury Department and the IRS understand that some taxpayers who have integrated operations may need additional time to comply with the PWA requirements where construction has already begun, or is imminent, before publication of these final regulations. To alleviate these circumstances, the rule for qualified facilities with integrated operations has a delayed applicability date that is 60 days after publication of the final regulations.</P>
                    <HD SOURCE="HD3">E. Election To Group Qualified Facilities for Purposes of PWA Requirements Under Section 45Y</HD>
                    <P>Commenters suggested that the taxpayers should be allowed to group facilities as they chose when applying the PWA requirements for an increased credit amount. For example, a commenter suggested that a taxpayer that owns interrelated facilities should be allowed elect to combine multiple interrelated facilities into one aggregated unit or, alternatively, elect to treat the facilities individually for the PWA requirements. Some commenters asserted that it is difficult to certify compliance at each qualified facility level, so taxpayers should be allowed to certify PWA compliance at an interrelated facilities level.</P>
                    <P>To claim an increased credit amount for satisfying the PWA requirements, section 45Y requires that each qualified facility satisfy the requirements. The statute does not support commenters' request to allow PWA certification for qualified facilities based on one qualified facility. If a taxpayer does not satisfy the PWA requirements for a qualified facility, the taxpayer may cure with correction payments paid to impacted workers and a penalty paid to the IRS. The PWA final regulations provide taxpayers the rules for the Prevailing Wage Requirement, Apprenticeship Requirement, and the recordkeeping and reporting applicable to section 45Y.</P>
                    <HD SOURCE="HD3">F. One Megawatt Exception Under Section 48E</HD>
                    <P>The preamble to the PWA final regulations explained that the One Megawatt Exception for purposes of section 48E would be addressed in these final regulations. Proposed § 1.48-13 would have provided by cross-reference that maximum net output is based on nameplate capacity and proposed conversion formulas for certain types of qualified facilities and ESTs.</P>
                    <P>Some commenters recommended revisions to the conversion formulas. For example, one commenter asserted that by defining the threshold for the One Megawatt Exception for thermal systems at about a quarter of the equivalent output of electrical energy systems, investors in thermal energy storage systems will not qualify for the One Megawatt Exception. The commenter recommended that the One Megawatt Exception be measured as the maximum net output according to a facility's electrical equivalent. The commenter explained this means that for thermal energy resources, the use of electricity (in kW) that would be avoided or offset by each unit of thermal energy (Btu/h for heat, or Ton of cooling) provided by the thermal energy resource. The commenter recommended that the conversion value for thermal energy cooling systems for purposes of measuring the One Megawatt Exception for qualified facilities be 1,550 tons for water-cooled systems and 870 tons for air-cooled systems.</P>
                    <P>The Treasury Department and the IRS have concluded that the conversion formulas in the proposed regulations provide a direct and accurate conversion and that no changes are needed to the conversion factors for thermal energy storage property. By providing a broadly applicable rule, the conversion formulas should provide accurate results for a broad set of applications and technologies. The commenters' requests for specific formulas applicable to specific technologies conflict with the approach of these final regulations to provide general, rather than narrow, rules. Therefore, the final regulations do not adopt these comments. The final regulations provide conversion formulas for thermal energy storage technology in § 1.48E-3(c)(3)(iii) and hydrogen storage technology in § 1.48E-2(g)(6)(iii).</P>
                    <P>Commenters also stated that certain technologies generate electricity in direct current, not alternating current, so it is unclear how such qualified facilities could qualify for the One Megawatt Exception. The Treasury Department and the IRS agree that the One Megawatt Exception under section 48E requires clarification for technologies that generate output in direct current.</P>
                    <P>The final regulations provide that the determination of whether a qualified facility has a maximum net output of less than one megawatt of electricity (as measured in alternating current) is based on the nameplate capacity of the qualified facility. The nameplate capacity for purposes of the One Megawatt Exception is the maximum electrical generating output in megawatts that a qualified facility is capable of producing on a steady state basis and during continuous operation under standard conditions, as specified by the manufacturer and consistent with the definition of nameplate capacity provided in 40 CFR 96.202. If applicable, taxpayers must use the ISO conditions to measure the maximum electrical generating output of a facility. Section 48E(a)(2)(B)(ii)(I) describes the One Megawatt Exception for EST as based on the capacity of the EST. The final regulations adopt this general term, and also clarify that the nameplate capacity of the for EST is based on the output of the EST.</P>
                    <P>For qualified facilities that generate electrical output in direct current, the final regulations provide a new alternative nameplate capacity measurement. Only for qualified facilities that generate electricity in direct current, the taxpayer may choose to determine the maximum net output (in alternating current) of each qualified facility by using the lesser of: (i) the sum of the nameplate generating capacities within the unit of qualified facility in direct current, which is deemed the nameplate generating capacity of the unit of qualified facility in alternating current; or (ii) the nameplate capacity of the first component of property that inverts the direct current electricity into alternating current. The final regulations also provide these same rules apply for ESTs that have output in direct current for the purposes of determining if the EST One Megawatt Exception applies.</P>
                    <P>
                        Commenters also stated opposition to adopting the concept of an “energy project” or aggregation rule similar to those in the section 48 proposed regulations for purposes of claiming the increased rate for meeting the PWA requirements under section 48E (as well as section 45Y). Commenters asserted that there is no legal basis for using the definition of an energy project or any aggregation rule for the section 48E 
                        <PRTPAGE P="4045"/>
                        credit. A commenter instead suggested permitting a taxpayer to elect to combine multiple interrelated facilities into one aggregated unit or, alternatively, elect to treat the facilities individually for purposes of the PWA requirements. Another commenter requested permitting taxpayers to certify that individual qualified facilities meet the PWA requirements if interrelated facilities meet the PWA requirements. The commenter stated that taxpayers typically contract with mechanics and laborers for an entire project, rather than for an individual qualified facility, and that it would be difficult to certify compliance with the PWA requirements at the qualified facility level.
                    </P>
                    <P>
                        The Treasury Department and the IRS do not agree with commenters that there is no legal basis to incorporate an aggregation rule into section 48E. Section 48E(d)(3) provides that “[r]ules similar to the rules of section 48(a)(10) shall apply.” Section 48(a)(10) applies the prevailing wage requirements to “energy projects,” which requires the aggregation of energy properties under section 48. Additionally, the reference in section 48E(d)(3) to the prevailing wage requirements provided in section 48(a)(10) 
                        <SU>4</SU>
                        <FTREF/>
                         indicates that the express delegation of authority in section 48(a)(16) also applies in the context of section 48E for implementation of the prevailing wage requirements. Although the apprenticeship requirements provided in section 48E(d)(4) applies rules similar to section 45(b)(8) rather than section 48(a)(11), an appropriate reading of the statute is to apply a consistent interpretation to both of section 48E's prevailing wage requirements and apprenticeship requirements, as inconsistent interpretations would frustrate congressional intent by creating different standards for the prevailing wage requirements and apprenticeship requirements and would be difficult for the IRS to administer. For the reasons noted in this Summary of Comments and Explanation of Revisions, interpreting the PWA requirements for section 48E consistently with section 48(a)(10) is the best implementation of the overall statutory framework because it results in the PWA requirements being applied appropriately and consistently across credits.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             Section 48(a)(16) provides the same broad authority for administering the PWA provisions in section 48(a).
                        </P>
                    </FTNT>
                    <P>The concept of interrelated facilities raised by commenters is relevant to the One Megawatt Exception. As discussed in section IV.B. of this Summary of Comments and Explanation of Revisions, these final regulations apply a functional definition to implement the term “qualified facility.” These final regulations provide, in part, that the unit of qualified facility includes all functionally interdependent components of property owned by the taxpayer that are operated together and that can operate apart from other property to produce electricity. This functional definition could result in some qualified facilities with a maximum net output that is far greater than one megawatt being treated as though they were many separate facilities each with a maximum net output of less than one megawatt. This would have unintended impacts on the PWA requirements. Accordingly, the Treasury Department and the IRS intend to give effect to the term “operated together” when considering whether and how the One Megawatt Exception applies to the PWA requirements.</P>
                    <P>A plain reading of the statutory exception for facilities with a maximum net output of less than one megawatt demonstrates Congress's intent to have only lower output, small facilities excepted from the PWA requirements and still be eligible for the increased credit amount. Any other interpretation undermines the purpose of the statutory exception and Congress's intent to have PWA requirements apply to the construction of clean energy facilities. For purposes of determining whether a qualified facility must satisfy the PWA requirements to obtain an increased credit amount, the output of any qualified facility must be evaluated consistent with its operations. This supports the purpose of the One Megawatt Exception, provides certainty for taxpayers seeking increased credit amounts under section 48E, and furthers sounds tax administration.</P>
                    <P>
                        When measuring nameplate capacity for the purposes of the One Megawatt Exception, the final regulations provide a special rule. Solely for the purposes of the One Megawatt Exception, if the qualified facility has 
                        <E T="03">integrated operations</E>
                         with one more other qualified facilities, then the aggregate nameplate capacity of the qualified facilities is used for the purposes of determining if the One Megawatt Exception applies. The final regulations under § 1.48E-3(c)(4)(i) provide that solely for the purposes of the One Megawatt Exception, a qualified facility is treated as having 
                        <E T="03">integrated operations</E>
                         with any other qualified facility of the same technology type, if the facilities are: (i) owned by the same or related taxpayers; (ii) placed in service in the same taxable year; and (iii) transmit electricity generated by the facilities through the same point of interconnection or, if the facilities are not grid-connected or are delivering electricity directly to an end user behind a utility meter, are able to support the same end user. The final regulations under § 1.48E-3(c)(4)(ii) provide a similar 
                        <E T="03">integrated operations</E>
                         rule for EST.
                    </P>
                    <P>
                        As discussed in section IV.G. of this Summary of Comments and Explanation of Revisions, the final regulations provide for a generally applicable related taxpayer rule in § 1.48E-1(c), including for purposes of the One Megawatt Exception. The term 
                        <E T="03">related taxpayers</E>
                         means members of a group of trades or businesses that are under common control as defined in § 1.52-1(b). Related taxpayers are treated as one taxpayer in determining whether a qualified facility or EST has integrated operations.
                    </P>
                    <P>As with section 45Y, the Treasury Department and the IRS understand that some taxpayers who have integrated operations may need additional time to comply with the PWA requirements where construction has already begun, or is imminent, before publication of these final regulations. To alleviate these circumstances, final regulations for § 1.48-3 have an applicability date that applies 60 days after publication of the final regulations.</P>
                    <P>For the reasons provided herein, aggregation of the nameplate capacity of qualified facilities with integrated operations is applicable only to the One Megawatt Exception under the PWA requirements and is not applicable to other circumstances related to qualified facilities, such as the Five-Megawatt Limitation for qualified interconnection property for Qualified Interconnection Property, evaluation of eligibility for the domestic content or energy communities bonuses.</P>
                    <HD SOURCE="HD3">G. Election To Group Qualified Facilities or ESTs for Purposes of the PWA Requirements Under Section 48E</HD>
                    <P>
                        As with section 45Y, commenters suggested that the taxpayers should be allowed to group facilities as they chose when applying the PWA requirements for an increased credit amount under section 48E. A commenter suggested that a taxpayer that owns interrelated facilities should be allowed to elect to combine multiple interrelated facilities into one aggregated unit or, alternatively, elect to treat the facilities individually for the PWA requirements. A commenter suggested that taxpayers should be allowed to certify compliance with the PWA requirements for an individual facility based on compliance of interrelated facilities. Commenters' 
                        <PRTPAGE P="4046"/>
                        suggestions to allow elective grouping to certify compliance with the PWA requirements or allow taxpayers to certify for an individual qualified facility based on compliance of interrelated facilities are not adopted. The statute requires that each qualified facility satisfy the requirements and for this reason the commenter's suggestions cannot be adopted. If a taxpayer does not satisfy the PWA requirements for a qualified facility, the taxpayer may cure with correction payments paid to impacted workers and a penalty paid to the IRS. The PWA final regulations provide taxpayers the rules for the Prevailing Wage Requirement, Apprenticeship Requirement, and the recordkeeping and reporting applicable to section 48E.
                    </P>
                    <HD SOURCE="HD2">VI. Domestic Content Bonus</HD>
                    <P>The proposed regulations provided rules related to the increase in credit rate for qualified facilities (or EST in the case of section 48E) that meet the domestic content bonus requirements.</P>
                    <P>Some commenters supported and some commenters opposed adopting the concept of an “energy project” or aggregation rule similar to those in the section 48 proposed regulations for purposes of claiming the domestic content bonus credit amount under section 45Y or 48E. Commenters contended that there is no legal basis for importing the definition of an energy project or any aggregation rule for the section 48E credit. A commenter instead suggested permitting a taxpayer to elect to combine multiple interrelated facilities into one aggregated unit or, alternatively, elect to treat the facilities individually for purposes of the domestic content bonus credit amount.</P>
                    <P>An aggregation rule is incorporated into the section 48 final regulations for purposes of claiming the domestic content bonus credit amount, because section 48 applies the domestic content bonus credit amount to an entire energy project defined as one or more energy properties that are part of a single project. However, section 45Y(g)(11)(A) defines the domestic content bonus credit amount in general with respect to a qualified facility, without reference to section 48. Although section 48E(a)(3)(B) provides that “[r]ules similar to the rules of section 48(a)(12) shall apply” for purposes of the domestic content bonus credit amount, section 48(a)(12)(B) dictates that “[r]ules similar to the rules of section 45(b)(9)(B) shall apply.” Additionally, even though section 48(a)(12)(A) describes the domestic content bonus credit amount rules “[i]n the case of any energy project,” sections 45Y and 48E do not have the energy project concept like section 48 to allow grouping. Under section 45(b)(9)(B), the domestic content bonus credit amount applies with respect to a qualified facility. Accordingly, for purposes of claiming the domestic content bonus credit amount, more than one qualified facility under section 45Y and more than one qualified facility or EST under section 48E may not be treated as a single qualified facility or EST. Each qualified facility under section 45Y and each qualified facility or EST under section 48E must separately qualify for the increased credit rate for meeting domestic content bonus requirements.</P>
                    <HD SOURCE="HD2">VII. Energy Communities</HD>
                    <P>Similar to some commenters' opposition to aggregation with respect to the domestic content bonus credit amounts, some commenters also opposed adopting the concept of an “energy project” or aggregation rule similar to those in the section 48 proposed regulations for purposes of the increase in credit for energy communities, under section 45Y or 48E. Commenters contended that there is no legal basis for importing the definition of an energy project or any aggregation rule for the section 48E credit. However, one commenter instead suggested permitting a taxpayer to elect to combine multiple interrelated facilities into one aggregated unit or, alternatively, elect to treat the facilities individually for purposes of the increase in credit in energy communities.</P>
                    <P>An aggregation rule is incorporated into the section 48 regulations for purposes of claiming the increase in credit rate in energy communities under section 48, because section 48 applies the increase in credit rate to an entire energy project defined as one or more energy properties that are part of a single project. However, section 45Y(g)(7) and section 48E(a)(3)(A)(i) define an energy community by cross-reference to section 45(b)(11)(B), instead of section 48. Section 45 does not have the energy project concept like section 48 to allow grouping. Nor do section 45Y or 48E. Accordingly, for purposes of claiming the increase in credit in energy communities, more than one qualified facility under section 45Y and more than one qualified facility or EST under section 48E will not be treated as a single qualified facility or EST. Each qualified facility under section 45Y and each qualified facility or EST under section 48E must separately qualify for the increased credit rate for a qualified facility or EST located in an energy community.</P>
                    <HD SOURCE="HD2">VIII. Greenhouse Gas Emissions Rates for Qualified Facilities</HD>
                    <P>
                        Section 45Y(b)(2) provides rules for determining GHG emissions rates. Section 48E(b)(3)(B)(ii) provides that rules similar to the rules of section 45Y(b)(2) regarding GHG emissions rates apply for purposes of section 48E.
                        <SU>5</SU>
                        <FTREF/>
                         Proposed § 1.45Y-5 provided rules pertaining to GHG emissions rates as well as definitions of terms relevant to determining GHG emissions rates.
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             Some of the proposed regulations related to recapture and substantiation are relevant only to section 48E and not section 45Y. Those rules are discussed separately later.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">A. Definitions Related to Greenhouse Gas Emissions Rates</HD>
                    <P>Proposed § 1.45Y-5(b) provided definitions of terms relevant to determining GHG emissions rates.</P>
                    <HD SOURCE="HD3">
                        1. CO
                        <E T="52">2</E>
                        e per kWh
                    </HD>
                    <P>
                        Section 45Y(e)(1) defines the term “CO
                        <E T="52">2</E>
                        e per kWh” to mean, with respect to any GHGs, the equivalent carbon dioxide (as determined based on global warming potential (GWP)) per kilowatt hour of electricity produced. Proposed § 1.45Y-5(b)(1) clarified that the determination must be based on the 100-year time horizon global warming potential (GWP-100). Proposed § 1.45Y-5(b)(1) also provided GWP-100 amounts for certain specific GHGs from the Intergovernmental Panel on Climate Change's (IPCC) Fifth Assessment Report (AR5).
                    </P>
                    <P>
                        Commenters presented a range of views on the proposed definition of “CO
                        <E T="52">2</E>
                        e per kWh.” Some agreed with the proposed definition, including one commenter who noted that the proposed definition aligns with Congressional intent in enacting sections 45Y and 48E.
                    </P>
                    <P>
                        Some commenters advocated for revisions to the proposed definition of “CO
                        <E T="52">2</E>
                        e per kWh.” One commenter stated that the urgent need for near-term GHG emissions reductions may justify the use of different GWP values. Several commenters suggested that the proposed definition be revised to use a 20-year GWP for methane to appropriately prioritize methane reductions. The commenters asserted that despite its prevalence, relying on GWP-100 is arbitrary and lacks scientific basis. To support this position, one commenter further asserted that the IPCC does not specifically recommend the use of GWP-100, or any other specific metric for the conversion of non-CO
                        <E T="52">2</E>
                         GHG emissions into CO
                        <E T="52">2</E>
                         equivalents. The commenter also noted recent adoptions of a 20-year GWP by individual States and asserted that other policymakers 
                        <PRTPAGE P="4047"/>
                        recognize the urgency to incorporate the use of the 20-year GWP to accelerate efforts towards reducing methane emissions.
                    </P>
                    <P>After consideration of the comments the Treasury Department and the IRS decline to modify the proposed definition of the term “CO2e per kWh.” GWP-100 is a commonly accepted standard that appropriately captures the GWP of relevant GHGs and it is the internationally accepted standard for reporting GHG emissions. Specifically, the AR5 GWP-100 is required for all nations reporting national GHG emissions inventories to the United Nations Framework Convention on Climate Change (UNFCCC). Additionally, the use of a GWP-100 is consistent with the use of GWP-100 to calculate GHG emissions rates reported to the EPA Inventory of U.S. Greenhouse Gas Emissions and Sinks (GHGI). The GHGI is one of the datasets that proposed § 1.45Y-1(c)(4) requires to confirm when the applicable year threshold has been passed as required by section 45Y(d). The Treasury Department and the IRS view a uniform standard for GWP that is consistent across GHGs as necessary for evaluating the GWP of different GHGs for purposes of the section 45Y and 48E credits. An approach that uses different GWP time horizons for different types of GHGs would not provide a consistent basis for evaluating GHG emissions rates. Therefore, proposed § 1.45Y-5(b)(1) will be adopted without change.</P>
                    <HD SOURCE="HD3">2. Combustion</HD>
                    <P>Section 45Y(b)(2)(B) provides rules for determining a GHG emissions rate for a facility that produces electricity through combustion or gasification. Proposed § 1.45Y-5(b)(2) provided that the term “combustion” means a rapid exothermic chemical reaction, specifically the oxidation of a fuel that liberates energy including heat and light. This proposed definition of “combustion” would include, for example, burning fossil fuels, but it would not include the reaction that produces electricity from hydrogen inside a hydrogen fuel cell. The Treasury Department and the IRS received no comments on the proposed definition of “combustion” and the definition will be adopted as proposed. For discussion of the definition of Facility which Produces Electricity through Combustion or Gasification (C&amp;G Facility) see section VIII.A.4. of this Summary of Comments and Explanation of Revisions.</P>
                    <HD SOURCE="HD3">3. Gasification</HD>
                    <P>Proposed § 1.45Y-5(b)(3) provided that the term “gasification” means a thermochemical process that converts carbon-containing materials into syngas, a gaseous mixture that is composed primarily of carbon monoxide, carbon dioxide, and hydrogen. Commenters expressed support for this definition and it will be adopted without change. For discussion of the definition of Facility which Produces Electricity through Combustion or Gasification (C&amp;G Facility) see section VIII.A.4. of this Summary of Comments and Explanation of Revisions.</P>
                    <HD SOURCE="HD3">4. Facility Which Produces Electricity Through Combustion or Gasification (C&amp;G Facility)</HD>
                    <P>Building on the definitions of “combustion” and “gasification” provided in the proposed regulations, proposed § 1.45Y-5(b)(4) defined the phrase “facility which produces electricity through combustion or gasification” (C&amp;G Facility) in section 45Y(b)(2)(B) as a facility that produces electricity through combustion or uses an input energy source to produce electricity, if the input energy source was produced through a fundamental transformation, or multiple transformations, of one energy source into another using combustion or gasification. In the preamble to the proposed regulations, the Treasury Department and the IRS requested comment on this proposed definition of a C&amp;G Facility, including comment on whether the application of this proposed interpretation should be clarified with respect to any type of fundamental transformation of an energy source and any related activities or operations.</P>
                    <P>Many commenters supported the proposed definition of a C&amp;G Facility. Several commenters noted that the proposed definition is a reasonable interpretation of section 45Y(b)(2)(B) because it reflects the reality that electricity production can drive combustion and gasification reactions elsewhere in the production chain even if those reactions are not occurring directly at the electricity generation facility. Other commenters supported the proposed definition and noted that section 45Y(b)(2)(B) provides the appropriate statutory basis for looking at transformations beyond the generation facility to determine GHG emissions from a C&amp;G Facility. The commenters asserted that this interpretation is supported by two concepts within the statutory language. First, the inclusion of gasification in section 45Y(b)(2)(B) supports the proposed interpretation because “gasification produces fuel not electricity,” and, therefore, gasification must be given independent meaning from the term combustion. Second, the commenters asserted that it is appropriate to look at transformations outside the generation facility because the statute's use of the word “through” requires looking at the larger electricity production process to determine whether electricity is produced “through” combustion or gasification. In this context, the commenters noted that “through” means “because of,” “by means of,” or “as a result of.” Therefore, the commenters asserted that the plain meaning of “through” is broad enough to indicate that all the reactions leading up to the production of electricity are relevant in determining whether electricity is produced through gasification.</P>
                    <P>Some commenters questioned or suggested revisions to the proposed definition of the term C&amp;G Facility. Many of these commenters raised questions and concerns regarding the application of the proposed definition of C&amp;G Facility, particularly as applied to fuel cells. Several commenters asserted that the proposed definition of a C&amp;G Facility misinterprets the statute. Commenters asserted that Congress intended the determination of whether a facility should be treated as being described under section 45Y(b)(2)(B) to be based on consideration of only the activities occurring at the facility such as a fuel cell itself, not a far-removed process concerning a third-party fuel or feedstock producer's production process, or inputs used in such process. These commenters further asserted that the proposed definition of C&amp;G Facility is not a credible reading of the statutory reference to a “facility which produces electricity through combustion or gasification,” in section 45Y(b)(2)(B) because that language should be interpreted narrowly as requiring consideration of facilities that engage in combustion or gasification within the facility itself, such as within a solid oxide fuel cell. In other words, the commenters suggested that consideration of fuel production processes occurring upstream from the electricity-generating facility is not relevant to determining whether a facility is a “facility which produces electricity through combustion or gasification,” as provided in section 45Y(b)(2)(B).</P>
                    <P>
                        Commenters also asserted that the proposed definition would result in most or all fuel cells being categorized as C&amp;G Facilities. The commenters asserted that this categorization is 
                        <PRTPAGE P="4048"/>
                        erroneous and further asserted that fuel cell GHG emissions are not directly produced by the fundamental transformation of the input energy source into electricity. The commenters stated that fuel cell systems, including non-hydrogen fuel cells, use neither combustion nor gasification to produce electricity but are electrochemical devices. Other commenters asserted that at least a subset of fuel cells should be unequivocally treated as Non-C&amp;G Facilities by drawing a comparison to nuclear facilities. A commenter stated that nuclear facilities (which are categorized as Non-C&amp;G Facilities by proposed § 1.45Y-5(c)(2)) generally use uranium fuel that is enriched, in part, using grid electricity generated through combustion.
                    </P>
                    <P>Another commenter specifically noted that fuel cells that directly use biogas or renewable natural gas (RNG) do not require combustion or gasification to produce electricity because combustion is not necessary to produce biogas or RNG. As a result, the commenter asserted that fuel cells utilizing biogas or RNG should be categorized as Non-C&amp;G Facilities. After consultation with the DOE, the Treasury Department and the IRS note that in some cases, biogas or RNG can be produced through gasification or combustion. Therefore, categorizing fuel cells that directly use biogas or RNG as Non-C&amp;G Facilities would be improper.</P>
                    <P>Some commenters disagreed with the proposed definition of C&amp;G Facility because of its application to hydrogen fuel cells. These commenters requested that if the proposed definition is retained, the GHG emissions determination for hydrogen used to operate a fuel cell facility should follow the carbon intensity standards provided in section 45V of the Code. The commenters asserted that this approach would appropriately result in a hydrogen fuel cell that uses “qualified clean hydrogen” as defined in section 45V being considered a Non-C&amp;G Facility. Another commenter noted that the proposed definition of combustion and gasification included the entire supply chain for hydrogen fuel cells and recommended an alternative approach to determining whether hydrogen fuel cells produce electricity through combustion. Under this alternative approach, only transformations happening at the fuel production and generation facilities would be considered and a full examination of the supply chain would not be required.</P>
                    <P>The Treasury Department and the IRS acknowledge that the preamble to the proposed regulations addressed the application of the definition of a C&amp;G Facility to fuel cells by explaining that, under proposed § 1.45Y-5(b)(4), a facility that produces electricity using any fuel that was produced using electricity that had been produced, in whole or in part, from the combustion of fossil fuels would be considered a C&amp;G Facility. Thus, because the energy transformation that produces electricity in a fuel cell would not be considered combustion under the definition in proposed § 1.45Y-5(b)(2), a fuel cell facility would only be considered a C&amp;G Facility if the fuel it used to produce electricity was produced through combustion or gasification under the proposed regulations.</P>
                    <P>The Treasury Department and the IRS generally agree with the commenters' rationale for retaining the proposed definition of the term C&amp;G Facility but view certain modifications to this definition as appropriate to address some of the concerns raised by other commenters. To appropriately give effect to the term “gasification” in section 45Y(b)(2)(B), consideration of transformations beside the transformation directly producing electricity are necessary in determining the appropriate classification of a facility as a C&amp;G Facility. Congress's use of the word “through” in section 45Y(b)(2)(B) indicates that the steps leading up to the production of electricity by a C&amp;G Facility are relevant in determining whether electricity is produced through combustion or gasification. However, requiring an evaluation of whether a fuel or feedstock used by an electricity-generating facility involved combustion or gasification at any point of the fuel or feedstock supply chain would be difficult to administer, particularly given the complexity of such supply chains. To enable the section 45Y and 48E credits to be administered, the Treasury Department and the IRS are limiting the analysis of production “through combustion or gasification” to the electricity production itself and the production of the input energy source.</P>
                    <P>The Treasury Department and the IRS continue to view proposed § 1.45Y-5(b)(4) as reflecting the best interpretation of the term “facility that produces electricity through combustion or gasification” in section 45Y(b)(2)(B). However, after consideration of the comments and the administrability challenges the proposed definition may pose, the final regulations revise the definition of the term “facility that produces electricity through combustion or gasification” to “a facility that produces electricity through combustion or uses an input energy source to produce electricity, if the input energy source was produced through a fundamental transformation of one energy source into another using combustion or gasification.”</P>
                    <P>Under the revised definition in these final regulations, a hydrogen fuel cell would still be considered a C&amp;G Facility if it produced electricity using hydrogen that was produced through combustion or gasification, for example through steam methane reforming. A fuel cell facility such as a solid oxide fuel cell, which uses methane as fuel, would also still be considered a C&amp;G Facility, because the methane reforming reaction that produces syngas within the fuel cell prior to the production of electricity would be considered a gasification reaction. In contrast, a hydrogen fuel cell facility using hydrogen produced using electrolysis would not be considered a C&amp;G Facility, because the input energy source was not produced through a transformation of one energy source into another using combustion or gasification. This modified definition of C&amp;G Facility is consistent with section 45Y(b)(2)(B) because it gives appropriate effect to the word “gasification” and considers whether the facility produces electricity through combustion or through the use of a fuel produced using combustion or gasification in determining the net GHG emissions rate for the qualified facility in the production of electricity. Considering only the process that produced the input energy source that is used by a facility to generate electricity implements section 45Y(b)(2)(B)'s directive to assess whether electricity was produced “through combustion or gasification” while addressing significant administrability concerns posed by the task of tracing complex fuel and feedstock supply chains beyond the production of the input energy source to assess whether they involved combustion or gasification.</P>
                    <HD SOURCE="HD3">5. Non-C&amp;G Facility</HD>
                    <P>Proposed § 1.45Y-5(b)(7) defined a “Non-C&amp;G Facility” as a facility that produces electricity and is not described in proposed § 1.45Y-5(b)(4). Generally, commenters supported the proposed definition of a “Non-C&amp;G Facility.” Several commenters requested that the final regulations remove the terms “C&amp;G Facility” and “Non-C&amp;G Facility” in favor of the term “qualified facility.”</P>
                    <P>
                        Section 45Y(b)(2)(A) specifically provides rules to determine the GHG emissions rate for a Non-C&amp;G Facility and section 45Y(b)(2)(B) provides similar rules for a C&amp;G Facility. As a result, the Treasury Department and the IRS view the proposed definitions of a “Non-C&amp;G facility” and a “C&amp;G 
                        <PRTPAGE P="4049"/>
                        Facility” as required to implement the distinct requirements provided in section 45Y(b)(2)(A) and (B). An electricity-generating facility must be a qualified facility to be eligible for the credits provided under section 45Y or 48E but categorizing a facility as a C&amp;G Facility or a Non-C&amp;G Facility is required for purposes of section 45Y(b)(2)(A) and (B). The proposed definition of the term “Non-C&amp;G Facility” is therefore adopted as proposed.
                    </P>
                    <HD SOURCE="HD3">6. Greenhouse Gas Emissions Rate</HD>
                    <P>
                        Proposed § 1.45Y-5(b)(5) provided that, consistent with section 45Y(b)(2)(A), the term “greenhouse gas emissions rate” means the amount of GHGs emitted into the atmosphere by a facility in the production of electricity, expressed as grams of CO
                        <E T="52">2</E>
                        e per kWh. Several commenters requested that the definition of “greenhouse gas emissions rate” be expanded to take account of emitted co-pollutants such as particulate matter, nitrogen oxides, and sulfur dioxides. Some commenters noted that, because of their effect on local air quality, environmental justice communities are significantly impacted in the near term by the co-pollutants of energy generation in addition to the impact of GHGs. The commenters further noted that increased and prolonged exposure to co-pollutants results in increased local air pollution and the development of a plethora of diseases, from skin conditions to cancer. The commenters asserted that co-pollutant emissions must be integrated into all GHG emissions rate calculations to view emissions holistically and understand and account for both climate impacts and human health impacts. The commenters further asserted that this approach would ensure that electricity production does not contribute to climate change and global GHG emissions and does not increase the levels of local air pollution.
                    </P>
                    <P>Section 45Y(e)(2) defines the term “greenhouse gas” as having the same meaning given such term under section 211(o)(1)(G) of the Clean Air Act (CAA) (42 U.S.C. 7545(o)(1)(G)), as in effect on August 16, 2022. Pollutants or gases that are described in 42 U.S.C. 7545(o)(1)(G) are already treated as GHGs under sections 45Y and 48E. However, pollutants or gases that are not described in 42 U.S.C. 7545(o)(1)(G) may not be treated as GHGs under section 45Y or 48E and any requests to do so cannot be adopted. Therefore, proposed § 1.45Y-5(b)(5) will be adopted without change.</P>
                    <HD SOURCE="HD3">7. Greenhouse Gases Emitted Into the Atmosphere by a Facility in the Production of Electricity</HD>
                    <P>Proposed § 1.45Y-5(b)(6) provided that, for purposes of section 45Y(b)(2)(A), and for both C&amp;G Facilities and Non-C&amp;G Facilities, the term “greenhouse gases emitted into the atmosphere by a facility in the production of electricity” means emissions from a facility that directly occur from the process that transforms the input energy source into electricity. Proposed § 1.45Y-5(b)(6)(i) through (vi) provided a list of certain GHG emissions associated with a facility and relevant electricity production process excluded from the definition in proposed § 1.45Y-5(b)(6) (for example, GHG emissions associated with facility siting). For Non-C&amp;G Facilities only, proposed § 1.45Y-5(c)(1)(i) provided additional types of excluded emissions associated with a facility and relevant electricity production process (for example, emissions occurring due to activities and operations occurring off-site such as the production and transportation of fuels used by the facility). For C&amp;G Facilities only, proposed § 1.45Y-5(d)(2) provided additional rules on included and excluded GHG emissions associated with a facility and relevant electricity production processes that apply in order to conduct a GHG emissions lifecycle analysis (LCA) as required by section 45Y(b)(2)(B). The Treasury Department and the IRS received a wide range of comments in response to the definition of “greenhouse gases emitted into the atmosphere by a facility in the production of electricity” at proposed § 1.45Y-5(b)(6).</P>
                    <P>One commenter suggested that the final regulations clarify which emissions (both direct and indirect) must be included (rather than excluded) in determining GHG emissions. The Treasury Department and the IRS note that the proposed definition would include emissions that occur from the processes that transform the input energy source into electricity. This definition provides a standard for determining included emissions that may be applied to multiple types of facilities that may be eligible for the section 45Y and 48E credits. However, the Treasury Department and the IRS have made modifications to the proposed standard for determining included emissions to further clarify the principles outlined in the proposed regulations.</P>
                    <P>
                        Several commenters requested additions to the list of excluded emissions. A commenter requested an exclusion for emissions from standby and auxiliary power for critical infrastructure that is not used directly for the production of an input used to produce electricity. Proposed §  1.45Y-5(b)(6)(i) and these final regulations provide that emissions from electricity production by back-up or auxiliary generators that are primarily used in maintaining critical systems in case of a power system outage or for supporting restart of a generator after an outage would be excluded. The Treasury Department and the IRS would generally consider standby and auxiliary power systems to fall within this exclusion. This commenter also requested an exclusion for emissions offset by indirect financial or “book” accounting methods, including but not limited to, renewable energy certificates and environmental attribute certificates that demonstrate a carbon intensity no greater than 0 kg CO
                        <E T="52">2</E>
                        e per unit of output. Whether indirect or book-and-claim accounting methods are permitted is addressed in section VIII.E.4.d. of this Summary of Comments and Explanation of Revisions and whether offsets are permitted is addressed in section VIII.C.2.d of this Summary of Comments and Explanation of Revisions.
                    </P>
                    <P>
                        Another commenter requested that emissions associated with various processes related to the production of electricity from stationary fuel cells be excluded from the scope of assessed emissions. The commenter specifically requested that this exclusion cover upstream emissions occurring due to the production of fuels, including hydrogen, methane, RNG, and other hydrocarbons, for stationary fuel cell systems; and emissions related to the production or refinement of fuel for stationary fuel cell systems, such as steam reformation, whether or not such processes are internal reactions. This commenter also requested an exclusion for emissions associated with the distribution of hydrogen to consumers. The Treasury Department and the IRS decline to adopt these requested revisions to the proposed definition of the term “greenhouse gases emitted into the atmosphere by a facility in the production of electricity.” Because the final regulations provide rules that may result in fuel cells being categorized as either a C&amp;G Facility or a Non-C&amp;G Facility depending on its operations and the fuel it uses to produce electricity, which would entail different rules for assessing emissions, it would not be appropriate to provide fuel-cell-specific emissions exclusions applicable to all categories of fuel cells. In addition, some of the exclusions requested by the 
                        <PRTPAGE P="4050"/>
                        commenter would inappropriately deviate from the requirement in section 45Y(b)(2)(B) to take into account lifecycle GHG emissions, as described in 42 U.S.C. 7545(o)(1)(H). The final regulations thus do not adopt the changes recommended by the commenter.
                    </P>
                    <P>Commenters requested other changes to the list of excluded emissions. Several commenters supported excluding emissions from backup generators, step-up transformers, routine operational and maintenance activities, construction, infrastructure, and distribution associated activities from the definition. Other commenters voiced concerned about the breadth of emissions excluded from the proposed definition for certain activities. A commenter asserted that the definition improperly excluded emissions from the activities listed in proposed § 1.45Y-5(b)(6)(i) through (vi). The commenter noted that each of these activities are critical steps in electricity generation, production, and distribution. As an example, the commenter noted that if operational and maintenance activities are disrupted, an energy producing facility may need to shut down and pause production. Therefore, the commenter asserted that routine maintenance is a vital component to electricity generation. Additionally, several commenters specifically opposed the exclusion of emissions from infrastructure associated with a facility, including, but not limited to, emissions from road construction for feedstock production. A commenter noted that road construction generates substantial emissions from the clearing of vegetation, ground disturbance, and equipment operation. Commenters asserted that GHG emissions from these activities must be factored into the definition of the GHG emissions rate.</P>
                    <P>
                        Several commenters asserted that the breadth of the exclusions proposed was too narrow. A commenter specifically disagreed with the scope of the exclusion for emissions from electricity production by back-up generators that are primarily used in maintaining critical systems in case of a power system outage or for supporting restart of a generator after an outage. The commenter asserted that the proposed definition includes emissions from back-up generators used to 
                        <E T="03">avoid</E>
                         system outages while only excluding emissions that occur during or after an outage. The commenter stated that as a result, this exclusion could significantly limit the time period during which a qualified facility could be eligible for the section 45Y and 48E credits.
                    </P>
                    <P>The Treasury Department and the IRS decline to modify the list of excluded emissions as requested by these commenters. The excluded emissions are appropriate in scope because they address emissions associated with activities that are ancillary to the electricity generating operations of a facility. Excluding emissions from contingency operations, operations that are tangentially related to the regular electricity generating operations of a facility, or activities that are beyond the scope of the production of electricity (for example, emissions from construction of a facility or distribution of the electricity) allows for a more accurate evaluation of the emissions stemming from a facility's production of electricity and related processes. Although the activities covered by these exclusions (such as construction, routine maintenance, or distribution) may in fact enable a facility to generate electricity, these activities are ancillary to the process of generating electricity and the final regulations retain the list of excluded emissions as originally proposed.</P>
                    <HD SOURCE="HD3">B. Determining GHG Emissions Rates for Non-C&amp;G Facilities</HD>
                    <HD SOURCE="HD3">1. General Rules</HD>
                    <P>Proposed § 1.45Y-5(c) provided rules for determining a GHG emissions rate for Non-C&amp;G Facilities, including for determinations by the Secretary when publishing the table described in section 45Y(b)(2)(C)(i) or by the Secretary when determining a provisional emissions rate under section 45Y(b)(2)(C)(ii). Proposed § 1.45Y-5(c)(1)(i) provided that, with respect to Non-C&amp;G Facilities only, GHG emissions that are not directly produced by the fundamental transformation of the input energy source into electricity are excluded from the emissions accounting. The proposed regulations excluded emissions that may relate to a Non-C&amp;G Facility but do not occur “in the production of electricity” as specified in section 45Y(b)(2)(A) because such emissions do not arise directly from the transformation of the input energy source into electricity. Proposed § 1.45Y-5(c)(2) provided a list of specific types or categories of facilities that are Non-C&amp;G Facilities with a GHG emissions rate that is not greater than zero. The Treasury Department and the IRS received a number of comments on this proposed provision, including several in support of it.</P>
                    <P>While one commenter requested that these Non-C&amp;G Facilities be listed in the Secretary's Annual Table as having a GHG emissions rate that is not greater than zero, another recommended that the Treasury Department and the IRS confirm that inclusion of these types or categories of facilities in the Annual Table or PER certification described in proposed § 1.45Y-5(f) and (g) are not required for such listed facilities. The Treasury Department and the IRS confirm that taxpayers may rely on the inclusion of these types or categories of facilities in these final regulations as having a GHG emissions rate that is not greater than zero unless and until the regulations are amended.</P>
                    <P>The Treasury Department and the IRS received a variety of comments regarding the inclusion of specific technologies in proposed § 1.45Y-5(c)(2), which are discussed in sections VIII.B.2. through 6. of this Summary of Comments and Explanation of Revisions by type of technology.</P>
                    <HD SOURCE="HD3">2. Nuclear</HD>
                    <P>
                        Several commenters expressed their support for the inclusion of nuclear fission and nuclear fusion facilities as a type or category of facility that is a Non-C&amp;G Facility with a GHG emissions rate of not greater than zero in proposed § 1.45Y-5(c)(2)(vi) and (vii). One commenter recommended clarification of why the use of electricity, which may be produced through combustion and gasification, to enrich uranium and produce nuclear fuel would not render nuclear energy a C&amp;G Facility. Based on the definition of a facility that produces electricity through combustion or gasification provided in § 1.45Y-5(b)(4), only the fundamental transformations of energy from one energy source into another are considered when determining whether a facility uses combustion or gasification. In the case of nuclear fission and nuclear fusion facilities, the fundamental transformations of energy are the conversion of nuclear binding energy in the nuclear fuel into heat and electricity. Nuclear fuel often contains uranium, which may require enrichment. However, the energy used to enrich the uranium only increases the concentration of the isotope needed for nuclear fuel. It does not transform the energy in the isotope, and accordingly, it does not transform one energy source into another. Therefore, enrichment is not considered when determining whether a facility is a C&amp;G Facility. Because there is no other process in the production of enriched uranium or nuclear energy that would involve combustion or gasification, the final regulations retain nuclear fission as a type or category of facility that is a Non-C&amp;G Facility.
                        <PRTPAGE P="4051"/>
                    </P>
                    <P>Some commenters who supported this inclusion asked that the final regulations amend the reference to “nuclear fusion” in proposed § 1.45Y-5(c)(2)(vii) to reduce confusion with nuclear fission. These commenters noted that Congress recently enacted the ADVANCE Act of 2024, Public Law 118-67, which included a definition of “fusion energy machine” within the Atomic Energy Act and asked that the final regulations amend proposed § 1.45Y-5(c)(2)(vii) to align with that terminology. The Treasury Department and the IRS agree that the term “nuclear fusion” in proposed § 1.45Y-5(c)(2)(vii) should be amended and adopt one commenter's suggestion that the new term be “fusion energy.” The final regulations under § 1.45Y-5(c)(2)(vii) reflect this change.</P>
                    <HD SOURCE="HD3">3. Hydropower</HD>
                    <P>Proposed § 1.45Y-5(c)(1)(i)(A) and (B) provided that in the case of Non-C&amp;G Facilities, emissions from hydropower reservoirs due to anoxic conditions and ebullitive, diffuse, and degassing emissions from hydropower operations are not GHGs emitted into the atmosphere by a facility in the production of electricity. Proposed § 1.45Y-5(c)(1)(i) explained that these emissions are not directly produced by the fundamental transformation of the input energy source into electricity.</P>
                    <P>Some commenters stated that the Treasury Department and the IRS erred in excluding the emissions related to hydropower as described in proposed § 1.45Y-5(c)(1)(i)(A) and (B). These commenters stated that, because the language in section 45Y(b)(2)(A) provides that a GHG emissions rate means the amount of GHGs emitted into the atmosphere by a facility in the production of electricity, the exclusion of such emissions because they are not “directly produced by the fundamental transformation of the input energy source into electricity” by the facility is flawed. Several commenters noted that hydropower facilities do in fact result in GHG emissions that are directly produced by the fundamental transformation of the input energy source into electricity within the meaning of proposed § 1.45Y-5(c)(1)(i). The commenters noted that a reservoir, which is an integral component of a hydropower facility, is one of the primary sources of emissions because they emit GHGs due to the decomposition of organic matter through diffusion and ebullition. Accordingly, the commenters asserted that such emissions should not be excluded for hydropower facilities.</P>
                    <P>Another commenter stated that degassing emissions that result from water passing through a turbine in a hydropower facility are part of the “fundamental transformation of [the input energy source into] electricity,” because the kinetic energy of flowing water passing through turbines is harnessed to produce electricity. The GHGs that may be released during degassing exist before flowing water passes through turbines that are harnessed to create electricity. Such methane is therefore not directly produced or created by flowing water passing through turbines. In addition, the GHGs associated with degassing may have been emitted passively into the atmosphere even in the absence of hydropower electricity generation. For these reasons, the Treasury Department and the IRS affirm that GHGs released during degassing are properly excluded because they are not directly produced by the fundamental transformation of the input energy source into electricity.</P>
                    <P>The Treasury Department and the IRS have determined that the proposed treatment of emissions accounting for hydropower is appropriate and the best implementation of section 45Y(b)(2)(A). A hydropower facility converts the kinetic energy of flowing water into electricity with a turbine that spins a rotor within a generator to produce electricity. GHGs may be released from the hydropower reservoir due to diffusion at the water surface or due to ebullition, and from degassing from water passing through a pump house or turbine. The GHGs that may be released during degassing exist before flowing water passes through turbines that are harnessed to create electricity. Such GHGs are therefore not directly produced or created by flowing water passing through turbines. In addition, the GHGs associated with degassing may be emitted passively into the atmosphere even in the absence of hydropower electricity generation. It is not appropriate to treat such emissions as GHGs emitted into the atmosphere by a hydropower facility in the production of electricity because these emissions are not created by the fundamental transformation of potential energy in flowing water into electricity.</P>
                    <P>Some commenters stated that because dams and reservoirs are required components of hydropower facilities in order for such facilities to generate energy, GHG emissions associated with these components should not be excluded from emissions accounting. The Treasury Department and the IRS have determined that GHG emissions associated with dams and reservoirs are properly excluded emissions. Emissions associated with the construction and maintenance of such dams and reservoirs are properly excluded under proposed § 1.45Y-5(b)(6)(iv), which states, in relevant part, that emissions that occur before commercial operations commence are properly excluded. Furthermore, emissions associated with the continued existence of such dams or reservoirs are properly excluded because they are not directly produced by the fundamental transformation of the input energy source into electricity within the meaning of proposed § 1.45Y-5(c)(1)(i).</P>
                    <P>Commenters also had varied reactions to the inclusion of hydropower as a type or category of Non-C&amp;G Facility with a GHG emissions rate of not greater than zero in proposed § 1.45Y-5(c)(2)(ii). Many commenters supported the proposed designation of and rationale for treating hydropower as a type or category of Non-C&amp;G Facility with a GHG emissions rate of not greater than zero. For the reasons summarized earlier in this section, the Treasury Department and the IRS agree with these commenters that the fundamental energy transformation of kinetic energy into electricity does not result in GHGs emitted in the production of electricity.</P>
                    <P>Some commenters, however, questioned this proposed treatment of hydropower by questioning the excluded emissions rules in proposed § 1.45Y-5(c)(1)(i)(A) and (B), citing aspects of hydropower operations that they asserted give rise to emissions from a hydropower facility's production of electricity. For the reasons summarized earlier in this part of the Summary of Comments and Explanation of Revisions, the Treasury Department and the IRS disagree with these commenters. One commenter opposed to this proposed treatment of hydropower stated that hydropower causes adverse ecological impacts and recommended that facilities be eligible for the credit based not only on whether they have a GHG emissions rate that is not greater than zero but also on whether they have an “environmentally low impact” more generally.</P>
                    <P>
                        Section 45Y(b)(1) defines a qualified facility, in relevant part, as a facility used for the generation of electricity, placed in service after December 31, 2024, and for which the GHG emissions rate is not greater than zero. The statute does not provide the Treasury Department and the IRS the authority to consider environmental impacts beyond GHG emissions rates in determining eligibility for the section 45Y and 48E credits. Therefore, the final regulations do not adopt the commenter's suggestion.
                        <PRTPAGE P="4052"/>
                    </P>
                    <HD SOURCE="HD3">4. Waste Energy Recovery Property (WERP)</HD>
                    <P>Proposed § 1.45Y-5(c)(2)(viii) provided that waste energy recovery property (WERP) that derives energy from a source described in proposed § 1.45Y-5(c)(2)(i) through (vii) is a Non-C&amp;G Facility with a GHG emissions rate that is not greater than zero. The preamble to the proposed regulations explained that WERP is property that generates electricity solely from heat from buildings or equipment if the primary purpose of such building or equipment is not the generation of electricity. In the preamble to the proposed regulations, the Treasury Department and the IRS requested comment on this proposed definition and on whether and why it would be appropriate to revise proposed § 1.45Y-5(c)(2)(viii) to include additional energy sources (such as energy from exothermic chemical reactions or pressure drop technologies) that do not rely on combustion or gasification but could include equipment related to the transport of fossil fuels (for example, natural gas).</P>
                    <P>Some commenters supported the proposed definition of WERP. One commenter stated that this long-standing definition is appropriate for the purpose of the section 45Y and 48E credits and would provide taxpayers with strong incentives to install WERP to produce electricity using heat that would otherwise be wasted. The commenter further noted that this definition would also prevent facilities whose primary purpose is to generate electricity from “double dipping” by taking a tax credit on the original electricity generated and again on electricity generated from WERP.</P>
                    <P>Some commenters requested that facilities using exothermic reactions or pressure drop technologies be included in the definition of WERP for purposes of the section 45Y and 48E credits. Additionally, these commenters asserted that these types of technologies do not rely on combustion or gasification and thus could and should be classified as Non-C&amp;G Facilities. A commenter further recommended that GHG emissions that occur with respect to exothermic reactions or pressure drop technologies (for example, turboexpanders on a pipeline) that do not rely on combustion or gasification should be treated as Non-C&amp;G Facilities and any significant direct or indirect emissions should be accounted for. Other commenters suggested that the final regulations revise proposed § 1.45Y-5(c)(2)(viii) to include additional energy sources (such as energy from exothermic chemical reactions or pressure drop technologies) that do not rely on combustion or gasification but could include equipment related to the transport of fossil fuels (for example, natural gas).</P>
                    <P>The Treasury Department and the IRS have determined that the final regulations should not be revised to explicitly include these additional types of facilities as WERP, which is included as a Non-C&amp;G Facility at § 1.45Y-5(c)(2)(viii). Because some facilities that employ exothermic reactions release energy into the environment in the form of heat via combustion, it would not be appropriate to classify all WERP facilities using exothermic reactions as Non-C&amp;G Facilities.</P>
                    <P>Pressure drop technologies are also not appropriately considered WERP for purposes of the section 45Y and 48E credits because they convert pressure, rather than heat, directly to electricity. As a result, this type of technology does not fall within the definition of WERP provided in the preamble to the proposed regulations. At this time, this type of technology is also not included within the list of certain Non-C&amp;G Facilities with a GHG emissions rate that is not greater than zero provided at § 1.45Y-5(c)(2). The preamble to the proposed regulations defined WERP as property that generates electricity solely from heat from buildings or equipment if the primary purpose of such building or equipment is not the generation of electricity. This definition of WERP is appropriate for the purposes of the section 45Y and 48E credits because it mirrors the statutory definition provided in section 48(c)(5)(A). As a result, these final regulations add the definition of WERP, as provided in the preamble to the proposed regulations, to § 1.45Y-1(a)(12) and to § 1.48E-1(a)(12).</P>
                    <P>The Treasury Department and the IRS also received a number of comments recommending that the final regulations provide that all WERP be included in the list of Non-C&amp;G Facilities with a GHG emissions rate that is not greater than zero at § 1.45Y-5(c)(2). The Treasury Department and the IRS have determined that because many of the energy sources for WERP rely on combustion or gasification, it would not be appropriate to classify all WERP facilities as Non-C&amp;G Facilities because some WERP facilities produce electricity using an input energy source that was produced through a fundamental transformation of one energy source into another using combustion or gasification. WERP facilities that produce electricity through combustion or gasification would be considered C&amp;G Facilities and can be evaluated for inclusion in the Annual Table or for a PER as described later in section VIII.H. of this Summary of Comments and Explanation of Revisions.</P>
                    <P>One commenter recommended that the definition of WERP be amended to allow for the use of waste heat to create thermal energy. However, section 45Y(b)(1)(A)(i) requires a facility to be “used for the generation of electricity” to be considered a qualified facility that is eligible for the section 45Y and 48E credits and section 45Y(a)(1)(A) provides that the credit is granted on the basis of the electricity produced by a qualified facility. The facilities described by the commenter do not produce electricity, so they would not qualify on that basis. The Treasury Department and the IRS do not have authority under the statute to expand the scope of eligible facilities as requested by the commenter. The final regulations thus adopt the provisions of proposed § 1.45Y-5(c)(2)(viii) and the proposed definition of WERP without modification. To aid taxpayers in determining whether a specific facility meets that definition, the final regulations include examples in § 1.45Y-1(a)(12) that illustrate buildings or equipment the primary purpose of which is not the generation of electricity. These examples remain largely the same as those provided in the preamble of the proposed regulations, but, for clarity, pipeline compressor stations have not been included in the examples in the final regulations. While pipeline compressor stations are buildings or equipment the primary purpose of which is not the generation of electricity, they do not generate electricity solely from heat and thus are not appropriately considered WERP.</P>
                    <HD SOURCE="HD3">5. Geothermal</HD>
                    <P>Proposed § 1.45Y-5(c)(2)(v) provided that facilities using geothermal energy, including flash and binary plants, were Non-C&amp;G Facilities with a GHG emissions rate that is not greater than zero. The Treasury Department and the IRS requested comment on whether the identification of flash geothermal facilities as Non-C&amp;G Facilities with a GHG emissions rate that is not greater than zero in proposed § 1.45Y-5(c)(2)(v) was appropriate.</P>
                    <P>
                        Several commenters supported the inclusion of geothermal facilities in proposed § 1.45Y-5(c)(2)(v), with some noting that inclusion of these facilities on this list is appropriate because the carbon dioxide emitted by the geothermal facility is emitted naturally and passively from geothermal 
                        <PRTPAGE P="4053"/>
                        reservoirs. Commenters noted that some emissions often occur even without a geothermal facility in place.
                    </P>
                    <P>One commenter stated that the Treasury Department and the IRS should consider measuring the incremental emissions associated with the production of electricity at flash geothermal facilities as compared to the emissions occurring without such production. The Treasury Department and the IRS have determined that such measurement will not be required in the final regulations. As described in the preamble to the proposed regulations, such emissions from flash geothermal facilities would not be considered GHGs emitted into the atmosphere by a facility in the production of electricity under proposed §  1.45Y-5(c)(1)(i)(C), because the GHGs are already present in the underground water and are not created by the fundamental transformation of the thermal energy in the water into electricity, but rather by processes that are not fundamental to the transformation of the thermal energy into electricity. This proposed treatment of flash geothermal facilities is also supported by surveys indicating that underground carbon dioxide in certain geothermal reservoirs is emitted passively into the atmosphere even in the absence of geothermal electricity generation. Furthermore, such measurement may not be possible given the challenges associated with quantifying emissions from geothermal sites with and without electricity production facilities. Therefore, proposed § 1.45Y-5(c)(2)(v) is adopted without change.</P>
                    <HD SOURCE="HD3">6. Solar Technologies</HD>
                    <P>Concentrated solar power facilities may have auxiliary burners that in some cases use combustion exclusively for the purposes of cold starts or freeze protection of thermal working fluids, but in other cases, may also be used to generate electricity in hybrid configurations. The Treasury Department and the IRS requested comment on whether the existing definitions of C&amp;G Facility and Non-C&amp;G Facility are sufficient to distinguish between these two categories of facilities, or whether additional clarification is needed.</P>
                    <P>One commenter requested that the Treasury Department and the IRS clarify that the use of auxiliary burners at a concentrated solar power (CSP) facility does not necessarily mean that a facility will be considered a C&amp;G Facility. This commenter stated that CSP facilities may have auxiliary burners that in some cases use combustion exclusively for the purposes of cold starts or freeze protection of thermal working fluids, but in other cases, may also be used to generate electricity in hybrid configurations. As previously indicated in the preamble to the proposed regulations and reiterated here, in the former instance, such use of auxiliary burners would not mean that a facility is properly categorized as a C&amp;G Facility. However, in the latter instance, a facility would be producing electricity through combustion within the meaning of proposed § 1.45Y-5(b)(4) and thus would be a C&amp;G Facility.</P>
                    <HD SOURCE="HD3">C. GHG Emissions Rates for C&amp;G Facilities</HD>
                    <HD SOURCE="HD3">1. Determining a Greenhouse Gas Emissions Rate for C&amp;G Facilities</HD>
                    <P>
                        Consistent with section 45Y(b)(1)(A)(iii), proposed § 1.45Y-2(a)(3) provided that, for purposes of the section 45Y credit, a qualified facility must have a GHG emissions rate of not greater than zero. Proposed § 1.45Y-5(d) provided the rules applicable to the Secretary for determining a net GHG emissions rate for C&amp;G Facilities, including for publishing a table described in section 45Y(b)(2)(C)(i) or determining an emissions rate as provided in section 45Y(b)(2)(C)(ii). Proposed § 1.45Y-5(d)(1) provided, consistent with section 45Y(b)(2)(B), that the GHG emissions rate for a facility that produces electricity through combustion or gasification (C&amp;G Facility) equals the net rate of GHGs emitted into the atmosphere by such facility (taking into account lifecycle GHG emissions, as described in 42 U.S.C. 7545(o)(1)(H)) in the production of electricity, expressed as grams of CO
                        <E T="52">2</E>
                        e per kWh.
                    </P>
                    <P>The Treasury Department and the IRS received comments supporting these proposed regulations and some comments recommending alternative approaches for evaluating the GHG emissions rate of a C&amp;G Facility. One commenter recommended that the final regulations apply a standard of “commercially acceptable practices” or “commercially reasonable practices” as of the date of passage of the section 45Y and 48E credits for inputs and considerations in determining the LCA of GHG emissions from a C&amp;G Facility. Other commenters recommended that the final regulations not take into account lifecycle GHG emissions in the production of electricity for a C&amp;G Facility. Some commenters suggested that the final regulations permit the GHG emissions rate of a facility to be greater than zero. The changes requested by these commenters cannot be adopted because they are not permitted by the statutory mandate to take into account lifecycle GHG emissions for C&amp;G Facilities as required by section 45Y(b)(2)(B).</P>
                    <P>A number of commenters also requested that certain types of C&amp;G Facilities be categorically deemed to have a net GHG emissions rate of not greater than zero in the final regulations. Other commenters requested that certain types of C&amp;G Facilities be categorically deemed to have a net GHG emissions rate of greater than zero in the final regulations. The Treasury Department and the IRS decline to adopt this request at this time. Additional analysis is required to achieve sufficient certainty that a type or category of facility has a net GHG emissions rate that is greater than or not greater than zero as determined by an LCA conducted in accordance with the principles required under section 45Y(b)(2)(B) and these final regulations.</P>
                    <P>
                        The Treasury Department and the IRS note that many C&amp;G Facilities using particular technologies and fuel sources are highly likely to have GHG emissions rates that are greater than zero, whereas other C&amp;G Facilities with similar but varied technologies or fuels may have GHG emissions rates that are not greater than zero. For example, review of existing scientific and technical literature indicates that C&amp;G Facilities that combust natural gas—such as natural gas-fired boilers and combustion turbines—are expected to have GHG emissions rates greater than zero, even with the use of carbon capture and sequestration (CCS) technology, because the LCA must consider emissions in the fuel lifecycle prior to CCS through the point of electricity production and the rate of capture and sequestration of carbon dioxide produced when combusting the gas is not technically capable of reaching 100 percent.
                        <SU>6</SU>
                        <FTREF/>
                         However, subject to further analysis and dependent on specific facts and circumstances, there may be cases in which a C&amp;G Facility that uses a blend of natural gas and other feedstocks that have negative lifecycle emissions and use CCS could potentially achieve lifecycle GHG emissions not greater than zero.
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             
                            <E T="03">See, e.g.,</E>
                             National Renewable Energy Laboratory (2021), Life Cycle Greenhouse Gas Emissions from Electricity Generation: Update, NREL/FS-6A50-80580, 
                            <E T="03">https://www.nrel.gov/docs/fy21osti/80580.pdf;</E>
                             O'Donoughue, P.R., Heath, G.A., Dolan, S.L. and Vorum, M. (2014), Life Cycle Greenhouse Gas Emissions of Electricity Generated from Conventionally Produced Natural Gas. Journal of Industrial Ecology, 18: 125-144. 
                            <E T="03">https://doi.org/10.1111/jiec.12084.</E>
                        </P>
                    </FTNT>
                    <P>
                        A number of commenters submitted analyses or referred to studies supporting their request that certain 
                        <PRTPAGE P="4054"/>
                        types of C&amp;G Facilities that burn biomass be categorically deemed to have a net GHG emissions rate of not greater than zero in the final regulations. Some of these comments state that biomass, industrial wastes, or manufacturing residuals used for generating electricity have negative lifecycle GHG emissions. The studies submitted in support of this recommendation rely on studies that (i) use assumptions that are not adopted in this final rule, (ii) use assumptions that are potentially specific to a particular facility and thus are not appropriate for use in evaluating the emissions rate for a type or category of facility as listed in the Annual Table without further study, or (iii) do not consistently apply the requirements for an LCA that are required by these final regulations pursuant to the statute. For example, some of these studies consider grid electricity displacement or fossil fuel displacement, neither of which can be considered in an LCA for electricity generation from C&amp;G Facilities as it is outside of the LCA boundary. Moreover, some studies do not take into account the direct emissions and significant indirect emissions outlined in § 1.45Y-5(d)(2)(v)(A) and (B) or other requirements finalized in this rule. The Treasury Department and the IRS will continue to consider all analysis submitted by commenters in evaluating the emissions of the relevant types or categories of facilities. However, studies that rely on assumptions or LCA principles that are inconsistent with the requirements of this final rule or those within the underlying statute will be given less weight. Several commenters note that any LCA must include rigorous modeling, carefully consider assumptions, follow recognized protocols, as well as apply consistent principles. The Treasury Department and the IRS agree that the principles identified in these comments reflect appropriate LCA practices.
                    </P>
                    <P>Furthermore, as stated in the preamble to the proposed regulations, the Treasury Department and the IRS intend to include in the Annual Table the types or categories of facilities that are described in the final regulations as having a GHG emissions rate of not greater than zero and intend to publish the first Annual Table after the publication of the final regulations. In addition, the Treasury Department and the IRS intend to include in the Annual Table the types or categories of facilities that are described in the final regulations as having a GHG emissions rate of greater than zero. Any types or categories of facilities that are added or removed from this list in the first publication of the Annual Table will be accompanied by the publication of an expert analysis of such change as provided in proposed § 1.45Y-5(f)(2). If any type or category of C&amp;G Facility is added to this list in the publication of the Annual Table, the accompanying expert analysis of the addition will explain the basis for the lifecycle GHG emissions analysis that has been conducted to determine that a given type or category of facility has a net GHG emissions rate of not greater than zero or greater than zero.</P>
                    <P>One commenter noted that the proposed regulations assumed a binary distinction between C&amp;G Facilities and Non-C&amp;G Facilities and requested that the final regulations clarify how the rules for categorizing facilities would apply in the case of fuel-switching facilities such as linear generators. The Treasury Department and the IRS have determined that the classification of a facility, such as a linear generator, that may or may not produce electricity through combustion or gasification depends upon the fuel's method of production and whether the facility does in fact produce electricity through combustion or gasification, and this assessment must be made separately for each taxable year. A facility that uses a fuel produced via combustion or gasification in the production of electricity any time during a given taxable year is properly classified as a C&amp;G Facility for the duration of that taxable year. For example, if a linear generator exclusively uses hydrogen produced with electrolysis or other fuels not produced via combustion or gasification during a taxable year, then that linear generator would be a Non-C&amp;G Facility for that taxable year. However, if in the production of electricity, a facility uses a fuel produced using combustion or gasification (for example, steam methane reforming) during a taxable year, even if only to produce a portion of the electricity generated that year, that facility is a C&amp;G Facility for that year. Such facility's status can change from year to year depending on the fuel it uses during a taxable year. The Treasury Department and the IRS view this scenario as analogous to the treatment of WERP facilities and fuel cells.</P>
                    <P>
                        A few commenters recommended that the net rate of GHGs emitted into the atmosphere by a C&amp;G Facility should not take into account lifecycle GHG emissions because there is no similar requirement when calculating the GHG emissions rate of Non-C&amp;G Facilities. Section 45Y(b)(2)(B) states that, “[i]n the case of a facility which produces electricity through combustion or gasification, the [GHG] emissions rate for such facility shall be equal to the net rate of [GHGs] emitted into the atmosphere by such facility (taking into account lifecycle GHG emissions, as described in . . . 42 U.S.C. 7545(o)(1)(H))) in the production of electricity, expressed as grams of CO
                        <E T="52">2</E>
                        e per kWh.” Because the requirement that lifecycle GHG emissions be taken into account for C&amp;G Facilities is statutory and does not apply to Non-C&amp;G Facilities, the final regulations cannot implement this recommendation.
                    </P>
                    <P>One commenter recommended that C&amp;G Facilities be subject to an attributional LCA rather than a consequential LCA. This commenter stated that consequential models are highly dependent on the assumptions used, are more complex, and have more uncertainty.</P>
                    <P>The Treasury Department and the IRS have determined that a consequential analysis is required to accurately assess GHG emissions outcomes under section 45Y(b)(2)(B), which requires taking into account lifecycle GHG emissions, as described in 42 U.S.C. 7545(o)(1)(H). As explained in the preamble to the proposed regulations, in a 2010 notice-and-comment rulemaking establishing the regulatory framework for the updated renewable fuel standard (RFS) program, the EPA interpreted 42 U.S.C. 7545(o)(1)(H) as requiring the agency to account for the real-world emissions consequences of increased production of biofuels. The EPA determined that, in the context of the RFS program, the inclusion of “direct emissions and significant indirect emissions such as significant emissions from land-use changes” in 42 U.S.C. 7545(o)(1)(H) requires a “consequential” approach to considering the real-world emissions associated with biofuel production. Such an approach includes consideration of market interactions induced by expanded biofuel production and use that may result in secondary or indirect greenhouse gas emissions. The Treasury Department and the IRS have determined it is appropriate to adopt this interpretation and overall approach in the context of the section 45Y and 48E credits. The Treasury Department and the IRS further note that attributional analytical approaches may be part of the broader consequential analysis in appropriate cases.</P>
                    <HD SOURCE="HD3">2. LCA Requirements</HD>
                    <P>
                        Proposed § 1.45Y-5(d)(2) provided certain requirements for conducting an LCA of GHG emissions for purposes of the section 45Y and 48E credits. These 
                        <PRTPAGE P="4055"/>
                        requirements and responsive comments are discussed in section VIII.C. of this Summary of Comments and Explanation of Revisions. 
                        <E T="03">See also</E>
                         section VIII.F. (Carbon Capture and Sequestration) and section VIII.E.4. (Use of Natural Gas Alternatives) of this Summary of Comments and Explanation of Revisions for a discussion of responsive comments addressing the requirements of proposed § 1.45Y-5(d)(2) in relation to those topics.
                    </P>
                    <HD SOURCE="HD3">a. Starting Boundary</HD>
                    <P>Proposed § 1.45Y-5(d)(2)(i) provided, for the purposes of the section 45Y and 48E credits, a definition of the starting boundary for an LCA involving generation-derived feedstocks (such as biogenic feedstocks) and for an LCA involving extraction-derived feedstocks (such as fossil fuel feedstocks).</P>
                    <P>One commenter expressed support for the starting boundaries provided in the proposed regulations. Another commenter opposed the proposed starting boundary, asserting that the boundaries for a C&amp;G Facility should be the same as those for a Non-C&amp;G Facility. Because the statute requires distinct treatment of a C&amp;G Facility and a Non-C&amp;G Facility in assessing their GHG emissions rate, the final regulations do not adopt this commenter's request.</P>
                    <P>One commenter asserted that section 45Y is “limited by statute to the boundaries of the electricity generation facility (which may include carbon capture equipment) but excludes upstream and downstream emissions.” The Treasury Department and the IRS have determined that the change requested by this commenter would be contrary to the statute because it would fail to give effect to the requirement in section 45Y(b)(2)(B) that the net rate of GHG emissions for a C&amp;G Facility take into account lifecycle GHG emissions as described in 42 U.S.C. 7545(o)(1)(H). Therefore, the final regulations do not adopt this commenter's recommendation.</P>
                    <P>Another commenter requested that the final regulations clarify the activities that constitute the starting boundary. The commenter requested that the final regulations provide a specific example illustrating that the starting boundary for biomass feedstock includes the activities to grow the plant material. The Treasury Department and the IRS have determined that such activities are sufficiently included within the definition of starting boundary, and no further examples are required within the final regulations.</P>
                    <P>After consideration of all comments, the Treasury Department and the IRS have determined that the final definition of starting boundary should be adopted without substantive change.</P>
                    <HD SOURCE="HD3">b. Ending Boundary</HD>
                    <P>Proposed § 1.45Y-5(d)(2)(ii) provided, for the purposes of the section 45Y and 48E credits, that the ending boundary of the LCA for electricity that is transmitted to the grid or electricity that is used on-site is the meter at the point of electricity production at a C&amp;G Facility. The use of such electricity generated by the C&amp;G Facility (and what other types of energy sources it displaces), including emissions from transmission and distribution, are outside of the LCA boundary. For the reasons provided in the preamble to the proposed regulations, the distribution, transmission, and use of such electricity generated by a C&amp;G Facility (and other types of energy sources it may displace while in use) are outside of the LCA boundary, such emissions would not be taken into account because they do not occur in the “production of electricity” as described in section 45Y(b)(2)(B) but rather occur in the distribution and use of such electricity. The preamble to the proposed regulations further explained that this result is consistent with section 45Y(b)(2)(B) (and the term “ultimate consumer” in 42 U.S.C. 7545(o)(1)(H) as referenced therein) because it would treat the C&amp;G Facility as the ultimate consumer of the fuel used to produce electricity.</P>
                    <P>Several commenters supported the ending boundary of the LCA provided in the proposed regulations. Other commenters requested that the ending boundary of the LCA be extended to take into the account circumstances in which the emissions from a C&amp;G Facility or the emissions related to the production of electricity available on the grid are less than they would have been in the absence of the credits because of a facility's use of a different fuel or feedstock.</P>
                    <P>The Treasury Department and the IRS have determined that extending the ending boundary of the LCA as requested by these commenters would impermissibly shift the GHG emissions rate inquiry from whether electricity production at a C&amp;G Facility has a net GHG emissions rate of not greater than zero to whether such facility has fewer emissions than either (i) the emissions the C&amp;G Facility would have or did have in the absence of the credit or (ii) the marginal unit emissions of the grid to which the facility is connected. Conducting the LCA in such a manner would conflict with the plain text of the statute, which requires that the net rate of GHGs emitted by a C&amp;G Facility, considering lifecycle GHG emissions, in the production of electricity not be greater than zero.</P>
                    <P>
                        Furthermore, the Treasury Department and the IRS have determined that the meter at the point of electricity production at a C&amp;G Facility is an appropriate ending boundary because eligibility for the section 45Y and 48E credits depends on the net rate of GHG emissions associated with electricity production rather than use. Extending the boundary beyond the meter would consider activities that are beyond the scope of electricity generation which is beyond the scope of these provisions. For these reasons and the reasons further explained in section VIII.C.2.f. of these Summary of Comments and Explanation of Revisions, the final regulations do not adopt this request, and the definition of ending boundary is adopted as proposed. 
                        <E T="03">See</E>
                         section VIII.C.2.f. of these Summary of Comments and Explanation of Revisions for further discussion of the interaction between the LCA ending boundary, avoided emissions, and use of a particular fuel or feedstock in the generation of electricity in lieu of a fuel or feedstock with a greater rate of GHG emissions.
                    </P>
                    <P>
                        The Treasury Department and the IRS further note that the ending boundary of an LCA, as discussed earlier, is not intended to limit the rules applicable to carbon capture and sequestration. 
                        <E T="03">See</E>
                         section VIII.F. of these Summary of Comments and Explanation of Revisions for further discussion of these carbon capture and sequestration rules.
                    </P>
                    <HD SOURCE="HD3">c. Baseline</HD>
                    <P>Proposed § 1.45Y-5(d)(2)(iii) provided that an LCA must be based on a future anticipated baseline, which projects future status quo in the absence of the availability of the section 45Y and 48E credits (taking into account anticipated changes in technology, policies, practices, and environmental and other socioeconomic conditions).</P>
                    <P>
                        The Treasury Department and the IRS received comments on several aspects of the proposed rule regarding an LCA baseline. A number of commenters recommended that an LCA baseline take into account the relevant laws and regulations already in place, including any mitigation of emissions already legally required. The Treasury Department and the IRS have determined that this recommendation is already incorporated in the proposed rule on LCA baselines, which project the future status quo, including relevant laws and regulations, in the absence of the availability of the section 45Y and 48E credits. As such, a baseline would 
                        <PRTPAGE P="4056"/>
                        necessarily incorporate mitigation of emissions already required, and the effects of other law and regulations. Accordingly, further clarification in the final rule is unnecessary.
                    </P>
                    <P>Some commenters supported the proposed rule, while providing recommendations on how to approach the creation of an LCA future anticipated baseline. For instance, one commenter recommended considering historical data and anticipated future conditions under a business-as-usual trajectory, incorporating key drivers and trends to project future emissions; a second commenter recommended a dynamic, adaptive baseline that would account for broader system effects such as market dynamics; and a third commenter recommended that the baseline focus on the geographic location of the facility to accurately reflect local conditions and market dynamics. The Treasury Department and the IRS appreciate this feedback and will consider these recommendations at a later time as development of LCA baselines continues.</P>
                    <P>The Treasury Department and the IRS also received comments specifically addressing the approach to LCA baselines for biomass feedstocks. One commenter encouraged the use of historical forest data to inform the creation of a baseline, taking into account longer growth cycles of forests, drivers of regional forest management, and economic factors. Another commenter recommended that each source of woody biomass have its own LCA baseline. Finally, one commenter recommended that the LCA baseline take into account the current use of pertinent feedstocks and existing facilities.</P>
                    <P>The Treasury Department and the IRS appreciate these recommendations and have taken them into consideration. However, given the diversity of fuels and feedstocks that may be evaluated in creating LCA baselines for the purposes of the section 45Y and 48E credits, the final regulations provide general requirements for baseline development but do not specify requirements for specific fuels or feedstocks. Therefore, the commenters' specific recommendations will not be included in the final regulations, but they will be considered in developing LCAs for purposes of the section 45Y and 48E credits in the future. Specific recommendations related to LCA baselines will be considered and addressed as their development continues.</P>
                    <P>Several commenters recommended that the final regulations provide an LCA scenario design that compares a future anticipated baseline with biomass use to one without biomass use. The Treasury Department and the IRS have determined that this is not the most appropriate scenario design with which to assess GHG emissions pursuant to 45Y(b)(2)(B). Such a scenario would model a situation in which the entirety of the feedstock required for additional electricity production comes from additional removals of biomass materials. The commenters' suggestion would mean testing impacts from only one potential outcome at one end of a range of potential real-world responses. This contrasts with the scenario design approach that considers more than one likely scenario, which more accurately assesses the various ways that feedstock is sourced based on the supply options and markets in a model. This design approach is more accurate because, in reality, biomass feedstocks for a facility could be sourced from a variety of sources, including being diverted from other end uses. An LCA should reflect best estimates of how and from where biomass may be sourced taking into account historical and future anticipated feedstock, region, and market specific conditions. The Treasury Department and the IRS therefore decline to include these commenters' recommendation in the final regulations.</P>
                    <P>The Treasury Department and the IRS, in consideration of the comments received, have determined that certain additional principles pertaining to LCA baselines will be provided in the final regulations. LCA future anticipated baselines, which project future status quo in the absence of the availability of the section 45Y and 48E credits (taking into account anticipated changes in technology, policies, practices, and environmental and other socioeconomic conditions), will be updated as necessary to capture material regulatory, economic, supply chain, or environmental changes. The baseline must be updated at least every ten years, but not more often than every five years. Such updates will ensure that any LCA baseline applied for purposes of determining the net rate of GHG emissions associated with C&amp;G Facilities under this rule robustly reflects the projected future status quo in the absence of the section 45Y and 48E credits.</P>
                    <HD SOURCE="HD3">d. Offsets and Offsetting Activities</HD>
                    <P>Proposed § 1.45Y-5(d)(2)(iv) provided that offsets and offsetting activities that are unrelated to the production of electricity by the C&amp;G Facility, including the production and distribution of any input fuel, may not be taken into account in the LCA.</P>
                    <P>Several commenters supported this proposed rule. However, one commenter requested that the final rules clarify that offsets and offsetting activities are not the same as accounting for avoided emissions, as avoided emissions are directly related to the electricity production value chain. The Treasury Department and the IRS have determined that such clarification is not necessary given the prohibition on offsets and offsetting activities provided in proposed § 1.45Y-5(d)(2)(iv) and the rule provided in proposed § 1.45Y-5(d)(2)(vii) that the LCA may consider alternative fates of feedstocks and fuels and account for avoided emissions. Both the prohibition on offsets and offsetting activities and the rule that the LCA may consider alternative fates and account for avoided emissions are retained in this final rule.</P>
                    <P>Furthermore, after reviewing the comments, the Treasury Department and the IRS have determined that the proposed regulations were not clear in the description of offsets and offsetting activities. In particular, the reference to offsets and offsetting activities that are unrelated to the production of electricity by the C&amp;G Facility could have been read overly broadly to suggest that offsets and offsetting activities that are related to the production of electricity would be allowed. The reference was intended to make clear that offsets and offsetting activities should not be included because they are not related to the production of electricity or the lifecycle of the fuel used in electricity production rather than to specify a set of offsets and offsetting activities that may be permissible. The statute requires a C&amp;G Facility's net GHG emissions rate to include the facility's lifecycle emissions from the production of electricity. To avoid taxpayer confusion, the Treasury Department and the IRS have revised the rule in proposed § 1.45Y-5(d)(2)(iv) to remove the phrase “that are unrelated to the production of electricity by the C&amp;G Facility, including the production and distribution of any input fuel.”</P>
                    <HD SOURCE="HD3">e. Principles for Included Emissions</HD>
                    <P>
                        Proposed § 1.45Y-5(d)(2)(v) provided that the LCA must take into account direct emissions, significant indirect emissions in the United States or other countries, emissions associated with market-mediated changes in related commodity markets, emissions associated with feedstock generation or extraction, emissions consequences of increased production of feedstocks, emissions at all stages of fuel and 
                        <PRTPAGE P="4057"/>
                        feedstock production and distribution, and emissions associated with distribution, delivery, and use of feedstocks to and by a C&amp;G Facility. The preamble to the proposed regulations explained that this provision interprets the reference to 42 U.S.C. 7545(o)(1)(H) as requiring under section 45Y(b)(2)(B) that an LCA must take into account these emissions as they are a part of the full fuel lifecycle through the point of electricity production. Proposed § 1.45Y-5(d)(2)(v)(A) provided that, for purposes of proposed § 1.45Y-5(d)(2)(v), direct emissions include, but are not limited to: (1) Emissions from feedstock generation, production, and extraction (including emissions from feedstock and fuel harvesting and extraction and direct land use change and management, including emissions from fertilizers, and changes in carbon stocks); (2) Emissions from feedstock and fuel transport (including emissions from transporting the raw or processed feedstock to the fuel processing facility); (3) Emissions from transporting and distributing fuels to electricity production facility; (4) Emissions from handling, processing, upgrading, and/or storing feedstocks, fuels and intermediate products (including emissions from on/offsite storage and preparation/pre-treatment for use (for example, torrefaction or pelletization) and emissions from process additives); and (5) Emissions from combustion and gasification at the electricity generating facility (including emissions from the combustion and/or gasification process and emission from gasification or combustion additives). Proposed § 1.45Y-5(d)(2)(v)(B) provided that, for purposes of proposed § 1.45Y-5(d)(2)(v), examples of significant indirect emissions include, but are not limited to, emissions from indirect land use and land use change and induced emissions associated with the increased use of the feedstock for energy production. The preamble to the proposed regulations explained that significant indirect emissions may include positive or negative emissions, and that, for biogenic resources, significant indirect emissions may include emissions from growth and regrowth.
                    </P>
                    <P>The Treasury Department and the IRS received a range of comments about the proposal to include these emissions in the LCA. Most comments were supportive of this proposed approach. A few commenters suggested revisions to the proposal. One commenter recommended that market effects and induced land-use change not be assessed in the emissions included in an LCA due to what the commenters view as limited credible estimates of such dynamics. Another commenter cited a lack of Congressional intent to include market-mediated effects within the meaning of “significant indirect emissions” as this term does not appear in the statute. As explained earlier, the Treasury Department and the IRS interpret section 45Y(b)(2)(B) as requiring these emissions to be considered in the LCA, which by citing 42 U.S.C. 7545(o)(1)(H) directly specifies inclusion of “significant indirect emissions such as land use change”. Estimating the emissions effects associated with increased electricity production, including significant indirect emissions such as land use change necessarily involves some amount of uncertainty, but inclusion of such elements was the clear Congressional directive. The final regulations will therefore not include the revisions requested by commenters.</P>
                    <P>
                        Another commenter suggested that the LCA include emissions from “co-pollutants” such as sulfur dioxide, nitrogen oxides, and fine particulate matter, which are not GHG emissions within the meaning of sections 45Y and 48E. The Treasury Department and the IRS do not have the authority to adopt this proposal, as it is contrary to the text of the statute. Section 45Y(b)(2)(B) requires that an LCA be conducted to determine the amount of GHGs emitted into the atmosphere by a facility in the production of electricity, expressed in grams of CO
                        <E T="52">2</E>
                        e per kWh. Section 45Y(e)(1) states that “CO
                        <E T="52">2</E>
                        e per kWh” means, with respect to any greenhouse gas, the equivalent carbon dioxide (as determined based on global warming potential) per kilowatt hour of electricity produced. Section 45Y(e)(2) states that “greenhouse gas” has the same meaning given such term under 42 U.S.C. 7545(o)(1)(G), as in effect on the date of the enactment of this section. 42 U.S.C. 7545(o)(1)(G) defines greenhouse gas as “carbon dioxide, hydrofluorocarbons, methane, nitrous oxide, perfluorocarbons, sulfur hexafluoride.” The provision further states that “[t]he Administrator may include any other anthropogenically-emitted gas that is determined by the Administrator, after notice and comment, to contribute to global warming.” Because “co-pollutants” such as sulfur dioxide, nitrogen oxides, and fine particulate matter are not GHGs within the meaning of 42 U.S.C. 7545(o)(1)(G), the Treasury Department and the IRS do not have the authority to adopt the commenter's proposal.
                    </P>
                    <P>The Treasury Department and the IRS generally adopt § 1.45Y-5(d)(2)(v) as proposed. The Treasury Department and the IRS clarify in § 1.45Y-5(b)(10) that market-mediated effects are those resulting from policy interventions and other factors (for example, technological advances) that alter the availability of and demand for marketed goods and activities and their related GHG emissions profiles. These effects are driven by and result in changes in absolute and relative prices which can occur at local, national, and global boundaries. Examples of market-mediated effects include direct and significant indirect emissions, such as land use changes or land use management changes that result from the production of fuels derived from biomass and shifts in total market demand and supply for input fuels, feedstocks and related commodities, and other materials, as a result of changes associated with the policy intervention.</P>
                    <P>For further clarity, the final regulations better distinguish in § 1.45Y-5(d)(2)(v) between included emissions that are direct emissions and those that are significant indirect emissions. The final rule also clarifies that all these emissions are within the system boundary of the LCA.</P>
                    <HD SOURCE="HD3">f. Principles for Excluded Emissions</HD>
                    <P>Proposed § 1.45Y-5(d)(2)(vi) provided a list of types of emissions that the LCA must not take into account. The Treasury Department and the IRS received several comments on these proposed excluded emissions from the LCA. Several commenters requested that further items be excluded from emissions accounting in the LCA. For instance, a few commenters requested the exclusion of emissions resulting from standby auxiliary power for electrolyzers or emissions from supplementary “peaker plants”. A few commenters proposed that emissions resulting from the conditioning and distribution of hydrogen be excluded from the LCA. In each of these instances, the Treasury Department and the IRS have determined that such emissions may be considered emitted into the atmosphere in the production of electricity within the meaning of section 45Y(b)(2)(B), and thus may not be appropriately excluded from an LCA. The Treasury Department and the IRS therefore decline to adopt these changes in the final regulations. The final regulations adopt the principles for excluded emissions as proposed.</P>
                    <HD SOURCE="HD3">g. Alternative Fates and Avoided Emissions</HD>
                    <P>
                        Proposed § 1.45Y-5(d)(2)(vii) provided that an LCA may consider alternative fates and may account for 
                        <PRTPAGE P="4058"/>
                        avoided emissions. The preamble to the proposed regulations defined the term “alternative fate” to mean a set of informed assumptions (for example, production processes, material outcomes, and market-mediated effects) used to estimate the emissions from the use of each feedstock were it not for the feedstock's new use due to the implementation of policy (that is, to produce electricity). The final regulations adopt this definition of alternative fate in § 1.45Y-5(d)(2)(vii). Because the alternative fate for some feedstocks may be disposal, in the interest of completeness and clarity, these final regulations clarify that the term “alternative fate” may include the disposal of a feedstock.
                    </P>
                    <P>The preamble to the proposed regulations defined the term “avoided emissions” to mean the estimated emissions associated with the feedstock, including the feedstock's production and use or disposal, that would have occurred in the alternative fate (if such feedstock had not been diverted for electricity production) but are instead avoided with the feedstock's use for electricity production. The preamble to the proposed regulations further explained that, while, in some circumstances, emissions may be avoided if compared to the alternative fate, in other circumstances the new use of the material (for example, for electricity production) may involve additional emissions that were not emitted in the alternative fate estimation. Relatedly, in some circumstances, emissions may be avoided in one part of the supply chain only to occur elsewhere along the supply chain due to the new use. The final regulations adopt this definition of avoided emissions in § 1.45Y-5(d)(2)(vii) without change.</P>
                    <P>Many commenters generally supported the proposed rule. Several commenters opposed allowing the LCA to consider alternative fates or avoided emissions because the commenters asserted that it is not possible to accurately measure avoided emissions and hence many claims of avoided emissions are unreliable.</P>
                    <P>Finally, a number of commenters suggested guardrails that might be implemented in the final regulations or in the analysis of emissions to enhance accuracy. One commenter recommended that the final regulations set a minimum carbon intensity score of zero for all fuels and feedstocks. The Treasury Department and the IRS have determined that, while this recommendation may have merit with respect to certain types of fuels or feedstocks, such an approach may not be appropriate for all fuels and feedstocks. Thus, this recommendation will not be adopted in the final regulations as a generally applicable rule but will be considered in targeted cases where the relevant facts and circumstances support its application.</P>
                    <P>Another commenter suggested that analysis of avoided emissions or alternative fates of fuel or feedstock employ a geographical limiting element to address local air pollution and health issues. However, sections 45Y and 48E do not authorize the Treasury Department and the IRS to specifically take into account local air pollution and health issues in the assessment of GHG emissions. Therefore, the Treasury Department and the IRS decline to adopt this commenter's recommendation in the final regulations.</P>
                    <P>Several commenters recommended that the LCA take into account only reliable and documented alternative fates that are supported by data, including land management records and market statistics, showing customary practice for the relevant feedstocks or fuels. The Treasury Department and the IRS agree that taking care to assess the reliability and documentation of any data elements, including those concerning alternative fates is good practice for conducting a GHG LCA. However, the Treasury Department and the IRS decline at this time to require the use of specific forms of documentation and data sources in the final regulations given the diversity of fuels and feedstocks and their alternative fates that may be evaluated for the purposes of the section 45Y and 48E credits. Therefore, the commenters' recommendation will not be adopted in the final regulations. Specific substantiation and documentation data requirements related to alternative fates or avoided emissions may be identified for specific fuels or feedstocks in future guidance.</P>
                    <P>One commenter further recommended that prospective claimants of the section 45Y credit be required to support the alternative fate of a feedstock or fuel with credible evidence and that verification of such fate be required to the maximum extent possible. The Treasury Department and the IRS view this request as covered by a taxpayer's existing general substantiation obligations under section 6001 of the Code so further clarification in the final regulations is not necessary. Therefore, the final regulations do not adopt this commenter's suggestion.</P>
                    <P>A number of commenters recommended that the evaluation of alternative fates be comprehensive, with suggestions including that the LCA assess multiple alternative fates to improve the robustness of the analysis, that such alternative fates account for emissions related to the full fuel lifecycle, that alternative fate assumptions be updated regularly, and that consideration be given to the influence of market conditions and effects.</P>
                    <P>The Treasury Department and the IRS agree that ensuring that the LCA assessment of alternative fates and avoided emissions is comprehensive and up to date is critical to ensure robust estimation of the net GHG emissions rates for C&amp;G Facilities. These recommendations will be considered in the development of future LCA assessments.</P>
                    <P>Commenters also opined on whether the LCA should take into account emissions “displacement” from electricity grids. This analytical framework assumes that, in the absence of the incentive provided by the section 45Y and 48E credits, fuels or feedstocks that would otherwise have a greater GHG emissions rate will be used to generate electricity, and that the assumed reduction in emissions due to the use of fuels or feedstocks with a lesser GHG emissions rate at a facility due to this rule should be taken into account when evaluating the net GHG emissions rate of a facility using those fuels or feedstocks. A number of commenters recommended treating this displacement as an avoided emission that could lessen the net GHG emissions rate of a facility using those fuels or feedstocks, stating that such treatment would spur investment in a number of technologies and reduce net GHG emissions.</P>
                    <P>Other commenters recommended against treating this displacement as an avoided emission that could lessen the net GHG emissions rate of a facility using those fuels or feedstocks, asserting that to do so would improperly shift the GHG emissions rate inquiry from whether a C&amp;G Facility has a net GHG emissions rate of not greater than zero to whether the facility has fewer emissions than the marginal unit emissions of the grid the facility is on.</P>
                    <P>
                        The Treasury Department and the IRS have determined that the proposed rule in § 1.45Y-5(d)(2)(ii), which states that energy sources displaced by the electricity generated by a C&amp;G Facility are outside of the LCA boundary, should be retained in the final regulations. This rule appropriately requires that the net GHG emissions rate be assessed at the level of the C&amp;G Facility, with an ending boundary for assessment for electricity that is transmitted to the grid 
                        <PRTPAGE P="4059"/>
                        or electricity that is used on-site is the meter at the point of electricity production of the C&amp;G Facility. This ending boundary is consistent with section 45Y's focus on the C&amp;G Facility and the full fuel lifecycle of any fuel or feedstock used by the C&amp;G Facility to produce electricity as the relevant sources of GHG emissions, rather than any change to the emissions profile of the electricity grid.
                    </P>
                    <P>The Treasury Department and the IRS agree with commenters that taking into account potential post-production grid electricity displacement as an avoided emission would impermissibly shift the GHG emissions rate inquiry from whether electricity production at a qualified facility has a net GHG emissions rate of not greater than zero to whether the facility has fewer emissions than the marginal unit emissions of the grid to which the facility is connected. Conducting the LCA in such a manner would conflict with the plain text of the statute, which requires that the net rate of GHGs emitted by a C&amp;G Facility, considering lifecycle GHG emissions, in the production of electricity not be greater than zero. In contrast to this distinct concept of displacement of electricity production from other more highly polluting sources on the electricity grid due to electricity produced by a C&amp;G Facility, the LCA of electricity production calculates the net GHG emissions of the electricity production by that facility, including by taking into account alternative fates and avoided emissions of the fuels or feedstocks that are themselves used to produce electricity at such a facility over the entire lifecycle of that particular fuel or feedstock or its supply chain. The statute directs the Treasury Department to calculate the GHG emissions associated with electricity production by a specific facility. The statute does not direct or authorize the Secretary to conduct a relative assessment of a facility's GHG emissions before and after earning the tax credit or a relative assessment of a facility's electricity production volumes and related GHG emissions compared to other facilities on the grid. For additional clarity, the Treasury Department and the IRS have determined that proposed § 1.45Y-5(d)(2)(vii) should be modified to add the phrase “including for the fuels and feedstocks consumed in the fuel and feedstock supply chain and at the electricity generating facility.”</P>
                    <P>The Treasury Department and the IRS also received many comments regarding the purported alternative fates or avoided emissions associated with the use of a particular fuel or feedstock. Several commenters requested that an LCA of municipal solid waste take into account emissions that may be avoided by use of such waste to produce electricity rather than placement in a landfill. Others shared their views or research on common alternative fates of woody biomass, including natural decay, prescribed burning, wildfire fuel, and transfer to disposal sites.</P>
                    <P>The Treasury Department and the IRS appreciate the information shared by commenters on these matters and have taken it into consideration. Because these assertions make technical claims that must be evaluated in the context of an LCA and because they are applicable to only certain categories of feedstocks, the Treasury Department and the IRS have determined that incorporation of these recommendations in the final regulations as a broadly applicable rule would not be appropriate.</P>
                    <P>Finally, commenters had mixed reactions to the assertion that the use of woody biomass in the production of electricity drives forest regrowth that might render the use of such feedstock carbon neutral for purposes of the section 45Y and 48E credits. Some commenters asserted that woody biomass, when used to produce electricity, has a net GHG emissions rate of not greater than zero, and that therefore, facilities using such feedstock should be included as qualified facilities in the final regulations and in the Annual Table.</P>
                    <P>Because section 45Y(b)(2)(B) requires taking into account lifecycle GHG emissions as described in 42 U.S.C. 7545(o)(1)(H), the Treasury Department and the IRS do not have the authority to designate such facilities as qualified facilities before ensuring that an LCA specific to implementation of sections 45Y and 48E is conducted in accordance with statutory requirements. The Treasury Department and the IRS thus decline to adopt these commenters' recommendations in the final regulations. The Treasury Department and the IRS appreciate commenters' feedback and note in particular that certain woody biomass-derived feedstocks require significant energy inputs which could make qualification of facilities using these specific feedstocks unlikely (for example, pelletized biomass due to the electricity used in pelletization processes).</P>
                    <HD SOURCE="HD3">D. Additional Issues Regarding Greenhouse Gas Emissions Rates for C&amp;G Facilities</HD>
                    <P>The determination of net GHG emissions rates for C&amp;G Facilities raises a range of complex technical questions that are relevant to determining eligibility for the section 45Y and 48E credits. The Treasury Department and the IRS requested comment on the following topics: (i) the treatment of RNG and fugitive sources of methane; (ii) analytical LCA parameters, including spatial scales and time horizons; (iii) whether and how to distinguish between co-products, byproducts, and waste products and how emissions should be allocated to each in LCAs; (iv) how to attribute emissions to the heat produced by facilities using combined heat and power systems; (v) how to create and maintain LCA baselines; and (vi) certain issues related to LCA modeling.</P>
                    <HD SOURCE="HD3">1. Analytical LCA Parameters, Including Spatial Scales and Time Horizons</HD>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS requested comment on the analytical LCA parameters that are most relevant to particular types of categories of C&amp;G Facilities that may be eligible for the section 45Y and 48E credits. In particular, the Treasury Department and the IRS requested comment regarding spatial and temporal scales, including the factors that should be considered in setting the spatial and temporal scales for LCAs conducted for the section 45Y and 48E credits. As noted in the preamble to the proposed regulations, spatial scale involves defining the area over which emissions outcomes will be evaluated. Temporal scale involves defining the time period over which emissions outcomes will be evaluated. The decision of setting the spatial scale should be considered in conjunction with decisions on temporal scale, as the two can interact in ways that affect greenhouse gas assessment outcomes. The Treasury Department and the IRS received a number of comments on these topics.</P>
                    <HD SOURCE="HD3">a. Temporal Scales</HD>
                    <P>
                        In the preamble to the proposed regulations, the Treasury Department and the IRS requested comment regarding what factors should be considered in establishing the timeframe for the LCA analysis. Commenters suggested a number of specific considerations. Multiple commenters advocated for the LCA to account for the full timeframe over which lifecycle emissions can occur, with some commenters specifically asking for a “climate-relevant” timeframe. A commenter argued that a full accounting of the effects of activities should include the effects of small-scale projects over long time frames with each activity assessed individually. Another commenter argued that the full 
                        <PRTPAGE P="4060"/>
                        timeframe over which emission effects persist into the future should be included. Conversely, a commenter noted that any approach that requires use of long-run future marginal grid emissions projections could be prohibitively challenging or problematically inaccurate. Some commenters advocated for inclusion of all relevant emissions fluxes on the same timescale. A commenter suggested counting any emissions counterbalanced by the regrowth of feedstock on the same time scale as the positive emissions from combustion and other direct and indirect positive emissions. A commenter also asked to match the time horizon with the economic life of a plant that abates existing methane or other GHG emissions. Some commenters argued that no specific geographic or temporal requirements were required as long as the timeframe covered the occurrence of emissions in the counterfactual scenario.
                    </P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS requested comment regarding what timeframe would provide confidence that significant emissions have been accounted for. Commenters suggested a wide variety of specific lengths of time, citing a variety of policy reasons. Some commenters suggested time horizons of 100 years (or more), citing the importance of accounting for potential long-term changes in emissions in order for certain feedstocks to qualify. Other commenters advocated for much shorter time horizons. One commenter requested that CHP property which relies on combustion, such as woody biomass energy, should be required to show carbon-neutrality over a short period of time such as a year. Multiple commenters advocated for a 10-year time horizon. Commenters also cited potential ranges somewhere in the middle, such as 20 to 50 years or 20 to 25 years.</P>
                    <P>
                        After thorough review of the comments the Treasury Department and the IRS have determined that it is appropriate to base the selection of temporal scale on the regulatory context. This is reinforced by the 2019 recommendations by the Science Advisory Board (SAB) on EPA's Draft 2014 Framework for Assessing Biogenic CO
                        <E T="52">2</E>
                         Emissions from Stationary Sources. The SAB recommended “using the `emissions horizon' that is determined to be relevant by the specific regulatory objective,” meaning the technical choice should be contingent upon the specific policy and regulatory context. The SAB went further to state that “the SAB favors selecting the time horizon for calculating the [factor representing the net atmospheric biogenic CO
                        <E T="52">2</E>
                         contributions associated with biogenic feedstock production, processing, and use at a stationary source] to comport with the objective under consideration, which is generally dependent on the regulation mandating use of that particular [factor].” ISO guidance also states that an LCA should be conducted within the context of a specified goal.
                    </P>
                    <P>The broader regulatory context requires the Treasury Department and the IRS to balance multiple considerations. The statute creates a pathway for C&amp;G Facilities that have a net GHG emissions rate of zero or less as determined via LCA to qualify for the credit. Setting a relatively short time horizon would not allow for the consideration of potential increases or decreases in emissions that can occur as the result of electricity production, such as the regrowth of biogenic feedstocks or increased emissions from land use or land use management changes. However, while biogenic feedstock regrowth can occur over long timescales, commenters have raised significant concerns that longer time horizons introduce additional uncertainty about the likelihood that these theoretical future scenarios and emissions-offsetting activities will occur in practice. This uncertainty significantly decreases the confidence of the Treasury Department and the IRS that LCAs with a longer time horizon will ensure that a facility meets the requirements of the statute. Moreover, the broader structure of the IRA and specific features of sections 45Y and 48E—including the phase-out of the credit occurring after the later of 2032 or the achievement of specified GHG emissions reduction target and the requirement that qualified facilities have a GHG emissions rate of zero or less—demonstrate congressional intent for the section 45Y and 48E credits to contribute to significant reductions of GHG emissions in the power sector in the near- to medium-term. Setting a temporal scale that allows C&amp;G Facilities that do not contribute to the reduction of GHG emissions (or even increase GHG emissions) in the near- and medium-term would also frustrate congressional intent.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS asked whether the LCA should distinguish between an “emissions horizon” (the timeframe over which emissions effects from the feedstock use persist into the future) and an “assessment horizon” (the timeframe over which the emissions effects are included in the analysis), and how that would be reflected in the choice of temporal scale. Although some commenters advocated for applying different time horizons in different contexts (for example, for different electricity production pathways), the Treasury Department and the IRS have determined that it furthers the interest of fairness and administrability in the tax system to apply consistent rules for all LCAs under sections 45Y and 48E. Applying different time horizons, including different assessment and emissions horizons, in different contexts could lead to taxpayer confusion and disparate treatment for similarly situated facilities. Moreover, a single time horizon would allow LCAs to be conducted as efficiently and accurately as possible. The Treasury Department and the IRS further clarify that the final rules in § 1.45Y-5(d)(2)(viii) adopt the same assessment horizon and emissions horizon.</P>
                    <P>
                        In balancing these considerations and commenters' different views, the final regulations adopt a time horizon for LCA of 30 years from the year in which a qualified facility produces electricity (or, for purposes of the section 48E credit, the year in which a qualified facility was placed in service). This 30-year time horizon is supported by several points, including consistency with the longstanding time horizon for EPA's RFS program. This program, authorized under the Energy Policy Act of 2005 and expanded under the Energy Independence and Security Act of 2007, determined that GHG emissions analysis for renewable fuels would quantify the GHG impacts over a 30-year period in a March 2010 rule (75 FR 14670) (RFS2). A 30-year analysis time period was further maintained in the Final Renewable Fuels Standards Rule for 2023, 2024, and 2025.
                        <SU>7</SU>
                        <FTREF/>
                         The RFS2 rule made this determination balancing a number of considerations, including the expected life of biofuel production facilities—and their long-term market impacts on emissions—and the inherent uncertainty in estimating GHG emissions over a longer period of time. The Treasury Department and the IRS assess that solely for the purposes of setting temporal scales in these final regulations, the section 45Y and 48E credits and RFS2 are similar regulatory contexts based on the information currently available.
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             Regulatory Impact Analysis for Renewable Fuel Standard (RFS) Program: Standards for 2023-2025 and Other Changes, Section 4.2.2. (pp129-130), available at 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1017OW2.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        A commenter advocated for modifying the Greenhouse Gases, 
                        <PRTPAGE P="4061"/>
                        Regulated Emissions, and Energy use in Transportation model (GREET model) to capture 20-year and 100-year time horizons as the GREET model already uses the GWP metric to capture both near-term and long-term climate impacts. The Treasury Department and the IRS note that the temporal scale of the LCA is the time period over which GHG emissions are assessed in the context of sections 45Y and 48E, rather than the warming potential of such emissions. Reliance upon specific GWPs to determine time horizons or upon the GREET model, which is a particular model that does not generally include explicit temporal considerations when applying certain assumptions about what activities and related GHG emissions to include, is therefore separate from the issue of temporal scales. The decision to use GWP-100 is discussed in section VIII.A.1. of this Summary of Comments and Explanation of Revisions.
                    </P>
                    <HD SOURCE="HD3">b. Spatial Scales</HD>
                    <P>Commenters also submitted a wide range of recommendations pertaining to spatial scales. A few commenters recommended that spatial boundaries be set narrowly around the geographic location of the facility, which they stated would more accurately reflect local conditions. Another commenter advocated for setting spatial scales such that they capture the potential impact of having multiple facilities with a GHG emissions rate of greater than zero in the same area. One commenter suggested that the LCA spatial scales not be beyond the facility producing the feedstock.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS asked (i) what factors should be considered to assess whether a global scale is necessary for certain feedstocks to ensure that significant emissions are captured, and (ii) whether all feedstock/fuels assessments should be conducted with the same spatial scale to determine the extent to which increased use has estimated global ramifications. Some commenters had feedstock-specific suggestions regarding appropriate spatial scales. Several commenters recommended that, in the case of woody biomass, spatial boundaries be broad to more accurately represent forest dynamics. A commenter also suggested that spatial scales not be limited when taking into account wastes, including when such wastes are managed outside of the United States.</P>
                    <P>After consideration of all comments and of LCA modeling practices that take into account the full lifecycle of emissions as described by 42 U.S.C. 7545(o)(1)(H), the Treasury Department and the IRS have determined and provided in § 1.45Y-(d)(2)(ix) that spatial scales analysis for LCAs conducted for the section 45Y and 48E credits should identify GHG effects from changes in input fuel or feedstock production and use, including indirect emissions effects stemming from market-related changes in supply and demand. When estimating the net GHG emissions outcomes associated with a fuel or feedstock that has current or anticipated market uses and thus potential market-mediated impacts for the entity-level analysis (that is, for a Provisional Emissions Rate (PER)) or generally applicable analysis (that is, for the Annual Table), the LCA assessment must start with a qualitative market analysis to aid with the formation of parameters and other decisions in the LCA modeling. This market analysis serves the purpose of analyzing whether the prospective fuel or feedstock has been or is anticipated to be used directly in or as an input to an activity or commodity in local markets, is transported for use in domestic markets elsewhere, or is traded for use in international markets, whether use of the material does or is anticipated to have significant ramifications on other markets, and the magnitude of the use or anticipated use. Findings of this assessment should inform the decisions about what spatial scales, such as sub-regional, regional, national, or international, are most appropriate for assessing the market and related GHG emissions effects associated with the feedstock and use case under consideration. The GHG emissions analysis should then be conducted using the designated model(s) with the applicable spatial scales to estimate the market and GHG emissions implications of changing supply flows to provide the feedstock for energy purposes and sourcing new or additional feedstock material for electricity generation across the applicable market and spatial scales for use in the LCA assessment to determine the net GHG emissions rate needed as part of the eligibility qualification for the section 45Y and 48E credits. If the initial market analysis concludes that the prospective feedstock is (i) not currently, has not recently, nor is anticipated in the future in the absence of the section 45Y and 48E credits to be used or sold on the market, (ii) not used as an input to an activity or good in local markets, (iii) not transported for use in domestic markets elsewhere, (iv) not traded for use in international markets, or (v) use of the material does not or is not anticipated to have significant ramifications on other markets, then an analysis of market-mediated impacts would only need to apply across the spatial scales that are applicable to the fuel or feedstock in the LCA emissions assessment.</P>
                    <HD SOURCE="HD3">2. Distinguishing Between Co-Products, Byproducts, and Waste Products and How Emissions Should Be Allocated to Each in LCAs</HD>
                    <P>As explained in the preamble to the proposed regulations, the categorization and assessment of products as co-products, byproducts, or waste products in an LCA may affect the LCA's results. The preamble to the proposed regulations provided potential definitions to guide the categorization of co-products, by products or waste products and further provided that products, co-products, byproducts, and wastes may all be produced in the full fuel cycle or used as inputs to the same.</P>
                    <P>The preamble to the proposed regulations further explained that the categorization of products as co-products, byproducts, and waste products may be relevant to an LCA's assessment of the GHG emissions related to the production of inputs to electricity generation or in the generation of electricity itself if the LCA modeling approach or approaches used for purposes of the section 45Y and 48E credits have the ability to distinguish between such categories.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS stated an intent to clarify the principles for categorizing products as co-products, byproducts, or waste input materials and products and assessing the emissions outcomes for such products in an LCA for C&amp;G Facilities in the final regulations for the section 45Y and 48E credits if such categorization is relevant to the LCA model or models used. To inform the development of these categorization principles for the final regulations, in the preamble to proposed regulations the Treasury Department and the IRS requested comment on what principles should be used to distinguish between co-products, byproducts, and waste products for the purposes of the section 45Y and 48E credits. The Treasury Department and the IRS also asked whether there are common scientific or industry definitions that can be relied upon to distinguish between co-products, byproducts, and waste products.</P>
                    <P>
                        The Treasury Department and the IRS received a large number of comments in response to these questions. A few commenters suggested broad principles 
                        <PRTPAGE P="4062"/>
                        that should be used to distinguish between co-products, byproducts, or waste products. One such commenter recommended that the definitions of co-products, byproducts, and waste products be less rigid than those shared in the preamble to the proposed regulations and that they reflect the scientific literature on the lifecycle GHG emissions of various materials. Another commenter recommended that the final regulations adopt simple common-sense definitions that assign emissions of the facility to primary products and co-products. This commenter further suggested that all materials left over after the production of any primary products be deemed waste unless they have significant value, and that the full breadth of potential co-product materials be considered. Another commenter recommended that the final regulations provide a broad definition of residue materials, citing the need to give industry the ability to respond to local market forces. Another commenter recommended using mass-based allocation to allocate emissions to co-products, byproducts, and waste products, stating that such an approach is straightforward to administer and can reduce abuse.
                    </P>
                    <P>A number of commenters opposed distinguishing between co-products, byproducts, and waste products for the purposes of the section 45Y and 48E credits. Several stated that such categorization of products would result in impermissibly failing to associate all GHG emissions to the feedstock or fuel that produced the electricity, or that if such categories do not do so, they are therefore irrelevant. Some commenters opposed to such categorization noted its complexity, with one commenter stating opposition to including these categories in the final rule in favor of expert agencies due to the highly technical nature of the work. Another commenter, noting the complexity of the designations, recommended using caution in any such categorization process to avoid rewarding emissions shifting rather than a true reduction in emissions.</P>
                    <P>The Treasury Department and the IRS have determined that distinguishing between co-products, byproducts, and waste products will help facilitate efficient and consistent LCA taking into account lifecycle GHG emissions as described in 42 U.S.C. 7545(o)(1)(H). Moreover, providing a framework of categorization will facilitate communications among stakeholders by providing a common set of terms. Such designations were also used in EPA's 2010 notice-and-comment rulemaking establishing the regulatory framework for the updated RFS program, in which EPA interpreted 42 U.S.C. 7545.</P>
                    <P>The Treasury Department and the IRS have determined that, as noted in the preamble to the proposed regulations, it is appropriate to provide clarifications to the definitions of products, co-products, byproducts, and waste and the principles for categorizing and informing the assessment of the GHG emissions associated with such materials in an LCA for C&amp;G Facilities in the final regulations under § 1.45Y-5(d)(2)(x) for the section 45Y and 48E credits. These clarifications were informed by consideration of the comments received on these definitions and principles in the proposed regulations. The Treasury Department and the IRS have also determined that these clarifications are consistent with the statutory direction in section 45Y to determine GHG emissions rates taking into account lifecycle GHG emissions as described in 42 U.S.C. 7545(o)(1)(H). The EPA interpreted 42 U.S.C. 7545(o)(1)(H) as requiring the agency, in the RFS context, to account for the real-world emissions consequences of increased production of biofuels, including consideration of market interactions that may result in indirect emissions. The Treasury Department and the IRS find that the clarifications to these definitions and principles therefore appropriately incorporate the concepts of marketability and market effects in the context of the designation and emissions assessment of primary products, co-products, byproducts, and waste products.</P>
                    <P>
                        These clarifications include the definitions in § 1.45Y-(d)(2)(x)(A)(
                        <E T="03">1</E>
                        ) through (
                        <E T="03">4</E>
                        ):
                    </P>
                    <P>• A “primary product” is an input or an output with marketability and is the main driver of the process from which it is produced.</P>
                    <P>• A “co-product” is an input or an output with marketability that is produced together with another product, both of which are economic drivers of the process from which they are produced.</P>
                    <P>• A “byproduct” is an input or an output that is produced together with another product, and which has a market recognized economic value of zero or greater, but the output is not an economic driver of the process from which it is produced.</P>
                    <P>• A “waste product” is an input or an output with negative economic value, demonstrated by (1) the absence of a market in which the product is purchased and sold and (2) the existence of a market in which producers pay for the collection and removal or disposal of the input or output material or the existence of a predominant operational practice in which producers themselves collect and remove, give away, or dispose of the input or output material as part of operational processes.</P>
                    <P>For the purposes of these definitions, the Treasury Department and the IRS note that a “market” should be an established set of transactions between parties and that whether or not a market exists—and therefore the categorization of the same product—may vary by region. A single or very small number of local transactions of insignificant volumes at nominal prices to expedite disposal generally would not constitute a market. Moreover, the existence of a market and therefore the analysis of market-mediated effects for a particular product or material does not prejudge the magnitude of those effects. For example, a market may have existed in the past for a particular product or material, but market analysis may indicate that this market is anticipated to not exist in the future, and vice versa. Relatedly, for the purposes of these definitions, marketability is defined as the ability to be consistently sold or marketed in the regular course of business.</P>
                    <P>For example, an input or output generated as part of operational processes that would otherwise be subsequently: (i) given away; (ii) sold at nominal prices to expedite disposal; or (iii) disposed of (without creating a commercial product or generating electricity) by burning onsite, burying, piling and burning onsite or leaving to decompose, or scattering would generally be considered a waste for the purposes of these definitions.</P>
                    <P>
                        Consistent with this approach, the final regulations also add in § 1.45Y-5(d)(2)(x)(B)(
                        <E T="03">1</E>
                        ) through (
                        <E T="03">6</E>
                        ) principles for categorizing and informing the assessment of the GHG emissions for such materials in an LCA for C&amp;G Facilities for the section 45Y and 48E credits if such categorization is relevant to the LCA model or models used. The principles are as follows:
                    </P>
                    <P>• All classification of materials and LCAs should take into account relevant geospatial variations in supply and demand (that is, differences across local, sub-regional, and larger regions), as well as variations across specific product types and characteristics, and producer types as relevant. For example, a material may meet the previously described definition of a waste in certain regions and the definition of a by-product or co-product in other regions.</P>
                    <P>
                        • The LCA should assess whether there are market-mediated effects and, if 
                        <PRTPAGE P="4063"/>
                        so, take these into account as part of the GHG analysis. In some cases, market-mediated effects will be small or nonexistent.
                    </P>
                    <P>• Regardless of how a material is categorized, the LCA should consider whether the availability of the section 45Y and 48E credits is expected to result in additional production of that material or in material changes in the supply chain, and, if so, should take into account the direct and indirect emissions impact of the additional production or changes in the supply chain.</P>
                    <P>• Policy and other interventions (for example, technological advances) can alter the availability and demand for marketed goods and services, which can alter the treatment of materials once disposed of. Therefore, reevaluation of material categorization should occur at least every ten years, but not more often than every five years.</P>
                    <P>• All determinations of marketability, market-mediated effects, and behavioral changes must be supported by an analytical assessment performed by one or more National Laboratories, in consultation with other Federal agency experts as appropriate.</P>
                    <P>• A material should be considered to have a market recognized economic value and an established market if one existed within the last five years as of the date of the analysis.</P>
                    <P>To inform the development of these categorization principles for the final regulations, in the preamble to proposed regulations the Treasury Department and the IRS requested comment on what principles should be used to determine whether a product has sufficient value to be considered a co-product or byproduct. Two comments were received in response. These commenters stated that if a policy rewards the use of a waste product, that product has inherent value, and that that value could possibly surpass the value of the ostensible primary product. One such commenter noted that this would make these materials co-products. Another recommended that the Treasury Department rigorously interrogate the designation of waste fuels because of the change in value of such items due to the section 45Y and 48E credits as well as any other relevant subsidies. This commenter further suggested that when product designation is likely shifted as a result of these incentives, so should the associated emissions accounting.</P>
                    <P>
                        The Treasury Department and the IRS have considered these comments and others in evaluating the appropriate definition and treatment of co-products. The Treasury Department and the IRS have determined that the definition of “co-product” will be amended in the final regulations under § 1.45Y-5(d)(2)(x)(A)(
                        <E T="03">2</E>
                        ) to reflect that a co-product not only must be an economic driver of the production process alongside another product, but also must have marketability. However, regardless of how a material is categorized, the LCA will consider whether the availability of the section 45Y and 48E credits can result in additional production of that material or changes within the production and supply chain of that material and take into account any direct and indirect GHG emissions outcomes of the additional production or any such supply chain changes. Furthermore, because policy and other interventions can alter the availability and demand for marketed goods and services, even turning waste products into byproducts, co-products, or even primary products, the categorization of materials will be reevaluated and must be updated at least every ten years, but not more often than every five years.
                    </P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS also requested comment regarding whether the section 45Y and 48E credits may provide additional economic incentive for the consumption of a product categorized as waste prior to the availability of the incentive provided by the section 45Y and 48E credits. The Treasury Department and the IRS also asked how this additional economic incentive should be considered to determine if a product is a waste product, byproduct, or co-product, and asked whether this categorization should be reevaluated and, if so, how often.</P>
                    <P>The Treasury Department and the IRS received several comments about the economic incentive for the consumption of a product categorized as waste prior to the availability of the incentive provided by the section 45Y and 48E credits. One commenter recommended that, because of this possible incentive, the final regulations not distinguish between co-products, byproducts, and wastes for the purposes of emissions allocation. For all materials, the LCA must consider whether the availability of the section 45Y and 48E credits can result in additional production or use of that material, or changes in the production of or supply chain to provide that material and take into account any direct and indirect emissions outcomes of the additional production or use and any supply chain changes.</P>
                    <P>
                        Another commenter similarly warned about the risk of incentivizing the classification of waste when such categorization is not factually justified. This commenter stated that the European Union's Renewable Energy Directive (RED) waives sustainability criteria for solid biomass fuels that are considered industrial residues, but that to protect against the risk of fraudulent classification of such fuels as waste, the RED requires that feedstock auditing verify such classification. The commenter recommended that the Treasury Department adopt similar measures for the section 45Y and 48E credits. The Treasury Department and the IRS have determined that a similar requirement would be appropriate to ensure accurate tracking and verification of any materials determined to constitute waste materials. If a qualified facility uses feedstocks that do not have marketability, but which are indistinguishable from marketable feedstocks (for instance, after processing), the taxpayer will be expected to maintain documentation substantiating the origin and original form of the feedstock. 
                        <E T="03">See</E>
                         section VIII.J. of this Summary of Comments and Explanation of Revisions for further discussion of substantiation.
                    </P>
                    <P>The Treasury Department and the IRS also received several comments regarding the possible reevaluation of a material's categorization as a waste. A few commenters were opposed to recategorizing a material from a waste to another designation, arguing that such actions could be damaging to emissions mitigation efforts or to efforts to find productive uses for materials previously disposed of. Another commenter recommended that any reevaluation of the classification of waste be conducted predictably and only to prospective qualified facilities. The commenter further recommended that such reevaluations focus on only major changes external to the section 45Y and 48E credits or other Federal incentives.</P>
                    <P>
                        The Treasury Department and the IRS have determined that reevaluation of material categorization should occur at least every ten years, but not more often than every five years, consistent with the reevaluation period outlined for baselines, because policy interventions and other developments in the market can alter the availability and demand for marketed goods and services, and can sometimes turn waste products into byproducts, co-products, or even primary products. This reevaluation is therefore necessary to ensure robust estimation of the net GHG emissions rates for C&amp;G Facilities in a manner consistent with section 45Y(b)(2)(B). Regardless of the results of any such reevaluation, taxpayers may rely on the Annual Table in effect as of the date a 
                        <PRTPAGE P="4064"/>
                        facility began construction or the provisional emissions rate determined by the Secretary for the taxpayer's facility to determine the facility's greenhouse gas emissions rate for any taxable year that is within the 10-year period described in section 45Y(b)(1)(B), provided that the facility continues to operate as a type or category of facility that is described in the Annual Table or the facility's emissions value request, as applicable, for the entire taxable year. If the facility changes the type or method of production of their fuel or feedstock, this constitutes a potential change in their provisional emissions rate determined by the Secretary.
                    </P>
                    <P>To limit the additional production of waste, in the preamble to the proposed regulations, the Treasury Department and the IRS requested comment regarding whether the final regulations should limit eligible waste sources that existed as of a certain date, or waste or waste streams that were produced before a certain date, such as the date that the IRA was enacted. The Treasury Department and the IRS also requested comment regarding how these factual scenarios could be documented or verified, including any changes in volumes of waste and waste capacity at existing sources, and additional capture of existing waste or waste streams.</P>
                    <P>The Treasury Department and the IRS received several comments in response to these questions. One commenter recommended that, to limit the additional production of waste, materials be classified as waste only if the material was created before a qualified facility begins claiming the section 45Y and 48E credits. The Treasury Department and the IRS have determined that prohibiting classification of a material used by a qualified facility as waste after the qualified facility begins claiming the section 45Y and 48E credits is unnecessary in light of the requirements that the LCA take into account the emissions impact of any additional production or use of such material and the requirements that the LCA be conducted at the market level. In some cases, this may result in different emissions determinations for materials that make up waste streams that existed prior to the credits versus for those same materials produced after and potentially in response to the credits.</P>
                    <P>Another commenter responded to this question with a recommendation that materials not be classified as wastes unless disposal or incineration, as opposed to repurposing, is the only option for such material. The commenter offered the “cascading” principle in the European Union's revised RED that prioritize material use, reuse, and recycling of wood over burning for energy as a model for how incentives to burn materials should be treated under the section 45Y and 48E credits. The Treasury Department and the IRS have determined that, for the purposes of the final regulations, a waste product is defined as noted earlier. The requirement that a waste material lacks marketability for sale but has a market for disposal is consistent with this commenter's recommendation that materials be classified as waste only if such material lacks a productive use beyond such disposal.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS also requested comment regarding the potential for and approaches to prevent the intentional generation of waste or co-products for the purposes of lowering the allocated process emissions to electricity. The Treasury Department and the IRS received several comments in response to this question. A few commenters, as discussed earlier, recommended against designating materials as wastes, co-products, or byproducts to avoid intentional generation of waste. Another commenter recommended use of a dynamic LCA that incorporates every product, flow, and material use when accounting for emissions, including assessing the environmental impact of production processes such as generation of waste or co-products. This commenter stated that this practice would prevent intentional generation of waste because the dynamic LCA would accurately reflect the potential benefit of not intentionally generating the waste. As discussed earlier, the Treasury Department and the IRS have determined that distinguishing between these products will facilitate efficient and consistent evaluation of GHG emissions rates taking into account lifecycle GHG emissions as described in 42 U.S.C. 7545(o)(1)(H). However, regardless of how a material is categorized, the LCA must consider whether the availability of the section 45Y and 48E credits will result in additional production or use of that material or changes in the supply chain of that material resulting in GHG emissions effects and take into account any direct and indirect emissions impact of the additional production or use and such changes.</P>
                    <P>Another commenter stated that, in the case of municipal solid waste facilities, intentional generation of waste is unlikely because the cost of waste disposal will be greater than the value of the credit. The Treasury Department and the IRS appreciate this commenter feedback and have taken it into consideration. Because this is a technical claim that must be evaluated in the context of an LCA and is applicable to only certain categories of feedstock, it would not be appropriate to incorporate these recommendations in the text of the final regulations as a generally applicable rule.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS also requested comment on whether the classification of feedstocks as products, co-products, byproducts, or waste change depending on the technology. Specifically, the Treasury Department and the IRS asked whether products, co-products, byproducts, and waste should be described and accounted for differently if derived from biogenic sources.</P>
                    <P>The Treasury Department and the IRS received a wide range of comments in response to this question. A number of commenters requested that either all or a subset of woody biomass feedstocks be designated as waste or residue, with many pointing to woody biomass-specific industry definitions of terms like waste, residue, co-product, and byproduct. Some commenters requested that woody biomass feedstocks be designated as waste or residue if the feedstock is not intentionally grown and harvested for wood energy applications or if the feedstock is grown in a particular region where woody biomass has an alternative fate that is typically high in GHG emissions. One commenter requested that woody biomass feedstock that is left over from the manufacturing and repair of wood pallets be classified as a residue.</P>
                    <P>One commenter suggested that products, co-products, byproducts, and waste be accounted for differently if derived from biogenic sources by using ASTM D6866 Method B to determine and report their biogenic content. This commenter noted this standard's use in Canada's Clean Fuels Regulation.</P>
                    <P>Other commenters recommended against classifying woody biomass feedstocks as waste or residue. Some stated that the definition of these terms as used in the forest industry is broadly defined and does not sufficiently consider alternative uses of the feedstock. Some further expressed concern that the appropriate designation of woody biomass as a residue or a waste is not verifiable after its initial processing by foresters.</P>
                    <P>
                        One commenter asked that the final regulations clarify whether the LCA will recognize treatment of residue materials as distinct from waste. The commenter further recommended that forestry and logging residues should be defined as 
                        <PRTPAGE P="4065"/>
                        “materials generated by some other process, where the alternative fate is decomposition or burning without energy recovery.” The commenter suggested that such materials should not be designated as residues if their most likely alternative fate is decay because it is less carbon intensive than burning the materials for electricity.
                    </P>
                    <P>One commenter recommended that trees harvested for the forest biomass industry that come from land harvested entirely (or almost entirely) to satisfy wood pellet or bioenergy demand not be designated as byproducts. The commenter stated that because the trees would not have been harvested but for demand from the forest biomass industry, they are therefore the primary economic driver of the harvest and thus not a byproduct. The commenter further recommended that the final regulations clarify what it means for a material to be the primary economic driver of a process.</P>
                    <P>The Treasury Department and the IRS also received a comment about the designation of materials used by a WERP facility. A commenter recommended that the final regulations treat such waste heat as a waste product.</P>
                    <P>The Treasury Department and the IRS appreciate these commenters' feedback and have taken it into consideration. Because technical and fact-specific suggestions regarding designation or emissions accounting for a particular feedstock must be evaluated in the context of an LCA, the suitability of these recommendations requires further consideration of their application to specific cases and these recommendations are not included in these final regulations at this time.</P>
                    <P>The Treasury Department and the IRS have also determined that distinguishing between residues and wastes in the final regulations is unnecessary. The principles for categorizing and evaluating the GHG emissions of materials that are provided in these final regulations require an assessment of their associated uses or removal or disposal processes, as applicable, and associated GHG emissions. This requirement mitigates the need to address a distinction between residues and wastes as a residue may be categorized within one of the categories defined earlier.</P>
                    <P>The Treasury Department and the IRS have further determined that further clarification of the term “the primary economic driver of the process” within the previously described definitions is not necessary in the final regulations because this concept provides sufficient clarity in conducting an LCA.</P>
                    <HD SOURCE="HD3">3. LCA Modeling Topics</HD>
                    <HD SOURCE="HD3">a. Certain Issues Related to LCA Baselines and Modeling</HD>
                    <P>The preamble to the proposed regulations posed twelve questions related to factors that must be considered to assess the net GHG emissions associated with the production of electricity by a C&amp;G Facility in the context of the section 45Y and 48E credits. This list included questions on six subtopics, including about: (1) the creation and maintenance of LCA baselines; (2) existing models and data sources that could be used for modeling; (3) how to account for incentives created by the section 45Y and 48E credits; (4) how to establish feedstock categories; (5) how to assess shocks; and (6) how to account for variation and uncertainty in models. Responses to comments received about the creation and maintenance of LCA baselines can be found in section VIII.C.2.c. of this Summary of Comments and Explanation of Revisions. Responses to comments received about how to account for incentives created by the section 45Y and 48E credits can be found in section VIII.D.2. of this Summary of Comments and Explanation of Revisions. This section contains responses to the comments received on the other four sub-topics listed earlier.</P>
                    <HD SOURCE="HD3">i. Feedstock Categorization</HD>
                    <P>The preamble to the proposed regulations requested comment on feedstock classification and posed a series of questions. The Treasury Department and the IRS received a number of comments in response to these questions. One comment expressed support generally for the idea of differentiating between subcategories of feedstock in the LCA, and another comment recommended subcategorizing feedstocks to the greatest extent possible.</P>
                    <P>
                        The Treasury Department received a number of comments on the topic of whether to subcategorize biomass feedstocks to differentiate between feedstock that is waste and feedstock that is not. Several commenters expressed support for this idea, while several others expressed opposition to it. 
                        <E T="03">See</E>
                         section VIII.D.2. of this Summary of Comments and Explanation of Revisions for further discussion of categorizing some feedstock as waste.
                    </P>
                    <P>The Treasury Department and the IRS received comments that provided a range of suggestions regarding how best to categorize woody biomass feedstocks. A few opposed subcategorization of woody biomass feedstocks. One commenter recommended that forest biomass feedstocks be considered one type or category of facility to avoid unduly burdensome complex analysis. Another who opposed subcategorizing feedstock altogether urged that, in the event that forest biomass feedstocks are subcategorized, the Treasury Department require reliable, verifiable bases for each sub-categorization as a means of reducing uncertainty. Several commenters endorsed the idea of creating subcategories of woody biomass feedstock and provided various recommendations about how to do so. One commenter recommended that trees be categorized based upon species and upon management practices such as clear cutting or thinning to most accurately capture “carbon debt payback times.” Another recommended that woody biomass forest feedstock be categorized based on use, with at least five categories, including saw timber, low-grade roundwood or pulpwood, forestry or harvesting residues, sawmill and other woody industry residues, and post-consumer waste wood. A different commenter suggested creating feedstock categories that are further divided by the feedstock's potential alternative fates.</P>
                    <P>Several commenters provided information or recommendations on how blends of fuels or feedstocks should be treated in the LCA or the annual publication of emissions rates. One commenter suggested that precaution is warranted to ensure that facilities using a blend of fuels are not deemed to have a net GHG emissions rate of not greater than zero if they do in fact have a positive net GHG emissions rate. Another commenter recommended that the LCA accommodate site specific feedstock use, which may include mixed feedstocks or blending with RNG. Finally, one commenter stated that there are several options for providing an emissions rate to facilities that use a mix of feedstocks. This commenter further stated that the Secretary could provide a formula by which taxpayers can use the published emissions rates in the Annual Table to calculate their facility's rate; that all facilities using a blend of fuels could be required to obtain an emissions rate via the provisional emissions rate (PER) process; or that facilities using multiple fuels could be deemed to be multiple separate facilities for the purposes of the credit and a rate calculated for each facility.</P>
                    <P>
                        The Treasury Department and the IRS, appreciate these recommendations and have taken them into consideration. However, given the diversity of fuel and feedstock blends that may be evaluated for the purposes of the section 45Y and 
                        <PRTPAGE P="4066"/>
                        48E credits, incorporating specific requirements suggested by these commenters in the text of the final regulations would be inappropriate as a generally applicable rule. Therefore, the commenters' recommendations will not be included in the text of the final regulations.
                    </P>
                    <HD SOURCE="HD3">ii. Shocks</HD>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS posed several questions about the treatment of shocks in modeling. One such question solicited comment regarding what factors should be considered to determine the appropriate scale(s) of feedstock demand changes or other shocks to evaluate the extent to which the production, processing, and use of the feedstocks used for electricity production results in net greenhouse gas emissions. One commenter recommended that the scale of demand be assessed in the context of what types of feedstocks are most likely to be used, which the commenter recommends projecting based on current practice.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS further requested comment on whether shocks should reflect a small incremental increase in the use of the feedstock to reflect the marginal impact or a large increase to reflect the average effect of all potential users. One commenter recommended that both approaches be used to provide a comprehensive understanding of the potential impacts of the change.</P>
                    <P>Another commenter suggested that incremental increases may not accurately reflect the consequences of a policy because large demand shocks can have qualitatively different effects than incremental shocks. This commenter further stated that a shock that reflects all users can be a poor tool in cases in which local markets are important. This commenter recommended estimating regional factors before averaging to find the effect on all users and suggested that model testing be similarly applied to evaluate differences between marginal increases in feedstock demand and absolute demand provided in the region.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS also requested comment on what the general increment of the shock could be and whether it should be specified as an absolute or relative increase. One commenter suggested that when demand is not pre-determined, scenario modeling could be used to evaluate potential effects. The commenter recommended complementing this analysis with a series of marginal model runs to evaluate how an increase in demand impacts model results.</P>
                    <P>Finally, in the preamble to the proposed regulations, the Treasury Department and the IRS requested comment on what factors should be considered to determine whether shocks for different feedstocks should be implemented in isolation (separate model runs), in aggregate (for example, as an across-the-board increase in biomass usage endogenously allocated by the model across feedstocks), or something in between (for example, separately model agriculture-derived and forest-derived feedstocks, but endogenously allocate within each category). A commenter recommended that similar feedstocks that offer comparable results in model testing be implemented in aggregate. Another commenter suggested that in a regulatory framework, it is likely most appropriate to model at the asset level, such as by modeling a shock applied to the surrounding landscape based on anticipated demand for feedstock of a new bioenergy investment.</P>
                    <P>The Treasury Department and the IRS appreciate these recommendations and have taken them into consideration. However, given the complexity of modeling shocks in the LCA and the diversity of fuels and feedstocks that may be evaluated for the purposes of the section 45Y and 48E credits, incorporating the specific requirements suggested by these commenters in the final regulations would be inappropriate as a generally applicable rule. Therefore, the commenters' recommendations will not be included in the final regulations.</P>
                    <HD SOURCE="HD3">iii. Variation and Uncertainty in Models</HD>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS posed a number of questions about the treatment of variation and uncertainty in evaluating model estimates. Commenters provided a range of recommendations in response to these questions. Some suggested that modeling multiple outcomes is an important factor in reducing the uncertainty of modeled GHG emissions changes. One commenter further recommended that Treasury be transparent about the assumptions made when modeling, ensure that biomass feedstock utilization assumptions are backed by robust traceability and a supply chain of custody to ensure that the biomass modeled in the LCA is the biomass transported across the supply chain, and use conservative estimates. Another commenter recommended a similarly precautionary approach in situations in which a given assumption could “fully flip” an outcome from being calculated as a net climate benefit to being calculated as a net climate harm.</P>
                    <P>One commenter noted their support for the use of consequential modeling, stating that their recommendation is “in part” because land sector modeling is frequently subject to large uncertainties that are better addressed by effective policy design than by embedding quantified impacts within the regulatory framework. The commenter stated that this is especially true when applying complex econometric modeling to scenarios relying on large temporal and spatial boundaries.</P>
                    <P>Another commenter similarly noted that longer assessment horizons increase uncertainties and asserted that using an assessment horizon that constrains the compounding effects of uncertainties is an essential component to limit uncertainty. This commenter further recommended against the use of economic models, stating that they generate unacceptable levels of uncertainty.</P>
                    <P>The Treasury Department and the IRS appreciate these recommendations and have taken them into consideration. However, given the complexity of considering variation and uncertainty in evaluating model estimates and the diversity of fuels and feedstocks that may be evaluated for the purposes of the section 45Y and 48E credits, incorporating the specific requirements suggested by these commenters in these final regulations would be inappropriate as a generally applicable rule. Therefore, although the considerations that commenters raise—such as the importance of verification and the uncertainty inherent to modeling—have been incorporated in concept in other aspects of the LCA and substantiation requirements, the commenters' specific recommendations will not be included in these final regulations.</P>
                    <HD SOURCE="HD3">b. Recommended Models and Modeling Sources</HD>
                    <HD SOURCE="HD3">i. Recommended LCA Models</HD>
                    <P>
                        In the preamble to the proposed regulations, the Treasury Department and the IRS requested comment regarding what existing model or suite of models are capable of completing an LCA consistent with the section 45Y(b)(2)(B) and proposed § 1.45Y-5(d) and (e) and asked for additional information regarding suggested models. Commenters provided a wide range of views. Several commenters requested a consistent and technology-neutral approach be adopted for LCA assessment of all renewable energy 
                        <PRTPAGE P="4067"/>
                        technology and from all feedstocks. Another commenter emphasized that whatever model is employed, it is critical that it reflects current peer reviewed literature and is well supported by available data and science.
                    </P>
                    <P>Most commenters strongly advocated for the use of a version of the GREET model to complete an LCA consistent with requirements of the section 45Y and 48E credits. Several commenters noted that the GREET model is thorough, widely accepted, and the ideal model to be used for tax incentives in the IRA. These commenters further asserted that allowing the GREET model as the assessment tool for the section 45Y and 48E credits (in addition to the section 40B and 45V credits) would further bring all the emission calculations required under the IRA tax credit provisions under a single verification regime, which could be controlled by U.S. Federal agencies responsible for implementing the IRA 2022 tax incentives. A commenter emphasized that methodological consistency between IRA tax credits is important to avoid unintended market effects, particularly if credited products under sections 45Y and 48E, 40B, and 45V have overlapping accounting boundaries (for example, RNG lifecycle emissions are relevant under all four). Notably, most commenters overwhelmingly supported the use of the GREET model for the emissions assessment required by sections 45Y and 48E without specifying a specific version of the GREET model.</P>
                    <P>While supporting the use of the GREET model, a commenter noted that the GREET model is still an approximation of reality and must be regularly updated to reflect real-world trends and the latest research. Several commenters recommended that the Treasury Department and the IRS leverage both the existing GREET model and EPA modeling to inform feedstock-specific GHG emissions rates and associated avoided emissions.</P>
                    <P>Other commenters specifically requested that the former ANL-GREET model, (now referred to as the R&amp;D GREET model) be used. Specially, these commenters asserted that the Treasury Department and the IRS adopt the 2023 R&amp;D GREET model (or a successor) for emissions assessments for the section 45Y and 48E credits. These commenters note that this would assist the Treasury Department and the IRS in timely providing a model and allow for efficiencies going forward as the R&amp;D GREET model is already regularly updated. These commenters also assert that using the R&amp;D GREET model (or a successor) will make the LCA process clearer, more certain, and more effective, consistent with congressional intent to encourage the deployment of zero-emission technologies. Other commenters suggested the use of the R&amp;D GREET model because it takes methane leakage and counterfactual assumptions into account. A commenter noted that using the R&amp;D GREET model will reduce the prospect of relying on the PERs process because the R&amp;D GREET model allows for site-specific RNG carbon intensity scores. Another commenter noted that the R&amp;D GREET model is another publicly available model which has incorporated a process model for estimating emissions from landfills. However, the commenter noted that the current version of the GREET R&amp;D model needs several updates and modifications to properly reflect the latest peer-reviewed information.</P>
                    <P>Several commenters opposed the use of the GREET model. A commenter noted that the GREET model lags deployment and so favors longer established technologies like wind and solar to the detriment of technologies such as biomass gasification with CCS. This commenter noted that relying on the GREET model would certainly disadvantage and perhaps disqualify new technologies that are the most carbon-negative, while simultaneously favoring projects which would use a fuel such as municipal solid waste, which is not climate friendly, yet is considered by the model to be carbon-negative. This commenter also asserted that such a perverse incentive is not a desired outcome and yet is possible with the application of a static model to a dynamic industry deploying novel and first-of-kind technologies. Other commenters opposed the use of the GREET model by asserting that the GREET model underestimates avoided methane emissions from diverting waste from a landfill. The Treasury Department and the IRS do not believe that the R&amp;D GREET model is the appropriate model for determining GHG emissions rates for the section 45Y and 48E credits because it does not conform to the principles and requirements for LCA analysis provided in this final regulation.</P>
                    <P>Several commenters suggested the use of alternate models for a specific type of feedstock. For municipal solid waste (referred to as MSW), several commenters recommended the use of the MSW-DST and the EPA's WARM models, which are publicly available waste management-focused lifecycle models. The MSW-DST is an LCA model tailored directly for the waste sector that has been used by the DOE's National Renewable Energy Laboratory (NREL) for previous analyses. The WARM model is provided by the EPA and specifically built to allow high-level comparisons of potential greenhouse gas emissions reductions, energy savings, and economic impacts when considering different materials management practices.</P>
                    <P>A commenter expressed concern that both the MSW-DST and the WARM models require further refinements to ensure they are accurately quantifying the GHG emissions outcomes associated with diverting post-recycled waste from landfills to waste-to energy (WTE) facilities. The commenter noted that these models are not equipped to model emissions for other energy generation technologies and acknowledges that the use of these models for wastes, while potentially using the GREET model to evaluate other technologies, could pose challenges.</P>
                    <P>For biomass, several commenters recommended the use of the California Biomass Residue Emissions Characterization (C-BREC) model. These commenters note that the C-BREC model provides a robust LCA for forest residues used for electricity generation, which enables detailed and transparent accounting for GHG and air pollutant emissions and evaluates emissions across different project profiles, including the reference fate of unutilized biomass. The commenter noted that although the C-BREC model results show that the emissions associated with wildfire risk are significant for biomass residues left in the forest, the wildfire probability factors used in the model are outdated and the real risk is much higher. Therefore, the commenter asserts that C-BREC likely underestimates the actual risk of wildfires in California, leading to potential underestimation of emissions from biomass residues left in forests.</P>
                    <P>Several commenters suggested models related to forest-related feedstocks. A commenter suggested the use of the published C-ROADS and En-ROADS models to calculate forest ecosystem and harvested carbon estimates. The commenter noted that these dynamic models represent the carbon cycle, budgets and stocks of GHGs, radiative forcing, and the heat balance of the Earth. The commenter also noted that both models are freely available and fully documented.</P>
                    <P>
                        Another commenter supported the use of timber projection models like ATLAS (Aggregate Timberland Assessment System), which is managed and updated by the U.S. Forest Service, providing projections at regional and 
                        <PRTPAGE P="4068"/>
                        national scales. This commenter noted that ATLAS models different timber yield scenarios, and their respective implications for carbon stocks.
                    </P>
                    <P>Additionally, a commenter supported the use of the Landscape Carbon Factor Tool, developed by the American Forest Foundation, to calculate net carbon stock changes in forest regions of variable sizes using the USFS Forest Inventory Assessment (FIA) data. The commenter noted that this tool can provide important data on the current state of carbon stocks in a sourcing area that can be used to inform a full consequential LCA, which will also predict future changes in carbon stocks. The commenter pointed out that this tool could be used as an initial screen to determine whether biomass will meet the “not greater than zero” emissions rate criterion provided that net forest stocks in the region of consideration are maintained or increased.</P>
                    <P>While no commenters suggested using the Forestry and Agricultural Sector Optimization Model with Greenhouse Gases (FASOM-GHG) Model to assess GHG emissions for purposes of the section 45Y and 48E credits, several commenters specifically asserted that the Treasury Department and the IRS should not adopt it for this purpose. These commenters noted that the FASOM-GHG model is not a credible source of estimates of wood harvest emissions due to a lack of global analysis, poor performance for this purpose, lack of reasonable cost data and contradiction with known estimates, and structural bias.</P>
                    <P>The Treasury Department and the IRS appreciate the thoughtful responses provided by commenters. After taking into account the wide variety of different mechanisms for generating electricity through combustion or gasification that would require an LCA, the Treasury Department and the IRS have determined that there is not a clear or obvious single model or models that would be appropriate for all situations. After consideration of these comments, the Treasury Department and the IRS will coordinate with Federal agency scientific and technical experts on the selection and development of a model or models to assess net GHG emissions for purposes of the section 45Y and 48E credits.</P>
                    <HD SOURCE="HD3">ii. Recommended Data Sources and Peer-Reviewed Studies</HD>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS requested comments regarding what data sources and peer-reviewed studies provide information on different feedstock production systems that would be most important to consider for gathering data for LCA modeling. The Treasury Department and the IRS also noted that these sources and studies should provide information on the feedstock production process (ideally, beginning with the extraction or generation of the feedstock and ending at the electrical meter) and on markets related to the feedstock production process.</P>
                    <P>The commenters recommended a wide range of data sets to provide information on different feedstock production systems. A commenter noted that feedstock production systems vary by industry and should be assessed on an industry-by-industry basis. However, the same commenter also noted that the same principles can be used to make decisions on feedstock production system irrespective of the industry.</P>
                    <P>For biomass, a commenter recommended the use of forest inventories that characterize the stocks of carbon in different forests. This commenter noted the USDA Forest Service's Forest Inventory and Analysis (FIA) Program as an open-source, nationally consistent inventory of forest resources that is regularly updated. Further, the commenter noted that the FIA database provides comprehensive information on forest stand characteristics, growth rates, and carbon stocks across different regions of the United States. It employs direct measurements from a network of permanent sample plots, offering high-quality, empirical data at both regional and national scales.</P>
                    <P>For MSW, several commenters noted that the EPA should be referenced as a primary source of information on the physical properties of MSW and specifically pointed to the EPA's emission factor database, AP-42: A Compilation of Emissions Factors from Stationary Sources (AP-42), based on data from 40 landfills, U.S. EPA Landfill Gas Emission Model (LandGEM) default L0 for inventory purposes. Additionally, a commenter noted that the importance of data reported from the combustion of MSW at existing WTE facilities to the EPA's GHGRP. These commenters asserted that given the extensive monitoring employed at WTE facilities, they can serve as a critical source of lifecycle data, including for biogenic carbon fraction and total carbon content both for WTE emissions and to serve as a possible resource for data on process inputs used for the baseline scenario of landfilling.</P>
                    <P>The Treasury Department and the IRS appreciate the data sources provided by commenters. Given the extensive range of feedstocks and types of facilities, and the fact that no data source seems to address all use cases, the Treasury Department and the IRS are continuing to evaluate and consider the utility of the data sources identified by commenters. The Treasury Department and the IRS will coordinate with Federal agency scientific and technical experts on the use of data sets in the development of a model or models to assess GHG emissions for purposes of the section 45Y and 48E credits.</P>
                    <HD SOURCE="HD3">E. Treatment of Specific Types of Facilities and Feedstocks</HD>
                    <HD SOURCE="HD3">1. Combined Heat and Power (CHP) Property</HD>
                    <P>Section 45Y(g)(2)(A) provides that the kWh of electricity produced by a taxpayer at a qualified facility includes any production in the form of useful thermal energy by any CHP property within such facility, and the amount of GHGs emitted into the atmosphere by such facility in the production of such useful thermal energy will be included for purposes of determining the GHG emissions rate for such facility. The inclusion of thermal energy production-related emissions in an LCA for a CHP property introduces additional considerations, such as how to set an appropriate baseline for useful energy production-related emissions and what rules should govern the attribution of emissions for thermal energy production. In the preamble to the proposed regulations, the Treasury Department and the IRS indicated an intention to clarify the principles for assessing the emissions related to the generation of useful thermal energy by a CHP property in an LCA in the final regulations for the section 45Y and 48E credits and posed a number of questions.</P>
                    <P>
                        Several commenters requested that CHP property be categorized as non-C&amp;G Facilities. A commenter requested that CHP property that derives its energy from facilities on the “categorically non-C&amp;G” list should also be included on that list. However, the statute does not alter the definition of a “qualified facility” for CHP property, and the Treasury Department and the IRS therefore do not have the authority to treat CHP property that produce electricity through combustion or gasification any differently from other facilities (that is, the same rules for classifying facilities and determining emissions rates apply). However, the Treasury Department and the IRS note that certain types of CHP facilities may meet the definition of a Non-C&amp;G Facility if they do not produce electricity and heat through combustion.
                        <PRTPAGE P="4069"/>
                    </P>
                    <P>Under the statute, to determine the amount of GHGs emitted by a C&amp;G CHP property, the LCA must include the net GHG emissions emitted by that facility in the production of useful thermal energy. For purposes of an LCA for a CHP property, the Treasury Department and the IRS asked what principles should govern how GHG emissions from the production of useful thermal energy are calculated. In response, several commenters advocated for the use of an output-based standard for emissions calculation for a CHP property. An output-based standard is based on emissions per unit of energy generated rather than amount of fuel used, which is addressed in an input-based standard. Commenters asserted that an output-based standard is appropriate to govern an LCA for a CHP property because it produces two useful outputs (electrical and thermal energy) that are each fully credited under this analysis.</P>
                    <P>Additionally, several commenters recommended that the final regulations adopt LCA principles similar to those incorporated by the 2023 R&amp;D GREET model (or a successor), which includes inputs for “equivalent electric efficiency using fuel allocated to power generation” and “overall plant conversion efficiency.” These commenters supported this recommendation by noting that this LCA approach would incorporate principles similar to the LCA principles used for the section 40B and 45V credits. A commenter noted that an LCA for natural gas-fired CHP property should account for lower emission gas supplies, or use assumptions for project-specific leakage rates, to encourage suppliers to reduce methane leakages. The Treasury Department and the IRS appreciate this feedback and will consider these recommendations as LCA development for CHP property continues.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS requested comment regarding what principles should be used to determine the baseline for useful thermal energy production by a CHP property. In response, several commenters noted that fossil fuel displacement should be the baseline for an LCA for a CHP property. The commenters asserted that to quantify the GHG emissions savings of a CHP property, the emissions from the CHP property should be subtracted from the fuel use that would normally occur without the CHP property in place—normally generating heat from an onsite natural gas boiler and using power from offsite generation powering the grid. The commenters suggested establishing a baseline emissions profile and then quantifying expected GHG emission reductions and providing methods for accounting for the displacement of marginal grid resources to account for energy efficiency improvements. To support this recommendation, the commenters generally cited common LCA practice, ISO guidance, and the plain language of the CAA for calculating GHG emissions.</P>
                    <P>A commenter recommended that an LCA assess GHG emissions from the production of useful thermal energy in a CHP property by using a baseline emissions rate composed of (i) an electric-only plant using the same prime mover design (make/model of the steam turbine, combustion turbine or reciprocating engine plant) producing the same net quantity of electricity generation as produced in the CHP property; and (ii) a natural gas boiler producing the same net quantity of useful thermal energy produced in the CHP property. The GHG emissions from the production of useful thermal energy in the CHP property would then be calculated by subtracting the emissions of the CHP property (based on LCA emissions per unit of fuel consumed) and the net generation of electrical and thermal energy (net of energy produced and used within the facility before energy is exported from the facility) from the baseline emissions.</P>
                    <P>Similarly, a commenter noted that following the GHG Protocol for Project Accounting, the typical baseline for C&amp;G projects would include the current fate of the residue, the current emissions associated with the grid where the project would be located, and the current energy source for thermal energy when looking at a CHP property. The commenter recommended that an LCA is conducted for the baseline, and an LCA is conducted for the proposed project. The difference between these two is the “net” GHG emissions rate for the project.</P>
                    <P>Additionally, several commenters supported the adoption of displacement principles by noting that biologic carbon (such as wood) would enter the atmosphere regardless of whether it is combusted or through the ecological process of decomposition once a tree dies. Conversely, these commenters noted that fossil fuels are sources of geologic carbon that would otherwise not enter the atmosphere if not for their combustion. Therefore, the commenters asserted that wood utilized for cogeneration releases no additional net carbon to this cycle and can even reduce emissions when used as a substitute for fossil fuels.</P>
                    <P>While supporting the adoption of displacement principles in an LCA, several commenters also advocated for the final regulations to give credit for avoided GHG emissions from the alternative fate of the biomass which include being piled and burned with uncontrolled criteria pollutants and GHG emissions; masticated and left on-site, increasing fuels for future fires; or transported long distances to available disposal sites, incurring high costs and associated emissions. These commenters also noted that an LCA must credit emissions offsets by biomass generated energy when compared to the emissions from alternative replacement power. These commenters noted that if these two considerations are allowed, utilization of woody biomass will easily be shown to be carbon neutral or likely negative, with net GHG emissions at an acceptable level. The issues raised by these comments are addressed in section VIII.C. of this Summary of Comments and Explanation of Revisions.</P>
                    <P>Section 45Y(g)(2)(A) provides a special rule for CHP property, which explicitly includes any production in the form of useful thermal energy in the calculation of the credit as well as the amount of GHG emissions from the facility in the production of such useful thermal energy. After consideration of the comments, the Treasury Department and the IRS have determined that the best reading of section 45Y(g)(2)(A) is that thermal energy produced by a CHP property is accounted for with the electricity produced by the facility in assessing the GHG emissions from the facility. As a result, the baseline for GHG emissions from thermal energy produced by a CHP property are zero, which is consistent with LCA accounting for electricity and provides a consistent baseline between electrical and thermal energy. Even though it is a departure from some of the LCA methods typically used within the CHP industry, this treatment is an option within LCA accounting methodology that is consistent with the principles and requirements for an LCA used to determine a GHG emissions rate for purposes of sections 45Y and 48E.</P>
                    <P>
                        Additionally, the preamble to the proposed regulations noted that there may be scenarios in which a facility generates electricity that is used (i) by the electricity generation facility in the production of electricity; or (ii) in the production of fuel ultimately consumed by that facility to generate electricity. For example, a wastewater treatment plant's post-processing materials are digested to produce biogas; this biogas is then used in a CHP property that 
                        <PRTPAGE P="4070"/>
                        produces electricity; and this electricity is consumed by the wastewater treatment facility. The Treasury Department and the IRS requested comment on what principles should be used to determine how GHG emissions from the consumption of electricity in the production of electricity or in the production of the fuel consumed by the facility are calculated. In response, a commenter noted they were not aware of any circumstances in which any CHP property host would consume electricity from the CHP property for the sole or primary purpose of generating electricity. The commenter also noted that generally facilities hosting CHP property use the electricity and thermal energy onsite to meet the needs of host facility or export that energy via the grid or district energy system respectively. The commenter asserted that to the extent such facilities support the production of useful biogas from the wastewater stream that can be used for future fuel for the CHP property, the Treasury Department and the IRS should not craft rules that would discourage productive use of byproducts as fuel.
                    </P>
                    <P>The Treasury Department and the IRS confirm that the rules provided in these final regulations are not intended to encourage or discourage certain fuels or feedstocks for electricity production but to outline LCA principles such that LCAs of C&amp;G Facilities, including CHP property, result in impartial and robust assessments of net GHG emissions across feedstocks, fuels, and facility types to determine eligibility.</P>
                    <P>
                        The preamble to the proposed regulations similarly noted that there may be scenarios in which a facility self-consumes thermal energy that it produces, for example, if a facility generates steam as a byproduct that is used (a) by the facility to turn a turbine that generates electricity or (b) to clean or compress fuel ultimately consumed by that facility to generate electricity. The Treasury Department and the IRS requested comment regarding what principles should be used be used to determine GHG emissions from the self-consumption of thermal energy by the CHP property. In response, a commenter proposed that facilities should not be assessed based on the purposes for which the useful energy is used, including both electricity and the heat in the case of a CHP property. Proposed § 1.45Y-5(d)(2)(ii) provided that the ending boundary “for electricity that is transmitted to the grid or electricity that is used on-site is the meter at the point of production of the C&amp;G Facility” therefore the use of the electricity does not impact the LCA assessment as it is outside of the LCA system boundary. 
                        <E T="03">See</E>
                         section VIII.C. of this Summary of Comments and Explanation of Revisions for additional discussion of comments pertaining to the LCA ending boundary.
                    </P>
                    <P>The anticipated future baseline scenario as described in § 1.45Y-5(d)(2)(iii) will not be impacted by whether the electricity is sold to the grid or used onsite. Therefore, whether the electricity generated from any type of facility, including a CHP property, is supplementing or replacing an existing power source onsite or grid electricity for the host facility (for example, a wastewater treatment plant) will not impact the LCA of the generating facility.</P>
                    <HD SOURCE="HD3">2. Biomass</HD>
                    <P>The Treasury Department and the IRS received a number of comments pertaining to the use of biomass as a feedstock in the production of electricity. While these comments and their responses are addressed throughout this Summary of Comments and Explanation of Revisions, the following paragraphs address comments regarding the substantiation of eligibility for the section 45Y and 48E credits for taxpayers whose C&amp;G Facility uses biomass as a feedstock.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS requested comment on the types of documentation that taxpayers should be required to maintain to substantiate eligibility for the section 45Y and 48E credits. Specifically, comment was requested on the types of documentation or substantiation a taxpayer should maintain to establish that an input in the supply chain of a fuel or feedstock used for electricity production has the energy attributes or other relevant characteristics that were taken into account in determining a GHG emissions rate; what existing systems, industry standards, or practices may be used to substantiate that a facility's operations and supply chain for such inputs resulted in a GHG emissions rate that is not greater than zero; how to develop such tracking and verification systems if they do not currently exist and how long development of such systems may take; and what supply chain tracing systems or verification bodies address fuels or feedstocks that may be commonly used by facilities that may be eligible for the section 45Y and 48E credits.</P>
                    <P>The Treasury Department and the IRS received a number of comments about whether taxpayers should be required to maintain documentation or provide third-party verification of fuels or feedstocks in order for their qualified biomass facility to be eligible for the section 45Y and 48E credits. While some noted the importance of oversight and independent means of verification to properly substantiate that inputs to fuel or feedstock have the energy attributes or other relevant characteristics that were taken into account in determining a GHG rate, others disagreed. Some commenters requested that taxpayers whose qualified facilities have less than one megawatt of capacity not be required to maintain or provide any documentation to be eligible for the section 45Y and 48E credits. These commenters further recommended that taxpayers be required only to self-attest to the volume of biogenic feedstock received under a given category for that year, total generation, and percentage of fuel usage, similar to the procedure that currently exists for biomass facilities participating in the California Bioenergy Market Adjusting Tariff (BioMAT).</P>
                    <P>Other commenters suggested verification bodies or tools for use in confirming the GHG emissions rate of qualified biomass facilities. One commenter suggested a tool in development that they have commissioned to calculate net carbon stock changes in forest regions. Other commenters suggested existing third-party certifications, such as those provided by the Sustainable Forestry Initiative (SFI), the Forest Stewardship Council (FSC), the Sustainable Biomass Program (SBP), and the International Sustainability and Carbon Certification System (ISCC). However, some commenters critiqued the design of these certifications, asserting that they provide inadequate monitoring and enforcement.</P>
                    <P>
                        The Treasury Department and the IRS appreciate the information shared by commenters on these matters and have taken it into consideration. Woody biomass can pose unique issues warranting verification because wood sourced from different types and parts of trees may have very different LCA profiles but appear uniform after processing and upon delivery to an electricity production facility. The Treasury Department and the IRS intend to provide additional information in future guidance about how taxpayers should substantiate compliance with the statute's requirements. 
                        <E T="03">See</E>
                         section VIII.J. of this Summary of Comments and Explanation of Revisions for more information about substantiation. To ensure that C&amp;G Facilities that utilize biomass feedstocks meet the statutory requirement of a net GHG emissions rate not greater than zero, the Treasury Department and the IRS anticipate that 
                        <PRTPAGE P="4071"/>
                        it may be appropriate to require or encourage taxpayers to maintain third-party certification that verifies that these facilities meet the criteria that the LCA has found are necessary for a facility to meet this statutory requirement.
                    </P>
                    <HD SOURCE="HD3">3. Waste-to-Energy (WTE) Facilities</HD>
                    <P>The Treasury Department and the IRS received many comments pertaining to the use of WTE facilities in the production of electricity. While these comments and their responses are addressed throughout this preamble, including in section VIII.C. (LCA Requirements), the following paragraphs address comments regarding the eligibility for the section 45Y and 48E credits for taxpayers that use WTE facilities (such as landfills and waste incinerators) in the production of electricity.</P>
                    <P>Commenters have sharply divergent views regarding the eligibility of WTE facilities for the section 45Y and 48E credits. Many commenters requested that the production of electricity from WTE facilities be specifically excluded from qualifying for the credits. To support this view, several commenters noted that WTE facilities are significant emitters of GHG emissions, and as it was clearly not the intent of Congress to allow GHG producing industries to be eligible for the credits, WTE facilities should not be eligible. These commenters also asserted that WTE facilities should not be eligible for the credits because WTE facilities are disproportionately located in low-income and marginalized communities and can endanger a community's health.</P>
                    <P>Conversely, several commenters strongly advocated for the eligibility of WTE facilities for the section 45Y and 48E credits. These commenters noted that WTE facilities would have traditionally fit into the category of landfill or trash facilities once eligible for the section 45 credit and therefore, should be eligible for the section 45Y and 48E credits. Several commenters requested that WTE facilities be included as Non-C&amp;G Facilities on the Annual Table that will be published by the Treasury Department and the IRS.</P>
                    <P>The Treasury Department and the IRS appreciate the input shared by commenters and have taken it into consideration. Because WTE facilities produce electricity through combustion, they are C&amp;G Facilities, and whether a WTE facility is eligible for the section 45Y or 48E credits must be assessed through an LCA. Accordingly, categorically excluding or including WTE facilities as eligible for the section 45Y and 48E credits is not appropriate unless and until their eligibility has been assessed and confirmed through an LCA that satisfies all the requirements of section 45Y(b)(2)(B) and these final regulations. The final regulations will therefore not reflect these commenters' suggestions.</P>
                    <HD SOURCE="HD3">4. Use of Natural Gas Alternatives</HD>
                    <P>The Treasury Department and the IRS announced in the preamble to the proposed regulations an intent to provide final regulations addressing electricity production that uses biogas, RNG, and fugitive sources of methane (collectively, natural gas alternatives), for purposes of the section 45Y and 48E credits. The assessment of GHG emissions with respect to such natural gas alternatives presents a complex set of technical questions. Thus, the preamble to the proposed regulations described various rules related to the use of natural gas alternatives in the production of electricity that the Treasury Department and the IRS were considering for inclusion in these final regulations. The preamble to the proposed regulations also included detailed comment requests about various aspects of the use of natural gas alternatives to inform the development of these final rules.</P>
                    <P>The Treasury Department and the IRS received many comments regarding the treatment of natural gas alternatives. While specific recommendations are addressed later in this section, commenters broadly emphasized the importance and complexity of establishing appropriate alternative fates for these feedstocks. For example, some commenters noted that it is critical for the Treasury Department and the IRS to provide clear rules to enable RNG to be used in the production of clean electricity. Other commenters warned that failure to specify appropriate guardrails in this area could lead to incorrect emissions assessments and substantial claims under sections 45Y and 48E for C&amp;G Facilities that in fact have net rates of GHG emissions that are greater than zero, which would undermine the purpose of sections 45Y and 48E.</P>
                    <P>The Treasury Department and the IRS agree with commenters that the determination of alternative fates for natural gas alternatives is both complex and important for accurately determining eligibility under sections 45Y and 48E. GHG emissions rates for C&amp;G Facilities generally must be determined consistent with section 45Y(b)(2)(B) and the rules provided in § 1.45Y-5(d) and (f). Within this statutory and regulatory framework, the Treasury Department and the IRS have determined that specifically addressing the assessment of alternative fates for natural gas alternatives will help ensure accurate lifecycle GHG emissions determinations and prevent improper credit claims, advance sound tax administration, and increase certainty for taxpayers. Therefore, § 1.45Y-5(e)(3) applies the rules in § 1.45Y-5(d) and (f) to establish alternative fates for natural gas alternatives from certain sources that are used by a C&amp;G Facility in the production of electricity. In assessing the alternative fates for certain sources of natural gas alternatives that may be used by a C&amp;G Facility in the production of electricity, as provided in § 1.45Y-5(e)(3), the Treasury Department and the IRS consulted extensively with interagency technical experts, including technical experts from the National Laboratories, to ensure that the requirements of the section 45Y and 48E credits, as well as the rules in § 1.45Y-5(d) and (f), were applied consistent with sound scientific principles.</P>
                    <P>The use of natural gas alternatives and the assessment of lifecycle GHG emissions (as defined in section 42 U.S.C. 7545(o)(1)(H)) associated with such use is relevant beyond the section 45Y and 48E credits. For example, for purposes of the section 45V credit, § 1.45V-4(f)(3) establishes alternative fates for certain natural gas alternatives used in the production of hydrogen. The Treasury Department and the IRS have concluded that it will provide taxpayer certainty and advance sound tax administration to require that alternative fates for natural gas alternatives be addressed consistently across sections 45V, 45Y, and 48E, to the extent possible consistent with the requirements of each statute and incorporating consideration of comments.</P>
                    <P>
                        After careful consideration of the numerous comments submitted in response to the proposed regulations' specific requests for comment, the final regulations provide rules in § 1.45Y-5(e) related to the use of natural gas alternatives in the production of electricity and the assessment of GHG emissions with respect to natural gas alternatives. Rather than provide rules that would specify a single, generic alternative fate for all natural gas alternatives (for example, capture and flaring), the Treasury Department and the IRS have considered the technical characteristics of different sources of natural gas alternatives and sought to apply the approach most appropriate for each type of source to provide an administrable and robust alternative fate for each sector.
                        <PRTPAGE P="4072"/>
                    </P>
                    <HD SOURCE="HD3">a. Definitions</HD>
                    <HD SOURCE="HD3">i. Biogas</HD>
                    <P>The preamble to the proposed regulations did not define the term “biogas,” but, in the interest of completeness and clarity, § 1.45Y-5(e)(2)(i) clarifies that the term “biogas” means gas containing methane that results from the decomposition of organic matter under anaerobic conditions.</P>
                    <HD SOURCE="HD3">ii. Coal Mine Methane</HD>
                    <P>The preamble to the proposed regulations did not offer a definition of the term “coal mine methane,” but, in the interest of completeness and clarity, § 1.45Y-5(e)(2)(ii) provides that the term “coal mine methane” means methane that is stored within coal seams and is liberated as a result of current or past mining activities. “Liberated” coal mine methane (CMM) can be released intentionally by the mine for safety purposes, such as through mine degasification boreholes or underground mine ventilation systems, or it may leak out of the mine through vents, fissures, or boreholes. For the purpose of these regulations, the term “coal mine methane” does not include methane removed from virgin coal seams (for example, coal bed methane).</P>
                    <HD SOURCE="HD3">iii. Fugitive Methane</HD>
                    <P>The preamble to the proposed regulations would have defined the term “fugitive methane” to mean the release of methane through, for example, equipment leaks, or venting during the extraction, processing, transformation, and delivery of fossil fuels to the point of final use, such as CMM. Commenters noted that this definition was broad but did not recommend alternatives. The proposed definition is adopted in these final regulations without substantive change in § 1.45Y-5(e)(2)(iii). One commenter asserted that under no circumstances should methane from oil and gas operations be treated as fugitive methane because methane from oil and gas operations should be attributed the emissions profile of oil and natural gas production. The Treasury Department and IRS understand this concern and note that the baseline and alternative fates relevant to certain sources of fugitive methane are further discussed at sections VIII.E.4.c.i.C. and E. of this Summary of Comments and Explanation of Revisions.</P>
                    <HD SOURCE="HD3">iv. Renewable Natural Gas</HD>
                    <P>The preamble to the proposed regulations would have defined the term “renewable natural gas” to mean “biogas that has been upgraded to be equivalent in nature to fossil natural gas.” Some commenters suggested that the term “renewable” is misleading in this context because the production and use of such gas results in significant adverse impacts on public health and welfare. Although the Treasury Department and the IRS recognize these concerns, § 1.45Y-5(e)(2)(iv) does not adopt the suggested change in terminology because the term “renewable natural gas” is sufficiently clear, is a commonly used term in other regulatory programs and in commerce, and is unlikely to result in confusion. The term “renewable natural gas” and its proposed definition is therefore adopted without substantive change.</P>
                    <HD SOURCE="HD3">b. Considerations Regarding GHG Emissions Assessments of the Production of Electricity Using Methane From Natural Gas Alternatives</HD>
                    <P>The preamble to the proposed regulations explained that the rules provided in the final regulations regarding natural gas alternatives would apply to all natural gas alternatives used for purposes of sections 45Y and 48E. The preamble to the proposed regulations described and requested comment on several provisions the Treasury Department and the IRS were considering adopting in the final regulations to address the risk of significant indirect emissions and induced emissions from the use of natural gas alternatives in the production of electricity. This risk of significant indirect emissions and induced emissions can arise when natural gas alternatives are diverted from another productive use. In these situations, such productive uses may be backfilled with a different source that is not a natural gas alternative, such as fossil natural gas, which could result in associated emissions. For example, a facility that previously used its biogas for heat may opt to import fossil natural gas to satisfy its on-site energy needs. There is also a risk of significant indirect emissions, induced emissions, or inappropriate claims of the section 45Y and 48E credits with respect to facilities that do not meet the statutory emissions requirements, if the incentives provided by sections 45Y and 48E result in the creation of new or expanded sources of methane or other GHGs that otherwise would not have existed, or the creation of additional methane that would not have been created or would have remained sequestered. Section 1.45Y-5(e)(3)(i) implements section 45Y(b)(2)(B), which, by reference to 42 U.S.C. 7545(o)(1)(H) requires consideration of direct and significant indirect emissions in the determination of the net rate of lifecycle GHG emissions into the atmosphere by a C&amp;G Facility in the production of electricity.</P>
                    <HD SOURCE="HD3">i. GHG Emissions Associated With the Use of Natural Gas Alternatives</HD>
                    <P>The accurate assessment of GHG emissions is vital to determining eligibility under sections 45Y and 48E. GHG emissions assessments that underestimate the emissions associated with the production of electricity would mean that the section 45Y and 48E credits could be claimed for a facility even if its GHG emissions rates in fact exceed the zero-emissions eligibility threshold established by Congress. Because the Treasury Department and the IRS lack authority under sections 45Y and 48E to allow a facility that produces electricity with a GHG emissions rate (or, in the case of section 48E, an anticipated rate) that is greater than zero to be a qualified facility under section 45Y(b) and section 48E(b), guardrails are needed in the final regulations to address the risk of such credit claims.</P>
                    <P>The preamble to the proposed regulations requested comments on the LCA considerations for methane derived from natural gas alternatives. To account for direct and significant indirect emissions, these considerations include, among other things, appropriate alternative fate scenarios and the assessment of current feedstock management practices. After consideration of the comments received, the final regulations address aspects of the GHG emissions analysis for natural gas alternatives used in the production of electricity. The following sections of this Summary of Comments and Explanation of Revisions address first productive use and general alternative fate assumptions ranging from venting to responsible avoidance of methane.</P>
                    <P>
                        The Treasury Department and the IRS agree with commenters who assert that accurately measuring GHG emissions rates for facilities that rely on methane from natural gas alternatives to produce electricity requires taking into account a wide range of factors to establish the alternative fate against which the use of methane to produce electricity should be assessed. Consistent with the reference to 42 U.S.C. 7545(o)(1)(H), the Treasury Department and the IRS interpret section 45Y(b)(2)(B) as requiring any LCA of a C&amp;G Facility to address direct and significant indirect emissions. For a facility using methane as a fuel or feedstock for the production of electricity, that means accounting for direct and significant indirect emissions associated with the methane including 
                        <PRTPAGE P="4073"/>
                        emissions resulting from the diversion of methane from an alternative productive use or from the expansion of existing sources or creation of new sources of natural gas alternatives. Consideration of such emissions is required under the principles for included emissions specified in § 1.45Y-5(d)(2)(v).
                    </P>
                    <HD SOURCE="HD3">ii. First Productive Use</HD>
                    <P>The preamble to the proposed regulations provided that the Treasury Department and the IRS intended to require that in order for natural gas alternatives to receive an emissions value consistent with that gas (and not fossil natural gas), the natural gas alternative used in the production of electricity must originate from the first productive use of the relevant methane. The preamble to the proposed regulations further noted that for any specific source, productive use would generally be defined as any valuable application of the relevant methane (for example, providing heat or cooling, generating electricity, or upgrading to RNG) and productive use would specifically exclude venting to the atmosphere or capture and flaring. The preamble to the proposed regulations further proposed to define “first productive use” as the time when a producer of the relevant methane first begins using or selling it for productive use in the same taxable year as (or after) the relevant electricity-generating facility was placed in service. Under this proposal, RNG produced from any source of methane, where the methane had been productively used in a taxable year prior to the taxable year in which the relevant electricity-generating facility was placed in service, would not have received an emission value consistent with biogas-based RNG, but would instead have received a value consistent with fossil natural gas. This proposal was intended to address emissions associated with the diversion of natural gas alternatives from other productive uses and the risk of emissions associated with the creation of new or expansion of existing sources of natural gas alternatives.</P>
                    <P>The preamble to the proposed regulations noted that, for existing biogas or fugitive methane sources that typically productively use or sell a portion of the biogas and flare or vent the remainder, the flared or vented portion may be eligible for first productive use, provided the flaring or venting volume can be adequately demonstrated and verified. The Treasury Department and the IRS requested comment on these and other potential conditions on the use of natural gas alternatives in the production of electricity.</P>
                    <P>After full consideration of the comments and as further explained elsewhere in this section, these final regulations do not impose a first productive use requirement. Although a first productive use requirement could effectively address important considerations in the determination of a GHG emissions rate, the Treasury Department and the IRS acknowledge that the requirement may be difficult for taxpayers to substantiate and to independently verify. Establishing compliance with a first productive use requirement could involve taxpayers needing to obtain detailed, often unavailable, historical documentation of the operations of the methane source, including historical production levels, material changes in waste source composition and volume, use of capture equipment and capture rates, sales or uses of captured methane, and waste management practices.</P>
                    <P>Moreover, challenges in the administration of a first productive use requirement raise questions about the practical ability of a first productive use requirement to address the risk of direct or significant indirect emissions effectively. Instead of a first productive use requirement, for determining GHG emissions rates associated with the use of natural gas alternatives, the more appropriate approach is to take the likelihood of alternative productive use into account in assessing the alternative fate of such gas.</P>
                    <P>The Treasury Department and the IRS received many comments addressing the first productive use requirement. Many commenters questioned the legal and technical basis of a first productive use requirement. Several commenters asserted that a first productive use requirement is not authorized by statute, overly restricts otherwise eligible biogas and RNG feedstocks that could support clean electricity production and ignores the fact that there are numerous reasons an existing biogas facility may switch productive uses, including, but not limited to, the expiration of existing contracts, like power purchase agreements. Other commenters asserted that there is no evidence that using RNG to generate electricity will result in the induced emissions that appear to underlie the first productive use requirement.</P>
                    <P>Several commenters argued that industry data suggests that domestic production of biogas and RNG can support both new electricity production and current end uses like compressed natural gas (CNG) transportation vehicles; thus, within the timeframe within which the section 45Y and 48E credits will be available there is ample capacity to serve demand in many sectors, without causing induced emissions. Similarly, several commenters stated that much of the RNG produced in the United States is used in the transportation sector for compliance with the RFS and/or state clean fuel programs like the California Low Carbon Fuel Standard (LCFS). Further, these commenters suggested that since these programs drive deployment of a specific amount of compliant fuels, if an existing RNG supplier leaves these transportation markets to supply RNG as a feedstock to an electricity-generating facility, the prior end use of such RNG will be backfilled with other compliant fuels (for example, those that meet the RFS's GHG requirements).</P>
                    <P>In response to these comments, the Treasury Department and the IRS acknowledge that these existing transportation fuel programs, chiefly the RFS and California's LCFS, have been the primary drivers for deployment of RNG domestically. The Treasury Department and the IRS agree that the existence of these programs mitigates the risk that RNG currently produced for such programs will be redirected to electricity production. Despite this, there still remains a risk that RNG (or biogas) could be redirected to electricity production from other current uses. Additionally, because RNG currently comprises the vast majority of cellulosic biofuel credits generated under the RFS program, it is not necessarily the case that RNG previously used in this program would be backfilled with other compliant fuels should insufficient RNG be available for use as U.S. transportation fuel. As discussed previously, however, these final regulations do not impose a first productive use requirement at this time, but instead take an alternate approach to addressing these concerns.</P>
                    <P>
                        Several commenters suggested the Treasury Department adopt a mid-program 5-year “check-in” to evaluate whether electricity produced using RNG is leading to unintended increases in emissions. Facilities that have achieved commercial operation during this period could qualify as “additional” for purposes of tax credit eligibility. Several commenters suggested that a robust assessment of any induced emissions associated with redirecting RNG from its prior use would demonstrate that such consideration would not result in an increase in the emissions rate and, therefore, such emissions need not be considered due to the speculative nature of the initial premise. One commenter 
                        <PRTPAGE P="4074"/>
                        noted that a potential alternative is to add an indirect emission charge equal to the emissions associated with the extraction, processing, and delivery of fossil natural gas to backfill the prior demand for such gas.
                    </P>
                    <P>In response to these comments, the Treasury Department and the IRS acknowledge that the first productive use requirement, which is not required as part of these final regulations due to the difficulties in proving and verifying first productive use, would address two aspects of lifecycle GHG emissions assessments, both of which must be considered under section 45Y(b)(2)(B). First, a first productive use requirement would mitigate the risk of emissions associated with the diversion of natural gas alternatives from a productive use other than the production of electricity. Although methane from natural gas alternatives could be used for different productive uses, the potential emissions associated with changes in use are nonetheless relevant in the determination of a GHG emissions rate. Second, a first productive use requirement aids in the determination of the appropriate alternative fate of natural gas alternatives used in the production of electricity. Comments questioning a first productive use requirement because of a lack of evidence of induced emissions arising from shifts in behavior due to the availability of the section 45Y and 48E credits are not dispositive. Section 45Y(b)(2)(B) does not require empirical evidence of direct and significant indirect emissions associated with a newly available incentive like the section 45Y and 48E credits before the likelihood of such emissions may be considered, and such a restriction would systematically underestimate such emissions. As further explained elsewhere in this section, it is necessary for a GHG emissions assessment that is consistent with the statutory definition of lifecycle GHG emissions in 45Y(b)(2)(B) to reflect the emissions effects that can be reasonably expected to occur based on current or future market trends and drivers, inclusive of incentives and regulation.</P>
                    <P>Many commenters raised concerns about the effect a first productive use requirement would have on deployment of RNG production technologies and suggested it could also have other undesirable effects on the market for certain methane sources. Several comments suggested the first productive use rule limits RNG pathways by creating a de facto strict additionality requirement that is unnecessary. Several commenters stated that the first productive use requirement is overly burdensome and will unnecessarily curtail methane abatement at scale.</P>
                    <P>Several commenters argued that the proposed “first productive use” requirement would cause a significant value discrepancy for new projects, creating a market distortion, greater risk of stranded gas for existing projects, added complexity, and higher prices for end-consumers. Several commenters argued that adding a first productive use rule creates potential unintended consequences of RNG plants sitting idle if the deployment of a facility does not coincide with the RNG plant completion dates.</P>
                    <P>Assuming the implementation of the first productive use requirement, many comments requested modifications, changes to, or transitional relief to the first productive use requirement outlined in the preamble to the proposed regulations. One commenter recommended the first productive use requirement be satisfied by any use that is more productive than the prior use. This commenter suggested that the first productive use rule may be overly restrictive and that it could be beneficial to relax the first productive use requirement, so long as the new use of the RNG delivers overall lower net emissions than its original fate. One commenter suggested there should be no restrictions on RNG; however, if a first productive use rule is implemented, then it should apply a look-back period of 36 months. Several commenters stated the first productive use requirement should be eliminated or modified as it relates to production using CMM. Several comments recommended that each individual borehole for CMM be seen as additional and as a first productive use of supply due to each of them being a unique investment decision requiring incremental capital expenditure to mitigate leaking methane. Several commenters asserted that if the first productive use requirement is adopted, it must be applied to each methane source—that is, at the digester or lagoon-level for RNG and borehole-level for CMM so as to reflect how investment decisions are made. Several commenters noted that once a low-carbon gas source is accepted as meeting a first productive use requirement (if adopted), it should not be exclusively tied to a particular electricity-generating facility.</P>
                    <P>For the reasons previously discussed, these final regulations do not impose a first productive use requirement, and so modifications, changes, and transitional relief are not necessary. The Treasury Department and the IRS will continue to consider the recommendations raised by these comments in evaluating whether imposing a first productive use requirement, with potential modifications, may be appropriate in future guidance under sections 45Y and 48E.</P>
                    <P>
                        Many commenters supported imposing a first productive use requirement and some recommended additional guardrails. One commenter asserted that the proposed first productive use rule would help direct biomethane that is otherwise vented (or, in some cases, flared) to electricity generation, rather than creating an additional demand for methane by taking from other sources that may meet that demand through dirtier sources of energy. According to the commenter, a first productive use requirement is important to avoid significant indirect emissions associated with electricity generation from biomethane. The commenter noted that avoiding significant indirect emissions is especially important for agricultural methane emissions, which have risen over the last few decades despite overall declines in national methane emissions. Several commenters supported the proposed regulations and argued that enforcing the first productive use rule and narrowly tailoring the definition of first productive use are critical to prevent the significant amount of RNG production today shifting to electricity generation. The commenters posited that diversion of currently produced and used RNG to electricity generation would be backfilled with fossil natural gas and contended that this is especially true for existing RNG heat applications and CNG-powered vehicles. One commenter stated that the proposed rule requiring the first productive use be matched to the same taxable year as (or after) the electricity-generating facility is placed in service would help to limit any diversion of biogas or RNG from other pre-existing uses, which might otherwise increase overall emissions. Several comments supported prohibiting crediting biomethane or fugitive methane that has previously been put to productive use and stated that a first productive use requirement would ensure emissions reductions claimed under the section 45Y and 48E credits are indeed additional to the climate system overall. The Treasury Department and the IRS agree with many of the observations made in these comments. While these final regulations do not adopt a first productive use requirement for the reasons stated earlier in this Summary of Comments and Explanation of Revisions, the Treasury Department and the IRS have considered these observations regarding 
                        <PRTPAGE P="4075"/>
                        alternative productive use of natural gas alternatives when establishing the alternative fates.
                    </P>
                    <HD SOURCE="HD3">c. Alternative Fates</HD>
                    <P>Section 1.45Y-5(d)(2)(vii) clarifies that an LCA of a C&amp;G Facility may consider alternative fates and account for avoided emissions, including for the fuels and feedstocks consumed in the fuel and feedstock supply chain and at the electricity generating facility.</P>
                    <P>These final regulations establish general requirements for lifecycle GHG emissions determinations for facilities that use methane derived from natural gas alternatives to produce electricity, requiring such determinations to consider the alternative fates of that methane, including avoided emissions and alternative productive uses of that methane; the risk that the availability of tax credits creates incentives to produce additional methane or otherwise induces additional emissions; and observable trends and anticipated changes in waste management and disposal practices over time as they are applicable to methane generation and uses. The emissions risks that would have been addressed by a first productive use requirement are addressed in the development of the appropriate alternative fates for certain sources of natural gas alternatives, thereby reflecting an accurate assessment of GHG emissions pursuant to section 45Y(b)(2)(B). The factors considered in establishing the appropriate alternative fate are interrelated and must account for other aspects of these final regulations. For example, because these final regulations do not impose a first productive use requirement, there may be a greater likelihood that the appropriate alternative fate for certain sources of natural gas alternatives should be productive use.</P>
                    <P>As previously discussed, analytical decisions regarding the alternative fate of natural gas alternatives are critical in the assessment of their carbon intensity. Commenters suggested a range of broadly applicable alternative fate assumptions for methane from natural gas alternatives. Recommendations included venting, flaring, productive use, and responsible avoidance of waste-stream-generated methane. Rather than adopting a single alternative fate for all natural gas alternatives, these final regulations instead address specific considerations for each major source of natural gas alternatives. This section of this Summary of Comments and Explanation of Revisions addresses comments recommending broadly applicable alternative fates, while comments addressing alternative fates for specific sources of methane are discussed in section VIII.E.4.c.i. of this Summary of Comments and Explanation of Revisions.</P>
                    <P>Several commenters stated that it is only appropriate to compare alternative fates against a suite of alternative best practices. The commenters noted that only comparing utilization emissions against a limited scope of alternatives may exclude practices that offer the greatest potential climate and environmental justice benefits. For example, one commenter asserted that any methane that can be captured should be assigned a baseline counterfactual of capture and flare, which would acknowledge the cost of methane pollution and other economic and regulatory factors already driving abatement. Several commenters suggested that the assessment of an alternative fate should consider practices that offer the best climate and environmental justice benefits. The Treasury Department and the IRS understand these comments but emphasize that an alternative fate must reflect the appropriate assumptions that are relevant to estimating emissions impacts that would have occurred in the absence of the implementation of policy.</P>
                    <P>One commenter stated that specificity should be critical in designating alternative fates because, for example, while RNG, biogas, or fugitive methane may be chemically the same, they may have very different emissions. Several commenters stated that any alternative fate must assume that relevant laws would have been followed if the tax credits did not exist. For example, according to one commenter, emissions should not be based on a venting alternative fate, if venting would have been illegal.</P>
                    <P>Commenters supported and opposed a venting alternative fate (that is, assuming the methane in question would have been released directly to the atmosphere rather than flared or productively used) for a range of reasons that are discussed further in the discussion of specific sources of natural gas alternatives that follow. In response to these commenters, the Treasury Department and the IRS note that venting is not an appropriate alternative fate to apply across all sources of natural gas alternatives, because it does not account for the prevalence of flaring and productive use, nor does it address the risk of induced emissions due to the incentives provided by the section 45Y and 48E credits. The Treasury Department and the IRS also anticipate that a venting baseline would become increasingly inappropriate over time, due to ongoing and anticipated changes in regulations and operational practices. The section 45Y and 48E credits are available for facilities that begin construction before these credits are phased out under sections 45Y(d) and 48E(e). These final regulations also permit taxpayers to rely on the Annual Table that was in effect when a facility began construction or a PER determined with respect to a facility for the duration of the facility's 10-year credit period, provided the facility continues to operate as a type of facility that is described in the Annual Table or in the facility's emissions value request. Therefore, consistent with the requirement in § 1.45Y-5(d)(2)(iii) to apply a future anticipated baseline, § 1.45Y-5(e)(3) provides that the GHG emissions rate of a C&amp;G Facility that uses methane derived from biogas, RNG, or CMM (or any hydrogen derived from methane from these sources) as a fuel or feedstock to produce electricity must take into account anticipated changes in waste disposal practices or use of that methane over the relevant timeframe.</P>
                    <P>The Treasury Department and the IRS expect venting prohibitions to expand in future years, as local, state, and Federal policy restrictions on venting are becoming increasingly common. While the policy landscape for specific methane sources is discussed later in this section, a range of current and prospective state policies limiting venting of different RNG sources or encouraging more responsible methane management practices indicates the trajectory of state action in this area. For example, California, Colorado, Maryland, Michigan, Oregon, and Washington have all recently taken or imminently plan to take action to restrict venting and require more responsible methane management practices, in some cases beyond the Federal standards currently in place.</P>
                    <P>
                        As discussed in more detail regarding specific sources of natural gas alternatives, there are significant voluntary Federal incentives to encourage responsible methane management practices. There is also evidence of ongoing growth in methane capture through proliferation of landfill gas capture and anaerobic digesters. For example, as shown in updated project database files from EPA's Landfill Methane Outreach Program (LMOP), as of September 2024 there are 1,245 landfills with operational gas collection and control systems, as compared to 
                        <PRTPAGE P="4076"/>
                        1,187 in 2014.
                        <SU>8</SU>
                        <FTREF/>
                         Additionally, LMOP data shows growth in the number of landfill gas energy projects upgrading landfill gas to RNG. As of September 2024, there are 110 operational RNG projects (as compared to 63 projects in 2019) and 102 planned or under construction.
                        <SU>9</SU>
                        <FTREF/>
                         In addition, as subsequently discussed, there has been rapid growth in the construction of animal waste digesters, largely as a result of policy incentives, with data from AgSTAR showing an additional 172 operational anaerobic digesters accepting livestock manure in 2024 relative to 2019 (267 digesters).
                        <SU>10</SU>
                        <FTREF/>
                         AgSTAR data also demonstrates rapid growth in RNG projects (including pipeline injection and CNG for vehicle fuel or other uses), with 191 RNG projects in 2024 compared to 32 in 2019, and only 8 in 2017.
                        <SU>11</SU>
                        <FTREF/>
                         As of 2023, CNG has surpassed CHP property as the most common end use of biogas from manure-based anaerobic digestion systems in AgSTAR.
                        <SU>12</SU>
                        <FTREF/>
                         In light of all these trends, a methane venting baseline across all natural gas alternatives is inaccurate today, and, over time, the assumptions and inputs will likely become increasingly erroneous as regulations, markets, and resource management practices evolve during the period over which the section 45Y and 48E credits are available. This supports the use of reasonably conservative alternative fates in the face of uncertainty to provide greater assurance that facilities will comply with the statutory emissions requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             LMOP Landfill and Project Database, U.S. Environmental Protection Agency, available at 
                            <E T="03">https://www.epa.gov/lmop/lmop-landfill-and-project-database</E>
                             (last updated Sept. 20, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             
                            <E T="03">AgSTAR Data and Trends, Biogas Data and Trends,</E>
                             U.S. Environmental Protection Agency, available at 
                            <E T="03">https://www.epa.gov/agstar/agstar-data-and-trends#biogasfacts</E>
                             (last updated Nov. 27, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>The Treasury Department and the IRS also agree that conservative approaches to assessing alternative fates of natural gas alternatives may be an appropriate response to challenges in documenting and verifying alternative fates applicable to specific sources of natural gas alternatives in order to better ensure compliance with the statutory emissions requirements of sections 45Y and 48E. However, such conservative approaches should consider the distinct characteristics of each source or type of source, to the extent reasonably practicable. Thus, although a capturing and flaring alternative fate may be generally appropriate for some categories of sources of natural gas alternatives, it is not appropriate for all sources of natural gas alternatives.</P>
                    <P>Some commenters suggested that the alternative fate assumption for all methane derived from waste streams should be alternative productive use. As explained subsequently, the Treasury Department and the IRS have concluded that the significant and, in some cases, growing rates of productive use of methane from certain waste streams is an important consideration in establishing alternative fate assumptions for measuring GHG emissions rates. Because not all methane from waste streams is used productively, however, applying an alternative fate of productive use as a general rule for natural gas alternatives would understate the potential emissions benefits of using such gas in the production of electricity in some contexts. The final regulations, therefore do not adopt these comments.</P>
                    <P>Some commenters suggested that the alternative fate assumption for all waste stream-generated methane should be responsible avoidance of such methane production by applying practices that minimize its production. These commenters highlighted the risk that incentives created by the section 45Y and 48E credits would lead to the production of more methane than would have otherwise occurred. The Treasury Department and the IRS agree that this is an important consideration that must be addressed pursuant to § 1.45Y-5(d)(2)(v)(A) and (B).</P>
                    <P>For new methane that would not have been produced in the absence of the section 45Y and 48E credits, use of such methane for electricity production must not be reflected as avoided methane emissions in an LCA for a C&amp;G Facility. For example, for certain waste streams, the volumes of waste-stream-generated methane produced by a certain practice can be affected by operator actions, such as a change in manure management practices from land disposal to lagoon disposal, or heating an anaerobic digester to increase the amount of methane produced. Moreover, in some cases, the cost of generating additional methane may be small compared to the value of the section 45Y and 48E credits.</P>
                    <P>The availability of the section 45Y and 48E credits may lead to generation of methane in the form of natural gas alternatives for the purpose of supplying feedstocks or fuel that would be used to produce electricity by a facility seeking to claim a credit under sections 45Y and 48E. In those instances, the appropriate alternative fate is that the methane generated from waste streams, or increments of it, would not have been created in the first place or that it would have remained sequestered. In such scenarios, it would be inappropriate to credit electricity production with avoided emissions because the analysis must address methane leakage and combustion emissions that otherwise would not have occurred, and crediting these scenarios with avoided emissions would likely result in allowing a section 45Y or 48E credit with respect to a facility that is ineligible for the credit based on the statutory emissions requirements. This is a particularly important consideration for certain types of methane-producing practices and materials, and for determining the appropriateness of alternative fates that can result in highly negative GHG emissions rate estimates if emissions from additional methane generation are not accounted for, which would create potentially large incentives for additional waste production, potentially resulting in highly inaccurate lifecycle GHG emissions assessments.</P>
                    <P>In light of the substantial venting and flaring of methane that currently occurs, an alternative fate of avoidance would in many instances understate the emissions benefits of capturing such gas and using it to produce electricity. To meet statutory requirements, however, incentives for methane creation must be considered in the determination of a GHG emissions rate.</P>
                    <P>
                        It is not practicable for the Treasury Department and the IRS to ascertain which specific waste-stream-generated methane would not exist absent the incentives provided by the section 45Y and 48E credits, nor is it practicable to precisely estimate the market-mediated emissions of such an incentive effect. To ensure that these emissions are accounted for, as is required under the statute, the Treasury Department and the IRS have concluded that the most administrable and appropriate way to take into account the economic incentives for additional waste production is in the establishment of the alternative fates that generally apply to particular feedstocks. Specifically, in settings where a significant but non-identifiable share of methane from some sources could be produced in response to incentives provided by the section 45Y and 48E credits or other programs, alternative fate assumptions that result in highly negative emissions estimates are likely to be inaccurate and understate the real-world GHG emissions. The final regulations require that determinations of alternative fates for methane derived from biogas, RNG, or fugitive methane consider the risk that the availability of tax credits creates 
                        <PRTPAGE P="4077"/>
                        incentives to produce additional methane.
                    </P>
                    <HD SOURCE="HD3">i. Alternative Fate Considerations for Methane From Certain Sources</HD>
                    <P>Informed by the considerations discussed previously, § 1.45Y-5(e)(3)(ii) through (vi) specifically address the alternative fate considerations for methane from landfill gas, wastewater, CMM, animal waste sources, and fugitive methane other than CMM. The following sections of this Summary of Comments and Explanation of Revisions address these specific sources of natural gas alternatives in further detail. These final regulations have developed alternative fates on a sector-by-sector basis because determining and validating alternative fates on an entity-by-entity basis would not be practicable. As discussed previously, identifying an appropriate alternative fate for specific sources of natural gas alternatives would depend not only on the specific facts and circumstances (for example, whether methane from the source was already being productively used), but would also require an entity-by-entity assessment of the applicability of alternative fate scenarios with many complex factors potentially relevant to that assessment (for example, financial incentives absent the section 45Y and 48E credits, regulatory considerations, or trends in waste management or disposal practices). It would be highly burdensome for taxpayers to demonstrate, and impractical to confirm as a matter of tax administration, that a specific methane source had certain historic practices and whether in the future that source would have had a certain disposition other than the one that actually occurred. Quantities of methane from an individual source could even have different alternative fates. For example, assuming a situation where, absent tax incentives, a source capturing and using methane would have produced less methane and vented it, the alternative fate for that amount of methane (venting) would differ dramatically from the alternative fate of the additional methane produced due to the tax incentive (no methane produced or emitted). Given these significant administrative challenges, alternative fates are assessed and applied on a sector-by-sector basis in these final regulations.</P>
                    <HD SOURCE="HD3">A. Alternative Fate Considerations for Methane From Landfill Gas</HD>
                    <P>A number of commenters highlighted competing considerations in determining the appropriate alternative fate for methane from landfill gas. Several commenters stated that venting is the correct alternative fate for landfill gas. Several commenters stated that a venting alternative fate is not appropriate where relevant laws and regulations require a landfill to capture biogas. Several commenters stated that capture and flare is the correct alternative fate for methane and that, in the case of landfills, the uncaptured portion of methane gas should be part of the lifecycle analysis. One commenter specified the appropriate alternative fate is flaring at a 95-98 percent destruction efficiency. Another commenter noted the GREET model does not currently include fugitive methane emissions at a landfill in the LCA, even though fugitive methane emissions can negate the climate and environmental benefits of biomethane projects. One commenter stated that landfills do not deliberately generate additional biogas in order to qualify for a tax credit.</P>
                    <P>
                        The Treasury Department and the IRS note that regulations increasingly require flaring of landfill gas, and anticipated changes in regulatory requirements and operational practice are an important consideration in determining appropriate alternative fates. The EPA currently regulates emissions (in the form of landfill gas using non-methane organic compound (NMOC) emissions as a surrogate) from landfills under section 111 of the CAA; EPA regulations under the Solid Waste Disposal Act (commonly known as the Resource Conservation and Recovery Act, or RCRA) mandate certain landfill management practices that also affect methane emissions from landfills. As noted later, several states have adopted additional more stringent requirements for landfill methane emissions. Also, the EPA has announced that it intends to update and strengthen its existing landfill regulations under section 111 of the CAA in 2025 (the current rules for landfill gas emissions were finalized in 2016).
                        <SU>13</SU>
                        <FTREF/>
                         Pursuant to the EPA's regulatory plan, the EPA plans to revisit the rule to understand how new technologies and approaches could be incorporated into updated New Source Performance Standards (NSPS) and Emissions Guidelines to reduce emissions from municipal solid waste landfills and to protect the environment and the health of people that live nearby.
                        <SU>14</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             
                            <E T="03">Non-regulatory Public Docket: Municipal Solid Waste Landfills,</E>
                             U.S. Environmental Protection Agency, available at 
                            <E T="03">https://www.epa.gov/stationary-sources-air-pollution/non-regulatory-public-docket-municipal-solid-waste-landfills</E>
                             (last updated Dec. 9, 2024); Press Release, The White House, 
                            <E T="03">Fact Sheet: Biden-Harris Administration Announces New Actions to Detect and Reduce Climate Super Pollutants</E>
                             (Jul. 23, 2024), available at 
                            <E T="03">https://www.whitehouse.gov/briefing-room/statements-releases/2024/07/23/fact-sheet-biden-harris-administration-announces-new-actions-to-detect-and-reduce-climate-super-pollutants;</E>
                             Keaton Peters, 
                            <E T="03">Is the EPA About to get Serious About Methane Pollution from Landfills?,</E>
                             Canary Media (Jul. 10, 2024), available at 
                            <E T="03">https://www.canarymedia.com/articles/methane/is-the-epa-about-to-get-serious-about-methane-pollution-from-landfills.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             Reconsideration of Standards of Performance and Emissions Guidelines for Municipal Solid Waste Landfills (RIN 2060-AU24) available at 
                            <E T="03">https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&amp;RIN=2060-AU24.</E>
                        </P>
                    </FTNT>
                    <P>In particular, certain landfills are subject to NSPS (40 CFR part 60, subpart XXX) and Emissions Guidelines (40 CFR part 60, subpart Cf) under section 111 of the CAA (collectively, NSPS/EG Rules). The listed regulated pollutant under these regulations is “landfill gas.” The EPA has also promulgated National Emissions Standards for Hazardous Air Pollutants (NESHAP) (40 CFR part 63, subpart AAAA) in 2020 that regulate the emissions of Hazardous Air Pollutants (HAP) from landfills. The NESHAP regulates HAP emissions by requiring landfills that exceed the size and NMOC emission thresholds to install and operate a landfill gas collection and control system (GCCS). As in the NSPS/EG, the GCCS is required to include a control device capable of reducing NMOC emissions by 98 percent. This system will also reduce emissions of methane since methane makes up approximately 50 percent of the landfill gas.</P>
                    <P>
                        The EPA's current CAA section 111 NSPS provides emissions control requirements for new (since 2014) municipal solid waste landfills. 40 CFR part 60, subparts WWW and XXX. The section 111 emissions guidelines (EG) cover existing (pre-2014) municipal solid waste landfills through requirements that are adopted by states through state plans, or by the EPA in the event a state does not submit an approvable plan. 40 CFR part 60, subpart Cf. Both new and existing landfills that exceed specified size and emissions thresholds must install landfill gas GCCS and use, sell, or flare (combust) the gas. The EPA estimated that 846 landfills would be required to collect and control landfill gas under these regulations by 2025.
                        <SU>15</SU>
                        <FTREF/>
                         In addition, landfills covered by these regulations and that have GCCS installed must conduct quarterly surface monitoring for leaks. In the states with more stringent state requirements, the requirements 
                        <PRTPAGE P="4078"/>
                        commonly apply to smaller landfills, landfills with lower emissions levels, and/or apply more stringent emissions control measures compared to the Federal requirements. A number of other landfills that are not subject to emissions control regulations nevertheless have installed landfill GCCS and are either flaring, combusting the gas for energy generation, or upgrading it and injecting it in the pipeline system for sale.
                        <SU>16</SU>
                        <FTREF/>
                         The LMOP tracks voluntary GCCS installation based on available data reported by program partners. As of 2024, at least 450 landfills operate a GCCS without being required by regulation. Many of the landfills that are not currently regulated or voluntarily collecting gas may be required to collect and control landfill gas emissions during the timeframe in which the section 45Y and 48E credits are available, as additional regulation is expected at both the Federal and state level.
                        <SU>17</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             U.S. Environmental Protection Agency, 
                            <E T="03">Final Updates to Performance Standards for New, Modified and Reconstructed Landfills, and Updated to Emission Guidelines for Existing Landfills: Fact Sheet</E>
                             (Sept. 2016), available at 
                            <E T="03">https://www.epa.gov/sites/default/files/2016-09/documents/landfills-final-nsps-eg-factsheet.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             
                            <E T="03">Landfill Methane Outreach Program (LMOP),</E>
                             U.S. Environmental Protection Agency, available at 
                            <E T="03">https://www.epa.gov/lmop</E>
                             (last updated Dec. 5, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             In addition to upcoming EPA regulations, additional states are also contemplating regulations. 
                            <E T="03">See, for example, Landfill Methane Reductions in Colorado,</E>
                             Colorado Department of Public Health and Environment, available at 
                            <E T="03">https://cdphe.colorado.gov/landfill-methane-reductions-in-colorado;</E>
                             New York Department of Environmental Conservation et al., 
                            <E T="03">Methane Reduction Plan</E>
                             (May 2017), available at 
                            <E T="03">https://extapps.dec.ny.gov/docs/administration_pdf/mrpfinal.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Given that landfill gas collection and use or flaring is widespread, as it is required by regulation for an increasing number of landfills and often supported by GHG credit programs when it is not otherwise required, an assumption that absent the section 45Y and 48E credits the typical practice would be uncontrolled venting is not supportable. The Treasury Department and the IRS have determined that since collection and flaring is required by law for the largest sources of landfill gas, and is increasingly being required for smaller sources as well, collection and flaring is the most appropriate alternative fate assumption for the sector as a whole given its prevalence. Although a flaring alternative fate will result in an underestimate of lifecycle GHG emissions for landfills with current productive use, the fact that there are some landfills where capture and flaring or productive use is not yet occurring, in combination with the prevalence of flaring, makes a flaring alternative fate the most robust approach for the sector as a whole. Section 1.45Y-5(e)(3)(ii) of the final regulations provides that, for purposes of determining the GHG emissions rate of a C&amp;G Facility (as defined in § 1.45Y-5(b)(4)) that produces electricity through combustion or gasification using methane derived from landfill sources as a fuel or feedstock, the alternative fate of such gas must be flaring.</P>
                    <HD SOURCE="HD3">B. Alternative Fate Considerations for Methane From Wastewater</HD>
                    <P>Several commenters stated that the R&amp;D GREET 2023 model provides a reasonable baseline assumption that should be applied for all wastewater sludge projects. These commenters noted that a digester would be present on site and the biogas would be flared or consumed on site, and this should inform the baseline in establishing the alternative fate of the methane. Another commenter stated that it would be incorrect to presume both that most wastewater treatment plants have operational biogas/anaerobic digester systems and that operational biogas systems are flaring their gas. The commenter further asserted that, based on the American Biogas Council's database of wastewater facilities maintained under a memorandum of understanding with the Water Environment Federation, the vast majority of operational digester systems at wastewater plants are using such biogas to produce renewable electricity, RNG, or heat, which, according to the commenter, offsets fossil fuel use and its related emissions.</P>
                    <P>
                        National-level data on anaerobic digestion at wastewater treatment plants and the use of biogas produced is limited. There are more than 16,000 wastewater treatment plants in the U.S. While most wastewater treatment plants in the U.S. serve small populations and do not process sufficiently large wastewater flows to justify the installation of anaerobic digesters, which are capital-intensive, anaerobic digesters are very prevalent among the smaller number of large wastewater treatment facilities that process the large majority of wastewater: the largest 8 percent of facilities (1,132 facilities that each handle greater than 5 million gallons per day) process 77 percent of total national wastewater flow, according to Argonne National Laboratory.
                        <SU>18</SU>
                        <FTREF/>
                         Among the 1,100 generally large wastewater treatment plants that have anaerobic digesters, 860 have the equipment to use their biogas on site, according to the U.S. Department of Energy Alternative Fuels Data Center.
                        <SU>19</SU>
                        <FTREF/>
                         Additionally, nearly all biogas-producing wastewater treatment plants surveyed in 2018 reported flaring at least some of their biogas, based on the Nationwide Survey of WRRF Biosolids Programs released in 2022.
                        <SU>20</SU>
                        <FTREF/>
                         Venting practices are not reported in any national datasets, although vents are required to prevent over-pressurization events in biogas storage systems and local regulators may require facilities to track and report venting events. Some facilities combust biogas to heat their digesters and some also take advantage of the additional heat availability for on-site biosolids drying.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             Ha, Miae, et al. “Opportunities for Recovering Resources from Municipal Wastewater.”, Jul. 2022. 
                            <E T="03">https://doi.org/10.2172/1876441.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             See 
                            <E T="03">https://afdc.energy.gov/fuels/natural-gas-renewable.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             National Biosolids Data Project, Nationwide Survey of WRRF Biosolids Programs 
                            <E T="03">https://www.biosolidsdata.org/downloads/nationwide-wrrf-survey-cleaned-data-spreadsheet.</E>
                        </P>
                    </FTNT>
                    <P>Given that use or flaring of methane from wastewater is generally applied to the majority of wastewater generated domestically, an assumption that absent the section 45Y and 48E credits the typical practice would be uncontrolled venting is not supportable. Section 1.45Y-5(e)(3)(iii) of the final regulations therefore provides that, for purposes of determining the GHG emissions rate of a C&amp;G Facility (as defined in § 1.45Y-5(b)(4)) that produces electricity through combustion or gasification using methane derived from wastewater sources as a fuel or feedstock, the alternative fate of such gas must be flaring of gas not used to heat the anaerobic digester.</P>
                    <P>For the large majority of biogas from wastewater treatment plants, this is either consistent with current practice or modestly overestimates avoided emissions in cases where the portion of biogas not needed to satisfy on-site heat requirements would otherwise have been productively used. Although a flaring alternative fate for this additional biogas will result in an over-estimate of avoided GHG emissions for wastewater treatment plans with current productive use beyond satisfying on-site heat demands, this potential overestimation of GHG emissions avoidance is counterbalanced by the existence of wastewater treatment plants where capture and flaring or productive use is not yet occurring, thus making the specified alternative fate the most appropriate approach for the sector as a whole.</P>
                    <HD SOURCE="HD3">C. Alternative Fate Considerations for Coal Mine Methane</HD>
                    <P>
                        The Treasury Department and the IRS recognize that fossil sources of fugitive methane can be utilized for the production of electricity. Many commenters specifically noted the feasibility of producing electricity from 
                        <PRTPAGE P="4079"/>
                        CMM and identified venting as a common alternative fate. One commenter noted concerns associated with allowing for the use of fugitive methane from sources such as coal mines until robust lifecycle analysis, verifiability, incrementality, and other principles related to the emissions impacts of this gas are demonstrated. Another commenter recommended that the emissions associated with coal mine methane be determined consistent with the GREET model maintained by Argonne National Laboratory.
                    </P>
                    <P>
                        Drainage gas is the subset of CMM that is most likely to be used for electricity generation, due to its high methane content. Drainage systems are a mechanism of recovering methane from underground mines to maintain safe operating conditions.
                        <SU>21</SU>
                        <FTREF/>
                         These systems are typically installed when ventilation systems are insufficient to maintain underground methane concentrations within permissible limits. Unlike drainage gas, ventilation gas is typically dilute in methane content and therefore is not widely used for electricity production.
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             Active underground mines that liberate more than 36,500,000 actual cubic feet of methane per year report annually to GHGRP on whether their drainage gas is vented or destroyed.
                        </P>
                    </FTNT>
                    <P>Based on consultation with interagency experts, the Treasury Department and the IRS understand that the EPA's GHGRP is the only national public database with historical information provided annually by large active underground mines regarding their treatment of drainage gas. Review of data submitted by coal mines to GHGRP under 40 CFR part 98, subpart FF, indicates that, while the majority of ventilation gas liberated by coal mines over the past decade has been vented, the majority of drainage gas has been productively used or flared. Mine practices have fluctuated, with some mines transitioning from predominantly venting drainage gas to predominantly using or destroying such gas. Factors that can affect the extent to which a mine vents, flares, and/or productively uses such gas in a given year include the amount of methane required by onsite equipment (for example, engines); proximity to offsite infrastructure (for example, pipelines); and the lucrativeness of programs incentivizing the capture of CMM. Incentives for CMM destruction and utilization that are currently available include state offset programs, state renewable portfolio standards, and voluntary offsets, some of which specifically do not allow for pipeline injection.</P>
                    <P>There is considerable uncertainty associated with establishing the appropriate alternative fate scenarios for CMM for the period over which a facility may be able to claim the section 45Y and 48E credits. Coal mines that are currently injecting CMM into pipelines may transition to flaring if natural gas prices fall, or may exercise flaring at future boreholes if those boreholes are distant from existing pipeline infrastructure. Mines that are currently predominantly venting may transition to productive use if pipeline infrastructure is built in their vicinity. A flaring baseline is therefore the most appropriate approach for CMM sourced from drainage systems given the uncertainty with respect to these emissions in particular in the United States, and reduces the risk of inappropriately attributing extremely negative lifecycle emissions rates to the capture of CMM which would have already been captured and productively used.</P>
                    <P>Accordingly, § 1.45Y-5(e)(3)(iv) of these final regulations provides that for purposes of determining the GHG emissions rate of a C&amp;G Facility (as defined in § 1.45Y-5(b)(4)) that produces electricity through combustion or gasification using coal mine methane that is drainage gas as a fuel or feedstock, the alternative fate of such gas must be flaring. This alternative fate accounts for the uncertainties associated with future practices, as previously described, while recognizing that most drainage gas is destroyed today.</P>
                    <HD SOURCE="HD3">D. Alternative Fate Considerations for Animal Waste</HD>
                    <P>Commenters suggested a variety of alternative fate assumptions for purposes of estimating GHG emissions for biogas derived from animal waste sources, including venting, alternative productive use, and responsible waste management, with some commenters recommending a single alternative fate for biogas produced from these sources and others recommending differentiated alternative fates. There is no national database that tracks farm-level methane emissions, capture, and usage in the agricultural sector. Additionally, there are no nationally applicable reporting requirements for animal waste management practices at livestock and poultry farms, which differ substantially on a farm-to-farm basis, and state-level animal waste management reporting requirements vary. Therefore, lack of data and heterogeneity of animal waste management practices are limiting factors in establishing a single specific alternative fate for methane generated from animal waste.</P>
                    <P>Many commenters highlighted competing considerations in determining the appropriate alternative fate for methane derived from animal waste. Several commenters recommended that the R&amp;D GREET 2023 model be used to calculate the avoided emissions from anerobic digestion and the associated biogas using site-specific baseline manure management practices. The commenters suggested that the correct alternative fates could be entered into the model manure management categories and practices to accurately quantify baseline emissions prevented by a biogas project. Several commenters suggested that for biogas produced from livestock manure, the alternative fate should be that methane would continue venting from manure handling facilities until such time as that venting is no longer permissible by law or regulation. The consequence of the commenters' suggestion is that any biogas utilized would be associated with avoided GHG emissions. The commenters noted that this alternative fate is similar to what the commenters assert is appropriate for the landfill gas industry, where once regulations are in place requiring landfill gas to be captured and destroyed, then flaring becomes the appropriate alternative fate. One commenter noted that although the primary precedent for crediting avoided methane emissions is the California LCFS's treatment of biomethane from manure lagoons, this precedent is not appropriate for purposes of the section 45Y and 48E credits. The commenter stated that the avoided GHG emissions calculation was specifically incorporated within the LCFS as a means of subsidizing investments in anaerobic digesters to address pollution from California's dairies rather than as a reflection of the best available science.</P>
                    <P>
                        Determining the appropriate alternative fate and emissions intensity for biogas produced from animal waste sources presents several challenges. First, the emissions intensity of biogas produced from animal waste can vary widely based on the specific waste practices used by individual producers. These practices are not comprehensively tracked and, in many cases, would be extremely difficult to effectively verify. Different waste disposal practices produce very different quantities of methane per unit of manure, as methane generation is much higher in wet anaerobic conditions. As one example, the EPA's GHG Inventory data indicates that uncovered anaerobic lagoons produce roughly one hundred times the amount 
                        <PRTPAGE P="4080"/>
                        of methane as daily spread. Even among farms credited with methane venting counterfactuals under the California LCFS, the resulting GHG emissions intensities for biogas vary widely depending on specific practices. Factors impacting the emissions intensity calculations for that program include, but are not limited to, the type of animals producing waste for the digester, type(s) of feed provided for the animals, the digester technology, and ambient conditions at the digester. As discussed further later in this section, none of these practices are comprehensively tracked or reported at a national level. Commenters also noted the further uncertainty and variation introduced by a range of leakage rates from operations capturing and upgrading manure-derived methane, including the high likelihood that there are “super emitter” sources (consistent with the patterns seen in other fugitive methane streams). This could introduce additional uncertainty and risk of over crediting in measuring a GHG emissions rate.
                    </P>
                    <P>
                        Second, there is substantial and growing alternative productive use of methane from animal waste. There are 400 operational animal waste anaerobic digesters in the U.S. and 73 additional digesters under construction as of 2024, according to the AgSTAR Digester Database. Based on data from the AgSTAR Digester Database regarding the number of livestock (by head) feeding anaerobic digesters as of 2024, it is estimated that the waste from roughly 8 percent of dairy cattle and 2 percent of swine (by head) is currently sent to anaerobic digesters and these numbers increase to 10 percent and 3 percent, respectively, if digesters currently under construction are included.
                        <SU>22</SU>
                        <FTREF/>
                         The percentage of waste being sent to anaerobic digesters has been rising rapidly since 2019, with 400 operational projects and 73 under construction, and with the majority of new projects upgrading their biogas to RNG, due, in part, to incentives provided by the RFS, LCFS, and a California grant program. The digesters listed as newly operational and under construction as of 2023-2024 in the AgSTAR database represent a 28 percent increase in the dairy cattle waste and 50 percent increase in swine waste (by head) sent to anaerobic digesters relative to 2022 levels. While there has been some variation in the profitability of installing anaerobic digesters as credit values have fluctuated,
                        <SU>23</SU>
                        <FTREF/>
                         the financial incentives provided by the RFS and LCFS programs appear to be sufficient to incentivize some installations of anaerobic digesters at existing lagoons, which reduces emissions without any additional incentive from the section 45Y and 48E credits. There are also other possible sources of revenue from anaerobic digester systems including tipping fees from local food production, or the sale of secondary products such as digestate-based fertilizer or phosphorus pellets.
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             Values were calculated using data from the AgSTAR Digester Database. 
                            <E T="03">Livestock Anaerobic Digester Database,</E>
                             U.S. Environmental Protection Agency, available at 
                            <E T="03">https://www.epa.gov/agstar/livestock-anaerobic-digester-database</E>
                             (last updated Oct. 1, 2024). The sum of dairy cattle reported as feeding operational digesters in the AgSTAR database as of June 2024 was calculated to be 1.55 million. The sum of swine reported as feeding operational digesters was calculated to be 1.68 million. The total values including under-construction digesters are 1.87 million dairy cattle and 2.08 million swine. Percentages are calculated by dividing these values by the most up-to-date data on dairy cattle and swine head: total dairy cattle head in 2022 (18.6 million) and swine head (73.4 million) as reported in the EPA GHG Inventory. 
                            <E T="03">See also</E>
                             U.S. Environmental Protection Agency, “Inventory of U.S. Greenhouse Gas Emissions and Sinks,” available at 
                            <E T="03">https://www.epa.gov/ghgemissions/inventory-us-greenhouse-gas-emissions-and-sinks</E>
                             (last updated November 22, 2024); U.S. Department of Energy, “A Generic Counterfactual Greenhouse Gas Emission Factor for Life-Cycle Assessment of Manure-Derived Biogas and Renewable Natural Gas” (2025), available at 
                            <E T="03">www.energy.gov/45vresources.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             
                            <E T="03">How Much Should Dairy Farms Get Paid for Trapping Methane?—Energy Institute Blog,</E>
                             available at 
                            <E T="03">https://energyathaas.wordpress.com/2024/10/14/how-much-should-dairy-farms-get-paid-for-trapping-methane/.</E>
                        </P>
                    </FTNT>
                    <P>Complementing these incentives are a range of other voluntary programs that encourage capture and productive use of methane emissions from animal waste. For example, USDA is leveraging its authority under a variety of existing programs to encourage farmers and ranchers to install or upgrade equipment and adopt new practices that improve manure management and can substantially reduce methane emissions. One such program, AgSTAR, is a collaborative program sponsored by the EPA and USDA that promotes the use of biogas recovery systems, such as anaerobic digester systems, to reduce methane emissions from animal waste. Likewise, USDA Natural Resources Conservation Service programs—including the Environmental Quality Incentives Program (EQIP) and the Conservation Stewardship Program (CSP)—provide incentives for upgrading existing anaerobic lagoons, anaerobic digesters, and solid separators and covers to collect methane for use or destruction; install solid separators that reduce methane-producing slurries; and providing conservation assistance for transitions to alternative manure management systems, such as deep pits, composting, transitions to pasture, or other practices that have a lower GHG emissions profile. The Rural Energy for America Program (REAP) has offered more than $160 million in grants and loans to incentivize anaerobic digesters and biogas projects to control methane and biogas from dairy and other farms.</P>
                    <P>Given rapid recent and continuing growth and multiple existing incentive programs, it is reasonable to assume continued growth in the share of large dairies and concentrated animal feeding operations with anaerobic digesters, even absent an additional incentive under the section 45Y and 48E credits. Redirecting biogas that comes from these sources to electricity production will mean less displacement of natural gas elsewhere in the economy, and could therefore result in significant indirect emissions that must be taken into account under section 45Y(b)(2)(B).</P>
                    <P>Third, the magnitude of the incentive provided by the section 45Y and 48E credits itself creates a significant risk of additional waste production in response to the credit, with emissions that must be accounted for in the LCA. While some commenters noted that the EPA did not find that its RFS program's incentivization of anaerobic digesters had driven a proliferation of concentrated animal feeding operations or other large-scale animal agriculture, other commenters disagreed, stating that the availability of these credits may incentivize the operation of new or larger farming units and the deliberate production of methane. Commenters noted that, even with use of anaerobic digesters, GHG emissions may still result from leakage, use of digestate, and the need to use venting to accommodate fluctuating gas levels. Additional waste production could thus result in additional emissions; moreover, even if emissions from additional production are captured, crediting the additional waste with avoided emissions would result in inaccurate credit determinations.</P>
                    <P>For biogas produced from animal waste, there are several potential routes that may increase methane production:</P>
                    <P>• Shifting management practices for existing quantities of manure from land application to lagoon, thereby significantly increasing methane generation;</P>
                    <P>
                        • On the margin, making new or expanded concentrated animal feeding operations (CAFOs) more profitable (whether by increasing the overall numbers of animals raised, or by consolidating smaller existing operations) and thereby inducing additional manure and methane generation; and
                        <PRTPAGE P="4081"/>
                    </P>
                    <P>• Using management practices at biodigesters to produce more methane than would have been produced otherwise (for example, increasing the temperature at an anaerobic digester).</P>
                    <P>To the extent producers adopt these practices in response to incentives created by the section 45Y and 48E credits, failure to take this into account could lead to allowing facilities that do not meet statutory GHG emissions requirements to be treated as qualified facilities under section 45Y and 48E. This would be a particular concern with a venting alternative fate because it would result in a significantly negative estimated GHG emissions rate, creating strong incentives to produce additional methane for use by facilities to claim the section 45Y and 48E credits inappropriately.</P>
                    <P>
                        In light of these challenges, the Treasury Department and the IRS have determined that the most appropriate approach to determining the carbon intensity of biogas and ensuing RNG derived from animal waste is to use an alternative fate for the sector as a whole that is derived from the national average of all animal waste management practices. The rule provided in § 1.45Y-5(e)(3)(v) requires a best estimate of the nationwide average methane emissions from manure based on currently available data. As detailed in a technical analysis from the DOE,
                        <SU>24</SU>
                        <FTREF/>
                         this results in a carbon intensity score of −51 gCO
                        <E T="52">2</E>
                        e/MJ, where the MJ basis refers to the lower heating value of the methane contained in the biogas. This emissions attribute for the methane contained in biogas from animal waste can be subsequently used to calculate the carbon intensity of electricity and RNG by accounting for the GHG emissions associated with onsite electricity generation from biogas or for upgrading, transportation, and compressing into RNG.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             U.S. Department of Energy, “A Generic Counterfactual Greenhouse Gas Emission Factor for Life-Cycle Assessment of Manure-Derived Biogas and Renewable Natural Gas” (2025), available at 
                            <E T="03">www.energy.gov/45vresources.</E>
                        </P>
                    </FTNT>
                    <P>
                        As further explained in the DOE's analysis of animal waste sources, this carbon intensity of RNG derived from methane contained in biogas from animal waste has been calculated using a weighted average of U.S. manure management practices across manure from all types of livestock and poultry. Averaging over the full set of animal-waste management practices nationwide is an administrable way to take into account the range of existing waste management practices and represent emissions reductions that result from additional methane capture and use.
                        <SU>25</SU>
                        <FTREF/>
                         It is a reasonable and administrable representation of the carbon intensity of biogas from manure-based sources in light of the significant limitations of available data and verification mechanisms, the uncertainties associated with estimation of the GHG emissions, the benefits of different manure management systems, and the risks of perverse incentives At the same time, it provides taxpayers certainty and clarity regarding the carbon intensity of methane from certain animal waste sources.
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>The Treasury Department and the IRS considered alternative approaches suggested by commenters, in particular whether to provide differentiated alternative fates, for example based on a producer's prior waste management practices and methane production levels or the mix of animal types used to generate biogas. Differentiated alternative fates, however, is not feasible because it would not be administrable or practicable to set up a reporting and verification system to determine the prior practices and quantities of manure and biogas at each individual participating livestock and poultry operation that generates biogas. Such an approach would be infeasible given the large number of such operations and the lack of nationally applicable reporting requirements regarding numbers of animals or manure management practices by livestock and poultry operation (and wide variation in state reporting requirements). Additionally, 104 of the 473 digesters operational or under construction in the AgSTAR database report co-digesting their primary manure type with one or more other wastes, including other types of manure, food waste, agricultural residues, and dairy/food processor waste. These tracking and verification challenges are of particular concern because differences in waste disposal practices or specific waste sources can result in large differences in avoided emissions, meaning that highly specific prior waste management practices would need to be consistently reported and verified to support accurate differentiated alternative fates. In addition, as discussed previously, differentiated alternative fates that allow for highly negative emissions values raise concerns about incentives for additional waste production that could result in inappropriate claims of the section 45Y and 48E credits. The Treasury Department and the IRS will continue to monitor reporting and tracking systems and study the feasibility of introducing differentiated pathways in the future.</P>
                    <P>The Treasury Department and the IRS also considered whether the emissions values for RNG produced from animal waste should be adjusted to reflect the risk of additional waste production in response to the incentives provided by the section 45Y and 48E credits. The Treasury Department and IRS expect the modestly negative emissions values established in these rules will provide, at most, only modest incentives to generate new methane or other GHGs from animal waste. However, the Treasury Department and the IRS will continue to study this issue to determine whether adjustments are needed in the future.</P>
                    <HD SOURCE="HD3">E. Alternative Fate Considerations for Fugitive Methane From Fossil Fuel Activities Other Than Coal Mining</HD>
                    <P>The Treasury Department and the IRS have considered the alternative fate of fugitive methane from fossil fuel activities other than coal mining, which are overwhelmingly comprised of oil and gas operations, and determined that the generally applicable alternative fate for fugitive methane from these activities is productive use.</P>
                    <P>While some commenters viewed the alternative fate of fugitive emissions to be venting, others noted the extensive existing regulatory requirements and additional incentives for avoiding fugitive emissions from oil and gas operations and argued that productive use is the appropriate alternative fate for this source of methane. Some commenters stated that any program that would incentivize the capture of fugitive methane from oil and gas sources would be ineffective and inefficient because of the combination of: (i) variable emissions, (ii) the technical challenge of measuring emissions, and (iii) the counterproductive incentives the baseline setting process would create. Another commenter stated that, to avoid double counting methane emissions abatement, the final regulations must explicitly state that fugitive sources of methane arising from oil and gas activities are to be treated equivalently to fossil methane.</P>
                    <P>
                        The Treasury Department and the IRS note that EPA regulations under section 111 of the CAA seek to limit volatile organic compound (VOC) and methane emissions from oil and gas operations through a variety of requirements including performance standards as well as operational practices and leak detection and repair programs. 
                        <E T="03">See</E>
                         40 CFR part 60, subparts OOOO, OOOOa, OOOOb, and OOOOc. For example, 
                        <PRTPAGE P="4082"/>
                        EPA's latest rules for new sources of VOC and methane emissions require use of zero emitting process controllers in most scenarios. EPA's previous rules allowed low bleed and intermittent bleed controllers, which emit pollutants to the atmosphere by discharging natural gas. EPA's new rules keep that gas in the system instead of allowing it to be released. EPA's new rules also phase out routine flaring of associated gas from most new oil wells, establish strong performance standards for emissions from storage tanks, include requirements for the efficiency of flares, and strengthen requirements for regular leak monitoring and the deadline for repairs at well sites. EPA's leak detection and repair program at well sites requires frequent monitoring of oil and gas equipment with approved technology and methods to look for leaks. If a leak is found, then it must be repaired quickly so that the equipment stops leaking fugitive emissions to the atmosphere. This program will reduce the amount of emissions coming from leaking components. EPA's rules also require owners and operators of new wells to use best management practices to minimize or eliminate venting of emissions from gas well liquids unloading.
                    </P>
                    <P>
                        As discussed in section VIII.4.c.i.A. of this Summary of Comments and Explanation of Revisions, while some of the compliance deadlines under each of the updated regulations under section 111 and updated reporting requirements in 40 CFR part 98, subpart W, have not yet passed, operators must plan for timely compliance with those requirements and must currently comply with other requirements such as the new source requirements under section 111. Thus, operators have significant incentives to make certain compliance investments now and are required to do so well within the period of the tax credit. In addition, the Bureau of Land Management and most oil and gas producing states also regulate the “waste” of gas through venting and flaring, and some, such as New Mexico and Colorado, have regulations equally or more stringent than EPA requirements in many respects.
                        <SU>26</SU>
                        <FTREF/>
                         As a consequence, the majority of the actions that an oil or gas operator could take to avoid fugitive emissions are already required by law or will be during the period in which the section 45Y and 48E credits will be available.
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             
                            <E T="03">See,</E>
                             for example, 
                            <E T="03">Waste Prevention, Production Subject to Royalties, and Resource Conservation,</E>
                             89 FR 25378 (Apr. 10, 2024).
                        </P>
                    </FTNT>
                    <P>Given the extensive regulatory environment already in place requiring oil and gas operators to minimize GHG emissions from oil and gas operations, and the strong incentive and existing infrastructure to sell gas that is not lost through venting or flaring, the generally applicable alternative fate for fugitive emissions from fossil fuel activities other than coal mining is productive use. Accordingly, § 1.45Y-5(e)(3)(vi) provides that for purposes of determining the GHG emissions rate of a C&amp;G Facility (as defined in § 1.45Y-5(b)(4)) that produces electricity through combustion or gasification using fugitive methane other than coal mine methane as a fuel or feedstock, such as fugitive methane from oil and gas operations, the alternative fate of such gas must be productive use, which would result in emissions equivalent to the carbon intensity of using fossil natural gas. For example, the production of methane from virgin coal seams, which is commonly referred to as “coal bed methane” (CBM), may be for the purpose of natural gas production or may result from pre-mining activities. Since it is typically of a comparable methane content as other natural gas sources, it is commonly sold for use. Nationwide, emissions that result from CBM extraction are currently reported to EPA's Greenhouse Gas Reporting Program under 40 CFR part 98, subpart W, which informs background estimates of upstream methane emissions for the natural gas supply chain. Accordingly, GHG emissions analyses conducted for purposes of sections 45Y and 48E would represent CBM with a carbon intensity that is equivalent to that of other sources of fossil natural gas.</P>
                    <HD SOURCE="HD3">d. Book-and-Claim</HD>
                    <P>Book-and-claim accounting has been used in some contexts to track the attributes associated with the production of a unit of energy in a manner that prevents double counting. In such a system, producers of energy are required to acquire and retire corresponding attribute certificates through a book-and-claim system that can verify, generally in an electronic tracking system, that all applicable requirements are met. The preamble to the proposed regulations requested comment on whether book-and-claim accounting may be suitable for use in substantiating and verifying claims to the energy attributes of fuels and feedstocks used by a facility to generate electricity. Examples of the relevant fuels and feedstocks for which book-and-claim accounting may be considered include natural gas alternatives or other feedstocks such as hydrogen. The preamble to the proposed regulations further noted that the Treasury Department and the IRS are considering providing rules that may permit the use of book-and-claim accounting for the section 45Y and 48E credits in the final regulations if there are sufficient assurances that the energy attributes claimed under such system are verifiable and not susceptible to double counting. The preamble to the proposed regulations further noted that tracking and verification mechanisms for natural gas alternatives specific to the needs of the section 45Y and 48E credits are not yet available, and existing systems have limited capabilities for tracking and verifying pathways for natural gas alternatives, especially in the part of the production process before the methane has been reformed to RNG.</P>
                    <P>A wide range of comments arguing in favor of and against allowing the use of book-and-claim systems for natural gas alternatives were received in response to the proposed regulations. Several commenters discussed how book-and-claim systems were commonplace within the RNG industry. In addition, several commenters expressed concern about the ability of the RNG industry to take advantage of the section 45Y and 48E credits if a book-and-claim approach was not adopted. Several commenters stated that, because sources of natural gas alternatives are unevenly distributed throughout the United States and may not be located near prospective electricity-generating facilities, book-and-claim allows entities that do not have access to such sources to be eligible for the section 45Y and 48E credits. One commenter suggested that a mass balance model or an “identity preservation” model could be adopted if a book-and-claim system was disallowed.</P>
                    <P>
                        Several commenters suggested that existing systems, such as the Midwest Renewable Energy Tracking Systems (M-RETS), the EPA's RFS, or the California LCFS, might have sufficient capabilities to enable book-and-claim accounting for purposes of the section 45Y and 48E credits. Other commenters argued that these systems do not have sufficient tracking capabilities and that the Treasury Department and the IRS should disallow book-and-claim given these limitations. Several commenters recommended that if a book-and-claim system were allowed, then such system should take measures to avoid double-counting of the same environmental attributes. Several commenters suggested that any tracking system should be able to allocate emissions based on different levels of gas blending from different feedstocks and enable the differentiation of carbon capture rates to 
                        <PRTPAGE P="4083"/>
                        those different feedstock production pathways. Several commenters noted that any tracking system would not address the issue on which proposed regulations invited comment, such as ensuring that biomethane is not produced for the purpose of meeting demand for the biomethane market. In response to these comments, the Treasury Department and the IRS note that existing tracking and verification systems have limited capabilities for tracking and verifying RNG pathways and that there is no sufficiently accurate, nationally available, auditable and reliable third-party tracking system (or registry) in place today.
                    </P>
                    <P>Several commenters suggested there was clear Congressional intent to allow book-and-claim. However, other commenters suggested that allowing the section 45Y and 48E credits solely on the basis of RNG certificates would be contrary to requirements of the statute. These commenters argued that the requirement to assess the emissions rates of the facility precludes the use of book-and-claim in the specific context of the section 45Y and 48E credits. These commenters asserted that the use of a book-and-claim system was not statutorily authorized because such use would not comply with the requirement of section 45Y(b)(2)(A) and (B) and section 48E(b)(3)(ii) to assess the emissions emitted by a facility in the production of electricity. Commenters also argued that the result of allowing book-and-claim would be to allow facilities to claim the credits with no meaningful change in operations, contrary to the intended purpose of the section 45Y and 48E credits.</P>
                    <P>In response to these comments, the Treasury Department and the IRS have examined whether book-and-claim accounting is permissible under the statutes. As further explained later in this section, the final regulations do not permit the use of book-and-claim accounting for purposes of the section 45Y and 48E credits because the use of book-and-claim accounting would conflict with the statutory directive to assess the GHG emissions specific to a facility.</P>
                    <P>Congress set the statutory boundaries for determining greenhouse gas emissions rates for the section 45Y and 48E credits in section 45Y(b)(2). Section 45Y(b)(2)(A) defines “greenhouse gas emissions rate” as “the amount of greenhouse gases emitted into the atmosphere by a facility in the production of electricity, expressed as grams of CO2e per kWh.” This general rule for determining emissions rates requires an analysis of the emissions associated with a facility's production of electricity. Section 45Y(b)(2)(B) clarifies that for facilities that produce electricity through combustion or gasification, the GHG emissions rate for such facilities is equal to “the net rate of greenhouse gases emitted into the atmosphere by such facility (taking into account lifecycle greenhouse gas emissions, as described in 42 U.S.C. 7545(o)(1)(H) in the production of electricity, expressed as grams of CO2e per kWh.” Section 45Y(b)(2)(C) provides the rules for specifying a GHG emissions rate for a particular facility. Section 45Y(b)(2)(C)(i) requires the Secretary to annually publish a table (Annual Table) that sets forth the GHG emissions rates “for types or categories of facilities.” Taxpayers must use this Annual Table to determine the GHG emissions rate of any facility for which the Annual Table provides a rate. Section 45Y(b)(2)(C)(ii) provides that if the Annual Table does not provide a rate for a facility, the taxpayer that owns such facility may petition the Secretary for a provisional emissions rate. Finally, section 45Y(b)(2)(D) requires the amount of GHGs emitted into the atmosphere “by a facility in the production of electricity” to not include any qualified carbon dioxide that is captured by the taxpayer and sequestered pursuant to certain requirements. Taken together, these statutory rules provide the framework to assess the GHG emissions of a facility based on the facility's operations.</P>
                    <P>Sections 45Y(b)(2)(C) and (f) provide the Secretary authority to specify and clarify how GHG emissions rates are determined within this framework. Section 45Y(b)(2)(C) directs the Secretary to publish an Annual Table or consider petitions for provisional emissions rates. Section 45Y(f) directs the Secretary to “issue guidance regarding implementation of [section 45Y], including calculation of greenhouse gas emission rates for qualified facilities and determination of clean electricity production credits under this [section 45Y].” To establish the GHG emissions rates as directed by the statute, the Secretary must first establish a process to calculate these rates. Because of this broad statutory mandate, the emissions rate determination process must account for the varied production methods that are currently viable or those that may be devised in the future, the idiosyncrasies of each facility's electricity-generating process, and scientific advancements and uncertainty associated with lifecycle analysis.</P>
                    <P>Upon consideration of the comments submitted regarding book-and-claim, the Treasury Department and the IRS have determined that the statute requires a facility's eligibility for the section 45Y and 48E credits to be determined by the electricity-generating operations undertaken by the facility itself to produce electricity and that book-and-claim, by its nature, cannot establish what fuel or feedstock is physically used within a facility to produce electricity or the actual fundamental transformations of energy that are used to produce a facility's input energy source. Sections 45Y(b)(1)(A) and 48E(b)(3)(A)(iii) provide that “qualified facility” means a facility that is owned by the taxpayer and is used for the generation of electricity, placed in service after December 31, 2024, and for which the GHG emissions rate or, for purposes of section 48E, the anticipated GHG emissions rate, is not greater than zero.</P>
                    <P>For both the determination of whether a facility produces electricity through combustion or gasification and the determination of the emissions associated with a facility's production of electricity, Congress directed the Secretary to assess the activities of a given facility in the course of electricity production, rather than, for example, the process used to produce the electricity. The use of book-and-claim could misrepresent the activities taking place in the facility or the actual fundamental transformations of energy that are used to produce a facility's input energy source, resulting in inaccurate determinations both with respect to whether the facility is producing electricity through combustion and gasification and with respect to the emissions associated with the facility's production of electricity.</P>
                    <P>
                        Book-and-claim accounting may appropriately be used in contexts other than the section 45Y and 48E credits to substantiate claims to the energy attributes of certain fuels and feedstocks. However, such claims do not necessarily correspond to the actual physical use of the relevant fuels and feedstocks. For example, where fuel is delivered through a common pipeline, the acquisition and retirement of certificates representing the attributes a particular fuel or feedstock may not (and are in fact unlikely to) reflect the physical delivery of fuel or feedstock with those attributes and its use by a facility in the production of electricity. In addition, the statutory authorization for credits other than the section 45Y and 48E credits may provide broader authority to support the use of a book-and-claim system, but the Treasury Department and the IRS agree with the commenters that such authority is not 
                        <PRTPAGE P="4084"/>
                        available with respect to the section 45Y and 48E credits.
                    </P>
                    <P>Whether a facility produces electricity through combustion or gasification is an inherently factual question that requires an assessment of (i) a facility's operations that produce electricity and (ii) the operations that produced the fuel, if any, used by that facility in the production of electricity. The emissions assessment for a facility that produces electricity through the combustion of a particular set of fuels must be based on the fuels in fact used by the facility, as well as any emissions from the full lifecycle of those fuels through the point of electricity production. The acquisition and retirement of certificates representing the attributes of certain types of fuel on behalf of this facility would have no bearing on which fuels it in fact used to produce electricity or the operations or feedstocks used to produce such fuel. As a result, permitting a facility to use book-and-claim accounting for this purpose could result in treating a facility that produced electricity through combustion or gasification as if it did not do so. For example, a hydrogen fuel cell that produces electricity using hydrogen produced entirely by steam methane reforming would be considered under the final regulations to have produced electricity through combustion or gasification. If the fuel or feedstock used by such facility were allowed to be determined using book-and-claim accounting, that facility could acquire and retire the attributes of hydrogen produced through electrolysis to be classified as a facility that did not produce electricity through combustion or gasification even though its operations did not support such a determination. This result would be inappropriate because section 45Y(b)(2)(B) requires consideration of the actual operations at a facility to produce electricity and the actual fundamental transformations of energy that are used to produce the facility's input energy source. The final regulations, therefore, cannot permit book-and-claim accounting in determining whether a facility produces electricity through combustion or gasification.</P>
                    <P>For the reasons explained previously, book-and-claim accounting also cannot establish the characteristics of the fuels used in a specific facility to produce electricity. Both sections 45Y(b)(2)(A) and (B) require an assessment of the greenhouse gases emitted into the atmosphere by the facility. The statute thus requires this inquiry to be based on the facility's actual operations and the emissions associated with it, both of which could be misrepresented by book-and-claim accounting. The final regulations, therefore, also cannot permit book-and-claim accounting in determining the amount of greenhouse gases emitted into the atmosphere by a facility in the production of electricity.</P>
                    <P>Thus, after consideration of the comments, §§ 1.45Y-5(e)(4) and 1.48E-5(e) of these final regulations do not permit the use of a book-and-claim accounting system to determine or claim the energy attributes of biogas, RNG, coal mine methane, any other methane used in the production of electricity, or any other input or feedstock. A facility that produces electricity through the combustion of RNG, for example, may substantiate its use of RNG by having a direct connection to an RNG source or records establishing exclusive, physical delivery of the RNG from that source to the facility for use in generating electricity. Because book-and-claim accounting of RNG energy attributes is not permitted for purposes of section 48E, such substantiation must address the actual anticipated operations of the qualified facility.</P>
                    <HD SOURCE="HD3">F. Carbon Capture and Sequestration</HD>
                    <P>
                        Section 45Y(b)(2)(D) provides that for purposes of section 45Y(b), the amount of GHGs emitted into the atmosphere by a facility in the production of electricity does not include any qualified carbon dioxide that is captured by the taxpayer and (i) pursuant to any regulations established under section 45Q(f)(2)
                        <E T="03">,</E>
                         disposed of by the taxpayer in secure geological storage, or (ii) utilized by the taxpayer in a manner described in paragraph (5) of such section. The Treasury Department and the IRS interpret this statutory language to mean that, for the calculation of the GHG emissions rate, the GHG emissions of a qualified facility in the production of electricity must be reduced by the amount of qualified carbon dioxide that is captured by the taxpayer at the qualified facility, and disposed of in secure geological storage; used in an enhanced oil and gas recovery (EOR) project and then disposed of in secure geological storage; or utilized (as defined in section 45Q(f)(5)).
                    </P>
                    <P>Proposed § 1.45Y-5(e) provided that for purposes of paragraphs (c) and (d) of the section, a GHG emissions rate for a Non-C&amp;G Facility or C&amp;G Facility must exclude any qualified carbon dioxide (as defined in section 45Y(c)(3)) that is produced in such facility's production of electricity, captured by the taxpayer, and pursuant to any regulations established under section 45Q(f)(2), disposed of by the taxpayer in secure geological storage, or utilized by the taxpayer in a manner described in section 45Q(f)(5) and any regulations established under such section. Several commenters requested that the final regulations more closely track the statutory language with respect to treatment of qualified carbon dioxide within the meaning of section 45Q by changing the language in proposed § 1.45Y-5(e) from “must exclude” to “shall not include.” The Treasury Department and the IRS acknowledge that the proposed regulatory text created ambiguity and have revised the final rule accordingly.</P>
                    <P>Additionally, in the preamble to the proposed regulations, the Treasury Department and the IRS requested comments regarding what requirements should apply to substantiate and verify that carbon dioxide that is captured by the taxpayer is (a) disposed of by the taxpayer in secure geological storage pursuant to any regulations established under section 45Q(f)(2), disposed of by the taxpayer in secure geological sequestration, or (b) utilized by the taxpayer in a manner described in section 45Q(f)(5). Commenters almost universally recommended adopting the requirements for substantiation and verification of CCS provided by regulations and Internal Revenue Bulletin guidance under section 45Q, referred to collectively as “the section 45Q rules.” The commenters cited support for adopting the requirements for substantiation and verification provided by the section 45Q rules because they provide taxpayer certainty, particularly as industry has already adopted these procedures. Other commenters supported adopting the rules because these commenters view the rules as appropriately stringent.</P>
                    <P>
                        Several commenters provided specific recommendations regarding the adoption of requirements for substantiation and verification provided by the section 45Q rules. The commenters requested that the final regulations adopt the requirements for secure geological storage provided under § 1.45Q-3, which include allowing the taxpayer to contract with a third party for secure geological storage activities consistent with the requirements under § 1.45Q-1(h)(2) and providing documentation to verify secure geological storage in accordance with 40 CFR part 98, subparts RR and VV (GHGRP), and the CSA/ANSI ISO 27916:2016 pathway. Several commenters also requested that the final regulations adopt the utilization requirements provided under § 1.45Q-4, including providing a written LCA report in conformity with ISO 14040:2006 and 14044:2006, third-party 
                        <PRTPAGE P="4085"/>
                        independent review, and technical review by the DOE. Commenters also recommended imposing reporting requirements consistent with those imposed on taxpayers that claim the section 45Q credit on IRS Form 8933. Other commenters asserted that verification and substantiation requirements must include detailed records of the CCS process, third-party verification, and compliance with GHGRP reporting standards.
                    </P>
                    <P>Several commenters recommended the adoption of a less stringent version of the requirements for substantiation and verification provided by the section 45Q rules. A commenter recommended that taxpayers not be required to obtain pre-approval of LCA reports, which is required for utilization under the section 45Q regulations and Notice 2024-60, 2024-34 I.R.B. 515. Instead, the commenter suggested that the final regulations provide an option for taxpayers that claim the section 45Y or 48E credits for capturing and utilizing carbon dioxide to use different LCA parameters than currently apply under the section 45Q rules. Another commenter requested that in addition to procedures provided by the section 45Q rules, that the final regulation provide that taxpayers may use other workable methods and protocols for verifying secure geological storage. After consideration of the comments, the Treasury Department and the IRS have determined that based on the explicit statutory direction in section 45Y(b)(2)(D) to rely upon the regulations established under section 45Q(f)(2) for secure geological storage and the reference to the requirements for utilization provided in section 45Q(f)(5), the final regulations adopt the requirements for substantiation and verification provided by regulations and Internal Revenue Bulletin guidance under section 45Q.</P>
                    <P>The Treasury Department and the IRS also asked whether it would be appropriate to limit the carbon dioxide that may be considered as qualified carbon dioxide (as defined under section 45Y(e)(3)), and thus excluded under section 45Y(b)(2)(D), to carbon dioxide that has been reported to the EPA's GHGRP, and if so, which GHGRP subpart or subparts should be used. Several commenters supported limiting the qualified carbon dioxide excluded from the GHG emissions of a qualified facility based on the amount of qualified carbon dioxide reported by the taxpayer to the GHGRP. A commenter also recommended that 40 CFR part 98, subpart RR (GHGRP), be used to verify secure geological storage.</P>
                    <P>Another commenter asserted that the GHGRP procedures are not stringent enough to be the basis for excluding qualified carbon dioxide from the GHG emissions rate of a qualified facility for purposes of the section 45Y or 48E credits. This commenter noted that the current methodology for the GHGRP does not accurately track emissions to conduct LCAs and determine emissions from C&amp;G Facilities. The commenter also noted that measurements of carbon dioxide that is captured, sequestered, or injected into an EOR project are based on volumetric and mass flow-related mathematical and engineering calculations once a quarter, whereas calculations within the GHGRP assume that operations and measurement are consistent, excluding any considerations of site-specific equipment, operations, or malfunctions. The commenter asserted that this assumption may lead to inaccurate reporting to the GHGRP.</P>
                    <P>After consideration of the comments, the final regulations at § 1.45Y-5(e)(2) provide that the requirements for substantiation and verification of carbon capture and sequestration provided by regulations and Internal Revenue Bulletin guidance under section 45Q must be satisfied for qualified carbon dioxide to be taken into account to compute the GHG emissions rate of a qualified facility. Further, all taxpayers must comply with applicable GHGRP requirements under 40 CFR part 98, subpart PP (for carbon capture), subpart RR (for geological storage), and subpart RR or VV (for geological storage through enhanced oil recovery). In addition to the section 45Q rules, taxpayers using the ISO 27916 standard for EOR must report information to GHGRP under 40 CFR part 98, subpart VV. Additionally, a taxpayer claiming the section 45Y credit while conducting carbon capture and sequestration must also include their applicable GHGRP ID number(s) on any applicable IRS Form when claiming the section 45Y credit, with the exception of taxpayers claiming the section 45Y credit by performing carbon capture and utilization. The GHGRP does not provide a reporting mechanism for utilization.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS provided an example in which carbon dioxide that was captured and sequestered as required by section 45Y(e)(3) subsequently escapes into the atmosphere after such carbon dioxide was taken into account by a taxpayer that claimed a section 45Y or 48E credit. The Treasury Department and the IRS asked what enforcement mechanisms or regulatory regimes should be used to identify when such emissions leakages have occurred. The Treasury Department and the IRS also requested comment regarding how such emissions leakages should be taken into account in determining compliance with the GHG emissions rate requirements under sections 45Y and 48E.</P>
                    <P>Several commenters endorsed using recapture concepts from the section 45Q rules to address instances in which qualified carbon dioxide taken into account for the section 45Y or 48E credits later leaks. Other commenters recommended that for cases in which captured and sequestered carbon dioxide subsequently escapes into the atmosphere, enforcement mechanisms should include regular monitoring and reporting requirements outlined in 40 CFR part 98, subpart RR, or CSA/ANSI ISO 27916:2019, as referenced in § 1.45Q-5(c). A commenter noted that stricter standards of measurement and reporting, and accounting for leakages are required to accurately determine if a facility's carbon capture and sequestration adequately accounts for leaked emissions. Another commenter suggested that for purposes of the section 45Y and 48E credits, treatment of emissions leakages must be adjusted from the section 45Q rules to require recalculation of the emissions rate of the qualified facility if the recalculated GHG emissions rate exceeds the required threshold.</P>
                    <P>After consideration of the comments the Treasury Department and the IRS have determined that the provisions of the section 45Q rules will apply to qualified carbon dioxide taken into account by a taxpayer for purposes of the section 45Y or 48E credits. These provisions include rules and standards for quantifying, certifying, and verifying when metric tons of qualified carbon dioxide have leaked into the atmosphere.</P>
                    <P>
                        Further, the Treasury Department and the IRS also asked whether the existing recapture provisions under section 45Q are sufficient to address emissions leakages. Several commenters recommended that the final regulations incorporate the recapture requirements provided under § 1.45Q-5 to address captured and sequestered carbon oxide that later escapes into the atmosphere when a taxpayer has taken that carbon dioxide into account for purpose of the section 45Y or 48E credits. The section 45Q rules provide for a 3-year recapture period using a LIFO method and provide that for each year during the recapture period the amount of qualified carbon dioxide that is injected into secure geological storage is netted against the amount of qualified carbon 
                        <PRTPAGE P="4086"/>
                        dioxide that may leak from such secure geological storage.
                    </P>
                    <P>A commenter noted that the mechanics of attributing leakage events across years must be adapted for the section 45Y and 48E credits, with the effect of disqualifying a facility for the credit in years for which the recalculated GHG emissions rate exceeds the threshold. While most commenters endorsed adopting the concepts of the section 45Q recapture rule to the section 45Y and 48E credits, a commenter requested that the recapture rules not apply to taxpayers that use carbon capture and utilization to claim the section 45Y or 48E credits. The Treasury Department and the IRS have determined that the provisions of the section 45Q rules will apply to qualified carbon dioxide taken into account by a taxpayer for purposes of the section 45Y or 48E credits. These provisions include rules and standards for quantifying, certifying, and verifying when metric tons of qualified carbon dioxide have leaked into the atmosphere.</P>
                    <P>In the preamble to the proposed regulations, the Treasury Department and the IRS also requested comment regarding whether carbon capture and sequestration that occurs in the production of fuel that is used by a facility to produce electricity should be taken into account under proposed § 1.45Y-5(e) and section 45Y(e)(3) and, if so, how should such use of carbon capture and sequestration be assessed in an LCA. Several commenters asserted that fuel production is within the boundaries of an LCA for a C&amp;G Facility and the determination of the GHG emissions rates for the qualified facility, and therefore, emissions captured and sequestered in the production of fuel for the qualified facility should be taken into account. Additionally, several commenters recommended that for carbon capture and sequestration occurring in the production of fuel used by a qualified facility to produce electricity, the LCA should account for emissions from the entire carbon capture and sequestration process, including capture, purification, compression, transportation, and injection because these processes all require energy input and will potentially result in further fugitive emissions and leaks. These commenters noted that a contrary approach would ignore a large portion of GHG emissions in the LCA. As a result, the commenters assert that the GHG emissions from these stages should be included in determining the net GHG emissions rate of a C&amp;G Facility.</P>
                    <P>Other commenters asserted that if carbon capture and sequestration occurs in the production of a fuel used as a feedstock for a qualified facility, such emissions should be excluded from the GHG emissions of the qualified facility. A commenter noted that where fuel is produced from a process that involves carbon capture and sequestration (such as natural gas steam methane reforming, or gasification of biomass), the entity producing that fuel would claim any carbon removal credits. Therefore, the commenter asserted that the carbon dioxide captured and sequestered from the production of the fuel should not be accounted for by the qualified facility that uses such the fuel to produce electricity.</P>
                    <P>
                        After consideration of the comments, the Treasury Department and the IRS have determined that for purposes of determining a net GHG emissions rate of a qualified facility, the section 45Q rules will apply 
                        <E T="03">only</E>
                         to qualified carbon dioxide subject to CCS at such qualified facility 
                        <E T="03">during</E>
                         the production of electricity. While the section 45Q rules are applicable to a taxpayer that uses CCS at a qualified facility during the production of electricity, there currently is no known administrable method to apply those provisions to third parties that produce fuel used by a qualified facility. Accordingly, the final regulations do not adopt the commenters' recommendation that CCS that occurs in the production of fuel that is used by a qualified facility to produce electricity should be taken into account for purpose of determining the net GHG emissions rate of such qualified facility.
                    </P>
                    <HD SOURCE="HD3">G. Annual Publication of Emissions Rates</HD>
                    <P>Proposed § 1.45Y-5(f)(1) provided that, as required by section 45Y(b)(2)(C)(i), the Secretary will annually publish a table that sets forth the GHG emissions rates for types or categories of facilities (Annual Table), which a taxpayer must use for purposes of section 45Y. Proposed § 1.45Y-5(f)(1) further provided that, except as provided in proposed § 1.45Y-5(h), a taxpayer that owns a facility that is described in the Annual Table on the first day of the taxpayer's taxable year in which the section 45Y or section 48E credit is determined with respect to such facility must use the Annual Table as of such date to determine an emissions rate for such facility for such taxable year.</P>
                    <P>Types or categories of facilities must be added or removed from the Annual Table consistent with, for Non-C&amp;G Facilities, a technical assessment of the fundamental energy transformation into electricity as provided in proposed § 1.45Y-5(c)(1)(ii), and, for C&amp;G Facilities, an LCA that complies with proposed § 1.45Y-5(d) and (e). Proposed § 1.45Y-5(f)(2) also provided that in connection with the publication of the Annual Table, the Secretary must publish an accompanying expert analysis that addresses any types or categories of facilities added or removed from the Annual Table since its last publication. Such analysis must be prepared by one or more of the National Laboratories, in consultation with other Federal agency experts, such as experts from DOE, the Treasury Department, the United States Department of Agriculture (USDA), and the EPA, as appropriate, and must address whether the addition or removal of types or categories of facilities from the Annual Table complies with section 45Y(b)(2)(A) and (B) (which refers to the definition of lifecycle GHG emissions in 42 U.S.C. 7545(o)(1)(H)) of the Code and proposed § 1.45Y-5. The Treasury Department and the IRS view the requirement to publish an expert analysis prepared by the National Laboratories of changes to the Annual Table as essential to ensuring public accountability and adherence to sound scientific principles. This requirement would also ensure that the Secretary has a robust record to inform any changes to the Annual Table.</P>
                    <P>
                        The Treasury Department and the IRS intend to include in the Annual Table the types or categories of facilities that are described in the final regulations as having a GHG emissions rate that is not greater than zero. To provide clarity and certainty to taxpayers regarding eligibility, the Treasury Department and the IRS may also include in the Annual Table the types or categories of facilities that have a GHG emissions rate that is greater than zero and therefore do not meet the definition of a qualified facility. The Treasury Department and the IRS intend to publish the first Annual Table after the publication of the final regulations. Until the first publication of the Annual Table, taxpayers may treat the types or categories of facilities that are listed in proposed § 1.45Y-5(c)(2)(i) through (viii) as being described in an Annual Table as having a GHG emissions rate that is not greater than zero. Further, any types or categories of facilities that are added or removed from this list in the first publication of the Annual Table or any changes to emissions determinations for any types or categories of facilities in the Annual Table must be accompanied by the publication of an expert analysis of such 
                        <PRTPAGE P="4087"/>
                        change as provided in proposed § 1.45Y-5(f)(2). If there are no changes to the Annual Table in a given taxable year, the Treasury Department and the IRS intend to notify taxpayers accordingly.
                    </P>
                    <P>Commenters provided multiple perspectives on the substance and form of the Annual Table. Commenters noted that the Treasury Department and the IRS are required to publish an Annual Table that includes “the GHG emissions rates for types or categories of facilities.” Some commenters stated that the Annual Table should include the emissions rates of components used in different C&amp;G technologies, that would be consistent for all facilities under specific conditions. Other commenters stated that the Treasury Department and the IRS should either not list the facility type in the Annual Table or should be conservative about the criteria listed for facilities with zero or negative emissions.</P>
                    <P>As noted earlier in this section of this Summary of Comments and Explanation of Revisions, section 45Y(b)(2)(C)(i) requires the Secretary to annually publish a table that sets forth the GHG emissions rates for types or categories of facilities. In order to promote taxpayer certainty and fulfill the requirements of the statute, the Annual Table should include sufficient information about what types or categories of facilities meet the GHG emissions rate requirements in sections 45Y and 48E. The Treasury Department and the IRS therefore do not adopt commenters' suggestions that the Annual Table should not include specific facility types.</P>
                    <P>From a technical perspective, many taxpayer situations cannot be covered in the Annual Table in a way that would be consistent with the statutory requirements for determining GHG emissions rates, as specific factual circumstances will impact the outcomes of this analysis. In order to avoid false precision, the Treasury Department and the IRS have determined that the Annual Table should capture whether a particular type or category of facility has a GHG emissions rate of less than or equal to zero or a rate that is greater than zero. These determinations will be made consistent with the requirements of sections 45Y and 48E and these final regulations.</P>
                    <P>Some commenters requested that the publication of the Annual Table be expedited to release the first Annual Table at the same time as the final regulations. Commenters also suggested that, for types or categories of facilities that are listed as having a GHG emissions rate that is less than or equal to zero in the final regulations, publication of the Annual Table or a PER certification is unnecessary for those facilities to meet the emissions rate requirement.</P>
                    <P>Given the time and effort necessary to conduct emissions analysis that meets the requirements of the statute and these final regulations, the Treasury Department and the IRS cannot commit to a specific timeline for publication of the first Annual Table at this time. However, as noted earlier in this section of this Summary of Comments and Explanation of Revisions, taxpayers may treat the types or categories of facilities that are listed in these final regulations as having an emissions rate that is less than equal to zero or an emissions rate of greater than zero in accordance with the rules provided in the final regulations.</P>
                    <P>Commenters also raised concerns regarding consistency between the approach to the Annual Table and the PER process. Some commenters stated that the Treasury Department should take a conservative approach to the evaluation of any petitions for C&amp;G Facility types not listed in the Annual Table. The Treasury Department and the IRS have adopted an approach that harmonizes the technical requirements for the Annual Table and the PER process. For example, for purposes of determining the net GHG emissions rate for a C&amp;G Facility under sections 45Y and 48E, any LCA must meet the requirements of the statutes, including taking into account lifecycle GHG emissions as described in 42 U.S.C. 7545(o)(1)(H) and these final regulations.</P>
                    <P>Commenters supported the proposed regulations' approach to updating the Annual Table, including the requirement to produce analysis led by one or more of the National Laboratories, in consultation with other Federal agency experts, and the requirement to publish that analysis. The Treasury Department and the IRS agree that such an approach is essential to ensuring public accountability and adherence to sound scientific principles and adopt the approach as proposed in the final regulations.</P>
                    <HD SOURCE="HD3">H. Provisional Emissions Rates</HD>
                    <HD SOURCE="HD3">1. In General</HD>
                    <P>For purposes of section 45Y, proposed § 1.45Y-5(g) provided the rules applicable to provisional emissions rates. Proposed § 1.45Y-5(g)(1) provided that, in the case of any facility that is of a type or category for which an emissions rate has not been established by the Secretary under proposed § 1.45Y-5(g), a taxpayer that owns such facility may file a petition with the Secretary for the determination of the emissions rate with respect to such facility (Provisional Emissions Rate or PER).</P>
                    <P>For purposes of section 48E, proposed § 1.48E-5(g) provided the rules applicable to provisional emissions rates. Proposed § 1.48E-5(g)(1) provided that, in the case of any facility that is of a type or category for which an emissions rate has not been established by the Secretary under proposed § 1.48E-5(g), a taxpayer that owns such facility may file a petition with the Secretary for the determination of the emissions rate with respect to such facility (Provisional Emissions Rate or PER). The proposed rule is adopted without change.</P>
                    <HD SOURCE="HD3">2. Rate Not Established</HD>
                    <P>Proposed § 1.45Y-5(g)(2) provided that an emissions rate has not been established by the Secretary for a facility for purposes of section 45Y(b)(2)(C)(ii) if such facility is not described in the Annual Table. If a taxpayer's request for an emissions value pursuant to proposed § 1.45Y-5(g)(5) is pending at the time such facility is or becomes described in the Annual Table, the taxpayer's request for an emissions value will be automatically denied.</P>
                    <P>Proposed § 1.48E-5(g)(2) provided that an emissions rate has not been established by the Secretary for a facility for purposes of sections 45Y(b)(2)(C)(ii) and 48E(b)(3)(B)(ii) if such facility is not described in the Annual Table. If a taxpayer's request for an emissions value pursuant to proposed § 1.48E-5(g)(5) is pending at the time such facility is or becomes described in the Annual Table, the taxpayer's request for an emissions value will be automatically denied.</P>
                    <HD SOURCE="HD3">3. Process for Filing a PER Petition</HD>
                    <P>Proposed § 1.45Y-5(g)(3) provided the process for filing a PER petition. Proposed § 1.45Y-5(g)(3) provided that to file a PER petition with the Secretary, a taxpayer must submit a PER petition by attaching it to the taxpayer's Federal income tax return or Federal return, as appropriate, for the first taxable year in which the taxpayer claims the section 45Y credit with respect to the facility to which the PER petition applies. A PER petition must contain an emissions value and, if provided by DOE, the associated DOE letter. An emissions value may be obtained from DOE or by using the LCA model designated in proposed § 1.45Y-5(g)(6).</P>
                    <P>
                        An emissions value obtained from DOE will be based on an analytical 
                        <PRTPAGE P="4088"/>
                        assessment of the emissions rate associated with the facility, performed by one or more National Laboratories, in consultation with Federal agency and other experts as appropriate, consistent with proposed § 1.45Y-5. A taxpayer would be required to retain in its books and records the request to DOE for an emissions value, including any information provided by the taxpayer to DOE pursuant to the emissions value request process provided in proposed § 1.45Y-5(g)(5).
                    </P>
                    <P>
                        Alternatively, an emissions value can be determined by the taxpayer for a facility using the most recent version of an LCA model or models, as of the time the PER petition is filed, that have been designated by the Secretary for such use under proposed § 1.45Y-5(g)(6). If an emissions value is determined using the designated model, a taxpayer is required to provide to the IRS information to support its determination of the emissions value in the form and manner prescribed in IRS forms or instructions or in publications or guidance published in the Internal Revenue Bulletin. 
                        <E T="03">See</E>
                         § 601.601 of this chapter. A taxpayer may not request an emissions value from DOE for a facility for which an emissions value can be determined by using the most recent version of an LCA model or models that have been designated by the Secretary for such use under proposed § 1.45Y-5(g)(6).
                    </P>
                    <P>Proposed § 1.48E-5(g)(3) provided the process for filing a PER petition. Proposed § 1.48E-5(g)(3) provided that to file a PER petition with the Secretary, a taxpayer must submit a PER petition by attaching it to the taxpayer's Federal income tax return or Federal return, as appropriate, for the first taxable year in which the taxpayer claims the section 48E credit with respect to the facility to which the PER petition applies. A PER petition must contain an emissions value and, if provided by DOE, the associated DOE letter. An emissions value may be obtained from DOE or by using the LCA model designated in proposed § 1.48E-5(g)(6).</P>
                    <P>An emission value obtained from DOE will be based on an analytical assessment of the emissions rate associated with the facility, performed by one or more National Laboratories, in consultation with other Federal agency experts as appropriate, consistent with proposed § 1.48E-5. A taxpayer would be required to retain in its books and records the request to DOE for an emissions value, including any information provided by the taxpayer to DOE pursuant to the emissions value request process provided in proposed § 1.48E-5(g)(5).</P>
                    <P>
                        Alternatively, an emissions value can be determined by the taxpayer for a facility using the most recent version of an LCA model or models, as of the time the PER petition is filed, that have been designated by the Secretary for such use under proposed § 1.48E-5(g)(6). If an emissions value is determined using the designated model, a taxpayer is required to provide to the IRS information to support its determination of the emissions value in the form and manner prescribed in IRS forms or instructions or in publications or guidance published in the Internal Revenue Bulletin. 
                        <E T="03">See</E>
                         § 601.601 of this chapter. A taxpayer may not request an emissions value from DOE for a facility for which an emissions value can be determined by using the most recent version of an LCA model or models that have been designated by the Secretary for such use under proposed § 1.48E-5(g)(6).
                    </P>
                    <P>A commenter supported the process provided in the proposed regulations for filing a PER petition and for permitting taxpayers to determine an emissions value during the PER process based on the most recent approved LCA model. However, the commenter cautioned that a self-certification option would be effective only to the extent that LCA models are approved for clean-electricity technologies for which an emissions rate is not available in the Annual Table. This commenter recommended that the Treasury Department and the IRS approve LCA models expeditiously and ensure that the LCA models take avoided emissions into account based on technologies like fuel cells. Another commenter suggested clarifying whether facilities with standardized configurations and equipment could rely upon a single PER, rather than having to independently apply for a PER. The commenter emphasized that a single PER could just as easily be applied to separate facilities, provided that material characteristics are sufficiently similar.</P>
                    <P>The Treasury Department and the IRS developed the PER process in consultation with the DOE and other agencies. The procedures developed for the PER process will designate an LCA model or models that are consistent with the requirements of sections 45Y and 48E and these regulations for use under § 1.45Y-5(g)(6). The Treasury Department and the IRS decline to permit taxpayers to rely upon a single PER for separate facilities, because, as a commenter recognized, whether a single PER could be applicable to separate facilities would depend on the facts and circumstances. Accordingly, to ensure that the taxpayer has a PER determination applicable to each qualified facility, the taxpayer must submit a request for a PER determination for each separate facility.</P>
                    <P>With respect to the Annual Table and the PER process, a commenter requested that the Treasury Department develop or design an incentive for those investors willing to invest in technological innovations that could improve on average results likely set forth in the Annual Table. The Treasury Department and the IRS decline to address this request because the addition of extra-statutory incentives is outside the scope of these final regulations.</P>
                    <HD SOURCE="HD3">4. PER Determination</HD>
                    <P>Proposed § 1.45Y-5(g)(4) provided that, upon the IRS's acceptance of the taxpayer's Federal income tax return or Federal return, as appropriate, containing a PER petition, the emissions value of the facility specified on such petition will be deemed accepted. Such PER petition must be submitted to the IRS in the first taxable year in which the taxpayer claims the section 45Y credit with respect to the facility to which the PER petition applies. A taxpayer would be able to rely upon an emissions value provided by DOE for purposes of calculating and claiming a section 45Y credit, provided that any information, representations, or other data provided to DOE in support of the request for an emissions value accurately reflect the facility's operations in each year the taxpayer seeks to rely on that emissions value. If applicable, a taxpayer may rely upon an emissions value determined for a facility using the most recent version of the LCA model or models that, as of the time the PER petition is filed, have been designated by the Secretary for such use under proposed § 1.45Y-5(g)(6), provided that any information, representations, or other data used to obtain such emissions value remain accurate. The IRS's deemed acceptance of an emissions value is the Secretary's determination of the PER. The taxpayer must still comply with all applicable requirements for the section 45Y credit and any information, representations, or other data supporting an emissions value are subject to later examination by the IRS.</P>
                    <P>
                        Proposed § 1.48E-5(g)(4) provided that, upon the IRS's acceptance of the taxpayer's Federal income tax return or Federal return, as appropriate, containing a PER petition, the emissions value of the facility specified on such petition will be deemed accepted. A taxpayer would be able to rely upon an emissions value provided by DOE for purposes of calculating and claiming a 
                        <PRTPAGE P="4089"/>
                        section 48E credit, provided that any information, representations, or other data provided to DOE in support of the request for an emissions value are accurate. If applicable, a taxpayer may rely upon an emissions value determined for a facility using the most recent version of the LCA model or models that, as of the time the PER petition is filed, have been designated by the Secretary for such use under proposed § 1.48E-5(g)(6), provided that any information, representations, or other data used to obtain such emissions value are accurate. The IRS's deemed acceptance of an emissions value is the Secretary's determination of the PER. The taxpayer must still comply with all applicable requirements for the section 48E credit and any information, representations, or other data supporting an emissions value are subject to later examination by the IRS.
                    </P>
                    <P>A commenter suggested permitting joint evaluations of similar PER requests, as well as leveraging information submitted under prior evaluations, to promote a more streamlined process. The commenter requested that the Treasury Department and the IRS prioritize certainty and expediency and clarify the timing by which taxpayers can expect to receive an official assessment from the National Laboratories and other involved experts. An additional commenter stated that a delay in PER determinations would be hugely detrimental and disadvantage early entrants and innovative technologies. This commenter suggested that the Treasury Department, the IRS, and the DOE assess their collective capacities and resource needs to conduct analytical assessments for PER applications efficiently and expeditiously. The commenter also recommended that the Treasury Department direct the DOE to assess applications and determine a facility's emissions rate within six months of a taxpayer's submission of a PER application.</P>
                    <P>The Treasury Department and the IRS recognize the importance of certainty and expediency in evaluating PER requests and have consulted with DOE to develop the PER application process. These agencies expect to review PER applications within an appropriate timeframe. Therefore, the changes suggested by the comments are not adopted. The Treasury Department and the IRS will continue to consult with the DOE as appropriate to assist in the administration of these final regulations.</P>
                    <HD SOURCE="HD3">5. Emissions Value Request Process</HD>
                    <P>Proposed § 1.45Y-5(g)(5) provided the rules applicable to the emissions value request process. Proposed § 1.45Y-5(g)(5) provided that an applicant that submits a request for an emissions value must follow the procedures specified by DOE to request and obtain such emissions value, and that emissions values will be determined consistent with the rules provided in proposed § 1.45Y-5. An applicant may request an emissions value from DOE only after a front-end engineering and design (FEED) study or similar indication of project maturity, as determined by DOE, such as the completion of a project specification and cost estimation sufficient to inform a final investment decision for the facility. DOE may decline to review applications that are non-responsive and those applications that relate to a facility that is described in the Annual Table (consistent with proposed § 1.45Y-5(g)(2)) or a facility that can determine an emissions value using a designated LCA model under proposed § 1.45Y-5(g)(6) (consistent with proposed § 1.45Y-5(g)(3)), or applications that are incomplete.</P>
                    <P>Proposed § 1.45Y-5(g)(5) also provided that applicants must follow DOE's guidance and procedures for requesting and obtaining an emissions value from DOE. DOE will publish guidance and procedures that applicants must follow to request and obtain an emissions value from DOE. DOE's guidance and procedure will include a process, under limited circumstances, for a taxpayer to request a revision to DOE's initial assessment of an emissions value on the basis of revised technical information or facility design and operation. The Treasury Department and the IRS anticipate that the emissions value request process will open after the publication of the final regulations.</P>
                    <P>Proposed § 1.48E-5(g)(5) provided the rules applicable to the emissions value request process. Proposed § 1.48E-5(g)(5) provided that an applicant that submits a request for an emissions value must follow the procedures specified by DOE to request and obtain such emissions value, and that emissions values will be determined consistent with the rules provided in proposed § 1.48E-5. An applicant may request an emissions value from DOE only after a FEED study or similar indication of project maturity, as determined by DOE, such as the completion of a project specification and cost estimation sufficient to inform a final investment decision for the facility. DOE may decline to review applications that are non-responsive and those applications that relate to a facility that is described in the Annual Table (consistent with proposed § 1.48E-5(g)(2)) or a facility that can determine an emissions value using a designated LCA model under proposed § 1.48E-5(g)(6) (consistent with proposed § 1.48E-5(g)(3)), or applications that are incomplete.</P>
                    <P>Proposed § 1.48E-5(g)(5) also provided that applicants must follow DOE's guidance and procedures for requesting and obtaining an emissions value from DOE. DOE will publish guidance and procedures that applicants must follow to request and obtain an emissions value from DOE. DOE's guidance and procedure will include a process, under limited circumstances, for a taxpayer to request a revision to DOE's initial assessment of an emissions value on the basis of revised technical information or facility design and operation. The Treasury Department and the IRS anticipate that the emissions value request process will open after the publication of the final regulations.</P>
                    <P>A commenter requested that the Treasury Department conservatively evaluate any petitions to assign an emissions rate for C&amp;G facility types not listed in the Annual Table and to strive to be fully confident that operation of the facility would not lead to net lifecycle emissions.</P>
                    <P>The Treasury Department and the IRS have adopted an approach that harmonizes the technical requirements for the Annual Table and the PER process. For example, for purposes of determining the GHG emissions rate for a C&amp;G Facility under sections 45Y and 48E, any LCA must meet the requirements of the statutes, including taking into account lifecycle GHG emissions as described in 42 U.S.C. 7545(o)(1)(H) and these final regulations.</P>
                    <P>
                        Another commenter contended that completion of a FEED study is an inappropriate indicator of project maturity to request a PER. The commenter asserted that such a requirement could substantially delay projects and that a more logical approach would be for the DOE to determine a PER using a pre-FEED or feasibility study as a demonstration of project maturity. An additional commenter claimed that the cost and related timing of a FEED study may be prohibitive for distributed or small-scale facilities. The commenter asserted that in order to access project financing, project developers must know early in the development process that a facility will be eligible for the section 45Y or 48E credit. However, the commenter stated that, a FEED study cannot typically be completed until well after a project developer will need to have provided prospective financiers with 
                        <PRTPAGE P="4090"/>
                        certainty about credit eligibility. The commenter noted that this disconnect could effectively prevent the development of clean energy production facilities that utilize pathways not already identified in the Annual Table.
                    </P>
                    <P>
                        As an alternative to requiring a FEED study, a commenter suggested accepting an LCA performed by a third-party, DOE-certified provider, conducted using the most current, approved GREET model, provided that the following criteria are satisfied: (i) the system is UL or CE certified, (ii) the total landed bill of materials (BOM) cost of the system is less than $20 million, and (iii) the system has less than 10 MW energy equivalent (thermal, total gas flow, or total electricity) in it. Similarly, a commenter asserted that FEED studies can cost up to $50 million and delay project development by 6-8 months and recommended considering projects at FEL-2 
                        <SU>27</SU>
                        <FTREF/>
                         of the project for PER applications.
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             FEL-2, also known as the conceptual design or feasibility design phase of a project, may typically result in deliverables which include project schedule, preliminary design report, site layout, and similar. 
                            <E T="03">See</E>
                             Stage Gate Project Management, Mark Ludwigson, PDH Academy, 
                            <E T="03">https://pdhacademy.com/wp-content/uploads/2024/01/524-Stage_Gate_Project_Management.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Proposed § 1.45Y-5(g)(5) provided flexibility to taxpayers by permitting a taxpayer to request an emissions value from DOE after an indication of project maturity, as determined by DOE, such as a FEED study or the completion of a project specification and cost estimation sufficient to inform a final investment decision for the facility. As proposed, DOE has some discretion to determine appropriate project maturity indicators, if not a FEED study. However, a pre-FEED or feasibility study are not adequate indicators of project maturity as there exists too high of a likelihood that the final design of the qualified facility will differ from the pre-FEED or feasibility study and therefore would undermine the implementation of the statutory definition of a qualified facility. Accordingly, the proposed rule is adopted without change.</P>
                    <P>An applicant can request an emissions value from DOE only after a front-end FEED study or similar indication of project maturity, as determined by DOE, such as the completion of a project specification and cost estimation sufficient to inform a final investment decision for the facility. The DOE will publish more information about the process to receive an emissions value in forthcoming guidance.</P>
                    <HD SOURCE="HD3">6. LCA Model for Determining an Emissions Value for C&amp;G Facilities</HD>
                    <P>Proposed § 1.45Y-5(g)(6) provided that the Secretary may designate one or more LCA models for a taxpayer to determine an emissions value for C&amp;G Facilities that are not described in the Annual Table. A model may only be designated if it complies with section 45Y(b)(2)(B) and proposed § 1.45Y-5(d) and (e). The Secretary may revoke the designation of an LCA model or models. In connection with the designation or revocation of a designation of an LCA model or models, the Secretary is required to publish an accompanying expert analysis of the model prepared by one or more of the National Laboratories, in consultation with other Federal agency experts as appropriate. Such analysis must address the model's compliance with section 45Y(b)(2)(B) and proposed § 1.45Y-5(d) and (e). The Treasury Department and the IRS view the requirement to publish an expert analysis prepared by the National Laboratories of the designation or revocation of designation of an LCA model or models as essential to ensuring public accountability and adherence to sound scientific principles. This requirement also ensures that the Secretary has a robust record to inform any designations or revocations of an LCA model or models.</P>
                    <P>The rules provided in proposed § 1.45Y-5(g)(6) regarding the designation of an LCA model or models for determining an emissions value for C&amp;G Facilities apply for purposes of section 48E and proposed § 1.48E-5(g)(6).</P>
                    <HD SOURCE="HD3">7. Effect of PER</HD>
                    <P>Proposed § 1.45Y-5(g)(7) provided that a taxpayer may use a PER determined by the Secretary to determine the section 45Y credit for the facility to which the PER applies, provided all other requirements of section 45Y are met. The Secretary's determination of a PER is not an examination or inspection of books of account for purposes of section 7605(b) of the Code and does not preclude or impede the IRS (under section 7605(b) or any administrative provisions adopted by the IRS) from later examining a return or inspecting books or records with respect to any taxable year for which the section 45Y credit is claimed. A PER determination does not signify that the IRS has determined that the requirements of section 45Y have been satisfied for any taxable year.</P>
                    <P>Proposed § 1.48E-5(g)(7) provided that a taxpayer may use a PER determined by the Secretary to determine the section 48E credit for the facility to which the PER applies, provided all other requirements of section 48E are met. The Secretary's determination of a PER is not an examination or inspection of books of account for purposes of section 7605(b) of the Code and does not preclude or impede the IRS (under section 7605(b) or any administrative provisions adopted by the IRS) from later examining a return or inspecting books or records with respect to any taxable year for which the section 48E credit is claimed. A PER determination does not signify that the IRS has determined that the requirements of section 48E have been satisfied for any taxable year.</P>
                    <HD SOURCE="HD3">8. Reliance on Annual Table or Provisional Emissions Rate</HD>
                    <P>Proposed § 1.45Y-5(h) provided that taxpayers may rely on the Annual Table in effect as of the date a facility began construction or the provisional emissions rate that has been determined by the Secretary for the taxpayer's facility under proposed § 1.45Y-5(g)(4) to determine the facility's GHG emissions rate for that facility for any taxable year that is within the 10-year period described in section 45Y(b)(1)(B), provided that the facility continues to operate as a type of facility that is described in the Annual Table or the facility's emissions value request, as applicable, for the entire taxable year.</P>
                    <P>A commenter requested a safe harbor for taxpayers with ongoing transactions in the event of any changes to categories of facilities and corresponding GHG emissions rates listed on the Annual Table, with a clearly advertised cutoff date for the applicability of the prior iteration.</P>
                    <P>The proposed regulations provided a rule allowing for reliance on the Annual Table in effect as of the date a facility began construction in order to give sufficient taxpayer certainty for projects in development. Specifying that reliance on the Annual Table in effect based on the beginning of construction date provides a clear point in time that is already well understood for tax purposes. The commenter's recommendation requires a fact intensive analysis of an event or series of events that lack a definitive date certain for when a transaction becomes “ongoing.” Such a rule is not administrable for taxpayers and the IRS. Therefore, the proposed rule is adopted without change.</P>
                    <HD SOURCE="HD3">I. Determining Anticipated Greenhouse Gas Emissions Rate</HD>
                    <P>
                        Consistent with section 48E(b)(3)(A)(iii), proposed § 1.48E-5(h) 
                        <PRTPAGE P="4091"/>
                        provided rules to determine an anticipated GHG emissions rate. As explained in the preamble to the proposed regulations, the Treasury Department and the IRS interpret the reference in section 48E(b)(3)(A)(iii) to an “anticipated greenhouse gas emissions rate” that is not greater than zero to require a reasonable expectation that a qualified facility will operate with a rate or net rate of greenhouse gas emissions that is not greater than zero over a specified period of time. Certain Non-C&amp;G Facilities, such as the facilities described in § 1.45Y-5(c)(2), may have an anticipated greenhouse gas emissions rate that is not greater than zero based on the technology and practices they rely upon to generate electricity. For facilities that require the use of certain fuel sources, which may vary, or carbon capture and sequestration, to generate electricity with a greenhouse gas emissions rate that is not greater than zero, objective indicia that such facilities will use such fuel sources or operate such carbon capture equipment, as applicable, in a manner that results in a greenhouse gas emissions rate that is not greater than zero for at least 10 years beginning from the date the facility is placed in service are required to establish a reasonable expectation that the combination of fuel, type of facility, and practice will result in a greenhouse gas emissions rate that is not greater than zero.
                    </P>
                    <P>The proposed regulations provided a non-exhaustive list of examples of objective indicia that may establish a reasonable expectation that a qualified facility will operate with an anticipated GHG emissions rate that is not greater than zero, including include co-location of the facility with a fuel source for which the combination of fuel, type of facility, and practice is reasonably expected to result in a GHG emissions rate that is not greater than zero; a 10-year contract to purchase fuels for which the combination of fuel, type of facility, and practice is reasonably expected to result in a GHG emissions rate that is not greater than zero; or a facility type that only accommodates one type of fuel or a small range of fuels for which the combination of fuel, type of facility, and practice is reasonably expected to result in a GHG emissions rate that is not greater than zero; or a 10-year contract for the capture, disposal, or utilization of qualified carbon dioxide from the facility for which the combination of fuel, type of facility, and practice is reasonably expected to result in a GHG emissions rate that is not greater than zero. These examples are adopted in the final regulations in § 1.48E-5(h)(2) with minor changes to clarify that such contracts must be binding written contracts and to more closely align the language used in the example pertaining to carbon capture and sequestration at proposed § 1.48E-5(h)(2)(iv) with that used for purposes of section 45Q and referenced in section 45Y(b)(2)(D).</P>
                    <P>The Treasury Department and the IRS requested comment on what evidence or substantiation taxpayers should be required to maintain to be able to establish an anticipated GHG emissions rate for a qualified facility. Two commenters recommended requiring that objective indicia take the form of physical features that make it more likely that the qualified facility will operate with a GHG emissions rate that is not greater than zero. In these commenters' view, if the objective indicia do not relate to physical features of the qualified facility, the qualified facility could be too easily repurposed in a way that results in a positive GHG emissions rate. Commenters provided examples of physical features such as evidence of carbon capture and sequestration equipment incorporated into the qualified facility or a direct pipeline connection from the qualified facility to a waste fuel or feedstock, as appropriate.</P>
                    <P>The Treasury Department and the IRS have determined that objective indicia need not always take the form of physical features. While in some cases physical features may provide objective indicia that a qualified facility will operate with a GHG emissions rate that is not greater than zero, such features are not relevant and therefore not required in all cases. Some qualified facilities may not have a physical feature that differentiates a facility with a GHG emissions rate that is not greater than zero from a comparable facility with a GHG emissions rate that is greater than zero. In such cases, the taxpayer must find another method of documenting its anticipated GHG emissions rate that is not greater than zero that provides a comparable level of substantiation as a physical feature. This could take the form of a long-term contract for fuel that would enable the facility to attain a GHG emissions rate that is not greater than zero, provided the contract imposes a binding obligation on the purchaser to compensate the seller for a sufficient volume of fuel to operate the entire facility for a substantial portion of the facility's lifetime, such as ten years. The Treasury Department and the IRS have determined that in some cases non-physical features that involve commitment to a third party, such as the aforementioned contract, can provide substantiation that a facility is reasonably expected to operate with a GHG emissions rate that is not greater than zero that is equivalent to the substantiation provided by a physical feature and relevant for a facts and circumstances analysis. Accordingly, the final regulations do not adopt the suggestion that objective indicia must take the form of physical features.</P>
                    <P>
                        The Treasury Department and the IRS also recognize that in some cases, a facility may seek to establish that it will operate with a GHG emissions rate that is not greater than zero on the basis that it will continuously operate carbon capture and sequestration equipment during electricity production. The physical presence of the carbon capture equipment would not generally be sufficient objective indicia to substantiate that the facility will operate using that equipment. The final regulations therefore provide at § 1.48E-5(h)(2)(iv) that one form of objective indicia substantiating operation of such equipment may include a 10-year binding written contract for the permanent geological storage (including after injection into an EOR project) or utilization of qualified carbon dioxide from the facility for which the combination of fuel, type of facility, and practice is reasonably expected to result in a GHG emissions rate that is not greater than zero. The final regulations further provide an additional example of such objective indicia substantiating the operation of this equipment at § 1.48E-5(h)(2)(v). Such objective indicia may include a legally binding Federal or State air permit which requires, as a condition of the permit, that the facility operates in a manner for which the combination of fuel, type of facility, and practice is reasonably expected to result in a greenhouse gas emissions rate that is not greater than zero and that any captured carbon dioxide is permanently geologically stored and subjects the holder to civil or criminal penalties in the event the relevant permit requirements are breached. In the case of a facility which requires the operation of carbon capture and sequestration equipment to achieve a qualifying GHG emissions rate of not greater than zero, the Treasury Department and the IRS have currently identified that such a permit requirement would provide sufficient assurance that the objective indicia requirement is met with respect to the operation of the carbon capture and sequestration and expect that taxpayers seeking to substantiate in other ways 
                        <PRTPAGE P="4092"/>
                        would need to substantiate with substantially similar objective indicia.
                    </P>
                    <P>The preamble to the proposed regulations also requested comment on the appropriate period of time for which taxpayers should be required to be able to demonstrate that there is a reasonable expectation that a qualified facility will operate with a GHG emissions rate that is not greater than zero. Commenters provided a range of views on this topic. Several commenters suggested that taxpayers be required to demonstrate objective indicia that a qualified facility will operate with a GHG emissions rate that is not greater than zero for the lifetime of the qualified facility. Several other commenters recommended that this period be shorter, asserting that longer timelines, such as those beyond ten years, could prove burdensome, in part due to greater uncertainty over such time periods.</P>
                    <P>Because the Treasury Department and the IRS have determined that the examples of objective indicia that account for a GHG emissions rate over ten years are sufficient to show that the operation of a qualified facility could reasonably be expected to result in a GHG emissions rate that is not greater than zero, these final regulations will not adopt the suggestion that the lifetime of the facility is the appropriate period of time for which a taxpayer is required to be able to demonstrate such expectation. The Treasury Department and the IRS have determined that demonstrating a reasonable expectation that a qualified facility will operate with a GHG emissions rate that is not greater than zero for the lifetime of a qualified facility would, for some long-lived facilities, be extremely challenging, if not impossible. However, these final regulations require taxpayers claiming the section 48E credit to attest under penalty of perjury in a manner prescribed by the IRS in forms or instructions that the anticipated GHG emissions rate as determined under the statute and these final regulations is not greater than zero. A facility subject to legally binding State or Federal permit conditions requiring that the facility operate in a manner that would be incompatible with a greenhouse gas emissions rate of not greater than zero is not a facility for which the anticipated greenhouse gas emissions rate is not greater than zero.</P>
                    <HD SOURCE="HD3">J. Substantiation</HD>
                    <P>Upon consideration of the comments and consultation with other Federal agency experts, the Treasury Department and the IRS have also determined that the proposed regulations would benefit from additional clarity regarding substantiation requirements. In particular, the Treasury Department and the IRS acknowledge commenters' concerns about verifying and substantiating the key characteristics that ensure a qualified facility has a GHG emissions rate not greater than zero. Accordingly, the final regulations make clear that substantiation requirements prescribed by the Secretary must include substantiation of the key parameters that would contribute to or impact the GHG emissions rates based on analytical assessments conducted by the National Laboratories, in consultation with other Federal agency experts as appropriate. The Treasury Department and the IRS will describe specific substantiation requirements for such facilities, including requirements for preparation or verification by an unrelated third party as appropriate, in future guidance. The Treasury Department and the IRS will require taxpayers to substantiate that the full electricity production process—including specific fuels or feedstocks used—is consistent with the taxpayer's claims and meets the specific criteria that the analytical assessment has found are necessary for it to meet the statutory requirement of a GHG emissions rate not greater than zero. Given feedback provided by commenters on biomass discussed in section VIII.E. of this Summary of Comments and Explanation of Revisions, the final regulations also specify that for C&amp;G Facilities utilizing biomass feedstocks, taxpayers must substantiate that the source of such fuels or feedstocks used are consistent with the taxpayer's claims. Moreover, in response to comments and as discussed in section VIII.D. of this Summary of Comments and Explanation of Revisions, if a qualified facility uses feedstocks that do not have marketability, but which are indistinguishable from marketable feedstocks (for instance, after processing), the taxpayer will be required to maintain documentation substantiating the origin and original form of the feedstock. To ensure that C&amp;G Facilities that utilize biomass feedstocks meet the statutory requirement of a net GHG emissions rate not greater than zero, the Treasury Department and the IRS anticipate that it may be appropriate to require or encourage taxpayers to maintain third-party certification that verifies that these facilities meet the criteria that the LCA has found are necessary for a facility to meet this statutory requirement.</P>
                    <HD SOURCE="HD1">Severability</HD>
                    <P>If any provision in this rulemaking is held to be invalid or unenforceable facially, or as applied to any person or circumstance, it shall be severable from the remainder of this rulemaking, and shall not affect the remainder thereof, or the application of the provision to other persons not similarly situated or to other dissimilar circumstances.</P>
                    <HD SOURCE="HD1">Applicability Dates</HD>
                    <P>These regulations apply to qualified facilities (and for §§ 1.48E-1 through 1.48E-4, ESTs) placed in service after December 31, 2024, and during taxable years ending on or after January 15, 2025.</P>
                    <HD SOURCE="HD1">Special Analyses</HD>
                    <HD SOURCE="HD2">I. Regulatory Planning and Review—Economic Analysis</HD>
                    <P>Pursuant to the Memorandum of Agreement, Review of Treasury Regulations under Executive Order 12866 (June 9, 2023), tax regulatory actions issued by the IRS are not subject to the requirements of section 6 of Executive Order 12866, as amended. Therefore, a regulatory impact assessment is not required.</P>
                    <HD SOURCE="HD2">II. Paperwork Reduction Act</HD>
                    <P>The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA) generally requires that a Federal agency obtain the approval of the Office of Management and Budget (OMB) before collecting information from the public, whether such collection of information is mandatory, voluntary, or required to obtain or retain a benefit. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a valid OMB control number.</P>
                    <P>The collections of information in these final regulations contain recordkeeping and reporting requirements that are required to substantiate eligibility to claim a section 45Y or section 48E credit. These collections of information would generally be used by the IRS for tax compliance purposes and by taxpayers to facilitate proper reporting and compliance. The general recordkeeping requirements mentioned within these final regulations are considered general tax records under § 1.6001-1(e).</P>
                    <P>
                        The recordkeeping requirements in these final regulations with respect to section 45Y include the requirement in § 1.45Y-5(h)(1) that taxpayers claiming the section 45Y credit must maintain in its books and records documentation regarding the design and operation of a facility that establishes that such facility 
                        <PRTPAGE P="4093"/>
                        had a GHG emissions rate that is not greater than zero for the taxable year. Included in § 1.45Y-5(h)(2) are examples of documentation that sufficiently substantiates that a facility has a GHG emissions rate that is not greater than zero for the taxable year, which includes documentation, or a report prepared by an unrelated party that verifies that a facility had such an emissions rate. A facility described in § 1.45Y-5(c)(2) can maintain sufficient documentation to demonstrate a GHG emissions rate that is not greater than zero for the taxable year by showing that it is a type of facility described in § 1.45Y-5(c)(2). Section 1.45Y-5(h)(2) provides that for other types of facilities not described in § 1.45Y-5(c)(2), the taxpayer must demonstrate that the qualified facility meets the specific criteria that the analytical assessment prepared by the National Laboratories, in consultation with other Federal agency experts as appropriate, has found are necessary for a facility to meet the statutory requirement of a greenhouse gas emissions rate not greater than zero. Section 1.45Y-5(j)(2) provides that for C&amp;G Facilities that utilize biomass feedstocks, the taxpayer must substantiate that the source of such fuels or feedstocks used are consistent with the taxpayer's claims. Section 1.45Y-5(j)(2) further provides that for the qualified facilities not described in § 1.45Y-5(c)(2), the Secretary may determine that other types of facilities can sufficiently substantiate a GHG emissions rate, as determined under this section, that is not greater than zero with certain documentation and will describe such facilities and documentation in IRS forms, instructions, or publications, or guidance published in the Internal Revenue Bulletin. For facilities that utilize unmarketable feedstocks that are indistinguishable from marketable feedstocks (for instance, after processing), the taxpayer will be required to maintain documentation substantiating the origin and original form of the feedstock. For PRA purposes, these general tax records are already approved by OMB under 1545-0074 for individuals, 1545-0123 for business entities, 1545-0092 for trust and estate filers, and 1545-0047 for tax-exempt organizations.
                    </P>
                    <P>
                        The recordkeeping requirements in these final regulations with respect to section 48E would include the requirement in § 1.48E-5(k)(1) that a taxpayer must maintain in its books and records documentation regarding the design and operation of a facility that establishes that such facility had an anticipated GHG emissions rate that is not greater than 10 grams of CO
                        <E T="52">2</E>
                        e per kWh during each year of the recapture period that applies for purposes of section 48E(g). Included in § 1.48E-5(k)(2) are examples of documentation that sufficiently substantiates that a facility has a GHG emissions rate that is not greater 10 grams of CO
                        <E T="52">2</E>
                        e per kWh during each year of the recapture period, which includes documentation, or a report prepared by an unrelated party that verifies that a facility had such an emissions rate. A facility described in § 1.45Y-5(c)(2) can maintain sufficient documentation to demonstrate a GHG emissions rate that is not greater than 10 grams of CO
                        <E T="52">2</E>
                        e per kWh by showing that it is a type of facility described in § 1.45Y-5(c)(2). The Secretary may determine that other types of facilities can sufficiently substantiate a GHG emissions rate that is not greater than 10 grams of CO
                        <E T="52">2</E>
                        e per kWh with certain documentation and will describe such facilities and documentation in IRS forms, instructions, or publications, or in guidance published in the Internal Revenue Bulletin. For such other types of facilities that utilize biomass feedstocks, the taxpayer must substantiate that the source of such fuels or feedstocks used are consistent with the taxpayer's claims. For all facilities that utilize unmarketable feedstocks that are indistinguishable from marketable feedstocks (for instance, after processing), the taxpayer will be required to maintain documentation substantiating the origin and original form of the feedstock. For PRA purposes, these general tax records are already approved by OMB under 1545-0074 for individuals, 1545-0123 for business entities, 1545-0092 for trust and estate filers, and 1545-0047 for tax-exempt organizations.
                    </P>
                    <P>The reporting requirements in these final regulations are in §§ 1.45Y-5 and 1.48E-5, which provide the process for applicants to file a petition with the Secretary for a PER determination. To file a PER petition with the Secretary, a taxpayer must submit the PER petition attached to the taxpayer's Federal income tax return or Federal return, as appropriate, for the taxable year in which the taxpayer claims the section 45Y credit or the section 48E credit with respect to the facility to which the PER petition relates. A PER petition must contain an emissions value. If the applicant obtained an emissions value from DOE, the PER petition made to the IRS must include and emissions value letter from DOE. This emission value letter process will be approved by OMB. A taxpayer must retain in its books and records a copy of the taxpayer's request to DOE for an emissions value, including the supporting documentation provided to DOE with the request. Alternatively, if applicable, a PER petition may contain an emissions value determined for a facility using the most recent version of an LCA model, as of the time the PER petition is filed, that has been designated by the Secretary for such use. If an emissions value is determined using a designated model, a taxpayer is required to provide to the IRS information to support its determination of the emissions value in the form and manner prescribed in IRS forms, instructions, or publications, or guidance published in the Internal Revenue Bulletin. The burden for these requirements will be included within the forms and instructions applicable to sections 45Y and 48E.</P>
                    <P>For section 45Y, the burden for these requirements will be associated the form and instructions applicable to claiming this credit and will be approved by OMB, in accordance with 5 CFR 1320.10, under the following OMB control numbers: 1545-0074 for individuals/sole proprietors, 1545-0123 for business entities, 1545-0047 for tax-exempt organizations, and 1545-0092 for trust and estate filers.</P>
                    <P>For section 48E, the burden for these requirements will be associated with Form 3468, Investment Credit, and will be approved by OMB, in accordance with 5 CFR 1320.10, under the following OMB control numbers: 1545-0074 for individuals/sole proprietors, 1545-0123 for business entities, 1545-0047 for tax-exempt organizations, and 1545-0092 for trust and estate filers.</P>
                    <HD SOURCE="HD2">III. Regulatory Flexibility Act</HD>
                    <P>
                        The Regulatory Flexibility Act (5 U.S.C. 601 
                        <E T="03">et seq.</E>
                        ) (RFA) imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act (5 U.S.C. 551 
                        <E T="03">et seq.</E>
                        ) and that are likely to have a significant economic impact on a substantial number of small entities.
                    </P>
                    <P>Unless an agency determines that a proposal is not likely to have a significant economic impact on a substantial number of small entities, section 604 of the RFA requires the agency to present a final regulatory flexibility analysis (FRFA) of the final regulations.</P>
                    <P>
                        The Treasury Department and the IRS have not determined whether the final rule will likely have a significant economic impact on a substantial number of small entities. This 
                        <PRTPAGE P="4094"/>
                        determination requires further study. However, because there is a possibility of significant economic impact on a substantial number of small entities, an IRFA is provided in these final regulations affected and the economic impact on small entities.
                    </P>
                    <P>In addition, pursuant to section 7805(f), the proposed regulations preceding these final regulations were submitted to the Chief Counsel for the Office of Advocacy of the Small Business Administration for comment on its impact on small business, and no comments were received from the Chief Counsel for the Office of Advocacy of the Small Business Administration. However, the Small Business Administration's Office of Advocacy provided comments in response to the PWA proposed regulations, including proposed § 1.48E-3, which is finalized as modified by this Treasury decision. See section III.B. of the Special Analysis of the PWA final regulations for a discussion of those comments.</P>
                    <HD SOURCE="HD3">A. Need for and Objectives of the Rule</HD>
                    <P>The final regulations provide greater clarity to taxpayers for purposes of claiming the section 45Y credit and section 48E credit. The final regulations provide necessary definitions rules regarding the determination of credit amounts and the procedure for requesting a provisional emissions rate. The final regulations provide greater clarity to taxpayers for purposes of claiming the section 45Y credit and the section 48E credit and encourage taxpayers to produce clean energy or invest in clean energy facilities and ESTs. Thus, the Treasury Department and the IRS intend and expect that the final regulations will deliver benefits across the economy that will beneficially impact various industries.</P>
                    <HD SOURCE="HD3">B. Affected Small Entities</HD>
                    <P>The RFA directs agencies to provide a description of, and if feasible, an estimate of, the number of small entities that may be affected by the final regulations. The Small Business Administration's Office of Advocacy estimates in its 2023 Frequently Asked Questions that 99.9 percent of American businesses meet its definition of a small business. The applicability of these final regulations does not depend on the size of the business, as defined by the Small Business Administration.</P>
                    <P>As described more fully in the preamble to this final regulation and in this IRFA, the section 45Y credit and the section 48E credit incentivize the production of clean energy and the investment in clean energy facilities and energy storage facilities. Because the potential credit claimants can vary widely, it is difficult to estimate at this time the impact of these final regulations, if any, on small businesses.</P>
                    <P>The Treasury Department and the IRS expect to receive more information on the impact on small businesses once taxpayers start to claim the section 45Y credit or the section 48E credit using the guidance and procedures provided in these final regulations.</P>
                    <HD SOURCE="HD3">C. Impact of the Rules</HD>
                    <P>The final regulations will allow taxpayers to plan investments and transactions based on the ability to claim the section 45Y production credit and/or the section 48E investment credit. The increased use of these credits will incentivize increased production and use of clean energy as well as the development of new methods and technologies for generating clean energy. The use of the credits will also incentivize additional investment in the facilities that produce and develop clean energy.</P>
                    <P>Because recordkeeping and reporting requirements relating to the section 45Y and 48E credits will not materially differ from the requirements relating to existing energy production and investment tax credits, the recordkeeping and reporting requirements should not materially increase for taxpayers that already claim existing credits. To claim the section 45Y credit or the section 48E credit, taxpayers will need to continue to execute the relevant form (or successor form, or pursuant to instructions and other guidance) and file such form with the taxpayer's timely filed return (including extensions) for the taxable year in which the property is placed in service.</P>
                    <P>Although the Treasury Department and the IRS do not have sufficient data to precisely determine the likely extent of the increased costs of compliance, the estimated burden of complying with the recordkeeping and reporting requirements are described in the Paperwork Reduction Act section of this preamble.</P>
                    <HD SOURCE="HD3">D. Alternatives Considered</HD>
                    <P>
                        The Treasury Department and the IRS considered alternatives to the final regulations. For example, the Treasury Department and the IRS considered whether to impose different rules for determining if a section 48E qualified facility had a recapture event, and how and when a taxpayer was required to notify the Secretary that the emissions rate at a qualified facility was greater than 10 grams of CO
                        <E T="52">2</E>
                        e per kWh. The final regulations were designed to minimize burdens on taxpayers while ensuring that the IRS has sufficient information to determine if a section 48E qualified facility's emissions rate exceeded the recapture threshold. The final regulations require that a taxpayer that claimed the section 48E credit to annually report to the IRS its GHG emissions rate in the form and manner prescribed in IRS forms or instructions or in guidance as published in the Internal Revenue Bulletin.
                    </P>
                    <P>An additional example is that the Treasury Department and the IRS considered alternatives to how a taxpayer should compute any increase in capacity at a qualified facility that, for purposes of sections 45Y and 48E, was a qualified facility due to an increase in capacity. The final regulations were designed to provide a rule that was administrable for the IRS and taxpayers. The final regulations offer taxpayers the following options for measuring capacity increases: use of capacity measures from modified or amended facility operating licenses from FERC or NRC, or related reports prepared by FERC or NRC as part of the licensing process; measurement of nameplate capacity of the facility consistent with the definition of nameplate capacity provided in 40 CFR 96.202; or a measurement standard prescribed by the Secretary in guidance published in the Internal Revenue Bulletin.</P>
                    <HD SOURCE="HD3">E. Duplicative, Overlapping, or Conflicting Federal Rules</HD>
                    <P>The final rules would not duplicate, overlap, or conflict with any relevant Federal rules. As discussed earlier, the regulations provide guidance relating to the section 45Y tax credit and the section 48E tax credit. The Treasury Department and the IRS invited input from interested members of the public about identifying and avoiding overlapping, duplicative, or conflicting requirements.</P>
                    <HD SOURCE="HD2">IV. Congressional Review Act</HD>
                    <P>
                        Pursuant to the Congressional Review Act (5 U.S.C. 801 
                        <E T="03">et seq.</E>
                        ), the Office of Information and Regulatory Affairs has determined that this rule meets the criteria set forth in 5 U.S.C. 804(2).
                    </P>
                    <HD SOURCE="HD2">V. Immediate Effective Date</HD>
                    <P>
                        These final regulations have an effective date of January 15, 2025. To the extent that a good cause statement is necessary under any provision of law, the Treasury Department and the IRS find that there would be good cause to make this rule immediately effective upon publication in the 
                        <E T="04">Federal Register</E>
                        .
                        <PRTPAGE P="4095"/>
                    </P>
                    <P>The IRA added the section 45Y and 48E credits to the Code, and provided that the section 45Y credit applies to facilities placed in service after December 31, 2024, and that the section 48E credit applies to property placed in service after December 31, 2024.</P>
                    <P>Following the enactment of the IRA and the addition of sections 45Y and 48E to the Code, the Treasury Department and the IRS published proposed regulations to provide certainty to taxpayers. In particular, as demonstrated by the wide variety of public comments in response to the proposed regulations, taxpayers and other stakeholders continue to express uncertainty regarding the proper application of the statutory rules under sections 45Y and 48E, and the need for timely final regulations, because the credits apply to facilities and property placed in service after December 31, 2024. Taxpayers have requested the certainty that these final regulations provide prior to making investment decisions that will affect such facilities and property. In addition, this uncertainty extends to the application of a number of important provisions in sections 45Y and 48E that require determinations to be made by the Secretary, in consultation with other Federal agency experts, that are intended to provide certainty for taxpayers embarking on highly capital intensive projects intended to qualify for the section 45Y and 48E credits. Certainty with respect to these provisions is essential given the January 1, 2025 statutory effective date, and so that taxpayers can accurately predict the economic return from making particular investments and make informed business decisions. In addition, while taxpayers have requested clarity regarding the specific requirements of these rules, the public already has been provided notice of the general contents of these rules and their proposed applicability to qualified facilities and energy storage technologies placed in service after December 31, 2024, and during taxable years ending on or after the date of publication of these final regulations. As provided in the IRA, sections 45Y and 48E replace existing production and investment tax credits for facilities placed in service after December 31, 2024. The statute and proposed rules, therefore, provide notice that the rules will apply to qualified facilities and energy storage technologies placed in service beginning in 2025, and provide notice of the qualification requirements being promulgated in this final rule. Moreover, section 45Y(f) directs the Secretary to issue guidance regarding the implementation of section 45Y not later than January 1, 2025. Section 48E(i) similarly directs the Secretary to issue guidance regarding implementation of section 48E not later than January 1, 2025.</P>
                    <P>Consistent with Executive Order 14008 (January 27, 2021) and commenters' request for finalized rules, the Treasury Department and the IRS have determined that an effective date of the final regulations as soon in time after the 45Y and 48E credits go into effect on January 1, 2025 as possible is appropriate to provide certainty to taxpayers seeking to place facilities and property in service after December 31, 2024, in order to claim the section 45Y and 48E credits. The final regulations provide needed rules on what the law requires for taxpayers to claim these credits. Accordingly, to the extent that a finding of good cause is necessary, the Treasury Department and the IRS have found good cause for the rules in this Treasury decision to take effect on January 15, 2025.</P>
                    <HD SOURCE="HD2">VI. Unfunded Mandates Reform Act</HD>
                    <P>Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any one year by a State, local, or Indian Tribal government, in the aggregate, or by the private sector, of $100 million (updated annually for inflation). This final rule does not include any Federal mandate that may result in expenditures by State, local, or Indian Tribal governments, or by the private sector in excess of that threshold.</P>
                    <HD SOURCE="HD2">VII. Executive Order 13132: Federalism</HD>
                    <P>Executive Order 13132 (Federalism) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial, direct compliance costs on State and local governments, and is not required by statute, or preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This final rule does not have federalism implications and does not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.</P>
                    <HD SOURCE="HD2">VIII. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</HD>
                    <P>Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments) prohibits an agency from publishing any rule that has Tribal implications if the rule either imposes substantial, direct compliance costs on Indian Tribal governments, and is not required by statute, or preempts Tribal law, unless the agency meets the consultation and funding requirements of section 5 of the Executive order. This final rule does not have substantial direct effects on one or more federally recognized Indian tribes and does not impose substantial direct compliance costs on Indian Tribal governments within the meaning of the Executive order.</P>
                    <HD SOURCE="HD1">Statement of Availability of IRS Documents</HD>
                    <P>
                        Guidance cited in this preamble is published in the Internal Revenue Bulletin and is available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at 
                        <E T="03">https://www.irs.gov.</E>
                    </P>
                    <HD SOURCE="HD1">Drafting Information</HD>
                    <P>The principal authors of these final regulations are Maksim Berger, John M. Deininger, Martha M. Garcia, Boris Kukso, Nathaniel Kupferman, and Alexander Scott (Passthroughs and Special Industries). Other personnel from the Treasury Department, the DOE, the EPA, the USDA, and the IRS participated in the development of the final regulations.</P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 26 CFR Part 1</HD>
                        <P>Income taxes, Reporting and recordkeeping requirements.</P>
                    </LSTSUB>
                    <HD SOURCE="HD1">Adoption of Amendments to the Regulations</HD>
                    <P>Accordingly, the Treasury Department and the IRS amend 26 CFR part 1 as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 1—INCOME TAXES</HD>
                    </PART>
                    <REGTEXT TITLE="26" PART="1">
                        <AMDPAR>
                            <E T="04">Paragraph 1.</E>
                             The authority citation for part 1 is amended by:
                        </AMDPAR>
                        <AMDPAR>a. Adding entries in numerical order for §§ 1.45Y-1 and 1.45Y-2;</AMDPAR>
                        <AMDPAR>b. Revising the entry for § 1.45Y-3; and</AMDPAR>
                        <AMDPAR>c. Adding entries in numerical order for §§ 1.45Y-4 and 1.45Y-5 and 1.48E-1 through 1.48E-5.</AMDPAR>
                        <P>The revision and additions read in part as follows:</P>
                        <AUTH>
                            <HD SOURCE="HED">Authority: </HD>
                            <P> 26 U.S.C. 7805 * * *</P>
                        </AUTH>
                        <STARS/>
                        <EXTRACT>
                            <PRTPAGE P="4096"/>
                            <P>Section 1.45Y-1 also issued under 26 U.S.C. 45Y(f).</P>
                            <P>Section 1.45Y-2 also issued under 26 U.S.C. 45Y(f).</P>
                            <P>Section 1.45Y-3 also issued under 26 U.S.C. 45Y(f).</P>
                            <P>Section 1.45Y-4 also issued under 26 U.S.C. 45Y(f).</P>
                            <P>Section 1.45Y-5 also issued under 26 U.S.C. 45Y(b) and (f).</P>
                            <STARS/>
                            <P>Section 1.48E-1 also issued under 26 U.S.C. 48E(i).</P>
                            <P>Section 1.48E-2 also issued under 26 U.S.C. 48E(i).</P>
                            <P>Section 1.48E-3 also issued under 26 U.S.C. 48E(i).</P>
                            <P>Section 1.48E-4 also issued under 26 U.S.C. 48E(i).</P>
                            <P>Section 1.48E-5 also issued under 26 U.S.C. 48E(i).</P>
                            <STARS/>
                        </EXTRACT>
                    </REGTEXT>
                    <REGTEXT TITLE="26" PART="1">
                        <AMDPAR>
                            <E T="04">Par. 2.</E>
                             Add an undesignated center heading immediately following § 1.37-3 to read as follows:
                        </AMDPAR>
                        <HD SOURCE="HD1">General Business Credits</HD>
                        <STARS/>
                    </REGTEXT>
                    <REGTEXT TITLE="26" PART="1">
                        <AMDPAR>
                            <E T="04">Par. 3.</E>
                             Sections 1.45Y-0 through 1.45Y-2 are added to read as follows:
                        </AMDPAR>
                        <CONTENTS>
                            <SECHD>Sec.</SECHD>
                            <STARS/>
                            <SECTNO>1.45Y-0</SECTNO>
                            <SUBJECT>Table of contents.</SUBJECT>
                            <SECTNO>1.45Y-1</SECTNO>
                            <SUBJECT>Clean electricity production credit.</SUBJECT>
                            <SECTNO>1.45Y-2</SECTNO>
                            <SUBJECT>Qualified facility for purposes of section 45Y.</SUBJECT>
                        </CONTENTS>
                        <STARS/>
                        <SECTION>
                            <SECTNO>§ 1.45Y-0 </SECTNO>
                            <SUBJECT>Table of contents.</SUBJECT>
                            <P>This section lists the captions contained in §§ 1.45Y-1 through 1.45Y-5.</P>
                            <EXTRACT>
                                <FP SOURCE="FP-2">§ 1.45Y-1 Clean electricity production credit.</FP>
                                <P>(a) Overview.</P>
                                <P>(1) In general.</P>
                                <P>(2) CHP property.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Components excluded.</P>
                                <P>(3) Code.</P>
                                <P>(4) kWh.</P>
                                <P>(5) Metering device.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Standards for maintaining and operating a metering device.</P>
                                <P>(iii) Network equipment.</P>
                                <P>(iv) Examples.</P>
                                <P>(6) Qualified facility.</P>
                                <P>(7) Related person.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Member of a consolidated group.</P>
                                <P>(8) Secretary.</P>
                                <P>(9) Section 45Y credit.</P>
                                <P>(10) Section 45Y regulations.</P>
                                <P>(11) Unrelated person.</P>
                                <P>(12) Waste energy recovery property (WERP).</P>
                                <P>(b) Credit amount.</P>
                                <P>(1) In general.</P>
                                <P>(2) Applicable amount.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Base amount.</P>
                                <P>(iii) Alternative amount.</P>
                                <P>(3) Inflation adjustment.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Annual computation.</P>
                                <P>(iii) Inflation adjustment factor.</P>
                                <P>(iv) GDP implicit price deflator.</P>
                                <P>(4) Energy communities increase in credit.</P>
                                <P>(5) Domestic content bonus credit amount.</P>
                                <P>(c) Credit phase-out.</P>
                                <P>(1) In general.</P>
                                <P>(2) Phase-out percentage.</P>
                                <P>(3) Applicable year.</P>
                                <P>(4) Phase-out data.</P>
                                <P>(5) Determination of phase-out.</P>
                                <P>(d) Requirements for CHP property.</P>
                                <P>(1) In general.</P>
                                <P>(2) Energy efficiency percentage.</P>
                                <P>(3) Special rule for calculating electricity produced by CHP property.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Conversion from Btu to kWh.</P>
                                <P>(e) Applicability date.</P>
                                <FP SOURCE="FP-2">§ 1.45Y-2 Qualified facility for purposes of section 45Y.</FP>
                                <P>(a) Qualified facility.</P>
                                <P>(b) Property included in qualified facility.</P>
                                <P>(1) In general.</P>
                                <P>(2) Unit of qualified facility.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Functionally interdependent.</P>
                                <P>(3) Integral part.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Power conditioning and transfer equipment.</P>
                                <P>(iii) Roads.</P>
                                <P>(iv) Fences.</P>
                                <P>(v) Buildings.</P>
                                <P>(vi) Shared integral property.</P>
                                <P>(vii) Examples.</P>
                                <P>(c) Coordination with other credits.</P>
                                <P>(1) In general.</P>
                                <P>(2) Allowed.</P>
                                <P>(3) Examples.</P>
                                <P>(d) Applicability date.</P>
                                <FP SOURCE="FP-2">§ 1.45Y-3 Rules relating to the increased credit amount for prevailing wage and apprenticeship.</FP>
                                <P>(a) In general.</P>
                                <P>(b) Qualified facility requirements.</P>
                                <P>(c) Nameplate capacity for purposes of the One Megawatt Exception.</P>
                                <P>(1) In general.</P>
                                <P>(2) Nameplate capacity for qualified facilities that generate in direct current for purposes of the One Megawatt Exception.</P>
                                <P>(3) Integrated operations.</P>
                                <P>(4) Related taxpayers.</P>
                                <P>(i) Definition.</P>
                                <P>(ii) Related taxpayer rule.</P>
                                <P>(d) Applicability date.</P>
                                <FP SOURCE="FP-2">§ 1.45Y-4 Rules of general application.</FP>
                                <P>(a) Only production in the United States taken into account for purposes of section 45Y.</P>
                                <P>(b) Production attributable to the taxpayer.</P>
                                <P>(1) In general.</P>
                                <P>(2) Example of gross sales.</P>
                                <P>(3) Section 761(a) election.</P>
                                <P>(c) Expansion of facility; Incremental production (Incremental Production Rule).</P>
                                <P>(1) In general.</P>
                                <P>(2) Measurement standard.</P>
                                <P>(3) Special rule for restarted facilities.</P>
                                <P>(4) Computation of increased amount of electricity produced.</P>
                                <P>(5) Examples.</P>
                                <P>(d) Retrofit of an existing facility (80/20 Rule).</P>
                                <P>(1) In general.</P>
                                <P>(2) Cost of new components of property.</P>
                                <P>(3) Examples.</P>
                                <P>(e) Applicability date.</P>
                                <FP SOURCE="FP-2">§ 1.45Y-5 Greenhouse gas emissions rates for qualified facilities under section 45Y.</FP>
                                <P>(a) In general.</P>
                                <P>(b) Definitions.</P>
                                <P>
                                    (1) CO
                                    <E T="52">2</E>
                                    e per kWh.
                                </P>
                                <P>(2) Combustion.</P>
                                <P>(3) Gasification.</P>
                                <P>(4) Facility that produces electricity through combustion or gasification (C&amp;G Facility).</P>
                                <P>(5) Greenhouse gas emissions rate.</P>
                                <P>(6) Greenhouse gases emitted into the atmosphere by a facility in the production of electricity.</P>
                                <P>(7) Non-C&amp;G Facility.</P>
                                <P>(8) Fuel.</P>
                                <P>(9) Feedstock.</P>
                                <P>(10) Market-mediated effects.</P>
                                <P>(c) Non-C&amp;G Facilities.</P>
                                <P>(1) Determining a greenhouse gas emissions rate for Non-C&amp;G Facilities.</P>
                                <P>(i) Excluded emissions.</P>
                                <P>(ii) Emissions assessment process.</P>
                                <P>(iii) Example of greenhouse gas emissions rate determination for a Non-C&amp;G Facility.</P>
                                <P>(2) Non-C&amp;G Facilities with a greenhouse gas emissions rate that is not greater than zero.</P>
                                <P>(d) C&amp;G Facilities.</P>
                                <P>(1) Determining a greenhouse gas emissions rate for C&amp;G Facilities.</P>
                                <P>(2) LCA requirements.</P>
                                <P>(i) Starting boundary.</P>
                                <P>(ii) Ending boundary.</P>
                                <P>(iii) Baseline.</P>
                                <P>(iv) Offsets and offsetting activities.</P>
                                <P>(v) Principles for included emissions.</P>
                                <P>(vi) Principles for excluded emissions.</P>
                                <P>(vii) Alternative fates and avoided emissions.</P>
                                <P>(viii) Temporal scales.</P>
                                <P>(ix) Spatial scales.</P>
                                <P>(x) Categorization of products.</P>
                                <P>(e) Use of methane from certain sources to produce electricity.</P>
                                <P>(1) In general.</P>
                                <P>(2) Definitions.</P>
                                <P>(i) Biogas.</P>
                                <P>(ii) Coal mine methane.</P>
                                <P>(iii) Fugitive methane.</P>
                                <P>(iv) Renewable natural gas.</P>
                                <P>(3) Considerations regarding the lifecycle greenhouse gas emissions associated with the production of electricity using methane from certain sources.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Methane from landfill sources.</P>
                                <P>(iii) Methane from wastewater sources.</P>
                                <P>(iv) Coal mine methane.</P>
                                <P>(v) Methane from animal waste.</P>
                                <P>(vi) Fugitive methane other than coal mine methane.</P>
                                <P>(4) Book and claim.</P>
                                <P>(f) Carbon capture and sequestration.</P>
                                <P>(1) In general.</P>
                                <P>(2) Substantiation.</P>
                                <P>(g) Annual publication of emissions rates.</P>
                                <P>(1) In general.</P>
                                <P>
                                    (2) Publication of analysis required for changes to the Annual Table.
                                    <PRTPAGE P="4097"/>
                                </P>
                                <P>(h) Provisional emissions rates.</P>
                                <P>(1) In general.</P>
                                <P>(2) Rate not established.</P>
                                <P>(3) Process for filing a PER petition.</P>
                                <P>(4) PER determination.</P>
                                <P>(5) Emissions value request process.</P>
                                <P>(6) LCA model for determining an emissions value for C&amp;G Facilities.</P>
                                <P>(7) Effect of PER.</P>
                                <P>(i) Reliance on Annual Table or Provisional Emissions Rate.</P>
                                <P>(j) Substantiation.</P>
                                <P>(1) In general.</P>
                                <P>(2) Sufficient substantiation.</P>
                                <P>(k) Applicability date.</P>
                            </EXTRACT>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1.45Y-1</SECTNO>
                            <SUBJECT>Clean electricity production credit.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Overview</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 For purposes of section 38 of the Internal Revenue Code (Code), the section 45Y credit (defined in paragraph (a)(9) of this section) is determined under section 45Y of the Code and the section 45Y regulations (defined in paragraph (a)(10) of this section). This paragraph (a) provides definitions of terms that, unless otherwise specified, apply for purposes of section 45Y, the section 45Y regulations, and any provision of the Code or this chapter that expressly refers to any provision of section 45Y or the section 45Y regulations. Paragraph (b) of this section provides rules for determining the amount of the section 45Y credit for any taxable year. Paragraph (c) of this section provides rules regarding the phase-out of the section 45Y credit. Paragraph (d) of this section provides rules regarding combined heat and power system (CHP) property. 
                                <E T="03">See</E>
                                 § 1.45Y-2 for rules relating to qualified facilities for purposes of the section 45Y credit. 
                                <E T="03">See</E>
                                 § 1.45Y-4 for rules of general application for the section 45Y credit. 
                                <E T="03">See</E>
                                 § 1.45Y-5 for rules to determine greenhouse gas emissions rates for qualified facilities.
                            </P>
                            <P>
                                (2) 
                                <E T="03">CHP property</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 For purposes of section 45Y(g)(2)(B) and paragraph (d) of this section, the term 
                                <E T="03">CHP property</E>
                                 means property comprising a system that uses the same energy source for the simultaneous or sequential generation of electrical power, mechanical shaft power, or both, in combination with the generation of steam or other forms of useful thermal energy (including for heating and cooling applications).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Components excluded.</E>
                                 CHP property does not include property used to transport the energy source to the generating facility or to distribute energy produced by the facility.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Code.</E>
                                 The term 
                                <E T="03">Code</E>
                                 means the Internal Revenue Code.
                            </P>
                            <P>
                                (4) 
                                <E T="03">kWh.</E>
                                 The term 
                                <E T="03">kWh</E>
                                 means kilowatt hours.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Metering device</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 For purposes of section 45Y(a)(1)(A)(ii)(II), the term 
                                <E T="03">metering device</E>
                                 means equipment that is owned and operated by an unrelated person (as defined in paragraph (a)(11) of this section) for energy revenue metering to measure and register the continuous summation of an electricity quantity with respect to time.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Standards for maintaining and operating a metering device.</E>
                                 For purposes of section 45Y(a)(1)(A)(ii)(II) and this section, a metering device must—
                            </P>
                            <P>(A) Be maintained in proper working order in accordance with the instructions of its manufacturer;</P>
                            <P>(B) Be certified as meeting generally accepted industry performance standards, such as the American National Standards Institute C12.1-2022 standard, or subsequent revisions;</P>
                            <P>(C) Be revenue grade with a +/−0.5 percent accuracy; and</P>
                            <P>(D) Be properly calibrated.</P>
                            <P>
                                (iii) 
                                <E T="03">Network equipment.</E>
                                 For purposes of operating the metering device, the unrelated person may share network equipment, such as spare fiber optic cable owned by the taxpayer that produces the electricity, and may co-locate network equipment in the taxpayer's facilities.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Examples.</E>
                                 This paragraph (a)(5)(iv) provides examples illustrating the application of paragraph (a)(5) of this section.
                            </P>
                            <P>
                                (A) 
                                <E T="03">Example 1. Qualified facility equipped with a metering device owned and operated by an unrelated person.</E>
                                 X owns a qualified facility equipped with a metering device that is owned and operated by Y, an unrelated person. The metering device meets the requirements of paragraphs (a)(5)(i) through (iii) of this section. X sells electricity produced at the qualified facility to Z, a related person during the taxable year. Because the qualified facility is equipped with a metering device that is owned and operated by an unrelated person and meets the requirements of paragraphs (a)(5)(i) through (iii), X may claim a section 45Y credit based on the electricity produced by X and sold to Z during the taxable year.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Example 2. Electricity produced by the taxpayer at a qualified facility sold, consumed, or stored by the taxpayer during the taxable year.</E>
                                 X owns a qualified facility equipped with a metering device that is owned and operated by an unrelated person, Y. The metering device meets the requirements of paragraphs (a)(5)(i) through (iii) of this section. Because the qualified facility is equipped with a metering device that is owned and operated by an unrelated person and the metering device meets the requirements of paragraphs (a)(5)(i) through (iii), X may sell electricity produced at the qualified facility during the taxable year to a related or unrelated person. X may also consume the electricity produced at the qualified facility during the taxable year onsite. Additionally, X may store the electricity produced at the qualified facility during the taxable year in energy storage technology owned by X. In any of these three situations, X may claim a section 45Y credit for the taxable year for the kWh of electricity produced at the qualified facility measured by the metering device and sold, consumed, or stored by X during the taxable year.
                            </P>
                            <P>
                                (6) 
                                <E T="03">Qualified facility.</E>
                                 The term 
                                <E T="03">qualified facility</E>
                                 for purposes of the section 45Y credit has the meaning provided in § 1.45Y-2(a).
                            </P>
                            <P>
                                (7) 
                                <E T="03">Related person</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 The term 
                                <E T="03">related person</E>
                                 means a person that is related to another person if such persons would be treated as a single employer under the regulations in this chapter under section 52(b) of the Code.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Member of a consolidated group.</E>
                                 In the case of a corporation that is a member of a consolidated group (as defined in § 1.1502-1(h)), such member will be treated as selling electricity to an unrelated person if such electricity is sold to an unrelated person by another member of such group.
                            </P>
                            <P>
                                (8) 
                                <E T="03">Secretary.</E>
                                 The term 
                                <E T="03">Secretary</E>
                                 means the Secretary of the Treasury or their delegate.
                            </P>
                            <P>
                                (9) 
                                <E T="03">Section 45Y credit.</E>
                                 The term 
                                <E T="03">section 45Y credit</E>
                                 means the clean electricity production credit determined under section 45Y of the Code and the section 45Y regulations.
                            </P>
                            <P>
                                (10) 
                                <E T="03">Section 45Y regulations.</E>
                                 The term 
                                <E T="03">section 45Y regulations</E>
                                 means this section and §§ 1.45Y-2 through 1.45Y-5.
                            </P>
                            <P>
                                (11) 
                                <E T="03">Unrelated person.</E>
                                 For purposes of section 45Y(a), the term 
                                <E T="03">unrelated person</E>
                                 means a person who is not a related person as defined in section 45Y(g)(4) and paragraph (a)(7) of this section. In the case of sales of electricity to an individual consumer, such sales will be treated as sales to an unrelated party for purposes of the section 45Y credit. For example, assume Taxpayer X produces electricity at a qualified facility and sells it to Consumer Y. Consumer Y is an individual consumer and is not subject to aggregation under the regulations at 26 CFR 1.52-1 prescribed under section 52(b). Therefore, Consumer Y is not treated as a single employer with Taxpayer X under section 52(b), and a sale to Consumer Y is treated as a sale to an unrelated person. The result is the same 
                                <PRTPAGE P="4098"/>
                                if Consumer Y is an individual consumer who is a member of a cooperative or Indian tribe that owns or controls, directly or indirectly, Taxpayer X. The result is also the same if Consumer Y is an individual consumer who is a resident of a State or municipality that owns or controls, directly or indirectly, Taxpayer X.
                            </P>
                            <P>
                                (12) 
                                <E T="03">Waste energy recovery property (WERP).</E>
                                 WERP is property that generates electricity solely from heat from buildings or equipment if the primary purpose of such building or equipment is not the generation of electricity. Examples of buildings or equipment the primary purpose of which is not the generation of electricity include, but are not limited to, manufacturing plants, medical care facilities, facilities on school campuses, and associated equipment.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Credit amount</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 The section 45Y credit for any taxable year is an amount equal to the product of the kWh of electricity that is produced at a qualified facility and sold by the taxpayer to an unrelated person during the taxable year, multiplied by the applicable amount with respect to such qualified facility. In the case of a qualified facility equipped with a metering device (as defined in paragraph (a)(5) of this section) that is owned and operated by an unrelated person, the section 45Y credit for any taxable year is an amount equal to the product of the kWh of electricity that is produced, as measured by the metering device, at such qualified facility and sold, consumed, or stored by the taxpayer during the taxable year, multiplied by the applicable amount with respect to such qualified facility. Only one section 45Y credit can be claimed for each kWh of electricity produced by the taxpayer at a qualified facility. The credit amount may also be increased as provided in section 45Y(g)(11) and paragraph (b)(5) of this section in the case of a qualified facility that satisfies the domestic content requirements of section 45Y(g)(11)(B).
                            </P>
                            <P>
                                (2) 
                                <E T="03">Applicable amount</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 The term 
                                <E T="03">applicable amount</E>
                                 means the base amount described in paragraph (b)(2)(ii) of this section or the alternative amount described in paragraph (b)(2)(iii) of this section. The applicable amount is subject to the inflation adjustment as provided in section 45Y(c)(1) and paragraph (b)(3) of this section. The applicable amount may also be increased as provided in section 45Y(g)(7) and paragraph (b)(4) of this section in the case of a qualified facility that is located in an energy community.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Base amount.</E>
                                 Under section 45Y(a)(2)(A), in the case of any qualified facility that does not satisfy the requirements provided in section 45Y(a)(2)(B), the applicable amount is the 
                                <E T="03">base amount,</E>
                                 which is 0.3 cents.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Alternative amount.</E>
                                 Under section 45Y(a)(2)(B), in the case of any qualified facility that satisfies the prevailing wage and apprenticeship requirements provided in section 45Y(a)(2)(B), the applicable amount is the 
                                <E T="03">alternative amount,</E>
                                 which is 1.5 cents.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Inflation adjustment</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 Pursuant to section 45Y(c)(1), in the case of a calendar year beginning after 2024, the base amount and the alternative amount will each be adjusted by multiplying such amount by the inflation adjustment factor for the calendar year in which the sale, consumption, or storage of the electricity occurs. If the base amount as adjusted under this paragraph (b)(3)(i) is not a multiple of 0.05 cent, such amount will be rounded to the nearest multiple of 0.05 cent. If the alternative amount as adjusted under this paragraph (b)(3)(i) is not a multiple of 0.1 cent, such amount will be rounded to the nearest multiple of 0.1 cent.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Annual computation.</E>
                                 Pursuant to section 45Y(c)(2), the inflation adjustment factor for each calendar year will be published in the 
                                <E T="04">Federal Register</E>
                                 not later than April 1 of that calendar year. The base amount and the alternative amount, as adjusted under paragraph (b)(3)(i) of this section, will also be published in the 
                                <E T="04">Federal Register</E>
                                 not later than April 1 of each calendar year.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Inflation adjustment factor.</E>
                                 Under section 45Y(c)(3), the term 
                                <E T="03">inflation adjustment factor</E>
                                 means, with respect to a calendar year, a fraction—
                            </P>
                            <P>(A) The numerator of which is the GDP implicit price deflator for the preceding calendar year; and</P>
                            <P>(B) The denominator of which is the GDP implicit price deflator for the calendar year 1992.</P>
                            <P>
                                (iv) 
                                <E T="03">GDP implicit price deflator.</E>
                                 Under section 45Y(c)(3), the term 
                                <E T="03">GDP implicit price deflator</E>
                                 means the most recent revision of the implicit price deflator for the gross domestic product as computed and published by the Department of Commerce before March 15 of the calendar year.
                            </P>
                            <P>
                                (4) 
                                <E T="03">Energy communities increase in credit.</E>
                                 In the case of any qualified facility that is located in an energy community (as defined in section 45(b)(11)(B)), for purposes of determining the amount of the section 45Y credit with respect to any electricity produced by the taxpayer at such facility during the taxable year, the applicable amount will be increased by an amount equal to 10 percent of the applicable amount that would otherwise be in effect before application of this paragraph (b)(4). The 10 percent increase under this paragraph (b)(4) applies after the inflation adjustment under paragraph (b)(3) of this section.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Domestic content bonus credit amount.</E>
                                 In the case of any qualified facility that satisfies the requirements of section 45Y(g)(11)(B)(i) (domestic content requirement), for purposes of determining the amount of the section 45Y credit with respect to any electricity produced by the taxpayer at such facility during the taxable year, the amount of the credit otherwise determined under this paragraph (b), without application of paragraph (b)(4) of this section (related to energy communities), is increased by 10 percent.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Credit phase-out</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 The amount of the section 45Y credit for any qualified facility, the construction of which begins during a calendar year provided in section 45Y(d)(2) and described in paragraph (c)(2) of this section, is equal to the product of—
                            </P>
                            <P>(i) The amount of the credit determined under section 45Y(a) and described in paragraph (b) of this section, without regard to section 45Y(d) and this paragraph (c); multiplied by</P>
                            <P>(ii) The phase-out percentage provided under section 45Y(d)(2) and described in paragraph (c)(2) of this section.</P>
                            <P>
                                (2) 
                                <E T="03">Phase-out percentage.</E>
                                 The phase-out percentage described in this paragraph (c)(2) is equal to—
                            </P>
                            <P>(i) For a facility the construction of which begins during the first calendar year following the applicable year, 100 percent;</P>
                            <P>(ii) For a facility the construction of which begins during the second calendar year following the applicable year, 75 percent;</P>
                            <P>(iii) For a facility the construction of which begins during the third calendar year following the applicable year, 50 percent; and</P>
                            <P>(iv) For a facility the construction of which begins during any calendar year subsequent to the calendar year described in paragraph (c)(2)(iii) of this section, 0 percent.</P>
                            <P>
                                (3) 
                                <E T="03">Applicable year.</E>
                                 For purposes of this paragraph (c), the term 
                                <E T="03">applicable year</E>
                                 means the later of—
                            </P>
                            <P>
                                (i) The calendar year in which the Secretary makes the determination that the annual greenhouse gas emissions from the production of electricity in the United States are equal to or less than 25 percent of the annual greenhouse gas emissions from the production of 
                                <PRTPAGE P="4099"/>
                                electricity in the United States for calendar year 2022; or
                            </P>
                            <P>(ii) 2032.</P>
                            <P>
                                (4) 
                                <E T="03">Phase-out data.</E>
                                 For purposes of paragraph (c)(3)(i) of this section, the annual greenhouse gas emissions from the production of electricity in the United States for any calendar year must be assessed separately using both of the data sources described in paragraphs (c)(4)(i) and (ii) of this section:
                            </P>
                            <P>(i) The U.S. Energy Information Administration's Electric Power Annual, summing the annual carbon dioxide emissions data from conventional power plants and combined heat and power plants and the Monthly Energy Review annual carbon dioxide emissions from the combustion of biomass to produce electricity in the Electric Power Sector; and</P>
                            <P>(ii) The U.S. Environmental Protection Agency (EPA) Inventory of U.S. Greenhouse Gas Emissions and Sinks (GHGI) annual electric power-related carbon dioxide, methane, and nitrous oxide emissions data including carbon dioxide emissions from the combustion of biomass to produce electricity.</P>
                            <P>
                                (5) 
                                <E T="03">Determination of phase-out.</E>
                                 For purposes of paragraph (c)(3)(i) of this section, the Secretary will determine that the annual greenhouse gas emissions from the production of electricity in the United States are equal to or less than 25 percent of the annual greenhouse gas emissions from the production of electricity in the United States for calendar year 2022 only if the annual greenhouse gas emissions from the production of electricity in the United States, as determined separately under both of the data sources described in paragraph (c)(4) of this section, are each equal to or less than 25 percent of the annual greenhouse gas emissions from the production of electricity in the United States for calendar year 2022. If a data source described in paragraph (c)(4) of this section becomes unavailable (for example, it is no longer published or does not provide the specified data), the Secretary must designate a similar data source to replace the unavailable data source.
                            </P>
                            <P>
                                (d) 
                                <E T="03">Requirements for CHP property</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 To be eligible for the section 45Y credit, a CHP property must produce at least 20 percent of its total useful energy in the form of useful thermal energy that is not used to produce electrical or mechanical power (or combination thereof), and at least 20 percent of its total useful energy in the form of electrical or mechanical power (or combination thereof). The energy efficiency percentage of CHP property must exceed 60 percent. These percentages are determined on a British thermal unit (Btu) basis.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Energy efficiency percentage.</E>
                                 The energy efficiency percentage of a CHP property is the fraction the numerator of which is the total useful electrical, thermal, and mechanical power produced by the system at normal operating rates, and expected to be consumed in its normal application, and the denominator of which is the lower heating value of the fuel sources for the system. In the case of a qualified facility using nuclear energy, which does not involve combustion, the denominator is the reactor's maximum power level in megawatts thermal listed on the Nuclear Regulatory Commission (NRC) operating license, converted to Btus using 3,412,140 Btus per hour per megawatt. For other qualified facilities not using combustion, additional methodologies may be prescribed by the Secretary in guidance published in the Internal Revenue Bulletin (see § 601.601 of this chapter).
                            </P>
                            <P>
                                (3) 
                                <E T="03">Special rule for calculating electricity produced by CHP property</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 For purposes of section 45Y(a) and paragraph (b) of this section, the kWh of electricity produced by a taxpayer at a qualified facility includes any production in the form of useful thermal energy by any CHP property within such facility, and the amount of greenhouse gases emitted into the atmosphere by such facility in the production of such useful thermal energy is included for purposes of determining the greenhouse gas emissions rate for such facility.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Conversion from Btu to kWh</E>
                                —(A) 
                                <E T="03">In general.</E>
                                 For purposes of section 45Y(g)(2)(A)(i) and this paragraph (d)(3), the amount of kWh of electricity produced in the form of useful thermal energy is equal to the quotient of the total useful thermal energy produced by the CHP property within the qualified facility, divided by the heat rate for such facility.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Heat rate.</E>
                                 For purposes of this paragraph (d)(3), the term 
                                <E T="03">heat rate</E>
                                 means the amount of energy used by the qualified facility to generate 1 kWh of electricity, expressed as Btus per net kWh generated. In calculating the heat rate of a qualified facility that includes CHP property that uses combustion, a taxpayer must use the annual average heat rate, defined as the total annual fuel consumption of the CHP property (in Btus, using the lower heating value of the fuel) during the taxable year for which the section 45Y credit is claimed, divided by the annual net electricity generation (in kWh) of the CHP property during such taxable year. In the case of a qualified facility using nuclear energy, which does not involve combustion, the facility's reactor's total annual thermal output (in Btus, using a conversion rate of 3,412,140 Btus per megawatt hour thermal) shall be used in place of the total annual fuel consumption of the CHP property. For other qualified facilities not using combustion, additional methodologies may be prescribed by the Secretary in guidance published in the Internal Revenue Bulletin (see § 601.601 of this chapter).
                            </P>
                            <P>
                                (e) 
                                <E T="03">Applicability date.</E>
                                 This section applies to qualified facilities placed in service after December 31, 2024, and during a taxable year ending on or after January 15, 2025.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1.45Y-2</SECTNO>
                            <SUBJECT>Qualified facility for purposes of section 45Y.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Qualified facility.</E>
                                 For purposes of the section 45Y credit (defined in § 1.45Y-1(a)(9)), the term 
                                <E T="03">qualified facility</E>
                                 means a facility owned by the taxpayer that meets the requirements of paragraphs (a)(1) through (3) of this section:
                            </P>
                            <P>(1) The facility is used for the generation of electricity, meaning that it is a net generator of electricity taking into account any electricity consumed by the facility;</P>
                            <P>(2) The facility is placed in service after December 31, 2024; and</P>
                            <P>(3) The facility has a greenhouse gas emissions rate of not greater than zero (as determined under rules provided in § 1.45Y-5).</P>
                            <P>
                                (b) 
                                <E T="03">Property included in qualified facility</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 A qualified facility includes a unit of qualified facility (as defined in paragraph (b)(2) of this section) that meets the requirements of paragraph (b)(2). A qualified facility also includes property owned by the taxpayer that is an integral part (as defined in paragraph (b)(3) of this section) of the qualified facility. Any component of property that meets the requirements of this paragraph (b) is part of a qualified facility regardless of where such component of property is located. A qualified facility generally does not include equipment that is an addition or modification to an existing qualified facility. However, see § 1.45Y-4(c) for rules regarding the Incremental Production Rule and § 1.45Y-4(d) for rules regarding a retrofitted qualified facility (80/20 Rule).
                            </P>
                            <P>
                                (2) 
                                <E T="03">Unit of qualified facility</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 For purposes of the section 45Y credit, the unit of qualified facility includes all functionally interdependent components of property (as defined in paragraph (b)(2)(ii) of this section) owned by the taxpayer that are operated together and that can operate apart from 
                                <PRTPAGE P="4100"/>
                                other property to produce electricity, or, in the case of CHP property, useful thermal energy and electricity. No provision of this section, § 1.45Y-1, or §§ 1.45Y-3 through 1.45Y-5 uses the term 
                                <E T="03">unit</E>
                                 in respect of a qualified facility with any meaning other than that provided in this paragraph (b)(2)(i).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Functionally interdependent.</E>
                                 Components of property are functionally interdependent if the placing in service of each of the components is dependent upon the placing in service of each of the other components to produce electricity.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Integral part—</E>
                                (i) 
                                <E T="03">In general.</E>
                                 For purposes of thesection 45Ycredit, a component of property owned by a taxpayer is an integral part of a qualified facility if it is used directly in the intended function of the qualified facility and is essential to the completeness of such function. Property that is an integral part of a qualified facility is part of the qualified facility.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Power conditioning and transfer equipment.</E>
                                 Power conditioning equipment and transfer equipment are integral parts of a qualified facility. Power conditioning equipment includes, but is not limited to, transformers, inverters, and converters, which modify the characteristics of electricity or thermal energy into a form suitable for use, transmission, or distribution. Parts related to the functioning or protection of power conditioning equipment are also treated as power conditioning equipment and include, but are not limited to, switches, circuit breakers, arrestors, and hardware used to monitor, operate, and protect power conditioning equipment. Transfer equipment includes components of property that allow for the aggregation of electricity generated by a qualified facility and components of property that alter voltage to permit electricity to be transferred to a transmission or distribution line. Transfer equipment does not include transmission or distribution lines. Examples of transfer equipment include, but are not limited to, wires, cables, and combiner boxes that conduct electricity. Parts related to the functioning or protection of transfer equipment are also treated as transfer equipment and may include items such as current transformers used for metering, electrical interrupters (such as circuit breakers, fuses, and other switches), and hardware used to monitor, operate, and protect transfer equipment.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Roads.</E>
                                 Roads that are integral to the intended function of the qualified facility such as onsite roads that are used to operate and maintain the qualified facility are integral parts of a qualified facility. Roads used primarily for access to the site, or roads used primarily for employee or visitor vehicles, are not integral to the intended function of the qualified facility and thus are not an integral part of a qualified facility.
                            </P>
                            <P>
                                (iv)
                                <E T="03">Fences.</E>
                                 Fencing is not an integral part of a qualified facility because it is not integral to the intended function of the qualified facility.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Buildings.</E>
                                 Generally, buildings are not integral parts of a qualified facility because they are not integral to the intended function of the qualified facility. However, the structures described in paragraphs (b)(3)(v)(A) and (B) of this section are not treated as buildings for this purpose and are an integral part of a qualified facility:
                            </P>
                            <P>(A) A structure that is essentially an item of machinery or equipment; and</P>
                            <P>(B) A structure that houses components of property that are integral to the intended function of a qualified facility if the use of the structure is so closely related to the use of the components of property housed therein that the structure clearly can be expected to be replaced if the components of property it initially houses are replaced.</P>
                            <P>
                                (vi) 
                                <E T="03">Shared integral property.</E>
                                 Multiple qualified facilities (whether owned by one or more taxpayers), including qualified facilities with respect to which a taxpayer has claimed a credit under section 48E or another Federal income tax credit, may include shared property that may be considered an integral part of each qualified facility. In addition, a component of property that is shared by a qualified facility as defined in section 45Y(b) (45Y Qualified Facility) and a qualified facility as defined by section 48E(b)(3) (48E Qualified Facility) that is an integral part of both qualified facilities will not affect the eligibility of the 45Y Qualified Facility for the section 45Y credit or the 48E Qualified Facility for the section 48E credit (defined in § 1.48E-1(a)(10)).
                            </P>
                            <P>
                                (vii) 
                                <E T="03">Examples.</E>
                                 This paragraph (b)(3)(vii) provides examples illustrating the rules of paragraphs (b)(3)(i) through (vi) of this section.
                            </P>
                            <P>
                                (A) 
                                <E T="03">Example 1. Co-located qualified facilities owned by the same taxpayer that share integral property.</E>
                                 X constructs and owns a solar facility (Solar Facility) and nearby also constructs and owns a wind facility (Wind Facility) that are each a qualified facility. The Solar Facility and Wind Facility each connect to a shared transformer that steps up the electricity produced by each qualified facility to electrical grid voltage before it is transmitted to the electrical grid through an intertie. The fact that the Solar Facility and Wind Facility share property that is integral to both does not impact the ability of X to claim a section 45Y credit for both qualified facilities.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Example 2. Co-located qualified facilities owned by different taxpayers that share integral property.</E>
                                 X constructs and owns a solar facility (Solar Facility), and nearby Y constructs and owns a wind facility (Wind Facility) that are each a qualified facility. X's Solar Facility and Y's Wind Facility each connect to a shared transformer that steps up the electricity produced by both qualified facilities to electrical grid voltage before it is transmitted to the electrical grid through an intertie. The fact that the Solar Facility and Wind Facility share property that is integral to both does not impact the ability of X or Y to claim a section 45Y credit for the electricity produced by their respective qualified facilities.
                            </P>
                            <P>
                                (C) 
                                <E T="03">Example 3. Co-located qualified facility and Energy Storage Technology (EST) owned by the same taxpayer that share integral property.</E>
                                 X constructs and owns a wind facility that is a qualified facility (Wind Facility) that is co-located with an EST (as defined in § 1.48E-2(g)) that X also constructed and owns. The Wind Facility and EST share transfer equipment that is integral to both. The fact that the Wind Facility and EST share property that is integral to both does not impact the ability of X to claim a section 45Y credit for the electricity produced by the Wind Facility or to claim a section 48E credit for the EST.
                            </P>
                            <P>
                                (D) 
                                <E T="03">Example 4. Co-located wind qualified facility and Energy Storage Technology owned by different taxpayers that share integral property.</E>
                                 X constructs and owns a solar facility that is a qualified facility (Solar Facility) that is co-located with an EST (as defined in § 1.48E-2(g)) constructed and owned by Y. The Wind Facility and EST share transfer equipment that is integral to both. The fact that the Wind Facility and EST share property that is integral to both does not impact the ability of X to claim a section 45Y credit for the electricity produced by the Wind Facility or the ability of Y to claim a section 48E credit for the EST.
                            </P>
                            <P>
                                (E) 
                                <E T="03">Example 5. Qualified facility with integral property owned by a different taxpayer.</E>
                                 X constructs and owns a hydropower production facility that is a qualified facility (Hydropower Facility). The Hydropower Facility connects to a dam owned by Y, a government entity, that is an integral part of the Hydropower Facility. The fact that X does not own the dam does not impact the ability of X to claim a section 45Y 
                                <PRTPAGE P="4101"/>
                                credit for the production of electricity by the Hydropower Facility.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Coordination with other credits</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 The term 
                                <E T="03">qualified facility</E>
                                 (as defined in section 45Y(b) and paragraph (a) of this section) does not include any facility for which a credit determined under section 45, 45J, 45Q, 45U, 48, 48A, or 48E is allowed under section 38 of the Code for the taxable year or any prior taxable year. A taxpayer that directly owns a qualified facility (as defined in section 45Y(b)) that is eligible for both a section 45Y credit and a credit determined under one of section 45, 45J, 45Q, 45U, 48, 48A, or 48E is eligible for the section 45Y credit only if such other Federal income tax credit was not allowed with respect to the qualified facility. Nothing in this paragraph (c) precludes a taxpayer from claiming a section 45Y credit with respect to a qualified facility (as defined in section 45Y(b)) that is co-located with another facility for which a credit determined under section 45, 45J, 45Q, 45U, 48, 48A, or 48E is allowed under section 38 for the taxable year or any prior taxable year.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Allowed.</E>
                                 For purposes of paragraph (c)(1) of this section, the term 
                                <E T="03">allowed</E>
                                 only includes credits that a taxpayer has claimed on a Federal income tax return or Federal return, as appropriate, and that the Internal Revenue Service (IRS) has not challenged in terms of the taxpayer's eligibility.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Examples.</E>
                                 This paragraph (c)(3) provides examples illustrating the rules of paragraph (c) of this section.
                            </P>
                            <P>
                                (i) 
                                <E T="03">Example 1. Taxpayer claims a section 45Y credit on a solar farm and section 48E credit on co-located EST.</E>
                                 X owns a solar farm that is a qualifying facility (Solar Qualified Facility), and X owns a co-located EST (as defined in § 1.48E-2(g)) (Energy Storage). The Energy Storage is not part of the Solar Qualified Facility, and, therefore, X may claim the section 45Y credit based on the kWh of electricity produced by the Solar Qualified Facility, and X may also claim the section 48E credit based on its qualified investment in the Energy Storage.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Example 2. Different taxpayers claim a section 45Y credit for a solar farm</E>
                                 and 
                                <E T="03">a section 48E credit for co-located Energy Storage Technology.</E>
                                 X owns a solar farm that is a qualifying facility (Solar Qualified Facility), and Y owns a co-located EST (as defined in § 1.48E-2(g)) (Energy Storage). The Energy Storage is not part of the Solar Qualified Facility, and therefore, X may claim the section 45Y credit based on the kWh of electricity produced by the Solar Qualified Facility, and Y may claim the section 48E credit based on its qualified investment in the Energy Storage.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Example 3. Taxpayer claiming another credit is not allowed a section 45Y credit.</E>
                                 X owns a wind facility that satisfies the requirements of a qualified facility as well as the requirements of a qualified facility as defined in § 1.48E-2(a). X claims a section 48E credit with respect to the wind facility. While a credit may be available with regard to the wind facility under section 45Y, because X has already claimed a section 48E credit with respect to the wind facility, a section 45Y credit is not allowed.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Example 4. Interaction of section 45Y and section 45Q credits for single qualified facility.</E>
                                 X owns a qualified facility (Facility A) that includes carbon capture equipment, which is needed for the facility to meet the zero greenhouse gas requirement, so it is functionally interdependent to the production of electricity by Facility A. X used the carbon capture equipment to capture and utilize (as described in section 45Q(f)(5)) qualified carbon dioxide and claimed a section 45Q credit in a prior taxable year. As a result, X cannot claim a credit for its Facility A because a qualified facility does not include a facility for which a credit determined under section 45Q is allowed.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Example 5. Interaction of section 45Y and section 45Q credits for co-located qualified facilities.</E>
                                 Assume the same facts as in paragraph (c)(3)(iv) of this section (
                                <E T="03">Example 4</E>
                                ), except that X owns a co-located qualified facility (Facility B) that also includes carbon capture equipment, which is needed for the facility to meet the zero greenhouse gas requirement, so it is functionally interdependent to the production of electricity by Facility B. X used the carbon capture equipment to capture and utilize (as described in section 45Q(f)(5)) qualified carbon dioxide, but has not claimed a section 45Q credit with respect to Facility B. While X claimed a section 45Q credit in a prior taxable year for Facility A (
                                <E T="03">see</E>
                                 paragraph (c)(3)(iv) of this section (
                                <E T="03">Example 4</E>
                                )), Facility B is not part of Facility A, and, therefore, X may claim the section 45Y credit for Facility B.
                            </P>
                            <P>
                                (d) 
                                <E T="03">Applicability date.</E>
                                 This section applies to qualified facilities placed in service after December 31, 2024, and during a taxable year ending on or after January 15, 2025.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="26" PART="1">
                        <AMDPAR>
                            <E T="04">Par. 4.</E>
                             Section 1.45Y-3 is revised to read as follows:
                        </AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1.45Y-3 </SECTNO>
                            <SUBJECT>Rules relating to the increased credit amount for prevailing wage and apprenticeship.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">In general.</E>
                                 If any qualified facility satisfies the requirements in paragraph (b) of this section, the applicable amount used for calculating the amount of the credit for producing clean electricity determined under section 45Y(a) of the Internal Revenue Code is the alternative applicable amount described in section 45Y(a)(2)(B), subject to adjustment provided by section 45Y(c).
                            </P>
                            <P>
                                (b) 
                                <E T="03">Qualified facility requirements.</E>
                                 A qualified facility satisfies the requirements of this paragraph (b), if it is described in paragraph (b)(1), (2), or (3) of this section:
                            </P>
                            <P>(1) A qualified facility with a maximum net output of less than one megawatt (as measured in alternating current) determined based on the nameplate capacity as provided in paragraph (c) of this section (One Megawatt Exception);</P>
                            <P>(2) A qualified facility the construction of which began prior to January 29, 2023; or</P>
                            <P>(3) A qualified facility that meets the prevailing wage requirements of section 45(b)(7) and § 1.45-7, the apprenticeship requirements of section 45(b)(8) and § 1.45-8, and the recordkeeping and reporting requirements of § 1.45-12 with respect to the construction, alteration, or repair of a qualified facility within the meaning of section 45Y.</P>
                            <P>
                                (c) 
                                <E T="03">Nameplate capacity for purposes of the One Megawatt Exception—</E>
                                (1) 
                                <E T="03">In general.</E>
                                 For purposes of paragraph (b)(1) of this section, the determination of whether a qualified facility has a maximum net output of less than 1 megawatt (MW) of electrical energy (as measured in alternating current) is determined based on the nameplate capacity of the qualified facility. If a qualified facility has 
                                <E T="03">integrated operations</E>
                                 with one or more other qualified facilities, then the aggregate nameplate capacity of the qualified facilities is used for the purposes of determining if the qualified facility meets the requirements of paragraph (b)(1) of this section. The nameplate capacity for purposes of the One Megawatt Exception is the maximum electrical generating output in megawatts that a qualified facility is capable of producing on a steady state basis and during continuous operation under standard conditions, as measured by the manufacturer and consistent with the definition of nameplate capacity provided in 40 CFR 96.202. If applicable, the International Standard Organization conditions should be used 
                                <PRTPAGE P="4102"/>
                                to measure the maximum electrical generating output.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Nameplate capacity for qualified facilities that generate in direct current for purposes of the One Megawatt Exception.</E>
                                 For qualified facilities that generate electricity in direct current, the taxpayer determines the maximum net output (in alternating current) of each qualified facility by using the lesser of:
                            </P>
                            <P>(i) The sum of the nameplate generating capacities within the unit of qualified facility in direct current, which is deemed the nameplate generating capacity of the unit of qualified facility in alternating current; or</P>
                            <P>(ii) The nameplate capacity of the first component of property that inverts the direct current electricity into alternating current.</P>
                            <P>
                                (3) 
                                <E T="03">Integrated operations.</E>
                                 Solely for the purposes of the One Megawatt Exception, a qualified facility is treated as having 
                                <E T="03">integrated operations</E>
                                 with any other qualified facility of the same technology type if the facilities are owned by the same or related taxpayers, placed in service in the same taxable year; and transmit electricity generated by the facilities through the same point of interconnection or, if the facilities are not grid-connected or are delivering electricity directly to an end user behind a utility meter, are able to support the same end user.
                            </P>
                            <P>
                                (4) 
                                <E T="03">Related taxpayers</E>
                                —(i) 
                                <E T="03">Definition.</E>
                                 For purposes of this section, the term 
                                <E T="03">related taxpayers</E>
                                 means members of a group of trades or businesses that are under common control (as defined in § 1.52-1(b)).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Related taxpayer rule.</E>
                                 For purposes of this section, related taxpayers are treated as one taxpayer in determining whether a qualified facility has integrated operations.
                            </P>
                            <P>
                                (d) 
                                <E T="03">Applicability date</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 Except as provided in paragraph (d)(2) of this section, this section applies to qualified facilities placed in service in taxable years ending after January 15, 2025, and the construction of which begins after January 15, 2025. Taxpayers may apply this section to qualified facilities placed in service in taxable years ending on or before January 15, 2025, and qualified facilities placed in service in taxable years ending after January 15, 2025, the construction of which begins before January 15, 2025, provided that taxpayers follow this section in its entirety and in a consistent manner.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Paragraph (b)(1) of this section.</E>
                                 Paragraph (b)(1) of this section applies to qualified facilities placed in service in taxable years ending after January 15, 2025, and the construction of which begins after March 17, 2025. Taxpayers may apply this section to qualified facilities placed in service in taxable years ending on or before January 15, 2025, the construction of which begins before January 15, 2025, provided that taxpayers follow this section in its entirety and in a consistent manner.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="26" PART="1">
                        <AMDPAR>
                            <E T="04">Par. 5.</E>
                             Sections 1.45Y-4 and 1.45Y-5 are added to read as follows:
                        </AMDPAR>
                        <STARS/>
                        <CONTENTS>
                            <SECHD>Sec.</SECHD>
                            <SECTNO>1.45Y-4</SECTNO>
                            <SUBJECT>Rules of general application.</SUBJECT>
                            <SECTNO>1.45Y-5</SECTNO>
                            <SUBJECT>Greenhouse gas emissions rates for qualified facilities under section 45Y.</SUBJECT>
                        </CONTENTS>
                        <STARS/>
                        <SECTION>
                            <SECTNO>§ 1.45Y-4</SECTNO>
                            <SUBJECT> Rules of general application.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Only production in the United States is taken into account for purposes of section 45Y.</E>
                                 Consumption, sales, or storage are taken into account for purposes of the section 45Y credit (defined in § 1.45Y-2(a)) only with respect to electricity the production of which is within the United States (within the meaning of section 638(1) of the Internal Revenue Code (Code)), or a United States territory, which for purposes of section 45Y and the section 45Y regulations (defined in § 1.45Y-2(a)) has the meaning of the term a possession of the United States (within the meaning of section 638(2)).
                            </P>
                            <P>
                                (b) 
                                <E T="03">Production attributable to the taxpayer</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 In the case of a qualified facility in which more than one person has an ownership share (and the arrangement is not treated as a partnership for Federal tax purposes) production from the qualified facility is allocated among such persons in proportion to their respective ownership shares in the gross sales from such qualified facility. The respective owners each determine their respective section 45Y credit under section 45Y(a) and based on their respective ownership shares in the gross sales from such qualified facility during the taxable year.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Example of gross sales.</E>
                                 A, B and C, all calendar year taxpayers, each own an interest in a solar facility which is a qualified facility (as defined in § 1.45Y-2(a)) (Solar Facility). A owns 45 percent, B owns 35 percent, and C owns 20 percent, and each are allocated gross sales from the Solar Facility in proportion to their ownership interest. The Solar Facility produced 1000 kWh of electricity during the taxable year. A, B, and C will each determine their respective section 45Y credit under section 45Y(a) and § 1.45Y-1(b) based on their allocable share of the gross sales from the 1000 kWh of electricity produced at the Solar Facility during the taxable year.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Section 761(a) election.</E>
                                 If a qualified facility is owned through an unincorporated organization that has made a valid election under section 761(a) of the Code, each member's undivided ownership share in the qualified facility will be treated as a separate qualified facility owned by such member.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Expansion of facility; Incremental production (Incremental Production Rule)</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 Solely for purposes of this paragraph (c), the term 
                                <E T="03">qualified facility</E>
                                 includes either a new unit or an addition of capacity placed in service after December 31, 2024, in connection with a facility described in section 45Y(b)(1)(A) (without regard to section 45Y(b)(1)(A)(ii)) that was placed in service before January 1, 2025, but only to the extent of the increased amount of electricity produced at the facility by reason of such new unit or addition of capacity. This rule is only applicable to an addition of capacity or new unit that would not otherwise qualify as a separate qualified facility as defined in section 45Y(b)(1)(A). A new unit or an addition of capacity that meets the requirements of this paragraph (c) will be treated as a separate qualified facility. For purposes of this paragraph (c), a new unit or an addition of capacity requires the addition or replacement of components of property, including any new or replacement integral property, added to a facility necessary to increase capacity. For purposes of assessing the One Megawatt Exception provided in section 45Y(a)(2)(B)(i), the maximum net output for a new unit or an addition of capacity is the sum of the capacity of the added qualified facility and the capacity of the facility to which the qualified facility was added, as determined under § 1.45Y-3(c) and paragraph (c)(2) of this section.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Measurement standard.</E>
                                 For purposes of this paragraph (c), taxpayers must use one of the measurement standards described in paragraph (c)(2)(i), (ii), or (iii) of this section to measure the capacity and change in capacity of a facility, except a taxpayer cannot use the measurement standard described in paragraph (c)(2)(ii) of this section if they are able to use the measurement standard described in paragraph (c)(2)(i) of this section:
                            </P>
                            <P>(i) Modified or amended facility operating licenses from the Federal Energy Regulatory Commission (FERC) or the Nuclear Regulatory Commission (NRC), or related reports prepared by FERC or NRC as part of the licensing process;</P>
                            <P>
                                (ii) Nameplate capacity certified consistent with generally accepted 
                                <PRTPAGE P="4103"/>
                                industry standards, such as the International Standard Organization (ISO) conditions to measure the nameplate capacity of the facility consistent with the definition of nameplate capacity provided in 40 CFR 96.202; or
                            </P>
                            <P>(iii) A measurement standard prescribed by the Secretary in guidance published in the Internal Revenue Bulletin (see § 601.601 of this chapter).</P>
                            <P>
                                (3) 
                                <E T="03">Special rule for restarted facilities.</E>
                                 Solely for purposes of this paragraph (c), a facility that is decommissioned or in the process of decommissioning and restarts can be considered to have increased capacity from a base of zero if the conditions described in each of paragraphs (c)(3)(i) through (iv) of this section are met:
                            </P>
                            <P>(i) The existing facility must have ceased operations;</P>
                            <P>(ii) The existing facility must have a shutdown period of at least one calendar year during which it was not authorized to operate by its respective Federal regulatory authority (that is, FERC or NRC);</P>
                            <P>(iii) The restarted facility must be eligible to restart based on an operating license issued by either FERC or NRC; and</P>
                            <P>(iv) The existing facility may not have ceased operations for the purpose of qualifying for the special rule for restarted facilities in this paragraph (c)(3).</P>
                            <P>
                                (4) 
                                <E T="03">Computation of increased amount of electricity produced.</E>
                                 To determine the increased amount of electricity produced by a facility in a taxable year by reason of a new unit or an addition of capacity, a taxpayer must multiply the amount of electricity that the facility produces during that taxable year after the new unit or addition of capacity is placed in service by a fraction, the numerator of which is the added capacity that results from the new unit or addition of capacity, and the denominator of which is the total capacity of the facility with the new unit or addition of capacity added, provided the added capacity and resulting total capacity are measured using a measurement standard identified in paragraph (c)(2) of this section.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Examples.</E>
                                 This paragraph (c)(5) provides examples illustrating the rules of paragraph (c) of this section.
                            </P>
                            <P>
                                (i) 
                                <E T="03">Example 1. New Unit.</E>
                                 X owns a hydropower facility (Facility H) that was originally placed in service in 2020, with a FERC license authorizing an installed capacity of 60 megawatts. During taxable years 2020 through 2024, X claimed a section 45 credit for the electricity produced by Facility H. On July 1, 2025, as allowed by a FERC license amendment, X places in service components of property comprising a new unit that results in Facility H having an increased authorized installed capacity of 90 megawatts in 2025. For purposes of paragraph (c) of this section, this new unit will be treated as a separate facility (Facility J). X may claim a section 45Y credit during the 10-year credit period starting on July 1, 2025, based on the increased amount of electricity generated as a result of the new unit, which is determined by multiplying the electricity that Facility H produces with Facility J by one-third (equal to the 30-megawatt increase in capacity that results from the addition of Facility J divided by the 90 megawatt capacity of Facility H with Facility J). Even though X claimed a section 45 credit for the existing capacity of Facility H in taxable years 2020 through 2024, X can claim a section 45Y credit for the production of electricity associated with Facility J. X may also continue to claim the section 45 credit through taxable year 2030 for electricity generated by Facility H (excluding the incremental electricity generation related to Facility J).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Example 2. Addition of Capacity.</E>
                                 Y owns a nuclear facility (Facility N) that was originally placed in service on January 1, 2000. Y claimed a section 45U credit in taxable years 2024 and 2025 for the electricity generated by Facility N. On January 15, 2026, Y completed and placed in service an investment associated with a power uprate approved by an NRC license amendment that involved the removal and replacement of components of property and placing in service additional components of property. NRC reports associated with the license amendment describe the uprate as increasing the nuclear facility's electrical capacity by 100 MW to 900 MW. For purposes of this paragraph (c), Facility N's addition of capacity is treated as a new separate qualified facility placed in service on January 15, 2026 (Facility P). Y may claim a section 45Y credit during the 10-year credit period starting on January 15, 2026, based on the increased amount of electricity produced at Facility N that is attributable to the addition of capacity (Facility P), which is determined by multiplying the electricity that Facility N produces with Facility P by 
                                <FR>1/9</FR>
                                 (equal to the 100-megawatt increase in capacity divided by Facility N's new total capacity of 900 megawatts with Facility P, as described in NRC reports associated with the license amendment). Even though Y claimed a section 45U credit in taxable years 2024 and 2025 for the existing capacity of Facility N, Y can claim a section 45Y credit for the production of electricity associated with Facility P. Y may also continue to claim the section 45U credit for electricity generated by Facility N (excluding the incremental electricity generation related to Facility P).
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Example 3. Geothermal Turbine and Generator Additions of Capacity.</E>
                                 X owns a geothermal power plant (Facility G) with a 24 MW nameplate capacity, which is placed in service in 2007. Over the subsequent years, the plant's generating capability declines because of physical degradation of the turbine and generator. On March 1, 2027, X places in service components of property at Facility G that increase its capacity. The turbine rotor is removed, and the eroded blades are replaced with new blades. The generator is refurbished by removing old subcomponents of the generator and replacing those with new subcomponents, as well as replacing the old copper windings with new windings in concert with new insulation. After the upgrade, the plant increases its nameplate capacity to 26 MW, an increase of 2 MW over the previous nameplate capacity. For purposes of this paragraph (c), the addition of capacity to Facility G is treated as a new separate qualified facility placed in service on March 1, 2027 (Facility N). X may claim a section 45Y credit during the 10-year credit period starting on March 1, 2027, based on the amount of electricity produced by Facility N, which is determined by multiplying the aggregate amount of electricity that Facility G produces with Facility N by 1/13 (that is, the fraction equal to the 2-megawatt increase in nameplate capacity attributable to Facility N divided by the new total aggregate 26 megawatt nameplate capacity of Facility G with Facility N).
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Example 4. Hydropower Addition of Capacity.</E>
                                 X owns a hydropower plant (Facility H) that was placed in service in 1960. Facility H has become less efficient since it was placed in service with attendant reductions in its generating capacity. As approved by a FERC license amendment, X increases Facility H's capacity by installing new headcovers, new turbines with integrated dissolved oxygen injection, and a new high pressure digital governor system. The new turbines are more efficient and are capable of more power output than the original design. Improvements to the generators involve removing the old asphalt coated copper windings and purchasing and then installing new epoxy coated double wound windings. X adds digital 
                                <PRTPAGE P="4104"/>
                                controls to effectively utilize new digital governors while simultaneously investing in cybersecurity protection. As set forth in the FERC order amending its license, these investments, which are placed in service on April 15, 2026, increase Facility H's authorized installed capacity from 180 MW to 190 MW, an increase of 10 MW. For purposes of this paragraph (c), Facility H's addition of capacity is treated as a new separate qualified facility placed in service on April 16, 2026 (Facility A). X may claim a section 45Y credit during the 10-year credit period starting on April 16, 2026, based on the amount of electricity produced by Facility A, which is determined by multiplying the aggregate amount of electricity that Facility H produces with Facility A by 1/19 (equal to the 10-megawatt increase in capacity attributable to Facility A divided by the new total aggregate 190 MW capacity of Facility H with Facility A).
                            </P>
                            <P>
                                (v) 
                                <E T="03">Example 5. Nonoperational Nuclear Facility that Satisfies Restart Rule.</E>
                                 T owns a nuclear facility (Facility N) that was originally placed in service in 1982. In 2020, Facility N ceased operations, began decommissioning, and the NRC no longer authorized the operation of Facility N. T did not cease operations at Facility N for the purpose of qualifying for the special rule for restarted facilities under section 45Y. In 2028, the NRC authorized Facility N to restart and, on October 1, 2028, Facility N placed in service components of property and restarted and resumed operations, with an electrical capacity of 800 MW, as indicated in NRC documents related to the authorization to restart. For purposes of this paragraph (c), the restart of Facility N is considered to have increased capacity from a base of zero, and Facility N is treated as having an addition of capacity equal to 800 MW. For purposes of this paragraph (c), Facility N's 800 MW addition of capacity is treated as a new qualified facility placed in service on October 1, 2028 (Facility P). T may claim a section 45Y credit during the 10-year period starting on October 1, 2028, based on the increased amount of electricity produced at Facility N that is attributable to that addition of capacity (Facility P).
                            </P>
                            <P>
                                (d) 
                                <E T="03">Retrofit of an existing facility (80/20 Rule)—</E>
                                (1) 
                                <E T="03">In general.</E>
                                 For purposes of section 45Y(b)(1)(B), a facility may qualify as originally placed in service even if it contains some used components of property within the unit of qualified facility, provided the fair market value of the used components of the unit of qualified facility is not more than 20 percent of the total value of the unit of qualified facility (that is, the cost of the new components of property plus the fair market value of the used components of property within the unit of qualified facility) (80/20 Rule). If a facility satisfies the requirements of the 80/20 Rule, then the date on which such qualified facility is considered originally placed in service for purposes of section 45Y(b)(1)(B) is the date on which the new components of property of the unit of qualified facility are placed in service. A qualified facility that meets the 80/20 Rule may claim the section 45Y credit without regard to any addition of capacity to the qualified facility.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Cost of new components of property.</E>
                                 For purposes of the 80/20 Rule, the cost of new components of the unit of qualified facility includes all costs properly included in the depreciable basis of the new components of property of the unit of qualified facility.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Examples.</E>
                                 The following examples illustrate the rules of this paragraph (d).
                            </P>
                            <P>
                                (i) 
                                <E T="03">Example 1. Retrofitted facility that meets the 80/20 Rule.</E>
                                 A owns an existing wind facility. On February 1, 2026, A replaces used components of the unit of qualified facility of a wind facility with new components at a cost of $2 million. The fair market value of the remaining original components of the unit of qualified facility is $400,000, which is not more than 20 percent of the retrofitted unit of qualified facility's total fair market value of $2.4 million (the cost of the new components ($2 million) + the fair market value of the remaining original components of the unit of qualified facility ($400,000)). Thus, the retrofitted wind facility will be considered newly placed in service for purposes of section 45Y, and the section 45Y credit is allowable for electricity produced by A at the wind qualified facility and sold, consumed, or stored, during the 10-year period beginning on February 1, 2026, assuming all the other requirements of section 45Y are met.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Example 2. Retrofit of an existing facility that meets the 80/20 Rule.</E>
                                 Facility Z, a facility that was originally placed in service on January 1, 2026, was not a qualified facility (as described in § 1.45Y-2(a)) when it was placed in service because it did not meet the greenhouse gas emissions rate requirements (as determined under rules provided in § 1.45Y-5). On January 1, 2027, Facility Z was retrofitted and now meets the requirements to be a qualified facility under § 1.45Y-2(a). After the retrofit, the cost of the new property included in the unit of qualified facility of Facility Z is greater than 80 percent of the unit of qualified facility of Facility Z's total fair market value. Because Facility Z meets the 80/20 Rule, Facility Z is deemed to be originally placed in service on January 1, 2027. Therefore, a section 45Y credit is allowable for electricity produced by Facility Z and sold, consumed, or stored during the 10-year period beginning on January 1, 2027, assuming all the other requirements of section 45Y are met.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Example 3. Retrofitted nuclear facility that satisfied the 80/20 Rule.</E>
                                 T owns a nuclear facility (Facility N) that was originally placed in service on March 1, 1982. T replaces used components of property of unit of qualified facility of Facility N with new components at a cost of $200 million, placing in service the components of property on July 15, 2026. The fair market value of the remaining original components of the unit of qualified facility of Facility N, prior to the retrofit, is $30 million, which is less than 20 percent of the unit of qualified facility of Facility N's total fair market value of $230 million (the cost of the new components ($200 million) + the fair market value of the remaining original components of the unit of qualified facility ($30 million)) ($30 million/$230 million = 13%). Thus, Facility N will be considered newly placed in service on July 15, 2026, for purposes of section 45Y, and T will be able to claim a section 45Y credit based on the electricity generated at Facility N, assuming all the other requirements of section 45Y are met.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Example 4. Capital improvements to an existing qualified facility that do not satisfy the 80/20 Rule.</E>
                                 X owns an existing facility, Facility C, that was originally placed in service on January 1, 2023. X makes capital improvements to Facility C that are placed in service on June 1, 2026. The cost of the capital improvements to the unit of qualified facility of Facility C is $500,000 and the fair market value of the unit of qualified facility of Facility C after the improvements is $2 million. The value of the old components of property of the unit of qualified facility is $1,500,000 out of $2.0 million, or 75 percent ($500,000/$2,000,000) of the total fair market value of the unit of qualified facility after the improvements. Because the fair market value of the new property included in the unit of qualified facility is less than 80 percent of the total fair market value of the unit of qualified facility, Facility C does not meet the 80/20 Rule. Facility C will not be considered a qualified facility (as defined in § 1.45Y-2(a)) eligible for the section 45Y credit. If the capital 
                                <PRTPAGE P="4105"/>
                                improvements to Facility C increase its nameplate capacity, the determination that it does not meet the 80/20 Rule does not prevent X from claiming a section 45Y credit if the requirements under paragraph (c)(1) of this section are met.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Example 5. Upgrades to a hydropower qualified facility that satisfies the 80/20 Rule:</E>
                                 Y owns a hydropower qualified facility (hydropower facility) and no taxpayer, including Y, has ever claimed a section 45 credit for the hydropower facility. The hydropower facility consists of a unit of qualified facility including water intake, water isolation mechanisms, turbine, pump, motor, and generator. The associated impoundment (dam) and power conditioning equipment are integral parts of the unit of qualified facility. Y makes upgrades to the unit of qualified facility by replacing the turbine, pump, motor, and generator with new components at a cost of $1.5 million. Y does not make any upgrades to the property that is an integral part of the unit of qualified facility. The remaining original components of the unit of qualified facility have a fair market value of $100,000, which is not more than 20 percent of the retrofitted hydropower facility's total value of $1.6 million (that is, the cost of the new components ($1.5 million) + the value of the remaining original components ($100,000)). Thus, the retrofitted hydropower facility will be considered newly placed in service for purposes of section 45Y, and Y will be able to claim a section 45Y credit based on the cost of the new components ($1.5 million).
                            </P>
                            <P>
                                (e) 
                                <E T="03">Applicability date.</E>
                                 This section applies to qualified facilities placed in service after December 31, 2024, and during a taxable year ending on or after January 15, 2025.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1.45Y-5 </SECTNO>
                            <SUBJECT>Greenhouse gas emissions rates for qualified facilities under section 45Y.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">In general.</E>
                                 This section provides rules and definitions for determining emissions rates for purposes of section 45Y of the Internal Revenue Code (Code). Paragraph (b)(4) of this section provides a definition for a facility that produces electricity through combustion or gasification and paragraph (b)(7) of this section defines a facility that does not produce electricity through combustion or gasification. Paragraphs (c) through (e) provide rules for determining the greenhouse gas emissions rates for facilities for purposes of section 45Y. Paragraph (f) of this section provides rules for the annual publication of emissions rates. Paragraph (g) of this section provides rules related to provisional emissions rates. Paragraph (h) of this section provides rules regarding reliance on the annual publication of emissions rates and provisional emissions rates. Finally, paragraph (i) of this section provides rules regarding substantiation requirements.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Definitions.</E>
                                 The definitions in this paragraph (b) apply for purposes of this section.
                            </P>
                            <P>
                                (1) 
                                <E T="03">CO</E>
                                <E T="52">2</E>
                                <E T="03">e per kWh.</E>
                                 The term 
                                <E T="03">CO</E>
                                <E T="52">2</E>
                                <E T="03">e per kWh</E>
                                 means with respect to any greenhouse gas, the equivalent carbon dioxide (as determined based on global warming potential) per kWh of electricity produced. The 100-year time horizon global warming potentials (GWP-100) from the Intergovernmental Panel on Climate Change's Fifth Assessment Report (AR5) must be used to convert emissions to equivalent carbon dioxide emissions. For purposes of this paragraph (b)(1), the GWP-100 from AR5 (as shown in table 1 to this paragraph (b)(1)) excludes climate-carbon feedbacks. Table 1 to this paragraph (b)(1) provides GWP-100 amounts for certain greenhouse gases applicable to this section.
                            </P>
                            <GPOTABLE COLS="2" OPTS="L2,nj,i1" CDEF="s50,xs60">
                                <TTITLE>
                                    Table 1 to Paragraph (
                                    <E T="01">b</E>
                                    )(1)—100 Year Global Warming Potentials for Greenhouse Gases
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Greenhouse gas</CHED>
                                    <CHED H="1">GWP</CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">
                                        CO
                                        <E T="0732">2</E>
                                    </ENT>
                                    <ENT>1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        CH
                                        <E T="0732">4</E>
                                    </ENT>
                                    <ENT>28.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        N
                                        <E T="0732">2</E>
                                        O
                                    </ENT>
                                    <ENT>265.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        SF
                                        <E T="0732">6</E>
                                    </ENT>
                                    <ENT>23,500.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Hydrofluorocarbons</ENT>
                                    <ENT>Varies by gas.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Perfluorocarbons</ENT>
                                    <ENT>Varies by gas.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                (2) 
                                <E T="03">Combustion.</E>
                                 The term 
                                <E T="03">combustion</E>
                                 means a rapid exothermic chemical reaction, specifically the oxidation of a fuel, which liberates energy including heat and light.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Gasification.</E>
                                 The term 
                                <E T="03">gasification</E>
                                 means a thermochemical process that converts carbon-containing materials into syngas, a gaseous mixture that is composed primarily of carbon monoxide, carbon dioxide, and hydrogen.
                            </P>
                            <P>
                                (4) 
                                <E T="03">Facility that produces electricity through combustion or gasification (C&amp;G Facility).</E>
                                 Consistent with section 45Y(b)(2)(B), the term 
                                <E T="03">facility that produces electricity through combustion or gasification</E>
                                 (C&amp;G Facility) means a facility that produces electricity through combustion or uses an input energy source to produce electricity, if the input energy source was produced through a fundamental transformation of one energy source into another using combustion or gasification.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Greenhouse gas emissions rate.</E>
                                 Consistent with section 45Y(b)(2)(A), the term 
                                <E T="03">greenhouse gas emissions rate</E>
                                 means the amount of greenhouse gases emitted into the atmosphere by a facility in the production of electricity, expressed as grams of CO
                                <E T="52">2</E>
                                e per kWh.
                            </P>
                            <P>
                                (6) 
                                <E T="03">Greenhouse gases emitted into the atmosphere by a facility in the production of electricity.</E>
                                 For purposes of section 45Y(b)(2)(A), for both C&amp;G and Non-C&amp;G Facilities, the term 
                                <E T="03">greenhouse gases emitted into the atmosphere by a facility in the production of electricity</E>
                                 means emissions from a facility that directly occur from the processes that transform the input energy source into electricity but excludes emissions described in paragraphs (b)(6)(i) through (vi) of this section.
                            </P>
                            <P>(i) Emissions from electricity production by back-up or auxiliary generators that are primarily used in maintaining critical systems in case of a power system outage or for supporting restart of a generator after an outage.</P>
                            <P>(ii) Emissions from routine operational and maintenance activities that are integral to the production of electricity, including, but not limited to, emissions from internal combustion vehicles used to access and perform maintenance on remote electricity generating facilities or emissions occurring from heating and cooling control rooms or dispatch centers.</P>
                            <P>(iii) Emissions from a step-up transformer that conditions the electricity into a form suitable for productive use or sale.</P>
                            <P>(iv) Emissions that occur before commercial operations commence or after commercial operations terminate, including, but not limited to, on-site emissions occurring from construction or manufacturing of the facility itself, emissions from the off-site manufacturing of facility components, or emissions occurring due to siting or decommissioning.</P>
                            <P>(v) Emissions from infrastructure associated with the facility, including, but not limited to, emissions from road construction for feedstock production.</P>
                            <P>(vi) Emissions from the distribution of electricity to consumers.</P>
                            <P>
                                (7) 
                                <E T="03">Non-C&amp;G Facility.</E>
                                 The term 
                                <E T="03">Non-C&amp;G Facility</E>
                                 means a facility that produces electricity and is not described in paragraph (b)(4) of this section.
                            </P>
                            <P>
                                (8) 
                                <E T="03">Fuel.</E>
                                 The term 
                                <E T="03">fuel</E>
                                 means material directly used to produce electricity or energy inputs that are used to produce electricity.
                            </P>
                            <P>
                                (9) 
                                <E T="03">Feedstock.</E>
                                 The term 
                                <E T="03">feedstock</E>
                                 means any raw material used in a process for electricity generation or to produce an intermediate product or 
                                <PRTPAGE P="4106"/>
                                finished fuel used for electricity generation.
                            </P>
                            <P>
                                (10) 
                                <E T="03">Market-mediated effects.</E>
                                 The term 
                                <E T="03">market-mediated effects</E>
                                 means effects resulting from policy interventions and other factors (for example, technological advances) that alter the availability of and demand for marketed goods and activities and their related greenhouse gas (GHG) emissions profiles. These effects are driven by and result in changes in absolute and relative prices which can occur at local, national, and global boundaries. Examples of market-mediated effects include direct and significant indirect emissions, such as land use changes or land use management changes that result from the production of fuels derived from biomass and shifts in total market demand and supply for input fuels, feedstocks and related commodities, and other materials, as a result of changes associated with the policy intervention.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Non-C&amp;G Facilities</E>
                                —(1) 
                                <E T="03">Determining a greenhouse gas emissions rate for Non-C&amp;G Facilities.</E>
                                 Greenhouse gas emissions rates for Non-C&amp;G Facilities must be determined under paragraphs (c) and (e) of this section.
                            </P>
                            <P>
                                (i) 
                                <E T="03">Excluded emissions.</E>
                                 With respect to Non-C&amp;G Facilities only, greenhouse gases emitted into the atmosphere by a facility in the production of electricity excludes emissions of greenhouse gases that are not directly produced by the fundamental transformation of the input energy source into electricity, including, but not limited to:
                            </P>
                            <P>(A) Emissions from hydropower reservoirs due to anoxic conditions;</P>
                            <P>(B) Ebullitive, diffuse, and degassing emissions from hydropower operations;</P>
                            <P>(C) Emissions of non-condensable gases from underground reservoirs during geothermal operations; and</P>
                            <P>(D) Emissions occurring due to activities and operations occurring off-site, including but not limited to, the production and transportation of fuels used by the facility, or land use change from siting or changes in demand.</P>
                            <P>
                                (ii) 
                                <E T="03">Emissions assessment process.</E>
                                 Subject to paragraphs (b)(6) and (c)(1) of this section, a greenhouse gas emissions rate for a Non-C&amp;G Facility must be determined through a technical and engineering assessment of the fundamental energy transformation into electricity. This assessment must consider all input and output energy carriers and chemical reactions or mechanical processes taking place at the facility in the production of electricity.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Example of greenhouse gas emissions rate determination for a Non-C&amp;G Facility</E>
                                —(A) 
                                <E T="03">Facts.</E>
                                 A facility uses solar photovoltaic technologies to convert light directly into electricity through use of the photovoltaic effect. This is a physical phenomenon in which certain semiconducting materials upon exposure to light, absorb the light and transform the energy contained in the light directly into an electric current. There are many materials that may be used to generate electricity through this method, including crystalline silicon, amorphous silicon, cadmium telluride, copper indium gallium diselenide, perovskites, quantum dots, and carbon-based materials known as organic photovoltaics. The smallest unit of photovoltaic materials is a cell. Multiple cells are typically assembled into a panel or module and electrically connected. Multiple modules or panels are generally connected to comprise a solar system or installation. Solar photovoltaic technologies produce direct current electricity that can be used as is or, more typically, can be fed into inverters to transform it into alternating current. Solar panels can be ground mounted at a fixed angle or can be mounted with tracking systems that move the panels to track the location of the sun over the course of the day and season in order to maximize electricity production. Solar panels may also be mounted on buildings (for example, on roofs), or solar photovoltaic materials can be integrated into other building components such as roofing tiles.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Analysis.</E>
                                 For solar photovoltaic technologies, the fundamental transformation of input energy (solar electromagnetic radiation) into electricity using the photovoltaic effect involves no mechanical energy or chemical reactions. Academic studies on the lifecycle greenhouse gas emissions from solar photovoltaic power indicate that there is a small but non-zero amount of emissions associated with the operational phase of these technologies. However, these emissions exclusively occur due to ongoing maintenance (for example, the washing of solar panels), preventative maintenance (for example, the periodic replacement of electrical equipment such as inverters), and a minimal amount of project management (for example, inverter standby mode at night). These emissions do not occur directly due to the production of electricity. Therefore, consistent with paragraph (c)(1)(ii) of this section, the greenhouse gas emissions rate for facilities that produce electricity by solar photovoltaic properties is not greater than zero.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Non-C&amp;G Facilities with a greenhouse gas emissions rate that is not greater than zero.</E>
                                 The types or categories of facilities described in paragraphs (c)(2)(i) through (viii) of this section are Non-C&amp;G Facilities with a greenhouse gas emissions rate that is not greater than zero and may be treated as listed in the Annual Table (see paragraph (g) of this section) with an emissions rate that is not greater than zero:
                            </P>
                            <P>(i) Wind (including small wind properties);</P>
                            <P>(ii) Hydropower (including retrofits that add electricity production to non-powered dams, conduit hydropower, hydropower using new impoundments, and hydropower using diversions such as a penstock or channel);</P>
                            <P>(iii) Marine and hydrokinetic;</P>
                            <P>(iv) Solar (including photovoltaic and concentrated solar power);</P>
                            <P>(v) Geothermal (including flash and binary plants);</P>
                            <P>(vi) Nuclear fission;</P>
                            <P>(vii) Fusion energy; and</P>
                            <P>(viii) Waste energy recovery property that derives energy from a source described in paragraphs (c)(2)(i) through (vii) of this section.</P>
                            <P>
                                (d) 
                                <E T="03">C&amp;G Facilities</E>
                                —(1) 
                                <E T="03">Determining a greenhouse gas emissions rate for C&amp;G Facilities.</E>
                                 The greenhouse gas emissions rate for a C&amp;G Facility—
                            </P>
                            <P>(i) Must be determined by a lifecycle analysis (LCA) that complies with the requirements of paragraphs (d) and (e) of this section; and</P>
                            <P>
                                (ii) Equals the net rate of greenhouse gases emitted into the atmosphere by such facility (taking into account lifecycle greenhouse gas emissions, as described in 42 U.S.C. 7545(o)(1)(H)) in the production of electricity, expressed as grams of CO
                                <E T="52">2</E>
                                e per kWh.
                            </P>
                            <P>
                                (2) 
                                <E T="03">LCA requirements.</E>
                                 For purposes of this paragraph (d), an LCA must comply with the requirements of paragraphs (d)(2)(i) through (x) of this section:
                            </P>
                            <P>
                                (i) 
                                <E T="03">Starting boundary.</E>
                                 The starting boundary of the LCA for an LCA involving generation-derived feedstocks (such as biogenic feedstocks) is feedstock generation. The starting boundary of the LCA for an LCA involving extraction-derived feedstocks (such as fossil fuel feedstocks) is feedstock extraction. The starting boundaries include the processes and inputs necessary to produce and collect or extract the raw materials used to produce electricity from combustion or gasification technologies, including those used as energy inputs to electricity production. This includes, but is not limited to, the emissions effects, including associated direct and indirect greenhouse gas emissions, of relevant land management activities or changes related to or associated with the 
                                <PRTPAGE P="4107"/>
                                extraction or production of raw feedstock materials or fuel.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Ending boundary.</E>
                                 The ending boundary of the LCA for electricity that is transmitted to the grid or electricity that is used on-site is the meter at the point of production of the C&amp;G Facility. The use of such electricity generated by the C&amp;G Facility (and what other types of energy sources it displaces), including emissions from transmission and distribution, are outside of the LCA boundary.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Baseline.</E>
                                 The LCA must be based on a future anticipated baseline, which projects future status quo in the absence of the availability of the section 45Y and 48E credits (taking into account anticipated changes in technology, policies, practices, and environmental and other socioeconomic conditions). The future anticipated baseline must be updated as necessary to capture material regulatory, economic, supply chain, or environmental changes. The baseline must be updated at least every ten years, but not more often than every five years.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Offsets and offsetting activities.</E>
                                 Offsets and offsetting activities may not be taken into account in the LCA.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Principles for included emissions.</E>
                                 The LCA must take into account direct emissions and significant indirect emissions. Sources of direct emissions include those associated with feedstock production or extraction, including emissions at all stages of fuel and feedstock production, and distribution, and emissions associated with distribution, delivery, and use of feedstocks to and by a C&amp;G Facility. Sources of significant indirect emissions include emissions in the United States and other countries associated with market-mediated changes in related commodity markets, such as emission from indirect land use change and emissions consequences of commodity production. These included emissions are within the system boundary of the LCA.
                            </P>
                            <P>
                                (A) 
                                <E T="03">Direct emissions.</E>
                                 For purposes of this paragraph (d)(2)(v), direct emissions include, but are not limited to:
                            </P>
                            <P>
                                (
                                <E T="03">1</E>
                                ) Emissions from feedstock generation, production, and extraction (including emissions from feedstock and fuel harvesting and extraction and direct land use change and management, including emissions from fertilizers, and changes in carbon stocks);
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) Emissions from feedstock and fuel transport (including emissions from transporting the raw or processed feedstock to the fuel processing facility);
                            </P>
                            <P>
                                (
                                <E T="03">3</E>
                                ) Emissions from transporting and distributing fuels to electricity production facility;
                            </P>
                            <P>
                                (
                                <E T="03">4</E>
                                ) Emissions from handling, processing, upgrading, and/or storing feedstocks, fuels and intermediate products (including emissions from on/offsite storage and preparation/pre-treatment for use (for example, torrefaction or pelletization) and emissions from process additives); and
                            </P>
                            <P>
                                (
                                <E T="03">5</E>
                                ) Emissions from combustion and gasification at the electricity generating facility (including emissions from the combustion and/or gasification process and emission from gasification or combustion additives).
                            </P>
                            <P>
                                (B) 
                                <E T="03">Significant indirect emissions.</E>
                                 For purposes of this paragraph (d)(2)(v), examples of significant indirect emissions include, but are not limited to, emissions from indirect land use and land use change, and induced emissions associated with the increased use of the feedstock for energy production.
                            </P>
                            <P>
                                (vi) 
                                <E T="03">Principles for excluded emissions.</E>
                                 The LCA must not take into account the types of emissions described in paragraphs (d)(2)(vi)(A) through (D) of this section:
                            </P>
                            <P>(A) Emissions from facility construction, siting or decommissioning (including on-site emissions occurring from construction or manufacturing of the facility itself);</P>
                            <P>(B) Emissions from facility maintenance (including emissions from the on and offsite construction or maintenance of the facility; emissions from vehicles used to access and perform maintenance on electricity generating facilities; emissions from back-up generators that do not provide additional firm power and are used in maintaining critical systems in case of a power system outage or for supporting restart of a generator after an outage; and emissions occurring from heating and cooling control rooms or dispatch centers);</P>
                            <P>(C) Emissions from infrastructure associated with the facility (including emissions from road construction for feedstock production and emissions from onsite backup or emergency generators used in an emergency or unplanned outage); and</P>
                            <P>(D) Emissions from the distribution of electricity to consumers.</P>
                            <P>
                                (vii) 
                                <E T="03">Alternative fates and avoided emissions.</E>
                                 The LCA may consider alternative fates and account for avoided emissions, including for the fuels and feedstocks consumed in the fuel and feedstock supply chain and at the electricity generating facility. The term 
                                <E T="03">alternative fate</E>
                                 means a set of informed assumptions (for example, production processes, material outcomes, and market-mediated effects) used to estimate the emissions from the use or disposal of each feedstock were it not for the feedstock's new use due to the implementation of policy (that is, to produce electricity). The term 
                                <E T="03">avoided emissions</E>
                                 means the estimated emissions associated with the feedstock, including the feedstock's production and use or disposal, that would have occurred in the alternative fate (if such feedstock had not been diverted for electricity production) but are instead avoided with the feedstock's use for electricity production.
                            </P>
                            <P>
                                (viii) 
                                <E T="03">Temporal scales.</E>
                                 The LCA should evaluate the emissions over a time horizon of 30 years from the year in which a qualified facility first qualifies for the credit (or, for purposes of the section 48E credit, the year in which a qualified facility was placed in service).
                            </P>
                            <P>
                                (ix) 
                                <E T="03">Spatial scales.</E>
                                 To determine the initial spatial scope of the LCA, the initial qualitative assessment should analyze whether the feedstock has been or is anticipated: to be used or sold on the market in the absence of the section 45Y and 48E credits; to be used directly in or as an input to an activity or good in local markets; to be transported for use in domestic markets elsewhere; to be traded for use in international markets; and to be used in a manner that has significant ramifications on other markets. If this assessment concludes that the feedstock does not meet one or more of the criteria in this paragraph (d)(2)(ix), then the market-mediated effects analysis would not be necessary beyond the relevant spatial scale(s) (for example, if the feedstock is not traded or not anticipated to be traded for use in international markets and increased use in the United States is not anticipated to have significant market ramifications abroad, international market-mediated effects analysis would not be necessary). Based on the results of the assessment, the LCA should evaluate the emissions on a sub-regional, regional, national, or international scale as appropriate. The evaluation of emissions should include the market and emissions implications of sourcing new or additional material for electricity generation across the applicable market and spatial scales.
                            </P>
                            <P>
                                (x) 
                                <E T="03">Categorization of products.</E>
                                 As appropriate, the LCA should distinguish between primary products, co-products, byproducts, and waste products.
                            </P>
                            <P>
                                (A) Products should be categorized based on the definitions in paragraphs (d)(2)(x)(A)(
                                <E T="03">1</E>
                                ) through (
                                <E T="03">4</E>
                                ) of this section.
                            </P>
                            <P>
                                (
                                <E T="03">1</E>
                                ) A 
                                <E T="03">primary product</E>
                                 is an input or an output with marketability and is the main driver of the process from which it is produced.
                                <PRTPAGE P="4108"/>
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) A 
                                <E T="03">co-product</E>
                                 is an input or an output with marketability that is produced together with another product, both of which are economic drivers of the process from which they are produced.
                            </P>
                            <P>
                                (
                                <E T="03">3</E>
                                ) A 
                                <E T="03">byproduct</E>
                                 is an input or an output that is produced together with another product, and which has a market recognized economic value of zero or greater, but the output is not an economic driver of the process from which it is produced.
                            </P>
                            <P>
                                (
                                <E T="03">4</E>
                                ) A 
                                <E T="03">waste product</E>
                                 is an input or an output with negative economic value, demonstrated by—
                            </P>
                            <P>
                                (
                                <E T="03">i</E>
                                ) The absence of a market in which the product is purchased and sold; and
                            </P>
                            <P>
                                (
                                <E T="03">ii</E>
                                ) The existence of a market in which producers pay for the collection and removal or disposal of the input or output material or the existence of a predominant operational practice in which producers themselves collect and remove, give away, or dispose of the input or output material as part of operational processes.
                            </P>
                            <P>
                                (B) The LCA should adopt the principles in paragraphs (d)(2)(x)(B)(
                                <E T="03">1</E>
                                ) through (
                                <E T="03">6</E>
                                ) of this section for categorizing and assessing the emissions outcomes for different types of products if such categorization is relevant to the LCA model or models used.
                            </P>
                            <P>
                                (
                                <E T="03">1</E>
                                ) All classification of materials and LCAs should take into account relevant geospatial variations in supply and demand (that is, differences across local, sub-regional, and larger regions), as well as variations across specific product types and characteristics, and producer types as relevant.
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) The LCA should assess whether there are market-mediated effects and, if so, take these into account as part of the GHG analysis.
                            </P>
                            <P>
                                (
                                <E T="03">3</E>
                                ) Regardless of how a material is categorized, the LCA should consider whether the availability of the section 45Y and 48E credits is expected to result in additional production of that material or in material changes in the supply chain, and, if so, should take into account the direct and indirect emissions impact of the additional production or changes in the supply chain.
                            </P>
                            <P>
                                (
                                <E T="03">4</E>
                                ) Policy and other interventions (for example, technological advances) can alter the availability and demand for marketed goods and services, which can alter the treatment of materials once disposed of. Therefore, reevaluation of material categorization should occur at least every ten years, but not more often than every five years.
                            </P>
                            <P>
                                (
                                <E T="03">5</E>
                                ) All determinations of marketability, market-mediated effects, and behavioral changes must be supported by an analytical assessment performed by one or more National Laboratories, in consultation with other Federal agency experts as appropriate.
                            </P>
                            <P>
                                (
                                <E T="03">6</E>
                                ) A material should be considered to have a market recognized economic value and an established market if one existed within the last five years as of the date of the analysis.
                            </P>
                            <P>
                                (e) 
                                <E T="03">Use of methane from certain sources to produce electricity</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 The requirements provided by this paragraph (e) apply to C&amp;G Facilities (as defined in paragraph (b)(4) of this section) that produce electricity through combustion or gasification using methane derived from biogas, renewable natural gas (RNG) derived from biogas, or fugitive sources of methane (or any hydrogen derived from methane from these sources) as a fuel or feedstock.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Definitions.</E>
                                 The following definitions apply for purposes of paragraph (e) of this section:
                            </P>
                            <P>
                                (i) 
                                <E T="03">Biogas.</E>
                                 The term 
                                <E T="03">biogas</E>
                                 means gas containing methane that results from the decomposition of organic matter under anaerobic conditions.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Coal mine methane.</E>
                                 The term 
                                <E T="03">coal mine methane</E>
                                 means methane that is stored within coal seams and is liberated as a result of current or past mining activities. Liberated coal mine methane can be released intentionally by the mine for safety purposes, such as through mine degasification boreholes or underground mine ventilation systems, or it may leak out of the mine through vents, fissures, or boreholes. The term coal mine methane does not include methane removed from virgin coal seams (for example, coal bed methane).
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Fugitive methane.</E>
                                 The term 
                                <E T="03">fugitive methane</E>
                                 means methane released from equipment leaks or venting during the extraction, processing, transformation, or delivery of fossil fuels and other gaseous fuels to the point of final use.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Renewable natural gas.</E>
                                 The term 
                                <E T="03">renewable natural gas</E>
                                 (RNG) means biogas that has been upgraded to remove water, CO
                                <E T="52">2,</E>
                                 and other impurities such that it is interchangeable with fossil natural gas.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Considerations regarding the lifecycle greenhouse gas emissions associated with the production of electricity using methane from certain sources—</E>
                                (i) 
                                <E T="03">In general.</E>
                                 For purposes of determining the GHG emissions rate of a C&amp;G Facility (as provided in paragraph (d)(1) of this section) that produces electricity through combustion or gasification using methane derived from biogas, RNG derived from biogas, or fugitive sources of methane (or any hydrogen derived from methane from these sources) as a fuel or feedstock, measurements of lifecycle GHG emissions must consider all the direct and significant indirect emissions associated with a C&amp;G Facility's production of electricity. For purposes of determining the alternative fates and avoided emissions under paragraph (d)(2)(vii) of this section, such determinations must consider the alternative fates of that methane, including avoided emissions and alternative productive uses of that methane; the risk that the availability of tax credits creates incentives resulting in the production of additional methane or otherwise induces additional emissions; and observable trends and anticipated changes in waste management and disposal practices over time as they are applicable to methane generation and uses.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Methane from landfill sources.</E>
                                 For purposes of determining the GHG emissions rate of a C&amp;G Facility (as provided in paragraph (d)(1) of this section) that produces electricity through combustion or gasification using methane derived from landfill sources as a fuel or feedstock, the alternative fate of such gas must be flaring.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Methane from wastewater sources.</E>
                                 For purposes of determining the GHG emissions rate of a C&amp;G Facility (as provided in paragraph (d)(1) of this section) that produces electricity through combustion or gasification using methane derived from wastewater sources as a fuel or feedstock, the alternative fate of such gas must be flaring of gas not used to heat the anaerobic digester.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Coal mine methane.</E>
                                 For purposes of determining the GHG emissions rate of a C&amp;G Facility (as provided in paragraph (d)(1) of this section) that produces electricity through combustion or gasification using coal mine methane that is drainage gas as a fuel or feedstock, the alternative fate of such gas must be flaring.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Methane from animal waste.</E>
                                 For purposes of determining the GHG emissions rate of a C&amp;G Facility (as provided in paragraph (d)(1) of this section) that produces electricity through combustion or gasification using methane derived from animal waste as a fuel or feedstock, the emissions associated with producing and transporting such biogas must use an alternative fate derived from the national average of all animal waste management practices, which results in a carbon intensity score of -51 gCO
                                <E T="52">2</E>
                                e/megajoule (MJ), where the MJ basis refers to the lower heating value of the 
                                <PRTPAGE P="4109"/>
                                methane contained in the biogas prior to upgrading.
                            </P>
                            <P>
                                (vi) 
                                <E T="03">Fugitive methane other than coal mine methane.</E>
                                 For purposes of determining the GHG emissions rate of a C&amp;G Facility (as provided in paragraph (d)(1) of this section) that produces electricity through combustion or gasification using fugitive methane other than coal mine methane as a fuel or feedstock, such as fugitive methane from oil and gas operations, the alternative fate of such gas must be productive use, resulting in emissions equivalent to the carbon intensity of using fossil natural gas.
                            </P>
                            <P>
                                (4) 
                                <E T="03">Book-and-claim.</E>
                                 For purposes of determining a GHG emissions rate of a facility under section 45Y or 48E, a book-and-claim accounting system may not be used to establish or claim the energy attributes of biogas, RNG, coal mine methane, or any other methane described in this paragraph (e), or any other input or feedstock.
                            </P>
                            <P>
                                (f) 
                                <E T="03">Carbon capture and sequestration</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 For purposes of determining a greenhouse gas emissions rate for a Non-C&amp;G Facility or C&amp;G Facility, the greenhouse gas emissions rate must not include any qualified carbon dioxide (as defined in section 45Y(c)(3)) that is produced in such facility's production of electricity, that is captured by the taxpayer, and pursuant section 45Q(f)(2) and 26 CFR 1.45Q-3, disposed of by the taxpayer in secure geological storage, or utilized by the taxpayer in a manner described in section 45Q(f)(5) and 26 CFR 1. 45Q-4.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Substantiation.</E>
                                 The requirements for substantiation and verification of carbon capture and sequestration provided by regulations and guidance published in the Internal Revenue Bulletin (
                                <E T="03">see</E>
                                 § 601.601 of this chapter) under section 45Q (section 45Q requirements) must be satisfied for qualified carbon dioxide to be taken into account under paragraph (e)(1) of this section. A taxpayer that uses carbon capture and sequestration at a qualified facility for which a section 45Y credit is claimed must comply with applicable requirements of the U.S. Environmental Protection Agency's Greenhouse Gas Reporting Program (GHGRP) under 40 CFR part 98, subpart PP (for carbon capture), subpart RR (for geological storage), and subpart RR or VV (for storage through enhanced oil recovery). In addition to the section 45Q requirements, taxpayers using the ISO 27916 standard for enhanced oil recovery must report information to GHGRP under 40 CFR part 98, subpart VV. Furthermore, the taxpayer must also include their applicable GHGRP ID number(s) on the IRS Form used to claim the section 45Y or section 48E credit, with the exception of taxpayers claiming the credits by performing carbon capture and utilization. The GHGRP does not provide a reporting mechanism for utilization.
                            </P>
                            <P>
                                (g) 
                                <E T="03">Annual publication of emissions rates</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 As required by section 45Y(b)(2)(C)(i), the Secretary will annually publish a table that sets forth the greenhouse gas emissions rates for types or categories of facilities (Annual Table), which a taxpayer must use for purposes of section 45Y. Except as provided in paragraph (h) of this section, a taxpayer that owns a facility that is described in the Annual Table on the first day of the taxpayer's taxable year in which the section 45Y credit or section 48E credit is determined with respect to such facility must use the Annual Table as of such date to determine an emissions rate for such facility for such taxable year.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Publication of analysis required for changes to the Annual Table.</E>
                                 In connection with the publication of the Annual Table, the Secretary must publish an accompanying expert analysis that addresses any types or categories of facilities added or removed from the Annual Table, as well as any changes to emissions determinations for any types or categories of facilities in the Annual Table, since its last publication. Types or categories of facilities will be added or removed from the Annual Table consistent with, for Non-C&amp;G Facilities, a technical assessment of the fundamental energy transformation into electricity as provided in paragraph (c)(1)(ii) of this section, and, for C&amp;G Facilities, an LCA that complies with paragraphs (d) and (f) of this section. Such expert analysis must be prepared by one or more of the National Laboratories, in consultation with other Federal agency experts as appropriate, and must address whether the addition or removal of types or categories of facilities from the Annual Table complies with section 45Y(b)(2)(A) and (B) of the Internal Revenue Code and this section.
                            </P>
                            <P>
                                (h) 
                                <E T="03">Provisional emissions rates</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 In the case of any facility that is of a type or category for which an emissions rate has not been established by the Secretary under paragraph (g) of this section, a taxpayer that owns such facility may file a petition with the Secretary for the determination of the emissions rate with respect to such facility (Provisional Emissions Rate or PER). A PER must be determined and obtained under the rules of this section.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Rate not established.</E>
                                 An emissions rate has not been established by the Secretary for a facility for purposes of section 45Y(b)(2)(C)(ii) if such facility is not described in the Annual Table. If a taxpayer's request for an emissions value pursuant to paragraph (h)(5) of this section is pending at the time such facility is or becomes described in the Annual Table, the taxpayer's request for an emissions value will be automatically denied.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Process for filing a PER petition.</E>
                                 To file a PER petition with the Secretary, a taxpayer must submit a PER petition by attaching it to the taxpayer's Federal income tax return or Federal return, as appropriate, for the first taxable year in which the taxpayer claims the section 45Y credit with respect to the facility to which the PER petition applies. The PER petition must contain an emissions value, and, if applicable, the associated letter from the Department of Energy (DOE). An emissions value may be obtained from DOE or by using the designated LCA model in accordance with paragraph (h)(6) of this section. An emission value obtained from DOE will be based on an analytical assessment of the emissions rate associated with the facility, performed by one or more National Laboratories, in consultation with other Federal agency experts as appropriate, consistent with this section. A taxpayer must retain in its books and records a copy of the application and correspondence to and from DOE including a copy of the taxpayer's request to DOE for an emissions value and any information provided by the taxpayer to DOE pursuant to the emissions value request process provided in paragraph (h)(5) of this section. Alternatively, an emissions value can be determined by the taxpayer for a facility using the most recent version of an LCA model, as of the time the PER petition is filed, that has been designated by the Secretary for such use under paragraph (h)(6) of this section. If an emissions value is determined using the most recent version of the model or models, the taxpayer is required to provide to the IRS information to support its determination in the form and manner prescribed in IRS forms or instructions or in publications or guidance published in the Internal Revenue Bulletin. 
                                <E T="03">See</E>
                                 § 601.601 of this chapter. A taxpayer may not request an emissions value from DOE for a facility for which an emissions value can be determined by using the most recent version of an LCA model or models that have been designated by the Secretary for such use under paragraph (h)(6) of this section.
                            </P>
                            <P>
                                (4) 
                                <E T="03">PER determination.</E>
                                 Upon the IRS's acceptance of the taxpayer's Federal income tax return or Federal return, as 
                                <PRTPAGE P="4110"/>
                                appropriate, containing a PER petition, the emissions value of the facility specified on such petition will be deemed accepted. A taxpayer may rely upon an emissions value provided by DOE for purposes of claiming a section 45Y credit, provided that any information, representations, or other data provided to DOE in support of the request for an emissions value are accurate. If applicable, a taxpayer may rely upon an emissions value determined for a facility using the most recent version of the specific LCA model or models that, as of the time the PER petition is filed, have been designated by the Secretary for such use under paragraph (h)(6) of this section, provided that any information, representations, or other data used to obtain such emissions value are accurate. The IRS's deemed acceptance of an emissions value is the Secretary's determination of the PER. However, the taxpayer must still comply with all applicable requirements for the section 45Y credit and any information, representations, or other data supporting an emissions value are subject to later examination by the IRS.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Emissions value request process.</E>
                                 An applicant that submits a request for an emissions value must follow the procedures specified by DOE to request and obtain such emissions value. Emissions values will be determined consistent with the rules provided in this section. An applicant may request an emissions value from DOE only after a front-end engineering and design (FEED) study or similar indication of project maturity, as determined by DOE, such as completion of a project specification and cost estimation sufficient to inform a final investment decision for the facility. DOE may decline to review applications that are not responsive, including those applications that relate to a facility described in the Annual Table (consistent with paragraph (h)(2) of this section) or a facility for which an emissions value can be determined by an LCA model designated under paragraph (h)(6) of this section (consistent with paragraph (h)(3) of this section), or applications that are incomplete. DOE will publish guidance and procedures that applicants must follow to request and obtain an emissions value from DOE. DOE's guidance and procedures will include a process for, under limited circumstances, requesting a revision to DOE's initial assessment of an emissions value based on revised technical information or facility design and operation.
                            </P>
                            <P>
                                (6) 
                                <E T="03">LCA model for determining an emissions value for C&amp;G Facilities.</E>
                                 The Secretary may designate one or more LCA models for determining an emissions value for C&amp;G Facilities that are not described in the Annual Table. The Secretary may only designate a model under this paragraph (h)(6) if the model complies with section 45Y(b)(2)(B) and paragraphs (d) and (f) of this section. The Secretary may revoke the designation of an LCA model or models. In connection with the designation or revocation of a designation of an LCA model or models, the Secretary is required to publish an accompanying expert analysis of the model that is prepared by one or more of the National Laboratories, in consultation with other Federal agency experts as appropriate, and such analysis must address the model's compliance with section 45Y(b)(2)(B) of the Internal Revenue Code and paragraphs (d) and (f) of this section.
                            </P>
                            <P>
                                (7) 
                                <E T="03">Effect of PER.</E>
                                 A taxpayer may use a PER determined by the Secretary to determine eligibility for the section 45Y credit for the facility to which the PER applies, provided all other requirements of section 45Y are met. The Secretary's PER determination is not an examination or inspection of books of account for purposes of section 7605(b) of the Code and does not preclude or impede the IRS (under section 7605(b) or any administrative provisions adopted by the IRS) from later examining a return or inspecting books or records with respect to any taxable year for which the section 45Y credit is claimed. Further, a PER determination does not signify that the IRS has determined that the requirements of section 45Y have been satisfied for any taxable year.
                            </P>
                            <P>
                                (i) 
                                <E T="03">Reliance on Annual Table or provisional emissions rate.</E>
                                 Taxpayers may rely on the Annual Table in effect as of the date a facility began construction or the provisional emissions rate determined by the Secretary for the taxpayer's facility under paragraph (h)(4) of this section to determine the facility's greenhouse gas emissions rate for any taxable year that is within the 10-year period described in section 45Y(b)(1)(B), provided that the facility continues to operate as a type of facility that is described in the Annual Table or the facility's emissions value request, as applicable, for the entire taxable year.
                            </P>
                            <P>
                                (j) 
                                <E T="03">Substantiation</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 A taxpayer must maintain in its books and records documentation regarding the design, operation, and, if applicable, feedstock or fuel source used by the facility that establishes that such facility had a greenhouse gas emissions rate, as determined under this section, that is not greater than zero for the taxable year.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Sufficient substantiation.</E>
                                 Documentation sufficient to substantiate that a facility had a greenhouse gas emissions rate, as determined under this section, that is not greater than zero for the taxable year includes documentation or a report prepared by an unrelated party that verifies that a facility had such an emissions rate. For a facility described in paragraph (c)(2) of this section, the taxpayer can maintain sufficient documentation to demonstrate a greenhouse gas emissions rate that is not greater than zero for the taxable year by showing that it is the type of facility described in paragraph (c)(2). For qualified facilities not described in paragraph (c)(2), the taxpayer must demonstrate that the qualified facility meets the specific criteria that the analytical assessment prepared by the National Laboratories, in consultation with other Federal agency experts as appropriate, has found are necessary for a facility to meet the statutory requirement of a greenhouse gas emissions rate not greater than zero. For C&amp;G Facilities that utilize biomass feedstocks, the taxpayer must substantiate that the source of such fuels or feedstocks used are consistent with the taxpayer's claims. The Secretary may determine that qualified facilities not described in paragraph (c)(2) can sufficiently substantiate a greenhouse gas emissions rate, as determined under this section, that is not greater than zero with certain documentation and will describe such facilities and documentation in IRS forms or instructions or in publications or guidance published in the Internal Revenue Bulletin. 
                                <E T="03">See</E>
                                 § 601.601 of this chapter. For facilities that utilize unmarketable feedstocks that are indistinguishable from marketable feedstocks (for instance, after processing), the taxpayer will be required to maintain documentation substantiating the origin and original form of the feedstock.
                            </P>
                            <P>
                                (k) 
                                <E T="03">Applicability date.</E>
                                 This section applies to qualified facilities placed in service after December 31, 2024, and during a taxable year ending on or after January 15, 2025.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="26" PART="1">
                        <AMDPAR>
                            <E T="04">Par. 6.</E>
                             Sections 1.48E-0 through 1.48E-5 are added to read as follows:
                        </AMDPAR>
                        <CONTENTS>
                            <SECHD>Sec.</SECHD>
                            <STARS/>
                            <SECTNO>1.48E-0</SECTNO>
                            <SUBJECT>Table of contents.</SUBJECT>
                            <SECTNO>1.48E-1</SECTNO>
                            <SUBJECT>Clean electricity investment credit.</SUBJECT>
                            <SECTNO>1.48E-2</SECTNO>
                            <SUBJECT>
                                Qualified investments in qualified facilities and EST for purposes of section 48E.
                                <PRTPAGE P="4111"/>
                            </SUBJECT>
                            <SECTNO>1.48E-3</SECTNO>
                            <SUBJECT>Rules relating to the increased credit for prevailing wage and apprenticeship.</SUBJECT>
                            <SECTNO>1.48E-4</SECTNO>
                            <SUBJECT>Rules of general application.</SUBJECT>
                            <SECTNO>1.48E-5</SECTNO>
                            <SUBJECT>Greenhouse gas emissions rates for qualified facilities under section 48E.</SUBJECT>
                        </CONTENTS>
                        <STARS/>
                        <SECTION>
                            <SECTNO>§ 1.48E-0</SECTNO>
                            <SUBJECT>Table of contents.</SUBJECT>
                            <P>This section lists the captions contained in §§ 1.48E-1 through 1.48E-5.</P>
                            <EXTRACT>
                                <FP SOURCE="FP-2">§ 1.48E-1 Clean electricity investment credit.</FP>
                                <P>(a) Overview.</P>
                                <P>(1) In general.</P>
                                <P>(2) Claim.</P>
                                <P>(3) Code.</P>
                                <P>(4) EST.</P>
                                <P>(5) kWh.</P>
                                <P>(6) Qualified facility.</P>
                                <P>(7) Qualified investment with respect to a qualified facility.</P>
                                <P>(8) Qualified investment with respect to EST.</P>
                                <P>(9) Secretary.</P>
                                <P>(10) Section 48E credit.</P>
                                <P>(11) Section 48E regulations.</P>
                                <P>(12) Waste energy recovery property (WERP).</P>
                                <P>(b) Credit amount.</P>
                                <P>(1) In general.</P>
                                <P>(2) Applicable percentage.</P>
                                <P>(3) Base rate.</P>
                                <P>(4) Alternative rate.</P>
                                <P>(5) Energy communities increase in credit rate.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Applicable credit rate increase.</P>
                                <P>(6) Domestic content increase in credit rate.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Applicable credit rate increase.</P>
                                <P>(c) Credit phase-out.</P>
                                <P>(1) In general.</P>
                                <P>(2) Phase-out percentage.</P>
                                <P>(3) Applicable year.</P>
                                <P>(d) Related taxpayers.</P>
                                <P>(1) Definition.</P>
                                <P>(2) Related taxpayer rule.</P>
                                <P>(e) Applicability date.</P>
                                <FP SOURCE="FP-2">§ 1.48E-2 Qualified investments in qualified facilities and EST for purposes of section 48E.</FP>
                                <P>(a) Qualified investment with respect to a qualified facility.</P>
                                <P>(1) In general.</P>
                                <P>(2) Total basis amount.</P>
                                <P>(b) Qualified facility.</P>
                                <P>(1) In general.</P>
                                <P>(2) Placed in service.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Qualified facility subject to § 1.48-4 election to treat lessee as purchaser.</P>
                                <P>(c) Qualified property.</P>
                                <P>(1) In general.</P>
                                <P>(2) Location of property.</P>
                                <P>(d) Property included in qualified facility.</P>
                                <P>(1) In general.</P>
                                <P>(2) Unit of a qualified facility.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Functionally interdependent.</P>
                                <P>(3) Integral part.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Power conditioning and transfer equipment.</P>
                                <P>(iii) Roads.</P>
                                <P>(iv) Fences.</P>
                                <P>(v) Buildings.</P>
                                <P>(vi) Shared integral property.</P>
                                <P>(vii) Examples.</P>
                                <P>(e) Definitions related to requirements for qualified property.</P>
                                <P>(1) Tangible personal property.</P>
                                <P>(2) Other tangible property.</P>
                                <P>(3) Depreciation allowable.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Exclusions from allowable.</P>
                                <P>(4) Construction, reconstruction, or erection of the property.</P>
                                <P>(5) Acquisition of qualified property.</P>
                                <P>(6) Original use of the property.</P>
                                <P>(7) Retrofitted qualified facility.</P>
                                <P>(f) Coordination with other credits.</P>
                                <P>(1) In general.</P>
                                <P>(2) Allowed.</P>
                                <P>(3) Examples.</P>
                                <P>(g) EST.</P>
                                <P>(1) Property included in EST.</P>
                                <P>(2) Unit of EST.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Functionally interdependent.</P>
                                <P>(3) Integral part.</P>
                                <P>(4) Qualified investment with respect to EST.</P>
                                <P>(5) Placed in service.</P>
                                <P>(i) In general.</P>
                                <P>(ii) EST subject to § 1.48-4 election to treat lessee as purchaser.</P>
                                <P>(6) Types of EST.</P>
                                <P>(i) Electrical energy storage property.</P>
                                <P>(ii) Thermal energy storage property.</P>
                                <P>(iii) Hydrogen energy storage property.</P>
                                <P>(7) Modification of EST.</P>
                                <P>(h) Applicability date.</P>
                                <FP SOURCE="FP-2">§ 1.48E-3 Rules relating to the increased credit for prevailing wage and apprenticeship.</FP>
                                <P>(a) In general.</P>
                                <P>(b) Qualified facility or EST requirements.</P>
                                <P>(c) Nameplate capacity for purposes of the One Megawatt Exception.</P>
                                <P>(1) Qualified facilities.</P>
                                <P>(2) Nameplate capacity for qualified facilities that generate in direct current for purposes of the One Megawatt Exception.</P>
                                <P>(3) EST.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Electrical energy storage property.</P>
                                <P>(iii) Thermal energy storage property.</P>
                                <P>(iv) Hydrogen energy storage property.</P>
                                <P>(4) Integrated operations.</P>
                                <P>(i) One Megawatt Exception.</P>
                                <P>(ii) EST One Megawatt Exception.</P>
                                <P>(d) Transition waiver of penalty for prevailing wage requirements.</P>
                                <P>(e) No alteration or repair during recapture period described in § 1.48-13(c)(3).</P>
                                <P>(f) Applicability date.</P>
                                <FP SOURCE="FP-2">§ 1.48E-4 Rules of general application.</FP>
                                <P>(a) Qualified interconnection costs included in certain lower-output qualified facilities.</P>
                                <P>(1) In general.</P>
                                <P>(2) Qualified interconnection property.</P>
                                <P>(3) Five-Megawatt Limitation.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Nameplate capacity for purposes of the Five-Megawatt Limitation.</P>
                                <P>(iii) Nameplate capacity for qualified facilities that generate in direct current for purposes of the Five-Megawatt Limitation.</P>
                                <P>(4) Interconnection agreement.</P>
                                <P>(5) Utility.</P>
                                <P>(6) Reduction to amounts chargeable to capital account.</P>
                                <P>(7) Examples.</P>
                                <P>(b) Expansion of facility; Incremental production (Incremental Production Rule).</P>
                                <P>(1) In general.</P>
                                <P>(2) Measurement standard.</P>
                                <P>(3) Special rule for restarted facilities.</P>
                                <P>(4) Computation of qualified investment for a new unit or an addition of capacity.</P>
                                <P>(i) New unit.</P>
                                <P>(ii) Addition of capacity.</P>
                                <P>(5) Examples.</P>
                                <P>(c) Retrofit of an existing facility (80/20 Rule).</P>
                                <P>(1) In general.</P>
                                <P>(2) Expenditures taken into account.</P>
                                <P>(3) Cost of new components.</P>
                                <P>(4) New costs.</P>
                                <P>(5) Excluded costs.</P>
                                <P>(6) Examples.</P>
                                <P>(d) Special rules regarding ownership.</P>
                                <P>(1) Qualified investment with respect to a qualified facility or EST.</P>
                                <P>(2) Multiple owners.</P>
                                <P>(3) Section 761(a) election.</P>
                                <P>(4) Examples.</P>
                                <P>(e) Coordination rule for section 42 credits and section 48E credits.</P>
                                <P>(f) Recapture.</P>
                                <P>(1) In general.</P>
                                <P>(2) Recapture event.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Changes to the Annual Table.</P>
                                <P>(iii) Yearly determination.</P>
                                <P>(iv) Carryback and carryforward adjustments.</P>
                                <P>(3) Recapture amount.</P>
                                <P>(i) In general.</P>
                                <P>(ii) Applicable recapture percentage.</P>
                                <P>(4) Recapture period.</P>
                                <P>(5) Increase in tax for recapture.</P>
                                <P>(g) Qualified progress expenditure election.</P>
                                <P>(h) Incremental cost.</P>
                                <P>(i) Cross references.</P>
                                <P>(j) Applicability date.</P>
                                <FP SOURCE="FP-2">§ 1.48E-5 Greenhouse gas emissions rates for qualified facilities under section 48E.</FP>
                                <P>(a) In general.</P>
                                <P>(b) Definitions.</P>
                                <P>(c) Non-C&amp;G Facilities.</P>
                                <P>(d) C&amp;G Facilities.</P>
                                <P>(e) Use of methane from certain sources to produce electricity.</P>
                                <P>(f) Carbon capture and sequestration.</P>
                                <P>(g) Annual publication of emissions rates.</P>
                                <P>(h) Provisional emissions rates.</P>
                                <P>(1) In general.</P>
                                <P>(2) Rate not established.</P>
                                <P>(3) Process for filing a PER petition.</P>
                                <P>(4) PER determination.</P>
                                <P>(5) Emissions value request process.</P>
                                <P>(6) LCA model for determining an emissions value for C&amp;G Facilities.</P>
                                <P>(7) Effect of PER.</P>
                                <P>(i) Determining anticipated greenhouse gas emissions rate.</P>
                                <P>(1) In general.</P>
                                <P>(2) Examples of objective indicia.</P>
                                <P>(j) Reliance on Annual Table or Provisional Emissions Rate.</P>
                                <P>(k) Substantiation.</P>
                                <P>(1) In general.</P>
                                <P>
                                    (2) Sufficient substantiation.
                                    <PRTPAGE P="4112"/>
                                </P>
                                <P>(l) Applicability date.</P>
                            </EXTRACT>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1.48E-1</SECTNO>
                            <SUBJECT>Clean electricity investment credit.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Overview</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 For purposes of section 46 of the Internal Revenue Code (Code), the section 48E credit (defined in paragraph (a)(10) of this section) is determined under section 48E of the Code and the section 48E regulations (defined in paragraph (a)(11) of this section). This paragraph (a) provides definitions of terms that, unless otherwise specified, apply for purposes of section 48E, the section 48E regulations, and any provision of the Code or this chapter that expressly refers to any provision of section 48E or the section 48E regulations. Paragraph (b) of this section provides rules for determining the amount of the section 48E credit for any taxable year. Paragraph (c) of this section provides rules regarding the phase-out of the section 48E credit. 
                                <E T="03">See</E>
                                 § 1.48E-2 for rules relating to qualified investments in qualified facilities and energy storage technology (EST) for purposes of the section 48E credit. 
                                <E T="03">See</E>
                                 § 1.48E-4 for rules of general application for the section 48E credit. 
                                <E T="03">See</E>
                                 § 1.48E-5 for rules to determine greenhouse gas emissions rates for qualified facilities under section 48E.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Claim.</E>
                                 For purposes of determining a taxpayer's section 48E credit with respect to a qualified facility or EST or a credit described in section 48E(b)(3)(C), the term 
                                <E T="03">claim</E>
                                 means filing a completed Form 3468, Investment Credit, or any successor form(s), or other relevant form as it relates to the credits described in section 48E(b)(3)(C), with the taxpayer's timely filed (including extensions) Federal income tax return or Federal return, as appropriate, for the taxable year in which the qualified facility or EST is placed in service, and for the taxable year in which the facility for which the credit described in section 48E(b)(3)(C) is placed in service. It includes making an election under section 6417 or 6418 of the Code and 26 CFR 1.6417-1 and 1.6418-1, respectfully, with respect to such section 48E credit on the taxpayer's filed return.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Code.</E>
                                 The term 
                                <E T="03">Code</E>
                                 means the Internal Revenue Code.
                            </P>
                            <P>
                                (4) 
                                <E T="03">EST.</E>
                                 The term 
                                <E T="03">EST</E>
                                 for purposes of the section 48E credit means energy storage technology as defined in § 1.48E-2(g).
                            </P>
                            <P>
                                (5) 
                                <E T="03">kWh.</E>
                                 The term 
                                <E T="03">kWh</E>
                                 means kilowatt hours.
                            </P>
                            <P>
                                (6) 
                                <E T="03">Qualified facility.</E>
                                 The term 
                                <E T="03">qualified facility</E>
                                 for purposes of the section 48E credit has the meaning provided in § 1.48E-2(b).
                            </P>
                            <P>
                                (7) 
                                <E T="03">Qualified investment with respect to a qualified facility.</E>
                                 The term 
                                <E T="03">qualified investment with respect to a qualified facility</E>
                                 for purposes of the section 48E credit has the meaning provided in § 1.48E-2(a).
                            </P>
                            <P>
                                (8) 
                                <E T="03">Qualified investment with respect to EST.</E>
                                 The term 
                                <E T="03">qualified investment with respect to EST</E>
                                 for purposes of the section 48E credit has the meaning provided in § 1.48E-2(g)(4).
                            </P>
                            <P>
                                (9) 
                                <E T="03">Secretary.</E>
                                 The term 
                                <E T="03">Secretary</E>
                                 means the Secretary of the Treasury or their delegate.
                            </P>
                            <P>
                                (10) 
                                <E T="03">Section 48E credit.</E>
                                 The term 
                                <E T="03">section 48E credit</E>
                                 means the clean electricity investment credit determined under section 48E of the Code and the section 48E regulations.
                            </P>
                            <P>
                                (11) 
                                <E T="03">Section 48E regulations.</E>
                                 The term 
                                <E T="03">section 48E regulations</E>
                                 means this section and §§ 1.48E-2 through 1.48E-5.
                            </P>
                            <P>
                                (12) 
                                <E T="03">Waste energy recovery property (WERP).</E>
                                 WERP is property that generates electricity solely from heat from buildings or equipment if the primary purpose of such building or equipment is not the generation of electricity. Examples of buildings or equipment the primary purpose of which is not the generation of electricity include, but are not limited to, manufacturing plants, medical care facilities, facilities on school campuses, and associated equipment.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Credit amount</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 For purposes of section 46 of the Code, the section 48E credit for any taxable year is an amount equal to the applicable percentage of the qualified investment for such taxable year with respect to any qualified facility and any EST.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Applicable percentage.</E>
                                 The term 
                                <E T="03">applicable percentage</E>
                                 means the base rate described in paragraph (b)(3) of this section or the alternative rate described in paragraph (b)(4) of this section. The applicable percentage may be increased as provided in section 48E(a)(3)(A) and paragraph (b)(5) of this section in the case of a qualified facility that is located in an energy community. Similarly, the applicable percentage may be increased as provided in section 48E(a)(3)(B) and paragraph (b)(6) of this section in the case of a qualified facility that satisfies the domestic content requirements.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Base rate.</E>
                                 Under section 48E(a)(2)(A)(i) and (B)(i), in the case of any qualified facility or EST that does not satisfy the requirements provided in section 48E(a)(2)(A)(ii) or (B)(ii), the applicable percentage is the 
                                <E T="03">base rate,</E>
                                 which is 6 percent.
                            </P>
                            <P>
                                (4) 
                                <E T="03">Alternative rate.</E>
                                 In the case of any qualified facility or EST that satisfies the prevailing wage and apprenticeship requirements provided in section 48E(a)(2)(A)(ii) or (B)(ii), the applicable percentage is the 
                                <E T="03">alternative rate,</E>
                                 which is 30 percent.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Energy communities increase in credit rate</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 In the case of any qualified facility or EST that is placed in service within an energy community (as defined in section 45(b)(11)(B)), the applicable percentage under section 48E(a)(2) and paragraph (b)(2) of this section will be increased by the applicable credit rate increase described in section 48E(a)(3)(A)(ii) and paragraph (b)(5)(ii) of this section.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Applicable credit rate increase.</E>
                                 In the case of any qualified investment with respect to a qualified facility or EST to which the base rate is applicable, the applicable credit rate increase is 2 percentage points, and with respect to any qualified investment with respect to a qualified facility or EST to which the alternative rate is applicable, the applicable credit rate increase is 10 percentage points.
                            </P>
                            <P>
                                (6) 
                                <E T="03">Domestic content increase in credit rate</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 In the case of any qualified facility or EST that satisfies the requirements of section 45(b)(9)(B) (domestic content requirement), the applicable percentage under section 48E(a)(2) and paragraph (b)(2) of this section will be increased by the applicable credit rate increase described in paragraph (b)(6)(ii) of this section.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Applicable credit rate increase.</E>
                                 In the case of any qualified investment with respect to a qualified facility or EST to which the base rate is applicable, 2 percentage points, and with respect to any qualified investment with respect to a qualified facility or EST to which the alternative rate is applicable, 10 percentage points.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Credit phase-out</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 The amount of the credit as determined under section 48E(a) and paragraph (b) of this section for any qualified facility or EST, the construction of which begins during a calendar year described in section 48E(e)(2) and paragraph (c)(2) of this section is equal to the product of—
                            </P>
                            <P>(i) The amount of the credit determined under section 48E(a) and paragraph (b) of this section without regard to section 48E(e) and paragraph (c) of this section; multiplied by</P>
                            <P>(ii) The phase-out percentage under section 48E(e)(2) and paragraph (c)(2) of this section.</P>
                            <P>
                                (2) 
                                <E T="03">Phase-out percentage.</E>
                                 The phase-out percentage under this paragraph (c)(2) is equal to—
                            </P>
                            <P>
                                (i) For any qualified investment with respect to any qualified facility or EST the construction of which begins during the first calendar year following the applicable year, 100 percent;
                                <PRTPAGE P="4113"/>
                            </P>
                            <P>(ii) For any qualified investment with respect to any qualified facility or EST the construction of which begins during the second calendar year following the applicable year, 75 percent;</P>
                            <P>(iii) For any qualified investment with respect to any qualified facility or EST the construction of which begins during the third calendar year following the applicable year, 50 percent; and</P>
                            <P>(iv) For any qualified investment with respect to any qualified facility or EST the construction of which begins during any calendar year subsequent to the calendar year described in paragraph (c)(2)(iii) of this section, 0 percent.</P>
                            <P>
                                (3) 
                                <E T="03">Applicable year.</E>
                                 For purposes of this paragraph (c), the term 
                                <E T="03">applicable year</E>
                                 has the same meaning provided under § 1.45Y-1(c)(3).
                            </P>
                            <P>
                                (d) 
                                <E T="03">Related taxpayers</E>
                                —(1) 
                                <E T="03">Definition.</E>
                                 For purposes of the section 48E credit, the term 
                                <E T="03">related taxpayers</E>
                                 means members of a group of trades or businesses that are under common control (as defined in § 1.52-1(b)).
                            </P>
                            <P>
                                (2) 
                                <E T="03">Related taxpayer rule.</E>
                                 For purposes of the section 48E credit, related taxpayers are treated as one taxpayer in determining whether a taxpayer has made an investment in a qualified facility or EST with respect to which a section 48E credit may be determined.
                            </P>
                            <P>
                                (e) 
                                <E T="03">Applicability date.</E>
                                 This section applies to qualified facilities and ESTs placed in service after December 31, 2024, and during a taxable year ending on or after January 15, 2025.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1.48E-2 </SECTNO>
                            <SUBJECT>Qualified investments in qualified facilities and EST for purposes of section 48E.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Qualified investment with respect to a qualified facility</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 A 
                                <E T="03">qualified investment</E>
                                 of a taxpayer for a taxable year with respect to a qualified facility is the total basis amount for the taxable year with respect to the qualified facility.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Total basis amount.</E>
                                 The 
                                <E T="03">total basis amount</E>
                                 is the sum of:
                            </P>
                            <P>(i) The basis of any qualified property that is a part of the qualified facility and that is placed in service by the taxpayer during the taxable year; plus</P>
                            <P>(ii) The amount of any expenditures paid or incurred by the taxpayer for qualified interconnection property (as defined in section § 1.48E-4(a)(2)) in connection with a qualified facility which has a maximum net output of not greater than five megawatts (as measured in alternating current), that was placed in service during the taxable year of the taxpayer, and that are properly chargeable to the capital account.</P>
                            <P>
                                (b) 
                                <E T="03">Qualified facility</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 A qualified facility is a facility that:
                            </P>
                            <P>(i) Is used for the generation of electricity, meaning that it is a net generator of electricity taking into account any electricity consumed by the facility;</P>
                            <P>(ii) Is placed in service by the taxpayer after December 31, 2024; and</P>
                            <P>(iii) Has an anticipated greenhouse gas emissions rate of not greater than zero (as determined under the rules provided in § 1.48E-5).</P>
                            <P>
                                (2) 
                                <E T="03">Placed in service</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 A qualified facility is considered placed in service in the earlier of:
                            </P>
                            <P>(A) The taxable year in which, under the taxpayer's depreciation practice, the period for depreciation with respect to such qualified facility begins; or</P>
                            <P>(B) The taxable year in which the qualified facility is placed in a condition or state of readiness and availability to produce electricity, whether in a trade or business or in the production of income. A qualified facility in a condition or state of readiness and availability to produce electricity includes, but is not limited to, components of property that are acquired and set aside during the taxable year for use as replacements for a particular qualified facility (or facilities) in order to avoid operational time loss and equipment that is acquired for a specifically assigned function and is operational but is undergoing testing to eliminate any defects. However, components of property acquired to be used in the construction of a qualified facility are not considered in a condition or state of readiness and availability for a specifically assigned function.</P>
                            <P>
                                (ii) 
                                <E T="03">Qualified facility subject to § 1.48-4 election to treat lessee as purchaser.</E>
                                 Notwithstanding paragraph (b)(2)(i) of this section, a qualified facility with respect to which an election is made under section 50(d)(5) of the Code and § 1.48-4 to treat the lessee as having purchased such qualified facility is considered placed in service by the lessor in the taxable year in which possession is transferred to such lessee.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Qualified property</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 For purposes of this paragraph (c), the term 
                                <E T="03">qualified property</E>
                                 means all property owned by the taxpayer that meets all of the requirements of paragraphs (c)(1)(i) through (iii) of this section:
                            </P>
                            <P>(i) The property is tangible personal property (as defined in paragraph (e)(1) of this section) or other tangible property (as defined in paragraph (e)(2) of this section) but only if such other tangible property is used as an integral part of the qualified facility;</P>
                            <P>(ii) Depreciation (or amortization in lieu of depreciation) is allowable (as defined in paragraph (e)(3) of this section) with respect to the property; and</P>
                            <P>(iii) Either—</P>
                            <P>(A) The construction, reconstruction, or erection of the property is completed by the taxpayer (as defined in paragraph (e)(4) of this section) with respect to the property; or</P>
                            <P>(B) The taxpayer acquires the property (as defined in paragraph (e)(5) of this section) and the original use of the property (as defined in paragraph (e)(6) of this section) commences with the taxpayer.</P>
                            <P>
                                (2) 
                                <E T="03">Location of property.</E>
                                 Any component of qualified property that otherwise satisfies the requirements of this paragraph (c) is part of a qualified facility regardless of where such component is located.
                            </P>
                            <P>
                                (d) 
                                <E T="03">Property included in qualified facility</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 A qualified facility includes a unit of a qualified facility (as defined in paragraph (d)(2) of this section) owned by the taxpayer. A qualified facility also includes components of qualified property owned by the taxpayer that are an integral part (as defined in paragraph (d)(3) of this section) of the qualified facility. Any component of qualified property that meets the requirements of this paragraph (d) is part of a qualified facility regardless of where such component of qualified property is located. A qualified facility does not include any electrical transmission equipment, such as electrical transmission lines and towers, or any equipment beyond the electrical transmission stage. 
                                <E T="03">See</E>
                                 § 1.48E-4(b) regarding the Incremental Production Rule and § 1.48E-4(c) for rules regarding a retrofitted qualified facility (80/20 rule).
                            </P>
                            <P>
                                (2) 
                                <E T="03">Unit of a qualified facility</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 For purposes of the section 48E credit, a unit of a qualified facility includes all functionally interdependent components of property (as defined in paragraph (d)(2)(ii) of this section) owned by the taxpayer that are operated together and that can operate apart from other property to produce electricity. No provision of this section, § 1.48E-1, or §§ 1.48E-3 through 1.48E-5 uses the term 
                                <E T="03">unit</E>
                                 in respect of a qualified facility with any meaning other than that provided in this paragraph (d)(2)(i).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Functionally interdependent.</E>
                                 Components of property are functionally interdependent if the placing in service of each of the components is dependent upon the placing in service of the other components to generate electricity.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Integral part</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 For purposes of the section 48E credit, a 
                                <PRTPAGE P="4114"/>
                                component of property owned by a taxpayer is an integral part of a qualified facility if it is used directly in the intended function of the qualified facility and is essential to the completeness of such function. Property that is an integral part of a qualified facility is part of the qualified facility. A taxpayer may not claim the section 48E credit for any property not owned by the taxpayer that is an integral part of the qualified facility owned by the taxpayer.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Power conditioning and transfer equipment.</E>
                                 Power conditioning equipment and transfer equipment are integral parts of a qualified facility. Power conditioning equipment includes, but is not limited to, transformers, inverters and converters, which modify the characteristics of electricity into a form suitable for use, transmission, or distribution. Parts related to the functioning or protection of power conditioning equipment are also treated as power conditioning equipment and include, but are not limited to, switches, circuit breakers, arrestors, and hardware used to monitor, operate, and protect power conditioning equipment. Transfer equipment includes components of property that allow for the aggregation of electricity generated by a qualified facility and components of property that alter voltage to permit electricity to be transferred to a transmission or distribution line. Transfer equipment does not include transmission or distribution lines. Examples of transfer equipment include, but are not limited to, wires, cables, and combiner boxes that conduct electricity. Parts related to the functioning or protection of transfer equipment are also treated as transfer equipment and may include items such as current transformers used for metering, electrical interrupters (such as circuit breakers fuses, and other switches) and hardware used to monitor, operate, and protect transfer equipment.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Roads.</E>
                                 Roads that are integral to the intended function of the qualified facility such as onsite roads that are used to operate and maintain the qualified facility are an integral part of a qualified facility. Roads used primarily to access the site, or roads used primarily for employee or visitor vehicles, are not integral to the intended function of the qualified facility, and thus are not an integral part of a qualified facility.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Fences.</E>
                                 Fencing is not an integral part of a qualified facility because it is not integral to the intended function of the qualified facility.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Buildings.</E>
                                 Generally, buildings are not integral parts of a qualified facility because they are not integral to the intended function of the qualified facility. For purposes of section 48E, a structure that is essentially an item of machinery or equipment is not considered a building. In addition, a structure is not a building if it houses components of property that are integral to the intended function of the qualified facility and if the use of the structure is so closely related to the use of the housed components of property therein that the structure clearly can be expected to be replaced if the components of property it initially houses are replaced.
                            </P>
                            <P>
                                (vi) 
                                <E T="03">Shared integral property.</E>
                                 Multiple qualified facilities (whether owned by one or more taxpayers), including qualified facilities with respect to which a taxpayer has claimed a credit under section 48E or another Federal income tax credit, may include shared property that may be considered an integral part of each qualified facility so long as the cost basis for the shared property is properly allocated to each qualified facility and the taxpayer only claims a section 48E credit with respect to the portion of the cost basis properly allocable to a qualified facility for which the taxpayer is claiming a section 48E credit. The total cost basis of such shared property divided among the qualified facilities may not exceed 100 percent of the cost of such shared property. In addition, a component of property that is shared by a qualified facility as defined by section 48E(b)(3) (48E Qualified Facility) and a qualified facility as defined in section 45Y(b) (45Y Qualified Facility) that is an integral part of both qualified facilities will not affect the eligibility of the 48E Qualified Facility for the section 48E credit or the 45Y Qualified Facility for the section 45Y credit.
                            </P>
                            <P>
                                (vii) 
                                <E T="03">Examples.</E>
                                 This paragraph (d)(3)(vii) provides examples illustrating the rules of this paragraph (d).
                            </P>
                            <P>
                                (A) 
                                <E T="03">Example 1. Co-located qualified facilities owned by the same taxpayer that share integral property.</E>
                                 X constructs and owns a solar facility (Solar Facility) and nearby also constructs and owns a wind facility (Wind Facility) that are each a qualified facility. The Solar Facility and Wind Facility each connect to a shared transformer that steps up the electricity produced by each qualified facilities to electrical grid voltage before it is transmitted to the electrical grid through an intertie. X assigns 50% of the cost of the shared transformer to the Solar Facility and the Wind Facility, respectively. The fact that the Solar Facility and Wind Facility share property that is integral to both does not impact the ability of X to claim a section 48E credit for both qualified facilities. When X places the qualified facilities in service, 50% of the cost of the transformer is included in X's basis in each of the qualified facilities for purposes of computing the section 48E credit.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Example 2. Co-located qualified facilities owned by different taxpayers that share integral property.</E>
                                 X constructs and owns a solar facility (Solar Facility), and nearby Y constructs and owns a wind facility (Wind Facility) that are each a qualified facility. The Solar Facility and the Wind Facility both connect to a shared transformer that steps up the electricity produced by both qualified facilities to electrical grid voltage before it is transmitted to the electrical grid through an intertie. X and Y each pay 50% of the cost of the shared transformer. The fact that the Solar Facility and Wind Facility share property that is integral to both does not impact the ability of X or Y to claim a section 48E credit for their respective qualified facilities. When X and Y place their respective qualified facilities in service, 50% of the cost of the transformer is included in X's and Y's basis in their respective qualified facilities for purposes of computing the section 48E credit.
                            </P>
                            <P>
                                (C) 
                                <E T="03">Example 3. Co-located qualified facility and Energy Storage Technology (EST) owned by the same taxpayer.</E>
                                 X constructs and owns a wind facility (Wind Facility) that is co-located with an EST that X also constructs and owns. The Wind Facility and EST share transfer equipment that is integral to both. X assigns 50% of the cost of the shared transfer equipment to the Wind Facility and 50% of the cost to the EST. The fact that the Wind Facility and EST share property that is integral to both does not impact the ability of X to claim a section 48E credit for the Wind Facility and the EST. X may include 50% of the cost of the transfer equipment in its basis to determine a section 48E credit for the Wind Facility and the EST.
                            </P>
                            <P>
                                (D) 
                                <E T="03">Example 4. Co-located qualified facility and Energy Storage Technology owned by different taxpayers.</E>
                                 X constructs and owns a solar facility that is a qualified facility (Solar Facility) and is co-located with an EST constructed and owned by Y. The Solar Facility and EST share transfer equipment that is integral to both. X and Y each incur 50% of the cost of the transfer equipment. The fact that the Solar Facility and EST share property that is integral to both does not impact the 
                                <PRTPAGE P="4115"/>
                                ability of X to claim a section 48E credit for the Solar Facility or Y to claim a section 48E credit for the EST. When X and Y place in service the Solar Facility and EST, for purposes of computing the section 48E credit, 50% of the cost of the transfer equipment is included in X's basis in the Solar Facility and 50% of the cost is included in Y's basis in the EST.
                            </P>
                            <P>
                                (E) 
                                <E T="03">Example 5. Qualified facility with integral property owned by a different taxpayer.</E>
                                 X constructs and owns a hydropower production facility that is a qualified facility (Hydropower Facility). The Hydropower Facility connects to a dam owned by Y, a government entity, that is an integral part of the Hydropower Facility. X pays for upkeep of the dam. The fact that X does not own the dam does not impact the ability of X to claim a section 48E credit for the Hydropower Facility. When X places in service the Hydropower Facility, for purposes of computing the section 48E credit, the cost incurred by X related to the dam would not be included in X's basis in the Qualified Facility because X does not own the dam. 
                            </P>
                            <P>
                                (e) 
                                <E T="03">Definitions related to requirements for qualified property</E>
                                —(1) 
                                <E T="03">Tangible personal property.</E>
                                 The term 
                                <E T="03">tangible personal property</E>
                                 means any tangible property except land or improvements thereto, such as buildings or other inherently permanent structures (including items that are structural components of such buildings or structures. Tangible personal property includes all property (other than structural components) that is contained in or attached to a building. Further, all property that is in the nature of machinery (other than structural components of a building or other inherently permanent structure) is considered tangible personal property even though located outside a building. Machinery located outside of a building is qualified property if it is used for the generation of electricity and the components of machinery are functionally interdependent. Local law does not control whether property is tangible property or is tangible personal property for purposes of the section 48E credit. Thus, tangible property may be tangible personal property for purposes of the section 48E credit even though under local law the property is considered a fixture and therefore is real property under local law.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Other tangible property.</E>
                                 The term 
                                <E T="03">other tangible property</E>
                                 means tangible property other than tangible personal property (not including a building and its structural components) that is used as an integral part of furnishing electricity by a person engaged in a trade or business of furnishing any such service. Other tangible property may be tangible property for purposes of the section 48E credit even though under local law the property is considered a fixture and is therefore real property under local law.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Depreciation allowable</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 For purposes of applying paragraph (c) of this section, depreciation (or amortization in lieu of depreciation) (collectively, 
                                <E T="03">depreciation</E>
                                ) is allowable with respect to the property if such property is of a character subject to the allowance for depreciation under section 167 of the Code and the basis or cost of such property is recovered using a method of depreciation (for example, the straight line method), which includes any additional first year depreciation deduction method of depreciation (for example, under section 168(k) of the Code). Further, if an adjustment with respect to the Federal income tax or Federal return, as appropriate, for such taxable year requires the basis or cost of such qualified property to be recovered using a method of depreciation, depreciation is allowable to the taxpayer with respect to the qualified property.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Exclusions from allowable.</E>
                                 For purposes of paragraph (c) of this section, depreciation is not allowable with respect to a qualified facility if the basis or cost of such qualified facility is not recovered through a method of depreciation but, instead, such basis or cost is recovered through a deduction of the full basis or cost of the qualified facility in one taxable year (for example, under section 179 of the Code).
                            </P>
                            <P>
                                (4) 
                                <E T="03">Construction, reconstruction, or erection of the property.</E>
                                 The term 
                                <E T="03">construction, reconstruction, or erection of the property</E>
                                 means work performed to construct, reconstruct, or erect property either by the taxpayer or for the taxpayer in accordance with the taxpayer's specifications.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Acquisition of qualified property.</E>
                                 The term 
                                <E T="03">acquisition of qualified property</E>
                                 means a transaction by which a taxpayer acquires the rights and obligations to establish tax ownership of the property for Federal tax purposes.
                            </P>
                            <P>
                                (6) 
                                <E T="03">Original use of the property.</E>
                                 The term 
                                <E T="03">original use of the property</E>
                                 means the first use to which the unit of property is put, whether or not such use is by the taxpayer.
                            </P>
                            <P>
                                (7) 
                                <E T="03">Retrofitted qualified facility.</E>
                                 A retrofitted qualified facility acquired by the taxpayer will not be treated as being put to original use by the taxpayer unless the rules in § 1.48E-4(c) regarding retrofitted qualified facilities (80/20 Rule) apply. The question of whether a qualified facility meets the 80/20 Rule is a facts and circumstances determination.
                            </P>
                            <P>
                                (f) 
                                <E T="03">Coordination with other credits</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 The term 
                                <E T="03">qualified facility</E>
                                 (as defined in section 48E(b)(3)) and paragraph (b) of this section does not include any facility for which a credit determined under section 45, 45J, 45Q, 45U, 45Y, 48, or 48A is allowed under section 38 of the Code for the taxable year or any prior taxable year. A taxpayer that directly owns a qualified facility (as defined in section 48E(b)(3)) for which the taxpayer is eligible for both a section 48E credit and another Federal income tax credit is eligible for the section 48E credit only if the other Federal income tax credit was not allowed to the taxpayer with respect to the qualified facility. Nothing in this paragraph (f) precludes a taxpayer from claiming a section 48E credit with respect to a qualified facility (as defined in section 48E(b)(3)) that is co-located with another facility for which a credit determined under section 45, 45J, 45Q, 45U, 45Y, 48, or 48A is allowed under section 38 of the Code for the taxable year or any prior taxable year.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Allowed.</E>
                                 For purposes of this paragraph (f), the term 
                                <E T="03">allowed</E>
                                 only includes credits that taxpayers have claimed on a Federal income tax return or Federal return, as appropriate, and that the Internal Revenue Service (IRS) has not challenged in terms of the taxpayer's eligibility.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Examples.</E>
                                 This paragraph (f)(3) provides examples illustrating the rules provided in this paragraph (f).
                            </P>
                            <P>
                                (i) 
                                <E T="03">Example 1. Taxpayer claims a section 45Y credit on a solar farm and section 48E credit on co-located Energy Storage Technology.</E>
                                 X owns a solar farm that is a qualifying facility (as defined in § 1.45Y-2(a)) (Solar Qualified Facility), and a co-located EST (Energy Storage). The Energy Storage is not part of the Solar Qualified Facility, and therefore X may claim the section 45Y credit based on the kWh of electricity produced by the Solar Qualified Facility, and X may also claim the section 48E credit based on its qualified investment in the Energy Storage.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Example 2. Different taxpayers claim a section 45Y credit for a solar farm and a co-located Energy Storage Technology.</E>
                                 X owns a solar farm that is a qualifying facility (as defined in § 1.45Y-2(a)) (Solar Qualified Facility), and Y owns a co-located EST (Energy Storage). The Energy Storage is not part of the Solar Qualified Facility, and therefore, X may claim the section 45Y credit based on the kWh of electricity produced by the Solar Qualified Facility, and Y may claim the section 
                                <PRTPAGE P="4116"/>
                                48E credit based on its qualified investment in the Energy Storage.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Example 3. Taxpayer claiming a section 48E credit; another credit is not allowed.</E>
                                 X owns a wind facility that satisfies the requirements of a qualified facility under section 48E as well as the requirements of a qualified facility as defined in § 1.45Y-2(a) under section 45Y. X claims a section 45Y credit with respect to the wind facility. While a credit may be available with regard to the wind facility under section 48E, because X has already claimed a section 45Y credit with respect to the wind facility, a section 48E credit is not allowed. Local law is not controlling for purposes of determining whether property is or is not tangible property or tangible personal property. Thus, tangible property may be personal property for purposes of the energy credit even though under local law the property is considered a fixture and therefore real property.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Example 4. Interaction of section 48E and section 45Q credits for single qualified facility.</E>
                                 X owns a qualified facility (Facility A) that includes carbon capture equipment, which is needed for the facility to meet the zero greenhouse gas requirement, so it is functionally interdependent to the production of electricity by the Facility A. X uses the carbon capture equipment to capture and utilize (as described in section 45Q(f)(5)) qualified carbon dioxide and claimed a section 45Q credit in the current taxable year. As a result, X cannot claim a section 48E credit for its 48E Facility A because a qualified facility does not include a facility for which a credit determined under section 45Q is allowed.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Example 5. Interaction of section 48E and section 45Q credits for co-located qualified facilities.</E>
                                 Assume the same facts as in paragraph (f)(3)(iv) of this section (Example 4), except that X owns a co-located qualified facility (Facility B) that also includes carbon capture equipment, which is needed for the facility to meet the zero greenhouse gas requirement, so it is functionally interdependent to the production of electricity by the Facility B. X uses the carbon capture equipment to capture and utilize (as described in section 45Q(f)(5)) qualified carbon dioxide, but does not claim a section 45Q credit with respect to the Facility B. While X claimed a section 45Q credit in the current taxable year for the Facility A (see Example 4), the Facility B is not part of the Facility A, and, therefore, X may claim the section 48E credit for its Facility B.
                            </P>
                            <P>
                                (g) 
                                <E T="03">EST</E>
                                —(1) 
                                <E T="03">Property included in EST.</E>
                                 An EST includes a unit of energy storage technology (unit of EST) (as defined in paragraph (g)(2) of this section) that meets the requirements of paragraph (g)(2)(ii) of this section. An EST also includes property owned by the taxpayer that is an integral part (as defined in paragraph (g)(3) of this section) of the EST. An EST does not include equipment that is an addition or modification to an existing EST. For purposes of the section 48E credit, EST includes electrical energy storage property (as described in paragraph (g)(6)(i) of this section), thermal energy storage property (as described in paragraph (g)(6)(ii) of this section), and hydrogen energy storage property (as described in paragraph (g)(6)(iii) of this section).
                            </P>
                            <P>
                                (2) 
                                <E T="03">Unit of EST</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 For purposes of the section 48E credit, a unit of EST includes all functionally interdependent components of property (as defined in paragraph (g)(2)(ii) of this section) owned by the taxpayer that are operated together and that can operate apart from other property to perform the intended function of the EST. No provision of this section, § 1.48E-1, or §§ 1.48E-3 through 1.48E-5 uses the term 
                                <E T="03">unit</E>
                                 in respect of an EST with any meaning other than that provided in this paragraph (g)(2)(i).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Functionally interdependent.</E>
                                 Components of property are functionally interdependent if the placing in service of each of the components is dependent upon the placing in service of each of the other components to perform the intended function of the EST.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Integral part.</E>
                                 For purposes of the section 48
                                <E T="03">E</E>
                                 credit, property owned by a taxpayer is an integral part of an EST owned by the same taxpayer if it is used directly in the intended function of the EST and is essential to the completeness of such function. Property that is an integral part of an EST is part of that EST. A taxpayer may not claim the section 48E credit for any property not owned by the taxpayer that is an integral part of EST owned by the taxpayer.
                            </P>
                            <P>
                                (4) 
                                <E T="03">Qualified investment with respect to EST.</E>
                                 The qualified investment with respect to any EST for any taxable year is the basis of any EST placed in service by the taxpayer during such taxable year.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Placed in service—</E>
                                (i) 
                                <E T="03">In general.</E>
                                 An EST is considered placed in service in the earlier of:
                            </P>
                            <P>(A) The taxable year in which, under the taxpayer's depreciation practice, the period for depreciation with respect to such EST begins; or</P>
                            <P>(B) The taxable year in which the EST is placed in a condition or state of readiness and availability for the intended function of the EST, whether in a trade or business or in the production of income. An EST in a condition or state of readiness and availability for its intended function includes, but is not limited to, components of property that are acquired and set aside during the taxable year for use as replacements for a particular EST (or ESTs) in order to avoid operational time loss and equipment that is acquired for a specifically assigned function and is operational but is undergoing testing to eliminate any defects. However, components of property acquired to be used in the construction of an EST are not considered in a condition or state of readiness and availability for a specifically assigned function.</P>
                            <P>
                                (ii) 
                                <E T="03">EST subject to § 1.48-4 election to treat lessee as purchaser.</E>
                                 Notwithstanding paragraph (g)(5)(i) of this section, EST with respect to which an election is made under section 50(d)(5) of the Code and § 1.48-4 to treat the lessee as having purchased such EST is considered placed in service by the lessor in the taxable year in which possession is transferred to such lessee.
                            </P>
                            <P>
                                (6) 
                                <E T="03">Types of EST</E>
                                —(i) 
                                <E T="03">Electrical energy storage property.</E>
                                 Electrical energy storage property is property (other than property primarily used in the transportation of goods or individuals and not for the production of electricity) that receives, stores, and delivers energy for conversion to electricity, and has a nameplate capacity of not less than 5 kWh. For example, subject to the exclusion for property primarily used in the transportation of goods or individuals, electrical energy storage property includes but is not limited to rechargeable electrochemical batteries of all types (such as lithium-ion, vanadium redox flow, sodium sulfur, and lead-acid); ultracapacitors; physical storage such as pumped storage hydropower, compressed air storage, flywheels; and reversible fuel cells.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Thermal energy storage property—</E>
                                (A) 
                                <E T="03">In general.</E>
                                 Thermal energy storage property is property comprising a system that is directly connected to a heating, ventilation, or air conditioning (HVAC) system; removes heat from, or adds heat to, a storage medium for subsequent use; and provides energy for the heating or cooling of the interior of a residential or commercial building. Thermal energy storage property includes equipment and materials, and parts related to the functioning of such equipment, to store thermal energy for later use to heat or cool, or to provide hot water for use in heating a residential or commercial building. It does not 
                                <PRTPAGE P="4117"/>
                                include property that transforms other forms of energy into heat in the first instance. Property that “removes heat from, or adds heat to, a storage medium for subsequent use” is property that is designed with the particular purpose of substantially altering the time profile of when heat added to or removed from the thermal storage medium can be used for heating or cooling of the interior of a residential or commercial building. Paragraph (g)(6)(ii)(B) of this section provides a safe harbor for determining whether a thermal energy storage property has such a purpose. Thermal energy storage property does not include a swimming pool, combined heat and power system property (as defined in section 45Y(g)(2)), or a building or its structural components. For example, thermal energy storage property includes, but is not limited to, a system that adds heat to bricks heated to high temperatures that later use this stored energy to heat a building through the HVAC system; thermal ice storage systems that use electricity to run a refrigeration cycle to produce ice that is later connected to the HVAC system as an exchange medium for air conditioning a building, heat pump systems that store thermal energy in an underground tank, an artificial pit, an aqueous solution, a borehole field, or a solid-liquid phase change material to be extracted for later use for heating and/or cooling; and air-to-water heat pump systems with a water storage tank. However, consistent with § 1.48-14(d), if thermal energy storage property, such as a heat pump system, includes equipment, such as a heat pump, that also serves a purpose in an HVAC system that is installed in connection with the thermal energy storage property, the taxpayer's qualified investment with respect to the thermal energy storage property includes the total cost of the thermal energy storage property and HVAC system less the cost of an HVAC system without thermal storage capacity that would meet the same functional heating or cooling needs as the heat pump system with a storage medium, other than time shifting of heating or cooling. 
                                <E T="03">See</E>
                                 § 1.48-14(h) for application of the Incremental Cost Rule.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Safe harbor.</E>
                                 A thermal energy storage property will be deemed to have the purpose of substantially altering the time profile of when heat added to or removed from the thermal storage medium can be used to heat or cool the interior of a residential or commercial building if that thermal energy storage property is capable of storing energy that is sufficient to provide heating or cooling of the interior of a residential or commercial building for a minimum of one hour.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Hydrogen energy storage property.</E>
                                 Hydrogen energy storage property is property (other than property primarily used in the transportation of goods or individuals and not for the production of electricity) that stores hydrogen and has a nameplate capacity of not less than 5 kWh, equivalent to 0.127 kg of hydrogen or 52.7 standard cubic feet (scf) of hydrogen. Hydrogen energy storage property includes, but is not limited to, above ground storage tanks, underground storage facilities, and associated compressors. Property that is an integral part of hydrogen energy storage property includes, but is not limited to, hydrogen liquefaction equipment and gathering and distribution lines within a hydrogen energy storage property.
                            </P>
                            <P>
                                (7) 
                                <E T="03">Modification of EST.</E>
                                 With respect to an electrical energy storage property or a hydrogen energy storage property, modified as set forth in this paragraph (g)(7), such property will be treated as an electrical energy storage property (as described in paragraph (g)(6)(i) of this section) or a hydrogen energy storage property (as described in paragraph (g)(6)(iii) of this section), except that the basis of any existing electrical energy storage property or hydrogen energy storage property prior to such modification is not taken into account for purposes of this paragraph (g)(7) and section 48E. This paragraph (g)(7) applies to any electrical energy storage property and hydrogen energy storage property that either:
                            </P>
                            <P>(i) Was placed in service before August 16, 2022, and would be described in section 48(c)(6)(A)(i), except that such property had a nameplate capacity of less than 5 kWh and is modified in a manner that such property (after such modification) has a nameplate capacity of not less than 5 kWh; or</P>
                            <P>(ii) Is described in section 48(c)(6)(A)(i) and is modified in a manner that such property (after such modification) has an increase in nameplate capacity of not less than 5 kWh. The increase in nameplate capacity is equal to the difference between nameplate capacity immediately after the modification and nameplate capacity immediately prior to the modification.</P>
                            <P>
                                (h) 
                                <E T="03">Applicability date.</E>
                                 This section applies to qualified facilities and EST placed in service after December 31, 2024, and during a taxable year ending on or after January 15, 2025.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1.48E-3</SECTNO>
                            <SUBJECT>Rules relating to the increased credit for prevailing wage and apprenticeship.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">In general.</E>
                                 If any qualified facility or EST satisfies the requirements in paragraph (b) of this section, the applicable percentage used for calculating the amount of the credit for a qualified investment determined under section 48E(a) for the taxable year equals 30 percent.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Qualified facility or EST requirements.</E>
                                 A qualified facility or EST satisfies the requirements of this paragraph (b) if it is a facility described in one of paragraphs (b)(1) through (6) of this section:
                            </P>
                            <P>(1) A qualified facility with a maximum net output of less than one megawatt of electrical energy (as measured in alternating current) based on the nameplate capacity as provided in paragraph (c) of this section (One Megawatt Exception);</P>
                            <P>(2) A qualified facility the construction of which began prior to January 29, 2023;</P>
                            <P>(3) A qualified facility that meets the prevailing wage requirements of section 48E(d)(3) and §§ 1.45-7(a)(2) and (3) and (b) through (d) and 1.48-13(c), the apprenticeship requirements of section 45(b)(8) and § 1.45-8, and the recordkeeping and reporting requirements of § 1.45-12;</P>
                            <P>(4) An EST with a capacity of less than one megawatt based on the nameplate capacity as provided in paragraph (c) of this section (EST One Megawatt Exception);</P>
                            <P>(5) An EST the construction of which began prior to January 29, 2023; or</P>
                            <P>(6) An EST that satisfies the prevailing wage requirements of section 48E(d)(3) and §§ 1.45-7(a)(2) and (3) and (b) through (d) and 1.48-13(c), the apprenticeship requirements of section 45(b)(8) and § 1.45-8, and the recordkeeping and reporting requirements of § 1.45-12.</P>
                            <P>
                                (c) 
                                <E T="03">Nameplate capacity for purposes of the One Megawatt Exception</E>
                                —(1) 
                                <E T="03">Qualified facilities.</E>
                                 For purposes of paragraph (b)(1) of this section, whether a qualified facility has a maximum net output of less than 1 megawatt (MW) of electrical energy (as measured in alternating current) is determined based on the nameplate capacity of the facility. If a qualified facility has integrated operations (as defined in paragraph (c)(4)(i) of this section) with one or more other qualified facilities, then the aggregate nameplate capacity of the qualified facilities is used for the purposes of determining if the qualified facilities satisfy the One Megawatt Exception. If applicable, taxpayers should use the International Standard 
                                <PRTPAGE P="4118"/>
                                Organization (ISO) conditions to measure the maximum electrical generating output of a facility.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Nameplate capacity for qualified facilities that generate in direct current for purposes of the One Megawatt Exception.</E>
                                 For qualified facilities that generate electricity in direct current, the taxpayer determines the maximum net output (in alternating current) of each unit of qualified facility by using the lesser of:
                            </P>
                            <P>(i) The sum of the nameplate generating capacities within the unit of qualified facility in direct current, which is deemed the nameplate generating capacity of the unit of qualified facility in alternating current; or</P>
                            <P>(ii) The nameplate capacity of the first component of property that inverts the direct current electricity into alternating current.</P>
                            <P>
                                (3) 
                                <E T="03">EST</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 Paragraphs (c)(3)(ii) through (iv) of this section provide rules for applying the EST One Megawatt Exception described in paragraph (b)(4) of this section to different types of energy storage properties. If the EST has integrated operations (as defined in paragraph (c)(4)(ii) of this section) with one or more other ESTs, then the aggregate nameplate capacity of the ESTs is used for the purposes of the EST One Megawatt Exception. If applicable, taxpayers should use the ISO conditions to measure the maximum net output of an EST.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Electrical energy storage property.</E>
                                 In the case of electrical energy storage property (as defined in § 1.48E-2(g)(6)(i)), the EST One Megawatt Exception is determined by using the storage device's maximum net output. If the output of electrical energy storage property is in direct current, taxpayer should apply the rules of paragraph (c)(2) of this section.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Thermal energy storage property.</E>
                                 In the case of thermal energy storage property (as defined in § 1.48E-2(g)(6)(ii)), the EST One Megawatt Exception is determined by using the property's maximum net output. The maximum net output in MW is calculated by using a conversion whereby one MW is equal to 3.4 million British Thermal Units per hour (mmBtu/hour) for heating and 284 tons for cooling (Btu per hour/3,412,140 = MW). The maximum net output is the maximum instantaneous rate of discharge and is determined based on the nameplate capacity of the equipment that generates or distributes thermal energy for productive use (including distributing the thermal energy from the storage medium). For purposes of determining the maximum net output of thermal energy storage property, if the nameplate capacity of the thermal energy storage is not available, the nameplate capacity of the equipment delivering thermal energy to the thermal energy storage may be used. For thermal energy storage property distributing thermal energy to a building or buildings, the nameplate capacity can be assessed as either the aggregate maximum thermal capacity of all individual heating or cooling elements within the building or buildings, or as the maximum thermal output that the thermal energy storage property is capable of delivering to a building or buildings at any given moment. The maximum thermal capacity of an entire thermal energy storage property is capable of delivering at any given moment does not take into account the capacity of redundant equipment if such equipment is not operated when the system is at maximum output during normal operation. For thermal energy storage property and other energy property that generates or distributes thermal energy for a productive use, the maximum thermal capacity that the entire system is capable of delivering is considered to be the greater of the rate of cooling or the rate of heating of the aggregate of the nameplate capacity of the equipment distributing energy for productive use, including distributing the thermal energy from the thermal energy storage medium to the building or buildings. If such nameplate capacity is unavailable, in the case of thermal energy storage property only, the maximum thermal capacity may instead be considered to be the greater of the rate of cooling or the rate of heating of the aggregate of the nameplate capacity of all the equipment delivering energy to the thermal energy storage property in the project.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Hydrogen energy storage property.</E>
                                 In the case of a hydrogen energy storage property (as defined in § 1.48E-2(g)(6)(iii)), the EST One Megawatt Exception is determined by using the property's maximum net output. The maximum net output in MW is calculated by using a conversion whereby one MW is equal to 3.4 mmBtu/hour of hydrogen or equivalently 10,500 standard cubic feet (scf) per hour of hydrogen.
                            </P>
                            <P>
                                (4) 
                                <E T="03">Integrated operations</E>
                                —(i) 
                                <E T="03">One Megawatt Exception.</E>
                                 Solely for the purposes of the One Megawatt Exception described in paragraph (b)(1) of this section, a qualified facility is treated as having 
                                <E T="03">integrated operations</E>
                                 with any other qualified facility of the same technology type if the facilities are:
                            </P>
                            <P>(A) Owned by the same or related taxpayers;</P>
                            <P>(B) Placed in service in the same taxable year; and</P>
                            <P>(C) Transmit electricity generated by the facilities through the same point of interconnection or, if the facilities are not grid-connected or are delivering electricity directly to an end user behind a utility meter, are able to support the same end user.</P>
                            <P>
                                (ii) 
                                <E T="03">EST One Megawatt Exception.</E>
                                 Solely for the purposes of the EST One Megawatt Exception described in paragraph (b)(4) of this section, an EST is treated as having 
                                <E T="03">integrated operations</E>
                                 with any other EST of the same technology type if the ESTs are:
                            </P>
                            <P>(A) Owned by the same or related taxpayers;</P>
                            <P>(B) Placed in service in the same taxable year; and</P>
                            <P>(C) Transmit energy through the same point of interconnection or, if the ESTs are not grid-connected or are providing storage directly to an end user behind a utility meter, are able to support the same end user. In the case of EST described in paragraphs (c)(3)(iii) and (iv) of this section, which use the same piping and distribution systems for the respective type of EST.</P>
                            <P>
                                (d) 
                                <E T="03">Transition waiver of penalty for prevailing wage requirements.</E>
                                 For purposes of the transition waiver described in § 1.48-13(c)(2) (by reference to § 1.45-7(c)(6)(iii)), the penalty payment required by § 1.45-7(c)(1)(ii) to cure a failure to satisfy the prevailing wage requirements in paragraph (b)(3) or (6) of this section is waived with respect to a laborer or mechanic who performed work in the construction, alteration, or repair of an energy project on or after January 29, 2023, and prior to January 15, 2025, if the taxpayer relied upon Notice 2022-61, 2022-52 I.R.B. 560, or the PWA proposed regulations (REG-100908-23) (88 FR 60018), corrected in 88 FR 73807 (Oct. 27, 2023), corrected in 89 FR 25550 (April 11, 2024), to determine when the activities of any laborer or mechanic became subject to the prevailing wage requirements, and the taxpayer makes the correction payments required by § 1.45-7(c)(1)(i) with respect to such laborer and mechanics within 180 days of January 15, 2025.
                            </P>
                            <P>
                                (e) 
                                <E T="03">No alteration or repair during recapture period described in § 1.48-13(c)(3).</E>
                                 If no alteration or repair work occurs during the five-year recapture period, the taxpayer is deemed to satisfy the prevailing wage requirements described in paragraph (b)(3) or (6) of this section with respect to such taxable year.
                                <PRTPAGE P="4119"/>
                            </P>
                            <P>
                                (f) 
                                <E T="03">Applicability date.</E>
                                 This section applies to qualified facilities and qualified ESTs placed in service in taxable years ending after January 15, 2025, and the construction of which begins after March 17, 2025. Taxpayers may apply this section to qualified facilities and qualified ESTs placed in service in taxable years ending on or after January 15, 2025, the construction of which begins before January 15, 2025, provided that taxpayers follow this section in its entirety and in a consistent manner.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1.48E-4</SECTNO>
                            <SUBJECT> Rules of general application.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Qualified interconnection costs included in certain lower-output qualified facilities</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 For purposes of determining the section 48E credit (as defined in § 1.48E-1(a)), the qualified investment with respect to a qualified facility (as defined in § 1.48E-2(a)) includes amounts paid or incurred by the taxpayer for qualified interconnection property (as defined in paragraph (a)(2) of this section), in connection with a qualified facility (as defined in § 1.48E-2(a)) that has a maximum net output of not greater than 5 MW (as measured in alternating current) as described in paragraph (a)(3) of this section (Five-Megawatt Limitation). The qualified interconnection property must provide for the transmission or distribution of the electricity produced by a qualified facility and must be properly chargeable to the capital account of the taxpayer as reduced by paragraph (a)(6) of this section. If the costs borne by the taxpayer are reduced by utility or non-utility payments, Federal income tax principles may require the taxpayer to reduce the amounts of costs treated as paid or incurred for qualified interconnection property to determine a section 48E credit.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Qualified interconnection property.</E>
                                 For purposes of this paragraph (a), the term 
                                <E T="03">qualified interconnection property</E>
                                 means, with respect to a qualified facility, any tangible property that is part of an addition, modification, or upgrade to a transmission or distribution system that is required at or beyond the point at which the qualified facility interconnects to such transmission or distribution system in order to accommodate such interconnection; is either constructed, reconstructed, or erected by the taxpayer (as defined in § 1.48E-2(e)(4)), or for which the cost with respect to the construction, reconstruction, or erection of such property is paid or incurred by such taxpayer; and the original use (as defined in § 1.48E-2(e)(6)) of which, pursuant to an interconnection agreement (as defined in paragraph (a)(4) of this section), commences with a utility (as defined in paragraph (a)(5) of this section). For purposes of determining the original use of interconnection property in the context of a sale-leaseback or lease transaction, the principles of section 50(d)(4) of the Internal Revenue Code (Code) must be taken into account, as applicable, with such original use determined on the date of the sale-leaseback or lease. Qualified interconnection property is not part of a qualified facility. As a result, qualified interconnection property is not taken into account in determining whether a qualified facility satisfies the requirements for the increase in credit rate for energy communities provided in section 48E(a)(3)(A) of the Code, the increase in credit rate for domestic content referenced in section 48E(a)(3)(B) (by reference to the rules of section 48(a)(12)) or the increase in credit rate for prevailing wage requirements referenced in section 48E(d)(3) and apprenticeship requirements referenced in section 48E(d)(4).
                            </P>
                            <P>
                                (3) 
                                <E T="03">Five-Megawatt Limitation</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 For purposes of this paragraph (a), the Five-Megawatt Limitation is measured at the level of the qualified facility in accordance with section 48E(b)(1)(B). The maximum net output of a qualified facility is measured only by nameplate generating capacity (in alternating current) of the unit of qualified facility, which does not include the nameplate capacity of any integral property, at the time the qualified facility is placed in service. The nameplate generating capacity of the unit of qualified facility is measured independently from any other qualified facilities that share the same integral property.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Nameplate capacity for purposes of the Five-Megawatt Limitation.</E>
                                 For purposes of paragraph (a)(1) of this section, the determination of whether a qualified facility has a maximum net output of not greater than 5 MW (as measured in alternating current) is based on the nameplate capacity. The nameplate capacity for purposes of the Five-Megawatt Limitation is the maximum electrical generating output in megawatts that the unit of qualified facility is capable of producing on a steady state basis and during continuous operation under standard conditions, as measured by the manufacturer and consistent with the definition of nameplate capacity provided in 40 CFR 96.202. If applicable, taxpayers should use the International Standard Organization (ISO) conditions to measure the maximum electrical generating output of a unit of qualified facility.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Nameplate capacity for qualified facilities that generate in direct current for purposes of the Five-Megawatt Limitation.</E>
                                 For qualified facilities that generate electricity in direct current, a taxpayer determines whether a qualified facility has a maximum net output of not greater than five MW (in alternating current) by using the lesser of:
                            </P>
                            <P>(A) The sum of the nameplate generating capacities within the unit of qualified facility property in direct current, which is deemed the nameplate generating capacity of the unit of qualified facility property in alternating current; or</P>
                            <P>(B) The nameplate capacity of the first component of the qualified facility that inverts the direct current electricity into alternating current.</P>
                            <P>
                                (4) 
                                <E T="03">Interconnection agreement.</E>
                                 For purposes of this paragraph (a), the term 
                                <E T="03">interconnection agreement</E>
                                 means an agreement with a utility for the purposes of interconnecting the qualified facility owned by such taxpayer to the transmission or distribution system of the utility. In the case of the election provided under section 50(d)(5) (relating to certain leased property), the term includes an agreement regarding a qualified facility leased by such taxpayer.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Utility.</E>
                                 For purposes of this paragraph (a), the term 
                                <E T="03">utility</E>
                                 means the owner or operator of an electrical transmission or distribution system that is subject to the regulatory authority of a State or political subdivision thereof, any agency or instrumentality of the United States, a public service or public utility commission or other similar body of any State or political subdivision thereof, or the governing or ratemaking body of an electric cooperative.
                            </P>
                            <P>
                                (6) 
                                <E T="03">Reduction to amounts chargeable to capital account.</E>
                                 In the case of costs paid or incurred for qualified interconnection property as defined in paragraph (a)(2) of this section, amounts otherwise chargeable to capital account with respect to such costs must be reduced under rules of section 50(c) (including section 50(c)(3)).
                            </P>
                            <P>
                                (7) 
                                <E T="03">Examples.</E>
                                 This paragraph (a)(7) provides examples illustrating the application of the general rules provided in paragraph (a)(1) of this section and Five-Megawatt Limitation provided in this paragraph (a).
                            </P>
                            <P>
                                (i) 
                                <E T="03">Example 1. Application of Five-Megawatt Limitation to an interconnection agreement for qualified facilities owned by taxpayer.</E>
                                 X places in service two solar qualified facilities (48E Facilities) each with a maximum net output of 5 MW (as measured in 
                                <PRTPAGE P="4120"/>
                                alternating current by using the nameplate capacity of an inverter, which is the first component of property attached to each of the 48E Facilities that inverts the direct current electricity into alternating current). The two 48E Facilities each have their own inverter, which is integral property to each facility, and share a step-up transformer, which is integral property to both facilities. As part of the development of the 48E Facilities, interconnection costs are required by the utility to modify and upgrade the transmission system at or beyond the common intertie to the utility's transmission system to accommodate the interconnection. X has an interconnection agreement with the utility that allows for a maximum output of 10 MW (as measured in alternating current). The interconnection agreement provides the total cost to X of the qualified interconnection property. X may include the costs paid or incurred by X, respectively, for qualified interconnection property subject to the terms of the interconnection agreement, to calculate X's section 48E credit for each of the 48E Facilities because each qualified facility has a maximum net output of not greater than 5 MW (alternating current).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Example 2. Application of Five-Megawatt Limitation to an interconnection agreement for qualified facilities owned by separate taxpayers.</E>
                                 X places in service a solar farm that is a qualified facility (as defined in § 1.48E-2(a)) (Solar Qualified Facility) with a maximum net output of 5 MW (as measured in alternating current by using the nameplate capacity of the first component of property attached to the Solar Qualified Facility that inverts the direct current electricity into alternating current). The Solar Qualified Facility includes an inverter, which is integral property. Y places in service a wind facility (as defined in § 1.48E-2(a)) (Wind Qualified Facility), with a maximum net output of 5 MW (as measured in alternating current by using the nameplate capacity of the first component of property attached to the Wind Qualified Facility that inverts the direct current electricity into alternating current). The Solar Qualified Facility and the Wind Qualified Facility share a step-up transformer, which is integral to both facilities. As part of the development of the Solar Qualified Facility and Wind Qualified Facility, interconnection costs are required by the utility to modify and upgrade the transmission system at or beyond the common intertie to the utility's transmission system to accommodate the interconnection. X and Y are party to the same interconnection agreement with the utility that allows for a maximum output of 10 MW (as measured in alternating current). The interconnection agreement provides the total cost of the qualified interconnection property to X and Y. X and Y may include the costs paid or incurred by X and Y, respectively, for qualified interconnection property subject to the terms of the interconnection agreement, to calculate their respective section 48E credits for the Solar Qualified Facility and the Wind Qualified Facility because each has a maximum net output of not greater than 5 MW (alternating current).
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Example 3. Application of Five-Megawatt Limitation to an interconnection agreement for a single qualified facility.</E>
                                 X develops three solar farms (Solar Qualified Facilities) located in close proximity. Each of the Solar Qualified Facilities is a unit of qualified facility that has a maximum net output of 4 MW. The nameplate capacity of each Solar Qualified Facility is determined by using the sum of the nameplate generating capacities within the unit of each Solar Qualified Facility in direct current, which is deemed the nameplate generating capacity of each Solar Qualified Facility in alternating current. Electricity from the three Solar Qualified Facilities feeds into a single gen-tie line and a common point of interconnection with the transmission system. X is party to a separate interconnection agreement with the utility for each of the Solar Qualified Facilities and each interconnection agreement allows for a maximum output of 10 MW (as measured in alternating current). X may include the costs it paid or incurred for qualified interconnection property for each of the Solar Qualified Facilities to calculate its section 48E credit for each of the Solar Qualified Facilities, subject to the terms of each interconnection agreement, because each of the Solar Qualified Facilities has a maximum net output of not greater than 5 MW (in alternating current). X cannot include more than the total costs X paid or incurred for the qualified interconnection property in calculating the aggregate section 48E credit amount for the Solar Qualified Facilities.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Example 4. Utility payment reducing costs borne by taxpayer.</E>
                                 In year 1, X places in service a solar facility (Solar Qualified Facility) with a maximum net output of 3 MW (as measured in alternating current) by using the nameplate capacity of the inverter attached to the solar facility, which is the first component of the qualified facility that inverts the direct current electricity into alternating current. X is party to an interconnection agreement with a utility for the purpose of connecting the Solar Qualified Facility to the transmission or distribution system of the utility. Pursuant to the interconnection agreement, X pays $1 million to the utility, and the utility places in service qualified interconnection property. In year 1, X had no reasonable expectation of any payment from the utility or other parties with respect to the qualified interconnection property. The $1 million is properly chargeable to the capital account of X, subject to paragraph (a)(6) of this section. X properly includes the $1 million paid to the utility in determining its credit under section 48E for Year 1. In Year 4, taxpayer Y enters into an agreement with the utility under which Y pays the utility $100,000 for the use of qualified interconnection property placed in service by the utility pursuant to the interconnection agreement between X and the utility. The utility pays $100,000 to X. Under these circumstances, the payment from the utility in year 4 would not require X to reduce the amount treated as paid or incurred for the qualified interconnection property for the purpose of determining the section 48E credit in year 1; instead X would treat the payment as income.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Example 5. Non-utility payment reducing costs borne by taxpayer.</E>
                                 The facts in year 1 are the same as in paragraph (a)(7)(iii) of this section (
                                <E T="03">Example 3</E>
                                ). In Year 4, taxpayer Y enters into an agreement with the utility under which Y pays X $100,000 for the use of qualified interconnection property placed in service by the utility pursuant to the interconnection agreement between X and the utility. Y pays $100,000 to X. In year 1, X had no reasonable expectation of any payment from Y for subsequent agreements with Y or other parties with respect to the qualified interconnection property. Under these circumstances, the payment from Y in year 4 would not require X to reduce the amount treated as paid or incurred for the qualified interconnection property for the purpose of determining the section 48E credit in year 1; instead X would treat the payment as income.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Expansion of facility; Incremental production (Incremental Production Rule)</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 Solely for purposes of this paragraph (b), the term 
                                <E T="03">qualified facility</E>
                                 includes either a new unit or an addition of capacity placed in service after December 31, 2024, in connection with a facility described in section 48E(b)(3)(A) (without regard to 
                                <PRTPAGE P="4121"/>
                                section 48E(b)(3)(A)(ii)), which was placed in service before January 1, 2025, but only to the extent of the increased amount of electricity produced at the facility by reason of such new unit or addition of capacity. This paragraph (b) is only applicable to an addition of capacity or new unit that would not otherwise qualify as a separate qualified facility as defined in section 48E(b)(3). A new unit or an addition of capacity that meets the requirements of this paragraph (b) will be treated as a separate qualified facility. For purposes of this paragraph (b), a new unit or an addition of capacity requires the addition or replacement of qualified property (as defined in § 1.48E-2(e)), including any new or replacement integral property, added to a facility necessary to increase capacity. For purposes of assessing the One Megawatt Exception provided in section 48E(a)(2)(A)(ii)(I), the maximum net output for a new unit or an addition of capacity is the sum of the capacity of the added qualified facility and the capacity of the facility to which the qualified facility was added, as determined under § 1.48E-3(c) and paragraph (b)(2) of this section.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Measurement standard.</E>
                                 For purposes of this paragraph (b), taxpayers must use one of the measurement standards described in paragraph (b)(2)(i), (ii), or (iii) of this section to measure the capacity and change in capacity of a facility, except a taxpayer cannot use the measurement standard described in paragraph (b)(2)(ii) of this section if the taxpayer is able to use the measurement standard described in paragraph (b)(2)(i) of this section:
                            </P>
                            <P>(i) Modified or amended facility operating licenses from the Federal Energy Regulatory Commission (FERC) or the Nuclear Regulatory Commission (NRC), or related reports prepared by FERC or NRC as part of the licensing process;</P>
                            <P>(ii) Nameplate capacity certified consistent with generally accepted industry standards, such as the International Standard Organization (ISO) conditions to measure the nameplate capacity of the facility consistent with the definition of nameplate capacity provided in 40 CFR 96.202; or</P>
                            <P>(iii) A measurement standard prescribed by the Secretary in guidance published in the Internal Revenue Bulletin (see § 601.601 of this chapter).</P>
                            <P>
                                (3) 
                                <E T="03">Special rule for restarted facilities.</E>
                                 Solely for purposes of this paragraph (b), a facility that is decommissioned or in the process of decommissioning and restarts can be considered to have increased capacity from a base of zero if the conditions described in each of paragraphs (b)(3)(i) through (iv) of this section are met:
                            </P>
                            <P>(i) The existing facility must have ceased operations;</P>
                            <P>(ii) The existing facility must have a shutdown period of at least one calendar year during which it was not authorized to operate by its respective Federal regulatory authority (that is, FERC or NRC);</P>
                            <P>(iii) The restarted facility must be eligible to restart based on an operating license issued by either FERC or NRC; and</P>
                            <P>(iv) The existing facility may not have ceased operations for the purpose of qualifying for the special rule for restarted facilities.</P>
                            <P>
                                (4) 
                                <E T="03">Computation of qualified investment for a new unit or an addition of capacity.</E>
                                 For purposes of this paragraph (b), a new unit or an addition of capacity requires the addition or replacement of components of qualified property, including any new or replacement integral property, added to a facility necessary to increase capacity. The taxpayer's qualified investment during the taxable year that resulted in an increased capacity of a facility by reason of a new unit or addition of capacity is its total qualified investment associated with the components of property that result in the new unit or addition of capacity.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Examples.</E>
                                 This paragraph (b)(5) provides examples illustrating the rules of this paragraph (b).
                            </P>
                            <P>
                                (i) 
                                <E T="03">Example 1. New Unit.</E>
                                 X owns a hydropower facility (Facility H) that was originally placed in service in 2020, with a FERC license authorizing an installed capacity of 60 megawatts. During taxable years 2020 through 2024, X claimed a section 45 credit for the electricity produced by Facility H. On July 1, 2025, as allowed by a FERC license amendment, X places in service components of property comprising a new unit that results in Facility H having an increased authorized installed capacity of 90 megawatts in 2025. These components of property meet the requirements of qualified property (as defined in § 1.48E-2(e)). For purposes of this paragraph (b), this new unit will be treated as a separate facility (Facility J). X determines the amount of its section 48E credit based on the amount of its qualified investment in Facility J. Even though X claimed a section 45 credit for electricity produced by Facility H in taxable years 2020 through 2024, X can claim a section 48E credit for its qualified investment in Facility J. X may also continue to claim the section 45 credit through taxable year 2030 for electricity generated by Facility H (excluding the incremental electricity generation related to Facility J).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Example 2. Addition of Capacity.</E>
                                 Y owns a nuclear facility (Facility N) that was originally placed in service on January 1, 2000. Y claimed a section 45U credit in taxable years 2024 and 2025 for the electricity generated by Facility N. On January 15, 2026, Y completed and placed in service an investment associated with a power uprate approved by an NRC license amendment that involved the removal and replacement of components of property and placing in service additional components of property. Both of these replacement and additional components of property meet the requirements of qualified property (as defined in § 1.48E-2(c)). NRC reports associated with the license amendment describe the uprate as increasing the nuclear facility's electrical capacity by 100 MW to 900 MW. For purposes of this paragraph (b), Facility N's addition of capacity equal to 100 MW is treated as a new separate qualified facility placed in service on January 15, 2026 (Facility P). Y determines the amount of its section 48E credit based on the entire amount of its qualified investment on January 15, 2026. Even though Y claimed a section 45U credit in taxable years 2024 and 2025 for the existing capacity of Facility N, Y can claim a section 48E credit for its investment in components of property needed to support the increase in capacity. Y may also continue to claim the section 45U credit for electricity generated by Facility N (excluding the incremental electricity generation related to Facility P).
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Example 3. Geothermal Turbine and Generator Additions of Capacity.</E>
                                 X owns a geothermal power plant (Facility G) with a 24 MW nameplate capacity, which is placed in service in 2007. Over the subsequent years, the plant's generating capability declines because of physical degradation of the turbine and generator. On March 1, 2027, X places in service components of property at Facility G that increase its capacity. The turbine rotor is removed, and the eroded blades are replaced with new blades, with associated capital expenditures. The generator is refurbished by removing old subcomponents of the generator and replacing those with new subcomponents, as well as replacing the old copper windings with new windings in concert with new insulation. These components of property meet the requirements of qualified property (as defined in § 1.48E-2(c)). After the upgrade, the plant increases its nameplate capacity to 26 MW, an 
                                <PRTPAGE P="4122"/>
                                increase of 2 MW over the previous nameplate capacity. For purposes of this paragraph (b), the addition of capacity to Facility G is treated as a new separate qualified facility placed in service on March 1, 2027 (Facility N). X determines the amount of its section 48E credit based on the amount of its qualified investment in qualified property needed to increase the capacity of the facility.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Example 4. Hydropower Addition of Capacity.</E>
                                 X owns a hydropower plant (Facility H) placed in service in 1960. Facility H has become less efficient since it was placed in service with attendant reductions in its generating capacity. As approved by a FERC license amendment, X increases Facility H's capacity by installing new headcovers, new turbines with integrated dissolved oxygen injection, and a new high pressure digital governor system. All of the existing turbine systems are replaced with new turbine and governor systems. The new turbines are more efficient, and are capable of more power output, than the original design installed in 1960. Improvements to the generators involve removing the old asphalt coated copper windings and purchasing and then installing new epoxy coated double wound windings. X adds digital controls to effectively utilize new digital governors. These components of property meet the requirements of qualified property (as defined in § 1.48E-2(c)). X simultaneously invests in cybersecurity protection. As set forth in the FERC order amending its license, these investments, which are placed in service on April 15, 2026, increase Facility H's authorized installed nameplate capacity from 180 MW to 190 MW, an increase of 10 MW over the previous nameplate capacity. For purposes of this paragraph (b), Facility H's addition of capacity is treated as a new separate qualified facility placed in service on April 16, 2026 (Facility A). X determines the amount of its section 48E credit based on the amount of its qualified investment in qualified property needed in Facility A to result in the final 190 MW capacity, which would not include any investments in intangible property, such as those that might be associated with cybersecurity protection.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Example 5. Nonoperational Nuclear Facility that Satisfies Restart Rule.</E>
                                 T owns a nuclear facility (Facility N) that was originally placed in service in 1982. In 2020, Facility N ceased operations, began decommissioning, and the NRC no longer authorized the operation of Facility N. T did not cease operations at Facility N for the purpose of qualifying for the special rule for restarted facilities under section 48E. In 2028, the NRC authorized Facility N to restart, and, on October 1, 2028, Facility N placed in service qualified property that enabled Facility N to restart and resume operations, with an electrical capacity of 800 MW, as indicated in NRC documents related to the authorization to restart. For purposes of this paragraph (b), the restart of Facility N is considered to have increased capacity from a base of zero, and Facility N is treated as having an addition of capacity equal to 800 MW. For purposes of this paragraph (b), Facility N's 800 MW addition of capacity is treated as a new qualified facility placed in service on October 1, 2028 (Facility P). T determines the amount of its section 48E credit based on the amount of its qualified investment in qualified property needed to restart the facility.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Retrofit of an existing facility (80/20 Rule)</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 For purposes of section 48E(b)(3)(A)(ii), a retrofitted qualified facility or an energy storage technology (EST) may qualify as originally placed in service even if it contains some used components of property within the unit of qualified facility or unit of EST, provided that the fair market value of the used components of the unit of qualified facility or unit of EST is not more than 20 percent of the total value of the unit of qualified facility or unit of EST (that is, the cost of the new components of property plus the value of the used components of property within the unit of qualified facility or unit of EST) (80/20 Rule). A qualified facility or EST that meets the 80/20 Rule may claim the section 48E credit without regard to any addition of capacity to the qualified facility or EST.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Expenditures taken into account.</E>
                                 Notwithstanding the rule provided in paragraph (c)(1) of this section, only the cost of new components of the unit of qualified facility or unit of EST are taken into account for purposes of computing the credit determined under section 48E with respect to the qualified facility or EST.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Cost of new components.</E>
                                 For purposes of this 80/20 Rule, the cost of new components of the unit of qualified facility or unit of EST includes all costs properly included in the depreciable basis of the new components of the unit of qualified facility.
                            </P>
                            <P>
                                (4) 
                                <E T="03">New costs.</E>
                                 If the taxpayer satisfies the 80/20 Rule with regard to the unit of qualified facility or unit of EST and the taxpayer pays or incurs new costs for property that is an integral part of the qualified facility (as defined in § 1.48E-2(a)) or the EST (as defined in § 1.48E-2(g)), the taxpayer may include these new costs paid or incurred for property that is an integral part of the qualified facility or EST in the basis of the qualified facility or EST for purposes of the section 48E credit.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Excluded costs.</E>
                                 Costs incurred for new components of property added to used components of a unit of qualified facility or unit of EST may not be taken into account for purposes of the section 48E credit unless the taxpayer satisfies the 80/20 Rule by placing in service a unit of qualified facility or unit of EST for which the fair market value of the used components of property is not more than 20 percent of the total value of the unit of qualified facility or unit of EST taking into account the cost of the new components of property plus the value of the used components of property.
                            </P>
                            <P>
                                (6) 
                                <E T="03">Examples.</E>
                                 This paragraph (c)(6) provides examples illustrating the rules of this paragraph (c).
                            </P>
                            <P>
                                (i) 
                                <E T="03">Example 1. Retrofitted facility that satisfies the 80/20 Rule.</E>
                                 A owns an existing wind facility. On February 1, 2026, A replaces used components of unit of qualified facility of the wind facility with new components at a cost of $2 million. The fair market value of the remaining original components of the unit of qualified facility is $400,000, which is not more than 20 percent of the retrofitted unit of qualified facility's total fair market value of $2.4 million (the cost of the new components ($2 million) + the fair market value of the remaining original components of the unit of qualified facility ($400,000)). Thus, the retrofitted wind facility will be considered newly placed in service for purposes of section 48E, assuming all the other requirements of section 48E are met, and A will be able to claim a section 48E credit based on its investment in 2026 ($2 million).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Example 2. Retrofit of an existing facility that meets the 80/20 Rule.</E>
                                 Facility Z, a facility that was originally placed in service on January 1, 2026, was not a qualified facility (as defined in § 1.48E-2(a)) when it was placed in service because it did not meet the greenhouse gas emissions rate requirements (as determined under rules provided in § 1.48E-5). On January 1, 2027, Facility Z was retrofitted and now meets the requirements to be a qualified facility (as defined in § 1.48E-2(a)). After the retrofit, the cost of the new property included in the unit of qualified facility of Facility Z is greater than 80 percent of unit of qualified facility's total fair market value. Because Facility Z meets the 80/20 Rule, Facility Z is deemed to be originally placed in 
                                <PRTPAGE P="4123"/>
                                service on January 1, 2027. Assuming all the other requirements of section 48E are met, Z may claim a section 48E credit based on its investment in the new components used to retrofit the existing facility in 2027.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Example 3. Retrofitted nuclear facility that satisfied the 80/20 Rule.</E>
                                 T owns a nuclear facility (Facility N) that was originally placed in service on March 1, 1982. T replaces used components of property of the unit of qualified facility of Facility N with new components at a cost of $200 million, and then places in Facility N in service on July 15, 2026. The fair market value of the remaining original components of the unit of qualified facility, prior to the retrofit, is $30 million, which is not more than 20 percent of the unit of qualified facility's total fair market value of $230 million (the cost of the new components ($200 million) + the fair market value of the remaining original components of the unit of qualified facility ($30 million)) ($30 million/$230 million = 13%). Thus, assuming all the other requirements of section 48E are met, Facility N will be considered newly placed in service on July 15, 2026, for purposes of section 48E, and T will be able to claim a section 48E credit based on its investment in the new components ($200 million).
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Example 4. Capital improvements to an existing qualified facility that do not satisfy the 80/20 Rule.</E>
                                 X owns an existing facility, Facility C, that was originally placed in service on January 1, 2023. X makes capital improvements to Facility C that are placed in service on June 6, 2026. The cost of the capital improvements to the unit of qualified facility of Facility C total $500,000 and the fair market value of the unit of qualified facility after the improvements is $2 million. The fair market value of the old components of the unit of qualified facility is $1,500,000 or 75 percent of the total fair market value of the Facility C after the improvements. Because the fair market value of the new property included in the unit of qualified facility is less than 80 percent of the unit of qualified facility's total fair market value, Facility C does not meet the 80/20 Rule.
                            </P>
                            <P>
                                (v) 
                                <E T="03">Example 5. Upgrades to a hydropower qualified facility that satisfies the 80/20 Rule:</E>
                                 Y owns a hydropower qualified facility (hydropower facility) and no taxpayer, including Y, has ever claimed a section 45 credit for the hydropower facility. The hydropower facility consists of a unit of qualified facility including water intake, water isolation mechanisms, turbine, pump, motor, and generator. The associated impoundment (dam) and power conditioning equipment are integral parts of the unit of qualified facility. Y makes upgrades to the unit of qualified facility by replacing the turbine, pump, motor, and generator with new components at a cost of $1.5 million. Y does not make any upgrades to the property that is an integral part of the unit of qualified facility. The remaining original components of the unit of qualified facility have a fair market value of $100,000, which is not more than 20 percent of the retrofitted hydropower facility's total value of $1.6 million (that is, the cost of the new components ($1.5 million) + the value of the remaining original components ($100,000)). Thus, the retrofitted hydropower facility will be considered newly placed in service for purposes of section 48E, and Y will be able to claim a section 48E credit based on the cost of the new components ($1.5 million).
                            </P>
                            <P>
                                (d) 
                                <E T="03">Special rules regarding ownership</E>
                                —(1) 
                                <E T="03">Qualified investment with respect to a qualified facility or EST.</E>
                                 For purposes of this paragraph (d), a taxpayer that owns a qualified investment with respect to a qualified facility or EST is eligible for the section 48E credit only to the extent of the taxpayer's basis in the qualified facility or EST. In the case of multiple taxpayers holding direct ownership through their qualified investments in a single qualified facility or EST (and such arrangement is not treated as a partnership for Federal income tax purposes), each taxpayer determines its basis based on its fractional ownership interest in the qualified facility or EST.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Multiple owners.</E>
                                 A taxpayer must directly own at least a fractional interest in the entire unit of qualified facility (as defined in § 1.48E-2(b)(2)) or unit of EST (as defined in § 1.48E-2(g)(2)) for a section 48E credit to be determined with respect to such taxpayer's interest. No section 48E credit may be determined with respect to a taxpayer's ownership of one or more separate components of a qualified facility or an EST if the components do not constitute a unit of qualified facility (as defined in § 1.48E-2(b)(2)) or unit of EST (as defined in § 1.48E-2(g)(2)). However, the use of property owned by one taxpayer that is an integral part of a qualified facility or EST owned by another taxpayer will not prevent a section 48E credit from being determined with respect to the second taxpayer's qualified investment in a qualified facility or EST (though neither taxpayer would be eligible for a section 48E credit with respect to the first taxpayer's property). See § 1.48E-2(b)(3)(vi) for rules regarding shared integral property.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Section 761(a) election.</E>
                                 If a qualified facility or EST is owned through an unincorporated organization that has made a valid election under section 761(a) of the Code, each member's undivided ownership share in the qualified facility or EST will be treated as a separate qualified facility or EST owned by such member.
                            </P>
                            <P>
                                (4) 
                                <E T="03">Examples.</E>
                                 The following examples illustrate the rules in this paragraph (d). In each example, X and Y are unrelated taxpayers.
                            </P>
                            <P>
                                (i) 
                                <E T="03">Example 1. Fractional ownership required to satisfy section 48E.</E>
                                 X and Y each own a direct fractional ownership interest in an entire qualified facility (as defined in § 1.48E-2(b)) and as a result, a section 48E credit may be determined with respect to X's and Y's qualified investment in their fractional ownership interests in the qualified facility.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Example 2. Ownership of separate components of property that are part of a qualified facility.</E>
                                 X and Y each own separate components of a qualified facility, which taken together would constitute a unit of qualified facility but taken separately would not constitute a unit of qualified facility. X owns component A and Y owns component B. No section 48E credit may be determined with respect to either component A or component B because X and Y each owns a separate component of a qualified facility that does not constitute a unit of qualified facility (as defined in § 1.48E-2(b)(2)).
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Example 3. Separate ownership of property that is an integral part of separate qualified facilities.</E>
                                 X owns a solar farm that is a qualified facility (as defined in § 1.48E-2(b)) (Solar Qualified Facility), which includes property that is an integral part of the Solar Qualified Facility, specifically a transformer in which the electricity is stepped up to electrical grid voltage before being transmitted to the electrical grid through an intertie. Y owns a wind facility that is a qualified facility (as defined in § 1.48E-2(b)) (Wind Qualified Facility) that connects to X's transformer. X and Y are not related persons within the meaning of paragraph (d)(4)(i) of this section. Because Y does not hold an ownership interest in the transformer, Y may compute its section 48E credit for the Wind Qualified Facility, but it may not include any costs relating to the transformer in its section 48E credit base.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Example 4. Related taxpayers and property that is an integral part.</E>
                                 X owns a wind facility that is a unit of qualified facility and a solar facility that is a unit of qualified facility. Both the wind facility and the solar facility are connected to a transformer where the 
                                <PRTPAGE P="4124"/>
                                electricity is stepped up to electrical grid voltage before being transmitted to the electrical grid through an intertie. The transformer is an integral part of both the wind facility and the solar facility (within the meaning of § 1.48E-2(d)(3)(i)) and is owned by Y. X and Y are related persons within the meaning of paragraph (d)(4)(i) of this section. X and Y are treated as one taxpayer under paragraph (d)(4)(ii) of this section. X may include the basis of the transformer in computing its section 48E credit with respect to the wind facility and the solar facility (but may not include more than 100% of that basis in the aggregate).
                            </P>
                            <P>
                                (e) 
                                <E T="03">Coordination rule for section 42 credits and section 48E credits.</E>
                                 As provided under section 50(c)(3)(C) of the Code, in determining eligible basis for purposes of calculating a credit under section 42 of the Code (section 42 credit), a taxpayer is not required to reduce its basis in a qualified facility or EST by the amount of the section 48E credit determined with respect to the taxpayer's qualified investment with respect to such qualified facility or EST. The qualified investment with respect to a qualified facility or EST property may be used to determine a section 48E credit and may also be included in eligible basis to determine a section 42 credit. See paragraph (d) of this section for special rules regarding ownership.
                            </P>
                            <P>
                                (f) 
                                <E T="03">Recapture</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 The credit calculated under section 48E(a) and § 1.48E-1(b) is subject to general recapture rules under section 50(a). Additionally, section 48E(g) provides for recapture for any qualified facility for which a taxpayer claimed a section 48E credit that has a greenhouse gas emissions rate (as determined under rules provided in § 1.45Y-5) of greater than 10 grams of CO
                                <E T="52">2</E>
                                e per kWh during the five-year period beginning on the date such qualified facility is originally placed in service (five-year recapture period).
                            </P>
                            <P>
                                (2) 
                                <E T="03">Recapture event</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 Any event that results in a qualified facility having a greenhouse gas emissions rate (as determined under rules provided in § 1.45Y-5) of greater than 10 grams of CO
                                <E T="52">2</E>
                                e per kWh during the five-year period is a recapture event. If a qualified facility's greenhouse gas emissions rate exceeds 10 grams of CO
                                <E T="52">2</E>
                                e per kWh, the section 48E credit is subject to recapture.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Changes to the Annual Table.</E>
                                 A change to the greenhouse gas emissions rate for a type or category of facility that is published in the Annual Table (as defined in § 1.48E-5(f)) after a facility is placed in service does not result in a recapture event.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Yearly determination</E>
                                —(A) 
                                <E T="03">In general.</E>
                                 A determination of whether a recapture event occurred under this paragraph (f)(2) must be made for each taxable year (or portion thereof) occurring within the five-year recapture period, beginning with the taxable year ending after the date the qualified facility is placed in service. Thus, for each taxable year that begins or ends within the five-year recapture period, the taxpayer must determine, for any qualified facility for which it has claimed the section 48E credit, whether such facility has maintained a greenhouse gas emissions rate of not greater than 10 grams of CO
                                <E T="52">2</E>
                                e per kWh.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Annual reporting requirement.</E>
                                 A taxpayer that has claimed the section 48E credit amount under § 1.48E-1(b), including a taxpayer that has transferred a specified credit portion under section 6418 of the Code, is required to provide to the IRS information on the greenhouse gas emissions rate of the qualified facility during the recapture period at the time and in the form and manner prescribed in IRS forms or instructions or in publications or guidance published in the Internal Revenue Bulletin. 
                                <E T="03">See</E>
                                 § 601.601 of this chapter.
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Carryback and carryforward adjustments.</E>
                                 In the case of any recapture event described in this paragraph (f)(2), the carrybacks and carryforwards under section 39 of the Code must be adjusted by reason of such recapture event.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Recapture amount</E>
                                —(i) 
                                <E T="03">In general.</E>
                                 If a recapture event occurred as described in paragraph (f)(2) of this section, the tax under chapter 1 of the Code for the taxable year in which the recapture event occurs is increased by an amount equal to the applicable recapture percentage multiplied by the credit amount that was claimed by the taxpayer under § 1.48E-1(b).
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Applicable recapture percentage.</E>
                                 If the recapture event occurs:
                            </P>
                            <P>(A) Within one full year after the property is placed in service, the recapture percentage is 100;</P>
                            <P>(B) Within one full year after the close of the period described in paragraph (f)(3)(ii)(A) of this section, the recapture percentage is 80;</P>
                            <P>(C) Within one full year after the close of the period described in paragraph (f)(3)(ii)(B) of this section, the recapture percentage is 60;</P>
                            <P>(D) Within one full year after the close of the period described in paragraph (f)(3)(ii)(C) of this section, the recapture percentage is 40; and</P>
                            <P>(E) Within one full year after the close of the period described in paragraph (f)(3)(ii)(D) of this section, the recapture percentage is 20.</P>
                            <P>
                                (4) 
                                <E T="03">Recapture period.</E>
                                 The five-year recapture period begins on the date the qualified facility is placed in service and ends on the date that is five full years after the placed in service date. Each 365-day period (366-day period in case of a leap year) within the five-year recapture period is a separate recapture year for recapture purposes.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Increase in tax for recapture.</E>
                                 The increase in tax under chapter 1 of the Code for the recapture of the credit amount claimed under section 48E(a) and § 1.48E-1(b) occurs in the year of the recapture event.
                            </P>
                            <P>
                                (g) 
                                <E T="03">Qualified progress expenditure election.</E>
                                 A taxpayer may elect, as provided in § 1.46-5, to increase the qualified investment with respect to any qualified facility or EST of an eligible taxpayer for the taxable year, by any qualified progress expenditures made after August 16, 2022.
                            </P>
                            <P>
                                (h) 
                                <E T="03">Incremental cost</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 For purposes of section 48E, if a component of qualified property of a qualified facility or component of property of an EST is also used for a purpose other than the intended function of the qualified facility or EST, only the incremental cost of such component is included in the basis of the qualified facility or EST. The term 
                                <E T="03">incremental cost</E>
                                 means the excess of the total cost of a component over the amount that would have been expended for the component if that component were used for a non-qualifying purpose.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Example.</E>
                                 A installs a solar qualified facility above the surface of an existing roof of a building that A owns. The solar qualified facility uses bifacial panels that convert to energy the light that strikes both the front and back of the panels. Therefore, along with installing the bifacial panels, A is reroofing their building with a reflective roof that has a highly reflective surface. Because the reflective roof enables the panels' generation of significant amounts of electricity from reflected sunlight, when installed in connection with the solar qualified facility, it constitutes part of that solar qualified facility to the extent that the cost of the reflective roof exceeds the cost of reroofing A's building with a non-reflective roof. The cost of reroofing with the reflective roof is $15,000 whereas the cost of a reroofing with a standard roof for the building would be $10,000. The incremental cost of the reflective roof is $5,000, and that amount is included in A's basis in the solar qualified facility for purposes of the section 48E credit.
                                <PRTPAGE P="4125"/>
                            </P>
                            <P>
                                (i) 
                                <E T="03">Cross references.</E>
                                 (1) To determine applicable recapture rules, see section 50(a) of the Code.
                            </P>
                            <P>(2) For rules regarding the credit eligibility of property used outside the United States, see section 50(b)(1) of the Code.</P>
                            <P>(3) For rules regarding the credit eligibility of property used by certain tax-exempt organizations, see section 50(b)(3) of the Code. See section 6417(d)(2) of the Code for an exception to the rule in section 50(b)(3) in the case of an applicable entity making an elective payment election.</P>
                            <P>(4) For application of the normalization rules to the section 48E credit in the case of certain regulated companies, including rules regarding the election not to apply the normalization rules to EST (as defined in section 48(c)(6) of the Code without regard to section 48(c)(6)(D) of the Code), see section 50(d)(2) of the Code.</P>
                            <P>(5) For rules relating to certain leased property, see section 50(d)(5) of the Code.</P>
                            <P>
                                (j) 
                                <E T="03">Applicability date.</E>
                                 This section applies to qualified facilities and ESTs placed in service after December 31, 2024, and during a taxable year ending on or after January 15, 2025.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 1.48E-5 </SECTNO>
                            <SUBJECT>Greenhouse gas emissions rates for qualified facilities under section 48E.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">In general.</E>
                                 Section 48E(b)(3)(B)(ii) provides that rules similar to the rules of section 45Y(b)(2) regarding greenhouse emissions rates apply for purposes of section 48E. Paragraphs (b) through (f) of this section thus provide that the definitions and rules regarding greenhouse gas emissions rate requirements (as determined under rules provided in § 1.45Y-5) apply for purposes of section 48E and this section. Paragraph (g) of this section provides rules related to provisional emissions rates for purposes of section 48E and this section. Paragraph (h) of this section provides rules for determining an anticipated greenhouse gas emissions rate. Paragraph (i) of this section provides rules regarding reliance on the annual publication of emissions rates and provisional emissions rates. Finally, paragraph (j) of this section provides rules regarding substantiation requirements.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Definitions.</E>
                                 The definitions provided in § 1.45Y-5(b) apply for purposes of section 48E and this section.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Non-C&amp;G Facilities.</E>
                                 The rules provided in § 1.45Y-5(c) apply for purposes of determining greenhouse gas emissions rates for Non-C&amp;G Facilities for purposes of section 48E and this section.
                            </P>
                            <P>
                                (d) 
                                <E T="03">C&amp;G Facilities.</E>
                                 The rules provided in § 1.45Y-5(d) apply for purposes of determining greenhouse gas emissions rates for C&amp;G Facilities for purposes of section 48E and this section.
                            </P>
                            <P>
                                (e) 
                                <E T="03">Use of methane from certain sources to produce electricity.</E>
                                 The rules provided in § 1.45Y-5(e) regarding the use of methane from certain sources to produce electricity apply for purposes of section 48E and this section.
                            </P>
                            <P>
                                (f) 
                                <E T="03">Carbon capture and sequestration.</E>
                                 The rules provided in § 1.45Y-5(f) regarding carbon capture and sequestration apply for purposes of section 48E and this section.
                            </P>
                            <P>
                                (g) 
                                <E T="03">Annual publication of emissions rates.</E>
                                 The rules provided in § 1.45Y-5(g) regarding the annual publication of a table (Annual Table) that sets forth the greenhouse gas emissions rates for types or categories of facilities apply for purposes of section 48E and this section.
                            </P>
                            <P>
                                (h) 
                                <E T="03">Provisional emissions rates</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 In the case of any facility for which an emissions rate has not been established by the Secretary, a taxpayer that owns such facility may file a petition with the Secretary for determination of the emissions rate with respect to such facility (Provisional Emissions Rate or PER). A PER must be determined and obtained under the rules of this section.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Rate not established.</E>
                                 An emissions rate has not been established by the Secretary for a facility for purposes of sections 45Y(b)(2)(C)(ii) and 48E(b)(3)(B)(ii) if such facility is not described in the Annual Table. If a taxpayer's request for an emissions value pursuant to paragraph (h)(5) of this section is pending at the time such facility is or becomes described in the Annual Table, the taxpayer's request for an emissions value will be automatically denied.
                            </P>
                            <P>
                                (3) 
                                <E T="03">Process for filing a PER petition.</E>
                                 To file a PER petition with the Secretary, a taxpayer must submit a PER petition by attaching it to the taxpayer's Federal income tax return or Federal return, as appropriate, for the taxable year in which the taxpayer claims the section 48E credit with respect to the facility to which the PER petition relates. The PER petition must contain an emissions value and, if applicable, the associated letter from DOE. An emissions value may be obtained from DOE or by using the designated LCA model in accordance with paragraph (h)(6) of this section. An emission value obtained from DOE will be based on an analytical assessment of the emissions rate associated with the facility performed by one or more of the National Laboratories, in consultation with other Federal agency experts as appropriate, consistent with this section. A taxpayer must retain in its books and records the application and correspondence to and from DOE including a copy of the taxpayer's request to DOE for an emissions value and any information provided by the taxpayer to DOE pursuant to the emissions value request process provided in paragraph (h)(5) of this section. Alternatively, an emissions value can be determined by the taxpayer for a facility using the most the recent version of an LCA model, as of the time the PER petition is filed, that has been designated by the Secretary for such use under paragraph (h)(6) of this section. If an emissions value is determined using the designated LCA model under paragraph (h)(6) of this section, a taxpayer is required to provide to the IRS information to support its determination in the form and manner prescribed in IRS forms or instructions or in publications or guidance published in the Internal Revenue Bulletin. 
                                <E T="03">See</E>
                                 § 601.601 of this chapter. A taxpayer may not request an emissions value from DOE for a facility for which an emissions value can be determined using the most recent version of an LCA model or models designated for such use under paragraph (h)(6) of this section.
                            </P>
                            <P>
                                (4) 
                                <E T="03">PER determination.</E>
                                 Upon the IRS's acceptance of the taxpayer's return to which a PER petition is attached, the emissions value of the facility specified on such petition is deemed accepted. A taxpayer can rely upon an emissions value provided by DOE for purposes of claiming a section 48E credit, provided that any information, representations, or other data provided to DOE in support of the request for an emissions value are accurate. If applicable, a taxpayer may rely upon an emissions value determined for a facility using the LCA model designated under paragraph (h)(6) of this section, provided that any information, representations, or other data used to obtain such emissions value are accurate. The IRS's deemed acceptance of an emissions value is the Secretary's determination of the PER. However, the taxpayer must also comply with all applicable requirements for the section 48E credit and any information, representations, or other data supporting an emissions value are subject to later examination by the IRS.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Emissions value request process.</E>
                                 An applicant that submits a request for an emissions value must follow the procedures specified by DOE to request and obtain such emissions value. 
                                <PRTPAGE P="4126"/>
                                Emissions values will be determined consistent with the rules provided in this section. An applicant can request an emissions value from DOE only after a front-end engineering and design (FEED) study or similar indication of project maturity, as determined by DOE, such as the completion of a project specification and cost estimation sufficient to inform a final investment decision for the facility. DOE may decline to review applications that are not responsive, including those applications that relate to a facility described in the Annual Table (consistent with paragraph (h)(2) of this section) or a facility for which an emissions value can be determined by an LCA model under paragraph (h)(6) of this section (consistent with paragraph (h)(3) of this section), or applications that are incomplete. Applicants must follow DOE's guidance and procedures for requesting and obtaining an emissions value from DOE. DOE will publish this guidance and procedures, including a process for, under limited circumstances, a revision to DOE's initial assessment of an emissions value on the basis of revised technical information or facility design and operation.
                            </P>
                            <P>
                                (6) 
                                <E T="03">LCA model for determining an emissions value for C&amp;G Facilities.</E>
                                 The rules provided in § 1.45Y-5(h)(6) regarding the designation of an LCA model or models for determining an emissions value for C&amp;G Facilities apply for purposes of section 48E and this section.
                            </P>
                            <P>
                                (7) 
                                <E T="03">Effect of PER.</E>
                                 A taxpayer who files for a PER must use a PER determined by the Secretary to determine eligibility for the section 48E credit, provided all other requirements of section 48E are met. The Secretary's PER determination is not an examination or inspection of books of account for purposes of section 7605(b) of the Code and does not preclude or impede the IRS (under section 7605(b) or any administrative provisions adopted by the IRS) from later examining a return or inspecting books or records with respect to any taxable year for which the section 48E credit is claimed. Further, a PER determination does not signify that the IRS has determined that the requirements of section 48E have been satisfied for any taxable year.
                            </P>
                            <P>
                                (i) 
                                <E T="03">Determining anticipated greenhouse gas emissions rate</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 A facility's anticipated greenhouse gas emissions rate must be objectively determined based on an examination of all the facts and circumstances. Certain Non-C&amp;G Facilities, such as the facilities described in § 1.45Y-5(c)(2), may have an anticipated greenhouse gas emissions rate that is not greater than zero based on the technology and practices they rely upon to generate electricity. For facilities that require the use of certain fuel sources, which may vary, or carbon capture and sequestration, to generate electricity with a greenhouse gas emissions rate that is not greater than zero, objective indicia that such facilities will use such fuel sources or operate such carbon capture equipment, as applicable, in a manner that results in a greenhouse gas emissions rate that is not greater than zero for at least 10 years beginning from the date the facility is placed in service are required to establish a reasonable expectation that the combination of fuel, type of facility, and practice will result in a greenhouse gas emissions rate that is not greater than zero. Taxpayers must attest under penalty of perjury that the anticipated greenhouse gas emissions rate as determined under the statute and these final regulations is not greater than zero. A facility subject to legally binding Federal or State permit conditions requiring that the facility operate in a manner that would be incompatible with a greenhouse gas emissions rate of not greater than zero is not a facility for which the anticipated greenhouse gas emissions rate is not greater than zero.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Examples of objective indicia.</E>
                                 Examples of objective indicia that may establish an anticipated greenhouse gas emissions rate that is not greater than zero for specific elements of the type of facility, fuel source, or practice include, but are not limited to:
                            </P>
                            <P>(i) Co-location of the facility with a fuel source (for example, an anaerobic digester) for which the combination of fuel, type of facility, and practice is reasonably expected to result in a greenhouse gas emissions rate that is not greater than zero;</P>
                            <P>(ii) A 10-year binding written contract to purchase fuels for which the combination of fuel, type of facility, and practice is reasonably expected to result in a greenhouse gas emissions rate that is not greater than zero;</P>
                            <P>(iii) A facility type that only accommodates one type of fuel or a small range of fuels for which the combination of fuel, type of facility, and practice is reasonably expected to result in a greenhouse gas emissions rate that is not greater than zero;</P>
                            <P>(iv) A 10-year binding written contract for the permanent geological storage (including after injection into an enhanced oil and gas recovery (EOR) project) or utilization of qualified carbon dioxide from the facility for which the combination of fuel, type of facility, and capture and practice is reasonably expected to result in a greenhouse gas emissions rate that is not greater than zero; or</P>
                            <P>(v) A legally binding Federal or State air permit which requires, as a condition of the permit, that the facility operates in a manner for which the combination of fuel, type of facility, and practice is reasonably expected to result in a greenhouse gas emissions rate that is not greater than zero and that any captured carbon dioxide is permanently geologically stored and subjects the holder to civil or criminal penalties in the event the relevant permit requirements are breached.</P>
                            <P>
                                (j) 
                                <E T="03">Reliance on Annual Table or provisional emissions rate.</E>
                                 Taxpayers may rely on the Annual Table in effect as of the date a facility began construction or the provisional emissions rate determined by the Secretary for the taxpayer's facility under paragraph (h)(4) of this section to determine the facility's greenhouse gas emissions rate, provided that the facility continues to operate as a type of facility that is described in the Annual Table or the facility's emissions value request, as applicable, for the entire taxable year.
                            </P>
                            <P>
                                (k) 
                                <E T="03">Substantiation</E>
                                —(1) 
                                <E T="03">In general.</E>
                                 A taxpayer must maintain in its books and records documentation regarding the design and operation of a facility that establishes that such facility had an anticipated greenhouse gas emissions rate that is not greater than zero in the year in which the section 48E credit is determined and operated with a greenhouse gas emissions rate that is not greater than 10 grams of CO
                                <E T="52">2</E>
                                e per kWh during each year of the recapture period that applies for purposes of section 48E(g).
                            </P>
                            <P>
                                (2) 
                                <E T="03">Sufficient substantiation.</E>
                                 Documentation sufficient to substantiate that a facility had a greenhouse gas emissions rate, as determined under this section, not greater than 10 grams of CO
                                <E T="52">2</E>
                                e per kWh during each year of the recapture period that applies for purposes of section 48E(g) includes documentation or a report prepared by an unrelated party that verifies the facility's actual emissions rate. A facility described in § 1.45Y-5(c)(2) can maintain sufficient documentation to demonstrate a greenhouse gas emissions rate that is not greater than 10 grams of CO
                                <E T="52">2</E>
                                e per kWh during each year of the recapture period that applies for purposes of section 48E(g) by showing that it is the type of facility described in § 1.45Y-5(c)(2). The Secretary may determine that other types of facilities can sufficiently substantiate a greenhouse gas emissions rate, as determined under this section, that is 
                                <PRTPAGE P="4127"/>
                                not greater than 10 grams of CO
                                <E T="52">2</E>
                                e per kWh during each year of the recapture period that applies for purposes of section 48E(g) with certain documentation and will describe such facilities and documentation in IRS forms or instructions or in publications or guidance published in the Internal Revenue Bulletin. 
                                <E T="03">See</E>
                                 § 601.601 of this chapter. For such other types of facilities that utilize biomass feedstocks, the taxpayer must substantiate that the source of such fuels or feedstocks used are consistent with the taxpayer's claims. For all facilities that utilize unmarketable feedstocks that are indistinguishable from marketable feedstocks (for instance, after processing), the taxpayer will be required to maintain documentation substantiating the origin and original form of the feedstock.
                            </P>
                            <P>
                                (l) 
                                <E T="03">Applicability date.</E>
                                 This section applies to qualified facilities placed in service after December 31, 2024, and during a taxable year ending on or after January 15, 2025.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <SIG>
                        <NAME>Douglas W. O'Donnell,</NAME>
                        <TITLE>Deputy Commissioner.</TITLE>
                        <DATED>Approved: December 31, 2024.</DATED>
                        <NAME>Aviva R. Aron-Dine,</NAME>
                        <TITLE>Deputy Assistant Secretary of the Treasury (Tax Policy).</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2025-00196 Filed 1-7-25; 4:15 pm]</FRDOC>
                <BILCOD>BILLING CODE 4830-01-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4129"/>
            <PARTNO>Part III</PARTNO>
            <AGENCY TYPE="P"> Department of Transportation</AGENCY>
            <SUBAGY> National Highway Traffic Safety Administration</SUBAGY>
            <HRULE/>
            <CFR>49 CFR Parts 595 and 597</CFR>
            <TITLE>ADS-Equipped Vehicle Safety, Transparency, and Evaluation Program; Proposed Rule</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="4130"/>
                    <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                    <SUBAGY>National Highway Traffic Safety Administration</SUBAGY>
                    <CFR>49 CFR Parts 595 and 597</CFR>
                    <DEPDOC>[Docket No. NHTSA-2024-0100]</DEPDOC>
                    <RIN>RIN 2127-AM60</RIN>
                    <SUBJECT>ADS-Equipped Vehicle Safety, Transparency, and Evaluation Program</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Notice of proposed rulemaking.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This document proposes a voluntary framework for the evaluation and oversight of motor vehicles equipped with automated driving systems (ADS). The ADS-equipped Vehicle Safety, Transparency, and Evaluation Program (AV STEP) would establish a national program for ADS-equipped vehicles that operate or may operate on public roads in the United States under NHTSA's oversight with the goal of improving public transparency related to the safety of certain ADS-equipped vehicles, while allowing for responsible development of this technology. This proposal includes procedures for application, participation, public reporting, and program administration. It identifies content requirements for applications, including independent assessments of ADS safety processes, such as the safety cases used and conformance to industry standards. These application requirements will inform NHTSA's decisions on terms and conditions for participation. The proposal also contains reporting requirements for participants, including periodic and event-triggered reporting.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>
                            Comments are requested on or before March 17, 2025. In compliance with the Paperwork Reduction Act, NHTSA is also seeking comment on a new information collection. For additional information, see subsection D (Paperwork Reduction Act) under Section IX (Regulatory Notices and Analyses). All comments relating to the information collection requirements should be submitted to NHTSA and to the Office of Management and Budget (OMB) at the address listed in the 
                            <E T="02">ADDRESSES</E>
                             section on or before March 17, 2025.
                        </P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>You may submit comments to the docket number identified in the heading of this document by any of the following methods:</P>
                        <P>
                            • 
                            <E T="03">Federal eRulemaking Portal:</E>
                             Go to 
                            <E T="03">www.regulations.gov</E>
                             and follow the instructions for submitting comments.
                        </P>
                        <P>
                            • 
                            <E T="03">Mail:</E>
                             Docket Management Facility, M-30, U.S. Department of Transportation, West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                        </P>
                        <P>
                            • 
                            <E T="03">Hand Delivery or Courier:</E>
                             U.S. Department of Transportation, West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m. Eastern time, Monday through Friday, except Federal holidays.
                        </P>
                        <P>
                            • 
                            <E T="03">Fax:</E>
                             (202) 493-2251.
                        </P>
                        <P>
                            <E T="03">Instructions:</E>
                             All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted without change to 
                            <E T="03">www.regulations.gov,</E>
                             including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the “Public Participation” heading of the 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             section of this document. Comments on the proposed information collection requirements should be submitted to OMB at 
                            <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                             To find this particular information collection, select “Currently under Review—Open for Public Comment” or use the search function. It is requested that comments sent to OMB also be sent to the NHTSA rulemaking docket identified in the heading of this document.
                        </P>
                        <P>
                            <E T="03">Docket:</E>
                             For access to the dockets or to read background documents or comments received, please visit 
                            <E T="03">www.regulations.gov,</E>
                             and/or Docket Management Facility, M-30, U.S. Department of Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590. The Docket Management Facility is open between 9 a.m. and 4 p.m. Eastern time, Monday through Friday, except Federal holidays.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            For non-legal issues: Katherine L. Chasins, Rulemaking Office of Automation Safety by email: 
                            <E T="03">katherine.chasins@dot.gov,</E>
                             or phone: (202) 366-7396. For legal issues: Hunter B. Oliver, Office of the Chief Counsel by email: 
                            <E T="03">hunter.oliver@dot.gov,</E>
                             phone: (202) 366-8875. The mailing address for these officials is: National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590.
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Executive Summary</FP>
                        <FP SOURCE="FP-2">II. Program Context</FP>
                        <FP SOURCE="FP1-2">A. How the Current ADS Technology Landscape Shaped This NPRM</FP>
                        <FP SOURCE="FP1-2">B. How NHTSA's Authorities Shaped This NPRM</FP>
                        <FP SOURCE="FP1-2">1. NHTSA's Mission and ADS Activity</FP>
                        <FP SOURCE="FP1-2">2. NHTSA Exemptions</FP>
                        <FP SOURCE="FP-2">III. Program Structure (Regulatory Text Subpart A)</FP>
                        <FP SOURCE="FP1-2">A. Program Eligibility</FP>
                        <FP SOURCE="FP1-2">B. Program Steps</FP>
                        <FP SOURCE="FP1-2">C. Terms and Conditions</FP>
                        <FP SOURCE="FP-2">IV. Application and Review (Regulatory Text Subparts B and D)</FP>
                        <FP SOURCE="FP1-2">A. Application Form</FP>
                        <FP SOURCE="FP1-2">1. Operational Baseline</FP>
                        <FP SOURCE="FP1-2">2. Location Sheet</FP>
                        <FP SOURCE="FP1-2">3. Confirmation of Reporting During Participation</FP>
                        <FP SOURCE="FP1-2">B. Protocols for ADS Operations</FP>
                        <FP SOURCE="FP1-2">1. Law Abidance</FP>
                        <FP SOURCE="FP1-2">2. System Fallback Response</FP>
                        <FP SOURCE="FP1-2">3. User and Surrounding Road User Interactions</FP>
                        <FP SOURCE="FP1-2">C. Data Governance Plan</FP>
                        <FP SOURCE="FP1-2">D. Independent Assessment</FP>
                        <FP SOURCE="FP1-2">1. Focus of Independent Assessment</FP>
                        <FP SOURCE="FP1-2">2. Summary Report Requirements</FP>
                        <FP SOURCE="FP1-2">3. Assessment Context Requirements</FP>
                        <FP SOURCE="FP1-2">4. Reliability and Credibility Disclosures</FP>
                        <FP SOURCE="FP1-2">E. Application Review</FP>
                        <FP SOURCE="FP-2">V. Participation (Regulatory Text Subparts E and F)</FP>
                        <FP SOURCE="FP1-2">A. Reporting Requirements</FP>
                        <FP SOURCE="FP1-2">1. Periodic Reporting</FP>
                        <FP SOURCE="FP1-2">2. Event-Triggered Reporting</FP>
                        <FP SOURCE="FP1-2">3. Update Reporting</FP>
                        <FP SOURCE="FP1-2">B. Agency Protocols</FP>
                        <FP SOURCE="FP1-2">1. Amendment Process</FP>
                        <FP SOURCE="FP1-2">2. Concern Resolution Process</FP>
                        <FP SOURCE="FP-2">VI. Public Reporting Requirements (Regulatory Text Subpart G)</FP>
                        <FP SOURCE="FP-2">VII. Requirements for AV STEP Exemptions (Regulatory Text Subpart C)</FP>
                        <FP SOURCE="FP1-2">A. Exemption Eligibility Requirements</FP>
                        <FP SOURCE="FP1-2">B. Exemption Application Requirements</FP>
                        <FP SOURCE="FP1-2">C. Exemption Participation Requirements</FP>
                        <FP SOURCE="FP1-2">D. Exemption Public Reporting</FP>
                        <FP SOURCE="FP-2">VIII. Public Comments</FP>
                        <FP SOURCE="FP-2">IX. Regulatory Notices and Analyses</FP>
                        <FP SOURCE="FP1-2">A. Executive Orders 12866, 13563, 14094 and DOT Regulatory Policies and Procedures</FP>
                        <FP SOURCE="FP1-2">1. Need for Regulation</FP>
                        <FP SOURCE="FP1-2">2. Uncertainties and Assumptions</FP>
                        <FP SOURCE="FP1-2">3. Costs</FP>
                        <FP SOURCE="FP1-2">4. Benefits</FP>
                        <FP SOURCE="FP1-2">5. Regulatory Approaches Considered</FP>
                        <FP SOURCE="FP1-2">B. National Environmental Policy Act</FP>
                        <FP SOURCE="FP1-2">C. Regulatory Flexibility Act</FP>
                        <FP SOURCE="FP1-2">D. Paperwork Reduction Act</FP>
                        <FP SOURCE="FP1-2">E. Executive Order 13132 (Federalism)</FP>
                        <FP SOURCE="FP1-2">F. Executive Order 12988 (Civil Justice Reform)</FP>
                        <FP SOURCE="FP1-2">G. Executive Order 13609: Promoting International Regulatory Cooperation</FP>
                        <FP SOURCE="FP1-2">H. National Technology Transfer and Advancement Act</FP>
                        <FP SOURCE="FP1-2">I. Privacy Act</FP>
                        <FP SOURCE="FP1-2">J. Unfunded Mandates Reform Act of 1995</FP>
                        <FP SOURCE="FP1-2">K. Regulation Identifier Number</FP>
                        <FP SOURCE="FP1-2">L. Plain Language</FP>
                        <FP SOURCE="FP1-2">M. Rule Summary</FP>
                    </EXTRACT>
                    <PRTPAGE P="4131"/>
                    <HD SOURCE="HD1">I. Executive Summary</HD>
                    <P>
                        Automated driving systems (ADS) 
                        <SU>1</SU>
                        <FTREF/>
                         are evolving rapidly, posing challenges to vehicle manufacturers and the agency alike regarding the safety of the traveling public. It is important that ADS technology be deployed in a manner that protects the public from unreasonable safety risk while at the same time allowing for responsible development of this technology, which has the potential to advance safety. Under NHTSA's existing regulatory framework, which implements the National Traffic and Motor Vehicle Safety Act (Safety Act),
                        <SU>2</SU>
                        <FTREF/>
                         motor vehicle manufacturers may already deploy ADS-equipped vehicles on public roads, as long as they comply with existing Federal Motor Vehicle Safety Standards (FMVSS) and state and local laws.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Automated driving systems are systems developed (or being developed) to fully perform the driving task without any expectation of an attentive human driver. ADS-equipped vehicles are sometimes referred to as self-driving cars or autonomous vehicles. In contrast, driver support features (sometimes referred to as Advanced Driver Assistance Systems or ADAS), such as highway or parking assist features, must be continuously supervised by a human driver.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             49 U.S.C. Ch. 301.
                        </P>
                    </FTNT>
                    <P>
                        Many ADS operations take this approach, and the FMVSS do not currently set performance standards specifically for ADS. Vehicles that are compliant with all applicable FMVSS can generally be equipped with ADS technology without NHTSA approval. Alternatively, if an ADS-equipped vehicle does not comply with all applicable FMVSS, exemptions may be requested from NHTSA. Past exemption requests involving ADS have typically involved purpose-built vehicles (those designed specifically for ADS operations).
                        <SU>3</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             See 85 FR 7826, 7842 (February 11, 2020) (granting an exemption “to the requirements that an LSV be equipped with exterior and/or interior mirrors; have a windshield that complies with FMVSS No. 205, `Glazing materials'; and a backup camera system that meets the requirement in FMVSS No. 111, `Rear visibility,' limiting the length of time that a rearview image can remain displayed by the system after a vehicle's transmission has been shifted out of reverse gear.”) NHTSA also publishes notices of receipt of exemption requests under 49 CFR part 555, which provide examples of other standards for which exemptions have been requested for ADS-equipped vehicles. 
                            <E T="03">See</E>
                             89 FR 88856 (November 8, 2024); 87 FR 43602, 43607 (July 21, 2022); 87 FR 43595 (July 21, 2022).
                        </P>
                    </FTNT>
                    <P>To account for this current ADS landscape, this document proposes a national program, entitled the ADS-equipped Vehicle Safety, Transparency, and Evaluation Program (AV STEP), designed to complement and further NHTSA's ADS oversight, rulemaking, research, and transparency efforts as well as to support new proposed processes for exemptions involving ADS-equipped vehicles. This voluntary program would provide NHTSA with a framework for reviewing and overseeing ADS-equipped vehicles at a time when ADS technology continues to rapidly evolve.</P>
                    <P>In the future, as ADS technologies mature, NHTSA anticipates there may be a need to establish minimum standards for ADS safety performance, much as NHTSA's existing FMVSS govern the performance of conventional vehicle systems and attributes. However, the data, methods, and metrics to support such standards do not yet exist. Many of the elements included in this Notice of Proposed Rulemaking (NPRM) are intended to help NHTSA obtain insight and data that could, in turn, support the future development of such standards. Pending such future developments, AV STEP would serve as a national program built for the evolving state of the technology, offering an interim boost to regulatory oversight and a process for motor vehicle manufacturers and other participants to build public trust by demonstrating a commitment to responsible safety practices, accountability, and transparency.</P>
                    <P>As a voluntary program, AV STEP would be available to vehicle manufacturers, ADS developers, fleet operators, and system integrators of ADS-equipped vehicles seeking to operate on public roadways in the United States. NHTSA proposes AV STEP for two categories of ADS-equipped vehicles: ADS-equipped vehicles in need of exemptions and ADS-equipped vehicles that can lawfully operate on public roads today. For vehicles needing an exemption, AV STEP would offer an exemption pathway that is tailored for ADS-equipped vehicles (see Section VII (Requirements for AV STEP Exemptions (Regulatory Text Subpart C)) for additional details on the proposed exemption process). For all entities seeking participation in AV STEP (whether needing an exemption or not), the program would offer participants an opportunity to demonstrate their operational safety and their commitment to transparency for their vehicles and operations by engaging in a national program with well-defined participation and reporting criteria focused on advancing safety.</P>
                    <P>Under the proposed program, an applicant would provide NHTSA with information and data related to the safety of the design, development, and operations of ADS-equipped vehicles for their intended deployment under the program. NHTSA would review this information, engage with the applicant as needed to clarify or ask for additional information, and establish terms and conditions for participating in the program. Once admitted into AV STEP, a participant would be required to submit both periodic and event-triggered reports to NHTSA. To improve public transparency, the agency also proposes to publish much of the application and reporting information that NHTSA would receive.</P>
                    <P>Acceptance into the program would be based on the sufficiency of information supplied and after coordination with an applicant about terms and conditions for participation. Acceptance into the program would reflect a determination by NHTSA that the applicant has provided evidence showing it followed well-documented engineering processes and has the needed technical, operational, and management resources in place to mitigate safety concerns. Acceptance into the program would not be an assurance of safety, a validation of the ADS technology, or a guarantee that the applicant will execute its operational oversight functions as described. NHTSA would continue to exercise its existing defect and investigation authorities as ADS-equipped vehicles are deployed on public roadways.</P>
                    <P>
                        As proposed, the program would be structured around two levels of participation: Step 1 and Step 2. Generally, Step 1 would apply to vehicles that rely on fallback personnel 
                        <SU>4</SU>
                        <FTREF/>
                         and Step 2 would apply to vehicles that do not rely on fallback personnel. The proposed participation requirements differ between these steps, as the approach to managing risk is significantly different in these two cases. In ADS operations that rely on fallback personnel, a human is expected to intervene to compensate for any deficiency in the ADS, whereas in operations that do not rely on fallback personnel, the ADS must be able to safely respond to all driving scenarios without such intervention.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             As used within this proposal, fallback personnel are specially trained individuals that continuously supervise the performance of prototype ADS-operated vehicles and intervene whenever necessary to prevent a hazardous event by exercising any means of vehicle control. The full definition of “fallback personnel” appears in § 597.102 of the proposed rule.
                        </P>
                    </FTNT>
                    <P>
                        AV STEP would enhance public transparency and Federal oversight of ADS technologies to better understand and address emerging risks associated with their deployment. The agency proposes to examine applications for AV STEP in part through the use of an applicant's safety case, which would 
                        <PRTPAGE P="4132"/>
                        need to contain structured arguments, supported by evidence, intended to justify that a system is acceptably safe for a given use in a specified environment. The safety case concept is commonly used in safety-critical products and industries such as aviation, energy (including nuclear), medical devices, and other technology sectors. An application for AV STEP would require an assessment of an applicant's safety case by an independent entity with specialized experience and expertise. This independent assessment would consider the holistic safety of ADS-equipped vehicles, spanning technical, organizational, and operational challenges relevant to safety decision-making. While currently available testing and evaluation methods cannot conclusively determine an ADS' safety, this approach would facilitate NHTSA's review of the engineering rigor and due diligence applied to a system's development and operation. It would also provide a proactive opportunity to identify and resolve any safety concerns.
                    </P>
                    <P>It is the agency's expectation that, by promoting a safer, more transparent, and more responsible environment for developing and deploying ADS in the United States, AV STEP will help foster the technological innovation and public confidence needed to advance ADS and the potentially significant safety benefits of the technology.</P>
                    <HD SOURCE="HD1">II. Program Context</HD>
                    <P>AV STEP would build on NHTSA's other ADS transparency, oversight, and research activities. The first subsection below describes how the program would fit into the current ADS technology landscape. The second subsection describes the legal authorities for the AV STEP proposal and the agency's other ADS activity taken pursuant to these authorities.</P>
                    <HD SOURCE="HD2">A. How the Current ADS Technology Landscape Shaped This NPRM</HD>
                    <P>
                        Vehicle automation technologies, which include both ADS and advanced driver assistance systems (ADAS), have significantly transformed the automotive landscape over the last decade. Currently, the automation systems available to the public in consumer-owned vehicles are almost all driver support or convenience ADAS features, such as partial driving automation systems.
                        <SU>5</SU>
                        <FTREF/>
                         For these features, the human driver remains responsible for supervising the system and must stay engaged and attentive.
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             Partial driving automation systems are described by SAE International (SAE) as executing “both the lateral and longitudinal vehicle motion control subtasks of the [dynamic driving task] with the expectation that the driver . . . supervises the driving automation system.” SAE International, “J3016 APR2021: Taxonomy and Definitions for Terms Related to Driving Automation Systems for On-Road Motor Vehicles,” (Revised April 2021).
                        </P>
                    </FTNT>
                    <P>
                        In contrast, an ADS is responsible for performing the entire dynamic driving task (DDT) 
                        <SU>6</SU>
                        <FTREF/>
                         while operating within the system's operational design domain (ODD),
                        <SU>7</SU>
                        <FTREF/>
                         without any expectation that a human driver will be attentive. However, a human may still be expected to take over the driving task when the ADS exits its ODD or, during an ADS' development, to perform a safety oversight role, such as preventing the ADS from handling a situation incorrectly.
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             This NPRM defines DDT in part as “all of the real-time operational and tactical functions required to operate a vehicle in on-road traffic, excluding the strategic functions such as trip scheduling and selection of destinations and waypoints . . .” 
                            <E T="03">See</E>
                             § 597.102 of the proposed rule. This definition is largely derived from SAE International's definition. 
                            <E T="03">See</E>
                             SAE International, “J3016 APR2021: Taxonomy and Definitions for Terms Related to Driving Automation Systems for On-Road Motor Vehicles,” (Revised April 2021).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             This NPRM defines ODD as “the operating conditions under which the Automated Driving System or feature thereof is specifically designed to function, including, but not limited to, environmental, geographical, and time-of-day restrictions, and/or the requisite presence or absence of defined traffic or roadway characteristics.” This definition is largely derived from SAE International's definition. 
                            <E T="03">See id.</E>
                        </P>
                    </FTNT>
                    <P>
                        NHTSA proposes to limit AV STEP eligibility to ADS-equipped vehicles. This scope allows focus on the unique complexities of ADS while most ADS operations are within the control of the companies responsible for their testing. Currently, very few ADS-equipped vehicles are available for purchase by the general public.
                        <SU>8</SU>
                        <FTREF/>
                         Instead, almost all such vehicles are owned and operated by vehicle manufacturers, ADS developers, or fleet operators. Most of these vehicles remain in the testing and development stage. If they operate on public roads at all, they do so only in limited environments. Limited numbers of ADS-equipped vehicles are engaged in commercial applications, such as goods delivery platforms or mobility on demand operations.
                        <SU>9</SU>
                        <FTREF/>
                         However, even those commercial applications remain largely under development and operate in limited environments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             
                            <E T="03">See, e.g.,</E>
                             California Department of Motor Vehicle's announcement regarding its acceptance of Mercedes' DRIVE PILOT System, available at 
                            <E T="03">https://www.dmv.ca.gov/portal/news-and-media/california-dmv-approves-mercedes-benz-automated-driving-system-for-certain-highways-and-conditions.</E>
                             The announcement states: “The Level 3 Mercedes-Benz DRIVE PILOT system can only operate on highways during daylight at speeds not exceeding 40 miles per hour. This permit excludes operation on city or county streets, in construction zones, during heavy rain or heavy fog, on flooded roads and during weather conditions that are determined to impact performance of DRIVE PILOT.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             Mobility on demand is used to refer to vehicles that are often colloquially referred to as robotaxis, or, as discussed in SAE J3016, “robotic taxis.” 
                            <E T="03">See</E>
                             SAE International, “J3016 APR2021: Taxonomy and Definitions for Terms Related to Driving Automation Systems for On-Road Motor Vehicles,” (Revised April 2021).
                        </P>
                    </FTNT>
                    <P>
                        This proposal recognizes that the potential of ADS is still largely unproven. ADS technologies have the potential to improve safety, advance sustainability, provide accessible transportation for people with disabilities, increase mobility options for underserved communities, and enhance American competitiveness. However, positive outcomes are not inevitable.
                        <SU>10</SU>
                        <FTREF/>
                         The impact ADS may have in these areas and others, such as on the workforce and on the environment, will ultimately be the result of future engineering, deployment, policy, and other choices.
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             ADS are defined by their functionality rather than safety: “the hardware and software that are collectively capable of performing the entire [dynamic driving task] DDT on a sustained basis, regardless of whether it [the system] is limited to a specific operational design domain (ODD).” SAE International, “J3016 APR2021: Taxonomy and Definitions for Terms Related to Driving Automation Systems for On-Road Motor Vehicles,” (Revised April 2021).
                        </P>
                    </FTNT>
                    <P>The capabilities and expectations of ADS are likely to evolve significantly in the coming years. Currently, ADS can handle narrowly defined environments, but often struggle with driving tasks that humans consider relatively simple. Routine occurrences, such as adverse weather, overgrown foliage, or road construction, can exceed the capabilities of even the most advanced versions of existing ADS. To reach broader deployment, the roadway scenarios and ODDs that ADS can reliably navigate will have to substantially expand.</P>
                    <P>
                        The tools used to develop and evaluate ADS will also need to mature. Currently, many different approaches exist within the automotive industry for designing, testing, and overseeing ADS operation. Industry standards, guidance documents, and best practices for ADS have been proposed and published but remain, collectively, in an early stage of establishment and implementation. Published standards are frequently updated to reflect the evolving state of the art, and while generalized performance metrics are sometimes included in these standards, they do not define specific measurement and analysis methods or acceptable value ranges. Given their new and evolving state, little evidence exists to prove that existing methods of evaluating ADS 
                        <PRTPAGE P="4133"/>
                        technology are capable of ensuring safety. Instead, these industry approaches often aim to provide safety guidance, such as by recommending minimal content for safety decision-making frameworks or by detailing high-level vehicle behavior expectations.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             This issue has been referred to as a long-tail problem. 
                            <E T="03">See, e.g.,</E>
                             Phillip Koopman, “How Safe is Safe Enough: Measuring and Predicting Autonomous Vehicle Safety” (2022).
                        </P>
                    </FTNT>
                    <P>Given this uncertain landscape, too little transparency exists about ADS operations on public roads in the United States. There is sparse public information about basic facts, such as the number of ADS-equipped vehicles operating on public roads, the areas where those vehicles are operating, and attributes or limitations of the ADS that may affect other road users who interact with those vehicles. Publicly available information is often filtered through the companies that are proponents of their own technologies. Greater availability of objective information about ADS capabilities, operations, and outcomes would promote safety and more responsible growth of ADS technology.</P>
                    <P>AV STEP's proposed application, review, oversight, and reporting would create a holistic framework for evaluating and overseeing an ADS-equipped vehicle. To account for the current limits of performance-based ADS safety evaluations, the proposed evaluations would focus on the robustness of safety decision-making during all stages of an ADS operation—from development of the ADS to system operations on public roads. Reporting during participation would include data elements that are designed to oversee how this safety decision-making affects real-world safety performance. Collectively, these approaches would consider how comprehensively a company has identified the limits of its system, has accounted for risks likely to arise during operation, and is prepared to respond responsibly to problems encountered.</P>
                    <P>The agency proposes to examine this safety decision-making through a review of an applicant's safety case. The independent assessment of a safety case included with an AV STEP application and subsequent NHTSA review would consider the holistic safety of ADS-equipped vehicle operations. While currently available methods cannot definitively conclude that an ADS is safe, this approach would facilitate review of the robustness of the safety practices employed during a system's development and operation. It would also provide a proactive opportunity to identify and resolve any safety concerns.</P>
                    <P>The requirements for participating in AV STEP must be flexible enough to evolve as ADS technology evolves. To that end, the proposed independent assessment would consider industry consensus standards and best practices that exist at the time of an assessment. Likewise, the proposed ongoing reporting requirements would facilitate NHTSA's continued oversight of vehicle operations, and the proposed procedures would allow for review and changes in operations during participation. In addition, NHTSA proposes to tailor many of the reporting requirements to the specific systems under review, to evaluate and account for the current diversity in approaches to ADS.</P>
                    <P>AV STEP is also designed to increase the amount of publicly available information about ADS operations in the United States. This proposal includes two program steps based on the competency of an ADS. NHTSA proposes to publish regularly on the agency's website a list of applicants and participants in the program, along with details regarding the scope and status of each operation. This publication would increase the public's awareness and understanding of ADS operations on public roads.</P>
                    <HD SOURCE="HD2">B. How NHTSA's Authorities Shaped This NPRM</HD>
                    <P>
                        NHTSA proposes AV STEP as a national program available for two categories of vehicles. The first category consists of vehicles that can lawfully operate on public roads regardless of participation in AV STEP, as long as they comply with all other Federal, state, and local laws. These vehicles include those that are compliant with and certified to all applicable FMVSS, those that have received exemptions under other NHTSA programs, and those that may operate on public roads under 49 U.S.C. 30112(b)(10).
                        <SU>12</SU>
                        <FTREF/>
                         The second category consists of vehicles that seek an exemption from NHTSA through AV STEP. Under this proposal, vehicles that do not comply with all applicable FMVSS or those that originally complied but are taken out of compliance by an ADS retrofit could seek exemptions through AV STEP. This section discusses how NHTSA's authorities and other ADS work support both of these categories of participation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             This provision is described further later in this section.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. NHTSA's Mission and ADS Activity</HD>
                    <P>
                        The establishment of a national program for ADS-equipped vehicles stems from NHTSA's authority under the Safety Act,
                        <SU>13</SU>
                        <FTREF/>
                         in addition to other statutory authorities. Under 49 U.S.C 322(a), “[t]he Secretary of Transportation may prescribe regulations to carry out the duties and powers of the Secretary.” The Safety Act and other statutes provide NHTSA, by delegation, with authority relating to oversight, rulemaking, research, transparency, and exemptions. 
                        <E T="03">See, e.g.,</E>
                         49 U.S.C. 30101(b) (noting need “to prescribe motor vehicle safety standards” and “carry out . . . safety research and development”); Section 30111 (authority to “prescribe motor vehicle safety standards”); Section 30112 (restricting the activities of vehicles that do not comply with applicable vehicle standards or that contain a defect); Section 30114 (authority to issue FMVSS exemptions for particular purposes); Section 30122 (authority to issue exemptions from the make inoperative prohibition); and Section 30182 (authority to “conduct motor vehicle safety research, develop, and testing programs and activities, including activities related to new and emerging technologies that impact or may impact motor vehicle safety”).
                        <SU>14</SU>
                        <FTREF/>
                         This authority forms the foundation for AV STEP. The remainder of this subsection explains how AV STEP carries out each of these authorities, as well as how AV STEP fits into NHTSA's broader regulatory activities pertaining to ADS technologies.
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             These duties are generally set forth in 49 U.S.C. chapter 301.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             
                            <E T="03">See also</E>
                             49 CFR 1.95 (delegating to the National Highway Traffic Safety Administrator “the authority vested in the Secretary under chapter[ ] 301 . . .”), 
                            <E T="03">and</E>
                             49 CFR 1.81 (“each Administrator is authorized to . . . (3) Exercise the authority vested in the Secretary to prescribe regulations under 49 U.S.C. 322(a) with respect to statutory provisions for which authority is delegated by other sections in this part”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(a) Oversight and Transparency</HD>
                    <P>
                        AV STEP would carry out NHTSA's authorities relating to oversight and transparency by increasing the amount of information available to NHTSA about ADS-equipped vehicles, including for those vehicles that are already operating on public roads. Under the regulatory framework established by the Safety Act, NHTSA's review and approval is not needed for most current ADS operations on public roads. The Safety Act generally requires vehicles to comply with (and be certified as complying with) all applicable FMVSS 
                        <PRTPAGE P="4134"/>
                        and to be free of safety defects.
                        <SU>15</SU>
                        <FTREF/>
                         Once a manufacturer self-certifies that a vehicle meets all applicable FMVSS, it may sell the vehicle or operate it on public roads without further action from NHTSA. A manufacturer may also equip the vehicle with additional technologies not subject to an FMVSS, as long as the technologies do not pose an unreasonable risk to safety or take the vehicle out of compliance with an applicable FMVSS.
                        <SU>16</SU>
                        <FTREF/>
                         The FMVSS do not currently set performance standards specifically for ADS, and compliant vehicles can generally be equipped with ADS technologies without NHTSA approval. Many ADS operations already occur on public roads in the United States.
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             
                            <E T="03">See, e.g.,</E>
                             49 U.S.C. 30112.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30118, 30122.
                        </P>
                    </FTNT>
                    <P>
                        In addition, the 2015 Fixing America's Surface Transportation (FAST) Act added a provision to Section 30112 permitting certain entities to test or evaluate noncompliant vehicles on public roads, as long as they do not sell those vehicles or offer them for sale once the testing or evaluation concludes.
                        <SU>17</SU>
                        <FTREF/>
                         Entities eligible to conduct these testing or evaluation operations are those that had manufactured and distributed certified vehicles in the United States (as well as satisfied other information requirements in NHTSA's regulations) by the date of the FAST Act's enactment, December 4, 2015. Some manufacturers have relied on this provision to test noncompliant ADS-equipped vehicles on public roads.
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30112(b)(10).
                        </P>
                    </FTNT>
                    <P>
                        Because most ADS operations do not need NHTSA's upfront approval, the agency's oversight of the ADS in those vehicles primarily occurs once they are operating. Specifically, NHTSA enforces the general duty of vehicle and equipment manufacturers to recall and remedy vehicles and equipment—including ADS or ADS-equipped vehicles—if they contain a defect that poses an unreasonable risk to motor vehicle safety. To exercise this oversight on ADS and ADS-equipped vehicles, NHTSA relies on access to information about ADS and their operations.
                        <SU>18</SU>
                        <FTREF/>
                         NHTSA uses this information to monitor for ADS defects.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30166.
                        </P>
                    </FTNT>
                    <P>
                        To ensure that NHTSA has access to the information necessary to exercise its oversight authority, the Safety Act expressly includes information-gathering authorities.
                        <SU>19</SU>
                        <FTREF/>
                         NHTSA's traditional information-gathering tools apply to ADS in much the same way as any other item of motor vehicle equipment.
                        <SU>20</SU>
                        <FTREF/>
                         In recent years, NHTSA has overseen recalls for ADS 
                        <SU>21</SU>
                        <FTREF/>
                         and undertaken defects and compliance investigations into ADS.
                        <SU>22</SU>
                        <FTREF/>
                         NHTSA has also imposed standing reporting requirements for ADS crashes through a Standing General Order (SGO),
                        <SU>23</SU>
                        <FTREF/>
                         which requires identified manufacturers and operators to report certain crashes involving vehicles equipped with ADS to the agency. SGO reporting has led to hundreds of crash reports involving ADS operations, with many of those prompting NHTSA follow-up review. AV STEP would supplement SGO information through additional reporting requirements for participation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             
                            <E T="03">See id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             
                            <E T="03">See</E>
                             81 FR 65705, 65707 (September 23, 2016) (explaining that ADS is motor vehicle equipment).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             
                            <E T="03">See</E>
                             Pony.ai, “Part 573 Safety Recall Report, No. 22E-016,” (March 3, 2022), available at 
                            <E T="03">https://static.nhtsa.gov/odi/rcl/2022/RCLRPT-22E016-6814.PDF;</E>
                             Cruise, LLC, “Part 573 Safety Recall Report, No. 22E-072,” (August 29, 2022), available at 
                            <E T="03">https://static.nhtsa.gov/odi/rcl/2022/RCLRPT-22E072-8020.PDF;</E>
                             Cruise, LLC, “Part 573 Safety Recall Report, No. 23E-029,” (April 3, 2023), available at 
                            <E T="03">https://static.nhtsa.gov/odi/rcl/2023/RCLRPT-23E029-4270.PDF.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             
                            <E T="03">See, e.g.,</E>
                             NHTSA, “ODI Resume: Preliminary Evaluation PE 22-014” (December 12, 2022); NHTSA, “ODI Resume: Recall Query RQ 22-001” (Recall 22E-016) (April 10, 2022); and NHTSA, “ODI Resume: Audit Query AQ 23-001” (March 3, 2023), available at 
                            <E T="03">https://static.nhtsa.gov/odi/inv/2023/INOA-AQ23001-2603.PDF.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             NHTSA, “In re: Second Amended Standing General Order 2021-01: Incident Reporting for Automated Driving Systems (ADS) and Level 2 Advanced Driver Assistance Systems (ADAS)” (April 5, 2023), available at 
                            <E T="03">https://www.nhtsa.gov/sites/nhtsa.gov/files/2023-04/Second-Amended-SGO-2021-01_2023-04-05_2.pdf.</E>
                        </P>
                    </FTNT>
                    <P>However, by their nature, crash reporting and follow-up investigations are principally reactive, as a problem has already caused a crash before any reporting occurs. AV STEP aims to complement these efforts by adding an earlier layer of agency oversight for participating ADS-equipped vehicles. AV STEP would help NHTSA proactively identify safety concerns by proposing upfront submission requirements on the design and capabilities of an ADS and ongoing performance reporting during operations.</P>
                    <P>
                        In addition, AV STEP also aims to increase the amount of information publicly available about ADS operations. In doing so, AV STEP would further NHTSA's longstanding goal to promote awareness of matters related to motor vehicle safety. NHTSA has a history of doing so through a variety of information programs, such as recall awareness,
                        <SU>24</SU>
                        <FTREF/>
                         motor vehicle labeling requirements,
                        <SU>25</SU>
                        <FTREF/>
                         and driver behavior education.
                        <SU>26</SU>
                        <FTREF/>
                         This charge to increase public awareness of motor vehicle safety extends to advanced vehicle technologies as well,
                        <SU>27</SU>
                        <FTREF/>
                         and NHTSA has undertaken initiatives to publicize information about vehicle automation, such as by publishing SGO crash reporting, developing an interactive online tool through the Automated Vehicle Transparency and Engagement for Safe Testing (AV TEST) Initiative,
                        <SU>28</SU>
                        <FTREF/>
                         and publishing Voluntary Safety Self-Assessments (VSSAs) submitted by entities engaged in ADS operations.
                        <SU>29</SU>
                        <FTREF/>
                         NHTSA has designed this NPRM to build on these efforts through proposals to publish information about AV STEP applications and participations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30118; 49 CFR part 577.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. chapter 323; 49 CFR part 575.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             
                            <E T="03">See generally</E>
                             NHTSA, “Research &amp; Evaluation: Behavioral Research,” available at 
                            <E T="03">https://www.nhtsa.gov/behavioral-research.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 32302(e) (directing NHTSA to develop “a means for providing to consumers information relating to advanced crash-avoidance technologies”). 
                            <E T="03">See also</E>
                             87 FR 13452 (March 9, 2022).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             AV TEST is an interactive tool that lets the public view voluntarily submitted information about automated vehicle operations. 
                            <E T="03">See</E>
                             NHTSA, “Automated Vehicle Transparency and Engagement for Safe Testing (AV TEST) Initiative,” available at 
                            <E T="03">https://www.nhtsa.gov/automated-vehicle-test-tracking-tool.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             NHTSA, “Automated Driving Systems: Voluntary Safety Self-Assessment,” available at 
                            <E T="03">https://www.nhtsa.gov/automated-driving-systems/voluntary-safety-self-assessment.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(b) Rulemaking and Research</HD>
                    <P>
                        AV STEP also proposes to implement NHTSA's research and rulemaking authorities under the Safety Act. Pursuant to 49 U.S.C. 30111, NHTSA (as delegated from the Secretary of Transportation) “shall prescribe motor vehicle safety standards.” The Safety Act requires these FMVSS to be “practicable, meet the need for motor vehicle safety, and be stated in objective terms.” 
                        <SU>30</SU>
                        <FTREF/>
                         When developing an FMVSS, the agency must, among other things, “consider relevant available motor vehicle safety information” and “consider whether a proposed standard is reasonable, practicable, and appropriate for the particular type of motor vehicle or motor vehicle equipment for which it is prescribed.” 
                        <SU>31</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             49 U.S.C. 30111(a).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             49 U.S.C. 30111(b).
                        </P>
                    </FTNT>
                    <P>
                        As a result, when developing an FMVSS, NHTSA builds on extensive research about the aspect of vehicle performance at issue, including the extent to which a standard would drive positive safety outcomes and present objective requirements for regulated entities. Accordingly, Congress established a policy directing the agency to “conduct research, development, and testing on any area or aspect of motor 
                        <PRTPAGE P="4135"/>
                        vehicle safety necessary to carry out [chapter 301]” of Title 49.
                        <SU>32</SU>
                        <FTREF/>
                         This charge extends to advanced vehicle technologies. In the Moving Ahead for Progress in the 21st Century Act,
                        <SU>33</SU>
                        <FTREF/>
                         Congress instructed the Secretary to “[c]onduct motor vehicle safety research, development, and testing programs and activities, including activities related to new and emerging technologies that impact or may impact motor vehicle safety” 
                        <SU>34</SU>
                        <FTREF/>
                         and to “[c]ollect and analyze all types of motor vehicle and highway safety data” relating to motor vehicle performance and crashes.
                        <SU>35</SU>
                        <FTREF/>
                         This authority to carry out research includes programs that entail engagement and collaboration with third parties.
                        <SU>36</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30181. This chapter includes NHTSA's core authorities for prescribing motor vehicle safety standards (Section 30111), adjudicating general and special exemptions to those standards (Sections 30113 and 30114), evaluating the existence of unreasonable risks to motor vehicle safety (Section 30116 
                            <E T="03">et seq.</E>
                            ), overseeing the importation of motor vehicles (Section 30141 
                            <E T="03">et seq.</E>
                            ), and securing enforcement of these authorities (Section 30161 
                            <E T="03">et seq.</E>
                            ). §
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             
                            <E T="03">See</E>
                             Public Law 112-141 (2012).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30182(a). Subsection 30182(b) specifies activities NHTSA may undertake in carrying out subsection (a).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             NHTSA, 83 FR 50872, 50876 (October 10, 2018).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30182(b).
                        </P>
                    </FTNT>
                    <P>
                        In addition to other rulemaking activity regarding ADS, NHTSA has already begun the process of assessing how ADS may be affected by both existing and future FMVSS requirements.
                        <SU>37</SU>
                        <FTREF/>
                         For example, in 2022, NHTSA published a final rule that amended certain occupant protection FMVSS to account for future vehicles that would not have traditional manual controls associated with a human driver because they are equipped with ADS. This rulemaking work is supported by NHTSA's research portfolio, which spans a range of ADS safety topics and is the outgrowth of widespread coordination within DOT and with stakeholders. The agency publishes an Annual Modal Research Plan (AMRP) that summarizes its research priorities.
                        <SU>38</SU>
                        <FTREF/>
                         The agency also recently published a Report to Congress that provides a more detailed discussion of NHTSA's ADS research program.
                        <SU>39</SU>
                        <FTREF/>
                         NHTSA's ADS research portfolio aims to advance the body of knowledge on ADS-equipped vehicles, including their real-world performance, as well as explore the technical challenges associated with the safe testing and deployment of ADS.
                    </P>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             Information about NHTSA's full array of regulatory actions, including those pertaining to vehicle automation technologies, can be found within the biannually released Unified Agenda. 
                            <E T="03">See</E>
                             Office of Information and Regulatory Affairs, “Unified Agenda of Regulatory and Deregulatory Actions,” available at 
                            <E T="03">https://www.reginfo.gov/public/do/eAgendaMain.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             NHTSA, “United States Department of Transportation Annual Modal Research Plan FY 2022 and Program Outlook FY 2023” (September 10, 2021), available at 
                            <E T="03">https://www.transportation.gov/sites/dot.gov/files/2022-02/AMRP%20FY2022-2023%20NHTSA%20FINAL.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             NHTSA, “Report to Congress: Automated Vehicles” (2023), available at 
                            <E T="03">https://www.nhtsa.gov/sites/nhtsa.gov/files/2023-06/Automated-Vehicles-Report-to-Congress-06302023.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        AV STEP is designed to complement these research goals in support of future ADS rulemaking efforts. Given the nascent state of ADS technology, many of the metrics for evaluating ADS safety are new, limited, or under development. This AV STEP proposal would enable NHTSA to consider the effectiveness of such metrics for evaluating ADS safety by exploring their value to automotive safety, and in turn would help NHTSA identify data elements that could form effective oversight tools or be integrated into future FMVSS.
                        <SU>40</SU>
                        <FTREF/>
                         To that end, the AV STEP proposal would provide NHTSA with in-depth access to information about the development and operations of ADS technology as it continues to evolve.
                    </P>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             49 U.S.C. 30111.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. NHTSA Exemptions</HD>
                    <P>NHTSA proposes to use AV STEP to administer requests for exemptions of ADS-equipped vehicles under two statutory provisions: 49 U.S.C. 30114(a) and 49 U.S.C. 30122(c). This proposal would not replace any of NHTSA's existing exemption processes, which would remain available for any eligible vehicles, including those equipped with ADS. Instead, AV STEP would establish a streamlined way to seek exemptions through a framework expressly designed for ADS-equipped vehicles. This proposal would establish a new framework for ADS-equipped vehicles to seek Section 30114(a) and Section 30122(c) exemptions.</P>
                    <HD SOURCE="HD3">(a) Section 30114(a) Exemptions</HD>
                    <P>With AV STEP, NHTSA proposes to carry out the agency's special exemption authority to administer FMVSS exemptions in 49 U.S.C. 30114(a). This statutory authority permits NHTSA to grant special exemptions to “vehicles used for particular purposes.” Specifically, NHTSA “may exempt a motor vehicle or item of motor vehicle equipment from Section 30112(a) of this title on terms [it] decides are necessary for research, investigations, demonstrations, training, competitive racing events, show, or display.” This proposed exemption process would not replace NHTSA's existing two FMVSS exemption processes, as described below. However, in administering those two exemption processes, NHTSA has observed that both the frequency and complexity of ADS exemption requests continue to grow as the technology progresses.</P>
                    <P>Those two exemption processes were designed to handle any type of FMVSS exemption that NHTSA receives, originally for traditional vehicles that do not utilize automation. ADS technologies entail an array of unique safety and oversight considerations compared to traditional automotive components. As a result, NHTSA believes that an exemption process designed from the ground up to account for these unique considerations could enhance the agency's administration of exemptions that involve ADS, such as through improved oversight and efficiency. As described below, NHTSA's two existing exemption processes would also remain available for ADS-equipped vehicles and may provide advantages for certain types of operations. However, NHTSA believes that the current ADS landscape warrants the availability of a dedicated exemption process for ADS-equipped vehicles, and the existence of this process would also better equip NHTSA for the potential growth of ADS technology in the future.</P>
                    <P>
                        By creating a pathway specifically designed for ADS-equipped vehicles, NHTSA proposes to use many of the principles that have proven effective under NHTSA's other exemption programs that implement Section 30114(a). NHTSA currently administers Section 30114(a) through two programs: (1) exemptions for vehicles imported for purposes of show or display 
                        <SU>41</SU>
                        <FTREF/>
                         and (2) the Temporary Import Exemption (TIE) program, which administers Section 30114(a) exemptions for vehicles requesting importation for purposes of research, investigation, demonstrations, training, or competitive racing events.
                        <SU>42</SU>
                        <FTREF/>
                         In 2016, the TIE program processed the first Section 30114(a) exemption for an ADS-equipped vehicle. In 2018, NHTSA 
                        <PRTPAGE P="4136"/>
                        developed the ADS-equipped Vehicle Exemption Program (AVEP), within the TIE program, to process the increasing number of Section 30114(a) exemption requests for the importation of ADS-equipped vehicles. This number of requests has continued to grow since then, both in number and complexity. Since the first ADS exemption request in 2016 to the end of 2023, NHTSA permitted 293 imported ADS-equipped vehicles to operate in 249 projects across 25 states. The last several years have accounted for much of this activity: between 2020 to the end of 2023, NHTSA permitted 222 imported ADS-equipped vehicles to operate in 194 projects across 23 states.
                    </P>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             
                            <E T="03">See</E>
                             generally, NHTSA, “How to Import a Motor Vehicle for Show or Display” (October 15, 2012), available at 
                            <E T="03">https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/how_to_import_show_display_10152012-tag.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             TIE is often colloquially known as NHTSA's Box 7 program, a reference to the numbered box associated with this exemption on the HS-7 Declaration form used during the importation process. 
                            <E T="03">See generally,</E>
                             NHTSA, “Temporary Importation of a Motor Vehicle Under Box 7 on the HS-7 Form,” available at 
                            <E T="03">https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/box7_form_111920_v3_secured.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Many of the requirements proposed for AV STEP build on AVEP processes or apply the agency's experience from that program. Like the proposed AV STEP process, AVEP uses an iterative review process that considers the safety of the ADS along with the overall safety of the vehicle and the purposes for which the exemption is requested. This process culminates in terms and conditions in an exemption letter, which govern the exempted vehicles' operation. This proposal does not intend to replace AVEP. However, just as NHTSA's Section 30114(a) review process evolved to establish AVEP shortly after ADS exemption requests began, the increasing complexity of ADS exemption requests merits the development of another framework. NHTSA proposes for AV STEP to meet this need through a more comprehensive application and participation framework designed specifically for larger and more complex ADS operations.</P>
                    <P>In general, AVEP exemptions do not cover large numbers of vehicles, with many of those exemptions covering only a single vehicle. AVEP vehicles often operate on a fixed route expressly approved by NHTSA in a permission letter. As a result, NHTSA's review of an AVEP application often involves a detailed turn-by-turn review of the route. NHTSA receives much of the information about the vehicle's ADS in response to follow-up questions that arise during review of an application. Likewise, unique terms and reporting requirements are often developed for each operation. The AVEP review and participation process is iterative, and companies often need to request amendments for even minor changes to a permission, such as requesting to add a turn or stop to a route.</P>
                    <P>The AVEP process has proven an effective way to oversee small numbers of vehicles. Because its processes are tailored to each exemption, AVEP also offers a flexible program that reduces the burden on companies who seek smaller-scale importation exemptions. If AV STEP is finalized, NHTSA expects many companies would still choose to use the AVEP process, especially for vehicles that are tested in small numbers, such as early prototypes.</P>
                    <P>However, AVEP's detailed, iterative process is less efficient for larger operations. The AV STEP proposal accounts for this by adapting many of the safety lessons learned from AVEP into processes that are capable of administering and overseeing exemptions at scale. For instance, aspects of this proposal—such as the independent assessment, application review procedures, and reporting on updates to operations—aim to make reviewing evolving operations with growing numbers of vehicles or routes more manageable. In turn, AV STEP should help NHTSA process and oversee complex ADS exemptions more efficiently.</P>
                    <P>
                        Apart from Section 30114(a), NHTSA also administers exemptions to ADS-equipped vehicles under 49 U.S.C. 30113. These exemptions are implemented in NHTSA's regulations in 49 CFR part 555. Compared to Section 30114(a), companies have not used Section 30113 exemptions as frequently for ADS-equipped vehicles. NHTSA has received fewer than five part 555 exemption requests for ADS-equipped vehicles, with only one of those to date receiving an exemption.
                        <SU>43</SU>
                        <FTREF/>
                         The terms and conditions on the sole ADS exemption issued under part 555 were significantly influenced by terms that NHTSA developed for AVEP.
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             NHTSA, 85 FR 7826, 7842 (February 11, 2020).
                        </P>
                    </FTNT>
                    <P>
                        Exemptions issued under Section 30113 are for more general purposes than exemptions issued under Section 30114(a). Vehicles receiving them do not need to meet one of the specific purposes enumerated in Section 30114(a) and, absent restrictions placed by NHTSA, can be more broadly introduced into interstate commerce. In general, each vehicle manufactured under a Section 30113 exemption retains the exemption in perpetuity. Such a broader exemption is warranted because a vehicle that receives an exemption under Section 30113 must meet one of several express statutory standards, such as proving that the vehicle's “overall level of safety is at least equal to the overall safety level of the nonexempt vehicles.” 
                        <SU>44</SU>
                        <FTREF/>
                         Thus, even if AV STEP exists, NHTSA expects that some manufacturers will elect to use Section 30113 for their ADS-equipped vehicles, especially if ADS technologies mature to the point that more entities consider equipping them on vehicles intended for sale.
                    </P>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             49 U.S.C. 30113(b)(3).
                        </P>
                    </FTNT>
                    <P>
                        As a result, AV STEP would complement existing Section 30113 and Section 30114(a) exemption processes to create a comprehensive NHTSA FMVSS exemption portfolio, with each process offering advantages for certain types of ADS-equipped vehicle use cases. Entities requesting exemptions for imported vehicles in early development stages would likely request exemptions through AVEP, due to its flexibility and potential to reach quicker decisions for limited-scope projects.
                        <SU>45</SU>
                        <FTREF/>
                         AV STEP would provide an exemption process designed for ADS-equipped vehicles—regardless of whether they are imported—that are in later or final stages of development but still within the control of essential stakeholders. Given their more developed state, vehicles in AV STEP could begin to engage in some types of commercial operations as long as that commercialization did not undermine the public purposes for which the exemption was issued. Finally, manufacturers in need of exemptions for their ADS-equipped vehicles that have reached a more mature development state may prefer part 555, especially if the vehicle is designed for sale. In this way, AV STEP would fill the need for an FMVSS exemption suited for the current interim stage of ADS technology development. NHTSA specifically requests comment on how the proposed AV STEP exemptions would likely be utilized in comparison to NHTSA's other exemption programs, as well as on how best to design AV STEP to complement those other exemptions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             Although this process is currently only for imported vehicles, NHTSA is undertaking a rulemaking to create an equivalent exemption option for vehicles manufactured in the United States. 
                            <E T="03">See</E>
                             Office of Information and Regulatory Affairs, “Unified Agenda of Regulatory and Deregulatory Actions,” RIN 2127-AM14: Expansion of Temporary Exemption Program to Domestic Manufacturers for Research, Demonstrations, and Other Purposes. This issue is discussed further in Section VII (Requirements for AV STEP Exemptions (Regulatory Text Subpart C)) of this NPRM.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(b) Section 30122(c) Exemptions</HD>
                    <P>
                        NHTSA proposes to allow exemptions under Section 30122, which generally prohibits activities that take a previously compliant vehicle out of compliance with the FMVSS.
                        <SU>46</SU>
                        <FTREF/>
                         NHTSA 
                        <PRTPAGE P="4137"/>
                        is authorized to prescribe regulations for Make Inoperative Exemptions as long as those exemptions are consistent with motor vehicle safety and with 49 U.S.C. 30101, which is the Safety Act's general purpose and policy statement.
                        <SU>47</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30122(b) (“A manufacturer, distributor, dealer, rental company, or motor vehicle repair business may not knowingly make inoperative any part of a device or element of design installed on or in a motor vehicle or motor vehicle equipment in compliance with an applicable motor vehicle safety standard”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30122(c).
                        </P>
                    </FTNT>
                    <P>
                        NHTSA has carried out this authority through regulations that govern specific situations where making certain safety devices inoperable, such as airbags, is permissible.
                        <SU>48</SU>
                        <FTREF/>
                         For instance, NHTSA's regulations create procedures for invoking the exemption to “install retrofit air bag on-off switches and to otherwise modify motor vehicles to enable people with disabilities to operate or ride as a passenger in a motor vehicle.” 
                        <SU>49</SU>
                        <FTREF/>
                         Part 595 was most recently updated in 2024 to allow law enforcement vehicles to be modified in a way that deactivates an automatic emergency braking system required by 49 CFR 571.127, S5.4.2.
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             49 CFR part 595 (Make Inoperative Exemptions).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             49 CFR 595.2; 
                            <E T="03">see also</E>
                             87 FR 14406 (March 15, 2022).
                        </P>
                    </FTNT>
                    <P>The proposed Make Inoperative Exemption in AV STEP would continue NHTSA's practice of exempting specific situations where the general make inoperative prohibition may not account for unique vehicle needs. Engagement with stakeholders on how ADS technology relates to NHTSA's authorities has repeatedly raised the possibility that equipping an FMVSS-certified vehicle with an ADS may implicate the make inoperative prohibition in Section 30122.</P>
                    <P>
                        NHTSA's 2022 Final Rule on Occupant Protection for Vehicles With Automated Driving Systems discussed comments that raised hypothetical situations where ADS modifications to a vehicle may relate to the make inoperative prohibition.
                        <SU>50</SU>
                        <FTREF/>
                         Questions about how the make inoperative prohibition in Section 30122 affects ADS equipment will likely persist over the coming years, particularly as NHTSA promulgates new FMVSS that govern the performance of vehicle automation features.
                        <SU>51</SU>
                        <FTREF/>
                         NHTSA has also explored the relationship between Section 30122 and ADS-equipped vehicles—including the use of exemptions under Section 30122(c)—in past regulatory notices.
                        <SU>52</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             NHTSA, 87 FR 18560, 18571 n.36 (September 26, 2022).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             
                            <E T="03">See, e.g.,</E>
                             89 FR 39686 (May 9, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             
                            <E T="03">See</E>
                             NHTSA, 83 FR 50872, 50882 (October 10, 2018) (requesting comment on: what role could a pilot program play in determining when to grant an exemption from the make inoperative prohibition under Section 30122 for certain dual mode vehicles).
                        </P>
                    </FTNT>
                    <P>NHTSA takes no position in this rulemaking on the effect of the make inoperative prohibition in Section 30122 on ADS equipment or associated aftermarket modifications. The AV STEP framework would enable NHTSA to address this issue by providing a set of procedures to govern the review and oversight of make inoperative exemptions for ADS-equipped vehicles.</P>
                    <P>The AV STEP Make Inoperative Exemption is proposed pursuant to NHTSA's authority in Section 30122(c). The proposed AV STEP framework would further the purposes of the Safety Act in carrying out NHTSA's oversight, rulemaking, research, and transparency authorities, as explained previously in this section. The AV STEP framework is designed to help NHTSA identify potential safety issues with an ADS and to oversee its performance during the course of program participation. These review and oversight procedures would help NHTSA assess the statutory criteria for such an exemption.</P>
                    <P>Exemptions to the make inoperative provision are codified in 49 CFR part 595. NHTSA proposes to add a new subsection in part 595 that incorporates the proposed procedures for AV STEP that would be codified in the new part 597. In addition, NHTSA proposes to amend the Purpose and Applicability subsections in part 595 so that they encompass all of the exemptions set forth in the part.</P>
                    <P>The discussion in this preamble is generally organized around the sequence in which an entity would engage with AV STEP. The first section below (Section III) explains the threshold requirements for AV STEP, including eligibility and required terms and conditions for all participants. Sections IV through VI provide an overview of the application process, the participation stage, and the information that NHTSA proposes to make public regarding both applications and participations. These aspects of AV STEP would all apply across the entirety of the program, while Section VII outlines proposals specific to AV STEP exemptions. For reader convenience, NHTSA includes reference to the associated subparts of the proposed regulatory text in the headings for each of these sections.</P>
                    <P>In past exercises of its authorities, NHTSA has often implemented standalone voluntary or exemption programs analogous to AV STEP's various components, and NHTSA intends that the components of the proposal be severable. AV STEP is proposed as a national framework that encompasses three independent structural components: (1) a voluntary program for compliant vehicles; (2) a process for administering FMVSS exemptions; and (3) a process for administering exemptions from the make inoperative prohibition. As explained in this proposal, each of these structural elements stems from independent NHTSA authorities under the Safety Act. Although NHTSA believes that AV STEP offers an opportunity to combine all three of these elements into a national framework, as the proposal explains, each of these structural elements has independent value.</P>
                    <HD SOURCE="HD1">III. Program Structure (Regulatory Text Subpart A)</HD>
                    <P>This section explains the threshold requirements for AV STEP, such as those relating to eligibility and the required terms and conditions for all participants. AV STEP would be available to vehicles that can lawfully operate on public roads without AV STEP, as well as those that would need one of the two types of exemptions proposed in this NPRM.</P>
                    <P>In several places, this document proposes unique requirements for AV STEP exemptions to account for their particular attributes. However, in general, the proposed requirements for AV STEP are the same regardless of whether a subject vehicle needs an AV STEP exemption. Keeping these requirements consistent would further the continuity of the program, reduce confusion for potential applicants and the public about what participation entails, and simplify NHTSA's administration of the program. When developing these proposed requirements, NHTSA sought to make program application and participation requirements stringent enough to require meaningful commitments to safety while also making them feasible for participating entities. Participation in AV STEP, as proposed, would be valuable both for vehicles that need one of the AV STEP exemptions and for entities choosing voluntary participation.</P>
                    <P>
                        NHTSA's experience suggests that a variety of incentives may exist for entities to voluntarily participate in AV STEP. Voluntary programs have historically played an important role in advancing automotive safety, particularly for advanced vehicle technologies. Recent examples include voluntary industry commitments to equip vehicles with specific safety technologies,
                        <SU>53</SU>
                        <FTREF/>
                         the submission of 
                        <PRTPAGE P="4138"/>
                        VSSAs to NHTSA by entities engaged in ADS testing and deployment,
                        <SU>54</SU>
                        <FTREF/>
                         the participation of entities engaged in ADS testing in NHTSA's AV TEST Initiative,
                        <SU>55</SU>
                        <FTREF/>
                         and the participation of vehicle manufacturers in the Partnership for Analytics Research in Traffic Safety.
                        <SU>56</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             NHTSA, “NHTSA Announces Update to Historic AEB Commitment by 20 Automakers” 
                            <PRTPAGE/>
                            (December 17, 2019), available at 
                            <E T="03">https://www.nhtsa.gov/press-releases/nhtsa-announces-update-historic-aeb-commitment-20-automakers.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             NHTSA, “Automated Driving Systems: Voluntary Safety Self-Assessment,” available at 
                            <E T="03">https://www.nhtsa.gov/automated-driving-systems/voluntary-safety-self-assessment.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             NHTSA, “AV TEST Initiative: Automated Vehicle Transparency and Engagement for Safe Testing Initiative,” available at 
                            <E T="03">https://www.nhtsa.gov/automated-vehicle-test-tracking-tool.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             NHTSA, “PARTS: Partnership for Analytics Research in Traffic Safety,” available at 
                            <E T="03">https://www.nhtsa.gov/parts-partnership-for-analytics-research-in-traffic-safety.</E>
                        </P>
                    </FTNT>
                    <P>The extent and nature of the incentives for entities to participate in AV STEP may depend on the entity and the type of operation. NHTSA believes that companies that strive to develop and implement robust safety practices will understand that AV STEP participation entails a public commitment to safety, transparency, and the continuous refinement of their ADS operations. Public trust is often difficult to establish for ADS operations, particularly given that incidents involving ADS-equipped vehicles receive significant negative attention. Within this climate, some entities may see AV STEP as an opportunity to demonstrate their commitment to transparency and willingness to subject their safety decision-making to external scrutiny.</P>
                    <P>Other entities that engage with ADS operations may find value in the review and oversight that would be conducted by NHTSA through AV STEP. Examples of these types of entities could include state or local authorities that regulate ADS, insurers of ADS-equipped vehicles, entities providing grants for ADS projects, or business partners, such as goods delivery services looking to partner with an ADS company. These third-party relationships could motivate companies to participate in AV STEP even if their vehicles could lawfully operate without the program.</P>
                    <P>As participation in the program grows, competitive forces may motivate other companies to participate. Accounting for these potential incentives for voluntary participation, as well as the clear incentives that would exist for entities in need of exemptions, the proposed AV STEP requirements balance the value of encouraging participation with the need to ensure that participation requirements are meaningful. NHTSA requests comment on how this proposal strikes that balance.</P>
                    <HD SOURCE="HD2">A. Program Eligibility</HD>
                    <P>
                        This proposal is designed to oversee ADS-equipped vehicles under the control of motor vehicle manufacturers, ADS developers (
                        <E T="03">i.e.,</E>
                         manufacturers of ADS, which is motor vehicle equipment), fleet operators, or system integrators that plan to engage in public road operations where the ADS will perform the driving task.
                        <SU>57</SU>
                        <FTREF/>
                         Section 597.103 of the proposed rule contains the following eligibility requirements:
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             For this NPRM's definition of these terms, see § 597.102 of the proposed rule.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Vehicle Eligibility.</E>
                         NHTSA proposes two eligibility requirements for vehicles participating in AV STEP. First, the vehicles must be equipped with an ADS being used or developed for operation without an expectation of an attentive human driver (whether in-vehicle or remote) while engaged. Second, the ADS equipped on such vehicles must perform the entirety of the DDT for all or part of the participating operations. These vehicle eligibility criteria focus on the ultimate design intent of the system.
                        <SU>58</SU>
                        <FTREF/>
                         Although these eligibility criteria are not tied to any preexisting taxonomy for vehicle automation, for illustration purposes, under the current SAE International levels of driving automation, these eligibility criteria could apply to certain vehicles operating at SAE Levels 3, 4, or 5.
                        <SU>59</SU>
                        <FTREF/>
                         The proposal does not extend AV STEP eligibility to partial driving automation systems, also known as SAE Level 2 ADAS. Excluding such systems optimizes AV STEP to address ADS' unique safety considerations and complexities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             For instance, a vehicle would be considered to be equipped with an ADS even if the ADS remained in development and dependent, at times, on a human operator such as an onboard test driver.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             SAE International, “J3016 APR2021: Taxonomy and Definitions for Terms Related to Driving Automation Systems for On-Road Motor Vehicles,” (Revised April 2021). A limited number of Level 3 systems have recently become available on consumer-owned vehicles. Those vehicles would not be eligible for participation because they do not meet the separate program requirement that a vehicle manufacturer, ADS developer, fleet operator, or system integrator retain operational control over a subject vehicle.
                        </P>
                    </FTNT>
                    <P>
                        Beyond these ADS requirements, NHTSA proposes to consider the effect of other vehicle attributes on a case-by-case basis during the agency's review, especially insofar as they may impact safety. NHTSA does not propose to categorically restrict program participation to any particular vehicle classes or types of operations (
                        <E T="03">e.g.,</E>
                         public transit). However, NHTSA recognizes there may be unique considerations related to certain vehicle attributes or classes, such as those relating to accessibility for people with disabilities or impacts on labor and employment. NHTSA requests comment on incorporating such considerations into AV STEP, for example, through program limitations or specialized requirements.
                    </P>
                    <P>
                        <E T="03">Applicant Eligibility.</E>
                         NHTSA proposes to limit AV STEP participation to motor vehicle manufacturers, ADS developers, fleet operators, and system integrators for the subject vehicle. Section 597.102 of the proposed rule defines these entities as follows:
                    </P>
                    <P>“ADS Developer” means the entity that is principally responsible for the manufacture of the ADS at the system level, including but not limited to its design, development, and testing.</P>
                    <P>“Manufacturer” has the meaning given in 49 U.S.C. 30102(a)(6). Under Section 30102, the term manufacturer includes a person (A) manufacturing or assembling motor vehicles or motor vehicle equipment; or (B) importing motor vehicles or motor vehicle equipment for resale. Under § 597.102 of the proposed rule, an entity qualifying as a manufacturer would need to be the manufacturer of the subject vehicle. Other than ADS developers, who are manufacturers of the ADS, which is motor vehicle equipment, NHTSA is not currently proposing to extend eligibility to manufacturers of motor vehicle equipment unless they can meet one of the other eligible classes of applicants. NHTSA does not believe that other manufacturers of motor vehicle equipment, such as suppliers of an individual component on a vehicle, are likely to have a broad enough understanding of the system-level performance of the vehicle to satisfy the considerations described in the following paragraphs.</P>
                    <P>“Fleet Operator” means the individual or entity that exercises all or part of the operational control over the ADS installed in a subject vehicle or group of subject vehicles. The threshold for “operational control” is described further in the next subsection.</P>
                    <P>“System Integrator” means an entity responsible for integration of an ADS at the vehicle level. For example, an ADS that was developed for use across varied vehicle platforms could be integrated into a given vehicle and validated for that vehicle integration by an entity that does not qualify as any of the three preceding stakeholders.</P>
                    <P>
                        In many cases, the same entity may perform the role of multiple entities. For instance, some vehicle manufacturers 
                        <PRTPAGE P="4139"/>
                        are responsible for the development and system integration of the vehicle's ADS and many ADS developers conduct fleet operations for their own vehicles. However, when one or more of these entities are separate, their collective contributions are critical to the system-level operation of an ADS-equipped vehicle. Under the proposal, any of these four entities or any combination of these four entities could apply to participate in AV STEP.
                    </P>
                    <P>The agency believes that an application and a participation must include at least one of these entities to ensure successful program engagement. An entity other than these four stakeholders could not meet the application requirements without relying heavily on these stakeholders' representations. Likewise, it could not meet the participation requirements without relying on their commitments regarding the vehicle's operation or data collection. Limiting participation to these four entities would promote direct accountability. NHTSA may also engage with other entities throughout the application and participation stages. Other proposed provisions address such engagement.</P>
                    <P>
                        <E T="03">Operational Control.</E>
                         As a precondition for participation in AV STEP, NHTSA proposes to limit all operational control of the subject vehicles to the vehicle manufacturer, ADS developer, fleet operator, or system integrator. This limitation would ensure that vehicle operations remain within the direct reach of the entities with the technical knowledge of the vehicle systems and operations. This requirement would also maintain a direct relationship between NHTSA and the parties that exercise control over the subject vehicles. This “operational control” standard has provided an effective threshold for maintaining oversight in past NHTSA ADS exemptions.
                        <SU>60</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             For instance, a 2020 exemption issued by NHTSA for an ADS-equipped vehicle under 49 CFR part 555 (which implements 49 U.S.C. 30113) imposed the condition that the vehicle manufacturer: must maintain ownership and operational control over the [exempted vehicles] that are built pursuant to this exemption for the life of the vehicles. 85 FR 7826, 7842 (February 11, 2020).
                        </P>
                    </FTNT>
                    <P>
                        For operations where only one of those four entities maintains full ownership and possession of the subject vehicles, this requirement would be straightforward. In contrast, certain fleet operations may involve more complicated arrangements, such as projects that involve multiple entities. For instance, some operations may involve an ADS developer responsible for the ADS software and a fleet operator responsible for the fallback personnel present during operations. Other types of projects may involve entities other than Essential System-Level Stakeholders,
                        <SU>61</SU>
                        <FTREF/>
                         such as a grocery store that takes possession of the vehicle while loading goods for delivery. In these situations, requiring the Essential System-Level Stakeholders to retain ownership or even possession of the subject vehicles may not always be feasible given the specific logistics of an operation.
                        <SU>62</SU>
                        <FTREF/>
                         To account for this possibility, NHTSA proposes to require Essential System-Level Stakeholders to retain operational control of the subject vehicles. NHTSA proposes a scope of operational control similar to the scope of a dispatching entity that exercises control over fleet operations, as described in SAE J3016.
                        <SU>63</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             As proposed in the AV STEP definitions, the list of Essential System-Level Stakeholders would include, at a minimum, the vehicle manufacturer, ADS developer, fleet operator, and system integrator. Additional entities may be listed as well depending on their role in the operation.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             Those receiving an exemption under AV STEP would, however, be subject to additional restrictions on possession or ownership. 
                            <E T="03">See</E>
                             Section VII (Requirements for AV STEP Exemptions (Regulatory Text Subpart C)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             
                            <E T="03">See generally</E>
                             SAE International, “J3016 APR2021: Taxonomy and Definitions for Terms Related to Driving Automation Systems for On-Road Motor Vehicles,” (Revised April 2021).
                        </P>
                    </FTNT>
                    <P>
                        Definition 3.3 of J3016 defines a “dispatching entity” as “an entity that dispatches an ADS-equipped vehicle(s) in driverless operations.” 
                        <SU>64</SU>
                        <FTREF/>
                         Definition 3.4 defines “dispatch” as “[t]o place an ADS-equipped vehicle into service in driverless operation by engaging the ADS.” 
                        <SU>65</SU>
                        <FTREF/>
                         Finally, definition 3.13 describes “fleet operations” or fleet functions as:
                    </P>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             
                            <E T="03">Id.</E>
                             at 3.3, p. 7 (“[Driverless Operation] Dispatching Entity”) (bracketed language in original).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             
                            <E T="03">Id.</E>
                             at 3.4, p. 7 (“Dispatch [In Driverless Operation]”) (bracketed language in original). Note 1 of this definition clarifies that “[t]he term `dispatch,' as used outside of the context of ADS-equipped vehicles, is generally understood to mean sending a particular vehicle to a particular pick-up or drop-off location for purposes of providing a transportation service. In the context of ADS-equipped vehicles, and as used herein, this term includes software-enabled dispatch of multiple ADS-equipped vehicles in driverless operation that may complete multiple trips involving pick-up and drop-off of passengers or goods throughout a day or other pre-defined period of service, and which may involve multiple agents performing various tasks related to the dispatch function. To highlight this specialized use of the term dispatch, the term is modified and conditioned by the stipulation that it refers exclusively to dispatching vehicles in driverless operation.”).
                        </P>
                    </FTNT>
                    <P>The activities that support the management of a fleet of ADS-equipped vehicles in driverless operation, which may include, without limitation:</P>
                    <P>• Ensuring operational readiness.</P>
                    <P>
                        • Dispatching ADS-equipped vehicles in driverless operation (
                        <E T="03">i.e.,</E>
                         engaging the ADSs prior to placing the vehicles in service on public roads).
                    </P>
                    <P>
                        • Authorizing each trip (
                        <E T="03">e.g.,</E>
                         payment, trip route selection).
                    </P>
                    <P>
                        • Providing fleet asset management services to vehicles while in use (
                        <E T="03">e.g.,</E>
                         managing emergencies, summoning or providing remote assistance as needed, responding to customer requests and breakdowns).
                    </P>
                    <P>• Serving as the responsible agent vis-a-vis law enforcement, emergency responders, and other authorities for vehicles while in use.</P>
                    <P>• Disengaging the ADS at the end of service.</P>
                    <P>
                        • Performing vehicle repair and maintenance as needed.
                        <SU>66</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             
                            <E T="03">Id.</E>
                             at 3.13, p. 14 (“Fleet Operations [Functions]”) (bracketed language in original).
                        </P>
                    </FTNT>
                    <P>
                        Under this proposal, a vehicle manufacturer, ADS developer, fleet operator, or system integrator (or any combination thereof) could each exercise aspects of this control even if only one of them were an AV STEP participant. For instance, if the ADS developer were the sole participant, a fleet operator could exercise some measure of operational control. Likewise, this proposed requirement is not intended to prohibit vehicle passengers from having limited control authority over the vehicle, such as selecting a destination for a ride-hailing operation.
                        <SU>67</SU>
                        <FTREF/>
                         Given the complex relationships among different stakeholders in operations, NHTSA requests comment on the workability of the proposed operational control requirement.
                    </P>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             In such cases, the vehicle user would be acting within a set of parameters controlled by an ADS developer, such as by selecting a destination within a developer-established ODD.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Location Eligibility.</E>
                         NHTSA proposes to require that AV STEP operations take place, in part or entirely, on public streets, roads, and highways in the United States. This eligibility requirement mirrors statutory language for the Safety Act's definition of “motor vehicle” in 49 U.S.C. 30102. Since the program framework for AV STEP is designed principally to oversee vehicles operating on public roads, this eligibility requirement ensures that each operation involves at least some public road usage. During participation, NHTSA expects that subject vehicles may also engage in operations on non-public roads, such as closed course testing. In general, the proposed application and reporting requirements 
                        <PRTPAGE P="4140"/>
                        for AV STEP would not cover such private road operations.
                        <SU>68</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             However, non-public road testing would likely be relevant to the validation evidence for the safety case assessment discussed in Section IV.D.1.b) (Independent Assessment, Safety Case).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Program Steps</HD>
                    <P>AV STEP would have two program participation categories. In general, Step 1 would apply to vehicles that rely on fallback personnel, and Step 2 would apply to vehicles that do not rely on fallback personnel. Given the increased responsibility of the ADS at Step 2, the level of system maturity is expected to be higher than at Step 1. As proposed, a vehicle could start participation at either step level. It would not be necessary to complete Step 1 before moving to Step 2. However, Step 1 participants could apply to participate at Step 2 as their systems and operations mature. Likewise, under this proposal, if a company had multiple vehicle platforms or systems, some of which were more mature than others, the company could apply to participate in Step 1 for some operations and in Step 2 for others.</P>
                    <P>The reliance on fallback personnel is used to delineate between Steps 1 and 2 because the approach to managing risk is significantly different in these two cases. In an operation that relies on fallback personnel, a human is expected to compensate for known limitations or unproven aspects of the ADS. In contrast, in an operation that does not rely on fallback personnel, the ADS must be capable of handling all scenarios within an ODD without the intervention of fallback personnel. AV STEP can more easily account for these unique safety considerations by dedicating a separate step to each type of operation.</P>
                    <P>The ADS industry acknowledges the significance of these differences. For instance, when discussing its ADS, referred to as the Aurora Driver, Aurora Innovation Inc. (Aurora) explained in its 2022 VSSA that:</P>
                    <EXTRACT>
                        <FP>
                            as we continue to develop with the Aurora Driver, we currently have vehicle operators . . . monitoring the performance of the Aurora Driver at all times and ready to take over as necessary to ensure operational safety. Therefore, our tailored safety case for this use case includes claims focused on vehicle controllability and vehicle operator hiring, training, and operational procedures, among others. However, when we reach the point of removing the vehicle operators from cabs, these vehicle operator-centric claims will no longer be relevant.
                            <SU>69</SU>
                            <FTREF/>
                        </FP>
                        <FTNT>
                            <P>
                                <SU>69</SU>
                                 Aurora, “Safety Report” (2022), available at 
                                <E T="03">https://info.aurora.tech/hubfs/website%20Public%20Files/Q4_Safety_VSSA%202022_digital_r2.pdf</E>
                                .
                            </P>
                        </FTNT>
                    </EXTRACT>
                    <P>Similarly, Waymo LLC explained in a 2020 discussion of safety readiness determinations that:</P>
                    <EXTRACT>
                        <FP>
                            [d]eterminations to move from public road testing with trained vehicle operators to driverless operations, of course, are conducted at the greatest level of detail. Going completely driverless entails extremely rigorous analysis of expected behaviors and risks within the ODD, including unique risks presented by the absence of a human driver (
                            <E T="03">e.g.,</E>
                             responding to system failures through fallback maneuvers that do not rely on human intervention).
                            <SU>70</SU>
                            <FTREF/>
                        </FP>
                        <FTNT>
                            <P>
                                <SU>70</SU>
                                 Webb, N., Smith, D., Ludwick, C., Victor, T.W., Hommes, Q., Favarò F., Ivanov, G., and Daniel, T., “Waymo's Safety Methodologies and Safety Readiness Determinations,” (2020) available at 
                                <E T="03">https://arxiv.org/abs/2011.00054.</E>
                            </P>
                        </FTNT>
                    </EXTRACT>
                    <P>
                        Under the proposal, an entity would be eligible to apply for Step 1 participation for vehicles that operate with fallback personnel during all participating operations on public roads.
                        <SU>71</SU>
                        <FTREF/>
                         An entity would be eligible to apply for Step 2 participation for vehicles that operate, at any time during participation on public roads, without fallback personnel. NHTSA proposes to define “Fallback Personnel” as an individual specially trained and skilled in supervising the performance of prototype ADS-operated vehicles in on-road traffic, who continuously supervises the performance of an ADS-operated vehicle in real time and intervenes whenever necessary to prevent a hazardous event by exercising any means of vehicle control. This intervention may occur as part of a DDT Fallback 
                        <SU>72</SU>
                        <FTREF/>
                         or in anticipation of possible future ADS behavior that is unsafe or otherwise unwanted by the user. This definition of fallback personnel would not include vehicle assistance, which does not involve directly exercising vehicle control authority.
                        <SU>73</SU>
                        <FTREF/>
                         An ADS that relied only on vehicle assistance during public road operations would fall under Step 2 rather than Step 1.
                    </P>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             Stakeholders use a variety of terms to refer to the fallback personnel role, such as in-vehicle fallback test drivers, safety operators, or testing safety operators.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             Section 597.102 of the proposed rule defines 
                            <E T="03">DDT Fallback</E>
                             as: the response by an individual to either perform the DDT or achieve a minimal risk condition after occurrence of a DDT performance-relevant system failure(s) or upon operational design domain exit, or the response by an ADS to achieve a minimal risk condition, given the same circumstances.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             Section 597.102 of the proposed rule defines 
                            <E T="03">Vehicle Assistance</E>
                             as: an individual providing information or instruction about a situation to an ADS-equipped vehicle in driverless operation (instead of exercising direct control of the vehicle) to help the ADS continue a trip when encountering a situation that the ADS cannot manage. Vehicle assistance may be provided remotely, by an individual not physically present in the vehicle, or by an individual on board (physically present in) the vehicle. Unlike fallback personnel, as defined in this section, vehicle assistance personnel provide information or instruction to an ADS-equipped vehicle rather than directly exercising vehicle control authority.
                        </P>
                    </FTNT>
                    <P>
                        As defined in this proposal, individuals who perform the fallback role could do so from within the vehicle or remotely. Remote fallback personnel would be considered remote drivers under the proposed definition of remote driving—the real-time performance of part or all of the DDT by an individual physically located outside of the vehicle.
                        <SU>74</SU>
                        <FTREF/>
                         However, NHTSA proposes to narrowly limit remote driving in AV STEP, as described in Section III.C (Terms and Conditions).
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             Some vehicle designs do not facilitate any human occupancy. Remote fallback personnel would be the only option for such vehicles to rely on fallback personnel.
                        </P>
                    </FTNT>
                    <P>
                        The proposed eligibility requirements of Step 2 are not intended to disincentivize the limited use of fallback personnel when a participant deems it beneficial for safety. Therefore, once admitted into AV STEP, a vehicle participating under Step 2 could rely on fallback personnel on a limited basis during public road operations. For example, fallback personnel could be temporarily reintroduced during the validation of a software update. Such limited exceptions notwithstanding, Step 2 is intended to demarcate an ADS' readiness to operate without fallback personnel, and the agency does not intend participants in Step 2 to functionally operate as Step 1 participants through the widespread or sustained use of fallback personnel. To oversee this expectation, NHTSA proposes reporting requirements to monitor the extent to which Step 2 operations use fallback personnel.
                        <SU>75</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             These requirements are set forth in § 597.501(f) of the proposed rule and described further in Section V.A (Reporting Requirements) of this document.
                        </P>
                    </FTNT>
                    <P>
                        For both steps, NHTSA proposes to prohibit vehicle operations that rely on fallback personnel from providing rides to public passengers.
                        <SU>76</SU>
                        <FTREF/>
                         This would mean that no public ridership would be permitted under Step 1 or in any of the limited situations where fallback personnel could be used under Step 2. This prohibition is proposed in light of the lower level of ADS maturity that is expected of a system that must rely on a human as a fallback. The need for fallback personnel indicates that an ADS has known limitations or requires 
                        <PRTPAGE P="4141"/>
                        further validation. The presence of fallback personnel also introduces training and human factor considerations into the safety of those vehicles, such as whether fallback personnel remain attentive while monitoring the ADS. Although the use of fallback personnel can be beneficial for safety during testing, NHTSA believes their role is better suited for operations engaged in significant development than those ready to carry public passengers. NHTSA requests comment generally on the conditions under which AV STEP should permit public ridership, including, more specifically, whether it should be permitted during operations that rely on fallback personnel.
                    </P>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             This prohibition would apply to any passenger who is a member of the public other than an employee or agent of an entity designated as an Essential System-Level Stakeholder or a public official acting in an official capacity, such as law enforcement or government personnel. 
                            <E T="03">See</E>
                             § 597.105(c) of the proposed rule.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">C. Terms and Conditions</HD>
                    <P>
                        Each AV STEP participation would be governed by a Final Determination Letter that establishes the full set of terms and conditions for the participation. NHTSA's proposed review process that would lead to the issuance of a Final Determination Letter is described in Section IV.E (Application Review). In general, the terms and conditions established by a letter would be tailored to the unique aspects of a participation and may cover subjects other than those expressly enumerated in § 597.105(b) of the proposed rule. Section IV.E lists seven subjects that would, at a minimum, be addressed in a Final Determination Letter. These include whether the participation is permitted under Step 1 or 2, the vehicles approved for participation,
                        <SU>77</SU>
                        <FTREF/>
                         the locations where participation is permitted, the duration of participation, and the stakeholders deemed essential for the participation. This letter would also govern the permitted uses of those vehicles, which could include commercial operations.
                        <SU>78</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             Section VII (Requirements for AV STEP Exemptions (Regulatory Text Subpart C)) explains a unique set of procedures for vehicles receiving exemptions under AV STEP.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             Section VII (Requirements for AV STEP Exemptions (Regulatory Text Subpart C)) explains the requirements for FMVSS exemptions that involve commercial operations.
                        </P>
                    </FTNT>
                    <P>
                        A Final Determination Letter would also govern the maximum number of vehicles approved for participation.
                        <SU>79</SU>
                        <FTREF/>
                         This number would be informed by NHTSA's review of the information submitted in the application. NHTSA proposes, when appropriate, to authorize increases in vehicle numbers over time if requested by the participant. Incrementally increasing participation would allow the scope of participation to mature along with a technology, enabling expansions to correspond to performance benchmarks or limiting initial operations until the agency gains further insight from overseeing the vehicles. Conversely, NHTSA could reduce the number of vehicles permitted to participate in AV STEP. For instance, this could occur during participation by lowering the cap on permitted vehicles through the concern resolution procedures proposed in this document or through a term in a Final Determination Letter that sets benchmarks for expanding or contracting vehicle participation numbers. NHTSA requests comment on whether the proposed rule should establish a cap on the number of vehicles allowed for each participant, including what such a cap should be and the grounds for setting it, as well as whether the cap should be able to be modified during program participation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             Setting limits on participation numbers through the adjudication of each request rather than through a categorical cap that applies to all participants would align with the longstanding approaches of the other NHTSA programs that administer exemptions under Section 30114(a).
                        </P>
                    </FTNT>
                    <P>
                        NHTSA also proposes for Final Determination Letters to contain terms governing the use of remote driving during participation. NHTSA proposes, in § 597.105(j) of the proposed rule, to generally prohibit remote driving in AV STEP except as temporarily needed to briefly move a vehicle after the ADS initiates a minimal risk maneuver or during any situations expressly permitted in a Final Determination Letter.
                        <SU>80</SU>
                        <FTREF/>
                         This proposal would limit remote driving to short distances, such as moving a vehicle to the side of the road after it has stopped in a travel lane or moving a vehicle in response to direction from emergency responders. Conditioning remote driving on the initiation of a minimal risk maneuver would, for example, allow this brief use of remote driving after the vehicle achieves a minimal risk condition or if remote personnel realize that a vehicle undertaking a minimal risk maneuver is taking inappropriate action. Minimal risk maneuvers and minimal risk conditions are discussed further in Section IV.B.2 (System Fallback Response).
                    </P>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             Human factors issues, connection latency, and jitter can result in unavoidable challenges for remote driving operations, even in locations with optimal connectivity. Therefore, although the agency extends eligibility to prospective operations that would entail limited remote driving, NHTSA expects, through the review framework described in the ensuing sections, to significantly scrutinize such uses. For further discussion of latency, jitter, and other remote driving considerations, 
                            <E T="03">see, e.g.,</E>
                             Y. Yu and S. Lee, “Remote Driving Control With Real-Time Video Streaming Over Wireless Networks: Design and Evaluation” (June 2022), available at 
                            <E T="03">https://ieeexplore.ieee.org/stamp/stamp.jsp?arnumber=9797698.</E>
                        </P>
                    </FTNT>
                    <P>
                        As proposed, this general prohibition on remote driving also allows an exception for other situations expressly delineated in a Final Determination Letter. An application would need to describe any such situations for which permission is requested.
                        <SU>81</SU>
                        <FTREF/>
                         NHTSA requests comment on the proposed approach to remote driving and, specifically: (1) whether to include operations that use remote fallback personnel within the scope of the program; (2) whether the proposed rule should include a limited allowance for remote driving after the ADS achieves a minimal risk condition or after the ADS initiates a minimal risk maneuver; and (3) whether the proposed rule should expressly include any other exceptions to the general prohibition on remote driving.
                        <SU>82</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             The required information about remote driving in an application is discussed in Section IV.B (Protocols for ADS Operations).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             Other potential exceptions could include if remote driving is unexpectedly needed to respond to a hazardous circumstance or if remote driving could enable temporary navigation around a roadway change, such as a construction zone, for which the ADS has not yet been validated.
                        </P>
                    </FTNT>
                    <P>
                        The proposed rule contains several terms to promote NHTSA's engagement with other regulatory authorities, such as states and local governments, during the review of an application and participation in the program. The proposed rule would require all vehicles, including their operations, to comply with all Federal, state, and local laws and requirements during participation.
                        <SU>83</SU>
                        <FTREF/>
                         This provision would cover both generally applicable requirements, including local traffic laws, and those specific to ADS technologies. The proposed application and reporting requirements would provide NHTSA with information to consider whether an entity has a responsible process for identifying and following these laws. NHTSA intends to coordinate with Federal, state, and local governments, as appropriate, regarding these and other issues associated with ADS operations in their jurisdictions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             This requirement would maintain NHTSA's practice of imposing a similar term in other exemptions issued under Section 30114(a).
                        </P>
                    </FTNT>
                    <P>
                        The Federal, state, and local regulatory frameworks and programs that also cover ADS operations span a range of different regulatory approaches. At the Federal level, examples include grants for ADS projects funded by other parts of DOT 
                        <SU>84</SU>
                        <FTREF/>
                         and pilot projects to 
                        <PRTPAGE P="4142"/>
                        explore the potential for ADS to further the mission of other agencies.
                        <SU>85</SU>
                        <FTREF/>
                         Examples at the state and local levels include state permitting requirements for ADS-equipped vehicles 
                        <SU>86</SU>
                        <FTREF/>
                         and traffic laws that are specific to ADS-equipped vehicles.
                        <SU>87</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             
                            <E T="03">See, e.g.,</E>
                             U.S. Department of Transportation, “Automated Driving Systems Demonstration Grants Program,” available at 
                            <E T="03">
                                https://
                                <PRTPAGE/>
                                www.transportation.gov/policy-initiatives/automated-vehicles/ads-demonstration-grants.
                            </E>
                             The Federal Transit Administration also administers grants for ADS. 
                            <E T="03">See generally</E>
                             Federal Transit Administration, “Transit Automation Research,” available at 
                            <E T="03">https://www.transit.dot.gov/automation-research.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             National Park Service, “NPS Emerging Mobility: Summary Evaluation of Low-Speed Automated Shuttle Pilots at NPS Sites,” June 2022. 
                            <E T="03">https://www.nps.gov/subjects/transportation/upload/NPS-Automated-Shuttle-Pilots-Evaluation-Summary.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             
                            <E T="03">See, e.g.,</E>
                             California Department of Motor Vehicles, “Autonomous Vehicles,” available at 
                            <E T="03">https://www.dmv.ca.gov/portal/vehicle-industry-services/autonomous-vehicles/#:~:text=The%20DMV%20administers%20the%20Autonomous,and%20applying%20for%20a%20permit.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             
                            <E T="03">See, e.g.,</E>
                             National Conference of State Legislatures, “Autonomous Vehicles Legislation Database,” available at 
                            <E T="03">https://www.ncsl.org/transportation/autonomous-vehicles-legislation-database.</E>
                        </P>
                    </FTNT>
                    <P>The goals of these initiatives are varied, given the diverse regulatory missions of the different jurisdictions. It is not feasible or appropriate to design AV STEP around all of the various approaches that other authorities may take concerning ADS. At the same time, AV STEP would not override any of those other authorities, such as by imposing Federal preemption of state requirements. Instead, NHTSA considers AV STEP best suited to exist in parallel with those other requirements. The proposed requirement that an AV STEP participant comply with all Federal, state, and local laws and requirements would ensure the requirements of those other authorities coexist with AV STEP. This requirement is consistent with how NHTSA has historically approached exemptions for ADS-equipped vehicles that are issued under Section 30114(a).</P>
                    <P>
                        During the review of an AV STEP application, NHTSA will engage with applicants and other authorities, as appropriate, to explore opportunities to harmonize certain AV STEP requirements with those of overlapping authorities. As a result of such engagement, if a reporting requirement of another authority is identified that is similar to a subject for which NHTSA proposes a customized requirement in AV STEP, a Final Determination Letter could scope AV STEP's customized reporting requirements in a way that harmonizes with another report. Other jurisdictions could likewise harmonize their own processes with AV STEP or otherwise find value in the enhanced Federal oversight and transparency of participating operations when considering whether to allow those vehicles to operate under their own authorities. As one example, the Federal Motor Carrier Safety Administration (FMCSA) has oversight authority for motor carrier use and operations of ADS technologies. Opportunities may exist to harmonize, as appropriate, certain requirements in AV STEP operations that involve commercial motor vehicles (CMVs) with any applicable FMCSA activities, in the interest of a consistent Departmental approach. For instance, FMCSA is engaged in rulemaking that would govern motor carrier operation of ADS-equipped CMVs 
                        <SU>88</SU>
                        <FTREF/>
                         and other activities related to AV technologies. NHTSA specifically requests comment on other ways that AV STEP could help to harmonize regulatory requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             
                            <E T="03">See</E>
                             Office of Information and Regulatory Affairs, “Unified Agenda of Regulatory and Deregulatory Actions,” Federal Motor Carrier Safety Administration, RIN 2126-AC17: Motor Carrier Operation of Automated Driving Systems (ADS)-Equipped Commercial Motor Vehicles, available at 
                            <E T="03">https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&amp;RIN=2126-AC17.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">IV. Application and Review (Regulatory Text Subparts B and D)</HD>
                    <HD SOURCE="HD2">A. Application Form</HD>
                    <P>
                        NHTSA proposes that all AV STEP applications contain a standard set of information, regardless of program step or whether an exemption is requested.
                        <SU>89</SU>
                        <FTREF/>
                         This proposal would create a common foundation for the program through consistent, structured responses from all applicants. It would also ensure that NHTSA has a fundamental understanding of the systems and requested participation when making decisions on program admission and overseeing operations. NHTSA proposes that this information be furnished through an application form containing three parts: the Operational Baseline; Location Sheet(s); and a Reporting Confirmation Sheet.
                        <SU>90</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             An exemption would require an additional application form specific to that purpose, as discussed later in Section VII.C (Exemption Participation Requirements).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             An example form, based on the proposed requirements, is available in the docket for this rulemaking under the title “NPRM Example of AV STEP Application Form.”
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Operational Baseline</HD>
                    <P>
                        The Operational Baseline portion of an application would focus on critical characteristics of an operation. Section 597.201 of the proposed rule requires 14 items of information, most of which NHTSA proposes to make public because they reflect basic facts about the entity's requested participation.
                        <SU>91</SU>
                        <FTREF/>
                         These items are listed below, accompanied by a description of the expected level of detail:
                    </P>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             
                            <E T="03">See</E>
                             Section VI (Public Reporting Requirements (Regulatory Text Subpart G)).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Participation Category.</E>
                         An applicant would indicate whether it requests participation under Step 1 or Step 2.
                    </P>
                    <P>
                        <E T="03">Applicant(s).</E>
                         Each of the entities requesting to participate would need to be listed. An application could be submitted by a single applicant or multiple applicants (co-applicants). In either situation, every applicant would need to meet the eligibility requirements for participation set forth in § 597.103 of the proposed rule. This field would also require primary and secondary points of contact for each applicant.
                    </P>
                    <P>
                        <E T="03">Essential System-Level Stakeholders.</E>
                         Applicants would identify any entities that have a significant role in the safety of the operation covered by the application. At a minimum, these would include the vehicle manufacturer, the ADS developer, the fleet operator, and the system integrator. These entities would need to be listed regardless of whether they were applying for the program or would be participating in the proposed operation. This requirement is included because, whether active participants or not, the products or services they provide factor directly into the vehicle's system-level performance.
                    </P>
                    <P>
                        <E T="03">Vehicle Platform.</E>
                         Applicants would identify a baseline vehicle platform being used. This information includes the vehicle make, model, model year, unloaded vehicle weight,
                        <SU>92</SU>
                        <FTREF/>
                         Gross Vehicle Weight Rating (GVWR),
                        <SU>93</SU>
                        <FTREF/>
                         and vehicle class.
                        <SU>94</SU>
                        <FTREF/>
                         If the vehicle was certified as FMVSS compliant, the FMVSS certifying entity should also be listed in this field. Different vehicle models could not be considered a single vehicle platform for the purposes of this field,
                        <SU>95</SU>
                        <FTREF/>
                         and would instead require separate program applications. As long as all vehicles in an application were the same vehicle model, a single application could be used for different versions of the model, such as differences in the model year, trim level, or GVWR. NHTSA would review any differences within the vehicle model to decide whether any of the vehicles 
                        <PRTPAGE P="4143"/>
                        should participate separately. This approach would help to streamline individual applications and preserve the consistency of operations contained in a single application or participation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             
                            <E T="03">See</E>
                             49 CFR 571.3.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             
                            <E T="03">See</E>
                             49 CFR part 523.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             Even if the traditional use of the term “vehicle platform” often includes multiple vehicle models, NHTSA considers a narrower use of the term appropriate in this context. This narrower use is to account for any developers or manufacturers that do not characterize their purpose-built ADS vehicle platforms as vehicle models.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Sensing Suite.</E>
                         An applicant would identify any sensors, such as cameras, radar, lidar, and microphones, involved in the perception of the ADS.
                        <SU>96</SU>
                        <FTREF/>
                         For any such sensors on the vehicle, a response to this field would need to identify the specific sensor (
                        <E T="03">i.e.,</E>
                         make and model information), the type of sensor, its location on the subject vehicle, and its use in ADS operations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             ADS perception is defined in SAE International publication J3131 as “an ADS' capability to sense and characterize the entities, events, and situations, in its environment.” SAE International, “J3131 MAR2022: Definitions for Terms Related to Automated Driving Systems Reference Architecture,” Section 3.1.3, (Revised March 2022).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Crash Detection Capabilities.</E>
                         Applicants would detail the subject vehicle's crash detection capabilities including, if applicable, any units towed by the subject vehicle. This response would need to identify any limitations or thresholds for detecting physical contact relating to a crash. For example, if only certain scenarios involving debris impacts are identified as crashes, a response to this element should explain how those crashes are identified.
                    </P>
                    <P>
                        <E T="03">Certain Vehicle Modifications.</E>
                         An applicant would identify any modifications to safety features installed as original equipment on the subject vehicles, other than any modifications for which an AV STEP exemption is sought. Modifications associated with an exemption request would be identified in a response to the requirements detailed in Section VII.B (Exemption Application Requirements).
                    </P>
                    <P>
                        <E T="03">Data Logging.</E>
                         Applicants would identify the designed data-logging functionality, including the continuously recorded data and event-triggered data logged by a subject vehicle. For each type of data identified, an applicant would also need to describe the onboard or offboard storage protocols and the duration of data retention. For this element, NHTSA anticipates focusing on whether responses explain the scope of data logging for reporting required under AV STEP, such as the regular and event-triggered reporting in §§ 597.500 and 597.501 of the proposed rule.
                    </P>
                    <P>
                        <E T="03">Onboard Fallback Personnel.</E>
                         A response to this field would identify the seating position(s) of any onboard fallback personnel who may be physically present in the subject vehicle(s) during requested operations. Even though Step 2 applications would largely not rely on the presence of fallback personnel during participating operations, those applications should still list the seating positions of any onboard fallback personnel that may be present on a limited basis.
                        <SU>97</SU>
                        <FTREF/>
                         If the subject vehicles would never use fallback personnel, even on a limited basis, a response could indicate that this field is not applicable.
                    </P>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             The possibility of limited reliance on fallback personnel under Step 2 is discussed in Sections III.B (Program Steps) and V.A.2 (Event-Triggered Reporting).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Use of Remote Driving.</E>
                         A response to this field should indicate whether remote driving may be used to control a subject vehicle at any time during operation. Applicants would need to identify any restrictions in place for any planned use of remote driving, such as speed thresholds or limiting its use to locations with validated network strength. This response would inform whether NHTSA should permit narrow uses of remote driving in a Final Determination Letter beyond those allowed under § 597.105(j) of the proposed rule.
                        <SU>98</SU>
                        <FTREF/>
                         In addition, given the potential risks associated with remote driving,
                        <SU>99</SU>
                        <FTREF/>
                         NHTSA believes that information about the extent of remote driving in a participation should be publicly available. Accordingly, an application that involves remote driving would need to also include a public summary of limitations on the use of remote driving. NHTSA would publish this summary along with other information from an application, as discussed in Section VI (Public Reporting Requirements (Regulatory Text Subpart G)).
                    </P>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             More detailed information regarding the technical parameters and safety of any remote driving included in a participation request would also need to be provided to NHTSA under the requirements proposed in Section IV.B (Protocols for ADS Operations).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>99</SU>
                             
                            <E T="03">See</E>
                             supra n.80.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Use of Vehicle Assistance.</E>
                         A response to this field would need to indicate whether any remote or onboard vehicle assistance may be used to direct the subject vehicle at any time during a requested operation. The proposed rule defines vehicle assistance as an individual providing information or advice about a situation to an ADS-equipped vehicle in driverless operation (instead of performing the DDT for the vehicle) to help the ADS continue a trip when encountering a situation that the ADS cannot manage. Vehicle assistance may be provided remotely, by an individual not physically present in the vehicle,
                        <SU>100</SU>
                        <FTREF/>
                         or by an individual on board (physically present in) the vehicle.
                        <SU>101</SU>
                        <FTREF/>
                         Any applications indicating that vehicle assistance may occur would need to describe the specific capabilities that this assistance could entail.
                        <SU>102</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>100</SU>
                             For additional discussion of “remote assistance,” 
                            <E T="03">see</E>
                             SAE International, “J3016 APR2021: Taxonomy and Definitions for Terms Related to Driving Automation Systems for On-Road Motor Vehicles,” Section 3.23: Remote Assistance, (Revised April 2021).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>101</SU>
                             Unlike Fallback Personnel, as defined in this proposal, vehicle assistance personnel provide information or instruction to an ADS-equipped vehicle rather than directly exercising vehicle control authority.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             As with the preceding remote driving field, more detailed information regarding any vehicle assistance included in a participation request would also need to be provided to NHTSA, as detailed in Section IV.B (Protocols for ADS Operations).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Operational Permits Required.</E>
                         An application would indicate whether any other Federal, state, or local permits are required for the operations requested in the application. If so, the application should list each such permit, the regulatory entity requiring a permit, and the status of each permit. For any permits that have already been issued at the time of application, an applicant would need to identify the effective dates of each permit, describe any conditions imposed by those permits, and provide a copy of each such permit.
                    </P>
                    <P>
                        <E T="03">AV STEP Exemption.</E>
                         An application would indicate whether the request to participate in AV STEP includes a request for an AV STEP exemption. If so, an application would also need to include a separate exemption form that covers unique application requirements for the exemption.
                        <SU>103</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             
                            <E T="03">See</E>
                             Section VII.C (Exemption Application Requirements).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Accessibility.</E>
                         An application would summarize any features or design modifications of the vehicles that are the subject of an application that are intended to promote the safe accommodation of passengers with disabilities. This required disclosure would include any such features or modifications that are intended for passengers with physical, sensory, and cognitive disabilities—including passengers who use wheelchairs and other mobility equipment. NHTSA proposes to publish this summary to enable the public to understand the accessibility options offered in an operation.
                        <SU>104</SU>
                        <FTREF/>
                         NHTSA also proposes to require an application to include more information and technical detail about any such features or designs in response to the separate application requirements detailed in Section IV.B.3 (Operator, User, and Surrounding Road User Interactions). NHTSA encourages entities to include accessibility features for passengers with disabilities in their 
                        <PRTPAGE P="4144"/>
                        vehicle designs and believes that it is important for the public to understand the availability of such features.
                    </P>
                    <FTNT>
                        <P>
                            <SU>104</SU>
                             
                            <E T="03">See</E>
                             Section VI (Public Reporting Requirements (Regulatory Text Subpart G)).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Location Sheet</HD>
                    <P>The second proposed portion of an application is a Location Sheet. Each application would be required to contain at least one Location Sheet. An application that requests participation in multiple distinct locations would need to include a Location Sheet for each location. Entities may combine operations in multiple locations in the same application or participation, as long as the Operational Baseline characteristics of the operations remain the same across the locations.</P>
                    <P>
                        AV STEP's use of Location Sheets would provide enough flexibility for an operation to evolve over the course of time, including by adding more Location Sheets during participation as operations expand to new areas.
                        <SU>105</SU>
                        <FTREF/>
                         It would also reduce the administrative burden of applications and participations by enabling NHTSA to focus on the aspects of an operation unique to a particular location once the agency understands the baseline approach to an operation that would apply no matter where the operation occurs. The proposed rule would require applications to include the following information for each Location Sheet:
                    </P>
                    <FTNT>
                        <P>
                            <SU>105</SU>
                             The process for adding new Location Sheets during participation is discussed in Section V.B.1 (Amendment Process).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Location Name.</E>
                         Applicants would assign a unique reference name to the operation proposed in the Location Sheet. The Location Name field in a Location Sheet would provide a unique identifier for each location that a participation includes. Much of the reporting described in Sections V.A (Reporting Requirements) and VI (Public Reporting Requirements (Regulatory Text Subpart G)) is segmented by Location Sheet.
                    </P>
                    <P>
                        <E T="03">Location Limitation.</E>
                         Applicants would define the geographical boundaries for the operations in the Location Sheet, generally by using maps to define this boundary.
                        <SU>106</SU>
                        <FTREF/>
                         This field could be changed during an active participation, as discussed in Section V.B.1 (Amendment Process). However, this response should cover the full breadth of operations that are anticipated at the time of an application.
                    </P>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             For example, a .kmz/.kml file containing a varied map boundary could be provided. If operations would be constrained to specific route maps, this constraint should be reflected in a response to this field.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Maximum Number of Vehicles Proposed for Participation.</E>
                         An applicant would identify the maximum number of vehicles for which they seek to participate under the Location Sheet. This number could correspond to the actual number of vehicles that an applicant is ready to operate or reflect a projected number of vehicles.
                        <SU>107</SU>
                        <FTREF/>
                         During participation, the actual number of vehicles operating would be reported to NHTSA under the proposed periodic reporting requirements described in Section V.A.1 (Periodic Reporting).
                    </P>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             If an application requests such a projected number of vehicles, the application information would still need to support the full scope of requested operations.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Legal Speed Limits.</E>
                         This field would require information about the posted speed limits on roadways on which a vehicle plans to operate. An applicant would identify specific information for: (1) the road segments in an operation that have the highest legal speed limit; and (2) the road segments with the greatest speed differential between the legal speed limit and the maximum speed allowed for the ADS while operating on the road segment. NHTSA expects that the most efficient way to identify roadway segments will usually be pairs of GPS coordinates for the start and end points. However, an applicant could use other methods to identify the roadway segments, for example, if such segments represent a significant portion of an operation. NHTSA will use this information to understand the speeds of traffic around which a vehicle could operate and whether the vehicle could pose a risk by operating at different speeds from the surrounding traffic.
                    </P>
                    <P>
                        <E T="03">Vehicle Speeds.</E>
                         An application would identify the highest speed allowed for the ADS upon commencing participation at the location, as well as the highest speed for which participation is requested for the ADS at the location. In many cases, these two speeds may be the same. However, the two answers could diverge, such as if an ADS initially operates at lower speeds to complete further validation before planned speed increases are pursued.
                        <SU>108</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             As with any other proposed requirements, the application information would need to support the full scope of operations requested, even if it included projected future changes.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Public Ridership.</E>
                         An application would indicate whether the subject vehicle would carry public passengers during the requested operations.
                        <SU>109</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             The proposed rule refers to public passengers as “public ridership.” 
                            <E T="03">See</E>
                             § 597.102.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Intended Use.</E>
                         An applicant would describe the planned use or uses of vehicles during operations, such as a shuttle or ride hailing service, goods delivery, or research and development.
                        <SU>110</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>110</SU>
                             For an applicant seeking an exemption under 49 U.S.C. 30114(a), additional information on use would be required by the exemption portion of the application.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Operational Design Domain.</E>
                         An applicant would provide a complete specification of all aspects of the ODD. This response should be a detailed answer that comprehensively explains the entire ODD, which the proposed rule defines as “the operating conditions under which the automated driving system or feature thereof is specifically designed to function, including, but not limited to, environmental, geographical, and time-of-day restrictions, and/or the requisite presence or absence of defined traffic or roadway characteristics.” 
                        <SU>111</SU>
                        <FTREF/>
                         If an application contains multiple Location Sheets, a response to this element should identify any ODD differences among the Location Sheets. Several industry documents provide guidance on the specification of an ODD.
                        <SU>112</SU>
                        <FTREF/>
                         However, this general guidance may not necessarily address the full level of detail associated with an ADS developer's particular approach to defining its system's ODD. NHTSA seeks comment on incorporating any such guidance into the regulation or otherwise specifying the form in which minimum information about the proposed ODD should be described in an application. An applicant would also need to include a public summary of the ODD. NHTSA proposes to publish this summary along with other information about an application or participation. The public reporting section of this document describes those aspects of the proposal.
                        <SU>113</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>111</SU>
                             
                            <E T="03">See</E>
                             § 597.102 of the proposed rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             
                            <E T="03">See, e.g.,</E>
                             International Organization for Standardization, “ISO 34503: Road Vehicles—Test scenarios for automated driving systems—Specification for operational design domain” (2023); 
                            <E T="03">and</E>
                             Automated Vehicle Safety Consortium (AVSC), “AVSC00002202004: Best Practice for Describing an Operational Design Domain: Conceptual Framework and Lexicon” (2020).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>113</SU>
                             
                            <E T="03">See</E>
                             Section VI (Public Reporting Requirements (Regulatory Text Subpart G)).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Vehicle Equipment.</E>
                         An applicant would describe how several attributes of a vehicle covered by the Location Sheet compare to the base model of the vehicle. This information would help NHTSA gauge whether differences in the same vehicle model may need to be considered during the application review. This field should disclose how three categories of equipment or vehicle characteristics compare between the subject vehicle and the base model, if applicable: (1) any trim level characteristics that affect safety; (2) any 
                        <PRTPAGE P="4145"/>
                        optional technologies that affect safety; and (3) any other distinguishing safety characteristics. If an application contains multiple Location Sheets, a response to this element should also identify any differences among the Location Sheets. For example, if sensor heating elements are used in one location but not necessary in another, that information should be provided in response to this field.
                    </P>
                    <HD SOURCE="HD3">3. Confirmation of Reporting During Participation</HD>
                    <P>The third portion of the application form would focus on information necessary to carry out the reporting requirements discussed in Section V.A (Reporting Requirements) if an applicant is admitted for participation.</P>
                    <P>
                        First, an applicant would need to confirm its ability to carry out all of the AV STEP reporting requirements if approved for participation. Some reporting requirements may require coordination with third parties, such as Essential System-Level Stakeholders that are not participants, or may involve specific technical capabilities. This confirmation would ensure that an applicant understands these responsibilities up front. If an application has a single applicant, that applicant would be responsible for compliance with all of the reporting requirements. If an application has multiple co-applicants, they could collectively meet the reporting requirements. If reporting responsibilities are to be shared by co-applicants, a response to this element should explain which entity would be primarily responsible for meeting each reporting requirement that is set forth in Subpart E of the proposed rule.
                        <SU>114</SU>
                        <FTREF/>
                         In addition to clarifying reporting responsibilities for co-applicants, this proposed requirement would ensure that data generation and processing capabilities support the AV STEP reporting elements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>114</SU>
                             Even if reporting is shared among multiple participants, NHTSA proposes that it may suspend, revoke, or take other appropriate action to address a failure to fully comply with all reporting required under AV STEP by any participant.
                        </P>
                    </FTNT>
                    <P>Second, this portion of the application would solicit proposals for “customized” reporting terms. For reporting requirements designated as customized, NHTSA has proposed the subject matter for a required report but has not defined a specific metric or threshold for the reporting. Applications would need to propose specific metrics or thresholds to be used for the terms of the reporting. Each such proposal should be informed by the independent assessment submitted in an application (and described further in Section IV.D, Independent Assessment). In developing these proposals, applicants should consider the extent to which the proposed reporting would support an evaluation of the operation, performance, and safety of the subject vehicles. Each proposal should be accompanied by enough information to allow NHTSA to interpret the proposed metrics or thresholds, as well as explain their value and relevance to the applicable requirement. In Section V.A (Reporting Requirements), NHTSA provides high-level examples of potential terms for each of the proposed customized requirements.</P>
                    <P>The current state of ADS technology necessitates flexibility in reporting certain subjects. Even so, these subjects represent important safety considerations for any ADS operation. Establishing customized terms would provide this necessary flexibility while ensuring meaningful reporting. The proposed approach to customized requirements would enable NHTSA to consider the value of these different types of reporting metrics and thresholds across various participants.</P>
                    <HD SOURCE="HD2">B. Protocols for ADS Operations</HD>
                    <P>
                        Section 597.204 of the proposed rule would require applications to explain two types of protocols critical to the safety of subject vehicle operations. The first pertains to the ADS' compliance with traffic safety laws and the second covers situations where an ADS is unable to continue performing the driving task reliably. These protocols both relate to how an ADS will execute roadway responsibilities that may arise during an operation. Detailed information regarding each of these topics in an application would provide necessary context for the proposed reporting on these topics that would occur during participation.
                        <SU>115</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             
                            <E T="03">See</E>
                             Section V.A (Reporting Requirements).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Law Abidance</HD>
                    <P>Compliance with traffic safety laws and local requirements for operating is a critical aspect of safety for ADS-equipped vehicles on public roads. Section 597.204(a) of the proposed rule lists four elements of information required in an application that would enable NHTSA to consider an applicant's strategy for complying with Federal, state, and local laws that apply to the subject vehicles or their operations.</P>
                    <P>
                        A response to this element would, at minimum, summarize how applicable traffic safety laws are identified (including both initially and during operations), describe how an ADS' compliance with traffic safety laws is monitored,
                        <SU>116</SU>
                        <FTREF/>
                         and describe any conditions under which the design of the ADS may allow the subject vehicle to violate traffic laws. A response would also need to summarize recognition, interaction, and response strategies for emergency, law enforcement, and construction vehicles, personnel, and equipment, as well as crossing guards and other traffic control personnel. The response should cover laws that explicitly address ADS-equipped vehicles as well as those that apply to road users more broadly.
                        <SU>117</SU>
                        <FTREF/>
                         NHTSA recognizes that in some situations, temporary deviations from traffic safety laws may be necessary to safely react to roadway conditions. Many traffic safety laws specifically allow for such exigencies. The information provided in response to this element is intended to help NHTSA understand the ADS' approach to determining what behavior is appropriate in these situations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>116</SU>
                             As noted elsewhere by NHTSA, vehicle automation features that contribute to behaviors that cause traffic violations can constitute a motor vehicle defect. This has been demonstrated by partial driving automation system recalls relating to such incidents. 
                            <E T="03">See</E>
                             Tesla, Inc., “Part 573 Safety Recall Report, Recall No. 23V-085” (February 15, 2023), available at 
                            <E T="03">https://static.nhtsa.gov/odi/rcl/2023/RCLRPT-23V085-3451.PDF.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>117</SU>
                             A response to this element would not need to include “unwritten rules of the road” or “implicit traffic rules,” which are phrases used within the industry to refer to behaviors associated with good roadway citizenship that are not typically defined by traffic laws. However, these concepts would likely be relevant to other aspects of an application, such as certain claims and evidence in the safety case that would be reviewed by an independent assessment. For further discussion of these concepts, see, 
                            <E T="03">e.g.,</E>
                             Mobileye Technologies Ltd., “The Unwritten Rules of the Road, Codified in RSS” (February 2023), available at 
                            <E T="03">https://www.mobileye.com/blog/responsibility-sensitive-safety-unwritten-rules-of-the-road/</E>
                             and Aptiv et al., “Safety First for Automated Driving” (2019), available at 
                            <E T="03">https://static.mobileye.com/website/corporate/media/Intel-Safety-First-for-Automated-Driving.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        An applicant's response to this element should also describe a vehicle's response plans for emergency, law enforcement, and other traffic control interactions. In particular, this response would help the agency evaluate how ADS technologies interact with first responders. An ADS-equipped vehicle's behavior should be easily anticipated and understood by these personnel during such interactions.
                        <SU>118</SU>
                        <FTREF/>
                         NHTSA would use this information to consider whether the ADS may negatively affect safety-critical functions performed by first responders.
                    </P>
                    <FTNT>
                        <P>
                            <SU>118</SU>
                             
                            <E T="03">See</E>
                             AVSC, “AVSC00005202012: Best Practice for First Responder Interactions with Fleet-Managed Automated Driving System-Dedicated Vehicles (ADS-DVs)” (December 2020).
                        </P>
                    </FTNT>
                    <PRTPAGE P="4146"/>
                    <HD SOURCE="HD3">2. System Fallback Response</HD>
                    <P>
                        Section 597.204(b) of the proposed rule would require an application to explain protocols surrounding ADS failure scenarios. The response of an ADS-equipped vehicle to these situations is varyingly referred to as minimal risk maneuvers (MRMs), fallback strategy, failsafe response, or other similar terms. For simplicity, this proposal refers to the achievement of a minimal risk condition (MRC), which is defined in the proposed rule as “a stable, stopped condition to which a user or an ADS may bring a vehicle after performing the DDT fallback, including after a DDT takeover, to reduce the risk of a crash when a given trip cannot or should not be continued.” 
                        <SU>119</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>119</SU>
                             
                            <E T="03">See</E>
                             § 597.102 of the proposed rule. This proposed definition is derived from SAE International's definition of an MRC: “a stable, stopped condition to which a user or an ADS may bring a vehicle after performing the DDT fallback in order to reduce the risk of a crash when a given trip cannot or should not be continued.” SAE International, “J3016 APR2021: Taxonomy and Definitions for Terms Related to Driving Automation Systems for On-Road Motor Vehicles,” (Revised April 2021).
                        </P>
                    </FTNT>
                    <P>
                        NHTSA proposes to require an applicant to describe any system fallback strategies or designs, as well as any protocols for their execution or activation. A response to this element should describe any MRCs that might be undertaken by the subject ADS. This description should identify the circumstances under which each MRC would be triggered, detail how MRMs to achieve each MRC would be initiated and executed, and explain any protocols for the ADS following the achievement of each MRC. An applicant should also explain the engineering rationale for selecting each MRC and setting triggering conditions for them.
                        <SU>120</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>120</SU>
                             For example, do the trigger conditions fully capture any feasible ODD exits, such as sudden weather changes?
                        </P>
                    </FTNT>
                    <P>In addition, an applicant would need to provide an overview of any other protocols associated with averting or achieving a minimal risk condition. This response should focus on protocols that apply to individuals who may interact with the vehicle rather than protocols that are followed by the ADS. This would include any protocols for providing input to the ADS or disengaging the ADS prior to or during an MRM, resuming ADS driving following the achievement of an MRC, and vehicle recovery. This information would provide NHTSA additional context for the MRC strategies employed by an operation, such as the role of any vehicle assistance or onboard test drivers and potential impacts to traffic after an MRC is achieved.</P>
                    <P>
                        To further understand these issues, NHTSA proposes to require a response to this element to provide information about the personnel responsible for each such protocol. This response should include the role and number 
                        <SU>121</SU>
                        <FTREF/>
                         of responsible personnel and each such personnel's: (1) responsibilities under the protocol, (2) physical location when performing those responsibilities, (3) expected response time in performing those responsibilities, (4) potential control authority over the subject vehicle, (5) means of exercising that control authority, and (6) any operational restrictions on the use of that control authority. In addition to informing NHTSA's review of an application, this information would contribute to the agency's assessment, during operations that occur under an AV STEP participation, of whether an ADS-equipped vehicle responded appropriately after an incident occurred.
                    </P>
                    <FTNT>
                        <P>
                            <SU>121</SU>
                             For example, a minimum number of personnel in a certain role who would be available to respond relative to a given number of subject vehicles operating on-road.
                        </P>
                    </FTNT>
                    <P>Lastly, NHTSA proposes to require that an application describe any protocols for vehicle immobilizations that occur without the achievement of an MRC. This description could include protocols for responding to a crash or a catastrophic vehicle failure that results in a vehicle immobilization that the ADS did not initiate. For example, a vehicle could coast to a stop after loss of all motive power.</P>
                    <HD SOURCE="HD3">3. User and Surrounding Road User Interactions</HD>
                    <P>This section of an application is intended to consider the safety of members of the public who may interact with the vehicles that are the subject of an application. Section 597.204(c) of the proposed rule would require that an application include an overview of any design and process measures that are in place to facilitate safe and predictable interactions with members of the public. This element does not include the inherent functionality of the ADS, such as the object and event detection and response (OEDR) involved in avoiding collisions. Although that ADS functionality is, of course, crucial to the safety of both occupants and surrounding road users, an application would need to cover it separately in response to the independent assessment requirements in Section IV.D (Independent Assessment).</P>
                    <P>To focus the information provided in response to this element, the proposed rule contains four sub-elements of required information. The first three relate to communication and behavioral strategies for promoting safe and predictable interactions with the subject vehicle. NHTSA considers such predictability an important aspect of ADS safety. Through ADS crash reporting, NHTSA has observed incidents in which the unexpected behavior of an ADS-equipped vehicle may have contributed to a collision even when the ADS was operating as intended. The following are the sub-elements relating to communication and behavioral strategies:</P>
                    <P>• Any communication strategies to convey information to individuals outside of a subject ADS-equipped vehicle, including individuals with physical, sensory, and cognitive disabilities;</P>
                    <P>
                        • Any measures to promote the predictability of the ADS' behavior for other road users in the vicinity of the subject vehicle. This response should include information about how the ADS accounts for “unwritten rules of the road” or “roadmanship.” 
                        <SU>122</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>122</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Fraade-Blanar, Laura, Marjory S. Blumenthal, James M. Anderson, and Nidhi Kalra, “Measuring Automated Vehicle Safety: Forging a Framework. Santa Monica,” CA: RAND Corporation (2018), available at 
                            <E T="03">https://www.rand.org/pubs/research_reports/RR2662.html.</E>
                        </P>
                    </FTNT>
                    <P>
                        • Any communication strategies for non-operator occupants of the subject ADS-equipped vehicle. This disclosure would be expected to encompass the communication of safety information or the availability of safety controls to occupants of the subject vehicles who are not operators. Examples of responses to this sub-element could include a system's logic for communicating with occupants about whether they are wearing a seat belt during a trip or ways in which a passenger could initiate an emergency stop.
                        <SU>123</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>123</SU>
                             
                            <E T="03">See</E>
                             AVSC, “AVSC00003202006: Best Practice for Passenger-Initiated Emergency Trip Interruption” (June 2020).
                        </P>
                    </FTNT>
                    <P>NHTSA also proposes a fourth sub-element, which would focus on the applicant's approach to ensuring safe and predictable interactions for passengers with disabilities. An application would need to include information in response to this fourth sub-element regarding the response to the Operational Baseline question about accessibility of subject vehicles containing features or design modifications that are intended to promote the safe accommodation of passengers with disabilities. NHTSA proposes for this sub-element to cover:</P>
                    <P>
                        • Any features or design modifications that are intended to promote safe accommodation of passengers with disabilities. Information 
                        <PRTPAGE P="4147"/>
                        provided in response to this sub-element should describe how, under this design, passengers with physical, sensory, and cognitive disabilities—including passengers who use wheelchairs and other mobility equipment—would safely locate and enter the vehicle, secure themselves and any mobility equipment, input information, interact with the ADS in routine and emergency situations, communicate with any support personnel in such situations, and exit the vehicle.
                    </P>
                    <P>Promoting the safety of passengers with disabilities is critical for ADS-equipped vehicles to reach their full potential for improving accessible options for mobility. The availability of ADS-equipped vehicles with effective accessibility features would enable greater choice, independence, and access to needed transportation for people with physical, sensory, and cognitive disabilities, as well as others whose current transportation options are limited, such as older adults. However, these benefits cannot be realized without intentional inclusive design choices that consider the needs of such individuals. NHTSA requests comment on this approach to considering the safety of accessible design choices, as well as whether any safety data specific to the experience of passengers with disabilities should be collected as part of AV STEP and how it could inform the program.</P>
                    <HD SOURCE="HD2">C. Data Governance Plan</HD>
                    <P>
                        ADS-equipped vehicles depend on an array of sensors, computer systems, and electronic communications. These technologies introduce cyber risks. To promote good cybersecurity practices for modern vehicles, NHTSA has embraced a multi-faceted approach that leverages industry consensus standards 
                        <SU>124</SU>
                        <FTREF/>
                         and encourages industry to adopt practices that improve the cybersecurity posture of their vehicles. NHTSA has also issued voluntary guidance on cybersecurity best practices for all motor vehicles.
                        <SU>125</SU>
                        <FTREF/>
                         The agency requests comment on how participants should validate to NHTSA that they have taken the proper precautions in evaluating and mitigating cyber risks associated with ADS operations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>124</SU>
                             
                            <E T="03">See</E>
                             Section IV.D.1.a) (Conformance with Industry Standards).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>125</SU>
                             NHTSA, “Cybersecurity Best Practices for the Safety of Modern Vehicles” (September 2022), available at 
                            <E T="03">https://www.nhtsa.gov/sites/nhtsa.gov/files/2022-09/cybersecurity-best-practices-safety-modern-vehicles-2022-tag.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        While NHTSA is not proposing that participations meet specific cybersecurity standards, this section proposes to require that an application contain a governance plan for data relevant to AV STEP. This plan would outline the applicant's processes for managing the data to ensure its integrity and security. Participants would need a continuous stream of reliable data to responsibly monitor the safety of their ADS operations and comply with the proposed reporting requirements for AV STEP.
                        <SU>126</SU>
                        <FTREF/>
                         NHTSA requests comment on seven potential subjects for the data management plan, listed in § 597.207 of the proposed rule.
                        <SU>127</SU>
                        <FTREF/>
                         In general, these subjects consider organizational processes, including any safeguards or shared responsibilities for operations in which data are available to multiple stakeholders or jointly managed. These seven subjects are listed below, accompanied by a description of the expected level of detail: 
                        <SU>128</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>126</SU>
                             Subpart E of the proposed rule outlines required data reporting during participation.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>127</SU>
                             These subjects would supplement the data logging information that would be required for an application under § 597.201(f) of the proposed rule, as discussed in Section IV.A.1 (Operational Baseline).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>128</SU>
                             NHTSA expects that some applications may jointly respond to some of these subjects if information responsive to one is also responsive to others.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">A top-level accountability and management process for the data governance plan, including a description of the applicable positions and roles.</E>
                         An explanation of the relevant processes for each stakeholder that generates or accesses the data,
                        <SU>129</SU>
                        <FTREF/>
                         including the titles and responsibilities of key individuals.
                    </P>
                    <FTNT>
                        <P>
                            <SU>129</SU>
                             Such as an ADS developer and fleet operator for operations in which these are different entities.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Access control mechanisms to maintain data security and privacy.</E>
                         Training or procedures for granting data access, the means of authenticating such access, and anonymization processes—particularly to the extent they may impact the safety value of the data. This disclosure should include information regarding the protections in place for both onboard vehicle data logging and physical or wireless data transmission.
                    </P>
                    <P>
                        <E T="03">Processes for maintaining data quality and integrity.</E>
                         Detection and correction of data corruption and data processing errors.
                    </P>
                    <P>
                        <E T="03">Monitoring and enforcement mechanisms for adherence to the plan.</E>
                         How applicants would oversee the governance plan, such as through automated mechanisms or spot-checking, to ensure that the plan is followed.
                    </P>
                    <P>
                        <E T="03">Procedures for identifying and responding to incidents that compromise data security or integrity.</E>
                         How the responsible parties would recognize that an incident has occurred 
                        <SU>130</SU>
                        <FTREF/>
                         and react to it, including monitoring for and responding to cybersecurity incidents.
                    </P>
                    <FTNT>
                        <P>
                            <SU>130</SU>
                             Including, for instance, if an applicant has a process for quantifying a level of confidence that an incident would be identified, a response to this element could describe those calculations.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Risk management strategies for mitigating internal and external data-related risks, including cybersecurity risks.</E>
                         Risk management strategies not already addressed by other elements in this subsection, such as data backup protocols.
                    </P>
                    <P>
                        <E T="03">A list of any published industry standards, guidance, or best practices with which the plan conforms.</E>
                         This element does not propose to prescribe standards to which a process must conform. However, if an applicant claims conformance with any standards, those standards would need to be identified in response to this element.
                        <SU>131</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>131</SU>
                             While many potentially relevant standards exist, one example of such a standard is the International Organization for Standardization's road vehicle standard: “Safety and Cybersecurity for Automated Driving Systems—Design, Verification and Validation.” (2020).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">D. Independent Assessment</HD>
                    <P>
                        NHTSA proposes to require that AV STEP applications contain assessments conducted by an independent third party. The independent assessment requirements are proposed to enhance the efficiency and efficacy of NHTSA's review. An assessment from a third party with expertise in the subject technologies would provide value to this process. In rapidly evolving technology fields, such as ADS, independent assessments provide an opportunity for the oversight of such technologies to remain agile and adapt with the changing state of the art, while also more efficiently managing voluminous data.
                        <SU>132</SU>
                        <FTREF/>
                         The ADS technologies in AV STEP applications would be complex, technically specialized, and accompanied by extensive documentation. An independent assessor's review would streamline NHTSA's review by pinpointing important aspects of a system and add a neutral perspective on 
                        <PRTPAGE P="4148"/>
                        an applicant's claims. In addition, the proposed assessments would provide NHTSA with insight into the value of different third-party ADS review methodologies and subject matters.
                    </P>
                    <FTNT>
                        <P>
                            <SU>132</SU>
                             Outside of the automotive industry, independent assessments have long existed as standard practice for sophisticated technologies, such as software systems. For instance, industry standards and best practices for third-party audits of software systems have been in place for decades and provide routine and pivotal support for many aspects of software development. 
                            <E T="03">See, e.g.,</E>
                             Institute of Electrical and Electronics Engineers, “IEEE 1028-2008: IEEE Standard for Software Reviews and Audits” (August 2008); International Organization for Standardization, “ISO/IEC 20246:2017: Software and systems engineering—Work product reviews” (February 2017).
                        </P>
                    </FTNT>
                    <P>
                        These assessments would be informative but not determinative. A favorable assessment would not necessarily lead to admission into AV STEP. Instead, NHTSA would consider the perspective provided by an assessment along with the full context of the other application materials. This role resembles NHTSA's engagement with third parties in other oversight activities.
                        <SU>133</SU>
                        <FTREF/>
                         Likewise, the automotive industry often uses third parties to assess vehicle design or corporate processes. The proposed assessment for AV STEP builds on these practices.
                        <SU>134</SU>
                        <FTREF/>
                         NHTSA seeks comment on the proposed independent assessment, particularly regarding the scope, timing, and logistics of reviews and assessor qualification requirements and disclosures.
                    </P>
                    <FTNT>
                        <P>
                            <SU>133</SU>
                             Examples include third parties performing failure analyses in defects investigations, contractors adding specialized expertise in vehicle testing, and independent monitors promoting accountability in regulatory compliance oversight.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>134</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Pete Bigelow, “Self-driving tech companies take a hard look at their own blind spots, Automotive News,” (October 14, 2024), available at 
                            <E T="03">https://www.autonews.com/mobility-report/autonomous-driving-companies-seek-independent-safety-reviews/.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Focus of Independent Assessment</HD>
                    <P>AV STEP proposes a comprehensive independent assessment of the subject vehicles, which would encompass an applicant's holistic approach to vehicle safety. This assessment would consider the full extent of ADS operations requested in an application. The proposed rule organizes this assessment around three subjects: (a) conformance with relevant industry standards, best practices, and guidance; (b) a safety case, including safety management systems; and (c) specific policies and capabilities.</P>
                    <P>NHTSA proposes to apply the same independent assessment requirements for applications requesting participation under Step 1 and Step 2. However, an independent assessment at Step 2 would need to be more rigorous because it would need to consider whether the ADS could be exclusively relied on during operations. In contrast, an independent assessment at Step 1 could consider the fallback personnel's ability to mitigate certain risks rather than fully reviewing the ADS' ability to address those risks. For instance, a review of a Step 1 safety case could consider safety claims to be satisfied by fallback personnel even if the evidence available for the ADS would not support those claims. In contrast, at Step 2, an ADS would be solely responsible for the DDT within its ODD, and the independent assessment would need to reflect these heightened expectations.</P>
                    <HD SOURCE="HD3">(a) Conformance With Industry Standards</HD>
                    <P>
                        First, NHTSA proposes to require third-party review of the conformance of subject vehicles with relevant industry standards, best practices, and guidance pertaining to the design, development, or operation of the ADS.
                        <SU>135</SU>
                        <FTREF/>
                         Industry standards are established through consensus processes in which a written standard is refined by the collective contributions of members of the standard-setting bodies, who possess substantial expertise. Industry standards conformance provides valuable insight into safety design and the extent to which applicants adopt state-of-the-art practices. Considering industry standards conformance also aligns with the goals of the National Technology Transfer and Advancement Act of 1995 (NTTAA).
                        <SU>136</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>135</SU>
                             While not all best practices or guidance may be considered “standards,” for simplicity, they are collectively referred to as “standards” or “industry standards” hereafter.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>136</SU>
                             
                            <E T="03">See</E>
                             Public Law 104-113 (1996).
                        </P>
                    </FTNT>
                    <P>For the conformance review, an independent assessment would need to consider which industry standards are relevant to the ADS under review. Because the relevant standards will likely differ based on the system in question and the standards used by a manufacturer during the development process, NHTSA is not currently proposing to prescribe particular standards with which conformity is required. This flexibility accounts for the current early stage of industry standards pertaining to ADS, which continue to evolve along with the technologies. A variety of standards currently exist, with the approaches of some standards overlapping or conflicting with others. Affording an assessor the flexibility to identify the most relevant standards in place at the time of the assessment would allow the assessment to adapt to the ADS safety community's prevailing views on safety approaches and best practices.</P>
                    <P>For the standards identified as relevant, the independent assessment would need to determine full conformance, partial conformance, or nonconformance with each standard. If an entity had previously obtained an independent assessment for a standard (such as for an applicant's internal purposes), NHTSA anticipates that a third party conducting an assessment for AV STEP could consider this prior review instead of re-assessing to the standard. To do so, the third-party assessor for AV STEP would need to verify the approach, results, and continued applicability of the prior assessment.</P>
                    <P>
                        For each standard with which partial conformance or nonconformance is determined, an assessor would also need to assess any justification provided by an applicant for not conforming with the standard or portion of the standard and consider any potential safety implications of the nonconformances. If a third-party reviewer's reasoning for not assessing conformance with a published industry standard relies upon an alternative standard,
                        <SU>137</SU>
                        <FTREF/>
                         the reviewer should assess conformance with the alternative standard and explain how the two standards compare.
                    </P>
                    <FTNT>
                        <P>
                            <SU>137</SU>
                             This alternative standard could include a standard used in the entity's development process, such as a company-specific standard, in lieu of a comparable published standard.
                        </P>
                    </FTNT>
                    <P>In addition, the independent assessment would need to evaluate whether, collectively, the degree of conformance with relevant standards represents a responsible approach to developing and operating the subject vehicles. Despite the evolving landscape of industry standards, understanding how an ADS conforms to industry standards in the aggregate would help NHTSA ascertain the level of due diligence applied to the system's development. Disregarding industry standards without carefully considering how the safety goals of those standards could be met may be indicative of whether the system was developed in a responsible way that reflects state-of-the-art safety practices for ADS.</P>
                    <P>Finally, to inform how the assessed approach to industry standards should shape any further development of the system, an assessor would also need to provide recommendations regarding: (1) the list of industry standards with which conformance should, in full or in part, be achieved or maintained during operations; and (2) how to address any safety gaps that would not be covered even if this recommended conformance was met. Collectively, the recommendations regarding these two subjects would help NHTSA consider the practical impacts of the reviewed approach to industry standards.</P>
                    <HD SOURCE="HD3">(b) Safety Case</HD>
                    <P>
                        The second subject for which NHTSA proposes to require an independent assessment is the safety
                        <FTREF/>
                         case 
                        <SU>138</SU>
                          
                        <PRTPAGE P="4149"/>
                        detailing how the safety of the subject vehicle, including the safety of the vehicle's occupants and surrounding road users, is assured for the operations requested in an application. Many diverse stakeholders have generally encouraged the agency to consider such safety cases for ADS. For example, in response to NHTSA's 2020 “Framework for ADS Safety” Advance Notice of Proposed Rulemaking (ANPRM),
                        <SU>139</SU>
                        <FTREF/>
                         a wide variety of organizations—including consumer advocacy groups,
                        <SU>140</SU>
                        <FTREF/>
                         ADS developers,
                        <SU>141</SU>
                        <FTREF/>
                         and local authorities 
                        <SU>142</SU>
                        <FTREF/>
                        —advocated for NHTSA to collect and review safety cases. Such comments informed the safety case review requirements that NHTSA proposes in this subsection.
                    </P>
                    <FTNT>
                        <P>
                            <SU>138</SU>
                             This proposal defines a safety case as “a structured argument, consisting of claims supported by a body of evidence, that provides a complete, 
                            <PRTPAGE/>
                            comprehensible, and valid case that a system is acceptably safe for a given use in a specified environment.” 
                            <E T="03">See</E>
                             § 597.102 of the proposed rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>139</SU>
                             85 FR 78058 (December 3, 2020).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>140</SU>
                             Center for Automotive Safety, Docket No. NHTSA-2020-0106, Comment ID NHTSA-2020-0106-0763 (April 2, 2021), available at 
                            <E T="03">https://www.regulations.gov/comment/NHTSA-2020-0106-0763.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>141</SU>
                             Waymo, Docket No. NHTSA-2020-0106-0771 (April 28, 2021), available at 
                            <E T="03">https://www.regulations.gov/comment/NHTSA-2020-0106-0771.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>142</SU>
                             City of New York, Docket No. NHTSA-2020-0106-0764 (April 2, 2021), available at 
                            <E T="03">https://www.regulations.gov/comment/NHTSA-2020-0106-0764.</E>
                        </P>
                    </FTNT>
                    <P>
                        In general, an independent assessment of an applicant's safety case would be required to review the validity and soundness of the safety case. This review would entail considering whether the safety case claims for the operations of the subject vehicle are supported by sufficient evidence, as well as whether appropriate processes exist for maintaining the safety case throughout the operations. Where a standardized safety case framework has been adopted,
                        <SU>143</SU>
                        <FTREF/>
                         or where conformance with industry standards supports safety case claims, this safety case assessment could incorporate the industry standards assessment described in the prior subsection.
                    </P>
                    <FTNT>
                        <P>
                            <SU>143</SU>
                             Such as that published by the UL Standards and Engagement organization: American National Standards Institute (ANSI), “UL Standard ANSI/UL4600: Standard for Evaluation of Autonomous Products:” (March 2022).
                        </P>
                    </FTNT>
                    <P>As with industry standards for ADS more generally, standardized safety case frameworks for ADS have not yet been universally adopted. A variety of approaches to arguing the safety of ADS design and operations are currently used across the ADS safety community. NHTSA currently prefers to encourage the evolution of these different approaches so that their maximum potential benefit can be realized. This proposal does not prescribe a specific format for safety cases. However, to mitigate the potential for variability in safety cases, NHTSA proposes to require assessment of a set of minimum considerations fundamental to operational safety.</P>
                    <P>Specifically, the proposed rule would require detailed analysis for these nine aspects of a safety case:</P>
                    <P>
                        <E T="03">Safety Risk Assessment.</E>
                         Whether the safety case comprehensively identifies and assesses safety risks, including potential vehicle and operational hazards and faults.
                    </P>
                    <P>
                        <E T="03">Safety Risk Management.</E>
                         Whether the safety case contains appropriate risk management, including mitigations, for the risks identified.
                    </P>
                    <P>
                        <E T="03">System Evolution.</E>
                         Whether the safety case contains appropriate processes for maintaining or improving safety over time.
                    </P>
                    <P>
                        <E T="03">Safety Performance Indicators.</E>
                         Whether the safety case relies on appropriate safety performance indicators and thresholds.
                    </P>
                    <P>
                        <E T="03">Conformance with Traffic Safety Law.</E>
                         Whether appropriate processes exist for identifying applicable traffic safety laws in an area of operation and overseeing their conformance during operations.
                    </P>
                    <P>
                        <E T="03">Vehicle Fallback and Assistance.</E>
                         Whether the safety case contains appropriate processes for ensuring the effectiveness of any expected fallback or vehicle assistance.
                    </P>
                    <P>
                        <E T="03">Human Factors.</E>
                         Whether the safety case appropriately accounts for human factors considerations that may affect safety, including, where applicable, those related to fallback personnel, vehicle assistance, vehicle occupants, or surrounding road users.
                    </P>
                    <P>
                        <E T="03">Crash Avoidance.</E>
                         Whether the safety case appropriately identifies and considers the variety of crash-imminent situations that could occur within the operations.
                        <SU>144</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>144</SU>
                             This should cover the full extent of potential crash circumstances within the system's ODD, including the full range of environmental conditions, such as poor lighting or adverse weather conditions, as well as the full range of other road users that a subject vehicle could encounter, such as those using mobility aids or those with sensory impairments.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Tool Qualification.</E>
                        <SU>145</SU>
                        <FTREF/>
                         Whether software tools used to evaluate expected ADS performance are representative and accurate.
                    </P>
                    <FTNT>
                        <P>
                            <SU>145</SU>
                             For further discussion of tool qualification, particularly with regards to summarizing the tool qualification approaches outlined by industry consensus standards, including ISO 26262, 
                            <E T="03">see, e.g.,</E>
                             M. Conrad, G. Sandmann, and P. Munier, “Software Tool Qualification According to ISO 26262” (April 2011), available at 
                            <E T="03">https://www.mathworks.com/content/dam/mathworks/tag-team/Objects/s/68068-2011-01-1005-mathworks.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        These nine aspects of the safety case review would probe the robustness of the analytical framework used to develop and oversee the ADS. In addition, NHTSA proposes for an assessment of the safety case to further evaluate the safety processes that govern such development and oversight by also including a review of the safety management systems 
                        <SU>146</SU>
                        <FTREF/>
                         in place to oversee the safety of subject vehicles, including during development and operations. This review should focus on the organizations responsible for the safety of operations involving the subject vehicles, including any Essential System-Level Stakeholders that would remain engaged with an operation during AV STEP participation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>146</SU>
                             
                            <E T="03">See, e.g.,</E>
                             AVSC, “AVSC00007202107: Information Report for Adapting a Safety Management System (SMS) for Automated Driving System (ADS) SAE Level 4 and 5 Testing and Evaluation” (July 2021).
                        </P>
                    </FTNT>
                    <P>As with the prior elements, NHTSA is not prescribing a specific type of safety management system for this requirement but, instead, proposes eight elements for the required review:</P>
                    <P>• Whether the leadership fosters a positive safety culture and demonstrates a safety commitment throughout the organization. This element focuses on how leadership support for safety management policies may affect their use in the organization. For instance, if leadership prioritizes achieving development milestones in a way that tacitly discourages internal reporting of safety concerns, internal reporting policies that read well may not be followed in practice. Such policies are more likely to reach their full potential if leadership rewards identifying and resolving safety issues early.</P>
                    <P>• Whether those responsible for the implementation of the safety management systems possess appropriate resources, authorities, and accountability. This element would include considerations that affect the responsibilities of the workforce that would oversee safe ADS operations. A review under this element may span working conditions, such as work intensity, fatigue risk, shift length, length between shifts, and human-to-vehicle ratios for fallback or vehicle assistance personnel.</P>
                    <P>• Whether there are appropriate policies and processes for encouraging the reporting and timely investigation of safety-related concerns from internal staff and members of the public.</P>
                    <P>• Whether appropriate capabilities and policies exist for monitoring the location and state of each participating vehicle.</P>
                    <P>
                        • Whether appropriate processes exist to monitor safety performance indicators.
                        <PRTPAGE P="4150"/>
                    </P>
                    <P>• Whether sufficient capabilities and policies exist for timely responding to a vehicle incident or immobilization and, if necessary, to clear a disabled vehicle from the roadway. This review must estimate a range of time for an expected response.</P>
                    <P>• Whether an appropriate plan exists for reaching timely decisions regarding future operations if an emergency arises. For instance, this element should consider the decision-making processes for determining when and how operations should be curtailed or paused after an incident.</P>
                    <P>• Whether there are appropriate processes in place for how Essential System-Level Stakeholders will engage with each other regarding ongoing operations, including for carrying out software updates, operational updates, vehicle maintenance, and the collection and reporting of safety data.</P>
                    <P>Collectively, these two focuses of a safety case assessment would provide insight into whether robust safety assurance frameworks exist for the public operation of subject vehicles and whether sufficient organizational support underpins those frameworks.</P>
                    <HD SOURCE="HD3">(c) Policies and Capabilities</HD>
                    <P>Finally, NHTSA proposes to require an independent assessment to cover three other topics. Each of these topics may already be covered by a comprehensive safety case or by industry standards conformance. If so, to the extent an assessment already reviewed these topics, it could be incorporated in satisfying these requirements. However, the proposed rule separately enumerates the following topics to ensure that they would be covered by an assessment:</P>
                    <P>
                        <E T="03">Community Engagement.</E>
                         Whether policies for engaging with state and local authorities, local communities, and other entities affected by the subject vehicle's operation are sufficiently robust to identify the relevant stakeholders, provide them with appropriate information regarding operations, engage with them about concerns, and meaningfully address those concerns as needed. These relevant stakeholders may range from law enforcement, first responders, and local regulatory authorities to labor organizations representing the transportation workforce to residents that live in the area in which the subject vehicles would operate. The appropriate engagement processes likely depend on the stakeholders and operations in question. However, examples of potentially effective engagement strategies from NHTSA's past experience administering ADS exemptions in AVEP include town halls hosted by an ADS developer to allow members of the community to express their views on local operations, demonstrations with local law enforcement of how to interact with the vehicle during an emergency situation, and coordination with local officials and law enforcement about how proposed operations may affect local traffic patterns.
                    </P>
                    <P>
                        <E T="03">Training and Qualifications of Personnel.</E>
                         Whether the personnel responsible for developing and maintaining the safety case or executing safety critical processes possess appropriate qualifications and training. This should include consideration of training procedures and materials used, on both an initial and ongoing basis. ADS-equipped vehicles rely, and are expected to continue to rely, on a skilled human workforce. Working conditions and training are a key component of achieving safe ADS operations. To help the agency explore the potential scope of information that a review of this element should cover, NHTSA requests comment on the following topics pertaining to how workforce considerations may affect ADS safety: (1) what data could participants in AV STEP provide to further the Department's understanding of impacts, both positive and negative, to the safety of the transportation workforce; and (2) what data could participants in AV STEP provide regarding safety-promoting working conditions, including training, certifications, workplace location, shift length, and workload, for both vehicle assistance and fallback personnel?
                    </P>
                    <P>
                        <E T="03">Data Capture.</E>
                         Whether the data capture capabilities for the subject vehicle suffice to meet the data reporting requirements in AV STEP.
                        <SU>147</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>147</SU>
                             This aspect of an assessment would focus on the data logging capabilities of the vehicle and their ability to support the requirements detailed in Subpart E of the proposed rule. It would not necessarily need to cover the data governance plan information described earlier in this section.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Summary Report Requirements</HD>
                    <P>NHTSA proposes to require that information regarding an assessment be submitted in an application in the form of a summary report prepared by the independent assessor. NHTSA is not proposing a particular format, as the specific subjects under assessment will likely impact the optimal format. However, for each subject an assessment is required to review, a summary report would need to provide an overview of the assessor's findings and the basis for each finding.</P>
                    <P>A report would also be required to provide an overview of how these findings were made. To do so, a report would describe the materials reviewed during the assessment, such as by outlining the material and the means of review. A report would also describe the process and format of the review. For instance, this description could include information regarding the review approach (such as analysis methods and tools or in-person meetings and reviews) and the procedures used to structure the review (such as procedures for identifying relevant standards or reviewing the safety case). A report would further describe the methods used to identify potential inconsistencies, gaps, logical fallacies, or other concerns about the information provided for review. And to help understand how the assessment was overseen, a report would describe any processes in place to manage the assessment.</P>
                    <P>
                        The proposed rule lists two additional aspects of an assessment that would be addressed in a summary report to help NHTSA consider how the findings of the assessment translate to the agency's review of the operations requested in an application. First, the report would need to provide an overview of any concerns identified during an assessment, including all recommendations made to the applicant(s) regarding those concerns.
                        <SU>148</SU>
                        <FTREF/>
                         Second, the report would define the parameters under which the assessment and its conclusions are valid. This overview should account for potential future changes to operations, system design, or processes for which the assessment would remain valid. The overview should also explain any limitations or qualifiers to the conclusions of the assessment. This information would help NHTSA to consider whether any changes to an operation during participation exceeded the scope of a prior assessment.
                        <SU>149</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>148</SU>
                             This information would help NHTSA evaluate the extent to which an applicant sought to implement an assessor's feedback when reviewing an applicant's response to the information required under § 597.205(e) of the proposed rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>149</SU>
                             Section V.A.3 (Update Reporting) and § 597.502 of the proposed rule describe how changes to an operation would be overseen.
                        </P>
                    </FTNT>
                    <P>
                        Lastly, a report would need to describe any access restrictions that limited the assessment.
                        <SU>150</SU>
                        <FTREF/>
                         This information, along with the context information submitted by an applicant under the next subsection, would help NHTSA gauge whether any procedural 
                        <PRTPAGE P="4151"/>
                        difficulties may have impacted the assessment's informative value.
                    </P>
                    <FTNT>
                        <P>
                            <SU>150</SU>
                             For example, if an applicant refused to make certain documentation or data available to the assessor.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Assessment Context Requirements</HD>
                    <P>NHTSA proposes to require an applicant to submit additional information about the broader context of the independent assessment. The proposed rule focuses on two topics for this context. First, an applicant would need to explain any measures taken in response to each of the recommendations listed in the independent assessment summary report. To explain these measures, an applicant would likely need to not only describe the changes made but also explain how they were responsive to the recommendations. In addition, this element would provide an applicant with an opportunity to explain the reasoning for not following any recommendations.</P>
                    <P>
                        Second, the applicant would need to describe any other independent assessments initiated for the subjects required of an AV STEP assessment.
                        <SU>151</SU>
                        <FTREF/>
                         This information would inform whether an applicant engaged in forum shopping for a favorable assessment. For instance, this element would reveal if an assessment submitted in an application replaced a less favorable assessment or if an assessment was terminated early to avoid unfavorable findings. This information would help inform the credibility of the conclusions in an assessment submitted under AV STEP. For instance, if an assessment submitted under AV STEP was favorable to an applicant but the applicant prematurely terminated a prior assessment to avoid unfavorable findings, that context could raise questions about the credibility of the completed assessment. Nevertheless, NHTSA recognizes that there may be good faith reasons to terminate, replace, or update a prior assessment. To account for this possibility, NHTSA proposes to require the disclosure of information about the prior assessments but is not proposing to automatically disqualify assessments that were preceded by other assessments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>151</SU>
                             Section 597.205(e) of the proposed rule explains the specific content that would be required for this description.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">4. Reliability and Credibility Disclosures</HD>
                    <P>To help NHTSA consider the informative value of an assessment, an application would need to contain information about the reliability and credibility of the assessor. This information would focus on the assessor's independence, qualifications, and resources.</P>
                    <HD SOURCE="HD3">(a) Assessor Qualifications and Resources</HD>
                    <P>NHTSA proposes to require that an assessment be conducted by a qualified assessor with adequate resources. The proposed rule would require an assessment to be carried out by an assessor (including its personnel) with suitable education, technical expertise, experience, and accreditations. The relevant qualifications would depend on the technical fields implicated by the analyses undertaken in each assessment. In addition, an assessor would need to maintain appropriate policies and practices for conducting and organizing an assessment. This requirement would ensure that reviewers apply their expertise in a structured and consistent manner, such as through standard procedures for completing and supervising assessments. Finally, assessors would need to maintain appropriate facilities and resources for the assessments. These could include physical facilities and resources as well as software capabilities.</P>
                    <P>An application would need to contain supporting information regarding these attributes. Specifically, the proposed rule would require the submission of the curriculum vitae of key personnel involved in the assessment, any accreditations relevant to the review, and a description of all policies or protocols that governed the assessment. NHTSA may ask for additional information about the assessor as part of the review process.</P>
                    <HD SOURCE="HD3">(b) Assessor Independence</HD>
                    <P>
                        The informative value of an independent assessment depends upon the assessor retaining independence to objectively apply its expertise. To that end, § 597.205(f) of the proposed rule would address two types of conflicts of interest: (1) disqualifying conflicts; and (2) potential conflicts for which disclosure is required. Even so, the conflict-of-interest situations expressly listed in the proposed rule may not be exhaustive.
                        <SU>152</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>152</SU>
                             Other agencies have acknowledged this limitation when considering third-party reviews for their own programs. For example, the Food and Drug Administration has stated that: it is not feasible to identify or state categorically or inflexibly all of the criteria for judging that a third party is free of conflicts of interest. 61 FR 14789, 14794 (April 3, 1996).
                        </P>
                    </FTNT>
                    <P>When conducting a case-by-case review of the credibility of assessments under this program, NHTSA would consider any other indication of a conflict of interest that may appear. The proposed requirements would provide a foundation for this inquiry. As an additional safeguard, NHTSA proposes to require each application submitted for AV STEP to contain a certification from the assessor that the assessment represents the assessor's independent judgment and that none of the disqualifying conflicts of interest discussed in the next paragraph exist.</P>
                    <P>
                        NHTSA proposes to consider three situations as causing such a significant risk of bias that the assessment would not fulfill AV STEP's independent assessment requirements. The first such situation is if an assessor 
                        <SU>153</SU>
                        <FTREF/>
                         is owned, operated, or controlled (directly or indirectly) by a party with a financial interest in a particular disposition of the application. The most common example of this situation would likely be full or partial ownership by an Essential System-Level Stakeholder or one of its subsidiaries,
                        <SU>154</SU>
                        <FTREF/>
                         but this situation could also arise through grants or other types of funding. The second disqualifying situation is if an assessor has any ownership or financial interest in an interested party to the application. An assessor that is an investor in an Essential-System Level Stakeholder would be one example of this second situation.
                        <SU>155</SU>
                        <FTREF/>
                         The third situation is if the fee structure for an assessment depends in any way on the outcome of the assessment or application. This situation could include a fee structure contingent on admission into AV STEP or on the submission of an application that includes the proposed assessment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>153</SU>
                             As proposed, the assessor in these situations would also include any personnel or contractors used by the assessor for the review.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>154</SU>
                             NHTSA understands that some companies have internal auditing organizations. This requirement would preclude those organizations from conducting an independent assessment for AV STEP. Nevertheless, NHTSA recognizes the value that internal auditing practices can add and expects those practices to reflect positively on the safety management systems under review in an assessment.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>155</SU>
                             This requirement is not meant to prohibit de minimis or sufficiently diversified interests. 
                            <E T="03">Cf.</E>
                             28 U.S.C. 208; 5 CFR part 2640.
                        </P>
                    </FTNT>
                    <P>
                        Even if an assessor does not have one of these disqualifying conflicts, an assessment's objectivity could be compromised by an assessor's history with the subjects under review. The proposed rule expressly lists two such situations: (1) if an assessor participated in the design, manufacture, or distribution of a product; 
                        <SU>156</SU>
                        <FTREF/>
                         or (2) if an assessor was otherwise separately engaged in the development of a project within the scope of the assessment.
                        <SU>157</SU>
                         
                        <SU>158</SU>
                        <FTREF/>
                         In either of these two 
                        <PRTPAGE P="4152"/>
                        types of situations, an assessor's judgment may be clouded by a direct stake in some of the decisions under review. However, given the nuances of these scenarios and the possibility that potential bias could be mitigated, NHTSA is not proposing to categorically disqualify an assessment where these circumstances exist. Instead, NHTSA proposes to require disclosure to allow the agency to consider how they affected the credibility of the assessment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>156</SU>
                             An assessor that previously conducted internal reviews for a company during the ADS design process would be an example of this first situation.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>157</SU>
                             An example of this second situation could involve an entity that, before conducting an 
                            <PRTPAGE/>
                            assessment, was engaged to help shape the project that is the subject of the request, such as by reviewing and recommending locations for operations.
                        </P>
                        <P>
                            <SU>158</SU>
                             Neither of these scenarios is meant to cover situations where the recommendations of an assessor during an assessment for AV STEP leads to changes in the product or proposed operation. NHTSA specifically encourages such recommendations and requests information about them in an application. 
                            <E T="03">See</E>
                             §§ 597.205(c) and 597.205(f) of the proposed rule.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">E. Application Review</HD>
                    <P>The proposed AV STEP application review is a three-phase process that considers the unique facts and circumstances of each request. NHTSA would consider the totality of the information available when issuing a Final Determination Letter governing the terms of participation.</P>
                    <P>Individualized review is necessary to account for the intricacies of each ADS and the operations that may be requested. The safety of the ADS depends on the full context of an operation. The relevant safety considerations for ADS are often as varied as the driving tasks that an ADS seeks to perform. Nuances of an operation—such as the time a nearby school dismisses students or how a system accounts for seasonal changes in vegetation—can meaningfully affect the risk of an operation. For these reasons, NHTSA proposes a review process that allows the agency to consider the most relevant aspects of each operation.</P>
                    <P>
                        The proposed procedures are also intended to expedite review. Reviews of ADS are complex and data-intensive. Aspects of the proposal, including the independent assessment and other upfront submission requirements, are specifically designed to enable efficient and transparent review.
                        <SU>159</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>159</SU>
                             As discussed in Section VI (Public Reporting Requirements (Regulatory Text Subpart G)), NHTSA proposes to publish the dates on which an application was received, progressed through each review phase, and reached a final decision. This will enable stakeholders and the public to observe the typical timing for an application review.
                        </P>
                    </FTNT>
                    <P>
                        NHTSA proposes three review phases: Initial Review (Phase 1); Follow-up Review (Phase 2); and Preliminary Determination (Phase 3). The first phase would immediately follow the submission of an application. NHTSA would provide each applicant with a notice of receipt of the application, which would identify an agency point of contact for the review and advise whether any required information appeared to be missing from the application. During Phase 1, NHTSA would likely schedule introductory meetings with the applicant(s) and any entities that performed an independent assessment.
                        <SU>160</SU>
                        <FTREF/>
                         NHTSA would focus on understanding the request and identifying any follow-up items.
                    </P>
                    <FTNT>
                        <P>
                            <SU>160</SU>
                             Section 597.106(b) of the proposed rule would establish, as a condition of the program, NHTSA's ability to communicate freely and without restriction with any entity that performed an independent assessment submitted as part of an application.
                        </P>
                    </FTNT>
                    <P>The second review phase would begin with NHTSA's issuance of a Follow-Up Index to an applicant, identifying items for which NHTSA requests additional information. Follow-up may involve either discussions or a written response and may be iterative. The extent of this engagement would depend on the breadth of follow-up required and the completeness and timeliness of an applicant's responses.</P>
                    <P>After all follow-up has been addressed, NHTSA would initiate Phase 3 of the review process by issuing a proposed decision (“Preliminary Determination”) to the applicant(s). This Preliminary Determination would contain the terms and conditions proposed to govern participation. Providing proposed conditions to applicants would facilitate resolving or mitigating any problems before a final decision is issued. For instance, an applicant might be able to eliminate the need for a condition by curing or clarifying an issue. Similarly, providing an applicant with the opportunity to review the conditions up front would encourage dialogue about refinements that could accomplish the agency's goals in a less burdensome or more technically feasible way.</P>
                    <P>Section 597.403 of the proposed rule would establish a consistent set of considerations for NHTSA when selecting terms and conditions. Specifically, NHTSA would evaluate the extent to which any required reports may further NHTSA's understanding of a vehicle's performance, operations, or ADS; the feasibility of analyzing any reported information; and the extent to which the terms and conditions are consistent with motor vehicle safety and further the purposes of 49 U.S.C. 30101.</P>
                    <P>During the application review process, NHTSA would assess an applicant's proposed metrics and thresholds and develop terms for each customized requirement, as discussed above. NHTSA would consider the extent to which the proposed terms fulfill the required subject of reporting and their anticipated value for overseeing the subject vehicle. This consideration would balance the need for consistent reporting subjects with the reality that many safety topics for ADS currently lack established approaches to judging performance. Different entities currently use a variety of metrics to measure the safety of certain subjects, and the differences among stakeholders' systems and approaches may cause some metrics to be more informative for some systems than others.</P>
                    <P>
                        Under the proposed procedures, on the tenth business day after issuing a preliminary determination, NHTSA would generally issue a final decision that adopts the proposed terms.
                        <SU>161</SU>
                        <FTREF/>
                         This timeline would be extended if any applicant requests, in writing, additional time or a change to a Preliminary Determination.
                        <SU>162</SU>
                        <FTREF/>
                         Upon such a request, any necessary next steps for an application would be determined on a case-by-case basis. To limit this process and enable timely determinations, unless NHTSA has granted a longer extension request, NHTSA may finalize any Preliminary Determination that has been pending for 60 days even if an applicant continues to request changes. The agency expects that it would likely consider extension requests for longer than 60 days for applicants seeking, in good faith, to resolve outstanding issues. However, this 60-day timeframe provides a backstop that would ensure efficient use of agency resources.
                    </P>
                    <FTNT>
                        <P>
                            <SU>161</SU>
                             The proposed procedures would allow NHTSA to withdraw a Preliminary Determination at any time before issuing a final decision. For example, this could occur if NHTSA becomes aware of new information after issuing a Preliminary Determination.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>162</SU>
                             Similarly, at any time after the issuance of a Preliminary Determination, an applicant would be able to request, in writing, that the Preliminary Determination become final. If this occurs, NHTSA would aim to issue a Final Determination Letter sooner than ten business days.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">V. Participation (Regulatory Text Subparts E and F)</HD>
                    <P>
                        Proposed requirements for participation in AV STEP include: (1) general reporting on a quarterly basis; (2) event-triggered reporting of certain incidents and events during operations; and (3) reporting on updates to an operation. NHTSA also proposes an amendment process for changes in terms or conditions of participation and a concern resolution process that the 
                        <PRTPAGE P="4153"/>
                        agency would use to investigate and respond to any concerns that arise during participation.
                    </P>
                    <HD SOURCE="HD2">A. Reporting Requirements</HD>
                    <P>
                        NHTSA proposes a reporting framework to help NHTSA oversee the performance of ADS-equipped vehicles admitted to AV STEP. For these reporting requirements, the agency drew on its experience overseeing ADS-equipped vehicle performance in other contexts, such as other exemptions and enforcement activities.
                        <SU>163</SU>
                        <FTREF/>
                         Table V-1 provides a high-level depiction of the reporting requirements detailed in Subpart E of the proposed rule. In addition to these generally applicable requirements, NHTSA may set further reporting requirements on a case-by-case basis, through terms and conditions in a Final Determination Letter.
                    </P>
                    <FTNT>
                        <P>
                            <SU>163</SU>
                             
                            <E T="03">See, e.g.,</E>
                             NHTSA, “Second Amended Standing General Order 2021-01: Incident Reporting for Automated Driving Systems (ADS) and Level 2 Advanced Driver Assistance Systems (ADAS)” (April 2023), available at 
                            <E T="03">https://www.nhtsa.gov/laws-regulations/standing-general-order-crash-reporting;</E>
                             and NHTSA and Cruise, LLC, “In re: Cruise, LLC Standing General Order 2021-01 Reporting, Consent Order” (September 26, 2024), available at 
                            <E T="03"> https://www.nhtsa.gov/sites/nhtsa.gov/files/2024-09/cruise-consent-order-2024-web.pdf.</E>
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="2" OPTS="L2,nj,p1,8/9,i1" CDEF="s50,r200">
                        <TTITLE>Table V-1—AV STEP Reporting Requirements Overview</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Periodic Reporting For Each Location Sheet</ENT>
                            <ENT>
                                Extent of Operations:
                                <LI O="oi3">• Number of Vehicles Operated &amp; Vehicle Identifiers.</LI>
                                <LI O="oi3">• Zip Code(s) of Operation.</LI>
                                <LI O="oi3">• Vehicle Miles Traveled (VMT) with ADS Engaged, segmented by: Zip Code, Hour of Day, &amp; Presence of Onboard Fallback Personnel.</LI>
                                <LI O="oi3">• Operational Context.</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>
                                Operational Performance:
                                <LI O="oi3">• Vehicle Recovery Events.</LI>
                                <LI O="oi3">• Otherwise Unreported Contact Events.</LI>
                                <LI O="oi3">• Aggressive Jerk and Acceleration/Deceleration Instances.</LI>
                                <LI O="oi3">• Instances of Unplanned Interruptions to ADS Operation.</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>
                                Step 1 Specific:
                                <LI O="oi3">• Customized—Fallback Personnel Performance Metrics.</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>
                                Step 2 Specific:
                                <LI O="oi3">• Minimal Risk Condition Description, Duration, and Location.</LI>
                                <LI O="oi3">• Customized—Objective Performance Metrics, Design Adherence Metrics, &amp; Process Adherence Metrics.</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>AV STEP Exemption Specific: VMT Segmentation by VIN.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Event-Triggered Reporting</ENT>
                            <ENT>
                                • Otherwise Unreported Crash Data.*
                                <LI>• Citable Offenses.</LI>
                                <LI>• Reportable Changes.</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Reportable Changes</ENT>
                            <ENT>Operational Changes that Exceed Customized Thresholds.</ENT>
                        </ROW>
                        <TNOTE>* NHTSA proposes for current reporting requirements to largely satisfy this element; subsection 2 discusses this proposal in further detail.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD3">1. Periodic Reporting</HD>
                    <P>To continually assess the performance of participating operations, NHTSA proposes that certain data be reported on a quarterly basis. These periodic reporting requirements are in § 597.500 of the proposed rule. As proposed, each quarterly report would be due on the final business day of the first month that follows the reporting period. This schedule would provide participants with nearly a month to process data and prepare reports for the previous quarter. This quarterly timeframe would balance the need for timely performance updates with the burden of more frequent reporting. NHTSA seeks comment on whether this quarterly cadence is appropriate and whether any reporting requirements should be revised, added, or removed.</P>
                    <HD SOURCE="HD3">(a) Reporting Requirements for All Participants</HD>
                    <P>NHTSA proposes a set of baseline reporting requirements for all participants, to ensure receipt of standard information about all participating operations. This proposed standard reporting would be by Location Sheet for a given reporting period. The first five requirements below are proposed to capture the extent of operations, while the latter five requirements are proposed to cover aspects of ADS performance during operations. These proposed reporting requirements, detailed in § 597.500(c) of the proposed rule, are:</P>
                    <P>
                        <E T="03">Number of Vehicles Operated.</E>
                         The total number of vehicles that operated under the Location Sheet during the reporting period. As proposed, this number would include any vehicles that accumulated vehicle miles traveled (VMT) on public roads. However, NHTSA requests comment on whether it should specify a de minimis VMT threshold below which a vehicle need not be reported.
                    </P>
                    <P>
                        <E T="03">Vehicle Identification Number (VIN).</E>
                         The VIN of each vehicle included under the preceding requirement. This would link a particular vehicle to the associated terms and conditions of a participation.
                    </P>
                    <P>
                        <E T="03">Zip Codes of Operation.</E>
                         Each zip code in which a vehicle operated on a public road.
                    </P>
                    <P>
                        <E T="03">Vehicle Miles Traveled (VMT) with the ADS Engaged.</E>
                         The aggregate vehicle miles traveled with the ADS engaged, segmented by:
                    </P>
                    <P>
                        (1) Hour of day; 
                        <SU>164</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>164</SU>
                             For example, a report could state that “
                            <E T="03">x</E>
                            ” VMT were accrued between 8:00 a.m. and 9:00 a.m. and “
                            <E T="03">x</E>
                            ” VMT were accrued between 9:00 a.m. and 10:00 a.m.
                        </P>
                    </FTNT>
                    <P>(2) Presence of onboard fallback personnel; and</P>
                    <P>(3) Each zip code, which would serve as the primary means of segmenting VMT to better understand where operations occur within the geographic area of a Location Sheet. Alternatively, the agency could require that participants report VMT data by road type in addition to zip code. This information would reveal how driving environments are represented in operations. The agency seeks comment on this alternative, particularly as to feasibility.</P>
                    <P>
                        <E T="03">Operational Context.</E>
                         This requirement would provide insight into how a particular participating operation compares to other, non-AV STEP operations conducted by the same key entities and help NHTSA and the public understand whether numbers reported under AV STEP represent a large or small proportion of those broader operations. This context would also 
                        <PRTPAGE P="4154"/>
                        help avoid misleading the public about the state of a participant's technology.
                        <SU>165</SU>
                        <FTREF/>
                         To do so, NHTSA proposes reporting on two types of comparisons. The first would consider how the number of subject vehicles that participated under each Location Sheet compared to the number of vehicles for three types of total operations (if they involved the same combination of vehicle manufacturer, ADS developer, and fleet operator, regardless of AV STEP participation): (1) operations on public roads in the United States; (2) operations on public roads in a geographical area that overlaps the area for the Location Sheet; and (3) operations on public roads that involve the same vehicle model as the subject vehicle. The second comparison would be similar but based on VMT instead of vehicle numbers. Specifically, it would consider how the VMT accumulated with the ADS engaged on public roads under each Location Sheet compared to the VMT for the same three types of broader operations described earlier in this paragraph.
                    </P>
                    <FTNT>
                        <P>
                            <SU>165</SU>
                             This might occur, for example, where participation is sought at Step 2 in a very limited environment when most of the applicant's operations outside of AV STEP are less mature.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Vehicle Recovery Events (VREs).</E>
                         Describe each VRE involving a subject vehicle. NHTSA proposes to define a VRE as any instance in which a vehicle needed to be recovered during roadway operations by personnel other than those already on board the subject vehicle. This would include, but not be limited to, recovery after achieving an MRC. A report for this requirement should include, for each VRE, the duration and location of the vehicle's immobilization before its recovery and the reason that vehicle recovery was required. A report for this requirement should also, wherever applicable, cross-reference any other report required by AV STEP associated with the VRE, such as a report of a crash or contact event.
                    </P>
                    <P>
                        <E T="03">Otherwise Unreported Contact Events.</E>
                         Describe any contact event that does not meet the event-triggered crash reporting criteria discussed in Section V.A.2 (Event-Triggered Reporting). The proposed rule defines a contact event as any event in which a subject vehicle comes into physical contact with another vehicle, road user, individual, animal, or physical object. This definition would not include benign intentional contact, such as upon a passenger entering or exiting a vehicle while it is stationary, or intentional tire contact with a curb 
                        <SU>166</SU>
                        <FTREF/>
                         below speeds of 5 miles per hour. The less serious nature of contact events that do not meet the injury or property damage thresholds for crash reporting reduces the need for more immediate reporting. Nevertheless, this reporting could provide valuable insight on ADS performance. The agency seeks comment on whether the reporting threshold for these contact events may be refined to better distinguish potentially meaningful events.
                    </P>
                    <FTNT>
                        <P>
                            <SU>166</SU>
                             For example, when coming to a stop at low speeds to maximize passing space for other vehicles.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Instances of Aggressive Vehicle Jerk.</E>
                        <SU>167</SU>
                        <FTREF/>
                         Report the total number of instances of a rate of change in vehicle acceleration that exceeds a customized threshold. NHTSA is considering two options for the applicable thresholds and the subsequent reporting requirement. First, the agency could allow applicants to submit proposed thresholds during the application process. Ideally, these would consist of thresholds that an entity already uses internally. This information could enable a greater level of insight if applicants propose more stringent thresholds than those that the agency might impose. It would also enable NHTSA to review the reporting through the same lens used by an entity to review its own operations. Alternately, the agency could establish default thresholds but accept proposals of lower thresholds.
                        <SU>168</SU>
                        <FTREF/>
                         While such a requirement would add some consistency to this reporting, it could dissuade applicants from proposing more stringent thresholds.
                    </P>
                    <FTNT>
                        <P>
                            <SU>167</SU>
                             For discussion of the use of jerk as a suggested predictor of safe vehicle motion control, 
                            <E T="03">see</E>
                             AVSC, “AVSC00006202103: Best Practice for Metrics and Methods for Assessing Safety Performance of ADS” (March 2021).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>168</SU>
                             For instance, it may be less burdensome for an entity to report based off of a more stringent internal threshold than to set up a new process for collecting events based on NHTSA's default threshold.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Instances of Aggressive Vehicle Acceleration or Deceleration.</E>
                         Report the total number of instances of vehicle acceleration or deceleration exceeding a customized threshold.
                        <SU>169</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>169</SU>
                             See the discussion for 
                            <E T="03">Instances of Aggressive Vehicle</E>
                             Jerk regarding potential approaches to establishing such thresholds.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Unplanned Interruptions.</E>
                         Report the total number of each of the following types of interruptions to the ADS, if unplanned:
                    </P>
                    <P>• Initiation of an MRM by: (1) the ADS; (2) an occupant of the subject vehicle; or (3) remote personnel. This reporting requirement would encompass instances in which an MRC is achieved as well as instances in which an MRM is initiated but an MRC is not achieved (for any reason).</P>
                    <P>
                        • DDT takeovers 
                        <SU>170</SU>
                        <FTREF/>
                         other than those reported under the prior element. Most of these interruptions will likely entail intervention by onboard fallback personnel to disengage the ADS and take control of the vehicle. If an ADS initiated or completed an MRM and fallback personnel subsequently assumed control of the vehicle to resume driving, the situation would be reported under the prior element rather than this one to avoid double counting events.
                    </P>
                    <FTNT>
                        <P>
                            <SU>170</SU>
                             
                            <E T="03">See</E>
                             § 597.102 of the proposed rule for definition of 
                            <E T="03">DDT Takeover.</E>
                        </P>
                    </FTNT>
                    <P>• Instances in which any direct control authority of the vehicle is exercised remotely, other than those reported under the two preceding elements. For example, if remote steering was used to correct the path of a vehicle but the ADS retained responsibility for lateral control of the vehicle and an MRM was never executed.</P>
                    <P>
                        • Instances in which onboard vehicle assistance alters the ADS' operations. This requirement would capture situations in which an individual providing vehicle assistance from within the subject vehicle corrects or changes the anticipated behavior of the ADS.
                        <SU>171</SU>
                        <FTREF/>
                         This requirement would not cover a situation where an individual providing remote vehicle assistance only confirms the projected ADS behavior. For instance, if an ADS-equipped vehicle encountered a potential obstacle in the roadway and requested vehicle assistance regarding whether to proceed on an identified path, this element would count situations where the assistance changed the path identified by the ADS but not situations where assistance simply confirmed the ADS' prospective path.
                        <SU>172</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>171</SU>
                             In some situations, personnel may be physically present in the vehicle but acting in a vehicle assistance role rather than as onboard test drivers who would have the ability to exercise full control over the vehicle's DDT.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>172</SU>
                             If the ADS initiates an MRC in circumstances where it requests vehicle assistance, but none is received within a certain time frame, such an event would require reporting under the first category of interruptions. If subsequent vehicle assistance changed the behavior projected by the ADS, that would require vehicle assistance reporting as well.
                        </P>
                    </FTNT>
                    <P>• Instances in which remote vehicle assistance alters the ADS' operation. This element covers the same situation as the preceding element, but for vehicle assistance provided from a physical location outside of the subject vehicle.</P>
                    <P>
                        • Any occurrence other than the five types of interruptions described above that significantly alters the intended operation of the ADS. Although the preceding categories would likely make up the majority of unplanned 
                        <PRTPAGE P="4155"/>
                        interruptions, this category provides a catch-all for any other circumstances in which unplanned interruptions could occur. For instance, it would include a situation where a vehicle component experienced a catastrophic failure that caused the vehicle to stop operating without any initiation of an MRC.
                    </P>
                    <P>
                        NHTSA recognizes that the ADS community has a range of perspectives on the value of considering unplanned interruptions (such as disengagements) when assessing ADS performance. Some stakeholders express concern that disengagements do not provide a meaningful point of comparison between ADS 
                        <SU>173</SU>
                        <FTREF/>
                         because disengagement metrics are affected by many factors that vary across operations. For instance, a lower rate of disengagement may simply mean that a system is traveling on less complicated roads than another system. Relying too heavily on disengagement numbers to assess ADS safety could disincentivize fallback personnel from intervening for safety. Nevertheless, NHTSA's experience in receiving this type of data in other contexts indicates the data's value. For instance, periodic reporting can illustrate how a particular system is performing on a given route, such as by pinpointing particularly difficult intersections or identifying how other variables, such as seasonal changes or weather patterns, can affect the same ADS operations over time.
                    </P>
                    <FTNT>
                        <P>
                            <SU>173</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Levi Sumagaysay, “Self-driving companies: Don't measure us by `disengagements,' ” Protocol (February 26, 2020).
                        </P>
                    </FTNT>
                    <P>Finally, NHTSA is also considering an additional reporting requirement for instances in which vehicle assistance or remote driving inputs are not executed by the vehicle. Examples of this reporting could include instances in which an ADS does not follow a route provided by vehicle assistance due to a change in the roadway environment, such as a VRU entering the vehicle's path, or instances in which a malfunction or design flaw causes the ADS to not follow an input to the system. NHTSA is not currently proposing to include this reporting element because the agency believes these situations would either be a desired result of intended functionality or, for ADS failures, largely covered by other proposed reporting elements. However, NHTSA seeks comment on the frequency of such occurrences and their reporting value.</P>
                    <HD SOURCE="HD3">(b) Step 1 Unique Reporting</HD>
                    <P>
                        In addition to the standard requirements in the previous subsection, participants at Step 1 would be required to report safety metrics to gauge the performance of fallback personnel under customized terms.
                        <SU>174</SU>
                        <FTREF/>
                         These reports would occur with the same periodic cadence as the other requirements in this subsection (V.A.1) and be segmented by Location Sheet. Applications for Step 1 participation would need to contain proposed metrics for this requirement and include the information required for customized terms in § 597.206 of the proposed rule. Possible examples of these types of safety metrics include reporting of violations of fallback personnel processes or data associated with distraction monitoring. For instance, SAE J3018 provides that companies engaged in ADS testing should use a “monitoring system in the test vehicle capable of detecting and recording incidents of prolonged inattention, error and/or misuse by [in-vehicle fallback test drivers] during test trips.” 
                        <SU>175</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>174</SU>
                             Section IV.A.3 (Confirmation of Reporting During Participation) discusses NHTSA's proposed approach to using customized terms for certain reporting requirements.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>175</SU>
                             SAE International, “J3018 DEC2020: Safety-Relevant Guidance for On-Road Testing of Prototype Automated Driving System (ADS)-Operated Vehicles,” Section 6.3: IFTD State Monitoring, (Revised December 2020).
                        </P>
                    </FTNT>
                    <P>Currently, many different approaches exist for monitoring the effectiveness of onboard test drivers in performing the DDT fallback function, and many stakeholders have their own unique standards for doing so. As a result, it would be premature to impose standard metrics for this assessment. Establishing customized terms would instead enable these metrics to fit each stakeholder's processes and allow NHTSA to consider a range of approaches.</P>
                    <HD SOURCE="HD3">(c) Step 2 Unique Reporting</HD>
                    <P>This proposal includes additional reporting requirements for Step 2 participation to account for the elevated scope and maturity expected of Step 2 systems. This reporting would also occur on a quarterly basis and be segmented by Location Sheet. Section 597.500(e) of the proposed rule includes four reporting requirements for Step 2 participants. First, it would require reporting of the VIN, duration, location, and cause of each minimal risk condition that was achieved. For this requirement, the agency is considering defining the relevant duration as either the period of time that elapses between the initiation of an MRM and the termination of an achieved MRC, or the period of time that elapses between the time MRC is achieved and its termination. Resumption of ADS operation, completion of a VRE, and DDT takeover are all examples of events that would be considered as terminating achievement of an MRC.</P>
                    <P>
                        For the remaining three proposed reporting requirements, Step 2 participants would be required to report metrics for the following subjects under customized terms: 
                        <SU>176</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>176</SU>
                             Section IV.A.3 (Confirmation of Reporting During Participation) discusses NHTSA's proposed approach to using customized terms for certain reporting requirements.
                        </P>
                    </FTNT>
                    <P>
                        • 
                        <E T="03">The safety performance of the ADS, including adherence to the expected driving behavior and scenarios in which there is an increased likelihood of a crash.</E>
                         Metrics proposed for this term should be feasible to measure without proprietary access to the ADS.
                        <SU>177</SU>
                        <FTREF/>
                         This would enable the agency to evaluate whether metrics that rely on data that can be collected and analyzed independent of the ADS, such as via a separately-installed measurement device, can effectively monitor safety performance.
                        <SU>178</SU>
                        <FTREF/>
                         For example, this element could involve tracking and analyzing a safety envelope metric 
                        <SU>179</SU>
                        <FTREF/>
                         or other instantaneous safety metrics.
                        <SU>180</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>177</SU>
                             In practice, AV STEP participations will involve direct access to vehicle data. As such, the data actually used for this metric may be collected via proprietary access to the ADS even if that data could also have been measured independently.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>178</SU>
                             NHTSA is already undertaking research in this area, as explained in a recent report to Congress: NHTSA is researching the development of ground truth trip recorder tools that can be installed on an ADS equipped vehicle. Such a system would record the surround view data with its own independent perception stack to identify scenarios and ADS behaviors of interest that are encountered during public on-road driving. The ground truth trip recorder is separate from the ADS itself and would not interfere with any aspects of the ADS functionality. 
                            <E T="03">See</E>
                             NHTSA, “Report to Congress: Automated Vehicles,” 
                            <E T="03">https://www.nhtsa.gov/sites/nhtsa.gov/files/2023-06/Automated-Vehicles-Report-to-Congress-06302023.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>179</SU>
                             AVSC, “AVSC00006202103: Best Practice for Metrics and Methods for Assessing Safety Performance of ADS” (March 2021) describes a violation of a safety envelope metric as “a violation of a kinematically defined state space around a vehicle that represents a buffer between the subject vehicle and other objects in the environment,” and notes that “the separation threshold may be contextually modified.” This AVSC best practice also discusses the potential correlation of these types of metrics to safety outcomes and provides additional relevant references.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>180</SU>
                             ISM and MPrISM are examples of instantaneous safety metrics. 
                            <E T="03">See, respectively,</E>
                             Joshua Every et al., “A Novel Method To Evaluate The Safety Of Highly Automated Vehicles,” No. 17-0076, available at 
                            <E T="03">https://www-esv.nhtsa.dot.gov/Proceedings/25/25ESV-000076.pdf</E>
                             and Bowen Weng et al., “Model Predictive Instantaneous Safety Metric for Evaluation of Automated Driving Systems” (May 2020), available at 
                            <E T="03">https://arxiv.org/abs/2005.09999.</E>
                        </P>
                    </FTNT>
                    <P>
                        • 
                        <E T="03">The extent to which the system-level performance of the ADS adheres to design assumptions or expectations.</E>
                         This element could involve a variety of metrics, such as those regarding object and event detection and response 
                        <PRTPAGE P="4156"/>
                        (OEDR) reaction time,
                        <SU>181</SU>
                        <FTREF/>
                         other system latency considerations, or metrics regarding the identification and reduction of system errors.
                        <SU>182</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>181</SU>
                             Defined as “the time it takes for the ADS to initiate a measurable response following the onset of an initiating event in the context of scenario-based testing in a controlled environment (
                            <E T="03">e.g.,</E>
                             track testing or simulation)” by AVSC, “AVSC00006202103: Best Practice for Metrics and Methods for Assessing Safety Performance of ADS” (March 2021).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>182</SU>
                             Specific system error reduction concepts—for example, identification of observed anomalies relative to model assumptions or object classification accuracy and precision—can be found in ANSI, “UL Standard ANSI/UL4600: Standard for Evaluation of Autonomous Products,” (March 2022).
                        </P>
                    </FTNT>
                    <P>
                        • 
                        <E T="03">Adherence to internal safety processes during the subject vehicle's development or operations.</E>
                         This element could include reporting of response times relative to established thresholds or metrics associated with understanding what proportion of issues that may arise result from best practice violations.
                    </P>
                    <HD SOURCE="HD3">2. Event-Triggered Reporting</HD>
                    <P>In addition to the periodic reporting discussed above, NHTSA also proposes to require AV STEP participants to report certain incidents or events on an ad hoc basis when they occur. Section 597.501 of the proposed rule sets forth three such “event-triggered” categories of reporting.</P>
                    <P>
                        Crash reporting is the first proposed category of event-triggered reporting. NHTSA proposes to largely incorporate the current scope of crash reporting under NHTSA's Second Amended Standing General Order (SGO) 2021-01, which was issued in April 2023.
                        <SU>183</SU>
                        <FTREF/>
                         To incorporate the scope of the SGO, § 597.501(b) of the proposed rule would incorporate the SGO definition of a crash. The content required for a crash report would be set by a term in the Final Determination Letter. NHTSA expects this content to match the most current Incident Report Form for the SGO.
                        <SU>184</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>183</SU>
                             NHTSA, “Second Amended Standing General Order 2021-01: Incident Reporting for Automated Driving Systems (ADS) and Level 2 Advanced Driver Assistance Systems (ADAS)” (April 5, 2023) available at 
                            <E T="03">https://www.nhtsa.gov/sites/nhtsa.gov/files/2023-04/Second-Amended-SGO-2021-01_2023-04-05_2.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>184</SU>
                             The current Incident Report Form is available as appendix C to the SGO. 
                            <E T="03">See id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The SGO has enabled NHTSA to quickly identify crashes and assess whether they should be investigated. NHTSA anticipates that most—if not all—participants in AV STEP would also be responsible for reporting under the SGO. As long as the SGO or any analogous form of reporting remains in place, reports outside of AV STEP should provide NHTSA with effective oversight of crashes involving subject vehicles. To avoid duplicate reporting between AV STEP and the SGO, § 597.501(f) of the proposed rule would treat a timely report under the SGO (including any future form it may take) 
                        <SU>185</SU>
                        <FTREF/>
                         as meeting the AV STEP crash reporting requirement, as long as the SGO report contained all of the information required for a crash report in this program. As explained in the prior paragraph, the scope of crash reporting in AV STEP would be set by the combined requirements of the proposed rule and terms of a Final Determination Letter. NHTSA expects the scope of this reporting to mirror the most current version of the SGO. Therefore, timely crash reporting under the SGO would typically satisfy crash reporting for AV STEP. If an SGO report containing the information required by a Final Determination Letter is submitted for a subject vehicle, a participant would simply need to submit notice of the Location Sheet applicable to the report (as well as potentially submit any video, as discussed in the next paragraph).
                    </P>
                    <FTNT>
                        <P>
                            <SU>185</SU>
                             NHTSA is considering a rulemaking relating to the SGO's requirements since the SGO was issued as an enforcement order and is scheduled to sunset in April 2026 if not renewed. 
                            <E T="03">See</E>
                             Office of Information and Regulatory Affairs, “Unified Agenda of Regulatory and Deregulatory Actions,” RIN 2127-AM63: Incident Reporting Requirements for Automated Driving Systems and Level 2 Advanced Driver Assistance Systems, available at 
                            <E T="03">https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&amp;RIN=2127-AM63.</E>
                        </P>
                    </FTNT>
                    <P>
                        NHTSA also proposes to expand on the current scope of SGO reporting in two ways. First, NHTSA proposes to require reporting of all crashes involving subject vehicles regardless of the engagement status of the ADS, whereas the SGO applies only if the ADS was engaged at any point within 30 seconds of a crash. This expanded reporting would ensure that any crashes involving AV STEP vehicles are known.
                        <SU>186</SU>
                        <FTREF/>
                         Second, NHTSA proposes to require a participant to submit any video footage possessed by an Essential System-Level Stakeholder for any incident that meets the most urgent level of proposed crash reporting.
                        <SU>187</SU>
                        <FTREF/>
                         NHTSA often obtains video footage of ADS crashes to help assess incidents as part of its follow-up with entities on their SGO reports. Crashes that would require video reporting in AV STEP would also be reportable under the current scope of the SGO. As described in the prior paragraph, those SGO reports would likely satisfy the need to report the crash in AV STEP apart from providing this video footage and advising NHTSA of the Location Sheet applicable to the crash.
                    </P>
                    <FTNT>
                        <P>
                            <SU>186</SU>
                             A report would also need to indicate whether the ADS was engaged at any point during the time surrounding the crash.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>187</SU>
                             This would apply to any crashes that meet the one-day reporting requirement of the SGO. Because the processing of video files may add logistical difficulty to a report, NHTSA proposes to require video to be submitted within two business days after an Essential System-Level Stakeholder obtains possession of the video.
                        </P>
                    </FTNT>
                    <P>
                        For the second category of event-triggered reporting, NHTSA proposes to require participants to report citable offenses of traffic safety law violations. This reporting would include any violations that result in an actual citation, as well as any known violations that did not result in citations. For actual citations, this reporting standard is straightforward and would require reports for any citations issued by an authority responsible for enforcing traffic safety laws where the vehicle is operating. For violations that did not result in citations, NHTSA proposes to scope reporting to events for which a participant is aware and understands, in good faith, the behavior to constitute a violation of an applicable traffic safety law. The “known” threshold for non-ticketed violations means that this reporting requirement would not create an affirmative duty to search for those incidents. Instead, as part of the application requirements proposed for AV STEP, participants would provide information about their processes for identifying applicable traffic safety laws and monitoring adherence to them.
                        <SU>188</SU>
                        <FTREF/>
                         These processes should ensure that participants are not willfully ignoring behavior that may form non-ticketed violations. Likewise, these processes should ensure that the participants exercise reasonable judgment as to whether necessity permits a vehicle to deviate from the general rule of conduct expected by a traffic safety law. For instance, vehicles may appropriately cross a double yellow line or drive onto the shoulder to avoid an obstacle or when directed by law enforcement.
                    </P>
                    <FTNT>
                        <P>
                            <SU>188</SU>
                             As proposed, the Protocols for ADS Operations and Independent Assessment portions of an application would include information about traffic safety law compliance. 
                            <E T="03">See</E>
                             Section IV.A (Application Form).
                        </P>
                    </FTNT>
                    <P>
                        The last category of proposed event-triggered reporting relates to changes in the extent to which fallback personnel are used for a Step 2 participation. Under the AV STEP eligibility requirements, vehicles participating at Step 2 should generally operate without fallback personnel during participating operations. However, NHTSA recognizes that some Step 2 participants may rely on fallback personnel 
                        <PRTPAGE P="4157"/>
                        sparingly. For example, a participant could temporarily introduce onboard fallback personnel as a safeguard after the release of a software update or rely on fallback personnel for a subset of the participating fleet that would be engaged in specific validation operations. NHTSA does not intend the scope of Step 2 to disincentivize such limited uses of fallback personnel if a participant deems them beneficial for safety.
                    </P>
                    <P>
                        At the same time, Step 2 participation should demarcate readiness to operate with an ADS competent enough to not need fallback personnel when operating in its ODD. Therefore, participants in Step 2 should not functionally operate as Step 1 participants through the widespread and sustained use of fallback personnel. To oversee this balance and provide more transparency regarding operations, NHTSA proposes that participants at Step 2 be required to report the percentage of subject vehicles using fallback personnel at each location. If this percentage changes, a participant would need to report that change by the time it occurs. As under Step 1, any Step 2 vehicle would be prohibited from carrying public passengers when operating with fallback personnel.
                        <SU>189</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>189</SU>
                             
                            <E T="03">See</E>
                             Section III.C (Terms and Conditions) for more explanation of this restriction.
                        </P>
                    </FTNT>
                    <P>NHTSA is also considering whether, as a fourth category of event-triggered reporting, participants should be required to report cyber-related incidents with a potential safety impact. The agency seeks comment on such a requirement, particularly regarding how cyber incidents should be defined and thresholds for reporting such incidents, timing requirements for reporting such events, and how such requirements may relate to NHTSA's existing requirements for safety-related defect reporting.</P>
                    <HD SOURCE="HD3">3. Update Reporting</HD>
                    <P>NHTSA expects a participant's authorized ADS operations to evolve over time. Routes or other aspects of an operation may need to be refined, an ADS should continue to mature, and participants should maintain and refine their internal processes. To accommodate this continuous improvement, NHTSA proposes a reporting framework for updates that occur during AV STEP participation. This reporting framework is designed to ensure NHTSA is notified of meaningful changes without slowing the pace of progress. If a change is significant enough to affect important premises of NHTSA's original decision on an application, this framework also would enable NHTSA to request more information before the change could take effect.</P>
                    <P>This change reporting supplements rather than supplants the amendment process described in the next subsection. If a reportable change would violate a term or condition of a Final Determination Letter, a participant would need to separately request and receive an amended letter before any such change could take effect. For such a change, the report described in this subsection would still be necessary.</P>
                    <P>
                        Final Determination Letters would contain terms that set customized thresholds for changes that would need to be reported to NHTSA. Applicants would propose such thresholds.
                        <SU>190</SU>
                        <FTREF/>
                         These proposals should be based on the extent to which changes may alter information submitted in an application or reviewed by an independent assessor for the assessment submitted with an application. They should avoid capturing routine changes or those contemplated in an application. NHTSA's goal in proposing these thresholds is to craft standards specific to a particular operation that account for the information upon which the agency's decision on the application was based.
                    </P>
                    <FTNT>
                        <P>
                            <SU>190</SU>
                             Section IV.A.3 (Confirmation of Reporting During Participation) discusses NHTSA's proposed approach to using customized terms for certain reporting requirements.
                        </P>
                    </FTNT>
                    <P>
                        Any change that exceeds these customized thresholds would need to be reported to NHTSA. A report would need to describe the change, identify the date on which it is proposed to occur, and contain an independent assessor's position on whether the change would materially affect an earlier independent assessment of the safety case for the operation. This requirement would not entail a new independent assessment for each reportable change. Instead, the agency anticipates a much narrower independent review of whether the prospective change would alter a critical aspect of the safety case or exceed the bounds of the safety case in a way not accounted for by the earlier independent assessment. As proposed, an independent assessment summary report submitted as part of an application would need to include an overview of the parameters under which the assessment and its conclusions are valid.
                        <SU>191</SU>
                        <FTREF/>
                         NHTSA expects these parameters to significantly inform whether reportable changes would materially affect a prior assessment.
                        <SU>192</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>191</SU>
                             
                            <E T="03">See</E>
                             § 597.205(d)(3)(vi) of the proposed rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>192</SU>
                             As proposed, this position could be provided by an assessor other than the one that conducted the original analysis.
                        </P>
                    </FTNT>
                    <P>NHTSA proposes to require seven days of advance notice for reportable changes an independent assessor has indicated will not materially affect a prior assessment. NHTSA would not plan to require affirmative approval of any such non-material changes. However, advance notice would provide NHTSA with an opportunity to request more information or explore concerns before a change takes effect. In contrast, any changes that an independent assessor has indicated will materially affect a prior assessment would require written NHTSA approval before they could occur. As part of its review, the agency could require a more robust update to any portions of an independent assessment affected by such changes.</P>
                    <HD SOURCE="HD2">B. Agency Protocols</HD>
                    <HD SOURCE="HD3">1. Amendment Process</HD>
                    <P>As proposed, the terms and conditions in a Final Determination Letter would govern the scope of participation. Changes to these terms and conditions would require NHTSA's review and approval through the issuance of an Amended Final Determination Letter. This NPRM proposes a process through which a participant could request amendments to a Final Determination Letter. During NHTSA's review of an amendment request, a program participant would remain able to continue AV STEP participation under the existing terms.</P>
                    <P>
                        The specific contents of an amendment request would vary depending on the scope of changes requested. However, any amendment request should describe each requested change and how it may affect the system design, process, or operations. In addition, the amendment request would be required to include an updated response to each of the affected elements of the participant's AV STEP application, apart from the independent assessment.
                        <SU>193</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>193</SU>
                             The change reporting framework described in the prior subsection is designed to consider how changes would affect the conclusions of a prior independent assessment. If changes that prompted an amendment request also met the change reporting thresholds, those reports would provide insight into how the changes bear upon an assessment.
                        </P>
                    </FTNT>
                    <P>
                        Certain changes that are expected to occur during normal operations would not require written approval from NHTSA, even if they might potentially implicate terms in a Final Determination Letter. A participant could make such changes at any time by providing written notice to NHTSA by the time the change takes effect. These changes, detailed in § 597.601(e) of the 
                        <PRTPAGE P="4158"/>
                        proposed rule, include: (1) changes to a participant's contact information; (2) changes to the geographical boundaries of an approved location, as long as all other information in the application remains the same; and (3) the addition of entirely new locations through Location Sheets, as long as the new locations are substantially similar operations to at least one already approved location. Any such new location under this third type of change could not expand the total number of vehicles for which participation has been permitted without requiring an amendment to that effect. In addition, the new location would need to involve the same ODD (other than the geographical location), vehicle equipment, intended use, and approach to public ridership as for the previously approved participation location(s). If any of those conditions are not met, a participant could add a new location only by requesting an amendment and receiving approval from NHTSA.
                    </P>
                    <P>
                        In contrast, certain changes to a participation are so fundamental that NHTSA proposes that they would not be eligible for an amendment and, instead, would require a new application. These proposed changes are: (1) any change to a program step; or (2) the removal, replacement, or addition of an Essential System-Level Stakeholder. In addition, for participations with an AV STEP exemption, a new application would be required for any change to: (1) the type of AV STEP exemption; (2) the exempted subject vehicle; 
                        <SU>194</SU>
                        <FTREF/>
                         (3) the FMVSS or bumper standard (including subsection) for which an FMVSS Exemption is granted; (4) the device or element made inoperative for a Make Inoperative Exemption; or (5) the FMVSS subsection affected by the requested modification for a Make Inoperative Exemption.
                    </P>
                    <FTNT>
                        <P>
                            <SU>194</SU>
                             This category would include changes to the subject vehicle platform, such as requesting a new model year or vehicle model. This proposal includes a separate procedure to add exemptions for identical vehicles to those already in receipt of an exemption, as described in Section VII (Requirements for AV STEP Exemptions (Regulatory Text Subpart C)).
                        </P>
                    </FTNT>
                    <P>The next subsection describes the proposed procedure through which NHTSA may unilaterally amend the terms or conditions of a Final Determination Letter in response to concerns that arise during participation. In addition, NHTSA may change a term with the consent of all participants, such as to issue a technical correction or to refine a condition.</P>
                    <HD SOURCE="HD3">2. Concern Resolution Process</HD>
                    <P>
                        The oversight goals of AV STEP necessitate an effective and transparent process for resolving concerns that arise during participation. This process should enable NHTSA to swiftly modify the terms of participation when required for safety, while also, when possible, affording program participants opportunities to participate in the resolution process. To account for these considerations, NHTSA proposes procedures for reviewing and resolving concerns that arise during AV STEP participation.
                        <SU>195</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>195</SU>
                             This process would not replace NHTSA's traditional defects process under the Safety Act. No part of AV STEP, including this proposed concern resolution process, is intended to supplant or affect NHTSA's defect process. Participants would not be absolved from any obligations under the Safety Act to identify and provide notice of safety defects nor would NHTSA be precluded from using its defect process or other applicable authorities for participants in AV STEP. 
                            <E T="03">See</E>
                             49 CFR part 573 and 49 U.S.C. 30116 
                            <E T="03">et seq.</E>
                        </P>
                    </FTNT>
                    <P>
                        NHTSA proposes a response process for AV STEP in which issues would be classified as either: (1) apparent issues; and (2) severe apparent issues. Apparent issues would consist of any circumstance that calls into question the safety of an operation, compliance with AV STEP responsibilities, or the reliability of information provided under the program.
                        <SU>196</SU>
                        <FTREF/>
                         A concern may emerge even before a problem has materialized in real-world operations or risen to the level of an unreasonable risk to motor vehicle safety under the Safety Act.
                    </P>
                    <FTNT>
                        <P>
                            <SU>196</SU>
                             Although these types of concerns are expected to most commonly involve potential safety issues, they may also entail process violations, such as deviating from approved program parameters, failing to report required information, or problems with the accuracy or completeness of information submitted.
                        </P>
                    </FTNT>
                    <P>Once a concern arises, the agency would undertake a preliminary review aimed at ascertaining whether an apparent issue exists and, if so, the severity. Severity would be determined on a case-by-case basis, considering how timely a response to the problem would need to be. As proposed, the biggest difference in apparent and severe apparent issues is the imminency with which a concern may need to be addressed during existing operations. NHTSA expects that severe concerns would typically entail significant safety problems or the disregard of program requirements in a manner that undermines confidence in ongoing operations. The severity of an apparent issue may also reflect how quickly a risk is likely to manifest itself in operations. While the severity of a concern will depend on the specific circumstances, potential examples of severe apparent issues could include crashes stemming from a problem with an ADS that also exists in other continuing operations or learning that participants violated terms and conditions of a permission in a manner that calls into question the safety of their operations.</P>
                    <P>
                        The agency may engage with participants to learn more about the concern during this preliminary review. If a concern is substantiated, the agency would notify the participant of the apparent issue, describe it with reasonable particularity, advise whether it is categorized as severe, and describe any impending modifications of a term or condition of a Final Determination Letter to mitigate the concern. NHTSA would seek to develop a narrow modification tailored to the scope of the issue but could impose a full suspension from participation if needed.
                        <SU>197</SU>
                        <FTREF/>
                         In other contexts, NHTSA has found that working with the affected stakeholders throughout the review of a problem increases the chances the problem can be addressed in a way that prioritizes safety while limiting the scope of operational impacts.
                    </P>
                    <FTNT>
                        <P>
                            <SU>197</SU>
                             This practice would match NHTSA's practice in administering Section 30114(a) exemptions. For instance, if an ADS demonstrates problems navigating a particular intersection or roadway feature, such as a traffic circle, NHTSA has typically aimed to curtail operations around the feature rather than suspend all operations. This tailored approach, in particular, highlights the need for the flexibility of a case-by-case concern resolution process.
                        </P>
                    </FTNT>
                    <P>For apparent issues identified by NHTSA but not categorized as severe, any modifications of participation terms listed in the notice would automatically take effect 10 business days after the agency issues a notice to a participant. For issues designated as severe, the timing of the modification would be determined on a case-by-case basis. NHTSA would aim to provide as much notice as possible for severe apparent issues, but if needed, modifications for severe apparent issues could become effective as soon as issued. In practice, if a situation is serious enough to warrant an immediate modification of a permission, NHTSA expects a company's internal policies would independently lead the company to take appropriate and timely measures, such as curtailing its operations while it evaluates the issue.</P>
                    <P>
                        NHTSA would retain the discretion to further modify or cancel a planned modification to the terms of participation, including by extending the time by which the modifications would take effect. For instance, a participant may moot a problem by implementing a sufficient mitigation or deciding to voluntarily suspend 
                        <PRTPAGE P="4159"/>
                        operations of all affected vehicles.
                        <SU>198</SU>
                        <FTREF/>
                         NHTSA intends this framework to encourage participants to use responsible incident response protocols that quickly and proactively address problems.
                    </P>
                    <FTNT>
                        <P>
                            <SU>198</SU>
                             As appropriate, NHTSA could also unilaterally revoke an operation from AV STEP or suspend it through the modifications described in this section.
                        </P>
                    </FTNT>
                    <P>Reinstating any curtailed aspects of an operation would also be handled case-by-case. Given the variety of potential issues and their range of complexity, NHTSA anticipates working iteratively with participants and project stakeholders to develop tailored plans for resolving each issue. If mitigations or corrections are required, participants would need to develop proposed mitigations, prepare corrective action plans, and demonstrate their sufficiency to the agency. NHTSA would review the proposed mitigations and develop a return-to-service plan. Where possible and consistent with safety, participants would be afforded flexibility in how vehicles could be returned to service, such as by deciding whether to implement mitigations on a rolling basis or all at once. NHTSA has used a similar process for the reinstatement of suspended ADS operations with Section 30114(a) exemptions and believes this approach would translate well to AV STEP.</P>
                    <HD SOURCE="HD1">VI. Public Reporting Requirements (Regulatory Text Subpart G)</HD>
                    <P>
                        NHTSA intends for AV STEP to boost transparency surrounding ADS technology and, through this increased access to information, lay the groundwork for greater public understanding of participating operations. To promote such transparency, NHTSA proposes to publish certain information about each application and participation.
                        <SU>199</SU>
                        <FTREF/>
                         This information focuses on the topics most relevant to the public's engagement with the vehicles. Given the importance of this information to the public, its availability via NHTSA's intended public AV STEP reporting would be a condition of AV STEP application and participation.
                        <SU>200</SU>
                        <FTREF/>
                         In addition to specific comment requests below, the agency seeks comment on any topics that are important to the public's engagement with ADS operations that are not covered by the proposed public reporting elements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>199</SU>
                             
                            <E T="03">See</E>
                             Subpart G of the proposed rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>200</SU>
                             Due to the public-facing nature of the specific information NHTSA proposes to publish, the agency does not believe a claim of confidential business information (CBI) is appropriate in this context and would not provide an assurance of privacy for that information. 
                            <E T="03">See</E>
                             5 U.S.C. 552(b)(4); 18 U.S.C. 1905; 
                            <E T="03">Food Marketing Inst.</E>
                             v. 
                            <E T="03">Argus Leader Media,</E>
                             139 S. Ct. 2356, 2363 (2019).
                        </P>
                    </FTNT>
                    <P>Upon receipt of an application, NHTSA proposes to publish a subset of information from the application, including much of the material in the Operational Baseline and Location Sheet sections of an application. Through this information, NHTSA intends for the public to understand the scope and nature of requested participation. In addition to publishing the date an application was received, NHTSA would publish the current application review phase to provide transparency regarding the status of each application. Published information about an application would identify the relevant stakeholders, describe the subject vehicles, and identify any use of fallback personnel, remote driving, or vehicle assistance. NHTSA also proposes to publish information about the operations requested under each Location Sheet of an application. This information would cover the location, vehicle numbers, maximum vehicle speed, speed limits, intended use of the vehicles, whether the applicant seeks to transport public passengers, and a summary of the ODD.</P>
                    <P>
                        In addition to these elements, NHTSA proposes to publish a list of each industry standard, best practice, or guidance with which the subject vehicle fully conforms according to the independent assessment submitted as part of the application. In proposing to publish this information, NHTSA recognizes that entities, including ADS developers, sometimes proactively publish claims of conformance to industry standards.
                        <SU>201</SU>
                        <FTREF/>
                         Including this express disclosure provision in the rule enables entities to understand how the agency intends to publicly communicate about an application or participation and allows them to make informed decisions about whether to apply to this voluntary program. NHTSA specifically requests comment on its proposal to publish industry standards conformance.
                    </P>
                    <FTNT>
                        <P>
                            <SU>201</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Argo AI, LLC, “Press Release: Argo AI Conforms to Autonomous Vehicle Testing Standards According to Leading Independent Auditor” (December 20, 2021), available at 
                            <E T="03">https://www.prnewswire.com/news-releases/argo-ai-conforms-to-autonomous-vehicle-testing-standards-according-to-leading-independent-auditor-301447984.html#:~:text=The%20result%20of%20T%C3%9CV%20S%C3%9CD's,being%20compliant%20with%20these%20applicable.</E>
                        </P>
                    </FTNT>
                    <P>
                        NHTSA proposes to publish each Final Determination Letter, including any Amended Final Determination Letter, that reflects a decision on an application. A letter granting admission to AV STEP would contain the full set of terms and conditions that govern participation.
                        <SU>202</SU>
                        <FTREF/>
                         Thereafter, NHTSA would publish information about each participation's operational status, including the dates of participation. Doing so would allow the public to understand whether an operation remains active, is inactive, is under a suspension, or has concluded.
                        <SU>203</SU>
                        <FTREF/>
                         To help the public understand ongoing operations, NHTSA proposes to publish certain information from quarterly reports. This information would include the number of subject vehicles operated on public roads, a list of zip codes where such operations occurred, and the number and location of any vehicle recovery events.
                        <SU>204</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>202</SU>
                             To the extent this letter memorializes information for which an applicant requested treatment as CBI under NHTSA's regulations in 49 CFR part 512, those portions of the letter may require redaction.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>203</SU>
                             For the proposed definitions of these statuses, 
                            <E T="03">see</E>
                             § 597.701(b)(1) of the proposed rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>204</SU>
                             NHTSA is not currently proposing to separately publish crash reporting through this program. As proposed, an SGO report would fulfill a crash report requirement in AV STEP. As such, NHTSA does not expect extensive crash reporting unique to this program and believes the transparency goals of crash reporting are already met through NHTSA's periodic publication of SGO reports.
                        </P>
                    </FTNT>
                    <P>In general, the information proposed for publication focuses on public-facing information about an operation. However, in other contexts, stakeholders have expressed interest in NHTSA collecting and publicizing information about VMT for ADS operations. The periodic reporting to NHTSA proposed for AV STEP includes several categories of VMT, as well as an element entitled “Operational Context,” which would indicate how such VMT compares to analogous operations outside of AV STEP. NHTSA requests comment on whether any of this information should be published for AV STEP.</P>
                    <P>
                        In general, information would be published for AV STEP as it is submitted to the agency. While NHTSA's publication of the information would not be an endorsement of its accuracy, as with any other reporting requirement, an entity is responsible for ensuring the accuracy of the information reported to NHTSA, and the agency would take appropriate action if it became aware of incorrect information. NHTSA is considering how best to present all of this information as well as exploring information technology solutions for doing so. In addition to the above-described information, the agency would consider periodically publishing broader insights gained through administering AV STEP.
                        <PRTPAGE P="4160"/>
                    </P>
                    <HD SOURCE="HD1">VII. Requirements for AV STEP Exemptions (Regulatory Text Subpart C)</HD>
                    <P>
                        As described in Section II (Program Context), this proposal includes two types of exemptions: (1) an FMVSS Exemption under 49 U.S.C. 30114(a); and (2) a Make Inoperative Exemption under 49 U.S.C. 30122. For consistency, where possible, the same AV STEP requirements would apply to all vehicles regardless of whether an exemption is sought. However, several additional requirements are proposed only for vehicles seeking exemptions. Some requirements would apply to both types of AV STEP exemptions and others to only one of the two exemptions. A Final Determination Letter would set the full terms and conditions for an exemption. Vehicles exempted under AV STEP would retain their exempt status only while participating in AV STEP.
                        <SU>205</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>205</SU>
                             Under § 597.303(f) of the proposed rule, vehicles imported into the United States under an AV STEP exemption could remain in the country after AV STEP participation ends, as long as they do not operate on public roads.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Exemption Eligibility Requirements</HD>
                    <P>
                        In addition to the general eligibility requirements, at least one applicant for each AV STEP FMVSS Exemption must satisfy an eligibility requirement specific to exemptions as specified in § 597.103 of the proposed rule. If the vehicles for which exemptions are sought require importation into the United States, at least one applicant must be the importer of record for each vehicle. This requirement would ensure accountability for the importation process. For vehicles that do not require importation, at least one applicant must be the manufacturer of each subject vehicle. This requirement is necessary because, absent an exemption, the manufacturer is the only party eligible to participate in AV STEP that is responsible for compliance and certification of the vehicle with all applicable FMVSS.
                        <SU>206</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>206</SU>
                             
                            <E T="03">See</E>
                             49 U.S.C. 30115.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Exemption Application Requirements</HD>
                    <P>Each application would need to specify whether it includes a request for an FMVSS Exemption under Section 30114(a) or Make Inoperative Exemption under Section 30122(c). Either exemption would require an additional application form. The application requirements for an AV STEP exemption are proposed in § 597.202 of the proposed rule, and include the following:</P>
                    <P>
                        <E T="03">Vehicle Information:</E>
                         An application for an exemption would need to include identifying information about each vehicle for which an exemption is sought, as well as the total anticipated number of vehicles for which each exemption will be sought during AV STEP participation. Under the process described in the next subsection, this number would be used to cap the actual number of vehicles that could receive an exemption. In addition, an application would need to identify each proposed vehicle label to meet the exemption labeling requirements detailed in the next subsection.
                    </P>
                    <P>
                        <E T="03">Insurance Disclosure:</E>
                         NHTSA proposes that an entity requesting either exemption confirm it will maintain insurance coverage from a regulated insurance company at all times in an amount sufficient to cover liability for damages, including for bodily injury or death, that may result from the operation of the vehicle in the manner and location(s) described in the application. This requirement resembles one currently used in NHTSA exemption programs under 49 U.S.C. 30114(a).
                        <SU>207</SU>
                        <FTREF/>
                         NHTSA has found this disclosure helpful in confirming that sufficient coverage exists while allowing state law to govern specifics about such coverage.
                    </P>
                    <FTNT>
                        <P>
                            <SU>207</SU>
                             This question is used in the existing process for temporary import exemptions, including in the ADS-equipped Vehicle Exemption Process, which implements 49 CFR part 591. 
                            <E T="03">See</E>
                             NHTSA, “Form: Temporary Import Exemption Application for Vehicles, Section 2: Vehicles Interacting with the Public,” Question 2.2.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Safety Comparisons and Mitigations:</E>
                         An applicant for an exemption would need to describe, in detail, each requirement of an FMVSS or bumper standard for which there is noncompliance or, in the case of a Make Inoperative Exemption, the device or element rendered inoperative. It would also need to describe any mitigations of associated safety impacts and how the vehicle's safety compares to that of a compliant vehicle, including comparisons of the crash protection for vehicle occupants and the safety of vulnerable road users. An application for a Make Inoperative Exemption would also need to describe each modification at issue and the extent to which the vehicle's original manufacturer was consulted regarding the modification. This disclosure would provide insight into how well the system-level effects of the modification are understood by the applicant. NHTSA would consider all of this information when assessing whether risks have been sufficiently addressed to justify the exemption sought.
                    </P>
                    <P>
                        NHTSA proposes that any FMVSS or bumper standard may be the subject of an AV STEP exemption request, consistent with NHTSA's other exemption programs. However, NHTSA requests comment on whether any standards should be ineligible for exemption under AV STEP.
                        <SU>208</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>208</SU>
                             For instance, in 2022, NHTSA amended occupant protection standards to account for ADS-equipped vehicles that lack traditional manual controls. 87 FR 18560 (March 30, 2022).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Eligibility of Domestic and Imported Vehicles:</E>
                         As proposed, both domestic and imported vehicles could apply for an FMVSS or Make Inoperative Exemption through AV STEP. NHTSA proposes to treat domestic and imported vehicles equally in the proposal, apart from unique requirements necessary for the importation process.
                    </P>
                    <P>
                        For the proposed Make Inoperative Exemption, this approach is consistent with Section 30122, which does not make any distinction between imported and domestic vehicles. NHTSA's regulations implementing other make inoperative exemptions likewise do not distinguish between imported and domestic vehicles. For the proposed FMVSS Exemption, this approach implements the express language of Section 30114(a), which contains no restrictions on a vehicle's country of origin. In this respect, the language of Section 30114(a) is consistent with other provisions in Section 30114, which apply equally to domestic and imported vehicles. For instance, Section 30114(b) authorizes an exemption for replica vehicles through similarly broad language that applies generally to any motor vehicles. NHTSA's regulations implement Section 30114(b) through a replica vehicle exemption program that applies to vehicles built both in the United States and abroad.
                        <SU>209</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>209</SU>
                             
                            <E T="03">See</E>
                             49 CFR part 586.
                        </P>
                    </FTNT>
                    <P>
                        In the past, NHTSA has implemented Section 30114(a) only for imported vehicles. The original statutory language for Section 30114(a) first arose to refine exemptions that the agency was already issuing in the imports context in conjunction with the U.S. Customs Service.
                        <SU>210</SU>
                        <FTREF/>
                         NHTSA implemented Section 30114(a) authority in the imports context through the regulatory framework codified in 49 CFR part 591. Because the text of Section 30114(a) is not by its terms limited to imported vehicles, however, NHTSA has since initiated a rulemaking to consider creating an equivalent to the part 591 exemptions for domestic vehicles.
                        <FTREF/>
                        <SU>211</SU>
                          
                        <PRTPAGE P="4161"/>
                        Separately implementing Section 30114(a) exemptions for domestic vehicles in the AV STEP rulemaking would be consistent with this ongoing work to equalize the opportunities for domestic vehicles.
                    </P>
                    <FTNT>
                        <P>
                            <SU>210</SU>
                             
                            <E T="03">See</E>
                             58 FR12905, 12906 (March 8, 1993) (explaining the legislative and regulatory history of the provision).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>211</SU>
                             This rulemaking remains ongoing. 
                            <E T="03">See</E>
                             Office of Information and Regulatory Affairs, “Unified Agenda of Regulatory and Deregulatory Actions,” 
                            <PRTPAGE/>
                            RIN 2127-AM14: 
                            <E T="03">Expansion of Temporary Exemption Program to Domestic Manufacturers for Research, Demonstrations, and Other Purposes.</E>
                        </P>
                    </FTNT>
                    <P>
                        Since AV STEP exemptions would span imported and domestic vehicles, an AV STEP exemption application would need to identify whether any vehicles require importation into the United States to ensure that requirements for importation were met. NHTSA proposes to amend the agency's HS-7 declaration form to add a new box for vehicles imported under an AV STEP exemption. A new box is needed because none of the existing fields for the HS-7 form fit the AV STEP exemptions.
                        <SU>212</SU>
                        <FTREF/>
                         All vehicles currently imported under a Section 30114(a) exemption use Box 7 of the form. However, Box 7 is limited to research and demonstration purposes under Section 30114(a) and is also specific to the importation restrictions in 49 CFR part 591. Thus, a new box is needed to declare that a vehicle does not conform to all applicable FMVSS and Bumper Standards but is being imported pursuant to an AV STEP exemption. NHTSA requests comment on whether the agency should amend 49 CFR 591.5 to specify that AV STEP vehicles may be imported in this way.
                    </P>
                    <FTNT>
                        <P>
                            <SU>212</SU>
                             
                            <E T="03">See</E>
                             Declaration HS-7, Importation of Motor Vehicles and Motor Vehicle Equipment Subject to Federal Motor Vehicle Safety, Bumper and Theft Prevention Standards, available at 
                            <E T="03">https://www.nhtsa.gov/sites/nhtsa.gov/files/documents/hs7_111920_v3_secured.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Proposed Section 30114(a) Purpose:</E>
                         An application for an FMVSS Exemption would need to identify which purpose in 49 U.S.C. 30114(a) is the basis for the exemption. The applicant would bear the burden of persuasion to demonstrate that a statutory purpose applies to the requested vehicles.
                        <SU>213</SU>
                        <FTREF/>
                         While any purpose enumerated in Section 30114(a) could be claimed for an exemption, NHTSA's experience administering AVEP suggests that most ADS exemption requests claim research, investigations, or demonstration purposes.
                        <SU>214</SU>
                        <FTREF/>
                         Any of these statutory purposes claimed under Section 30114(a) should be proportionate to the scope of a requested exemption, given the increased potential risk from exposure to larger numbers of noncompliant vehicles. For instance, if a request claimed a research purpose, the extent of the research interest should scale with the scope of the requested exemption. As a high-level example, the research purposes and scope of operations may be misaligned if a request claimed to research how ADS operations improve mobility options in rural communities but the operations in question occurred primarily in urban environments. To that end, § 597.202(b) of the proposed rule contains application requirements that allow the applicant to explain the rationale for a stated purpose, its relation to the exemption sought, and whether that purpose is expected to remain valid throughout the exemption.
                    </P>
                    <FTNT>
                        <P>
                            <SU>213</SU>
                             
                            <E T="03">See</E>
                             58 FR 12905, 12906 (March 8, 1993).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>214</SU>
                             NHTSA has explained that “research” and “investigations” often entail some sort of “test or experiment.” 58 FR 12905, 12906 (March 8, 1993). NHTSA has similarly stated that a demonstration of a motor vehicle has traditionally involved exhibiting its operation or use, both in the showroom and on the road. 
                            <E T="03">Id.</E>
                             Earlier versions of the statute also listed “studies” as an express statutory purpose. 
                            <E T="03">See</E>
                             15 U.S.C. 1397(j). NHTSA has looked to ordinary use of the word “study” when construing this term, explaining that the primary meaning of the word `study' is `the application of the mind to the acquisition of knowledge. 58 FR 12905, 12907 (March 8, 1993). NHTSA has historically considered vehicles of “technological interest” as emblematic of vehicles contemplated by this purpose. 
                            <E T="03">Id.</E>
                             Although the term “studies” was dropped in the 1994 recodification of the Safety Act, Congress made clear that this recodification was non-substantive. 
                            <E T="03">Compare</E>
                             15 U.S.C. 1397(j), 
                            <E T="03">with</E>
                             Public Law 103-272, 108 Stat. 947 (1994). As such, and given the overlap in terminology in research, demonstration, investigations, and studies, the recodification maintained the prior scope under this more streamlined set of terms.
                        </P>
                    </FTNT>
                    <P>NHTSA proposes to allow vehicles exempted under AV STEP to engage in commercial activities. The statutory language of Section 30114(a) does not prohibit commercial activity, provided a statutory purpose is met.</P>
                    <P>
                        For Section 30114(a) exemptions administered under part 591, NHTSA has typically set terms that prohibit certain public-facing commercial activities, such as charging fares during passenger-carrying services or imposing fees in goods delivery services. This restriction is designed to limit situations in which the Section 30114(a) purposes are claimed as a pretense for other private interests.
                        <SU>215</SU>
                        <FTREF/>
                         That approach reflects the practical difficulty of disentangling an entity's stated research, demonstration, or other interest from the inherent commercial motivations that may accompany an operation that generates revenue. A commercial operation prohibition sets a bright line that prevents the comingling of these motivations and ensures the statutory purpose is the reason the exemption is sought.
                    </P>
                    <FTNT>
                        <P>
                            <SU>215</SU>
                             58 FR 12905, 12907 (March 8, 1993) (expressing concern with a purpose, such as static display, that: can be undermined, however, by importations under subterfuge, where the hidden but real intent of the importer is to operate the vehicle on the public roads for his or her private enjoyment.).
                        </P>
                    </FTNT>
                    <P>However, since AV STEP proposes to accommodate more complex exemptions than part 591, NHTSA considers a more nuanced approach to commercialization appropriate. The procedural safeguards proposed for AV STEP would provide NHTSA with information necessary to ensure an appropriate statutory purpose for the exemption even if an operation is commercialized. These safeguards would include a robust disclosure of any commercialization and a justification for how the statutory purposes are nevertheless met. In addition, NHTSA proposes to require any AV STEP exemption involving commercial activity to demonstrate that the claimed Section 30114(a) purpose furthers a public, rather than purely private, interest. It is difficult to weigh an applicant's competing private interests, especially when one involves monetary gain. However, if an applicant can establish that a claimed Section 30114(a) purpose furthers a public interest, the agency could consider whether it justifies the requested exemption, even if some commercialization were to occur.</P>
                    <P>
                        NHTSA does not propose to delineate appropriate public interests in advance. Given the wide range of potential societal benefits from ADS, NHTSA intends for an applicant to describe and substantiate the public interest instead. Examples of potential public interests could range from environmental, accessibility for people with disabilities, equity, or labor impacts to interests relating to the improvement of transportation efficiency. As NHTSA explained recently in another exemption context: ADS vehicles have the potential to benefit our transportation system significantly beyond the analysis required in the safety determination. As NHTSA considers the potentially transformative impact of ADS technology, it is also considering its role in encouraging the use of ADS vehicles in ways that maximize their benefit to society. Specifically, NHTSA is exploring its role and responsibility in considering environmental impacts, accessibility, and equity when an exemption is sought for an ADS equipped vehicle. Climate, accessibility, and equity, in addition to road safety, are important public interest goals of the Department and NHTSA. NHTSA will also continue to consider how exemptions affect the 
                        <PRTPAGE P="4162"/>
                        development of advanced vehicle technologies.
                        <SU>216</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>216</SU>
                             87 FR 43602, 43607 (July 21, 2022).
                        </P>
                    </FTNT>
                    <P>The information submitted through an application would enable NHTSA to review the claimed statutory purpose in light of any expected commercialization.</P>
                    <HD SOURCE="HD2">C. Exemption Participation Requirements</HD>
                    <P>
                        The proposed rule also includes several participation requirements specific to exempted vehicles. In general, an exemption would expire at the end of a vehicle's AV STEP participation. However, imported vehicles that relied on the exemption to enter the United States could remain in the country as long as they did not operate on public roads or otherwise engage in interstate commerce. In addition to the operational control requirements for all AV STEP participants, an AV STEP exemption holder would need to maintain ownership and possession of each exempted vehicle and could not license it for use, unless otherwise permitted by NHTSA. This restriction ensures that tighter control is exercised over the vehicles to account for their nonconformance with safety standards. As with all participations, the terms of a Final Determination Letter could generally be amended under AV STEP's proposed amendment process. However, NHTSA proposes to require a new application for several fundamental changes to an exemption.
                        <SU>217</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>217</SU>
                             
                            <E T="03">See</E>
                             § 597.601(d)(3) of the proposed rule.
                        </P>
                    </FTNT>
                    <P>
                        NHTSA also proposes to require vehicles receiving either exemption to display at least two labels—one on the vehicle's exterior and one on the interior—stating that the vehicles might not conform with all applicable FMVSS. Exterior labels would inform surrounding road users or those entering the vehicle, whereas interior labels would inform vehicle occupants.
                        <SU>218</SU>
                        <FTREF/>
                         NHTSA would review each label proposed by an applicant during the review of an application and set terms for the labels in the Final Determination Letter.
                    </P>
                    <FTNT>
                        <P>
                            <SU>218</SU>
                             As proposed in § 597.105(g) of the proposed rule, the interior label would only be necessary for vehicle occupants. As such, if the design of a subject vehicle precluded passengers, no such interior label would be required.
                        </P>
                    </FTNT>
                    <P>
                        The Final Determination Letter would also list the specific vehicles receiving an exemption at that time, as well as cap the maximum number of vehicles that may be exempted.
                        <SU>219</SU>
                        <FTREF/>
                         As long as the list of exempted vehicles has not exceeded this cap, an exemption holder would be able to notify NHTSA of an intent to apply the exemption to additional vehicles. Unless NHTSA provides otherwise within 30 days of this notice, those additional vehicles would be exempt and subject to the same terms as previously exempted vehicles of the same type. The proposed rule would not set a limit on the number of vehicles that may receive an exemption in each participation, because NHTSA proposes the terms of a Final Determination Letter to govern vehicle numbers.
                        <SU>220</SU>
                        <FTREF/>
                         However, NHTSA requests comment on whether the proposed rule should include such a limit.
                    </P>
                    <FTNT>
                        <P>
                            <SU>219</SU>
                             As with other terms in a Final Determination Letter, an exemption-holder could request to amend this cap during participation.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>220</SU>
                             Since the original promulgation of part 591, NHTSA has recognized that Section 30114(a) may support issuing exemptions to multiple vehicles at once 
                            <E T="03">See</E>
                             57 FR 2043, 2046 (January 17, 1992) (noting that the exemption could apply to a fleet of test vehicles).
                        </P>
                    </FTNT>
                    <P>
                        This procedure is proposed to remain consistent with NHTSA's practice of issuing Section 30114(a) exemptions for existing vehicles rather than prospectively for vehicles that have not yet been built.
                        <SU>221</SU>
                        <FTREF/>
                         It would also avoid the burden of restarting the application process for new vehicles. Moreover, NHTSA believes that the agency, applicants, and the public should understand the volume of exemptions expected over the course of a participation. This information would help NHTSA assess the full scope of the anticipated participation when reviewing an application, provide applicants with more regulatory certainty for their vehicle manufacturing plans, and better enable the public to understand the extent of expected ADS-equipped vehicle activity.
                    </P>
                    <FTNT>
                        <P>
                            <SU>221</SU>
                             This usual approach to Section 30114(a) exemptions differs from how NHTSA currently administers exemptions under Section 30113 through part 555. Specifically, 49 CFR 555.7 provides: unless a later effective date is specified in the notice of the grant, a temporary exemption is effective upon publication of the notice in 
                            <E T="03">the</E>
                              
                            <E T="04">Federal Register</E>
                             and exempts vehicles manufactured on and after the effective date. 49 CFR 555.7(f) (Processing of applications). Some entities have expressed that part 555's current limitation to vehicles manufactured on or after the date the exemption is granted presents difficulties. NHTSA has received a petition for rulemaking from an ADS developer to this effect. NHTSA is currently considering a proposed rule to change this provision to allow part 555 exemptions to be granted to vehicles manufactured prior to the issuance of the grant of petition, if they are identical to the vehicles for which the exemption was sought. 
                            <E T="03">See</E>
                             Office of Information and Regulatory Affairs, “Unified Agenda of Regulatory and Deregulatory Actions,” DOT, RIN 2127-AM57: Temporary Exemption From Motor Vehicle Safety and Bumper Standards.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">D. Exemption Public Reporting</HD>
                    <P>NHTSA proposes to publish additional information about AV STEP exempted vehicles beyond the information that NHTSA proposes to make public about all AV STEP participations. That additional information is set forth in § 597.701(a) of the proposed rule and includes the type of exemption requested or received, the exempted FMVSS or bumper standard requirements, a summary of risk mitigations, and the Section 30114(a) purpose for FMVSS Exemptions.</P>
                    <HD SOURCE="HD1">VIII. Public Comments</HD>
                    <P>NHTSA requests comment on all aspects of this proposed rule. This section describes how you can participate in this process.</P>
                    <HD SOURCE="HD2">How do I prepare and submit comments?</HD>
                    <P>
                        Your comments must be written and in English.
                        <SU>222</SU>
                        <FTREF/>
                         To ensure that your comments are correctly filed in the docket, please include the docket number NHTSA-2024-0100 in your comments. If you are submitting comments electronically as a PDF (Adobe) file, we ask that the documents submitted be scanned using the optical character recognition (OCR) process, thus allowing NHTSA to search and copy certain portions of your submissions.
                        <SU>223</SU>
                        <FTREF/>
                         Please note that pursuant to the Data Quality Act, in order for the substantive data to be relied upon and used by NHTSA, it must meet the information quality standards set forth in the Office of Management and Budget (OMB) and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at 
                        <E T="03">https://www.whitehouse.gov/omb/information-regulatory-affairs/information-policy.</E>
                         DOT's guidelines may be accessed at 
                        <E T="03">https://www.transportation.gov/dot-information-dissemination-quality-guidelines.</E>
                    </P>
                    <FTNT>
                        <P>
                            <SU>222</SU>
                             
                            <E T="03">See</E>
                             49 CFR 553.21.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>223</SU>
                             OCR is the process of converting an image of text, such as a scanned paper document or electronic fax file, into computer-editable text.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">Tips for Preparing Your Comments</HD>
                    <P>When submitting comments, please remember to:</P>
                    <P>
                        • Identify the rulemaking by docket number and other identifying information (subject heading, 
                        <E T="04">Federal Register</E>
                         date and page number).
                    </P>
                    <P>• Explain why you agree or disagree, suggest alternatives and substitute language for your requested changes.</P>
                    <P>
                        • Describe any assumptions and provide any technical information and/or data that you used.
                        <PRTPAGE P="4163"/>
                    </P>
                    <P>• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.</P>
                    <P>• Provide specific examples to illustrate your concerns and suggest alternatives.</P>
                    <P>• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.</P>
                    <P>
                        • Make sure to submit your comments by the comment period deadline identified in the 
                        <E T="02">DATES</E>
                         section above.
                    </P>
                    <HD SOURCE="HD2">How can I be sure that my comments were received?</HD>
                    <P>If you submit your comments by mail and wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.</P>
                    <HD SOURCE="HD2">How do I submit confidential business information?</HD>
                    <P>
                        If you wish to submit any information under a claim of confidentiality, you should submit your complete submission, including the information you claim to be confidential business information (CBI), to the NHTSA Chief Counsel. When you send a comment containing CBI, you should include a cover letter setting forth the information specified in our CBI regulation.
                        <SU>224</SU>
                        <FTREF/>
                         In addition, you should submit a copy from which you have deleted the claimed CBI to the Docket by one of the methods set forth above.
                    </P>
                    <FTNT>
                        <P>
                            <SU>224</SU>
                             
                            <E T="03">See</E>
                             49 CFR part 512.
                        </P>
                    </FTNT>
                    <P>
                        NHTSA is treating electronic submission as an acceptable method for submitting CBI to the agency under 49 CFR part 512. Any CBI submissions sent via email should be sent to an attorney in the Office of the Chief Counsel at the address given above under 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        . Likewise, for CBI submissions via a secure file transfer application, an attorney in the Office of Chief Counsel must be set to receive a notification when files are submitted and have access to retrieve the submitted files. At this time, regulated entities should not send a duplicate hardcopy of their electronic CBI submissions to DOT headquarters.
                    </P>
                    <P>
                        If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section.
                    </P>
                    <HD SOURCE="HD2">Will NHTSA consider late comments?</HD>
                    <P>
                        NHTSA will consider all comments received before the close of business on the comment closing date indicated above under 
                        <E T="02">DATES</E>
                        . To the extent practicable, we will also consider comments received after that date. If interested persons believe that any information that NHTSA places in the docket after the issuance of the NPRM affects their comments, they may submit comments after the closing date concerning how NHTSA should consider that information for the final rule. However, NHTSA's ability to consider any such late comments in this rulemaking will be limited due to the time frame for issuing a final rule.
                    </P>
                    <P>If a comment is received too late for us to practicably consider in developing a final rule, we will consider that comment as an informal suggestion for future rulemaking action.</P>
                    <HD SOURCE="HD2">How can I read the comments submitted by other people?</HD>
                    <P>
                        You may read the materials placed in the docket for this document (
                        <E T="03">e.g.,</E>
                         the comments submitted in response to this document by other interested persons) at any time by going to 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the online instructions for accessing the dockets. You may also read the materials at the NHTSA Docket Management Facility by going to the street addresses given above under 
                        <E T="02">ADDRESSES</E>
                        .
                    </P>
                    <HD SOURCE="HD1">IX. Regulatory Notices and Analyses</HD>
                    <HD SOURCE="HD2">A. Executive Orders 12866, 13563, 14094 and DOT Regulatory Policies and Procedures</HD>
                    <P>NHTSA has considered the impact of this rulemaking action under Executive Order (E.O.) 12866, “Regulatory Planning and Review,” as supplemented by E.O. 13563, “Improving Regulation and Regulatory Review,” and amended by E.O. 14094, “Modernizing Regulatory Review,” as well as under DOT's regulatory procedures. Although the rule does not meet the $200 million threshold for significance pursuant to section 3(f)(1) of E.O. 12866 as amended, this NPRM has been designated as significant and was reviewed by the Office of Management and Budget (OMB) under E.O. 12866. This section summarizes NHTSA's assessment of potential benefits and costs relating to this proposal.</P>
                    <P>NHTSA proposes AV STEP as a voluntary national program that would be available for two categories of vehicles. The first category consists of vehicles that can lawfully operate on public roads regardless of participation in AV STEP, as long as they comply with all other Federal, state, and local laws. These vehicles include those that are compliant with and certified to all applicable FMVSS, those that have received exemptions under other NHTSA programs, and those that may operate on public roads pursuant to the FAST Act, as provided for by 49 U.S.C. 30112(b)(10). The second category consists of vehicles that would seek an exemption from NHTSA through AV STEP. Under this proposal, vehicles that do not comply with all applicable FMVSS or those that originally complied but are taken out of compliance by an ADS retrofit could seek exemptions through AV STEP.</P>
                    <P>NHTSA has qualitatively assessed many of the costs and benefits of AV STEP because the agency does not currently have sufficient data to calculate all costs and benefits. Data is limited because the novel aspects of this proposal and ADS-equipped vehicles create significant uncertainties. NHTSA seeks comment and additional data regarding the potential impacts of this proposed program.</P>
                    <HD SOURCE="HD3">1. Need for Regulation</HD>
                    <P>The AV STEP proposal was developed to address several complexities relating to the current nascent state of ADS technology. Those challenges, as well as the ways in which AV STEP proposes to address them, are explained in Section II (Program Context) of this NPRM. Specifically, that section explains how definitive, objective ADS safety assessment test methods are lacking, and that this proposal is designed to account for the current ADS technological landscape as well as complement NHTSA's other activities pertaining to ADS.</P>
                    <P>ADS technology is in a transitional period of development. The technology has reached a point at which ADS operations are increasingly occurring and expanding on public roads. However, the technology is still in a relative state of infancy. Most ADS operations focus on testing or demonstrating the ADS. The tools used to evaluate the safety of an ADS are likewise in early stages of development. Existing industry standards and best practices for ADS safety continue to evolve and are often used differently across the industry. As the performance capabilities of ADS continue to mature, the expectations about the performance of the technology will likewise evolve. As a result, more information and development are needed before ADS technology will be ready for minimum performance standards, such as FMVSS.</P>
                    <P>
                        However, safety must remain a priority, even though ADS technologies 
                        <PRTPAGE P="4164"/>
                        are in a nascent state of development. Many ADS-equipped vehicles are currently operating on public roads across the United States, in proximity to other road users. Some of those ADS operations are carrying public passengers. As such, the operation of ADS-equipped vehicles entails a safety responsibility to the public, even as the technology continues to develop. The Safety Act formalizes this responsibility by requiring vehicles and vehicle equipment, including ADS, to be free of safety defects. NHTSA oversees these Safety Act responsibilities, and the agency's oversight relies on access to information about the vehicles and their ADS to monitor for safety-related defects.
                    </P>
                    <P>AV STEP would complement NHTSA's existing oversight, transparency, rulemaking, and research efforts relating to ADS in a way that builds on the agency's precedent for the technology and enhances the agency's ability to carry out each of these statutory responsibilities when regulating ADS. The additional information that AV STEP would provide about ADS operations on public roads would improve NHTSA's oversight of vehicles that participate in the program. Likewise, AV STEP would help to increase the amount of information that is publicly available about participating ADS-equipped vehicle operations.</P>
                    <P>In addition, evolving approaches to assessing ADS safety merit a flexible safety assessment framework that is designed for the current transitional stage of ADS. Focusing on the engineering rigor and level of due diligence applied to an ADS' development and operation would allow a review to probe the safety of an ADS even though proven performance standards do not currently exist. This approach to safety reviews would also allow the review framework to evolve as best practices and understanding of ADS safety evolve. This document proposes such a framework for AV STEP and would enable NHTSA to gain insight into how a company's safety practices and metrics for assessing safety correspond to real world ADS performance.</P>
                    <P>Finally, over the last several years, the number and complexity of FMVSS exemption requests involving ADS-equipped vehicles has significantly increased. In addition, questions have arisen about how the make inoperative prohibition in 49 U.S.C. 30122 affects ADS equipment retrofits. Currently, NHTSA's regulations lack a way for an entity to request a Make Inoperative Exemption in order to equip a compliant vehicle with an ADS in a way that would take the vehicle out of compliance with an FMVSS. AV STEP would address both of these situations by providing a framework through which NHTSA could consider FMVSS Exemptions under 49 U.S.C. 30114(a) or Make Inoperative Exemptions under Section 30122 for ADS-equipped vehicles. The agency designed AV STEP to review and oversee complex ADS operations, which would improve the agency's ability to efficiently administer FMVSS Exemptions for ADS-equipped vehicles under Section 30114(a) and afford eligible entities an opportunity to request a Make Inoperative Exemption for an ADS retrofit.</P>
                    <HD SOURCE="HD3">2. Uncertainties and Assumptions</HD>
                    <P>As part of the cost-benefit analysis for this rulemaking, NHTSA estimated the costs that would arise from compliance with the key aspects of the application and participation requirements that are proposed for AV STEP. This analysis is informed by the agency's past regulatory activity pertaining to ADS, such as exemptions issued under Section 30114(a) through the AVEP process, reporting under the SGO, and voluntary agency initiatives involving ADS, such as AV TEST and VSSAs. The agency's experience administering those programs helped shape the proposed requirements for AV STEP, as well as informed the agency's expectations about both the level of interest that ADS companies may have in participating in AV STEP and the burden that such participation would entail. Nevertheless, the specific type of national program proposed in this NPRM is new, as are many aspects of the ADS technology that it covers. As a result, inherent uncertainties exist regarding the projected impacts of this rule.</P>
                    <P>First, uncertainty exists as to the number of entities that would apply to AV STEP. Since NHTSA proposes AV STEP as a voluntary program, the number of entities directly affected by this proposal would depend upon the level of interest in participation amongst eligible entities.</P>
                    <P>As a starting point in estimating the number of entities interested in participating, NHTSA first estimated the number of entities that would be eligible to participate in AV STEP. The pool of eligible applicants is limited to entities that meet the proposed eligibility requirements in § 597.103 of the proposed rule. Eligible entities would be vehicle manufacturers, ADS developers, fleet operators, or system integrators of ADS-equipped vehicles.</P>
                    <P>
                        The SGO reporting provides a starting point for estimating the total number of eligible entities who may qualify to apply to AV STEP. The SGO contains a service list of entities that NHTSA has identified as potentially engaged in activities relating to ADS and SAE Level 2 ADAS in the United States. NHTSA actively maintains this service list and has updated it in amended versions of the SGO, as the agency becomes aware of new entities or updates regarding previously served entities. The service list for the latest version of the SGO, which was issued in April 2023, contains 114 entities.
                        <SU>225</SU>
                        <FTREF/>
                         Apart from a small number of component suppliers and several other miscellaneous entities that were project stakeholders in particular operations, most of the entities on the SGO's service list are vehicle manufacturers, system developers, fleet operators, or system integrators of vehicles equipped with automation technologies. Thus, the entities on the SGO service list helps estimate the potential pool of eligible applicants for AV STEP.
                    </P>
                    <FTNT>
                        <P>
                            <SU>225</SU>
                             The SGO service list can be found at the end of the published Order. 
                            <E T="03">See</E>
                             NHTSA, “Second Amended Standing General Order 2021-01” (April 2023), available at: 
                            <E T="03">https://www.nhtsa.gov/document/sgo-crash-reporting-adas-ads.</E>
                        </P>
                    </FTNT>
                    <P>However, the SGO encompasses both Level 2 ADAS and ADS, whereas AV STEP is proposed to only encompass ADS. As such, the full service list for the SGO is broader than the pool of eligible applicants for AV STEP. Instead, a more analogous segment of the SGO data is the number of entities that have submitted ADS reports under the SGO. When submitting a crash report under the SGO, an entity must indicate whether the vehicle automation system that is the subject of the report is classified as an ADS or Level 2 ADAS. Thus far, 42 entities have submitted ADS crash reports under the SGO.</P>
                    <P>
                        This number would not account for any new ADS entities that may emerge during the course of AV STEP. Given the evolving state of ADS technology, companies engaged in ADS operations are in a constant state of change, with new startups frequently created and existing companies often winding down. This state of change adds uncertainty to any estimated number of eligible entities. In addition, the figure of 42 entities that have submitted an ADS crash report does not account for SGO entities involved in ADS who have not yet experienced a reportable crash. The level of participation interest from eligible entities that have not submitted an ADS report under the SGO is less certain because the absence of any reporting may suggest that the company 
                        <PRTPAGE P="4165"/>
                        is not involved in extensive public road ADS operations. To estimate the potential interest of these entities in AV STEP, NHTSA analyzed entities' engagement with other ADS regulatory activities, such as VSSA, other NHTSA exemption programs, and state and local ADS permitting programs. Through this, the agency identified additional entities that may have some future interest in participating in AV STEP. Given these considerations, NHTSA considers the figure of 50 entities a reasonable starting point for estimating the number of entities that are currently engaged in ADS operations on public roads in the United States at a level that may generate interest in participating in AV STEP.
                    </P>
                    <P>Additionally, given the potential growth of the ADS industry, NHTSA believes that it is reasonable to assume that the number of entities engaged in more extensive ADS operations will continue to grow over the coming years. Therefore, rather than exclusively relying on the number of entities that have already reported an ADS crash under the SGO, NHTSA considers an estimate of 60 eligible entities a more appropriate estimate for AV STEP. NHTSA seeks comment on this estimate of the eligible pool of participants.</P>
                    <P>Since AV STEP is proposed as voluntary, NHTSA does not expect all eligible entities would decide to apply to the program. In addition, as proposed, AV STEP would permit joint applications from essential system-level stakeholders on a project. As a result, some of these eligible entities may jointly apply to AV STEP for operations that they work on together. This may further reduce the total number of unique applications compared to the total number of eligible entities.</P>
                    <P>Finally, NHTSA considers many of the incentives to participate in AV STEP applicable to all eligible entities. However, an eligible entity's particular level of interest in participating would likely be affected by the type of participation requested. This is particularly the case for FMVSS and Make Inoperative Exemptions requested through AV STEP because vehicles subject to those requests would not be permitted to operate on public roads in the United States without an exemption (attained through either existing exemption programs or through AV STEP). In contrast, vehicles that are compliant with all applicable NHTSA requirements could conduct operations without AV STEP. As a result, entities with ADS-equipped vehicles in need of an exemption because they do not comply with all applicable NHTSA requirements would be more likely to apply to AV STEP. Entities with compliant ADS-equipped vehicles may have less obvious interest in the program, as discussed further in Section III (Program Structure (Regulatory Text Subpart A)).</P>
                    <P>These variables create uncertainty in the number of eligible entities that would apply to participate in AV STEP. Given these considerations, NHTSA estimates that one in 12 of the entities eligible to participate in AV STEP would apply to the program annually. Given that some eligible entities will likely take time to gain familiarity with the program and consider whether to participate, the agency expects participation to ramp up over the first 3 to 5 years followed by a tapering-off of new applicants. For purposes of this analysis, NHTSA estimated an average of five applicants to AV STEP each year.</P>
                    <P>For purposes of this analysis, NHTSA did not adjust the anticipated number of participants in AV STEP for any estimated denials of applications. In practice, as explained in this document, NHTSA may deny an application based on concerns that arise during the application review process or suspend or revoke permission to participate based on concerns that arise during participation. However, sufficient data does not currently exist to project the number of applications that would be denied or the number of participations that would be suspended or revoked. Moreover, AV STEP, as proposed, is structured to reduce the likelihood of deficient applications. The proposed requirements for AV STEP set forth clear expectations for an application, and the proposed application review process would afford applicants an opportunity to rectify issues prior to NHTSA's final decision on an application. As proposed, NHTSA could also set terms and conditions in an AV STEP Final Determination Letter that restrict the requested operation, enabling NHTSA to address certain issues with a requested operation without resorting to a full denial. As a result of these considerations, NHTSA estimated that AV STEP participation will increase by the number of applicants every year. As explained above, the agency estimated that an average of five entities would apply annually during the first seven years of the program.</P>
                    <P>The agency also expects that, over time, some entities will conclude operations that participated in AV STEP. For example, an entity could cease ADS operations entirely or choose to operate differently in a way that would require a new, distinct application. The continuing changes to the ADS industry landscape discussed above, with frequent acquisitions and market exits influenced by varied unpredictable factors, such as funding, make projections difficult. For the purposes of this analysis, NHTSA has estimated that by the seventh year after initiation of the program, a total of 35 entities would have applied for and been accepted into AV STEP. At the same time, NHTSA expects that, starting in the fourth year after the initiation of AV STEP, some program participations would conclude (for a variety of reasons, as noted earlier) such that total participation in the program would reach 29 participants in the seventh year of the program. NHTSA seeks comment and data on these assumptions and estimates.</P>
                    <P>A second notable uncertainty inherent to this proposal is the rate at which ADS technology will progress and the extent to which the technology will be adopted by the public. This proposal recognizes that the potential of ADS is still largely unproven. ADS technologies have the potential to improve safety as well as provide other societal benefits. The impacts of ADS, however, will ultimately be the cumulative result of numerous engineering, deployment, policy, and other choices. Likewise, the capabilities and expectations of ADS are likely to evolve significantly in the coming years.</P>
                    <P>To account for this evolving technological landscape, certain proposed AV STEP requirements are crafted to evolve over time or allow for a customized approach that can account for the unique attributes of individual applications. For instance, NHTSA proposes for independent assessments to consider relevant industry standards, guidance, and best practices, which should evolve as the industry's understanding of the technology improves. Likewise, as proposed, NHTSA would oversee operations that participate in AV STEP through terms and conditions set in a Final Determination Letter. Those terms would be tailored to the details of each operation, such as the types of subject vehicles, the ODDs in they would operate, and the use cases for such operations. As a result, those terms would depend on the types of applications that NHTSA receives and the capabilities of the ADS equipped on those vehicles. Thus, the specific impacts of this proposal would be largely contingent on the unknown future levels of ADS maturity.</P>
                    <P>
                        Another uncertainty in this rulemaking is the extent to which the independent assessment proposed for AV STEP would represent unique costs 
                        <PRTPAGE P="4166"/>
                        for an applicant. As explained in Section IV.D (Independent Assessment), an application would need to contain a summary report of an independent assessment covering three focus areas regarding the subject vehicles' ADS and operations: (a) their conformance with industry standards; (b) the applicant's safety case; and (c) specific other policies and ADS capabilities. NHTSA developed these requirements based on the agency's experience with independent assessments conducted for other sectors of the automotive industry, as well as the burgeoning practice of ADS companies voluntarily obtaining independent assessments for their own operations.
                    </P>
                    <P>Nevertheless, the assessment proposed for AV STEP is new, as are independent assessments for ADS. As ADS technologies mature and the independent assessment landscape grows, NHTSA expects that companies will more commonly undertake third-party assessments as part of their own development processes. Nevertheless, the extent to which companies would voluntarily conduct assessments in the future is still uncertain, as is the scope of those assessments.</P>
                    <P>For purposes of this analysis, NHTSA estimates that half of AV STEP applicants will have already voluntarily obtained an independent assessment of their ADS operations before applying to AV STEP or would have done so even if they did not apply to AV STEP. This estimate is based on the agency's understanding of the current frequency with which ADS companies initiate such assessments and the expectation that, given the history of other safety-critical industries with independent assessments, the voluntary usage of these assessments will grow as ADS practices and operations evolve. As a result, NHTSA has discounted the projected costs of an independent assessment for AV STEP to account for this estimate that applicants would have incurred similar costs from assessments in the absence of AV STEP.</P>
                    <HD SOURCE="HD3">3. Costs</HD>
                    <P>NHTSA assessed, in 2023 dollars, multiple categories of costs for this proposal. First, the agency assessed costs for which NHTSA could estimate monetized impacts of the rule. These costs primarily relate to the costs that an entity would incur to apply to AV STEP and participate in the program if admitted, as well as the costs that NHTSA would incur to administer the program. NHTSA also assessed several types of costs as baseline costs that would be incurred even in the absence of AV STEP. Finally, NHTSA assessed several types of costs qualitatively because insufficient data currently exist to support any approach to estimating their monetized impact.</P>
                    <P>Two characteristics of this proposal are overarching considerations in NHTSA's assessment of costs. First, given that AV STEP is proposed as a voluntary program, any costs incurred by an entity would be voluntarily incurred because the entity has chosen to engage with the program. Moreover, entities that apply to AV STEP would have other regulatory options to legally operate their vehicles. This includes entities that request exemptions under AV STEP, who could decide instead to comply with NHTSA's requirements so that no exemptions are needed. Likewise, certain entities requesting an FMVSS exemption through AV STEP could alternatively request an FMVSS exemption under two other NHTSA programs, set forth in 49 CFR parts 555 and 591. An FMVSS exemption could also offset certain costs of complying with the FMVSS, such as designing a vehicle or equipment to meet a particular performance standard or conducting certification testing. As such, entities that elect to engage with AV STEP would presumably consider the benefits of this program to justify its costs.</P>
                    <P>The Make Inoperative Exemption proposed for AV STEP would be new. No such exemption process for ADS-equipped vehicles is currently available in NHTSA's regulations. However, as explained in this document, this exemption would be largely proactive and would provide additional regulatory flexibility for entities to pursue ADS retrofits to compliant vehicles in ways that they could not otherwise consider. In addition, only a portion of ADS-equipped vehicles are equipped with ADS through aftermarket modifications. As a result, this exemption would be of interest to only a limited subset of ADS-equipped vehicles, which themselves currently represent only a very small percentage of all motor vehicles on public roads in the United States.</P>
                    <P>Second, this document proposes a set of procedures to organize the information NHTSA would receive for its review of AV STEP applications and administration of AV STEP participation. This rulemaking would not exempt or admit any particular vehicles into AV STEP. Those decisions would be left to future NHTSA adjudication of applications. As explained throughout this document, while the information proposed for AV STEP would be helpful in informing NHTSA's review, the agency would reserve discretion for its ultimate adjudications of AV STEP admission, including exemptions. Thus, many potential impacts associated with AV STEP would ultimately stem from NHTSA's decisions on those applications rather than the procedures proposed in this document. Because there are requirements set forth in the rule that would accrue as a result of participation however, such as reporting to NHTSA, NHTSA considers the costs of those requirements for program participants in this analysis.</P>
                    <HD SOURCE="HD3">(a) Baseline Costs</HD>
                    <P>NHTSA estimates that several notable requirements for AV STEP would not involve significant unique costs for an applicant or participant. This is because those costs are part of the baseline and would be incurred by the entity in the absence of AV STEP. As a result, NHTSA does not consider those costs attributable to AV STEP and has not included them in the estimated costs of this proposal. Subsection 2 (Uncertainties and Assumptions) above explains one of them: the cost of an independent assessment for applicants that would have voluntarily conducted an assessment even apart from AV STEP. Other baseline costs pertain to data generation and storage, crash reporting, and information submitted as part of application or reporting requirements for FMVSS exemptions.</P>
                    <P>
                        NHTSA does not anticipate data generation and storage costs for AV STEP beyond those costs incurred by entities during operations in the baseline. The agency designed the program to largely use data that entities should already generate and store as part of responsible operations. The application and reporting requirements proposed for AV STEP focus on a company's internal processes and assessment methods for its operations. This proposal expressly recognizes that those practices may vary between entities. To account for this variation, NHTSA proposes to tailor the most technology-dependent reporting elements to the data and metrics already used by a company, to the extent that these would further the goals of AV STEP. These are framed as “customized” requirements in the proposed rule. For such requirements, applications would need to include proposals for specific metrics or thresholds that could be used for the terms of customized reporting. As a result, this reporting is expected to correspond to data that a company is already using, reducing the likelihood that these requirements would entail 
                        <PRTPAGE P="4167"/>
                        new data generation or storage capabilities.
                    </P>
                    <P>
                        Likewise, NHTSA does not anticipate crash reporting costs from AV STEP beyond those incurred in the baseline from other crash reporting requirements. As proposed, entities would be required to submit several types of reports about crashes involving a subject vehicle. The first type of required report would consist of reports of crashes that occur during or near a time that the vehicle's ADS is engaged. Crash report under the SGO is expected to satisfy this ADS crash reporting requirement in AV STEP.
                        <SU>226</SU>
                        <FTREF/>
                         As explained in Section V.A.2 (Event-Triggered Reporting), the crash reporting requirements in AV STEP are largely designed to mirror the crash reporting requirements under the SGO. To avoid duplicate reporting, a timely crash report under the SGO would satisfy obligations to report that information for AV STEP. NHTSA expects participants in AV STEP to be reporting entities under the SGO. As such, NHTSA would not expect AV STEP participants to incur reporting requirements for ADS crashes beyond those incurred in the baseline.
                    </P>
                    <FTNT>
                        <P>
                            <SU>226</SU>
                             For NHTSA's cost analysis of SGO reporting requirements, see 86 FR 74217 (December 2021).
                        </P>
                    </FTNT>
                    <P>
                        The second type of crash reporting proposed for AV STEP would require, participants to submit video footage of the most severe types of crashes that are reported. The SGO does not require crash reports to include video.
                        <SU>227</SU>
                        <FTREF/>
                         However, NHTSA usually requests video for the most serious crashes reported under the SGO, as part of the agency's follow-up on SGO reports. NHTSA also typically requires video submission for crashes involving ADS-equipped vehicles exempted under other NHTSA programs. As such, baseline costs in the absence of AV STEP already include costs associated with the submission of video footage, and the video reporting requirement proposed in AV STEP would not expand on the amount of effort required of a reporting entity to process video footage and transmit it to NHTSA. Therefore, NHTSA considers the costs of submitting video footage in AV STEP to be costs that exist in the baseline and not costs attributable to this program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>227</SU>
                             The other difference between the proposed AV STEP crash reporting requirement and the SGO is that AV STEP proposes to require reports of all crashes whereas the SGO only requires reports of crashes that occur with the ADS engaged during or immediately preceding the crash event. This difference is covered under Section IX.A.3.c)(2) (Participation Costs).
                        </P>
                    </FTNT>
                    <P>
                        Finally, costs associated with an FMVSS exemption in AV STEP also exist in the baseline because they would be incurred if an entity sought an FMVSS exemption under a different NHTSA exemption program instead. As explained in Section III (Program Structure (Regulatory Text Subpart A)), apart from AV STEP, certain ADS-equipped vehicles could request FMVSS exemptions under two other NHTSA regulations: (1) 49 CFR part 591, which implements Section 30114(a) exemptions; and (2) 49 CFR part 555, which implements Section 30113 exemptions.
                        <SU>228</SU>
                        <FTREF/>
                         The application and reporting requirements proposed for AV STEP are based on information that NHTSA receives when administering each of those exemptions, either directly as part of an application or through follow-up with an applicant. Specifically, the proposed application for an FMVSS Exemption under AV STEP focuses on each noncompliance and the ways in which an applicant mitigated any safety risks from each noncompliance. Entities that request FMVSS exemptions under AVEP or part 555 must provide similar information about each noncompliance for which an exemption is requested.
                    </P>
                    <FTNT>
                        <P>
                            <SU>228</SU>
                             NHTSA has previously analyzed costs of FMVSS exemption processes under Section 30114(a) (the authority that the agency proposes to use for AV STEP) for the TIE program. As discussed in Section II.B.2 (NHTSA Exemptions), the TIE program is used for both non-ADS exemptions and ADS exemptions. Thus, ADS operations represent only a portion of the cost analysis for the TIE program. For this analysis, 
                            <E T="03">see</E>
                             87 FR 41861 (July 2022).
                        </P>
                    </FTNT>
                    <P>As such, even in the baseline, an entity that requested an FMVSS Exemption under one of NHTSA's other exemption programs would incur the costs of providing this information. If AV STEP did not exist, NHTSA expects most, if not all, of the applicants for an FMVSS Exemption under AV STEP would request exemptions under either part 591 or part 555. As such, NHTSA considers costs from the requirements for an FMVSS Exemption in AV STEP to be baseline costs that would be incurred without this program.</P>
                    <HD SOURCE="HD3">(b) Non-Quantified Costs</HD>
                    <P>Several types of potential costs of an AV STEP application or participation are dependent on currently unknown future variables. As such, NHTSA analyzed these qualitatively. The first such cost is the cost to applicants associated with the application review process. For AV STEP, NHTSA proposes a phased application review process that entails follow-up with an applicant on their application, as well as coordination on terms and conditions of participation. The amount of engagement necessary for this process will depend significantly on variables such as the thoroughness of an application, the complexity of the operations requested, and the responsiveness of an applicant. Those factors are largely within the control of the applicant and influenced by the capabilities of the ADS that is the subject of an application.</P>
                    <P>Costs associated with the concern resolution process are also dependent on similar variables. The concern resolution process proposed for AV STEP would be initiated only if problems arose during a participation. NHTSA cannot currently predict the frequency or nature of such problems. Likewise, the agency also cannot currently predict the types of resolutions that may be necessary under this process, as these would turn on the specific mitigations for a problem and a participant's willingness to cooperate when concerns arise. NHTSA also cannot predict the extent to which a participant may have mitigated those concerns on their own even in the absence of AV STEP.</P>
                    <P>Finally, NHTSA did not quantify safety costs as part of this proposal. The overall objective of this proposal is to further public safety, and NHTSA expects AV STEP to have a net safety benefit. The variety of benefits to motor vehicle safety from this proposal are explained throughout this document. NHTSA does not expect safety costs to result from AV STEP, particularly since compliant vehicles that participate in AV STEP could conduct the same operations on public roads without this program.</P>
                    <P>NHTSA likewise does not expect the FMVSS or Make Inoperative Exemptions in AV STEP to entail negative safety impacts. As explained in Section VII.B (Exemption Application Requirements), applications for FMVSS or Make Inoperative Exemptions would need to identify each requirement or modification for which an exemption is needed, explain all associated mitigations of safety impacts, and explain how the vehicle's safety compares to that of a compliant vehicle. NHTSA would consider all of this information, in conjunction with the other information submitted in an application, when assessing whether risks have been sufficiently addressed to justify granting the exemption sought. Given these requirements, NHTSA does not expect FMVSS nonconformance to lead to negative safety impacts.</P>
                    <HD SOURCE="HD3">(c) Quantified Costs</HD>
                    <P>
                        NHTSA's analysis of the quantified costs for AV STEP estimated the burden to applicants of preparing an application as well as the burden to 
                        <PRTPAGE P="4168"/>
                        participants from reporting or preparing amendment requests during participation. NHTSA's general methodology for estimating these costs entailed projecting the annual burden that an applicant or participant would incur for each program requirement. Specifically, these costs were calculated by predicting the types of personnel that would be necessary to complete each requirement, the burden hours for each of those types of personnel, and the wage rates for such personnel. NHTSA used the National Occupational Employment and Wage Estimates of the U.S. Bureau of Labor Statistics in conducting this analysis.
                        <SU>229</SU>
                        <FTREF/>
                         In general, most burden hours were assumed to be incurred by one or more of the following occupational categories: Administration Specialist ($34.04 per hour); Operations Specialist ($80.60 per hour); Engineer ($84.74 per hour); Senior Manager ($116.22); or Lawyer ($120.64 per hour).
                        <SU>230</SU>
                        <FTREF/>
                         The labor rates for these occupational categories are based on average rates for multiple occupational titles/codes within a particular category (and as listed in the National Occupational Employment and Wage Estimates of the U.S. Bureau of Labor Statistics). For example, wage rates for the “Engineer” category are based on an average of the wage rates for: Electrical and Electronic Engineers (17-2070), Industrial Engineers (17-2112), Mechanical Engineers (17-2141), Computer Engineers (17-2061), Computer Systems Analysts (15-1211), Computer and Information Research Scientists (15-1221), and Software Developers (15-1252). NHTSA will publish spreadsheets in the docket for this rulemaking that reflect the estimates summarized below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>229</SU>
                             
                            <E T="03">See</E>
                             U.S. Bureau of Labor Statistics, “National Occupational Employment and Wage Estimates, United States” (May 2023), available at 
                            <E T="03">https://www.bls.gov/oes/current/oes_nat.htm#11-0000.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>230</SU>
                             These labor costs include wages and fringe benefits, including paid leave, bonuses and overtime pay, health and other types of insurance, retirement plans, and legally required benefits (Social Security, Medicare, unemployment insurance, and workers' compensation insurance). NHTSA estimated that the fringe benefits are approximately 42.2 percent of the average hourly wage. For the information that NHTSA used to derive this, 
                            <E T="03">see</E>
                             Bureau of Labor Statistics, “Employer Costs for Employee Compensation” (September 2024), available at: 
                            <E T="03">https://www.bls.gov/news.release/ecec.htm.</E>
                        </P>
                    </FTNT>
                    <P>These projections were informed by NHTSA's engagement with regulated entities in NHTSA programs that contain certain requirements analogous to those proposed in AV STEP, such as the agency's review of applications and oversight of exemptions under AVEP or follow-up with entities after a reported SGO crash. Through administering these programs, NHTSA has gained experience with the types of personnel that typically handle various types of responsibilities as well as the level of work that certain tasks typically entail. NHTSA seeks comment on these estimated costs and requests data that may further inform the agency's projections.</P>
                    <HD SOURCE="HD3">(1) Application Costs</HD>
                    <P>The first set of costs that NHTSA estimated are those that would be incurred by an applicant to prepare and submit an AV STEP application. These costs would arise from the four major areas of proposed application requirements, as discussed in Section IV (Application and Review (Regulatory Text Subparts B and D)): (1) application form information requirements; (2) required information regarding certain protocols for ADS operations; (3) required information regarding the applicant's data governance plan; and (4) independent assessment requirements.</P>
                    <P>When projecting the burden that filling out application forms would impose, NHTSA separately considered the costs of each requirement within the four proposed form sheets. One set of operational baseline sheet responses would need to be provided for each application, as would one set of responses to a second sheet regarding confirmation of ongoing reporting. Together, these would be expected to incur a total of 207 burden hours. NHTSA expects that these hours would be accrued by personnel with the occupational titles listed above and would impose a total cost of $17,501 per application.</P>
                    <P>Similarly, responses to a single Location Sheet would be expected to incur a total of 145 burden hours, with a cost of $12,482. While at least one Location Sheet would be required for each application, multiple Location Sheets could be submitted for a single application. Accordingly, NHTSA projected that one in ten applicants would submit two Location Sheets, and that one in ten applicants would submit three Location Sheets. This accounts for NHTSA's observation that once an ADS operation expands beyond its initial location, subsequent expansions occur more frequently. The agency translated this projection into an estimated average of 1.3 Location Sheets per application, which would result in a total Location Sheet average cost of $16,227 per application from 189 average burden hours.</P>
                    <P>As proposed, the application form would require a separate sheet for information about any exemptions requested under AV STEP. NHTSA considers these costs part of the baseline costs for FMVSS Exemptions, as discussed in Section IX.A.3.a) (Baseline Costs). Thus, requests for Make Inoperative Exemptions would incur the only separate cost for this portion of an application. As explained in the introduction of this Costs section, NHTSA expects that Make Inoperative Exemptions will represent only a limited proportion of AV STEP interest. Accordingly, the agency projected that one in fifteen applications to AV STEP would include a request for a Make Inoperative Exemption. The agency estimated that preparing this sheet for each Make Inoperative Exemption request would entail 232 burden hours at a cost of $22,737. But using the projected one in fifteen multiplier, this would translate to an average of 15 burden hours with an average cost of $1,516 per application.</P>
                    <P>The second and third types of proposed requirements for an application would respectively require an applicant to provide information about certain protocols for the requested ADS operations and certain aspects of the data governance plan for those operations. Only one set of such information would need to be provided per application for each of these subjects. NHTSA estimated that detailing and submitting the protocols for ADS operations would entail 286 burden hours, for a cost of $26,676 per application. The agency further estimated that detailing and submitting the data governance plan would entail 210 burden hours, for a cost of $19,511 per application.</P>
                    <P>
                        When projecting the burden of the proposed independent assessment requirements, NHTSA separately estimated the amount that an applicant would pay to an independent assessor and the burden that applicants would incur directly when engaging with and preparing certain required information about independent assessments for an application. As explained in Section IX.A.2 (Uncertainties and Assumptions), these costs are largely unknown. Nonetheless, NHTSA considered available data regarding similar assessments from other industries 
                        <SU>231</SU>
                        <FTREF/>
                         and the agency's experience in non-ADS contexts.
                    </P>
                    <FTNT>
                        <P>
                            <SU>231</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Commission for Energy Regulation, “Safety Case Fees Structure and Methodology” (February 2016), available at: 
                            <E T="03">https://cruie-live-96ca64acab2247eca8a850a7e54b-5b34f62.divio-media.com/documents/CER16032-Safety-Case-Fees-Version-2.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        NHTSA projected that paying for an independent assessment of the scope proposed for AV STEP would cost an 
                        <PRTPAGE P="4169"/>
                        applicant $800,000 on average. However, as explained in Section IX.A.2 (Uncertainties and Assumptions), NHTSA assumed that more than half of applicants will already have undertaken some form of an independent assessment or would have undertaken such an assessment even in the absence of AV STEP. As such, NHTSA believes that it is appropriate to offset this projected cost and has assumed an average cost of $400,000 per application.
                    </P>
                    <P>NHTSA projected additional burdens for an applicant's engagement with an independent assessment, as well as an applicant's preparation of information about the assessment for an application. NHTSA estimated that this additional burden would entail 304 burden hours, with a total cost of $25,301 per application. Together with the $400,000 cost explained above, the agency estimated an average cost of $425,301 per application for the proposed independent assessment requirements.</P>
                    <P>Overall, these estimated application burdens sum to an average net cost of $506,732 per application, due (in part) to a net average of 1,211 burden hours. As noted in Section IX.A.2 (Uncertainties and Assumptions), it is difficult to project how many eligible entities would apply to AV STEP. In general, NHTSA would expect to receive fewer applications in the years immediately following a Final Rule, due to the time that would be needed for interested entities to undertake independent assessments and prepare applications. The agency would expect to receive increasing numbers of applications in subsequent years, particularly as more entities reach the more mature state of ADS development for which AV STEP has been shaped. Although NHTSA expects such fluctuation, the agency believes that assuming an average of five applications annually over the first seven years of the program would be appropriate. Multiplying this with the estimated average net cost of an application, NHTSA estimated that the average annual cost to industry associated with the preparation and submission of AV STEP applications would be $2,533,660 due (in part) to a net average of 6,055 burden hours.</P>
                    <HD SOURCE="HD3">(2) Participation Costs</HD>
                    <P>NHTSA estimated the costs of participation by projecting the costs of each of the reporting requirements in AV STEP, as well as the costs of preparing a request for an amendment during participation. Participation in AV STEP may entail other costs as well, such as those incurred through the concern resolution process if problems arise during an operation. However, as explained in Section IX.A.2 (Uncertainties and Assumptions), those costs are unpredictable because they are contingent on variables that are currently unknown. The proposed AV STEP reporting requirements break down into three main categories: (1) periodic reporting; (2) event-triggered reporting; and (3) reportable changes to an operation.</P>
                    <P>As proposed, AV STEP would include periodic reporting that occurs on a quarterly basis. To estimate periodic reporting costs, NHTSA projected the burden of several subsets of the quarterly reporting requirements. These estimates assume that administration and operations specialists would primarily prepare these responses, with support from engineers and senior managers. First, all entities in AV STEP would be required to report the ten elements of information that are set forth in § 597.500(c) of the proposed rule. NHTSA estimates that a participant's responses to this information would require a total of 216 burden hours, for a cost of $14,373. Given that four such reports would be required each year, this would translate to 864 burden hours, for a cost of $57,492 annually. Since the information reported under these elements largely entails standardized characteristics about an operation, such as VMT or performance metrics, some entities may find ways to reduce these estimated costs by automating the collection and organization of this information.</P>
                    <P>The second proposed type of periodic reporting requirement is specific to the step at which an entity is participating. Step 1 participants would need to report customized metrics regarding fallback personnel performance and Step 2 participants would need to report customized metrics for the ADS, as well as information about MRCs. NHTSA estimates that this requirement at Step 1 would entail 46 burden hours, for a cost of $3,624 per report. At Step 2, NHTSA estimates that this requirement would entail 176 burden hours, for a cost of $14,447 per report. As these reports would also be required four times a year, these would translate to annual burdens of 184 burden hours, for a cost of $14,496, at Step 1 and 704 burden hours, for a cost of $57,788 at Step 2. One of the benefits of NHTSA's proposal to use customized reporting requirements is that entities may propose metrics and thresholds that they already use for other purposes. As such, some entities may be able to offset portions of these costs through customized reporting that mirrors metrics used apart from AV STEP.</P>
                    <P>The third proposed type of periodic reporting requirement is only for vehicles that participate under an AV STEP exemption. For this requirement, an entity would need to report the VMT segmented by each exempted vehicle's VIN. The first category of periodic reporting, discussed above, includes reports of several data elements pertaining to the VMT of subject vehicles. As a result, NHTSA's estimates for the first category of periodic reporting already include the costs of reviewing and organizing VMT data for vehicles operating under AV STEP. That same data would support the VMT reporting requirement for AV STEP Exemptions. As such, NHTSA expects that the estimated costs for the first category of periodic reporting would already account for the costs of this reporting requirement.</P>
                    <P>The next category of reporting during participation is event-triggered reporting of incidents within a specified timeframe after their occurrence. This requirement encompasses crash reporting, the submission of videos for particularly severe crashes, and the reporting of citable offenses. Most crash reporting under this requirement will likely entail ADS crash reports. As explained in subsection a) (Baseline Costs) above, NHTSA does not consider costs for ADS crash reporting to be attributable to AV STEP because all of these reporting costs exist in the baseline due to separate NHTSA requirements.</P>
                    <P>In this document, NHTSA also proposes to require AV STEP participants to report crashes involving subject vehicles even if the ADS was not engaged during or near the time of the crash. NHTSA did not estimate separate costs for this reporting, however, because the agency's experience with a similar requirement in other exemption programs indicates that such crashes are infrequent enough to result in de minimis reporting costs. The final proposed crash reporting requirement would require an entity to submit video footage for the most severe types of crashes. NHTSA also did not estimate unique costs for this reporting requirement, as explained in Section IX.A.3.a) (Baseline Costs) above, because video footage of such crashes is typically obtained through the SGO and other NHTSA exemption programs.</P>
                    <P>
                        For the last type of incident reporting, NHTSA estimated that annual reporting for citable offenses will require 336 burden hours, for a cost of $30,050 per participant. ADS developers and operators already regularly collect and 
                        <PRTPAGE P="4170"/>
                        analyze such performance data as part of their normal product monitoring and improvement programs. However, NHTSA did not specifically offset these estimates for this work because those practices vary among entities.
                    </P>
                    <P>As explained in Section V.A.3 (Update Reporting), for the third type of reporting proposed, AV STEP participants would also need to submit certain information about changes that occur during participation. The Final Determination Letter would set the parameters for when such reports are needed. Depending on the extent of a reported change, the required information may entail updated independent assessments. While the agency anticipates that AV STEP operations will continually evolve over the course of program participation, NHTSA expects that eligible entities would endeavor to minimize the need to submit these update reports. Applicants could do so by ensuring that the independent assessments submitted in an application are as comprehensive as possible, since the scope of an independent assessment would inform the parameters for this reporting. This would make it more likely that a greater proportion of updates would not require reports. Although the number of reportable changes under this requirement will likely vary for each participant, NHTSA estimates that, on average, each participant would submit one update report per year. The agency estimated that the cost of preparing and submitting the information required for an update report would entail 237 burden hours, with a cost of $20,575.</P>
                    <P>Whether a reportable update requires an updated independent assessment would depend on a number of variables that are dependent on the specific changes at issue. The agency assumed for the purposes of this analysis that half of these reportable updates would require an updated independent assessment. While the cost of these updated independent assessments is also likely to vary significantly according to the specific nature of the changes, NHTSA estimated that each such assessment would cost a participant, on average, one eighth of what a complete independent assessment would cost (as discussed in the preceding subsection), or $100,000. Using the projection that this would only be necessary for half of the assumed update reports, NHTSA annualized this cost to $50,000. Combining this with the burden of preparing and submitting the update report, NHTSA estimated that update reporting would incur an average annual cost of $70,575 per participant.</P>
                    <P>As with this update reporting, given that NHTSA expects participating operations to continue to evolve, the agency expects that participants will also incur costs that result from the preparation and submission of amendment requests. Under this proposal, a participant that wished to change any of the terms or conditions contained in a Final Determination Letter could request to do so through the submission of such amendment requests. NHTSA proposes specific required information that an amendment request would need to include, as discussed in Section V.B.1 (Amendment Process). The agency has estimated that preparing such information would entail 400 burden hours, with a cost of $35,757 per amendment request. NHTSA projects that each participant would request one amendment every two years. Accordingly, the agency estimated that the annual average burden of submitting amendment requests would entail 200 burden hours, for a cost of $17,879 per participant.</P>
                    <P>Combining all of these participation costs, NHTSA estimated that the proposed AV STEP participation requirements would impose an average annual burden of 2,081 burden hours, with a cost of $212,138 per participant. The agency further projected the average number of annual participants that would be expected during the first seven years of the program. Using the previously discussed average of five applicants per year over this time period, and assuming that, starting in the fourth year of the program, two participations would conclude each year, NHTSA estimated that there would be an average of 17 active participants annually. Multiplying this by the burden of each participation, the agency estimated that AV STEP participation would represent an annual burden for participants of 35,377 burden hours, with a cost of $3,606,346.</P>
                    <HD SOURCE="HD3">(3) Costs of NHTSA's Review and Oversight</HD>
                    <P>
                        NHTSA will also incur costs, through its review of AV STEP applications and oversight of AV STEP participants. The agency will thoroughly review applications under the process proposed in Section IV.E (Application Review). NHTSA estimated that its review of an application would entail 953 burden hours across administrative and engineering staff in pay grades from GS-9 through GS-14, GS-15 and Senior Executive Service leadership positions, and legal staff. Using corresponding wages from the Office of Personnel Management 
                        <SU>232</SU>
                        <FTREF/>
                         and assuming Washington, DC locality pay, NHTSA estimated that these burden hours would translate to a cost of $102,748 per application.
                    </P>
                    <FTNT>
                        <P>
                            <SU>232</SU>
                             Office of Management and Budget, “Salaries and Wages” (January 2024), available at: 
                            <E T="03">https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/.</E>
                        </P>
                    </FTNT>
                    <P>Agency personnel would oversee AV STEP participants through monitoring of the reporting discussed in the preceding subsection, as well as through the concern resolution process discussed in Section V.B.2 (Concern Resolution Process). While NHTSA did not quantify the latter, as explained in Section IX.A.3.b) (Non-Quantified Costs), the agency estimated that monitoring and analyzing the information it would receive from AV STEP participants would entail an average of 329 burden hours annually per participant, across the same types of personnel identified in the previous paragraph. These burden hours would translate to an estimated annual cost of $35,237 per participant.</P>
                    <P>NHTSA further used these values as well as the applicant and participant numbers the agency projected (as discussed in the two preceding subsections) to estimate its average annual burden across the first seven years of the program. For the projected average of 5 applicants per year, NHTSA estimated that reviewing AV STEP applications would require 4,700 burden hours, with a cost of $513,740. For the projected average of 17 participants over the first seven years of program, NHTSA estimated that overseeing AV STEP participants would require 5,593 burden hours, with a cost of $599,029. Combining these, NHTSA estimated that its average annual burden to administer AV STEP over the first seven years of the program would entail 10,293 burden hours, with a cost of $1,112,769.</P>
                    <HD SOURCE="HD3">(4) Total Program Costs</HD>
                    <P>
                        Summing the burdens explained under subsections (1) and (2) above, NHTSA estimated that the average annual burden to all AV STEP applicants and participants, over the first seven years of the program, would amount to 41,432 burden hours, with a cost of $6,140,006. Combining this with the estimated burden AV STEP would entail for NHTSA, as explained in the preceding subsection, the agency estimated that the program would entail a net annual average burden of 51,725 burden hours, with a cost of $7,252,775. Over this first seven years of the program, this would present a net 
                        <PRTPAGE P="4171"/>
                        burden of 362,075 burden hours, with a cost of $50,769,425.
                    </P>
                    <HD SOURCE="HD3">4. Benefits</HD>
                    <P>As explained throughout this NPRM, including in subsection 1 (Need for Regulation) above, NHTSA intends for AV STEP to enhance the transparency and oversight of ADS-equipped vehicles, accelerate learning relating to ADS safety, and provide an efficient framework for reviewing ADS operations and exemptions. NHTSA has qualitatively assessed these benefits because the nature of how they may arise and uncertainties surrounding the progression of ADS technology preclude sufficient data to quantify them. Nevertheless, NHTSA considers each of these benefits significant. This section summarizes those benefits, which are also discussed throughout this proposal.</P>
                    <P>AV STEP would further safety in several important ways. First, AV STEP would provide a new type of assessment framework tailored specifically for the nascent stage of ADS technology. This would enhance the agency's ability to review and oversee the safety of participating ADS-equipped vehicles. Second, AV STEP would likely motivate some ADS companies to more thoroughly refine their own approaches to ADS development and operations if interested in participating in this program. AV STEP's proposed clear, upfront application and participation requirements should allow prospective participants to understand the level of safety commitment needed for this program and to prepare for this commitment. AV STEP may also accelerate the pace at which ADS safety practices evolve, such as by creating a broader market for independent assessments, evaluating the use of industry standards, and probing the effectiveness of safety metrics. The insight gained through AV STEP would also help to inform NHTSA's consideration of potential FMVSS for ADS.</P>
                    <P>NHTSA expects that AV STEP would also provide an effective framework for administering exemptions to ADS-equipped vehicles. In turn, this would enable the agency to effectively process and oversee complex exemptions involving ADS, including potential future requests to retrofit compliant vehicles with ADS. This would improve regulatory flexibility for innovative ADS technologies in a way that still prioritizes the safety of those vehicles.</P>
                    <P>In addition, the information that NHTSA proposes to publish about AV STEP applications and participations would increase transparency surrounding ADS operations. The data NHTSA would make available would better inform the public about where participating operations are occurring, the nature and status of those operations, and opportunities to interact with those vehicles. In turn, this additional information would enable the public to make more informed decisions about how to engage with ADS technologies.</P>
                    <P>ADS safety and transparency is a prerequisite to other societal benefits ADS technology may offer. ADS has the potential to positively impact many aspects of society, including the environment, accessibility for people with disabilities, and equity. The public safety benefits that NHTSA expects from AV STEP could improve the prospects for ADS technologies to achieve non-safety benefits as well.</P>
                    <P>AV STEP also offers an opportunity to improve regulatory harmonization for jurisdictions with overlapping engagement with ADS technologies. As explained in Section III (Program Structure (Regulatory Text Subpart A)), AV STEP would require that participants comply with all applicable Federal, state, and local laws. During the review of an AV STEP application, NHTSA would engage with applicants and other authorities, as appropriate, to explore opportunities to harmonize certain AV STEP requirements with those that other jurisdictions may impose. Those authorities may likewise consider harmonizing their own requirements with AV STEP. As a result, AV STEP would offer an opportunity to enhance regulatory collaboration and dialogue in a way that could benefit both regulatory authorities and regulated entities.</P>
                    <P>Similarly, NHTSA anticipates that AV STEP may increase the opportunities for ADS companies with responsible safety practices to demonstrate their public commitment to safety in a more objective and transparent way. In turn, this may help those entities establish public trust and build potential relationships with other entities looking to engage with ADS business partners that prioritize safety. As such, this program offers the potential to encourage more responsible growth of ADS technology.</P>
                    <HD SOURCE="HD3">5. Regulatory Approaches Considered</HD>
                    <P>This section presents three alternatives to the proposed rule that NHTSA considered when developing this proposal. None of these options were incorporated into the lead proposal as they would not address the complexities of regulating ADS technologies as well or otherwise appropriately balance encouraging AV STEP participation with the need for program participation to entail a meaningful commitment to safety.</P>
                    <HD SOURCE="HD3">(a) Baseline (No Action)</HD>
                    <P>The no action alternative would maintain the status quo and not propose a national program for ADS-equipped vehicles. NHTSA does not prefer this alternative because, as described throughout this NPRM, NHTSA believes that AV STEP would address multiple unique challenges posed by the evolving state of ADS technology. Currently, detailed information about ADS-equipped vehicles operating on public roads is often limited. More information about participating vehicles would enhance NHTSA's oversight of those vehicles and increase the amount of public transparency. The information gleaned through this program could also inform and expedite NHTSA's consideration of future standards for ADS by providing greater insight into the effectiveness of ADS safety assessment methods and metrics. As a result, keeping the status quo would maintain the challenges that the agency has identified throughout this document.</P>
                    <HD SOURCE="HD3">(b) Less Stringent Program Alternative</HD>
                    <P>The second alternative considered by NHTSA when developing this rule entailed a less stringent version of the proposal that placed a greater priority on encouraging participation through reduced application and participation requirements. For example, the agency considered reducing the stringency by adding an entry level of program participation that would remove the substantive technical review of an application and focus exclusively on more limited participation reporting. In such a scenario, this entry level of participation would be available only for vehicles that do not need an exemption under AV STEP. Because those vehicles can operate currently without AV STEP, some entities with such vehicles may be more motivated to participate if participation burdens are reduced.</P>
                    <P>
                        NHTSA did not include such an entry-level of participation in the lead proposal because the agency believes that adding such a less stringent participation option, particularly at the outset of this program, would disrupt the appropriate balance between encouraging participation and ensuring participation is meaningful. Encouraging participation should not come at the expense of the robustness of the program. Participation should remain meaningful in terms of the types of information submitted to the agency 
                        <PRTPAGE P="4172"/>
                        and the scrutiny of the agency's oversight. At least some minimum requirements for participation should exist for the sake of consistency between entities and to ensure that Program participation translates to a commitment to responsible safety practices.
                    </P>
                    <P>
                        The alternative of an entry-level option for compliant vehicles to participate in AV STEP would strike this balance differently than the primary proposal by prioritizing increased participation over meaningful participation. Although this alternative might boost FMVSS-certified vehicle participation, it would mean that some vehicles are admitted into AV STEP without a substantive review. Including both unreviewed operations (
                        <E T="03">e.g.,</E>
                         those entities requesting participation for FMVSS compliant vehicles) and operations that would be reviewed within AV STEP (
                        <E T="03">e.g.,</E>
                         those entities requesting participation for vehicles needing an exemption), could increase confusion for interested applicants and the public. Further, this alternative would stratify step eligibility requirements based on whether vehicles were seeking an exemption under AV STEP instead of based on the ADS' use of fallback personnel during operations. Applicants may not necessarily understand the differences in these participation options, which could lead to confusion as to which step an entity should request for program admission. In addition, those differences may not be apparent to the public, which could lead to public perception that entry-level participation is more meaningful than would actually be the case. These risks of confusion could undermine the transparency goals of AV STEP.
                    </P>
                    <P>Finally, NHTSA intends for AV STEP to require a participant's meaningful commitment to responsible safety practices and due diligence in the design and development of an ADS and its operation. A key aspect of this meaningful commitment is providing NHTSA with critical safety information through an application. Providing a participation option that would not entail such a safety commitment may disincentivize certain companies from participating at higher levels with their compliant vehicles because they could forego such a commitment and still participate in AV STEP.</P>
                    <P>Even without an entry-level participation step, NHTSA still believes that many entities will have strong incentives to participate in AV STEP with their compliant vehicles. Those incentives are discussed further in Section II (Program Context). As such, NHTSA does not currently consider this alternative to be an effective option for satisfying the goals of this rulemaking.</P>
                    <HD SOURCE="HD3">(c) More Stringent Program Alternative</HD>
                    <P>The third alternative considered by NHTSA when developing this proposal was a more stringent version of the Program. One structural way to increase the stringency of AV STEP would be to omit Step 1, which would narrow the program to vehicles that would operate without fallback personnel during participating operations on public roads.</P>
                    <P>This alternative would require all participants to meet the most stringent aspects of the program to participate in AV STEP. As explained in Section IV (Application and Review (Regulatory Text Subparts B and D)) and Section V (Participation (Regulatory Text Subparts E and F)), the requirements for AV STEP are designed to become more stringent as the responsibility of the ADS increases. For instance, under the lead proposal, an independent assessment at Step 2 would need to be more rigorous than at Step 1 because it would need to consider whether the ADS could be exclusively relied on during operations. In contrast, an independent assessment at Step 1 could consider fallback personnel's ability to mitigate certain risks rather than fully reviewing the ADS' ability to address those risks.</P>
                    <P>NHTSA does not consider this more stringent alternative an optimal balance of participation and stringency. Whereas a less stringent alternative would favor participation numbers at the expense of meaningful participation, this more stringent alternative would move too far in the opposite direction. Excluding ADS operations that rely on fallback personnel would miss a valuable opportunity to improve transparency and insight surrounding the safety of a significant portion of current ADS operations. Fallback personnel play an important role in the safety of ADS development and are frequently used across industry. One of the primary goals of AV STEP is to provide a framework for assessing the safety of ADS while the technology remains in a state of development. Omitting operations that rely on fallback personnel at all times from this framework would limit the potential for AV STEP to accomplish this goal.</P>
                    <P>Moreover, this more stringent alternative would likely take an oversimplified approach to the realities of the development cycle for ADS operations. In practice, most ADS operations continue to use fallback personnel under certain circumstances or for specific vehicles even once they begin some operations without fallback personnel. For example, a portion of a fleet could operate without fallback personnel while the remainder of the fleet continues to use fallback personnel to validate certain aspects of an operation, such as new software versions or new potential routes. Fallback personnel may also need to be temporarily reintroduced for safety reasons if concerns arise about the ADS' performance. As such, NHTSA considers the option to participate in AV STEP with fallback personnel an important program characteristic that accounts for the reality of ADS operations and that avoids disincentivizing the use of fallback personnel for safety.</P>
                    <HD SOURCE="HD2">B. National Environmental Policy Act</HD>
                    <P>
                        NHTSA has analyzed this proposed rule for the purposes of the National Environmental Policy Act. NHTSA is aware of the November 12, 2024 decision in 
                        <E T="03">Marin Audubon Society</E>
                         v. 
                        <E T="03">Federal Aviation Administration,</E>
                         No. 23-1067 (D.C. Cir. Nov. 12, 2024). To the extent that a court may conclude that the Council on Environmental Quality (CEQ) regulations implementing NEPA are not judicially enforceable or binding on this agency action, NHTSA has nonetheless elected to follow those regulations at 40 CFR parts 1500-1508, in addition to DOT's procedures/regulations implementing NEPA at DOT NEPA Order 5610.1C, to meet the agency's obligations under NEPA, 42 U.S.C. 4321 
                        <E T="03">et seq.</E>
                    </P>
                    <P>In accordance with 49 CFR 1.81, 42 U.S.C. 4336, and DOT NEPA Order 5610.1C, NHTSA has determined that this rule is categorically excluded pursuant to 23 CFR 771.118(c)(4) (planning and administrative activities, such as promulgation of rules, that do not involve or lead directly to construction). This rulemaking is not anticipated to result in any environmental impacts, and there are no extraordinary circumstances present in connection with this rulemaking.</P>
                    <P>
                        The rulemaking proposes a procedural framework for organizing information that NHTSA receives to inform future adjudications of participation in AV STEP. NHTSA's decisions on AV STEP participation and any actions taken while overseeing participants would constitute separate agency actions that are independent of this proposal. Similarly, the information required by the proposed rule should largely already exist or be planned for subject vehicles independent of this proposal. Finally, all vehicles that are eligible to participate in AV STEP under this proposal would either do so voluntarily or under an exemption that 
                        <PRTPAGE P="4173"/>
                        is analogous to exemptions already available under NHTSA's regulations. As such, this proposal is not expected to significantly affect the quality of the human environment compared to the baseline regulatory framework for subject vehicles in the status quo.
                    </P>
                    <HD SOURCE="HD2">C. Regulatory Flexibility Act</HD>
                    <P>
                        Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 
                        <E T="03">et seq.,</E>
                         as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency is required to publish a notice of proposed rulemaking or final rule, it must evaluate the potential effects of the rule on small entities (
                        <E T="03">i.e.,</E>
                         small businesses, small organizations, and small governmental jurisdictions). The Small Business Administration's regulations at 13 CFR part 121 define a small business, in part, as a business entity “which operates primarily within the United States.” (13 CFR 121.105(a)(1)). A regulatory flexibility analysis is not required if the head of an agency certifies the proposed or final rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a proposed or final rule will not have a significant economic impact on a substantial number of small entities.
                    </P>
                    <P>NHTSA has undertaken an initial regulatory flexibility analysis to understand the possible impacts of this rulemaking on small entities. NHTSA requests comment from small businesses that would be eligible for and interested in AV STEP regarding this analysis and the potential impacts of this proposal. Ultimately, given the analysis presented below and the burden estimates in Section IX.A (Executive Orders 12866, 13563, 14094 and DOT Regulatory Policies and Procedures), NHTSA believes this proposal is unlikely to have a significant economic impact on a substantial number of small businesses. As such, the agency seeks comment, in particular, on whether any significant impacts to small businesses would be expected to result from AV STEP. A description of the reasons why action by the agency is being considered and the objectives of and legal basis for the proposal rule are explained elsewhere in the preamble and not repeated here.</P>
                    <P>
                        <E T="03">Description and estimate of the number of small entities to which the proposal or final rule will apply:</E>
                    </P>
                    <P>
                        For the purposes of receiving Small Business Administration (SBA) assistance, the thresholds for considering entities to be small businesses vary for each North American Industry Classification System (NAICS) code.
                        <SU>233</SU>
                        <FTREF/>
                         These criteria for determining small business size, as stated in 13 CFR 121.201, may be monetary or based on number of employees. As proposed in this NPRM, vehicle manufacturers, ADS developers, fleet operators, and system integrators would be eligible to participate in AV STEP. As such, a variety of business categories may be affected by this proposal and the applicable small business size thresholds under the SBA's regulations may vary accordingly:
                    </P>
                    <FTNT>
                        <P>
                            <SU>233</SU>
                             U.S. Small Business Administration, “Table of Small Business Size Standards” (March 2023), available at: 
                            <E T="03">https://www.sba.gov/sites/default/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%282%29.pdf.</E>
                        </P>
                    </FTNT>
                    <P>• A vehicle manufacturer may qualify as a small Automobile and Light Duty Motor Vehicle Manufacturing business (NAICS 336110) or as a small Heavy Duty Truck Manufacturing business (NAICS 336120) if it has fewer than 1,500 employees.</P>
                    <P>• An ADS developer that is not a vehicle manufacturer or fleet operator may qualify as a small business under technology-specific NAICS codes, such as those for Software Developers (NAICS 513210, for which a 47 million dollar threshold is used) or Custom Computer Programming Services (NAICS 541511, for which a 34 million dollar threshold is used).</P>
                    <P>• A fleet operator may similarly fall under a variety of NAICS codes, such as those beginning with “484” (Truck Transportation), “485” (Transit and Ground Passenger Transportation), or “492” (Couriers and Messengers). The monetary thresholds for being considered a small business under these classifications range from 19 to 34 million dollars.</P>
                    <P>• A system integrator that does not qualify as any of the above may be considered under Motor Vehicle Electrical and Electronic Equipment Manufacturing (NAICS 336320) or Other Motor Vehicle Parts Manufacturing (NAICS 336390), among other possible classifications. For both of these, an entity must have fewer than 1,000 employees to be considered a small business by the SBA.</P>
                    <P>As this list illustrates, it is difficult to identify the NAICS codes and associated thresholds used by the SBA for all of the individual entities that may be eligible to apply to AV STEP under this proposal. For purposes of this analysis, NHTSA uses the 1,000-employee threshold to consider whether eligible entities may qualify as a small business. NHTSA expects this threshold to encompass any entities that may qualify as a small business under applicable monetary thresholds as well. The companies eligible to apply to AV STEP would predominantly consist of entities, such as ADS developers, that are relatively new and employ less than 1,000 individuals and are unlikely to have annual receipts in excess of the applicable monetary thresholds. As such, it is unlikely that a monetary threshold would identify additional small entities not already accounted for by this employee threshold. NHTSA seeks comment on whether this employee threshold fully encompasses eligible small entities and, if not, data to identify other such entities based on monetary thresholds.</P>
                    <P>To identify entities with less than 1,000 employees, the agency analyzed entities that have reported under NHTSA's SGO ADS requirements, submitted VSSAs to the agency, received exemptions under AVEP, or that NHTSA has other reason to believe would be potentially eligible for AV STEP. NHTSA estimates that 25 of these entities have fewer than 1,000 employees and considers these entities to be small businesses for the purpose of this analysis. Given that AV STEP application and participation would be voluntary, the agency does not expect that all 25 of these entities would ultimately be affected by these proposals.</P>
                    <P>
                        <E T="03">Description of the projected reporting, record keeping and other compliance requirements for small entities:</E>
                    </P>
                    <P>As proposed, AV STEP would be a voluntary program that would include both initial application requirements as well as ongoing participation requirements. Due to its voluntary nature, NHTSA expects that eligible small businesses would only apply if they deem it economically prudent to do so and if they would be able to comply with these requirements. AV STEP participation would not be a Federal requirement for entities with ADS-equipped vehicles that can already lawfully operate on public roads, because these entities could operate those vehicles even if they were not a part of this program.</P>
                    <P>
                        Moreover, since AV STEP is designed to complement other NHTSA programs, those other programs may provide preferable alternatives for certain small entities with smaller scale operations. As explained in Section II.B.2 (NHTSA Exemptions), AV STEP is especially designed for the review and oversight of ADS-equipped vehicle operations at scale. Many of the proposed requirements and objectives of AV STEP 
                        <PRTPAGE P="4174"/>
                        reflect this goal, such as fleetwide reporting metrics or reviews of an organization's safety management systems for conducting complex operations. NHTSA maintains other programs that entities with smaller scale operations may consider capable of providing analogous benefits to AV STEP in a less burdensome way. For instance, entities with smaller-scale operations that involve imported vehicles in need of an FMVSS exemption may prefer to use AVEP rather than AV STEP. Similarly, a small entity that sought to increase transparency for its operations but did not want to undergo the level of commitment needed for AV STEP could voluntarily submit information about its ADS or operations under a VSSA or NHTSA's AV TEST initiative.
                    </P>
                    <P>NHTSA's analysis of the burden that these AV STEP requirements would impose on applicants and participants includes cost ranges in several areas. This is because, while the requirements themselves are not differentiated by business size, this burden is expected to increase along with the scale and complexity of an operation. In general, NHTSA anticipates that small businesses that choose to apply and participate would incur costs closer to the lower end of these ranges. The costs to a small entity may even be below those estimated, because the agency's analysis of some requirements assumed an average cost across the program or the cost anticipated for greater scale or complexity of operations than might be relevant for a small business. Section IX.A (Executive Orders 12866, 13563, 14094 and DOT Regulatory Policies and Procedures) describes NHTSA's cost analysis in more detail.</P>
                    <P>The initial cost of applying to AV STEP is estimated to be, on average, $506,732. NHTSA expects that the proposed application requirements—discussed in Section IV (Application and Review (Regulatory Text Subparts B and D)—would impose a lower burden for small businesses, since those requirements generally scale with the size and complexity of the requested participation. In general, smaller operations involve reduced exposure and a narrower set of considerations for safety oversight. As a result, certain subjects in an application may not be applicable to a small operation or may entail less detailed information. Likewise, an independent assessment of a smaller operation could likely be completed more quickly and easily than an assessment of a larger, more complex operation.</P>
                    <P>The annual cost of participating in AV STEP is estimated to be, on average, $212,138. Similar to the application requirements, NHTSA expects the participation requirements proposed in Section V.A (Reporting Requirements) to present a lower burden for small businesses. All participants would be required to provide standard information quarterly and additional information after certain incidents occur. Collecting and reporting the required quarterly information for smaller operations would entail less effort than would be necessary for larger operations. Likewise, given their lower exposure, smaller operations would be expected to have fewer incidents that would need to be separately reported. The customized nature of many reporting requirements (as described in Section IV.A.3 (Confirmation of Reporting During Participation)) could also help to reduce the burden for small businesses.</P>
                    <P>
                        <E T="03">Duplication with other Federal rules:</E>
                    </P>
                    <P>This NPRM proposes to establish a voluntary review and oversight framework for ADS-equipped vehicles. No other existing Federal regulation provides such a program. While ADS-equipped vehicles may be eligible to request FMVSS exemptions under existing exemption processes, AV STEP would provide a process specifically tailored for ADS-equipped vehicles. Section II.B (How NHTSA's Authorities Shaped this NPRM) discusses how this proposal has been shaped to complement, rather than duplicate, NHTSA's existing exemption processes. NHTSA also shaped certain reporting requirements for AV STEP participation to avoid duplication with overlapping requirements. Examples of this design include the event-triggered reporting requirements for AV STEP, which are proposed to avoid duplication with any other NHTSA reporting requirement that covers the same information (see Section V.A.2 (Event-Triggered Reporting)), and customized requirements that could be harmonized with requirements from other jurisdictions (see Section III.C (Terms and Conditions)).</P>
                    <P>
                        <E T="03">Description of any significant alternatives to the proposed rule:</E>
                    </P>
                    <P>AV STEP is designed to enhance the transparency and oversight of ADS-equipped vehicles in a way that affords enough flexibility to account for the evolving nature of ADS technology. When developing this program, the agency sought to strike an effective balance between encouraging participation and ensuring that participation was meaningful. Ultimately, NHTSA found that a comprehensive but voluntary program would best support the goals of this proposal, which are described further in Section II (Program Context).</P>
                    <P>If NHTSA were to take no action, the agency would not be able to realize the advantages AV STEP would offer that are described throughout this NPRM. Critically, NHTSA would bypass the opportunity for AV STEP to help the agency proactively identify safety concerns with an ADS prior to the occurrence of negative safety outcomes. NHTSA developed AV STEP to meet the needs of this crucial transitional time in ADS development and to inform future NHTSA regulation and oversight. If the agency were to take no action, small businesses would not have the option to participate in such a national program for ADS-equipped vehicles or to request an exemption to take a previously compliant vehicle out of compliance with FMVSS when retrofitting it with an ADS.</P>
                    <P>NHTSA has also considered the potential impacts of altering the burden associated with the proposed application and participation requirements for AV STEP. Section IX.A (Executive Orders 12866, 13563, 14094 and DOT Regulatory Policies and Procedures) explains how NHTSA specifically considered changing program characteristics to alter this stringency, as well as the reasons that the agency did not feel such changes were effective options for AV STEP. While eliminating or reducing the stringency of specific requirements across the program could reduce the costs they would incur, this would undermine the intended safety benefits of the program. Reducing the stringency only for small businesses could reduce the value of AV STEP participation for these entities, such as by reducing the program's potential to represent a meaningful safety commitment for these entities. A different level of stringency for small businesses would also increase the complexity of the program in a way that would make AV STEP more difficult for the public and eligible entities to understand.</P>
                    <P>
                        In addition, the agency considered increasing the stringency of participation in AV STEP. Although more stringent requirements could potentially provide more insight into the development and operation of participating ADS-equipped vehicles, heightened stringency would increase the burden to apply for AV STEP and participate if admitted, which could more significantly impact small entities seeking to apply. As a result, fewer entities may consider applying, and the program's overall value could be comprised. NHTSA considers the proposed rule an appropriate balance of 
                        <PRTPAGE P="4175"/>
                        these considerations, as discussed throughout this NPRM and particularly in the introduction to Section III (Program Structure (Regulatory Text Subpart A)).
                    </P>
                    <HD SOURCE="HD2">D. Paperwork Reduction Act</HD>
                    <P>
                        In this proposed rule, the Department proposes new collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 49 U.S.C. 3501 
                        <E T="03">et seq.</E>
                        ). Notwithstanding any other provisions of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number. An Information Collection Request (ICR) for the new information collection described in this subsection has been submitted to OMB for review and comment. The ICR describes the nature of the information collections and their expected burden.
                    </P>
                    <P>While AV STEP would be voluntary, this proposed rule would establish new collection of information requirements for eligible entities that choose to apply to participate in AV STEP. The information collected would be intended to inform NHTSA's review of an application, adjudication of program admission, oversight of program participation, and, ultimately, the agency's future research, rulemaking, and other actions related to ADS. Since AV STEP participation would be voluntary, this information collection requirement would apply only if a vehicle manufacturer, ADS developer, fleet operator, or system integrator decided to apply to participate in the Program. Entities that choose not to apply to AV STEP would not be subject to these proposed information collection requirements.</P>
                    <P>
                        Most of the information required for an application would be consistent across the program,
                        <SU>234</SU>
                        <FTREF/>
                         but additional information would be required if the applicant sought one of two types of exemptions under AV STEP.
                        <SU>235</SU>
                        <FTREF/>
                         In addition, this document proposes to establish ongoing information collection requirements for AV STEP participants, including both periodic and event-triggered reporting requirements.
                        <SU>236</SU>
                        <FTREF/>
                         In general, the information collected under these AV STEP requirements would be expected to help NHTSA identify potential safety issues with requested or participating ADS operations, gain insight into the performance of the ADS technology in those operations, and enhance the transparency of those operations on public roads in the United States.
                    </P>
                    <FTNT>
                        <P>
                            <SU>234</SU>
                             These requirements are described in Section IV (Application and Review (Regulatory Text Subparts B and D)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>235</SU>
                             
                            <E T="03">See</E>
                             Section VII.B (Exemption Application Requirements).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>236</SU>
                             These requirements are described in Section V.A (Reporting Requirements).
                        </P>
                    </FTNT>
                    <P>In compliance with the requirements of the PRA and OMB's implementing regulations, NHTSA has prepared the following analysis relating to the proposed rule to establish AV STEP. NHTSA requests public comments on this collection of information.</P>
                    <P>
                        <E T="03">Title:</E>
                         49 CFR part 597, ADS-equipped Vehicle Safety, Transparency, and Evaluation Program.
                    </P>
                    <P>
                        <E T="03">Type of Request:</E>
                         New collection.
                    </P>
                    <P>
                        <E T="03">Affected Public:</E>
                         Manufacturers of ADS-equipped vehicles, ADS developers, fleet operators, or system integrators of ADS-equipped vehicles who seek to participate in AV STEP.
                    </P>
                    <P>
                        <E T="03">Requested Expiration Date of Approval:</E>
                         Three years from the date of approval.
                    </P>
                    <P>
                        <E T="03">Summary of the Collection of Information:</E>
                    </P>
                    <P>This proposed rule would establish a national program for ADS-equipped vehicles that operate on public roads in the United States. As proposed, four types of eligible entities could apply for AV STEP at one of two steps—Step 1 or Step 2. Entities admitted to the program would be subject to terms and conditions that would govern the subject vehicles during their participation.</P>
                    <P>NHTSA proposes AV STEP as a voluntary program and would not require eligible entities to participate. Those entities in need of an exemption could receive the exemption through AV STEP, but could also use NHTSA's existing exemption processes if they expect those processes to be better suited to their request. The information collection requirements proposed in this document would apply only to entities that chose to apply to AV STEP. As a result, all of the information collection requirements proposed in this document are voluntary in nature because entities may forego them by deciding not to apply to participate in AV STEP.</P>
                    <P>To administer AV STEP, NHTSA proposes to impose information collection requirements on applicants and participants. The application requirements would generally entail information collections about the ADS-equipped vehicles that are the subject of the request, the nature of the requested operations, and the safety processes used for ADS development and operations. This document also proposes to consider applications for two types of exemptions through AV STEP—FMVSS exemptions for particular purposes enumerated in 49 U.S.C. 30114 and exemptions to the prohibition in 49 U.S.C. 30122 on making a safety device or element inoperative on a vehicle that is certified as compliant with all applicable FMVSS. AV STEP would entail additional information collection requirements for applicants requesting either of these exemptions. These requirements focus on information about the specific exemption requested, the manner in which an applicant would mitigate any safety risks stemming from the nonconformance that requires an exemption, and, for an FMVSS exemption, the purposes for which the exemption is requested.</P>
                    <P>This NPRM also includes three types of proposed reporting requirements for participants that are admitted to AV STEP. The first type of reporting proposed is periodic reporting, under which quarterly reports of information about subject vehicle operations and performance would be required. The second type of reporting proposed is event-triggered reporting, under which information about certain safety-relevant incidents, such as crashes, would be required within specified timeframes after their occurrence. The third type of proposed reporting focuses on information that would be required regarding updates to an operation, if a participant planned to pursue such updates during the course of participation. Overall, these reporting requirements would be more extensive for Step 2 participation compared to Step 1 participation.</P>
                    <P>Last, NHTSA proposes information collection requirements for requests from participants to amend the specific terms and conditions governing a participation. This information would focus on the nature of requested changes and the participants' reasons for seeking such changes.</P>
                    <P>
                        <E T="03">Description of the Need for the Information and Use of the Information:</E>
                    </P>
                    <P>
                        The information required for an application would inform NHTSA's review and adjudication of applications to participate in AV STEP, including (for any agency decision to grant an application's request to participate) the terms and conditions that would govern a specific operation. The information required for reporting would facilitate NHTSA's oversight of participating operations. This oversight would include monitoring for potential safety issues and ensuring participants adhere to the terms and conditions that apply to subject vehicles. Collectively, the information received under these 
                        <PRTPAGE P="4176"/>
                        requirements would also inform future NHTSA ADS activities outside of AV STEP, such as the agency's consideration of potential safety standards for ADS. The information required for an amendment would enable NHTSA to review requests from participants to change the terms and conditions that govern the participation.
                    </P>
                    <P>
                        <E T="03">Description of the Likely Respondents (Including Estimated Number, and Proposed Frequency of Response to the Collection of Information):</E>
                    </P>
                    <P>Respondents would be limited to entities that meet the proposed eligibility requirements for AV STEP and who elect to apply to the program. As mentioned above, four types of entities would be eligible to apply and participate in the program: vehicle manufacturers, ADS developers, fleet operators, or system integrators of ADS-equipped vehicles. Section IX.A (Executive Orders 12866, 13563, 14094 and DOT Regulatory Policies and Procedures) of this NPRM explains the approach used by NHTSA to estimate the likely number of AV STEP applicants and participants that would be respondents to this collection of information. That section also discusses how NHTSA estimated the frequency of responses.</P>
                    <P>
                        NHTSA estimates that over the first seven years of the program an average of 5 entities would apply for AV STEP each year and that an average of 17 entities would participate in AV STEP each year.
                        <SU>237</SU>
                        <FTREF/>
                         For the proposed periodic reporting, each participant would be required to submit four quarterly reports each year. NHTSA further estimates that participation would entail, on average, reporting for 5 incidents, 1 update, and 0.5 amendment requests per participant each year, under the corresponding requirements proposed for AV STEP.
                    </P>
                    <FTNT>
                        <P>
                            <SU>237</SU>
                             As described in Section IX.A (Executive Orders 12866, 13563, 14094 and DOT Regulatory Policies and Procedures), NHTSA expects that both of these numbers of entities would initially be lower—during the time period immediately following the publication of a Final Rule—but would increase over time.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Estimated Total Annual Burden Hours:</E>
                    </P>
                    <P>As with the description of likely respondents above, the methodology used by NHTSA to estimate the total annual burden hours is explained in Section IX.A (Executive Orders 12866, 13563, 14094 and DOT Regulatory Policies and Procedures). NHTSA estimates that each application would require an average of 1,211 burden hours. Multiplying by 5, the estimated average number of annual applicants, this would yield 6,055 annual burden hours for applications. Assuming the frequency of reporting described above, NHTSA estimates that periodic reporting, event-triggered reporting, and amendment requests would require an average of 2,081 annual burden hours. Multiplying by 17, the estimated average number of annual participants, this would yield 35,377 annual burden hours for participations. Finally, NHTSA estimates that the agency's review of applications and oversight of participants would require 10,293 burden hours. Combining these 6,055 annual application burden hours, 35,377 annual participation burden hours, and 10,293 annual agency burden hours, NHTSA estimates a total of 51,725 annual burden hours for this ICR.</P>
                    <P>
                        <E T="03">Estimate of the Total Annual Reporting and Recordkeeping Burden Resulting from the Collection of Information:</E>
                    </P>
                    <P>Section IX.A (Executive Orders 12866, 13563, 14094 and DOT Regulatory Policies and Procedures) also explains NHTSA's approach to estimating the annual burden from this collection. Using the estimated burden hours described above as well as the other costs described in Section IX.A, NHTSA estimates the following annual burdens: for applicants, $2,533,660; for participants, $3,606,346; and for agency resources $1,112,769. Summing these, NHTSA estimates that the total annual burden of this ICR would be $6,252,775.</P>
                    <P>
                        <E T="03">Public Comments Invited:</E>
                    </P>
                    <P>The public is asked to comment on any aspects of this information collection, including (a) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (b) the accuracy of the Department's estimate of the burden of the information collection; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.</P>
                    <P>
                        Please submit any comments, identified by the docket number in the heading of this document, by the methods described in the 
                        <E T="02">ADDRESSES</E>
                         section of this document to NHTSA and OMB.
                    </P>
                    <HD SOURCE="HD2">E. Executive Order 13132 (Federalism)</HD>
                    <P>
                        Executive Order 13132 requires NHTSA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” 
                        <SU>238</SU>
                        <FTREF/>
                         “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” 
                        <SU>239</SU>
                        <FTREF/>
                         Executive Order 13132 imposes additional consultation requirements on two types of regulations that have federalism implications: (1) A regulation that imposes substantial direct compliance costs on state and local governments, and that is not required by statute; and (2) a regulation that preempts state law.
                        <SU>240</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>238</SU>
                             Executive Order 13132, Federalism, sec. 1(a) (August 4, 1999).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>239</SU>
                             
                            <E T="03">Id.</E>
                             at sec. 1(a).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>240</SU>
                             
                            <E T="03">Id.</E>
                             at sec. 6(b), (c).
                        </P>
                    </FTNT>
                    <P>This proposed rule does not propose either type of regulation covered by Executive Order 13132's consultation requirements. NHTSA does not propose for AV STEP to preempt any state or local approaches to regulating ADS-equipped vehicles within their jurisdictions. To the contrary, this proposal recognizes that states and local governments are often best situated to understand the unique needs of their communities, including the value or concerns regarding ADS-equipped vehicle operations within their respective communities.</P>
                    <P>Under this proposal, NHTSA would require vehicles participating in AV STEP to comply with all applicable state and local requirements, including adherence to any licensure or permitting requirements and traffic laws. NHTSA proposes to require an applicant to explain the subject vehicle's law abidance protocols to ensure appropriate safeguards exist for identifying and adhering to applicable state and local requirements.</P>
                    <P>
                        As such, although NHTSA believes that AV STEP could provide a valuable tool for states and local governments, this rulemaking does not propose to override any state or local approaches to ADS-equipped vehicles or otherwise alter any existing distribution of power and responsibilities among the various levels of Federal, state, and local governments. Finally, NHTSA notes that although this rulemaking does not implicate the consultation conditions under Executive Order 13132, the agency engaged with state and local authorities as part of the broader stakeholder engagement that led up to this rulemaking. More information on this engagement can be found in a 
                        <PRTPAGE P="4177"/>
                        memorandum available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD2">F. Executive Order 12988 (Civil Justice Reform)</HD>
                    <P>When promulgating a regulation, Executive Order 12988, “Civil Justice Reform” (61 FR 4729; February 7, 1996), specifically requires that the agency must make every reasonable effort to ensure that the regulation, as appropriate: (1) Specifies in clear language the preemptive effect; (2) specifies in clear language the effect on existing Federal law or regulation, including all provisions repealed, circumscribed, displaced, impaired, or modified; (3) provides a clear legal standard for affected conduct rather than a general standard, while promoting simplification and burden reduction; (4) specifies in clear language the retroactive effect; (5) specifies whether administrative proceedings are to be required before parties may file suit in court; (6) explicitly or implicitly defines key terms; and (7) addresses other important issues affecting clarity and general draftsmanship of regulations.</P>
                    <P>Pursuant to this Order, NHTSA notes as follows. The preemptive effect of this proposal is discussed above in connection with Executive Order 13132. NHTSA has also determined that this proposed rule would not have any retroactive effect. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceedings before they may file suit in court.</P>
                    <HD SOURCE="HD2">G. Executive Order 13609: Promoting International Regulatory Cooperation</HD>
                    <P>Under Executive Order 13609 (77 FR 26413, May 4, 2012), agencies must consider whether the impacts associated with significant variations between domestic and international regulatory approaches are unnecessary or may impair the ability of American business to export and compete internationally. In meeting shared challenges involving health, safety, labor, security, environmental, and other issues, international regulatory cooperation can identify approaches that are at least as protective as those that are or would be adopted in the absence of such cooperation. International regulatory cooperation can also reduce, eliminate, or prevent unnecessary differences in regulatory requirements. Sections 3 and 4 of Executive Order 13609 direct an agency to conduct a regulatory analysis and ensure that a proposed rule does not cause unnecessary obstacles to foreign trade. This requirement applies if a rule constitutes a significant regulatory action, or if a regulatory evaluation must be prepared for the rule.</P>
                    <P>NHTSA has analyzed this action under the policies and agency responsibilities of Executive Order 13609 and has determined that this action would have no effect on international regulatory cooperation. This rulemaking proposes a set of procedures to govern NHTSA's adjudication and administration of participation in a national program for ADS-equipped vehicles. This proposal does not impose any mandatory requirements on motor vehicles or regulated entities or otherwise alter the existing regulatory landscape that governs motor vehicles in the United States under the Safety Act. As such, this proposal does not affect any regulatory cooperation with respect to the harmonization of vehicle standards or establish any requirements for vehicles that may conflict with those in other countries. Likewise, this rule would also not impose any obstacles to foreign trade. The two exemption procedures proposed in this document may even provide regulatory flexibility for certain vehicles facing importation.</P>
                    <P>Moreover, as described in the ensuing subsection on the National Technology Transfer and Advancement Act, this proposal incorporates existing global industry standards as part of the independent assessment required in applications. To the extent applicants use international standards or approaches not expressly referenced in the proposed disclosure requirements of an application, this proposal includes options for an applicant to identify and explain those alternative approaches. Ultimately, NHTSA believes that this proposed framework would afford sufficient flexibility for entities to explain the safety methodologies used for their vehicles, including those that incorporate international standards. Moreover, the disclosure requirements in this proposal should foster greater agency insight into the use of any such international standards, better equipping NHTSA to account for them in future agency actions regarding ADS.</P>
                    <P>NHTSA requests public comment on whether any regulatory approaches taken by foreign governments concerning the subject matter of this rulemaking have any implications for this rulemaking.</P>
                    <HD SOURCE="HD2">H. National Technology Transfer and Advancement Act</HD>
                    <P>
                        Under the National Technology Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104-113), all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards to carry out policy objectives or activities determined by the agencies and departments, except when use of such a voluntary consensus standard would be inconsistent with the law or otherwise impractical. Voluntary consensus standards are technical standards (
                        <E T="03">e.g.,</E>
                         materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies, such as the International Organization for Standardization (ISO) and SAE International. The NTTAA directs NHTSA to provide Congress, through OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards.
                    </P>
                    <P>This document explains at length the proposed approach to incorporating industry standards, best practices, and guidance into AV STEP's requirements and procedures. NHTSA does not currently view any specific industry standards for ADS as mature enough to require conformance for AV STEP. Industry standards, best practices, and guidance regarding ADS remain in their infancy. Existing standards are, to a large extent, untested, continue to evolve, and are often used differently when applied to varied ADS technologies. As such, NHTSA believes that it is premature to require conformance with any particular industry standard for AV STEP.</P>
                    <P>Nevertheless, the agency recognizes the value in understanding, at an aggregate level, how an entity approaches relevant industry standards when developing its ADS-equipped vehicles. Considering how an entity accounts for or deviates from industry standards would help the agency understand the overall safety approaches built into an ADS. This perspective would also provide valuable context for the other technical material that NHTSA proposes to require as part of an AV STEP application. Accordingly, although NHTSA does not propose to require conformance with any particular industry standards in AV STEP, the agency proposes instead to require an independent assessment of conformance with relevant industry standards.</P>
                    <P>
                        As proposed, these disclosure and assessment requirements would account for the relevant available industry standards for ADS as well as provide an applicant with enough flexibility to identify alternative approaches to those 
                        <PRTPAGE P="4178"/>
                        standards or otherwise justify why those standards were not appropriate or sufficient for the safety design of its ADS. Moreover, NHTSA intends for this approach to enhance the agency's understanding of industry standards applicable to ADS, to better assess whether any such standards would be appropriate to incorporate into future FMVSS for ADS in any capacity. This approach would ultimately further the NTTAA's goals of promoting the use of technical standards that are developed or adopted by voluntary consensus standards bodies.
                    </P>
                    <P>Finally, by using existing standards to gain better insight into the ADS technologies under review, NHTSA aims to efficiently use agency resources by making use of the pertinent technical information and processes already incorporated into those standards. This effort to preserve resources is consistent with the NTTAA's goal of reducing, when possible, the agency's cost of developing its own standards.</P>
                    <HD SOURCE="HD2">I. Privacy Act</HD>
                    <P>
                        Please note that anyone is able to search the electronic form of all comments received into any of DOT's dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). For information on DOT's compliance with the Privacy Act, please visit 
                        <E T="03">https://www.transportation.gov/privacy.</E>
                    </P>
                    <HD SOURCE="HD2">J. Unfunded Mandates Reform Act of 1995</HD>
                    <P>The Unfunded Mandates Reform Act of 1995, Public Law 104-4, requires agencies to prepare a written assessment of the cost, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by state, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted annually for inflation with base year of 1995). The 2024 inflationary adjustment for this threshold is $200 million. Because this rulemaking is not expected to include a Federal mandate or exceed an impact over this amount, no unfunded mandate assessment will be prepared.</P>
                    <HD SOURCE="HD2">K. Regulation Identifier Number</HD>
                    <P>The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document (RIN 2127-AM60) to find this action in the Unified Agenda.</P>
                    <HD SOURCE="HD2">L. Plain Language</HD>
                    <P>Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:</P>
                    <P>• Have we organized the material to suit the public's needs?</P>
                    <P>• Are the requirements in the rule clearly stated?</P>
                    <P>• Does the rule contain technical language or jargon that isn't clear?</P>
                    <P>• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?</P>
                    <P>• Would more (but shorter) sections be better?</P>
                    <P>• Could we improve clarity by adding tables, lists, or diagrams?</P>
                    <P>• What else could we do?</P>
                    <P>If you have any responses to these questions, please write to us with your views.</P>
                    <HD SOURCE="HD2">M. Rule Summary</HD>
                    <P>This notice proposes a framework for the review and assessment of Automated Driving System (ADS)-equipped vehicles, to evaluate operations or requests for exemptions involving such technologies while also informing the agency's approach to future rulemaking and oversight.</P>
                    <P>
                        As required by 5 U.S.C. 553(b)(4), a summary of this rule can be found in the rulemaking docket at 
                        <E T="03">www.regulations.gov</E>
                         and in the entry for RIN 2127-AM60 in the Department's portion of the Unified Agenda of Regulatory And Deregulatory Affairs, available at 
                        <E T="03">https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&amp;RIN=2127-AM60.</E>
                    </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects</HD>
                        <CFR>49 CFR Part 595</CFR>
                        <P>Exemptions, Labeling, Motor vehicles, Motor vehicle safety, Reporting and recordkeeping requirements.</P>
                        <CFR>49 CFR Part 597</CFR>
                        <P>Exemptions, Imports, Labeling, Motor vehicles, Motor vehicle equipment, Motor vehicle safety, Reporting and recordkeeping requirements.</P>
                    </LSTSUB>
                    <P>In consideration of the foregoing, NHTSA proposes to add 49 CFR part 597 and amend 49 CFR part 595 as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 595—MAKE INOPERATIVE EXEMPTIONS</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 595 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 49 U.S.C. 322, 30111, 30115, 30117, 30122 and 30166; delegation of authority at 49 CFR 1.95.</P>
                    </AUTH>
                    <AMDPAR>2. Amend § 595.2 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 595.2</SECTNO>
                        <SUBJECT> Purpose.</SUBJECT>
                        <P>The purpose of this part is to provide exemptions from the “make inoperative” provision of 49 U.S.C. 30122 for specific situations set forth in each exemption.</P>
                    </SECTION>
                    <AMDPAR>3. Amend § 595.3 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 595.3</SECTNO>
                        <SUBJECT> Applicability.</SUBJECT>
                        <P>The exemptions in this part apply, collectively, to manufacturers, distributors, dealers, motor vehicle repair businesses, and rental companies. Each exemption set forth in this part specifies the entities eligible for the exemption.</P>
                    </SECTION>
                    <AMDPAR>4. Add subpart E to read as follows: </AMDPAR>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart E—Vehicle Modifications for Automated Driving Systems</HD>
                        <SECTION>
                            <SECTNO>§ 595.10</SECTNO>
                            <SUBJECT> Vehicle Modifications for Automated Driving Systems.</SUBJECT>
                            <P>An applicant to the ADS-Equipped Vehicle Safety, Transparency, and Evaluation Program in part 597 of this chapter may request an exemption from the “make inoperative” provision in 49 U.S.C. 30122(a) for modifications to ADS-equipped vehicles. Part 597 sets forth the conditions governing such exemptions.</P>
                        </SECTION>
                    </SUBPART>
                    <AMDPAR>5. Add part 597 to read as follows.</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 597—REQUIREMENTS AND PROCEDURES FOR ADS-EQUIPPED VEHICLE SAFETY, TRANSPARENCY, AND EVALUATION PROGRAM</HD>
                        <CONTENTS>
                            <SECHD>Sec.</SECHD>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart A—General</HD>
                                <SECTNO>597.100 </SECTNO>
                                <SUBJECT>Scope.</SUBJECT>
                                <SECTNO>597.101 </SECTNO>
                                <SUBJECT>Purpose.</SUBJECT>
                                <SECTNO>597.102 </SECTNO>
                                <SUBJECT>Definitions.</SUBJECT>
                                <SECTNO>597.103 </SECTNO>
                                <SUBJECT>Eligibility for participation.</SUBJECT>
                                <SECTNO>597.104 </SECTNO>
                                <SUBJECT>Program step eligibility.</SUBJECT>
                                <SECTNO>597.105 </SECTNO>
                                <SUBJECT>Terms and conditions of participation.</SUBJECT>
                                <SECTNO>597.106 </SECTNO>
                                <SUBJECT>Engagement with entities other than an applicant or participant. </SUBJECT>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart B—Application Requirements</HD>
                                <SECTNO>597.200 </SECTNO>
                                <SUBJECT>General application requirements.</SUBJECT>
                                <SECTNO>597.201 </SECTNO>
                                <SUBJECT>Operational baseline information.</SUBJECT>
                                <SECTNO>597.202 </SECTNO>
                                <SUBJECT>Vehicle exemption information.</SUBJECT>
                                <SECTNO>597.203 </SECTNO>
                                <SUBJECT>Location sheet information.</SUBJECT>
                                <SECTNO>597.204 </SECTNO>
                                <SUBJECT>Protocols for ADS operations.</SUBJECT>
                                <SECTNO>597.205 </SECTNO>
                                <SUBJECT>Independent Assessment.</SUBJECT>
                                <SECTNO>597.206 </SECTNO>
                                <SUBJECT>Customized terms.</SUBJECT>
                                <SECTNO>597.207 </SECTNO>
                                <SUBJECT>Data governance plan.</SUBJECT>
                                <SECTNO>597.208 </SECTNO>
                                <SUBJECT>Confirmation of reporting during participation. </SUBJECT>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart C—AV STEP Exemptions</HD>
                                <SECTNO>597.300 </SECTNO>
                                <SUBJECT>In general.</SUBJECT>
                                <SECTNO>597.301 </SECTNO>
                                <SUBJECT>AV STEP FMVSS exemption.</SUBJECT>
                                <SECTNO>597.302 </SECTNO>
                                <SUBJECT>
                                    AV STEP Make Inoperative exemption.
                                    <PRTPAGE P="4179"/>
                                </SUBJECT>
                                <SECTNO>597.303 </SECTNO>
                                <SUBJECT>Restrictions on exemptions.</SUBJECT>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart D—Application Review Process</HD>
                                <SECTNO>597.400 </SECTNO>
                                <SUBJECT>In general</SUBJECT>
                                <SECTNO>597.401 </SECTNO>
                                <SUBJECT>Review Phase 1: Initial Review.</SUBJECT>
                                <SECTNO>597.402 </SECTNO>
                                <SUBJECT>Review Phase 2: Follow-up Review.</SUBJECT>
                                <SECTNO>597.403 </SECTNO>
                                <SUBJECT>Review Phase 3: Preliminary Determination.</SUBJECT>
                                <SECTNO>597.404 </SECTNO>
                                <SUBJECT>Final determination. </SUBJECT>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart E—Reporting by Participants</HD>
                                <SECTNO>597.500 </SECTNO>
                                <SUBJECT>General reporting requirements.</SUBJECT>
                                <SECTNO>597.501 </SECTNO>
                                <SUBJECT>Event-triggered reporting requirements.</SUBJECT>
                                <SECTNO>597.502 </SECTNO>
                                <SUBJECT>Changes to an operation.</SUBJECT>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart F—Procedures During Participation</HD>
                                <SECTNO>597.600 </SECTNO>
                                <SUBJECT>Concern resolution process.</SUBJECT>
                                <SECTNO>597.601 </SECTNO>
                                <SUBJECT>Amendment process. </SUBJECT>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart G—Public Reporting Requirements</HD>
                                <SECTNO>597.700 </SECTNO>
                                <SUBJECT>In general.</SUBJECT>
                                <SECTNO>597.701 </SECTNO>
                                <SUBJECT>Information for publication.</SUBJECT>
                            </SUBPART>
                        </CONTENTS>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P> 49 U.S.C. 322, 30111, 30112, 30114, 30122, 30166, and 30182; delegation of authority at 49 CFR 1.95. </P>
                        </AUTH>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—General</HD>
                            <SECTION>
                                <SECTNO>§ 597.100</SECTNO>
                                <SUBJECT> Scope.</SUBJECT>
                                <P>This part specifies requirements and procedures for eligibility and participation in the ADS-equipped Vehicle Safety, Transparency, and Evaluation Program (AV STEP), including the conditions under which:</P>
                                <P>(a) Certain ADS-equipped motor vehicles may receive special exemptions under 49 U.S.C. 30114 from compliance with one or more Federal motor vehicle safety standards (FMVSS) issued under part 571 of this chapter and bumper standards issued under part 581 of this chapter;</P>
                                <P>(b) Persons may receive exemptions under 49 U.S.C. 30122 from the prohibition on making inoperative any part of a device or element of design installed on an ADS-equipped vehicle in compliance with an applicable FMVSS; and</P>
                                <P>(c) Persons may participate in AV STEP with an ADS-equipped vehicle that separately complies with all applicable requirements of 49 CFR chapter V without an exemption under AV STEP.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.101</SECTNO>
                                <SUBJECT> Purpose.</SUBJECT>
                                <P>This part specifies eligibility requirements for entities to participate in AV STEP, identifies the information that must be submitted in an application, describes how NHTSA will review and respond to applications, sets forth the requirements for participating in AV STEP, and specifies the processes associated with the revocation or amendment of Program admission.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.102</SECTNO>
                                <SUBJECT> Definitions.</SUBJECT>
                                <P>
                                    <E T="03">ADS Developer</E>
                                     means the entity principally responsible for the manufacture of the 
                                    <E T="03">ADS</E>
                                     at the system level, including but not limited to its design, development, and testing.
                                </P>
                                <P>
                                    <E T="03">Applicant</E>
                                     means an entity seeking NHTSA approval for an 
                                    <E T="03">ADS</E>
                                    -equipped vehicle to participate in 
                                    <E T="03">AV STEP.</E>
                                </P>
                                <P>
                                    <E T="03">Automated Driving System (ADS)</E>
                                     means the hardware and software that are collectively capable of performing the entire 
                                    <E T="03">Dynamic Driving Task</E>
                                     on a sustained basis, regardless of whether the system is limited to a specific 
                                    <E T="03">operational design domain.</E>
                                </P>
                                <P>
                                    <E T="03">AV STEP</E>
                                     or 
                                    <E T="03">Program</E>
                                     means the 
                                    <E T="03">ADS</E>
                                    -equipped Vehicle Safety, Transparency, and Evaluation Program.
                                </P>
                                <P>
                                    <E T="03">AV STEP Exemption</E>
                                     means an 
                                    <E T="03">AV STEP FMVSS Exemption</E>
                                     or an 
                                    <E T="03">AV STEP Make Inoperative Exemption.</E>
                                </P>
                                <P>
                                    <E T="03">AV STEP FMVSS Exemption</E>
                                     means an exemption, requested through 
                                    <E T="03">AV STEP</E>
                                     under 49 U.S.C. 30114(a), to one or more of the FMVSS issued under part 571 of this chapter or the bumper standards issued under part 581 of this chapter.
                                </P>
                                <P>
                                    <E T="03">AV STEP Make Inoperative Exemption</E>
                                     means an exemption, requested through 
                                    <E T="03">AV STEP,</E>
                                     to 49 U.S.C. 30122(b).
                                </P>
                                <P>
                                    <E T="03">Contact event</E>
                                     means any event in which a subject vehicle comes into physical contact with another vehicle, road user, individual, animal, or physical object. For the purposes of this part, a contact event does not include benign intentional contact, such as upon a vehicle passenger entering or exiting a stationary vehicle, or intentional tire contact with a curb below a speed of 5 miles per hour.
                                </P>
                                <P>
                                    <E T="03">Customized term</E>
                                     means a term or condition related to the operation, performance, and safety of a subject vehicle, including metric(s) and threshold(s), proposed by an applicant informed by the Independent Assessment, and set by the agency in the terms and conditions of an approval.
                                </P>
                                <P>
                                    <E T="03">Dynamic Driving Task (DDT)</E>
                                     means all of the real-time operational and tactical functions required to operate a vehicle in on-road traffic, excluding the strategic functions such as trip scheduling and selection of destinations and waypoints, and including, without limitation, the following subtasks:
                                </P>
                                <P>
                                    (1) Lateral vehicle motion control, 
                                    <E T="03">e.g.,</E>
                                     via steering.
                                </P>
                                <P>(2) Longitudinal vehicle motion control via acceleration and deceleration.</P>
                                <P>(3) Monitoring the driving environment via object and event detection, recognition, classification, and response preparation.</P>
                                <P>(4) Object and event response execution.</P>
                                <P>(5) Maneuver planning.</P>
                                <P>(6) Enhancing conspicuity, such as via lighting, sounding the horn, signaling, and gesturing.</P>
                                <P>
                                    <E T="03">Dynamic Driving Task Fallback (DDT Fallback)</E>
                                     means the response by an individual to either perform the 
                                    <E T="03">DDT</E>
                                     or achieve a 
                                    <E T="03">minimal risk condition</E>
                                     after occurrence of a 
                                    <E T="03">DDT</E>
                                     performance-relevant system failure(s) or upon 
                                    <E T="03">operational design domain</E>
                                     exit, or the response by an 
                                    <E T="03">ADS</E>
                                     to achieve a 
                                    <E T="03">minimal risk condition,</E>
                                     given the same circumstances.
                                </P>
                                <P>
                                    <E T="03">Dynamic Driving Task Takeover (DDT Takeover)</E>
                                     means an individual's planned or unplanned overriding of the operation of the 
                                    <E T="03">ADS</E>
                                     to manually perform the 
                                    <E T="03">DDT,</E>
                                     including to achieve a 
                                    <E T="03">minimal risk condition.</E>
                                     A 
                                    <E T="03">DDT Takeover</E>
                                     may occur as part of a 
                                    <E T="03">DDT Fallback</E>
                                     or in anticipation of possible future 
                                    <E T="03">ADS</E>
                                     behavior unwanted by the user.
                                </P>
                                <P>
                                    <E T="03">Essential system-level stakeholder</E>
                                     means an entity with a significant role in the safety of an operation requested in an application to participate in 
                                    <E T="03">AV STEP,</E>
                                     including but not limited to, a 
                                    <E T="03">manufacturer</E>
                                     of the subject vehicle, an 
                                    <E T="03">ADS developer</E>
                                     for the subject vehicle, a 
                                    <E T="03">fleet operator</E>
                                     of the subject vehicle, and a 
                                    <E T="03">system integrator.</E>
                                </P>
                                <P>
                                    <E T="03">Fallback personnel</E>
                                     means an individual specially trained and skilled in supervising the performance of prototype 
                                    <E T="03">ADS</E>
                                    -operated vehicles in on-road traffic, who continuously supervises the performance of an 
                                    <E T="03">ADS</E>
                                    -operated vehicle in real time and intervenes whenever necessary to prevent a hazardous event by exercising any means of vehicle control. This intervention may occur as part of a 
                                    <E T="03">DDT Fallback</E>
                                     or in anticipation of possible future 
                                    <E T="03">ADS</E>
                                     behavior that is unsafe or otherwise unwanted by the user. Fallback personnel may be physically present in the vehicle or remote. The fallback personnel role does not include 
                                    <E T="03">Vehicle Assistance,</E>
                                     as defined in this section.
                                </P>
                                <P>
                                    <E T="03">Fleet operator</E>
                                     means the individual or entity that exercises all or part of the 
                                    <E T="03">operational control</E>
                                     over the 
                                    <E T="03">ADS</E>
                                     installed in a subject vehicle or group of subject vehicles.
                                </P>
                                <P>
                                    <E T="03">Manufacturer</E>
                                     has the meaning given in 49 U.S.C. 30102(a)(6).
                                </P>
                                <P>
                                    <E T="03">Minimal risk condition</E>
                                     means a stable, stopped condition to which a user, such as fallback personnel, or an 
                                    <E T="03">ADS</E>
                                     may bring a vehicle after performing the 
                                    <E T="03">DDT Fallback, including after a DDT Takeover,</E>
                                     to reduce the risk of a crash when a given trip cannot or should not be continued.
                                    <PRTPAGE P="4180"/>
                                </P>
                                <P>
                                    <E T="03">Minimal risk maneuver</E>
                                     means a driving maneuver intended to achieve a 
                                    <E T="03">minimal risk condition.</E>
                                </P>
                                <P>
                                    <E T="03">Operational control</E>
                                     means control over functions of 
                                    <E T="03">ADS</E>
                                    -equipped vehicles that include, without limitation, ensuring operational readiness; authorizing each trip; dispatching 
                                    <E T="03">ADS</E>
                                    -equipped vehicles; providing fleet asset management services to vehicles while in-use; serving as the responsible agent vis-à-vis law enforcement, emergency responders and other authorities for vehicles while in use; disengaging the 
                                    <E T="03">ADS</E>
                                     at the end of service; and performing vehicle repair and maintenance as needed.
                                </P>
                                <P>
                                    <E T="03">Operational Design Domain (ODD)</E>
                                     means the operating conditions under which the 
                                    <E T="03">ADS</E>
                                     or feature thereof is specifically designed to function, including, but not limited to, environmental, geographical, and time-of-day restrictions, and/or the requisite presence or absence of defined traffic or roadway characteristics.
                                </P>
                                <P>
                                    <E T="03">Participant</E>
                                     means an entity that has received NHTSA approval for an 
                                    <E T="03">ADS</E>
                                    -equipped vehicle to participate in 
                                    <E T="03">AV STEP,</E>
                                     provided such approval has not expired. A participant may be involved in multiple 
                                    <E T="03">Participations</E>
                                     at a time.
                                </P>
                                <P>
                                    <E T="03">Participation</E>
                                     means the entire operation or group of operations that is governed by a Final Determination Letter issued under § 597.404, including any Amended Final Determination Letter under § 597.601.
                                </P>
                                <P>
                                    <E T="03">Public ridership</E>
                                     means transporting as a passenger any member of the public other than an employee or agent of an 
                                    <E T="03">Essential system-level stakeholder</E>
                                     or a public official acting in an official capacity, such as law enforcement or government personnel.
                                </P>
                                <P>
                                    <E T="03">Remote driving</E>
                                     means the real-time performance of part or all of the 
                                    <E T="03">DDT</E>
                                     by an individual physically located outside of the vehicle.
                                </P>
                                <P>
                                    <E T="03">Safety case</E>
                                     means a structured argument, consisting of claims supported by a body of evidence, that provides a complete, comprehensible, and valid case that a system is acceptably safe for a given use in a specified environment.
                                </P>
                                <P>
                                    <E T="03">Subject vehicle</E>
                                     means a motor vehicle operating, or that an 
                                    <E T="03">applicant</E>
                                     intends to operate, under 
                                    <E T="03">AV STEP.</E>
                                </P>
                                <P>
                                    <E T="03">System integrator</E>
                                     means an entity responsible for integration of an 
                                    <E T="03">ADS</E>
                                     at the vehicle level.
                                </P>
                                <P>
                                    <E T="03">Vehicle assistance</E>
                                     means an individual providing information or instruction about a situation to an 
                                    <E T="03">ADS</E>
                                    -equipped vehicle in driverless operation (instead of exercising direct control of the vehicle) to help the 
                                    <E T="03">ADS</E>
                                     continue a trip when encountering a situation that the 
                                    <E T="03">ADS</E>
                                     cannot manage. 
                                    <E T="03">Vehicle assistance</E>
                                     may be provided remotely, by an individual not physically present in the vehicle, or by an individual on board (physically present in) the vehicle. Unlike 
                                    <E T="03">fallback personnel,</E>
                                     as defined in this section, vehicle assistance personnel provide information or instruction to an ADS-equipped vehicle rather than directly exercising vehicle control authority.
                                </P>
                                <P>
                                    <E T="03">Vehicle recovery event</E>
                                     means any instance in which a vehicle needs to be recovered during roadway operations by personnel other than those already on board the subject vehicle, including, but not limited to, recovery after a 
                                    <E T="03">minimal risk condition</E>
                                     has been achieved.
                                </P>
                                <P>
                                    <E T="03">Vulnerable road user</E>
                                     means any person who is not an occupant of a motor vehicle with more than three wheels, heavy equipment, or a railway vehicle. This definition includes, but is not limited to, pedestrians, persons traveling in wheelchairs, bicyclists, motorcyclists, and riders or occupants of other transport vehicles that are not motor vehicles, such as all-terrain vehicles and lawnmowers.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.103</SECTNO>
                                <SUBJECT> Eligibility for participation.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">In general.</E>
                                     An entity may apply for one or more ADS-equipped vehicles to participate in AV STEP only upon meeting the eligibility requirements of this subpart.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Vehicle eligibility.</E>
                                     Subject vehicles must be equipped with an ADS that:
                                </P>
                                <P>(1) Is being used or developed for operation without an expectation of an attentive human driver (whether in-vehicle or remote) while engaged; and</P>
                                <P>(2) Performs the entirety of the dynamic driving task for all or part of the operations for which participation is requested.</P>
                                <P>
                                    (c) 
                                    <E T="03">Applicant eligibility.</E>
                                     (1) An application may be submitted by a single applicant or multiple co-applicants, all of whom must meet the eligibility requirements in this section.
                                </P>
                                <P>(2) Every applicant must qualify as at least one of the following:</P>
                                <P>(i) The manufacturer of the subject vehicle(s);</P>
                                <P>(ii) The ADS developer for the subject vehicle(s);</P>
                                <P>(iii) The fleet operator for the subject vehicle(s); or</P>
                                <P>(iv) The system integrator.</P>
                                <P>(3) In addition to the requirements in paragraph (c)(1) of this section, every applicant (or at least one co-applicant in applications that have multiple co-applicants) requesting an AV STEP FMVSS Exemption must:</P>
                                <P>(i) Be the manufacturer of all subject vehicles in an application that are not subject to importation; or</P>
                                <P>(ii) Be the importer of record of all subject vehicles in an application that are subject to importation into the United States.</P>
                                <P>
                                    (d) 
                                    <E T="03">Operational eligibility.</E>
                                     The operation of a subject vehicle during AV STEP participation must:
                                </P>
                                <P>(1) Take place, in part or entirely, on public streets, roads, and highways in the United States; and</P>
                                <P>(2) Take place in a manner in which all operational control is exercised, at all times, by one or more of the following:</P>
                                <P>(i) The manufacturer of the subject vehicle;</P>
                                <P>(ii) The ADS developer for the subject vehicle;</P>
                                <P>(iii) The fleet operator of the subject vehicle; or</P>
                                <P>(iv) The system integrator for the subject vehicle.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.104</SECTNO>
                                <SUBJECT> Program step eligibility.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">In general.</E>
                                     Participation in AV STEP must occur at one of the two program steps defined in paragraph (b) of this section.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Eligibility criteria.</E>
                                     The minimum eligibility requirements for the program steps are as follows:
                                </P>
                                <P>
                                    (1) 
                                    <E T="03">Step 1: ADS operations with fallback personnel.</E>
                                     An entity is eligible to apply for Step 1 participation for subject vehicle(s) that would operate only with continuous supervision from fallback personnel during all participating operations on public roads.
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Step 2: ADS operations without fallback personnel.</E>
                                     An entity is eligible to apply for Step 2 participation for subject vehicle(s) that would operate without fallback personnel during participating operations on public roads.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.105</SECTNO>
                                <SUBJECT> Terms and conditions of participation.</SUBJECT>
                                <P>(a) NHTSA may place terms and conditions as appropriate on participation in AV STEP. In addition to the terms and conditions specified in this section, NHTSA may prescribe other terms and conditions governing an operation in a Final Determination Letter issued under § 597.404.</P>
                                <P>(b) At a minimum, the terms and conditions in a Final Determination Letter granting AV STEP participation will govern the following subjects:</P>
                                <P>(1) The program step in which participation is permitted;</P>
                                <P>(2) The maximum number of vehicles approved for participation;</P>
                                <P>(3) The vehicles approved for participation;</P>
                                <P>
                                    (4) The permitted use(s) of participating vehicles;
                                    <PRTPAGE P="4181"/>
                                </P>
                                <P>(5) The permitted duration of participation;</P>
                                <P>(6) The permitted location(s) for participation; and</P>
                                <P>(7) The Essential System-Level Stakeholders for the participation.</P>
                                <P>(c) A subject vehicle may not operate with public ridership during operations involving fallback personnel.</P>
                                <P>(d) All participants must report the information specified in subpart E of this part, and NHTSA may establish additional reporting requirements as a term or condition of participation.</P>
                                <P>(e) All subject vehicles, including their operations, must comply with all Federal, state and local laws and requirements during participation.</P>
                                <P>(f) All subject vehicles participating through an AV STEP Exemption must display vehicle labels advising that the vehicles may not conform with all applicable Federal motor vehicle safety standards. These labels must be formatted in a manner that can be easily read and consist of:</P>
                                <P>(1) At least one label on the exterior of the vehicle that is readily visible to persons external to the vehicle; and</P>
                                <P>(2) One or more labels on the interior of the vehicle such that at least one label is readily visible to vehicle occupants in all seating positions.</P>
                                <P>(g) Unless NHTSA provides otherwise in a term or condition of a Final Determination Letter, a participant with an AV STEP Exemption must maintain ownership and possession of each subject vehicle.</P>
                                <P>(h) A participant with an AV STEP exemption may not license the subject vehicle for use or operate it except as provided in a term or condition of a Final Determination Letter.</P>
                                <P>(i) Unless otherwise provided by NHTSA in a term or condition of a Final Determination Letter, remote driving of a subject vehicle is prohibited during participation in AV STEP except as temporarily needed to briefly move a vehicle after the ADS initiates a minimal risk maneuver.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.106 </SECTNO>
                                <SUBJECT>Engagement with entities other than an applicant or participant.</SUBJECT>
                                <P>(a) An applicant or participant is required to furnish sufficient information to NHTSA, directly or through other stakeholders, to enable NHTSA to assess the system-level performance of the subject vehicle in the requested operations.</P>
                                <P>(b) NHTSA's ability to fully communicate with any entity performing an independent assessment under § 597.205 regarding any aspect of an application or participation is a condition of this Program.</P>
                            </SECTION>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart B—Application Requirements</HD>
                            <SECTION>
                                <SECTNO>§ 597.200 </SECTNO>
                                <SUBJECT>General application requirements.</SUBJECT>
                                <P>To be considered for participation in AV STEP, an applicant must:</P>
                                <P>(a) Write the application in the English language;</P>
                                <P>
                                    (b) Submit the application electronically using the NHTSA Product Information Catalog and Vehicle Listing (vPIC) platform (
                                    <E T="03">https://vpic.nhtsa.dot.gov</E>
                                    ) or send to: Director, Office of Automation Safety, NRM-400, 1200 New Jersey Avenue SE, Washington, DC 20590;
                                </P>
                                <P>(c) Include the information described in this subpart;</P>
                                <P>(d) During the pendency of an application, promptly notify NHTSA upon becoming aware of information in an application that is inaccurate or that has changed since the application was submitted.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.201 </SECTNO>
                                <SUBJECT>Operational baseline information.</SUBJECT>
                                <P>An applicant seeking participation must, as part of the application:</P>
                                <P>(a) Identify the program step under which participation is requested;</P>
                                <P>(b) Identify each applicant;</P>
                                <P>(c) Provide primary and secondary contact information for each applicant;</P>
                                <P>(d) Identify each Essential System-Level Stakeholder;</P>
                                <P>(e) Identify the vehicle platform for which participation is requested, including the following for the subject vehicle:</P>
                                <P>(1) Make;</P>
                                <P>(2) Model;</P>
                                <P>(3) Model year;</P>
                                <P>(4) Unloaded vehicle weight;</P>
                                <P>(5) Gross Vehicle Weight Rating;</P>
                                <P>(6) Claimed vehicle class; and</P>
                                <P>(7) FMVSS certifying entity, if applicable.</P>
                                <P>(f) For the ADS on a subject vehicle, identify:</P>
                                <P>(1) The following information regarding each sensor contributing to the perception capabilities of the ADS:</P>
                                <P>(i) The type of sensor;</P>
                                <P>(ii) The make and model of the sensor;</P>
                                <P>(iii) The use of the sensor in ADS operations; and</P>
                                <P>(iv) The location of the sensor on the subject vehicle;</P>
                                <P>(2) The crash detection capabilities of the subject vehicle's ADS and, if applicable, any units towed by the subject vehicle, including any limitations or thresholds for detecting physical contact relating to a crash;</P>
                                <P>(3) Any modifications to safety features installed as original equipment on the subject vehicle, other than modifications identified pursuant to § 597.202; and</P>
                                <P>(4) The designed data logging functionality of the subject vehicle, including:</P>
                                <P>(i) Continuously recorded data;</P>
                                <P>(ii) Event-triggered data; and </P>
                                <P>(iii) For each type of data identified in response to paragraphs (f)(4)(i) and (f)(4)(ii) of this section:</P>
                                <P>(A) The onboard or offboard storage protocols; and</P>
                                <P>(B) The duration of retention.</P>
                                <P>(g) Identify the seating position(s) of any onboard fallback personnel that may be present during a subject vehicle's participating operation.</P>
                                <P>(h) Identify whether any remote driving of the subject vehicle may occur during participating operations and, if so:</P>
                                <P>(1) Whether any participating operations will rely on fallback personnel who possess remote driving control authority;</P>
                                <P>(2) Any restrictions in place for the use of remote driving; and</P>
                                <P>(3) Provide a public summary of the limitations in place on the use of remote driving for reporting purposes under § 597.701(a)(2)(ix).</P>
                                <P>(i) Identify whether any other remote or onboard vehicle assistance may occur during participating operations.</P>
                                <P>(j) Identify whether any Federal, State, or local permits are required for the operations described in the application. If so, provide a copy of each such permit if it has been issued, and describe, for each required permit:</P>
                                <P>(1) The regulatory entity requiring the permit;</P>
                                <P>(2) The status of the permit;</P>
                                <P>(3) The effective dates of any existing permits; and</P>
                                <P>(4) Any conditions imposed by the permit.</P>
                                <P>(k) Identify whether an AV STEP Exemption is sought for any subject vehicle in the application.</P>
                                <P>(l) Identify whether the subject vehicle(s) contain any features or design modifications that are intended to promote the safe accommodation of passengers with disabilities and, if so, provide a public summary of the features or design modifications for reporting purposes under § 597.701(a)(2)(xii).</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.202 </SECTNO>
                                <SUBJECT>Vehicle exemption information.</SUBJECT>
                                <P>(a) Any application seeking an AV STEP Exemption must identify the following information concerning each subject vehicle for which an exemption is requested.</P>
                                <P>(1) Whether an AV STEP FMVSS Exemption or an AV STEP Make Inoperative Exemption is requested for the subject vehicle;</P>
                                <P>
                                    (2) The total anticipated number of vehicles for which each AV STEP 
                                    <PRTPAGE P="4182"/>
                                    Exemption will be sought during the course of participation;
                                </P>
                                <P>(3) Each subject vehicle for which an exemption is requested, including:</P>
                                <P>(i) The vehicle make;</P>
                                <P>(ii) The vehicle model;</P>
                                <P>(iii) The vehicle model year or date of manufacture; and</P>
                                <P>(iv) The vehicle identification number or unique identifier for the subject vehicle.</P>
                                <P>(4) Whether sufficient insurance coverage for each subject vehicle for which an exemption is requested will be maintained at all times for the operations described in the application;</P>
                                <P>(5) All labels proposed for the requirements of § 597.105(g);</P>
                                <P>(6) Whether the subject vehicle requires importation into the United States;</P>
                                <P>(7) How the safety performance of the subject vehicle compares to the safety performance required by the FMVSS standard(s) at issue in the requested FMVSS Exemption or Make Inoperative Exemption, including:</P>
                                <P>(i) A comparison of the following:</P>
                                <P>(A) Crash protection for vehicle occupants;</P>
                                <P>(B) The safety of vulnerable road users; and</P>
                                <P>(C) The overall safety of the subject vehicle during its expected operation.</P>
                                <P>(ii) The process and evidence used to assess each element of  § 597.202(a)(7)(i);</P>
                                <P>(8) All mitigations of safety risks resulting from:</P>
                                <P>(i) Each noncompliance identified in paragraph (b)(1) of this section; and</P>
                                <P>(ii) Each modification identified in paragraph (c) of this section.</P>
                                <P>(9) A public summary of the mitigations of safety risks for reporting purposes under § 597.701(a)(1).</P>
                                <P>(b) For each subject vehicle for which an AV STEP FMVSS Exemption is requested, the applicant must:</P>
                                <P>(1) Identify each applicable standard and subsection with which the vehicle may not comply and provide a description of each noncompliance;</P>
                                <P>(2) List each purpose under § 597.202(b) applicable to a requested exemption, and for each identified purpose:</P>
                                <P>(i) Describe how the purpose is fulfilled; and</P>
                                <P>(ii) Explain the timeframe for which the purpose applies.</P>
                                <P>(3) Describe whether operations of the subject vehicle(s) will involve any commercialization. If so, the applicant must describe:</P>
                                <P>(i) The type of commercialization;</P>
                                <P>(ii) The extent of the commercialization; and</P>
                                <P>(iii) Any public interest furthered through a purpose claimed under paragraph (b)(2) of this section.</P>
                                <P>(c) For each subject vehicle for which an AV STEP Make Inoperative Exemption is requested, the applicant must identify each modification for which an exemption is requested and, for each modification:</P>
                                <P>(1) The device(s) or element(s) rendered inoperative by the modification;</P>
                                <P>(2) The FMVSS and subsection affected by the modification;</P>
                                <P>(3) The extent of the applicant's consultation with the original manufacturer of the subject vehicle or affected device regarding the modification, including:</P>
                                <P>(i) Any information provided to the original manufacturer about the modification;</P>
                                <P>(ii) Any safety effects of the modification identified by the original manufacturer;</P>
                                <P>(iii) Any recommendations by the original manufacturer regarding mitigations of such potential safety effects; and</P>
                                <P>(iv) Any mitigations undertaken by the applicant to address such potential safety effects.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.203 </SECTNO>
                                <SUBJECT>Location sheet information.</SUBJECT>
                                <P>An application must include the following information concerning each geographical location in which participation is requested:</P>
                                <P>
                                    (a) 
                                    <E T="03">Location Name.</E>
                                     Provide a unique reference name for the location;
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Location Limitation.</E>
                                     Define the geographical boundaries for the operation of the subject vehicle;
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Maximum Number of Vehicles Proposed for Participation.</E>
                                     Identify the maximum number of vehicles for which AV STEP participation is requested for the location;
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Legal Speed Limits.</E>
                                     Provide the following information regarding the speed limits for roadways on which operation is planned for the subject vehicle for the location:
                                </P>
                                <P>
                                    (1) 
                                    <E T="03">Highest Speed.</E>
                                     Identify the highest legal speed limit for the operation and the segment(s) of road in which this speed limit occurs; and
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Maximum Speed Differential.</E>
                                     For the road segment with the largest differential between the legal speed limit and the maximum allowed speed of the subject vehicle with the ADS engaged while operating on the road segment, identify:
                                </P>
                                <P>(i) The segment(s) of road in which the differential exists;</P>
                                <P>(ii) The legal speed limit; and</P>
                                <P>(iii) The maximum allowable speed of the ADS on the segment of the road.</P>
                                <P>
                                    (e) 
                                    <E T="03">Vehicle Speeds.</E>
                                     Identify:
                                </P>
                                <P>(1) The highest speed currently allowed for the ADS while operating in the location; and</P>
                                <P>(2) The highest speed for which participation is requested for the ADS while operating in the location.</P>
                                <P>
                                    (f) 
                                    <E T="03">Public Ridership.</E>
                                     Identify whether the operation will involve any public ridership.
                                </P>
                                <P>
                                    (g) 
                                    <E T="03">Intended Use.</E>
                                     Describe the planned use case(s) for the subject vehicle(s) during operation.
                                </P>
                                <P>
                                    (h) 
                                    <E T="03">Operational Design Domain.</E>
                                     Describe the operational design domain for the subject vehicles, including the following:
                                </P>
                                <P>(1) A complete specification of all aspects of the operational design domain, which must identify operational design domain differences between Location Sheets, where applicable; and</P>
                                <P>(2) A summary of the operational design domain for public reporting purposes under § 597.701(a)(3)(viii).</P>
                                <P>
                                    (i) 
                                    <E T="03">Vehicle Equipment.</E>
                                     Identify the following equipment and characteristics for each subject vehicle operating under a Location Sheet as compared to the base model of the subject vehicle, when applicable, and if multiple Location Sheets are requested, any differences between Location Sheets:
                                </P>
                                <P>(1) Any trim level characteristics that affect safety;</P>
                                <P>(2) Any optional technologies that affect safety; and</P>
                                <P>(3) Any other distinguishing safety characteristics.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.204 </SECTNO>
                                <SUBJECT>Protocols for ADS Operations.</SUBJECT>
                                <P>An application must include the following information concerning any applicable protocols for the development and operation of the subject vehicles and ADS:</P>
                                <P>(a) An explanation of the subject vehicle's adherence with Federal, State, and local laws, including:</P>
                                <P>(1) A summary of how applicable traffic safety laws are identified;</P>
                                <P>(2) A description of how an ADS' compliance with traffic safety laws is monitored;</P>
                                <P>(3) A description of any conditions under which the design of the ADS may allow the subject vehicle to not follow traffic laws; and</P>
                                <P>(4) A summary of recognition, interaction, and response strategies for:</P>
                                <P>(i) Emergency and law enforcement vehicles, personnel, and equipment;</P>
                                <P>(ii) Construction vehicles, personnel, and equipment; and</P>
                                <P>(iii) Crossing guards or other traffic control personnel.</P>
                                <P>(b) A description of any system fallback or failure mitigation strategies, including:</P>
                                <P>
                                    (1) A description of any minimal risk conditions the ADS may achieve, which must include:
                                    <PRTPAGE P="4183"/>
                                </P>
                                <P>(i) A description of each minimal risk condition and the engineering rationale for its use;</P>
                                <P>(ii) The circumstances under which each minimal risk condition is triggered;</P>
                                <P>(iii) A description of how the minimal risk maneuver is initiated and executed; and</P>
                                <P>(iv) Any protocols for the ADS following the achievement of each minimal risk condition.</P>
                                <P>(2) An overview of any protocols not identified under paragraph (b)(1) of this section that are associated with averting or achieving a minimal risk condition, which:</P>
                                <P>(i) Includes any protocols for the following:</P>
                                <P>(A) Providing input to the ADS or disengaging the ADS prior to or during a minimal risk maneuver;</P>
                                <P>(B) Resuming ADS driving following the achievement of a minimal risk condition; and</P>
                                <P>(C) Vehicle recovery events.</P>
                                <P>(ii) Identifies the role and number of persons responsible for each protocol described in paragraph (b)(2)(i) of this section and describes each such person's:</P>
                                <P>(A) Responsibilities under the protocol;</P>
                                <P>(B) Physical location when performing an identified responsibility;</P>
                                <P>(C) Expected response time in performing an identified responsibility;</P>
                                <P>(D) Potential control authority over the subject vehicle;</P>
                                <P>(E) Means of exercising any control authority over the subject vehicle; and</P>
                                <P>(F) Operational restrictions on the use of any control authority.</P>
                                <P>(3) A description of any protocols for vehicle immobilizations that occur without the achievement of a minimal risk condition.</P>
                                <P>(c) An overview of any design and process measures that are in place to facilitate safe and predictable interactions with members of the public, including:</P>
                                <P>(1) Any communication strategies to convey information to individuals outside of a subject ADS-equipped vehicle;</P>
                                <P>(2) Any measures to promote the predictability of the ADS' behavior for other road users in the vicinity of the subject vehicle;</P>
                                <P>(3) Any communication strategies for non-operator occupants of the subject ADS-equipped vehicle; and</P>
                                <P>(4) Any features or design modifications that are intended to promote the safe accommodation of passengers with disabilities.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.205 </SECTNO>
                                <SUBJECT>Independent assessment.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">In general.</E>
                                     An application requires an independent assessment that conforms to the requirements of this section. Information regarding this assessment must be conveyed to NHTSA through a summary report, as provided under subsection (d), prepared by an assessor that meets the independence and qualification requirements of this section.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Scope of Independent Assessment.</E>
                                     An independent assessment must consider the full extent of operations requested for the subject vehicle(s) in an application.
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Subjects of Independent Assessment.</E>
                                     An independent assessment must include a review of the following:
                                </P>
                                <P>(1) The conformance of the subject vehicle's ADS and its operations with relevant industry standards, best practices, and guidance. This conformity assessment must:</P>
                                <P>(i) Determine non-, partial, or full conformance with each such industry standard, best practice, or guidance;</P>
                                <P>(ii) Assess the justification and safety implications of any non- or partial compliance determined under paragraph (c)(1)(i) of this section;</P>
                                <P>(iii) Assess whether, collectively, the degree of conformance with relevant industry standards, best practices, and guidance represents a responsible approach to developing and operating the subject vehicle; and</P>
                                <P>(iv) Contain recommendations regarding:</P>
                                <P>(A) The list of industry standards, best practices, and guidance with which conformance should, in full or in part, be achieved or maintained during operations; and</P>
                                <P>(B) How to address any safety gaps in the design and operation of the subject vehicle that would not be covered by the conformance recommended under paragraph (c)(1)(iv)(A) of this section.</P>
                                <P>(2) A safety case that details how the safety of the subject vehicle, including the safety of the subject vehicle's occupants and surrounding road users, is assured for the operations requested in an application. The assessment of the safety case by the assessor:</P>
                                <P>(i) May incorporate the assessment under paragraph (c)(1) of this section;</P>
                                <P>(ii) Must include a review of the validity and soundness of the safety case, including whether:</P>
                                <P>(A) The safety case arguments and claims support the operations of the subject vehicle;</P>
                                <P>(B) The safety case claims are supported with sufficient evidence; and</P>
                                <P>(C) Appropriate processes exist for maintaining the safety case throughout the operations.</P>
                                <P>(iii) Must include a detailed analysis of the following aspects of the safety case:</P>
                                <P>
                                    (A) 
                                    <E T="03">Safety Risk Assessment.</E>
                                     Whether the safety case comprehensively identifies and assesses safety risks, including potential vehicle and operational hazards and faults;
                                </P>
                                <P>
                                    (B) 
                                    <E T="03">Safety Risk Management.</E>
                                     Whether the safety case contains appropriate risk management, including mitigations, for the risks identified;
                                </P>
                                <P>
                                    (C) 
                                    <E T="03">System Evolution.</E>
                                     Whether the safety case contains appropriate processes for maintaining or improving safety over time;
                                </P>
                                <P>
                                    (D) 
                                    <E T="03">Safety Performance Indicators.</E>
                                     Whether the safety case relies on appropriate safety performance indicators and thresholds;
                                </P>
                                <P>
                                    (E) 
                                    <E T="03">Conformance with Traffic Safety Law.</E>
                                     Whether appropriate processes exist for identifying applicable traffic safety laws in an area of operation and overseeing their conformance during operations;
                                </P>
                                <P>
                                    (F) 
                                    <E T="03">Vehicle Fallback and Assistance.</E>
                                     Whether the safety case contains appropriate processes for ensuring the effectiveness of any expected fallback or vehicle assistance;
                                </P>
                                <P>
                                    (G) 
                                    <E T="03">Human Factors.</E>
                                     Whether the safety case appropriately accounts for human factors considerations that may affect safety, including, where applicable, those related to fallback personnel, vehicle assistance, vehicle occupants, or surrounding road users;
                                </P>
                                <P>
                                    (H) 
                                    <E T="03">Crash Avoidance.</E>
                                     Whether the safety case appropriately identifies and considers the variety of crash-imminent situations that could occur within the operations; and
                                </P>
                                <P>
                                    (I) 
                                    <E T="03">Tool Qualification.</E>
                                     Whether software tools used to evaluate expected ADS performance are representative and accurate.
                                </P>
                                <P>(iv) Must include a review of the safety management systems in place to oversee the safety of the subject vehicle for the operations requested in an application. This review must include an assessment of the following for the organizations responsible for the safety of the operations involving the subject vehicle:</P>
                                <P>(A) Whether the leadership fosters a positive safety culture and demonstrates a safety commitment throughout the organization;</P>
                                <P>(B) Whether those responsible for the implementation of the safety management systems possess appropriate resources, authorities, and accountability;</P>
                                <P>(C) Whether there are appropriate policies and processes for encouraging reporting and timely investigation of safety-related concerns from internal staff and members of the public;</P>
                                <P>
                                    (D) Whether appropriate capabilities and policies exist for monitoring the 
                                    <PRTPAGE P="4184"/>
                                    location and state of each participating vehicle;
                                </P>
                                <P>(E) Whether appropriate processes exist to monitor safety performance indicators;</P>
                                <P>(F) Whether sufficient capabilities and policies exist for timely responding to a vehicle incident or immobilization and, if necessary, to clear a disabled vehicle from the roadway. This review must estimate a range of time for an expected response;</P>
                                <P>(G) Whether an appropriate plan exists for reaching timely decisions regarding future operations if an emergency arises; and</P>
                                <P>(H) Whether there are appropriate processes in place for how Essential System-Level Stakeholders will engage with each other regarding ongoing operations, including for carrying out:</P>
                                <P>
                                    (
                                    <E T="03">1</E>
                                    ) Software updates;
                                </P>
                                <P>
                                    (
                                    <E T="03">2</E>
                                    ) Operational updates;
                                </P>
                                <P>
                                    (
                                    <E T="03">3</E>
                                    ) Vehicle maintenance; and
                                </P>
                                <P>
                                    (
                                    <E T="03">4</E>
                                    ) The collection and reporting of safety data.
                                </P>
                                <P>(3) The following policies and capabilities:</P>
                                <P>
                                    (i) 
                                    <E T="03">Community Engagement.</E>
                                     Whether the policies for engaging with State and local authorities, local communities, and other entities affected by the subject vehicle's operation are sufficiently robust to identify the relevant stakeholders, provide them with appropriate information regarding operations, engage with them about concerns, and meaningfully address those concerns as needed;
                                </P>
                                <P>
                                    (ii) 
                                    <E T="03">Training and Qualifications of Personnel.</E>
                                     Whether the personnel who are responsible for developing and maintaining the safety case or executing safety critical processes possess appropriate qualifications and training; and
                                </P>
                                <P>
                                    (iii) 
                                    <E T="03">Data Capture.</E>
                                     Whether the data capture capabilities for the subject vehicle suffice to meet the data reporting requirements in subpart E of this part.
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Independent Assessment Summary Report.</E>
                                     An application must include a report prepared by the independent assessor that summarizes the independent assessment. This summary report must be submitted in an application in its original form, and must include the following:
                                </P>
                                <P>(1) An overview of any assessor processes in place to manage the assessment;</P>
                                <P>(2) Any access restrictions that limited the assessment;</P>
                                <P>(3) For the assessment requirements detailed in paragraph (c) of this section, an overview of:</P>
                                <P>(i) The assessor's findings and the basis for each finding;</P>
                                <P>(ii) Materials reviewed during the assessment;</P>
                                <P>(iii) The processes and format of reviews;</P>
                                <P>(iv) The methods used to identify potential inconsistencies, gaps, logical fallacies, or other concerns with the information provided for a review;</P>
                                <P>(v) Concerns identified during an assessment, including all recommendations made to the applicant(s) regarding identified concerns; and</P>
                                <P>(vi) The parameters under which the assessment and its conclusions are valid. This overview should account for potential future changes to operations, system design, or processes for which the assessment would remain valid.</P>
                                <P>
                                    (e) 
                                    <E T="03">Context for the Assessment.</E>
                                     An application must include the following information regarding an assessment conducted for an application:
                                </P>
                                <P>
                                    (1) 
                                    <E T="03">Applicant Response to Assessor Recommendations.</E>
                                     A summary report from an applicant that explains any measures taken in response to each assessor recommendation; and
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Prior Assessments.</E>
                                     A description of any other independent assessment initiated for the topics covered in paragraph (c) of this section, which includes:
                                </P>
                                <P>(i) The identity of the entity conducting the assessment;</P>
                                <P>(ii) The purpose of the assessment;</P>
                                <P>(iii) If the assessment was completed, the conclusions of the assessment; and</P>
                                <P>(iv) If the assessment was not completed, the reasons for its termination.</P>
                                <P>
                                    (f) 
                                    <E T="03">Assessor Independence.</E>
                                     (1) An assessment conducted under this section must not be performed by an entity with any of the following conflicts of interest:
                                </P>
                                <P>(i) The assessor, including any personnel and contractors used by the assessor for review, is owned, operated, or controlled, directly or indirectly, by a party with a financial interest in a particular disposition of the AV STEP application;</P>
                                <P>(ii) The assessor, including any of its personnel and contractors used for a review, has any ownership or financial interest in an interested party to the AV STEP application; or</P>
                                <P>(iii) The fee structure for the assessment is dependent in any way on the outcome of the assessment or the outcome of the AV STEP application.</P>
                                <P>(2) An application must contain the following information regarding the independence of the assessor:</P>
                                <P>(i) A disclosure of the existence of any of any other circumstance that may affect the objectivity of an assessor, including:</P>
                                <P>(A) Whether the assessor, including any personnel and contractors used by the assessor for review, participated in the design, manufacture, or distribution of a product within the scope of the assessment; and</P>
                                <P>(B) Whether the assessor, including any personnel and contractors used by the assessor for review, were separately engaged in the development of a project or operation within the scope of an application.</P>
                                <P>(ii) For any circumstances disclosed pursuant to paragraph (f)(2)(i) of this section, a description of any measures put in place to uphold the independence of an assessment; and</P>
                                <P>(iii) A certification from the assessor that:</P>
                                <P>(A) The assessment represents the independent judgment of the assessor; and</P>
                                <P>(B) No conflict of interest in paragraph (f)(1) of this section exists or existed at any time during the assessment.</P>
                                <P>
                                    (g) 
                                    <E T="03">Assessor Qualifications and Resources.</E>
                                     (1) An assessment conducted under this section must be conducted by an entity with the following qualifications and capabilities:
                                </P>
                                <P>(i) The assessor and its personnel have suitable education, technical expertise, experience, and appropriate accreditations to be qualified to carry out the assessment;</P>
                                <P>(ii) The assessor maintains appropriate policies and practices for conducting and organizing assessments; and</P>
                                <P>(iii) The assessor maintains facilities and resources appropriate for the types of assessments conducted.</P>
                                <P>(2) An application must contain supporting information regarding the assessor's qualifications, policies, and protocols for personnel involved in the assessment, including:</P>
                                <P>(i) Curriculum Vitae (CV) of key personnel that demonstrate their relevant education, training, and experience;</P>
                                <P>(ii) Any relevant accreditations of the assessor or key personnel conducting the assessment; and</P>
                                <P>(iii) A description of all policies or protocols that governed the conduct of assessor personnel during the assessment or the scope of the assessment.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.206 </SECTNO>
                                <SUBJECT>Customized terms.</SUBJECT>
                                <P>(a) An applicant must propose customized terms for consideration by the agency in setting the terms and conditions of participation.</P>
                                <P>(b) Each such proposed customized term shall include:</P>
                                <P>
                                    (1) Proposed metric(s) and threshold(s) to assist in the agency's 
                                    <PRTPAGE P="4185"/>
                                    evaluation of operation, performance, and safety of the subject vehicles, including an explanation and any context necessary to interpret the metric(s) and threshold(s); and
                                </P>
                                <P>(2) A justification of the value and relevance of the proposed metric(s) and threshold(s).</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.207 </SECTNO>
                                <SUBJECT>Data governance plan.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">In general.</E>
                                     An application must contain a data governance plan that outlines the processes for the integrity, security, and management of data generated by the subject vehicle that are relevant to AV STEP. The plan must include:
                                </P>
                                <P>(1) A top-level accountability and management process for the data governance plan, including a description of the applicable positions and roles;</P>
                                <P>(2) Access control mechanisms to maintain data security and privacy;</P>
                                <P>(3) Processes for maintaining data quality and integrity;</P>
                                <P>(4) Monitoring and enforcement mechanisms for adherence to the plan;</P>
                                <P>(5) Procedures for identifying and responding to incidents that compromise data security or integrity;</P>
                                <P>(6) Risk management strategies for mitigating internal and external data-related risks, including cybersecurity; and</P>
                                <P>(7) A list of any published industry standards, guidance, or best practices with which the plan conforms.</P>
                                <P>(b) [Reserved]</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.208 </SECTNO>
                                <SUBJECT>Confirmation of Reporting During Participation.</SUBJECT>
                                <P>(a) As part of an application, the applicant must confirm that if a request for participation is granted by NHTSA, the applicant is capable of carrying out all of the AV STEP reporting requirements set forth in this part for the program step at which the application requests participation.</P>
                                <P>(b) An application must contain the information detailed in § 597.206(b) for each reporting requirement in this part that is labeled as customized.</P>
                            </SECTION>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart C—AV STEP Exemptions</HD>
                            <SECTION>
                                <SECTNO>§ 597.300 </SECTNO>
                                <SUBJECT>In general.</SUBJECT>
                                <P>(a) An applicant may request the following types of exemptions through AV STEP:</P>
                                <P>(1) An AV STEP FMVSS Exemption; and</P>
                                <P>(2) An AV STEP Make Inoperative Exemption.</P>
                                <P>(b) A subject vehicle's participation in AV STEP is a requirement for an AV STEP exemption of the subject vehicle to remain in effect.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.301 </SECTNO>
                                <SUBJECT>AV STEP FMVSS exemption.</SUBJECT>
                                <P>(a) An applicant for AV STEP participation may request an exemption for a subject vehicle from one or more Federal motor vehicle safety standards issued under part 571 of this chapter or bumper standards issued under part 581 of this chapter.</P>
                                <P>(b) An exemption issued under this section must be for:</P>
                                <P>(i) Research;</P>
                                <P>(ii) Investigations;</P>
                                <P>(iii) Demonstrations;</P>
                                <P>(iv) Training;</P>
                                <P>(v) Competitive racing events; or</P>
                                <P>(vi) Show or Display.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.302 </SECTNO>
                                <SUBJECT>AV STEP Make inoperative exemption.</SUBJECT>
                                <P>An applicant may request an exemption from the “make inoperative” provision in 49 U.S.C. 30122(a).</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.303 </SECTNO>
                                <SUBJECT>Restrictions on exemptions.</SUBJECT>
                                <P>(a) NHTSA may place such terms and conditions as it deems appropriate on AV STEP exemptions issued under this part. NHTSA will review the appropriateness of terms and conditions based on the information and review processes set forth in this part and issue a written Final Determination Letter under § 597.404 at the conclusion of the review.</P>
                                <P>(b) When an AV STEP exemption is granted under this part, a Final Determination Letter issued under § 597.404 will include the following terms regarding the number of subject vehicles receiving an exemption:</P>
                                <P>(1) A list of each vehicle receiving an exemption at the time a Final Determination Letter is issued. This list will designate each vehicle by its vehicle identification number or other unique identifier; and</P>
                                <P>(2) A maximum number of unique vehicles that may be exempted during the participation.</P>
                                <P>(c) The number of vehicles receiving an AV STEP exemption under paragraph (b)(1) of this section may not exceed the maximum number of unique vehicles that may be exempted under paragraph (b)(2) of this section.</P>
                                <P>(d) If the number of vehicles receiving an AV STEP exemption under paragraph (b)(1) of this section has not reached the maximum number of unique vehicles that may be exempted under paragraph (b)(2) of this section, the recipient of the AV STEP exemption may provide notice to NHTSA of an intent to apply the exemption to additional vehicles. Such notice shall:</P>
                                <P>(1) Identify each new vehicle by its vehicle identification number or other unique identifier;</P>
                                <P>(2) Specify the applicable Location Sheet(s) for the new vehicle(s);</P>
                                <P>(3) Include a statement from the applicant that:</P>
                                <P>(i) Compared to already exempted vehicles, the new vehicles are the same make and model, and all equipment is substantially similar; and</P>
                                <P>(ii) Acknowledges that the new vehicles would be subject to all applicable terms and conditions as the already exempted vehicles participating under the same Location Sheet(s).</P>
                                <P>(4) Unless NHTSA provides otherwise, vehicles properly identified in a notice that contains all of the required disclosures and statements in this subsection will automatically receive the applicable AV STEP exemption 30 calendar days after the submission of the notice. In such case, all terms and conditions applicable to already exempted vehicles participating under the same Location Sheet(s) will apply to vehicles that receive an exemption through a notice under this subsection.</P>
                                <P>(e) Any violation of a term or condition on an exemption imposed under this part shall be considered a violation of 49 U.S.C. 30112(a) or 49 U.S.C. 30122(b), as applicable, for which a civil penalty may be imposed. Such a violation may also act to void the authorization for the exemption under the AV STEP Concern Resolution process in § 597.600.</P>
                                <P>(f) The expiration of a vehicle's AV STEP exemption terminates any exemption to the restrictions in chapter 301 of title 49 of the United States Code, including the general prohibitions in 49 U.S.C. 30112(a), except to the extent that a vehicle:</P>
                                <P>(1) Is the subject of other exemptions under 49 CFR chapter V, which remain in place;</P>
                                <P>(2) Receives subsequent exemptions under 49 CFR chapter V; or</P>
                                <P>(3) Was imported into the United States after receiving the AV STEP exemption, in which case all original restrictions on the vehicle in chapter 301 of title 49 of the United States Code continue to apply, except that, unless NHTSA provides otherwise, the vehicle may remain in the United States as long as it does not operate on public streets, roads, and highways and is not otherwise introduced in interstate commerce. </P>
                            </SECTION>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart D—Application Review Process</HD>
                            <SECTION>
                                <SECTNO>§ 597.400 </SECTNO>
                                <SUBJECT>In general.</SUBJECT>
                                <P>
                                    (a) NHTSA will conduct a case-by-case review of each application under the procedures in this subpart and based on the totality of the information available to NHTSA.
                                    <PRTPAGE P="4186"/>
                                </P>
                                <P>(b) Notwithstanding any other procedure described in this subpart, NHTSA may request additional information from an applicant at any time during a review of an application.</P>
                                <P>(c) An applicant may amend or withdraw an application at any time before a Final Determination is issued under § 597.404. The effect of an amendment on the phase of review will depend on the nature and extent of the amended material.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.401 </SECTNO>
                                <SUBJECT>Review Phase 1: Initial Review.</SUBJECT>
                                <P>Phase 1 commences upon NHTSA's receipt of an application. During Phase 1, NHTSA will issue each applicant a notice of receipt, which confirms receipt of the application and identifies a NHTSA point of contact for the review, and will undertake an initial review of all application materials. As part of this review, NHTSA will review the proposed customized terms.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.402 </SECTNO>
                                <SUBJECT>Review Phase 2: Follow-up Review.</SUBJECT>
                                <P>Phase 2 commences upon NHTSA's issuance of a Follow Up Index to each applicant, which identifies items for which NHTSA requests additional information. NHTSA may subsequently request additional information as needed.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.403 </SECTNO>
                                <SUBJECT>Review Phase 3: Preliminary Determination.</SUBJECT>
                                <P>(a) Phase 3 commences upon NHTSA's issuance of a Preliminary Determination to each applicant, which contains NHTSA's proposed decision on an application, including, if applicable, the full set of terms and conditions proposed to govern AV STEP participation.</P>
                                <P>(b) NHTSA will determine terms and conditions, including those associated with proposed customized terms. In determining terms and conditions, NHTSA will:</P>
                                <P>(1) With respect to proposed customized terms, evaluate the extent to which they fulfill the applicable requirement and their anticipated value for overseeing the subject vehicles; and</P>
                                <P>(2) With respect to all terms and conditions, evaluate the extent to which any required reports may further NHTSA's understanding of the subject vehicle's performance, operations, or ADS; the feasibility of analyzing any reported information; and the extent to which the terms and conditions are consistent with motor vehicle safety and further the purposes of 49 U.S.C. 30101.</P>
                                <P>(c) A Preliminary Determination is not a final decision on an application and does not confer approval to participate under its proposed terms.</P>
                                <P>(d) On the tenth business day after issuing a Preliminary Determination, NHTSA will issue a Final Determination under § 597.404, which contains the same decision as proposed in the Preliminary Determination, including any terms and conditions, unless before a Final Determination is issued:</P>
                                <P>(1) NHTSA revokes the Preliminary Determination;</P>
                                <P>(2) An applicant requests, in writing, additional time or changes to the Preliminary Determination, pursuant to paragraphs (d) or (e) of this section;</P>
                                <P>(3) All applicants confirm, in writing, acceptability of the Preliminary Determination, in which case NHTSA may issue a Final Determination as soon as practicable; or</P>
                                <P>(4) The application is withdrawn or amended.</P>
                                <P>(e) Any applicant may request, in writing, additional time before a Preliminary Determination becomes final, stating the reasons for the request. NHTSA shall promptly respond in writing, granting or denying the request, and provide the reason for its decision.</P>
                                <P>(f) Any applicant may request, in writing, changes to the Preliminary Determination. Such a request must be submitted before a Preliminary Determination becomes final, identify each term or condition of the Preliminary Determination for which a change is requested, describe the nature of the requested change; and briefly explain the basis for each requested change.</P>
                                <P>(g) If, under paragraphs (c)(1) or (c)(2) of this section, a Preliminary Determination does not become final, NHTSA will reissue a Preliminary Determination once any remaining issues are addressed. The procedures in this section apply to both an initial Preliminary Determination and any reissued Preliminary Determination.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.404 </SECTNO>
                                <SUBJECT>Final Determination.</SUBJECT>
                                <P>(a) NHTSA may issue a Final Determination Letter at any point more than 60 days after issuance of a Preliminary Determination on the same application, unless an extension for longer than 60 days has been granted under § 597.403(d).</P>
                                <P>(b) A written Final Determination Letter will convey NHTSA's final decision to all applicants. The Final Determination Letter grants or denies a request to participate in AV STEP, including any request for an AV STEP Exemption.</P>
                                <P>(c) A Final Determination Letter granting a request to participate contains the full set of terms and conditions governing participation, including any metrics or reporting thresholds associated with customized terms. These terms and conditions may impose additional participation requirements or limitations beyond those set forth in this part.</P>
                            </SECTION>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart E—Reporting by Participants</HD>
                            <SECTION>
                                <SECTNO>§ 597.500 </SECTNO>
                                <SUBJECT>General reporting requirements.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">In general.</E>
                                     Participants must comply with the reporting requirements of this subpart and any reporting requirement in a term or condition of a Final Determination Letter issued under § 597.404. Unless otherwise provided, a report under this subpart does not satisfy any other reporting requirement and compliance with a reporting requirement outside of this subpart does not satisfy a reporting requirement of this subpart.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Timing.</E>
                                     All reports submitted under this section must be submitted on a quarterly basis, for the duration of participation. Each quarterly report is due on the final business day of the first month that follows the reporting period.
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Reporting requirements for all participants.</E>
                                     All AV STEP participants must report the following information for operations on public roads during each reporting period, segmented by Location Sheet and covering all subject vehicles participating under the Location Sheet during the reporting period:
                                </P>
                                <P>(1) The total number of subject vehicles that operated under the Location Sheet during the reporting period;</P>
                                <P>(2) The vehicle identification number or other unique vehicle identifier of each vehicle reported under paragraph (c)(1) of this section;</P>
                                <P>(3) Each zip code in which a subject vehicle reported under paragraph (c)(1) of this section operated with the ADS engaged on a public road;</P>
                                <P>(4) Aggregate vehicle miles traveled with the ADS engaged, segmented by:</P>
                                <P>(i) Each zip code reported under paragraph (c)(3) of this section;</P>
                                <P>(ii) The hour of the day during which the vehicle miles were traveled; and</P>
                                <P>(iii) The presence of onboard fallback personnel.</P>
                                <P>(5) What percentage the participation numbers in paragraph (c)(4)(i) of this section comprise of each of the three categories of operations in paragraph (c)(4)(ii) of this section.</P>
                                <P>
                                    (i) 
                                    <E T="03">Participation numbers.</E>
                                     (A) The number of subject vehicles participating under the Location Sheet, reported under paragraph (c)(1) of this section; and
                                </P>
                                <P>
                                    (B) The total number of vehicle miles traveled with the ADS engaged on public roads under the Location Sheet.
                                    <PRTPAGE P="4187"/>
                                </P>
                                <P>
                                    (ii) 
                                    <E T="03">Categories of Operations.</E>
                                     Each of the following ADS operations, regardless of AV STEP participation status, if they involve the same combination of vehicle manufacturer, ADS developer, and fleet operator:
                                </P>
                                <P>(A) Operations on public roads in the United States;</P>
                                <P>(B) Operations on public roads in an overlapping geographical area of the Location Sheet; and</P>
                                <P>(C) Operations on public roads in the United States that involve the same vehicle model as the subject vehicle.</P>
                                <P>(6) A description of each vehicle recovery event that occurred for a vehicle reported under paragraph (c)(1) of this section. This description must include:</P>
                                <P>(i) The location of the event;</P>
                                <P>(ii) The duration of the vehicle's immobilization prior to its recovery;</P>
                                <P>(iii) The reason a vehicle recovery was required; and</P>
                                <P>(iv) A cross-reference to any other report under this section associated with the reported recovery.</P>
                                <P>(7) A description of any contact event involving a subject vehicle that does not meet the reporting criteria under § 597.501(b);</P>
                                <P>(8) The total number of instances of rate of change in vehicle acceleration (including deceleration) exceeding a threshold associated with a customized term;</P>
                                <P>(9) The total number of instances of vehicle acceleration or deceleration exceeding a threshold associated with a customized term; and</P>
                                <P>(10) The total number of each of the following types of interruptions to the ADS, if unplanned:</P>
                                <P>(i) Initiation of a maneuver to put the subject vehicle in a minimal risk condition by:</P>
                                <P>(A) The ADS;</P>
                                <P>(B) An occupant of the subject vehicle; or</P>
                                <P>(C) Remote personnel.</P>
                                <P>(ii) DDT takeovers, other than those reported under paragraph (c)(10)(i) of this section;</P>
                                <P>(iii) Instances in which any direct control authority of the vehicle is exercised remotely, other than those reported under paragraphs (c)(10)(i) or (c)(10)(ii) of this section;</P>
                                <P>(iv) Instances in which onboard vehicle assistance alters the ADS' operation;</P>
                                <P>(v) Instances in which remote vehicle assistance alters the ADS' operation; and</P>
                                <P>(vi) Any other occurrence that significantly alters the intended operation of the ADS.</P>
                                <P>
                                    (d) 
                                    <E T="03">Step 1 reporting requirements.</E>
                                     In addition to the requirements in paragraph (c) of this section, participants at Step 1 must report for each reporting period, segmented by Location Sheet and covering all subject vehicles participating under the Location Sheet during the reporting period, safety metric(s) for customized terms, to gauge the performance of fallback personnel.
                                </P>
                                <P>
                                    (e) 
                                    <E T="03">Step 2 reporting requirements.</E>
                                     In addition to the requirements in paragraph (c) of this section, participants at Step 2 must report the following information for each reporting period, segmented by Location Sheet and covering all subject vehicles participating under the Location Sheet during the reporting period:
                                </P>
                                <P>(1) The duration, location, and cause of each minimal risk condition achieved on a public road, and the VIN of the vehicle involved;</P>
                                <P>(2) Performance metrics for customized terms for the following:</P>
                                <P>(i) The safety performance of the ADS, including:</P>
                                <P>(A) Adherence to expected driving behavior; and</P>
                                <P>(B) For scenarios in which there is an increased likelihood of a crash.</P>
                                <P>(ii) The extent to which the system-level performance of the ADS adheres to design assumptions or expectations; and</P>
                                <P>(iii) Adherence to internal safety processes during the subject vehicle's development or operations.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.501 </SECTNO>
                                <SUBJECT>Event-triggered reporting requirements.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">In general.</E>
                                     All AV STEP participants must report events to NHTSA pursuant to the requirements in this section. These reports must be submitted on a rolling basis, as determined based on the time of the event's occurrence.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Crash reporting.</E>
                                     Report each crash that occurs involving a subject vehicle. For this requirement, a crash is any physical impact between a subject vehicle and another road user (such as a vehicle, pedestrian, or cyclist) or property that results or allegedly results in any property damage, injury, or fatality. A subject vehicle is involved in a crash if it physically impacts another road user or if it contributes or is alleged to contribute (by steering, braking, acceleration, or other operational performance) to another vehicle's physical impact with another road user or property involved in that crash. Each report must:
                                </P>
                                <P>(1) Contain the information for a crash report specified in a term of a Final Determination Letter;</P>
                                <P>(2) Identify whether:</P>
                                <P>(i) the ADS was active at any time during the 30 seconds immediately prior to the commencement of the crash through the conclusion of the crash event; or</P>
                                <P>(ii) An attempt was made to engage the ADS or to transfer partial or full control to the ADS, even if the attempt is rejected, aborted, or underway during the 30 seconds immediately prior to the commencement of the crash through the conclusion of the crash event.</P>
                                <P>(3) Be submitted to NHTSA within the following timeframes after any Essential System-Level Stakeholder receives notice of the crash:</P>
                                <P>(i) One calendar day, if the crash results in a fatality or any individual being transported to a hospital for medical treatment, or involves a vulnerable road user;</P>
                                <P>(ii) Five calendar days, if the crash results in a vehicle tow-away or an air bag deployment but does not result in a fatality or any individual being transported to a hospital for medical treatment and does not involve a vulnerable road user; or</P>
                                <P>(iii) For each crash that is not reportable under subsections (b)(3)(i) or (b)(3)(ii) of this section, by the fifteenth calendar day of the month following the calendar month in which notice of the crash was received.</P>
                                <P>
                                    (c) 
                                    <E T="03">Crash video reporting.</E>
                                     For any crash requiring a report within one calendar day under paragraph (b)(3)(i) of this section, an AV STEP participant must also submit all video footage in the possession of any Essential System-Level Stakeholder that depicts any aspect of the crash during the 30 seconds immediately prior to the commencement of the crash through the conclusion of the crash event. Video footage must be submitted within two business days of the date the Essential System-Level Stakeholder obtains possession of the video.
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Crash report updates.</E>
                                     A participant must submit updates to a crash report within the following timeframes:
                                </P>
                                <P>(1) For any report required under paragraph (b)(3)(i) of this section, on the tenth calendar day following the initial report;</P>
                                <P>(2) For any report required under paragraph (b) of this section, on the fifteenth calendar day of the month following any calendar month in which an Essential System-Level Stakeholder receives notice of any material new or materially different information about the crash; and</P>
                                <P>(3) As otherwise requested by NHTSA.</P>
                                <P>
                                    (e) 
                                    <E T="03">Citable offense reporting.</E>
                                     Report known citable offenses involving a subject vehicle. For this requirement, a citable offense includes any ticketed 
                                    <PRTPAGE P="4188"/>
                                    traffic safety violation and non-ticketed traffic safety violations. Each report must be submitted to NHTSA within 5 business days after any Essential System-Level Stakeholder's notice of the incident and identify:
                                </P>
                                <P>(1) The date and location of the offense, and whether the offense was ticketed or non-ticketed;</P>
                                <P>(2) The traffic safety violation in question;</P>
                                <P>(3) The applicable Location Sheet;</P>
                                <P>(4) Whether:</P>
                                <P>(i) The ADS was active at any time during the 30 seconds immediately prior to the commencement of the maneuver that resulted in the citable offense; or</P>
                                <P>(ii) An attempt was made to engage the ADS or to transfer partial or full control to the ADS, even the attempt is rejected, aborted, or underway during the 30 seconds immediately prior to the commencement of the maneuver that resulted in the citable offense.</P>
                                <P>(5) In the case of a Step 2 participant, whether the operation of the subject vehicle involved fallback personnel at the time of the offense.</P>
                                <P>
                                    (f) 
                                    <E T="03">Avoiding duplicative reporting.</E>
                                     A participant required to report an incident pursuant to any other NHTSA requirement outside of this part will be deemed to comply with the reporting requirement for the same incident under this section, provided:
                                </P>
                                <P>(1) The participant timely satisfies the other reporting requirement, including any requirements to update an initial report;</P>
                                <P>(2) The other report covers all of the information required by this section; and</P>
                                <P>(3) Within the timeframe in which an AV STEP crash report would otherwise be required, the participant submits to NHTSA through AV STEP a notice of the other report that:</P>
                                <P>(i) Identifies the report number for the other report; and</P>
                                <P>(ii) Identifies the AV STEP Location Sheet with which the incident is associated.</P>
                                <P>
                                    (g) 
                                    <E T="03">Reporting use of fallback personnel (Step 2).</E>
                                     A Step 2 participant must report changes in the extent to which fallback personnel are used in its operations. This report must:
                                </P>
                                <P>(1) Identify the Location Sheet(s) to which the report applies;</P>
                                <P>(2) Identify the updated percentage of subject vehicles using fallback personnel under the Location Sheet; and</P>
                                <P>(3) Be submitted to NHTSA in writing by the time the change occurs.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.502 </SECTNO>
                                <SUBJECT>Changes to an operation.</SUBJECT>
                                <P>(a) A participant must report to NHTSA any prospective change to its operations that exceeds existing thresholds for customized terms. In proposing new thresholds for such customized terms, an applicant must address the extent to which a prospective change may alter information submitted in an application or reviewed by an independent assessor under § 597.205.</P>
                                <P>(b) A participant's report of a prospective change must:</P>
                                <P>(1) Identify the Location Sheet(s) to which the prospective change would apply;</P>
                                <P>(2) Describe the prospective change;</P>
                                <P>(3) Identify the date on which the change is proposed to occur; and</P>
                                <P>(4) Contain an independent assessor's position regarding whether the prospective change would materially affect a prior independent assessment of the safety case conducted under § 597.205(c)(2).</P>
                                <P>(c) Any proposed change considered material under paragraph (b)(4) of this section may occur only upon written approval from NHTSA. Before determining whether to approve the change, NHTSA may require an updated independent assessment of any aspect of the safety case reviewed in § 597.205(c)(2) that would be materially affected by the proposed change.</P>
                                <P>(d) Prospective changes considered immaterial under paragraph (b)(4) of this section must be reported to NHTSA at least seven calendar days before the change takes effect.</P>
                                <P>(e) In addition to the requirements of this section, a participant must request and receive an amendment under § 597.601 for any change that modifies a term or a condition of a Final Determination Letter.</P>
                            </SECTION>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart F—Procedures During Participation</HD>
                            <SECTION>
                                <SECTNO>§ 597.600 </SECTNO>
                                <SUBJECT>Concern resolution process.</SUBJECT>
                                <P>(a) The procedures in this subpart govern the review of how concerns of potential issues, as defined in paragraphs (b)(3) and (b)(4) of this section, may affect a party's participation in AV STEP. Nothing in this part is intended to limit or otherwise affect NHTSA's authority under chapter 301 of title 49 of the United States Code, including but not limited to the authority to inspect, investigate, or otherwise take enforcement action, as appropriate. In addition, nothing in this subpart is intended to limit or otherwise affect a party's obligations under chapter 301 of title 49 of the United States Code, including but not limited to the requirements for notification and remedy of defects related to motor vehicle safety and noncompliance set forth in subchapter II of chapter 301 of title 49 of the United States Code.</P>
                                <P>(b) NHTSA may modify any term or condition of participation, including suspending or revoking permission to participate in AV STEP, in accordance with the following procedures:</P>
                                <P>(1) NHTSA will undertake a preliminary review of concerns that arise during participation. NHTSA may engage with the participant during this review.</P>
                                <P>(2) If a concern persists following a preliminary review, NHTSA will provide each applicant with a written notice of the concern that:</P>
                                <P>(i) Identifies whether the concern is an Apparent Issue or a Severe Apparent Issue, as described in paragraphs (b)(3) and (b)(4) of this section;</P>
                                <P>(ii) Describes the concern with reasonable particularity; and</P>
                                <P>(iii) Identifies the date on which a change in terms or conditions, including a suspension or revocation, is scheduled to take effect.</P>
                                <P>(3) An Apparent Issue consists of any circumstance that calls into question the safety of an operation, compliance with an AV STEP responsibility, or the reliability of information provided by a participant under AV STEP. The change in terms and conditions will take effect 10 business days after issuance of notice of an Apparent Issue.</P>
                                <P>(4) A Severe Apparent Issue consists of an Apparent Issue where the facts and circumstances signify an elevated concern that undermines confidence in the safety of continued operations or the participant's ability to otherwise comply with AV STEP requirements. NHTSA will determine the appropriate timing for a change in terms or conditions due to a Severe Apparent Issue on a case-by-case basis, including the imposition of a suspension or revocation. If NHTSA deems it appropriate, a change in terms or conditions due to a Severe Apparent Issue may take effect as early as the time of issuance.</P>
                                <P>(5) NHTSA may change terms and conditions imposed under paragraphs (b)(3) or (b)(4) of this section, as appropriate.</P>
                                <P>(6) After a term or condition has been modified under this section, NHTSA will engage with each affected participant to determine the possibility and conditions of a reinstatement. Reinstatements will be considered on a case-by-case basis depending on the nature of the concern and the appropriateness and effectiveness of any mitigation of the concern.</P>
                            </SECTION>
                            <SECTION>
                                <PRTPAGE P="4189"/>
                                <SECTNO>§ 597.601 </SECTNO>
                                <SUBJECT>Amendment process.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">In general.</E>
                                     Terms and condition in a Final Determination Letter may be changed only by issuance of an Amended Final Determination Letter.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Amendment of Final Determination Letter by NHTSA.</E>
                                     NHTSA may modify any term or condition of a Final Determination Letter at any time upon the agreement of all participants or pursuant to the amendment or concern resolution processes set forth in this part.
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Participant request to amend a Final Determination Letter.</E>
                                     A participant may submit a written request to NHTSA to amend a Final Determination Letter, which must include:
                                </P>
                                <P>(1) A description of each requested amendment;</P>
                                <P>(2) A description of each prospective change to system design, processes, or operations that relates to the requested amendment;</P>
                                <P>(3) An updated response to each application requirement in subpart B of this part that would be affected by the prospective change(s), apart from § 597.205; and</P>
                                <P>(d) NHTSA will review each request from a participant to amend a Final Determination Letter on a case-by-case basis.</P>
                                <P>
                                    (e) 
                                    <E T="03">Changes requiring a new application.</E>
                                     The following changes require a new application to participate in AV STEP, rather than an amendment request to an existing approval to participate:
                                </P>
                                <P>(1) Any change to program step;</P>
                                <P>(2) The removal, replacement, or addition of an Essential System-Level Stakeholder; or</P>
                                <P>(3) For participants with an AV STEP Exemption, a change to any of the following Vehicle Exemption Information required under § 597.202:</P>
                                <P>(i) The type of exemption requested under § 597.202(a)(1);</P>
                                <P>(ii) The subject vehicle for which an exemption is requested, other than as provided under § 597.303(d);</P>
                                <P>(iii) For an AV STEP FMVSS Exemption, each requirement of an FMVSS or bumper standard for which an exemption is requested under § 597.202(b)(1);</P>
                                <P>(iv) For an AV STEP Make Inoperative Exemption, the device or element requested to be rendered inoperative under § 597.202(c))(1); or</P>
                                <P>(v) For an AV STEP Make Inoperative Exemption, each requirement of an FMVSS affected by the requested modification under § 597.202(c)(2).</P>
                                <P>
                                    (f) 
                                    <E T="03">Changes not requiring an amendment.</E>
                                     No amendment is needed for the following changes:
                                </P>
                                <P>(1) Changes to the primary and secondary contact information field of the Operational Baseline Definition required under § 597.201. A participant may change this information at any time by providing written notice to NHTSA;</P>
                                <P>(2) Changes to an existing Location Sheet required under § 597.203, as long as the changes:</P>
                                <P>(i) Are submitted to NHTSA through an updated Location Sheet before the change takes effect; and</P>
                                <P>(ii) Are limited to the Location Limitation of § 597.203(b).</P>
                                <P>(3) The addition of a new Location Sheet required under § 597.203, as long as:</P>
                                <P>(i) The new Location Sheet is submitted to NHTSA before operations under the new Location Sheet commence;</P>
                                <P>(ii) The new Location Sheet does not require a report under § 597.502; and</P>
                                <P>(iii) All of the following fields under § 597.203 for the new Location Sheet are the same as those in an existing Location Sheet for the participation:</P>
                                <P>(A) Maximum number of vehicles requested;</P>
                                <P>(B) Public ridership;</P>
                                <P>(C) Intended use;</P>
                                <P>(D) Operational design domain elements other than location; and</P>
                                <P>(E) Vehicle equipment. </P>
                            </SECTION>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart G—Public Reporting Requirements</HD>
                            <SECTION>
                                <SECTNO>§ 597.700 </SECTNO>
                                <SUBJECT>In general.</SUBJECT>
                                <P>(a) The public availability of the information described in this subpart is a condition of participation in AV STEP. NHTSA will publish the information described in this subpart for each application and participation and update it on an ongoing basis.</P>
                                <P>(b) The information published pursuant to this subpart reflects the information as reported to NHTSA by an applicant or participant.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 597.701 </SECTNO>
                                <SUBJECT>Information for Publication.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Application Information.</E>
                                     NHTSA will publish:
                                </P>
                                <P>(1) The following information regarding each application:</P>
                                <P>(i) The date an application was received;</P>
                                <P>(ii) The status of the application, including the phase and history of the Application Review Process as described in subpart D of this part;</P>
                                <P>(iii) Whether the application requests an AV STEP exemption and, if so:</P>
                                <P>(A) The type of exemption requested;</P>
                                <P>(B) Each requirement of an FMVSS or bumper standard affected by the exemption;</P>
                                <P>(C) A summary of risk mitigations, as required under  § 597.202(a)(9); and</P>
                                <P>(D) For an FMVSS Exemption, the purpose requested for the exemption.</P>
                                <P>(iv) After review of an application concludes, the Final Determination Letter.</P>
                                <P>(2) The following information from the Operational Baseline section of an application, as required by § 597.201:</P>
                                <P>(i) The name of each applicant;</P>
                                <P>(ii) The name of each Essential System-Level Stakeholder;</P>
                                <P>(iii) The subject vehicle make, model, and model year;</P>
                                <P>(iv) Unloaded vehicle weight;</P>
                                <P>(v) Gross Vehicle Weight Rating;</P>
                                <P>(vi) Claimed vehicle class;</P>
                                <P>(vii) FMVSS certifying entity, if applicable;</P>
                                <P>(viii) Whether an application includes the use of onboard fallback personnel and the number of such personnel per subject vehicle;</P>
                                <P>(ix) Whether an application includes the use of remote driving and, if so, a summary of limitations in place on the use of remote driving, as required under § 597.201(h)(3);</P>
                                <P>(x) Whether an application includes the use of any remote fallback personnel who will not utilize remote driving; and</P>
                                <P>(xi) Whether an application includes use of any remote or onboard vehicle assistance.</P>
                                <P>(xii) Whether the subject vehicle(s) contain any features or design modifications that are intended to promote the safe accommodation of passengers with disabilities and, if so, a summary of the features or design modifications.</P>
                                <P>(3) The application's response to each of the following fields in each Location Sheet section of an application, as required by § 597.203:</P>
                                <P>(i) Location Name;</P>
                                <P>(ii) Location Limitation;</P>
                                <P>(iii) Maximum Number of Vehicles Requested;</P>
                                <P>(iv) Legal Speed Limits;</P>
                                <P>(v) Vehicle Speeds;</P>
                                <P>(vi) Public Ridership;</P>
                                <P>(vii) Intended Use; and</P>
                                <P>(viii) A summary of the operational design domain requested in an application.</P>
                                <P>(4) A list of each standard, best practice, or guidance with which an independent assessment has determined full conformance in response to the requirements in § 597.205.</P>
                                <P>
                                    (b) 
                                    <E T="03">Participation Information.</E>
                                     NHTSA will publish:
                                </P>
                                <P>(1) The following information regarding the status of each participation:</P>
                                <P>(i) The date participation commenced;</P>
                                <P>
                                    (ii) The current status of each Location Sheet in the participation, indicating whether subject vehicle operations are:
                                    <PRTPAGE P="4190"/>
                                </P>
                                <P>
                                    (A) 
                                    <E T="03">Active.</E>
                                     This status applies if any vehicle miles traveled were reported during the preceding reporting period under § 597.500(c)(5) of this part;
                                </P>
                                <P>
                                    (B) 
                                    <E T="03">Inactive.</E>
                                     This status applies if no vehicle miles traveled were reported during the preceding reporting period under § 597.500(c)(5) of this part or if a participant has otherwise notified NHTSA of a temporary stoppage of operations;
                                </P>
                                <P>
                                    (C) 
                                    <E T="03">Suspended.</E>
                                     This status applies if any subject vehicles are subject to a suspension under § 597.600 of this part; or
                                </P>
                                <P>
                                    (D) 
                                    <E T="03">Concluded.</E>
                                     This status applies if the term limit for participation has expired or if all participants have otherwise notified NHTSA of the conclusion of the operations.
                                </P>
                                <P>(iii) The date participation is scheduled to conclude or concluded, as applicable; and</P>
                                <P>(iv) Any Amended Final Determination Letter, if applicable.</P>
                                <P>(2) The following information from responses to the reporting requirements in § 597.500:</P>
                                <P>(i) The number of subject vehicles operated on public roads during the reporting period for each Location Sheet;</P>
                                <P>(ii) A list of zip codes in which subject vehicles operated on public roads during the reporting period; and</P>
                                <P>(iii) The number and location of vehicle recovery events reported during the reporting period.</P>
                            </SECTION>
                        </SUBPART>
                        <SIG>
                            <DATED>Issued in Washington, DC, on December 19, 2024, under authority delegated in 49 CFR 1.95 and part 501.</DATED>
                            <NAME>Adam Raviv,</NAME>
                            <TITLE>Chief Counsel.</TITLE>
                        </SIG>
                    </PART>
                </SUPLINF>
                <FRDOC>[FR Doc. 2024-30854 Filed 1-14-25; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 4910-59-P</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4191"/>
            <PARTNO>Part IV</PARTNO>
            <AGENCY TYPE="P">Department of Labor</AGENCY>
            <SUBAGY> Employee Benefits Security Administration</SUBAGY>
            <HRULE/>
            <CFR>29 CFR Parts 2560 and 2570</CFR>
            <TITLE>Voluntary Fiduciary Correction Program; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="4192"/>
                    <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                    <SUBAGY>Employee Benefits Security Administration</SUBAGY>
                    <CFR>29 CFR Parts 2560 and 2570</CFR>
                    <RIN>RIN 1210-AB64</RIN>
                    <SUBJECT>Voluntary Fiduciary Correction Program</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Employee Benefits Security Administration, Department of Labor.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Notification of adoption of Updated Voluntary Fiduciary Correction Program.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This document contains an amended and restated Voluntary Fiduciary Correction Program (VFC Program or Program) under title I of the Employee Retirement Income Security Act of 1974, as amended (ERISA). The VFC Program is designed to encourage correction of fiduciary breaches and compliance with the law by permitting persons to avoid potential Department of Labor civil enforcement actions and civil penalties if they voluntarily correct eligible transactions in a manner that meets the requirements of the Program. The amendments to the Program simplify and expand the VFC Program to make the Program easier to use and more useful for employers and others who wish to avail themselves of the relief provided. Specifically, the Program amendments add a self-correction feature for delinquent transmittal of participant contributions and loan repayments to a pension plan under certain circumstances; clarify some existing transactions eligible for correction under the Program; expand the scope of other transactions currently eligible for correction; and simplify certain administrative or procedural requirements for participation in and correction of transactions under the VFC Program. In addition, the amendments implement section 305(b)(2) and (3) of the SECURE 2.0 Act of 2022 (SECURE 2.0 Act) by adding a self-correction feature for certain participant loan failures self-corrected under the Internal Revenue Service's Employee Plans Compliance Resolution System (as described in Rev. Proc. 2021-30, or any successor guidance) (IRS's EPCRS).</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>The amendments to the VFC Program contained in this document are effective on March 17, 2025.</P>
                    </EFFDATE>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>Brian J. Buyniski or Yolanda Wartenberg, Office of Regulations and Interpretations, Employee Benefits Security Administration (EBSA), (202) 693-8500, for questions regarding the VFC Program amendments in this document. Emily Harris, Office of Exemption Determinations, EBSA, (202) 693-8540, for questions regarding the amended associated class exemption PTE 2002-51. James Butikofer, Office of Research and Analysis, EBSA, (202) 693-8410, for questions regarding the regulatory impact analysis. (These are not toll-free numbers.)</P>
                        <P>
                            <E T="03">For general questions regarding the VFC Program:</E>
                             contact Dawn Miatech-Plaska, Office of Enforcement, EBSA, (202) 693-8691. For questions regarding specific applications and self-corrections under the VFC Program: contact the appropriate EBSA Regional Office listed in appendix C. (These are not toll-free numbers.)
                        </P>
                        <P>
                            <E T="03">Customer Service Information:</E>
                             Individuals interested in obtaining information from the Department concerning ERISA and employee benefit plans may call the EBSA Toll-Free Hotline, at 1-866-444-EBSA (3272) or visit the Department's website (
                            <E T="03">www.dol.gov/ebsa</E>
                            ).
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P/>
                    <HD SOURCE="HD1">A. Summary Overview</HD>
                    <P>
                        The Voluntary Fiduciary Correction Program (VFC Program or Program) gives plans and fiduciaries a ready means to correct violations of ERISA, without the transaction costs and burden associated with enforcement actions for violations of the fiduciary standards in title I of ERISA), 29 U.S.C. 1132(a)(2) and 1132(a)(5). As an enforcement policy, the Program simultaneously promotes compliance with the law, correction of violations, and the efficient use of scarce enforcement resources. The Department also has the authority under section 408(a) of ERISA (29 U.S.C. 1108) to issue exemptions from the prohibited transaction rules in sections 406 and 407 of ERISA (29 U.S.C. 1106 and 1107) and in section 4975 of the Internal Revenue Code (Code).
                        <SU>1</SU>
                        <FTREF/>
                         Accordingly, in tandem with this amendment to the Program and in this same issue of the 
                        <E T="04">Federal Register</E>
                        , the Department has also published associated amendments to Prohibited Transaction Exemption (PTE) 2002-51, which implements important components of the VFC Program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Under Reorganization Plan No. 4 of 1978, 5 U.S.C. App., the authority of the Secretary of Treasury to issue exemptions pursuant to Code section 4975 was transferred, with certain exceptions not relevant here, to the Secretary of Labor.
                        </P>
                    </FTNT>
                    <P>
                        The EBSA adopted the VFC Program in 2002, and later revised it in 2005 and 2006.
                        <SU>2</SU>
                        <FTREF/>
                         EBSA designed the VFC Program to encourage employers and plan fiduciaries to voluntarily comply with ERISA and allow those potentially liable for certain specified fiduciary breaches under ERISA to voluntarily apply for relief from civil enforcement actions and certain civil penalties, provided they meet the Program's criteria and follow the procedures outlined in the Program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             67 FR 15062 (March 28, 2002), 70 FR 17516 (April 6, 2005), 71 FR 20262 (April 19, 2006).
                        </P>
                    </FTNT>
                    <P>Although the Department is not required to seek public comments on changes to an enforcement policy, in November 2022, EBSA published proposed revisions to the VFC Program with a request for public comments. The Department also proposed amendments to PTE 2002-51 for coordination. Additionally, because the VFC Program includes information collections that are subject to the Paperwork Reduction Act, the Department sought public comment in the November 2022 proposal on the revisions to the information collections included in the amendments to the VFC Program. The proposal discussed the revisions and incorporated them into a restatement of the VFC Program in its entirety for ease of reference. Comments received on the 2022 VFC Program proposed revisions and the proposed amendments to the related class exemption are posted on EBSA's website.</P>
                    <P>
                        After careful consideration of the issues raised in the comment letters, EBSA decided to adopt final changes to the Program as discussed herein. In tandem with this publication of the 2025 VFC Program, EBSA is publishing final amendments to PTE 2002-51 to conform with certain revisions in the 2025 VFC Program. For a discussion of the amendments to the class exemption and the public comments to those changes, see amended PTE 2002-51, which is also published elsewhere in this issue of the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                    <P>
                        With these amendments, EBSA intends to facilitate more efficient and less costly corrections of fiduciary breaches under the Program, encourage greater participation in the Program, and respond to requests from stakeholders for adjustments based on their experiences using the Program. In this regard, the amendments are designed to simplify the Program and make it easier to use by employers and others who wish to avail themselves of the relief provided. Notably, the new self-correction procedures will apply to the transaction most frequently corrected under the Program—the delinquent transmittal of participant contributions 
                        <PRTPAGE P="4193"/>
                        and loan repayments to pension plans—as well as to certain participant loan failures self-corrected under IRS's EPCRS. The amendments also clarify language and simplify certain administrative and procedural requirements for participation in and correction of transactions under the Program. This includes revisions to eligibility criteria that allow the submission of applications covering multiple plans by a single service provider under certain circumstances (
                        <E T="03">i.e.,</E>
                         bulk applicants), as well as additional flexibility in the corrections methods for several violations. The Department anticipates that many users of the Program, as amended, will find it improved and less resource intensive, without sacrificing protections of the affected plans.
                    </P>
                    <P>The following section of this document is an overview of the 2025 VFC Program and the Department's response to issues raised in the public comments. This document includes a restatement of the Program in its entirety to facilitate reference to and future use of the Program as amended.</P>
                    <HD SOURCE="HD1">B. Overview of Changes in the 2025 VFC Program</HD>
                    <P>
                        The 2025 VFC Program retains the fundamentals of the 2006 VFC Program. The Program describes how to apply for relief, lists the specific transactions covered,
                        <SU>3</SU>
                        <FTREF/>
                         and sets forth acceptable methods for correcting fiduciary breaches under the Program. It also provides examples of potential breaches and related permissible corrective actions. The Program defines the term “Breach” to mean any transaction that is or may be a violation of the fiduciary responsibilities contained in part 4 of title I of ERISA. The Program also provides a model application form, a checklist, and an online calculator for determining correction amounts. The VFC Program will continue to be administered in EBSA Regional Offices. Eligible applicants that satisfy the terms and conditions of the VFC Program application process receive a “no action” letter from EBSA and are not subject to civil monetary penalties for the corrected transactions. Excise tax relief for six specific VFC Program transactions is conditionally available under the amended associated class exemption, PTE 2002-51.
                        <SU>4</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             EBSA acknowledges that it has experience with certain transactions fitting within one or more of the listed categories of transactions, even if not specifically named in the category, for example certain transactions involving contributions in kind under section 7.4(a) of the Program. EBSA encourages potential applicants to discuss eligibility and similar issues with the appropriate regional VFC Program coordinator.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             Stakeholders interested in a discussion of the components of the VFC Program that are not being revised in this document should review the 
                            <E T="04">Federal Register</E>
                             notices announcing the original 2002 Program and the 2005 and 2006 updates, as well as the 2022 proposed revisions to the Program. 
                            <E T="03">See</E>
                             67 FR 15062 (March 28, 2002), 70 FR 17516 (April 6, 2005), 71 FR 20262 (April 19, 2006), and 87 FR 71164 (Nov. 21, 2022). For PTE 2002-51, 
                            <E T="03">see</E>
                             67 FR 70623 (2002); 71 FR 20135 (2006), and 87 FR 70753 (Nov. 21, 2022). Prior to adoption in March 2002, the VFC Program was made available on an interim basis during which the Department invited and considered public comments on the Program. 
                            <E T="03">See</E>
                             65 FR 14164 (March 15, 2000).
                        </P>
                    </FTNT>
                    <P>
                        The most significant changes to the VFC Program involve the addition of two new self-correction features. The first is in section 7.1(b) for certain failures to timely transmit participant contributions (and participant loan repayments) to pension plans,
                        <SU>5</SU>
                        <FTREF/>
                         and the second is in section 7.3(c) for certain participant loan failures self-corrected under IRS's EPCRS. The other Program amendments in this document: (1) clarify existing transactions eligible for correction under the Program; (2) expand the scope of certain transactions currently eligible for correction; and (3) simplify certain administrative or procedural requirements for participation in the VFC Program and correction of transactions under the Program. A more detailed summary of the Program revisions is set forth below in this preamble.
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             The term pension plans include both defined contribution plans and defined benefit plans. 
                            <E T="03">See</E>
                             ERISA section 3(34) and 3(35).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">1. Self-Correction Component for Delinquent Participant Contributions to Pension Plans—Section 7.1(b)</HD>
                    <P>The 2025 VFC Program includes a new self-correction component (SCC) for failures to timely transmit participant contributions (and participant loan repayments) to pension plans in specified circumstances. The new SCC adds a more streamlined correction mechanism than is currently available under section 7.1(a) for instances in which employers have retained participant contributions or loan repayments beyond the time contemplated by the Department's regulations at 29 CFR 2510.3-102.</P>
                    <P>This transaction, referred to as “delinquent participant contributions,” is the type of transaction most frequently corrected under the Program. The Department received input from stakeholders who said the time and expense required to file a VFC Program application with the Department is a disincentive to use the Program to correct delinquent participant contribution transactions, especially when they involve small dollar amounts. Many of the comment letters submitted on the 2022 VFC Program proposed revisions expressed support for the self-correction feature, pointing out that it will promote voluntary, timely, and efficient correction of errors; increase compliance; eliminate unnecessary administrative requirements and costs; free up EBSA resources; and help ensure participants' retirement savings are secure. One commenter expressed concern, however, that the elimination of notices or official approvals in the final Program could open the Program to abuse and create an impression that no one is monitoring the system.</P>
                    <P>
                        After carefully considering the public comments, the Department agrees that a streamlined self-correction feature for delinquent participant contributions to pension plans with appropriately designed safeguards will encourage more voluntary corrections by employers and other persons who are in a position to correct a Breach (Plan Officials). It will also enable EBSA to better allocate resources currently dedicated to processing VFC Program applications for these transactions. Accordingly, the 2025 VFC Program adds the SCC as the correction method for the list of eligible transactions in section 7.1(b) entitled “Delinquent Participant Contributions and Loan Repayments to Pension Plans under the Self-Correction Component.” 
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             To reflect the inclusion of the SCC into the Program, section 6 has been renamed “VFC Program Application and Self-Correction Component Procedures” and the prior section 6 has been renamed and re-designated as section 6.1 “VFC Program Application Procedures.”
                        </P>
                    </FTNT>
                    <P>
                        Under the final amendments, relief under the SCC for delinquent participant contributions and delinquent plan loan repayments is available in connection with any pension plan regardless of the size of the plan's participant population or amount of plan assets, so long as the applicant is eligible to use the Program and meets the conditions discussed below. While self-correctors that satisfy the terms and conditions of the VFC Program do not receive a no-action letter from EBSA, the SCC provides that compliance with the Program's terms and conditions will avoid the imposition of civil monetary penalties or an EBSA civil enforcement action against the SCC participant. As with any application under the Program, however, and in accordance with section 2(b) “Verification,” EBSA reserves the right to conduct an investigation with respect to the transaction corrected through the SCC, 
                        <PRTPAGE P="4194"/>
                        to determine the truthfulness and completeness of the factual statements set forth in the SCC notice and to confirm the corrective action was in fact taken.
                    </P>
                    <HD SOURCE="HD3">(a) Self-Correction Component $1,000 Lost Earnings Amount Limit—Section 7(b)(1)(ii)(A)</HD>
                    <P>
                        Eligibility to use the SCC in section 7.1(b) is conditioned on the amount of Lost Earnings 
                        <SU>7</SU>
                        <FTREF/>
                         on the delinquent participant contributions or loan repayments being $1,000 or less (excluding any excise tax amounts paid to the plan under the related class exemption PTE 2002-51).
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             Section 5(b)(6) defines “Lost Earnings” as an approximate amount that would have been earned by the plan on the Principal Amount, but for the Breach, and sets forth methodology for calculating Lost Earnings for purposes of the SCC.
                        </P>
                    </FTNT>
                    <P>Several commenters recommended eliminating, increasing, or changing the Lost Earnings $1,000 cap. Some of these commenters expressed the view that it would be desirable from a standpoint of cost and efficiency to allow broader availability, while other commenters asserted the cap would restrict large and mid-size plan sponsors from participating and could result in others bifurcating the correction to skirt the limit. Several commenters observed that using the cap on Lost Earnings as determined by the online calculator, which utilizes the Code section 6621(a)(2) underpayment rates, will result in fluctuations leading to inconsistency and confusion with respect to SCC eligibility.</P>
                    <P>
                        A variety of options were recommended by commenters, including increasing the Lost Earnings to $2,500 or $10,000; addition of a cost-of-living adjustment; adopting a cap that varies based on the amount of plan assets or number of participants; and eliminating the cap altogether. Commenters further recommended the Program allow the use of plan's forfeiture accounts to pay for Lost Earnings, arguing that such use would be consistent with the IRS's EPCRS, which allows a plan sponsor to use plan forfeitures to fund corrective allocations in certain circumstances. Another commenter suggested that the Program include a 
                        <E T="03">de minimis</E>
                         provision under which Lost Earnings would not have to be calculated and included in corrective payments. Alternatively, the commenter suggested that the Department should allow 
                        <E T="03">de minimis</E>
                         Lost Earnings amounts to be paid from the plan's forfeiture account.
                    </P>
                    <P>
                        After consideration of the comments, the Department has determined to finalize the $1,000 Lost Earnings cap as proposed. The Department believes that a substantial majority of delinquencies will be eligible for correction under the SCC even with the $1,000 Lost Earnings cap.
                        <SU>8</SU>
                        <FTREF/>
                         However, as noted in the 2022 VFC Program proposed revisions, the $1,000 Lost Earnings cap along with the 180-day remittance deadline (discussed below) are intended to exclude delinquencies from the SCC when the amount or length of delinquency suggest a need for EBSA to actively evaluate the circumstances surrounding the breach and the timing of the correction under the VFC Program application process. The Department believes it is appropriate to retain these protective parameters as it proceeds with a new element of the VFC Program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             The 2022 VFC Program proposed revisions estimated that the SCC would streamline the process for 74% of small and large VFC Program applicants involving Lost Earnings less than or equal to $1,000.
                        </P>
                    </FTNT>
                    <P>With respect to the suggestion that the Lost Earnings calculation be based on the amount of plan assets or number of participants, EBSA believes that the Lost Earnings cap should continue to be a fixed figure. The VFC Program, and especially the SCC, is designed to provide simplicity and uniformity with an approach that eliminates complicated requirements for computation. A variable cap based on the total amount of plan assets or the total number of participants, by contrast, would complicate eligibility determinations and the Department's oversight of those determinations, undermining the goal of simplicity.</P>
                    <P>
                        Regarding the use of forfeitures to pay for Lost Earnings, from its inception in 2000, the Program has required that the cost of correction not be paid from plan assets. Lost Earnings is part of the correction amount which is described in section 5(b) as a combination of the Principal Amount involved in the transaction, Lost Earnings, and any interest on the Lost Earnings. It was further clarified in section 5(c) of the 2022 VFC Program proposed revisions that the cost of correction cannot be paid from plan assets, including charges against participant accounts or plan forfeitures accounts.
                        <SU>9</SU>
                        <FTREF/>
                         This is still the right approach. It would defeat ERISA's remedial purposes, and undermine enforcement of the law's protections, to permit employers and fiduciaries to shift the cost of the correction to the plan itself, thereby causing new injury to the plan. Thus, this requirement and the clarification regarding forfeitures will continue to be part of the VFC Program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             87 FR 71164, 71181 (November 21, 2022).
                        </P>
                    </FTNT>
                    <P>
                        Several commenters seeking clarification of the timeframe to calculate the Lost Earnings cap asked whether each pay period is viewed as a separate transaction. Generally, the Department has considered each pay period as a separate transaction; however, the Department has permitted more than one pay period to be treated as one transaction under the VFC Program if the pay periods are close together in time and the delinquencies are related to the same cause.
                        <SU>10</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             For a discussion on whether each pay period can be viewed as a separate transaction, refer to the associated class exemption, PTE 2002-51 and the Voluntary Fiduciary Correction Program Class Exemption FAQs which can be found in EBSA's website at 
                            <E T="03">https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/vfcp-class-exemption-faqs.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(b) Self-Correction Component 180-Day Contribution Remittance Deadline—Section 7(b)(1)(ii)(B)</HD>
                    <P>To be eligible for the SCC in section 7.1(b), the delinquent participant contributions or loan repayments must have been remitted to the plan within 180 calendar days from the date of withholding from participants' paychecks or receipt by the employer.</P>
                    <P>
                        Several commenters argued that a 180-calendar day contribution remittance deadline was too restrictive and suggested extending it to either 120 days following the end of the plan year or until the due date of the Annual Return/Report of Employee Benefit Plans (Form 5500 or Form 5500-SF, as applicable). As noted above, the preamble to the 2022 VFC Program proposed revisions states that the 180-day remittance deadline is designed to exclude delinquencies that suggest the need for EBSA to actively evaluate the circumstances surrounding the breach and the timing of the correction. The Department continues to believe that a failure to identify a delinquency and remit contributions or loan payments due to the plan within 180 days indicates a potentially serious problem with the plan's processes and procedures for handling participant contributions and loan payments. It would not be consistent with prudent fiduciary administration of a plan to wait until the end of the plan year, the completion of the annual audit of the plan for annual reporting purposes, or the due date of the Form 5500 or Form 5500-SF to check for timely transmission of participant contributions and loan repayments. The Department also does not believe it would be appropriate to structure the VFC Program in a way that suggests that it is consistent with ERISA's fiduciary 
                        <PRTPAGE P="4195"/>
                        duties to wait until the end of the year, the annual audit, or the filing of the plan's annual report to check for delinquent transmittal of contributions and loan repayments. Accordingly, EBSA has decided to retain this requirement, which has also been part of the class exemption since its inception in 2002, and which is intended to provide protection to participants and beneficiaries especially in situations outside of the full VFC Program application process.
                    </P>
                    <HD SOURCE="HD3">(c) Requirements for the Self-Correction Component—Sections 5(b)(3)(ii), 7.1(b)(2)(i)</HD>
                    <P>As with the current VFC Program application-based procedure for delinquent participant contribution transactions in section 7.1(a), correction amounts under the SCC consist of the (1) Principal Amount and (2) Lost Earnings, with the Principal Amount being the amount of participant contributions or loan repayments that would have been contributed to the plan if the employer had not retained such amounts and the Lost Earnings being the amount of earnings that would have been earned on the Principal Amount but for the failure to timely remit such amounts to the plan.</P>
                    <P>
                        The SCC requires that Lost Earnings be paid from the “Date of Withholding or Receipt,” and mandates the use of the online calculator to determine the amount of the loss payable to the plan. The term “Date of Withholding or Receipt” means the date the amount would otherwise have been payable to the participant in cash in the case of amounts withheld by an employer from a participant's wages, or the date on which the participant contribution or loan payment is received by the employer in the case of amounts that a participant or beneficiary pays to an employer. The calculation of Lost Earnings from the Date of Withholding or Receipt is a special rule for purposes of the SCC and differs from the calculation of Lost Earnings under the full VFC Program application process, which begins on the earliest date on which the participant contributions or loan repayments could reasonably have been segregated from the employer's general assets (
                        <E T="03">i.e.,</E>
                         the date on which the contributions become plan assets under the Department's regulation at 29 CFR 2510.3-102). Use of the earlier date and the use of the online calculator are important elements of the SCC that are intended to help ensure full correction without the need for the protections afforded by the Program's otherwise applicable application and Department approval process. These elements also will provide self-correctors with certainty that the calculation of Lost Earnings will meet the requirements of the SCC.
                    </P>
                    <HD SOURCE="HD3">(d) Self-Correction Component Notice Requirement—Section 7.1(b)(2)(iii)</HD>
                    <P>Section 7.1(b)(2)(iii) of the SCC sets forth a requirement for an electronically filed notice (SCC notice) in place of the generally applicable paper application requirements in section 7.1(a)(3) of the Program. The required data elements in the SCC notice include: the name and an email address for the self-corrector; the plan name; the plan sponsor's nine-digit employer identification number (EIN) and the plan's three-digit number (PN); the Principal Amount; the amount of Lost Earnings and the date paid to the plan; the Loss Date (for purposes of the SCC, the Date(s) of Withholding or Receipt); and the number of participants affected by the correction. The SCC notice must be submitted electronically to EBSA using a new online VFC Program web tool located on EBSA's website. Self-correctors using the web tool will receive an automatic EBSA email acknowledging the SCC notice submission.</P>
                    <P>Several commenters asserted that the SCC notice requirement would discourage plan sponsors from using the SCC, although one commenter acknowledged it would not appear to impose a significant burden. Commenters also stated that the SCC notice was unnecessary because delinquent contributions and delinquent loan repayments are already reported on the Form 5500. Another commenter observed that self-correction under the IRS's EPCRS does not require notice to the Internal Revenue Service (IRS), while another commenter proposed a minimum dollar threshold before there would be a requirement for the completion of the SCC notice. However, as discussed above, another commenter expressed concern that any elimination of notices or official approvals can leave open doors for abuse and create the impression that no one is monitoring the system.</P>
                    <P>
                        As noted in the preamble to the 2022 VFC Program proposed revisions, EBSA has been reluctant to adopt overbroad self-correction features because of the danger that it would have insufficient information regarding the breach and correction for which it is providing no-action relief. The decision to adopt the SCC is premised, however, on a conclusion that a well-designed self-correction feature can result in the Department receiving sufficient timely information to meet oversight objectives and ensuring appropriate corrections while also encouraging more Plan Officials to utilize the Program. In the Department's view, a well-designed program requires parties to file the basic data that is necessary for the Department to ensure adequate corrections, and appropriate oversight and accountability for fiduciary violations. Further, although EBSA supports appropriate harmonization of VFC Program provisions with the IRS's EPCRS when dealing with corrections of the same transaction, the Department does not believe that the SCC needs to match the requirements under the Self-Correction Program (SCP) of the IRS's EPCRS in every respect.
                        <SU>11</SU>
                        <FTREF/>
                         In addition, EBSA does not believe reporting delinquencies and corrections on the Form 5500 or Form 5500-SF is an adequate alternative to the SCC notice. The SCC notice is intended to provide a relatively contemporaneous report of the delinquency being corrected. Reporting delinquencies and corrections on the Form 5500 or Form 5500-SF may not happen until many months after the delinquency has been corrected. For example, a delinquency that occurs in January of a calendar year plan would not be reported until the end of July or, with a generally available extension, until the middle of October of the following year. EBSA, accordingly, has decided to retain the SCC notice and electronic filing requirements as proposed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             Unlike the IRS program, the SCC includes PTE 2002-51, which provides an exemption from the prohibited transaction excise tax for certain transactions identified in the VFC Program.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(e) Self-Correction Component “Retention Record Checklist”—Penalty of Perjury Statement—Sections 6.2(d), 6.2(e) and 7.1(b)</HD>
                    <P>
                        Self-correctors under the SCC in section 7.1(b) must prepare or collect the documents listed in the SCC Retention Record Checklist, printed below in appendix F, and provide the completed checklist and required documentation to the plan administrator as required under sections 6.2(d) and 7.1(b)(3). Also, to participate in the SCC, a plan fiduciary with knowledge of the transaction that is being self-corrected and each Plan Official seeking relief under the program must sign a penalty of perjury statement as follows: “Under penalties of perjury I certify that I am not Under Investigation (as defined in section 3(b)(3) of the VFC Program) and that I have reviewed the SCC notice acknowledgment and summary, the checklist, and all the required documentation, and to the best of my knowledge and belief the contents are 
                        <PRTPAGE P="4196"/>
                        true, correct, and complete.” The penalty of perjury statement also appears in Appendix F.
                        <SU>12</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             As discussed below, the Department made a change in this 2025 VFC Program to permit an employer in a multiemployer plan or multiple employer plan who wishes to correct on its own behalf to sign the application or SCC penalty of perjury statement and, regardless of the employer's status as a plan fiduciary, the penalty of perjury statement need not be signed by another plan fiduciary. 
                            <E T="03">See</E>
                             sections 6.1 and 6.2.
                        </P>
                    </FTNT>
                    <P>
                        One commenter opposed the penalty of perjury requirement on the basis that it may have a chilling effect on utilization of the SCC and may increase litigation risk against Plan Officials. However, since its inception in 2002, the VFC Program has required a penalty of perjury statement as a necessary safeguard.
                        <SU>13</SU>
                        <FTREF/>
                         As noted in the 2006 Program, EBSA believes that an important result under the Program is a level of certainty that those using the Program have complied with the terms of the Program and have revealed the details of the transaction and the correction.
                        <SU>14</SU>
                        <FTREF/>
                         The penalty of perjury statement is part of what provides that level of certainty. Accordingly, the final SCC in section 7.1(b) retains the penalty of perjury statement as a fundamental part of the Program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             67 FR 15062, 15068, (March 28, 2002).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             71 FR 20262, 20265 (April 19, 2006).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(f) Self-Correction Component Protections and Frequency of Use</HD>
                    <P>
                        In the preamble to the 2022 VFC Program proposed revisions, the Department stated that it had considered but did not include a limit on the frequency with which a self-corrector may use the SCC.
                        <SU>15</SU>
                        <FTREF/>
                         The Department explained that it intended instead to monitor participation for frequent use of the SCC and that it may communicate with repeat users or open investigations to identify and correct systemic issues leading to repeated failures to transmit participant contributions in a timely fashion. The Department requested comments on whether the SCC should incorporate other protections for pension plans that are classified as small based on their participant population. For example, EBSA asked whether the SCC should limit small plan participation to only those small plans whose plan sponsors comply with the safe harbor standard in 29 CFR 2510.3-102(a)(2) for the timely handling of participant contributions. The Department noted that compliance could require, for example, either an existing practice or an agreement to put in place a customary practice of depositing participant contributions and loan payments with the plan not later than the 7th business day following the day on which such amount would otherwise have been payable to the participant in cash in the case of amounts withheld by an employer from a participant's wages, or the 7th business day following the day on which the participant contribution or loan payment is received by the employer in the case of amounts that a participant or beneficiary pays to an employer.
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             The proposal noted that the class exemption PTE 2002-51 is generally unavailable to VFC Program applicants that have, within the previous there years, taken advantage of the relief provided by the VFC Program and the exemption for a similar type of transaction. Comments were solicited on whether to eliminate the three-year use limitation in the exemption PTE 2002-51. A discussion of that issue and the Department's conclusion can be found in the final amendment to PTE 2002-51 which appears in this issue of the 
                            <E T="04">Federal Register</E>
                            .
                        </P>
                    </FTNT>
                    <P>Commenters generally supported the decision not to impose a limit on the frequency of use of the SCC. One commenter believed that, given the Lost Earnings cap, repeat use of the SCC is unlikely to present a risk to participants. Another commenter argued that plan sponsors will be disincentivized from using the SCC if their frequency of use is monitored by EBSA and asked for guidance as to the level of usage that is likely to generate follow-up inquiries from EBSA. Commenters also asked that no additional requirements be imposed on self-corrections by small plans. They argued additional requirements were unnecessary because the Department retains the right to investigate a plan fiduciary if it fails to meet the SCC requirements and additional requirements could discourage participation in the SCC. One commenter argued that in its experience most small employers followed the 7-business day safe harbor, but a more restrictive standard in the SCC would fail to acknowledge that there are occasions when a particular deposit cannot be reasonably segregated from the employer's general assets within the 7-business day period. The Department has decided not to adopt additional requirements for small plans at this time. As discussed in the preamble to the 2022 VFC Program proposed revisions, EBSA will monitor the use of the SCC and evaluate the potential merit of added requirements based on that data.</P>
                    <P>With respect to the request for guidance on the level of repeat usage of the SCC that might trigger communications from the Department or initiation of an investigation, the Department does not believe a general standard would be appropriate for determining whether repeated use of the SCC will generate an inquiry or investigation. Rather, the Department's actions with respect to any particular repeat user will depend on the facts and circumstances of the individual corrections.</P>
                    <HD SOURCE="HD3">(g) Self-Correction Component: Miscellaneous</HD>
                    <P>The VFC Program does not relieve plans from reporting delinquent participant contributions on the plan's Form 5500 or Form 5500-SF, as applicable. That remains the case under these amendments to the Program for violations, regardless of whether corrected under the SCC or the application-based component of the VFC Program.</P>
                    <P>A commenter urged the Department to provide guidance on whether and how plan administrators should report use of the SCC on the Form 5500 (Line 4a of the Schedule H or Schedule I for small plans; line 9(a) of the Schedule DCG) or Form 5500-SF (Line 10a). The instructions for the Form 5500 and the Form 5500-SF already specifically address reporting of delinquent contributions. EBSA directs filers to the instructions for the Form 5500 to determine their reporting obligation regarding delinquent participant contributions. The information submitted on the SCC notice enables the Department to cross-reference SCC correctors to the Form 5500/5500-SF data. The Department has a project on its regulatory agenda that involves an evaluation of general improvements to the annual reporting forms and instructions. The Department is open to input on that project from stakeholders related to whether the Department should propose adding questions to the Form 5500 and Form 5500-SF that specifically relate to use of the SCC.</P>
                    <P>
                        In the 2006 VFC Program, the Department rejected a recommendation that EBSA implement a 
                        <E T="03">de minimis</E>
                         rule under the VFC Program under which applicants would not be required to correct a previously filed Form 5500 in circumstances where the breach involved a defined de minimis threshold amount of the plan's assets.
                        <SU>16</SU>
                        <FTREF/>
                         EBSA continues to believe that such an exception from the requirement to file a complete and accurate annual report is not appropriate. Rather, when a prohibited transaction is not reported or is reported incorrectly on the plan's Form 5500 or Form 5500-SF annual report, the Form 5500 or Form 5500-SF filing must be amended so the plan's annual report correctly reflects the fiduciary breach and prohibited transaction.
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             71 FR 20262, 20266 (2006).
                        </P>
                    </FTNT>
                    <PRTPAGE P="4197"/>
                    <P>Another commenter recommended that the Department create an online excise tax calculator in coordination with the Department of the Treasury. A requirement for the use of the SCC under section 7.1(b)(2)(i) is that the Lost Earnings on the delinquent remittance of participant contributions and participant loan repayments be calculated using the online calculator. This requirement was supported by commenters as a straightforward method to determine the Lost Earnings amount. The Department will consider the recommended addition and consult with the Department of the Treasury, but believes that step is beyond the scope of the current amendments and is not prepared to adopt such an expansion of the online calculator concurrent with this release.</P>
                    <HD SOURCE="HD2">2. Self-Correction Component for Participant Loan Transactions Corrected Pursuant to IRS's EPCRS—Section 7.3</HD>
                    <P>The current VFC Program covers certain participant loans that fail to qualify for ERISA's statutory exemption for plan loan programs in ERISA section 408(b)(1). Specifically, these covered loan transactions are loans in which the terms of the loan did not comply with plan provisions that incorporated requirements of section 72(p) of the Code concerning amount, duration, or level amortization, or which defaulted due to a failure to withhold loan repayments from the participant's wages. The correction under the 2006 VFC Program for these transactions requires that the Plan Official voluntarily correct the loan with IRS approval under the Voluntary Correction Program (VCP) of the IRS's EPCRS and provide to the Department information regarding the correction.</P>
                    <P>In July 2021, IRS updated EPCRS to permit use of SCP for correction of certain participant loan failures. In December 2022, the SECURE 2.0 Act was enacted. Section 305(b)(1) of the SECURE 2.0 Act provides that an “eligible inadvertent failure” related to a loan from a plan to a participant may be self-corrected according to the rules of section 6.07 of Revenue Procedure 2021-30 or any successor guidance.</P>
                    <P>Section 305(b)(2) of the SECURE 2.0 Act requires the Department to treat eligible inadvertent failures related to participant loans that are self-corrected under the IRS's EPCRS as described above as meeting the requirements of the VFC Program “if, with respect to the violation of the fiduciary standards of the Employee Retirement Income Security Act of 1974, there is a similar loan error eligible for correction under the IRS's EPCRS and the loan error is corrected in such manner.” Section 305(b)(3) of the SECURE 2.0 Act permits the Department to impose reporting or other procedural requirements with respect to parties that intend to rely on the VFC Program for correction of these eligible inadvertent failures.</P>
                    <P>The 2022 VFC Program proposed revisions were published for public comment in November 2022 before the SECURE 2.0 Act was enacted, with a comment period closing date of January 20, 2023. Some commenters addressed SECURE 2.0 Act section 305 during that comment period. However, because the amendments were published for public comment before the SECURE 2.0 Act was enacted, the Department reopened the comment period from February 14 to April 17, 2023, to specifically solicit comments on the SECURE 2.0 Act section 305 directive. In the notice reopening the comment period, the Department asked specific questions about section 305 of the SECURE 2.0 Act, including (i) whether VFC Program section 7.3 should be amended to include a paragraph treating participant loan transactions self-corrected under the IRS's EPCRS as meeting the requirements of the VFC Program, (ii) whether the VFC Program should impose additional reporting or other procedural requirements for these specific corrections, and (iii) whether changes were needed to PTE 2002-51.</P>
                    <P>Several commenters expressed general support for the implementation of the changes required by the SECURE 2.0 Act section 305, including support for adding a self-correction component to the VFC Program for participant loans self-corrected in accordance with the SCP of the IRS's EPCRS. The commenters urged the Department to remove requirements in section 7.3 of the VFC Program that correctors must use VCP (under the IRS's EPCRS) and that they must provide the Department with proof of payment and an IRS compliance statement. A commenter further recommended amending section 2 of the VFC Program to provide that EBSA will not initiate a civil investigation or assess civil penalties for participant loan transactions corrected under the SCP of the IRS's EPCRS.</P>
                    <P>
                        Several commenters stated that the Department should not impose any requirements on parties who self-correct plan loans under the VFC Program beyond what is required by the SCP of the IRS's EPCRS. The commenters noted that the SCP of the IRS's EPCRS does not impose notice or reporting requirements for employers that self-correct. One commenter stated that consistency between the IRS's EPCRS and the Department's VFC Program would simplify corrections and reduce burden. A different commenter stated that reporting to EBSA or other procedural requirements are unnecessary because a plan loan that is self-corrected under the SCP of the IRS's EPCRS puts the affected participants in the position they would have been if no failure occurred. One commenter recommended that the Department also include other “eligible inadvertent failures” (
                        <E T="03">i.e.,</E>
                         eligible inadvertent failures other than those relating to loans to participants) in a VFC Program self-correction component as soon as practicable after the IRS provides guidance on the meaning of “eligible inadvertent failures” and how such failures can be self-corrected under EPCRS.
                    </P>
                    <P>After evaluating the comments, and pursuant to section 305 of the SECURE 2.0 Act, the Department is modifying section 7.3 of the VFC Program to accept EPCRS self-corrections of eligible inadvertent failures of participant loan transactions. Specifically, the 2025 VFC Program adds a new self-correction component in section 7.3(c) entitled “Eligible Inadvertent Participant Loan Failures Corrected under the Self-Correction Component.”</P>
                    <P>
                        The description of the transaction set forth in section 7.3(c)(1) states, “A plan extended a loan to a plan participant who is a party in interest with respect to the plan based solely on their status as an employee of any employer whose employees are covered by the plan, as defined in section 3(14)(H) of ERISA. There is an Eligible Inadvertent Participant Loan Failure that involves a Breach as defined in section 3(b)(1) [of the VFC Program].” Section 7.3(c) further provides that an Eligible Inadvertent Participant Loan Failure is a participant loan failure that occurs despite the existence of practices and procedures that satisfy the standards set forth in, and is eligible for correction under, the IRS's EPCRS, and does not include any participant loan failure that is egregious, relates to the diversion or misuse of plan assets, or is directly or indirectly related to an abusive tax avoidance transaction. In addition, in connection with the new provision in section 7.3(c), a new exception is added to section 4 titled “Exception for Eligible Inadvertent Participant Loan Failures” to clarify that a self-corrector is eligible to correct an Eligible Inadvertent Participant Loan Failure under section 7.3(c) even if the plan or the self-corrector is “Under Investigation,” within the meaning of the VFC Program so long as the self-corrector is eligible to correct the 
                        <PRTPAGE P="4198"/>
                        participant loan failure under the IRS's EPCRS.
                        <SU>17</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             Under Q&amp;A-4 of Notice 2023-43, once a plan or plan sponsor comes under examination (as defined in section 5.08 of Rev. Proc. 2021-30), an Eligible Inadvertent Participant Loan Failure is no longer eligible for self-correction under the IRS's EPCRS unless the plan sponsor has, before the plan or plan sponsor comes under examination, demonstrated a specific commitment to implement a self-correction. However, under Q&amp;A-5 of Notice 2023-43, a plan sponsor may self-correct an Eligible Inadvertent Participant Loan Failure that is insignificant, determined in accordance with the factors set forth in section 8.02 of Rev. Proc. 2021-30, even if the plan or plan sponsor is under examination, and even if the failure is discovered on examination.
                        </P>
                    </FTNT>
                    <P>
                        The new SCC for participant loan failures in section 7.3(c) accordingly allows self-correction of transactions currently described in section 7.3(a) and (b) of the VFC Program—
                        <E T="03">i.e.,</E>
                         loans the terms of which did not comply with plan provisions that incorporated requirements of section 72(p) of the Code concerning amount, duration, or level amortization, or loans that defaulted due to a failure to withhold loan repayments from the participant's wages—if such transactions are eligible for, and have been self-corrected under, the IRS's EPCRS. The new SCC in section 7.3(c) also extends to the failure to obtain spousal consent for a plan loan and to allowing a loan when the loan exceeds the number permitted under the terms of the plan, also provided that the transactions are eligible for, and have been self-corrected under, the IRS's EPCRS.
                    </P>
                    <P>
                        IRS Notice 2023-43 (IRS Notice) provides interim guidance under section 305 of the SECURE 2.0 Act with respect to the expansion of EPCRS, including with respect to the expansion of self-correction for eligible inadvertent failures relating to loans from plans to participants under section 305(b)(1).
                        <SU>18</SU>
                        <FTREF/>
                         Among other things, the IRS Notice provides that plan sponsors may self-correct any eligible inadvertent failure relating to a loan from a plan to a participant that is corrected in accordance with section 6.07 of EPCRS, before EPCRS is formally updated pursuant to section 305(g) of the SECURE 2.0 Act, if certain conditions are satisfied.
                        <SU>19</SU>
                        <FTREF/>
                         The IRS Notice also provides that plan sponsors may rely on the notice beginning on the date it was issued, May 25, 2023, and ending on the date EPCRS is updated pursuant to section 305(g) of the SECURE 2.0 Act. Likewise, with respect to the new SCC in section 7.3(c), the Department will accept self-correction in accordance with section 6.07 of the IRS's EPCRS before EPCRS is formally updated. Once the IRS's EPCRS is formally updated, the Department will accept self-correction in accordance with the updated EPCRS. In this regard, with respect to a failure to obtain spousal consent for a plan loan, the Department's SCC will initially accept only a correction that involves obtaining spousal consent, unless and until additional correction methods are identified in an updated IRS's EPCRS.
                        <SU>20</SU>
                        <FTREF/>
                         The Department intends to monitor use of the SCC as well as any additional changes to the IRS's EPCRS to determine whether additional guidance appears necessary on the scope of the SCC in section 7.3(c) or on any correction methods.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             Notice 2023-43, Guidance on Section 305 of the SECURE 2.0 Act of 2022 with Respect to Expansion of the Employee Plans Compliance Resolution System, available at 
                            <E T="03">https://www.irs.gov/pub/irs-drop/n-23-43.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             
                            <E T="03">Id.</E>
                             at Q&amp;A 1.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             See section 6.07(4) of Revenue Procedure 2021-30 (relating to correction of failure to obtain spousal consent for plan loan).
                        </P>
                    </FTNT>
                    <P>
                        The Department does not agree with the commenters who suggested that the Department should not impose any requirements in the VFC Program on parties who self-corrected participant loans beyond what is required by the IRS's EPCRS. Rather, similar to the Department's position described above with respect to self-correction of delinquent participant contributions and loan repayments, the Department believes self-correction of participant loan transactions is a new approach that merits a level of oversight to ensure that transactions are adequately corrected and that breaching fiduciaries have an appropriate level of accountability. Accordingly, under section 7.3(c), self-correctors are required to complete a SCC notice and submit the notice electronically to EBSA using the online VFC Program web tool located on EBSA's website. Self-correctors are also required to complete and retain the documents required under section 6.2 (including the Penalty of Perjury Statement). The SCC for participant loan transactions has been designed so that the burden of providing information to the Department is minimal and mirrors the IRS recordkeeping requirements 
                        <SU>21</SU>
                        <FTREF/>
                         by requiring only contact information, a short description of type of participant loan failure, the loan amount or amounts in the case of multiple loans, the date the failure was identified, the date or dates of correction, the correction, and the number of participants affected by the correction. Unlike self-correctors under section 7.1(b), who must complete a SCC Record Retention Checklist, self-correctors under section 7.3(c) do not need to complete that checklist.
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             Notice 2023-43, at Q&amp;A-11.
                        </P>
                    </FTNT>
                    <P>The existing correction method under sections 7.3(a) and (b) are retained to permit those that would prefer to correct under the EPCRS VCP to utilize the application-based process under the VFC Program.</P>
                    <P>
                        The Department also does not agree with the suggestion that section 2 be amended to provide that EBSA will not initiate a civil investigation or assess civil penalties for a self-correction of a participant loan failure corrected under the IRS's EPCRS. Consistent with EBSA's historical practice under the VFC Program, the Department generally does not anticipate taking enforcement action in response to a compliant application or eligible self-correction except in the unusual situation where EBSA becomes aware of possible criminal behavior, material misrepresentations or omissions in the VFC Program application or SCC notice, or other abuse of the Program.
                        <SU>22</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             67 FR 15062, 15063 (2002).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">3. Other Revisions to the VFC Program</HD>
                    <HD SOURCE="HD3">(a) Revisions to Application Process Provisions for Delinquent Participant Contributions—Sections 7.1(a), (c) and (d)</HD>
                    <P>
                        Section 7.1(a) has been renamed “Delinquent Participant Contributions and Loan Repayments to Pension Plans under VFC Program Applications” to clarify that it applies only to corrections pursuant to Program applications in contrast to self-corrections under section 7.1(b). Additionally, section 7.1(a) has been revised to reflect the Department's amendment of its regulation defining plan assets in 2010 to include participant loan repayments within these regulatory principles.
                        <SU>23</SU>
                        <FTREF/>
                         Language has also been added to sections 7.1(a)(3)(ii)(A) and (iii)(A) to explain that the required narrative in the application must include a description of any steps taken to prevent future delinquencies.
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             
                            <E T="03">See</E>
                             29 CFR 2510.3-102(a)(1).
                        </P>
                    </FTNT>
                    <P>
                        Sections 7.1(b) “Delinquent Participant Contributions to Insured Welfare Plans” and (c) “Delinquent Participant Contributions to Welfare Plan Trusts” are re-designated as sections 7.1(c) and (d) respectively. A change also has been made to each of these sections to clarify that the participant contributions were remitted to the insurance provider in section 7.1(c)(3)(iii) and to the trust in section 7.1(d)(3)(ii) rather than the plan as previously stated to clarify the provision.
                        <PRTPAGE P="4199"/>
                    </P>
                    <P>The Department also had proposed deleting language regarding Restoration of Profits as a correction method under sections 7.1(a)(2)(i) and (ii) and 7.1(d)(2)(i) and (ii). The proposal was based on the view that this correction method may be unnecessary in this context, as applicants had not reported generating a profit through use of the delinquent amounts, and therefore, deletion would simplify the Program. Although the Department did not receive comments opposing these changes, the Department determined to retain Restoration of Profits as a potential correction method in the 2025 VFC Program in order to leave the option available should it become relevant to an applicant in the future. Many commenters on the 2022 VFC Program proposed revisions generally supported expansive availability of the Program to promote timely correction of errors.</P>
                    <P>The 2022 VFC Program proposed revisions also clarified that the VFC Program does not include a correction for delinquent matching employer contributions. However, as explained in the notice, to the extent that a Program application provides that the employer will apply the same correction formula to the employer matching contributions that it is required to apply to delinquent participant contributions, EBSA does not expect to reject or refuse to process such applications merely because delinquent employer matching contributions are included even though the “correction” of the employer contribution is not a covered transaction under the VFC Program, is not entitled to any relief under the Program, and will not be covered by any no action letter.</P>
                    <HD SOURCE="HD3">(b) Revisions to Application Process Provisions for Loans—Sections 7.2(b), (c) and (d)</HD>
                    <P>The 2022 VFC Program proposed revisions included several changes to section 7.2 related to the application process for correction of certain plan loans made at below-market interest rates. The Department received no comments on the proposed revisions, and as described below, is adopting the changes as proposed.</P>
                    <P>The original VFC Program included as an eligible transaction “Loan at Below-Market Interest Rate to a Party in Interest with Respect to the Plan.” The corrective action in section 7.2(b) for such transactions requires the payment of the loan in full, plus penalties, and the greater of the Lost Earnings or Restoration of Profits. In addition to the required section 6.1 documentation, the 2006 VFC Program required applicants to provide both a written copy of an independent commercial lender's fair market interest rate determination under section 7.2(b)(3)(ii) and a copy of an independent fiduciary's dated, written approval of the fair market interest rate determination under section 7.2(b)(3)(iii). To reduce applicants' costs, the 2025 VFC Program revises section 7.2(b)(3)(iii) to eliminate the requirement that an independent fiduciary validate in writing the process used to determine the fair market interest rate determination for loans in the amount of $10,000 or less. The 2025 VFC Program also clarifies the wording in section 7.2(b)(3)(i) to require a narrative describing the process used to determine the interest rate at the time the loan was made.</P>
                    <P>Section 7.2(c) “Loan at Below-Market Interest Rate to a Person Who is Not a Party in Interest With Respect to the Plan” is also a transaction that dates from the original VFC Program. Sections 7.2(c)(2)(i) and (ii) are being re-organized to clarify the required correction for this transaction. Section 7.2(c)(2)(ii) also adds an alternative to payment of the present value of the Principal Amounts from the Recovery Date to the loan's maturity date. The present value payment method must be coupled with the borrower's continued payment of the outstanding loan balance under the original repayment schedule for the duration of the loan. The new alternative permits the borrower's payment of the amortized outstanding loan balance over the remaining payment schedule of the loan at the interest rate that would have been applicable if the loan had originally been made at the fair market interest rate. When this new alternative is used, the applicant must submit a copy of the loan repayment schedule for the re-amortized loan repayments under section 7.2(c)(3)(iii). Any fair market interest rate must be determined by an independent commercial lender. The wording in section 7.2(c)(3)(i) is revised in a similar fashion to the wording in section 7.2(b)(3)(i) to require a narrative describing the process used to determine the interest rate at the time the loan was made.</P>
                    <P>Section 7.2(d) “Loan at Below-Market Interest Rate Solely Due to a Delay in Perfecting the Plan's Security Interest” is another transaction dating back to the original VFC Program. It provides a correction for when a plan made a purportedly secured loan to a non-party in interest, but a delay occurred in recording or otherwise perfecting the plan's interest in the loan collateral, resulting in the loan being treated as an unsecured loan until the plan's security interest was perfected. Section 7.2(d)(2) is re-organized to clarify the correction. Section 7.2(d)(2)(ii) specifically requires that the plan's interest in the loan collateral be recorded or perfected. For situations where the delay in perfecting the loan's security caused a permanent change in the risk characteristics of the loan, section 7.2(d)(2)(iii) requires the payment of the present value of the remaining Principal Amounts from the date the loan is fully secured to the maturity date of the loan. The 2025 VFC Program clarifies that the present value payment method must be coupled with the borrower's continued payment of the outstanding loan balance under the original repayment schedule for the duration of the loan. Section 7.2(d)(2)(iii) is also being amended in the 2025 VFC Program to add an alternative that permits the borrower's payment of the amortized outstanding loan balance over the remaining payment schedule of the loan at the interest rate that would have been applicable for a loan with the changed risk characteristics. When this new alternative in the 2025 VFC Program is used, the applicant must submit a copy of the loan repayment schedule for the re-amortized loan repayments under section 7.2(d)(3)(iii). Any fair market interest rate must be determined by an independent commercial lender.</P>
                    <P>In a related modification applicable to these three types of loans, section 5(a) is revised to include a specific explanation in section 5(a)(5) for when a commercial lender will be “independent” using the same criteria as is used to determine the “independence” of an appraiser. As an ongoing protection for plans and their participants, EBSA staff, as part of the application review process, will continue to monitor a commercial lender's interest rate determination process and will object if it appears that a lender is not truly “independent” of the plan's fiduciaries and parties in interest, or the interest rate determination process is otherwise flawed.</P>
                    <HD SOURCE="HD3">(c) Revisions to Application Process Provisions for Purchases, Sales and Exchanges, Sales and Leasebacks—Section 7.4</HD>
                    <P>
                        The 2022 VFC Program proposed revisions included several changes to Section 7.4(a) “Purchase of an Asset (Including Real Property) by a Plan from a Party in Interest,” Section 7.4(b) “Sale of an Asset (Including Real Property) by a Plan to a Party in Interest,” and Section 7.4(c) “Sale and Leaseback of Real Property to Employer.” The Department did not receive any 
                        <PRTPAGE P="4200"/>
                        comments on the proposed revisions, and as described below, is adopting the changes as proposed.
                    </P>
                    <P>
                        Section 7.4(a) provides a method of correction for situations when the plan purchased an asset (including real property) from a party in interest in a transaction to which no prohibited transaction exemption applies. A plan's purchase from a party in interest can be corrected under the VFC Program by reversing the transaction provided the plan receives the higher of the fair market value at resale or the Principal Amount plus the greater of either Lost Earnings or Restoration of Profits.
                        <SU>24</SU>
                        <FTREF/>
                         As an alternative correction, a plan may retain the asset plus receive an amount resulting from application of a formulaic calculation, but only if an independent fiduciary determines that the plan will realize a greater benefit from this alternative correction than from the resale of the asset. Section 7.4(a)(2) of the 2025 VFC Program includes a new paragraph (iii) that provides a third method of correction in situations when the purchase cannot be reversed or the asset retained because the plan no longer owns the asset (
                        <E T="03">e.g.,</E>
                         sales, maturity, destruction). Under this new correction, the plan can receive a “cash settlement” if the asset has been sold and a Plan Official provides a statement, as required by section 7.4(a)(3)(v), that the sale was upon the advice of an independent fiduciary and not in anticipation of applying for relief under the Program. The determination of the cash settlement amount is prescribed in section 7.4(a)(2)(iii) and considers, among other factors, whether the plan realized a profit on the resale of the asset, or a loss on the resale, maturity or destruction of the asset.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             The terms Principal Amount, Lost Earnings, and Restoration of Profits are defined in VFC Program section 5.
                        </P>
                    </FTNT>
                    <P>As a further clarifying change, the wording in section 7.4(a)(2)(ii) is modified to permit the subtraction of any earnings received on the asset up to the Recovery Date from Lost Earnings.</P>
                    <P>
                        The 2025 VFC Program also includes an amendment to section 7.4(b) “Sale of an Asset (Including Real Property) by a Plan to a Party in Interest.” Section 7.4(b) provides a method of correction in situations when the plan sold an asset for cash to a party in interest in a transaction to which no prohibited transaction exemption applies. The amendment adds a condition to the section 7.4(b)(2)(ii) correction to permit the plan to receive the correction amount rather than to repurchase the asset by permitting a Plan Official to determine that the asset cannot be repurchased (
                        <E T="03">e.g.,</E>
                         destruction, maturity). This new condition in section 7.4(b)(2)(ii) is an alternative to the section's existing condition requiring an independent fiduciary to determine that the plan will recognize a greater benefit from this correction than the correction in section 7.4(b)(2)(i). As part of the required documentation under section 7.4(b)(3)(iv), the Plan Official making this determination must provide a written explanation of why the asset cannot be repurchased.
                    </P>
                    <P>Section 7.4(c) “Sale and Leaseback of Real Property to Employer” provides a method of correction for a plan sponsor that sells a parcel of real property to the plan, which is then leased back to the plan sponsor and is not otherwise exempt. To more accurately reflect the statutory exemption provided by ERISA section 408(e), which does not limit the transaction to the plan sponsor, section 7.4(c) is being revised to explicitly allow correction of leases to affiliates of the plan sponsor. The final associated class exemption, PTE 2002-51, has been revised for consistency with this amendment.</P>
                    <HD SOURCE="HD3">(d) Revisions to Application Process Provisions for Illiquid Assets—Section 7.4(f)</HD>
                    <P>The VFC Program includes correction for a transaction that permits a plan to divest, rather than continue to hold in its investment portfolio, a previously purchased asset that is determined to be illiquid and that had been acquired under circumstances described in the Program. The 2022 VFC Program proposed revisions retained those circumstances, as well as the correction method, which permits the sale of the asset to a party in interest provided the plan receives the higher of (A) the fair market value of the asset at the time of resale, without a reduction for the costs of sale; or (B) the Principal Amount, plus Lost Earnings as described in section 5(b). This correction encompasses a sale of the illiquid asset to a party in interest by the plan even if the original purchase of the asset by the plan was not a prohibited transaction or otherwise imprudent. However, the amendments modified the definition of Principal Amount to take into account the possibility that the transaction being corrected was neither a prohibited transaction nor a fiduciary breach. Section 7.4(f)(2)(ii) now defines Principal Amount as either the amount that would have been available had the Breach not occurred, or the plan's original purchase price if the original purchase was not a prohibited transaction or imprudent. The amendments also clarify that in the case of an illiquid asset that is a parcel of real estate, no party in interest may own real estate that is contiguous to the plan's parcel of real estate on the Recovery Date. There were no comments addressing these proposed revisions, and the 2025 VFC Program includes these changes as proposed.</P>
                    <HD SOURCE="HD3">(e) Revisions to the VFC Program General Eligibility Criteria—Sections 3, 4, and 5</HD>
                    <HD SOURCE="HD3">(i) Under Investigation Definition—Section 3(b)(3)</HD>
                    <P>To be eligible to correct under the VFC Program, a plan, applicant, or self-corrector may not be “Under Investigation” as defined in section 3(b)(3). The 2022 VFC Program proposed revisions included a modification to section 3(b)(3)(i) to state that a review by an EBSA Benefits Advisor is considered an investigation by EBSA that automatically makes an applicant or self-corrector ineligible to participate in the Program. However, the proposed change to section 3(b)(3) makes clear that a plan will not be considered to be Under Investigation merely because EBSA staff has contacted the plan, the applicant, the self-corrector, or the plan sponsor in connection with a participant complaint unless the participant complaint concerns the transaction described in the application or identified in the SCC notice and the plan has not received the correction amount due under the Program as of the date EBSA staff contacted the plan, the applicant, the self-corrector, or the plan sponsor.</P>
                    <P>One commenter opposed including in the definition of Under Investigation contact from an EBSA staff member regarding a participant complaint arguing that the fiduciary may have not known the breach occurred until the fiduciary received the call from the EBSA staff member. The commenter further suggested that EBSA instead could put time parameters around when the fiduciary must act based on receiving information from the EBSA staff member.</P>
                    <P>
                        The VFC Program has limited eligibility for participation in the Program to plans and applicants that are not Under Investigation since its inception. The requirement does not turn on the fiduciary's knowledge of the breach (or allegations of a breach), but rather on the absence of an investigation by the Department. An important premise of the VFC Program is that fiduciaries should not wait to see if the agency has spotted the potential breach or if a participant has complained to the agency before they take action to correct 
                        <PRTPAGE P="4201"/>
                        violations. Instead, they should timely correct violations, and the VFC Program should be structured to avoid incentives for fiduciaries to adopt a “wait and see” approach focused on the likelihood of getting caught, instead of the need to correct violations promptly. Accordingly, the Department is not persuaded that the changes suggested by the commenter are consistent with the purpose of the provision and, accordingly, declines to adopt the suggestions. Rather, the 2025 VFC Program retains the definition of Under Investigation as proposed.
                    </P>
                    <HD SOURCE="HD3">(ii) Eligibility Exceptions—Section 4</HD>
                    <P>Section 4 of the Program provides that in order to be eligible for the VFC Program, the plan, applicant, or self-corrector may not be Under Investigation (discussed above) and the VFC Program application must contain no evidence of potential criminal violations. The 2025 VFC Program added two new limited exceptions to the existing eligibility requirements to promote increase usage of the Program.</P>
                    <P>The first exception involves the “potential criminal violations” provision in paragraph (b)(2) and allows participation in the VFC Program by an innocent plan administrator, plan sponsor, or applicant for cases involving delinquent participant contributions and loan repayments when (1) all funds have been repaid to the plan; (2) the appropriate law enforcement agency has been notified of the alleged criminal activity; and (3) the applicant submits a statement (covered by the Penalty of Perjury Statement) with the application providing contact information for the law enforcement agency, certifying that the applicant was not involved in the alleged criminal activity, and reporting whether a claim relating to the potential criminal violation has been made under an ERISA section 412 fidelity bond. To accommodate this change, section 4(b) is re-named and re-designated as section 4(b)(1), “In general.” EBSA always retains the right to reject any VFC Program application based on its review of the criminal activity involved.</P>
                    <P>The second exception being added in the 2025 VFC Program is in section 4(d), which provides that an applicant is eligible to submit a “bulk application” when certain conditions are met. As noted in the 2022 VFC Program proposed revisions, over the past several years, EBSA has received Program applications from service providers to correct Breaches involving multiple plans. Some of these applications have involved hundreds, or even thousands, of plans, some of which are Under Investigation by EBSA. As noted elsewhere in this document, a plan is automatically ineligible to participate in the Program if it is considered “Under Investigation” as defined in section 3(b)(3) of the Program. Consequently, such plans could not be included in any resulting no action letter. EBSA noted that it would like to be able to issue a no action letter to the service provider that covers all plans named in the application in certain circumstances. EBSA received one comment letter in support of the changes described in the 2022 VFC Program proposed revisions, and the Program's eligibility provision have been expanded as proposed. Specifically, to qualify: (1) the application must cover at least ten named plans and each plan must have participated in the transaction being corrected; (2) the applicant must be a service provider that is applying for relief only on its own behalf; (3) the applicant is currently or was providing services to each of the named plans at the time of the transaction being corrected; and (4) the service provider cannot be Under Investigation by EBSA and the corrective action cannot have been taken as a result of an EBSA investigation or review of any named plan. EBSA retains the right to determine whether the corrective action was taken as a result of any investigation, and to exclude any plan involved in the investigation from the no action letter. Also, section 6.1(d)(3) is being amended to permit a bulk applicant to provide for each named plan either the Annual Report Form 5500 filing information or the plan sponsor's nine-digit number (EIN). This procedural change will avoid undue delay while a service provider attempts to secure Annual Report Form 5500 filing information, which may not be directly related to the Breach. Section 6.1(g) is also being amended to permit a bulk applicant with knowledge of the transaction that is the subject of the application to sign and date the Penalty of Perjury Statement in which the applicant certifies that it is not Under Investigation by EBSA instead of requiring a signature from a plan fiduciary for each plan covered by the application.</P>
                    <HD SOURCE="HD3">(iii) Lost Earnings De Minimis Exception—Section 5(e)</HD>
                    <P>The 2006 VFC Program provides a de minimis exception that applies to corrective distributions of less than $20 each to former employees, their beneficiaries, and alternate payees who neither have account balances with nor have a right to future benefits from the plan if the applicant demonstrates that the cost of making a distribution to the individual exceeds the amount of the corrective payment. In that case, the distribution does not have to be paid to the individuals but rather the total amount can be paid to the plan. The 2022 VFC Program proposed revisions included an increase in the de minimis amount to $35. Several commenters asked for a de minimis rule for Lost Earnings on delinquent remittance of participant contributions and participant loan repayments under which the correction would be limited to payment of the principal amount and there would not be an obligation to pay Lost Earnings to the participants or to the plan. The suggestion was not to be limited to former employees, their beneficiaries, and alternate payees who neither have account balances with nor have a right to future benefits from the plan. Some commenters argued that the costs of processing the corrective Lost Earnings payments should be avoided when the per participant amount is very small while other commenters proposed a total amount threshold of $50 or $75 on a per event basis before correction would have to include Lost Earnings. The Department is not persuaded that the de minimis amount should be increased above the $35 amount in the proposal or that it should be expanded to include individuals with account balances or a right to future benefits from the plan. Rather, in the Department's view, a de minimis level for the VFC Program should reinforce, not undercut, the overarching obligation that plan sponsors and other Plan Officials who fail to follow the legal requirements (such as for depositing participant contributions and loan repayments) should make full correction to the plan and its participants and beneficiaries. Accordingly, the 2025 VFC Program retains the requirements in section 5(e) with the increase from $20 to $35.</P>
                    <HD SOURCE="HD3">(f) Payment of Correction and Correction Costs by Plan Officials</HD>
                    <P>
                        Although section 7 of the VFC Program provides that any Plan Official may correct a breach in accordance with section 5 and the applicable correction method, section 7.1(a) through (d) provides that any penalties, late fees or other charges must be paid by the employer. Several commenters suggested that the VFC Program expressly allow service providers, as well as employers, to pay Lost Earnings on delinquent remittance of participant contributions and loan repayments. The commenters argued that in certain circumstances when the amount of the delinquent participant contributions and loan repayments are small, the cost 
                        <PRTPAGE P="4202"/>
                        incurred by service providers to collect Lost Earnings from a plan sponsor or employer can exceed the amount of Lost Earnings. EBSA has decided to adopt this suggestion by modifying section 7.1(a) through (d) to better conform with section 5(b) by stating that the cost of the correction must be paid by a Plan Official and not from the employee contributions and loan repayments. This change is consistent with existing section 5(c) of the VFC Program which provides that the responsible fiduciary, plan sponsor or other Plan Official must pay correction amounts and any costs of correction and also prohibits payment of any part of the correction amount or costs of correction from plan assets. Plan Official is defined in section 3(b)(2) as a plan fiduciary, plan sponsor, party in interest with respect to a plan, or other person who is in a position to correct a breach by filing an application or submitting a SCC notice. Although the service providers may pay Lost Earnings amounts resulting from another Plan Official's breach, a proper VFC Program application or SCC notice, which includes the penalty of perjury statement by a plan fiduciary, must be completed or EBSA will not issue a no action letter or self-correction acknowledgment.
                    </P>
                    <P>
                        In the 2022 VFC Program proposed revisions, the Department also stated that, with respect to a multiemployer plan or multiple employer plan, both the plan administrator and any contributing or adopting employer would be permitted to use the amended VFC Program and the SCC.
                        <SU>25</SU>
                        <FTREF/>
                         The Department explained that the plan administrator of such a plan could apply on behalf of the entire plan and any participating employer may apply on its own behalf. Although no comments were received on that aspect of the 2022 proposal, to provide additional clarity, the Department made a change in this 2025 VFC Program to permit an employer in a multiemployer plan or multiple employer plan who wishes to correct on its own behalf to sign the application or SCC penalty of perjury statement and, regardless of the employer's status as a plan fiduciary, the penalty of perjury statement need not be signed by another plan fiduciary. 
                        <E T="03">See</E>
                         sections 6.1 and 6.2.
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             
                            <E T="03">See</E>
                             87 FR 71165 (citing the preamble to the 2006 VFC Program, 71 FR 20262, 20264 (April 19, 2006)). An employer would be considered a Plan Official for purposes of the Program.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(g) Miscellaneous Modifications—Sections 5 and 7</HD>
                    <P>
                        The 2025 VFC Program includes assorted other clarifying changes that were in the November 2022 notice designed to update the Program, assist Program users, and maintain consistency among provisions. For example, section 5(d) “Distributions” is revised to reflect the cessation of both the IRS and Social Security Administration letter forwarding services for missing participants, and to provide a reference to the Missing Participants—Best Practices for Pension Plans guidance issued by the Department.
                        <SU>26</SU>
                        <FTREF/>
                         Another example is sections 7.3(a)(3) and (b)(3). Those sections provide that only certain supporting documentation must be provided with the application. The words “unless otherwise requested by EBSA” have been added to confirm that EBSA may, in individual cases, request copies of other supporting documentation. Similarly, references to self-corrector, self-correction, and the SCC notice have been added to various provisions where appropriate. Additionally, in sections 7.4(d) and (e) dealing with transactions at greater and less than fair market value respectively, the documentation requirement for the qualified, independent appraiser's report has been revised to correctly specify value rather than fair market value at the time of the transaction. In section 7.5 (“Benefits”) concerning the distribution of overvalued plan assets in a defined contribution plan, the correction specifically requires the restoration to the plan of the amount that exceeded the paid distribution amount to which all affected participants were entitled under the terms of the plan, plus Lost Earnings as described in section 5(b) on the overpaid distributions.
                        <SU>27</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             Available at 
                            <E T="03">www.dol.gov/agencies/ebsa/employers-and-advisers/plan-administration-and-compliance/retirement/missing-participants-guidance.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             The preamble to the 2022 VFC Program proposed updates noted that, although a copy of the fidelity bond was originally required to be included with an application, the 2002 Program was modified to instead permit applicants to include information concerning the plan's ERISA fidelity bond, and this informational requirement was eliminated in the 2006 Program. Although the informational requirement was not proposed to be added back to the Program, the preamble to the 2022 proposed revisions emphasized that the prior modifications focused merely on streamlining the application process and should not be misconstrued as eliminating or modifying the ERISA section 412 bonding requirements that protect plans against loss by reason of acts of fraud or dishonesty. For information on the ERISA section 412 bonding requirements, 
                            <E T="03">see</E>
                             FAB 2008-04, (Nov. 25, 2008); 29 CFR 2550.412-1 (1975) and Part 2580 (1985).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">4. Decisions on Requests for Comment on Further Expansion of VFC Program</HD>
                    <P>The preamble to the 2022 VFC Program proposed updates included a solicitation of public comments on potential further expansion or revision of the Program in four specific areas: (i) missing and nonresponsive participants and beneficiaries, (ii) integration of the VFC Program with corrections under the IRS's EPCRS, (iii) adoption of a pre-audit compliance program, and (iv) electronic VFC Program submissions. Commenters were generally supportive of further changes to the VFC Program in these areas.</P>
                    <P>
                        With respect to revising the program to either permit or require that VFC Program applications be submitted electronically, the Department intends to continue to evaluate alternative approaches to e-submission, 
                        <E T="03">e.g.,</E>
                         email versus an internet or web-based portal, but has decided to continue the current process under which the EBSA Regional Offices that administer the VFC Program application process can make available email boxes that can be used for e-submission of VFC Program applications and supporting documents. Text was added to the VFC Program to encourage applicants to contact the relevant Regional Office about email submission options and format requirements, 
                        <E T="03">e.g.,</E>
                         penalty of perjury statements.
                    </P>
                    <PRTPAGE P="4203"/>
                    <P>However, with respect to missing and nonresponsive participants and beneficiaries and the other two areas identified for potential expansion, the Department believes they all involve important fiduciary compliance issues and central aspects of the Program that require careful development of issues and options. For example, with respect to revising the Program to extend to Breaches in connection with missing and nonresponsive participants and beneficiaries, the Department may consider ways to incorporate, as corrective action, the provision of information to the Department for its Retirement Savings Lost and Found searchable database described in ERISA section 523. While the Department has not included these areas of expansion in the 2025 VFC Program, it will consider these issues further and may propose expansion of the Program in these areas in a separate project.</P>
                    <HD SOURCE="HD1">C. Regulatory Impact Analysis</HD>
                    <P>
                        The following is a discussion of the examination of the effects of this regulatory action as required by Executive Order 12866,
                        <SU>28</SU>
                        <FTREF/>
                         Executive Order 13563,
                        <SU>29</SU>
                        <FTREF/>
                         the Paperwork Reduction Act of 1995,
                        <SU>30</SU>
                        <FTREF/>
                         the Regulatory Flexibility Act,
                        <SU>31</SU>
                        <FTREF/>
                         section 202 of the Unfunded Mandates Reform Act of 1995,
                        <SU>32</SU>
                        <FTREF/>
                         Executive Order 13132,
                        <SU>33</SU>
                        <FTREF/>
                         and the Congressional Review Act.
                        <SU>34</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             Improving Regulation and Regulatory Review, 76 FR 3821 (Jan. 18, 2011).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             44 U.S.C. 3506(c)(2)(A) (1995).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             5 U.S.C. 601 
                            <E T="03">et seq.</E>
                             (1980).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             2 U.S.C. 1501 
                            <E T="03">et seq.</E>
                             (1995).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             Federalism, 64 FR 153 (Aug. 4, 1999).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             5 U.S.C. 804(2) (1996).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">1. Executive Orders 12866 and 13563</HD>
                    <P>Executive Orders 12866 (as amended by 14094) and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing and streamlining rules, and of promoting flexibility.</P>
                    <P>Under Executive Order 12866, “significant” regulatory actions are subject to the requirements of the executive order and review by the Office of Management and Budget (OMB). As amended by Executive Order 14094, section 3(f) of Executive Order 12866 defines a “significant regulatory action” as any regulatory action that is likely to result in a rule that may: (1) have an annual effect on the economy of $200 million or more (adjusted every three years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, Territorial, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case.</P>
                    <P>For this purpose, a “rule” includes “an agency statement of general applicability and future effect . . . that is designed to implement, interpret, or prescribe . . . policy or to describe the procedure or practice requirements of an agency.”</P>
                    <P>OMB has determined that this action is significant under section 3(f) Accordingly, OMB has reviewed this action, and the Department has assessed the costs and benefits of its amended enforcement policy and related PTE proposal.</P>
                    <P>The VFC Program is designed to provide an efficient, cost-effective method for Plan Officials to correct a variety of ERISA fiduciary breaches and prohibited transactions and receive Departmental recognition of the correction. Specifically, the amendments to the Program add a SCC for delinquent transmittal of participant contributions and loan repayments to a pension plan under certain circumstances; clarify some existing transactions eligible for correction under the Program; expand the scope of other transactions currently eligible for correction; and simplify certain administrative or procedural requirements for participation in and correction of transactions under the VFC Program. In addition, the amendments to the Program add a SCC for certain participant loan failures self-corrected under the IRS's EPCRS.</P>
                    <P>The Department expects that the amendments to the VFC Program will increase efficiency and accessibility for potential applicants and self-correctors. These changes, described further below, include in part, a new SCC for delinquent participant contributions and loan repayments involving Lost Earnings less than or equal to $1,000, acceptance of bulk applications with modified requirements, and increased flexibility in the procedures for a variety of other transactions. These changes also include elimination from the exemption of a three-year limitation for VFC Program applicants that take advantage of the relief provided by the VFC Program and the exemption for a similar type of transaction.</P>
                    <HD SOURCE="HD3">(a) Affected Entities</HD>
                    <P>
                        All pension and welfare plans can utilize the VFC Program if they have a fiduciary breach for which there is an eligible transaction. Parties that are covered by section 4975 of the Code can rely on the related class exemption for excise tax relief for transactions identified in the exemption that are corrected under the VFC Program. In 2021 there were 718,736 defined contribution plans and 46,388 defined benefit plans that would be impacted by these changes.
                        <SU>35</SU>
                        <FTREF/>
                         In 2022 there were an estimated 2,790,000 health plans 
                        <SU>36</SU>
                        <FTREF/>
                         and 630,000 other welfare benefit plans that would also be impacted by these changes.
                        <SU>37</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             Employee Benefits Security Administration, 
                            <E T="03">Private Pension Plan Bulletin: Abstract of 2021 Form 5500 Annual Reports,</E>
                             (September 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             U.S. Department of Labor, EBSA calculations using the 2022 Medical Expenditure Panel Survey, Insurance Component (MEPS-IC), and 2020 Census County Business Patterns.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             U.S. Department of Labor, EBSA calculations using non-health welfare plan Form 5500 filings and projecting non-filers using estimates based on the non-filing health universe.
                        </P>
                    </FTNT>
                    <PRTPAGE P="4204"/>
                    <P>
                        An average of 1,226 applicants per year used the VFC Program from 2021 to 2023. The Department estimates that the 73 percent of VFC Program applicants will move to the SCC.
                        <SU>38</SU>
                        <FTREF/>
                         The Department also estimates a one percent increase in the number of self-corrections, or 909 self-corrections,
                        <SU>39</SU>
                        <FTREF/>
                         resulting from the removal of the three-year limitation provision for self-correctors.
                    </P>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             The Department estimates that the SCC will streamline the process for the 73 percent of small and large VFC Program applicants involving Lost Earnings less than or equal to $1,000.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             1,226 applicants × 73.4% × 1.01 = 909 self-corrections.
                        </P>
                    </FTNT>
                    <P>
                        The Department also projects that changes to the VFC Program will result in two new Program users filing bulk applications and 326 Program users filing non-bulk applications.
                        <SU>40</SU>
                        <FTREF/>
                         Please see Table 1 for the number of plans that will utilize the VFC Program and exemption.
                    </P>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             1,226 applicants × (100% minus 74.3%) = 326 non-bulk applicants.
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="2" OPTS="L2,nj,i1" CDEF="s50,8">
                        <TTITLE>Table 1—Number of Plans That Will Utilize the VFC Program and Exemption</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                Number
                                <LI>of plans</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Filing Bulk Applications</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Filing Non-Bulk Applications</ENT>
                            <ENT>326</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">SCC</ENT>
                            <ENT>909</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>1,237</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">(b) Benefits and Costs</HD>
                    <P>The Department believes that the benefits of the amended VFC Program and related PTE justify its costs. Because participation is voluntary, the VFC Program imposes no costs unless Plan Officials choose to avail themselves of the opportunity to correct a potential fiduciary breach under the terms of the VFC Program. Plans are expected to only utilize the program if the benefits of using the program exceed the costs. The Department expects that the revised VFC Program will be easier and more useful for potential applicants. The greater efficiency and accessibility that will result from the availability of a SCC for delinquent participant contributions, and other expansions and clarifying modifications of the Program, are expected to make the Program easier to use, to lessen the cost of participation in many instances, and to increase efficiency for both applicants and reviewers.</P>
                    <P>The VFC Program provides incentives for fiduciaries to correct a potential fiduciary breach. Benefits for Plan Officials who are granted relief under the VFC Program include elimination of risks arising from an otherwise uncorrected fiduciary breach, as well as savings of resources that otherwise might have been needed to defend against a civil action by the Department based on the breach. The VFC Program has been very successful to date in encouraging and facilitating the correction of violations.</P>
                    <P>The changes to the VFC Program will allow Plan Officials to obtain the benefits of the program at a reduced cost. The Department hopes that this cost reduction may encourage other Plan Officials to correct previously undetected and unreported fiduciary breaches and reimburse plan losses, which would enhance the retirement income security of participants and beneficiaries; however, it has no data to reliably predict the extent of the increased usage. The Department will continue to actively monitor the use of the VFC Program and evaluate its benefits and costs. The Department is unable to predict with certainty either the reduction in application costs that will arise from the revisions to the Program, or the potential increase in participation that will be associated with these revisions. One commenter requested the Department collect additional data from the VFCP applications to assess the VFC Program and SCC. The commenter suggested collecting data on the characteristics of the corrections and plans utilizing the program, including the amount of correction, the types of transactions corrected, the size of retirement plans, the date of the prohibited transaction, and the date by which participant contributions or loan repayments were supposed to be remitted to the plan. The commenter also suggested to conduct follow-up surveys or interviews with plans that use the VFC program. While this data could be beneficial, the Department seeks to minimize administrative costs.</P>
                    <P>An additional and significant benefit of the VFC Program accrues to participants and beneficiaries through the correction of fiduciary breaches and the restoration to the plan of amounts representing losses or improperly generated profits arising from impermissible transactions, resulting in greater security of plan assets and future benefits. Encouraging greater participation in the VFC Program by lowering the costs of using it could help reduce the need for plan participants to pursue legal action.</P>
                    <P>
                        These changes to the VFC Program will reduce associated costs by reducing the number of hours required to make corrections and file applications. Compared with the existing VFC Program, the Department expects the amended Program's per-user costs to be lower because the amendments could move 73 percent of the expected VFC Program applications to the SCC.
                        <SU>41</SU>
                        <FTREF/>
                         Moreover, implementing the SCC will reduce the recordkeeping and reporting cost for Plan Officials with small amounts of delinquent participant contributions and loan repayments, because they no longer will have to submit an application to the Department with extensive supporting documentation, but instead will merely submit a self-correction notice with minimal data to the Department and provide corroborating documentation to the plan administrator.
                    </P>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             The Department estimates that the SCC will streamline the process for 73 percent of small and large VFC cases involving Lost Earnings less than or equal to $1,000.
                        </P>
                    </FTNT>
                    <P>This SCC also provides additional flexibility and potentially increase use to Plan Officials by eliminating the three-year limitation in the PTE. Please see Table 2 for estimates and cost savings for VFC Program applicants. The estimates presented in Column A are obtained using similar assumptions and methods as in Column B. The estimates presented in Column B are based on the estimates presented in Table 7.</P>
                    <PRTPAGE P="4205"/>
                    <GPOTABLE COLS="4" OPTS="L2(,0,),nj,i1" CDEF="s100,17,17,12">
                        <TTITLE>Table 2—Cost Savings for VFC Program Applicants From Program and Exemption Changes</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                Cost before
                                <LI>program and</LI>
                                <LI>exemption changes</LI>
                            </CHED>
                            <CHED H="1">Cost after program and exemption changes</CHED>
                            <CHED H="1">Cost savings</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT>(A)</ENT>
                            <ENT>(B)</ENT>
                            <ENT>(A−B)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Traditional VFC Program (annual)</ENT>
                            <ENT>$765,570</ENT>
                            <ENT>$215,876</ENT>
                            <ENT>$549,693</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">SCC (annual)</ENT>
                            <ENT/>
                            <ENT>355,910</ENT>
                            <ENT>−355,910</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">VFCP Exemption (annual)</ENT>
                            <ENT>120,236</ENT>
                            <ENT>120,236</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total (annual)</ENT>
                            <ENT>885,806</ENT>
                            <ENT>692,023</ENT>
                            <ENT>193,784</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>Plans or their service providers will need to familiarize themselves with the changes to the VFC Program and amendments to the PTE. Service providers may help multiple plans in a year or across years, so while it could take a service provider multiple hours to review the amended requirements, the actual burden impact on an individual plan would be less. The Department assumes that it will take two hours per plan to review the changes and fill out the VFCP application. Please see Table 3 for calculations and burden totals.</P>
                    <GPOTABLE COLS="6" OPTS="L2(,0,),nj,i1" CDEF="s50,11,10,10,7,11">
                        <TTITLE>Table 3—Hour Burden for Rule Familiarization</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Number of entities</CHED>
                            <CHED H="1">
                                Number of hours per
                                <LI>entity</LI>
                            </CHED>
                            <CHED H="1">
                                Total hour
                                <LI>burden</LI>
                            </CHED>
                            <CHED H="1">
                                Hourly
                                <LI>wage</LI>
                            </CHED>
                            <CHED H="1">
                                Dollar
                                <LI>equivalent</LI>
                                <LI>of hour</LI>
                                <LI>burden</LI>
                            </CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"/>
                            <ENT>(A)</ENT>
                            <ENT>(B)</ENT>
                            <ENT>(A × B)</ENT>
                            <ENT>(C)</ENT>
                            <ENT>(A × B × C)</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Compensation and benefits managers familiarize with the changes to the VFC Program and Exemption (first year)</ENT>
                            <ENT>1,237</ENT>
                            <ENT>2</ENT>
                            <ENT>2,474</ENT>
                            <ENT>$124.75</ENT>
                            <ENT>$308,632</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>1,237</ENT>
                            <ENT/>
                            <ENT>2,474</ENT>
                            <ENT/>
                            <ENT>308,632</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        Overall, the Department estimates that the costs of the VFC Program and the associated class exemption, in their amended forms, would total approximately $690,798 ($669,600 in annual equivalent costs reflecting the monetized cost of the work performed by in-house personnel and outside service providers and $21,198 in annual cost burden reflecting the cost of materials and postage). Over 10 years, the costs associated with the VFC Program and associated class exemption would total approximately $7.5 million, annualized to $1 million per year (using a 7 percent discount rate).
                        <SU>42</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             Over 10 years, the costs associated with the VFCP Program and associated class exemption would total approximately $8.8 million, annualized to $1 million per year (using a 3 percent discount rate).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">2. Paperwork Reduction Act</HD>
                    <P>
                        In accordance with the Paperwork Reduction Act of 1995 (PRA 95) (
                        <E T="03">44 U.S.C. 350(c))(2)(A)</E>
                        ), the Department solicited comments concerning the information collection request (ICR) included in the 2022 VFC Program proposed revisions. At the same time, the Department also submitted the ICR to OMB, in accordance with 
                        <E T="03">44 U.S.C. 3507(d).</E>
                    </P>
                    <P>The Department received a comment that specifically addressed the paperwork burden analysis of the information collection requirements contained in the 2022 VFC Program proposed revisions. The commenter attempted to adjust the labor wage rates; however, the Department has already accounted for inflation in the labor rates.</P>
                    <P>
                        The changes made by these final rules affect the existing OMB control number, 1210-0118. A copy of the ICR for OMB Control Number 1210-0118 may be obtained by contacting the PRA addressee listed in the following sentence or at 
                        <E T="03">www.RegInfo.gov.</E>
                         For additional information contact, U.S. Department of Labor, Employee Benefits Security Administration, Office of Research and Analysis, Attention: PRA Officer, 200 Constitution Avenue NW, Room N-5718, Washington, DC 20210; or send to 
                        <E T="03">ebsa.opr@dol.gov.</E>
                    </P>
                    <P>The amended VFC Program, described above, includes a SCC for delinquent participant contributions and loan repayments to pension plans involving Lost Earnings less than or equal to $1,000, streamlined requirements for bulk applications, and it expands and modifies transactions that are currently eligible for the VFC Program. The SCC permits applicants to self-correct, and then provide EBSA with a notice of the self-correction through the online VFC Program web tool. Service providers are able to submit bulk applications to the VFC Program, under the existing terms and requirements of the Program, with some easing of the eligibility and information requirements. Under the new bulk applicant provisions, the bulk applicant will receive a no action letter providing relief only to the service provider correcting transactions involving each of the plans named in the application.</P>
                    <P>
                        An average of 1,226 applicants per year used the VFC Program from 2021 to 2023. The Department estimates that the 73 percent of VFC Program applicants will move to the SCC.
                        <SU>43</SU>
                        <FTREF/>
                         Please see Table 1 for the number of plans that will utilize the VFC Program and associated class exemption PTE 2002-51.
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             The Department estimates that the Self-Correction Component will streamline the process for the 73 percent of small and large VFC Program applicants involving Lost Earnings less than or equal to $1,000.
                        </P>
                    </FTNT>
                    <P>
                        In addition to the VFC Program, the Department is publishing a final amendment to the associated class exemption PTE 2002-51, which applies only to qualifying applicants and self-correctors participating in the VFC Program. The exemption is currently unavailable to VFC Program applicants that have, within the previous three years, taken advantage of the relief 
                        <PRTPAGE P="4206"/>
                        provided by the VFC Program and the exemption for a similar type of transaction. The three-year provision was initially included in the exemption to prevent parties from becoming lax in complying with fiduciary and other ERISA duties because of the availability of the exemption. Based on the Department's experience with the VFC Program and the exemption, the Department concluded that the risk of such behavior is low and therefore is eliminating the three-year limitation.
                    </P>
                    <P>The overall paperwork burden for the amended VFC Program and the amended PTE 2002-51 is provided below.</P>
                    <HD SOURCE="HD3">VFC Program</HD>
                    <P>For the VFC Program, the Department estimates that Plan Officials will devote 2.5 hours of clerical staff gathering paperwork, one hour of a compensation and benefits manager calculating Lost Earnings, and one hour of clerical staff engaging in recordkeeping activities for each non-bulk application or self-correction. The Department estimates that for each bulk application, Plan Officials will devote 25 hours of clerical staff gathering paperwork, 10 hours of a compensation and benefits manager calculating Lost Earnings, and 10 hours of clerical staff engaging in recordkeeping activities. Please see Table 4 for calculations and burden totals.</P>
                    <GPOTABLE COLS="6" OPTS="L2(,0,),nj,i1" CDEF="s50,11,10,10,7,15">
                        <TTITLE>Table 4—Hour Burden of VFC Program</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                Number
                                <LI>of entities</LI>
                            </CHED>
                            <CHED H="1">
                                Number of
                                <LI>hours per</LI>
                                <LI>entity</LI>
                            </CHED>
                            <CHED H="1">
                                Total hour
                                <LI>burden</LI>
                            </CHED>
                            <CHED H="1">
                                Wage
                                <LI>rate</LI>
                            </CHED>
                            <CHED H="1">
                                Dollar
                                <LI>equivalent</LI>
                                <LI>of hour burden</LI>
                            </CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT>(A)</ENT>
                            <ENT>(B)</ENT>
                            <ENT>(A × B)</ENT>
                            <ENT>(C)</ENT>
                            <ENT>(A × B × C)</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">Traditional VFC Program</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Compensation and benefits managers calculate Lost Earnings (non-bulk)</ENT>
                            <ENT>326</ENT>
                            <ENT>1</ENT>
                            <ENT>326</ENT>
                            <ENT>$140.32</ENT>
                            <ENT>$45,744</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Clerical staff gather information (non-bulk)</ENT>
                            <ENT>326</ENT>
                            <ENT>2.5</ENT>
                            <ENT>815</ENT>
                            <ENT>65.99</ENT>
                            <ENT>53,782</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Clerical staff maintain recordkeeping (non-bulk)</ENT>
                            <ENT>326</ENT>
                            <ENT>1</ENT>
                            <ENT>326</ENT>
                            <ENT>65.99</ENT>
                            <ENT>21,513</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Compensation and benefits managers calculate Lost Earnings (bulk)</ENT>
                            <ENT>2</ENT>
                            <ENT>10</ENT>
                            <ENT>20</ENT>
                            <ENT>140.32</ENT>
                            <ENT>2,806</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Clerical staff gather information (bulk)</ENT>
                            <ENT>2</ENT>
                            <ENT>25</ENT>
                            <ENT>50</ENT>
                            <ENT>65.99</ENT>
                            <ENT>3,300</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Clerical staff maintain recordkeeping (bulk)</ENT>
                            <ENT>2</ENT>
                            <ENT>10</ENT>
                            <ENT>20</ENT>
                            <ENT>65.99</ENT>
                            <ENT>1,320</ENT>
                        </ROW>
                        <ROW EXPSTB="05" RUL="s">
                            <ENT I="21">
                                <E T="02">SCC</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Compensation and benefits managers calculate Lost Earnings</ENT>
                            <ENT>909</ENT>
                            <ENT>1</ENT>
                            <ENT>909</ENT>
                            <ENT>140.32</ENT>
                            <ENT>127,551</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Clerical staff gather information</ENT>
                            <ENT>909</ENT>
                            <ENT>2.5</ENT>
                            <ENT>2,273</ENT>
                            <ENT>65.99</ENT>
                            <ENT>149,962</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Clerical staff maintain recordkeeping</ENT>
                            <ENT>909</ENT>
                            <ENT>1</ENT>
                            <ENT>909</ENT>
                            <ENT>65.99</ENT>
                            <ENT>59,985</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>1,237</ENT>
                            <ENT/>
                            <ENT>5,648</ENT>
                            <ENT/>
                            <ENT>465,963</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        The Department estimates that external service providers will spend about 10 minutes completing and submitting the online SCC notice, 20 hours completing and submitting bulk applications, and two hours completing and submitting all other applications.
                        <SU>44</SU>
                        <FTREF/>
                         The mailing cost per application is approximately $10.
                        <SU>45</SU>
                        <FTREF/>
                         Please see Table 5 for calculations and burden totals.
                    </P>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             It should be noted that the required checklist for applications filed with the Department under the Program appears twice within the Appendices to the Program. While it is required to be submitted only once, it is included as the separate Appendix B for applicants who do not choose to use the model application in Appendix E, and separately as the final item in the model application for ease of use for those who do choose to use the model application.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             United States Postal Service, Priority Mail, (2024), 
                            <E T="03">https://www.usps.com/ship/priority-mail.htm.</E>
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="8" OPTS="L2(,0,),nj,p7,7/8,i1" CDEF="s50,11,10,10,7,11,11,10">
                        <TTITLE>Table 5—Hour and Cost Burden of Service Providers for VFC Program</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                Number
                                <LI>of entities</LI>
                            </CHED>
                            <CHED H="1">
                                Number of
                                <LI>hours per</LI>
                                <LI>entity</LI>
                            </CHED>
                            <CHED H="1">
                                Total hour
                                <LI>burden</LI>
                            </CHED>
                            <CHED H="1">
                                Wage
                                <LI>rate</LI>
                            </CHED>
                            <CHED H="1">
                                Dollar
                                <LI>equivalent</LI>
                                <LI>of hour</LI>
                                <LI>burden</LI>
                            </CHED>
                            <CHED H="1">Mailing cost per entity</CHED>
                            <CHED H="1">Cost burden</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT>(A)</ENT>
                            <ENT>(B)</ENT>
                            <ENT>(A × B)</ENT>
                            <ENT>(C)</ENT>
                            <ENT>(A × B × C)</ENT>
                            <ENT>(D)</ENT>
                            <ENT>(A × D)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Service providers prepare information (non-bulk)</ENT>
                            <ENT>326</ENT>
                            <ENT>2</ENT>
                            <ENT>652</ENT>
                            <ENT>$121.53</ENT>
                            <ENT>$79,238</ENT>
                            <ENT>$10.10</ENT>
                            <ENT>$3,293</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Service providers prepare information (bulk)</ENT>
                            <ENT>2</ENT>
                            <ENT>20</ENT>
                            <ENT>40</ENT>
                            <ENT>121.53</ENT>
                            <ENT>4,861</ENT>
                            <ENT>10.10</ENT>
                            <ENT>20</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Service providers maintain recordkeeping for SCC</ENT>
                            <ENT>909</ENT>
                            <ENT>0.17</ENT>
                            <ENT>152</ENT>
                            <ENT>121.53</ENT>
                            <ENT>18,412</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>1,237</ENT>
                            <ENT/>
                            <ENT>844</ENT>
                            <ENT/>
                            <ENT>102,511</ENT>
                            <ENT/>
                            <ENT>3,313</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">VFCP Class Exemption (PTE 2002-51)</HD>
                    <P>
                        The Department estimates that all self-correctors and VFC Program applicants will use the amended class exemption. The Department has determined that service providers will prepare the documentation required by the exemption which will require approximately one hour for completion and delivery. VFC Program applicants are required to send notices to their participants and beneficiaries. The mailing cost per notice is $0.78.
                        <SU>46</SU>
                        <FTREF/>
                         Please see Table 6 for calculations and burden totals.
                    </P>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             The mailing cost is calculated in the following manner: (1 page × $0.73 for postage + $0.05 for material costs) = $0.78.
                        </P>
                    </FTNT>
                    <PRTPAGE P="4207"/>
                    <GPOTABLE COLS="8" OPTS="L2(,0,),nj,p7,7/8,i1" CDEF="s50,11,10,10,7,11,11,10">
                        <TTITLE>Table 6—Hour and Cost Burden of VFCP Exemption</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                Number
                                <LI>of entities</LI>
                            </CHED>
                            <CHED H="1">
                                Number of
                                <LI>hours per</LI>
                                <LI>entity</LI>
                            </CHED>
                            <CHED H="1">
                                Total hour
                                <LI>burden</LI>
                            </CHED>
                            <CHED H="1">
                                Wage
                                <LI>rate</LI>
                            </CHED>
                            <CHED H="1">
                                Dollar
                                <LI>equivalent</LI>
                                <LI>of hour</LI>
                                <LI>burden</LI>
                            </CHED>
                            <CHED H="1">Mailing cost per entity</CHED>
                            <CHED H="1">Cost burden</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT>(A)</ENT>
                            <ENT>(B)</ENT>
                            <ENT>(A × B)</ENT>
                            <ENT>(C)</ENT>
                            <ENT>(A × B × C)</ENT>
                            <ENT>(D)</ENT>
                            <ENT>(A × D)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Service providers prepare information</ENT>
                            <ENT>389</ENT>
                            <ENT>1</ENT>
                            <ENT>389</ENT>
                            <ENT>$121.53</ENT>
                            <ENT>$47,235</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Participants receiving notices for exemption through mail, prepared by service providers</ENT>
                            <ENT>24,500</ENT>
                            <ENT>0.03</ENT>
                            <ENT>817</ENT>
                            <ENT>65.99</ENT>
                            <ENT>53,892</ENT>
                            <ENT>$0.78</ENT>
                            <ENT>$19,110</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Total</ENT>
                            <ENT>24,889</ENT>
                            <ENT/>
                            <ENT>1,205</ENT>
                            <ENT/>
                            <ENT>101,126</ENT>
                            <ENT/>
                            <ENT>19,110</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">Summary</HD>
                    <P>Please see Table 7 for the total annual hour and cost burden for the information collection arising from the VFC Program and the exemption.</P>
                    <GPOTABLE COLS="5" OPTS="L2(,0,),nj,i1" CDEF="s50,12,12,12,12">
                        <TTITLE>Table 7—Total Annual Hour and Cost Burden</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">
                                Total hour
                                <LI>burden</LI>
                            </CHED>
                            <CHED H="1">
                                Total dollar
                                <LI>equivalent of</LI>
                                <LI>hour burden</LI>
                            </CHED>
                            <CHED H="1">
                                Total cost
                                <LI>burden</LI>
                            </CHED>
                            <CHED H="1">Total cost</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT>(A)</ENT>
                            <ENT>(B)</ENT>
                            <ENT>(C)</ENT>
                            <ENT>(B + C)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">VFC Program</ENT>
                            <ENT>6,491</ENT>
                            <ENT>$568,473</ENT>
                            <ENT>$3,313</ENT>
                            <ENT>$571,786</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">VFCP Exemption</ENT>
                            <ENT>1,205</ENT>
                            <ENT>101,126</ENT>
                            <ENT>19,110</ENT>
                            <ENT>120,236</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>7,696</ENT>
                            <ENT>669,600</ENT>
                            <ENT>22,423</ENT>
                            <ENT>692,023</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>In summary, the categories in the table below encompass the numbers for both the VFC Program and the amended class exemption:</P>
                    <P>
                        <E T="03">Type of Review:</E>
                         Revision of currently approved collection of information.
                    </P>
                    <P>
                        <E T="03">Agency:</E>
                         Department of Labor, Employee Benefits Security Administration.
                    </P>
                    <P>
                        <E T="03">Title:</E>
                         Voluntary Fiduciary Correction Program.
                    </P>
                    <P>
                        <E T="03">OMB Number:</E>
                         1210-0118.
                    </P>
                    <P>
                        <E T="03">Affected Public:</E>
                         Individuals or households; Business or other for-profit; Not-for-profit institutions.
                    </P>
                    <P>
                        <E T="03">Respondents:</E>
                         1,237.
                    </P>
                    <P>
                        <E T="03">Frequency of Response:</E>
                         On occasion.
                    </P>
                    <P>
                        <E T="03">Responses:</E>
                         59,991.
                    </P>
                    <P>
                        <E T="03">Estimated Total Burden Hours:</E>
                         7,696.
                    </P>
                    <P>
                        <E T="03">Total Annual Cost (Operating and Maintenance):</E>
                         $22,423.
                    </P>
                    <HD SOURCE="HD2">3. Regulatory Flexibility Analysis</HD>
                    <P>
                        The Regulatory Flexibility Act (RFA) 
                        <SU>47</SU>
                        <FTREF/>
                         imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act, or any other law, and are likely to have a significant economic impact on a substantial number of small entities.
                        <SU>48</SU>
                        <FTREF/>
                         Unless the head of an agency certifies that a final rule will not have a significant economic impact on a substantial number of small entities, section 604 
                        <SU>49</SU>
                        <FTREF/>
                         of the RFA requires the agency to present a final regulatory flexibility analysis of these final rules.
                    </P>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             5 U.S.C. 601 
                            <E T="03">et seq.</E>
                             (1980).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             5 U.S.C. 551 
                            <E T="03">et seq.</E>
                             (1946).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             5 U.S.C. 604 (1980).
                        </P>
                    </FTNT>
                    <P>This document describes an enforcement policy of the Department that is not being issued as a general notice of final rulemaking. Therefore, the RFA does not apply. However, the Department is also issuing a final amendment to a class exemption (PTE 2002-51) to which the Regulatory Flexibility Act does apply. The Department certifies that the amendments to PTE 2002-51 will not have a significant economic impact on a substantial number of small entities. However, EBSA considered the potential costs and benefits of this action for small pension plans and the Plan Officials in developing the final amendment to the class exemption and believes that its greater simplicity and accessibility would make the Program more useful to small employers who wish to avail themselves of the relief offered under the exemption. Below is the factual basis for the certification.</P>
                    <P>
                        As mentioned previously, all pension and welfare plans can utilize the VFC Program with the related PTE if they have a fiduciary breach for which there is an eligible transaction. In 2021 there were 630,423 small defined contribution plans and 39,673 small defined benefit plans and plan officials that would be impacted by these changes.
                        <SU>50</SU>
                        <FTREF/>
                         In 2022 there were 2,710,128 small health plans that would also be impacted by these changes.
                        <SU>51</SU>
                        <FTREF/>
                         Currently 1,226 plan fiduciaries make use of the VFC Program in a given year and the Department projects a small increase to 1,237 fiduciaries making use of the VFC Program in a given year.
                        <SU>52</SU>
                        <FTREF/>
                         Please see Table 1 for the number of plans that will utilize the VFC Program and exemption.
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             Employee Benefits Security Administration, 
                            <E T="03">Private Pension Plan Bulletin: Abstract of 2021 Form 5500 Annual Reports,</E>
                             (September 2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             U.S. Department of Labor, EBSA calculations using the 2022 Medical Expenditure Panel Survey, Insurance Component (MEPS-IC), and 2020 Census County Business Patterns.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             As discussed earlier in this regulatory impact analysis, the Department estimates a one percent increase in the number of self-corrections, or 909 self-corrections, resulting from the removal of the three-year limitation provision for self-correctors. Additionally, the Department also projects that changes to the VFC Program will result in two new Program users filing bulk applications and 326 Program users filing non-bulk applications. Thus, the number of fiduciaries making use of the VFC Program in a given year is calculated in the following manner: 909 self-corrections + 326 non-bulk applications + 2 bulk applications = 1,237.
                        </P>
                    </FTNT>
                    <P>
                        The Department is amending the related PTE so that excise tax relief will be available for transactions that are corrected under the SCC. The Department is also amending the PTE to eliminate the three-year limitation. Thus, all plans eligible to use the VFC Program would be eligible to use the PTE more than just once every three years. However, the Department 
                        <PRTPAGE P="4208"/>
                        estimates that, of the total number of pension and welfare plans significantly less than one percent will use the PTE in a given year.
                        <SU>53</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             In 2021, there were 765,124 pension plans. (
                            <E T="03">Source:</E>
                             Employee Benefits Security Administration, 
                            <E T="03">Private Pension Plan Bulletin: Abstract of 2021 Form 5500 Annual Reports,</E>
                             (September 2023).) In 2022, there were 630,000 welfare benefit plans. (
                            <E T="03">Source:</E>
                             U.S. Department of Labor, EBSA calculations using non-health welfare plan Form 5500 filings and projecting non-filers using estimates based on the non-filing health universe.) Thus, 0.08% of all pension and welfare plans will use the PTE in a given year. (909 plans/(765,124 plans + 630,000 welfare benefit plans) = 0.07 percent.)
                        </P>
                    </FTNT>
                    <P>
                        The final amended PTE provides excise tax relief for self-correctors if they pay the amount of the excise tax owed to the plan. The SCC can only be used in situations where the size of Lost Earnings is $1,000 or less. Code section 4975(a) imposes an excise tax on each prohibited transaction equal to 15 percent of the amount involved with respect to the prohibited transaction for each year (or part thereof) in the taxable period. Therefore, the maximum excise tax owed for each year would generally not exceed $150.
                        <SU>54</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             Under Reorganization Plan No. 4 of 1978, supra n. 1, the Secretary of the Treasury retains interpretive authority over Code sections 4975(a) and (b).
                        </P>
                    </FTNT>
                    <P>
                        Plans or their service providers will need to familiarize themselves with the amendments to the PTE. Service providers can help multiple plans in a year or across years, so, although it could take a service provider multiple hours to review the amended requirements, the actual burden impact on an individual plan would be less. The Department estimates that all self-correctors will use the new provisions of the amended class exemption. The per-plan cost for rule familiarization would be $140.
                        <SU>55</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             With an hourly rate for the in-house compensation and benefits manager of $140.32 per hour and one hour of burden allocated to a plan, the burden be plan would be $140 (rounded).
                        </P>
                    </FTNT>
                    <P>For plans with the maximum Lost Earnings of $1,000 and an excise tax of 15 percent the maximum excise tax in each year would generally not exceed $150. Including the cost of rule familiarization of $140, the total expense could be $290 in a year. Based on the foregoing, the Department hereby certifies that these final amendments will not have a significant economic impact on a substantial number of small entities. Therefore, the Department has not prepared a Final Regulatory Flexibility Analysis.</P>
                    <HD SOURCE="HD2">4. Unfunded Mandates Reform Act</HD>
                    <P>For purposes of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), as well as Executive Order 12875, this action does not include any Federal mandate that may result in expenditures by State, local, or Tribal governments in the aggregate of more than $100 million, adjusted for inflation, or increase expenditures by the private sector of more than $100 million, adjusted for inflation.</P>
                    <HD SOURCE="HD2">5. Federalism Statement</HD>
                    <P>Executive Order 13132 (August 4, 1999) outlines fundamental principles of federalism and requires the adherence to specific criteria by Federal agencies in the process of their formulation and implementation of policies that have “substantial direct effects” on the States, the relationship between the national government and States, or on the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have federalism implications must consult with State and local officials and describe the extent of their consultation and the nature of the concerns of State and local officials. This action does not have federalism implications because it has no substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Section 514 of ERISA provides, with certain exceptions specifically enumerated, that the provisions of titles I and IV of ERISA supersede any and all laws of the States as they relate to any employee benefit plan covered under ERISA. The amendments of the VFC Program in this document do not alter the fundamental provisions of the statute with respect to employee benefit plans, and as such would have no implications for the States or the relationship or distribution of power between the national government and the States.</P>
                    <HD SOURCE="HD2">6. Congressional Review Act</HD>
                    <P>
                        The VFC Program is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 
                        <E T="03">et seq.</E>
                        ) and will be transmitted to the Congress and the Comptroller General for review. OIRA has determined that The Program does not meet the criteria set forth in 5 U.S.C. 803(2) under the Act. The Program is not a “major rule” as that term is defined in 5 U.S.C. 804.
                    </P>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>Authority: Secretary of Labor's Order 1-2011, 77 FR 1088 (January 9, 2012). 29 U.S.C. 1132(a)(2) and (a)(5), 1136(b).</P>
                    </AUTH>
                    <HD SOURCE="HD1">Voluntary Fiduciary Correction Program </HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">Section 1. Purpose and Overview of the VFC Program</FP>
                        <FP SOURCE="FP-2">Section 2. Effect of the VFC Program</FP>
                        <FP SOURCE="FP-2">Section 3. Definitions</FP>
                        <FP SOURCE="FP-2">Section 4. VFC Program Eligibility</FP>
                        <FP SOURCE="FP-2">Section 5. General Rules for Acceptable Corrections</FP>
                        <FP SOURCE="FP1-2">(a) Fair Market Determinations</FP>
                        <FP SOURCE="FP1-2">(b) Correction Amount</FP>
                        <FP SOURCE="FP1-2">(c) Costs of Correction</FP>
                        <FP SOURCE="FP1-2">(d) Distributions</FP>
                        <FP SOURCE="FP1-2">(e) De Minimis Exception</FP>
                        <FP SOURCE="FP-2">Section 6. VFC Program Application and Self-Correction Component Procedures</FP>
                        <FP SOURCE="FP1-2">6.1 VFC Program Application Procedures</FP>
                        <FP SOURCE="FP1-2">6.2 VFC Program Self-Correction Component Procedures</FP>
                        <FP SOURCE="FP-2">Section 7. Description of Eligible Transactions and Corrections Under the VFC Program</FP>
                        <FP SOURCE="FP1-2">7.1 Delinquent Remittance of Participant Funds</FP>
                        <FP SOURCE="FP1-2">(a) Delinquent Participant Contributions and Loan Repayments to Pension Plans Under VFC Program Applications</FP>
                        <FP SOURCE="FP1-2">(b) Delinquent Participant Contributions and Loan Repayments to Pension Plans Under the Self-Correction Component</FP>
                        <FP SOURCE="FP1-2">(c) Delinquent Participant Contributions to Insured Welfare Plans</FP>
                        <FP SOURCE="FP1-2">(d) Delinquent Participant Contributions to Welfare Plan Trusts</FP>
                        <FP SOURCE="FP1-2">7.2 Loans</FP>
                        <FP SOURCE="FP1-2">(a) Loan at Fair Market Interest Rate to a Party in Interest With Respect to the Plan</FP>
                        <FP SOURCE="FP1-2">(b) Loan at Below-Market Interest Rate to a Party in Interest With Respect to the Plan</FP>
                        <FP SOURCE="FP1-2">(c) Loan at Below-Market Interest Rate to a Person Who Is Not a Party in Interest With Respect to the Plan</FP>
                        <FP SOURCE="FP1-2">(d) Loan at Below-Market Interest Rate Solely Due to a Delay in Perfecting the Plan's Security Interest</FP>
                        <FP SOURCE="FP1-2">7.3 Participant Loans</FP>
                        <FP SOURCE="FP1-2">(a) Loans Failing To Comply With Plan Provisions for Amount, Duration, or Level Amortization Under VFC Program Applications</FP>
                        <FP SOURCE="FP1-2">(b) Default Loans Under VFC Program Applications</FP>
                        <FP SOURCE="FP1-2">(c) Eligible Inadvertent Participant Loan Failures Under the Self-Correction Component</FP>
                        <FP SOURCE="FP1-2">7.4 Purchases, Sales and Exchanges</FP>
                        <FP SOURCE="FP1-2">(a) Purchase of an Asset (Including Real Property) by a Plan From a Party in Interest</FP>
                        <FP SOURCE="FP1-2">(b) Sale of an Asset (Including Real Property) by a Plan to a Party in Interest</FP>
                        <FP SOURCE="FP1-2">(c) Sale and Leaseback of Real Property to Employer</FP>
                        <FP SOURCE="FP1-2">(d) Purchase of an Asset (Including Real Property) by a Plan From a Person Who Is Not a Party in Interest With Respect to the Plan at a Price More Than Fair Market Value</FP>
                        <FP SOURCE="FP1-2">(e) Sale of an Asset (Including Real Property) by a Plan to a Person Who Is Not a Party in Interest With Respect to the Plan at a Price Less Than Fair Market Value</FP>
                        <FP SOURCE="FP1-2">
                            (f) Holding of an Illiquid Asset Previously Purchased by a Plan
                            <PRTPAGE P="4209"/>
                        </FP>
                        <FP SOURCE="FP1-2">7.5 Benefits</FP>
                        <FP SOURCE="FP1-2">(a) Payment of Benefits Without Properly Valuing Plan Assets on Which Payment Is Based</FP>
                        <FP SOURCE="FP1-2">7.6 Plan Expenses</FP>
                        <FP SOURCE="FP1-2">(a) Duplicative, Excessive, or Unnecessary Compensation Paid by a Plan</FP>
                        <FP SOURCE="FP1-2">(b) Expenses Improperly Paid by a Plan</FP>
                        <FP SOURCE="FP1-2">(c) Payment of Dual Compensation to a Plan Fiduciary</FP>
                        <FP SOURCE="FP-2">Appendix A. Sample VFC Program No Action Letter</FP>
                        <FP SOURCE="FP-2">Appendix B. VFC Program Application Checklist (Required)</FP>
                        <FP SOURCE="FP-2">Appendix C. List of EBSA Regional Offices</FP>
                        <FP SOURCE="FP-2">Appendix D. Lost Earnings Example</FP>
                        <FP SOURCE="FP-2">Appendix E. Model Application Form (Optional)</FP>
                        <FP SOURCE="FP-2">Appendix F. SCC Retention Record Checklist (Required)</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">Section 1. Purpose and Overview of the VFC Program</HD>
                    <P>The purpose of the Voluntary Fiduciary Correction Program (VFC Program or Program), including its Self-Correction Component (SCC), is to protect the financial security of workers by encouraging identification and correction of transactions that violate or may violate Part 4 of Title I of the Employee Retirement Income Security Act of 1974, as amended (ERISA). Part 4 of Title I of ERISA sets out the responsibilities of employee benefit plan fiduciaries. Section 409 of ERISA provides that a fiduciary who breaches any of these responsibilities shall be personally liable to make good to the plan any losses to the plan resulting from each breach and to restore to the plan any profits the fiduciary made through the use of the plan's assets. Section 405 of ERISA provides that a fiduciary may be liable, under certain circumstances, for a breach of fiduciary responsibility by a co-fiduciary. In addition, under certain circumstances, there may be liability for knowing participation in a fiduciary breach. In order to assist all affected persons in understanding the requirements of ERISA and meeting their legal responsibilities, the Employee Benefits Security Administration (EBSA) is providing guidance on what constitutes adequate correction under Title I of ERISA for the Breaches described in this Program.</P>
                    <HD SOURCE="HD1">Section 2. Effect of the VFC Program</HD>
                    <P>
                        (a)(1) 
                        <E T="03">Effect of a no action letter.</E>
                         EBSA generally will issue to the applicant a no action letter 
                        <SU>56</SU>
                        <FTREF/>
                         with respect to a Breach identified in the Program application if the eligibility requirements of section 4 are satisfied and a Plan Official corrects a Breach, as defined in section 3, in accordance with the requirements of sections 5, 6 and 7. Pursuant to the no action letter it issues, EBSA will not initiate a civil investigation under Title I of ERISA regarding the applicant's responsibility for any transaction described in the no action letter, or assess civil penalties under either section 502(l) or 502(i) of ERISA on the correction amount paid to the plan or its participants.
                    </P>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             
                            <E T="03">See</E>
                             appendix A.
                        </P>
                    </FTNT>
                    <P>
                        (2) 
                        <E T="03">Effect of correction under the Self-Correction Component.</E>
                         EBSA will not issue a no action letter to a self-corrector under the Program's SCC. A self-corrector will receive an acknowledgment and summary of the SCC notice submission by email. If the self-corrector satisfies the eligibility requirements of section 4 and corrects a Breach, as defined in section 3, in accordance with the requirements of sections 5, 6 and 7, EBSA will not initiate a civil investigation under Title I of ERISA regarding the self-corrector's responsibility for the Breach identified in the SCC notice or assess civil penalties under section 502(l) or 502(i) of ERISA on the correction amount paid to the plan or its participants.
                    </P>
                    <P>
                        (b) 
                        <E T="03">Verification.</E>
                         EBSA reserves the right to conduct an investigation at any time to determine (1) the truthfulness and completeness of the factual statements set forth in the Program application or the SCC notice and (2) that the corrective action was, in fact, taken.
                    </P>
                    <P>
                        (c) 
                        <E T="03">Limits on the effect of a no action letter under the VFC Program.</E>
                         (1) 
                        <E T="03">In general.</E>
                         Any no action letter issued under the VFC Program is limited to the Breach and applicants identified therein. Moreover, the method of calculating the correction amount described in this Program is only intended to correct the specific Breach described in the application. Methods of calculating losses other than, or in addition to, those set forth in the Program may be more appropriate, depending on the facts and circumstances, if the transaction violates provisions of ERISA other than those that can be corrected under the Program. If a transaction gave rise to Breaches not specifically described in the Program, the relief afforded by the Program would not extend to such additional Breaches.
                    </P>
                    <P>
                        (2) 
                        <E T="03">No implied approval of other matters.</E>
                         A no action letter does not imply Departmental approval of matters not included therein, including steps that the fiduciaries take to prevent recurrence of the Breach described in the application and to ensure the plan's future compliance with Title I of ERISA.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Material misrepresentation.</E>
                         Any no action letter issued under the VFC Program is conditioned on the truthfulness, completeness, and accuracy of the statements made in the application and of any subsequent oral and written statements or submissions. Any material misrepresentations or omissions will void the no action letter, retroactive to the date that the letter was issued by EBSA, with respect to the transaction that was materially misrepresented.
                    </P>
                    <P>
                        (4) 
                        <E T="03">Applicant fails to satisfy terms of the VFC Program.</E>
                         If an application fails to satisfy the terms of the VFC Program, as determined by EBSA, EBSA reserves the right to investigate and take any other action with respect to the transaction and/or plan that is the subject of the application, including issuing a rejection letter.
                    </P>
                    <P>
                        (5) 
                        <E T="03">Criminal investigations not precluded.</E>
                         Participation in the VFC Program will not preclude:
                    </P>
                    <P>(i) EBSA or any other governmental agency from conducting a criminal investigation of the transaction identified in the application;</P>
                    <P>(ii) EBSA's assistance to such other agency; or</P>
                    <P>
                        (iii) EBSA from making the appropriate referrals of criminal violations as required by section 506(b) of ERISA.
                        <SU>57</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             Section 506(b) provides that the Secretary of Labor shall have the responsibility and authority to detect and investigate and refer, where appropriate, civil and criminal violations related to the provisions of Title I of ERISA and other related Federal laws, including the detection, investigation, and appropriate referrals of related violations of Title 18 of the United States Code.
                        </P>
                    </FTNT>
                    <P>
                        (6) 
                        <E T="03">Other actions not precluded.</E>
                         Compliance with the terms of the VFC Program will not preclude EBSA from taking any of the following actions:
                    </P>
                    <P>(i) Seeking removal from positions of responsibility with respect to a plan or other non-monetary injunctive relief against any person responsible for the transaction at issue;</P>
                    <P>
                        (ii) Referring information regarding the transaction to the Internal Revenue Service as required by section 3003(c) of ERISA; 
                        <SU>58</SU>
                        <FTREF/>
                         or
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             Section 3003(c) provides that, whenever the Secretary of Labor obtains information indicating that a party in interest or disqualified person is violating section 406 of ERISA, the Secretary of Labor shall transmit such information to the Secretary of the Treasury.
                        </P>
                    </FTNT>
                    <P>
                        (iii) Imposing civil penalties under section 502(c)(2) of ERISA based on the failure or refusal to file a timely, complete and accurate Annual Report Form 5500.
                        <SU>59</SU>
                        <FTREF/>
                         Applicants should be aware that amended annual report filings may be required if possible Breaches of ERISA have been identified, or if action is taken to correct possible 
                        <PRTPAGE P="4210"/>
                        Breaches in accordance with the VFC Program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             References herein to the Form 5500 include the Form 5500-SF as applicable.
                        </P>
                    </FTNT>
                    <P>
                        (7) 
                        <E T="03">Not binding on others.</E>
                         The issuance of a no action letter does not affect the ability of any other government agency, or any other person, to enforce any rights or carry out any authority they may have, with respect to matters described in the no action letter.
                    </P>
                    <P>
                        (8) 
                        <E T="03">Example.</E>
                         A plan fiduciary causes the plan to purchase real estate from the plan sponsor under circumstances to which no prohibited transaction exemption applies. In connection with this transaction, the purchase causes the plan assets to be no longer diversified, in violation of ERISA section 404(a)(1)(C). If the application reflects full compliance with the requirements of the Program, the Department's no action letter would apply to the violation of ERISA section 406(a)(1)(A) but would not apply to the violation of section 404(a)(1)(C).
                    </P>
                    <P>
                        (d) 
                        <E T="03">Limits on the effect of self-correction under the Self-Correction Component. (1) In general.</E>
                         Any relief afforded by a self-correction under the SCC is limited to the Breaches described in sections 7.1(b) and 7.3(c) of the Program and to the Plan Officials who complete the Penalty of Perjury Statement in accordance with section 6.2(e) and (f) respectively. If a transaction gives rise to Breaches not specifically described in sections 7.1(b) and 7.3(c) of the Program, the relief afforded by the SCC will not extend to such additional Breaches.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Self-corrector fails to satisfy the terms of the Self-Correction Component.</E>
                         If a self-corrector fails to satisfy the terms of the SCC, as determined by EBSA, EBSA reserves the right to investigate and take any other action with respect to the transaction and/or plan that is the subject of the self-correction.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Criminal investigations not precluded.</E>
                         Participation in the SCC will not preclude:
                    </P>
                    <P>(i) EBSA or any other governmental agency from conducting a criminal investigation of the transactions identified in sections 7.1(b) and 7.3(c) of the Program;</P>
                    <P>(ii) EBSA's assistance to such other agency; or</P>
                    <P>
                        (iii) EBSA from making the appropriate referrals of criminal violations as required by section 506(b) of ERISA.
                        <SU>60</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             
                            <E T="03">See supra</E>
                             note 54.
                        </P>
                    </FTNT>
                    <P>
                        (4) 
                        <E T="03">Other actions not precluded.</E>
                         Compliance with the terms of the SCC will not preclude EBSA from taking any of the following actions:
                    </P>
                    <P>(i) Seeking removal from positions of responsibility with respect to a plan or other non-monetary injunctive relief against any person responsible for the transaction at issue; or</P>
                    <P>(ii) Imposing civil penalties under section 502(c)(2) of ERISA based on the failure or refusal to file a timely, complete and accurate Annual Report Form 5500. Self-correctors should be aware that amended annual report filings may be required if action is taken to correct a Breach in accordance with submitting an SCC notice.</P>
                    <P>
                        (5) 
                        <E T="03">Not binding on others.</E>
                         Compliance with the SCC does not affect the ability of any other government agency, or any other person, to enforce any rights or carry out any authority they may have regarding the Breach corrected under the SCC.
                    </P>
                    <P>
                        <E T="03">Example.</E>
                         The plan sponsor withheld monies from employees' paychecks, which were to be contributed, in part, to both a 401(k) plan and an insured health benefit plan. The plan sponsor did not remit the funds to either plan until four months after the Date of Withholding or Receipt. The plan sponsor corrects both Breaches and pays the appropriate Lost Earnings amount to each of the plans. The plan sponsor properly completes and submits an SCC notice to EBSA identifying the transaction involving the 401(k) plan. Assuming all conditions of the SCC have been met, relief under the Program is provided to the plan sponsor as the self-corrector for the delinquent participant contributions to the 401(k) plan, but not for the delinquent participant contributions to the insured health benefit plan. However, the plan sponsor may submit an application to correct the Breach involving the insured health benefit plan contributions under section 7.1(c) of the Program.
                    </P>
                    <P>
                        (e) 
                        <E T="03">Correction.</E>
                         The correction criteria listed in the VFC Program represent EBSA enforcement policy with respect to both applications under the Program and use of the SCC, and are provided for informational purposes to the public, but are not intended to confer enforceable rights on any person who purports to correct a Breach. Applicants and self-correctors are advised that the term “correction” as used in the VFC Program is not necessarily the same as “correction” pursuant to section 4975 of the Internal Revenue Code (Code).
                        <SU>61</SU>
                        <FTREF/>
                         Correction may not be achieved under the Program by engaging in a prohibited transaction that is not subject to a prohibited transaction administrative exemption.
                    </P>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             
                            <E T="03">See</E>
                             section 4975(f)(5) of the Code; section 141.4975-13 of the temporary Treasury Regulations and section 53.4941(e)-1(c) of the Treasury Regulations. The Federal tax treatment of a violation and correction under the VFC Program (including the Federal income and employment tax consequences to participants, beneficiaries, and plan sponsors) are determined under the Code. The IRS has indicated that, unless and until the Department of the Treasury and the IRS issue further guidance, except in those instances where the fiduciary breach or its correction involve a tax abuse, correction under the VFC Program for a breach that constitutes a prohibited transaction under section 4975 of the Code generally will be treated as correction for purposes of section 4975. Also, correction under the VFC Program for a breach for which there is a similar failure under the IRS's EPCRS would generally be taken into account as correction under EPCRS.
                        </P>
                    </FTNT>
                    <P>
                        (f) 
                        <E T="03">EBSA's authority to investigate.</E>
                         EBSA reserves the right to conduct an investigation and take any other enforcement action relating to the transaction identified in a VFC Program application or SCC notice in certain circumstances, such as prejudice to the Department that may be caused by the expiration of the statute of limitations period, material misrepresentations or omissions, other abuses of the VFC Program, or significant harm to the plan or its participants that is not cured by the correction provided under the VFC Program. EBSA may also conduct a civil investigation and take any other enforcement action relating to matters not covered by the VFC Program application or SCC notice, or relating to other plans sponsored by the same plan sponsor, while a VFC Program application involving the plan or the plan sponsor is pending.
                    </P>
                    <P>
                        (g) 
                        <E T="03">Confidentiality.</E>
                         EBSA will maintain the confidentiality of any documents submitted under the VFC Program, to the extent permitted by law. However, as noted in paragraphs (c)(5) and (6) and (d)(3) and (4) of this section, EBSA has an obligation to make referrals to the Internal Revenue Service (IRS) and to refer to other agencies evidence of criminality and other information for law enforcement purposes.
                    </P>
                    <HD SOURCE="HD1">Section 3. Definitions</HD>
                    <P>(a) The terms used in this document have the same meaning as provided in section 3 of ERISA, 29 U.S.C. 1002, unless separately defined herein.</P>
                    <P>(b) The following definitions apply for purposes of the VFC Program:</P>
                    <P>
                        (1) 
                        <E T="03">Breach.</E>
                         The term “Breach” means any transaction that is or may be a violation of the fiduciary responsibility provisions contained in Part 4 of Title I of ERISA.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Plan Official.</E>
                         The term “Plan Official” means a plan fiduciary, plan sponsor, party in interest with respect to a plan, or other person who is in a position to correct a Breach by filing an 
                        <PRTPAGE P="4211"/>
                        application or submitting a SCC notice in accordance with the VFC Program's requirements.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Under Investigation.</E>
                         For purposes of section 4(a), a plan, potential applicant, or self-corrector shall be considered to be “Under Investigation” if any investigation, review or examination described in (i), (ii), (iii), (iv), or (v) of this section 3 exists, and the plan, a Plan Official, or any authorized plan representative has received a written or oral notice of the investigation, review or examination.
                    </P>
                    <P>(i) EBSA is conducting an investigation or review of the plan;</P>
                    <P>(ii) EBSA is conducting an investigation of the potential applicant, self-corrector, or plan sponsor in connection with an act or transaction directly related to the plan;</P>
                    <P>(iii) any governmental agency is conducting a criminal investigation of the plan, or of the potential applicant, self-corrector, or plan sponsor in connection with an act or transaction directly related to the plan;</P>
                    <P>(iv) the IRS is conducting an Employee Plans examination of the plan; or</P>
                    <P>(v) Other than investigations identified in sections 3(b)(3)(i), (ii), (iii), or (iv), the Pension Benefit Guaranty Corporation (PBGC), any state attorney general, any federal governmental agency, or any state insurance commissioner is conducting an investigation or examination of the plan, or of the applicant, self-corrector, or plan sponsor in connection with an act or transaction directly related to the plan, unless in the case of a VFC Program application, the applicant notifies EBSA, in writing, of such an investigation or examination at the time of the application.</P>
                    <P>An applicant notifying EBSA of an investigation or examination under section 3(b)(3)(v) must submit the name of the examining agency and a contact person at such agency. Upon receipt of an application including such information, EBSA will promptly notify the investigating agency in writing of the VFC Program application. EBSA's notice will afford the examining agency an opportunity to provide EBSA with information relevant to the investigation or examination. In response to the information received from the investigating agency, EBSA, in its sole discretion, may decline to issue a no action letter to the applicant.</P>
                    <P>For purposes of section 4(a), a plan shall not be considered to be “Under Investigation” merely because EBSA staff has contacted the plan, the applicant, the self-corrector, or the plan sponsor in connection with a participant complaint, unless the participant complaint concerns the transaction described in the application or identified in the SCC notice and the plan has not received the correction amount due under the Program as of the date EBSA staff contacted the plan, the applicant, the self-corrector, or the plan sponsor. A plan also is not considered to be “Under Investigation” if the accountant of the plan is undergoing a work paper review based on such accountant's audit of the plan by EBSA's Office of the Chief Accountant under the authority of ERISA section 504(a).</P>
                    <P>
                        <E T="03">Example 1.</E>
                         On March 1, the plan sponsor of a multiple employer welfare arrangement (MEWA) received written notification from an agent of the state insurance commissioner's office that the MEWA has been scheduled for examination. The applicant does not notify EBSA of the examination. As of March 1, the plan is ineligible for participation in the VFC Program because the plan sponsor has received a notice from the state insurance commissioner's office concerning its intent to examine the plan, and the applicant did not provide EBSA written notice of the examination with the application.
                    </P>
                    <P>
                        <E T="03">Example 2.</E>
                         Assume the same facts as in Example 1, except that the applicant chooses to notify EBSA in writing of the examination. The plan's eligibility to apply under the VFC Program would not be affected because the applicant provides written notice of the examination to EBSA with the application. EBSA will promptly notify the state insurance commissioner of the pending VFC Program application so that the state insurance commissioner's office has an opportunity to provide information about its examination to EBSA. EBSA will include the information received from the state insurance commissioner's office in its review of the VFC Program application.
                    </P>
                    <HD SOURCE="HD1">Section 4. VFC Program Eligibility</HD>
                    <P>Eligibility for the VFC Program is conditioned on the following:</P>
                    <P>(a) Except as provided in paragraphs (d) or (e) of this section 4, the plan, the applicant, or the self-corrector is not Under Investigation.</P>
                    <P>
                        (b)(1) 
                        <E T="03">In general.</E>
                         The Program application contains no evidence of potential criminal violations as determined by EBSA.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Exception for VFC Program applications correcting transactions described in Section 7.1(a).</E>
                         Participation in the VFC Program to correct delinquent participant contributions and loan repayments is permitted in cases where there is evidence of potential criminal violation by parties other than the plan administrator, the plan sponsor or the applicant provided:
                    </P>
                    <P>(i) All funds have been repaid to the plan;</P>
                    <P>(ii) The appropriate law enforcement agency has been notified of the potential criminal violation; and</P>
                    <P>(iii) The applicant submits to the appropriate EBSA office a statement (A) providing contact information for the law enforcement agency that has been notified of the alleged criminal activity; (B) asserting that the applicant was not involved in the potential criminal violation; and (C) stating whether a claim relating to the criminal activity has been made under an ERISA section 412 fidelity bond.</P>
                    <P>
                        <E T="03">Example.</E>
                         The bookkeeper of the plan sponsor of a 401(k) plan allegedly embezzled funds from the plan sponsor, including amounts which had been withheld from employees' paychecks but not yet forwarded to the plan. As a result of the embezzlement, participant contributions were remitted to the plan two months later than the plan sponsor's usual practice. The owner of the company sponsoring the plan was not involved in the embezzlement and notified local law enforcement of the embezzlement. This owner is eligible to submit an application for relief under the VFC Program despite the potential criminal violation if the requirements under section 4(b)(2) are met. Note that the owner is not eligible for relief under the SCC because the exception under section 4(b)(2) is only available under the VFC Program application process and not the SCC.
                    </P>
                    <P>(c) EBSA has not conducted an investigation which resulted in written notice to a plan fiduciary that the transaction, for which the potential applicant or self-corrector could otherwise have sought relief under the Program, has been referred to the IRS. This condition applies only to those transactions specifically identified in EBSA's written notice of referral to the IRS.</P>
                    <P>
                        (d) 
                        <E T="03">Exception for Bulk VFC Program Applicants.</E>
                         An applicant is eligible to submit a bulk application under the VFC Program, even if one or more of the plans named in the application (“named plans”) is Under Investigation, and to receive a no action letter covering each of the named plans provided: (1) the applicant is a service provider that is seeking the relief afforded by the Program only on its own behalf; (2) the applicant was providing services to each of the named plans at the time of the transaction being corrected; (3) the 
                        <PRTPAGE P="4212"/>
                        application includes at least ten named plans; (4) all named plans participated in the transaction being corrected; and (5) the corrective action was not taken as a result of an investigation of any named plan. A determination by EBSA that the corrective action was taken as a result of an investigation of any named plan results in the no action letter specifically excluding such plan.
                    </P>
                    <P>
                        <E T="03">Example.</E>
                         A bank provides investment management services to pension plans. As part of these services, it bought bonds on behalf of its plan clients directly from a broker dealer's inventory. The bank independently discovered that the broker dealer is an affiliate of the bank and consequently, a party in interest to the plans (PII). No available class exemption permitted these purchases. The bank's review showed it had bought bonds for thirty-three (33) of its plan clients from the PII broker dealer. The bank, as a service provider to the plans, may submit a bulk application correcting the transaction in compliance with section 7.4(a) of the Program provided the application names all 33 plans that participated in the transaction and the bank is seeking relief only on its own behalf under the Program. Assuming the applicant has complied with the terms of the VFC Program, EBSA will issue a no action letter to the service provider, which includes the name of each of the participating plans.
                    </P>
                    <P>
                        (e) 
                        <E T="03">Exception for Eligible Inadvertent Participant Loan Failures.</E>
                         A self-corrector is eligible to correct an Eligible Inadvertent Participant Loan Failure under the VFC Program section 7.3(c) even if the plan or the self-corrector is Under Investigation provided the failure is eligible for self-correction under the IRS's EPCRS.
                    </P>
                    <HD SOURCE="HD1">Section 5. General Rules for Acceptable Corrections</HD>
                    <P>
                        (a) 
                        <E T="03">Fair Market Determinations.</E>
                         Many corrections require that the current or fair market value (FMV) of an asset be determined as of a particular date, usually either the date the plan originally acquired the asset or the date of the correction, or both. In order to be acceptable as part of a VFC Program correction, the valuation must meet the conditions in (1) through (4) below. Other corrections require that a fair market interest rate be determined as of a particular date, usually the date the loan was made. In order to be acceptable as part of a VFC Program correction, this determination must be made by an independent commercial lender, which meets the conditions in (5) below:
                    </P>
                    <P>
                        (1) If there is a generally recognized market for the property (
                        <E T="03">e.g.,</E>
                         the New York Stock Exchange), the FMV of the asset is the average value of the asset on such market on the applicable date, unless the plan document specifies another objectively determined value (
                        <E T="03">e.g.,</E>
                         the closing price).
                    </P>
                    <P>(2) If there is no generally recognized market for the asset, the FMV of that asset must be determined in accordance with generally accepted appraisal standards by a qualified, independent appraiser and reflected in a written appraisal report signed by the appraiser.</P>
                    <P>(3) An appraiser is “qualified” if the appraiser has met the education, experience, and licensing requirements that are generally recognized for appraisal of the type of asset being appraised.</P>
                    <P>(4) An appraiser is “independent” if the appraiser is not one of the following, does not own or control any of the following, and is not owned or controlled by, or affiliated with, any of the following:</P>
                    <P>(i) The prior owner of the asset, if the asset was purchased by the plan;</P>
                    <P>(ii) The purchaser of the asset, if the asset was, or is now being, sold by the plan;</P>
                    <P>(iii) Any other owner of the asset, if the plan is not the sole owner;</P>
                    <P>(iv) A fiduciary of the plan (except to the extent the appraiser becomes a fiduciary when retained to perform this appraisal for the plan);</P>
                    <P>(v) A party in interest with respect to the plan (except to the extent the appraiser becomes a party in interest when retained to perform this appraisal for the plan); or</P>
                    <P>(vi) The VFC Program applicant.</P>
                    <P>(5) A commercial lender is “independent” if it is not one of the following, does not own or control any of the following, and is not owned or controlled by, or affiliated with any of the following:</P>
                    <P>(i) A person or entity who was involved in securing or maintaining the loan, or in determining or modifying the terms of the loan at any time during the life of the loan;</P>
                    <P>(ii) A fiduciary of the plan (except to the extent the commercial lender becomes a fiduciary when retained to provide this service for the plan);</P>
                    <P>(iii) A party in interest with respect to the plan (except to the extent the commercial lender becomes a party in interest when retained to provide this service for the plan); or</P>
                    <P>(iv) The VFC Program applicant.</P>
                    <P>
                        (b) 
                        <E T="03">Correction Amount.</E>
                         (1) 
                        <E T="03">In general.</E>
                         For purposes of the VFC Program, the correction amount is the amount that must be paid to the plan as a result of the Breach in order to make the plan whole. In most instances, the correction amount will be a combination of the Principal Amount involved in the transaction (
                        <E T="03">see</E>
                         paragraph (b)(2) of this section), the Lost Earnings amount, which is earnings that would have been earned on the Principal Amount for the period of the transaction (
                        <E T="03">see</E>
                         paragraph (b)(6) of this section, and 
                        <E T="03">also see</E>
                         paragraph (b)(3) of this section for a special rule for Loss Date under the SCC), and any interest on Lost Earnings. However, in circumstances when the Restoration of Profits amount (
                        <E T="03">see</E>
                         paragraph (b)(7) of this section) exceeds the Lost Earnings amount and any interest on Lost Earnings, the correction amount will be a combination of the Principal Amount and the Restoration of Profits amount. The responsible fiduciary, plan sponsor or other Plan Official, must pay the correction amount and any costs of correction. No part of the correction amount or costs of correction can be paid from plan assets, including charges against participant accounts or plan forfeiture accounts.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Principal Amount.</E>
                         “Principal Amount” is the amount that would have been available to the plan for investment or distribution on the date of the Breach, had the Breach not occurred. The Principal Amount, when applicable, must be determined for each transaction by reference to section 7 of the VFC Program. Generally, the Principal Amount is the base amount on which Lost Earnings and, if applicable, Restoration of Profits is calculated. The Principal Amount shall include any transaction costs associated with entering into the transaction that constitutes the Breach, which were paid by the plan.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Loss Date. (i) In general</E>
                         “Loss Date” is the date that the plan lost the use of the Principal Amount.
                    </P>
                    <P>
                        <E T="03">(ii) Special rule for delinquent participant contributions and loan repayments under the SCC section 7.1(b).</E>
                         “Loss Date” is the Date of Withholding or Receipt.
                    </P>
                    <P>
                        (4) 
                        <E T="03">Date of Withholding or Receipt.</E>
                         “Date of Withholding or Receipt” is the date the amount would otherwise have been payable to the participant in cash in the case of amounts withheld by an employer from a participant's wages, or the day on which the participant contribution or loan payment is received by the employer in the case of amounts that a participant or beneficiary pays to an employer. Date of Withholding or Receipt is not the same date as the date on which contributions or loan repayments could reasonably have been segregated from the employer general assets.
                    </P>
                    <P>
                        <E T="03">Example 1.</E>
                         An employer pays its employees' wages on the 1st and the 
                        <PRTPAGE P="4213"/>
                        15th of each month. Participant contributions to a pension plan are withheld from employees' wages on these dates. The employer determined that it could reasonably take two business days to segregate these withholdings from its general assets for transmittal to the plan. The “Date of Withholding or Receipt” is the 1st and 15th of each month. For purposes of a Program application to correct delinquent participant contributions, without taking into account any non-business days, the “Loss Date” would be the 3rd and 17th of each month.
                    </P>
                    <P>
                        <E T="03">Example 2.</E>
                         Assuming the same facts as Example 1, except the delinquent participant contributions are being corrected using the SCC. The “Date of Withholding or Receipt” is the 1st and 15th of each month. For purposes of using the SCC to correct delinquent participant contributions, the “Loss Date” would be the 1st and 15th of each month.
                    </P>
                    <P>
                        (5) 
                        <E T="03">Recovery Date.</E>
                         “Recovery Date” is the date that the Principal Amount is restored to the plan.
                    </P>
                    <P>
                        (6) 
                        <E T="03">Lost Earnings.</E>
                         (i) 
                        <E T="03">General.</E>
                         “Lost Earnings” is intended to approximate the amount that would have been earned by the plan on the Principal Amount, but for the Breach. For purposes of this Program, Lost Earnings shall be calculated in accordance with this paragraph.
                    </P>
                    <P>
                        (ii) 
                        <E T="03">Initial Calculation.</E>
                         Lost Earnings shall be calculated by: (A) determining the applicable corporate underpayment rate(s) established under section 6621(a)(2) of the Code 
                        <SU>62</SU>
                        <FTREF/>
                         for each quarter (or portion thereof) for the period beginning with the Loss Date and ending with the Recovery Date; (B) determining, by reference to IRS Revenue Procedure 95-17,
                        <SU>63</SU>
                        <FTREF/>
                         the applicable factor(s) for such quarterly underpayment rate(s) for each quarter (or portion thereof) of the period beginning with the Loss Date and ending with the Recovery Date; and (C) multiplying the Principal Amount by the first applicable factor to determine the amount of earnings for the first quarter (or portion thereof). If the Loss Date and Recovery Date are within the same quarter, the initial calculation is complete. If the Recovery Date is not in the same quarter as the Loss Date, the applicable factor for each subsequent quarter (or portion thereof) must be applied to the sum of the Principal Amount and all earnings as of the end of the immediately preceding quarter (or portion thereof), until Lost Earnings have been calculated for the entire period, ending with the Recovery Date.
                    </P>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             These underpayment rates are displayed on EBSA's website and will be updated when necessary.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             Rev. Proc. 95-17, 1995-1 C.B. 556 (Feb. 8, 1995). These factors, which are displayed on EBSA's website in a tabular format, incorporate daily compounding of an interest rate over a set period of time.
                        </P>
                    </FTNT>
                    <P>
                        (iii) 
                        <E T="03">Payment of Lost Earnings after Recovery Date.</E>
                         If Lost Earnings are not paid to the plan on the Recovery Date along with the Principal Amount, payment of Lost Earnings shall include interest on the amount of Lost Earnings. Such interest shall be calculated in the same manner as Lost Earnings described in paragraph (b)(6)(ii) above, for the period beginning on the Recovery Date and ending on the date the Lost Earnings are paid to the plan.
                    </P>
                    <P>
                        (iv) 
                        <E T="03">Special Rule for Transactions Causing Large Losses.</E>
                         If the amount of Lost Earnings (determined in accordance with paragraph (b)(6)(ii) above) and any interest added to such Lost Earnings (determined in accordance with paragraph (b)(6)(iii) above), exceed $100,000, the amount of Lost Earnings and interest, if any, to be paid to the plan shall be determined in accordance with paragraphs (b)(6)(ii) and (iii) above, substituting the applicable underpayment rates under section 6621(c)(1) of the Code 
                        <SU>64</SU>
                        <FTREF/>
                         in lieu of the rates under section 6621(a)(2).
                    </P>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             These underpayment rates are displayed on EBSA's website and will be updated when necessary.
                        </P>
                    </FTNT>
                    <P>
                        (v) 
                        <E T="03">Method of Calculation for VFC Program Applications.</E>
                         For purposes of calculating Lost Earnings and interest, if any, a Plan Official may either (A) use the Online Calculator described in paragraph (b)(8) below, or (B) perform a manual calculation in accordance with subparagraphs (i) through (iv) of this paragraph (b)(6). A Plan Official using the Online Calculator or performing a manual calculation shall include as part of the VFC Program application sufficient information to verify the correctness of the amounts to be paid to the plan.
                    </P>
                    <P>
                        (vi) 
                        <E T="03">Method of Calculation under the SCC.</E>
                         For purposes of calculating Lost Earnings and interest, if any, the self-corrector must use the Online Calculator described in paragraph (b)(8) below.
                    </P>
                    <P>
                        (7) 
                        <E T="03">Restoration of Profits.</E>
                         (i) 
                        <E T="03">General.</E>
                         If the Principal Amount was used for a specific purpose such that a profit on the use of the Principal Amount is determinable, the Plan Official must calculate the Restoration of Profits amount and compare it to the Lost Earnings amount to determine the correction amount (
                        <E T="03">see</E>
                         paragraph (b)(1) of this section). If the Restoration of Profits amount exceeds Lost Earnings and interest, if any, the Restoration of Profits amount must be paid to the plan instead of Lost Earnings. “Restoration of Profits” is a combination of two amounts: (A) the amount of profit made on the use of the Principal Amount by the fiduciary or party in interest who engaged in the Breach, or by a person who knowingly participated in the Breach, and (B) if the profit is returned to the plan on a date later than the date on which the profit was realized (
                        <E T="03">i.e.,</E>
                         received or determined), the amount of interest earned on such profit from the date the profit was realized to the date on which the profit is paid to the plan. The amount of such interest shall be determined in accordance with paragraph (b)(7)(ii) below.
                    </P>
                    <P>
                        (ii) 
                        <E T="03">Calculation of Interest.</E>
                         Interest shall be calculated by: (A) determining the applicable corporate underpayment rate(s) established under section 6621(a)(2) of the Code for each quarter (or portion thereof) for the period beginning with the date the profit was realized (
                        <E T="03">i.e.</E>
                         received or determined) and ending with the date on which the profit is paid to the plan; (B) determining, by reference to IRS Revenue Procedure 95-17, the applicable factor(s) for such quarterly underpayment rate(s) for each quarter (or portion thereof) of the period beginning with the date the profit was realized and ending with the date on which the profit is paid to the plan; and (C) multiplying the first applicable factor by the profit on the Principal Amount, referred to in paragraph (b)(7)(i)(A) above, to determine the amount of interest for the first quarter (or portion thereof). If the date the profit was realized and the date the profit is paid to the plan are within the same quarter, the initial calculation is complete. If the date the profit was realized is not in the same quarter as the date the profit was paid to the plan, the applicable factor for each subsequent quarter (or portion thereof) must be applied to the sum of the profit on the Principal Amount, referred to in paragraph (b)(7)(i)(A) above, and all interest as of the end of the immediately preceding quarter (or portion thereof), until interest has been calculated for the entire period, ending with the date the profit is paid to the plan.
                    </P>
                    <P>
                        (iii) 
                        <E T="03">Special Rule for Transactions Resulting in Large Restorations.</E>
                         If the amount of Restoration of Profits (determined in accordance with paragraph (b)(7)(i) above) exceeds $100,000, the amount of any interest on the Restoration of Profits to be paid to the plan shall be determined in accordance with paragraph (b)(7)(ii) above, substituting the applicable underpayment rates under section 
                        <PRTPAGE P="4214"/>
                        6621(c)(1) of the Code in lieu of the rates under section 6621(a)(2).
                    </P>
                    <P>
                        (iv) 
                        <E T="03">Method of Calculation for VFC Program Applications.</E>
                         For purposes of calculating the interest amount for Restoration of Profits, pursuant to paragraphs (b)(7)(ii) and (iii) above, a Plan Official may either (A) use the Online Calculator described in paragraph (b)(8) below, or (B) perform a manual calculation in accordance with subparagraphs (ii) and (iii) of this paragraph (b)(7). A Plan Official using the Online Calculator or performing a manual calculation shall include as part of the VFC Program application sufficient information to verify the correctness of the amounts to be paid to the plan.
                    </P>
                    <P>
                        (8) 
                        <E T="03">Online Calculator.</E>
                         “Online Calculator” is an internet based compliance assistance tool provided on EBSA's website that permits applicants and self-correctors to calculate the amount of Lost Earnings, any interest on Lost Earnings, and the interest amount for Restoration of Profits, if applicable, for certain transactions. The Online Calculator will be updated as necessary.
                    </P>
                    <P>
                        (i) 
                        <E T="03">Lost Earnings and Interest.</E>
                         To calculate Lost Earnings, applicants or self-correctors must input the (A) Principal Amount, (B) Loss Date, (C) Recovery Date, and, if the final payment will occur after the Recovery Date, (D) the date of such final payment. The Online Calculator selects the applicable factors under Revenue Procedure 95-17 after referencing the underpayment rates over the relevant time period. The Online Calculator then automatically applies the factors to provide applicants and self-correctors with the amount of Lost Earnings and interest, if any, that must be paid to the plan.
                    </P>
                    <P>
                        (ii) 
                        <E T="03">Interest Amount for Restoration of Profits.</E>
                         To calculate the interest amount on the profit, applicants must input (A) the amount of profit, (B) the date the amount of profit was realized (
                        <E T="03">i.e.</E>
                         received or determined), and (C) the date of payment of the Restoration of Profits amount. The Online Calculator selects the applicable factors under Revenue Procedure 95-17 after referencing the underpayment rates over the relevant time period. The Online Calculator then automatically applies the factors to provide applicants with the interest amount on the profit that must be paid to the plan.
                    </P>
                    <P>(9) The principles of paragraph (b) of this section are illustrated by example in Appendix D.</P>
                    <P>
                        (c) 
                        <E T="03">Costs of Correction.</E>
                         (1) The fiduciary, plan sponsor or other Plan Official, must pay the correction amount and costs of correction. The costs of correction cannot be paid from plan assets, including charges against participant accounts or plan forfeiture accounts.
                    </P>
                    <P>(2) The correction amount and the costs of correction include, where appropriate, the Principal Amount and Lost Earnings and such expenses of correction as closing costs, prepayment penalties, or sale or purchase costs associated with correcting the transaction.</P>
                    <P>(3) The principle of paragraph (c)(1) of this section is illustrated in the following example and in paragraph (d) below:</P>
                    <P>
                        <E T="03">Example.</E>
                         The plan fiduciaries did not obtain a required independent appraisal in connection with a transaction described in section 7. In connection with correcting the transaction, the plan fiduciaries now propose to have the appraisal performed as of the date of purchase. The plan document permits the plan to pay reasonable and necessary expenses; the fiduciaries have objectively determined that the cost of the proposed appraisal is reasonable and is not more expensive than the cost of an appraisal contemporaneous with the purchase. The plan may therefore pay for this appraisal. However, the plan may not pay any costs associated with recalculating participant account balances to take into account the new valuation. There would be no need for these additional calculations or any increased appraisal cost if the plan's assets had been valued properly at the time of the purchase. Therefore, the cost of recalculating the plan participants' account balances is not a reasonable plan expense but is part of the costs of correction.
                    </P>
                    <P>
                        (d) 
                        <E T="03">Distributions.</E>
                         Plans will have to make supplemental distributions to former employees, beneficiaries receiving benefits, or alternate payees, if the original distributions were too low because of the Breach. In these situations, the Plan Official or plan administrator must determine who received distributions from the plan during the time period affected by the Breach, recalculate the account balances, and determine the amount of the underpayment to each affected individual. The applicant must demonstrate proof of payment to participants and beneficiaries whose current location is known to the plan and/or applicant. For individuals whose location is unknown, applicants must demonstrate that they have segregated adequate funds to pay the missing individuals and that the applicant has commenced the process of locating the missing individuals using methods involving nominal expense such as certified mail and electronic search technologies as well as checking related plan records and with any designated plan beneficiary. If these methods are unsuccessful, the applicant should consider the use of commercial locator services, credit reporting agencies, information brokers and investigation databases as well as analogous computer services depending on the amount of underpayment in relation to the cost of the services. The costs of such efforts are part of the costs of correction. See Missing Participants—Best Practices for Pension Plans (available at 
                        <E T="03">www.dol.gov/agencies/ebsa/employers-and-advisers/plan-administration-and-compliance/retirement/missing-participants-guidance</E>
                        ) for more information on fiduciary best practices that based on EBSA's experience working with plans have proven effective at minimizing and mitigating the problem of missing or nonresponsive participants.
                    </P>
                    <P>
                        (e) 
                        <E T="03">De Minimis Exception.</E>
                         Where correction under the Program requires distributions in amounts less than $35 to former employees, their beneficiaries and alternate payees, who neither have account balances with, nor have a right to future benefits from the plan, and the applicant demonstrates in its submission that the cost of making the distribution to each such individual exceeds the amount of the payment to which such individual is entitled in connection with the correction of the transaction that is the subject of the application, the applicant need not make distributions to such individuals who would receive less than $35 each as part of the correction. However, the applicant must pay to the plan as a whole the total of such de minimis amounts not distributed to such individuals.
                    </P>
                    <P>
                        <E T="03">Example.</E>
                         Employer X sponsors Plan Y. Employer X submits an application under the VFC Program to correct a failure to timely forward participant contributions to Plan Y. Employer X had paid the delinquent contributions six months late but had not paid Lost Earnings on the delinquency. The correction under the VFC Program, therefore, required only payment of Lost Earnings for the six-month delinquency. During the six-month period 25 employees separated from service and rolled over their plan accounts to individual retirement accounts. The amount of Lost Earnings due to 20 of those former employees is less than $35, and Employer X demonstrates that the cost of making the distribution to those former employees is $42 per individual. Employer X need not make distributions to those 20 former employees. However, the total amount of distributions that 
                        <PRTPAGE P="4215"/>
                        would have been due to those former employees must be paid to Plan Y. The payment to Plan Y may be used for any purpose that payments or credits, which are not allocated directly to participant accounts, are used.
                        <SU>65</SU>
                        <FTREF/>
                         Employer X must make distributions to the five former employees who are entitled to receive distributions of more than $35.
                    </P>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             For example, the Department has taken the position that where a plan document is silent as to the payment of reasonable administrative expenses, the plan may pay reasonable administrative expenses. Where a plan document provides that the employer will pay any such expenses, and if the employer has reserved the right to amend the plan document, ERISA would not prevent the employer from amending the plan to require, prospectively, that the relevant expenses be paid by the plan. The Department does not believe that ERISA would permit a fiduciary to implement a plan amendment that attempted to retroactively relieve the employer of an obligation to pay plan expenses.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">Section 6. VFC Program Application and Self-Correction Component Procedures</HD>
                    <HD SOURCE="HD2">6.1 VFC Program Application Procedures</HD>
                    <P>
                        (a) 
                        <E T="03">In general.</E>
                         Each application must adhere to the requirements set forth below. Failure to do so may render the application invalid.
                    </P>
                    <P>
                        (b) 
                        <E T="03">Applicant.</E>
                         The application must be prepared by a Plan Official or an authorized representative (
                        <E T="03">e.g.,</E>
                         attorney, accountant, or other service provider). If a representative of the Plan Official is submitting the application, the application must include a statement signed by the Plan Official that the representative is authorized to represent the Plan Official. Any fees paid to such representative for services relating to the preparation and submission of the application may not be paid from plan assets, including charges to participants accounts or plan forfeiture accounts.
                    </P>
                    <P>
                        (c) 
                        <E T="03">Contact person.</E>
                         Each application must include the name, address (street and email) and telephone number of a contact person. The contact person must be familiar with the contents of the application and have authority to respond to inquiries from EBSA.
                    </P>
                    <P>
                        (d) 
                        <E T="03">Detailed narrative.</E>
                         The applicant must provide to EBSA a detailed narrative describing the Breach and the corrective action. The narrative must include:
                    </P>
                    <P>
                        (1) A list of all persons materially involved in the Breach and its correction (
                        <E T="03">e.g.,</E>
                         fiduciaries, service providers, borrowers);
                    </P>
                    <P>(2) The plan sponsor's nine-digit number (EIN), plan number, and address of the plan sponsor and administrator;</P>
                    <P>(3) The date the plan's most recent Form 5500 was filed; or, in the case of a bulk VFC Program application, for each plan named in the application, either the date the most recent Form 5500 was filed or the plan sponsor's nine-digit number (EIN);</P>
                    <P>(4) An explanation of the Breach, including the date it occurred;</P>
                    <P>(5) An explanation of how the Breach was corrected, by whom and when; and</P>
                    <P>(6)(i) If the applicant performs a manual calculation in accordance with paragraphs (b)(6)(i) through (iv) of section 5 or paragraphs (b)(7)(i) through (iii), specific calculations demonstrating how Principal Amount and Lost Earnings or, if applicable, Restoration of Profits were computed;</P>
                    <P>
                        (ii) If the applicant uses the Online Calculator in accordance with paragraph (b)(8) of section 5, the data elements required to be input into the Online Calculator under paragraphs (b)(8)(i) and/or (ii) of section 5, as applicable (to satisfy this requirement, applicants may submit a copy of the page(s) that results from the “
                        <E T="03">View Printable Results</E>
                        ” function used after inputting data elements and completing use of the Online Calculator); and
                    </P>
                    <P>(iii) An explanation of why payment of Lost Earnings or Restoration of Profits was chosen to correct the Breach.</P>
                    <P>
                        (e) 
                        <E T="03">Supporting documentation.</E>
                         The applicant must also include:
                    </P>
                    <P>
                        (1) Copies of the relevant portions of the plan document and any other pertinent documents (such as the adoption agreement, trust agreement, or insurance contract); 
                        <SU>66</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             Applicants must supply complete copies of the plan documents and other pertinent documents if requested by EBSA during its review of the application.
                        </P>
                    </FTNT>
                    <P>(2) Documentation that supports the narrative description of the transaction and its correction;</P>
                    <P>(3) Documentation establishing the Lost Earnings amount;</P>
                    <P>(4) Documentation establishing the amount of Restoration of Profits, if applicable;</P>
                    <P>(5) All documents described in section 7 with respect to the transaction involved; and</P>
                    <P>(6) Proof of payment of Principal Amount and Lost Earnings or Restoration of Profits.</P>
                    <P>Applicants using the Online Calculator may satisfy the requirements of paragraph (e)(3) above, with respect to Lost Earnings, and paragraph (e)(4) above, as to the amount of interest, if any, payable with respect to the profit amount, by complying with the requirements of paragraph (d)(6)(ii) of this section. Except for proof of payment, as described in paragraph (e)(6) above, applicants correcting participant loan transactions in section 7.3(a) and (b) are not required to submit the other documentation described above unless requested by EBSA.</P>
                    <P>
                        (f) 
                        <E T="03">Examples of supporting documentation.</E>
                         (1) Examples of documentation supporting the description of the transaction and correction are leases, appraisals, notes and loan documents, service provider contracts, invoices, settlement documents, deeds, perfected security interests, and amended annual reports.
                    </P>
                    <P>(2) Examples of acceptable proof of payment include copies of canceled checks, executed wire transfers, a signed, dated receipt from the recipient of funds transferred to the plan (such as a financial institution), and bank statements for the plan's account.</P>
                    <P>
                        (g) 
                        <E T="03">Penalty of Perjury Statement.</E>
                         Each application must include the following statement: “Under penalties of perjury I certify that I am not Under Investigation (as defined in section 3(b)(3) of the VFC Program) and that I have reviewed this application, including all supporting documentation, and to the best of my knowledge and belief the contents are true, correct, and complete.”
                    </P>
                    <P>
                        (1) 
                        <E T="03">Applicants in general.</E>
                         The Penalty of Perjury Statement must be signed and dated by a plan fiduciary with knowledge of the transaction that is the subject of the application and the authorized representative of the applicant, if any. In addition, each Plan Official applying under the VFC Program must sign and date the Penalty of Perjury Statement. The statement must accompany the application and any subsequent additions to the application. Use of the Penalty of Perjury Statement included with the Model Application Form in Appendix E will satisfy the requirements of paragraph (g) of this section.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Bulk Applicants.</E>
                         The Penalty of Perjury Statement must be signed and dated by the bulk applicant with knowledge of the transaction that is the subject of the application and the authorized representative of the bulk applicant, if any. The statement must accompany the application and any subsequent additions to the application. Use of the Penalty of Perjury Statement included with the Model Application Form in Appendix E will satisfy the requirements of paragraph (g) of this section.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Contributing or Adopting Employers in Multiemployer Plans or Multiple Employer Plans.</E>
                         In the case of an employer that contributes to or has adopted a multiemployer plan or multiple employer plan and wishes to correct a Breach, the Penalty of Perjury Statement may be signed and dated by 
                        <PRTPAGE P="4216"/>
                        the employer and, regardless of the employer's status as a plan fiduciary, the Penalty of Perjury Statement need not be signed by another plan fiduciary.
                    </P>
                    <P>
                        (h) 
                        <E T="03">Checklist.</E>
                         The checklist in Appendix B must be completed, signed, dated and submitted with the application. Use of the checklist included with the Model Application Form in Appendix E also will satisfy the requirements of paragraph (h) of this section.
                    </P>
                    <P>
                        (i) 
                        <E T="03">Where to apply.</E>
                         The application shall be submitted to the appropriate EBSA Regional Office listed in Appendix C. Applicants should check with the relevant EBSA Regional Office whether the office accepts email submissions of applications and supporting documentation.
                    </P>
                    <P>
                        (j) 
                        <E T="03">Submission of Additional Documentation.</E>
                         If EBSA determines that required information is missing from the application or that additional documentation is needed to complete EBSA's review, EBSA will request such documentation in writing from the applicant or authorized representative. If EBSA does not receive the requested documentation within a time period specified in writing by the EBSA reviewer, EBSA may suspend its review of the application and consider appropriate action. EBSA will notify the applicant or authorized representative in writing regarding such suspension. If EBSA does not receive the requested documentation within a reasonable time after providing notice of the suspension, EBSA will issue a rejection letter.
                    </P>
                    <P>
                        (k) 
                        <E T="03">Recordkeeping.</E>
                         The applicant must maintain copies of the application and any subsequent correspondence with EBSA for the period required by section 107 of ERISA.
                    </P>
                    <HD SOURCE="HD2">
                        6.2 
                        <E T="03">VFC Program Self-Correction Component Procedures</E>
                    </HD>
                    <P>
                        (a) 
                        <E T="03">In general.</E>
                         Each self-corrector must adhere to the requirements set forth below. Failure to do so may render the self-correction invalid.
                    </P>
                    <P>
                        (b) 
                        <E T="03">Self-corrector.</E>
                         The SCC notice must be submitted by the self-corrector who is a Plan Official or an authorized representative (
                        <E T="03">e.g.,</E>
                         attorney, accountant, or other service provider). If a representative of the Plan Official is submitting the SCC notice, the plan administrator must retain a statement signed by the Plan Official that the representative is authorized to represent the Plan Official. Use of the model authorization included in the SCC Retention Record Checklist in Appendix F will satisfy this requirement. Any fees paid to such representative for services relating to the correction under the SCC may not be paid from plan assets.
                    </P>
                    <P>
                        (c) 
                        <E T="03">Submission of SCC notice.</E>
                         The self-corrector must notify EBSA of participation in the SCC by submitting the SCC notice through the online VFC Program web tool in accordance with paragraphs 7.1(b)(2)(iii) and 7.3(c)(2)(ii).
                        <SU>67</SU>
                        <FTREF/>
                         EBSA will acknowledge receipt of a properly completed and submitted SCC notice in an email addressed to the self-corrector.
                    </P>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             The online VFC Program web tool will be located on EBSA's website.
                        </P>
                    </FTNT>
                    <P>
                        (d)
                        <E T="03"> SCC Retention Record Checklist—Applicable to Self-Corrections under section 7.1(b).</E>
                         The self-corrector of delinquent participant contributions and loan repayments under section 7.1(b) must complete the SCC Retention Record Checklist in Appendix F, prepare or collect the documents listed in this Appendix, and provide copies of the completed checklist and required documentation to the plan administrator.
                    </P>
                    <P>
                        (e) 
                        <E T="03">Penalty of Perjury Statement for Self-Corrections under Section 7.1(b).</E>
                         The plan administrator must retain the following statement: “Under penalties of perjury I certify that I am not Under Investigation (as defined in section 3(b)(3) of the VFC Program) and that I have reviewed the SCC notice acknowledgment and summary, the checklist and all the required documentation, and to the best of my knowledge and belief the contents are true, correct, and complete.” The statement must be signed and dated by a plan fiduciary with knowledge of the transaction that is the subject of the self-correction and the authorized representative of the plan sponsor, if any. In addition, each Plan Official who is seeking the relief afforded under the Program must sign and date the Penalty of Perjury Statement. Use of the Penalty of Perjury Statement included in Appendix F will satisfy the requirements of paragraph (e) of this section.
                    </P>
                    <P>
                        (f) 
                        <E T="03">Penalty of Perjury Statement for Self-Corrections under Section 7.3(c).</E>
                         The plan administrator must retain the following statement: “Under penalties of perjury I certify that I have reviewed the SCC notice acknowledgment and summary, and all the required documentation, and to the best of my knowledge and belief the contents are true, correct, and complete.” The statement must be signed and dated by a plan fiduciary with knowledge of the transaction that is the subject of the self-correction and the authorized representative of the plan sponsor, if any. In addition, each Plan Official who is seeking the relief afforded under the Program must sign and date the Penalty of Perjury Statement.
                    </P>
                    <P>
                        (g) 
                        <E T="03">Contributing or Adopting Employers in Multiemployer Plans or Multiple Employer Plans.</E>
                         In the case of an employer that contributes to or has adopted a multiemployer plan or multiple employer plan and wishes to self-correct a Breach, the Penalty of Perjury Statement may be signed and dated by the employer and, regardless of the employer's status as a plan fiduciary, the Penalty of Perjury Statement need not be signed by another plan fiduciary.
                    </P>
                    <P>
                        (h) 
                        <E T="03">Recordkeeping.</E>
                    </P>
                    <P>(1) For self-corrections of delinquent participant contributions and loan repayments under section 7.1(b), the plan administrator must retain a copy of the SCC Retention Record Checklist in Appendix F along with copies of the required documentation, the authorization form, if any, and a signed Penalty of Perjury Statement, for the period required by section 107 of ERISA.</P>
                    <P>(2) For self-corrections of participant loan failures under section 7.3(c), the plan administrator must retain proof of payment of Principal Amount and Lost Earnings, or Restoration of Profits, as applicable; a copy of the SCC Notice Acknowledgment and Summary page; the authorization form, if any; and a signed Penalty of Perjury Statement, for the period required by section 107 of ERISA.</P>
                    <HD SOURCE="HD1">Section 7. Description of Eligible Transactions and Corrections Under the VFC Program</HD>
                    <P>EBSA has identified certain Breaches and methods of correction that are suitable for the VFC Program. Any Plan Official may correct a Breach listed in this section in accordance with section 5 and the applicable correction method. The correction methods set forth are strictly construed and are the only acceptable correction methods under the VFC Program and the SCC for the identified transactions described in this section.</P>
                    <HD SOURCE="HD2">7.1 Delinquent Remittance of Participant Funds</HD>
                    <HD SOURCE="HD3">(a) Delinquent Participant Contributions and Loan Repayments to Pension Plans Under VFC Program Applications</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         An employer receives directly from participants, or withholds from employees' paychecks, certain amounts for either participants' contribution to a pension plan or for repayment of participants' plan loans. Instead of forwarding such contributions or loan 
                        <PRTPAGE P="4217"/>
                        repayments to the plan for investment in accordance with the provisions of the plan and by reference to the principles of the Department's regulation at 29 CFR 2510.3-102, the employer retains such amounts for a longer period of time.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) 
                        <E T="03">Unpaid Participant Contributions or Loan Repayments.</E>
                         Pay to the plan the Principal Amount plus the greater of (A) Lost Earnings on the Principal Amount or (B) Restoration of Profits resulting from the employer's use of the Principal Amount, as described in section 5(b). The Loss Date for such contributions or repayments is the date on which each contribution reasonably could have been segregated from the employer's general assets. In no event shall the Loss Date for such contributions or repayments be later than the applicable maximum time period described in 29 CFR 2510.3-102.
                        <SU>68</SU>
                        <FTREF/>
                         Any penalties, late fees or other charges shall be paid by the employer or another Plan Official and not from such contributions or loan repayments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             The Department amended paragraph (a)(1) of 29 CFR 2510.3-102 to extend the application of the regulation to amounts paid by a participant or beneficiary or withheld by an employer from a participant's wages for purposes of repaying a participant's loan (regardless of plan size). 75 FR 2068 (2010).
                        </P>
                    </FTNT>
                    <P>
                        (ii) 
                        <E T="03">Late Participant Contributions or Loan Repayments.</E>
                         If participant contributions or loan repayments were remitted to the plan outside of the time periods described above, the only correction required is to pay to the plan the greater of (A) Lost Earnings or (B) Restoration of Profits resulting from the employer's use of the Principal Amount as described in section 5(b). Any penalties, late fees or other charges shall be paid by the employer or another Plan Official and not from participant contributions or loan repayments.
                    </P>
                    <P>(iii) For this transaction, the Principal Amount is the amount of delinquent participant contributions or loan repayments retained by the employer.</P>
                    <P>
                        (iv) 
                        <E T="03">Example.</E>
                         The principles of paragraph (a)(2) of this section are illustrated by example in Appendix D.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) A statement from a Plan Official identifying the earliest date on which the participant contributions and/or repayments reasonably could have been segregated from the employer's general assets, along with the supporting documentation on which the Plan Official relied in reaching this conclusion;</P>
                    <P>(ii) If restored participant contributions and/or repayments (exclusive of Lost Earnings) either total $50,000 or less, or exceed $50,000 and were remitted to the plan within 180 calendar days from the date such amounts were received by the employer, or the date such amounts otherwise would have been payable to the participants in cash (regarding amounts withheld by an employer from employees' paychecks), submit:</P>
                    <P>(A) A narrative describing the applicant's contribution and/or repayment remittance practices before and after the period of unpaid or late contributions and/or repayments including any steps taken to prevent future delinquencies, and</P>
                    <P>(B) Summary documents demonstrating the amount of unpaid or late contributions and/or repayments; and</P>
                    <P>(iii) If restored participant contributions and/or repayments (exclusive of Lost Earnings) exceed $50,000 and were remitted to the plan more than 180 calendar days after the date such amounts were received by the employer, or the date such amounts otherwise would have been payable to the participants in cash (regarding amounts withheld by an employer from employees' paychecks), submit:</P>
                    <P>(A) A narrative describing the applicant's contribution and/or repayment remittance practices before and after the period of unpaid or late contributions and/or repayments including any steps taken to prevent future delinquencies;</P>
                    <P>(B) For participant contributions and/or repayments received from participants, a copy of the accounting records which identify the date and amount of each contribution received; and</P>
                    <P>(C) For participant contributions and/or repayments withheld from employees' paychecks, a copy of the payroll documents showing the date and amount of each withholding.</P>
                    <HD SOURCE="HD3">(b) Delinquent Participant Contributions and Loan Repayments to Pension Plans Under the Self-Correction Component</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         (i) An employer receives directly from participants, or withholds from employees' paychecks, certain amounts for either participants' contribution to a pension plan or for repayment of participants' plan loans. Instead of forwarding such contributions or loan repayments to the plan for investment in accordance with the provisions of the plan and by reference to the principles of the Department's regulation at 29 CFR 2510.3-102, the employer retains such amounts for a longer period of time.
                        <SU>69</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             
                            <E T="03">See</E>
                             29 CFR 2510.3-102(a)(2), 75 FR 2068 (2010).
                        </P>
                    </FTNT>
                    <P>(ii) For this transaction: (A) the amount of Lost Earnings resulting from the correction of the delinquent participant contributions or loan repayments is less than or equal to $1,000, excluding any excise tax amounts paid to the plan under the related class exemption PTE 2002-51; and</P>
                    <P>(B) the delinquent participant contributions or loan repayments were remitted to the plan within 180 calendar days from the date such amounts were received by the employer, or the date such amounts otherwise would have been payable to the participants in cash (regarding amounts withheld by an employer from employees' paychecks).</P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) 
                        <E T="03">Unpaid Participant Contributions or Loan Repayments.</E>
                         Pay to the plan the Principal Amount plus Lost Earnings on the Principal Amount as described in section (5)(b). The Loss Date for such contributions or repayments is the Date of Withholding or Receipt in accordance with section 5(b)(3)(ii). All calculations must be made using the Online Calculator in accordance with section 5(b)(6)(vi). Any penalties, late fees or other charges shall be paid by the employer or other Plan Official and not from participant loan repayments.
                    </P>
                    <P>
                        (ii) 
                        <E T="03">Principal Amount.</E>
                         For this transaction, the Principal Amount is the amount of delinquent participant contributions or loan repayments retained by the employer.
                    </P>
                    <P>
                        (iii) 
                        <E T="03">SCC Notice.</E>
                         The self-corrector must input the required information in the fields provided in the SCC notice and submit the notice to EBSA through the online VFC Program web tool.
                        <SU>70</SU>
                        <FTREF/>
                         The required information includes certain data elements listed below:
                    </P>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             The online VFC Program web tool will be located on EBSA's website.
                        </P>
                    </FTNT>
                    <P>(A) name and email address of the self-corrector;</P>
                    <P>(B) plan name;</P>
                    <P>(C) plan sponsor's nine-digit number (EIN) and the plan's three-digit number (PN);</P>
                    <P>(D) Principal Amount;</P>
                    <P>(E) amount of Lost Earnings and the date paid to the plan;</P>
                    <P>(F) Loss Date (Date(s) of Withholding or Receipt); and</P>
                    <P>(G) number of participants affected by the correction.</P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         The self-corrector must complete the SCC Retention Record Checklist in Appendix F, prepare or collect the documents listed 
                        <PRTPAGE P="4218"/>
                        in this Appendix, and provide copies of the completed checklist and required documentation to the plan administrator.
                    </P>
                    <HD SOURCE="HD3">(c) Delinquent Participant Contributions to Insured Welfare Plans</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         Benefits are provided exclusively through insurance contracts issued by an insurance company or similar organization licensed to do business in any state or through a health maintenance organization (HMO) defined in section 1310(c) of the Public Health Service Act, 42 U.S.C. 300e-9(c). An employer receives directly from participants or withholds from employees' paychecks certain amounts that the employer forwards to an insurance provider for the purpose of providing group health or other welfare benefits. The employer fails to forward such amounts in accordance with the terms of the plan (including the provisions of any insurance contract) or the requirements of the Department's regulation at 29 CFR 2510.3-102. There are no instances in which claims have been denied under the plan, nor has there been any lapse in coverage, due to the failure to transmit participant contributions on a timely basis.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) Pay to the insurance provider or HMO the Principal Amount, as well as any penalties, late fees, or other charges necessary to prevent a lapse in coverage due to such failure. Any penalties, late fees or other such charges shall be paid by the employer or a Plan Official and not from participant contributions.
                    </P>
                    <P>(ii) For this transaction, the Principal Amount is the amount of delinquent participant contributions retained by the employer.</P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) A statement from a Plan Official: (A) identifying the earliest date on which the participant contributions reasonably could have been segregated from the employer's general assets, along with the supporting documentation on which the Plan Official relied in reaching this conclusion; (B) attesting that there are no instances in which claims have been denied under the plan for nonpayment, nor has there been any lapse in coverage; and (C) attesting that any penalties, late fees or other such charges have been paid by the Plan Official and not from participant contributions;</P>
                    <P>(ii) Copies of the insurance contract or contracts for the group health or other welfare benefits for the plan;</P>
                    <P>(iii) If restored participant contributions either total $50,000 or less, or exceed $50,000 and were remitted to the insurance provider within 180 calendar days from the date such amounts were received by the employer, or the date such amounts otherwise would have been payable to the participants in cash (regarding amounts withheld by an employer from employees' paychecks), submit:</P>
                    <P>(A) a narrative describing the applicant's contribution practices before and after the period of unpaid or late contributions, and</P>
                    <P>(B) summary documents demonstrating the amount of unpaid or late contributions; and</P>
                    <P>(iv) If restored participant contributions exceed $50,000 and were remitted to the insurance provider more than 180 calendar days after the date such amounts were received by the employer, or the date such amounts otherwise would have been payable to the participants in cash (regarding amounts withheld by an employer from employees' paychecks), submit:</P>
                    <P>(A) a narrative describing the applicant's contribution remittance practices before and after the period of unpaid or late contributions including any steps taken to prevent future delinquencies,</P>
                    <P>(B) for participant contributions received directly from participants, a copy of the accounting records which identify the date and amount of each contribution received, and</P>
                    <P>(C) for participant contributions withheld from employees' paychecks, a copy of the payroll documents showing the date and amount of each withholding.</P>
                    <HD SOURCE="HD3">(d) Delinquent Participant Contributions to Welfare Plan Trusts</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         An employer receives directly from participants or withholds from employees' paychecks certain amounts that the employer forwards to a trust maintained to provide, through insurance or otherwise, group health or other welfare benefits. The employer fails to forward such amounts in accordance with the terms of the plan or the requirements of the Department's regulation at 29 CFR 2510.3-102. There are no instances in which claims have been denied under the plan, nor has there been any lapse in coverage, due to the failure to transmit participant contributions on a timely basis.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) 
                        <E T="03">Unpaid Contributions.</E>
                         Pay to the trust (A) the Principal Amount, and, where applicable, any penalties, late fees, or other charges necessary to prevent a lapse in coverage due to the failure to make timely payments, and (B) the greater of (
                        <E T="03">1</E>
                        ) Lost Earnings on the Principal Amount or (
                        <E T="03">2</E>
                        ) Restoration of Profits resulting from the employer's use of the Principal Amount as described in section 5(b). The Loss Date for such contributions is the date on which each contribution would become plan assets under 29 CFR 2510.3-102. Any penalties, late fees or other charges shall be paid by the employer or a Plan Official and not from participant contributions.
                    </P>
                    <P>
                        (ii) 
                        <E T="03">Late Contributions.</E>
                         If participant contributions were remitted to the trust outside of the time period required by the regulation, the only correction required is to pay to the trust the greater of (A) Lost Earnings or (B) Restoration of Profits resulting from the employer's use of the Principal Amount as described in section 5(b). Any penalties, late fees or other such charges shall be paid by the employer or a Plan Official and not from participant contributions.
                    </P>
                    <P>(iii) For this transaction, the Principal Amount is the amount of delinquent participant contributions retained by the employer.</P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) A statement from a Plan Official: (A) identifying the earliest date on which the participant contributions reasonably could have been segregated from the employer's general assets, along with the supporting documentation on which the Plan Official relied in reaching this conclusion, and (B) attesting that there are no instances in which claims have been denied under the plan for nonpayment, nor has there been any lapse in coverage;</P>
                    <P>(ii) If restored participant contributions (exclusive of Lost Earnings) either total $50,000 or less, or exceed $50,000 and were remitted to the trust within 180 calendar days from the date such amounts were received by the employer, or the date such amounts otherwise would have been payable to the participants in cash (regarding amounts withheld by an employer from employees' paychecks), submit:</P>
                    <P>(A) a narrative describing the applicant's contribution practices before and after the period of unpaid or late contributions including any steps taken to prevent future delinquencies, and</P>
                    <P>(B) summary documents demonstrating the amount of unpaid or late contributions; and</P>
                    <P>
                        (iii) If restored participant contributions (exclusive of Lost Earnings) exceed $50,000 and were remitted to the trust more than 180 
                        <PRTPAGE P="4219"/>
                        calendar days after the date such amounts were received by the employer, or the date such amounts otherwise would have been payable to the participants in cash (regarding amounts withheld by an employer from employees' paychecks), submit:
                    </P>
                    <P>(A) a narrative describing the applicant's contribution remittance practices before and after the period of unpaid or late contributions,</P>
                    <P>(B) for participant contributions received directly from participants, a copy of the accounting records which identify the date and amount of each contribution received, and</P>
                    <P>(C) for participant contributions withheld from employees' paychecks, a copy of the payroll documents showing the date and amount of each withholding.</P>
                    <HD SOURCE="HD2">7.2 Loans</HD>
                    <HD SOURCE="HD3">(a) Loan at Fair Market Interest Rate to a Party in Interest With Respect to the Plan</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan made a loan to a party in interest at an interest rate no less than that for loans with similar terms (for example, the amount of the loan, amount and type of security, repayment schedule, and duration of loan) to a borrower of similar creditworthiness. The loan was not exempt from the prohibited transaction provisions of Title I of ERISA.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         Pay off the loan in full, including any prepayment penalties. An independent commercial lender must also confirm in writing that the loan was made at a fair market interest rate for a loan with similar terms to a borrower of similar creditworthiness.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit a narrative describing the process used to determine the fair market interest rate at the time the loan was made, validated in writing by an independent commercial lender.
                    </P>
                    <HD SOURCE="HD3">(b) Loan at Below-Market Interest Rate to a Party in Interest With Respect to the Plan</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan made a loan to a party in interest with respect to the plan at an interest rate that, at the time the loan was made, was less than the fair market interest rate for loans with similar terms (for example, the amount of loan, amount and type of security, repayment schedule, and duration of the loan) to a borrower of similar creditworthiness. The loan was not exempt from the prohibited transaction provisions of Title I of ERISA.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) Pay off the loan in full, including any prepayment penalties. Pay to the plan the Principal Amount, plus the greater of (A) the Lost Earnings as described in section 5(b), or (B) the Restoration of Profits, if any, as described in section 5(b).
                    </P>
                    <P>(ii) For purposes of this transaction, each loan payment has a Principal Amount equal to the excess of the loan payment that would have been received if the loan had been made at the fair market interest rate (from the beginning of the loan until the Recovery Date) over the loan payment actually received under the loan terms during such period. Under the VFC Program, the fair market interest rate must be determined by an independent commercial lender.</P>
                    <P>
                        <E T="03">Example.</E>
                         The plan made to a party in interest a $150,000 mortgage loan, secured by a first Deed of Trust, at a fixed interest rate of 4% per annum. The loan was to be fully amortized over 30 years. The fair market interest rate for comparable loans, at the time this loan was made, was 7% per annum. The party in interest or Plan Official must repay the loan in full plus any applicable prepayment penalties. The party in interest or Plan Official also must pay the difference between what the plan would have received through the Recovery Date had the loan been made at 7% and what, in fact, the plan did receive from the commencement of the loan to the Recovery Date, plus Lost Earnings on that amount as described in section 5(b).
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) A narrative describing the process used to determine the interest rate at the time the loan was made;</P>
                    <P>(ii) A copy of the independent commercial lender's fair market interest rate determination(s); and</P>
                    <P>(iii) A copy of the independent fiduciary's dated, written approval of the fair market interest rate determination(s), except for below-market interest rate loans of $10,000 or less.</P>
                    <HD SOURCE="HD3">(c) Loan at Below-Market Interest Rate to a Person Who Is Not a Party in Interest With Respect to the Plan</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan made a loan to a person who is not a party in interest with respect to the plan at an interest rate which, at the time the loan was made, was less than the fair market interest rate for loans with similar terms (for example, the amount of loan, amount and type of security, repayment schedule, and duration of the loan) to a borrower of similar creditworthiness.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) Pay to the plan the Principal Amounts from the inception of the loan until the Recovery Date, plus Lost Earnings on the series of Principal Amounts through the Recovery Date, as described in section 5(b).
                    </P>
                    <P>(ii) In addition, the applicant or other party must pay to the plan the present value of the Principal Amounts from the Recovery Date to the maturity date of the loan, as determined by an independent commercial lender. The borrower must continue to pay to the plan the outstanding loan balance according to the repayment schedule for the duration of the loan. Alternatively, instead of the applicant or other party paying the present value of the Principal Amounts, the borrower may pay to the plan the outstanding loan balance amortized over the remaining payment schedule for the duration of the loan at the interest rate that would have been applicable if the loan had been made at the fair market interest rate.</P>
                    <P>(iii) For purposes of this transaction, each loan payment has a Principal Amount equal to the excess of the loan payment that would have been received if the loan had been made at the fair market interest rate (from the inception of the loan until the Recovery Date) over the loan payment actually received under the loan terms during such period. Under the VFC Program, the fair market interest rate must be determined by an independent commercial lender.</P>
                    <P>(iv) The principles of paragraph (c)(2) of this section are illustrated in the following example:</P>
                    <P>
                        <E T="03">Example.</E>
                         The plan made a $150,000 mortgage loan, secured by a first Deed of Trust, at a fixed interest rate of 4% per annum. The loan was to be fully amortized over 30 years. The fair market interest rate for comparable loans, at the time this loan was made, was 7% per annum. The applicant or other person must pay the excess of what the plan would have received through the Recovery Date had the loan been made at 7% over what, in fact, the plan did receive from the commencement of the loan to the Recovery Date (the Principal Amounts from the loan's inception until the Recovery Date), plus Lost Earnings on that amount as described in section 5(b). The applicant must also pay on the Recovery Date the present value of the difference of what the plan would have received between the 7% and the 4% interest rate for the remaining payments on the loan for the duration of the time the plan is owed repayments on the loan (the Principal Amounts from the Recovery Date until the loan's maturity 
                        <PRTPAGE P="4220"/>
                        date). The borrower must continue to repay the outstanding loan balance based on the loan's repayment schedule.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) A narrative describing the process used to determine the interest rate at the time the loan was made;</P>
                    <P>(ii) A copy of the independent commercial lender's fair market interest rate determination(s); and</P>
                    <P>(iii) If applicable, a copy of the loan repayment schedule for the re-amortized loan repayments.</P>
                    <HD SOURCE="HD3">(d) Loan at Below-Market Interest Rate Solely Due to a Delay in Perfecting the Plan's Security Interest</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         For purposes of the VFC Program, if a plan made a purportedly secured loan to a person who is not a party in interest with respect to the plan, but there was a delay in recording or otherwise perfecting the plan's interest in the loan collateral, the loan will be treated as an unsecured loan until the plan's security interest is perfected.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) Pay to the plan the Principal Amounts through the date the loan became fully secured, plus Lost Earnings on the series of Principal Amounts, as described in section 5(b).
                    </P>
                    <P>(ii) Record or perfect the plan's interest in the loan collateral.</P>
                    <P>(iii) In addition, if the delay in perfecting the loan's security caused a permanent change in the risk characteristics of the loan, the fair market interest rate for the remaining term of the loan must be determined by an independent commercial lender. In that case the correction amount includes an additional payment to the plan. The applicant must pay to the plan the present value of the Principal Amounts from the date the loan is fully secured to the maturity date of the loan, as determined by an independent commercial lender. The borrower must continue to pay to the plan the outstanding loan balance according to the repayment schedule for the duration of the loan. Alternatively, instead of the applicant paying the present value of the Principal Amounts, the borrower may pay to the plan the outstanding loan balance amortized over the remaining payment schedule for the duration of the loan at the interest rate that would have been applicable if the loan had been made at the fair market interest rate that would have been applicable for a loan with the changed risk characteristics.</P>
                    <P>(iv) For purposes of this transaction, each loan payment has a Principal Amount equal to the excess of the loan payment that would have been received if the loan had been made at the fair market interest rate for an unsecured loan (from the inception of the loan until the Recovery Date) over the loan payment actually received under the loan terms during such period. Under the VFC Program, the fair market interest rate must be determined by an independent commercial lender.</P>
                    <P>(v) The principles of paragraph (d)(2) of this section are illustrated in the following examples:</P>
                    <P>
                        <E T="03">Example 1.</E>
                         The plan made a mortgage loan, which was supposed to be secured by a Deed of Trust. The plan's Deed was not recorded for six months, but, when it was recorded, the Deed was in first position. The interest rate on the loan was the fair market interest rate for a mortgage loan secured by a first-position Deed of Trust. The loan is treated as an unsecured, below-market loan for the six months prior to the recording of the Deed of Trust.
                    </P>
                    <P>
                        <E T="03">Example 2.</E>
                         Assume the same facts as in Example 1, except that, as a result of the delay in recording the Deed, the plan ended up in second position behind another lender. The risk to the plan is higher and the interest rate on the note is no longer commensurate with that risk. The loan is treated as a below-market loan (based on the lack of security) for the six months prior to the recording of the Deed of Trust and as a below-market loan (based on secondary status security) from the time the Deed is recorded until the end of the loan.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) A narrative describing the process used to determine the fair market interest rate for the period that the loan was unsecured and, if applicable, for the remaining term of the loan;</P>
                    <P>(ii) A copy of the independent commercial lender's fair market interest rate determination(s); and</P>
                    <P>(iii) If applicable, a copy of the loan repayment schedule for the re-amortized loan repayments.</P>
                    <HD SOURCE="HD2">7.3 Participant Loans</HD>
                    <HD SOURCE="HD3">(a) Loans Failing To Comply With Plan Provisions for Amount, Duration, or Level Amortization Corrected Under VFC Program Applications</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan extended a loan to a plan participant who is a party in interest with respect to the plan based solely on their status as an employee of any employer whose employees are covered by the plan, as defined in section 3(14)(H) of ERISA. The loan was a prohibited transaction that failed to qualify for ERISA's statutory exemption for plan loan programs because the loan terms did not comply with applicable plan provisions, which incorporated the requirements of section 72(p) of the Code concerning:
                    </P>
                    <P>(i) the amount of the loan,</P>
                    <P>(ii) the duration of the loan, or</P>
                    <P>(iii) the level amortization of the loan repayment.</P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         Plan Officials must make a voluntary correction of the loan with IRS approval under the Voluntary Correction Program of the IRS's EPCRS.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         The applicant is not required to submit any of the supporting documentation listed in section 6.1(e) unless otherwise requested by EBSA, except that the applicant must provide (i) proof of payment, as described in paragraph (e)(6) of section 6.1, and (ii) a copy of the IRS compliance statement.
                    </P>
                    <HD SOURCE="HD3">(b) Default Loans Corrected Under VFC Program Applications</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan extended a loan to a plan participant who is a party in interest with respect to the plan based solely on their status as an employee of any employer whose employees are covered by the plan, as defined in section 3(14)(H) of ERISA. At origination, the loan qualified for ERISA's statutory exemption for plan loan programs because the loan complied with applicable plan provisions, which incorporated the requirements of section 72(p) of the Code. During the loan repayment period, the Plan Official responsible for loan administration failed to properly withhold a number of loan repayments from the participant's wages and included the amount of such repayments in the participant's wages based on administrative or systems processing errors. The failure to withhold is a Breach causing the loan to become non-compliant with applicable plan provisions, which incorporated the requirements of section 72(p) of the Code.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         Plan Officials must make a voluntary correction of the loan with IRS approval under the Voluntary Correction Program of the IRS's EPCRS.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         The applicant is not required to submit any of the supporting documentation listed in section 6.1(e) unless otherwise requested by EBSA, except that the applicant must provide (i) proof of payment, as described in paragraph (e)(6) of section 6.1, and (ii) a copy of the IRS compliance statement.
                        <PRTPAGE P="4221"/>
                    </P>
                    <HD SOURCE="HD3">(c) Eligible Inadvertent Participant Loan Failures Under the Self-Correction Component</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan extended a loan to a plan participant who is a party in interest with respect to the plan based solely on their status as an employee of any employer whose employees are covered by the plan, as defined in section 3(14)(H) of ERISA. There is an Eligible Inadvertent Participant Loan Failure that involves a Breach as defined in section 3(b)(1) of the Program. An Eligible Inadvertent Participant Loan Failure is a participant loan failure that occurs despite the existence of practices and procedures that satisfy the standards set forth in, and is eligible for self-correction under, the IRS's EPCRS. An Eligible Inadvertent Participant Loan Failure shall not include any participant loan failure that is egregious, relates to the diversion or misuse of plan assets, or is directly or indirectly related to an abusive tax avoidance transaction.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) Plan Officials must make a voluntary self-correction of the Eligible Inadvertent Participant Loan Failure under the Self-Correction Program (SCP) of the IRS's EPCRS.
                    </P>
                    <P>
                        (ii) 
                        <E T="03">SCC Notice.</E>
                         The self-corrector must input the required information in the fields provided in the SCC notice and submit the notice electronically to EBSA through the online VFC Program web tool. The required information includes certain data elements listed below:
                    </P>
                    <P>(A) name and email address of the self-corrector;</P>
                    <P>(B) plan name;</P>
                    <P>(C) plan sponsor's nine-digit number (EIN) and the plan's three-digit number (PN);</P>
                    <P>(D) Type of participant loan failure;</P>
                    <P>(E) Loan amount;</P>
                    <P>(F) Date the failure is identified;</P>
                    <P>(G) Date of correction;</P>
                    <P>(H) Correction method; and</P>
                    <P>(I) Number of participants affected by the correction.</P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         The self-corrector shall provide the plan administrator with copies of the documentation required under section 6.2. Completion of the SCC Retention Record Checklist in Appendix F and supporting documents is not required.
                    </P>
                    <HD SOURCE="HD2">7.4 Purchases, Sales and Exchanges</HD>
                    <P>(a) Purchase of an Asset (Including Real Property) by a Plan from a Party in Interest</P>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan purchased an asset with cash from a party in interest with respect to the plan, in a transaction to which no prohibited transaction exemption applies.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) The plan may sell the asset back to the party in interest who originally sold the asset to the plan 
                        <SU>71</SU>
                        <FTREF/>
                         or to a person who is not a party in interest. Whether the asset is sold to a person who is not a party in interest with respect to the plan or is sold back to the original seller, the plan must receive the higher of (A) the FMV of the asset at the time of resale, without a reduction for the costs of sale, plus restoration to the plan of the party in interest's investment return from the proceeds of the sale, to the extent they exceed the plan's net profits from owning the property; or (B) the Principal Amount, plus the greater of (
                        <E T="03">1</E>
                        ) Lost Earnings on the Principal Amount as described in section 5(b), or (
                        <E T="03">2</E>
                        ) the Restoration of Profits, if any, as described in section 5(b).
                    </P>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             The resale of the same property to the party in interest from whom the asset was purchased is a reversal of the original prohibited transaction. The resale is not a new prohibited transaction and therefore does not require an exemption.
                        </P>
                    </FTNT>
                    <P>
                        (ii) As an alternative to the correction described in paragraph (a)(2)(i) above, the plan may retain the asset and receive (A) the greater of (
                        <E T="03">1</E>
                        ) Lost Earnings less any earnings received on the asset up to the Recovery Date or (
                        <E T="03">2</E>
                        ) the Restoration of Profits, if any, as described in section 5(b), on the Principal Amount, but only to the extent that such Lost Earnings or Restoration of Profits exceeds the difference between the FMV of the asset as of the Recovery Date and the original purchase price; and (B) the amount by which the Principal Amount exceeded the FMV of the asset (at the time of the original purchase), plus the greater of (
                        <E T="03">1</E>
                        ) Lost Earnings or (
                        <E T="03">2</E>
                        ) Restoration of Profits, if any, as described in section 5(b), on such excess; provided an independent fiduciary determines that the plan will realize a greater benefit from this correction than it would from the resale of the asset described in paragraph (a)(2)(i) above.
                    </P>
                    <P>
                        (iii) As a cash settlement alternative, when the plan no longer owns the asset and the transaction cannot be reversed or the asset cannot be retained as described respectively in paragraphs (a)(2)(i) and (ii) above, the plan may accept in cash the amounts specified in (A) plus (B) where (A) is—the greater of (
                        <E T="03">1</E>
                        ) Lost Earnings less any earnings received on the asset up to the Recovery Date or (
                        <E T="03">2</E>
                        ) the Restoration of Profits, if any, as described in section 5(b), on the Principal Amount, and (3) with the resulting amount from (1) or (2) reduced by any profit if the asset were resold or matured at a gain, or increased by any loss including Lost Earnings on such loss if either the asset was resold at a loss or the plan otherwise ceased to own the asset (
                        <E T="03">e.g.,</E>
                         maturity; destruction); and (B) is—the amount by which the Principal Amount exceeded the FMV of the asset (at the time of the original purchase), plus the greater of (
                        <E T="03">1</E>
                        ) Lost Earnings or (
                        <E T="03">2</E>
                        ) Restoration of Profits, if any, as described in section 5(b), on such excess. If the plan sold the asset, the asset must have been sold upon the advice of an independent fiduciary and not in anticipation of applying under the VFC Program.
                    </P>
                    <P>(iv) For this transaction, the Principal Amount is the plan's original purchase price.</P>
                    <P>(v) The principles of paragraph (a)(2) of this section are illustrated in the following examples:</P>
                    <P>
                        <E T="03">Example 1.</E>
                         A plan purchased a parcel of real property from the plan sponsor. The plan does not lease the property to any person. Instead, the plan uses the property as an office. The plan paid $120,000 for the property and $5,000 in transaction costs. As part of the correction, the Plan Official obtains two appraisals from a qualified, independent appraiser in order to determine the FMV of the property at the time of the purchase and at the time of the correction (the “Recovery Date”). The FMV of the property at the time of purchase was $100,000 ($20,000 less than the plan paid for the property). As of the Recovery Date, the appraiser values the property at $110,000. To correct the transaction, the plan sponsor repurchases the property for $120,000 with no reduction for the costs of sale and reimburses the plan for the $5,000 in initial costs of sale. The plan sponsor also must pay the plan the greater of the plan's Lost Earnings or the sponsor's investment return on these amounts. The determination of an independent fiduciary is not required because the applicant is correcting the transaction by selling the asset back to the party in interest pursuant to paragraph (a)(2)(i) of this section.
                    </P>
                    <P>
                        <E T="03">Example 2.</E>
                         On February 1, 2002, a plan purchased from a party in interest a parcel of commercial real estate for $120,000 and incurred $5,000 in costs of sale. The plan initially uses the property as an office. At the same time, it is discovered that the original purchase was a prohibited transaction, the plan enters into a lucrative lease with an unrelated party for use of the property to begin January 1 of the following year. Due to commercial developments in adjacent properties, the Plan Official believes that the property will increase in value and that the plan would be able 
                        <PRTPAGE P="4222"/>
                        to obtain substantially increasing rental payments for the use of the property. As part of the correction, the Plan Official obtains two appraisals from a qualified, independent appraiser in order to determine the FMV of the asset at the time of the purchase and at the time of the correction (the “Recovery Date”). The FMV of the property at the time of purchase was $120,000 (the same as the original purchase price). As of the Recovery Date, the property is valued at $150,000. Lost Earnings are calculated through September 30, 2005, the anticipated Recovery Date. The Online Calculator determined that Lost Earnings is $26,098.23 on the Principal Amount of $125,000 (purchase price plus transaction costs). There were no determinable profits. The increase in the FMV, $30,000, is greater than Lost Earnings or Restoration of Profits. Because the property is rapidly appreciating in value, and because the Plan Official expects to realize significant rental income from the property, the Plan Official would like to correct by retaining the property pursuant to paragraph (a)(2)(ii) of this section rather than selling the asset back to the party in interest pursuant to paragraph (a)(2)(i) of this section. The Plan Official must obtain a determination by an independent fiduciary that the plan will realize a greater benefit by retaining the asset than by selling the asset back to the party in interest. Because the original purchase price was the same as the FMV, and the increase in the FMV is greater than any earnings or investment return on the original purchase price, the only cash payment to the plan involved in this correction is the $5,000 in costs of sale, plus Lost Earnings.
                    </P>
                    <P>
                        <E T="03">Example 3.</E>
                         The plan purchased bonds from a party in interest on November 30, 2011 (the “Loss Date”) at a face value of $100,000 with a yield of 2% interest annually. The purchase was at FMV, and the bonds' maturity date was November 30, 2012. The plan received $102,000 on November 30, 2012 (the “Recovery Date”). In January 2013, the plan trustee realized that the original purchase was a prohibited transaction because the seller is a party in interest. There were no determinable profits. Under these facts, because the plan no longer owns the asset, the transaction cannot be reversed under paragraph (a)(2)(i) above. Similarly, the plan cannot use the correction under paragraph (a)(2)(ii) above. A Plan Official may correct the transaction under paragraph (a)(2)(iii) by paying to the plan on January 7, 2013 (the “Final Payment Date”) an amount of cash equal to the Lost Earnings as calculated using the Online Calculator less the interest paid on the bonds ($3,055.55-$2,000).
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) Documentation of the plan's purchase of the asset, including the date of the purchase, the plan's purchase price, and the identity of the seller;</P>
                    <P>(ii) A narrative describing the relationship between the original seller of the asset and the plan;</P>
                    <P>(iii) The qualified, independent appraiser's report addressing the FMV of the asset purchased by the plan, both at the time of the original purchase and at the recovery date;</P>
                    <P>(iv) If applicable, a report of the independent fiduciary's determination that the plan will realize a greater benefit by receiving the correction amount described in paragraph (a)(2)(ii) of this section than by reselling the asset pursuant to paragraph (a)(2)(i) of this section; and</P>
                    <P>(v) In a transaction involving a cash settlement correction under section 7.4(a)(2)(iii) where the plan sold the asset, a statement by a Plan Official that the asset was sold upon the advice of an independent fiduciary and not in anticipation of applying under the VFC Program.</P>
                    <HD SOURCE="HD3">(b) Sale of an Asset (Including Real Property) by a Plan to a Party in Interest</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan sold an asset for cash to a party in interest with respect to the plan, in a transaction to which no prohibited transaction exemption applies.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) The plan may repurchase the asset from the party in interest 
                        <SU>72</SU>
                        <FTREF/>
                         at the lower of (A) the price for which it originally sold the property or (B) the FMV of the property as of the Recovery Date plus restoration to the plan of the party in interest's net profits from owning the property, to the extent they exceed the plan's investment return from the proceeds of the sale.
                    </P>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             The repurchase of the same property from the party in interest to whom the asset was sold is a reversal of the original prohibited transaction. The repurchase is not a new prohibited transaction and therefore does not require an individual prohibited transaction exemption.
                        </P>
                    </FTNT>
                    <P>
                        (ii) As an alternative to the correction described in paragraph (b)(2)(i) above, the plan may receive the Principal Amount plus the greater of (A) Lost Earnings as described in section 5(b) or (B) the Restoration of Profits, if any, as described in section 5(b), provided an independent fiduciary determines that the plan will realize a greater benefit from this correction than it would from the repurchase of the asset described in paragraph (b)(2)(i), or provided a Plan Official determines that the asset cannot be repurchased (
                        <E T="03">e.g.,</E>
                         maturity, destruction).
                    </P>
                    <P>(iii) For this transaction, the Principal Amount is the amount by which the FMV of the asset (at the time of the original sale) exceeds the original sale price.</P>
                    <P>(iv) The principles of paragraph (b)(2) of this section are illustrated in the following examples:</P>
                    <P>
                        <E T="03">Example 1.</E>
                         A plan sold a parcel of unimproved real property to the plan sponsor. The sponsor did not make any profit on the use of the property. As part of the correction, the Plan Official obtains an appraisal of the property reflecting the FMV of the property as of the date of sale from a qualified, independent appraiser. The appraiser values the property at $130,000, although the plan sold the property to the plan sponsor for $120,000. The plan did not incur any transaction costs during the original sale. As of the Recovery Date, the appraiser values the property at $140,000. The plan corrects the transaction by repurchasing the property at the original sale price of $120,000, with the party in interest assuming the costs of the reversal of the sale transaction. The determination of an independent fiduciary is not required because the applicant is correcting the transaction by repurchasing the property from the party in interest pursuant to paragraph (b)(2)(i) of this section.
                    </P>
                    <P>
                        <E T="03">Example 2.</E>
                         Assume the same facts as in Example 1, except that the appraiser values the property as of the Recovery Date at $100,000, and the plan fiduciaries believe that the property will continue to decrease in value based on environmental studies conducted in adjacent areas. Based on the determination of an independent fiduciary that the plan will realize a greater benefit by receiving the Principal Amount (FMV of the asset at the time of the original sale less the original sales price equals $10,000) plus the greater of Lost Earnings or Restoration of Profits, as described in section 5(b), the transaction is corrected by cash settlement pursuant to paragraph (b)(2)(ii) of this section, rather than by repurchasing the asset.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) Documentation of the plan's sale of the asset, including the date of the sale, the sales price, and the identity of the original purchaser;</P>
                    <P>
                        (ii) A narrative describing the relationship of the purchaser to the asset 
                        <PRTPAGE P="4223"/>
                        and the relationship of the purchaser to the plan;
                    </P>
                    <P>(iii) The qualified, independent appraiser's report addressing the FMV of the property at the time of the sale from the plan and as of the Recovery Date; and</P>
                    <P>(iv) If applicable, a report of the independent fiduciary's determination that the plan will realize a greater benefit by receiving the correction amount described in paragraph (b)(2)(ii) of this section than by repurchasing the asset pursuant to paragraph (b)(2)(i) of this section, or if the asset cannot be repurchased, a written explanation of such circumstance from the Plan Official making this determination.</P>
                    <HD SOURCE="HD3">(c) Sale and Leaseback of Real Property to Employer</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         The plan sponsor, or an affiliate of the plan sponsor, sold a parcel of real property to the plan, which then was leased back to the sponsor or affiliate, in a transaction that is not otherwise exempt.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) The transaction must be corrected by the sale of the parcel of real property back to the plan sponsor or affiliate of the plan sponsor, or to a person who is not a party in interest with respect to the plan.
                        <SU>73</SU>
                        <FTREF/>
                         The plan must receive the higher of (A) FMV of the asset at the time of resale, without a reduction for the costs of sale; or (B) the Principal Amount, plus the greater of (
                        <E T="03">1</E>
                        ) Lost Earnings on the Principal Amount as described in section 5(b), or (
                        <E T="03">2</E>
                        ) the Restoration of Profits, if any, as described in section 5(b).
                    </P>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             If the plan purchased the property from the plan sponsor or an affiliate of the plan sponsor, the sale of the same property back to the plan sponsor or affiliate is a reversal of the prohibited transaction. The sale is not a new prohibited transaction and therefore does not require an individual prohibited transaction exemption, as long as the plan did not make improvements while it owned the property.
                        </P>
                    </FTNT>
                    <P>(ii) For purposes of this transaction, the Principal Amount is the plan's original purchase price.</P>
                    <P>(iii) If the plan has not been receiving rent at FMV, as determined by a qualified, independent appraisal, the sale price of the real property should not be based on the historic below-market rent that was paid to the plan.</P>
                    <P>(iv) In addition to the correction amount in subparagraph (1), if the plan was not receiving rent at FMV, as determined by a qualified, independent appraiser, the Principal Amount also includes the difference between the rent actually paid and the rent that should have been paid at FMV. The plan sponsor or an affiliate of the plan sponsor must pay to the plan this additional Principal Amount, plus the greater of (A) Lost Earnings or (B) Restoration of Profits resulting from the plan sponsor's or affiliate's use of the Principal Amount, as described in section 5(b).</P>
                    <P>(v) The principles of paragraph (c)(2) of this section are illustrated in the following example:</P>
                    <P>
                        <E T="03">Example.</E>
                         The plan purchased at FMV from the plan sponsor an office building that served as the sponsor's primary business site. Simultaneously, the plan sponsor leased the building from the plan at below the market rental rate. The Plan Official obtains from a qualified, independent appraiser an appraisal of the property reflecting the FMV of the property and rent. To correct the transaction, the plan sponsor purchases the property from the plan at the higher of the appraised value at the time of the resale or the original sales price and also pays the Lost Earnings. Because the rent paid to the plan was below the market rate, the sponsor must also make up the difference between the rent paid under the terms of the lease and the amount that should have been paid, plus Lost Earnings on this amount, as described in section 5(b).
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) Documentation of the plan's purchase of the real property, including the date of the purchase, the plan's purchase price, and the identity of the original seller;</P>
                    <P>(ii) Documentation of the plan's sale of the asset, including the date of sale, the sales price, and the identity of the purchaser;</P>
                    <P>(iii) A narrative describing the relationship of the original seller to the plan and the relationship of the purchaser to the plan;</P>
                    <P>(iv) A copy of the lease;</P>
                    <P>(v) Documentation of the date and amount of each lease payment received by the plan; and</P>
                    <P>(vi) The qualified, independent appraiser's report addressing both the FMV of the property at the time of the original sale and at the Recovery Date, and the FMV of the lease payments.</P>
                    <HD SOURCE="HD3">(d) Purchase of an Asset (Including Real Property) by a Plan From a Person Who Is Not a Party in Interest With Respect to the Plan at a Price More Than Fair Market Value</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan acquired an asset from a person who is not a party in interest with respect to the plan, without determining the asset's FMV. As a result, the plan paid more than it should have for the asset.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         The Principal Amount is the difference between the actual purchase price and the asset's FMV at the time of purchase. The plan must receive the Principal Amount plus the Lost Earnings, as described in section 5(b).
                    </P>
                    <P>(i) The principles of paragraph (d)(2) of this section are illustrated in the following example:</P>
                    <P>
                        <E T="03">Example.</E>
                         A plan bought unimproved land without obtaining a qualified, independent appraisal. Upon discovering that the purchase price was $10,000 more than the appraised FMV, the Plan Official pays the plan the Principal Amount of $10,000, plus Lost Earnings as described in section 5(b).
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) Documentation of the plan's original purchase of the asset, including the date of the purchase, the purchase price, and the identity of the seller;</P>
                    <P>(ii) A narrative describing the relationship of the seller to the plan; and</P>
                    <P>(iii) A copy of the qualified, independent appraiser's report addressing the value at the time of the plan's purchase.</P>
                    <HD SOURCE="HD3">(e) Sale of an Asset (Including Real Property) by a Plan to a Person Who Is Not a Party in Interest With Respect to the Plan at a Price Less Than Fair Market Value</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan sold an asset to a person who is not a party in interest with respect to the plan, without determining the asset's FMV. As a result, the plan received less than it should have from the sale.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         The Principal Amount is the amount by which the FMV of the asset as of the Recovery Date exceeds the price at which the plan sold the property. The plan must receive the Principal Amount plus Lost Earnings as described in section 5(b).
                    </P>
                    <P>(i) The principles of paragraph (e)(2) of this section are illustrated in the following example:</P>
                    <P>
                        <E T="03">Example.</E>
                         A plan sold unimproved land without taking steps to ensure that the plan received FMV. Upon discovering that the sale price was $10,000 less than the FMV, the Plan Official pays the plan the Principal Amount of $10,000 plus Lost Earnings as described in section 5(b).
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                        <PRTPAGE P="4224"/>
                    </P>
                    <P>(i) Documentation of the plan's original sale of the asset, including the date of the sale, the sale price, and the identity of the buyer;</P>
                    <P>(ii) A narrative describing the relationship of the buyer to the plan; and</P>
                    <P>(iii) A copy of the qualified, independent appraiser's report addressing the value at the time of the plan's sale.</P>
                    <HD SOURCE="HD3">(f) Holding of an Illiquid Asset Previously Purchased by a Plan</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan is holding an asset previously purchased from (i) a party in interest with respect to the plan in an acquisition for which relief was available under a statutory or administrative prohibited transaction exemption, (ii) a party in interest with respect to the plan at no greater than FMV at that time in an acquisition to which no prohibited transaction exemption applied, (iii) a person who was not a party in interest with respect to the plan in an acquisition in which a plan fiduciary failed to appropriately discharge their fiduciary duties, or (iv) a person who was not a party in interest with respect to the plan in an acquisition in which a plan fiduciary appropriately discharged their fiduciary duties. Currently, a plan fiduciary determines that such asset is an illiquid asset because: (A) the asset failed to appreciate, failed to provide a reasonable rate of return, or caused a loss to the plan; (B) the sale of the asset is in the best interest of the plan; and (C) following reasonable efforts to sell the asset to a person who is not a party in interest with respect to the plan, the asset cannot immediately be sold for its original purchase price, or its current FMV, if greater. Examples of assets that may meet this definition include, but are not limited to, restricted and thinly traded stock, limited partnership interests, real estate and collectibles. In the case of an illiquid asset that is a parcel of real estate, no party in interest may own real estate that is contiguous to the plan's parcel of real estate on the Recovery Date.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) The transaction may be corrected by the sale of the asset to a party in interest, provided the plan receives the higher of (A) the FMV of the asset at the time of resale, without a reduction for the costs of sale; or (B) the Principal Amount, plus Lost Earnings as described in section 5(b). The Plan Official may cause the plan to sell the asset to a party in interest. This correction provides relief for both the original purchase of the asset, if required, and the sale of the illiquid asset by the plan to a party in interest; relief from the prohibited transaction excise tax also is provided if the Plan Official satisfies the applicable conditions of the VFC Program class exemption.
                    </P>
                    <P>(ii) For this transaction, the Principal Amount is (A) the amount that would have been available had the Breach not occurred, or (B) the plan's original purchase price if the original purchase was not a prohibited transaction or imprudent.</P>
                    <P>(iii) The principles of paragraph (f)(2) of this section are illustrated in the following examples:</P>
                    <P>
                        <E T="03">Example 1.</E>
                         A plan purchases undeveloped real property from a party in interest with respect to the plan for $60,000 in June 1999. In April 2004, Plan Officials determine that the property is an illiquid asset. A qualified, independent appraiser appraises the property at a current FMV of $20,000. The plan sponsor pays the plan the Principal Amount of $60,000 plus Lost Earnings as described in section 5(b), and Plan Officials transfer the property from the plan to the plan sponsor. The Plan Officials also comply with the applicable terms of the related exemption.
                    </P>
                    <P>
                        <E T="03">Example 2.</E>
                         A plan purchases a limited partnership interest for $60,000 in June 1999 from an unrelated party after plan fiduciaries properly fulfill their fiduciary duties with respect to the purchase. In April 2004, Plan Officials determine that the interest is an illiquid asset because the interest has failed to generate a reasonable rate of return. A qualified, independent appraiser appraises the interest at a current FMV of $80,000. The plan sponsor pays the plan the FMV of $80,000 without a reduction for the costs of the sale, which is greater than the Principal Amount plus Lost Earnings, and Plan Officials transfer the interest from the plan to the plan sponsor. The Plan Officials also comply with the applicable terms of the related exemption.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) Documentation of the plan's original purchase of the asset, including the date of the purchase, the plan's purchase price, the identity of the original seller, and a description of the relationship, if any, between the original seller and the plan;</P>
                    <P>(ii) The qualified, independent appraiser's report addressing the FMV of the asset purchased by the plan at the recovery date;</P>
                    <P>(iii) A narrative describing the plan's efforts to sell the asset to persons who are not parties in interest with respect to the plan and any documentation of such efforts to sell the asset;</P>
                    <P>(iv) A statement from a Plan Official attesting that: (A) the asset failed to appreciate, failed to provide a reasonable rate of return, or caused a loss to the plan; (B) the sale of the asset is in the best interest of the plan; (C) the asset is an illiquid asset; and (D) the plan made reasonable efforts to sell the asset to persons who are not parties in interest with respect to the plan without success; and</P>
                    <P>(v) In the case of an illiquid asset that is a parcel of real estate, a statement from a Plan Official attesting that no party in interest owns real estate that is contiguous to the plan's parcel of real estate on the Recovery Date.</P>
                    <HD SOURCE="HD2">7.5 Benefits</HD>
                    <HD SOURCE="HD3">(a) Payment of Benefits Without Properly Valuing Plan Assets on Which Payment Is Based</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A defined contribution pension plan pays benefits based on the value of the plan's assets. If one or more of the plan's assets are not valued at current value, the benefit payments are not correct. If the plan's assets are overvalued, the current benefit payments will be too high. If the plan's assets are undervalued, the current benefit payments will be too low.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) Establish the correct value of the improperly valued asset for each plan year, starting with the first plan year in which the asset was improperly valued. In the case of undervalued plan assets, restore to the plan for distribution to the affected plan participants, or restore directly to the plan participants, the amount by which all affected participants were underpaid distributions to which they were entitled under the terms of the plan, plus Lost Earnings as described in section 5(b) on the underpaid distributions. In the case of overvalued plan assets, restore to the plan the amount which exceeded the paid distribution amount to which all affected participants were entitled under the terms of the plan, plus Lost Earnings as described in section 5(b) on the overpaid distributions. File amended Annual Report Forms 5500, as detailed below.
                    </P>
                    <P>(ii) To correct the valuation defect, a Plan Official must determine the FMV of the improperly valued asset per section 5(a) for each year in which the asset was valued improperly.</P>
                    <P>
                        (iii) Once the FMV has been determined, the participant account 
                        <PRTPAGE P="4225"/>
                        balances for each year must be adjusted accordingly.
                    </P>
                    <P>(iv) The Annual Report Forms 5500 must be amended and refiled for (A) the last three plan years or (B) all plan years in which the value of the asset was reported improperly, whichever is less.</P>
                    <P>(v) The Plan Official or plan administrator must determine who received distributions from the plan during the time the asset was valued improperly. For distributions that were too low, the amount of the underpayment is treated as a Principal Amount for each individual who received a distribution. The Principal Amount and Lost Earnings must be paid to the affected individuals. For distributions that were too high, the total of the overpayments constitutes the Principal Amount for the plan. The Principal Amount plus the Lost Earnings, as described in section 5(b), must be restored to the plan or to any participants who received distributions that were too low.</P>
                    <P>(vi) The principles of paragraph (a)(2) of this section are illustrated in the following examples:</P>
                    <P>
                        <E T="03">Example 1.</E>
                         On December 31, 1995, a profit-sharing plan purchased a 20-acre parcel of real property for $500,000, which represented a portion of the plan's assets. The plan has carried the property on its books at cost, rather than at FMV. One participant left the company on January 1, 1997, and received a distribution, which included the participant's portion of the value of the property. The separated participant's account balance represented 2% of the plan's assets. As part of the correction for the VFC Program, a qualified, independent appraiser has determined the FMV of the property for 1996, 1997, and 1998. The FMV as of December 31, 1996, was $400,000. Therefore, this participant was overpaid by $2,000 (($500,000−$400,000) multiplied by 2%). The Plan Officials corrected the transaction by paying to the plan the $2,000 Principal Amount plus Lost Earnings as described in section 5(b).
                    </P>
                    <P>The plan administrator also filed an amended Form 5500 for plan years 1996 and 1997, to reflect the proper values. The plan administrator will include the correct asset valuation in the 1998 Form 5500 when that form is filed.</P>
                    <P>
                        <E T="03">Example 2.</E>
                         Assume the same facts as in Example 1, except that the property had appreciated in value to $600,000 as of December 31, 1996. The separated participant would have been underpaid by $2,000. The correction consists of locating the participant and distributing to the participant the $2,000 Principal Amount plus Lost Earnings as described in section 5(b), as well as filing the amended Forms 5500.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) A copy of the qualified, independent appraiser's report for each plan year in which the asset was revalued;</P>
                    <P>(ii) A written statement confirming the date that amended Annual Report Forms 5500 with correct valuation data were filed;</P>
                    <P>(iii) If losses are restored to the plan, proof of payment to the plan and copies of the adjusted participant account balances; and</P>
                    <P>(iv) If supplemental distributions are made, proof of payment to the individuals entitled to receive the supplemental distributions or to the plan if paid pursuant to the de minimis exception in section 5(e).</P>
                    <HD SOURCE="HD2">7.6 Plan Expenses</HD>
                    <HD SOURCE="HD3">(a) Duplicative, Excessive, or Unnecessary Compensation Paid by a Plan</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan used plan assets to pay compensation, including commissions or fees, to a service provider (such as an attorney, accountant, recordkeeper, actuary, financial adviser, or insurance agent), and the compensation was:
                    </P>
                    <P>(i) excessive in amount for the services provided to the plan;</P>
                    <P>(ii) duplicative, in that a plan paid two or more providers for the same service; or</P>
                    <P>(iii) unnecessary for the operation of the plan, in that the services were not helpful and appropriate in carrying out the purposes for which the plan is maintained.</P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) Restore to the plan the Principal Amount, plus the greater of (A) Lost Earnings or (B) Restoration of Profits resulting from the use of the Principal Amount, as described in section 5(b).
                    </P>
                    <P>
                        (ii) (A) For the transactions described in paragraph (a)(1)(i) above, the Principal Amount is the difference between (
                        <E T="03">1</E>
                        ) the amount of compensation paid by the plan to the service provider and (
                        <E T="03">2</E>
                        ) the reasonable market value of such services.
                    </P>
                    <P>
                        (B) For the transactions described in paragraph (a)(1)(ii) above, the Principal Amount is the difference between (
                        <E T="03">1</E>
                        ) the total amount of compensation paid to the service providers and (
                        <E T="03">2</E>
                        ) the least amount of compensation paid to one of the service providers for the duplicative services.
                    </P>
                    <P>(C) For the transactions described in paragraph (a)(1)(iii) above, the Principal Amount is the amount of compensation paid by the plan to the service provider for the unnecessary services.</P>
                    <P>(iii) The principles of paragraph (a)(2) of this section are illustrated in the following examples:</P>
                    <P>
                        <E T="03">Example 1. Excessive compensation.</E>
                         A plan hired an investment adviser who advised the plan's trustees about how to invest the plan's entire portfolio. In accordance with the plan document, the trustees instructed the adviser to limit the plan's investments to equities and bonds. In exchange for the services, the plan paid the investment adviser 3% of the value of the portfolio's assets. If the trustees had inquired, they would have learned that comparable investment advisers charged 1% of the value of the assets for the type of portfolio that the plan maintained. To correct the transaction, the plan must be paid the Principal Amount of 2% of the value of the plan's assets, plus the higher Lost Earnings or Restoration of Profits, as described in section 5(b).
                    </P>
                    <P>
                        <E T="03">Example 2. Unnecessary Compensation.</E>
                         A plan paid a travel agent to arrange a fishing trip for the plan's investment adviser as a way of rewarding the adviser because the plan's investment return for the year exceeded the plan's investment goals by 10%. An internal auditor discovered the charge on the plan's record books. To correct the transaction, the plan must be paid the Principal Amount, which is the total amount paid to the travel agent, plus the higher of Lost Earnings or Restoration of Profits as described in section 5(b).
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit the following documents:
                    </P>
                    <P>(i) For the transactions described in paragraph (a)(1)(i) above, a written estimate of the reasonable market value of the services and the estimator's qualifications; and</P>
                    <P>(ii) The cost of the services at issue during the period that such services were provided to the plan.</P>
                    <HD SOURCE="HD3">(b) Expenses Improperly Paid by a Plan</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan used plan assets to pay expenses, including commissions or fees, which should have been paid by the plan sponsor, to a service provider (such as an attorney, accountant, recordkeeper, actuary, financial adviser, or insurance agent) for:
                    </P>
                    <P>
                        (i) services provided in connection with the administration and maintenance of the plan (“plan expenses” 
                        <SU>74</SU>
                        <FTREF/>
                        ) in circumstances where a 
                        <PRTPAGE P="4226"/>
                        plan provision requires that such plan expenses be paid by the plan sponsor, or
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             
                            <E T="03">See</E>
                             Advisory Opinion 2001-01A (Jan. 18, 2001).
                        </P>
                    </FTNT>
                    <P>
                        (ii) services provided in connection with the establishment, design, or termination of the plan (“settlor expenses” 
                        <SU>75</SU>
                        <FTREF/>
                        ), which relate to the activities of the plan sponsor in its capacity as settlor.
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             
                            <E T="03">See id.</E>
                        </P>
                    </FTNT>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) Restore to the plan the Principal Amount, plus the greater of (A) Lost Earnings or (B) Restoration of Profits resulting from the use of the Principal Amount, as described in section 5(b).
                    </P>
                    <P>(ii) The Principal Amount is the entire amount improperly paid by the plan to the service provider for expenses that should have been paid by the plan sponsor.</P>
                    <P>(iii) The principles of paragraph (b)(2) of this section are illustrated in the following example:</P>
                    <P>
                        <E T="03">Example.</E>
                         Employer X, the plan sponsor of Plan Y, is considering amending its defined contribution plan to add a 5% matching contribution. Employer X operates in a competitive industry, and a human resources consultant has recommended, among other improvements, that Employer X provide a competitive matching contribution to help attract and retain a highly qualified workforce. Employer X hired an actuary to estimate the cost of providing this matching contribution over the next ten years. In exchange for these services, the plan paid the actuary $10,000. Several months after the actuary's bill has been paid, a Plan Official realizes that one of Employer X's employees erroneously paid the bill from the defined contribution plan's assets. The bill should have been paid by Employer X because the bill related to settlor expenses incurred by Employer X in analyzing whether to add a matching contribution to the plan. To correct the transaction, the plan must be paid the Principal Amount ($10,000), plus Lost Earnings or Restoration of Profits, as described in section 5(b).
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit copies of the plan's accounting records which show the date and amount of expenses paid by the plan to the service provider.
                    </P>
                    <HD SOURCE="HD3">(c) Payment of Dual Compensation to a Plan Fiduciary</HD>
                    <P>
                        (1) 
                        <E T="03">Description of Transaction.</E>
                         A plan used plan assets to pay compensation to a fiduciary for services rendered to the plan when the fiduciary already receives full-time pay from an employer or an association of employers, whose employees are participants in the plan, or from an employee organization whose members are participants in the plan. The plan's payments to the plan fiduciary are not reimbursements of expenses properly and actually incurred by the fiduciary in the performance of their fiduciary duties.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Correction of Transaction.</E>
                         (i) Restore to the plan the Principal Amount, plus the greater of (A) Lost Earnings or (B) Restoration of Profits resulting from the fiduciary's use of the Principal Amount, as described in section 5(b).
                    </P>
                    <P>(ii) The Principal Amount is the amount of compensation paid to the fiduciary by the plan.</P>
                    <P>(iii) The principles of paragraph (c)(2) of this section are illustrated in the following example:</P>
                    <P>
                        <E T="03">Example.</E>
                         A union sponsored a health plan funded through contributions by employers. The union president receives $50,000 per year from the union in compensation for services as union president. The president is appointed as a trustee of the health plan while retaining the position as union president. In exchange for acting as plan trustee, the union president is paid a salary of $200 per week by the plan while still receiving the $50,000 salary from the union. Since $50,000 is full-time pay, the plan's weekly salary payments are improper. To correct the transaction, the plan must be paid the Principal Amount, which is the $200 weekly salary amount for each week that the salary was paid, plus the higher of Lost Earnings or Restoration of Profits, as described in section 5(b).
                    </P>
                    <P>
                        (3) 
                        <E T="03">Documentation.</E>
                         In addition to the documentation required by section 6.1, submit copies of the plan's accounting records which show the date and amount of compensation paid by the plan to the identified fiduciary.
                    </P>
                    <HD SOURCE="HD1">Appendix A—Sample VFC Program No Action Letter</HD>
                    <EXTRACT>
                        <FP>Applicant (Plan Official)</FP>
                        <FP>Address</FP>
                        <FP>Dear Applicant (Plan Official):</FP>
                        <FP SOURCE="FP1-2">Re: VFC Program Application No. xx-xxxxxx </FP>
                        <P>The Department of Labor, Employee Benefits Security Administration (EBSA), administers and enforces Title I of the Employee Retirement Income Security Act of 1974 (ERISA). EBSA established a Voluntary Fiduciary Correction (VFC) Program to encourage the voluntary correction of breaches of fiduciary responsibility and the restoration of losses to the plan participants and beneficiaries.</P>
                        <P>You submitted a VFC Program application identifying the following transactions as breaches, or potential breaches, of the fiduciary duty provisions in Part 4 of Title I of ERISA. You also submitted documentation to EBSA under the VFC Program on the corrective action you have taken. Your application was assigned the application number indicated above.</P>
                        <P>
                            [Briefly recap the transaction and correction. 
                            <E T="03">Example:</E>
                             Failure to deposit participant contributions to the XYZ Corp. 401(k) plan within the time frames required by ERISA from (date) to (date). All participant contributions were deposited by (date) and Lost Earnings on the delinquent contributions were deposited and allocated to participants' plan accounts on (date).]
                        </P>
                        <P>Based on your representations and the corrective actions taken, in accordance with the terms and limitations set forth in the VFC Program, EBSA will not recommend that the Solicitor of Labor initiate legal action against you, and EBSA will not seek to impose civil penalties under section 502(l) or section 502(i) of ERISA with respect to the transactions described above.</P>
                        <P>EBSA's decision is conditioned on the representations in your VFC Program application being complete and accurate. The decision does not preclude EBSA from conducting an investigation of any potential violations of criminal law in connection with the transaction identified in the application or seeking appropriate relief from any other person. EBSA's decision is binding on EBSA only, and does not bar other governmental agencies, plan fiduciaries, participants or beneficiaries, and other interested persons from seeking separate or additional remedies.</P>
                        <P>[If the transaction is a prohibited transaction for which no exemptive relief is available, add the following language: The Secretary of Labor is required by section 3003(c) of ERISA, 29 U.S.C. 1203(c), to transmit to the Secretary of the Treasury information indicating that a prohibited transaction has occurred. Accordingly, this matter will be referred to the Internal Revenue Service.]</P>
                        <P>
                            If you have any questions about this letter, you may contact the Regional VFC Program Coordinator at (insert 
                            <E T="03">applicable address and telephone number).</E>
                        </P>
                    </EXTRACT>
                    <HD SOURCE="HD1">Appendix B—VFC Program Application Checklist (Required)</HD>
                    <EXTRACT>
                        <P>Use this checklist to make sure you are submitting a complete application. Indicate “Yes”, “No” or “N/A” next to each item. A “No” answer or the failure to include a completed checklist will delay review of the application until all required items are received. The applicant must sign and date the checklist and include it with the application. Check with the relevant Regional Office whether it accepts email submissions of VFC Program applications.</P>
                        <FP>__1. Have you reviewed the eligibility, definitions, transaction and correction, and documentation sections of the VFC Program?</FP>
                        <FP>__2. Have you included the name, address (street or email) and telephone number of a contact person familiar with the contents of the application?</FP>
                        <FP>__3. Have you provided the EIN, Plan Number, and address (street and email) of the plan sponsor and plan administrator?</FP>
                        <FP>
                            __4. Have you provided the date that the most recent Form 5500 was filed by the plan 
                            <PRTPAGE P="4227"/>
                            (or for a bulk application as described in section 4(d), the nine-digit employer identification number for each plan sponsor of a named plan)?
                        </FP>
                        <FP>__5. Have you enclosed a signed and dated certification under penalty of perjury for the plan fiduciary with knowledge of the transactions and for each applicant and the applicant's representative, if any? In the case of a bulk application, have you enclosed a signed and dated certification under penalty of perjury for the bulk applicant based on knowledge of the transactions and for the bulk applicant's representative, if any? In the case of a contributing or adopting employer in a multiemployer plan or multiple employer plan, the employer may sign the Penalty of Perjury statement and, without regard to the employer's status as a plan fiduciary, no other plan fiduciary need sign.</FP>
                        <FP>__6. Have you enclosed relevant portions of the plan document and any other pertinent documents (such as the adoption agreement, trust agreement, or insurance contract) with the relevant sections identified?</FP>
                        <FP>__7. If applicable, have you provided written notification to EBSA of any current investigation or examination of the plan, or of the applicant or plan sponsor in connection with an act or transaction directly related to the plan by the PBGC, any state attorney general, or any state insurance commissioner?</FP>
                        <FP>__8. If applicable (under section 4(b)(2) of the Program), have you included the following items?</FP>
                        <FP>__a. Contact information for the law enforcement agency notified of the criminal activity;</FP>
                        <FP>__b. A statement from the applicant asserting no involvement in the potential criminal activity; and</FP>
                        <FP>__c. A statement as to whether a claim relating to the criminal activity has been made under an ERISA section 412 fidelity bond.</FP>
                        <FP>__9. Where applicable, have you enclosed a copy of an appraiser's report?</FP>
                        <FP>__10. Where applicable, have you enclosed a copy of an independent fiduciary's approval?</FP>
                        <FP>__11. Have you enclosed supporting documentation, including:</FP>
                        <FP>__a. A detailed narrative of the Breach, including the date it occurred;</FP>
                        <FP>__b. Documentation that supports the narrative description of the transaction;</FP>
                        <FP>__c. An explanation of how the Breach was corrected, by whom and when, with supporting documentation;</FP>
                        <FP>
                            __d. A list of all persons materially involved in the Breach and its correction (
                            <E T="03">e.g.,</E>
                             fiduciaries, service providers, borrowers, lenders);
                        </FP>
                        <FP>__e. Specific calculations demonstrating how Principal Amount and Lost Earnings or Restoration of Profits were computed, or, if the Online Calculator was used, a copy of the “Print Viewable Results” page(s) after completing use of the Online Calculator;</FP>
                        <FP>__f. Proof of payment of principal amount;</FP>
                        <FP>__g. Proof of payment of Lost Earnings or restoration of profits to the plan; and</FP>
                        <P>
                            <E T="03">Caution: The correction amount and the costs of correction cannot be paid from plan assets, including by charges against participant accounts or plan forfeiture accounts.</E>
                        </P>
                        <FP>__h. If application concerns delinquent participant contributions or loan repayments, a statement from a Plan Official identifying the earliest date on which participant contributions/loan repayments reasonably could have been segregated from the employer's general assets and supporting documentation on which the Plan Official relied?</FP>
                        <FP>__12. If you are an eligible applicant and wish to avail yourself of excise tax relief under the VFC Program Class Exemption:</FP>
                        <FP>__a. Have you made proper arrangements to provide within 60 calendar days after submission of this application a copy of the VFC Program Class Exemption notice to all interested persons and to the EBSA Regional Office to which the application is filed; or</FP>
                        <FP>__b. If you are relying on the exception to the notice requirement in section IV.C. of the VFC Program Class Exemption because the amount of the excise tax otherwise due would be less than or equal to $100.00, have you provided to the appropriate EBSA Regional Office a copy of a completed IRS Form 5330 or other written documentation containing the information required by IRS Form 5330 and proof of payment?</FP>
                        <FP>__13. In calculating Lost Earnings, have you elected to use:</FP>
                        <FP>__a. The Online Calculator; or</FP>
                        <FP>__b. A manual calculation performed in accordance with section 5(b) of the VFC Program?</FP>
                        <FP>__14. If the application involves payments to participants and beneficiaries:</FP>
                        <FP>__a. Have you enclosed a description demonstrating proof of payment to participants and beneficiaries whose current location is known to the plan and/or applicant in accordance with section 5(d) of the VFC Program?</FP>
                        <FP>__b. For individuals who need to be located, have you demonstrated how adequate funds have been segregated to pay missing individuals and included a description of the process that you commenced to locate missing individuals in accordance with section 5(d)?</FP>
                        <FP>__15. For purposes of the three transactions involving participant contributions covered under section 7.1, has the plan implemented measures to ensure that such transactions do not recur?</FP>
                        <FP SOURCE="FP-1">
                            <E T="03">Signature of Applicant and Date Signed:</E>
                        </FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-1">
                            <E T="03">Name of Applicant:</E>
                        </FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-1">
                            <E T="03">Title/Relationship to the Plan:</E>
                        </FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-1">
                            <E T="03">Name of Plan, EIN and Plan Number:</E>
                        </FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-1">
                            <E T="03">Contact information: Phone; email:</E>
                        </FP>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">Paperwork Reduction Act Notice</HD>
                        <P>The information identified on this form is required for a valid application for the Voluntary Fiduciary Correction Program of the U.S. Department of Labor's Employee Benefits Security Administration (EBSA). You must complete this form and submit it as part of the application in order to receive the relief offered under the Program with respect to a breach of fiduciary responsibility under Part 4 of Title I of ERISA. EBSA will use this information to determine that you have satisfied the requirements of the Program. EBSA estimates that completing and submitting this form will require an average of 2 to 4 minutes. This collection of information is currently approved under OMB Control Number 1210-0118. You are not required to respond to a collection of information unless it displays a currently valid OMB Control Number.</P>
                    </EXTRACT>
                    <HD SOURCE="HD1">Appendix C—EBSA Regional Offices</HD>
                    <EXTRACT>
                        <P>
                            Submit your VFC Program application to the appropriate EBSA Regional Office. Verify current telephone numbers and addresses on EBSA's website, 
                            <E T="03">www.dol.gov/ebsa/</E>
                             before you submit your application. Check with the relevant Regional Office on whether it accepts email submissions of VFC Program applications.
                        </P>
                        <P>
                            <E T="03">Atlanta Regional Office,</E>
                             61 Forsyth Street SW, Suite 7B54, Atlanta, GA 30303, telephone (404) 302-3900, fax (404) 302-3975; jurisdiction: Alabama, Florida, Georgia, Mississippi, North Carolina, South Carolina, Tennessee, Puerto Rico.
                        </P>
                        <P>
                            <E T="03">Boston Regional Office,</E>
                             J.F.K. Federal Building, 15 New Sudbury Street, Room 575, Boston, MA 02203, telephone (617) 565-9600, fax: (617) 565-9666; jurisdiction: Connecticut, Maine, Massachusetts, New Hampshire, central and western New York, Rhode Island, Vermont.
                        </P>
                        <P>
                            <E T="03">Chicago Regional Office,</E>
                             John C. Kluczynski Federal Building, 230 South Dearborn Street, Suite 2160, Chicago, IL 60604, telephone (312) 353-0900, fax (312) 353-1023; jurisdiction: northern Illinois, northern Indiana, Wisconsin.
                        </P>
                        <P>
                            <E T="03">Cincinnati Regional Office,</E>
                             1885 Dixie Highway, Suite 210, Ft. Wright, KY 41011-2664, telephone (859) 578-4680, fax (859) 578-4688; jurisdiction: southern Indiana, Kentucky, Michigan, Ohio.
                        </P>
                        <P>
                            <E T="03">Dallas Regional Office,</E>
                             525 South Griffin Street, Rm. 900, Dallas, TX 75202-5025, telephone (972) 850-4500, fax (214) 767-1055; jurisdiction: Arkansas, Louisiana, New Mexico, Oklahoma, Texas.
                        </P>
                        <P>
                            <E T="03">Kansas City Regional Office,</E>
                             2300 Main Street, Suite 1100, Kansas City, MO 64108, telephone (816) 285-1800, fax (816) 285-1888; jurisdiction: Colorado, southern Illinois, Iowa, Kansas, Minnesota, Missouri, Montana, Nebraska, North Dakota, South Dakota, Wyoming.
                        </P>
                        <P>
                            <E T="03">Los Angeles Regional Office,</E>
                             35 N Lake Ave., Suite 300, Pasadena, CA 91101, telephone (626) 229-1000, fax (626) 229-1098; jurisdiction: 10 southern counties of California, Arizona, Hawaii, American Samoa, Guam, Wake Island.
                        </P>
                        <P>
                            <E T="03">New York Regional Office</E>
                            , 201 Varick Street, Room 746, New York, NY 10014, telephone (212) 607-8600, fax (212) 607-8611; jurisdiction: southeastern New York, northern New Jersey.
                        </P>
                        <P>
                            <E T="03">Philadelphia Regional Office</E>
                            , 1835 Market Street, 21st Floor, Mailstop EBSA/21, Philadelphia, PA 19103, telephone (215) 861-5300, fax (215) 861-5347; jurisdiction: Delaware, Maryland, southern New Jersey, 
                            <PRTPAGE P="4228"/>
                            Pennsylvania, Virginia, Washington, DC, West Virginia.
                        </P>
                        <P>
                            <E T="03">San Francisco Regional Office</E>
                            , 90 7th Street, Suite 11-300, San Francisco, CA 94103, telephone (415) 625-2481, fax (415) 625-2450; jurisdiction: Alaska, 48 northern counties of California, Idaho, Nevada, Oregon, Utah, Washington.
                        </P>
                    </EXTRACT>
                    <HD SOURCE="HD1">Appendix D—Lost Earnings Example (Manual Calculation)</HD>
                    <EXTRACT>
                        <HD SOURCE="HD1">Delinquent Participant Contributions</HD>
                        <P>Company A pays its employees every other Friday. Each pay date, participant contributions total $10,000, which reasonably can be segregated from Company A's general assets by ten business days following each pay date. Company A should have remitted participant contributions for the pay date ending March 2, 2001 to the plan by March 16, 2001, the Loss Date, but actually remitted them on April 13, 2001, the Recovery Date. In early 2004, a Plan Official discovers that participant contributions for this pay period were not remitted on a timely basis. To comply with the Program, the Plan Official decided to repay all Lost Earnings on January 30, 2004.</P>
                        <P>Based on the above facts:</P>
                        <FP SOURCE="FP-1">
                            • 
                            <E T="03">Principal Amount</E>
                             is $10,000
                        </FP>
                        <FP SOURCE="FP-1">
                            • 
                            <E T="03">Loss Date</E>
                             is March 16, 2001
                        </FP>
                        <FP SOURCE="FP-1">
                            • 
                            <E T="03">Recovery Date</E>
                             is April 13, 2001
                        </FP>
                        <FP SOURCE="FP-1">
                            • 
                            <E T="03">Number of Days Late</E>
                             is 28 (Recovery Date less Loss Date)
                        </FP>
                        <P>The basic formula for computing earnings using the applicable factors under IRS Revenue Procedure 95-17 is: Dollar Amount * IRS factor.</P>
                        <P>
                            <E T="03">Step 1.</E>
                             The Plan Official must calculate Lost Earnings, based on the Principal Amount, that should have been paid on the Recovery Date.
                        </P>
                        <P>The first period of time is from March 16, 2001 to March 31, 2001 (15 days). The Code underpayment rate is 9%. Using Revenue Procedure 95-17, the factor for 15 days at 9% is 0.003705021 from table 23.</P>
                        <FP SOURCE="FP-2">$10,000 * 0.003705021 = $37.05</FP>
                        <P>The plan is due $10,037.05 as of March 31, 2001. The second period of time is April 1, 2001 through April 13, 2001 (13 days). The Code underpayment rate is 8%. Using Revenue Procedure 95-17, the factor for 13 days at 8% is 0.002853065 from table 21.</P>
                        <FP SOURCE="FP-2">$10,037.05 * 0.002853065 = $28.64</FP>
                        <P>Therefore, Lost Earnings of $65.69 ($37.05 plus $28.64) must be paid to the plan.</P>
                        <P>
                            <E T="03">Step 2.</E>
                             If Lost Earnings are paid to the plan after the Recovery Date, the Plan Official must calculate the amount of interest on the Lost Earnings (determined in Step 1) that must also be paid to the plan. This calculation is shown by the following chart: (The “Interest” column is the previous time period's “Amnt. Due” multiplied by the Factor. “Amnt. Due” is the previous “Amnt. Due” plus “Interest”. The calculation in the first row is based on the $65.69 Lost Earnings.)
                        </P>
                        <GPOTABLE COLS="8" OPTS="L2,tp0,i1" CDEF="s50,10,8,10,10,12,12,12">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">1st day</CHED>
                                <CHED H="1">To</CHED>
                                <CHED H="1">Days</CHED>
                                <CHED H="1">
                                    Underpmnt.
                                    <LI>rate</LI>
                                    <LI>(%)</LI>
                                </CHED>
                                <CHED H="1">
                                    Rev. proc.
                                    <LI>table</LI>
                                </CHED>
                                <CHED H="1">Factor</CHED>
                                <CHED H="1">Interest</CHED>
                                <CHED H="1">Amnt. due</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">4/14/01</ENT>
                                <ENT>6/30/01</ENT>
                                <ENT>78</ENT>
                                <ENT>8</ENT>
                                <ENT>21</ENT>
                                <ENT>.017240956</ENT>
                                <ENT>1.132558</ENT>
                                <ENT>66.82256</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">7/1/01</ENT>
                                <ENT>9/30/01</ENT>
                                <ENT>92</ENT>
                                <ENT>7</ENT>
                                <ENT>19</ENT>
                                <ENT>.017798686</ENT>
                                <ENT>1.189354</ENT>
                                <ENT>68.01191</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">10/1/01</ENT>
                                <ENT>12/31/01</ENT>
                                <ENT>92</ENT>
                                <ENT>7</ENT>
                                <ENT>19</ENT>
                                <ENT>.017798686</ENT>
                                <ENT>1.210523</ENT>
                                <ENT>69.22243</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">1/1/02</ENT>
                                <ENT>3/31/02</ENT>
                                <ENT>90</ENT>
                                <ENT>6</ENT>
                                <ENT>17</ENT>
                                <ENT>.014903267</ENT>
                                <ENT>1.031640</ENT>
                                <ENT>70.25408</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">4/1/02</ENT>
                                <ENT>6/30/02</ENT>
                                <ENT>91</ENT>
                                <ENT>6</ENT>
                                <ENT>17</ENT>
                                <ENT>.015070101</ENT>
                                <ENT>1.058736</ENT>
                                <ENT>71.31281</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">7/1/02</ENT>
                                <ENT>9/30/02</ENT>
                                <ENT>92</ENT>
                                <ENT>6</ENT>
                                <ENT>17</ENT>
                                <ENT>.015236961</ENT>
                                <ENT>1.086591</ENT>
                                <ENT>72.39940</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">10/1/02</ENT>
                                <ENT>12/31/02</ENT>
                                <ENT>92</ENT>
                                <ENT>6</ENT>
                                <ENT>17</ENT>
                                <ENT>.015236961</ENT>
                                <ENT>1.103147</ENT>
                                <ENT>73.50255</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">1/1/03</ENT>
                                <ENT>3/31/02</ENT>
                                <ENT>90</ENT>
                                <ENT>5</ENT>
                                <ENT>15</ENT>
                                <ENT>.012404225</ENT>
                                <ENT>0.911742</ENT>
                                <ENT>74.41429</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">4/1/03</ENT>
                                <ENT>6/30/03</ENT>
                                <ENT>91</ENT>
                                <ENT>5</ENT>
                                <ENT>15</ENT>
                                <ENT>.012542910</ENT>
                                <ENT>0.933372</ENT>
                                <ENT>75.34766</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">7/1/03</ENT>
                                <ENT>9/30/03</ENT>
                                <ENT>92</ENT>
                                <ENT>5</ENT>
                                <ENT>15</ENT>
                                <ENT>.012681615</ENT>
                                <ENT>0.955530</ENT>
                                <ENT>76.30319</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">10/1/03</ENT>
                                <ENT>12/31/03</ENT>
                                <ENT>92</ENT>
                                <ENT>4</ENT>
                                <ENT>13</ENT>
                                <ENT>.010132630</ENT>
                                <ENT>0.773152</ENT>
                                <ENT>77.07634</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">1/1/04</ENT>
                                <ENT>1/30/04</ENT>
                                <ENT>30</ENT>
                                <ENT>4</ENT>
                                <ENT>61</ENT>
                                <ENT>.003283890</ENT>
                                <ENT>0.253110</ENT>
                                <ENT>
                                    <E T="03">77.32945</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="05">
                                <ENT I="03">Total Interest</ENT>
                                <ENT>11.64</ENT>
                                <ENT/>
                            </ROW>
                        </GPOTABLE>
                        <P>Note that the last factor comes from the Revenue Procedure 95-17 tables for leap years. The plan is also owed $11.64. This is the amount of interest on $65.69 (Lost Earnings on the Principal Amount) accrued between April 13, 2001, the Recovery Date, when the Principal Amount $10,000 was paid to the plan, and January 30, 2004, the date chosen to repay Lost Earnings.</P>
                        <P>
                            Therefore, the Plan Official must pay 
                            <E T="03">$77.33</E>
                             to the plan on January 30, 2004, as Lost Earnings ($65.69) plus interest on Lost Earnings ($11.64) for the pay period ending March 2, 2001, in addition to the Principal Amount ($10,000) that was paid on April 13, 2001. This total corresponds with the final Total Due in the above chart (emphasized).
                        </P>
                    </EXTRACT>
                    <HD SOURCE="HD1">Appendix E—Model Application Form (Optional)</HD>
                    <EXTRACT>
                        <HD SOURCE="HD1">Voluntary Fiduciary Correction Program Application Form</HD>
                        <P>
                            This application form provides a recommended format for your VFC Program application. Please make sure you have attached all documents identified on the VFC Program Checklist (for example, proof of payment). If you choose to use a different format to submit the required information for your VFC Program Application, your application must still include a completed copy of the VFC Program Checklist. Submit your application to the appropriate EBSA Regional Office. Check with the relevant Regional Office whether it accepts email submissions of VFC Program applications. For full application procedures, consult 
                            <E T="03">www.dol.gov/ebsa/.</E>
                        </P>
                        <FP SOURCE="FP-1">Applicant Name(s) and Address(es) (street and email)</FP>
                        <FP SOURCE="FP-1">List separately:</FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">List Transaction(s) Corrected</HD>
                        <P>Check which transaction(s) listed in the VFC Program you have corrected:</P>
                        <FP SOURCE="FP-1">__Delinquent Participant Contributions and Loan Repayments to Pension Plans</FP>
                        <FP SOURCE="FP-1">__Delinquent Participant Contributions to Insured Welfare Plans</FP>
                        <FP SOURCE="FP-1">__Delinquent Participant Contributions to Welfare Plan Trusts</FP>
                        <FP SOURCE="FP-1">__Loan at Fair Market Interest Rate to a Party in Interest</FP>
                        <FP SOURCE="FP-1">__Loan at Below-Market Interest Rate to a Party in Interest</FP>
                        <FP SOURCE="FP-1">__Loan at Below-Market Interest Rate to a Non-Party in Interest</FP>
                        <FP SOURCE="FP-1">__Loan at Below-Market Interest Rate Due to Delay in Perfecting Plan's Security Interest</FP>
                        <FP SOURCE="FP-1">__Loans Failing to Comply with Plan Provisions for Amount, Duration or Level Amortization</FP>
                        <FP SOURCE="FP-1">__Default Loans</FP>
                        <FP SOURCE="FP-1">__Purchase of an Asset by a Plan from a Party in Interest</FP>
                        <FP SOURCE="FP-1">__Sale of an Asset by a Plan to a Party in Interest</FP>
                        <FP SOURCE="FP-1">__Sale and Leaseback of Real Property to Employer</FP>
                        <FP SOURCE="FP-1">__Purchase of Asset by a Plan from a Non-Party in Interest at More Than Fair Market Value</FP>
                        <FP SOURCE="FP-1">__Sale of an Asset by a Plan to a Non-Party in Interest at Less Than Fair Market Value</FP>
                        <FP SOURCE="FP-1">__Holding of an Illiquid Asset Previously Purchased by a Plan</FP>
                        <FP SOURCE="FP-1">__Payment of Benefits Without Properly Valuing Plan Assets on Which Payment is Based</FP>
                        <FP SOURCE="FP-1">__Duplicative, Excessive, or Unnecessary Compensation Paid by a Plan</FP>
                        <FP SOURCE="FP-1">__Expenses Improperly Paid by a Plan</FP>
                        <FP SOURCE="FP-1">__Payment of Dual Compensation to a Plan Fiduciary</FP>
                        <HD SOURCE="HD1">Correction Amount</HD>
                        <FP SOURCE="FP-1">
                            <E T="03">Principal Amount: $</E>
                             ______ 
                            <PRTPAGE P="4229"/>
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">Date Paid _/_/_</E>
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">Lost Earnings/Restoration of Profit: $</E>
                             ______ 
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">Date Paid _/_/_</E>
                        </FP>
                        <HD SOURCE="HD2">Narrative and Calculations</HD>
                        <P>List:</P>
                        <P>
                            (1) All persons materially involved in the Breach and its correction (
                            <E T="03">e.g.,</E>
                             fiduciaries, service providers): 
                        </P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <P>(2) An explanation of the Breach, including the date(s) it occurred (attach separate sheets if necessary): </P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <P>(3) An explanation of how the Breach was corrected, by whom, and when (attach separate sheets if necessary): </P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <P>(4) For a correction of Delinquent Participant Contributions or Loan Repayments, provide a statement from a Plan Official identifying the earliest date on which participant contributions/loan repayments reasonably could have been segregated from the employer's general assets (attach supporting documentation on which Plan Official relied).</P>
                        <P>Number of days used to determine the date on which participant contributions/loan repayments withheld from employees' pay could reasonably have been segregated from the employer's general assets: </P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <P>Description of how this date was determined, including the applicant's current contribution and/or repayment remittance practices: </P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <P>(5) For a correction of Delinquent Participant Contributions or Loan Repayments, provide a narrative describing any changes to the applicant's contribution and/or repayment remittance practices after the period of unpaid or late contributions and/or repayments, including any steps taken to prevent future delinquencies: (attach separate sheets if necessary) </P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <P>(6) Specific calculations demonstrating how Principal Amount and Lost Earnings or Restoration of Profits were calculated (attach separate sheets if necessary): If the Online Calculator was used, you only need to indicate this and attach a copy of the “View Printable Results” page.</P>
                        <P>__Online Calculator—“View Printable Results” page attached.</P>
                        <P>__Manual calculation—see attached calculations, which must follow the method used in subparagraphs (i) through (iv) of section 5(b)(6). See Appendix D for a sample.</P>
                        <HD SOURCE="HD1">Supplemental Information</HD>
                        <P>(1) Plan Sponsor Name: </P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH">EIN: </FP>
                        <FP SOURCE="FP-DASH">Address: </FP>
                        <P>(2)(a) Plan Name:</P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH">Plan Number: </FP>
                        <P>(2)(b) For Bulk Applicants (attach additional sheets identifying this information for each Plan named in the application involved in the transaction):</P>
                        <FP SOURCE="FP-DASH">Plan Name: </FP>
                        <FP SOURCE="FP-1">Plan Sponsor EIN or date the most recent Form 5500 was filed: ______ </FP>
                        <P>(3) Plan Administrator Name: </P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH">EIN:</FP>
                        <FP SOURCE="FP-DASH">Address:</FP>
                        <P>(4) Name of Authorized Representative: (Submit written authorization signed by the Plan Official.)</P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH">Address:</FP>
                        <FP SOURCE="FP-DASH">Telephone:</FP>
                        <P>(5) Name of Contact Person:</P>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH">Address:</FP>
                        <FP SOURCE="FP-DASH">Telephone:</FP>
                        <FP SOURCE="FP-DASH">Email:</FP>
                        <P>(6) Date of Most Recent Annual Report Form 5500 Filing, if applicable: _/_/_ for Plan Year Ending: _/_/_</P>
                        <P>(7) Is Applicant Seeking Relief From Excise Tax Under PTE 2002-51?</P>
                        <FP SOURCE="FP-1">__Yes—Either:</FP>
                        <FP SOURCE="FP1-2">__Submit a copy of the notice to interested parties within 60 calendar days of this application and indicate date of the notice if not on the notice itself; or</FP>
                        <FP SOURCE="FP1-2">__If you are relying on the exception to the notice requirement contained in section IV.C. of PTE 2002-51, provide a copy of a completed IRS Form 5330 or other written documentation and proof of payment.</FP>
                        <FP SOURCE="FP-1">__No.</FP>
                        <P>(8) Proof of Payment:</P>
                        <FP SOURCE="FP-1">__Canceled check</FP>
                        <FP SOURCE="FP-1">__Executed wire transfer</FP>
                        <FP SOURCE="FP-1">__Signed, dated receipt from the recipient of funds transferred to the plan (such as a financial institution)</FP>
                        <FP SOURCE="FP-1">__Bank statements for the plan's account</FP>
                        <FP SOURCE="FP-1">__Other: ______</FP>
                        <P>
                            <E T="03">Caution: The correction amount and the costs of correction cannot be paid from plan assets, including by charges against participant accounts or plan forfeiture accounts.</E>
                        </P>
                        <P>(9) Disclosure of a current investigation or examination of the plan by an agency, to comply with section 3(b)(3)(v):</P>
                        <FP SOURCE="FP-1">__PBGC</FP>
                        <FP SOURCE="FP-1">__Any state attorney general </FP>
                        <FP SOURCE="FP-1">__State: ______ </FP>
                        <FP SOURCE="FP-1">__Any state insurance commissioner </FP>
                        <FP SOURCE="FP-1">__State: ______</FP>
                        <FP SOURCE="FP-1">__Other federal governmental agency: ______</FP>
                        <FP SOURCE="FP-1">__Contact person for the agency identified: ______</FP>
                        <P>
                            (10) Be sure to include the required VFC Program Application Checklist and all other documentation identified as being enclosed. The checklist is available at 
                            <E T="03">http://www.dol.gov/ebsa/calculator/2006vfcpchecklist.html.</E>
                        </P>
                        <P>(11) In order to help us improve our service, please indicate how you learned about the VFC Program: ______</P>
                        <HD SOURCE="HD1">Authorization of Representative</HD>
                        <P>
                            <E T="03">I have authorized (insert name of authorized representative) to represent me concerning this VFC Program application.</E>
                        </P>
                        <FP>Name of Plan Official</FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP>Signature of Plan Official </FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH">Date </FP>
                        <HD SOURCE="HD1">Penalty of Perjury Statement</HD>
                        <P>The following statement must be signed and dated by a plan fiduciary, (or pursuant to special rules, a bulk applicant or an employer with respect to a multiemployer plan or multiple employer plan), with knowledge of the transaction that is the subject of the application and by the authorized representative, if any. Each Plan Official applying under the VFC Program must also sign and date the statement, which must accompany any subsequent additions to the application.</P>
                        <P>“Under penalties of perjury I certify that I am not Under Investigation (as defined in section 3(b)(3) of the VFC Program) and that I have reviewed this application, including all supporting documentation, and to the best of my knowledge and belief the contents are true, correct, and complete.”</P>
                        <FP SOURCE="FP-DASH"/>
                        <FP>Name and Title</FP>
                        <FP SOURCE="FP-DASH">Signature </FP>
                        <FP SOURCE="FP-DASH">Date </FP>
                        <FP>Name and Title</FP>
                        <FP SOURCE="FP-DASH">Signature </FP>
                        <FP SOURCE="FP-DASH">Date </FP>
                        <HD SOURCE="HD1">Paperwork Reduction Act Notice</HD>
                        <P>The information identified on this form is required for a valid application for the Voluntary Fiduciary Correction Program of the U.S. Department of Labor's Employee Benefits Security Administration (EBSA). You are not required to use this form; however, you must supply the information identified in order to receive the relief offered under the Program with respect to a breach of fiduciary responsibility under Part 4 of Title I of ERISA. EBSA will use this information to determine whether you have satisfied the requirements of the Program. EBSA estimates that assembling and submitting this information will require an average of 7 hours. This collection of information is currently approved under OMB Control Number 1210-0118. You are not required to respond to a collection of information unless it displays a currently valid OMB Control Number.</P>
                        <HD SOURCE="HD1">VFC Program Application Checklist (Required)</HD>
                        <P>
                            Use this checklist to make sure you are submitting a complete application. Indicate “Yes”, “No” or “N/A” next to each item. A “No” answer or the failure to include a completed checklist will delay review of the 
                            <PRTPAGE P="4230"/>
                            application until all required items are received. The applicant must sign and date the checklist and include it with the application. Check with the relevant Regional Office whether it accepts email submissions of VFC Program applications.
                        </P>
                        <FP>__1. Have you reviewed the eligibility, definitions, transaction and correction, and documentation sections of the VFC Program?</FP>
                        <FP>__2. Have you included the name, address (street or email) and telephone number of a contact person familiar with the contents of the application?</FP>
                        <FP>__3. Have you provided the EIN, Plan Number, and address (street and email) of the plan sponsor and plan administrator?</FP>
                        <FP>__4. Have you provided the date that the most recent Form 5500 was filed by the plan (or for a bulk application as described in section 4(d), the nine-digit employer identification number for each plan sponsor of a named plan)?</FP>
                        <FP>__5. Have you enclosed a signed and dated certification under penalty of perjury for the plan fiduciary with knowledge of the transactions and for each applicant and the applicant's representative, if any? In the case of a bulk application, have you enclosed a signed and dated certification under penalty of perjury for the bulk applicant based on knowledge of the transactions and for the bulk applicant's representative, if any? In the case of a contributing or adopting employer in a multiemployer plan or multiple employer plan, the employer may sign the Penalty of Perjury statement and, without regard to the employer's status as a plan fiduciary, no other plan fiduciary need sign.</FP>
                        <FP>__6. Have you enclosed relevant portions of the plan document and any other pertinent documents (such as the adoption agreement, trust agreement, or insurance contract) with the relevant sections identified?</FP>
                        <FP>__7. If applicable, have you provided written notification to EBSA of any current investigation or examination of the plan, or of the applicant or plan sponsor in connection with an act or transaction directly related to the plan by the PBGC, any state attorney general, or any state insurance commissioner?</FP>
                        <FP>__8. If applicable (under section 4(b)(2) of the Program), have you included the following items?</FP>
                        <FP>__a. Contact information for the law enforcement agency notified of the criminal activity;</FP>
                        <FP>__b. A statement from the applicant asserting no involvement in the potential criminal activity; and</FP>
                        <FP>__c. A statement as to whether a claim relating to the criminal activity has been made under an ERISA section 412 fidelity bond.</FP>
                        <FP>__9. Where applicable, have you enclosed a copy of an appraiser's report?</FP>
                        <FP>__10. Where applicable, have you enclosed a copy of an independent fiduciary's approval?</FP>
                        <FP>__11. Have you enclosed supporting documentation, including:</FP>
                        <FP>__a. A detailed narrative of the Breach, including the date it occurred;</FP>
                        <FP>__b. Documentation that supports the narrative description of the transaction;</FP>
                        <FP>__c. An explanation of how the Breach was corrected, by whom and when, with supporting documentation;</FP>
                        <FP>
                            __d. A list of all persons materially involved in the Breach and its correction (
                            <E T="03">e.g.,</E>
                             fiduciaries, service providers, borrowers, lenders);
                        </FP>
                        <FP>__e. Specific calculations demonstrating how Principal Amount and Lost Earnings or Restoration of Profits were computed, or, if the Online Calculator was used, a copy of the “Print Viewable Results” page(s) after completing use of the Online Calculator;</FP>
                        <FP>__f. Proof of payment of principal amount;</FP>
                        <FP>__g. Proof of payment of Lost Earnings or restoration of profits to the plan; and</FP>
                        <P>
                            <E T="03">Caution: The correction amount and the costs of correction cannot be paid from plan assets, including by charges against participant accounts or plan forfeiture accounts.</E>
                        </P>
                        <FP>__h. If application concerns delinquent participant contributions or loan repayments, a statement from a Plan Official identifying the earliest date on which participant contributions/loan repayments reasonably could have been segregated from the employer's general assets and supporting documentation on which the Plan Official relied?</FP>
                        <FP>__12. If you are an eligible applicant and wish to avail yourself of excise tax relief under the VFC Program Class Exemption:</FP>
                        <FP>__a. Have you made proper arrangements to provide within 60 calendar days after submission of this application a copy of the VFC Program Class Exemption notice to all interested persons and to the EBSA Regional Office to which the application is filed; or</FP>
                        <FP>__b. If you are relying on the exception to the notice requirement in section IV.C. of the VFC Program Class Exemption because the amount of the excise tax otherwise due would be less than or equal to $100.00, have you provided to the appropriate EBSA Regional Office a copy of a completed IRS Form 5330 or other written documentation containing the information required by IRS Form 5330 and proof of payment?</FP>
                        <FP>__13. In calculating Lost Earnings, have you elected to use:</FP>
                        <FP>__a. The Online Calculator; or</FP>
                        <FP>__b. A manual calculation performed in accordance with section 5(b) of the VFC Program?</FP>
                        <FP>__14. If the application involves payments to participants and beneficiaries:</FP>
                        <FP>__a. Have you enclosed a description demonstrating proof of payment to participants and beneficiaries whose current location is known to the plan and/or applicant in accordance with section 5(d) of the VFC Program?</FP>
                        <FP>__b. For individuals who need to be located, have you demonstrated how adequate funds have been segregated to pay missing individuals and included a description of the process that you commenced to locate missing individuals in accordance with section 5(d)?</FP>
                        <FP>__15. For purposes of the three transactions involving participant contributions covered under section 7.1, has the plan implemented measures to ensure that such transactions do not recur?</FP>
                        <FP>Signature of Applicant and Date Signed:</FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP>Name of Applicant:</FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP>Title/Relationship to the Plan:</FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP>Name of Plan, EIN and Plan Number:</FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH"/>
                        <FP>Contact information: Phone; email</FP>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">Paperwork Reduction Act Notice</HD>
                        <P>The information identified on this form is required for a valid application for the Voluntary Fiduciary Correction Program of the U.S. Department of Labor's Employee Benefits Security Administration (EBSA). You must complete this form and submit it as part of the application in order to receive the relief offered under the Program with respect to a breach of fiduciary responsibility under Part 4 of Title I of ERISA. EBSA will use this information to determine that you have satisfied the requirements of the Program. EBSA estimates that completing and submitting this form will require an average of 2 to 4 minutes. This collection of information is currently approved under OMB Control Number 1210-0118. You are not required to respond to a collection of information unless it displays a currently valid OMB Control Number.</P>
                    </EXTRACT>
                    <HD SOURCE="HD1">Appendix F—SCC Retention Record Checklist</HD>
                    <EXTRACT>
                        <HD SOURCE="HD1">Delinquent Participant Contributions or Loan Repayments</HD>
                        <P>A self-corrector must complete this checklist, prepare or collect the listed documents and provide a copy of the completed checklist and the required documentation to the plan administrator (generally the plan sponsor/employer) to obtain relief under the SCC.</P>
                        <P>__Did you attach a brief statement explaining why the employer retained the participant contributions or loan repayments instead of timely forwarding such amounts to the plan (the Breach).</P>
                        <P>
                            __Did you attach proof of payment, such as canceled checks, executed wire transfers, bank statements for the plan's account, or other documents showing the actual date the plan received the corrective payment(s)? If you paid the total amount of delinquent contributions and loan repayments (Principal Amount) separately from the total amount of earnings (Lost Earnings) that would have been earned on the Principal Amount but for the delinquency, make sure to attach proof of payment of both amounts. (
                            <E T="03">Caution—Plan Assets, including charges to participant accounts or plan forfeiture accounts, cannot be used to pay the correction amount or the costs of correction</E>
                            );
                        </P>
                        <P>__Did you attach other documents (if any) to support proof of payment, such as offsetting overpayments or annotations that provide a clear record of the correction?</P>
                        <P>
                            __Did you attach a copy of the page(s) that results from the “View Printable Results” function of the Online Calculator? Self-correctors must use the Online Calculator to determine Lost Earnings and 
                            <PRTPAGE P="4231"/>
                            print a copy of the “View Printable Results” page.
                        </P>
                        <P>__Did you attach a statement describing policies and procedures (if any) that the employer put into place to prevent future delinquencies of participant contributions or loan repayments?</P>
                        <P>__Did you attach a copy of the SCC Notice Acknowledgement and Summary page that you received from EBSA after submission of the SCC notice?</P>
                        <P>__Did a plan fiduciary and each plan official seeking relief complete the following Penalty of Perjury Statement and provide the signed statement to the plan administrator?</P>
                        <P>
                            <E T="03">Penalty of Perjury Statement</E>
                            —The following statement must be signed and dated by a plan fiduciary with knowledge of the transaction that is the subject of the SCC notice and by the authorized representative, if any. Each plan official who is seeking the relief afforded under the SCC must also sign and date the statement, which must be retained by the plan administrator. (In the case of a contributing or adopting employer in a multiemployer plan or multiple employer plan, the employer may sign the Penalty of Perjury statement and, without regard to the employer's status as a plan fiduciary, no other plan fiduciary need sign.)
                        </P>
                        <P>Under penalties of perjury I certify that I am not Under Investigation (as defined in VFC Program section 3(b)(3)) and that I have reviewed the SCC notice acknowledgement and summary, the checklist and all the required documentation, and to the best of my knowledge and belief the contents are true, correct, and complete. </P>
                        <FP SOURCE="FP-DASH">Name and Title </FP>
                        <FP SOURCE="FP-DASH">Signature </FP>
                        <FP SOURCE="FP-DASH">Date </FP>
                        <FP SOURCE="FP-DASH">Name and Title </FP>
                        <FP SOURCE="FP-DASH">Signature </FP>
                        <FP SOURCE="FP-DASH">Date</FP>
                        <P>__Did a plan official complete the following authorization, if an authorized preparer was used to submit the SCC notice?</P>
                        <HD SOURCE="HD1">Authorization of Plan Official </HD>
                        <P>I have authorized ______ to submit the VFCP SCC notice.</P>
                        <FP SOURCE="FP-DASH">Name of Plan Official</FP>
                        <FP SOURCE="FP-DASH">Signature</FP>
                        <FP SOURCE="FP-DASH">Date</FP>
                        <HD SOURCE="HD1">Paperwork Reduction Act Notice</HD>
                        <P>The information identified on this form is required for a valid use of the Self-Correction Component for Delinquent Participant Contributions or Loan Repayments of the Voluntary Fiduciary Correction Program of the U.S. Department of Labor's Employee Benefits Security Administration (EBSA). You must complete this form and provide a copy of the completed checklist and the required documentation to the plan administrator to receive the relief under the Self-Correction Component of the Program with respect to the breach of fiduciary responsibility under Part 4 of Title I of ERISA associated with the delinquent participant contributions or loan repayments. EBSA may request a copy of this information to determine that you have satisfied the requirements of the Self-Correction Component of the Program. EBSA estimates assembling this information will require an average of 4 hours and completing this form will require an average of 2 to 4 minutes. This collection of information is currently approved under OMB Control Number 1210-0118. You are not required to respond to a collection of information unless it displays a currently valid OMB Control Number.</P>
                    </EXTRACT>
                    <SIG>
                        <DATED>Signed at Washington, DC, this 3rd day of January 2025.</DATED>
                        <NAME>Lisa M. Gomez,</NAME>
                        <TITLE>Assistant Secretary, Employee Benefits Security Administration, U.S. Department of Labor.</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2025-00327 Filed 1-14-25; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 4510-29-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4233"/>
            <PARTNO>Part V</PARTNO>
            <AGENCY TYPE="P">Department of the Interior</AGENCY>
            <SUBAGY>Fish and Wildlife Service </SUBAGY>
            <HRULE/>
            <CFR>50 CFR Part 17</CFR>
            <TITLE>Endangered and Threatened Wildlife and Plants; Grizzly Bear Listing on the List of Endangered and Threatened Wildlife With a Revised Section 4(d) Rule; Proposed Rule</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="4234"/>
                    <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                    <SUBAGY>Fish and Wildlife Service</SUBAGY>
                    <CFR>50 CFR Part 17</CFR>
                    <DEPDOC>[Docket No. FWS-R6-ES-2024-0186; FXES1111090FEDR-256-FF09E21000]</DEPDOC>
                    <RIN>RIN 1018-BI14</RIN>
                    <SUBJECT>Endangered and Threatened Wildlife and Plants; Grizzly Bear Listing on the List of Endangered and Threatened Wildlife With a Revised Section 4(d) Rule</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Fish and Wildlife Service, Interior.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Proposed rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>
                            We, the U.S. Fish and Wildlife Service (Service or FWS), propose to revise the listing of the grizzly bear (
                            <E T="03">Ursus arctos horribilis</E>
                            ) in the lower-48 States under the Endangered Species Act of 1973, as amended (Act or ESA). After a review of the best scientific and commercial data available, we affirm that the currently listed grizzly bear population meets our requirements for consideration as a distinct population segment (DPS) under the Act and that the population remains likely to become an endangered species within the foreseeable future. However, we find that clarification of the geographic areas included within the DPS is warranted. Therefore, we propose to revise the listing by defining the boundaries of the contiguous U.S. grizzly bear DPS. The revised entity would include all geographic portions of the currently listed lower-48 entity that contain suitable habitat and where grizzly bears are currently found or are likely to be found in the future as populations recover. This area includes all of Washington and portions of Idaho, Montana, and Wyoming. The contiguous U.S. grizzly bear DPS would retain threatened species status. This proposed rule would promote conservation of the grizzly bear by ensuring that the listing under the Act explicitly reflects the areas where grizzly bears currently occur and are likely to occur in the future. Clarifying that the listing does not include areas outside of the grizzly bear's historical range will assist as recovery proceeds. We are also proposing to revise protective regulations for the grizzly bear issued under section 4(d) of the Act.
                        </P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P/>
                        <P>
                            <E T="03">Written comments:</E>
                             We will accept comments received or postmarked on or before March 17, 2025. Comments submitted electronically using the Federal eRulemaking Portal (see 
                            <E T="02">ADDRESSES</E>
                            , below) must be received by 11:59 p.m. eastern time on the closing date.
                        </P>
                        <P>
                            <E T="03">Public informational meetings and public hearings:</E>
                             Four public hearings will be held on this proposed rule on the following dates:
                        </P>
                        <P>• On January 30, 2025, a virtual public informational meeting will run from 6 p.m. to 8 p.m.</P>
                        <P>• On January 29, 2025, in Coeur d'Alene, Idaho. The public informational meeting will run from 3 p.m. to 5 p.m., and the public hearing will run from 6 p.m. to 8 p.m.</P>
                        <P>• On January 28, 2025, in Missoula, Montana. The public informational meeting will run from 3 p.m. to 5 p.m., and the public hearing will run from 6 p.m. to 8 p.m.</P>
                        <P>• On February 10, 2025, in Cody, Wyoming. The public informational meeting will run from 3 p.m. to 5 p.m., and the public hearing will run from 6 p.m. to 8 p.m.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P/>
                        <P>
                            <E T="03">Comment submission:</E>
                             You may submit comments by one of the following methods:
                        </P>
                        <P>
                            (1) 
                            <E T="03">Electronically:</E>
                             Go to the Federal eRulemaking Portal:
                        </P>
                        <P>
                            <E T="03">https://www.regulations.gov.</E>
                             In the Search box, enter FWS-R6-ES-2024-0186, which is the docket number for this rulemaking. Then, click on the Search button. On the resulting page, in the panel on the left side of the screen, under the Document Type heading, check the Proposed Rule box to locate this document. You may submit a comment by clicking on “Comment.”
                        </P>
                        <P>
                            (2) 
                            <E T="03">By hard copy:</E>
                             Submit by U.S. mail to: Public Comments Processing, Attn: FWS-R6-ES-2024-0186, U.S. Fish and Wildlife Service, MS: PRB/3W, 5275 Leesburg Pike, Falls Church, VA 22041-3803.
                        </P>
                        <P>
                            We request that you send comments only by the methods described above. We will post all comments on 
                            <E T="03">https://www.regulations.gov.</E>
                             This generally means that we will post any personal information you provide us (see 
                            <E T="02">Information Requested</E>
                            , below, for more information).
                        </P>
                        <P>
                            <E T="03">Availability of supporting materials:</E>
                             Supporting materials, such as the species status assessment report, are available at 
                            <E T="03">https://www.fws.gov/species/grizzly-bear-ursus-arctos-horribilis</E>
                             or at 
                            <E T="03">https://www.regulations.gov</E>
                             at Docket No. FWS-R6-ES-2024-0186.
                        </P>
                        <P>
                            <E T="03">Public informational meetings and public hearings:</E>
                             The public information meetings and public hearings will be held on the dates and the times listed above in 
                            <E T="02">DATES</E>
                             at the following locations:
                        </P>
                        <P>• Coeur d'Alene, Idaho. Kootenai County Fairgrounds, 4056 N. Government Way, Building 19.</P>
                        <P>• Missoula, Montana. Hilton Garden Inn, 3720 N Reserve Street.</P>
                        <P>• Cody, Wyoming. Holiday Inn, 1701 Sheridan Ave.</P>
                        <P>
                            • Virtual: We will announce the details regarding how to participate on our website at 
                            <E T="03">https://www.fws.gov/grizzlyrulemaking.</E>
                        </P>
                        <P>
                            For more information on the public informational meetings and public hearings, see 
                            <E T="03">Public Hearings,</E>
                             below.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            Hilary Cooley, Grizzly Bear Recovery Coordinator, U.S. Fish and Wildlife Service, #356 Corbin, University of Montana, Missoula, MT 59812; telephone 406-243-4903. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States. Please see Docket No. FWS-R6-ES-2024-0186 on 
                            <E T="03">https://www.regulations.gov</E>
                             for a document that summarizes this proposed rule.
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">Executive Summary</HD>
                    <P>
                        <E T="03">Why we need to publish a rule.</E>
                         On July 28, 1975, we published in the 
                        <E T="04">Federal Register</E>
                         (40 FR 31734) a final rule to list the grizzly bear in the lower-48 States as a threatened species under the Act (16 U.S.C. 1531 
                        <E T="03">et seq.</E>
                        ). According to our “Policy Regarding the Recognition of Distinct Vertebrate Population Segments Under the Endangered Species Act” (DPS policy; 61 FR 4722, February 7, 1996), the appropriate application of the policy to pre-1996 DPS listings will be considered in our 5-year status reviews. We conducted a DPS analysis as part of our 2011 5-year status review, and concluded that the population segment of the grizzly bear in the lower-48 States is discrete from other grizzly populations and significant to the remainder of the taxon (
                        <E T="03">i.e., Ursus arctos horribilis</E>
                        ) and that it meets the 1996 DPS Policy's standards for recognition as a DPS under the Act.
                    </P>
                    <P>
                        We now reaffirm that the currently listed grizzly bear population satisfies the elements of our 1996 DPS Policy and that the population meets the Act's definition of a threatened species. 
                        <PRTPAGE P="4235"/>
                        However, we find that clarification of the DPS boundary is warranted, and we propose to revise the listing by defining the geographic extent of the contiguous U.S. DPS of the grizzly bear (hereafter, “grizzly bear DPS”) and to retain its threatened status. Pursuant to the Administrative Procedure Act, we must initiate a rulemaking to revise the listing (5 U.S.C. 551 
                        <E T="03">et seq.</E>
                        ). In a February 22, 2024, settlement agreement in 
                        <E T="03">Save the Yellowstone Grizzly</E>
                         v. 
                        <E T="03">U.S. Fish and Wildlife Service,</E>
                         No. 23-363 (D. Id), we committed to submit a final rule to the Office of the Federal Register on or before January 31, 2026.
                    </P>
                    <P>
                        <E T="03">What this document does.</E>
                         This document proposes to revise the current listing of the grizzly bear in the lower-48 States by defining the geographic extent of the grizzly bear DPS, to retain its status as a threatened species, and to revise its protective regulations under section 4(d) of the Act (a revised “4(d) rule”). As such, this action would revise the listing of the grizzly bear in title 50 of the Code of Federal Regulations (CFR) at § 17.11(h) (50 CFR 17.11(h)) and the grizzly bear's protective regulations under section 4(d) of the Act at 50 CFR 17.40(b).
                    </P>
                    <P>
                        <E T="03">The basis for our action.</E>
                         Under our 1996 DPS policy, in any proposed or final rule affecting the status of a possible DPS as an endangered or threatened species under the Act we analyze the following three elements: (1) discreteness of the population segment in relation to the remainder of the taxon to which it belongs; (2) the significance of the population segment to the taxon to which it belongs; and (3) the conservation status of the population segment in relation to the Act's standards for listing (61 FR 4725, February 7, 1996).
                    </P>
                    <P>Under the Act, we determine whether a species is an endangered species or a threatened species because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We have determined that the proposed grizzly bear DPS, which includes all of the grizzly bears in the currently listed entity, is a threatened species due to the following threats: habitat destruction and modification (Factor A); human-caused mortality (Factors B and C); and the isolated nature of some populations (Factor E).</P>
                    <HD SOURCE="HD1">Information Requested</HD>
                    <P>We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, Native American Tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:</P>
                    <P>(1) The proposed geographic boundary of the DPS;</P>
                    <P>(2) The species' biology, range, and population trends, including:</P>
                    <P>(a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;</P>
                    <P>(b) Genetics and taxonomy;</P>
                    <P>(c) Historical and current range, including distribution patterns and the locations of any additional populations of this species;</P>
                    <P>(d) Historical and current population levels, and current and projected trends; and</P>
                    <P>(e) Past and ongoing conservation measures for the species, its habitat, or both.</P>
                    <P>(3) Threats and conservation actions affecting the species, including:</P>
                    <P>(a) Factors that may be affecting the continued existence of the species, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors;</P>
                    <P>(b) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to this species; and</P>
                    <P>(c) Existing regulations or conservation actions that may be addressing threats to this species.</P>
                    <P>(4) Additional information concerning the historical and current status of this species.</P>
                    <P>(5) Information to assist with applying or issuing protective regulations under section 4(d) of the Act that may be necessary and advisable to provide for the conservation of the grizzly bear. In particular, we seek information concerning:</P>
                    <P>(a) The extent to which we should include or clarify any of the section 9 prohibitions in the 4(d) rule;</P>
                    <P>(b) Whether we should consider any additional or different exceptions from the prohibitions in the proposed 4(d) rule, such as: (i) incidental take resulting from legal trapping for other species conducted consistent with State and Tribal trapping rules or guidelines that contain steps to minimize the potential for capture and injury of grizzly bears; (ii) incidental take from issuance of State or Tribal hunting permits for other species; (iii) incidental take resulting from legal hunting of other species; and (iv) take from regulated State or Tribal grizzly bear hunting in areas where grizzly bear populations are expanding.</P>
                    <P>Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.</P>
                    <P>Please note that submissions merely stating support for, or opposition to, the action under consideration without providing supporting information, although noted, do not provide substantial information necessary to support a determination. Section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or a threatened species must be made solely on the basis of the best scientific and commercial data available.</P>
                    <P>
                        You may submit your comments and materials concerning this proposed rule by one of the methods listed in 
                        <E T="02">ADDRESSES</E>
                        . We request that you send comments only by the methods described in 
                        <E T="02">ADDRESSES.</E>
                    </P>
                    <P>
                        If you submit information via 
                        <E T="03">https://www.regulations.gov,</E>
                         your entire submission—including any personal identifying information—will be posted on the website. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        Our final determination may differ from this proposal because we will consider all comments we receive during the comment period as well as any information that may become available after this proposal. Based on the new information we receive (and, if relevant, any comments on that new information), we may conclude that the species is endangered instead of threatened, or we may conclude that the species does not warrant listing as either an endangered species or a threatened species. We may also change the geographic area included within the proposed DPS as the result of new information we receive. In addition, we 
                        <PRTPAGE P="4236"/>
                        may change the parameters of the prohibitions or the exceptions to those prohibitions in the protective regulations under section 4(d) of the Act if we conclude it is appropriate in light of comments and new information received. For example, we may expand the prohibitions if we conclude that the protective regulation as a whole, including those additional prohibitions, is necessary and advisable to provide for the conservation of the species. Conversely, we may establish additional or different exceptions to the prohibitions in the final rule if we conclude that the activities would facilitate or are compatible with the conservation and recovery of the species. In our final rule, we will clearly explain our rationale and the basis for our final decision, including why we made changes, if any, that differ from this proposal.
                    </P>
                    <HD SOURCE="HD2">Public Hearings</HD>
                    <P>
                        We will hold four public informational meetings and public hearings on the dates and at the locations listed above in 
                        <E T="02">DATES.</E>
                         The public informational meetings allow the public the opportunity to interact with Service staff, who will be available to provide information and address questions on the proposed rule and its supporting documents. In contrast to the public informational meetings, we are holding the public hearings to provide interested parties an opportunity to present verbal testimony (formal, oral comments) or written comments regarding the proposed rule and its supporting documents. A formal public hearing is not, however, an opportunity for dialogue with the Service; it is only a forum for accepting formal verbal testimony.
                    </P>
                    <P>We cannot accept verbal testimony at any of the public informational meetings; verbal testimony can only be accepted at the public hearings. Anyone wishing to make an oral statement at a public hearing for the record is encouraged to provide a written copy of their statement to us at the hearing. In the event there is a large attendance, the time allotted for oral statements may be limited. Speakers can sign up at a hearing if they desire to make an oral statement. Oral and written statements receive equal consideration. There are no limits on the length of written comments submitted to us.</P>
                    <P>Persons with disabilities needing reasonable accommodations to participate in a public informational meeting or public hearing should contact the person listed under</P>
                    <P>
                        <E T="02">FOR FURTHER INFORMATION CONTACT.</E>
                         Reasonable accommodation requests should be received at least 3 business days prior to the public informational meeting or public hearing to help ensure availability; American Sign Language or English as a second language interpreter needs should be received at least 2 weeks prior to the public informational meeting or public hearing.
                    </P>
                    <HD SOURCE="HD1">Previous Federal Actions</HD>
                    <HD SOURCE="HD2">Listing as Threatened and Recovery Plans</HD>
                    <P>
                        On July 28, 1975, we published in the 
                        <E T="04">Federal Register</E>
                         (40 FR 31734) a final rule to list the grizzly bear as a threatened species in the conterminous United States (lower-48 States). Accordingly, we developed a Grizzly Bear Recovery Plan (USFWS 1982) and have updated that plan several times (USFWS 1993, 1996, 1997, 2007a, 2007b, 2017, 2018). The 1993 recovery plan identified recovery ecosystems, each containing a recovery zone at its core, within the lower-48 States thought to be capable of supporting grizzly bears. The 1993 recovery plan, and subsequent supplements, outlined three demographic recovery criteria for each ecosystem (in their entirety: Service 1993, 1996, 1997, 2007a, 2017).
                    </P>
                    <HD SOURCE="HD2">Petitions Regarding Grizzly Bear Ecosystems (1990s)</HD>
                    <P>In the 1990s, we received a number of petitions to change the status on the List of Endangered and Threatened Wildlife (the List) of grizzly bear populations in three ecosystems: the North Cascades, Selkirk, and Cabinet-Yaak.</P>
                    <P>We determined that reclassifying grizzly bears in those ecosystems to endangered was warranted but precluded by higher priorities beginning in 1991 for the North Cascades ecosystem (56 FR 33892, July 24, 1991), 1993 for the Cabinet-Yaak ecosystem (CYE) (58 FR 8250, February 12, 1993), and 1999 for the Selkirk ecosystem (SE) (64 FR 26725, May 17, 1999).</P>
                    <P>However, in 2014, the Service determined that the CYE and SE populations had recovered to the point that they were no longer warranted for uplisting as endangered and should instead remain listed as threatened (79 FR 72450 at 72487 and 72488, December 5, 2014).</P>
                    <P>
                        In 2017, in 
                        <E T="03">Alliance for the Wild Rockies</E>
                         v. 
                        <E T="03">Zinke et al.,</E>
                         the District Court of Montana remanded the 2014 determination for the CYE grizzly bear back to the Service for further consideration.
                    </P>
                    <P>In 2022, the Service again determined that the CYE population had recovered to the point that it was no longer warranted for uplisting to endangered, and therefore should remain listed as threatened (87 FR 26152 at 26153 and 26171-26172, May 3, 2022).</P>
                    <P>In 2023, we determined that the North Cascades population was no longer warranted for uplisting to endangered because the population in that area of the United States is extirpated (88 FR 41560 at 41562, 41577, and 41579-41580, June 27, 2023).</P>
                    <HD SOURCE="HD2">Bitterroot Ecosystem</HD>
                    <P>On December 18, 2000, we designated the Bitterroot Ecosystem (BE) as a nonessential experimental population under section 10(j) of the Act and published a final environmental impact statement (EIS) and record of decision (ROD) to release an experimental population of grizzly bears in that ecosystem (65 FR 69624, November 17, 2000; 65 FR 69644, November 17, 2000; Service 2000a and 2000b, entire).</P>
                    <P>On June 22, 2001, we indicated a change of position and published a notice to propose the no action alternative as the preferred alternative (66 FR 33623) and a proposed rule to remove the section 10(j) regulations for grizzly bears in the BE 10(j) population (66 FR 33620). However, no further action was taken on the notice, and the proposed rule was never finalized. The 2000 ROD remains in effect, but it has never been implemented. Because we have not released or reintroduced any grizzly bears into the area, the current section 10(j) rule for grizzly bears in the Bitterroot grizzly bear nonessential experimental population area (50 CFR 17.84(1)) does not apply to grizzly bears that have dispersed into the area on their own. Grizzly bears that have dispersed into the area on their own, including all recent verified sightings, are not covered by the section 10(j) rule and receive the protection associated with the threatened status of the lower-48 States listed entity and associated section 4(d) regulations (50 CFR 17.40(b)).</P>
                    <P>
                        In November 2021, the Service was challenged in Federal district court for alleged unreasonable delay in implementing nondiscretionary actions described in the action alternative selected in the 2000 final EIS (
                        <E T="03">Alliance for the Wild Rockies et al.</E>
                         v. 
                        <E T="03">Cooley et al.,</E>
                         9:21-cv-136-DWM (D. Mont. 2021)). The court remanded this matter to the Service and ordered the Service to propose a timeline and plan for completion of a supplemental EIS and, if warranted, a new ROD and final rule. On April 26, 2023, the court issued an order approving the Service's proposal and timeline to complete this process within 43 months (
                        <E T="03">Alliance for the Wild Rockies et al.</E>
                         v. 
                        <E T="03">Cooley et al.,</E>
                        <PRTPAGE P="4237"/>
                         9:31-cv-136-DWM). On January 18, 2024, the Service published a notice to initiate the public scoping process to evaluate restoration of grizzly bears to the BE (89 FR 3411).
                    </P>
                    <HD SOURCE="HD2">Greater Yellowstone Ecosystem</HD>
                    <P>
                        On March 29, 2007, we published in the 
                        <E T="04">Federal Register</E>
                         (72 FR 14866) a final rule recognizing the Greater Yellowstone Ecosystem (GYE) population of grizzly bears as a DPS and removing it from the List (
                        <E T="03">i.e.,</E>
                         delisting it).
                    </P>
                    <P>
                        This final determination was vacated and remanded by the U.S. District Court for the District of Montana on September 21, 2009, in 
                        <E T="03">Greater Yellowstone Coalition</E>
                         v. 
                        <E T="03">Servheen, et al.,</E>
                         672 F.Supp.2d 1105 (D. Mont. 2009). The District Court ruled against the Service on two of the claims: (1) that the Service was arbitrary and capricious in its evaluation of whitebark pine; and (2) that the identified regulatory mechanisms were inadequate because they were not legally enforceable. In compliance with the court's order, we issued a final rule reinstating the Act's protections for the GYE grizzly bear population (see 75 FR 14496, March 26, 2010).
                    </P>
                    <P>
                        The Service appealed the 2009 district court decision, and on November 15, 2011, the U.S. Court of Appeals for the Ninth Circuit issued an opinion affirming in part and reversing in part the District Court's decision vacating and remanding the final rule delisting grizzly bears in the GYE (
                        <E T="03">Greater Yellowstone Coalition</E>
                         v. 
                        <E T="03">Servheen, et al.,</E>
                         665 F.3d 1015 (9th Cir. 2011)). The Ninth Circuit held that the Service's consideration of regulatory mechanisms was permissible because the elements of the 2007 GYE conservation strategy were incorporated into binding regulatory documents, specifically national forest (NF) plans and National Park Service (NPS) Superintendent's compendia. However, the Ninth Circuit found that the Service did not adequately explain why the loss of whitebark pine was not a threat to the GYE grizzly bear population. Therefore, the GYE population of grizzly bears remained federally listed as part of the lower-48 State threatened species listing under the Act, and the Interagency Grizzly Bear Study Team (IGBST) initiated more thorough research into the potential impact of whitebark pine decline on GYE grizzly bears.
                    </P>
                    <P>
                        On June 30, 2017, we published in the 
                        <E T="04">Federal Register</E>
                         (82 FR 30502) a final rule recognizing the GYE population of grizzly bears as a DPS and removing it from the List (
                        <E T="03">i.e.,</E>
                         delisting it). In that final rule, among the other findings, we responded to the District Court's remand and the Ninth Circuit's determination that the Service failed to support its conclusion that whitebark pine declines did not threaten GYE grizzly bears.
                    </P>
                    <P>
                        That final determination was vacated and remanded by the U.S. District Court for the District of Montana on September 24, 2018, in 
                        <E T="03">Crow Indian Tribe, et al.</E>
                         v. 
                        <E T="03">United States, et al.,</E>
                         343 F. Supp.3d 999 (D. Mont. 2018). The District Court cited three main deficiencies in support of vacatur: (1) the Service did not sufficiently assess the effect of delisting the GYE population on the recovery of grizzly bears in the rest of the lower-48 States; (2) the Service and its partners did not commit to recalibration of potential new population estimators in the future to ensure the ongoing applicability of the 2016 GYE conservation strategy's mortality limits; and (3) the Service inadequately analyzed the genetic health of the GYE grizzly bear population. In compliance with this order, we again issued a final rule reinstating the Act's protections for the GYE grizzly bear population (see 84 FR 37144, July 31, 2019).
                    </P>
                    <P>
                        The Service appealed the district court decision, and on July 8, 2020, the Ninth Circuit issued an opinion affirming the district court's decision vacating and remanding the final rule delisting grizzly bears in the GYE (
                        <E T="03">Crow Indian Tribe</E>
                         v. 
                        <E T="03">United States,</E>
                         965 F.3d 662 (9th Cir. 2020)).
                    </P>
                    <HD SOURCE="HD2">North Cascades Ecosystem</HD>
                    <P>On January 13, 2017, North Cascades National Park (NCNP) and the Service jointly released a North Cascades Draft Restoration Plan and EIS to evaluate the impacts of a range of alternatives for restoring grizzly bears to the North Cascades Ecosystem (NCE) (82 FR 4336).</P>
                    <P>On July 10, 2020, the Service and NPS announced their decision to discontinue the proposal to develop and implement a grizzly bear restoration plan for the NCE and to terminate the EIS process (85 FR 41624).</P>
                    <P>On November 14, 2022, the Service and NPS announced initiation of a new EIS process to evaluate options for restoring and managing grizzly bears in the North Cascades, including a section 10(j) experimental population designation (87 FR 68190). On September 29, 2023, NPS and the Service opened a public comment period on a draft EIS to evaluate restoration of grizzly bears to the North Cascades (88 FR 67277; NPS and Service 2024, entire) and on a proposed section 10(j) rule that would allow management flexibility for a reintroduced population (88 FR 67193). On March 21, 2024, the Service and NPS released a final EIS identifying translocation of grizzly bears to the North Cascades with an experimental designation as the preferred alternative (NPS and Service 2024, entire). On April 25, 2024, NPS and the Service published a ROD to release an experimental population of grizzly bears in the NCE with the goal of establishing an initial population of 25 grizzly bears and then continuing to monitor and adaptively manage the population (NPS and Service 2024, pp. v-vi). In addition, the Service designated the North Cascades as a nonessential experimental population under section 10(j) of the Act (89 FR 36982, May 3, 2024, codified at 50 CFR 17.84(y)).</P>
                    <HD SOURCE="HD2">Petitions Regarding the Grizzly Bear Listing (2020s)</HD>
                    <P>On December 17, 2021, we received a petition from the State of Montana to establish and delist a Northern Continental Divide Ecosystem (NCDE) DPS of the grizzly bear under the Act. On January 21, 2022, we received a petition from the State of Wyoming to establish and delist a GYE DPS of the grizzly bear under the Act. On March 9, 2022, we received a petition from the State of Idaho to delist the grizzly bear in the lower-48 States.</P>
                    <P>On February 6, 2023, we announced our 90-day findings on these three petitions (88 FR 7658). Based on our review, we found that the petitions pertaining to the NCDE and GYE presented substantial scientific or commercial information indicating that the petitioned actions may be warranted, and we initiated status reviews to determine whether the petitioned actions are warranted. We found that the petition from the State of Idaho to delist the grizzly bear in the lower-48 States on the basis of it not being a valid listable entity did not present substantial scientific or commercial information indicating that the petitioned action may be warranted; therefore, we took no further action on that petition.</P>
                    <P>
                        In today's issue of the 
                        <E T="04">Federal Register</E>
                        , we announce our 12-month findings on the petitions to establish and delist GYE and NCDE DPSs of grizzly bears, respectively. Based on a thorough review of the best scientific and commercial data available, we found that the petitioned GYE and NCDE DPS grizzly bear populations were not valid listable entities. We acknowledge that this determination differs from our 2017 determination that the GYE population was discrete because it was markedly, physically 
                        <PRTPAGE P="4238"/>
                        separated from other grizzly bear populations and was significant due to its persistence in an ecological setting unique for the taxon and because the loss of the population would result in a significant gap in the range (82 FR 30502 at 30517-30519, June 30, 2017). However, estimated occupied range now extends beyond the 2017 GYE DPS western boundary, and we expect this trend to increase over time. Similarly, the estimated occupied range for the NCDE population extends beyond the boundary proposed by the petitioner. As populations expand, individual grizzly bears are dispersing into new areas outside the estimated occupied range (see figure 1, below). Thus, we found that the petitioned actions to establish and delist GYE and NCDE DPSs were not warranted.
                    </P>
                    <GPH SPAN="3" DEEP="376">
                        <GID>EP15JA25.031</GID>
                    </GPH>
                    <P>
                        In 2023, the State of Idaho, a co-defendant in 
                        <E T="03">Save the Yellowstone Grizzly</E>
                         v. 
                        <E T="03">U.S. Fish and Wildlife Service,</E>
                         No. 23-363 (D. Id), raised counter-claims against the Service alleging that: (1) the lower-48 listing is invalid and the Service has exceeded the Act's jurisdiction by keeping the listing in place; (2) the Service unlawfully denied Idaho's petition to delist grizzlies in the lower-48 United States; and (3) take of the three grizzly bears at issue in the case was consistent with the grizzly bear's section 4(d) rule (50 CFR 17.40(b)). As part of a February 22, 2024, settlement with the plaintiff, Save the Yellowstone Grizzly, and the State of Idaho, the Service agreed to submit to the Office of the Federal Register by January 31, 2026, a final rule complying with the Act and its implementing regulations that revises or removes the entire listing of grizzly bears in the lower-48 States.
                    </P>
                    <HD SOURCE="HD2">Relationship of Grizzly Bear Listing to Legislative Changes to the Act</HD>
                    <P>The grizzly bear subspecies was first listed in its entirety in North America in 1967 under the Endangered Species Preservation Act, which only allowed the listing of species or subspecies. When the Act was passed in 1973, it allowed for listing of “any other group of fish or wildlife of the same species or smaller taxa in common spatial arrangement that interbreed when mature.” The 1975 listing was “designed to ensure the species' conservation” within the Yellowstone (the GYE), Bob Marshall (now the NCDE), and Selway-Bitterroot (the BE) ecosystems, and “to protect any members of the species occurring elsewhere in” the lower-48 States. (40 FR 31734 at 31735, July 28, 1975). It was not an indication that grizzly bears were present in all areas covered by the listing, or that the Service intended to recover grizzly bears throughout the lower-48 States.</P>
                    <P>
                        The listing of the grizzly bear as a threatened species in the lower-48 States in 1975 was not predicated upon a formal DPS analysis, because the listing predated the 1978 amendments to the Act, which revised the definition of “species” to include DPSs of vertebrate fish or wildlife. The 1978 amendments revised the definition of 
                        <PRTPAGE P="4239"/>
                        “species” by adding the phrase “any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature” (16 U.S.C. 1532(16)). In addition, in 1996, the Service and the National Marine Fisheries Service published our joint “Policy Regarding the Recognition of Distinct Vertebrate Population Segments Under the Endangered Species Act” (DPS Policy; 61 FR 4722, February 7, 1996).
                    </P>
                    <P>In the 2011 5-year status review of the grizzly bear, we reviewed the application of the DPS Policy to the grizzly bear listing (Service 2011, entire). We concluded that the population segment of grizzly bear in the lower-48 States was discrete from other grizzly populations and significant to the remainder of the taxon and that it met the standards for recognition as a DPS under the Act, but we did not propose to revise the listed entity. In this proposed rule, we are undertaking a new DPS analysis as part of our reevaluation of the current listed entity of grizzly bears in the lower-48 States.</P>
                    <HD SOURCE="HD1">Peer Review</HD>
                    <P>A species status assessment (SSA) team prepared an SSA report for the grizzly bear in the lower-48 States. The SSA team was composed of Service biologists, in consultation with other species experts. The SSA report represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species.</P>
                    <P>
                        In accordance with our joint policy on peer review published in the 
                        <E T="04">Federal Register</E>
                         on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review in listing and recovery actions under the Act (
                        <E T="03">https://www.fws.gov/sites/default/files/documents/peer-review-policy-directors-memo-2016-08-22.pdf</E>
                        ), we solicited independent scientific review of the information contained in the grizzly bear SSA report. We sent the SSA report to four independent peer reviewers and received three responses. Results of this structured peer review process can be found at 
                        <E T="03">https://www.regulations.gov</E>
                         and 
                        <E T="03">https://fws.gov/library/categories/peer-review-plans.</E>
                         In preparing this proposed rule, we incorporated the results of these reviews, as appropriate, into the SSA report, which is the foundation for this proposed rule.
                    </P>
                    <HD SOURCE="HD1">Summary of Peer Reviewer Comments</HD>
                    <P>As discussed in Peer Review, above, we received comments from three peer reviewers on the SSA report. We reviewed all comments we received from the peer reviewers for substantive issues and new information regarding the information contained in the SSA report. The peer reviewers generally concurred with our methods and conclusions, and provided additional information, clarifications, and suggestions, including clarifications in discussion of current conservation measures relating to human-caused mortality and habitat, clarifications in the discussion of connectivity and genetic health, additional scientific literature to consider, and other editorial suggestions. There were several comments regarding our assessment of current and future conditions for the two habitat and six demographic factors for each ecosystem under the current and future condition scenarios, which were further clarified in the SSA report for the species.</P>
                    <HD SOURCE="HD1">I. Proposed Revision of Grizzly Bear Listing</HD>
                    <HD SOURCE="HD2">Background</HD>
                    <P>
                        A thorough review of the taxonomy, life history, and ecology of the grizzly bear (
                        <E T="03">Ursus arctos horribilis</E>
                        ) in the lower-48 States is presented in the SSA report (version 2.2; Service 2024, pp. 39-48), which we summarize here.
                    </P>
                    <P>
                        Please note that, in this document, we refer to the grizzly bear in the lower-48 States both as a “species,” as it is listed as a threatened species under the Act, and as a “subspecies” because 
                        <E T="03">Ursus arctos horribilis</E>
                         is a subspecies of 
                        <E T="03">Ursus arctos.</E>
                         Later in this document (where indicated), we also use the term “the grizzly bear DPS” to refer to the contiguous U.S. grizzly bear DPS.
                    </P>
                    <HD SOURCE="HD2">Species Description</HD>
                    <P>
                        The grizzly bear is a large, long-lived mammal that occurs in a variety of habitat types. It is distributed across large portions of Alaska, as well as western and northern Canada, but its distribution in the lower-48 States is limited to portions of Idaho, Montana, Washington, and Wyoming. Grizzly bears hibernate in the winter, typically in dens; feed on a wide variety of foods; weigh up to 363 kilograms (800 pounds); and live more than 25 years in the wild. Grizzly bears are light brown to nearly black and are so named for their “grizzled” coats with silver or golden tips. Grizzly bears are a member of the brown bear species (
                        <E T="03">U. arctos</E>
                        ) that occurs in North America, Europe, and Asia. The subspecies 
                        <E T="03">U. a. horribilis</E>
                         is limited to North America and is the subspecies that occurs in the lower-48 States (Rausch 1963, p. 43; Servheen 1999, pp. 50-53). Grizzly bears have three life stages: dependent young, subadults, and adults.
                    </P>
                    <HD SOURCE="HD2">Habitat and Range</HD>
                    <P>Grizzly bears use a variety of habitats (LeFranc et al. 1987, p. 120). In general, a grizzly bear's individual habitat needs and daily movements are largely driven by the search for food, water, mates, cover, security, or den sites. The available habitat for bears is also influenced by people and their activities. Adult grizzly bears are normally solitary except when breeding or when females have dependent young (Nowak and Paradiso 1983, p. 971), but they are not territorial and home ranges of adult bears frequently overlap (Schwartz et al. 2003, pp. 565-566). Home range size is highly variable and is affected by resource availability, habitat quality, sex, age, and reproductive status (LeFranc et al. 1987, p. 31; Blanchard and Knight 1991, pp. 48-51; Mace and Waller 1997, p. 48). Grizzly bears hibernate in winter; hibernation is a life-history strategy that bears use to cope with seasons of low food abundance.</P>
                    <P>Adult bears are 4 years old or older when they reach sexual maturity, although some bears may not breed until they are older. Mating occurs from May through July (Craighead and Mitchell 1982, p. 522; Nowak and Paradiso 1983, p. 971); however, their fertilized embryos do not implant into the uterus for further development until late fall. Cubs are born in the den in late January or early February and nurse for 3 to 4 months inside the den. Offspring typically remain with the female for about 2.5 years. Reproduction may be related to nutritional state and/or density-dependent effects (Stringham 1990, p. 433; McLellan 1994, p. 20; Hilderbrand et al. 1999, pp. 135-136; Schwartz et al. 2006c, p. 21; van Manen et al. 2016, pp. 307-308; Hilderbrand et al. 2019, pp. 115-116). Grizzly bears have one of the slowest reproductive rates among terrestrial mammals (Nowak and Paradiso 1983, p. 971; Schwartz et al. 2003, p. 564), and it may take a female grizzly bear 10 or more years to replace herself in a population (Service 1993, p. 4).</P>
                    <P>
                        The lower-48 States provides highly diverse landscapes containing a wide array of habitat types and bear foods across and within the ecosystems. Grizzly bears are opportunistic omnivores and display great diet plasticity within and across populations (Edwards et al. 2011, pp. 883-886), shifting their diet according to foods that are most nutritious (
                        <E T="03">i.e.,</E>
                         high in fat, protein, and/or carbohydrates) and 
                        <PRTPAGE P="4240"/>
                        available (Mealey 1980, pp. 284-291; Servheen 1981, pp. 99-102; Kendall 1986, pp. 12-18; Mace and Jonkel 1986, p. 108; Martinka and Kendall 1986, pp. 21-22; LeFranc et al. 1987, pp. 111-114; Aune and Kasworm 1989, pp. 63-71; Kasworm and Thier 1993, pp. 38-41; McLellan and Hovey 1995, pp. 706-709; Schwartz et al. 2003, pp. 568-569; Van Daele et al. 2012, pp. 25-27; Gunther et al. 2014, p. 65). The ability to use whatever food resources are available is likely one reason brown bears are the most widely distributed bear species in the world, occupying habitats from deserts to alpine mountains and everything in between. This ability to live in a variety of habitats and eat a wide array of foods makes grizzly bears a generalist species.
                    </P>
                    <HD SOURCE="HD2">Recovery Criteria</HD>
                    <P>Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. Under section 4(f)(1)(B)(ii), recovery plans must, to the maximum extent practicable, include objective, measurable criteria that, when met, would result in a determination, in accordance with provisions of section 4 of the Act, that the species be removed from the Lists of Endangered and Threatened Wildlife and Plants.</P>
                    <P>Recovery plans provide a roadmap for us and our partners on methods of enhancing conservation and minimizing threats to listed species, as well as measurable criteria against which to evaluate progress towards recovery and assess the species' likely future condition. However, they are not regulatory documents and do not substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. A decision to revise the status of a species or to delist a species is ultimately based on an analysis of the best scientific and commercial data available to determine whether a species is no longer an endangered species or a threatened species, regardless of whether that information differs from the recovery plan.</P>
                    <P>There are many paths to accomplishing recovery of a species, and recovery may be achieved without all of the criteria in a recovery plan being fully met. For example, one or more criteria may be exceeded while other criteria may not yet be accomplished. In that instance, we may determine that the threats are minimized sufficiently and that the species is robust enough that it no longer meets the Act's definition of an endangered species or a threatened species. In other cases, we may discover new recovery opportunities after having finalized the recovery plan. Parties seeking to conserve the species may use these opportunities instead of methods identified in the recovery plan. Likewise, we may learn new information about the species after we finalize the recovery plan. The new information may change the extent to which existing criteria are appropriate for identifying recovery of the species. The recovery of a species is a dynamic process requiring adaptive management that may, or may not, follow all of the guidance provided in a recovery plan.</P>
                    <P>The 1993 recovery plan for the grizzly bear, and subsequent supplements, identified six recovery ecosystems, each containing a recovery zone at its core, within the lower-48 States thought to be capable of supporting grizzly bears (Service 1993, pp. 10-13, 17-18). Today, current grizzly bear distribution is primarily within and around four of these areas identified as recovery zones. The current recovery plan states an objective of “delisting each of the remaining populations by population as they achieve the recovery targets” (USFWS 1993, pp. ii, 33-34). The recovery plan outlines three demographic recovery criteria for each ecosystem. We updated the GYE demographic recovery criteria in 2007, and again in 2017, to reflect the best available science, including expansion of mortality limits in the third criterion to include total mortality (in their entirety: Service 2007b, 2017).</P>
                    <P>
                        Due to a settlement agreement in 
                        <E T="03">Fund for Animals</E>
                         v. 
                        <E T="03">Babbitt,</E>
                         967 F.Supp. 6 (D.D.C. 1997) regarding the 1993 recovery plan, the Service agreed to establish habitat-based recovery criteria for each ecosystem prior to publishing any proposed rule to delist that grizzly bear population. In addition, the Service agreed to convene a workshop during the public comment period on the draft habitat-based recovery criteria. Habitat-based recovery criteria were published as supplemental chapters to the 1993 recovery plan for the GYE and the NCDE in 2007 and 2018, respectively (in their entirety: Service 2007a, 2018). As explained in detail in our SSA report, because of the inability to calculate minimum habitat values for a recovered population, we use a “no net loss” approach by assessing which habitat factors are compatible with a stable to increasing grizzly bear population (Service 2024, pp. 79-82, 87-89).
                    </P>
                    <P>The following discussion provides a summary and assessment of the recovery criteria as they relate to evaluating the status of the species. Further details about the progress toward achieving recovery criteria can be found in our SSA report (Service 2024, pp. 80-100).</P>
                    <HD SOURCE="HD3">Habitat-Based Recovery Criteria</HD>
                    <P>For both the GYE and NCDE, habitat-based recovery criteria define threshold levels for habitat security (areas with no motorized access; “secure core” in the NCDE and “secure habitat” in the GYE, as defined in appendix B in the SSA report (Service 2024)), livestock allotments, and developed sites as their habitat-based recovery criteria (Service 2007a, pp. 2-6; Service 2018, pp. 5-8; Yellowstone Ecosystem Subcommittee (YES) 2024, chapter 3 and appendix E). These habitat-based recovery criteria have been met or improved upon since their incorporation into the recovery plan for both the GYE and NCDE (in their entirety: Service 2007a, 2018; Ake 2022, 2023a, 2023b; Grizzly Bear Habitat Monitoring Team 2024). The Service has not yet developed habitat-based recovery criteria for the remaining ecosystems.</P>
                    <HD SOURCE="HD3">Demographic Recovery Criterion 1</HD>
                    <P>
                        The first criterion establishes a minimum population size through the monitoring of females with cubs. In the GYE, this criterion has been met since 2003, with an estimated 87 females with cubs and 1,030 individuals in 2023 (Gould et al. 2024c, in prep.). A new trend monitoring program was implemented in the NCDE in 2004 because documenting females with cubs from visual observations is limited due to the forested nature of the NCDE (see 
                        <E T="03">Mortality Limits</E>
                         in the SSA report for further details; Service 2024, pp. 176-178). Based on the new methods, the population in the NCDE has likely met this criterion since at least 2004, with an estimated 1,163 individuals in 2023 (Costello et al. 2024, in prep.). Although progress has been made towards recovery in the CYE, this criterion has not yet been met. In 2023, there were an estimated 70 bears in the CYE, below the target of 100 bears (Kasworm et al. 2024a, p. 43). The SE, due to its small size in the United States, is the only population where the population criterion (90 bears) spans the U.S.-Canada border. In the U.S. portion of the SE, there were a minimum of 51 bears as of 2023 (Kasworm et al. 2024b, p. 21). There were an estimated 69 bears in the Canadian portion of the SE population as of 2021 (Proctor et al. 2022, p. 2). However, the U.S. and British Columbia (B.C). population estimates for the SE are not exclusive because numerous 
                        <PRTPAGE P="4241"/>
                        bears overlap their home ranges; therefore, adding the estimates together would cause some double counting. An effort to integrate the population estimates from the U.S. and B.C. portions of the SE is ongoing. There is no known population in either the BE or North Cascades; therefore, this criterion has not been met for all ecosystems.
                    </P>
                    <HD SOURCE="HD3">Demographic Recovery Criterion 2</HD>
                    <P>
                        The second criterion ensures reproductive females (
                        <E T="03">i.e.,</E>
                         females with young) are well distributed across the recovery zone, as measured by bear management units (BMUs), and are not concentrated in one portion of the ecosystem. In the GYE, this recovery criterion has been met since at least 2001, with 18 of 18 BMUs occupied by females with young for the most recent 6-year period of 2018-2023. In the NCDE, this recovery criterion has been met since at least 2009, with 23 of 23 BMUs occupied by females with young for the most recent 6-year period of 2018-2023. In the SE, this recovery criterion has been met since at least 2014, with 9 of 10 BMUs occupied by females with young for the most recent 6-year period of 2018-2023. Although progress has been made towards recovery in the CYE, this criterion has not yet been met. There is no known population in either the BE or North Cascades; therefore, this criterion has not been met for all ecosystems.
                    </P>
                    <HD SOURCE="HD3">Demographic Recovery Criterion 3</HD>
                    <P>The third criterion outlines annual human-caused mortality limits that would allow the population to achieve and sustain recovery. In 2017, this criterion was revised for the GYE to implement new scientific methods to estimate the population size and determine sustainable total mortality limits. In the GYE, this recovery criterion has been met for all age and sex classes since 2021. A new population estimation framework, an integrated population model (IPM), was implemented in 2022, which replaces the model-averaged Chao2 population estimation method (Gould et al. 2024a, entire). Demographic recovery criterion 3 relies on the model-averaged Chao2 method; therefore, we cannot assess the mortality limits as set forth in the recovery plan. However, mortality rates in 2023 for independent females, independent males, and dependent young were consistent with a population growth rate from 2020 to 2023 of 3.4 percent. Therefore, the GYE grizzly bear population has likely met the intent of this demographic recovery criterion.</P>
                    <P>
                        In the NCDE, human-caused mortality has been below the threshold since 2009, but the female proportion of human-caused mortality was above the threshold in 2021, 2022, and 2023. Even though the female mortality exceeded the criterion in these three years, the NCDE likely meets the intent of this criterion. In 1993, the mortality limits were set conservatively to compensate for unknown/unreported mortality, which we now have the ability to estimate (NCDE Subcommittee 2020, chapter 2 and appendix 2). The NCDE conservation strategy implements a methodology that includes an estimate of total reported and unreported (TRU) mortality, which includes known and probable mortality from all causes (
                        <E T="03">i.e.,</E>
                         human-caused, natural, and undetermined) as well as an estimate of unknown/unreported mortality (using the methods of Cherry et al. 2002, entire; Costello et al. 2016, p. 29). As discussed in the NCDE conservation strategy, during the period of 2018-2023, TRU mortalities for independent females and independent males were below the maximum threshold, compatible with an annual 2.3 percent growth in the population since 2004 (Costello et al. 2016, p. 2; Costello et al. 2024, in prep.; Montana Fish, Wildlife and Parks (MFWP), unpublished data).
                    </P>
                    <P>In the CYE and SE, the known, human-caused mortality threshold is 4 percent of the minimum population size, no more than 30 percent of which shall be females. In the CYE from 2018-2023, the average annual human-caused mortality was 1.7 bears per year and 0.5 female bears per year, which exceeds the calculated mortality limits for total and female bears of 1.4 and 0.4 bears per year, respectively. In the SE from 2018-2023, the average annual human-caused mortality was 2.0 bears per year and 0.5 female bears per year, which is at or below both the total and female mortality limits of 2.0 and 0.6 bears per year, respectively. Although progress has been made towards recovery in the CYE and SE, and this threshold has been met in some recent years, this criterion has not been met consistently. There is no known population in either the BE or North Cascades; therefore, this criterion has not been met for all ecosystems.</P>
                    <HD SOURCE="HD2">Recovery Criteria Applicability to the Grizzly Bear DPS</HD>
                    <P>The 1993 recovery plan identified six recovery areas (GYE, NCDE, CYE, SE, BE, and North Cascades), and recommended further evaluation of other potential areas to determine recovery potential (Service 1993, pp. 11, 15-16, 121). As discussed below in “Areas Where Bears Do Not or Are Unlikely To Occur,” the Service has completed this analysis, focusing on habitat security in the historical range outside of the six ecosystems (see Service 2024, appendix A, for further details). Given this analysis, the Service's approach to grizzly bear recovery under the Act is focused on, and will continue to be focused on, the current six ecosystems, and additional areas, such as the San Juan Mountains and other mountain ranges in the West, are not needed to recover the species.</P>
                    <P>
                        The current condition of the grizzly bear in the lower-48 States partially meets the recovery criteria set forth in the 1993 recovery plan and its supplements. Demographic criteria have been met for the GYE and NCDE populations and have been partially met for the CYE and SE populations, but the BE and North Cascades are functionally extirpated. Habitat-based recovery criteria have been met where they have been developed (
                        <E T="03">i.e.,</E>
                         for the GYE and NCDE populations), but they have not yet been developed for the other four ecosystems.
                    </P>
                    <P>
                        In recent decades, the amount of available science regarding the grizzly bear has increased, including knowledge about the species and its associated threats. For example, minimum population sizes (
                        <E T="03">i.e.,</E>
                         Demographic Recovery Criterion 1) did not consider long-term genetic health and population connectivity. Furthermore, the recovery zone boundaries and the application of annual human-caused mortality limits within them (
                        <E T="03">i.e.,</E>
                         Demographic Recovery Criterion 3) did not reflect the need for natural connectivity that may be necessary for the long-term genetic health of small or isolated populations in order for populations to be self-sustaining. As such, although we are not required to do so under the Act, we expect to revise the recovery plan for the grizzly bear in the future.
                    </P>
                    <HD SOURCE="HD1">Distinct Population Segment</HD>
                    <P>
                        Pursuant to the Act, we must consider for listing any species, subspecies, or, for vertebrates, any DPS of these taxa, if there is sufficient information to indicate that such action may be warranted. To interpret and implement the DPS provision of the Act and Congressional guidance, the Service and the National Marine Fisheries Service published an interagency “Policy Regarding the Recognition of Distinct Population Segments under the Act” (DPS Policy; 61 FR 4722, February 7, 1996). The DPS Policy addresses the recognition of DPSs for potential listing actions. The DPS Policy contemplates 
                        <PRTPAGE P="4242"/>
                        that listing DPSs, when appropriate, will help focus conservation efforts on populations that warrant protection under the Act while avoiding unnecessary regulations in other parts of the taxon's range.
                    </P>
                    <P>
                        Under our DPS Policy, three elements are considered in a decision regarding the status of a possible DPS as an endangered or threatened species under the Act. These are applied similarly for additions to the Lists of Endangered and Threatened Wildlife and Plants (Lists), reclassification, and removal from the Lists. They are: (1) Discreteness of the population segment in relation to the remainder of the taxon; (2) the biological or ecological significance of the population segment to the taxon to which it belongs; and (3) the population segment's conservation status in relation to the Act's standards for listing (
                        <E T="03">i.e.,</E>
                         whether the population segment is, when treated as if it were a species or subspecies, an endangered or threatened species). Discreteness refers to the degree of isolation of a population from other members of the species, and we evaluate this factor based on specific criteria. If the population segment is considered discrete, we must consider whether the discrete segment is “significant” to the taxon to which it belongs by using the best scientific and commercial data available. When determining if a potential DPS is significant, our policy directs us to sparingly list DPSs while encouraging the conservation of genetic diversity. If we determine that a population segment is both discrete and significant, we then evaluate it for endangered or threatened species status based on the Act's standards.
                    </P>
                    <HD SOURCE="HD2">Distinct Population Segment Analysis for Grizzly Bear in the Contiguous United States</HD>
                    <HD SOURCE="HD3">Background</HD>
                    <P>As discussed above in Previous Federal Actions, the listing of the grizzly bear as a threatened species in the lower-48 States occurred before the publication of our DPS Policy on February 7, 1996 (61 FR 4722). However, consistent with our DPS Policy, we evaluate the application of the DPS policy on a case-by-case basis if we consider revising a species' listing status, and in our 5-year reviews under section 4(c)(2) of the Act (61 FR 4722 at 4725, February 7, 1996). The 1975 grizzly bear listing was intended primarily to conserve grizzly bears in those areas where they occurred at that time, and to protect any individual bears found in other parts of the lower-48 States. It was not an indication that grizzly bears were present in all areas covered by the listing, or that the Service intended to recover them throughout the lower-48 United States. In fact, grizzly bears did not historically occur in the eastern United States and have long been extirpated from a large percentage of their historical range in the lower-48 States. Thus, the 1975 listing of grizzly bears in the “U.S.A., conterminous (lower 48) States” does not reflect where grizzly bears occur now and are expected to occur in the future as they recover.</P>
                    <P>
                        In this proposed rule, we are evaluating the currently listed entity of grizzly bears in the lower-48 States under the DPS Policy and revising the current listing to: (1) include all existing grizzly bear populations within the lower-48 States; (2) include any designated experimental populations; (3) encompass areas where the grizzly bear's range may naturally expand in the future; and (4) use landscape or anthropogenic features (
                        <E T="03">e.g.,</E>
                         highways) or administrative boundaries (
                        <E T="03">e.g.,</E>
                         State boundary) to clearly define the DPS boundary for the public. Areas outside of historical range of the subspecies and areas within historical range that are no longer suitable to support a grizzly bear population due to human development would not be part of a revised grizzly bear DPS (see below, “Areas Where Bears Do Not or Are Unlikely To Occur”).
                    </P>
                    <HD SOURCE="HD3">Proposed DPS Boundaries</HD>
                    <P>We are proposing to revise the existing lower-48 State grizzly bear listing by defining the DPS with the boundary depicted below in figure 2 for the reasons articulated in Previous Federal Actions and “Background,” above.</P>
                    <BILCOD>BILLING CODE 4333-15-P</BILCOD>
                    <GPH SPAN="3" DEEP="311">
                        <PRTPAGE P="4243"/>
                        <GID>EP15JA25.032</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4333-15-C</BILCOD>
                    <P>The proposed grizzly bear DPS includes all of the State of Washington and portions of the States of Idaho, Montana, and Wyoming. The northwest point of the northern boundary begins at the western terminus of the coterminous U.S.-Canada border near Blaine, Washington, and follows the international border east to its intersection with Montana Highway (MT) 16. The eastern boundary follows MT-16 from the Canadian border south to the intersection with Interstate (I) 94 near Glendive, Montana; then continues south along I-94 to the intersection with MT-47 in between Custer and Bighorn, Montana; then follows MT-47 south to the intersection with I-90 in Harden, Montana; then continues south along I-90 to the intersection with U.S. Highway (Hwy) 25 in Buffalo, Wyoming; then follows Hwy 25 south to the intersection with Wyoming Highway (WY) 220 in Casper, Wyoming; then continues south to the intersection with WY-287 near Three Forks, Wyoming; then follows WY-287 south to the intersection with I-80 in Rawlins, Wyoming. The southern boundary follows I-80 west from the southeastern point in Rawlins, Wyoming, to the intersection with Hwy 30, at which point it continues west on Hwy 30 to the intersection with the Snake River near Pocatello, Idaho, where it follows the Snake River west and north until it intersects with the Washington State line. The boundary then follows the Washington State line west to the Pacific Ocean. The western boundary follows the Washington coastline north to the U.S.-Canada border at Blaine, Washington.</P>
                    <P>The proposed grizzly bear DPS boundary encompasses all six grizzly bear recovery zones (GYE, NCDE, CYE, BE, North Cascades, and the U.S. portion of the SE), as well as important connectivity habitat between the recovery zones (USFWS 1993, p. 11; Sells et al. 2023, p. 6; Service 2024, p. 60). These areas include large amounts of public lands, including several national forests (Shoshone, Beaverhead-Deerlodge, Bridger-Teton, Caribou-Targhee, Custer-Gallatin, Flathead, Helena-Lewis and Clark, Mt. Baker-Snoqualmie, Gifford Pinchot, Wenatchee, Okanogan, Colville, Kootenai, Idaho Panhandle, Lolo, Nez Perce-Clearwater, Bitterroot, Payette, Salmon-Challis, Boise, Sawtooth, and Caribou-Targhee national forests (NFs)), several national parks (Yellowstone National Park (YNP), Grand Teton National Park (GTNP), Glacier National Park (GNP), and NCNP Complex), Bureau of Land Management (BLM) lands, Tribal lands, and State and private lands. As discussed below in “Areas Where Bears Do Not or Are Unlikely To Occur,” the proposed grizzly bear DPS boundary includes all habitat in the lower-48 States that is suitable for supporting self-sustaining grizzly bear populations.</P>
                    <HD SOURCE="HD3">Areas Where Bears Do Not or Are Unlikely To Occur</HD>
                    <P>
                        Grizzly bears are currently listed as they were originally listed in 1975 (40 FR 31734, July 28, 1975), as a threatened species in the lower-48 States (see 50 CFR 17.11(h)). The 1975 listing was intended primarily to ensure the species' conservation where grizzly bears were thought to occur at the time of listing and to protect any members of the species occurring elsewhere in the lower-48 States. However, this broadly described listing created confusion because it includes areas outside the historical and current range of the grizzly bear. Grizzly bears historically existed throughout all or portions of only 18 western States (
                        <E T="03">i.e.,</E>
                         Washington, Oregon, California, Idaho, Montana, Wyoming, Nevada, Colorado, Utah, New Mexico, Arizona, North Dakota, South Dakota, Minnesota, Nebraska, Kansas, Oklahoma, and Texas) (Servheen 1989, pp. 1-2; USFWS 1993, p. 9; Servheen 1999, pp. 50-51; Haroldson et al. 2021, pp. 163, 165). To ensure that grizzly 
                        <PRTPAGE P="4244"/>
                        bears are designated on the List as a valid listable entity, we are proposing to revise the current listing to recognize a DPS and are defining the boundaries of the DPS based on biological principles and the best scientific and commercial data available.
                    </P>
                    <P>
                        The proposed DPS boundary encompasses 800,116 square kilometers (km
                        <SU>2</SU>
                        ) (308,926 square miles (mi
                        <SU>2</SU>
                        )) or 26 percent of historical range circa 1850 (Haroldson et al. 2021, pp. 163, 165). Historically, grizzly bears were probably most common in the Rocky Mountains, along the Upper Missouri River, and in California (Storer and Tevis 1955, pp. 15-21; Schneider 1977, pp. 15, 17, 25-36; Mattson and Merrill 2002, pp. 1125, 1127-1128; Haroldson et al. 2021, pp. 163, 165). Grizzly bears were less common or did not occur in large expanses of the North American deserts and Great Plains ecoregions (Rollins 1935, p. 191; Wade 1947, p. 444; Mattson and Merrill 2002, p. 1128; Haroldson et al. 2021, pp. 163, 165). Large portions of the remaining historical range are no longer suitable habitat. Grizzly bears have experienced immense loss of historical range primarily due to human persecution and reduction of habitat (Roosevelt 1907, pp. 27-28; Wright 1909, p. vii; Storer and Tevis 1955, pp. 26-27; Leopold 1967, p. 30; Koford 1969, p. 95; Craighead and Mitchell 1982, p. 516; Servheen 1999, pp. 50-51). Many grizzly bear habitats within the species' historical range have been permanently developed and converted into agricultural land (Woods et al. 1999, entire). Traditional food sources, such as bison and elk, have been reduced, eliminated, or replaced with domestic livestock, such as cattle, sheep, chickens, goats, pigs, and agricultural products. Consequently, numerous large areas within the lower-48 States that historically supported grizzly bear populations are no longer suitable for grizzly bears.
                    </P>
                    <P>In 1993, the recovery plan identified six recovery areas (GYE, NCDE, CYE, SE, BE, and North Cascades), and recommended further evaluation of other potential areas to determine recovery potential (Service 1993, pp. 11, 15-16, 121). The San Juan Mountains were specifically identified for further evaluation, but no confirmed sightings of grizzly bears have occurred there since a grizzly bear mortality in 1979 (Service 1993, p. 11). The recovery plan recommended conducting an evaluation of these areas to focus on habitat values, size of area, human use and activities in general, relation to other areas where grizzly bears exist, and historical information (Service 1993, p. 121). The Service conducted this analysis as documented in the SSA report, focusing on habitat security in historical range outside of the six ecosystems in 2019-2020, which we summarize here (Service 2024, appendix A).</P>
                    <P>The most crucial element in grizzly bear recovery is habitat security, which is primarily influenced by motorized access management (USFWS 1993, pp. 21-22; Craighead and Mitchell 1982, p. 530). Unmanaged motorized access increases grizzly bear mortality risk and the potential for displacement from important habitat. For this reason, habitat-based recovery criteria for both the NCDE and GYE recovery zones include threshold levels for secure habitat (areas with no motorized access) (Service 2007a, entire; Service 2018, entire; Service 2024, pp. 80-82, 87-89). The recovery plan also recommended that areas to be considered for grizzly bear recovery must have the potential to sustain themselves as viable grizzly bear populations, either as large populations or through connectivity to other populations (Service 1982, p. 1; Service 1993, pp. 13, 15, 24, 121). Therefore, our evaluation of potentially suitable habitats considered habitat security (roads) and size, human population density, land ownership (Federal, State, and Tribal), historical range, and the potential to maintain a self-sustaining population.</P>
                    <P>
                        We analyzed habitat security within mapped historical grizzly bear range circa 1850 (Mattson and Merrill 2002, p. 1125). The largest area of secure core/habitat within the grizzly bear's historical range outside of the six recovery ecosystems (NCDE, GYE, North Cascades, BE, SE, and CYE) is the Sierra Nevada Mountain Range in California. We further analyzed the Sierra Nevada Range to determine if the area contains enough habitat security to support an isolated grizzly bear population. We also analyzed habitat security in the San Juan Mountains as recommended in the recovery plan (Service 1993, pp. 16, 121). Finally, we considered the potential of these areas to maintain a self-sustaining population by examining potential population size and the future ability of individuals to move between ecosystems (
                        <E T="03">e.g.,</E>
                         potential for connectivity), including distance from existing grizzly bear populations and potential barriers to dispersal (Service 1993, pp. 13, 24, 121). Details of this analysis can be found in our SSA report (Service 2024, appendix A).
                    </P>
                    <P>
                        To compare the amount of habitat security in the Sierra Nevada and San Juan mountains with habitat security in recovery zones, we calculated secure core using the definition used in the NCDE and secure habitat using the definition used in the GYE (see appendix B in the SSA report for those definitions (Service 2024)). The Sierra Nevada Mountains consists of 52,531 km
                        <SU>2</SU>
                         (20,282 mi
                        <SU>2</SU>
                        ) of habitat, of which 76 percent (39,872 km
                        <SU>2</SU>
                         (15,395 mi
                        <SU>2</SU>
                        )) is Federal, State, and Tribal lands. Forty-three percent of these Federal, State, and Tribal lands is secure core, and 47 percent is secure habitat. The San Juan Mountains analysis area consists of 26,512 km
                        <SU>2</SU>
                         (10,236 mi
                        <SU>2</SU>
                        ) of habitat, of which 82 percent (21,636 km
                        <SU>2</SU>
                         (8,354 mi
                        <SU>2</SU>
                        )) is Federal, State, and Tribal lands. Fifty-two percent of these Federal, State, and Tribal lands is secure core, and 56 percent is secure habitat. We note that the specific boundary and size of analysis areas influence the percent of secure core and secure habitat. Our selection of these boundaries was based primarily on the presence of large continuous patches of Federal lands and political boundaries; however, the analysis areas also include some patches of land that are primarily private land or checkerboards of private and public land.
                    </P>
                    <P>These percentages of secure core and secure habitat in the Sierra Nevada (43 and 47 percent, respectively) and San Juan Mountains (52 and 56 percent, respectively) are significantly lower than the percentages in the GYE and NCDE recovery zones (NCDE Subcommittee 2020, appendix 4; YES 2024, appendix E). Secure habitat averages 85.6 percent of the recovery zone in the GYE (YES 2024, appendix E), and secure core averages 76.4 percent of the recovery zone in the NCDE (NCDE Subcommittee 2020, appendix 4). The total amount of public access to Federal, State, and Tribal lands in the Sierra Nevada and San Juan Mountains is high, and we would expect resultant high human-caused mortality levels and habitat displacement (McLellan and Shackleton 1988, pp. 458-459; McLellan 1989, pp. 1862-1864; Mace et al. 1996, pp. 1402-1403; Schwartz et al. 2010, p. 661).</P>
                    <P>
                        The Sierra Nevada and San Juan Mountains are larger in area than either the CYE or SE recovery zones and could be large enough to support a population of grizzly bears. However, natural recolonization of these areas is unlikely because of the distance from existing grizzly bear populations. The Sierra Nevada and San Juan Mountain ranges are very far (a minimum of 1,000 km (621 mi) and 620 km (385 mi), respectively) from current grizzly bear populations. Maximum dispersal distances of 67-176 km (42-109 mi) for males have been documented in the GYE and NCDE (Blanchard and Knight 1991, pp. 50, 55; McLellan and Hovey 
                        <PRTPAGE P="4245"/>
                        2001, p. 841; Peck et al. 2017, p. 2), while female grizzly bears rarely disperse long distances (Swenson et al. 1998, pp. 822-824; Jerina and Adamič 2008, pp. 1495-1497). Recolonization and recovery of a new area would require continuous occupation by females, which is unlikely to occur in areas at great distance from existing populations.
                    </P>
                    <P>Additionally, the areas between the Sierra Nevada and San Juan Mountain ranges and current populations include large blocks of rangeland with open canopy coverage, agriculture, and private lands, and are bisected by several major highways and interstates. Increasing human development will increase these barriers in the future. Thus, the likelihood of even one male bear successfully immigrating from existing populations to these areas is minimal, and it is even more unlikely that a population would naturally recolonize and become self-sustaining.</P>
                    <P>
                        One or more populations of grizzly bears could be established through reintroduction. However, neither of these areas is large enough to sustain a sufficient number of bears to maintain long-term fitness, and ongoing translocations would likely be needed to ensure long-term genetic health. A total population size of approximately 400 grizzly bears is sufficient for short-term fitness of an isolated population (Miller and Waits 2003, p. 4338). For long-term genetic health, the population would require one to two effective immigrants from one of the other established grizzly bear populations approximately every 10 years (
                        <E T="03">e.g.,</E>
                         a generation interval) (Mills and Allendorf 1996, pp. 1510, 1516; Newman and Tallmon 2001, pp. 1059-1061; Miller and Waits 2003, p. 4338). Even if a population were reintroduced, there is a very low likelihood of natural connectivity to existing populations, which is needed for the reintroduced population to maintain long-term genetic fitness and become self-sustaining (Service 1982, p. 1; Service 1993, pp. 13, 24).
                    </P>
                    <P>
                        Although other grizzly bear populations and unoccupied recovery zones included in the lower-48 States, such as the GYE, North Cascades, and BE, are currently isolated, they are within male dispersal distance of existing populations, and connectivity is possible. In addition, with the expansion of the NCDE population, the BE is within female dispersal distance. Although the GYE grizzly bear population remains isolated today, the distance between current distributions of grizzly bears in the GYE and NCDE has decreased recently, and distributions are now close (98 km (61 mi)) (see figure 1, above; Costello et al. 2023, p. 14; Dellinger et al. 2023, p. 23), with multiple verified sightings in between. It is expected that, with the continued protections of the Act, natural connectivity will occur in the near future (see 
                        <E T="03">Connectivity and Genetic Health in the GYE</E>
                         in the SSA report for more information (Service 2024, pp. 187-190)).
                    </P>
                    <P>The SE and CYE are small recovery zones and do not have the potential to contain 400 bears. However, both recovery zones are contiguous with grizzly bear habitat northward into Canada, and a recovered population would be a subset of a much larger population. Bears can and do move between these recovery zones and contiguous habitat to the north in Canada, thereby enabling demographic connectivity and long-term genetic fitness.</P>
                    <P>Our initial analysis indicated other areas within the grizzly bear's historical range that currently contain substantial secure habitat, such as the Uinta and Mogollon mountains in the southwestern United States (Juliusson 2019, in litt.). However, each of these areas is smaller than the Sierra Nevada and San Juan mountains and has the same limiting factors that would most likely prevent them from supporting a self-sustaining population, including low amounts of secure core, extremely low potential of connectivity to existing grizzly bear populations due to high human densities, transecting highways and interstates, agriculture, lack of cover, and high densities of motorized routes. Therefore, we did not further analyze these other areas.</P>
                    <P>In conclusion, this proposed revision clarifies the original 1975 listing for grizzly bears by identifying a single DPS comprised of those areas within the lower-48 States where bears currently occur and are likely to occur in the future as recovery proceeds. The proposed DPS includes all six grizzly bear recovery zones, along with connectivity habitat between the recovery zones. The proposed grizzly bear DPS boundary does not include: (1) areas outside of historical range; (2) areas where bears do not currently occur; and (3) areas where bears are not likely to occur in the future.</P>
                    <HD SOURCE="HD3">Analysis of Discreteness</HD>
                    <P>Under our DPS Policy, a population segment of a vertebrate species may be considered discrete if it satisfies either one of the following conditions: (1) It is markedly separated from other populations of the same taxon as a consequence of physical, physiological, ecological, or behavioral factors (quantitative measures of genetic or morphological discontinuity may provide evidence of this separation); or (2) it is delimited by international governmental boundaries within which differences in control of exploitation, management of habitat, conservation status, or regulatory mechanisms exist that are significant in light of section 4(a)(1)(D) of the Act (inadequacy of existing regulatory mechanisms).</P>
                    <P>
                        <E T="03">Discreteness Based on Marked Separation</E>
                        —In our SSA report, we analyzed connectivity between populations within the lower-48 States and between populations within the lower-48 States and those in Canada. Grizzly bears have been documented moving between the NCDE, CYE, and SE populations and adjacent populations in southwestern Canada (Paetkau et al. 1998, p. 412; Kendall et al. 2009, p. 12; Proctor et al. 2012, pp. 12, 20-21, 39; Kasworm et al. 2024a, pp. 34, 76-112; Kasworm et al. 2024b, pp. 24, 61-79). The NCDE population is genetically and demographically well connected to Canadian populations (Proctor et al. 2012, p. 28). However, connectivity between the CYE and SE populations with those in Canada is more limited. Reproduction has been documented in the CYE from 9 individuals (8 males, 1 female) from the North Purcell Mountains in Canada, resulting in 26 offspring in the CYE (Kasworm et al. 2024a, p. 34). In the SE, reproduction has been documented for 5 individuals (4 males, 1 female) from the South Purcell Mountains, resulting in 25 offspring in the SE (Proctor et al. 2022, p. 25; Kasworm et al. 2024b, p. 24). For more information, see 
                        <E T="03">Connectivity and Genetic Health</E>
                         in our SSA report (Service 2024, pp. 182-197).
                    </P>
                    <P>
                        Several studies have documented genetic differences between grizzly bears in some populations in the grizzly bear DPS, including the GYE and SE, and other populations in North America (Paetkau et al. 1998, pp. 421-424; Waits et al. 1998, p. 310; Proctor et al. 2012, pp. 12, 31). However, these differences are likely a result of recent habitat fragmentation rather than long-term isolation that resulted in the evolution of unique traits (Proctor et al. 2012, p. 35). Please see 
                        <E T="03">Marked Genetic Differences,</E>
                         below, for further discussion.
                    </P>
                    <P>
                        Therefore, we find that there are no physical, physiological, ecological, or behavioral factors separating grizzly bears in the contiguous United States from grizzly bears in Canada. We do not consider grizzly bears in the contiguous United States to be genetically or morphologically discontinuous from grizzly bears in Canada, as existing 
                        <PRTPAGE P="4246"/>
                        genetic data support that Canadian grizzly bears are connected to the populations in the NCDE, CYE, and SE. Therefore, grizzly bears in the contiguous United States are not discrete based on marked separation from other populations of the same taxon.
                    </P>
                    <P>We next evaluate whether grizzly bear populations in the contiguous United States are discrete based on the international boundary with Canada. Specifically, we consider differences between the two countries in terms of control of exploitation, management of habitat, conservation status, or regulatory mechanisms that are significant in light of section 4(a)(1)(D) of the Act (inadequacy of existing regulatory mechanisms). In our analysis of discreteness at the international border, we compare existing regulatory mechanisms in Canada with non-Act regulatory mechanisms in the contiguous United States. This approach ensures that our analyses for listing and delisting a species are the same with respect to the international border discreteness element per our 1996 DPS Policy.</P>
                    <P>
                        <E T="03">Discreteness Based on the International Border—Differences in Control of Exploitation</E>
                        —In the absence of the protections of the Act, there are differences in control of exploitation of grizzly bears between the United States and Canada. A province-wide ban on grizzly bear hunting in B.C. came into effect on April 1, 2018. A similar ban on grizzly bear hunting was enacted in Alberta in 2006; however, hunting of potential conflict bears in Alberta recently became possible, albeit heavily restricted, pursuant to a Ministerial Order issued on June 17, 2024. Grizzly bear hunting is currently prohibited in the proposed grizzly bear DPS. However, absent the protections of the Act, we anticipate that State-authorized hunting seasons would be established in Idaho and Wyoming. In addition, hunting could occur in Montana within 5 years post-delisting (Administrative Rules of Montana (ARM) subchapter 12.9.14 at 12.9.1413). We do not anticipate grizzly bear hunting would occur in Washington in the foreseeable future because the population there is small and grizzly bears are currently listed by the State as an endangered species (Washington Administrative Code (WAC) at section 220-610-010).
                    </P>
                    <P>
                        <E T="03">Discreteness Based on the International Border—Differences in Conservation Status</E>
                        —There is also a difference in conservation status of grizzly bears between the United States and Canada. The grizzly bear population in Canada is estimated at nearly 29,000, with the populations of B.C. and Alberta estimated at around 15,000 and 700, respectively (Service 2024, appendix E, p. 343). Grizzly bears throughout Canada are designated as a species of “special concern” by the Canadian Committee on the Status of Endangered Wildlife in Canada (COSEWIC) (2012, entire) and under the Species at Risk Act (SARA) (2018). This designation is intended to ensure the species is managed to prevent it from becoming endangered or threatened. No federal protections are provided to them as a result of this designation. The conservation status of grizzly bears varies provincially, with separate conservation and management plans for each province.
                    </P>
                    <P>In B.C., grizzly bears are listed as a species of “special concern” by the B.C. Conservation Data Center (Environmental Reporting B.C. 2020, entire). A B.C. grizzly bear conservation strategy was prepared but never implemented (Office of the Auditor General of B.C. 2017, p. 29). In response to a 2017 audit, a draft grizzly bear stewardship framework was prepared and released for public comment in 2023; it is unknown when it will be finalized (B.C. Ministry of Forests 2023, entire).</P>
                    <P>In Alberta, grizzly bears were listed as threatened in 2010, under Alberta's Wildlife Act (Alberta Environment and Parks 2020, p. 9). In 2020, Alberta updated their provincial grizzly bear recovery plan that provides the basis for bear conservation and management (Alberta Environment and Parks 2020, entire). The plan identifies recovery zones where the province intends to recover bears, support zones to manage human-wildlife conflict to support the populations within the recovery zones, and linkage zones for dispersal (Alberta Environment and Parks 2020, p. 10).</P>
                    <P>The proposed grizzly bear DPS contains far fewer bears than Canada, with an estimated population of 2,314 bears as of 2023 (Costello et al. 2024, in prep.; Gould et al. 2024c, in prep.; Kasworm et al. 2024a, p. 43; Kasworm et al. 2024b, p. 21) versus an approximately 29,000 bears in Canada (Service 2024, appendix E, p. 343). Federal protections under the Act have been necessary to reach the current population sizes. Absent adequate conservation measures, human-caused mortality would continue to be a threat to grizzly bears in the proposed grizzly bear DPS because regulatory mechanisms currently in place would not adequately limit sources of human-caused mortality to sustainable thresholds (see “Mortality Limits,” below, for further details). In addition, habitat threats, such as motorized access and habitat security, remain an issue for the NCDE, CYE, SE, and North Cascades, where conservation mechanisms to address these stressors are not yet finalized or standards have not been met (see “Motorized Access,” below, for further details).</P>
                    <P>
                        <E T="03">Discreteness Conclusion</E>
                        —Based on our analysis described above and supported by information in the grizzly bear SSA report (Service 2024, entire), the contiguous U.S. population segment of grizzly bear meets the discreteness criterion in our DPS Policy (61 FR 4722, February 7, 1996). It is delimited by the international boundary with Canada, given the differences in control of exploitation and conservation status that are significant in light of section 4(a)(1)(D) of the Act. After determining that a vertebrate population is discrete, we are required to complete an analysis to determine if the population in question is significant pursuant to our DPS Policy; that analysis follows.
                    </P>
                    <HD SOURCE="HD3">Analysis of Significance</HD>
                    <P>
                        If we determine a population segment is discrete, we will then consider its biological and ecological significance in light of Congressional guidance that the authority to list DPSs be used sparingly while encouraging the conservation of genetic diversity. In carrying out this examination, we consider available scientific evidence of the population's importance to the taxon to which it belongs. Therefore, in this case, we consider the significance of the proposed grizzly bear DPS to the entire subspecies (
                        <E T="03">i.e., Ursus arctos horribilis</E>
                        ). Our DPS Policy states that this consideration may include, but is not limited to: (1) persistence of the discrete population segment in an ecological setting unusual or unique for the taxon; (2) evidence that loss of the discrete population segment would result in a significant gap in the range of the taxon; (3) evidence that the discrete population segment represents the only surviving natural occurrence of a taxon that may be more abundant elsewhere as an introduced population outside its historic range; or (4) evidence that the discrete population segment differs markedly from other populations of the species in its genetic characteristics. Below, we address considerations 1, 2, and 4. Consideration 3 does not apply to the proposed grizzly bear DPS because grizzly bears are distributed widely across Alaska and Canada.
                    </P>
                    <P>
                        Given the grizzly bear's historical occupancy of the lower-48 States, grizzly bear recovery in the lower-48 States has long been viewed as important to the taxon (40 FR 31734, 
                        <PRTPAGE P="4247"/>
                        July 28, 1975). As discussed further in our SSA report (Service 2024, pp. 231-264), the proposed DPS is significant because of the resiliency, redundancy, and representation it would provide to the taxon. Resiliency allows a species to recover from periodic disturbance and environmental variation. A species is more resilient if large populations exist in high-quality habitat that is distributed throughout the range of the species in such a way as to capture the environmental variability found within the range of the species. The wide geographic area over which grizzly bears in the proposed grizzly bear DPS exist extends the geographic distribution of the subspecies and increases the viability of grizzly bears in all of North America by making it less likely that an environmental disturbance or stochastic event would impact the entire subspecies. For example, grizzly bears in the proposed grizzly bear DPS would be less vulnerable than more northernly populations to a wildfire or a disease outbreak that originated in northern B.C. Additionally, with stark declines of grizzly bears across North America from 1850-1975, the fact that remnant populations exist in these ecosystems today demonstrates that these areas serve as refugia against human-caused mortality. For these reasons, the proposed grizzly bear DPS contributes to the resiliency of the subspecies in North America.
                    </P>
                    <P>
                        Redundancy of populations may be needed to provide a margin of safety for the species to withstand catastrophic events. The idea is to conserve enough areas of the range such that random catastrophes in the system act on only a few populations. In terms of redundancy, we view the proposed grizzly bear DPS as important because it ensures there are additional (
                        <E T="03">i.e.,</E>
                         redundant) populations outside of the large, contiguous populations in Canada and Alaska. Collectively, the multiple grizzly bear populations and habitat units provide a margin of safety to withstand catastrophic events and, thus, meaningfully contribute to the redundancy of grizzly bears in North America.
                    </P>
                    <P>Representation of populations in multiple ecological contexts increases the likelihood that a species' adaptive potential is conserved. The current distribution of grizzly bear populations in the GYE, NCDE, CYE, and SE, spread across multiple ecoregions, contributes to maintaining the species' adaptive potential. The addition of populations in the BE and North Cascades would contribute to additional ecosystem representation in the proposed grizzly bear DPS.</P>
                    <P>
                        <E T="03">Unusual or Unique Ecological Setting</E>
                        —Grizzly bears occupy a variety of habitats within North America, including coastal meadows and salmon streams, mid-elevation mountain forest communities, alpine grasslands and alpine tundra, western prairies, and tundra (Haroldson et al. 2021, pp. 166-169). In the contiguous United States, grizzly bears exist in ecosystems that range from a maritime climate to forested, mountainous habitat to dry sagebrush and prairie grasslands. Some of the ecoregions inhabited by grizzly bears in the proposed grizzly bear DPS are also present in portions of their occupied range in Canada, including the Northwestern Glaciated Plains, Canadian Rockies, Northern Rockies, and North Cascades. However, multiple ecoregions inhabited by grizzly bears in the contiguous United States are not present in other parts of their range, including the Idaho Batholith (the BE), Middle Rockies (the GYE and NCDE), Great Plains (the NCDE), Wyoming Basin (the GYE), and Snake River Plain (the GYE) (Woods et al. 1999, entire).
                    </P>
                    <P>Habitats within the proposed grizzly bear DPS provide a diverse landscape of habitat types and bear foods across and within the ecosystems. As discussed in further detail in our SSA report (Service 2024, pp. 46-48, 197-211), grizzly bears are opportunistic omnivores, and diets are highly variable among individuals, seasons, and years, and between ecosystems. Grizzly bears will consume almost any food available, including living or dead mammals or fish, insects, worms, plants, and human-related foods. In areas where animal matter is less available, berries, grasses, roots, bulbs, tubers, seeds, and fungi are important in meeting protein and caloric requirements. In the trans-boundary populations, grizzly bears in the contiguous United States appear to use food resources similar to grizzly bear populations in Canada and Alaska. Unique food resources, such as bison, may occur in the ecoregions present in the proposed grizzly bear DPS that are not present north of the U.S.-Canada border.</P>
                    <P>Within the proposed grizzly bear DPS, grizzly bears are unique in their consumption of bison (Mattson 1997, p. 167; Fortin et al. 2013, p. 275; Gunther 2017, in litt.) and in their interactions with wolves to obtain carcasses (Ballard et al. 2003, pp. 261-262; Smith et al. 2003, p. 336; Metz et al. 2012, p. 556). In addition, grizzly bears in the DPS have been documented to consume unique food items such as geothermal soil (Mattson et al. 1999, p. 109) and false-truffles (Fortin et al. 2013, p. 277; Gunther et al. 2014, p. 64). Consumption of these food sources, which are not known to be consumed in other parts of the species' range, is indicative of a unique ecological setting. Although grizzly bears have flexible diets and the availability of the wide variety of foods, the availability and use of unique food resources in certain ecological settings may increase a species' adaptive potential.</P>
                    <P>In light of data indicating that some grizzly bears in the DPS consume some unique food resources compared to other grizzly bear populations, where we have considerable information about the taxon's diet, we consider the proposed grizzly bear DPS to meet the DPS Policy standard for significance based on its persistence in an ecological setting unusual or unique for the taxon.</P>
                    <P>
                        <E T="03">Significant Gap in the Range of the Taxon</E>
                        —Historically, grizzly bears were distributed throughout the North American Rockies from Alaska and Canada, and south into central Mexico. During the late 1800s and early 1900s, grizzly bear populations declined or were extirpated from most of the southern portions of their historical range and the Canadian plains (Schwartz et al. 2003, pp. 557-558). Grizzly bear populations have since increased in size and range in parts of the contiguous United States, and the current estimated occupied range includes portions of Idaho, Montana, Washington, and Wyoming (Service 2024, figure 17). Although we have verified increasing numbers of outlier observations between the estimated occupied ranges, there are no known populations outside those in the GYE, NCDE, CYE, and SE (see figure 1, above).
                    </P>
                    <P>
                        The current estimated occupied range of grizzly bears in the contiguous United States covers approximately 152,643 km
                        <SU>2</SU>
                         (58,936 mi
                        <SU>2</SU>
                        ) (Costello et al. 2023, p. 14; Dellinger et al. 2023, p. 23; Kasworm et al. 2024a, p. 74; Kasworm et al. 2024b, p. 50; Service 2024, figure 17). This estimate does not include low-density outlying locations and represents a minimum known area of occupancy, not an extent of occurrence. The loss of this estimated occupied range would move the southern terminus of the subspecies' distribution approximately 6.5 degrees latitude (725 km (450 mi)) to the north.
                    </P>
                    <P>
                        The extirpation of peripheral populations is concerning because of the potential conservation value that peripheral populations can provide to the subspecies (Lesica and Allendorf 1995, p. 756; Fraser 1999, p. 50; Bunnell et al. 2004, p. 2242). Specifically, peripheral populations can possess slight genetic or phenotypic divergence 
                        <PRTPAGE P="4248"/>
                        from the core populations, which may be central to the survival of the subspecies in the face of environmental changes (Lesica and Allendorf 1995, p. 756; Bunnell et al. 2004, p. 2242). Therefore, we find that the proposed grizzly bear DPS meets the significance criterion under our DPS Policy because its loss would represent a significant gap in the range of the taxon.
                    </P>
                    <P>
                        <E T="03">Marked Genetic Differences</E>
                        —Several studies have documented genetic differences between some grizzly bears in the proposed grizzly bear DPS, including the GYE and SE, and other populations in North America, as evidenced by lower heterozygosity (
                        <E T="03">i.e.,</E>
                         lower level of genetic diversity within a population) (Paetkau et al. 1998, pp. 421-424; Waits et al. 1998, p. 310; Proctor et al. 2012, p. 12). However, the lower genetic diversity likely reflects recent population fragmentation rather than natural separation of populations that were on divergent evolutionary trajectories. Therefore, it is unknown if grizzly bears in the grizzly bear DPS possess unique genetic traits that evolved in response to the environment in the grizzly bear DPS such that they would meaningfully contribute to the survival of the subspecies. Therefore, we do not consider these genetic differences to meet the DPS Policy's standard for significance.
                    </P>
                    <P>
                        <E T="03">Summary of Significance</E>
                        —We evaluated whether the discrete population segment of grizzly bears in the contiguous United States is significant, considering factors such as whether the population segment is in an ecological setting unusual or unique for the taxon; whether the loss of the discrete population segment would result in a significant gap in the range of the taxon; whether the discrete population segment represents the only surviving natural occurrence of a taxon that may be more abundant elsewhere as an introduced population outside its historical range; or whether the discrete population segment differs markedly from other populations of the species in its genetic characteristics. We conclude that the grizzly bear DPS is significant because it occurs in an ecological setting unusual or unique for the subspecies and its loss would result in a significant gap in the range of the subspecies.
                    </P>
                    <HD SOURCE="HD3">DPS Conclusions</HD>
                    <P>Based on the best available information, we conclude that the grizzly bear DPS is discrete and significant in relation to the remainder of the subspecies in North America. As a result, the grizzly bear DPS meets the definition of a species under section 3(16) of the Act (16 U.S.C. 1532(16)) and therefore is a listable entity.</P>
                    <P>Where, as here, a vertebrate population is both discrete and significant under our DPS policy, we evaluate the conservation status of the population based on the factors enumerated at section 4(a) of the Act to determine whether it meets the definition of an endangered species or a threatened species. Below, we provide a status determination for the grizzly bear DPS.</P>
                    <HD SOURCE="HD1">Regulatory and Analytical Framework</HD>
                    <HD SOURCE="HD2">Regulatory Framework</HD>
                    <P>Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for endangered and threatened species. The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:</P>
                    <P>(A) The present or threatened destruction, modification, or curtailment of its habitat or range;</P>
                    <P>(B) Overutilization for commercial, recreational, scientific, or educational purposes;</P>
                    <P>(C) Disease or predation;</P>
                    <P>(D) The inadequacy of existing regulatory mechanisms; or</P>
                    <P>(E) Other natural or manmade factors affecting its continued existence.</P>
                    <P>These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.</P>
                    <P>We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself.</P>
                    <P>However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the species' expected response and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species, such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the Act's definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species.</P>
                    <P>
                        The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis which is further described in the 2009 Memorandum Opinion on the foreseeable future from the Department of the Interior, Office of the Solicitor (M-37021, January 16, 2009; “M-Opinion,” available online at 
                        <E T="03">https://www.doi.gov/sites/doi.opengov.ibmcloud.com/files/uploads/M-37021.pdf</E>
                        ). The foreseeable future extends as far into the future as the U.S. Fish and Wildlife Service and National Marine Fisheries Service (hereafter, the Services) can make reasonably reliable predictions about the threats to the species and the species' responses to those threats. We need not identify the foreseeable future in terms of a specific period of time. We will describe the foreseeable future on a case-by-case basis, using the best available data and taking into account considerations such as the species' life-history characteristics, threat-projection timeframes, and environmental variability. In other words, the foreseeable future is the period of time over which we can make reasonably 
                        <PRTPAGE P="4249"/>
                        reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction, in light of the conservation purposes of the Act.
                    </P>
                    <HD SOURCE="HD2">Analytical Framework</HD>
                    <P>The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent our decision on whether the species should remain listed as a threatened species, reclassified to an endangered species, or delisted under the Act. However, it does provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies.</P>
                    <P>The SSA report summarizes the results of our comprehensive viability analysis for the currently listed entity, the grizzly bear in the lower-48 States, which comprises all six ecosystems proposed for the grizzly bear DPS (Service 2024, entire). The six ecosystems are the foundation for the SSA analysis and are the scale at which we evaluated threats, the health of populations, and the species' overall viability. As a result, the SSA report's analysis provides the best scientific and commercial data available regarding the viability of the proposed grizzly bear DPS. Because the scales are the same, in the following summary, we replace “grizzly bear in the lower-48 States” from the SSA report with “grizzly bear DPS” for the purposes of this discussion.</P>
                    <P>To assess the viability of the grizzly bear DPS, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency is the ability of the grizzly bear DPS to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years); redundancy is the ability of the grizzly bear DPS to withstand catastrophic events (for example, droughts, large pollution events); and representation is the ability of the grizzly bear DPS to adapt to both near-term and long-term changes in its physical and biological environment (for example, climate conditions, pathogens). In general, viability will increase with increases in resiliency, redundancy, and representation (Smith et al. 2018, p. 306). Using these principles, we identified the grizzly bear DPS's ecological requirements for survival and reproduction at the individual, population, and grizzly bear DPS levels, and described the beneficial and risk factors influencing the grizzly bear DPS's viability.</P>
                    <P>The SSA process can be categorized into three sequential stages. During the first stage, we evaluated the individual grizzly bear DPS's life-history needs. The next stage involved an assessment of the historical and current condition of the grizzly bear DPS's demographics and habitat characteristics, including an explanation of how the grizzly bear DPS arrived at its current condition. The final stage of the SSA involved making predictions about the grizzly bear DPS's responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of the grizzly bear DPS to sustain populations in the wild over time, which we then used to inform our regulatory decision.</P>
                    <P>
                        The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket No. FWS-R6-ES-2024-0186 on 
                        <E T="03">https://www.regulations.gov</E>
                         and at 
                        <E T="03">https://www.fws.gov/species/grizzly-bear-ursus-arctos-horribilis.</E>
                    </P>
                    <HD SOURCE="HD1">Summary of Biological Status and Threats</HD>
                    <P>In this discussion, we review the biological condition of the grizzly bear DPS and its resources, and the threats that influence the grizzly bear DPS's current and future condition, in order to assess the grizzly bear DPS's overall viability and the risks to that viability.</P>
                    <HD SOURCE="HD2">Grizzly Bear DPS Needs</HD>
                    <P>Here we summarize, based on the SSA report, what individual grizzly bears in the grizzly bear DPS, need to breed, feed, and shelter. We also summarize the results of our analysis regarding the factors that ecosystems need to be resilient and the factors that grizzly bears in the grizzly bear DPS need with respect to redundancy and representation, with greater detail provided in our SSA report (Service 2024, pp. 7, 99-102).</P>
                    <P>
                        In general, food, water, mates, cover, security, and den sites drive a grizzly bear's habitat needs and daily movements. Grizzly bears in the grizzly bear DPS need access to habitat security (
                        <E T="03">i.e.,</E>
                         habitat that is relatively undisturbed by human influence), and habitat that provides cover, high-caloric foods, dens, and areas for dispersal. The specific quality and quantity of these resources influence the ability of individual grizzly bears to reproduce, grow, and survive at different life stages (Service 2024, pp. 100-101). These resources support resilient ecosystems, which may be characterized generally by grizzly bear abundance, population trends, survival rates, fecundity, and connectivity levels sufficient to withstand environmental stochasticity (Service 2024, p. 101). Grizzly bear populations need sufficient qualities and quantities of these habitat and demographic needs to be resilient, both currently and into the future (Service 2024, p. 101).
                    </P>
                    <HD SOURCE="HD2">Threats</HD>
                    <P>As documented in our SSA report, we evaluated stressors (also known as threats) that can negatively affect grizzly bears at the individual, ecosystem, or grizzly bear DPS levels, either currently or into the future (see figure 2, above; Service 2024, pp. 103-228). Although the SSA report is a rangewide analysis for the currently listed lower-48 State entity, we evaluated each stressor at the ecosystem level. A wide variety of stressors may influence the resiliency of the ecosystems, either by directly affecting individuals or by reducing the quality and quantity of habitats. The stressors we evaluated fit into three broad categories: sources of human-caused mortality, those with habitat-related effects, and other stressors. These stressors are interrelated to varying degrees; for example, motorized access influences both habitat availability and human-caused mortality.</P>
                    <P>
                        The primary stressors (
                        <E T="03">i.e.,</E>
                         threats) affecting grizzly bears at both the individual and ecosystem levels are excessive human-caused mortality and human activity that reduces the quality and quantity of habitats (Service 2024, pp. 150-178). We evaluated the following sources of human-caused mortality: management removals; accidental killings (
                        <E T="03">e.g.,</E>
                         train and vehicular strikes); mistaken-identity killings; illegal killings; and defense-of-life killings (Service 2024, pp. 155-166). We analyzed the following habitat-related stressors: motorized access and its management; developed sites; livestock allotments; mineral and energy development; recreation; vegetation management; habitat fragmentation; development on private lands; and activities that may disturb dens (Service 2024, pp. 110-150). We also evaluated other stressors, including: natural mortality; connectivity and genetic health; changes in food resources; effects of climate change; and stochastic events, such as widespread wildfires, earthquakes, and volcanic eruptions, some of which could be catastrophic if 
                        <PRTPAGE P="4250"/>
                        they occur on a large enough scale (Service 2024, pp. 178-222). With the exception of connectivity and genetic health, we did not find these other stressors to be current or future threats (Service 2024, pp. 223-225). We summarize the primary stressors below, with additional details and analysis provided in our SSA report (Service 2024, pp. 103-228).
                    </P>
                    <HD SOURCE="HD3">I. Human-Caused Mortality</HD>
                    <P>The primary factor contributing to grizzly bear decline during the 19th and 20th centuries was excessive human-caused mortality, including “indiscriminate illegal killing” and management removals (Leopold 1967, p. 30; Koford 1969, p. 95; Servheen 1990, p. 1; Servheen 1999, pp. 50-52; Mattson and Merrill 2002, pp. 1129, 1132; Schwartz et al. 2003, p. 571). This eventually led to their listing as a threatened species under the Act in 1975 (40 FR 31734, July 28, 1975).</P>
                    <P>Human-caused mortalities continue to be the leading cause of grizzly bear mortalities rangewide; therefore, understanding and managing for sustainable mortality levels is necessary to facilitate and maintain recovery. We differentiate between types of human-caused mortalities, as follows: (1) accidental killings; (2) management removals; (3) mistaken-identity killings; (4) defense-of-life killings; and (5) illegal killings or poaching. In addition, we use methods described by Cherry et al. (2002, entire) to calculate a statistical estimate of the number of unknown/unreported human-caused mortalities (see “Mortality Limits,” below, for further details). Grizzly bear mortalities may be detected because: the individual is radio-collared, the mortality resulted from a management removal, or it was reported by the public. For all causes of mortality, except management removals, there are unknown/unreported mortalities. Illegal mortalities, such as poaching, have the lowest rate of reporting (Costello et al. 2016, p. 30). Using the methods described by Cherry et al. (2002, entire) improves our understanding of mortality levels, but that study (Cherry et al. 2002, entire) was based on a small sample size and does not provide perfect knowledge, particularly of mortalities in connectivity areas where we do not have radio-collared bears for research. Table 1 provides a summary of the numbers of human-caused mortality, and a discussion for each ecosystem follows.</P>
                    <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s100,12,12,12,12,12,12">
                        <TTITLE>Table 1—Number of Grizzly Bear Mortalities by Causes in the GYE, NCDE, CYE, and the U.S. Portion of the SE, 2002-2023. Mortalities in the GYE and NCDE are Reported Inside and Outside the Demographic Monitoring Area (DMA) and Include All Known and Probable Mortalities for Independent-Age Bears; Mortalities of Dependent Young are Displayed in Parentheses. Mortalities in the CYE and SE Include Independent-Age and Dependent Young and are Reported Within the Recovery Zone (RZ) Plus a 10-Mile Buffer, Excluding Canada</TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                Cause of mortalities
                                <LI>(all sources)</LI>
                            </CHED>
                            <CHED H="1">
                                GYE:
                                <LI>Inside DMA</LI>
                            </CHED>
                            <CHED H="1">
                                GYE:
                                <LI>Outside DMA</LI>
                            </CHED>
                            <CHED H="1">
                                NCDE:
                                <LI>Inside DMA</LI>
                            </CHED>
                            <CHED H="1">
                                NCDE:
                                <LI>Outside DMA</LI>
                            </CHED>
                            <CHED H="1">
                                CYE:
                                <LI>Inside RZ</LI>
                            </CHED>
                            <CHED H="1">
                                SE:
                                <LI>Inside RZ</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Natural</ENT>
                            <ENT>42 (100)</ENT>
                            <ENT>1 (5)</ENT>
                            <ENT>11 (14)</ENT>
                            <ENT>0 (3)</ENT>
                            <ENT>9</ENT>
                            <ENT>4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                Undetermined 
                                <SU>a</SU>
                            </ENT>
                            <ENT>54 (12)</ENT>
                            <ENT>2 (1)</ENT>
                            <ENT>30 (5)</ENT>
                            <ENT>3 (1)</ENT>
                            <ENT>4</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Human-caused</ENT>
                            <ENT>433 (119)</ENT>
                            <ENT>163 (29)</ENT>
                            <ENT>357 (162)</ENT>
                            <ENT>48 (27)</ENT>
                            <ENT>34</ENT>
                            <ENT>18</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Total mortalities</ENT>
                            <ENT>529 (231)</ENT>
                            <ENT>166 (35)</ENT>
                            <ENT>398 (181)</ENT>
                            <ENT>51 (31)</ENT>
                            <ENT>47</ENT>
                            <ENT>22</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">
                                Human-caused mortalities: 
                                <SU>b</SU>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Accidental</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>3</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Automobile collision</ENT>
                            <ENT>42 (15)</ENT>
                            <ENT>5 (0)</ENT>
                            <ENT>45 (45)</ENT>
                            <ENT>8 (4)</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">Capture related</ENT>
                            <ENT>8 (5)</ENT>
                            <ENT>0 (2)</ENT>
                            <ENT>9 (5)</ENT>
                            <ENT>1 (0)</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">Drowning</ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>6 (2)</ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>1 (0)</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">Poisoning</ENT>
                            <ENT>1 (0)</ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>2 (0)</ENT>
                            <ENT>0 (2)</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">Train collision</ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>22 (18)</ENT>
                            <ENT>2 (2)</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">Defense-of-life</ENT>
                            <ENT>134 (60)</ENT>
                            <ENT>15 (4)</ENT>
                            <ENT>49 (20)</ENT>
                            <ENT>5 (6)</ENT>
                            <ENT>6</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                Illegal 
                                <SU>c</SU>
                            </ENT>
                            <ENT>27 (6)</ENT>
                            <ENT>4 (1)</ENT>
                            <ENT>67 (15)</ENT>
                            <ENT>12 (5)</ENT>
                            <ENT>7</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Management removal</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>2</ENT>
                            <ENT>4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">
                                Site conflicts/human safety 
                                <SU>d</SU>
                            </ENT>
                            <ENT>101 (27)</ENT>
                            <ENT>56 (12)</ENT>
                            <ENT>56 (33)</ENT>
                            <ENT>4 (4)</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">Injured or diseased bear</ENT>
                            <ENT>2 (5)</ENT>
                            <ENT>0 (3)</ENT>
                            <ENT>9 (7)</ENT>
                            <ENT>1 (1)</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">Livestock depredation</ENT>
                            <ENT>91 (1)</ENT>
                            <ENT>70 (5)</ENT>
                            <ENT>62 (15)</ENT>
                            <ENT>13 (2)</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="03">
                                Augmentation 
                                <SU>e</SU>
                            </ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>15 (0)</ENT>
                            <ENT>0 (0)</ENT>
                            <ENT/>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">Mistaken identification</ENT>
                            <ENT>27 (0)</ENT>
                            <ENT>7 (0)</ENT>
                            <ENT>16 (2)</ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>4</ENT>
                            <ENT>5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                Unknown 
                                <SU>f</SU>
                            </ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>0 (0)</ENT>
                            <ENT>5 (2)</ENT>
                            <ENT>1 (1)</ENT>
                            <ENT>12</ENT>
                            <ENT>3</ENT>
                        </ROW>
                        <TNOTE>
                            <SU>a</SU>
                             Under investigation and believed to be human-caused.
                        </TNOTE>
                        <TNOTE>
                            <SU>b</SU>
                             Orphaned dependent offspring were classified according to cause of death of their mother.
                        </TNOTE>
                        <TNOTE>
                            <SU>c</SU>
                             Illegal includes poaching, malicious, and defense-of-property kills.
                        </TNOTE>
                        <TNOTE>
                            <SU>d</SU>
                             Site conflicts/human safety include anthropogenic food and property damage-related management removals in the front- and backcountry.
                        </TNOTE>
                        <TNOTE>
                            <SU>e</SU>
                             When bears are relocated from the NCDE to augment the CYE population, they are counted as mortalities in the NCDE.
                        </TNOTE>
                        <TNOTE>
                            <SU>f</SU>
                             Cause unknown and may include mortalities that are under investigation.
                        </TNOTE>
                    </GPOTABLE>
                    <P>
                        <E T="03">Human-caused Mortality in the GYE</E>
                        —From 2002 to 2023, 82 percent (433) of the 529 known and probable grizzly bear mortalities of independent-age bears and 52 percent (119) of the 231 known and probable mortalities for dependent young within the GYE demographic monitoring area (DMA) were human-caused (Gould 2024, in litt.; table 1). For further details see 
                        <E T="03">Human-Caused Mortality in the GYE</E>
                         in the SSA report (Service 2024, pp. 154-155). Although the number of human-caused mortalities of independent female and male grizzly bears have increased gradually over this time period as the grizzly bear population increased, human-caused mortality as a proportion of estimated population size (
                        <E T="03">i.e.,</E>
                         the rate of mortality) has remained relatively constant (Gould 2024, in litt.). Under current management, including protections of the Act, human-caused mortality rates have been low enough to allow the GYE grizzly bear population to increase in number and range (Schwartz et al. 2006b, pp. 64-66; Schwartz et al. 2006c, p. 48; Bjornlie et al. 2014, p. 184). In addition, 98 percent (163) of the 166 known and probable 
                        <PRTPAGE P="4251"/>
                        grizzly bear mortalities of independent-age bears and 83 percent (29) of the 35 known and probable mortalities of dependent young that occurred outside the DMA were human-caused (Gould 2024, in litt.). Approximately 36 percent of estimated occupied range occurs beyond the DMA (Dellinger et al. 2023, p. 23). We do not have an estimate for the number of grizzly bears ecosystem-wide, and mortality limits absent protections of the Act do not apply outside of the DMA (see 
                        <E T="03">Mortality Limits in the GYE,</E>
                         below).
                    </P>
                    <P>
                        <E T="03">Human-caused Mortality in the NCDE</E>
                        —From 2002 to 2023, 90 percent (357) of the 3987 known and probable grizzly bear mortalities of independent-age bears and 90 percent (162) of the 181 of known and probable grizzly bear mortalities of dependent young within the NCDE DMA were human-caused (MFWP, unpublished data; table 1). In addition to the categories of human-caused mortalities discussed above, legal hunting of grizzly bears (
                        <E T="03">i.e.,</E>
                         for recreational purposes) was allowed in the NCDE from 1975 until 1991, under a rule authorizing take in the 1975 listing (40 FR 31734, July 28, 1975). For further details, see 
                        <E T="03">Human-Caused Mortality in the NCDE</E>
                         in the SSA report (Service 2024, pp. 155-156).
                    </P>
                    <P>
                        While human-caused mortalities of grizzly bears have increased gradually each year as the grizzly bear population has increased, the level of these mortalities as a proportion of the estimated population size (
                        <E T="03">i.e.,</E>
                         mortality rate) has remained relatively constant (MFWP, unpublished data). Under current management, including protections of the Act, human-caused mortality rates have been low enough to allow the NCDE grizzly bear population to increase in number and range (Costello 2019, in litt.; MFWP, unpublished data). In addition, 94 percent (48) of the 51 known and probable grizzly bear mortalities of independent-age bears and 87 percent (27) of the 31 known and probable mortalities of dependent young that occurred outside the DMA were human-caused (MFWP, unpublished data). Approximately 29 percent of estimated occupied range occurs beyond the DMA (MFWP, unpublished data). Although the population estimate includes the entire NCDE population, mortality limits absent protections of the Act do not apply outside of the DMA (see 
                        <E T="03">Mortality Limits in the NCDE,</E>
                         below).
                    </P>
                    <P>
                        <E T="03">Human-caused Mortality in the CYE, SE, BE, and North Cascades</E>
                        —From 2002 to 2023, 72 percent (34) of the 47 known and probable grizzly bear mortalities in the CYE were human-caused (Kasworm et al. 2024a, pp. 18-19; table 1). We recognize that some grizzly bears in the CYE and SE have home ranges that overlap the international border; however, it is most appropriate to discuss human-caused mortality for the U.S. portion of the SE because that is the area encompassed by the currently-listed entity and the proposed grizzly bear DPS. From 2002 to 2023, 82 percent (18) of the 22 known and probable grizzly bear mortalities in the U.S. portion of the SE recovery zone were human-caused (Kasworm et al. 2024b, pp. 14-15). There have been no known, human-caused mortalities in the North Cascades since 1967; however, the last verified sighting of a grizzly bear in the North Cascades occurred in 1996. In the BE recovery zone, the last known, human-caused mortality occurred in 1932, and there has only been one verified sighting in the recovery zone since the 1940s, a collared bear from the CYE that spent several weeks in the northern part of the recovery zone in 2019. There have been three known human-caused mortalities inside the grizzly bear DPS outside these recovery zones. For further details, see 
                        <E T="03">Human-Caused Mortality in the CYE, SE, BE, and North Cascades</E>
                         in the SSA report (Service 2024, pp. 156-157).
                    </P>
                    <HD SOURCE="HD3">Mortality Limits</HD>
                    <P>Within the GYE and NCDE, States, Tribes, and Federal agencies have adopted management protocols, rules, and regulations that would govern conservation and management of these grizzly bear populations, including human-caused mortality, in the absence of the Act's protections. Mortality limits in the GYE and NCDE apply only within the DMA (see figure 9 in the SSA report; Service 2024, p. 36). Within the CYE, SE, BE, and North Cascades, management protocols, rules, and regulations governing conservation and management of these populations are not yet complete. Our SSA report evaluates the ability of existing regulatory mechanisms to limit human-caused mortality consistent with a recovered population under future scenarios (Service 2024, pp. 245-249).</P>
                    <P>Independent of the Act, the States of Idaho, Montana, Washington, and Wyoming have regulations that make it illegal to kill a grizzly bear other than for defense-of-life, except for limited circumstances, as described below (Idaho Administrative Code (IAC) rules 13.01.06.100.05 and 13.01.06.300.01; Administrative Rules of Montana (ARM) subchapter 12.9.14; Washington Administrative Code (WAC) at section 220-610-010; Wyoming Administrative Rules (WAR) 040-0001-67). The States of Idaho, Montana, and Wyoming have additional regulations that would take effect upon delisting that are currently superseded by take prohibitions in the Act. In Idaho, upon delisting, it would be legal to kill a grizzly bear, without a permit, if it is “molesting or attacking livestock or domestic animals” (Idaho Statutes (I.S.) at title 36, chapter 11, section 36-1107(e)). All grizzly bears taken must be reported within 72 hours. In Montana, upon delisting, a livestock owner or other authorized persons would be able to take a grizzly bear at any time without a permit when a grizzly bear is attacking or killing livestock, subject to commission rules (Montana Code Annotated (MCA) at section 87-5-301). Additionally, for delisted ecosystems, Montana Department of Fish, Wildlife and Parks would be able to issue a kill permit to livestock owners when a grizzly bear is threatening livestock, subject to commission rules (MCA 87-5-301(4)). Montana's commission rules were incorporated into law in December 2023; the commission must annually set mortality limits for kill permits (MCA 87-5-301(3)(c)). However, these mortality limits would only apply within the DMA. In Wyoming, upon delisting, the Wyoming Game and Fish Commission may establish a hunting season for grizzly bears in accordance with the Tri-State memorandum of agreement (MOA) (WAR 040.0001.67).</P>
                    <P>
                        <E T="03">Mortality Limits in the GYE</E>
                        —Prior to our June 30, 2017, final rule to establish the GYE population as a DPS and delist it (82 FR 30502), in partnership with the States, other Federal agencies, and Tribes in the GYE, we developed a mortality-management framework that outlined sustainable mortality limits within the GYE DMA that would maintain recovery within the GYE DPS in the absence of the Act's protections. The goal of the framework was to manage the population in the GYE DMA to maintain the population around the long-term average population size for 2002-2014 of 674 bears (95 percent confidence interval (CI) = 600-747) (using the model-averaged Chao2 population estimate) (Service 2017, entire). Population growth inside the GYE DMA had slowed and stabilized at this population size, and the long-term estimate of 674 bears represented a population that was exhibiting density-dependent effects in the core area of its range (van Manen et al. 2016, entire). To achieve the population goal, mortality thresholds within the DMA were set for independent females, independent males, and dependent young. However, mortality limits did not apply to grizzly 
                        <PRTPAGE P="4252"/>
                        bears outside of the DMA, including in potential connectivity areas.
                    </P>
                    <P>
                        As discussed above in Previous Federal Actions, our final rule to establish and delist the GYE population as a DPS (82 FR 30502, June 30, 2017) was vacated and remanded by the U.S. District Court for the District of Montana (
                        <E T="03">Crow Indian Tribe et al.</E>
                         v. 
                        <E T="03">United States et al.,</E>
                         343 F. Supp. 3d 999 (D. Mont. 2018)). The Ninth Circuit affirmed the District Court decision vacating and remanding the final rule delisting the grizzly bears in the GYE (
                        <E T="03">Crow Indian Tribe et al.</E>
                         v. 
                        <E T="03">United States et al.,</E>
                         965 F.3d 662 (9th Cir. 2020)). As a result, the GYE population is currently listed as threatened as part of the larger listed entity of the grizzly bear in the lower-48 States.
                    </P>
                    <P>
                        One of the three main issues cited by the District Court in vacating the June 30, 2017, rule was that a commitment to recalibration was necessary and that removal of a commitment to recalibration was not consistent with the best available science as required by the Act (16 U.S.C. 1533(b)(1)(A)). “Recalibration refers to calibrating a new model's estimates for a given year (
                        <E T="03">e.g.,</E>
                         1,000 bears in 2020) to the Chao2 population estimates generated for the 2002-2014 time period (average of 674 bears) . . . if a new model estimates 1,000 bears where Chao2 found 700, the [S]tates will be able to treat the jump in population as they would treat it on paper—as if 300 new individuals had moved into the Greater Yellowstone Ecosystem” (
                        <E T="03">Crow Indian Tribe et al.</E>
                         v. 
                        <E T="03">United States et al.,</E>
                         343 F. Supp. 3d 999 (D. Mont. 2018)). The GYE conservation strategy, one of two separate delisting recommendations outlined in the recovery plan, is an interagency agreement to ensure that adequate regulatory mechanisms will continue to be present after delisting. The Ninth Circuit found that the Service, “violated the ESA's directive to make listing decisions `solely on the basis of the best scientific and commercial data', 16 U.S.C. 1533(b)(1)(A), when it failed to include a commitment to recalibration despite the FWS's acknowledgment that a failure to provide such provision could threaten the Yellowstone grizzlies” (
                        <E T="03">Crow Indian Tribe et al.</E>
                         v. 
                        <E T="03">United States et al.,</E>
                         965 F.3d 662 (9th Cir. 2020)).
                    </P>
                    <P>Beginning with 2022 grizzly bear demographic data, the IGBST began implementing an integrated population model (IPM) to estimate vital rates, population size, and mortality within the GYE population (Gould et al. 2024a, entire). The States have developed a new mortality-management framework using the IPM, which more accurately estimates population size and inherently recalibrates population estimates. In January 2024, the States of Idaho and Wyoming amended the Tri-State MOA to incorporate new commitments to maintain a biologically recovered population, including population objectives, total mortality thresholds, a threshold at which discretionary mortality (the amount of human-caused mortality over which state and Tribal agencies have discretionary authority, such as management removals and regulated harvest) ceases, and reproductive female distribution. The Montana Fish and Wildlife Commission adopted the Tri-State MOA in June 2024. The Yellowstone Ecosystem Subcommittee (YES) and the Interagency Grizzly Bear Committee (IGBC) approved incorporation of the new commitments into the conservation strategy in May 2024 and June 2024, respectively.</P>
                    <P>Previously, the 2016 conservation strategy and Tri-State MOA incorporated mortality thresholds to maintain the population within the DMA around the 2002-2014 model-averaged Chao2 population estimate of 674 bears. The 2002-2014 time period was selected because population growth slowed starting around 2000 associated with density-dependent effects, particularly in the core of the ecosystem (Schwartz et al. 2008, entire; van Manen et al. 2016, entire).</P>
                    <P>Using the IPM, the recalibrated numbers correspond to an IPM population estimate for 2002-2014 of 821. We note that a change point analysis of annual population growth using IPM detected a slowing in annual population growth around 2006 (vs. 2002), with minor population fluctuations around a mean of 1.4 percent since that time. Corresponding population estimates were 805 in 2006, and 1,030 in 2023 (Gould et al. 2024c, in prep.). The amended Tri-State MOA agrees to manage the GYE grizzly bear population in the DMA within or above a range of 800 to 950 grizzly bears (applying the IPM population estimate). At fewer than 800 bears, the Tri-State MOA commits to managing for a population increase above 800, closing hunting, and requesting a biology and monitoring review to determine appropriate management changes, but no interim management triggers exist.</P>
                    <P>Independent of the Act, all three affected States and the Eastern Shoshone and Northern Arapaho Tribes of the Wind River Reservation (WRR) have enacted regulatory mechanisms that require State or Tribal authorization for grizzly bear take, with illegal poaching remaining prosecutable under State and Tribal laws because grizzly bears are designated as a game animal (Wyoming Statutes (W.S.) at sections 23-1-101(a)(xii)(A) and 23-3-102(a); MCA at sections 87-2-101(4), 87-1-301, 87-1-304, and 87-5-302; I.S. at title 36, chapters 2 (section 36-202(h)) and 11 (section 36-1101(a)), and IAC at rule 13.01.06.100.05; Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, pp. 18-21; Eastern Shoshone and Northern Arapahoe Tribes 2009, p. 9; Wyoming Game and Fish Department (WGFD) 2016, p. 9; YES 2024, chapter 7; MFWP 2024, p. 13). As discussed above, the States of Montana and Idaho have additional circumstances under which it is legal to take grizzly bears.</P>
                    <P>
                        <E T="03">Mortality Limits in the NCDE</E>
                        —In 2018, we developed a mortality-management framework in partnership with the States, other Federal agencies, and Tribes in the NCDE, to ensure sustainable mortality limits within the DMA to maintain recovery within the NCDE. The agencies agreed to manage mortalities from all sources to support a greater than or equal to 90 percent estimated probability that the grizzly bear population within the DMA remains above 800 individuals, considering the uncertainty associated with the demographic parameters (NCDE Subcommittee 2020, chapter 2; ARM at subchapter 12.9.14 at 12.9.1403). In order to consider this uncertainty, the model that estimates the probability that the population is above 800 individuals incorporates the standard error associated with calculating survival rates for all age/sex classes (
                        <E T="03">e.g.,</E>
                         cubs, yearlings, independent males, and independent females) and reproductive parameters (
                        <E T="03">e.g.,</E>
                         proportion of females with cubs and litter size). The methods to determine thresholds for independent female survival, independent female mortality, and independent male mortality that allow achievement of this objective into the future are set forth in the NCDE conservation strategy (NCDE Subcommittee 2020, chapter 2, appendix 3).
                    </P>
                    <P>
                        The NCDE conservation strategy commits to developing and evaluating additional inputs to the model. Agencies are working to explicitly estimate the proportion of the population that has expanded outside of the DMA in order to exclude those individuals from the population estimate when calculating the mortality thresholds consistent with the probability that the population is above 800 individuals within the DMA (NCDE Subcommittee 2020, p. 238). If the population in the DMA is overestimated 
                        <PRTPAGE P="4253"/>
                        because it includes bears that have dispersed outside of the DMA, then the mortality limits are also overestimated. While mortality rates within the DMA were close to thresholds in several years (in 2021 for independent females, and in 2018, 2019, and 2021 for independent males), TRU mortalities as measured on a 6-year average have been below mortality limits since the implementation of this monitoring method in 2018 and are thus likely still sustainable.
                    </P>
                    <P>
                        The NCDE conservation strategy requires several population parameters to calculate allowable mortality limits that meet the population objective of supporting a greater than or equal to 90 percent estimated probability that the grizzly bear population within the DMA remains above 800 individuals: (1) the 6-year running average for the annual survival rate of independent females; (2) annual mortalities for independent males and females in the DMA (
                        <E T="03">i.e.,</E>
                         TRU mortality); and (3) population estimates. These estimates are calculated and reported annually by the Monitoring Team to the NCDE Subcommittee.
                    </P>
                    <P>Adherence to these survival and mortality thresholds for the DMA is evaluated by the Monitoring Team through continued demographic monitoring, application of stochastic population modeling to track size and trend, and management of mortality of independent female and independent male grizzly bears. The population modeling methods are set forth in detail in appendices 2 and 3 of the NCDE conservation strategy (NCDE Subcommittee 2020) and currently represent the best available science.</P>
                    <P>The State of Montana and the Blackfeet and Confederated Salish and Kootenai Tribes designated grizzly bears as a game animal and have enacted regulatory mechanisms independent of the Act that authorize grizzly bear take under certain situations, with illegal poaching remaining prosecutable under State and Tribal laws (MCA at sections 87-2-101(4), 87-1-301, 87-1-304, and 87-5-302; Flathead Indian Reservation (FIR) Tribal Ordinance 44D; Blackfeet Tribal Business Council 2018, p. 29; NCDE Subcommittee 2020, chapter 6). As discussed above, the State of Montana has additional circumstances under which it is legal to take grizzly bears.</P>
                    <P>
                        <E T="03">Mortality Limits in the CYE and SE</E>
                        —For the CYE and SE, the mortality limits as set forth in demographic recovery criterion 3 of the recovery plan continue to apply while the species is listed under the Act (Service 1993, pp. 33-34). These mortality limits apply within the recovery zone and a 10-mile buffer around the recovery zone. In 2022, the Selkirk-Cabinet-Yaak Subcommittee convened a technical team to draft a conservation strategy, listing commitments, and policies to ensure that adequate regulatory mechanisms will continue to be present after delisting. The conservation strategy would include the development of a mortality-management framework in partnership with the States, other Federal agencies, and Tribes in the CYE and SE, and is not yet complete. Therefore, a management framework is not currently in place to ensure mortality is within sustainable thresholds independent of the Act.
                    </P>
                    <P>
                        <E T="03">Mortality Limits in the BE</E>
                        —For the BE, which is not currently occupied, the mortality limits as set forth in demographic recovery criterion 3 of the recovery plan supplement continue to apply while the species is listed under the Act (Service 1996, p. 4). The mortality limits apply within the recovery zone and a 10-mile buffer around the recovery zone. A management framework has not been developed to ensure mortality limits for any potential future population would be within sustainable thresholds independent of the Act.
                    </P>
                    <P>
                        <E T="03">Mortality Limits in the North Cascades</E>
                        —Within the North Cascades, the reintroduced population will be managed as a nonessential experimental population under the section 10(j) rule at 50 CFR 17.84(y) while the species is listed under the Act. The Service has not set specific mortality limits for the North Cascades, though in the near term as that population develops, the intent is to avoid any human-caused mortalities, to the extent practicable (see 89 FR 36982 at 37012, May 4, 2024). Sustainable levels of human-caused mortality were not established in the recovery plan supplement for the North Cascades due to a lack of information for the ecosystem; however, the supplement established a goal of zero known, human-caused mortalities until the “population is large enough to offset some level of human-induced mortality” (Service 1997, pp. 3-4). A management framework has not been developed to ensure mortality is within sustainable thresholds independent of the Act.
                    </P>
                    <HD SOURCE="HD3">Summary of Mortality Limits Within the Grizzly Bear DPS</HD>
                    <P>Human-caused mortality can be a significant threat to grizzly bear populations if not effectively managed. Management frameworks to ensure mortality is within sustainable thresholds independent of the Act are currently only complete and incorporated into regulatory documents for two of the six ecosystems. In addition, there are no regulatory mechanisms to facilitate natural connectivity between grizzly bear populations, which could reduce the potential to improve long-term genetic health of small or isolated populations and natural recolonization of the unoccupied ecosystems. Therefore, without adequate conservation measures, human-caused mortality would continue to be a threat to the grizzly bear DPS.</P>
                    <HD SOURCE="HD3">Management Removals</HD>
                    <P>
                        Management removals encompass grizzly bear mortalities resulting from conflicts at developed sites (
                        <E T="03">e.g.,</E>
                         bears attracted to anthropogenic food sources), livestock depredation, and other situations where wildlife management agencies consider human life or property threatened by bear presence. Most management removals result from attractant-related conflicts at sites associated with frequent or permanent human presence (
                        <E T="03">i.e.,</E>
                         developed sites) and livestock depredations. These conflicts usually involve unsecured attractants, such as garbage, human foods, chickens, pet/livestock foods, bird food, livestock carcasses, wildlife carcasses, barbeque grills, compost piles, orchard fruits, or vegetable gardens. While these mortalities are directly related to unsecured, human attractants, they are also related to human attitudes, knowledge, and tolerance toward grizzly bears. Many of these mortalities can be prevented through changes in human perceptions and actions, including limiting bear access to human-related food sources and increasing human understanding and tolerance towards grizzly bears (see 
                        <E T="03">Preventative Measures</E>
                         in the SSA report for further discussion; Service 2024, pp. 167-171). These strategies are outlined in the GYE conservation strategy; the NCDE conservation strategy; and Federal, State, and Tribal information and education (I&amp;E) programs (U.S. Department of Agriculture's U.S. Forest Service (USDA FS or USFS) 2006b, pp. 16-17; USDA FS 2018b, pp. 80-81; USDA FS 2018c, pp. 1-10, 1-22, 1-34, 1-45; NCDE Subcommittee 2020, chapter 4; YES 2024, chapter 3; Service 2024, pp. 161-171).
                    </P>
                    <P>
                        Under the Act, management removals of grizzly bears—outside of any areas where bears have been reintroduced as a nonessential experimental population—must be consistent with 50 CFR 17.40(b) (the grizzly bear's “4(d) rule”). The 4(d) rule sets forth the 
                        <PRTPAGE P="4254"/>
                        conditions for legally taking (
                        <E T="03">e.g.,</E>
                         removing or relocating) grizzly bears without the need for additional permits under the Act. Anyone may take a grizzly bear constituting an immediate threat to human safety. Grizzly bears taken in self-defense must be reported to the Service's Office of Law Enforcement. The 4(d) rule allows additional take for bears constituting a demonstrable but non-immediate threat to human safety and for bears committing significant depredations to lawfully present livestock, crops, or beehives (50 CFR 17.40(b)(1)(i)(B) and (C)).
                    </P>
                    <P>
                        In the GYE DMA, between 2002 and 2023, management removals resulted in 194 mortalities of independent-age bears and 33 mortalities of dependent young, accounting for 45 percent and 28 percent, respectively, of human-caused mortalities (Gould 2024, in litt.). In the GYE outside of the DMA, management removals resulted in an additional 126 mortalities of independent-age bears and 20 mortalities of dependent young (Gould 2024, in litt.). In the NCDE, between 2002 and 2023, management removals resulted in 127 mortalities of independent-age bears and 55 mortalities of dependent young within the DMA, accounting for 36 percent and 34 percent of all human-caused mortalities, respectively (MFWP, unpublished data). In addition, 15 bears in the NCDE were trapped and moved to the CYE for population augmentation. Because these bears were “lost” from the population, they count against the mortality threshold. In the NCDE outside of the DMA, management removals resulted in an additional 18 mortalities of independent-age bears and 7 mortalities of dependent young (MFWP, unpublished data). Management removals resulted in 2 mortalities in the CYE and 4 mortalities in the SE, accounting for 6 percent and 22 percent, respectively, of all human-caused mortalities (Kasworm et al. 2024a, pp. 18-19; Kasworm et al. 2024b, pp. 14-15). For more information about this threat, see 
                        <E T="03">Management Removals</E>
                         in the SSA report (Service 2024, pp. 158-161).
                    </P>
                    <P>Multiple measures are in place to reduce livestock conflicts in the GYE and NCDE recovery zones, including phasing out sheep allotments on U.S. Forest Service (USFS) lands, retirement of livestock allotments with recurring conflicts, and livestock grazing permits that include proper food and attractant storage provisions (USDA FS 2006b, pp. 16-17; USDA FS 2018b, pp. 80-81; USDA FS 2018c, pp. 1-10, 1-22, 1-34, 1-45; USDA FS 2018e, p. 64; YES 2024, chapter 3). The GYE and NCDE conservation strategies also recognize that removal of individual conflict bears is sometimes required, as a few individual bears often are responsible for multiple livestock depredations (Jonkel 1980, p. 12; Knight and Judd 1983, p. 188; Anderson et al. 2002, pp. 252-253; YES 2024, chapter 4; NCDE Subcommittee 2020, chapter 4).</P>
                    <P>Currently, there are four active cattle allotments in the CYE recovery zone on the Kootenai National Forest (NF), three active cattle allotments in the SE recovery zone (two on the Idaho Panhandle NF and one on the Colville NF), and no active sheep allotments. On the Colville NF, livestock grazing permits include food storage measures, livestock depredation and carcass removal, measures for grizzly bear conflict situations, and closed road access measures (USDA FS 2019, pp. 63, 82). The Kootenai and Idaho-Panhandle NFs have food storage requirements (USDA FS 2015a, pp. 31, 34; USDA FS 2015b, pp. 31, 33). There are only four active allotments in the BE recovery zone (two cattle and two horse on the Salmon-Challis NF). As of 2023, there are 24 cattle and 9 sheep allotments on the Okanogan-Wenatchee NF in the North Cascades recovery zone.</P>
                    <P>
                        Mortality limits (see discussion above under “Mortality Limits”) must ensure that overall mortality, including management removals, remains within sustainable limits. For the past several decades, States have managed grizzly bear conflicts in cooperation with the Service and consistent with the IGBC guidelines. After delisting, the Service would not be involved in removal decisions, and the IGBC guidelines would no longer apply; therefore, mortality limits that apply to management removals post-delisting are needed. As discussed above, management frameworks to ensure mortality is within sustainable thresholds independent of the Act are currently only complete and incorporated into regulatory documents for two of the six ecosystems. In addition, the CYE, SE, BE, and North Cascades populations have not yet met demographic recovery criteria. Therefore, in the absence of adequate conservation measures, management removals would continue to be a threat to the grizzly bear DPS. For more information about the conservation measures that have ameliorated this threat, see 
                        <E T="03">Management Removals</E>
                         in the SSA report (Service 2024, pp. 156-159).
                    </P>
                    <HD SOURCE="HD3">Accidental Killings</HD>
                    <P>Humans kill grizzly bears unintentionally in a number of ways, including vehicle collisions, train collisions, unintentional poisoning, drowning, electrocution, and mortalities associated with research trapping. From 2002 to 2023, there were 51 reported accidental mortalities of independent-age bears and 20 reported accidental mortalities of dependent young inside the GYE DMA, totaling 12 percent and 17 percent, respectively, of human-caused mortality for this time period (Gould 2024, in litt.). In the GYE outside of the DMA, there were an additional 11 reported accidental mortalities of independent-age bears and 4 reported accidental mortalities of dependent young (Gould 2024, in litt.). From 2002 to 2023, 78 reported accidental mortalities accounted for nearly 22 percent of known and probable human-caused mortalities of independent-age bears and 68 mortalities accounted for nearly 42 percent of known and probable human-caused mortalities of dependent young in the NCDE DMA (MFWP, unpublished data). In the NCDE outside of the DMA, there were an additional 12 reported accidental mortalities of independent-age bears and 8 reported accidental mortalities of dependent young (MFWP, unpublished data). From 2002 to 2023, 9 percent (3 of 34) of all human-caused mortalities in the CYE and 11 percent (2 of 18) of all human-caused grizzly bear mortalities in the SE were accidental (Kasworm et al. 2024a, pp. 18-19; Kasworm et al. 2024b, pp. 14-15).</P>
                    <P>
                        Accidental killings of grizzly bears in the GYE, CYE, and SE populations comprise a small portion of total mortalities and are factored into mortality limits (described in detail above under “Mortality Limits”), which limit their impact on the resiliency of the population. Accidental killings, primarily as the result of automobile and train collisions, have constituted a higher portion of mortalities in the NCDE. Therefore, in the absence of preventative measures, accidental killings would continue to be a threat to the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Accidental Killings</E>
                         in the SSA report (Service 2024, pp. 161-163).
                    </P>
                    <HD SOURCE="HD3">Mistaken-Identity Killings</HD>
                    <P>
                        Mistaken-identity mortalities include mistaken identification by black bear hunters and mortalities that result from wolf and black bear hunting and trapping. Mistaken-identity killings are both accidental and illegal. Twenty-seven mortalities (7 percent of human-caused mortality) of independent-age bears were associated with mistaken identification of grizzly bears by black bear hunters within the GYE DMA from 2002 to 2023 (Gould 2024, in litt.). An additional seven mortalities of 
                        <PRTPAGE P="4255"/>
                        independent-age bears were associated with mistaken identification of grizzly bears by black bear hunters in the GYE outside of the DMA (Gould 2024, in litt.). Mistaken identification of grizzly bears by black bear hunters accounted for 4 percent (16 of 356) of human-caused grizzly bear mortalities of independent-age bears and 1 percent (2 of 162) of human-caused grizzly bear mortalities of dependent young in the NCDE DMA from 2002 to 2023. There were no mortalities associated with mistaken identification of grizzly bears by black bear hunters in the NCDE outside of the DMA (MFWP, unpublished data). From 2002 to 2023, mistaken identification killings of grizzly bears by black bear or other hunters (on one occasion, an elk hunter mistakenly killed a grizzly bear) accounted for 12 percent (4 of 34) of human-caused mortalities in the CYE and 28 percent (5 of 18) of human-caused grizzly bear mortalities in the SE (Kasworm et al. 2024a, pp. 18-19; Kasworm et al. 2024b, pp. 14-15). In addition, there have been three mistaken identification killings of grizzly bears outside of the GYE DMAs and NCDE and the CYE, SE, and BE recovery zones, two of which occurred during a hunt in which the hunter used bait. Black bear hunting over bait is allowed in Idaho and Wyoming inside portions of the estimated occupied grizzly bear range of the GYE, CYE, and SE and outside of estimated occupied grizzly bear range in the GYE, CYE, SE, and BE, and has resulted in some mistaken-identity mortality.
                    </P>
                    <P>The GYE and NCDE Conservation Strategies identify I&amp;E programs targeted at hunters that emphasize patience, awareness, and correct identification of targets to help reduce grizzly bear mortalities by inexperienced black bear and ungulate hunters (YES 2024, chapter 5; NCDE Subcommittee 2020, chapters 1 and 4). Mistaken-identity killings of grizzly bears in the GYE and NCDE populations comprise a small portion of total mortalities and are factored into total mortality limits (described above in detail in “Mortality Limits”), and I&amp;E programs aimed at preventing mistaken-identity killings limit potential risks to the GYE and NCDE grizzly bear populations from this stressor. Reducing this source of human-caused mortality is especially desirable in the CYE and SE due to the small population size, in the BE and North Cascades where there are currently no known populations, and in potential connectivity areas between the ecosystems.</P>
                    <P>Wolf trapping and snaring and black bear hunting have the potential to incidentally take grizzly bears. We have documented one mortality as the result of wolf snaring in the GYE DMA. In addition, one of the grizzly bears mistakenly killed by a black bear hunter in the CYE had a neck snare around its neck that may have ultimately killed the bear had it not been shot. Recent legislation in Montana and Idaho expanding hunting and trapping tools available for wolves and black bears will likely increase incidental take of grizzly bears. Reporting of all target and non-target trapped wildlife is required, and grizzly bear mortalities from these sources would count towards allowable mortality thresholds. However, there may be some mortalities that go unreported due to unknown mortalities/injuries resulting from grizzly bears breaking away from the site with the snare and/or trap still attached.</P>
                    <P>
                        In Idaho and Montana, regulations allow the commission to issue emergency closures of any hunting season (I.S. at title 36, chapter 1, section 36-104(b); MFWP 2023a, p. 2; MFWP 2023b, p. 15). There are measures in place to limit potential incidental take, including prohibiting black bear hunting in most of the estimated occupied grizzly bear range in Montana and delaying Montana's wolf season in grizzly bear occupied range until most grizzly bears have entered the den based on radio-collar data and field reports. However, measures to limit incidental take inside grizzly bear occupied range in Idaho are minimal, and measures to limit incidental take outside of occupied grizzly bear range in Montana are also minimal. This is important because, over the last several years, we have verified numerous bears dispersing outside the occupied range and through potential connectivity areas between the GYE and NCDE populations. There are no grizzly bear mortality limits in areas outside of the DMAs for the GYE and NCDE populations or in the CYE and SE populations; therefore, the number of grizzly bears that might be killed incidental to wolf and black bear hunting and trapping in these areas would not be limited. Incidental take of grizzly bears in these areas could reduce the potential for natural connectivity between the populations in the GYE, NCDE, CYE, SE, and BE, which could harm the long-term genetic health of grizzly bears. Therefore, in the absence of preventative measures, mistaken-identity killings would continue to be a threat to the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Mistaken-Identity Killings</E>
                         in the SSA report (Service 2024, pp. 164-167).
                    </P>
                    <HD SOURCE="HD3">Illegal Killings</HD>
                    <P>We define poaching as intentional, illegal killing of grizzly bears or the deliberative concealment of an unintentional killing of grizzly bears. People may illegally kill grizzly bears for several reasons, including a general perception that grizzly bears in the area may be dangerous, frustration over livestock depredations, or to protest land-use and road-use restrictions associated with grizzly bear habitat management (Servheen et al. 2004, p. 21). We are aware of at least 27 illegal killings of independent-age bears and 6 illegal killings of dependent young in the GYE DMA between 2002 and 2023 (Gould 2024, in litt.). This constituted 6 percent of human-caused mortalities of independent-age bears and 5 percent of human-caused mortalities of dependent young from 2002 to 2023. We are aware of an additional four illegal killings of independent-age bears and one illegal killing of a dependent-age bear in the GYE outside of the DMA (Gould 2024, in litt.). From 2002 to 2023, at least 67 illegal killings of independent-age bears and 15 illegal killings of dependent bears occurred within the NCDE DMA, constituting nearly 19 percent and 9 percent of human-caused mortalities, respectively (MFWP, unpublished data). We are aware of an additional 12 illegal killings of independent-age bears and 5 illegal killing of dependent-age bears in the NCDE outside of the DMA (MFWP, unpublished data). From 2002 to 2023, at least 7 illegal killings occurred in the CYE, constituting 21 percent of human-caused grizzly bear mortalities (Kasworm et al. 2024a, pp. 18-19). Two illegal killing, including one neck snare, occurred in the SE from 2002 to 2023 (Kasworm et al. 2024b, pp. 14-15).</P>
                    <P>
                        I&amp;E campaigns (described in detail in 
                        <E T="03">Preventative Measures</E>
                         in the SSA report; Service 2024, pp. 167-178) are used to reduce the potential threat of poaching. These programs address illegal killing by working to change human perceptions and beliefs about grizzly bears and to increase tolerance for restrictions on Federal lands designed for grizzly bear protection (Servheen et al. 2004, p. 27). Poaching still occurs; however, these mortalities are factored into total mortality limits (described above in detail in “Mortality Limits”), which limits their impact on population resiliency. However, in the absence of preventive measures, illegal killings would continue to be a threat to the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Illegal Killings</E>
                         in the SSA report (Service 2024, pp. 167-168).
                        <PRTPAGE P="4256"/>
                    </P>
                    <HD SOURCE="HD3">Defense-of-Life Killings</HD>
                    <P>Grizzly bears may be legally taken in self-defense or in defense-of-others while listed (50 CFR 17.40(b)(1)(i)(B)). In the GYE DMA, from 2002 to 2023, 31 percent (134 of 433) of human-caused mortalities of independent-age bears and 50 percent (60 of 119) of human-caused mortalities of dependent young were self-defense or defense-of-other-person kills (Gould 2024, in litt.). An additional 15 defense-of-life killings of independent-age bears and 4 defense-of-life killings of a dependent-age bear occurred in the GYE outside of the DMA (Gould 2024, in litt.). In the NCDE DMA, nearly 17 percent (49 of 357) of human-caused grizzly bear mortalities of independent-age bears and 12 percent (20 of 162) of human-caused mortalities of dependent young were defense-of-life kills (MFWP, unpublished data). An additional five defense-of-life killings of independent-age bears and six defense-of-life killings of a dependent-age bear occurred in the NCDE outside of the DMA (MFWP, unpublished data). In the CYE, nearly 18 percent (6 of 34) of human-caused mortalities were from defense-of-life kills (Kasworm et al. 2024a, pp. 18-19). Two defense-of-life killings occurred in the U.S. portion of the SE from 2002 to 2023 (Kasworm et al. 2024b, pp. 14-15). Many of these self-defense situations occurred during surprise encounters, at hunter-killed carcasses or gut piles, or when packing out carcasses.</P>
                    <P>
                        By promoting the use of bear spray and continuing I&amp;E programs pertaining to food and carcass storage and retrieval, risks to hunters can be substantially reduced and many of these grizzly bear deaths can be avoided. Defense-of-life mortalities will always occur with a species that can pose a threat to humans; however, they are factored into mortality limits (see discussion above under “Mortality Limits”), and this source of mortality is not a limiting factor on the resiliency of grizzly bear populations in the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Defense-of-Life Killings</E>
                         in the SSA report (Service 2024, p. 168).
                    </P>
                    <HD SOURCE="HD3">Legal Hunting</HD>
                    <P>Aside from a limited hunt in the NCDE from 1975 to 1991, legal hunting of grizzly bears has not been allowed in the lower-48 States since grizzly bears in the lower-48 States were listed as a threatened species under the Act in 1975 (40 FR 31734, July 28, 1975). Legal hunting of grizzly bears was allowed in the NCDE from 1975 until 1991, under a rule authorizing take in the 1975 listing (40 FR 31734 at 31736, July 28, 1975). During this time, recreational hunting accounted for 50 percent of human-caused mortality in the NCDE (124 of 249). The rule allowing a limited hunt in the NCDE was removed in 1992 (57 FR 37478, August 19, 1992).</P>
                    <P>Independent of the Act, the States of Idaho, Montana, Washington, and Wyoming, and the Blackfeet and Confederated Salish and Kootenai Tribes have enacted regulatory mechanisms that require State or Tribal authorization for grizzly bear take, with illegal poaching remaining prosecutable under State and Tribal laws (I.S. at title 36, chapters 2 (section 36-202(h)) and 11 (section 36-1101(a)); IAC rules 13.01.06.100.05 and 13.01.06.300.01; MCA at sections 87-2-101(4), 87-1-301, 87-1-304, and 87-5-302; W.S. at sections 23-1-101(a)(xii)(A) and 23-3-102(a); FIR Tribal Ordinance 44D; Blackfeet Tribal Business Council 2018, p. 29; NCDE Subcommittee 2020, chapter 6; WAC at section 220-610-010).</P>
                    <P>Legal hunting is one source of discretionary mortality (described in detail above in “Mortality Limits”) that would be regulated by mortality limits in the absence of the Act's protections. Hunting would not occur in Montana for a minimum of 5 years after delisting (ARM subchapter 12.9.14 at 12.9.1413). However, management frameworks to ensure mortality is within sustainable thresholds independent of protections of the Act are currently only complete and incorporated into regulatory documents for two of the six ecosystems. In addition, mortality limits in the GYE and NCDE do not apply to grizzly bears outside of the DMAs, including in potential connectivity areas. Therefore, in the absence of such management frameworks, we anticipate that hunting would be a threat to the grizzly bear DPS.</P>
                    <HD SOURCE="HD3">II. Habitat Destruction and Modification</HD>
                    <P>The most crucial element in grizzly bear recovery is habitat that is diverse, provides a wide range of foods, and is isolated from development and human activities, where human-bear interactions, which often result in higher bear mortalities, are minimal (Service 1993, p. 21; Craighead and Mitchell 1982, p. 530). In the 1993 recovery plan, the Service found that motorized access posed the most imminent stressor to grizzly bear habitat and recommended that road management be given the highest priority for grizzly bear recovery (Service 1993, pp. 21-22). Motorized access management is an important management tool for grizzly bear populations, as it can increase habitat security, which is crucial for female reproduction, and reduce potential mortalities from human-bear encounters and vehicle strikes.</P>
                    <P>
                        For this reason, habitat-based recovery criteria for the GYE and NCDE recovery zones include threshold levels for secure habitat (areas with no motorized access), as well as livestock allotments and developed sites, which are also associated with grizzly bear mortalities due to the potential for conflict and resultant management removals (Service 2007a, pp. 2-6; Service 2018, entire; Service 2024, pp. 79-80). For more information on the development of habitat-based recovery criteria, see 
                        <E T="03">Recovery Criteria</E>
                         in the SSA report (Service 2024, pp. 79-81, 87-88).
                    </P>
                    <P>
                        For the GYE, secure habitat refers to those areas with no motorized access that are at least 10 acres (0.31 km
                        <SU>2</SU>
                         (0.016 mi
                        <SU>2</SU>
                        )) in size and more than 500 meters (m) (1,650 feet (ft)) from a motorized access route (road or trail), prescribed footprint of a developed site, or recurring helicopter flight line (USDA FS 2004, p. 18; YES 2024, chapter 3). We established 1998 as the baseline year, the level at which we measure habitat criteria, because the levels of secure habitat and developed sites on public lands remained relatively constant in the 10 years preceding 1998 (USDA FS 2004, pp. 140-141), and represented a time when the population was increasing at a rate of 4 to 7 percent per year (Schwartz et al. 2006c, p. 48). In addition, levels of motorized routes were decreasing during the years preceding the 1998 baseline year.
                    </P>
                    <P>
                        For the NCDE, we define secure core habitat as those areas on Federal lands within the analysis area more than 500 m (1,650 ft) from an open or gated motorized access route and at least 2,500 acres (10.1 km
                        <SU>2</SU>
                         (3.9 mi
                        <SU>2</SU>
                        )) in size (Service 2018, pp. 5, 12). We selected 2011 levels (
                        <E T="03">i.e.,</E>
                         the “baseline”) as our baseline year because secure core habitat was increasing and motorized route density was decreasing between 2004 and 2011 (NCDE Subcommittee 2020, chapter 1; Service 2018, pp. 24-25), and the NCDE grizzly bear population was increasing at a rate of 2 to 3 percent annually during this time (Mace et al. 2012, p. 124; Mace 2012, in litt.; Costello et al. 2016, p. 2; Service 2018, p. 3).
                    </P>
                    <P>
                        Although we have not yet developed habitat-based recovery criteria for the remaining ecosystems, some habitat thresholds or protections occur through other mechanisms. For example, the BE recovery zone is 98 percent wilderness. In the CYE and SE, the national forests have implemented motorized access standards to create and protect grizzly 
                        <PRTPAGE P="4257"/>
                        bear habitat (USDA FS 2011a, entire). The national forests and NPS within the North Cascades have agreed to a “no net loss” of core areas approach on NPS and USFS-managed lands (USDA FS 1997, entire) to maintain habitat quality necessary to support a self-sustaining grizzly bear population. The Service is currently coordinating with the NPS and USFS through the IGBC North Cascades Subcommittee Technical Team to review and update the baseline and memorialize the “no net loss” agreement for the North Cascades Recovery Zone (USDA FS 1997, entire).
                    </P>
                    <HD SOURCE="HD3">Protected Lands</HD>
                    <P>Protected lands in the form of wilderness areas, proposed wilderness, recommended wilderness, wilderness study areas (WSAs), and inventoried roadless areas (IRAs) can enhance the security of habitat for grizzly bears since these designations protect grizzly bear habitat from new road construction, new oil and gas development, new livestock allotments, and timber harvest (Service 2024, pp. 108-112). These lasting land designations ensure that large proportions of recovery zones and additional areas outside the recovery zones remain secure for grizzly bears into the future without the development of new roads, extractive industries, or other human structures.</P>
                    <P>
                        Ninety-eight percent of the GYE recovery zone is federally managed land, including all of YNP, as well as portions of GTNP and the Shoshone, Beaverhead-Deerlodge, Bridger-Teton, Caribou-Targhee, and Custer Gallatin NFs. Approximately 82 percent (19,642 km
                        <SU>2</SU>
                         of 23,853 km
                        <SU>2</SU>
                         (7,583 mi
                        <SU>2</SU>
                         of 9,210 mi
                        <SU>2</SU>
                        )) of lands inside of the GYE recovery zone are considered “protected lands.” In addition, of the 23,131 km
                        <SU>2</SU>
                         (8,931 mi
                        <SU>2</SU>
                        ) of suitable habitat in the GYE outside of the recovery zone, 59 percent (13,685 km
                        <SU>2</SU>
                         (5,284 mi
                        <SU>2</SU>
                        )) is managed and protected by the USFS as “protected lands.”
                    </P>
                    <P>
                        Seventy-eight percent of the NCDE recovery zone is federally managed land, including all of GNP, as well as portions of the Flathead, Helena-Lewis and Clark, Kootenai, and Lolo NFs, and the FIR, and the Blackfeet Indian Reservation. Nearly 67 percent (15,653 km
                        <SU>2</SU>
                         of 23,119 km
                        <SU>2</SU>
                         (6,044 mi
                        <SU>2</SU>
                         of 8,926 mi
                        <SU>2</SU>
                        )) of lands inside the NCDE recovery zone are considered “protected lands.” In addition, five percent (748 km
                        <SU>2</SU>
                         (289 mi
                        <SU>2</SU>
                        )) of Zone 1 (the portion of the DMA outside of the recovery zone) is protected as wilderness, WSAs, or IRAs.
                    </P>
                    <P>
                        Nearly 98 percent of the CYE recovery zone is federally managed land, including portions of the Kootenai, Idaho Panhandle, and Lolo NFs. Within the CYE recovery zone, 44 percent of lands are protected as designated wilderness (Cabinet Mountain wilderness: 379 km
                        <SU>2</SU>
                         (146 mi
                        <SU>2</SU>
                        )) or IRAs (2,568 km
                        <SU>2</SU>
                         (992 mi
                        <SU>2</SU>
                        )). Nearly 79 percent of the SE recovery zone in the United States is federally managed land, including portions of the Idaho Panhandle and Colville NFs. Within the U.S. portion of the SE recovery zone, nearly 38 percent of lands are protected as designated wilderness (167 km
                        <SU>2</SU>
                         (65 mi
                        <SU>2</SU>
                        )), recommended wilderness (60 km
                        <SU>2</SU>
                         (23 mi
                        <SU>2</SU>
                        )), or IRAs (907 km
                        <SU>2</SU>
                         (350 mi
                        <SU>2</SU>
                        )). The BE recovery zone includes about 14,984 km
                        <SU>2</SU>
                         (5,785 mi
                        <SU>2</SU>
                        ) of contiguous national forest lands in central Idaho and western Montana, 98 percent (14,840 km
                        <SU>2</SU>
                         (5,730 mi
                        <SU>2</SU>
                        )) of which is designated wilderness. The North Cascades recovery zone is 97 percent public lands, including all of the NCNP Complex, most of the Mount Baker-Snoqualmie and Wenatchee-Okanogan NFs, and the westernmost unit of the Colville NF. Sixty-four percent of the recovery zone is protected as designated wilderness (10,843 km
                        <SU>2</SU>
                         (4,189 mi
                        <SU>2</SU>
                        )) or as IRAs (5,123 km
                        <SU>2</SU>
                         (1,978 mi
                        <SU>2</SU>
                        )). For more information about this conservation measure, see 
                        <E T="03">Protected Lands</E>
                         in the SSA report (Service 2024, pp. 108-112).
                    </P>
                    <HD SOURCE="HD3">Motorized Access</HD>
                    <P>When grizzly bears in the lower-48 States were listed in 1975, we recognized that managing human access to grizzly bear habitat, primarily through management of motorized access, would be the key to effective habitat management. Motorized access, which brings humans and their vehicles into grizzly bear habitats, may influence grizzly bears indirectly by reducing the quality and quantity of habitat security or directly by disturbing, displacing, or killing individual bears through increased noise, activity, presence, vehicle strikes, or other activities associated with human-caused mortality (figure 2 in the SSA report; Service 2024, pp. 112-122). Managing motorized access to ensure bears have secure areas away from humans is an effective habitat management tool for reducing grizzly bear mortality risk (Nielsen et al. 2006, p. 225; Schwartz et al. 2010, p. 661; Proctor et al. 2019, pp. 19-20).</P>
                    <P>Within the GYE and NCDE recovery zones, habitat standards that help reduce the potential effects of motorized access have been incorporated into USFS plans and the GYE and NCDE conservation strategies (USDA FS 2006b, entire; USDA FS 2018a, p. 31; USDA FS 2018c, pp. 10-11; NCDE Subcommittee 2020, chapter 3 and appendix 4; YES 2024, chapter 3 and appendix E). These standards include thresholds for habitat security, open motorized route densities, and total motorized route densities and are inventoried and tracked in geographic information system (GIS) databases. Habitat security is measured within bear management subunits, which approximate the annual home range size of adult females. In the GYE, secure habitat averages 85.6 percent throughout the recovery zone and in the NCDE, secure core habitat averages 76.4 percent throughout the recovery zone. These conservation mechanisms have reduced the negative effects of motorized access in the GYE and NCDE populations, and these conservation mechanisms are expected to continue into the future.</P>
                    <P>In the GYE outside of the recovery zone, the USFS manages 76 percent of suitable habitat and much of these lands are “protected lands” or protected by motorized access standards (USDA FS 2006a, pp. 78, 109; Service 2024, pp. 108-112). In addition, State and Tribal management plans add another layer of habitat protection in the GYE outside of the recovery zone (Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002, p. 10; Eastern Shoshone and Northern Arapaho Tribes 2009, p. 11; WGFD 2016, pp. 18-20; MFWP 2022, p. 54). In areas of the NCDE outside of the recovery zone but inside Zone 1, limitations on open motorized routes apply to lands managed by the USFS, BLM, and Montana Division of Natural Resources Conservation (DNRC) to maintain habitat conditions that existed in 2011 that were compatible with a stable to increasing grizzly bear population. In addition, specific protections within the demographic connectivity areas were identified to support female occupancy and eventual demographic connectivity to the CYE and BE. The Service and partner land management agencies will continue to monitor the effectiveness of these objectives and can modify motorized access management as new information becomes available.</P>
                    <P>
                        The majority of lands within the CYE and SE recovery zones are managed by the USFS, which has incorporated motorized route density standards into its management plans to effectively provide secure habitat (core) for grizzly bears (USDA FS 2011a, entire). However, the USFS is still working on an implementation schedule for the remaining BMUs, four in the CYE and two in the U.S. portion of the SE, to achieve all standards. Although motorized access standards have not yet been determined for the BE recovery 
                        <PRTPAGE P="4258"/>
                        zone, the BE recovery zone is more than 98 percent wilderness (see 
                        <E T="03">Protected Areas</E>
                         in the SSA report for further details (Service 2024, pp. 108-112)), and, therefore, any impact of motorized access on grizzly bears in the BE recovery zone is likely very minimal. In the North Cascades recovery zone, the Federal land management agencies are currently working to update the baseline and to memorialize the “no net loss” of core areas agreement from 1997 (USDA FS 1997, entire).
                    </P>
                    <P>
                        Well-managed motorized access provides large proportions of habitat security on Federal lands that helps ameliorate the impacts of displacement and increased human-caused mortality risk in grizzly bear habitat. Motorized access that is well-managed on State, local, or private lands also provides conservation benefits to grizzly bears. A variety of conservation efforts or mechanisms, such as the Wilderness Act (16 U.S.C. 1131 
                        <E T="03">et seq.</E>
                        ), IRAs, and Federal land management plans, helps reduce the potential effects of motorized access on the resiliency of ecosystems. Conservation mechanisms to reduce the negative effects of motorized access independent of the Act are currently only in place for two of the six ecosystems. They have not been met or finalized for the remaining four ecosystems or in connectivity areas. The Service and partner land management agencies will continue to monitor the effectiveness of these objectives and can modify motorized access management as new information becomes available. However, in the absence of conservation mechanisms to ameliorate effects of motorized access, motorized access would continue to be a threat to the grizzly bear DPS. For more information about the conservation measures that have ameliorated this threat, see 
                        <E T="03">Motorized Access</E>
                         in the SSA report (Service 2024, pp. 112-122).
                    </P>
                    <HD SOURCE="HD3">Developed Sites</HD>
                    <P>
                        The primary concern related to developed sites is direct mortality from human-bear conflicts, such as those caused by unsecured attractants (
                        <E T="03">e.g.,</E>
                         garbage), and resulting management removals (Harding and Nagy 1980, p. 277; McLellan and Shackleton 1988, p. 451; Mattson and Knight 1991, p. 3; Mattson et al. 1992, p. 432; Mace et al. 1996, p. 1403; McLellan et al. 1999, p. 918; Woodroffe 2000, entire; Johnson et al. 2004, pp. 974-975; Service 2024, pp. 120-123). While human-grizzly bear conflicts at developed sites on public lands continue to occur, agencies have successfully worked to reduce conflicts and resulting mortalities. However, human-bear conflicts on private land have been increasing due to expanding grizzly bear distributions and are now more common than those on public lands (Cooley et al. 2018, entire). Secondary concerns include temporary or permanent habitat loss and displacement due to increased length of time of human use and increased human disturbance to surrounding areas (Harding and Nagy 1980, p. 277; McLellan and Shackleton 1988, p. 451; Mattson 1990, entire; White et al. 1999, pp. 3-5; Fortin et al. 2016, pp. 9-19).
                    </P>
                    <P>In the GYE and NCDE recovery zones, developed sites on public lands are currently inventoried and tracked in GIS databases. Existing regulatory mechanisms ensure that the national parks and national forests will continue to manage developed sites with limited increases in the absence of protections of the Act (USDA FS 2006b, entire; USDA FS 2018b, p. 60; USDA FS 2018c, pp. 1-7, 1-19, 1-31, 1-42; GNP 2024, p. 12; YES 2024, chapter 3; NCDE Subcommittee 2020, chapter 3). In the GYE and NCDE recovery zones, the NPS and the USFS enforce food storage rules aimed at decreasing grizzly bear access to human foods (NCDE Subcommittee 2020, chapter 3; YES 2024, chapters 1 and 3). These regulations, which reduce the potential for human-grizzly bear conflicts, will continue to be enforced and are in effect for nearly all currently occupied grizzly bear habitat on NPS and USFS lands within the GYE and NCDE (NCDE Subcommittee 2020, chapter 3; YES 2024, chapter 1 and 3). The number and capacity of developed sites are subject to limits and commitments in Forest Plans and summarized in the GYE and NCDE conservation strategy. There are currently no standards or tracking for developed sites inside the CYE, SE, BE or North Cascades. However, the BE, CYE, and North Cascades recovery zones are characterized by large acreage of wilderness areas and IRAs.</P>
                    <P>
                        Operation and maintenance of developed sites may result in mortality of grizzly bears if interactions result in activities associated with human-caused mortality. Conservation mechanisms to reduce the negative effects of developed sites independent of the Act are currently only in place for two of the six ecosystems. We have not yet developed habitat-based recovery criteria for the CYE, SE, BE, and North Cascades. During that process, we would assess current levels and potential effects of developed sites on grizzly bear populations in the CYE, SE, BE, and North Cascades. In addition, protected areas and other regulations help minimize this stressor in the GYE, NCDE, CYE, SE, BE, and North Cascades. Without conservation mechanisms to ameliorate the effects of developed sites, developed sites would continue to be a threat to the grizzly bear DPS. For more information about this stressor and the conservation measures that have ameliorated this threat, see 
                        <E T="03">Developed Sites</E>
                         in the SSA report (Service 2024, pp. 122-125).
                    </P>
                    <HD SOURCE="HD3">Livestock Allotments</HD>
                    <P>
                        Human-caused mortality resulting from management removals is the main impact to grizzly bears associated with livestock (Service 2024, pp. 125-129). The effects of displacement and direct competition with livestock for forage are considered negligible to grizzly bear populations because, even with direct grizzly bear mortality, current levels of livestock allotments have not precluded grizzly bear population growth and expansion. Inside the GYE and NCDE recovery zones, regulatory mechanisms limit the impact of livestock allotments to grizzly bears on Federal lands (USDA FS 2006b, entire; USDA FS 2018b, p. 80; USDA FS 2018c, p. 20). Due to the higher prevalence of grizzly bear conflicts associated with sheep grazing, sheep allotments have been phased out as the opportunity arises with willing permittees, and there is only one active sheep allotment remaining within the each of the GYE and NCDE recovery zones as of 2023 (USDA FS 2006b, p. 6; USDA FS 2018d, pp. 468-469; USDA FS 2018e, pp. 138, 256; NCDE Subcommittee 2020, chapter 3; YES 2024, chapter 3; Grizzly Bear Habitat Monitoring Team 2024, in prep.). Existing sheep allotments will continue to be phased out as the opportunity arises with willing permittees (USDA FS 2006b, p. 6; USDA FS 2018c, pp. 1-11, 1-23, 1-35, 1-46; NCDE Subcommittee 2020, chapter 3; YES 2024, chapter 3). Cattle allotments are numerous in the GYE and NCDE, and occur in lower numbers in the CYE, SE, BE, and North Cascades. Grizzly bear conflicts related to livestock have also been reduced in the GYE and NCDE recovery zones through requirements to securely store and/or promptly remove attractants associated with livestock operations (
                        <E T="03">e.g.,</E>
                         livestock carcasses, livestock feed, etc.). In the GYE and NCDE recovery zones, livestock allotments are currently inventoried and tracked in GIS databases (USDA FS 2006b, p. 5; NCDE Subcommittee 2020, chapter 3; YES 2024, chapter 3). Forest plans in the GYE and NCDE also include commitments to continue efforts to reduce grizzly bear conflicts related to livestock through requirements to securely store and/or promptly remove attractants associated with livestock 
                        <PRTPAGE P="4259"/>
                        operations (
                        <E T="03">e.g.,</E>
                         livestock carcasses, livestock feed, etc.).
                    </P>
                    <P>There are currently no standards for livestock allotments inside the CYE, SE, BE, and North Cascades. However, the BE, CYE, and North Cascades recovery zones are characterized by large acreages of wilderness areas and IRAs, where the lack of roads limits access and, therefore, limits the areas where livestock are released for grazing.</P>
                    <P>
                        Habitat-based recovery criteria, which include limits to livestock allotments, are currently only in place for two of the six ecosystems. Protected areas and other regulations help to reduce this stressor in the GYE, NCDE, CYE, SE, BE, and North Cascades; however, development of habitat-based recovery criteria would include an assessment of current levels and potential effects of livestock allotments for the outstanding ecosystems (CYE, SE, BE, and North Cascades). Therefore, in the absence of conservation measures across the range, livestock allotments would continue to be a threat to the grizzly bear DPS. For more information about this stressor and the conservation measures that have ameliorated this threat, see 
                        <E T="03">Livestock Allotments</E>
                         in the SSA report (Service 2024, pp. 125-129).
                    </P>
                    <HD SOURCE="HD3">Energy and Mineral Development</HD>
                    <P>The primary concerns related to mineral and energy development are human-caused mortalities and displacement due to habitat loss (Service 2024, pp. 129-133). Oil and gas development is associated with higher road densities, increased human access, and resultant human-bear encounters and human-caused grizzly bear mortalities (McLellan and Shackleton 1988, pp. 458-459; McLellan and Shackleton 1989b, pp. 377-379; Mace et al. 1996, pp. 1402-1403). Mineral and energy development could also cause displacement and habitat loss. Disturbance in the den could result in increased energetic costs and possibly den abandonment, which could ultimately lead to a decline in physical condition of the individual or even cub mortality (Swenson et al. 1997, p. 37; Graves and Reams 2001, p. 41). However, den disturbance or abandonment is rarely observed, and there have been no documented cases of such abandonment by grizzly bears in the grizzly bear DPS resulting from energy and mineral development. Inside the GYE and NCDE recovery zones, regulatory mechanisms in place for secure habitat and developed site standards limit the impact of energy and mineral development to grizzly bears (USDA FS 2006b, entire; YES 2024, chapter 3). Management of oil and gas development, and mining, are tracked as part of the developed site standard (NCDE Subcommittee, chapter 3; YES 2024, chapter 3). Because any new mineral or energy development must conform to the secure habitat, developed site, and motorized access standards set forth in the habitat-based recovery criteria and the GYE and NCDE conservation strategies, negative impacts of such development on grizzly bear populations in the GYE and NCDE will be limited.</P>
                    <P>
                        There are currently no standards or tracking for energy and mineral development inside the CYE, SE, BE or North Cascades. However, motorized access standards in the CYE and SE, the “no net loss” agreement in the North Cascades, and the large wilderness areas and IRAs in the BE, CYE, and North Cascades may help avoid or minimize energy and mineral development effects by de facto increasing habitat security for grizzly bears. The Wilderness Act and other regulations minimize this stressor in the North Cascades, CYE, SE, and BE. Although there are no data or information suggesting energy and mineral development is limiting grizzly bear populations in the CYE, SE, BE, and North Cascades, the potential for disturbance exists, and monitoring will continue to support adaptive management decisions. Therefore, in the absence of minimizing measures across the range, energy and mineral development may be a threat to the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Energy and Mineral Development</E>
                         in the SSA report (Service 2024, pp. 129-133).
                    </P>
                    <HD SOURCE="HD3">Recreation</HD>
                    <P>
                        Outdoor recreation is increasing across the United States (White et al. 2016, pp. 3-4, 7). The primary concern related to increased recreation is that it may increase the probability of human-grizzly bear encounters, with subsequent increases in human-caused mortality (Mattson et al. 1996, p. 1014; Service 2024, pp. 131-136). In addition, individuals recreating in bear country could cause displacement from high-quality habitat. Developed sites associated with recreation (see “Developed Sites,” above) and motorized recreation (see “Motorized Access,” above) can also directly limit secure grizzly bear habitat. Grizzly bears exhibit a range of responses to non-motorized recreation depending on the age and sex of the bear (Jope 1985, p. 34; Gibeau et al. 2002, p. 232; Ladle et al. 2018, p. 6; Loggers 2022, p. 66), reproductive status (Ladle et al. 2018, p. 6), season (Elmeligi 2016, p. 113), and individual bear behavior (Elmeligi 2016, pp. 131-134; Ordiz et al. 2019, p. 232; Sahlén et al. 2015, p. 7). Although non-motorized trails may cause displacement of individual grizzly bears to varying degrees, grizzly bear mortality related to non-motorized recreation is rare and population-level impacts have not been documented (Jope 1985, pp. 34-36; McLellan and Shackleton 1989a, pp. 270-274; Kasworm and Manley 1990, pp. 81, 84; Mace and Waller 1996, pp. 463-465; White et al. 1999, p. 149). Motorized recreation impacts grizzly bears through increased mortality as a result of human-bear encounters, displacement, habitat loss, and fragmentation (Proctor et al. 2019, p. 18). Recreational hunting (
                        <E T="03">e.g.,</E>
                         hunting for elk, black bears, upland birds) within grizzly bear habitat can also increase the chances of grizzly bear mortalities due to defense-of-life and mistaken-identity killings.
                    </P>
                    <P>
                        Inside the GYE and NCDE recovery zones, the vast majority of lands available for recreation are accessible through non-motorized travel only (USDA FS 2006a, p. 179; NCDE Subcommittee 2020, chapter 3, figure 7). Motorized recreation during the summer, spring, and fall inside the recovery zone is limited to existing roads under standards in the habitat-based recovery criteria and the GYE and NCDE conservation strategies that restrict increases in roads or motorized trails. Recreation at developed sites, such as lodges, downhill ski areas, and campgrounds, is limited by the developed sites habitat standard described in the habitat-based recovery criteria and the GYE and NCDE conservation strategies. Ongoing I&amp;E efforts at these recreation sites are an important contributing factor to successful grizzly bear conservation and will continue under the GYE and NCDE conservation strategies (YES 2024, chapter 5; NCDE Subcommittee, pp. 103-1-5). Although there are no data or information suggesting recreation is negatively affecting grizzly bear populations in the CYE, SE, BE, and North Cascades, the potential for disturbance exists, and monitoring will continue to support adaptive management decisions. However, we do not have evidence indicating that current levels of recreation are limiting to grizzly bear populations. Therefore, in the absence of the protections of the Act, we do not anticipate that recreation would be a threat to the grizzly bear DPS. For more information about the conservation measures that have ameliorated this threat, see 
                        <E T="03">Recreation</E>
                         in the SSA report (Service 2024, pp. 133-138).
                        <PRTPAGE P="4260"/>
                    </P>
                    <HD SOURCE="HD3">Vegetation Management</HD>
                    <P>Depending on the type of project, vegetation management can be beneficial, neutral, or harmful to grizzly bears (Service 2024, pp. 138-141). The building of roads associated with vegetation management projects pose the largest potential threat to grizzly bear populations. Impacts to individual bears from timber management activities are usually temporary in nature. Vegetation management that improves food resources, such as berry producing shrubs, tubers or corms, succulent broadleaves, or grasses, can benefit grizzly bears. Manipulations that can produce these effects occur in the form of prescribed fire, thinning, or timber harvest, but all actions must consider the individual site and desired condition post-treatment.</P>
                    <P>Vegetation management occurs throughout all six ecosystems on lands managed by the USFS and NPS. Although there are known, usually temporary, impacts to individual bears from timber management activities, these impacts have been adequately minimized using the IGBC guidelines (USDA FS 1986, pp. 6-12) in place since 1986. These impacts will continue to be managed at levels compatible with a recovered grizzly bear population under the GYE and NCDE conservation strategies. These impacts will continue to be largely minimized through motorized access standards in the CYE and SE and the “no net loss” policy in the North Cascades. In addition, the large acreage of wilderness areas and IRAs reduce the effects of vegetation management in the six ecosystems.</P>
                    <P>
                        Conservation mechanisms to reduce the negative effects of motorized access, which minimize the impacts of vegetation management independent of the Act, are currently only in place for two of the six ecosystems. They have not been met or finalized for the remaining four ecosystems. Therefore, in the absence of conservation mechanisms across the range, vegetation management may be a threat to the grizzly bear DPS. For more information about the conservation measures that have ameliorated this threat, see 
                        <E T="03">Vegetation Management</E>
                         in the SSA report (Service 2024, pp. 138-141).
                    </P>
                    <HD SOURCE="HD3">Habitat Fragmentation</HD>
                    <P>
                        Habitat fragmentation can cause a loss of connectivity and may result from human activities, such as habitat modification, road building, and human developments and settlement (Proctor et al. 2012, p. 23; Lamb et al. 2017, p. 62). Human activities can result in human-caused mortality, such as automobile collisions and management removals, that also cause demographic (
                        <E T="03">i.e.,</E>
                         female) fragmentation (Service 2024, pp. 141-143). Long-distance dispersal by males enables immigrants to act as a counter to genetic fragmentation and loss of nuclear genetic diversity (
                        <E T="03">e.g.,</E>
                         GYE population) (Proctor et al. 2012, p. 27; Peck et al. 2017, p. 15).
                    </P>
                    <P>The GYE grizzly bear population is currently a contiguous population across its range, and there are no data to indicate habitat fragmentation within this population is occurring. In other words, there is no indication that human activities are preventing grizzly bears from moving freely within the ecosystem (Service 2024, p. 140).</P>
                    <P>In the NCDE, human-caused fragmentation has been identified across U.S. Hwy 2/the BNSF (Burlington Northern Santa Fe) Railway's rail line corridor; however, this corridor does not currently prevent demographic and genetic connectivity within the NCDE (Waller and Servheen 2005, pp. 996-998; Mikle et al. 2016b, supplementary table 3). Measures of genetic diversity from the NCDE are similar to those from undisturbed populations in Canada and Alaska, leading to the conclusion that the NCDE population has high genetic diversity and is sufficiently connected to other populations.</P>
                    <P>
                        Grizzly bear population fragmentation has occurred, and currently still occurs, between the Yaak and Cabinet Mountains portions of the CYE and is related to human settlement, U.S. Hwy 2, and a busy rail line (Proctor et al. 2018, p. 350). There is recent evidence that some grizzly bear movements between the Yaak and Cabinet Mountains are starting to take place (Kasworm et al. 2024a, p. 34) and functional connectivity within the CYE remains a management objective. There is no indication that similar potential barriers exist within the SE, BE, and North Cascades recovery zones. However, habitat fragmentation resulting from human activities associated with human population growth and increases in recreation may limit connectivity between ecosystems. Therefore, in the absence of measures to allow for connectivity, habitat fragmentation would continue to be a threat to the grizzly bear DPS. Please see 
                        <E T="03">Habitat Fragmentation</E>
                         in the SSA report for further information (Service 2024, pp. 141-143). See “Private Land Development,” below, for further discussion on potential impacts to connectivity between ecosystems.
                    </P>
                    <HD SOURCE="HD3">Private Land Development</HD>
                    <P>Private land development may lead to habitat fragmentation (see “Habitat Fragmentation,” above, for further discussion) (Service 2024, pp. 143-148). Urban and rural sprawl (low-density housing and associated businesses) have resulted in increasing numbers of human-grizzly bear conflicts, with subsequent increases in grizzly bear mortality rates in more human-dominated landscapes. Continued development of private lands will likely lead to further increases in conflicts and mortalities, potentially limiting the grizzly bear's range and connectivity between ecosystems.</P>
                    <P>Conservation easements on private lands maintain open lands for wildlife use by protecting against potential future subdivision and development while maintaining traditional land uses. Easements and land trusts can be especially effective at reducing habitat fragmentation and increasing connectivity of secure grizzly bear habitat. In addition to addressing threats from private land development through conservation easement programs, Federal, State, and Tribal wildlife management agencies respond to conflicts on public and private lands. While human-grizzly conflicts occur at developed sites on public lands, most management removals arise from conflicts on private lands (Servheen et al. 2004, p. 21; MFWP, unpublished data).</P>
                    <P>
                        In the GYE, only 1 percent of the recovery zone and nearly 13 percent of the DMA outside of the recovery zone is privately owned. In the NCDE, 7 percent of the recovery zone and nearly 47 percent of habitat in Zones 1 and 2 are privately owned. In the CYE and SE, nearly 2 percent and 14 percent of habitat within the recovery zone are privately owned, respectively. In the BE, less than 1 percent of habitat within the recovery zone is privately owned. Approximately 3 percent (873 km
                        <SU>2</SU>
                         (338 mi
                        <SU>2</SU>
                        )) of the North Cascades recovery zone is private land. The large areas of public lands protected by Federal legislation (
                        <E T="03">e.g.,</E>
                         designated wilderness or IRAs) help to minimize risks posed by human population growth on private lands and ensure that the grizzly bear population will continue to meet recovery criteria. Additional protections are provided by the placement of conservation easements or the purchase of private lands by public agencies (
                        <E T="03">e.g.,</E>
                         the Service) or qualified Land Trusts (
                        <E T="03">e.g.,</E>
                         The Nature Conservancy, The Vital Ground Foundation). We do not have information to indicate that current levels of private land development are limiting to grizzly bear populations at this time. Monitoring will continue to assess potential impacts associated with human activities (
                        <E T="03">i.e.,</E>
                         human 
                        <PRTPAGE P="4261"/>
                        population growth, private land development, and increases in recreation) that may limit connectivity between ecosystems. Therefore, in the absence of conservation measures, private land development may be a threat to the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Private Land Development</E>
                         in the SSA report (Service 2024, pp. 143-148).
                    </P>
                    <HD SOURCE="HD3">III. Connectivity and Genetic Health</HD>
                    <P>
                        The isolation and lack of connectivity between grizzly populations in the lower-48 States was a recognized threat at the time of the original listing (40 FR 31734, July 28, 1975). Although the 1993 recovery plan did not require connectivity for delisting of individual grizzly bear populations, it recognized that natural connectivity between grizzly bear populations would benefit long-term grizzly bear conservation through potential genetic exchange and is necessary for small or isolated populations to sustain themselves at recovery levels (Service 1993, pp. 15, 23-25). Small, isolated populations are vulnerable to extinction from demographic fluctuations resulting from environmental processes (
                        <E T="03">e.g.,</E>
                         poor food years, disease, human-caused mortality) and low genetic diversity due to genetic drift and inbreeding. Low genetic diversity can have deleterious effects on fitness and fecundity (Allendorf et al. 1991, p. 651; Burgman et al. 1993, p. 220), and ultimately reduces long-term population viability. Genetic health is typically assessed using a variety of metrics, including effective population size and measures of genetic diversity (
                        <E T="03">e.g.,</E>
                         allelic richness, heterozygosity, inbreeding rate).
                    </P>
                    <P>
                        Connectivity, or dispersal and successful immigration, of males or females enhances genetic diversity and reduces genetic fragmentation (
                        <E T="03">i.e.,</E>
                         provides genetic or demographic connectivity, respectively) (Miller and Waits 2003, pp. 4337-4338; Proctor et al. 2005, pp. 27-28). As few as one to two effective migrants per generation interval can maintain or enhance genetic diversity (Mills and Allendorf 1996, pp. 1510, 1516; Newman and Tallmon 2001, pp. 1059-1061; Miller and Waits 2003, p. 4338).
                    </P>
                    <P>
                        In the GYE, effective population size and genetic diversity (
                        <E T="03">e.g.,</E>
                         allelic richness, heterozygosity, inbreeding rate), in addition to other indicators of genetic health (
                        <E T="03">e.g.,</E>
                         reproduction, survival), are monitored by the IGBST for the GYE grizzly bear population (in their entirety: Miller and Waits 2003; Haroldson et al. 2010; Kamath et al. 2015). Although the GYE is isolated, genetic concerns are not a current threat to the GYE grizzly bear population (Miller and Waits 2003, p. 4338; Kamath et al. 2015, entire). Recent data indicate an extremely low rate of inbreeding and an increase in the effective population size over the 25-year period of 1982 to 2007, substantially reducing the prospects of potential negative effects associated with isolation of the GYE population in the short term (Kamath et al. 2015, p. 5517). These findings are likely a function of significant growth of the GYE grizzly population during the same 25-year period. Additionally, other measures of genetic health, such as heterozygosity and allelic richness, have not changed over a similar 25-year time period of 1985 to 2010 (Kamath et al. 2015, p. 5512). The current level of genetic diversity in the GYE grizzly bear population also coincides with robust demographic vital rates (
                        <E T="03">i.e.,</E>
                         reproduction, survival) that are fully comparable with other growing or stable brown bear populations in North America (van Manen 2016, in litt.).
                    </P>
                    <P>
                        Although the potential threat of inbreeding is currently low, the GYE remains isolated, and inbreeding could become an issue in the future without connectivity. The genetic health and long-term viability of the currently isolated GYE would benefit from one to two effective immigrants from one of the other established grizzly bear populations approximately every generation interval (Mills and Allendorf 1996, pp. 1510, 1516; Newman and Tallmon 2001, pp. 1059-1061; Miller and Waits 2003, p. 4338; Kamath et al. 2015, p. 5517). The IGBST monitors grizzly bear movements and observations, and the IGBST checks for the presence of alleles from grizzly bear populations outside the GYE population (YES 2024, chapter 2). We have not detected any effective migrants into the GYE population to date; however, the 2022 estimated occupied ranges for grizzly bears in the GYE and NCDE were only 98 km (61 mi) apart, within maximum dispersal distances documented for males (Blanchard and Knight 1991, pp. 50, 55; McLellan and Hovey 2001, p. 841; Peck et al. 2017, p. 2), and we have verified several outlier observations between the distributions (see figure 1, above). Nonetheless, successful immigration events will likely remain rare due to distance and barriers (
                        <E T="03">e.g.,</E>
                         interstates) unless current distributions continue to expand (Peck et al. 2017, pp. 15-16). Continued expansion of estimated occupied range will increase the likelihood of connectivity (Peck et al. 2017, p. 15). Researchers have modeled potential male and female dispersal pathways between the NCDE and GYE populations (Peck et al. 2017, entire; Sells et al. 2023, entire). These dispersal paths could be used to identify and prioritize conservation efforts that foster connectivity.
                    </P>
                    <P>The States have committed to genetic monitoring and translocation, if necessary, to address the ability of future GYE grizzly bears to adapt evolutionarily (Hedrick 1995, p. 1004; Miller and Waits 2003, p. 4338). The IGBST also monitors genetic diversity of the GYE grizzly bear population so that a possible reduction in genetic diversity will be detected and responded to accordingly with translocation of grizzly bears into the GYE population originating from another population in the grizzly bear DPS. A Tri-State MOA commits the States of Idaho, Montana, and Wyoming to translocate at least two grizzly bears from outside the GYE into the GYE by the end of 2025, unless migration from outside the GYE is detected in the interim (YES 2024, chapter 2; Wyoming Game and Fish Commission et al. 2024, p. 5). In July 2024, MFWP, in collaboration with Wyoming Game and Fish Department (WGFD) and YNP, translocated a subadult female and a young adult male from the NCDE to the GYE. While translocation has the potential to improve genetic connectivity and long-term genetic health, it cannot guarantee these needs, as translocated bears may leave the ecosystem or die before reproducing. Translocated bears often exhibit unusual movement patterns, which can increase their mortality risk. Natural connectivity between the GYE population and other populations would improve the chances of long-term genetic health in the GYE. Although natural immigration will likely remain rare, individuals that arrive naturally have a higher probability of remaining in the area and lower mortality risk than translocated individuals.</P>
                    <P>The NCDE grizzly bear population is genetically diverse, large enough to ensure genetic health, and genetically and demographically well connected to Canadian populations, and there is no indication that the genetic health of the NCDE grizzly bear population is likely to measurably decline in the future. Nevertheless, ongoing genetic sampling and radio telemetry enable scientists to examine movements, genetic diversity, and population structure within the NCDE grizzly bear population (in their entirety: Kendall et al. 2008; Kendall et al. 2009; Mace et al. 2012; Proctor et al. 2012; Mikle et al. 2016a; Morehouse et al. 2016).</P>
                    <P>
                        In the CYE, Proctor et al. (2012, entire) used several metrics to evaluate 
                        <PRTPAGE P="4262"/>
                        the genetic status and found that genetic diversity in the Yaak portion of the CYE was comparable to other healthy grizzly bear populations in North America. The sample size of native Cabinet bears was insufficient to include in the analysis. Because habitat in the CYE recovery zone can only support a small grizzly bear population, it is important to maintain connectivity with other populations. Multiple individuals (33 males, 3 females) are known to have moved into the Yaak portion of the CYE from the NCDE, SE, and the North Purcells in Canada. Data suggest that the Yaak has experienced gene flow only from B.C. grizzly bear populations. While there is evidence of movement into the Cabinets from the Yaak, NCDE, and the SE, reproduction that would contribute to the genetic health of the population has not been documented for any immigrants. Of additional concern is population linkage between the Yaak and Cabinet portions of this recovery zone, which is split along Hwy 2 (Proctor et al. 2012, p. 12; Kendall et al. 2016, pp. 320-321).
                    </P>
                    <P>Proctor et al. (2012, entire) found genetic diversity was lower in the SE than in other grizzly bear populations in the grizzly bear DPS and Canada and that the SE grizzly bear population had likely been isolated in the recent past. In recent years, reproduction has been documented from several immigrants to the SE, resulting in an increase in genetic diversity. Telemetry from collared individuals indicates that grizzly bears move freely across the length of the international border in the SE (Kasworm et al. 2024b, pp. 61-79). These changes demonstrate that grizzly bears in the SE are starting to exhibit increased connectivity with other grizzly bear populations.</P>
                    <P>There are currently no known populations in the BE and North Cascades, and isolation is a concern for any future populations, although of greater concern in the North Cascades than in the BE. Multiple grizzly bears have been confirmed in areas immediately surrounding the BE recovery zone over the last 15 years; they are most likely grizzly bears dispersing from the expanding populations in the GYE and NCDE. In the North Cascades, natural recolonization is unlikely in the near future due to the low numbers of bears in nearby populations and the highly fragmented landscape in between (NPS and Service 2024, p. 7).</P>
                    <P>
                        As discussed above in “Mistaken-identity Killings,” recent legislation in Montana and Idaho that expands hunting and trapping methods allowed for wolves and black bears could reduce the probability of natural connectivity between the GYE, NCDE, CYE, SE, and BE populations. In addition, there are no mortality thresholds in connectivity areas for grizzly bears taken by livestock owners or for other human-caused mortality, such as management removals (for more information, see “Mortality Limits,” above). The lack of mortality thresholds in connectivity areas may result in a contraction of estimated occupied range, which could decrease the likelihood of successful immigration. Therefore, in the absence of conservation measures, connectivity and genetic health would continue to be a threat to the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Connectivity and Genetic Health</E>
                         in the SSA report (Service 2024, pp. 182-197).
                    </P>
                    <HD SOURCE="HD3">IV. Food Resources</HD>
                    <P>Grizzly bears are resourceful omnivores that will make behavioral adaptations regarding food acquisition (Schwartz et al. 2014, p. 75). Diets of grizzly bears vary among individuals, seasons, years, and where they reside (Mealey 1980, pp. 284-287; Servheen 1981, pp. 119-123, 127-128; LeFranc et al. 1987, pp. 24-25; Mattson et al. 1991a, pp. 1625-1626; Mattson et al. 1991b, pp. 2433-2434; Felicetti et al. 2003, p. 767; Schwartz et al. 2003, pp. 568-569; Felicetti et al. 2004, p. 499; Koel et al. 2005, p. 14; Costello et al. 2014, p. 2013; Gunther et al. 2014, pp. 66-67), reflecting their ability to find adequate food resources across a diverse and changing landscape.</P>
                    <P>There are no indications that long-term trends in food availability, other than whitebark pine nuts, cutthroat trout, and salmon, have changed in the GYE, NCDE, CYE, SE, BE, and North Cascades in the last several decades. Although whitebark pine seed production and the availability of cutthroat trout in the Yellowstone Lake area varied dramatically over the last 3 decades due to both natural and human-introduced causes (Reinhart and Mattson 1990, pp. 345-349; Podruzny et al. 1999, pp. 134-137; Felicetti et al. 2004, p. 499; Haroldson et al. 2005, pp. 175-178; Haroldson 2015, p. 47; Teisberg et al. 2014, pp. 375-376), the GYE grizzly bear population has continued to increase and expand during this time period despite these changes in food availability (Schwartz et al. 2006a, p. 66; IGBST 2012, p. 34; Bjornlie et al. 2014, p. 184). While salmon abundance is reduced in the BE and North Cascades compared to historical numbers, several studies have concluded that there are sufficient alternative foods to maintain grizzly bear populations in those ecosystems.</P>
                    <P>
                        We anticipate that grizzly bears will be able to adapt to any future potential changes in individual food sources because of the great plasticity of grizzly bear diets and the range of available foods. Thus, the highly omnivorous and flexible diet of grizzly bears will enable the species to adapt to future changes in food availability. It is also clear that grizzly bears can compensate for changes in the availability of food as long as there is sufficient habitat security. Therefore, we do not anticipate changes in food resources to be a threat to the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Food Resources</E>
                         in the SSA report (Service 2024, pp. 197-212).
                    </P>
                    <HD SOURCE="HD3">V. Potential Effects of Climate Change</HD>
                    <P>We evaluated observed or likely future environmental changes resulting from ongoing and projected changes in climate (Service 2024, pp. 210-217). Effects related to climate change may result in a number of changes to grizzly bear habitat, including a reduction in snowpack levels (McKelvey et al. 2011, entire; Schwartz et al. 2016, p. 317; Livneh and Badger 2020, pp. 453-454), which may shorten the denning season (Leung et al. 2004, pp. 93-94), shifts in denning times (Craighead and Craighead 1972, pp. 33-34; Van Daele et al. 1990, p. 264; Haroldson et al. 2002, pp. 34-35), shifts in the abundance and distribution of some natural food sources (Rodriguez et al. 2007, pp. 41-42), and changes in fire regimes (Nitschke and Innes 2008, p. 853; McWethy et al. 2010, p. 55).</P>
                    <P>
                        Most grizzly bear biologists in the United States and Canada do not expect habitat changes predicted under climate change scenarios to have significant consequences for grizzly bears (Servheen and Cross 2010, p. 4). Climate change may even make some habitat more suitable and some food sources more abundant (Servheen and Cross 2010, appendix D). In addition, we anticipate that grizzly bears will adapt to any future potential changes in suitable habitat and food sources because they display great diet plasticity and switch foods according to which foods are most nutritious and available (Servheen 1981, pp. 119-123,127-128; Kendall 1986, pp. 12-18; Mace and Jonkel 1986, entire; Martinka and Kendall 1986, pp. 21-22; LeFranc et al. 1987, pp. 24-25; Aune and Kasworm 1989, pp. 64-72; Schwartz et al. 2003, pp. 568-569; Edwards et al. 2011, pp. 883-886; Gunther et al. 2014, pp. 65-69). Timing and frequency of human-grizzly bear interactions and conflicts may change (Servheen and Cross 2010, p. 4), and monitoring will continue to 
                        <PRTPAGE P="4263"/>
                        support adaptive management decisions. We expect that current conservation plans and strategies with mortality limits will further limit any potential negative effects of climate change on grizzly bears. Therefore, in the absence of the protections of the Act, we do not anticipate potential effects of climate change to be a threat to the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Potential Effects of Climate Change</E>
                         in the SSA report (Service 2024, pp. 212-219).
                    </P>
                    <HD SOURCE="HD3">VI. Stochastic Events</HD>
                    <P>Here, we analyze a number of possible stochastic events, including fire, volcanic activity, and earthquakes, that might reasonably occur in each of the recovery ecosystems within the 30-to-45-year future, to the extent possible (Service 2024, pp. 219-222). Some stochastic events could be catastrophic events if they occur on a large enough scale to rise to the level of affecting the resiliency of an entire population.</P>
                    <P>Volcanic activity is most relevant for the GYE population given their geographic location; however, fires and earthquakes are the most plausible potential stochastic stressor to all of the ecosystems given their geographic location. Fire is a natural part of all grizzly bear ecosystems. Even though fire frequency and severity may increase with late summer droughts predicted under climate change scenarios (Nitschke and Innes 2008, p. 853; McWethy et al. 2010, p. 55; Whitlock et al. 2017; pp. 123-131, 216, XXXII), increased frequency of low to moderate severity fires has the potential to improve grizzly bear habitat. The GYE has experienced several large volcanic eruptions in the past 2.1 million years, and such an event would devastate the GYE grizzly bear population (Lowenstern et al. 2005, pp. 1-2). In addition, nonexplosive lava flow eruptions and hydrothermal explosions have occurred over the past 640,000 years (Lowenstern et al. 2005, p. 2). Earthquakes also occur within the region and can impact the surrounding environment through fire damage, rockslides, ground cracks, and changes in ground water (Pardee 1926, entire).</P>
                    <P>
                        Most catastrophic stochastic events, such as volcanic activity, are unpredictable and unlikely to occur within the biologically meaningful timeframe evaluated in our SSA report (Service 2024, pp. 217-220). Other events that might occur within the future, such as fire and earthquakes, would likely cause only localized and temporary impacts that would not significantly reduce the resiliency of the GYE population. Therefore, no conservation measures are required to ameliorate these stressors, and, in the absence of the protections of the Act, we do not anticipate stochastic events to be a threat to the grizzly bear DPS. For more information about this threat, see 
                        <E T="03">Stochastic Events</E>
                         in the SSA report (Service 2024, pp. 217-219).
                    </P>
                    <HD SOURCE="HD2">Current Conditions</HD>
                    <P>As documented in our SSA report, we evaluated the resiliency of each of the six ecosystems, in terms of the habitat and demographic factors needed by the grizzly bear in the grizzly bear DPS (Service 2024, pp. 36-38, 232-247). We developed a categorical model to calibrate resiliency based on a range of conditions for two habitat factors (natural, high-caloric foods, and habitat security) and six demographic factors (adult female survival, abundance as measured by population targets and number of bears, population trend, reproductive female distribution, inter-ecosystem connectivity, and genetic diversity) (Service 2024, pp. 232-235). We selected these habitat and demographic factors based on their importance to resiliency and because we could evaluate them relatively consistently across all six ecosystems. We then used this categorical model as a key to evaluate resiliency for each ecosystem by systematically evaluating the current condition of each habitat and demographic factor. To calculate an overall score for resiliency, we assigned weighted values to the resiliency categories and then calculated a weighted average of the habitat and demographic factor ranking (Service 2024, p. 234). These scores were then used to classify resiliency in the predefined categories of high, moderate, low, or very low resiliency. Ecosystems with higher resiliency categories are at less risk from potential stochastic events, such as extreme weather events, than ecosystems in lower resiliency categories (Service 2024, p. 234). Our SSA report provides additional detail regarding the methodology we used to evaluate resiliency for each of the six ecosystems (Service 2024, pp. 232-235).</P>
                    <P>
                        Currently, the GYE population has high resiliency (table 21 in SSA report (Service 2024, p. 237)). A variety of land protections, particularly those that have reduced motorized access, and the availability and diversity of natural foods contribute to the currently high condition of the habitat factors in the GYE (Service 2024, p. 238). Additionally, State, Federal, Tribal, and nongovernmental organization partners have implemented conservation activities and land protections in the GYE that help reduce human-caused mortality and contribute to the large GYE population size (Service 2024, p. 238). In the GYE, the demographic factors of genetic diversity and inter-ecosystem connectivity could improve if natural immigration into the GYE population occurs in the future (Service 2024, p. 238). There currently is no inter-ecosystem connectivity to the GYE population, and genetic diversity for the GYE population is currently moderate because the population remains isolated. One to two effective immigrants from another grizzly bear population each generation interval (
                        <E T="03">i.e.,</E>
                         14 years) are necessary to ensure long-term genetic health (Service 2024, pp. 238-239).
                    </P>
                    <P>Currently, the NCDE population has high resiliency (table 21 in SSA report (Service 2024, p. 237)). A variety of land protections, particularly those that have reduced motorized access, and the availability and diversity of natural foods contribute to the currently high condition of the habitat factors in the NCDE (Service 2024, p. 239). Additionally, State, Federal, Tribal, and nongovernmental organization partners have implemented conservation activities and land protections in the NCDE that help reduce human-caused mortality and contribute to the large NCDE population size (Service 2024, p. 239). The demographic factors of genetic diversity and inter-ecosystem connectivity are in a high condition as a result of connectivity with Canadian populations (Service 2024, pp. 239-240).</P>
                    <P>Currently, the CYE population has low resiliency, and the SE population has moderate resiliency (table 21 in SSA report (Service 2024, p. 237)). The smaller size of the CYE and SE, with a narrower range of habitats that may limit the diversity of foods available, as well as somewhat limiting habitat security contribute to the currently moderate condition of the habitat factors in the CYE and SE (Service 2024, pp. 240-241). Despite high population trends and high and moderate adult female survival, both the CYE and SE currently have very low numbers of bears, although this factor could improve as bears reproduce and expand in the future (Service 2024, pp. 240-241). The demographic factors of genetic diversity and inter-ecosystem connectivity are in a low to moderate condition as a result of past isolation and limited reproducing immigrants from other populations (Service 2024, pp. 241-242).</P>
                    <P>
                        Despite the moderate to high condition of habitats, without known populations, the BE and North Cascades 
                        <PRTPAGE P="4264"/>
                        are currently in functionally extirpated condition, and therefore have no resiliency (Service 2024, pp. 242-244). Our SSA report provides additional detail regarding current resiliency for each of the six ecosystems (Service 2024, pp. 232-245).
                    </P>
                    <P>Redundancy describes the ability of the species to withstand catastrophic events. For the grizzly bear, we considered the number and distribution of ecosystems, such that the greater the number and the wider the distribution of the ecosystems, the better able grizzly bears in the grizzly bear DPS are to withstand catastrophic events. Grizzly bears in the grizzly bear DPS currently occupy four ecosystems, with two ecosystems with high resiliency, one with moderate resiliency, and one with low resiliency. Two ecosystems are currently in functionally extirpated condition, with no resiliency, so they do not contribute to redundancy.</P>
                    <P>Representation describes the ability of a species to adapt to changing environmental conditions. For the grizzly bear, we considered the breadth of ecological diversity as a proxy for evaluating this ability. Representation is currently captured by ecological diversity inherent within the grizzly bear populations in the four occupied ecosystems of the GYE, NCDE, CYE, and SE. For example, the GYE, contained in the Middle Rockies ecoregion, is dominated by forested, mountainous habitat, and dry sagebrush to the east and south, and includes hydrothermal features and other unique geologic features. The NCDE includes parts of the Great Plains, Middle Rockies, and Northern Rockies ecoregions, and habitat varies from wet forested lands west of GNP to much drier habitat to the east, including prairie grasslands. The CYE and SE are both contained within the Rocky Mountains, and are characterized by wet, forested mountains. The BE and North Cascades ecosystems are currently unoccupied by a grizzly bear population and therefore do not currently contribute to representation. The BE is primarily contained in the Idaho Batholith ecoregion. It contains mountainous regions; canyons; dry, partly wooded mountains; grasslands; high glacial valleys; and hot dry canyons. The North Cascades is part of the North Cascades ecoregion and is characterized by steep, rugged, glaciated peaks dividing wet temperate forests on the west side and semi-arid forests and shrub-steppe grasslands on the east side.</P>
                    <HD SOURCE="HD2">Future Conditions</HD>
                    <P>We evaluated future conditions for the six ecosystems using projections for the stressors, habitat factors, and demographic factors that influence the resiliency of the ecosystem, and the redundancy and representation of the grizzly bear in the grizzly bear DPS (Service 2024, pp. 248-252). To evaluate future conditions, we used the same methodology that we used to evaluate current condition, but instead considered the plausible conditions for the two habitat factors and six demographic factors projected into the future under a range of plausible future scenarios (Service 2024, pp. 248-252). We evaluated future conditions for the grizzly bear in the grizzly bear DPS 30 to 45 years into the future, a timeframe that captures approximately two to three grizzly bear generation intervals. A generation interval is the approximate time that it takes a female grizzly bear to replace herself in the population. Given the longevity of grizzly bears, two to three generation intervals represent a period during which a complete turnover of the population would have occurred; any positive or adverse changes in the status of the population would be evident. Additionally, this timeframe is sufficient to allow for the possibility that land management plans, which may provide important conservation measures to reduce potential stressors, could go through at least one revision (Service 2024, p. 248). Below, we summarize the future scenarios and our evaluation of future condition for the six ecosystems under each scenario; our full analysis is contained in the SSA report (Service 2024, pp. 248-265).</P>
                    <P>As documented in our SSA report, we used scenario planning to describe plausible futures for the grizzly bear and to capture uncertainty associated with our future projections. Using future scenarios allowed us to explore a range of possible future conditions for the grizzly bear in the grizzly bear DPS, given the uncertainty in the stressors grizzly bears in the grizzly bear DPS may face, their potential response to those stressors, and the potential for possible conservation efforts to influence future conditions (see table 28 in our SSA report (Service 2024, p. 266)). As described in more detail in our SSA report (Service 2024, pp. 248-252), we developed five future scenarios, as summarized below:</P>
                    <P>• Future Scenario 1—Significantly Decreased Conservation: Under this scenario, conservation actions decrease significantly, largely through the termination or non-renewal of plans or regulations, and the rate of private land development increases dramatically;</P>
                    <P>• Future Scenario 2—Decreased Conservation: Under this scenario, conservation actions decrease, but not as significantly as in Scenario 1, due to decreased effectiveness and implementation of conservation actions and mechanisms, and the rate of private land development increases;</P>
                    <P>• Future Scenario 3—Continuation of Conservation: Under this scenario, conservation actions continue at the same rate, magnitude, and effectiveness as they currently occur under the Act, and the rate of private land development remains the same;</P>
                    <P>• Future Scenario 4—Increased Conservation: Under this scenario, conservation actions increase or improve, and the rate of private land development decreases; and</P>
                    <P>• Future Scenario 5—Significantly Increased Conservation: Under this scenario, conservation actions increase significantly, and the rate of private land development decreases dramatically.</P>
                    <P>Although there are likely different probabilities associated with our future scenarios, we considered all five scenarios to be plausible for the purposes of our SSA analysis (Service 2024, p. 248). We used the same methodology to evaluate current condition and to project the resiliency of the six ecosystems 30 to 45 years into the future. We projected the future condition for the two habitat factors and six demographic factors under each of the five future scenarios and then calculated an overall resiliency score for each ecosystem under each scenario using the same weighted average as our current condition evaluation. After evaluating resiliency, we then evaluated redundancy and representation of the grizzly bear in the grizzly bear DPS for each future scenario.</P>
                    <HD SOURCE="HD3">Future Scenario 1</HD>
                    <P>With a significant decrease in conservation under Scenario 1, there are projected to be subsequent decreases in resiliency across the habitat and demographic factors for populations in all ecosystems over the next 30 to 45 years. The GYE and NCDE populations are projected to decrease in overall resiliency from high to moderate, the SE population declines from moderate to low, and the CYE population declines from low to very low under this scenario.</P>
                    <P>
                        Natural high-caloric foods remain high or moderate for all ecosystems under Scenario 1, due in part to the large amount of wilderness and national parks, which help ensure that a diversity of food sources would continue to be available to the grizzly bear into the future. However, as conservation declines significantly 
                        <PRTPAGE P="4265"/>
                        under Scenario 1, habitat security declines from high to moderate for the GYE and NCDE, and from moderate to low in the CYE and SE as motorized access increases, but habitat security remains high in the BE and moderate for the North Cascades. The quantity of wilderness areas and national parks that remain in these ecosystems helps ensure that the condition of this habitat factor does not fall below moderate for the GYE, NCDE, and North Cascades, or below high for the BE.
                    </P>
                    <P>
                        Under Scenario 1, there are projected to be overall declines in condition for most of the demographic factors for the populations in all ecosystems. Under this scenario, significant reductions in conservation actions that address unsecured attractants and other sources of human-caused mortality lead to increased mortality and hence declines in adult female survival, abundance, population trend, and reproductive female distribution. Human-caused mortalities would increase if State regulations are enacted that allow grizzly bears to be killed by the public (
                        <E T="03">e.g.,</E>
                         if bears “threaten” livestock) or if regulatory mechanisms limiting mortality to sustainable levels are not adequate. Reproductive female distribution in the GYE and NCDE populations declines from high to moderate, as at least one BMU in this ecosystem would likely be unoccupied as a result of significantly decreased conservation. Reproductive female distribution in the CYE and SE also declines under this scenario; however, due to the small size of BMUs in these ecosystems, single female home ranges will likely still overlap multiple BMUs, contributing to reproductive distribution. Finally, overall resiliency declines for the populations in all ecosystems as abundance declines due to increasing human-caused mortality, the GYE population continues to be isolated with no inter-ecosystem connectivity, and connectivity for the CYE and SE would decline as human-caused mortality would result in decreased connectivity.
                    </P>
                    <HD SOURCE="HD3">Future Scenario 2</HD>
                    <P>With a decrease in conservation efforts under Scenario 2, potential projected decreases in overall resiliency are less severe than under Scenario 1. Under Scenario 2, the NCDE population remains in high overall resiliency, the GYE population is projected to drop from high to moderate resiliency, the CYE population remains in low resiliency, and the SE drops from moderate to low overall resiliency.</P>
                    <P>As conservation is reduced under Scenario 2, natural high-caloric foods remain the same as the current condition for all ecosystems. However, in the GYE and NCDE, habitat security shifts from high to moderate as motorized access increases, but the quantity of wilderness areas and national parks that remain helps ensure that the condition of this habitat factor does not fall below moderate. Habitat security remains the same for the CYE, SE, BE, and North Cascades.</P>
                    <P>
                        Under Scenario 2, there are projected to be overall declines in condition for most of the demographic factors for the populations in all ecosystems, although not as significantly as in Scenario 1. Under this scenario, reductions in conservation actions that address unsecured attractants and other sources of human-caused mortality lead to some increased mortality and resultant declines in adult female survival, abundance, population trend, and reproductive female distribution. Human-caused mortalities would increase if State regulations are enacted that allow grizzly bears to be killed by the public (
                        <E T="03">e.g.,</E>
                         if bears “threaten” livestock) or if regulatory mechanisms limiting mortality to sustainable levels are not adequate.
                    </P>
                    <P>Despite reduced conservation, the number of bears is projected to remain high for the GYE and NCDE populations under Scenario 2. However, the number of bears is likely to hover around the threshold between high and moderate, and could drop below the population target such that the status decreases from high to moderate. The number of bears decreases to very low in the CYE and SE because small differences in adult female survival have a larger impact on all other demographic factors due to their small population size. In general, reduced conservation could increase human-caused mortality and reduce abundance for the populations in all ecosystems, but there is some uncertainty regarding the magnitude of the reduction under this scenario.</P>
                    <P>Reproductive female distribution in the GYE and NCDE populations declines from high to moderate under this scenario, as at least one BMU in these ecosystems would likely be unoccupied as a result of decreased conservation. However, reproductive female distribution would remain at moderate for the CYE and SE populations because a significant decline would be required to decrease distribution to less than 50 percent of BMUs occupied and because a female home range can overlap multiple BMUs in these ecosystems. Under Scenario 2, inter-ecosystem connectivity remains the same for the four current populations. In the CYE, lack of augmentation would likely increase the chances of inbreeding in the Cabinet portion of the CYE population under this scenario.</P>
                    <HD SOURCE="HD3">Future Scenario 3</HD>
                    <P>Future Scenario 3 is a continuation scenario, where all stressors and conservation efforts continue at their same rate and magnitude 30 to 45 years into the future, as they currently occur under the protections of the Act. The current levels of funding and effectiveness and implementation of conservation actions and mechanisms stay the same under this scenario. As a result, the GYE and NCDE populations are projected to remain in overall high resiliency, the SE population stays in moderate, but the CYE improves overall resiliency from low to moderate and the BE improves from functionally extirpated to very low.</P>
                    <P>Habitat factors remain the same under Scenario 3 for all ecosystems. Habitat security remains moderate for the SE and CYE by virtue of their smaller size, but we anticipate that conditions will improve due to ongoing implementation of current efforts to decrease motorized routes. Conditions improve for specific demographic factors, particularly in the CYE and SE, as continued conservation allows demographic factors to improve over time. Most notably, adult female survival improves from moderate to high in the SE and the status of population targets in the CYE and SE improves from low to moderate and moderate to high, respectively. We anticipate that a population will be established in the BE in the next 30 to 45 years with continuation of current dispersal into the ecosystem. Demographic factors are rated as very low, largely due to the uncertainty around estimation resulting from small sample sizes and a newly established population.</P>
                    <P>
                        If conservation continues as described under Scenario 3, inter-ecosystem connectivity for the GYE population is projected to improve from functionally extirpated to a moderate condition. Individuals moving south from the NCDE population are already very close to the GYE population, and we expect that, as these populations continue to expand their occupied range, at least one male will enter the GYE population, establish a home range, and breed within the next 30-45 years if conservation measures continue. Genetic diversity would improve from moderate to high as the result of effective immigration or, if natural immigration does not occur by 2025, the States have committed to translocate bears into the GYE from another 
                        <PRTPAGE P="4266"/>
                        population. We expect inter-ecosystem connectivity to increase from moderate to high for the CYE and SE with continuation of current conservation efforts that have already facilitated genetic connectivity.
                    </P>
                    <HD SOURCE="HD3">Future Scenario 4</HD>
                    <P>Under Scenario 4, conservation increases as funding increases, and the mechanisms that reduce motorized access and human-caused mortality increase or are more effective. Rates of development on private lands decrease, and there are increases in conservation easements, highway crossing structures for wildlife, and the amount of land designated as wilderness and IRAs. Under this scenario, individuals are successfully moved into the North Cascades, augmentation continues into the CYE, and translocations occur in the GYE population, as needed. The GYE and NCDE populations are projected to remain in overall high resiliency, the SE population remains in moderate resiliency, the CYE population improves from low to moderate resiliency, and both the BE and North Cascades shift from currently functionally extirpated with no resiliency to low resiliency.</P>
                    <P>
                        Habitat factors remain the same under Scenario 4 for all ecosystems. Demographic factors for the BE and North Cascades begin to improve from their currently functionally extirpated condition. We anticipate that a population will be established in the BE in the next 30 to 45 years with continuation of current dispersal into the ecosystem. In addition, we expect that successful reintroduction into the North Cascades would result in a positive population trend. However, many demographic factors are rated as very low, largely due to the uncertainty around estimation resulting from small sample sizes and a newly established population for the BE and North Cascades. Abundance improves in both the CYE and SE with increased conservation under this scenario. With increased conservation, inter-ecosystem connectivity improves for the GYE, SE, and BE populations. We do not anticipate any connectivity for the North Cascades under Scenario 4 because conditions in Canada are assumed to remain the same. Although the North Cascades is within male dispersal distance of the SE population and genetic connectivity is possible, we anticipate these events to be rare due to distance and barriers (
                        <E T="03">i.e.,</E>
                         human development).
                    </P>
                    <HD SOURCE="HD3">Future Scenario 5</HD>
                    <P>Under Scenario 5, conservation increases significantly. Conditions under Scenario 5 generally improve similarly to conditions under Scenario 4, but with additional increases in genetic diversity and population trend. Tolerance and acceptance also significantly increase, and there is general acceptance of grizzly bears persisting in all ecosystems and the importance of connectivity. The GYE and NCDE populations are projected to remain in overall high resiliency; the SE and CYE populations improve from moderate and low, respectively, to high resiliency; and both the BE and North Cascades shift from currently functionally extirpated with no resiliency to low resiliency. The condition for high-caloric foods improves from moderate to high for the BE with significantly increased conservation under Scenario 5. Habitat security in the North Cascades improves to high due to implementation of new habitat standards.</P>
                    <HD SOURCE="HD3">Cumulative Effects</HD>
                    <P>We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have analyzed the cumulative effects of identified threats and conservation actions on the species. To assess the current and future condition of the species, we evaluate the effects of all the relevant factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire species, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative-effects analysis.</P>
                    <HD SOURCE="HD2">Conservation Efforts and Regulatory Mechanisms</HD>
                    <P>The following existing regulatory mechanisms, as of December 31, 2023, are specifically considered and discussed in our SSA report, as summarized above, as they relate to the stressors under each relevant discussion, affecting grizzly bears in the grizzly bear DPS.</P>
                    <HD SOURCE="HD1">I. For Habitat-Related Effects</HD>
                    <P>• Conservation Strategy for the Grizzly Bear in the Greater Yellowstone Ecosystem, with appendices (YES 2024);</P>
                    <P>• Conservation Strategy for the Grizzly Bear in the Northern Continental Divide Ecosystem (NCDE Subcommittee 2020);</P>
                    <P>• 2006 Forest Plan Amendment for Grizzly Bear Habitat Conservation for the Greater Yellowstone Area National Forests (USDA FS 2006a, 2006b);</P>
                    <P>• 2011 Forest Plan Amendments for Motorized Access Management within the Selkirk and Cabinet-Yaak Grizzly Bear Recovery Zones for the Kootenai, Lolo, and Idaho Panhandle National Forests (USDA FS 2011b);</P>
                    <P>• 2015 Revision of the Land Management Plan for the Kootenai National Forest (USDA FS 2015c);</P>
                    <P>• 2015 Revision of the Land Management Plan for the Idaho Panhandle National Forest (USDA FS 2015b);</P>
                    <P>• 2019 Colville National Forest Land Management Plan (USDA FS 2019);</P>
                    <P>• 2000 Conservation Agreement between Stimson Lumber Company, Colville National Forest, and the Service (Service 2001);</P>
                    <P>• 1997 interim Forest direction for the North Cascades Federal land management agencies (USDA FS 1997);</P>
                    <P>• Flathead National Forest Land Management Plan (USDA FS 2018b);</P>
                    <P>• Custer Gallatin National Forest Land Management Plan (USDA FS 2022);</P>
                    <P>• Helena-Lewis and Clark National Forest Land Management Plan (USDA FS 2021);</P>
                    <P>• Final Environmental Impact Statement for the Forest Plan Amendments: Incorporating Habitat Management Direction for the Northern Continental Divide Ecosystem Grizzly Bear Population for the Helena-Lewis and Clark, Kootenai, and Lolo National Forests (USDA FS 2018e);</P>
                    <P>• Blackfeet Forest Management Plan (Blackfeet Nation 2008);</P>
                    <P>• Flathead Indian Reservation Forest Management Plan (CS&amp;KT 2000);</P>
                    <P>• Final Environmental Impact Statement for the Montana Department of Natural Resources and Conservation Forested Trust Lands Habitat Conservation Plan (DNRC 2010a, 2010b);</P>
                    <P>• Administrative Rules of Montana (ARM) subchapter 36.11.4 at 36.11.432 and subchapter 12.9.14 at 12.9.1401;</P>
                    <P>• Wilderness Act of 1964;</P>
                    <P>• The 2001 Roadless Rule (66 FR 3244, January 12, 2001);</P>
                    <P>
                        • Glacier National Park Superintendent's Compendium implemented under the National Park System Organic Act (GNP 2024). The NPS Organic Act of 1916, 54 U.S.C. 100101 
                        <E T="03">et seq.,</E>
                         created the NPS and assigned it the responsibility to manage the national parks. The Organic Act requires the NPS to manage park units to conserve scenery, natural and historic objects within parks, and wildlife, and to provide for their enjoyment in a manner that leaves them unimpaired for the enjoyment of future generations;
                    </P>
                    <P>
                        • Yellowstone National Park (YNP 2023) and Grand Teton National Park 
                        <PRTPAGE P="4267"/>
                        (GTNP and John D. Rockefeller, Jr. Memorial Parkway (JDR) 2024) compendia implemented under the NPS Organic Act;
                    </P>
                    <P>• Billings Field Office Approved Resource Management Plan, 2015 (BLM 2015a);</P>
                    <P>• Hiline Approved Resource Management Plan, 2015 (BLM 2015b);</P>
                    <P>• Butte Field Office Approved Resource Management Plan, 2009 (BLM 2009);</P>
                    <P>• Missoula Field Office Approved Resource Management Plan, 2021 (BLM 2021a);</P>
                    <P>• Record of Decision and Approved Lewiston Resource Management Plan, 2021 (BLM 2021b); and</P>
                    <P>• Dillion Field Office Approved Resource Management Plan, 2006 (BLM 2006).</P>
                    <HD SOURCE="HD1">II. For Human-Caused Mortality:</HD>
                    <P>• Conservation Strategy for the Grizzly Bear in the Greater Yellowstone Ecosystem with appendices (YES 2024);</P>
                    <P>• Conservation Strategy for the Grizzly Bear in the Northern Continental Divide Ecosystem (NCDE Subcommittee 2020);</P>
                    <P>• 2011 Forest Plan Amendments for Motorized Access Management within the Selkirk and Cabinet-Yaak Grizzly Bear Recovery Zones for the Kootenai, Lolo, and Idaho Panhandle National Forests (USDA FS 2011b);</P>
                    <P>• 2015 Revision of the Land Management Plan for the Kootenai National Forest (USDA FS 2015c);</P>
                    <P>• 2015 Revision of the Land Management Plan for the Idaho Panhandle National Forest (USDA FS 2015b);</P>
                    <P>• 2019 Colville National Forest Land Management Plan (USDA FS 2019);</P>
                    <P>• Montana Grizzly Bear Management Plan 2024 (MFWP 2024);</P>
                    <P>• Flathead Indian Reservation Grizzly Bear Management Plan (Servheen et al. 1981);</P>
                    <P>• Bear Management Plan and Guidelines for Bear Management on the Blackfeet Indian Reservation (Blackfeet Tribal Business Council 2013);</P>
                    <P>• Blackfeet National Fish and Wildlife Code (Blackfeet Tribal Business Council 2018);</P>
                    <P>• Nez Perce Tribal Code section 3-1-52;</P>
                    <P>• Flathead Indian Reservation Tribal Ordinance 44D;</P>
                    <P>• Grizzly Bear Management Plan for the Wind River Reservation (Eastern Shoshone and Northern Arapaho Tribes 2009);</P>
                    <P>• Administrative Rules of Montana (ARM) subchapter 12.9.14 at 12.9.1401, 12.9.1403, 12.9.1405, and 12.9.1413;</P>
                    <P>• Montana Code Annotated (MCA) at sections 87-2-101(4), 87-1-301, 87-1-304, 87-5-301, and 87-5-302;</P>
                    <P>• Idaho Administrative Code (IAC) rules 13.01.06.100.05 and 13.01.06.300.01;</P>
                    <P>• Idaho Statutes (I.S.) at title 36, chapter 2 (section 36-201) and chapter 11 (section 36-1101(a));</P>
                    <P>• Washington Administrative Code (WAC) at section 220-610-010;</P>
                    <P>• Wyoming Statutes (W.S.) at sections 23-1-101(a)(xii)(A) and 23-3-102(a);</P>
                    <P>• Wyoming Administrative Rules (WAR) 040-0001-67;</P>
                    <P>• State of Idaho Yellowstone Grizzly Bear Management Plan (Idaho's Yellowstone Grizzly Bear Delisting Advisory Team 2002);</P>
                    <P>• Proclamation of the Idaho Fish and Game Commission Relating to the Limit of the Take of Grizzly Bear in the Greater Yellowstone Ecosystem (Idaho Fish and Game Commission 2016);</P>
                    <P>• Draft Idaho State wildlife action plan 2023 (Idaho Department of Fish and Game (IDFG) 2023);</P>
                    <P>• Montana Hunting Regulations for Grizzly Bear (MFWP 2016);</P>
                    <P>• Wyoming Grizzly Bear Management Plan (WGFD 2016);</P>
                    <P>• Wyoming Game and Fish Commission (2016)—chapter 67, Grizzly Bear Management Regulation; and</P>
                    <P>• Tri-State Memorandum of Agreement Regarding the Management, Genetic Health, and Allocation of Discretionary Mortality of Grizzly Bears in the Greater Yellowstone Ecosystem (Wyoming Game and Fish Commission et al. 2024).</P>
                    <HD SOURCE="HD1">Determination of Status for the Grizzly Bear DPS</HD>
                    <P>Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species meets the definition of an endangered species or a threatened species. The Act defines an “endangered species” as a species in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether a species meets the definition of an endangered species or a threatened species because of any of the following factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence.</P>
                    <HD SOURCE="HD2">Status Throughout All of Its Range</HD>
                    <P>Although only four of the six ecosystems currently support populations, the grizzly bear DPS has improved in abundance and estimated occupied range since the listing of the subspecies in 1975. Historically, the grizzly bear occurred throughout much of the western half of North America, with an estimated 50,000 grizzly bears distributed in one large contiguous area that included all or portions of 18 western States. Populations declined in the late 1800s with the arrival of European settlers, government-funded bounty programs, and the conversion of habitats to agricultural uses. When we listed the grizzly bear in the lower-48 States as a threatened species under the Act in 1975, grizzly bears had been reduced to less than 2 percent of their former range in the lower-48 States; at the time, the estimated population in the lower-48 States, and the proposed grizzly bear DPS, was 700 to 800 individuals with populations confined to mountainous regions, national parks, and wilderness areas.</P>
                    <P>
                        Currently, four of the six ecosystems of the grizzly bear in the grizzly bear DPS are extant (Service 2024, pp. 60-63). Two of these ecosystems have high resiliency, one has moderate resiliency, and one has low resiliency (Service 2024, pp. 13-15, 212-227). The GYE and NCDE currently have high resiliency due to the high conditions of their habitat and demographic factors, such as widely available and protected large, intact blocks of land, positive population growth rates, expanding ranges, and high survival rates of adult females (Service 2024, pp. 12, 218-219). With high resiliency, the GYE and NCDE are currently the best able of the four extant ecosystems to withstand environmental and demographic stochasticity, followed by the SE with medium resiliency and the CYE with low resiliency. Ongoing conservation actions implemented since the time of listing, such as regulatory mechanisms that reduce habitat degradation and sources of human-caused mortality, have significantly improved the resiliency of these four ecosystems over the last several decades (Service 2024, pp. 102-106, 203-205). These levels of resiliency currently reduce extinction risk for the grizzly bear in the lower-48 States. Considered together, the four resilient ecosystems provide ecological diversity, and their longitudinal and latitudinal distribution helps reduce current catastrophic risk to the grizzly 
                        <PRTPAGE P="4268"/>
                        bear DPS (Service 2024, pp. 13-15, 212-227).
                    </P>
                    <P>The current condition of the grizzly bear in the grizzly bear DPS represents a marked improvement from the conditions in 1975, when we listed the grizzly bear as a threatened species. Over the last 45 years, threats to the grizzly bear in the lower-48 States, including the proposed grizzly bear DPS, have declined and, in some cases, have been ameliorated with conservation efforts and mechanisms, including: mortality limits; Federal land protections, such as the Wilderness Act and IRAs; State and private forestlands with motorized access restrictions; habitat improvements/vegetation management; attractant removal and community sanitation measures, such as food storage orders; conservation easements; I&amp;E programs; effective law enforcement; and translocation programs (Service 2024, pp. 103-229). States, Federal agencies, and Tribes have implemented regulatory mechanisms that help address the stressors we identified, including habitat destruction and modification (Factor A), human-caused mortality (Factors B and C), and the isolated nature of some populations (Factor E).</P>
                    <P>Since the original 1975 listing, new federally designated wilderness areas and IRAs helped secure large, intact blocks of land and reduce sources of human-caused mortalities. The management of motorized access similarly reduced stressors associated with habitat loss and human access in grizzly bear habitats. Additionally, in four of the six recovery zones (GYE, NCDE, CYE, and SE), Federal land managers have adopted land management plans that contain legally binding and enforceable science- and research-based measures and management practices designed specifically to conserve the grizzly bear in the grizzly bear DPS. These regulatory mechanisms also help reduce threats associated with habitat loss and fragmentation on the Federal lands where they apply (Service 2024, pp. 102-106, 203-205). While human-caused mortality continues to be an ongoing threat to grizzly bears in the grizzly bear DPS, under current management, including the protections of the Act, human-caused mortality rates have been low enough to allow the GYE, NCDE, CYE, and SE grizzly bear populations to increase in number and range (Schwartz et al. 2006b, pp. 64-66; Schwartz et al. 2006c, p. 48; Bjornlie et al. 2014, p. 184; Costello 2019, in litt.; Costello et al. 2023, p. 14; Costello et al. 2024, in prep.; Gould et al. 2024c, in prep.; Kasworm et al. 2024a, in prep.; Kasworm et al. 2024b, in prep.; MFWP, unpublished data). Due to these and many other conservation actions, the number of grizzly bears in the grizzly bear DPS has more than doubled since the time of listing, and grizzly bears have since expanded their range and abundance, growing from occupying approximately only 2 percent of their historical range in 1975 to 6 percent in 2022 (Haroldson et al. 2021, p. 164; Costello et al. 2023, p. 14; Dellinger et al. 2023, p. 23; Kasworm et al. 2024a, 2024b, in prep.; Service 2024, pp. 60-63). As a result, the viability of the grizzly bear DPS has improved since 1975.</P>
                    <P>Given the current levels of resiliency in four of six ecosystems, the high resiliency of the GYE and NCDE, and the lack of significant and imminent stressors, the grizzly bear DPS currently has sufficient ability to withstand stochastic and catastrophic events, and to adapt to environmental changes. Therefore, we conclude that the grizzly bear DPS's current risk of extinction is low, such that the grizzly bear DPS is not currently in danger of extinction throughout all of its range.</P>
                    <P>Having determined that the grizzly bear DPS is not in danger of extinction throughout all of its range, we next considered whether the grizzly bear DPS is likely to become an endangered species within the foreseeable future throughout all of its range. We defined the foreseeable future as 30 to 45 years into the future, a timeframe that is biologically meaningful by accounting for two to three generation intervals, or the average amount of time it takes a female to breed and replace herself in the population. Given the longevity of grizzly bears, up to 37 years in the wild (Kasworm et al. 2024a, in prep.), two to three generation intervals represent a period during which a complete turnover of the population would have occurred and any changes in the demographics of the population would be detectable. This timeframe also considers the possibility that conservation measures that reduce and regulate potential stressors, such as land management plans, could be revised at least once by any applicable land management agencies (Service 2024, pp. 15-16, 228). Moreover, it is a timeframe during which we can reasonably project both future threats and the grizzly bear's response to those threats.</P>
                    <P>
                        To assist us in evaluating the status of the grizzly bear DPS over the next 30 to 45 years (
                        <E T="03">i.e.,</E>
                         the foreseeable future), we evaluated the future condition for the six grizzly bear ecosystems in the lower-48 States under five plausible future scenarios, as summarized above and discussed in our SSA report (Service 2024, pp. 232-243). Over the next 30 to 45 years, we anticipate a range of future conditions for the grizzly bear DPS, with nearly the same levels of resiliency, redundancy, and representation as current condition under one future scenario, improved conditions under two future scenarios, and decreased conditions under two future scenarios (Service 2024, pp. 15-19, 232-243). In three of the five future scenarios, the GYE and NCDE retain high resiliency, but where conservation efforts decline in the future, the resiliency for both the GYE and NCDE declines from high to moderate (Service 2024, pp. 232-235).
                    </P>
                    <P>Resiliency in the CYE and SE is also projected to decrease under future scenarios with decreased conservation (Service 2024, p. 244), such that the grizzly bear DPS is at increased risk of extinction within the foreseeable future. In the foreseeable future, the CYE and SE have moderate to very low levels of resiliency, and only achieve high resiliency under one scenario (Service 2024, p. 244), such that the CYE and SE only contribute moderate, low, or very low levels of resiliency under four of the five future scenarios (Service 2024, p. 244). Finally, the BE and North Cascades only begin to contribute to the viability of the grizzly bear DPS under two scenarios with improvements in conservation efforts (Service 2024, p. 244). To summarize, under the plausible future conditions discussed in the SSA report (Service 2024, p. 244), the grizzly bear DPS would be less likely to withstand plausible stochastic and catastrophic events, and to retain sufficient adaptive capacity to withstand environmental change, 30 to 45 years into the future.</P>
                    <P>Additionally, as human populations continue to expand across all six ecosystems, humans may engage with grizzly bears and their habitats in increasingly unpredictable ways. In the foreseeable future, continued growth of human populations could lead to increased private land development, increased recreation, additional habitat loss, and more human-bear conflicts over the next 30 to 45 years. The uncertainty associated with the stressors of human-bear conflicts, human population growth, and potential reductions in connectivity further represent a possible reduction in overall viability of the grizzly bear DPS within the foreseeable future.</P>
                    <P>
                        After evaluating threats to the species and assessing the cumulative effect of the threats under the Act's section 4(a)(1) factors, we conclude that the grizzly bear DPS is at increased risk of extinction within the foreseeable future. 
                        <PRTPAGE P="4269"/>
                        In the future, human-caused mortality would continue to be a threat to the grizzly bear DPS because regulatory mechanisms may not adequately limit sources of human-caused mortality. Further, the lack of regulatory mechanisms to address the threats of human-bear conflicts, human population growth, and potential reductions in connectivity further increases the risk of a possible reduction in the resiliency of the grizzly bear populations in the grizzly bear DPS within the foreseeable future. In addition, habitat-related threats, such as motorized access and habitat security, would likely remain an issue in the future for the CYE, SE, and North Cascades, as conservation mechanisms to address these threats are not yet finalized (North Cascades) or standards have not been met (CYE and SE). Finally, demographic recovery criteria have been achieved in only two of six recovery zones, and regulatory mechanisms are not fully in place. Management frameworks to ensure grizzly bear mortality is within sustainable thresholds independent of the Act are currently only complete and incorporated into regulatory documents for two of the six ecosystems. Thus, after assessing the best available information, we conclude that the grizzly bear DPS is not in danger of extinction but is likely to become in danger of extinction within the foreseeable future throughout all of its range.
                    </P>
                    <HD SOURCE="HD2">Status Throughout a Significant Portion of Its Range</HD>
                    <P>
                        Under the Act and our implementing regulations, a species may warrant listing if it is in danger of extinction or likely to become so within the foreseeable future throughout all or a significant portion of its range. The court in 
                        <E T="03">Center for Biological Diversity</E>
                         v. 
                        <E T="03">Everson,</E>
                         435 F. Supp. 3d 69 (D.D.C. 2020) (
                        <E T="03">Everson</E>
                        ), vacated the provision of the Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (hereafter “Final Policy”; 79 FR 37578, July 1, 2014) that provided if the Service determines that a species is threatened throughout all of its range, the Service will not analyze whether the species is endangered in a significant portion of its range.
                    </P>
                    <P>Therefore, we proceed to evaluating whether the species is endangered in a significant portion of its range—that is, whether there is any portion of the species' range for which both (1) the portion is significant; and (2) the species is in danger of extinction in that portion. Depending on the case, it might be more efficient for us to address the “significance” question or the “status” question first. We can choose to address either question first. Regardless of which question we address first, if we reach a negative answer with respect to the first question that we address, we do not need to evaluate the other question for that portion of the species' range.</P>
                    <P>
                        Following the court's holding in 
                        <E T="03">Everson,</E>
                         we now consider whether the species is in danger of extinction in a significant portion of its range. In undertaking this analysis for the grizzly bear DPS, we choose to address the status question first.
                    </P>
                    <P>We evaluated the range of the grizzly bear DPS to determine if the species is in danger of extinction in any portion of its range. The range of a species can theoretically be divided into portions in an infinite number of ways. We focused our analysis on portions of the species' range that may meet the Act's definition of an endangered species. For the grizzly bear DPS, we considered whether the threats or their effects on the species are greater in any biologically meaningful portion of the species' range than in other portions such that the species is in danger of extinction in that portion.</P>
                    <P>We examined the following threats: habitat destruction and modification, human-caused mortality, natural mortality, effects due to genetic health, effects due to changes in food resources, and effects due to climate change, including cumulative effects (Service 2024, pp. 105-230). First, we evaluated whether there are portions of the grizzly bear DPS's range with a different biological status. The BE and North Cascades ecosystems are not significant portions of the range because they do not currently support populations. Similarly, although they may support movements between ecosystems and low densities of individuals, the areas between the six ecosystems are not significant portions of the range because they lack known populations of grizzly bears (Service 2024, pp. 59, 62). To identify potential portions, we considered whether the grizzly bear has different extinction risk in one or more ecosystems. Based on the information provided in the SSA report, we determined that a portion comprised of the GYE and NCDE, both with high resiliency, currently has less extinction risk than the remaining portion comprised of the CYE and SE, with low and moderate resiliency, respectively (Service 2024, p. 13). As a result, there may be differences in biological condition across the range of the grizzly bear DPS.</P>
                    <P>The CYE and SE currently have lower levels of resiliency than the GYE and NCDE, so we explored whether a portion of the overall range consisting of the CYE and SE may have a different risk of extinction, such that the grizzly bear may have a different regulatory status in that portion of the range. The CYE currently has low resiliency, and the SE has medium resiliency, due to low abundance and genetic diversity resulting from past isolation and the species' natural slow reproductive rates. Rates of human-caused mortality in the CYE and SE are similar to those in the GYE and NCDE (Kasworm et al. 2024a, in prep.; Kasworm et al. 2024b, in prep.; Gould et al. 2024b, in prep.; MFWP, unpublished data), and all four ecosystems have experienced positive population growth rates (Service 2024, p. 235). This indicates that although the CYE and SE are currently less resilient than the GYE and NCDE, the magnitude and immediacy of the threats are currently similar across the four ecosystems. Additionally, the current levels of resiliency for the CYE and SE, and the grizzly bear's distribution across the two ecosystems, are sufficient for the grizzly bear to withstand stochastic and catastrophic events within the portion. Therefore, we determined that the grizzly bear is not in danger of extinction within the portion composed of the CYE and SE.</P>
                    <P>
                        We found no biologically meaningful portion of the grizzly bear DPS where threats are impacting individuals differently from how they are affecting the species elsewhere in its range, or where the biological condition of the species differs from its condition elsewhere in its range. Therefore, no portion of the DPS's range provides a basis for determining that the grizzly bear is in danger of extinction in a significant portion of the range, and we determine that the grizzly bear DPS is likely to become in danger of extinction within the foreseeable future throughout all of its range. This does not conflict with the courts' holdings in 
                        <E T="03">Desert Survivors</E>
                         v. 
                        <E T="03">U.S. Department of the Interior,</E>
                         321 F. Supp. 3d 1011, 1070-74 (N.D. Cal. 2018) and 
                        <E T="03">Center for Biological Diversity</E>
                         v. 
                        <E T="03">Jewell,</E>
                         248 F. Supp. 3d 946, 959 (D. Ariz. 2017) because, in reaching this conclusion, we did not apply the aspects of the Final Policy, including the definition of “significant” that those court decisions held to be invalid.
                    </P>
                    <HD SOURCE="HD2">Determination of Status</HD>
                    <P>
                        Based on the best scientific and commercial data available, we 
                        <PRTPAGE P="4270"/>
                        determine that the grizzly bear DPS meets the Act's definition of a threatened species. Therefore, we propose to list the grizzly bear DPS as a threatened species in accordance with sections 3(20) and 4(a)(1) of the Act.
                    </P>
                    <HD SOURCE="HD2">Relationship of the Grizzly Bear DPS to Experimental Populations</HD>
                    <P>We have designated two experimental populations for the grizzly bear in the lower-48 States: one in the BE (65 FR 69624; November 17, 2000) and one in the North Cascades (89 FR 36982; May 3, 2024). Currently, grizzly bears have not been reintroduced to either area. Below, we clarify that these two experimental populations are part of the proposed grizzly bear DPS, consistent with our findings for the experimental population designations.</P>
                    <P>When we designate an experimental population for a species under the Act, we must find by regulation that such release will further the conservation of the species. See 50 CFR 17.81(b) for factors we consider in making such a finding. Furthermore, we must determine whether the experimental population is, or is not, essential to the continued existence of the species in the wild (50 CFR 17.81(c)(2)).</P>
                    <P>In both our experimental population designations for grizzly bears, we found that establishment of the experimental populations would further the conservation of the species (that is, grizzly bear in the lower-48 States). We also found that neither experimental population is essential to the continued existence of the grizzly bear in the lower-48 States.</P>
                    <P>This proposed rule would revise the entry for grizzly bear on the List of Endangered and Threatened Wildlife at 50 CFR 17.11(h) to clarify where grizzly bears are currently found or are likely to be found in the future as populations recover. Under this proposed rule, we would also retain the current entries at 50 CFR 17.11(h) for the Bitterroot and North Cascades nonessential experimental populations of the grizzly bear, as well as the applicable regulations at 50 CFR 17.84(l) and (y), respectively, unless we undertake separate rulemaking to revise or remove one or both of them. If we finalize this rule as proposed, the grizzly bear DPS will contain all currently extant populations of grizzly bears in the United States, as well as those areas likely to be occupied by grizzly bears in the future. This area includes both designated experimental populations. This proposed rule would not change the individuals of the species that are or will be protected by the Act, and grizzly bears would continue to be listed as a threatened species under the Act. As such, the two experimental populations would continue to be members of the grizzly bear DPS, and our previous findings for the two experimental populations designated for the grizzly bear would remain relevant and applicable to the grizzly bear DPS. The basis for those findings is summarized below.</P>
                    <P>Restoring grizzly bears to the BE and the NCE will further the conservation of grizzly bears by establishing additional populations in portions of the species' historical range where the species is presently extirpated. The recovery plan includes an objective to recover grizzly bears in all of the ecosystems known to have suitable space and habitat (USFWS 1993, pp. 15-16). Reestablishing grizzly bears in the BE and NCE will fulfill important recovery needs for the grizzly bear in the lower-48 States.</P>
                    <P>For both the North Cascades and Bitterroot experimental populations, we also confirm that these experimental populations of grizzly bears are not essential to the continued existence of the grizzly bear DPS. Because there are approximately 2,200 grizzly bears in other ecosystems in the lower-48 States that are intensively monitored and managed, the loss of either experimental population would not appreciably reduce the likelihood of survival of the species in the wild. Therefore, as required by 50 CFR 17.81(c)(2), we continue to find that the experimental populations are not essential to the continued existence of the species in the wild. For the BE, we are currently in the process of reassessing options for restoring grizzly bears to that ecosystem (89 FR 3411, January 18, 2024), which could result in revising or removing that experimental population designation.</P>
                    <HD SOURCE="HD1">II. Proposed Revision of the Protective Regulations Under Section 4(d) of the Act for the Grizzly Bear</HD>
                    <HD SOURCE="HD2">Background</HD>
                    <P>Section 4(d) of the Act states that the Secretary shall issue such regulations as she deems necessary and advisable to provide for the conservation of species listed as threatened species. Conservation is defined in the Act to mean the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Additionally, section 4(d) of the Act states that the Secretary may by regulation prohibit with respect to any threatened species any act prohibited under section 9(a)(1), in the case of fish or wildlife, or section 9(a)(2), in the case of plants. Congress delegated broad authority to the Secretary to determine what protections would be necessary and advisable to provide for the conservation of threatened species, and even broader authority to put in place any of the section 9 prohibitions for a given species.</P>
                    <P>
                        The courts have recognized the extent of the Secretary's discretion under this standard to develop rules that are appropriate for the conservation of a species. For example, courts have upheld, as a valid exercise of agency authority, rules developed under section 4(d) that included limited prohibitions against takings (see 
                        <E T="03">Alsea Valley Alliance</E>
                         v. 
                        <E T="03">Lautenbacher,</E>
                         2007 WL 2344927 (D. Or. 2007); 
                        <E T="03">Washington Environmental Council</E>
                         v. 
                        <E T="03">National Marine Fisheries Service,</E>
                         2002 WL 511479 (W.D. Wash. 2002)). Courts have also upheld 4(d) rules that do not address all of the threats a species faces (see 
                        <E T="03">State of Louisiana</E>
                         v. 
                        <E T="03">Verity,</E>
                         853 F.2d 322 (5th Cir. 1988)). As noted in the Act's legislative history, “once an animal is on the threatened list, the Secretary has an almost infinite number of options available to [her] with regard to the permitted activities for those species. [She] may, for example, permit taking, but not importation of such species, or [she] may choose to forbid both taking and importation but allow the transportation of such species” (H.R. Rep. No. 412, 93rd Cong., 1st Sess. 1973).
                    </P>
                    <P>
                        The grizzly bear (
                        <E T="03">Ursus arctos horribilis</E>
                        ) currently has a species-specific protective regulation at 50 CFR 17.40(b), which we are proposing to amend. The provisions of this species' proposed protective regulations under section 4(d) of the Act are one of the many tools that we would use to promote the conservation of the grizzly bear within the DPS. There are also population-specific protective regulations under section 10(j) of the Act for two nonessential experimental populations, the North Cascades and Bitterroot, that are not affected by this proposed rule, and any changes to those population-specific regulations would require separate rulemaking processes with opportunities for public review and comment.
                    </P>
                    <P>
                        Nothing in 4(d) rules change in any way the recovery planning provisions of section 4(f) of the Act, the consultation requirements under section 7 of the Act, or the ability of the Service to enter into partnerships for the management and protection of the grizzly bear DPS. Section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they authorize, 
                        <PRTPAGE P="4271"/>
                        fund, or carry out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of designated critical habitat of such species. In addition, even before the listing of any species or the designation of its critical habitat is finalized, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any agency action which is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of critical habitat proposed to be designated for such species. These requirements are the same for a threatened species regardless of what is included in its 4(d) rule.
                    </P>
                    <P>
                        Section 7 consultation is required for Federal actions that “may affect” a listed species regardless of whether take caused by the activity is prohibited or excepted by a 4(d) rule (the “blanket rule” at 50 CFR 17.31(a) or species-specific 4(d) rule). A 4(d) rule does not change the process and criteria for informal or formal consultations and does not alter the analytical process used for biological opinions or concurrence letters. For example, as with an endangered species, if a Federal agency determines that an action is “not likely to adversely affect” a threatened species, this will require the Service's written concurrence (50 CFR 402.13(c)). Similarly, if a Federal agency determines that an action is “likely to adversely affect” a threatened species, the action will require formal consultation with the Service and the formulation of a biological opinion (50 CFR 402.14(a)). Because consultation obligations and processes remain in effect despite the issuance of 4(d) rules, we may consider developing tools to streamline future intra-Service and interagency consultations for actions that result in forms of take that are not prohibited by the 4(d) rule (but that still require consultation). These tools may include consultation guidance; streamlined, online consultation processes via the Service's digital project planning tool (Information for Planning and Consultation; 
                        <E T="03">https://ipac.ecosphere.fws.gov/</E>
                        ); template language for biological opinions; or programmatic consultations.
                    </P>
                    <HD SOURCE="HD2">Provisions of the Proposed 4(d) Rule for the Grizzly Bear DPS</HD>
                    <P>
                        Exercising the Secretary's authority under section 4(d) of the Act, we have developed a proposed rule that is designed to address the grizzly bear DPS's conservation needs. As discussed previously in Summary of Biological Status and Threats, we have concluded that the grizzly bear DPS is likely to become an endangered species within the foreseeable future primarily due to habitat destruction and modification, human-caused mortality, and the isolated nature of some populations. Section 4(d) requires the Secretary to issue such regulations as she deems necessary and advisable to provide for the conservation of each threatened species and authorizes the Secretary to include among those protective regulations any of the prohibitions that section 9(a)(1) of the Act prescribes for endangered species. We are not required to make a “necessary and advisable” determination when we apply or do not apply specific section 9 prohibitions to a threatened species (
                        <E T="03">In re: Polar Bear Endangered Species Act Listing and 4(d) Rule Litigation,</E>
                         818 F. Supp. 2d 214, 228 (D.D.C. 2011) (citing 
                        <E T="03">Sweet Home Chapter of Cmtys. for a Great Or.</E>
                         v. 
                        <E T="03">Babbitt,</E>
                         1 F.3d 1, 8 (D.C. Cir. 1993), 
                        <E T="03">rev'd on other grounds,</E>
                         515 U.S. 687 (1995))). Nevertheless, even though we are not required to make such a determination, in the interest of transparency we explain below our finding that, if finalized, the protections, prohibitions, and exceptions in this proposed rule as a whole satisfy the requirement in section 4(d) of the Act to issue regulations deemed necessary and advisable to provide for the conservation of the grizzly bear DPS.
                    </P>
                    <P>The protective regulations we are proposing for the grizzly bear DPS incorporate prohibitions from section 9(a)(1) of the Act to address the threats to the species. The prohibitions of section 9(a)(1) of the Act, and implementing regulations codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to commit, to attempt to commit, to solicit another to commit, or to cause to be committed any of the following acts with regard to any endangered wildlife: (1) import into, or export from, the United States; (2) take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct) within the United States, within the territorial sea of the United States, or on the high seas; (3) possess, sell, deliver, carry, transport, or ship, by any means whatsoever, any such wildlife that has been taken illegally; (4) deliver, receive, carry, transport, or ship in interstate or foreign commerce, by any means whatsoever and in the course of commercial activity; or (5) sell or offer for sale in interstate or foreign commerce. We also propose to prohibit the acts of possessing, selling, delivering, carrying, transporting, or shipping, by any means whatsoever, grizzly bears that have been taken legally with specific exceptions described below. This protective regulation includes all of these prohibitions because the grizzly bear DPS is at risk of extinction within the foreseeable future and putting these prohibitions in place will help to conserve the species' remaining populations, slow its rate of decline, and decrease synergistic, negative effects from other stressors. In particular, this proposed 4(d) rule would provide for the conservation of the grizzly bear DPS by prohibiting the following activities, unless they fall within specific exceptions or are otherwise authorized or permitted: importing or exporting; take; possession and other acts with taken specimens; delivering, receiving, carrying, transporting, or shipping in interstate or foreign commerce in the course of commercial activity; or selling or offering for sale in interstate or foreign commerce.</P>
                    <P>Under the Act, “take” means to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. Some of these provisions have been further defined in regulations at 50 CFR 17.3. Take can result knowingly or otherwise, by direct and indirect impacts, intentionally or incidentally. Regulating take would help preserve the species' remaining populations, slow their rate of decline, and decrease synergistic, negative effects from other stressors. Therefore, we propose to prohibit take of the grizzly bear DPS, except for take resulting from those actions and activities specifically excepted by the 4(d) rule.</P>
                    <P>
                        Exceptions to the prohibitions would include allowing Federal and State law enforcement officers to possess, deliver, carry, transport, or ship grizzly bears as necessary in performing their official duties and additional exceptions, as described below. Despite the prohibitions regarding threatened species, we may under certain circumstances authorize one or more otherwise-prohibited activities, including those described above. The regulations that govern permits for threatened wildlife state that the Director may issue a permit authorizing any activity otherwise prohibited with regard to threatened species. These include permits issued for the following purposes: for scientific purposes, to enhance propagation or survival, for economic hardship, for zoological exhibition, for educational purposes, for incidental taking, or for special 
                        <PRTPAGE P="4272"/>
                        purposes consistent with the purposes of the Act (50 CFR 17.32). The statute also contains certain exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.
                    </P>
                    <P>Grizzly bears may obtain anthropogenic food sources, such as pet food, garbage, or livestock, if they are not properly secured. Grizzly bears that repeatedly obtain anthropogenic foods (food-conditioned bears) can become a threat to human safety. Additionally, depredating grizzly bears can affect the livelihood of ranchers and other livestock owners. The prompt response or removal of depredating and food-conditioned grizzly bears helps to prevent or minimize negative impacts, such as human safety concerns and livestock losses, leading to broader social receptiveness and tolerance. When limited by sustainable mortality rates according to specific populations or areas, lethal removal is an important component of long-term grizzly bear recovery that does not inhibit grizzly bear population growth. In this proposed 4(d) rule, we consider strategies, including nonlethal and lethal methods (depending on the site-specific situation), to increase human safety and reduce human-bear conflicts and thereby promote recovery of the grizzly bear DPS.</P>
                    <P>To further the conservation of the species, we propose not to apply the exceptions at 50 CFR 17.31(b), and instead propose multiple species-specific exceptions. For example, we propose that any employee or agent of the Service, any other Federal land management agency, the National Marine Fisheries Service, a State conservation agency, or a federally recognized Tribe, who is designated by their agency or Tribe for such purposes, may, when acting in the course of their official duties, take grizzly bears with prior authorization from the Service if such action is necessary to dispose of a dead specimen or salvage a dead specimen that may be useful for scientific study.</P>
                    <P>This proposed 4(d) rule clarifies grizzly bear management strategies on public and private lands in accordance with recovery status. This includes the requirement that agencies obtain prior authorization from the Service for conflict removals, as described in a memorandum of understanding (MOU) between the Service and authorized agency. Authorized agencies may relocate bears as a preemptive action to prevent conflict that appears imminent or in an attempt to break the habituated behavior of grizzly bears lingering near human-occupied areas. When a grizzly bear is captured, the employee will consult with the appropriate land management agency to determine a relocation site that is most suitable for the bear, considering age and sex of the bear, conflict history, and current human use at available relocation sites. Such taking must be coordinated with the Service as described in a current MOU between the Service and the authorized agency. In addition, we propose to except certain take associated with livestock grazing on private lands and public allotments, private property protection, authorized agency take outside of areas important for recovery or connectivity, grizzly bear deterrence, and take associated with trapping of other species for research or management conducted by authorized agencies; we describe each in more detail below.</P>
                    <HD SOURCE="HD3">(1) Public Land Grazing Allotments Outside Recovery Zones</HD>
                    <P>If authorized by the Service, take of grizzly bear depredating livestock on grazing allotments on public land outside of Recovery Zones would be excepted under a written, time-limited, conditioned lethal take authorization issued to an individual if the following conditions are met: (1) a depredation of livestock has been confirmed by the Service or authorized agency; and (2) the Service or authorized agency determine a grizzly bear poses a demonstrable and ongoing threat. The Service would consider various factors, including recovery status of the population involved, history of conflict in the area, severity of the incident, mitigation efforts in place, and alternative actions available prior to authorization.</P>
                    <HD SOURCE="HD3">(2) Private Land Livestock Operations Outside Recovery Zones</HD>
                    <P>
                        In addition to the excepted take described above, a producer, lessee, or designee would be allowed to take (injure or kill) a grizzly bear in the act of attacking livestock or working dogs on private land located outside of Recovery Zones provided that: (1) there were no excessive, unsecured attractants (
                        <E T="03">e.g.,</E>
                         carcasses or bone piles); (2) there was no intentional feeding or baiting of the grizzly bear or other wildlife; (3) the carcass of any grizzly bear taken and the area surrounding the carcass is not disturbed; (4) the take is reported to the Service or authorized agency within 24 hours; and (5) the Service or authorized agency is able to confirm that the livestock or working dog was injured or killed by a grizzly bear. The taking of any grizzly bear without such evidence may be referred to the appropriate authorities for prosecution. Authorized agencies must report such take to the Service within 24 hours.
                    </P>
                    <HD SOURCE="HD3">(3) Private Lands Outside Recovery Zones</HD>
                    <P>
                        If authorized by the Service, take of a grizzly bear on private lands outside of Recovery Zones would be excepted under a written, time-limited, conditioned lethal take authorization issued to an individual to kill a grizzly bear if the Service or an authorized agency identifies the bear as posing a demonstrable and ongoing threat to human safety or to other property (
                        <E T="03">e.g.,</E>
                         compost, chickens, beehives). The Service would consider various factors, including recovery status of the population involved, history of conflict in the area, severity of the incident, mitigation efforts in place, and alternative actions available prior to authorization.
                    </P>
                    <HD SOURCE="HD3">(4) Outside of Areas Important for Recovery or Connectivity</HD>
                    <P>This proposed 4(d) rule prescribes management practices within areas most important for recovery—such as recovery zones, areas adjacent to recovery zones, and current and potential connectivity zones—while allowing more flexible management in areas deemed less important for recovery within the proposed DPS. Areas less important for recovery include portions of Wyoming outside the DMA, as well as areas that do not have the potential to provide for connectivity as identified by the Service and partners in a planning document, such as a recovery plan, conservation strategy, or similar agency document. For example, Zone 3 identified in the NCDE Conservation Strategy does not provide for recovery or connectivity and therefore is an area where these management practices would apply. In these areas that are less important for recovery, take would be excepted for authorized agencies without prior authorization from the Service and without first attempting relocation if that bear meets the definition of a grizzly bear involved in conflict as described in this proposed rule. In these areas, authorized agencies may also issue written, time-limited, conditioned lethal take authorization under the conditions described in (b)(3)(vii) and (b)(3)(viii)(B) of this section.</P>
                    <HD SOURCE="HD3">(5) Deterrence</HD>
                    <P>
                        Take caused by conducting deterrence of grizzly bears for the purposes of avoiding human-bear conflicts or to discourage bears from using areas near homes and other human-occupied areas would be excepted from the take 
                        <PRTPAGE P="4273"/>
                        prohibitions when the deterrence is conducted according to Service-approved best practices, which are, at this time, the Service's current hazing guidelines. Deterrence means an intentional, nonlethal action to haze, disrupt, or annoy a grizzly bear out of close proximity to people or property to promote human safety, prevent conflict, or protect property. The deterrence must not cause lasting bodily injury to any grizzly bear and must be undertaken safely and responsibly. Acceptable deterrence techniques may include nonprojectile auditory deterrents, visual stimuli/deterrents, vehicle threat pressure, bear spray, noise-making projectiles, or soft projectiles fired from non-powder-actuated launchers intended to break on contact. For more information about appropriate nonlethal deterrents, individuals can contact the Service for the most current Service-approved best practices. Any person may deter a grizzly bear to protect themselves (
                        <E T="03">e.g.,</E>
                         using bear spray or loud noises). An individual may not bait, stalk, or pursue a grizzly bear for the purposes of deterrence. Individuals may deter grizzly bears away from the immediate vicinity, defined as 200 meters (656 feet), of a human-occupied residence or potential source of conflict. Once bears have moved beyond the immediate vicinity (200 meters (656 feet)), hazing is unlikely to be effective and is not excepted take under this proposed rule. Authorized agencies would be allowed to use additional tools, including contracted services for hazing as described in a current MOU.
                    </P>
                    <HD SOURCE="HD3">(6) Trapping of Other Species for Research and Management</HD>
                    <P>
                        The 4(d) rule would also provide for the conservation of the species by excepting otherwise prohibited take associated with several activities either intended to incentivize conservation actions or that are expected to have negligible impacts to the grizzly bear DPS. Although the activities may result in some minimal level of take of the grizzly bear DPS, such take is not expected to rise to a level that would have a negative impact (
                        <E T="03">i.e.,</E>
                         would have only de minimis impacts) on the species' conservation. We propose to except incidental take associated with research and management trapping of other species, such as the gray wolf (
                        <E T="03">Canis lupus</E>
                        ) and wolverine (
                        <E T="03">Gulu gulu</E>
                        ), by an authorized agency provided the trap is securely anchored to prevent a grizzly bear from leaving the area and traps are checked at least every 24 hours. This provision does not authorize the use of neck snares.
                    </P>
                    <P>We recognize the special and unique relationship that we have with our State natural resource agency partners in contributing to conservation of listed species. State agencies often possess scientific data and valuable expertise on the status and distribution of endangered, threatened, and candidate species of wildlife and plants. State agencies, because of their authorities and their close working relationships with local governments and landowners, are in a unique position to assist us in implementing the Act. Section 6 of the Act provides that we must cooperate to the maximum extent practicable with the States in carrying out programs authorized by the Act. Therefore, any employee of a State conservation agency that is a party to a signed and valid cooperative agreement pursuant to section 6(c) of the Act, who is designated by their agency for such purposes, would be able to conduct activities designed to conserve the grizzly bear DPS that may result in otherwise prohibited take without additional authorization, including surveys; tagging, handling and capture; and habitat management activities undertaken for the conservation benefit of the species. Under the proposed 4(d) rule, States would be “authorized agencies” for purpose of undertaking grizzly bear management, including lethal removal in conflict situations as described above, if approved by the Service in accordance with the 4(d) rule and implemented through a current MOU between the Service and the State. Under the proposed 4(d) rule, the authorization for employees or agents of States to remove grizzly bears from the State for the purposes of population introduction, population augmentation, or relocation to mitigate human-bear conflicts, or lethal removal of a grizzly bear in conflict, would replace the exception set forth in 50 CFR 17.31(b)(3).</P>
                    <HD SOURCE="HD2">Required Determinations</HD>
                    <HD SOURCE="HD3">Clarity of the Rule</HD>
                    <P>We are required by Executive Order (E.O.) 12866 and E.O. 12988 and by the Presidential memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:</P>
                    <P>(1) Be logically organized;</P>
                    <P>(2) Use the active voice to address readers directly;</P>
                    <P>(3) Use clear language rather than jargon;</P>
                    <P>(4) Be divided into short sections and sentences; and</P>
                    <P>(5) Use lists and tables wherever possible.</P>
                    <P>
                        If you feel that we have not met these requirements, send us comments by one of the methods listed in 
                        <E T="02">ADDRESSES</E>
                        . To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.
                    </P>
                    <HD SOURCE="HD3">
                        National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 
                        <E T="03">et seq.</E>
                        )
                    </HD>
                    <P>
                        Regulations adopted pursuant to section 4(a) of the Act are exempt from the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 
                        <E T="03">et seq.</E>
                        ) and do not require an environmental analysis under NEPA. We published a document outlining our reasons for this determination in the 
                        <E T="04">Federal Register</E>
                         on October 25, 1983 (48 FR 49244). This includes listing, delisting, and reclassification rules, as well as critical habitat designations and species-specific protective regulations promulgated concurrently with a decision to list or reclassify a species as threatened. The courts have upheld this position (
                        <E T="03">e.g., Douglas County</E>
                         v. 
                        <E T="03">Babbitt,</E>
                         48 F.3d 1495 (9th Cir. 1995) (critical habitat); 
                        <E T="03">Center for Biological Diversity</E>
                         v. 
                        <E T="03">U.S. Fish and Wildlife Service,</E>
                         2005 WL 2000928 (N.D. Cal. Aug. 19, 2005) (concurrent 4(d) rule)).
                    </P>
                    <HD SOURCE="HD3">Government-to-Government Relationship With Tribes</HD>
                    <P>
                        In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951, May 4, 1994), E.O. 13175 (Consultation and Coordination with Indian Tribal Governments), the President's memorandum of November 30, 2022 (Uniform Standards for Tribal Consultation; 87 FR 74479, December 5, 2022), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with federally recognized Tribes on a government-to-government basis. In accordance with Secretary's Order (SO) 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. In accordance with joint SO 3403 A1 of 
                        <PRTPAGE P="4274"/>
                        November 30, 2022, we recognize our responsibility to ensure our decisions with respect to wildlife safeguard the interests of potentially affected Tribes. We solicited information from the Tribes within the proposed grizzly bear DPS to inform the development of our SSA report, but we did not receive any responses. We will continue to coordinate with affected Tribes during the development of any final rules for the grizzly bear DPS, as appropriate.
                    </P>
                    <HD SOURCE="HD1">References Cited</HD>
                    <P>
                        A complete list of references cited in this rulemaking is available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         and upon request from the Grizzly Bear Recovery Office (see 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        ).
                    </P>
                    <HD SOURCE="HD1">Authors</HD>
                    <P>The primary authors of this proposed rule are the staff members of the U.S. Fish and Wildlife Service's Grizzly Bear Recovery Office.</P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 50 CFR Part 17</HD>
                        <P>Endangered and threatened species, Exports, Imports, Plants, Reporting and recordkeeping requirements, Transportation, Wildlife.</P>
                    </LSTSUB>
                    <HD SOURCE="HD1">Proposed Regulation Promulgation</HD>
                    <P>Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:</P>
                    <PART>
                        <HD SOURCE="HED">PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 17 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.</P>
                    </AUTH>
                    <AMDPAR>2. In § 17.11, in paragraph (h), amend the List of Endangered and Threatened Wildlife by revising the entry for “Bear, grizzly” under MAMMALS to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 17.11</SECTNO>
                        <SUBJECT>Endangered and threatened wildlife.</SUBJECT>
                        <STARS/>
                        <P>(h) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L2,nj,tp0,p7,7/8,i1" CDEF="s50,r50,r50,xls30,r75">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Common name</CHED>
                                <CHED H="1">Scientific name</CHED>
                                <CHED H="1">Where listed</CHED>
                                <CHED H="1">Status</CHED>
                                <CHED H="1">Listing citations and applicable rules</CHED>
                            </BOXHD>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Mammals</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Bear, grizzly [Grizzly Bear DPS]</ENT>
                                <ENT>
                                    <E T="03">Ursus arctos horribilis</E>
                                </ENT>
                                <ENT>U.S.A.: All of WA and portions of MT, ID, and WY, except where listed as an experimental population, as follows: (1) Northern boundary—the portion south of the western terminus of the U.S.-Canada border in WA east to Montana Highway 16; (2) Eastern boundary—the portion west of Montana Highway 16 south from the U.S.-Canada border to Interstate 94 continuing south to Montana Highway 47, then to Interstate 90, then to Highway 25, then to Wyoming Highway 220, then to Wyoming Highway 287 to the intersection with Interstate 80; (3) Southern boundary—the portion north of Interstate 80 west to Highway 30, then follows the Snake River near Pocatello, ID, to the WA State line to the Pacific Ocean; (4) Western boundary—the portion east of the coast of WA north to the U.S.-Canada border</ENT>
                                <ENT>T</ENT>
                                <ENT>
                                    32 FR 4001, 3/11/1967; 35 FR 16047, 10/13/1970; 40 FR 31734, 7/28/1975; 72 FR 14866, 3/29/2007; 75 FR 14496, 3/26/2010; 82 FR 30502, 6/30/2017; 84 FR 37144, 7/31/2019; [
                                    <E T="04">Federal Register</E>
                                     citation when published as a final rule]; 50 CFR 17.40(b).
                                    <SU>4d</SU>
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                    <AMDPAR>3. Amend § 17.40 by revising paragraph (b) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 17.40</SECTNO>
                        <SUBJECT>Species-specific rules—mammals.</SUBJECT>
                        <STARS/>
                        <P>
                            (b) Grizzly bear (
                            <E T="03">Ursus arctos horribilis</E>
                            ), Grizzly bear DPS. (1) 
                            <E T="03">Definitions.</E>
                             As used in paragraph (b) of this section:
                        </P>
                        <P>
                            <E T="03">Authorized agency</E>
                             means a Federal, State, or Tribal agency designated by the Service in a memorandum of understanding (MOU) to assist in implementing all or part of the specified actions in paragraph (b)(3) of this section.
                        </P>
                        <P>
                            <E T="03">Deterrence</E>
                             means an intentional, nonlethal action to haze, disrupt, or annoy a grizzly bear out of close proximity to people or property to promote human safety, prevent conflict, or protect property.
                        </P>
                        <P>
                            <E T="03">Grizzly bear</E>
                             means any member of the species 
                            <E T="03">Ursus arctos horribilis</E>
                             within the grizzly bear DPS, as described in 50 CFR 17.11(h), including any part, offspring, dead body, part of a dead body, or product of such species.
                        </P>
                        <P>
                            <E T="03">Grizzly bear involved in conflict</E>
                             means a grizzly bear that has caused substantial property damage, obtained anthropogenic foods (
                            <E T="03">e.g.,</E>
                             pet food, livestock feed, garbage), killed or injured lawfully present livestock, damaged beehives, breached an intact structure or electrified perimeter to obtain fruit or crops (
                            <E T="03">e.g.,</E>
                             greenhouse, garden, orchard, field, stackyard or grain bin), shown repeated and persistent signs of habituation in proximity to human-occupied areas (
                            <E T="03">e.g.,</E>
                             has been repeatedly hazed or previously relocated), exhibited aggressive behavior (
                            <E T="03">i.e.,</E>
                             not acting in defense of offspring or food or in response to a surprise encounter), or has been involved in a human-grizzly encounter resulting in 
                            <PRTPAGE P="4275"/>
                            substantial human injury or loss of human life.
                        </P>
                        <P>
                            <E T="03">Habituation</E>
                             means the decrease of an animal's flight response following repeated exposure to inconsequential stimuli.
                        </P>
                        <P>
                            <E T="03">Human food-conditioned bear</E>
                             means a grizzly bear that has learned to associate people, human activities, human-use areas, or food storage receptacles with anthropogenic food as a result of repeatedly accessing anthropogenic foods without negative consequences on numerous occasions.
                        </P>
                        <P>
                            <E T="03">In the act of attacking</E>
                             means the actual biting, wounding, grasping, or killing by a grizzly bear.
                        </P>
                        <P>
                            <E T="03">Incidental take</E>
                             is take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity; it must be unintentional and not due to negligent conduct.
                        </P>
                        <P>
                            <E T="03">Lasting bodily injury/injured</E>
                             means damage that limits a grizzly bear's ability to effectively move, obtain food, or defend itself for any length of time.
                        </P>
                        <P>
                            <E T="03">Non-target</E>
                             means a bear that is caught that is not believed to be the bear that is involved in the conflict.
                        </P>
                        <P>
                            <E T="03">Prior authorization from the Service</E>
                             means that an approved representative from the U.S. Fish and Wildlife Service, as specified in a current MOU, has agreed with the proposed management action.
                        </P>
                        <P>
                            <E T="03">Recovery Zones</E>
                             are outlined in the 1993 Recovery Plan, and subsequent supplements, and identify six recovery ecosystems, each containing a recovery zone at its core, within the lower-48 States thought to be capable of supporting grizzly bears.
                        </P>
                        <P>
                            <E T="03">Self-defense</E>
                             means that the person was acting to protect himself or herself, or any other individual, from bodily harm.
                        </P>
                        <P>
                            <E T="03">Serious injury</E>
                             means any permanent damage or injury that limits a grizzly bear's ability to effectively move, obtain food, or defend itself for any length of time.
                        </P>
                        <P>
                            <E T="03">Sick</E>
                             means affected with disease or ill health.
                        </P>
                        <P>
                            <E T="03">Threat to human safety</E>
                             means a grizzly bear that exhibits aggressive, non-defensive, behavior towards humans. Grizzly bear presence alone does not constitute a threat to human safety. Grizzly bears less than 2 years of age with no history of food-conditioning are not considered a threat to human safety.
                        </P>
                        <P>
                            <E T="03">Working dog</E>
                             means a herding or guard dog that is actively herding or guarding in close proximity to human-occupied areas or to lawfully present livestock.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Prohibitions.</E>
                             The following prohibitions that apply to endangered wildlife also apply to the grizzly bear DPS. Except as provided under paragraph (b)(3) of this section and §§ 17.4 and 17.5, it is unlawful for any person subject to the jurisdiction of the United States to commit, to attempt to commit, to solicit another to commit, or cause to be committed, any of the following acts in regard to this species:
                        </P>
                        <P>(i) Import or export, as set forth at § 17.21(b) for endangered wildlife.</P>
                        <P>(ii) Take, as set forth at § 17.21(c)(1) for endangered wildlife.</P>
                        <P>(iii) Possession, delivery, carriage, transport, or shipment of unlawfully or lawfully taken specimens of grizzly bears.</P>
                        <P>(iv) Interstate or foreign commerce in the course of commercial activity, as set forth at § 17.21(e) for endangered wildlife.</P>
                        <P>(v) Sale or offer for sale, as set forth at § 17.21(f) for endangered wildlife.</P>
                        <P>
                            (3) 
                            <E T="03">Exceptions from prohibitions.</E>
                             The following exceptions to the prohibitions apply to the grizzly bear DPS:
                        </P>
                        <P>(i) Federal, State, or Tribal authorities may import grizzly bears into the United States for scientific or research purposes with prior authorization from the Service.</P>
                        <P>(ii) Any person may conduct activities as authorized by a permit under § 17.32.</P>
                        <P>(iii) Any employee or agent of the Service, or any employee or agent of another Federal agency, State agency, or federally recognized Tribe defined in a current MOU with the Service who, as part of their official duties, normally handles large carnivores and is trained and/or experienced in immobilizing, marking, and handling grizzly bears (which we define as a Federal, State, or Tribal “authority”), may, when acting in the course of official duties, take or collect samples from a grizzly bear in the wild consistent with this paragraph (b) and the applicable MOU if such action is necessary for scientific, genetic, or population augmentation purposes.</P>
                        <P>(A) Mortalities or suspected serious injury must be reported to the Service as described in a current MOU.</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Take that results in a grizzly bear mortality must be reported to the Service within 24 hours.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Take that results in a grizzly bear injury must be reported to the Service within 5 days.
                        </P>
                        <P>(B) Authorized agencies may move a grizzly bear to aid recovery or increase the genetic health of the population after notification to the Service.</P>
                        <P>(C) In the absence of an MOU, a permit under § 17.32 is required.</P>
                        <P>(iv) Any person may take a grizzly bear in defense of their own life or the lives of others. Grizzly bears taken in self-defense or in defense of human life must be reported by the individual who has taken the bear or their designee within 24 hours of occurrence. Take must be reported to the Office of Law Enforcement, U.S. Fish and Wildlife Service, in the appropriate region (see 50 CFR 2.2 for regional office information), and to appropriate State and Tribal authorities. The specimen may only be retained, disposed of, or salvaged with the consent of, and consistent with directions from, the Office of Law Enforcement.</P>
                        <P>(v) Take is excepted for authorized agencies aiding sick and injured grizzly bears when conducted in a humane manner. Take associated with orphaned cubs must have prior authorization from the Service except when the conditions under paragraph (b)(3)(vi) apply.</P>
                        <P>(vi) An employee or agent of a Federal, State, or federally recognized Tribe defined in a current MOU with the Service who, as part of their official duties, normally handles large carnivores may, when acting in the course of official duties, humanely take a grizzly bear in the wild with prior authorization from the Service in order to avoid conflicts, prevent habituation, improve grizzly bear survival, release or relocate non-targets, aid in law enforcement investigations, salvage bear carcasses, or euthanize severely wounded bears under the following criteria:</P>
                        <P>(A) Efforts are made to eliminate such threat or depredation, when reasonably possible, by securing attractants, using deterrence, or live-capturing and releasing the bear unharmed in a remote area.</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Authorized agencies may relocate bears as a preemptive action for the purpose of preventing conflict that appears imminent or breaking habituated behavior of grizzly bears lingering near human-occupied areas.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) When a grizzly bear is captured, the employee or agent will consult with the appropriate land management agency to determine a relocation site that is most suitable for the bear, considering the age and sex of the bear, conflict history, and current human use at available relocation sites. Such taking must be coordinated with the Service as described in a current MOU.
                        </P>
                        <P>
                            (B) In grizzly bear Recovery Zones, management actions by authorized agencies include lethal removal of a grizzly bear involved in conflict (as defined in paragraph (b)(1) of this section) when the condition set forth in paragraph (b)(3)(vi)(A) of this section is met, with authorization from the Service, taking into consideration the 
                            <PRTPAGE P="4276"/>
                            age and sex of the bear, nature of the conflict, and the bear's conflict history.
                        </P>
                        <P>(C) Outside of areas important for recovery or connectivity as identified by the Service in a final recovery plan, or with the Service in an approved conservation strategy, other similar agency planning document, or, in Wyoming, outside the DMA, authorized agencies may, without prior approval from the Service:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Lethally remove a bear without first attempting relocation if it has been determined to be a grizzly bear involved in conflict, as defined in paragraph (b)(1) of this section.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Issue a written, time-limited, conditioned lethal take authorization as set forth in paragraphs (b)(3)(vii) and (b)(3)(viii)(A) of this section.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) When taking a bear or authorizing a take of a bear under this authority, the authorized agency assumes the responsibility of correctly applying the definition of a grizzly bear involved in conflict as defined in paragraph (b)(1) of this section.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) Authorized agencies must report any lethal take to the Service within 24 hours of the incident if take is by the agency, or within 24 hours of reporting if take is associated with a lethal take authorization.
                        </P>
                        <P>(vii) On public land grazing allotments outside Recovery Zones the Service may issue written, time-limited, conditioned lethal take authorization to an individual if all of the following conditions are met:</P>
                        <P>(A) All conditions set forth in paragraph (b)(3)(vi)(A) have been met;</P>
                        <P>(B) A depredation of livestock has been confirmed by the Service or authorized agency; and</P>
                        <P>(C) With the consideration of the recovery status of the population involved, the history of conflict in the area, and the severity of the incident, the Service or authorized agency determines that a bear is a demonstrable and ongoing threat.</P>
                        <P>(viii) On private lands outside Recovery Zones, the Service may authorize an individual to take a grizzly bear when all conditions set forth in paragraph (b)(3)(vi)(A) have been met, provided that:</P>
                        <P>(A) The Service issues a written, time-limited, conditioned lethal take authorization as described in paragraph (b)(3)(vii); and</P>
                        <P>
                            (B) The Service or an authorized agency identifies the bear as a demonstrable and ongoing threat to human safety or to protect property (
                            <E T="03">e.g.,</E>
                             compost, chickens, beehives). The identification will include consideration of the recovery status of the population involved, the history of conflict in the area, and the severity of the incident.
                        </P>
                        <P>(ix) On private lands outside Recovery Zones, a producer, lessee, or designee may take (injure or kill) a grizzly bear in the act of attacking livestock or working dogs on private land outside Recovery Zones provided:</P>
                        <P>
                            (A) Excessive unsecured attractants (
                            <E T="03">e.g.,</E>
                             carcasses or bone piles) are absent;
                        </P>
                        <P>(B) There was no intentional feeding or baiting of the grizzly bear or wildlife;</P>
                        <P>(C) The take is reported to the Service or authorized agency within 24 hours. If a report of lethal take is made to an authorized agency, then that agency must report that take to the Service within 24 hours;</P>
                        <P>(D) The Service or authorized agency is able to confirm that the livestock or working dog was injured or killed by a grizzly bear. The taking of any grizzly bear without such evidence may be referred to the appropriate authorities for prosecution; and (E) For lethal take, the carcass of any grizzly bear taken and the area surrounding it is not disturbed to preserve the physical evidence that the take was conducted according to these regulations.</P>
                        <P>(x) Take in the form of harassment is excepted for individuals to conduct deterrence of grizzly bears for the purposes of avoiding human-bear conflicts or to discourage bears from using areas near homes and other human-occupied areas under the following conditions:</P>
                        <P>(A) Any deterrence must be conducted in accordance with Service-approved best practices.</P>
                        <P>
                            (B) Any deterrence must not cause lasting bodily injury to any grizzly bear (
                            <E T="03">i.e.,</E>
                             permanent damage or injuries that limit the bear's ability to effectively move, obtain food, or defend itself for any length of time) or death to the grizzly bear.
                        </P>
                        <P>(C) Acceptable deterrence techniques may include non-projectile auditory deterrents, visual stimuli/deterrents, bear spray, vehicle threat pressure, noise-making projectiles, or soft projectiles fired from non-powder-actuated launchers intended to break on contact. Unacceptable deterrence methods include screamers, whistlers, rubber bullets, batons, bean bag and aero sock rounds, or other contact projectiles not intended to break on contact due to their potential to cause lasting injury. For more information about appropriate nonlethal deterrents, individuals can contact the U.S. Fish and Wildlife Service, in the appropriate region (see 50 CFR 2.2 for regional office information).</P>
                        <P>
                            (D) Anyone may deter a grizzly bear in the case of self-defense (
                            <E T="03">e.g.,</E>
                             by using bear spray or loud noises), but an individual must not bait, stalk, or pursue a grizzly bear for the purposes of deterrence.
                        </P>
                        <P>(E) Individuals may deter grizzly bears away from the immediate vicinity, defined as 200 meters (656 feet), of a human-occupied residence or potential source of conflict. Once bears have moved beyond the immediate vicinity (200 meters (656 feet)), deterrence must cease.</P>
                        <P>(F) Authorized agencies may use additional tools, including contracted services, as described in a current MOU.</P>
                        <P>
                            (xi) An authorized agency may take a grizzly bear if that take is incidental to, and not the purpose of, an otherwise lawful research and management trapping for other species, such as wolverine (
                            <E T="03">Gulu gulu</E>
                            ) and gray wolf (
                            <E T="03">Canis lupus</E>
                            ), provided that:
                        </P>
                        <P>(A) The trap is securely anchored to prevent a grizzly bear from leaving the area;</P>
                        <P>(B) The trap is checked at least every 24 hours;</P>
                        <P>(C) Trapping does not include use of neck snares; and</P>
                        <P>(D) Incidental take that results in a grizzly bear mortality must be reported to the Service within 24 hours; or</P>
                        <P>(E) Incidental take that results in a grizzly bear injury must be reported to the Service within 5 days.</P>
                        <P>(xii) In coordination with the Service's Office of Law Enforcement, authorized Federal, State, or Tribal employees, when acting in the course of their official duties, may, for scientific or research purposes, possess, deliver, carry, transport, ship, export, or receive grizzly bears.</P>
                        <P>(xiii) Federal and State law enforcement officers may possess, deliver, carry, transport, or ship grizzly bears as necessary in performing their official duties.</P>
                        <STARS/>
                    </SECTION>
                    <SIG>
                        <NAME>Martha Williams,</NAME>
                        <TITLE>Director, U.S. Fish and Wildlife Service.</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2025-00329 Filed 1-14-25; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 4333-15-P</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4277"/>
            <PARTNO>Part VI</PARTNO>
            <AGENCY TYPE="PNR">Department of Defense</AGENCY>
            <AGENCY TYPE="PNR">General Services Administration</AGENCY>
            <AGENCY TYPE="P">National Aeronautics and Space Administration</AGENCY>
            <CFR>48 CFR Parts 1, 2, 3, et al.</CFR>
            <TITLE>Federal Acquisition Regulation: Controlled Unclassified Information; Proposed Rule</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="4278"/>
                    <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                    <AGENCY TYPE="O">GENERAL SERVICES ADMINISTRATION</AGENCY>
                    <AGENCY TYPE="O">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                    <CFR>48 CFR Parts 1, 2, 3, 4, 5, 7, 9, 11, 12, 15, 27, 33, 42, 52, and 53</CFR>
                    <DEPDOC>[FAR Case 2017-016, Docket No. 2017-0016, Sequence No. 1]</DEPDOC>
                    <RIN>RIN 9000-AN56</RIN>
                    <SUBJECT>Federal Acquisition Regulation: Controlled Unclassified Information</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Proposed rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement the National Archives and Records Administration's Controlled Unclassified Information Program enacted under an Executive Order entitled Controlled Unclassified Information.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>Interested parties should submit written comments to the Regulatory Secretariat Division at the address shown below on or before March 17, 2025 to be considered in the formation of the final rule.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            Submit comments in response to FAR Case 2017-016 to the Federal eRulemaking portal at 
                            <E T="03">https://www.regulations.gov</E>
                             by searching for “FAR Case 2017-016”. Select the link “Comment Now” that corresponds with “FAR Case 2017-016”. Follow the instructions provided on the “Comment Now” screen. Please include your name, company name (if any), and “FAR Case 2017-016” on your attached document. If your comment cannot be submitted using 
                            <E T="03">https://www.regulations.gov,</E>
                             call or email the points of contact in the 
                            <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                             section of this document for alternate instructions.
                        </P>
                        <P>
                            <E T="03">Instructions:</E>
                             Please submit comments only and cite “FAR Case 2017-016” in all correspondence related to this case. Public comments may be submitted as an individual, as an organization, or anonymously (see frequently asked questions at 
                            <E T="03">https://www.regulations.gov/faq</E>
                            ). Comments submitted in response to this rule will be made publicly available and are subject to disclosure under the Freedom of Information Act. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information, or any information that you would not want publicly disclosed unless you follow the instructions below for confidential comments. Summary information of the public comments received, including any specific comments, will be posted on 
                            <E T="03">https://www.regulations.gov.</E>
                        </P>
                        <P>All filers using the portal should use the name of the person or entity submitting comments as the name of their files, in accordance with the instructions below. Anyone submitting business confidential/proprietary information should clearly identify any business confidential/proprietary portion at the time of submission, file a statement justifying nondisclosure and referencing the specific legal authority claimed, and provide a non-confidential/non-proprietary version of the submission. Any business confidential information should be in an uploaded file that has a file name beginning with the characters “BC.” Any page containing business confidential information must be clearly marked “BUSINESS CONFIDENTIAL/PROPRIETARY” on the top of that page.</P>
                        <P>
                            The corresponding non-confidential/non-proprietary version of those comments must be clearly marked “PUBLIC.” The file name of the non-confidential version should begin with the character “P.” The “BC” and “P” should be followed by the name of the person or entity submitting the comments or rebuttal comments. All filers should name their files using the name of the person or entity submitting the comments. Any submissions with file names that do not begin with a “BC” will be assumed to be public and will be made publicly available through 
                            <E T="03">https://www.regulations.gov.</E>
                        </P>
                        <P>
                            To confirm receipt of your comment(s), please check 
                            <E T="03">https://www.regulations.gov,</E>
                             approximately two-to-three days after submission to verify posting.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            For clarification of content, contact Mr. Michael O. Jackson, Procurement Analyst, at 202-821-9776 or by email at 
                            <E T="03">michaelo.jackson@gsa.gov.</E>
                             For information pertaining to status, publication schedules, or alternate instructions for submitting comments if 
                            <E T="03">https://www.regulations.gov</E>
                             cannot be used, contact the Regulatory Secretariat Division at 202-501-4755 or 
                            <E T="03">GSARegSec@gsa.gov.</E>
                             Please cite FAR Case 2017-016.
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P/>
                    <HD SOURCE="HD1">I. Background</HD>
                    <P>
                        Today, Federal information and information systems are increasingly the targets of sophisticated attacks by criminals and our adversaries, as well as subject to risks involving non-adversarial threats (
                        <E T="03">e.g.,</E>
                         accidental misuse of information). Executive Order (E.O.) 13556, 
                        <E T="03">Controlled Unclassified Information,</E>
                         established the Controlled Unclassified Information (CUI) Program to manage information that requires safeguarding or dissemination controls and designated the National Archives and Records Administration (NARA) as the executive agent of the CUI Program.
                    </P>
                    <P>
                        NARA published a final rule on September 14, 2016 (81 FR 63324) to implement the CUI requirements of E.O. 13556. As part of the implementation of the NARA final rule, NARA maintains a registry (
                        <E T="03">https://www.archives.gov/cui</E>
                        ) of unclassified information that requires safeguarding or dissemination controls. NARA's CUI Registry identifies the organizational index grouping and related categories of information and specifies how the information should be marked and disseminated, among other actions that must be taken.
                    </P>
                    <P>NARA's rule codified uniform policies and procedures for marking, safeguarding, disseminating, decontrolling, and disposing of CUI for Federal executive branch agencies at 32 CFR part 2002. These policies also affect contractors that are expected to collect, develop, receive, transmit, use, handle, or store CUI during contract performance. To apply the policies to contractors, the CUI Program must be incorporated into the acquisition process, specifically, when agencies define their requirements, issue solicitations, and award contracts. In order to do so, Government and contractor roles and responsibilities for safeguarding, using, marking, disseminating, and decontrolling CUI residing on both Federal and non-Federal information systems must be identified.</P>
                    <P>
                        DoD has implemented the requirements of the CUI Program within the clause at Defense Federal Acquisition Regulation Supplement (DFARS) 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting. DoD has also proposed amending the DFARS to incorporate contractual requirements associated with the Cybersecurity Maturity Model Certification program (CMMC) in order to verify contractor implementation of security controls through a proposed rule published in the 
                        <E T="04">Federal Register</E>
                         on August 15, 2024, at 89 FR 66327. Separately, the CMMC program was established in Title 32 of the Code of Federal Regulations through a final rule published in the 
                        <PRTPAGE P="4279"/>
                        <E T="04">Federal Register</E>
                         on October 15, 2024, at 89 FR 83092.
                    </P>
                    <P>DoD, GSA, and NASA are proposing to revise the FAR to implement NARA's final rule on the Federal CUI Program as it relates to performance under Federal contracts. The Privacy Act requirements at FAR part 24 are not changed by this rulemaking.</P>
                    <P>DoD, GSA, and NASA propose to create a common mechanism, the Standard Form XXX, Controlled Unclassified Information (CUI) Requirements, to enable a uniform process for communicating the information contractors must manage and safeguard as well as identify where a CUI incident must be reported and when there are CUI incident reporting requirements that differ from or are in addition to those in the clause at FAR 52.204-XX(g). Currently laws, Federal regulations, and Government-wide policies already mandate these protections, but there is not a standard way these requirements are identified and shared with contractors.</P>
                    <P>This proposed rule is just one element of a larger strategy to improve the Government's efforts to identify, deter, protect against, detect, and respond to increasingly sophisticated criminals and adversaries targeting Federal information and information systems.</P>
                    <HD SOURCE="HD1">II. Discussion and Analysis</HD>
                    <P>The proposed rule introduces a new standard form (SF) to support uniformity in Governmentwide implementation of these policies. It identifies roles and responsibilities for agencies and contractors when controlled unclassified information (CUI) is located on Federal information systems within a Federal facility or resides on or transits through contractor information systems or within contractor facilities, and it adds two new clauses and a provision to enable contractor reporting and compliance responsibilities in Federal solicitations and contracts.</P>
                    <P>The proposed rule is intended to provide for the following:</P>
                    <P>(1) SF XXX, Controlled Unclassified Information (CUI) Requirements, was developed to promote consistency, assist Federal agencies and contractors in the identification of CUI in agency requirements, and uniformly define all associated handling requirements in accordance with 32 CFR part 2002. The SF XXX will be included in solicitations and contracts that may result in the handling of CUI that will ultimately become performance requirements during contract performance.</P>
                    <P>(2) FAR 2.101 definitions for “contractor-attributional information,” “controlled unclassified information (CUI),” “CUI incident,” and “CUI Registry” are added to provide clarification as these terms are new to the FAR. The definition of “information system” is moved from FAR subpart 4.19 to 2.101. The term “Federally-controlled information system” is updated to “Federal information system.”</P>
                    <P>(3) FAR 3.104-4 is amended to clarify that certain information must be marked by the contractor before submitting it to the Government (contractor bid or proposal information, contractor-attributional information, contractor proprietary business information, and source selection information). Contracting officers should consult with the contractor if they are unsure whether information provided by the contractor falls into one of these categories. Contracting officers who are unsure how to handle such information, including whether it is CUI, should consult with agency officials as necessary.</P>
                    <P>(4) FAR subpart 4.4:</P>
                    <P>• The subpart heading is revised to read “Safeguarding Information and Information Systems” since the information referred to in subpart 4.4 is not limited to classified information and now includes CUI.</P>
                    <P>• Section 4.401 is amended to add a definition for “information” which was moved and revised from the definition currently at FAR 4.1901.</P>
                    <P>• At FAR 4.403 and 4.404, the current content is moved to FAR 4.402.</P>
                    <P>• FAR 4.403 is replaced with new content that provides instructions on the implementation of the CUI Program. The added language identifies the contracting officer's role in receiving and incorporating the SF XXX in solicitations and contracts and the contracting officer's responsibilities during contract administration. A new provision at FAR 52.204-WW, Notice of Controlled Unclassified Information Requirements, and new clauses at FAR 52.204-XX, Controlled Unclassified Information, and 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information, are also prescribed. The changes for FAR 4.403 include the following:</P>
                    <P> Existing FAR 4.403 has been renumbered as FAR 4.402-2.</P>
                    <P> The clause at FAR 4.404 was moved to a new FAR 4.402-3.</P>
                    <P> FAR 4.403-1 adds definitions for “CUI Basic,” “CUI categories,” “CUI Specified,” “handling,” “lawful Government purpose,” “limited dissemination control,” and “on behalf of an agency.”</P>
                    <P> FAR 4.403-2 provides information on E.O. 13556 including that the E.O. establishes NARA as the executive agent for the CUI Program.</P>
                    <P> FAR 4.403-3 gives the applicability of the SF XXX and the new FAR clauses 52.204-XX and 52.204-YY.</P>
                    <P> FAR 4.403-4 outlines the CUI policy and requires that CUI involved in performance of a contract shall be identified on a SF XXX and incorporated into the contract. Unmarked or mismarked CUI is not considered a CUI incident unless the mismarking or lack of marking has resulted in the mishandling or improper dissemination of the information. Offerors are requested and contractors are required to notify the Government within an 8 hour timeframe if they discover or suspect information is CUI, but that CUI is not listed on an SF XXX or is not marked or properly marked.</P>
                    <P> FAR 4.403-5 adds the usage of the SF XXX. The SF XXX itself has detailed instructions.</P>
                    <P> FAR 4.403-6 provides that the agency point of contact to whom the contractor reports an incident is found in the SF XXX at Part C, Section IV. When the SF XXX is not used in a contract, the point of contact is identified in FAR 52.204-YY(b). FAR 4.403-6 explains that the SF XXX should list any special incident reporting requirements for CUI Specified. FAR 4.403-6 also adds that the contracting officer shall provide instructions to the contractor for submitting the system images, in accordance with agency procedures. FAR 4.403-6 also explains that the contractor is required to hold the system images for 90 days unless the Government declines interest.</P>
                    <P> FAR 4.403-7 requires the contracting officer to insert the clause at FAR 52.204-XX, Controlled Unclassified Information, or the clause at FAR 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information, and to insert the provision at FAR 52.204-WW, Notice of Controlled Unclassified Information Requirements, in solicitations and contracts, excluding solicitations and contracts solely for the acquisition of commercially available off-the-shelf (COTS) items.</P>
                    <P>• FAR 4.404 clause prescription is moved to FAR 4.403-7. Coverage from FAR subpart 4.19 has been moved to FAR 4.404.</P>
                    <P>
                        • Several organizational changes, including relocation of text and definitions from FAR subpart 4.19, improve the logical flow of information.
                        <PRTPAGE P="4280"/>
                    </P>
                    <P>• FAR 4.404-1 adds definitions for “covered contractor information system” and “covered Federal information.” The term “Federal contract information” was changed to “covered Federal information” to align with the term “covered contractor information system,” and the definition of “covered Federal information” was revised to clarify that the term excludes CUI and classified information. The definition of “covered Federal information” is also amended in FAR clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems.</P>
                    <P>
                        • FAR 4.404-2, Applicability, has been added to state that while covered Federal information is not required to be marked or identified by the Government, some administrative markings (
                        <E T="03">e.g.,</E>
                         draft, deliberative process, predecisional, not for public release) can indicate that the information is covered Federal information.
                    </P>
                    <P>• FAR 4.404-3 has been added to require the contracting officer to insert the clause at FAR 52.204-21, Basic Safeguarding of Covered Contractor Information Systems, in solicitations and contracts, excluding solicitations and contracts solely for the acquisition of COTS items or Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189 when the agency does not provide any covered Federal information to the contractor. FAR 4.404-3 replaces the clause prescription section at FAR 4.1903. The prescription for the clause at FAR 52.204-21 was updated to match the prescription for the CUI clause, because, while both types of information are likely to be in a wide range of contracts, covered Federal information is more ubiquitous than CUI and it may be difficult for the contracting officer to identify during development of the solicitation when covered Federal information may be applicable for the procurement.</P>
                    <P>• FAR 4.1301 and 4.1303 have been updated to remove the references to “PUB Number” and “PUB” and edit the term “Federally-controlled information system” to make it “Federal information system”.</P>
                    <P>(5) FAR 7.103, Agency-head responsibilities. New language is added to describe agency planners' responsibilities for compliance with 32 CFR part 2002 and the completion of the SF XXX during acquisition planning.</P>
                    <P>(6) FAR 7.105, Contents of written acquisition plans. CUI is added to the security considerations to be addressed during acquisition planning.</P>
                    <P>(7) At FAR 7.503, Policy, language has been revised to clarify that the list of examples of functions generally not considered to be inherently governmental functions, includes contractors working in any situation that permits or might permit them to gain access to CUI.</P>
                    <P>(8) FAR subpart 9.5, Organizational and Consultant Conflicts of Interest, includes updates to FAR 9.505, 9.505-4, and 9.508 to make clear proprietary information is contractor proprietary business information.</P>
                    <P>(9) FAR 11.002, Policy. New language is added to incorporate the requirements for CUI and use of the SF XXX when describing agency needs.</P>
                    <P>(10) FAR 12.202, Market research and description of agency need. New language is added to incorporate the requirements for CUI and the SF XXX in requirements documents for the acquisition of commercial products and commercial services.</P>
                    <P>(11) At FAR 15.407-1, a reference to CUI and classified information is added to clarify the type of information that should be protected from improper disclosure.</P>
                    <P>(12) At FAR subpart 15.6, conforming changes are made to change “proprietary information” and “restrictive legend” or “legend” to “contractor proprietary business information” and “administrative marking,” respectively.</P>
                    <P>(13) FAR 27.203, Security requirements for patent applications and other patent information. A new section is added to inform contracting officers that CUI safeguarding requirements apply to patent application and other patent information.</P>
                    <P>(14) FAR part 52. A new provision FAR 52.204-WW, Notice of Controlled Unclassified Information Requirements, is added to inform offerors of requirements on restricted use of Government-provided information, on appropriately identifying sensitive offeror-provided information, and on notifying the Government regarding unmarked or mismarked CUI. A new FAR clause 52.204-XX, Controlled Unclassified Information, is added to require contractors to comply with applicable CUI requirements, if the SF XXX indicates that the contractor is expected to collect, develop, receive, transmit, use, handle, or store CUI under the contract. A new FAR clause 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information, is added to apply to contracts in which the requiring activity indicates on the SF XXX that no CUI is involved in the performance of the contract. CUI requirements include:</P>
                    <P>• Requirements for how the contractor must mark CUI submitted to the Government and notify the Government of any mismarked or unmarked CUI discovered;</P>
                    <P>• Restrictions on the contractor's use of Government-provided information apply whether or not the information is marked as CUI;</P>
                    <P>• Requirements for safeguarding CUI residing on Federal and non-Federal systems, as identified in the SF XXX, Controlled Unclassified Information (CUI) Requirements;</P>
                    <P>• Requirements for reporting and managing security incidents;</P>
                    <P>• Actions that may be necessary to validate compliance;</P>
                    <P>• Minimum CUI training requirements; and</P>
                    <P>• The requirement for contractors to flow down CUI requirements to subcontractors, if applicable.</P>
                    <P>(15) FAR 52.204-21, Basic Safeguarding of Covered Contractor Information Systems. Text is added for the definition and at paragraph (b)(3) for the identification of “covered Federal information”.</P>
                    <P>(16) FAR clause 52.212-5 is updated to reflect that FAR clause 52.204-XX is applicable to acquisitions of commercial products and services. FAR clause 52.213-4 is updated to reflect usage of the FAR 52.204-XX clause in simplified acquisitions for other than commercial products or services. FAR clause 52.244-6 is updated to address the flow down to subcontracts for the two new clauses.</P>
                    <P>(17) Additional minor edits are made at FAR 1.106 to add the OMB control number information for the provision and clause, at FAR 42.302 to update a cross-reference, and at FAR subpart 53.2 to add the new SF XXX, Controlled Unclassified Information (CUI) Requirements.</P>
                    <HD SOURCE="HD1">III. Applicability to Contracts at or Below the Simplified Acquisition Threshold (SAT) and for Commercial Products, Including Commercially Available Off-the-Shelf (COTS) Items, or Commercial Services</HD>
                    <P>
                        This rule proposes a new provision at FAR 52.204-WW, Notice of Controlled Unclassified Information Requirements. The proposed provision is prescribed at FAR 4.403-7(a) for use in solicitations that contain the clause at FAR 52.204-XX or the clause at FAR 52.204-YY. The rule proposes a new clause at FAR 52.204-XX, Controlled Unclassified Information. The proposed clause is 
                        <PRTPAGE P="4281"/>
                        prescribed at FAR 4.403-7(b) for use in solicitations and contracts if the requiring activity has marked the “Yes” box in Part A of the SF XXX, except for solicitations and contracts solely for the acquisition of COTS items. The rule proposes a new clause at FAR 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information. The proposed clause is prescribed at FAR 4.403-7(c) for use in solicitations and contracts if the requiring activity has marked the “No” box in Part A of the SF XXX, excluding solicitations and contracts solely for the acquisition of COTS items.
                    </P>
                    <P>This rule also proposes to amend the FAR to implement 32 CFR part 2002, Controlled Unclassified Information, in Federal solicitations and contracts. The objective of the rule is to implement uniform, Governmentwide policies and procedures for Federal agencies and contractors regarding handling of CUI. Since CUI requires protection regardless of dollar value or commerciality of the product or service, this rule will apply to contracts at or below the SAT and to commercial products and commercial services. The rule does not apply to contracts that are solely for the acquisition of COTS items.</P>
                    <HD SOURCE="HD1">IV. Expected Impact of the Rule</HD>
                    <HD SOURCE="HD2">A. General Compliance Requirements</HD>
                    <P>Under the terms of this proposed rule, contractors will be required to safeguard CUI that the Government identifies in the standard form (SF) XXX, Controlled Unclassified Information (CUI) Requirements, and ensure handling consistent with 32 CFR part 2002. This includes CUI that the agency provides to the contractor, or CUI that the contractor collects, develops, receives, transmits, uses, handles, or stores in performance of the contract. CUI is defined at FAR 2.101 as information that the Government creates or possesses, or that an entity creates or possesses for or on behalf of the Government, that a law, regulation, or Governmentwide policy requires or permits an agency to handle using safeguarding or dissemination controls.</P>
                    <P>The contractor shall permit access to CUI only as described in the SF XXX. A contractor will need to review the SF XXX to determine what information under the contract is considered CUI and how to properly safeguard the CUI. If the contractor intends to flow CUI down to a subcontractor, then the contractor will also be required to prepare an SF XXX and distribute it to the subcontractor to ensure the subcontractor properly safeguards CUI. Any contractor or subcontractor employee that handles CUI will be required to complete training on safeguarding CUI, as specified on the SF XXX.</P>
                    <P>
                        Identification of CUI on the SF XXX triggers compliance requirements as specified in the new contract clause at FAR 52.204-XX, Controlled Unclassified Information, 
                        <E T="03">e.g.,</E>
                         security requirements in NIST SP 800-171, Revision 2, or controls in NIST SP 800-53 depending on the type of information systems that process, store, or transmit CUI. The compliance requirements are discussed in more detail in section IV.C. of this preamble and will vary depending on the organizational Index Grouping and category of CUI being handled under the contract and how the information is being collected, developed, received, transmitted, used, handled, or stored. Prime contractors that flow down CUI to subcontractors will also be required to flow down the compliance requirements of the clause at FAR 52.204-XX; a requirement that applies at all subcontract tiers. The new clause at FAR 52.204-YY also flows down to subcontracts.
                    </P>
                    <P>A new solicitation provision at FAR 52.204-WW, Notice of Controlled Unclassified Information Requirements, is prescribed for use in solicitations that contain the new clause at FAR 52.204-XX or the new clause at FAR 52.204-YY. This provision provides a notice to offerors that agencies will provide agency procedures on handling CUI during the solicitation phase if handling CUI is necessary to prepare an offer. The notice also advises offerors that contractor bid or proposal information, proprietary business information, or contractor-attributional information must be properly marked to ensure adequate protection of their information. The provision also advises offerors that they should notify the contracting officer if there appears to be unmarked or mismarked CUI or an incident related to CUI handled by the offeror during the solicitation phase.</P>
                    <P>When the contract does not identify CUI, the new contract clause at FAR 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information, is used in lieu of the CUI clause. Similar to the solicitation provision, this clause requires the contractor to notify the Government if there appears to be unmarked or mismarked CUI or a suspected CUI incident related to information handled by the contractor in performance of the contract. This clause requires the contractor to properly mark proprietary business information or contractor-attributional information to ensure adequate protection.</P>
                    <P>The new solicitation provision and the new contract clauses all forbid an offeror or contractor from using Government-provided information for its own purposes, whether or not the information is marked as CUI, unless the information is in the public domain, or unless the information is lawfully made available to the offeror or contractor by someone other than the Government.</P>
                    <HD SOURCE="HD2">B. Benefits</HD>
                    <HD SOURCE="HD3">1. Uniform Cybersecurity Hygiene Baseline</HD>
                    <P>Establishing uniform requirements for how the acquisition workforce and Federal contractors manage CUI will significantly improve the Government and Federal contractors' ability to protect Federal information and information systems from criminals and our adversaries. Absent the uniform approach proposed in this rule, agencies will continue to employ ad hoc, agency-specific policies to manage this information, an approach that can cause agencies to mark and handle information inconsistently and inefficiently. While waivers may be applied in some circumstances, this rule is intended to establish a Governmentwide baseline that will lead to more effective implementation of protections for this sensitive information by the acquisition workforce and contractors. More effective implementation of requirements for identifying and marking CUI will reduce scenarios in which contractors may not realize the information that they are handling is sensitive information that must be safeguarded.</P>
                    <HD SOURCE="HD3">2. Protection From Potential Financial Impacts of CUI Incidents</HD>
                    <P>
                        Failure to adopt these basic cybersecurity requirements can have a substantial financial impact on a business. There have been many analyses regarding the cost of cybersecurity incidents and the estimates vary widely. In order to establish a defensible set of cost and loss data that is suitable for the analysis of cybersecurity incident costs in the Federal sector, the Cyber Security and Infrastructure Security Agency (CISA) Office of the Chief Economist (OCE), in the Department of Homeland Security, reviewed a broad range of cyber cost and loss studies and presented an analysis of the per-incident, aggregate, and scenario-based estimates of cyber loss. On October 26, 2020, the CISA 
                        <PRTPAGE P="4282"/>
                        OCE released a report with the results of their analyses and a summary of per-incident loss estimates available in the most widely cited published research, commercial datasets, and industry reports. OCE estimated the median cost of a cybersecurity incident cited in the surveyed publications ranged from $0.5 to $1.6 million. The maximum cost per incident cited ranged from $11.7 million to greater than $1 billion. The CISA OCE acknowledges in its report that the differences in the assumptions, approaches to data collection, and specific incidents included in the datasets for the above sources result in a high degree of variability among the loss estimates.
                        <SU>1</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             CISA OCE. (2020). 
                            <E T="03">Cost of a Cyber Incident: Systematic Review and Cross-Validation. https://www.cisa.gov/sites/default/files/publications/CISA-OCE_Cost_of_Cyber_Incidents_Study-FINAL_508.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Increased Protection of Sensitive Information</HD>
                    <P>Given the potential financial impacts a CUI incident may have on companies and individuals, it is imperative that Federal contractors who are entrusted with sensitive information in the performance of Government contracts adopt the basic cybersecurity hygiene requirements outlined in this rule. This increased baseline of cybersecurity hygiene across Federal contractors will reduce the number of incidents that have the potential to place sensitive information at risk and pose serious threats to individuals, Federal operations and assets, and the contractors themselves. For the remaining incidents that may occur, the requirement for contractors to report suspected or confirmed CUI incidents within 8 hours, unless a different time period is required for a specific category of CUI or a Federally-controlled facility, will allow the Federal Government to have appropriate situational awareness, quickly respond to the incident, and reduce the impact of the event.</P>
                    <HD SOURCE="HD2">C. Public Costs</HD>
                    <P>The total estimated public costs associated with this FAR rule in billions over a 10-year period are as follows:</P>
                    <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s50,12,12">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">Public cost</CHED>
                            <CHED H="1">Undiscounted</CHED>
                            <CHED H="1">2 Percent</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Present Value</ENT>
                            <ENT>$17.63</ENT>
                            <ENT>$15.89</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Annualized</ENT>
                            <ENT>1.76</ENT>
                            <ENT>1.77</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>Undiscounted public costs (in billions) by year over the 10-year period are summarized as follows:</P>
                    <GPOTABLE COLS="10" OPTS="L2,tp0,i1" CDEF="s25,8C,8C,8C,8C,8C,8C,8C,8C,8C">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">Year 1</CHED>
                            <CHED H="1">Year 2</CHED>
                            <CHED H="1">Year 3</CHED>
                            <CHED H="1">Year 4</CHED>
                            <CHED H="1">Year 5</CHED>
                            <CHED H="1">Year 6</CHED>
                            <CHED H="1">Year 7</CHED>
                            <CHED H="1">Year 8</CHED>
                            <CHED H="1">Year 9</CHED>
                            <CHED H="1">Year 10</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">$2.28</ENT>
                            <ENT>$1.71</ENT>
                            <ENT>$1.71</ENT>
                            <ENT>$1.71</ENT>
                            <ENT>$1.71</ENT>
                            <ENT>$1.71</ENT>
                            <ENT>$1.71</ENT>
                            <ENT>$1.71</ENT>
                            <ENT>$1.71</ENT>
                            <ENT>$1.71</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        The following is a summary from the Regulatory Impact Analysis (RIA) of the specific compliance requirements and the estimated costs of compliance. The new FAR clause is modeled after the most recent version of the clause at DFARS 252.204-7012, which introduced many of these compliance requirements on defense contractors and subcontractors in 2015 and required compliance not later than December 31, 2017. Therefore, the estimated costs of compliance have been segregated into those that are new for Federal offerors, contractors, and subcontractors (see section IV.C.1 of this preamble) and those that are new only for non-defense contractors and subcontractors (see section IV.C.2 of this preamble). The RIA includes a detailed discussion and explanation about the assumptions and methodology used to estimate the cost of this regulatory action, including the specific impact and costs for small businesses. Public comment is requested on the RIA, which is available at 
                        <E T="03">https://www.regulations.gov</E>
                         (search for “FAR Case 2017-016,” click “Open Docket,” and view “Supporting Documents”).
                    </P>
                    <HD SOURCE="HD3">1. Federal Offerors, Contractors, and Subcontractors</HD>
                    <P>The following compliance requirements are considered new for Federal offerors, contractors, and subcontractors required to safeguard CUI:</P>
                    <HD SOURCE="HD3">a. Regulatory Familiarization</HD>
                    <P>Familiarization accounts for the time to read and understand the rule. It is expected that most contractors will be required to become familiar with the various compliance requirements of the FAR, in order to be prepared to handle or receive CUI in performance of a Federal contract. According to award data in the Federal Procurement Data System (FPDS) for fiscal year (FY) 2021 through FY 2023, on average per year the Government awards contracts and orders for supplies and services to 67,547 unique contractors, all of whom are expected to become familiar with this rule. It is estimated that on average it will take two hours per contractor and subcontractor that handle CUI to review the rule. The estimated cost for regulatory familiarization in the first year of implementation is $10,267,144 (67,547 contractors and subcontractors * 2 hours/entity * $76/hour), of which $6,711,104 is attributed to 44,152 small businesses.</P>
                    <HD SOURCE="HD3">b. Review the SF XXX</HD>
                    <P>Offerors, contractors, or subcontractors will need to review the SF XXX to determine the information under the contract or subcontract that is considered CUI and how to properly safeguard the CUI. It is estimated that approximately 22,680 offerors, contractors, and subcontractors may review 2,092,918 forms for information on how to protect CUI each year. On average, it is estimated that it will take an offeror, contractor, or subcontractor two hours to review the SF XXX. The estimated annual cost to review standard forms is $334,866,880 (2,092,918 forms * 2 hours/form * $80), of which $5,058,880 is attributed to 15,809 small businesses.</P>
                    <HD SOURCE="HD3">c. Prepare and Distribute the SF XXX</HD>
                    <P>
                        If the contractor intends to flow down CUI to a subcontractor, then the contractor must prepare an SF XXX and distribute it to the subcontractor to ensure the subcontractor properly safeguards CUI. It is estimated 517,392 standard forms may be prepared and distributed by contractors and 
                        <PRTPAGE P="4283"/>
                        subcontractors each year. On average, it is estimated that it will take the contractor or subcontractor two hours to prepare and distribute the SF XXX. The estimated annual cost to prepare and distribute the SF XXX is $82,782,270 (517,392 forms * 2 hours/form * $80), of which $2,529,440 is attributed to 15,809 small business contractors and subcontractors.
                    </P>
                    <HD SOURCE="HD3">d. Train Employees on Handling CUI</HD>
                    <P>A contractor shall not permit any contractor employee to collect, develop, receive, transmit, use, handle, or store CUI unless the employee has completed training on properly handling CUI as described in the SF XXX. The contractor must provide evidence of employee training upon request by the contracting officer; however, such requests are expected to be limited to, for example, instances in which the Government is dealing with a CUI incident. It is estimated that approximately 2,191,400 contractor and subcontractor employees may be required to take training on handling CUI, which is expected to take one hour to complete. It is anticipated that agencies will provide their support contractors and personnel with CUI standard training aligned with Federal policy.</P>
                    <P>The estimated annual training cost is $166,546,400 (2,191,400 employees * 1 hour/employee * $76/hour), of which $26,440,400 is attributed to 34,790 small business contractors and subcontractors. The estimated annual recordkeeping cost to maintain contractor training records is $10,003,741 (2,191,400 records * 0.083 hours/record * $55/hour), of which $1,588,164 is attributed to the 34,790 small businesses. The estimated annual reporting cost is $19,664 (1,430 requests * 0.25 hours/response * $55/hour), of which $13,401 is attributed to 975 small businesses.</P>
                    <HD SOURCE="HD3">e. Comply With NIST SP 800-172</HD>
                    <P>A limited number of contractors may be required to implement NIST SP 800-172, Enhanced Security Requirements for Protecting Controlled Unclassified Information: A Supplement to NIST Special Publication 800-171, for components of non-Federal systems that process, store, or transmit CUI or that provide security protection for such components when the designated CUI is associated with a critical program or high-value assets. Contractors that are subject to these enhanced security requirements may incur additional process/information technology configuration, network isolation, and security operations center/threat-related costs; however, the impact on any particular contractor may vary considerably, depending on a contractor's current infrastructure and development environment, and the composition of their customer base.</P>
                    <P>It is estimated that approximately 160 contractors may be subject to the enhanced security requirements. Of these 160 contractors, 100 are categorized as small businesses with 25-50 end-point systems. The estimated cost of initial implementation of NIST SP 800-172 for each of these contractors is $202,500. Twenty contractors are estimated to have 50-100 end-point systems (medium businesses) and 40 are expected to have 750-1500 end-point systems (large businesses). The estimated costs of initial implementation for these contractors are approximately $1,000,000 per medium business and $2,315,000 per large business.</P>
                    <P>Therefore, the total estimated cost for 160 contractors to implement NIST SP 800-172 is $132,850,000, of which $20,250,000 is attributed to 100 small businesses. Annual recurring costs are estimated to be 20 percent of the cost of initial implementation.</P>
                    <HD SOURCE="HD3">f. Submit Supporting Documentation To Verify Compliance</HD>
                    <P>A contractor may also be required to submit to the Government a description of the system security plan required by NIST SP 800-171 Revision 2 to demonstrate their implementation of the security requirements in NIST SP 800-171 Revision 2. Requests for access to review the system security plan are expected to be rare, such as in response to a reported CUI incident. It is estimated that the system security plan may be requested 1,430 times and that it would take a contractor 30 minutes to submit the plan. The total estimated annual cost is $67,925 (1 request * 1,430 contractors * 0.5 hours/response * $95/hour), of which $46,294 is attributed to 975 small businesses.</P>
                    <P>Note, the cost to develop and maintain a system security plan in accordance with NIST SP 800-171 Revision 2 is attributed only to non-defense contractors (see sections IV.C.2.a. and IV.C.2.d. of this preamble) since defense contractors are subject to NIST SP 800-171 Revision 2 pursuant to DFARS clause 252.204-7012 and should already maintain system security plans.</P>
                    <HD SOURCE="HD3">g. Comply With Additional Security Requirements Identified in the Solicitation or Requirements Document</HD>
                    <P>In addition to the security requirements outlined in the SF XXX and the new FAR clause at 52.204-XX, the requirements document may require the contractor to comply with controls beyond NIST SP 800-171 Revision 2 to address unique requirements to protect CUI Basic at higher than the moderate confidentiality level in accordance with 32 CFR 2002.14(h)(2). Similarly, if offerors require access to CUI, the Government will provide agency procedures on handling the CUI to ensure compliance with the requirements in 32 CFR 2002. The contractor shall also implement additional information security requirements it reasonably determines necessary to provide adequate security in a dynamic environment. Given that agencies have discretion in developing their contract-specific requirements, the Government does not attempt to quantify these costs.</P>
                    <HD SOURCE="HD3">h. Comply With Additional Notification and Marking Requirements</HD>
                    <P>Offerors and contractors are required to notify the contracting officer representative or other designated agency official concerning any unmarked or mismarked CUI if discovered. These potential costs are not quantified since such occurrences are expected to be rare. In addition, to the maximum extent practicable, the offeror or contractor shall identify and mark its proprietary business and attributional information. These costs are also not quantified since an offeror or contractor usually marks its proprietary information as a best business practice to protect its own interests and information. Finally, offerors are required to notify the contracting officer of a potential CUI incident within 8 hours of discovery. Such occurrences are expected to be rare and are assumed to be accounted for under the public cost estimate for CUI incident reporting in section IV.C.2.b. of this preamble.</P>
                    <HD SOURCE="HD3">2. Non-Defense Contractors and Subcontractors</HD>
                    <HD SOURCE="HD3">a. Comply With NIST SP 800-171 Revision 2</HD>
                    <P>
                        A contractor may need to depend on the expertise of information security specialists to develop and document processes and procedures associated with each security requirement, perform the periodic scans, tests, and assessments necessary for some of the security requirements, and analyze the results. The amount of time necessary to perform the various tasks will vary by contractor depending on the number of employees and the complexity of its information systems. Some contractors may already have personnel performing some of the functions as a matter of good business practice to protect their 
                        <PRTPAGE P="4284"/>
                        networks, while others may be starting with no in-house expertise.
                    </P>
                    <P>The total estimated labor cost for a small business in the initial year is approximately $148,200 (average of 1,560 hours * $95), with a recurring annual labor cost of approximately $98,800 (1,040 hours * $95). The total estimated labor cost for a business other than a small business in the initial year is approximately $543,400 (average of 5,720 hours * $95), with a recurring annual labor cost of approximately $494,000 (5,200 hours * $95). Note, this does not include the time expected to maintain the system security plan (see section IV.C.2.d. of this preamble).</P>
                    <P>Businesses may also need to install software and/or hardware to implement NIST SP 800-171 Revision 2. Similar to the labor costs, the cost of the specific software or hardware varies based on the solution selected by the business, a decision that will take into consideration the number of users, the types of devices used, and the complexity of the network, among other things. The Government estimates that a small business, on average, may spend $27,500 on hardware and software during initial implementation and $5,000 annually thereafter to maintain compliance. On average, a business other than a small business may spend $140,000 on hardware and software in the initial year and $80,000 annually thereafter.</P>
                    <P>Therefore, the total estimated cost of labor, hardware, and software for 5,875 contractors to implement NIST SP 800-171 Revision 2 in the initial year is $1,524,706,500, of which $861,808,500 is attributed to 4,905 small businesses. The total estimated annual recurring maintenance costs are $1,065,919,000, of which $509,139,000 is attributed to 4,905 small businesses.</P>
                    <HD SOURCE="HD3">b. Assess and Report Suspected CUI Incidents</HD>
                    <P>
                        When the contractor discovers a suspected CUI incident, the contractor is required by the clause at FAR 52.204-XX and, when applicable, the clause at FAR 52.204-YY to: determine what CUI was or could have been improperly accessed, used, processed, stored, maintained, disseminated, disclosed, or disposed of; construct a timeline of user activity; and determine methods and techniques used to access CUI. The contractor shall report any suspected or confirmed CUI incident to the agency website or point of contact identified in the SF XXX, within 8 hours of discovery. The clause at FAR 52.204-XX also requires the contractor to include in the report as many of the applicable data elements located on the DIBNet website (
                        <E T="03">https://dibnet.dod.mil</E>
                        ) as are available and provide any remaining applicable data elements as soon as they become available. Subcontractors are required by FAR 52.204-XX(h) to notify the prime or next higher tier subcontractor within the same timeframe. When applicable, the clause at FAR 52.204-YY requires contractors to follow agency requirements related to the incident if it turns out CUI is involved.
                    </P>
                    <P>It is estimated that there may be 580 incident reports submitted each year and that it may take a contractor four hours to prepare and submit CUI incident reports to civilian agencies. The total estimated annual cost for CUI incident reporting for non-defense contractors is $275,500 (580 non-defense contractors * 1 incident/non-defense contractor * 4 hours/response * $95/hour), of which $188,482 is attributed to 397 small businesses.</P>
                    <HD SOURCE="HD3">c. Preserve and Protect Images for Suspected CUI Incidents and Submit Media and Data for Damage Assessments</HD>
                    <P>If a suspected or confirmed CUI incident has occurred on an information system, the contractor is required by the clause at FAR 52.204-XX to preserve and protect images of all known affected information systems and all relevant monitoring and packet capture data for at least 90 days from the submission of the report to allow the Government to request the media and data or decline interest during this 90 day period, after which, if no request has been made, the images need no longer be preserved.</P>
                    <P>It is estimated that it will take a contractor approximately 7.5 hours to preserve and protect images of all known affected information systems and all relevant monitoring and packet capture data, assuming 30 minutes to image, 2 hours to preserve monitoring and packet capture data, and 5 hours to upload images and set up storage space. The estimated annual cost to preserve and protect images associated with 580 CUI incidents is $413,250 (580 contractors * 1 recordkeeper/contractor * 7.5 hours/record * $95/hour), of which $282,722 is attributed to 397 small businesses. The estimated annual cost to submit media and data is $11,400 (48 non-defense contractors * 1 incident/non-defense contractor * 2.5 hours/response * 95/hour), of which $7,799 is attributed to 33 small businesses.</P>
                    <HD SOURCE="HD3">d. Maintain the System Security Plan</HD>
                    <P>It is assumed that each of 10,242 non-defense contractors required to implement NIST SP 800-171 Revision 2 has one information security analyst who spends one hour per month (or 12 hours per year) maintaining the system security plan. The estimated annual recordkeeping cost is $11,675,880 (10,242 contractors * 1 record/recordkeeper * 12 hours/record * $95/hour), of which $7,987,980 is attributed to 7,007 small businesses.</P>
                    <HD SOURCE="HD3">e. Cooperate With Validation Actions for Non-Federal Information Systems</HD>
                    <P>The contractor shall cooperate with validation actions conducted by an agency in accordance with NIST SP 800-171A, Assessing Security Requirements for Controlled Unclassified Information, and if applicable, NIST SP 800-172A for the enhanced security requirements. These types of validation actions are similar to the High Confidence Level Assessments being conducted by DoD pursuant to DFARS clause 252.204-7020, NIST SP 800-171 DoD Assessment Requirements, whereby the Government reviews the system security plan description of how each security requirement is met and the contractor demonstrates its implementation. While cooperating with validation actions, a contractor may need to provide the Government access to its facilities, systems, and personnel.</P>
                    <P>According to DoD, the total estimated cost for a contractor to participate in a strategic High Confidence Level Assessment is approximately $50,675 per contractor. Therefore, the total annual estimated cost for the 110 non-defense contractors to cooperate with Government validation of a system security plan is $5,574,250, of which $4,104,675 is attributed to 81 small businesses.</P>
                    <HD SOURCE="HD3">f. Comply With NIST SP 800-53 and the FedRAMP Moderate Baseline Standards</HD>
                    <P>The costs associated with contractor compliance with NIST SP 800-53 and the FedRAMP Moderate baseline standard for cloud service providers are excluded from this analysis of public cost, as they are being addressed under the proposed rule implementing section 2.i. of Executive Order 14028, Improving the Nation's Cyber Security (reference FAR Case 2021-019, Standardizing Cybersecurity Requirements for Unclassified Federal Information Systems).</P>
                    <HD SOURCE="HD2">D. Government Costs</HD>
                    <P>
                        The total estimated Government costs associated with this FAR rule in billions over a ten-year period are as follows:
                        <PRTPAGE P="4285"/>
                    </P>
                    <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s50,12,12">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">Government cost</CHED>
                            <CHED H="1">Undiscounted</CHED>
                            <CHED H="1">2 Percent</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Present Value</ENT>
                            <ENT>$4.69</ENT>
                            <ENT>$4.21</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Annualized</ENT>
                            <ENT>0.47</ENT>
                            <ENT>0.47</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>Undiscounted Government costs (in billions) by year over the ten-year period are summarized as follows:</P>
                    <GPOTABLE COLS="10" OPTS="L2,tp0,i1" CDEF="s25,8C,8C,8C,8C,8C,8C,8C,8C,8C">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">Year 1</CHED>
                            <CHED H="1">Year 2</CHED>
                            <CHED H="1">Year 3</CHED>
                            <CHED H="1">Year 4</CHED>
                            <CHED H="1">Year 5</CHED>
                            <CHED H="1">Year 6</CHED>
                            <CHED H="1">Year 7</CHED>
                            <CHED H="1">Year 8</CHED>
                            <CHED H="1">Year 9</CHED>
                            <CHED H="1">Year 10</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">0.47</ENT>
                            <ENT>$0.47</ENT>
                            <ENT>$0.47</ENT>
                            <ENT>$0.47</ENT>
                            <ENT>$0.47</ENT>
                            <ENT>$0.47</ENT>
                            <ENT>$0.47</ENT>
                            <ENT>$0.47</ENT>
                            <ENT>$0.47</ENT>
                            <ENT>$0.47</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>The following is a summary from the RIA of the Government costs associated with reviewing contractor training records, investigating reports of suspected or confirmed CUI incidents, and other action associated with this FAR rule.</P>
                    <HD SOURCE="HD3">1. Prepare the SF XXX</HD>
                    <P>While an SF XXX is required to be included in every solicitation and contract that involves CUI, except those exclusively for COTS items, the Government only incurs a significant cost when the CUI is identified on the form. The contracting officer is responsible for ensuring that the SF XXX identifies the protected information involved in the system of records and includes any safeguarding and marking requirements applicable to the information in accordance with FAR 4.403. Of the 2,092,918 forms expected to specify requirements for safeguarding CUI (see section IV.C.1.b. of this preamble), 1,573,582 are expected to be prepared by the Government (see section IV.C.1.c. of this preamble for the estimate of forms prepared by contractors and subcontractors). The total estimated annual Government cost is $453,191,616 (1,573,582 forms * 4 hour/form * $72/hour).</P>
                    <HD SOURCE="HD3">2. Review Training Records</HD>
                    <P>It is estimated that it will take a Government employee 30 minutes to review evidence of training submitted by the contractors (see section IV.C.1.d. of this preamble). Therefore, the estimated annual reporting cost is $51,480 (1,430 requests * 0.5 hours/response * $72/hour).</P>
                    <HD SOURCE="HD3">3. Review CUI Incident Reports</HD>
                    <P>It is estimated that it will take a Government employee four hours to review the CUI incident information reported by a contractor (see section IV.C.2.b. of this preamble). The estimated annual cost to the Government is $292,900 (580 reports * 5 hours/response * $101/hour).</P>
                    <HD SOURCE="HD3">4. Review Media and Data for Damage Assessment</HD>
                    <P>It is estimated that it will take a Government employee 10 hours to conduct a damage assessment of media and data submitted by a contractor (see section IV.C.2.c. of this preamble). The estimated annual cost to the Government is $48,480 (48 submissions * 10 hours/response * $101/hour).</P>
                    <HD SOURCE="HD3">5. Review System Security Plan</HD>
                    <P>It is estimated that it will take a Government employee four hours to review a system security plan submitted by a contractor (see section IV.C.1.g. of this preamble). The estimated annual cost to the Government is $577,720 (1,430 reports * 4 hours/response * $101/hour).</P>
                    <HD SOURCE="HD3">6. Conduct Validation Actions for Non-Federal Information Systems</HD>
                    <P>For the purposes of this analysis, it is assumed that the cost to a civilian agency to validate a contractor's system security plan (see section IV.C.2.e. of this preamble) will be similar to the cost for DoD to perform a strategic High Confidence Level Assessment, approximately $51,097 per action. Therefore, the total annual estimated cost for civilian agencies to perform these validations is $5,620,670 (110 non-defense contractor system security plan reviews * $51,097/review).</P>
                    <HD SOURCE="HD3">7. Training Government Employees on New Requirements for CUI</HD>
                    <P>It is expected that the Government contracting officers, contract specialists, contracting officer representatives, and others involved in the acquisition process, such as program managers and those involved in the development of requirements documents, will be required to become familiar with the technical requirements of this rule and receive additional training. While the requirement to remain current on policies for Government procurement, such as changes to the FAR, is considered a part of the normal duties of such individuals, there is expected to be specialized Government training on this topic, the cost of which is attributed to this rule. It is estimated that 250,000 Government employees may need to take 30 minutes of specialized training at an average wage rate equivalent to a GS-12, step 5, Government employee. Therefore, the estimated annual training cost is $9,000,000 (250,000 employees * 0.5 hours/employee * $72/hour).</P>
                    <HD SOURCE="HD2">E. Total Costs</HD>
                    <P>The total estimated costs (in billions) associated with this FAR rule over a ten-year period are as follows:</P>
                    <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s50,12,12">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">Government Cost</CHED>
                            <CHED H="1">Undiscounted</CHED>
                            <CHED H="1">2 percent</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Present Value</ENT>
                            <ENT>$22.32</ENT>
                            <ENT>$20.10</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Annualized</ENT>
                            <ENT>2.23</ENT>
                            <ENT>2.24</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        Undiscounted public and Government costs (in billions) by year over the ten-year period are summarized in the following table:
                        <PRTPAGE P="4286"/>
                    </P>
                    <GPOTABLE COLS="10" OPTS="L2,tp0,i1" CDEF="s25,8C,8C,8C,8C,8C,8C,8C,8C,8C">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">Year 1</CHED>
                            <CHED H="1">Year 2</CHED>
                            <CHED H="1">Year 3</CHED>
                            <CHED H="1">Year 4</CHED>
                            <CHED H="1">Year 5</CHED>
                            <CHED H="1">Year 6</CHED>
                            <CHED H="1">Year 7</CHED>
                            <CHED H="1">Year 8</CHED>
                            <CHED H="1">Year 9</CHED>
                            <CHED H="1">Year 10</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">$2.75</ENT>
                            <ENT>$2.17</ENT>
                            <ENT>$2.17</ENT>
                            <ENT>$2.17</ENT>
                            <ENT>$2.17</ENT>
                            <ENT>$2.17</ENT>
                            <ENT>$2.17</ENT>
                            <ENT>$2.17</ENT>
                            <ENT>$2.17</ENT>
                            <ENT>$2.17</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD2">F. Alternatives Considered</HD>
                    <HD SOURCE="HD3">1. Status Quo</HD>
                    <P>Absent this FAR rule, agencies will continue to employ ad hoc, agency-specific policies to manage CUI. This approach can cause agencies to mark and handle this information inconsistently and inefficiently, and forces defense and non-defense contractors to establish procedures and internal controls to meet different civilian and defense agency approaches for marking and handling CUI. This approach was determined to be counter to the purpose of the Federal Acquisition Regulations System, which was established for the codification and publication of uniform policies and procedures for acquisition by all executive agencies (see FAR 1.101).</P>
                    <HD SOURCE="HD3">2. No Standard Form</HD>
                    <P>The Government considered whether or not to establish a new standard form to communicate CUI requirements specific to the contract. As an alternative, the FAR could prescribe only a solicitation provision and contract clause to establish offeror and contractor responsibilities related to marking and handling CUI involved in the contract but would not dictate how agencies communicate what types of CUI may be involved in the contract. Given the importance of protecting CUI, it was determined that a Standard Form is the best way to ensure the Government is properly communicating specific CUI requirements for each contract. Absent a standard form, there is a risk that agencies may not provide enough information for contractors to understand what CUI is involved in the contract and what responsibilities they have with regard to this CUI. The standard form also provides a means for contractors to uniformly communicate CUI requirements to its subcontractors.</P>
                    <HD SOURCE="HD3">3. 100 Percent Inspection</HD>
                    <P>Several aspects of this proposed rule require the contractor to provide information upon request. For example, contractors may be requested to submit supporting documentation to verify compliance with the system security plan required by NIST SP 800-171 Revision 2 in instances where the Government is dealing with a CUI incident that is a confirmed breach or an agency determines that it is necessary to verify a contractor's system security plan based on the criticality of a program and the CUI being handled on the contractor's information system (see sections B.1.e. and D.1.g. of the Regulatory Impact Analysis). Similarly, when such CUI incidents have occurred, the Government may require the contractor to submit information to verify that the contractor and its subcontractors have provided appropriate training to their employees that handle CUI, as required by the clause at FAR 52.204-XX (see sections B.1.c. and D.1.b of the Regulatory Impact Analysis).</P>
                    <P>As an alternative, the Government considered whether to require contractors to submit evidence of its system security plan and evidence that employees have been trained on an annual basis. However, defense contractors should have already implemented system security plans in accordance with DFARS clause 252.204-7012 and non-defense contractors have incentive to ensure compliance with the requirements in FAR clause 52.204-XX to avoid liability for breaches of CUI that may result from improperly protecting CUI being handled on the contractor's information system. As such, implementing a 100 percent inspection requirement would unnecessarily and significantly increase the burden on contractors and the Government.</P>
                    <HD SOURCE="HD3">4. Implementation of NIST SP 800-171 Revision 3</HD>
                    <P>
                        This proposed rule requires contractors to implement the requirements of NIST SP 800-171 Revision 2. In May of 2024, NIST published Revision 3 to NIST SP 800-171 (see 
                        <E T="03">https://csrc.nist.gov/pubs/sp/800/171/r3/final</E>
                        ). The Government is currently assessing where the organizationally-defined parameters within Revision 3 should be standardized and implemented on a governmentwide basis. As stated in the benefits section of this rule, it is important for the Government to immediately implement requirements to protect CUI on non-Federal information systems; therefore, this proposed rule does not seek to implement NIST's most recent revision. The FAR Council anticipates that future rulemaking will be initiated to update NIST SP 800-171 and NIST SP 800-171A to the current version.
                    </P>
                    <HD SOURCE="HD1">V. Specific Questions for Public Comment</HD>
                    <P>To understand the exact scope of this impact and how this impact could be affected in the final rule, DoD, GSA, and NASA welcome input on the following questions regarding anticipated impact on affected parties. DoD, GSA, and NASA recognize that some agencies may need to tailor the approach to the information collected based on the unique mission and risks for their agency.</P>
                    <P>1. Is there additional information or guidance you view as necessary to effectively comply with this rule?</P>
                    <P>2. Are there specific situations you anticipate where your organization will be required to report on different timelines in order to comply with the CUI incident reporting requirements outlined in this proposed rule, other Federal contract requirements, or other regulations promulgated under Federal law? How would your organization handle disparate incident reporting timelines in other Federal Government contracting requirements or from other regulatory agencies?</P>
                    <P>3. Incident response and associated reporting are often iterative processes, with system owners updating reports as a situation evolves and more data becomes available. What implications are there for your organization, including with respect to incident response, to meet disparate timelines for incident reporting?</P>
                    <P>4. How much, if at all, would you estimate that the initial reporting requirement described in this proposed rule could increase the price of the products or services your organization provides to the Federal Government?</P>
                    <P>5. Understanding evolving data capabilities may change the nature or sensitivity of information over time, are there specific concerns not adequately addressed in this proposed rule? If possible, please provide any relevant use cases.</P>
                    <P>
                        6. The FAR Council notes there is also what is referred to as “CUI specified”, which is information that is considered CUI, but is also required to be handled in a certain way due to other laws, regulations, and policies (
                        <E T="03">e.g.,</E>
                         restrictions on disseminating information to foreign nationals or dual citizens under International Traffic in Arms Regulations (ITAR)). For CUI specified information, not only does it have to be treated and handled as CUI, 
                        <PRTPAGE P="4287"/>
                        but it also must be handled in accordance with the other applicable regulations and laws. Are there specific concerns not addressed in this proposed rule in this area? If so, please provide a relevant use case.
                    </P>
                    <HD SOURCE="HD1">VI. Executive Orders 12866 and 13563</HD>
                    <P>Executive Orders (E.O.s) 12866 (as amended by E.O. 14094) and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action and, therefore, was subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.</P>
                    <HD SOURCE="HD1">VII. Regulatory Flexibility Act</HD>
                    <P>DoD, GSA, and NASA expect this proposed rule, if finalized, to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601-612. The Initial Regulatory Flexibility Analysis (IRFA) is summarized as follows:</P>
                    <P>DoD, GSA, and NASA are proposing to revise the FAR to implement a NARA final rule on the Federal CUI Program as it relates to performance under Federal contracts (see 32 CFR part 2002).</P>
                    <P>This proposed rule creates two new clauses at FAR 52.204-XX, Controlled Unclassified Information, and FAR 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information, and a new FAR provision at 52.204-WW, Notice of Controlled Unclassified Information Requirements. These clauses and the provision work together to implement a uniform way for Federal agencies, offerors, and contractors to manage CUI. The rule also creates a new standard form (SF) XXX to standardize the way in which the Government identifies CUI that will be managed and safeguarded by a contractor in performance of a contract. This rule is just one element of a larger strategy to improve the Government's efforts to identify, deter, protect against, detect, and respond to increasingly sophisticated attacks by criminals and our adversaries targeting Federal information and information systems.</P>
                    <P>Promulgation of this FAR rule is authorized by 41 U.S.C. 1121(b); 41 U.S.C. 1303; 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.</P>
                    <P>This rule will apply to small businesses that are awarded Government contracts, other than those that receive awards exclusively for COTS items. According to award data in the Federal Procurement Data System (FPDS) for fiscal years (FY) 2021 through FY 2023, on average per year the Government awards contracts and orders for supplies and services (excluding those for supplies purchased using commercial item procedures) to 67,547 unique contractors, of which 44,152 (65 percent) are small businesses.</P>
                    <P>When an SF XXX is incorporated in the contract and identifies CUI that will be involved in the contract, the contractor will be subject to the new FAR clause at FAR 52.204-XX and more robust compliance requirements for safeguarding the CUI. Per the FPDS data, of the contractors that receive covered awards each year, approximately 37,933 are non-defense contractors and 29,614 are defense contractors, or contractors that do business with both civilian agencies and DoD. Based on consultation with subject matter experts, it is assumed that 18 percent of non-defense contractors (6,828) and 28 percent of defense contractors (8,292), or 15,120 total contractors, may receive awards each year that include an SF XXX listing CUI and the associated safeguarding requirements. It is further assumed that the ratio of subcontractors to prime contractors that handle CUI is 0.5:1, or 7,560 total subcontractors.</P>
                    <P>Therefore, each year, an estimated 22,680 contractors and subcontractors, of which 15,809 (70 percent) are estimated to be small businesses, will be required to safeguard CUI in performance of a contract, pursuant to the new clause at FAR 52.204-XX and the instructions provided on an SF XXX. These small entities may be impacted by the various compliance requirements in the clause, depending on the type of CUI required to be handled under the contract or subcontract, the way in which the information will be handled, and whether those small businesses have already been safeguarding sensitive Government information under other contract provisions.</P>
                    <P>The new FAR clause at 52.204-XX is modeled after the existing clause at DFARS 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting, the most recent version of which has been in effect since 2017 (the clause has been in effect since 2013, and the NIST SP 800-171 requirements were added in 2015). As such, small businesses that do business with DoD and handle CUI in performance of their contracts are already subject to requirements equivalent to the new FAR clause and provision. In addition, small businesses that do business with other agencies that have included similar or overlapping safeguarding requirements under agency-specific contract terms may already be in partial or substantial compliance with the clause requirements.</P>
                    <P>The following specific compliance requirements will apply to all Federal offerors, contractors, and subcontractors:</P>
                    <P>
                        • 
                        <E T="03">Review and Distribute the SF XXX.</E>
                         When the contract includes an SF XXX that identifies CUI to be safeguarded under the contract, the contract will include the CUI clause. The contractor or subcontractor will need to review the SF XXX to determine what information under the contract is considered CUI and subject to the compliance requirements of the CUI clause. If the contractor or subcontractor intends to flow down CUI in performance of the contract or subcontract, then the contractor or subcontractor will need to prepare an SF XXX, as appropriate for CUI that will flow down, and distribute it to the subcontractor that will be handling CUI.
                    </P>
                    <P>
                        • 
                        <E T="03">Train Contractor Employees on Handling CUI.</E>
                         Per the CUI clause, a contractor shall not permit any contractor employee to have, retain access to, create, collect, use, process, store, maintain, disseminate, disclose, dispose of, or otherwise handle, CUI unless the employee has completed training on properly handling CUI that, at a minimum, includes the elements required in the SF XXX. The SF XXX will also specify the frequency at which a contractor must provide the training, which is dependent on the type of CUI being handled by the contractor's employees and the criticality of the program being supported. The contractor must provide evidence of employee training upon request by the contracting officer; however, such requests are expected to be limited to, for example, instances where the Government is dealing with a CUI incident, or where an agency determines that it is necessary to verify training based on the criticality of a program and the CUI being handled by the contractor.
                    </P>
                    <P>
                        • 
                        <E T="03">Comply with NIST SP 800-172.</E>
                         A limited number of contractors may be required under FAR clause 52.204-XX, Controlled Unclassified Information, to 
                        <PRTPAGE P="4288"/>
                        implement some or all requirements of NIST SP 800-172, Enhanced Security Requirements for Protecting Controlled Unclassified Information: A Supplement to NIST Special Publication 800-171, Revision 2. NIST SP 800-172 provides enhanced security requirements that apply only to components of nonfederal systems that process, store, or transmit CUI or that provide security protection for such components when the designated CUI is associated with a critical program or high-value asset. The enhanced requirements supplement the basic and derived security requirements in NIST Special Publication 800-171, Revision 2, and address the protection of CUI by promoting: penetration-resistant architecture, damage-limiting operations, and designs to achieve cyber resiliency and survivability.
                    </P>
                    <P>
                        • 
                        <E T="03">Submit Supporting Documentation to Verify Compliance.</E>
                         Per FAR clause 52.204-XX, Controlled Unclassified Information, upon request, a contractor shall submit the description of the system security plan required by NIST SP 800-171, Revision 2, (and NIST SP 800-172, when applicable) and any associated plans of action for any planned implementations or mitigations to the Government to demonstrate the contractor's implementation or planned implementation of the security requirements. Requests for the system security plan are expected to be rare or limited to, for example, instances where the Government is dealing with a CUI incident, or an agency determines that it is necessary to verify a contractor's system security plan based on the criticality of a program and the CUI being handled on the contractor's information system.
                    </P>
                    <P>
                        • 
                        <E T="03">Comply with any additional security requirements identified in the Requirements Document.</E>
                         In addition to the security requirements outlined in the SF XXX and the CUI clause, the requirements document in the contract may require the Contractor to comply with additional security requirements beyond NIST SP 800-171, Revision 2, to address unique requirements to protect CUI Basic at higher than the moderate confidentiality level in accordance with 32 CFR 2002.14(h)(2). The Contractor shall also implement additional information security requirements it reasonably determines necessary to provide adequate security in a dynamic environment.
                    </P>
                    <P>
                        • 
                        <E T="03">Comply with Additional Notification Requirements.</E>
                         Unmarked or mismarked CUI is not considered a CUI incident if the mismarking has not resulted in the mishandling or improper dissemination of the information. Per the new solicitation provision and contract clauses, offerors are requested and contractors are required to notify the Contracting Officer Representative or other designated agency official concerning any unmarked or mismarked CUI if discovered. Such occurrences are expected to be rare.
                    </P>
                    <P>
                        • 
                        <E T="03">Comply with Additional Marking Requirements.</E>
                         To the maximum extent practicable, offerors and contractors are required to identify and mark any proprietary business or contractor-attributional information.
                    </P>
                    <P>The following compliance requirements are attributed only to non-defense contractors and subcontractors that handle CUI, since defense contractors are already required to comply with these requirements pursuant to DFARS clause 252.204-7012:</P>
                    <P>
                        • 
                        <E T="03">Comply with NIST SP 800-171, Revision 2.</E>
                         If the Contractor is operating a non-Federal information system that processes, stores, or transmits CUI identified in the contract, the CUI clause requires the contractor to comply with the security requirements in NIST Special Publication 800-171, Revision 2, or as authorized by the Contracting Officer and any CUI specified requirements identified in the SF XXX. NIST SP 800-171 Revision 2 includes 110 security requirements for non-Federal information systems that can be grouped into the following 14 categories: access control, awareness and training, audit and accountability, configuration management, identification and authentication, incident response, maintenance, media protection, personnel security, physical protection, risk assessment, security assessment, system and communications protection, and system and information integrity. Specific information on the 110 individual security requirements and various templates are available on the NIST website at 
                        <E T="03">https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final.</E>
                         Federal contractors that handle covered Federal information (CFI), a much broader category than CUI, on their information systems are already required to have implemented 17 of the 110 security requirements, which are already included in the clause at FAR 52.204-21, Basic Safeguarding of Covered Contractor Information Systems. Such requirements are considered “met” by all impacted contractors, regardless of size. For the remaining 93 security requirements, a contractor may need to establish a process or procedure, configure existing information technology that the contractor already owns, or acquire additional software or hardware.
                    </P>
                    <P>
                        • 
                        <E T="03">Assess and report suspected CUI incidents.</E>
                         When the Contractor discovers a suspected CUI incident, the CUI clause requires the contractor to determine what CUI was or could have been improperly accessed, used, processed, stored, maintained, disseminated, disclosed, or disposed of; construct a timeline of user activity; and determine methods and techniques used to access CUI. The Contractor shall report any suspected or confirmed CUI incident to the agency website or point of contact identified in the SF XXX, within 8 hours of discovery. The report shall include as many of the applicable data elements located on the DIBNet website as are available and provide any remaining applicable data elements as soon as they become available. In addition, if the Contractor is a FedRAMP authorized (Joint Authorization Board or Agency) Cloud Service Provider, the Contractor shall also report to the points of contact specified in the FedRAMP incident reporting guidelines as documented in the Cloud Service Provider Incident Response Plan. The requirements of the CUI clause are flowed down to subcontracts at all tiers; subcontractors are required to notify the prime contractor or next higher-tier subcontractor within the same timeframes.
                    </P>
                    <P>
                        • 
                        <E T="03">Preserve and protect images for suspected CUI incidents and submit media and data for damage assessments.</E>
                         If a suspected or confirmed CUI incident has occurred on an information system, the CUI clause requires the Contractor shall preserve and protect images of all known affected information systems and all relevant monitoring and packet capture data for at least 90 days from the submission of the report to allow the Government to request the media and data or decline interest during this 90-day period, after which, if no request has been made, the images need no longer be preserved.
                    </P>
                    <P>
                        • 
                        <E T="03">Cooperate with Validation Actions for Non-Federal Information Systems.</E>
                         The CUI clause requires the Contractor to cooperate with validation actions conducted by an agency in accordance with NIST SP 800-171A, Assessing Security Requirements for Controlled Unclassified Information, and if applicable, NIST SP 800-172A for enhanced security requirements. These types of validation actions are similar to the DoD's Strategic High Confidence Level Assessments being conducted by DoD pursuant to the clause at DFARS 252.204-7020, and NIST SP 800-171 DoD Assessment Requirements, whereby the Government reviews the system security plan description of how 
                        <PRTPAGE P="4289"/>
                        each security requirement is met and the contractor demonstrates its implementation. While cooperating with validation actions, a contractor may need to provide the Government access to its facilities, systems, and personnel.
                    </P>
                    <P>
                        • 
                        <E T="03">Comply with NIST SP 800-53.</E>
                         The CUI clause requires the Contractor, when it is operating an information system identified in the SF XXX as a Federal information system that processes, stores, or transmits CUI identified in the contract, to comply with agency-identified security controls from NIST Special Publication 800-53 and any CUI Specified requirements identified in the SF XXX. In addition, cloud service providers must meet security requirements established by the Government for the Federal Risk and Authorization Management Program (FedRAMP) Moderate Baseline (
                        <E T="03">https://www.fedramp.gov/documents/</E>
                        ).
                    </P>
                    <P>
                        The total estimated cost of compliance for small businesses is $937,017,841 in the initial year of implementation and $564,187,237 in each subsequent year. The cost per entity is dependent on whether the small business is required to implement NIST SP 800-171 Revision 2 or NIST SP 800-172 on their information systems. For more information on the specific compliance requirements and the expected cost impact on contractors, see section IV.C. of this preamble. A Regulatory Impact Analysis that includes a detailed discussion and explanation about the assumptions and methodology used to estimate the cost of this regulatory action, including the specific impact and costs for small businesses, is available at 
                        <E T="03">www.regulations.gov</E>
                         (search for “FAR Case 2017-016” click “Open Docket,” and view “Supporting Documents”).
                    </P>
                    <P>This proposed rule does not duplicate, overlap, or conflict with any other Federal rules. This proposed rule implements the requirements of 32 CFR part 2002 to ensure uniform implementation of Federal contractor requirements for managing CUI.</P>
                    <P>While this rule is modeled after DFARS clause 252.204-7012, it does not conflict with the existing clause. It is expected that the DFARS clause will be amended in the future to address DoD-specific requirements that may be in addition to the FAR clause.</P>
                    <P>DoD, GSA, and NASA were unable to identify any alternatives that would reduce the burden on small entities and still meet the objectives of 32 CFR part 2002. It is not possible to establish different compliance standards that take into account the resources available to small entities or exempt small entities from the rule, or any part thereof, that does not increase the risk of CUI incidents. However, by implementing a more standardized set of requirements for contractor information systems and for CUI safeguarding across agencies, small businesses that engage in contracts involving sensitive Government information might find it easier and less costly to meet security requirements for such information under this rule, because the variation of system configurations and requirements will be significantly reduced. This, in turn, may make such businesses more competitive for future Government contracts.</P>
                    <P>The Regulatory Secretariat Division has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat Division. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.</P>
                    <P>DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2017-016), in correspondence.</P>
                    <HD SOURCE="HD1">VIII. Paperwork Reduction Act</HD>
                    <P>The Paperwork Reduction Act (44 U.S.C. 3501-3521) applies because the proposed rule contains information collection requirements. Accordingly, the Regulatory Secretariat Division has submitted a request for approval of a new information collection requirement concerning controlled unclassified information to the Office of Management and Budget.</P>
                    <HD SOURCE="HD2">A. Public Burden for This Collection of Information</HD>
                    <P>
                        1. 
                        <E T="03">System Security Plan.</E>
                         Public reporting burden for this collection of information is estimated to average 0.50 hour per response including the time to prepare and submit the plan.
                    </P>
                    <P>The annual reporting burden is estimated as follows:</P>
                    <P>
                        <E T="03">Respondents:</E>
                         1,430.
                    </P>
                    <P>
                        <E T="03">Total annual responses:</E>
                         1,430.
                    </P>
                    <P>
                        <E T="03">Total burden hours:</E>
                         715.
                    </P>
                    <P>This estimate is based on approximately one response per respondent.</P>
                    <P>The annual recordkeeping burden is estimated as follows:</P>
                    <P>
                        <E T="03">Recordkeepers:</E>
                         10,242.
                    </P>
                    <P>
                        <E T="03">Total annual records:</E>
                         10,242.
                    </P>
                    <P>
                        <E T="03">Total recordkeeping burden hours:</E>
                         122,904.
                    </P>
                    <P>This estimate is based on one recordkeeper who spends one hour per month (or 12 hours per year) maintaining the system security plan.</P>
                    <P>
                        2. 
                        <E T="03">Preserve, Protect, and Submit Media and Data.</E>
                         Public reporting burden for this collection of information is estimated to average 2.5 hours per response including the time to prepare and complete the submission.
                    </P>
                    <P>The annual reporting burden is estimated as follows:</P>
                    <P>
                        <E T="03">Respondents:</E>
                         48.
                    </P>
                    <P>
                        <E T="03">Total annual responses:</E>
                         48.
                    </P>
                    <P>
                        <E T="03">Total burden hours:</E>
                         120.
                    </P>
                    <P>This estimate is based on approximately one response per respondent.</P>
                    <P>The annual recordkeeping burden is estimated as follows:</P>
                    <P>
                        <E T="03">Recordkeepers:</E>
                         580.
                    </P>
                    <P>
                        <E T="03">Total annual records:</E>
                         580.
                    </P>
                    <P>
                        <E T="03">Total recordkeeping burden hours:</E>
                         4,350.
                    </P>
                    <P>This estimate is based on one recordkeeper who spends 7.5 hours per year to preserve and protect images of all known affected information systems and all relevant monitoring and packet capture data, assuming 0.5 hours to image, 2 hours to preserve monitoring and packet capture data, and 5 hours to upload images and set up storage space.</P>
                    <P>
                        3. 
                        <E T="03">CUI Incident Reporting.</E>
                         Public reporting burden for this collection of information is estimated to average 5 hours per response including the time to prepare and submit a CUI incident report.
                    </P>
                    <P>The annual reporting burden is estimated as follows:</P>
                    <P>
                        <E T="03">Respondents:</E>
                         580.
                    </P>
                    <P>
                        <E T="03">Total annual responses:</E>
                         580.
                    </P>
                    <P>
                        <E T="03">Total burden hours:</E>
                         2,900.
                    </P>
                    <P>This estimate is based on approximately one response per respondent.</P>
                    <P>
                        4. 
                        <E T="03">Training Records.</E>
                         Public reporting burden for this collection of information is estimated to average 15 minutes (0.25 hour) per response including the time to prepare and submit the evidence of training.
                    </P>
                    <P>The annual reporting burden is estimated as follows:</P>
                    <P>
                        <E T="03">Respondents:</E>
                         1,430.
                    </P>
                    <P>
                        <E T="03">Total annual responses:</E>
                         1,430.
                    </P>
                    <P>
                        <E T="03">Total burden hours:</E>
                         357.5.
                    </P>
                    <P>This estimate is based on approximately one response per respondent.</P>
                    <P>The annual recordkeeping burden is estimated as follows:</P>
                    <P>
                        <E T="03">Recordkeepers:</E>
                         53,225.
                    </P>
                    <P>
                        <E T="03">Total annual records:</E>
                         2,191,400.
                    </P>
                    <P>
                        <E T="03">Total recordkeeping burden hours:</E>
                         181,886.
                        <PRTPAGE P="4290"/>
                    </P>
                    <P>This estimate is based on one recordkeeper who spends 5 minutes (0.083 hours) per record maintaining the employee training certificates.</P>
                    <P>
                        5. 
                        <E T="03">Prepare and Distribute the SF XXX.</E>
                         Public reporting burden for this collection of information is estimated to average 2 hours per response including the time to prepare and distribute the SF XXX.
                    </P>
                    <P>The annual reporting burden is estimated as follows:</P>
                    <P>
                        <E T="03">Respondents:</E>
                         22,680.
                    </P>
                    <P>
                        <E T="03">Total annual responses:</E>
                         517,392.
                    </P>
                    <P>
                        <E T="03">Total burden hours:</E>
                         1,034,784.
                    </P>
                    <HD SOURCE="HD2">B. Request for Comments Regarding Paperwork Burden</HD>
                    <P>
                        Submit comments on this collection of information no later than March 17, 2025 through 
                        <E T="03">https://www.regulations.gov</E>
                         and follow the instructions on the site. All items submitted must cite OMB Control No. 9000-XXXX, Controlled Unclassified Information. Comments submitted in response to this rule will be made publicly available and are subject to disclosure under the Freedom of Information Act. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information, or any information that you would not want publicly disclosed unless you follow the instructions below for confidential comments. Summary information of the public comments received, including any specific comments, will be posted on 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>All filers using the portal should use the name of the person or entity submitting comments as the name of their files, in accordance with the instructions below. Anyone submitting business confidential/proprietary information should clearly identify any business confidential/proprietary portion at the time of submission, file a statement justifying nondisclosure and referencing the specific legal authority claimed, and provide a non-confidential/non-proprietary version of the submission. Any business confidential information should be in an uploaded file that has a file name beginning with the characters “BC.” Any page containing business confidential information must be clearly marked “BUSINESS CONFIDENTIAL/PROPRIETARY” on the top of that page.</P>
                    <P>
                        The corresponding non-confidential/non-proprietary version of those comments must be clearly marked “PUBLIC.” The file name of the non-confidential version should begin with the character “P.” The “BC” and “P” should be followed by the name of the person or entity submitting the comments or rebuttal comments. All filers should name their files using the name of the person or entity submitting the comments. Any submissions with file names that do not begin with a “BC” will be assumed to be public and will be made publicly available through 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        To confirm receipt of your comment(s), please check 
                        <E T="03">https://www.regulations.gov,</E>
                         approximately two-to-three days after submission to verify posting. If there are difficulties submitting comments, contact the GSA Regulatory Secretariat Division at 202-501-4755 or 
                        <E T="03">GSARegSec@gsa.gov.</E>
                    </P>
                    <P>Public comments are particularly invited on:</P>
                    <P>• The necessity of this collection of information for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility;</P>
                    <P>• The accuracy of the estimate of the burden of this collection of information;</P>
                    <P>• Ways to enhance the quality, utility, and clarity of the information to be collected; and</P>
                    <P>• Ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.</P>
                    <P>
                        Requesters may obtain a copy of the supporting statement from the General Services Administration, Regulatory Secretariat Division by calling 202-501-4755 or emailing 
                        <E T="03">GSARegSec@gsa.gov.</E>
                         Please cite OMB Control Number 9000-XXXX, Controlled Unclassified Information, in all correspondence.
                    </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 48 CFR Parts 1, 2, 3, 4, 5, 7, 9, 11, 12, 15, 27, 33, 42, 52, and 53</HD>
                        <P>Government procurement.</P>
                    </LSTSUB>
                    <SIG>
                        <NAME>William F. Clark,</NAME>
                        <TITLE>Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.</TITLE>
                    </SIG>
                    <P>Therefore, DoD, GSA, and NASA propose amending 48 CFR parts 1, 2, 3, 4, 5, 7, 9, 11, 12, 15, 27, 33, 42, 52, and 53 as set forth below:</P>
                    <AMDPAR>1. The authority citation for 48 CFR Parts 1, 2, 3, 4, 5, 7, 9, 11, 12, 15, 27, 33, 42, 52, and 53 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.</P>
                    </AUTH>
                    <PART>
                        <HD SOURCE="HED">PART 1—FEDERAL ACQUISITION REGULATIONS SYSTEM</HD>
                    </PART>
                    <AMDPAR>2. In section 1.106 amend in the table following the introductory text, by adding in numerical order, entries for “52.204-WW” and “52.204-XX” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>1.106</SECTNO>
                        <SUBJECT>OMB approval under the Paperwork Reduction Act.</SUBJECT>
                        <STARS/>
                        <GPOTABLE COLS="2" OPTS="L1,tp0,i1" CDEF="s25,14">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">FAR segment</CHED>
                                <CHED H="1">OMB control No.</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*    *    *    *    *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">52.204-WW</ENT>
                                <ENT>9000-XXXX</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">52.204-XX</ENT>
                                <ENT>9000-0182 and 9000-XXXX</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*    *    *    *    *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 2—DEFINITIONS OF WORDS AND TERMS</HD>
                    </PART>
                    <AMDPAR>3. Amend section 2.101 by—</AMDPAR>
                    <AMDPAR>a. Adding in alphabetical order the definitions for “Contractor-attributional information”, “Controlled unclassified information (CUI)”, “CUI incident”, “CUI Registry”, “Federal information system”, and “Information system”; and</AMDPAR>
                    <AMDPAR>b. Removing the definition for “Federally controlled information system”.</AMDPAR>
                    <P>The additions read as follows:</P>
                    <SECTION>
                        <SECTNO>2.101</SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Contractor-attributional information</E>
                             means information that identifies the contractor or its employees directly or identifies them indirectly by grouping information that can be traced back to the contractor (
                            <E T="03">e.g.,</E>
                             program description or facility locations).
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Controlled unclassified information (CUI)</E>
                             means information that the Government creates or possesses, or that an entity creates or possesses for or on behalf of the Government, that a law, regulation, or Governmentwide policy requires or permits an agency to handle using safeguarding or dissemination controls. CUI does not include—
                        </P>
                        <P>(1) Classified information;</P>
                        <P>(2) Covered Federal information (see 4.404-1);</P>
                        <P>(3) Information a contractor possesses and maintains in its own systems that did not come from, or was not created or possessed by or for, an executive branch agency or an entity acting for an agency (see 32 CFR 2002.4); or</P>
                        <P>(4) Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189.</P>
                        <STARS/>
                        <PRTPAGE P="4291"/>
                        <P>
                            <E T="03">CUI incident</E>
                             means suspected or confirmed improper access, use, disclosure, modification, or destruction of CUI, in any form or medium.
                        </P>
                        <P>
                            <E T="03">CUI Registry</E>
                             means the online repository for all information, guidance, policy, and requirements on handling CUI. Among other information, the CUI Registry identifies all approved CUI categories and subcategories, provides general descriptions for each, identifies the basis for controls, establishes markings, and includes guidance on handling procedures (see 
                            <E T="03">https://www.archives.gov/cui</E>
                            ).
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Federal information system</E>
                             means an information system (44 U.S.C. 3502(8)) used or operated by an agency, by a contractor of an agency, or by another organization on behalf of an agency.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Information system</E>
                             means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502(8)).
                        </P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 3—IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST</HD>
                    </PART>
                    <AMDPAR>4. Amend section 3.104-4 by—</AMDPAR>
                    <AMDPAR>a. Revising the section heading;</AMDPAR>
                    <AMDPAR>b. Removing paragraph (c);</AMDPAR>
                    <AMDPAR>c. Redesignating paragraph (b) as paragraph (c);</AMDPAR>
                    <AMDPAR>d. Adding a new paragraph (b);</AMDPAR>
                    <AMDPAR>e. Revising the newly redesignated paragraph (c);</AMDPAR>
                    <AMDPAR>f. Revising paragraph (d); and</AMDPAR>
                    <AMDPAR>g. Removing from paragraph (e)(1) the words “A contractor” and adding “An offeror or contractor” in its place.</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>3.104-4</SECTNO>
                        <SUBJECT>Disclosure, protection, and marking of contractor information.</SUBJECT>
                        <STARS/>
                        <P>(b)(1) The clause at 52.204-XX, Controlled Unclassified Information, directs offerors and contractors to indicate or otherwise identify any contractor bid or proposal information, contractor-attributional information, proprietary business information, and source selection information submitted to the Government. The contracting officer should consult with the contractor if the contracting officer is unsure whether information provided by the contractor falls into one of these categories.</P>
                        <P>(2) Individuals responsible for preparing material that may be source selection information as described at paragraph (10) of the “source selection information” definition in 2.101 must mark the cover page and each page that the individual believes contains source selection information with the legend “Source Selection Information-See FAR 2.101 and 3.104.” Although the information in paragraphs (1) through (9) of the definition in 2.101 is considered to be source selection information whether or not marked, all reasonable efforts must be made to mark such material with the same legend.</P>
                        <P>
                            (c) Contractor bid or proposal information, contractor-attributional information, proprietary business information, and source selection information must be marked and protected from unauthorized disclosure in accordance with 4.403, 14.401, 15.207, applicable law, and regulations, including 32 CFR part 2002. If the offeror or contractor submits information that could be controlled unclassified information (
                            <E T="03">e.g.,</E>
                             proprietary business information), the contracting officer shall determine whether the information must be marked and protected in accordance with applicable law, policy, guidance, and agency procedures. Individuals who are unsure how to handle such information should consult with agency officials as necessary.
                        </P>
                        <P>(d) Except as provided in paragraph (d)(3) of this section, the contracting officer must promptly notify the offeror or contractor in writing if the contracting officer believes that contractor proprietary business information, contractor-attributional information, contractor bid or proposal information, or information marked in accordance with 52.215-1(e) has been inappropriately marked. Notification should occur upon discovery and may be made prior to award. The offeror or contractor that has affixed the marking must be given an opportunity to justify the marking.</P>
                        <P>(1) If the offeror or contractor agrees that the marking is not justified or does not respond within the time specified in the notice, the contracting officer may remove the marking and release the information.</P>
                        <P>(2) If, after reviewing the contractor's justification, the contracting officer determines that the marking is not justified, the contracting officer must notify the offeror or contractor in writing before releasing the information.</P>
                        <P>(3) For technical data marked as proprietary by an offeror or contractor, the contracting officer must follow the procedures in 27.404-5.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 4—ADMINISTRATIVE AND INFORMATION MATTERS</HD>
                    </PART>
                    <AMDPAR>5. Revise the heading of subpart 4.4 to read as follows:</AMDPAR>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart 4.4—Safeguarding Information and Information Systems</HD>
                    </SUBPART>
                    <AMDPAR>6. Add section 4.401 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>4.401</SECTNO>
                        <SUBJECT>Definition.</SUBJECT>
                        <P>
                            <E T="03">Information,</E>
                             as used in this subpart, means any communication or representation of knowledge such as facts, data, or opinions in any medium or form, including textual, numerical, graphic, cartographic, narrative, electronic, or audiovisual forms (see Office of Management and Budget (OMB) Circular A-130).
                        </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.402</SECTNO>
                        <SUBJECT>[Redesignated as 4.402-1]</SUBJECT>
                    </SECTION>
                    <AMDPAR>7. Redesignate section 4.402 as section 4.402-1.</AMDPAR>
                    <AMDPAR>8. Add section 4.402 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>4.402</SECTNO>
                        <SUBJECT>Classified information.</SUBJECT>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.403</SECTNO>
                        <SUBJECT>[Redesignated as 4.402-2].</SUBJECT>
                    </SECTION>
                    <AMDPAR>9. Redesignate section 4.403 as section 4.402-2.</AMDPAR>
                    <AMDPAR>10. Amend the newly redesignated section 4.402-2 by—</AMDPAR>
                    <AMDPAR>a. Revising paragraphs (b)(2)(i) and (ii); and</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (c)(1) the reference “4.402(d)(1)” and adding “4.402-1(d)(1)” in its place.</AMDPAR>
                    <P>The revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>4.402-2</SECTNO>
                        <SUBJECT>Responsibilities of contracting officers.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(2) * * *</P>
                        <P>(i) An appropriate Security Requirements clause in the solicitation (see 4.402-3(a)); and</P>
                        <P>(ii) As appropriate, in solicitations and contracts when the contract may require access to classified information, a requirement for security safeguards in addition to those provided in the clause 52.204-2, Security Requirements for Classified Information.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>11. Add sections 4.402-3, and 4.403 through 4.403-7 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>4.402-3</SECTNO>
                        <SUBJECT>Contract clause.</SUBJECT>
                        <P>
                            (a) The contracting officer shall insert the clause at 52.204-2, Security Requirements for Classified Information, in solicitations and contracts when the contract may require access to classified information, unless the conditions specified in paragraph (d) of this section apply.
                            <PRTPAGE P="4292"/>
                        </P>
                        <P>(b) If a cost contract (see 16.302) for research and development with an educational institution is contemplated, the contracting officer shall use the clause with its Alternate I.</P>
                        <P>(c) If a construction or architect-engineer contract under which employee identification is required for security reasons is contemplated, the contracting officer shall use the clause with its Alternate II.</P>
                        <P>(d) If the contracting agency is not covered by the NISP and has prescribed a clause and alternates that are substantially the same as those at 52.204-2, the contracting officer shall use the agency-prescribed clause as required by agency procedures.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.403</SECTNO>
                        <SUBJECT>Controlled unclassified information (CUI).</SUBJECT>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.403-1</SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <P>As used in section 4.403—</P>
                        <P>
                            <E T="03">CUI Basic</E>
                             means the subset of CUI for which the authorizing law, regulation, or Governmentwide policy does not set out specific handling or dissemination controls. CUI Basic must be handled according to the uniform set of controls set forth in 32 CFR part 2002 and the CUI Registry.
                        </P>
                        <P>
                            <E T="03">CUI Categories</E>
                             means those types of information for which laws, regulations, or Governmentwide policies require or permit agencies to exercise safeguarding or dissemination controls, and which has been listed in the CUI Registry.
                        </P>
                        <P>
                            <E T="03">CUI Specified</E>
                             means the subset of CUI for which the authorizing law, regulation, or Governmentwide policy contains specific handling controls that it requires or permits agencies to use and that differ from those for CUI Basic. The CUI Registry indicates which laws, regulations, and Governmentwide policies include such specific requirements.
                        </P>
                        <P>
                            <E T="03">Handling</E>
                             means any use of CUI, including but not limited to collecting, developing, receiving, transmitting, storing, marking, safeguarding, transporting, disseminating, reusing, and disposing of the information.
                        </P>
                        <P>
                            <E T="03">Lawful Government purpose</E>
                             means any activity, mission, function, operation, or endeavor that the Government authorizes or recognizes as within the scope of its legal authorities or the legal authorities of non-executive branch entities such as State and local law enforcement.
                        </P>
                        <P>
                            <E T="03">Limited dissemination control</E>
                             means any control identified on the CUI Registry that agencies may use to limit or specify CUI dissemination.
                        </P>
                        <P>
                            <E T="03">On behalf of an agency</E>
                             means a contractor uses or operates an information system or maintains or collects information for the purpose of processing, storing, or transmitting Federal information, and those activities are not incidental to providing a service or product to the Government.
                        </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.403-2</SECTNO>
                        <SUBJECT>General.</SUBJECT>
                        <P>(a) Executive Order 13556 of November 4, 2010, entitled “Controlled Unclassified Information,” establishes a program to standardize executive branch management of information that requires safeguarding or dissemination controls. The National Archives and Records Administration's (NARA) Information Security Oversight Office (ISOO) is the executive agent for the Controlled Unclassified Information Program.</P>
                        <P>(b) This section implements 32 CFR part 2002, Controlled Classified Information (CUI).</P>
                        <P>(c) Part 24, Protection of Privacy and Freedom of Information, contains additional policy and procedures for safeguarding records that are protected by the Privacy Act.</P>
                        <P>(d) Part 27, Patents, Data, and Copyrights, contains policy and procedures for safeguarding information in patent applications and patents.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.403-3</SECTNO>
                        <SUBJECT>Applicability.</SUBJECT>
                        <P>(a) The requirements for safeguarding CUI in this section apply when an offeror or contractor is expected to handle CUI, including instances when CUI resides on or transits through contractor information systems or within contractor facilities.</P>
                        <P>(b) The CUI requirements in the clause at 52.204-XX, Controlled Unclassified Information, apply when CUI will be involved in the contract. The CUI requirements in the clause at 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information, apply when no CUI will be involved in the contract.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.403-4</SECTNO>
                        <SUBJECT>Policy.</SUBJECT>
                        <P>(a) The requiring activity will identify any CUI in the standard form (SF) XXX, Controlled Unclassified Information (CUI) Requirements, which must be incorporated in the contract. Contractors are required to safeguard only the CUI that is identified in the SF XXX. However, see 52.204-XX(c)(2).</P>
                        <P>(b) Offerors and contractors are required to safeguard CUI pursuant to section 4.403-2. For CUI identified on an SF XXX that is incorporated into a contract, the contractor shall comply with the CUI requirements in the clause at 52.204-XX and on the form itself.</P>
                        <P>(c) Unmarked or mismarked CUI is not considered a CUI incident unless the mismarking or lack of marking has resulted in the mishandling or improper dissemination of the information. Offerors are requested, and contractors are required, to notify the Government within 8 hours of discovery if they discover during the solicitation phase or performance of a contract any information they suspect is CUI, but is not listed on an SF XXX or is not marked or properly marked as required by an SF XXX. Offerors and contractors are not responsible for identifying or marking unmarked or mismarked CUI that is not identified in the SF XXX.</P>
                        <P>(d) The Government shall protect against the improper use or release of information that includes contractor proprietary business information or contractor-attributional information to the extent required by law.</P>
                        <P>(e) Applicable CUI requirements can be waived by the Government in accordance with 32 CFR 2002.38.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.403-5</SECTNO>
                        <SUBJECT>Procedures.</SUBJECT>
                        <P>(a) For each requirement, except those exclusively for the acquisition of commercially available off-the-shelf items, the contracting officer shall obtain from the requiring activity an SF XXX that—</P>
                        <P>(1) Identifies what CUI is involved in the contract;</P>
                        <P>
                            (2) Specifies if and how the contractor is to mark CUI involved in the contract (
                            <E T="03">e.g.,</E>
                             when the contractor is generating or developing the CUI, or when the purpose of the contract is to mark CUI); and
                        </P>
                        <P>(3) Conforms to 11.002(i).</P>
                        <P>(b)(1) If the contracting officer has a reason to question the information on the SF XXX, the contracting officer shall request that the requiring activity verify that the SF XXX is accurate.</P>
                        <P>(2) If the requiring activity has marked the “Yes” box in Part A of SF XXX, the contracting officer shall incorporate the SF in the solicitation and contract and the clause at 52.204-XX, as prescribed at 4.403-7, to communicate requirements for safeguarding CUI during contract performance.</P>
                        <P>(3) If the requiring activity has marked the “No” box in Part A of SF XXX, the contracting officer shall include in the contract file a copy of the SF XXX and include in the solicitation and contract the clause at 52.204-YY, as prescribed at 4.403-7, to communicate requirements related to CUI should the contractor encounter suspected CUI during performance or the contract.</P>
                        <P>
                            (c) If the requiring activity states that there should be controlled access to the contents of the SF XXX or the SF XXX is marked as CUI itself, contracting officers shall follow agency procedures 
                            <PRTPAGE P="4293"/>
                            for safeguarding and disseminating the SF XXX.
                        </P>
                        <P>(d) If the contracting officer is notified or otherwise discovers that there is, or potentially could be CUI involved in the contract and it was not properly identified on an SF XXX, the contracting officer shall coordinate with the requiring activity to determine if the information is CUI. If the agency determines that the information is CUI, then the agency shall take the following steps:</P>
                        <P>(1) If the agency wants the contractor to handle this kind of CUI during performance of the contract, the contracting officer shall—</P>
                        <P>(i) Coordinate with the requiring activity to have the SF XXX updated;</P>
                        <P>(ii) Modify the contract to incorporate the new SF XXX and, if CUI was not previously anticipated under the contract, to remove the clause at 52.204-YY and incorporate the clause at 52.204-XX;</P>
                        <P>(iii) Consider any request for equitable adjustment submitted by the contractor, as appropriate; and</P>
                        <P>(iv) Provide to the contractor marking instructions for the CUI.</P>
                        <P>
                            (2) If the agency does not want the contractor to handle this kind of CUI, the contracting officer shall coordinate with the requiring activity to address the CUI (
                            <E T="03">e.g.,</E>
                             retrieve the CUI) and shall convey such instructions to the contractor.
                        </P>
                        <P>(e) Contracting officers shall also refer to 3.104-4 for procedures related to the disclosure, protection, and marking of contractor proprietary business information, contractor bid or proposal information, and source selection information submitted to the Government.</P>
                        <P>(f) The contracting officer shall follow agency procedures when providing any CUI to an offeror to ensure offeror compliance with the requirements in 32 CFR part 2002.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.403-6</SECTNO>
                        <SUBJECT>CUI incident reports.</SUBJECT>
                        <P>(a) Agencies shall protect against the improper use or release of information that includes contractor proprietary business information or contractor-attributional information to the extent required by law. See paragraph (g)(9) of 52.204-XX, Controlled Unclassified Information, for details on how contracting officers may use or share this information.</P>
                        <P>(b) For CUI in a non-Federally-controlled facility—</P>
                        <P>(1) Designate the agency point of contact to whom the contractor reports a CUI incident in the SF XXX Part C, Section IV. When the SF XXX is not used in a contract, the point of contact is the contracting officer (see 52.204-YY(b)).</P>
                        <P>(2) The SF XXX will list any special incident reporting requirements for CUI Specified.</P>
                        <P>(3) Upon notification of a CUI incident, the contracting officer shall notify the requiring activity of the CUI incident as soon as practicable and in accordance with agency procedures. If the CUI incident occurs on an order against an indefinite delivery contract, the ordering agency contracting officer shall make the contracting officer for the indefinite delivery contract aware of the notification.</P>
                        <P>(c) When the contractor is required to provide information system images preserved under the requirements of paragraph (g)(4) of the clause at 52.204-XX or as directed by the contracting officer in response to contractor notification under paragraph (b)(2) of the clause at 52.204-YY, in accordance with agency procedures, the contracting officer shall provide instructions to the contractor for submitting the system images. The contractor is required to hold the system images for 90 days unless the Government declines interest.</P>
                        <P>(d)(1) The contracting officer shall not interpret a contractor's report of a CUI incident to mean that the contractor or a subcontractor at any tier failed to provide adequate safeguards for CUI or otherwise failed to meet the requirements of the clause at 52.204-XX, without further analysis by the agency.</P>
                        <P>
                            (2) When a CUI incident is reported, the contracting officer shall consult with appropriate agency personnel (
                            <E T="03">e.g.,</E>
                             program office or requiring activity) before taking any action under the contract related to the CUI incident. When the contract includes the clause at 52.204-XX, the contracting officer shall consider such CUI incidents in the context of an overall assessment of the contractor's compliance with the requirements of the clause at 52.204-XX.
                        </P>
                        <P>(3) Unmarked or mismarked CUI is not considered a CUI incident unless the mismarking or lack of marking has resulted in the mishandling or improper dissemination of the information. The contracting officer shall consult with the appropriate agency personnel concerning any unmarked or mismarked CUI in accordance with agency procedures.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.403-7</SECTNO>
                        <SUBJECT>Solicitation provision and contract clauses.</SUBJECT>
                        <P>(a) Insert the provision at 52.204-WW, Notice of Controlled Unclassified Information Requirements, in solicitations that contain the clause at 52.204-XX or the clause at 52.204-YY.</P>
                        <P>(b) Except for solicitations and contracts solely for the acquisition of COTS items, insert the clause at 52.204-XX, Controlled Unclassified Information, and include an SF XXX Controlled Unclassified Information (CUI) Requirements, in solicitations and contracts if the requiring activity has marked the “Yes” box in Part A of the SF XXX.</P>
                        <P>(c) Insert the clause at 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information, in solicitations and contracts if the requiring activity has marked the “No” box in Part A of SF XXX, excluding solicitations and contracts solely for the acquisition of COTS items.</P>
                    </SECTION>
                    <AMDPAR>12. Revise section 4.404 and add sections 4.404-1 through 4.404-3 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>4.404</SECTNO>
                        <SUBJECT> Basic Safeguarding of Covered Contractor Information Systems.</SUBJECT>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.404-1</SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <P>As used in section 4.404—</P>
                        <P>
                            <E T="03">Covered contractor information system</E>
                             means an information system owned or operated by a contractor on which the contractor processes, stores, or transmits covered Federal information.
                        </P>
                        <P>
                            <E T="03">Covered Federal information</E>
                             means information provided by or created for the Government, when that information is other than—
                        </P>
                        <P>(1) Simple transactional information (such as that necessary to process payments);</P>
                        <P>(2) Information already publicly released (such as on public websites), or marked for public release, by the Government;</P>
                        <P>(3) Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189;</P>
                        <P>(4) Controlled unclassified information (CUI); or</P>
                        <P>(5) Classified information.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.404-2</SECTNO>
                        <SUBJECT>Applicability.</SUBJECT>
                        <P>(a) This section applies to all acquisitions, including acquisitions of commercial services or commercial products other than commercially available off-the-shelf (COTS) items, when a contractor's information system may contain covered Federal information as part of performance on the contract.</P>
                        <P>
                            (b) While covered Federal information is not required to be marked or identified by the Government, some 
                            <PRTPAGE P="4294"/>
                            administrative markings (
                            <E T="03">e.g.,</E>
                             draft, deliberative process, predecisional, not for public release) can indicate that the information is covered Federal information.
                        </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.404-3</SECTNO>
                        <SUBJECT>Contract clause.</SUBJECT>
                        <P>Insert the clause at 52.204-21, Basic Safeguarding of Covered Contractor Information Systems, in solicitations and contracts excluding solicitations and contracts solely for the acquisition of—</P>
                        <P>(a) COTS items; or</P>
                        <P>(b) Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189 when the agency does not provide any covered Federal information to the contractor.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>4.1301</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>13. Amend section 4.1301 by—</AMDPAR>
                    <AMDPAR>a. Removing from paragraph (a) the phrases “PUB Number 201”, and “Federally-controlled information” and adding the phrases “201” and “Federal information” in their places, respectively.</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (b) the phrases “PUB 201”, and “Federally-controlled information” and adding the phrases “201” and “Federal information” in their places, respectively.</AMDPAR>
                    <SECTION>
                        <SECTNO>4.1303</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>14. Amend section 4.1303 by removing the words “Federally-controlled information” and adding “Federal information” in its place.</AMDPAR>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart 4.19 [Removed and Reserved]</HD>
                    </SUBPART>
                    <AMDPAR>15. Remove and reserve subpart 4.19.</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 5—PUBLICIZING CONTRACT ACTIONS</HD>
                        <SECTION>
                            <SECTNO>5.202</SECTNO>
                            <SUBJECT>[Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>
                        16. Amend section 5.202 in paragraph (a)(8) by removing the phrase “proprietary information” and adding “controlled unclassified information (
                        <E T="03">e.g.,</E>
                         general proprietary business information)” in its place.
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>5.301</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>
                        17. Amend section 5.301 in paragraph (b)(1) by removing the phrase “proprietary information” and adding “controlled unclassified information (
                        <E T="03">e.g.,</E>
                         general proprietary business information)” in its place.
                    </AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 7—ACQUISITION PLANNING</HD>
                    </PART>
                    <AMDPAR>18. Amend section 7.103 by adding paragraph (z) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>7.103</SECTNO>
                        <SUBJECT>Agency-head responsibilities.</SUBJECT>
                        <STARS/>
                        <P>(z) Ensuring agency planners—(1) Comply with the requirements of Executive Order 13556 of November 4, 2010, as implemented at 32 CFR part 2002 and in agency procedures, for controlled unclassified information (CUI). This does not apply to acquisitions for commercially available off-the-shelf items or for Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189 when the agency does not provide any CUI to the contractor; and</P>
                        <P>(2) Identify all categories of CUI in proposed acquisitions and incorporate them and accompanying CUI standards in requirements planning and the SF XXX, Controlled Unclassified Information (CUI) Requirements, as appropriate (see 4.403-4, 11.002(i), and 39.105).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>19. Amend section 7.105 by—</AMDPAR>
                    <AMDPAR>a. Removing from paragraph (b)(18)(i) the phrase “(see subpart 4.4)” and adding “(see 4.402)” in its place;</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (b)(18)(iii) the phrase “Federally-controlled information” and adding “Federal information” in its place;</AMDPAR>
                    <AMDPAR>c. Revising paragraph (b)(18)(iv); and</AMDPAR>
                    <AMDPAR>d. Adding paragraph (b)(18)(v).</AMDPAR>
                    <P>The revision and addition read as follows:</P>
                    <SECTION>
                        <SECTNO>7.105</SECTNO>
                        <SUBJECT>Contents of written acquisition plans.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(18) * * *</P>
                        <P>(iv) For acquisitions that may require covered Federal information to reside in or transit through contractor information systems, discuss compliance with 4.404.</P>
                        <P>
                            (v) For acquisitions that may require a contractor to have access to, create, collect, use, process, store, maintain, disseminate, disclose, or dispose of CUI, discuss the security, marking, training, incident reporting, and other requirements (
                            <E T="03">e.g.,</E>
                             destruction) applicable to CUI (see 4.403-5 and 4.403-6).
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>20. Amend section 7.503 by revising paragraph (d)(11) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>7.503</SECTNO>
                        <SUBJECT>Policy.</SUBJECT>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(11) Contractors working in any situation that permits or might permit them to gain access to controlled unclassified information (CUI). See 4.403.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 9—CONTRACTOR QUALIFICATIONS</HD>
                        <SECTION>
                            <SECTNO>9.505</SECTNO>
                            <SUBJECT>[Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>21. Amend section 9.505 by removing from paragraph (b)(1) the phrase “Proprietary information” and adding the phrase “Contractor proprietary business information” in its place.</AMDPAR>
                    <AMDPAR>22. Amend section 9.505-4 by—</AMDPAR>
                    <AMDPAR>a. Removing from paragraph (a) introductory text the phrase “proprietary information from others” and adding “another contractor's proprietary business information” in its place; and</AMDPAR>
                    <AMDPAR>b. Revising paragraph (b).</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <SECTION>
                        <SECTNO>9.505-4</SECTNO>
                        <SUBJECT>Obtaining access to proprietary information.</SUBJECT>
                        <STARS/>
                        <P>(b) A contractor that gains access to another contractor's proprietary business information in performing advisory and assistance services for the Government must agree with the other company to protect its information from unauthorized use or disclosure for as long as it remains proprietary and refrain from using the information for any purpose other than that for which it was furnished. The contracting officer shall obtain copies of these agreements and ensure that they are properly executed.</P>
                        <STARS/>
                    </SECTION>
                    <SECTION>
                        <SECTNO>9.508</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>23. Amend section 9.508 by removing from paragraph (h) introductory text and paragraph (h)(1) the phrase “proprietary information” and adding “contractor proprietary business information” in their places, respectively.</AMDPAR>
                    <STARS/>
                    <PART>
                        <HD SOURCE="HED">PART 11—DESCRIBING AGENCY NEEDS</HD>
                    </PART>
                    <AMDPAR>24. Amend section 11.002 by adding paragraph (i) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>11.002</SECTNO>
                        <SUBJECT>Policy.</SUBJECT>
                        <STARS/>
                        <P>(i) When agencies acquire products and services subject to 32 CFR part 2002, Controlled Unclassified Information (CUI) (see 4.403), the SF XXX, Controlled Unclassified Information (CUI) Requirements, must be incorporated in the contract and must identify, at a minimum—</P>
                        <P>
                            (1) The CUI the contractor will handle in performance of the contract;
                            <PRTPAGE P="4295"/>
                        </P>
                        <P>(2) Any CUI access and dissemination requirements placed on the contractor during performance of the contract;</P>
                        <P>(3) Federal and non-Federal information systems the contractor will use to handle CUI in the performance of the contract;</P>
                        <P>(4) System security and privacy requirements for each information system, as appropriate, and any additional security and privacy measures required by the agency;</P>
                        <P>(5) Any instructions for handling CUI during performance of the contract;</P>
                        <P>(6) Any CUI training requirements the contractor must adhere to in order to comply with 32 CFR 2002.30; and</P>
                        <P>(7) Any CUI incident reporting instructions required by the agency, to include the agency website or single point of contact.</P>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 12—ACQUISITION OF COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES</HD>
                    </PART>
                    <AMDPAR>25. Amend section 12.202 by adding paragraph (f) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>12.202</SECTNO>
                        <SUBJECT>Market research and description of agency need.</SUBJECT>
                        <STARS/>
                        <P>(f) Requirements documents for acquisitions involving controlled unclassified information (CUI) shall—</P>
                        <P>(1) Comply with 32 CFR part 2002; and</P>
                        <P>(2) Incorporate all applicable handling and compliance instructions included in the SF XXX, Controlled Unclassified Information (CUI) Requirements (see 4.403 and 11.002(i)).</P>
                    </SECTION>
                    <AMDPAR>26. Amend section 12.301 by revising paragraph (d)(5) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>12.301</SECTNO>
                        <SUBJECT>Solicitation provisions and contract clauses for the acquisition of commercial products and commercial services.</SUBJECT>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(5) Insert the clause at 52.204-21, Basic Safeguarding of Covered Contractor Information Systems, in solicitations and contracts (except solicitations and contracts solely for the acquisition of COTS items), as prescribed in 4.404-3.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 15—CONTRACTING BY NEGOTIATION</HD>
                        <SECTION>
                            <SECTNO>15.407-1</SECTNO>
                            <SUBJECT>[Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>27. Amend section 15.407-1 by removing from the introductory text of paragraph (f) the phrase “improper disclosure.” and adding “improper disclosure such as requirements for controlled unclassified information or classified information.” in its place.</AMDPAR>
                    <AMDPAR>28. Amend section 15.604 by—</AMDPAR>
                    <AMDPAR>a. Removing from paragraph (a) introductory text the phrase “proprietary information” and adding “contractor proprietary business information” in its place; and</AMDPAR>
                    <AMDPAR>b. Revising paragraph (a)(7).</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <SECTION>
                        <SECTNO>15.604</SECTNO>
                        <SUBJECT>Agency points of contact.</SUBJECT>
                        <STARS/>
                        <P>(a) * * *</P>
                        <P>(7) Instructions for identifying and marking contractor proprietary business information so that it is protected and administrative markings conform to 15.609.</P>
                        <STARS/>
                    </SECTION>
                    <SECTION>
                        <SECTNO>15.606-2</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>29. Amend section 15.606-2 by removing from paragraph (a) introductory text the phrase “the legend” and adding “the administrative marking” in its place.</AMDPAR>
                    <AMDPAR>30. Amend section 15.609 by—</AMDPAR>
                    <AMDPAR>a. Removing from paragraphs (a) and (b) the phrase “the following legend” and adding the phrase “the following administrative marking” in its place;</AMDPAR>
                    <AMDPAR>b. Revising paragraph (c);</AMDPAR>
                    <AMDPAR>c. Removing from paragraph (d) the phrase “clearly mark” and adding the phrase “clearly administratively mark” in its place;</AMDPAR>
                    <AMDPAR>d. Removing from paragraph (e) the phrase “and privileged or confidential information to the Government” and adding “privileged or confidential information, or other controlled unclassified information” in its place;</AMDPAR>
                    <AMDPAR>e. Revising paragraph (f); and</AMDPAR>
                    <AMDPAR>f. Removing from paragraphs (g), (h) introductory text and (h)(1) the term “legend” and adding “administrative marking” in its place.</AMDPAR>
                    <P>The revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>15.609</SECTNO>
                        <SUBJECT>Limited use of data.</SUBJECT>
                        <STARS/>
                        <P>(c) The agency point of contact shall return to the offeror any unsolicited proposal marked with an administrative marking different from that provided in paragraph (a) of this section. The return letter will state that the proposal cannot be considered because it is impracticable for the Government to comply with the administrative marking and that the agency will consider the proposal if it is resubmitted with the proper administrative marking.</P>
                        <STARS/>
                        <P>(f) When an agency receives an unsolicited proposal without any restrictive administrative marking from an educational or nonprofit organization or institution, and an evaluation outside the Government is necessary, the agency point of contact shall—</P>
                        <P>(1) Attach a cover sheet clearly marked with the administrative marking in paragraph (d) of this section;</P>
                        <P>(2) Change the beginning of this administrative marking by deleting “All Government personnel” and adding “All Government and non-Government personnel”; and</P>
                        <P>(3) Require any non-Government evaluator to agree in writing that data in the proposal will not be disclosed to others outside the Government.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 27—PATENTS, DATA AND COPYRIGHTS</HD>
                    </PART>
                    <AMDPAR>31. Revise the heading of section 27.203 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>27.203</SECTNO>
                        <SUBJECT>Security requirements for patent applications and other patent information.</SUBJECT>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>32. Redesignate sections 27.203-1 and 27.203-2 as sections 27.203-2 and 27.203-3, and adding a new section 27.203-1 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>27.203-1</SECTNO>
                        <SUBJECT>Security requirements for controlled unclassified information.</SUBJECT>
                        <P>Contracts involving patent applications or other patent-related controlled unclassified information require safeguarding or dissemination controls that must be identified in the SF XXX, Controlled Unclassified Information (CUI) Requirements. See 4.403.</P>
                    </SECTION>
                    <AMDPAR>33. Revise the heading of newly redesignated section 27.203-2 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>27.203-2</SECTNO>
                        <SUBJECT>Security requirements for classified information.</SUBJECT>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 33—PROTESTS, DISPUTES, AND APPEALS</HD>
                    </PART>
                    <AMDPAR>34. Amend section 33.104 by—</AMDPAR>
                    <AMDPAR>a. Revising paragraph (a)(2); and</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (a)(5) introductory text the phrase “development or commercial information” and adding “development, commercial information, or other controlled unclassified information” in its place.</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <SECTION>
                        <SECTNO>33.104</SECTNO>
                        <SUBJECT>Protests to GAO.</SUBJECT>
                        <STARS/>
                        <P>(a) * * *</P>
                        <P>
                            (2) Immediately after receipt of the GAO's written notice that a protest has been filed, the agency shall give notice of the protest to the contractor if the award has been made, or, if no award has been made, to all parties who appear to have a reasonable prospect of receiving award if the protest is denied. 
                            <PRTPAGE P="4296"/>
                            The agency shall furnish copies of the protest submissions to such parties with instructions to—
                        </P>
                        <P>(i) Communicate directly with the GAO; and</P>
                        <P>(ii) Provide copies of any such communication to the agency and to other participating parties when they become known. However, if the protester has identified controlled unclassified information and requests a protective order, then the contracting officer shall obtain a redacted version from the protester to furnish to other interested parties, if one has not already been provided.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 42—CONTRACT ADMINISTRATION AND AUDIT SERVICES</HD>
                        <SECTION>
                            <SECTNO>42.302</SECTNO>
                            <SUBJECT>[Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>35. Amend section 42.302 by removing from paragraph (a)(21) the phrase “Subpart 4.4” and adding “4.402” in its place.</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 52—SOLICITATION PROVISIONS AND CONTRACT CLAUSES</HD>
                    </PART>
                    <AMDPAR>36. Amend section 52.204-2 by revising the section heading, the introductory text, the clause heading, and the date of the clause to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>52.204-2</SECTNO>
                        <SUBJECT>Security Requirements for Classified Information.</SUBJECT>
                        <P>As prescribed in 4.402-3(a), insert the following clause:</P>
                        <HD SOURCE="HD1">Security Requirements for Classified Information (DATE)</HD>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>37. Amend section 52.204-9 by—</AMDPAR>
                    <AMDPAR>a. Revising the date of the clause;</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (a) the phrase “(FIPS PUB) Number” and adding “(FIPS)” in its place; and</AMDPAR>
                    <AMDPAR>c. Removing from paragraph (d) the phrase “Federally-controlled information” and adding “Federal information” in its place.</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <SECTION>
                        <SECTNO>52.204-9</SECTNO>
                        <SUBJECT>Personal Identity Verification of Contractor Personnel.</SUBJECT>
                        <STARS/>
                        <HD SOURCE="HD1">Personal Identity Verification of Contractor Personnel (DATE)</HD>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>38. Amend section 52.204-16 by—</AMDPAR>
                    <AMDPAR>a. Revising the date of the clause; and</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (g) the phrase “Security Requirements” and adding “Security Requirements for Classified Information” in its place.</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <SECTION>
                        <SECTNO>52.204-16</SECTNO>
                        <SUBJECT>Commercial and Government Entity Code Reporting.</SUBJECT>
                        <STARS/>
                        <HD SOURCE="HD1">Commercial and Government Entity Code Reporting (DATE)</HD>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>39. Amend section 52.204-18 by—</AMDPAR>
                    <AMDPAR>a. Revising the date of the clause; and</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (f) the phrase “Security Requirements” and adding “Security Requirements for Classified Information” in its place.</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <SECTION>
                        <SECTNO>52.204-18</SECTNO>
                        <SUBJECT>Commercial and Government Entity Code Maintenance.</SUBJECT>
                        <STARS/>
                        <HD SOURCE="HD1">Commercial and Government Entity Code Maintenance (DATE)</HD>
                        <STARS/>
                    </SECTION>
                    <SECTION>
                        <SECTNO>40.</SECTNO>
                        <SUBJECT>Amend section 52.204-21 by—</SUBJECT>
                    </SECTION>
                    <AMDPAR>a. Revising the introductory text and date of the clause;</AMDPAR>
                    <AMDPAR>b. In paragraph (a):</AMDPAR>
                    <AMDPAR>i. Revising the definition of “Covered contractor information system”;</AMDPAR>
                    <AMDPAR>ii. Adding in alphabetical order the definition for “Covered Federal information”;</AMDPAR>
                    <AMDPAR>iii. Removing the definition for “Federal contract information”;</AMDPAR>
                    <AMDPAR>iv. Revising the definition of “Information”;</AMDPAR>
                    <AMDPAR>c. Removing from paragraph (b)(1)(vii) the phrase “Federal Contract Information” and adding “covered Federal information” in its place.</AMDPAR>
                    <AMDPAR>d. Removing from paragraph (b)(2) the phrase “controlled unclassified information (CUI)” and adding “CUI” in its place;</AMDPAR>
                    <AMDPAR>e. Adding paragraph (b)(3); and</AMDPAR>
                    <AMDPAR>f. Removing from paragraph (c) the phrase “Federal contract information” and adding “covered Federal information” in its place.</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>52.204-21</SECTNO>
                        <SUBJECT>Basic Safeguarding of Covered Contractor Information Systems.</SUBJECT>
                        <P>As prescribed in 4.404-3, insert the following clause:</P>
                        <HD SOURCE="HD1">Basic Safeguarding of Covered Contractor Information Systems (DATE)</HD>
                        <P>(a) * * *</P>
                        <P>
                            <E T="03">Covered contractor information system</E>
                             means an information system owned or operated by a contractor on which the contractor processes, stores, or transmits covered Federal information.
                        </P>
                        <P>
                            <E T="03">Covered Federal information</E>
                             means information provided by or created for the Government when that information is other than—
                        </P>
                        <P>(1) Simple transactional information (such as that necessary to process payments);</P>
                        <P>(2) Information already publicly released (such as on public websites), or marked for public release, by the Government;</P>
                        <P>(3) Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189;</P>
                        <P>(4) Controlled unclassified information (CUI); or</P>
                        <P>(5) Classified information.</P>
                        <P>
                            <E T="03">Information</E>
                             means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, electronic, or audiovisual forms (OMB Circular A-130, Managing Information as a Strategic Resource).
                        </P>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>
                            (3) 
                            <E T="03">Identification of covered Federal information.</E>
                             While covered Federal information is not required to be marked or identified by the Government, some administrative markings (
                            <E T="03">e.g.,</E>
                             draft, deliberative process, predecisional, not for public release) can indicate that the information is covered Federal information. If the Contractor is not sure whether specific information is covered Federal information, the Contractor can request clarification from the Contracting Officer.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>41. Add sections 52.204-WW, 52.204-XX, and 52.204-YY to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>52.204-WW</SECTNO>
                        <SUBJECT>Notice of Controlled Unclassified Information Requirements.</SUBJECT>
                        <P>As prescribed in 4.403-7(a), insert the following provision:</P>
                        <HD SOURCE="HD1">Notice of Controlled Unclassified Information Requirements (DATE)</HD>
                        <P>
                            (a) 
                            <E T="03">Definitions.</E>
                             As used in this provision, 
                            <E T="03">contractor-attributional information, contractor bid or proposal information, controlled unclassified information (CUI), CUI incident,</E>
                             and 
                            <E T="03">handling</E>
                             have the meaning provided in the clause 52.204-XX, Controlled Unclassified Information.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Government-provided information.</E>
                        </P>
                        <P>
                            (1) The Offeror shall not use Government-provided information for its own purposes, whether or not the information is marked as CUI, unless the information is in the public domain, or unless the information was lawfully made available to the Offeror by someone other than the Government.
                            <PRTPAGE P="4297"/>
                        </P>
                        <P>(2) If Offerors require access to CUI, the Government will provide agency procedures on handling the CUI to ensure compliance with the requirements in 32 CFR part 2002. Offerors shall comply with these agency procedures when handling CUI.</P>
                        <P>
                            (c) 
                            <E T="03">Offeror-provided information.</E>
                             The Offeror shall appropriately identify information the Offeror owns and provides to the Government, which is contractor bid or proposal information, contractor-attributional information, or Offeror proprietary business information. The Government will determine in accordance with agency procedures whether the information provided by the Offeror is CUI or entitled to other protections (
                            <E T="03">e.g.,</E>
                             contractor-attributional information associated with a CUI incident).
                        </P>
                        <P>
                            (d) 
                            <E T="03">Unmarked CUI or mismarked CUI.</E>
                             The Offeror should notify the Contracting Officer within 8 hours of discovery if the Offeror discovers any CUI that is not marked, not properly marked, not identified on the SF XXX, or is involved in a suspected or confirmed CUI incident. The Offeror should take action to appropriately safeguard any information the Offeror believes is CUI that is not identified in the SF XXX or is not marked or properly marked as required in the SF XXX until a Contracting Officer makes a determination.
                        </P>
                        <P>(End of provision)</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>52.204-XX</SECTNO>
                        <SUBJECT>Controlled Unclassified Information.</SUBJECT>
                        <P>As prescribed in 4.403-7(b), insert the following clause:</P>
                        <HD SOURCE="HD1">Controlled Unclassified Information (DATE)</HD>
                        <P>
                            (a) 
                            <E T="03">Identifying controlled unclassified information.</E>
                             The SF XXX, Controlled Unclassified Information, that is incorporated into this contract identifies what controlled unclassified information (CUI) is involved in the contract. The Contractor is required to safeguard only the CUI that is identified in the SF XXX. However, see paragraph (c)(2) of this clause.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Definitions.</E>
                             As used in this clause—
                        </P>
                        <P>
                            <E T="03">Adequate security</E>
                             means security protections commensurate with the risk of harm resulting from unauthorized access, use, disclosure, disruption, modification, or destruction of information.
                        </P>
                        <P>
                            <E T="03">Contractor-attributional information</E>
                             means information that identifies the Contractor or its employees directly or identifies them indirectly by grouping information that can be traced back to the Contractor (
                            <E T="03">e.g.,</E>
                             program description or facility locations).
                        </P>
                        <P>
                            <E T="03">Contractor bid or proposal information</E>
                             means any of the following information submitted to a Federal agency as part of or in connection with a bid or proposal to enter into a Federal agency procurement contract, if that information has not been previously made available to the public or disclosed publicly:
                        </P>
                        <P>(1) Cost or pricing data as defined by 10 U.S.C. 3701(1), with respect to procurements subject to that section, and 41 U.S.C. 3501(a)(2), with respect to procurements subject to that section.</P>
                        <P>(2) Indirect costs and direct labor rates.</P>
                        <P>(3) Proprietary information about manufacturing processes, operations, or techniques marked by the Contractor in accordance with applicable law or regulation.</P>
                        <P>(4) Information marked by the Contractor as “Contractor bid or proposal information” in accordance with applicable law or regulation.</P>
                        <P>(5) Information marked in accordance with 52.215-1(e).</P>
                        <P>
                            <E T="03">Controlled unclassified information (CUI)</E>
                             means information that the Government creates or possesses, or that an entity creates or possesses for or on behalf of the Government, that a law, regulation, or Governmentwide policy requires or permits an agency to handle using safeguarding or dissemination controls. CUI does not include—
                        </P>
                        <P>(1) Classified information;</P>
                        <P>(2) Covered Federal information;</P>
                        <P>(3) Information a Contractor possesses and maintains in its own systems that did not come from, or was not created or possessed by or for, an executive branch agency or an entity acting for an agency (see 32 CFR 2002.4); or</P>
                        <P>(4) Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189.</P>
                        <P>
                            <E T="03">CUI Basic</E>
                             means the subset of CUI for which the authorizing law, regulation, or Governmentwide policy does not set out specific handling or dissemination controls. CUI Basic must be handled according to the uniform set of controls set forth in 32 CFR part 2002 and the CUI Registry.
                        </P>
                        <P>
                            <E T="03">CUI categories</E>
                             means those types of information for which laws, regulations, or Governmentwide policies require or permit agencies to exercise safeguarding or dissemination controls, and which has been listed in the CUI Registry.
                        </P>
                        <P>
                            <E T="03">CUI incident</E>
                             means improper access, use, disclosure, modification, or destruction of CUI, in any form or medium.
                        </P>
                        <P>
                            <E T="03">CUI Registry</E>
                             means the online repository for all information, guidance, policy, and requirements on handling CUI. Among other information, the CUI Registry identifies all approved CUI categories and subcategories, provides general descriptions for each, identifies the basis for controls, establishes markings, and includes guidance on handling procedures (see 
                            <E T="03">https://archives.gov/cui</E>
                            ).
                        </P>
                        <P>
                            <E T="03">CUI Specified</E>
                             means the subset of CUI for which the authorizing law, regulation, or Governmentwide policy contains specific handling controls that it requires or permits agencies to use and that differ from those for CUI Basic. The CUI Registry indicates which laws, regulations, and Governmentwide policies include such specific requirements.
                        </P>
                        <P>
                            <E T="03">Federal information system</E>
                             means an information system (44 U.S.C. 3502(8)) used or operated by an agency, or by a contractor of an agency or by another organization, on behalf of an agency.
                        </P>
                        <P>
                            <E T="03">Handling</E>
                             means any use of CUI, including but not limited to collecting, developing, receiving, transmitting, storing, marking, safeguarding, transporting, disseminating, re-using, and disposing of the information.
                        </P>
                        <P>
                            <E T="03">Information</E>
                             means any communication or representation of knowledge such as facts, data, or opinions in any medium or form, including textual, numerical, graphic, cartographic, narrative, electronic, or audiovisual forms (see Office of Management and Budget (OMB) Circular No. A-130, Managing Information as a Strategic Resource).
                        </P>
                        <P>
                            <E T="03">Information system</E>
                             means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502(8)).
                        </P>
                        <P>
                            <E T="03">Lawful Government purpose</E>
                             means any activity, mission, function, operation, or endeavor that the Government authorizes or recognizes as within the scope of its legal authorities or the legal authorities of non-executive branch entities such as state and local law enforcement.
                        </P>
                        <P>
                            <E T="03">Limited dissemination control</E>
                             means any control identified on the CUI Registry that agencies may use to limit or specify CUI dissemination.
                        </P>
                        <P>
                            <E T="03">On behalf of an agency</E>
                             means a Contractor uses or operates an information system or maintains or collects information for the purpose of processing, storing, or transmitting Federal information, and those activities 
                            <PRTPAGE P="4298"/>
                            are not incidental to providing a service or product to the Government.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Identifying and reporting information the Contractor believes or has reason to know is potentially CUI.</E>
                        </P>
                        <P>(1) The Contractor shall notify the Contracting Officer within 8 hours of discovery if—</P>
                        <P>(i) The Contractor discovers any information that the Contractor believes is CUI that is not identified in the SF XXX or is not marked or properly marked as required in the SF XXX; or</P>
                        <P>(ii) There is any inconsistency between this clause and an SF XXX incorporated into the contract.</P>
                        <P>(2) The Contractor shall take action to appropriately safeguard any information the Contractor believes is CUI that is not identified in the SF XXX or is not marked or properly marked as required in the SF XXX until a Contracting Officer makes a determination.</P>
                        <P>(3) If the Contractor discovers any information that the contractor believes is CUI that is not identified in the SF XXX that is involved in a suspected or confirmed CUI incident, the Contractor shall notify the Contracting Officer and comply with paragraph (g) of this clause.</P>
                        <P>(4) The Contractor is not entitled to use Government-provided information for its own purposes, whether or not the information is marked as CUI, unless the information is in the public domain, or unless the information was lawfully made available to the Contractor by someone other than the Government.</P>
                        <P>
                            (5) The Contractor shall appropriately identify information the Contractor owns and provides to the Government (
                            <E T="03">e.g.,</E>
                             contractor bid or proposal information, contractor-attributional information, or contractor proprietary business information). The Government will determine in accordance with agency procedures whether the information provided by the Contractor is CUI or entitled to other protections (
                            <E T="03">e.g.,</E>
                             contractor-attributional information associated with a CUI incident).
                        </P>
                        <P>
                            (d) 
                            <E T="03">Safeguarding CUI.</E>
                        </P>
                        <P>(1) The Contractor shall safeguard CUI that the Government identifies in the SF XXX and ensure handling consistent with 32 CFR 2002.14.</P>
                        <P>(i) This includes CUI that the Government provides to the Contractor or CUI that the Contractor collects, develops, receives, transmits, uses, handles, or stores in performance of the contract.</P>
                        <P>(ii) For CUI located within a Federally-controlled facility, the Contractor shall follow agency CUI policies and shall ensure that any Contractor employees handling CUI within Federally-controlled facilities meet the prerequisites identified within Part B on the SF XXX for training and for access to CUI.</P>
                        <P>(iii) For CUI located within a non-Federally-controlled facility, the Contractor shall follow CUI policies and shall ensure that any Contractor employees handling CUI within the non-Federally-controlled facility comply with the requirements identified in Part C of the SF XXX.</P>
                        <P>(iv) Any applicable agency-specific policies for safeguarding or handling CUI will be identified in the SF XXX.</P>
                        <P>(v) When information is not identified as CUI, it may be covered Federal information requiring information system security controls in accordance with Federal Acquisition Regulation clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems.</P>
                        <P>(2) The Contractor shall permit access to CUI only as described in the SF XXX.</P>
                        <P>(3) Except for its own information, the Contractor is not responsible for identifying or marking unmarked or mismarked CUI unless doing so is specifically included in the SF XXX, such as when the Contractor generates or develops the CUI.</P>
                        <P>(4) No Contractor employee shall be permitted to have or retain access to, create, collect, use, process, store, maintain, disseminate, disclose, dispose of, or otherwise handle CUI unless the employee has completed training on properly handling CUI that, at a minimum, includes the elements required in the SF XXX.</P>
                        <P>(5) Contractors operating information systems that access, use, process, store, maintain, or transmit CUI identified in the contract, shall implement the following requirements:</P>
                        <P>(i) When the Contractor is operating an information system identified in the SF XXX as a Federal information system—</P>
                        <P>(A) The Contractor shall comply with agency-identified security requirements from the latest version of National Institute of Standards and Technology (NIST) Special Publication (SP) 800-53 and any CUI Specified requirements identified in the SF XXX; and</P>
                        <P>
                            (B) If using cloud computing services, the Contractor shall comply with agency-identified security requirements, but at no less than the Federal Risk and Authorization Management Program (FedRAMP) Moderate baseline (
                            <E T="03">https://www.fedramp.gov/documents/</E>
                            ).
                        </P>
                        <P>(ii) When the Contractor is operating a non-Federal information system, the Contractor shall—</P>
                        <P>
                            (A) Comply with the security requirements of NIST SP 800-171 Revision 2, “Protecting Controlled Unclassified Information in Non-Federal Information Systems and Organizations” (available via the internet at 
                            <E T="03">https://dx.doi.org/10.6028/NIST.SP.800-171</E>
                            ) or as authorized by the Contracting Officer. Additional controls other than NIST SP 800-171 Revision 2 may be specified in the contract's requirements document, in accordance with 32 CFR 2002.14(h)(2), to address unique requirements to protect CUI Basic at higher than the moderate confidentiality level;
                        </P>
                        <P>(B) Comply with all additional security requirements for CUI Specified identified by the agency in the SF XXX;</P>
                        <P>(C) Implement additional information security requirements the Contractor reasonably determines necessary to provide adequate security in a dynamic environment;</P>
                        <P>(D) Comply with any requirements from NIST SP 800-172, Enhanced Security Requirements for Protecting Controlled Unclassified Information, identified by the agency. For any requirements in NIST SP 800-172 identified by the agency, the organizational defined parameters (ODP) provided in Attachment 1 of SF XXX shall be applied for applicable security requirements;</P>
                        <P>(E) Ensure that, if the Contractor uses a cloud service provider to store, process, or transmit any CUI identified in SF XXX—</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) The cloud service provider meets security requirements established by the Government for the FedRAMP Moderate baseline (
                            <E T="03">https://www.fedramp.gov/documents/</E>
                            ); and
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) The additional requirements in paragraphs (d)(5)(ii)(B) and (C), and (g) of this clause are met; and
                        </P>
                        <P>(F) Submit the system security plan, and any associated plans of action required by NIST SP 800-171, Revision 2, for any planned implementations or mitigations to the Government upon request to demonstrate the Contractor's implementation or planned implementation of the security requirements.</P>
                        <P>
                            (e) 
                            <E T="03">Compliance.</E>
                        </P>
                        <P>(1) The Contracting Officer may require the submission of supporting documentation to verify compliance with the contract's security requirements, or may require access to Contractor facilities or systems, as listed in SF XXX.</P>
                        <P>
                            (2) For applicable non-Federal information systems, the agency may conduct validation actions in accordance with NIST SP 800-171A, Assessing Security Requirements for Controlled Unclassified Information and, if applicable, NIST SP 800-172A, 
                            <PRTPAGE P="4299"/>
                            Assessing Enhanced Security Requirements for Controlled Unclassified Information.
                        </P>
                        <P>
                            (f) 
                            <E T="03">Training.</E>
                        </P>
                        <P>
                            (1) 
                            <E T="03">General CUI training.</E>
                             All Contractor employees who will handle CUI shall complete general CUI training before doing so, and periodically complete refresher training thereafter, as described in the training sections at Section II of Part B and Section III of Part C of the SF XXX. The Contractor shall maintain documentation of employee training and shall provide it to the Contracting Officer upon request.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Additional training.</E>
                        </P>
                        <P>
                            <E T="03">Additional agency-specific training.</E>
                             Contractor employees shall also take any additional training described in the SF XXX sections on training. This additional training augments the general CUI training and may include specialized training for a particular category of CUI or for certain employees handling CUI in a specific situation, or other similar circumstances.
                        </P>
                        <P>
                            (g) 
                            <E T="03">CUI incidents.</E>
                        </P>
                        <P>(1) For CUI in a Federally-controlled facility, the Contractor shall report CUI incidents in accordance with agency policy.</P>
                        <P>(2) For CUI in a non-Federally-controlled facility, the Contractor shall report—</P>
                        <P>(i) Any suspected or confirmed CUI incident to the agency website or single point of contact identified in Part C, Section IV of the SF XXX; if there is no point of contact identified there the Contractor should contact the Contracting Officer for instructions;</P>
                        <P>(ii) Within 8 hours of discovery; and</P>
                        <P>
                            (iii) As many of the applicable data elements located at 
                            <E T="03">https://dibnet.dod.mil/portal/intranet/</E>
                             as are available in the initial report and provide any remaining applicable data elements as soon as they become available.
                        </P>
                        <P>(3) When the Contractor discovers a suspected or confirmed CUI incident, the Contractor shall—</P>
                        <P>(i) Determine and inventory what CUI was or could have been improperly accessed, created, collected, used, processed, stored, maintained, disseminated, disclosed, or disposed of;</P>
                        <P>(ii) Construct a timeline of user activity;</P>
                        <P>(iii) Determine methods and techniques used to access CUI; and</P>
                        <P>(iv) Cooperate and exchange information with agency officials, as determined necessary by the agency, in order to effectively report and manage a suspected or confirmed CUI incident.</P>
                        <P>(4) If the suspected or confirmed CUI incident has occurred on an information system, preserve and protect images of all known affected information systems and all relevant monitoring and packet capture data until the Government declines interest or 90 days from the date of the submission of the report passes without the Government requesting the media and data, whichever is sooner.</P>
                        <P>(5) Unmarked or mismarked CUI is not considered a CUI incident unless the mismarking or lack of marking has resulted in the mishandling or improper dissemination of the information.</P>
                        <P>(6) If the Contractor is a FedRAMP authorized (Joint Authorization Board or Agency) cloud service provider, the Contractor shall also report to the point(s) of contact specified in the FedRAMP incident reporting guidelines as documented in the Cloud Service Provider Incident Response Plan.</P>
                        <P>(7) The reporting requirements of this clause do not relieve the Contractor from the requirement to follow any applicable laws, regulations, or policies outside of this clause.</P>
                        <P>
                            (8) If the Contractor is determined to be at fault for a CUI incident (
                            <E T="03">e.g.,</E>
                             not safeguarding CUI in accordance with contract requirements), the Contractor may be financially liable for Government costs incurred in the course of the response and mitigation efforts in addition to any other damages at law or remedies available to the Government for noncompliance.
                        </P>
                        <P>(9)(i) The Government will protect contractor bid or proposal information, contractor proprietary business information, and contractor-attributional information related to a CUI incident, against unauthorized use or release to the extent required by law.</P>
                        <P>(ii) The agency may release outside the Government contractor bid or proposal information, contractor proprietary business information, and contractor-attributional information that is not created by or for the Government, but that is related to a CUI incident—</P>
                        <P>(A) To entities with missions that may be affected by such information;</P>
                        <P>(B) To entities that may be called upon to assist in the diagnosis, detection, or mitigation of CUI incidents; or</P>
                        <P>(C) For national security purposes, including cyber situational awareness.</P>
                        <P>(iii) The Government may use and release contractor bid or proposal information, contractor proprietary business information, and contractor-attributional information, created by or for the Government and related to a CUI incident, outside of the Government for purposes and activities associated with responding to a CUI incident and for any other lawful Government purpose or activity.</P>
                        <P>(iv) In any authorized release, the Government will minimize the contractor proprietary business information and contractor-attributional information that it includes.</P>
                        <P>(10) An agency, at its sole discretion, may obtain assistance from Federal agencies or entities outside the Government, such as third-party firms to aid incident response activities.</P>
                        <P>(11) The SF XXX will list in Part C, Section IV incident reporting requirements that differ from or are in addition to those in this clause, such as requirements for CUI in a CUI Specified category.</P>
                        <P>
                            (h) 
                            <E T="03">Subcontracts.</E>
                        </P>
                        <P>(1) Except for the acquisitions in paragraph (h)(2), in subcontracts at any tier, or other contractual instruments, for which performance involves CUI identified in the SF XXX, Controlled Unclassified Information (CUI) Requirements, the Contractor shall—</P>
                        <P>(i) Include this clause, including this paragraph (h), without alteration except to identify the parties;</P>
                        <P>(ii) Include the information in the SF XXX, Controlled Unclassified Information (CUI) Requirements, modified as required to address the CUI that applies to the subcontract; and</P>
                        <P>(iii) Require subcontractors to notify the prime Contractor or next higher tier subcontractor within 8 hours of discovery of a suspected or confirmed CUI incident.</P>
                        <P>(2) Paragraph (h)(1) of this clause does not apply to acquisitions exclusively for commercially available off-the-shelf items or Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189 when the Contractor does not provide any CUI to the subcontractor.</P>
                        <P>(End of clause)</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>52.204-YY</SECTNO>
                        <SUBJECT>Identifying and Reporting Information That Is Potentially Controlled Unclassified Information.</SUBJECT>
                        <P>As prescribed in 4.403-7(c), insert the following clause:</P>
                        <HD SOURCE="HD1">Identifying and Reporting Information That is Potentially Controlled Unclassified Information (DATE)</HD>
                        <P>
                            (a) 
                            <E T="03">Definitions.</E>
                             As used in this clause—
                        </P>
                        <P>
                            <E T="03">Contractor-attributional information</E>
                             means information that identifies the Contractor or its employees directly or identifies them indirectly by grouping information that can be traced back to the Contractor (
                            <E T="03">e.g.,</E>
                             program description or facility locations).
                        </P>
                        <P>
                            <E T="03">Contractor bid or proposal information</E>
                             means any of the following 
                            <PRTPAGE P="4300"/>
                            information submitted to a Federal agency as part of or in connection with a bid or proposal to enter into a Federal agency procurement contract, if that information has not been previously made available to the public or disclosed publicly:
                        </P>
                        <P>(1) Cost or pricing data as defined by 10 U.S.C. 3701(1), with respect to procurements subject to that section, and 41 U.S.C. 3501(a)(2), with respect to procurements subject to that section.</P>
                        <P>(2) Indirect costs and direct labor rates.</P>
                        <P>(3) Proprietary information about manufacturing processes, operations, or techniques marked by the Contractor in accordance with applicable law or regulation.</P>
                        <P>(4) Information marked by the Contractor as “Contractor bid or proposal information” in accordance with applicable law or regulation.</P>
                        <P>(5) Information marked in accordance with 52.215-1(e).</P>
                        <P>
                            <E T="03">Controlled unclassified information (CUI)</E>
                             means information that the Government creates or possesses, or that an entity creates or possesses for or on behalf of the Government, that a law, regulation, or Governmentwide policy requires or permits an agency to handle using safeguarding or dissemination controls. CUI does not include—
                        </P>
                        <P>(1) Classified information;</P>
                        <P>(2) Covered Federal information;</P>
                        <P>(3) Information a Contractor possesses and maintains in its own systems that did not come from, or was not created or possessed by or for, an executive branch agency or an entity acting for an agency (see 32 CFR 2002.4); or</P>
                        <P>(4) Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189.</P>
                        <P>
                            <E T="03">CUI incident</E>
                             means improper access, use, disclosure, modification, or destruction of CUI, in any form or medium.
                        </P>
                        <P>
                            <E T="03">Information</E>
                             means any communication or representation of knowledge such as facts, data, or opinions in any medium or form, including textual, numerical, graphic, cartographic, narrative, electronic, or audiovisual forms (see Office of Management and Budget (OMB) Circular No. A-130, Managing Information as a Strategic Resource).
                        </P>
                        <P>
                            <E T="03">Lawful Government purpose</E>
                             means any activity, mission, function, operation, or endeavor that the Government authorizes or recognizes as within the scope of its legal authorities or the legal authorities of non-executive branch entities such as state and local law enforcement.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Identifying and reporting information the contractor believes or has reason to know is potentially CUI.</E>
                             This contract does not identify CUI as being involved in the contract; nonetheless:
                        </P>
                        <P>(1) The Contractor shall notify the Contracting Officer within 8 hours of discovery if the Contractor discovers any information that the contractor believes, or has reason to know, is CUI. The potential unidentified CUI may be marked, unmarked, or improperly marked. The Contractor shall take action to appropriately safeguard any information the Contractor believes is CUI, until a Contracting Officer makes a determination.</P>
                        <P>(2) If the Contractor discovers any information that the Contractor believes is CUI and it is involved in a suspected or confirmed CUI incident, the Contractor shall notify the Contracting Officer as outlined in paragraph (b)(1), determine and inventory what CUI was or could have been improperly accessed, created, collected, used, processed, stored, maintained, disseminated, disclosed, or disposed of as part of the incident, and follow any additional incident response requirements the Contracting Officer provides if the Government determines the information is CUI.</P>
                        <P>(3) The reporting requirements of this clause do not relieve the Contractor from the requirement to follow any applicable laws, regulations, or policies outside of this clause.</P>
                        <P>
                            (c) 
                            <E T="03">Government-provided information.</E>
                             The Contractor is not entitled to use Government-provided information for its own purposes, whether or not the information is marked as CUI, unless the information is in the public domain, or unless the information was lawfully made available to the Contractor by someone other than the Government.
                        </P>
                        <P>
                            (d) 
                            <E T="03">Contractor information.</E>
                             The Contractor shall appropriately identify information the Contractor owns and provides to the Government (
                            <E T="03">i.e.,</E>
                             contractor bid or proposal information, contractor-attributional information, or contractor proprietary business information). The Government will determine in accordance with agency procedures whether the information provided by the Contractor is CUI or entitled to other protections (
                            <E T="03">e.g.,</E>
                             contractor-attributional information associated with a CUI incident).
                        </P>
                        <P>(1) If it is CUI or entitled to other protections, the Government will protect against the improper use or release of the information to the extent required by law.</P>
                        <P>(2) The agency may release outside the Government Contractor bid or proposal information, Contractor proprietary business information, and contractor-attributional information that is not created by or for the Government, but that is related to a CUI incident—</P>
                        <P>(i) To entities with missions that may be affected by such information;</P>
                        <P>(ii) To entities that may be called upon to assist in the diagnosis, detection, or mitigation of CUI incidents; or</P>
                        <P>(iii) For national security purposes, including cyber situational awareness.</P>
                        <P>(3) The Government may use and release Contractor bid or proposal information, Contractor proprietary business information, and contractor-attributional information, created by or for the Government and related to a CUI incident, outside of the Government for purposes and activities associated with responding to a CUI incident and for any other lawful Government purpose or activity.</P>
                        <P>(4) In any authorized release, the Government will include the Contractor proprietary business information or contractor-attributional information only to the extent necessary, as determined by the Government, to advance a lawful Government purpose or activity.</P>
                        <P>
                            (e) 
                            <E T="03">Subcontracts.</E>
                             The Contractor shall include this clause, including this paragraph (e) and without alteration except to identify the parties, in all subcontracts and other contractual instruments. The Contractor shall require subcontractors to notify the prime Contractor or next higher tier subcontractor within 8 hours of discovery of a suspected or confirmed CUI incident.
                        </P>
                        <P>(End of clause)</P>
                    </SECTION>
                    <AMDPAR>42. Amend section 52.212-5 by—</AMDPAR>
                    <AMDPAR>a. Revising the date of the clause;</AMDPAR>
                    <AMDPAR>b. Redesignating paragraphs (b)(12) through (65) as paragraphs (b)(14) through (67) and adding new paragraphs (b)(12) and (13);</AMDPAR>
                    <AMDPAR>c. Redesignating paragraphs (e)(1)(viii) through (xxvii) as paragraphs (e)(1)(x) through (xxix) and adding new paragraphs (e)(1)(viii) and (ix);</AMDPAR>
                    <AMDPAR>d. In Alternate II:</AMDPAR>
                    <AMDPAR>i. Revising the date of the alternate; and</AMDPAR>
                    <AMDPAR>ii. Redesignating paragraphs (e)(1)(ii)(H) through (Z) as paragraphs (e)(1)(ii)(J) through (BB); and</AMDPAR>
                    <AMDPAR>iii. Adding new paragraphs (H) and (I).</AMDPAR>
                    <P>The revisions read as follows:</P>
                    <SECTION>
                        <PRTPAGE P="4301"/>
                        <SECTNO>52.212-5</SECTNO>
                        <SUBJECT>Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services.</SUBJECT>
                        <STARS/>
                        <HD SOURCE="HD1">Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (DATE)</HD>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(12) 52.204-XX, Controlled Unclassified Information (DATE) (E.O. 13556).</P>
                        <P>(13) 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information (DATE).</P>
                        <STARS/>
                        <P>(e)(1) * * *</P>
                        <P>(viii) 52.204-XX, Controlled Unclassified Information (DATE) (E.O. 13556).</P>
                        <P>(ix) 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information (DATE).</P>
                        <STARS/>
                        <P>Alternate II (DATE) * * *</P>
                        <P>(e)(1) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(H) 52.204-XX, Controlled Unclassified Information (DATE) (E.O. 13556).</P>
                        <P>(I) 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information (DATE).</P>
                    </SECTION>
                    <AMDPAR>43. Amend section 52.213-4 by—</AMDPAR>
                    <AMDPAR>a. Revising the date of the clause;</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (a)(2)(vii) “NOV 2024” and adding “(DATE)” in its place; and</AMDPAR>
                    <AMDPAR>c. Revising paragraph (b)(2)(i);</AMDPAR>
                    <AMDPAR>d. Redesignating paragraphs (b)(2)(ii) through (v) as paragraphs (b)(2)(iv) through (vii); and</AMDPAR>
                    <P>e. Adding new paragraphs (b)(2)(ii) and (b)(2)(iii).</P>
                    <P>The revisions and addition read as follows:</P>
                    <SECTION>
                        <SECTNO>52.213-4</SECTNO>
                        <SUBJECT>Terms and Conditions—Simplified Acquisitions (Other Than Commercial Products and Commercial Services).</SUBJECT>
                        <STARS/>
                        <HD SOURCE="HD1">Terms and Conditions—Simplified Acquisitions (Other Than Commercial Products and Commercial Services) (DATE)</HD>
                        <P>(b) * * *</P>
                        <P>(2) * * *</P>
                        <P>(i) 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (DATE) (Applies to solicitations and contracts, except acquisitions solely for commercially available off-the-shelf items or Federally-funded basic and applied research in science, technology, and engineering at colleges, universities, and laboratories in accordance with National Security Decision Directive 189 when the agency does not provide any covered Federal information to the Contractor.)</P>
                        <P>(ii) 52.204-XX, Controlled Unclassified Information (DATE) (Applies to solicitations and contracts, except acquisitions solely for commercially available off-the-shelf items).</P>
                        <P>(iii) 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information (DATE).</P>
                        <STARS/>
                    </SECTION>
                    <SECTION>
                        <SECTNO>52.227-10</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>44. Amend section 52.227-10 by removing from the introductory text the phrase “27.203-2” and adding “27.203-3” in its place.</AMDPAR>
                    <AMDPAR>45. Amend section 52.244-6 by—</AMDPAR>
                    <AMDPAR>a. Revising the date of the clause;</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (c)(1)(v) “NOV 2021” and “FAR clause 52.204-21” and adding “DATE” and “clause 52.204-21” in their places, respectively; and</AMDPAR>
                    <AMDPAR>c. Redesignating paragraphs (c)(1)(x) through (xxiv) as paragraphs (c)(1)(xii) through (xxvi) and adding new paragraphs (c)(1)(x) through (xi).</AMDPAR>
                    <P>The revision and additions reads as follows:</P>
                    <SECTION>
                        <SECTNO>52.244-6</SECTNO>
                        <SUBJECT>Subcontracts for Commercial Products and Commercial Services.</SUBJECT>
                        <STARS/>
                        <HD SOURCE="HD1">Subcontracts for Commercial Products and Commercial Services (DATE)</HD>
                        <STARS/>
                        <P>(c)(1) * * *</P>
                        <P>(x) 52.204-XX, Controlled Unclassified Information (DATE), if flow down is required in accordance with paragraph (e) of clause 52.204-XX.</P>
                        <P>(xi) 52.204-YY, Identifying and Reporting Information That Is Potentially Controlled Unclassified Information (DATE), if flow down is required in accordance with paragraph (e) of clause 52.204-YY.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 53—FORMS</HD>
                    </PART>
                    <AMDPAR>46. Revise the heading of section 53.204 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>53.204</SECTNO>
                        <SUBJECT>Administrative and information matters.</SUBJECT>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>47. Amend section 53.204-1 by—</AMDPAR>
                    <AMDPAR>a. Revising the section heading;</AMDPAR>
                    <AMDPAR>b. Removing from the introductory text the phrase “subpart 4.4” and adding “4.402” in its place;</AMDPAR>
                    <AMDPAR>c. Removing from paragraph (a) the phrase “See 4.403 (c)(1).)” and adding “See 4.402-2 (c)(1).)” in its place.</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <SECTION>
                        <SECTNO>53.204-1</SECTNO>
                        <SUBJECT>Safeguarding information and information systems (DD Form 254, DD Form 441).</SUBJECT>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>48. Add section 53.204-2 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>53.204-2</SECTNO>
                        <SUBJECT>Controlled unclassified information (CUI) Requirements (SF XXX)</SUBJECT>
                        <P>
                            SF XXX 
                            <E T="03">(DATE) Controlled Unclassified Information (CUI) Requirements.</E>
                             SF XXX is described in 4.403 and 11.002(i). Except for solicitations and contracts solely for the acquisition of COTS items, the contracting officer shall insert the clause at 52.204-XX, Controlled Unclassified Information, and include an SF XXX Controlled Unclassified Information (CUI) Requirements, in solicitations and contracts if the requiring activity has marked the “Yes” box in Part A of the SF XXX.
                        </P>
                    </SECTION>
                    <AMDPAR>49. Amend section 53.300 in the table following paragraph (a) by adding at the beginning of the table, the entry for “SF XXX Controlled Unclassified Information (CUI) Requirements” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>53.300</SECTNO>
                        <SUBJECT>Listing of Standard, Optional, and Agency forms.</SUBJECT>
                        <STARS/>
                        <P>(a) * * *</P>
                        <GPOTABLE COLS="2" OPTS="L1,i1" CDEF="s10,r50">
                            <TTITLE>Table 53-1—Forms in the GSA Forms Library</TTITLE>
                            <BOXHD>
                                <CHED H="1">Form No.</CHED>
                                <CHED H="1">Form title</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">SF XXX</ENT>
                                <ENT>Controlled Unclassified Information (CUI) Requirements.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*    *    *    *    *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                        <NOTE>
                            <HD SOURCE="HED">Note:</HD>
                            <P>The following form, Controlled Unclassified Information (CUI) Requirements, will not be published in the CFR.</P>
                        </NOTE>
                        <BILCOD>BILLING CODE 6820-EP-P</BILCOD>
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                </SUPLINF>
                <FRDOC>[FR Doc. 2024-30437 Filed 1-14-25; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 6820-EP-C</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4319"/>
            <PARTNO>Part VII</PARTNO>
            <AGENCY TYPE="P"> Environmental Protection Agency</AGENCY>
            <CFR>40 CFR Part 1090</CFR>
            <TITLE>Fuels Regulatory Streamlining Sampling and Testing Updates; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="4320"/>
                    <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                    <CFR>40 CFR Part 1090</CFR>
                    <DEPDOC>[EPA-HQ-OAR-2024-0143; FRL-8513-01-OAR]</DEPDOC>
                    <RIN>RIN 2060-AV26</RIN>
                    <SUBJECT>Fuels Regulatory Streamlining Sampling and Testing Updates</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Environmental Protection Agency (EPA).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This action finalizes revisions, updates, and corrections to EPA's streamlined fuel quality regulations. This action does not change the stringency of the existing fuel quality standards.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>
                            <E T="03">Effective date.</E>
                             This rule is effective on July 1, 2025. The incorporation by reference of certain publications listed in this regulation is approved by the Director of the Federal Register as of July 1, 2025.
                        </P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2024-0143. All documents in the docket are listed on the 
                            <E T="03">https://www.regulations.gov</E>
                             website. Although listed in the index, some information is not publicly available, 
                            <E T="03">e.g.,</E>
                             confidential business information (CBI) or other information whose disclosure is restricted by statute. Certain other material is not available on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through 
                            <E T="03">https://www.regulations.gov.</E>
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            Nick Parsons, Environmental Protection Agency, Office of Transportation and Air Quality, Assessment and Standards Division, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: (734) 214-4479; email address: 
                            <E T="03">parsons.nick@epa.gov.</E>
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P/>
                    <HD SOURCE="HD1">Does this action apply to me?</HD>
                    <P>Entities potentially affected by this action are those involved with the production, distribution, and sale of transportation fuels, including gasoline and diesel fuel. Potentially affected categories include:</P>
                    <GPH SPAN="3" DEEP="212">
                        <GID>ER15JA25.002</GID>
                    </GPH>
                    <P>
                        This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities potentially affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your entity is affected by this action, you should carefully examine the applicability criteria in 40 CFR part 1090. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section.
                    </P>
                    <P>
                        <E T="03">Preamble acronyms and abbreviations.</E>
                         Throughout this document the use of “we,” “us,” or “our” is intended to refer to EPA. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, EPA defines the following terms and acronyms here:
                    </P>
                    <EXTRACT>
                        <FP SOURCE="FP-1">ARV accepted reference value</FP>
                        <FP SOURCE="FP-1">BOB gasoline before oxygenate blending</FP>
                        <FP SOURCE="FP-1">DFE denatured fuel ethanol</FP>
                        <FP SOURCE="FP-1">EMTS EPA Moderated Transaction System</FP>
                        <FP SOURCE="FP-1">GTAB gasoline treated as blendstock</FP>
                        <FP SOURCE="FP-1">NFSP National Fuel Survey Program</FP>
                        <FP SOURCE="FP-1">OFR Office of the Federal Register</FP>
                        <FP SOURCE="FP-1">PBMS Performance-based Measurement System</FP>
                        <FP SOURCE="FP-1">PCG previously certified gasoline</FP>
                        <FP SOURCE="FP-1">RTC response to comments</FP>
                        <FP SOURCE="FP-1">RVP Reid vapor pressure</FP>
                        <FP SOURCE="FP-1">SQC statistical quality control</FP>
                        <FP SOURCE="FP-1">TGP transmix gasoline product</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Background and Overview</FP>
                        <FP SOURCE="FP-2">II. Sampling and Testing</FP>
                        <FP SOURCE="FP1-2">A. Determining the Volume of Non-Compliant Fuel</FP>
                        <FP SOURCE="FP1-2">B. Requirements for In-Line Blending</FP>
                        <FP SOURCE="FP1-2">C. Process for Amending In-Line Blending Waivers</FP>
                        <FP SOURCE="FP1-2">D. Changes to Manual Sampling Provisions</FP>
                        <FP SOURCE="FP1-2">E. Homogeneity Samples Used for Batch Certification</FP>
                        <FP SOURCE="FP1-2">F. Retaining Samples</FP>
                        <FP SOURCE="FP1-2">G. Homogeneity Testing of PCG</FP>
                        <FP SOURCE="FP1-2">H. Precision and Accuracy Demonstration</FP>
                        <FP SOURCE="FP1-2">I. Excluding SQC Data Points</FP>
                        <FP SOURCE="FP1-2">J. Testing for Oxygenates in PCG Under Compliance by Subtraction</FP>
                        <FP SOURCE="FP1-2">K. Noncompliant Certified Butane or Certified Pentane Test Results</FP>
                        <FP SOURCE="FP-2">III. Other Technical Amendments</FP>
                        <FP SOURCE="FP1-2">A. Definition of Batch</FP>
                        <FP SOURCE="FP1-2">B. Truthful Reporting</FP>
                        <FP SOURCE="FP1-2">C. Clarification of RVP Standard in Federal 7.8 psi RVP Areas</FP>
                        <FP SOURCE="FP1-2">D. National Fuel Survey Program Notifications</FP>
                        <FP SOURCE="FP1-2">E. Fuel Certification With Domestic Marine Vessels</FP>
                        <FP SOURCE="FP1-2">F. Technical Corrections</FP>
                        <FP SOURCE="FP-2">
                            IV. Updates to the Boutique Fuels List
                            <PRTPAGE P="4321"/>
                        </FP>
                        <FP SOURCE="FP-2">V. Statutory and Executive Order Reviews</FP>
                        <FP SOURCE="FP1-2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review</FP>
                        <FP SOURCE="FP1-2">B. Paperwork Reduction Act (PRA)</FP>
                        <FP SOURCE="FP1-2">C. Regulatory Flexibility Act (RFA)</FP>
                        <FP SOURCE="FP1-2">D. Unfunded Mandates Reform Act (UMRA)</FP>
                        <FP SOURCE="FP1-2">E. Executive Order 13132: Federalism</FP>
                        <FP SOURCE="FP1-2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</FP>
                        <FP SOURCE="FP1-2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</FP>
                        <FP SOURCE="FP1-2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</FP>
                        <FP SOURCE="FP1-2">I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR Part 51</FP>
                        <FP SOURCE="FP1-2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All</FP>
                        <FP SOURCE="FP1-2">K. Congressional Review Act (CRA)</FP>
                        <FP SOURCE="FP-2">VI. Amendatory Instructions</FP>
                        <FP SOURCE="FP-2">VII. Statutory Authority</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Background and Overview</HD>
                    <P>
                        On December 4, 2020, EPA finalized the Fuels Regulatory Streamlining Rule (“streamlining rule”) that replaced EPA's prior gasoline, diesel fuel, and other fuel quality programs in 40 CFR part 80 with a new set of provisions and definitions in 40 CFR part 1090.
                        <SU>1</SU>
                        <FTREF/>
                         Since that time, EPA found that several provisions in 40 CFR part 1090 require further correction or clarification to better align with current market practices; this action makes such changes. As further discussed in section VI, the regulatory text in this document includes both text that EPA is changing as well as text that EPA is republishing without change for context and clarity in keeping with new guidance by the Office of the Federal Register (OFR). EPA did not reopen for comment any of the unchanged text. Specifically, EPA did not reopen any fuel quality standard (
                        <E T="03">e.g.,</E>
                         the sulfur, benzene, and Reid vapor pressure (RVP) standards for gasoline in 40 CFR part 1090, subpart C, or the sulfur and cetane standards for diesel fuel in 40 CFR part 1090, subpart D); the general requirements that regulated parties register with EPA, maintain records, submit reports, etc.; or the general requirements for averaging, banking, and trading.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             85 FR 78412.
                        </P>
                    </FTNT>
                    <P>This action makes amendments to two main areas of EPA's fuel quality regulations. First, EPA is making minor revisions to provide clarity and flexibility to provisions that govern how fuel, fuel additives, and regulated blendstocks are sampled and tested to demonstrate compliance. Since finalizing the streamlining rule, EPA identified, with stakeholder input, several areas in the sampling and testing provisions that need further consideration and clarification. These areas include the in-line blending waiver provisions, instructions for collecting samples through automatic and manual sampling, the process for demonstrating homogeneity for certification testing, and requirements related to demonstrating the accuracy and precision of test methods. The sampling and testing amendments are discussed in section II.</P>
                    <P>Second, EPA is making the following technical amendments, which are discussed in section III:</P>
                    <P>• Clarification of definitions and general provisions.</P>
                    <P>• Clarification of the truthful reporting requirement.</P>
                    <P>• Clarification of the RVP standard in federal 7.8 psi RVP areas.</P>
                    <P>• Adjustments to notifications under the National Fuel Survey Program (NFSP).</P>
                    <P>• Addition of provisions to allow for certifying fuel loaded onto domestic marine vessels.</P>
                    <P>• Numerous clarifications, corrections, and consistency edits to the regulations.</P>
                    <P>Responses to comments received from stakeholders on the proposed rule can be found in the associated Response to Comments (RTC) document, available in the docket for this action.</P>
                    <HD SOURCE="HD1">II. Sampling and Testing</HD>
                    <HD SOURCE="HD2">A. Determining the Volume of Non-Compliant Fuel</HD>
                    <P>
                        EPA is finalizing clarifications regarding how batches of fuel certified through automatic sampling will be treated when a test result indicates that a regulated parameter exceeds a per-gallon standard to make it clear that the definition is consistent with EPA's historic approach to per-gallon standards. A per-gallon standard is defined as “the maximum or minimum value for any parameter that applies to every volume unit of a specified fuel, fuel additive, or regulated blendstock.” 
                        <SU>2</SU>
                        <FTREF/>
                         Whether fuel is produced and tested by in-line blending or in storage tanks, each gallon of fuel must meet all applicable per-gallon standards. EPA expects fuel manufacturers to apply a margin of safety to their production targets to ensure that all fuel meets all applicable per-gallon standards in 40 CFR part 1090.
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             40 CFR 1090.80.
                        </P>
                    </FTNT>
                    <P>
                        The relevant regulations in the streamlining rule stated that “[a] batch is noncompliant if any tested sample does not meet all applicable per-gallon standards.” 
                        <SU>3</SU>
                        <FTREF/>
                         Since the streamlining rule was finalized in 2020, several stakeholders expressed concern that this language could be construed to mean that EPA would consider the entire volume of a batch produced by in-line blending to be in violation of a per-gallon standard whenever any test result exceeded the per-gallon standard. To address this concern, EPA is finalizing the removal of the above-referenced language in 40 CFR 1090.1335(e)(2) and replacing it with new clarifying language in 40 CFR 1090.1335(b) and (c). Specifically, EPA is first modifying the manual-sampling provisions in 40 CFR 1090.1335(b) to include the statement that “The entire batch volume is noncompliant if a sample fails to meet any applicable per-gallon standard.” This is intended to be consistent with the provision described above from 40 CFR 1090.1335(e)(2). Second, EPA is modifying the automatic-sampling provisions in 40 CFR 1090.1335(c) to clarify that the entire batch volume is noncompliant if the composite sample fails to meet any applicable per-gallon standard. However, if an in-line sample fails to meet any applicable per-gallon standard, EPA would consider the volume of noncompliant fuel to be the volume starting with the last passing result before the failing result (or the start of the batch), up to the first passing result after the failing result (or the end of the batch). For example, if a head sample exceeds a standard, followed shortly by a middle sample with a valid passing result, the volume of noncompliant fuel would be limited to the portion of the batch preceding the middle sample with the passing result. Also, if the fuel manufacturer took an extra sample between the head and middle samples and determined that the extra sample had a passing result, that would further limit the volume of fuel considered noncompliant.
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             40 CFR 1090.1335(e)(2).
                        </P>
                    </FTNT>
                    <P>
                        This approach is intended to preserve EPA's long-standing principle of requiring every tested sample to meet all applicable per-gallon standards, while allowing EPA to consider a portion of the in-line blended batch to be compliant based on tested samples that establish the boundaries of what should be considered noncompliant. As stated in the proposal, we believe this approach properly incentivizes fuel manufacturers both to design and 
                        <PRTPAGE P="4322"/>
                        manage their processes to provide for appropriate compliance margins and to perform spot testing as appropriate to verify that the blended fuel continues to meet all applicable per-gallon standards for the whole batch.
                    </P>
                    <P>Fuel manufacturers can measure fuel parameters using procedures that are different than the test methods used to generate official test results for certification. We recognize that those nonstandard measurements provide value to fuel manufacturers to inform the blending process and add assurance that the blend settings continue to maintain compliant fuel across the batch. However, as nonstandard tests, those measurements cannot be used to reduce the volume of fuel considered noncompliant if there are test results from any official test method showing that a sample fails to meet a per-gallon standard.</P>
                    <P>Commenters did not object to the proposed new provisions, but instead recommended a flexible approach for establishing the exact volume of fuel found to be noncompliant. As further discussed in RTC section 2.1, we understand the penalty provisions of 40 CFR 1090.1710(g) to already allow the flexibility recommended by the commenters. We are therefore adopting the amendments to 40 CFR 1090.1335 as proposed.</P>
                    <HD SOURCE="HD2">B. Requirements for In-Line Blending</HD>
                    <P>
                        In the streamlining rule, the in-line blending waiver provisions required that interested fuel manufacturers submit general information about their in-line blending equipment, including the location, layout, operation, and monitoring of equipment.
                        <SU>4</SU>
                        <FTREF/>
                         During EPA review and approval of in-line blending waiver requests following finalization of the streamlining rule, multiple stakeholders raised concerns regarding the requirement to follow ASTM D4177 
                        <SU>5</SU>
                        <FTREF/>
                         and the sampling and testing of spot samples. Through iterative discussion with these stakeholders, EPA approved multiple flexibilities addressing these and other concerns in several individual waiver requests. As described in the rest of this section, EPA is codifying these previously approved flexibilities in the regulations for in-line blending waivers to ensure a transparent framework. Including these provisions in the regulation also ensures that all fuel manufacturers will follow a consistent set of provisions for their in-line blending waivers. Because these in-line blending flexibilities codify existing industry practices, we do not anticipate any change in burdens on industry.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             40 CFR 1090.1315.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             ASTM D4177-22e1, “Standard Practice for Automatic Sampling of Petroleum and Petroleum Products,” approved July 1, 2022.
                        </P>
                    </FTNT>
                    <P>The rest of this section describes the provisions for in-line blending waivers, which generally provide further flexibility or provide EPA with additional information to help with overseeing in-line blending processes.</P>
                    <HD SOURCE="HD3">1. Scope of Measurements and Sampling Frequency</HD>
                    <P>EPA is finalizing as proposed the requirement at 40 CFR 1090.1315(a)(7) for fuel manufacturers to identify the blendstock parameters that will be measured for managing the blending process and the typical sampling frequency for those measurements. This will enable EPA to better understand the fuel manufacturer's ability to manage the blending process to keep fuel parameters within targeted values over the course of the blend and to not exceed per-gallon standards.</P>
                    <P>Regarding sampling frequency, the general instruction for automatic sampling at 40 CFR 1090.1335(c) is to follow ASTM D4177 and to create a composite sample from at least 9,604 grabs to represent the batch, with a secondary specification to collect samples with a sampling frequency that does not exceed 20 seconds throughout the batch. The underlying objective is to require a sampling frequency that corresponds to a margin of error of 0.01. EPA is amending 40 CFR 1090.1335(c) to identify three separate criteria to qualify sampling frequency: (1) Collecting at least 9,604 grabs; (2) Collecting sufficient grabs to achieve a margin of error of 0.01 or less; or (3) Maintaining a sampling frequency that does not exceed 20 seconds through the batch. In addition, we recognize that such a sampling frequency may be difficult to achieve for certain batch characteristics. EPA is therefore adding 40 CFR 1090.1315(a)(8) to allow fuel manufacturers to describe in their in-line blending waiver requests circumstances where they cannot meet the requirement to achieve a margin of error at or below 0.01. Any fuel manufacturer in those circumstances would need to quantify their measurement variability and adjust target values downward to account for the greater margin of error. This approach is intended to accommodate special circumstances without relaxing the per-gallon standards that apply for the fuel.</P>
                    <P>Commenters did not raise concerns regarding the substance of the amendments, but rather focused on properly describing the various criteria and related documentation. As discussed in RTC section 2.1, we have amended the regulation for the final rule consistent with the suggested changes.</P>
                    <HD SOURCE="HD3">2. Reduced Spot Sampling for Small Batches</HD>
                    <P>As described in section II.A, automatic sampling generally requires collection of head, middle, and tail samples to confirm that the blended fuel meets all applicable per-gallon standards across the batch. We acknowledge that collecting all three of these spot samples could be difficult for small batches due to the logistics of collecting and analyzing samples during the blending process. EPA is finalizing as proposed that in-line blending waivers may allow for reduced sampling requirements for certain batch sizes to provide additional flexibility. Specifically, EPA is allowing for collecting a single sample anytime during the blend for a batch involving up to 8 hours of blending or up to 1 million gallons of fuel, and for collecting two evenly distributed samples during the blend for a batch involving up to 16 hours of blending or up to 2 million gallons of fuel. These specified values will be based on actual volume and duration. If a batch volume or duration extends beyond what was anticipated and exceeds the specified threshold for relief from sampling requirements, the fuel manufacturer would need to collect additional samples.</P>
                    <P>
                        Another possible challenge for complying with the requirement to collect head, middle, and tail samples for automatic sampling is the possibility of process dynamics that cause the fuel manufacturer to terminate the batch earlier than planned. Any number of factors may cause the early termination, and the termination may involve different levels of urgency. We are aware that such an early termination may not allow for an orderly process of collecting all the required fuel samples. EPA is finalizing as proposed at 40 CFR 1090.1315(a)(10) that in-line blending waivers may allow for failing to perform required tests. The allowance for reduced sampling and testing is limited to unforeseen circumstances. When the unforeseen circumstances allow for it, fuel manufacturers should collect required samples whenever possible. This may involve shifting toward an earlier collection when there is uncertainty about blending duration for the batch, and there should be an effort to adjust plans for an earlier collection when the adjusted batch termination allows for it. However, to ensure that fuel manufacturers do not always rely on this reduced-sampling option, EPA is 
                        <PRTPAGE P="4323"/>
                        only allowing fuel manufacturers to exercise this reduced-sampling option for no more than 10 percent of their in-line blending batches for the calendar year.
                        <SU>6</SU>
                        <FTREF/>
                         If a fuel manufacturer exceeds the 10 percent limit, EPA may consider that their in-line blending waiver has proven inadequate in practice.
                        <SU>7</SU>
                        <FTREF/>
                         We received no comments on the proposed reduced sampling requirements and are therefore finalizing this provision as proposed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             We note that we have already allowed fuel manufacturers to use this approach of a 10 percent limit under the current regulations as a way to address situations where reduced sampling and testing of in-line blending batches is necessary.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             40 CFR 1090.20(d) and (e).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Contingency Plans for Equipment Failure</HD>
                    <P>Some current in-line blending waivers include provisions that describe how the fuel manufacturer would respond if their essential test equipment fails, which we believe is an important contingency to plan for. EPA is therefore adding a requirement at 40 CFR 1090.1315(a)(11) for in-line blending waivers to include this element of emergency planning. Rather than specifying a standard practice, fuel manufacturers will be required to describe their contingency plans for alternative sampling and testing in cases involving failure of the automatic compositor or other essential equipment. Such contingency plans might appropriately consider a wide range of possible scenarios. The overall goal of this contingency plan is to preserve the ability to collect an appropriate sample to properly represent the batch for purposes of demonstrating that the fuel meets all applicable per-gallon standards. EPA is including in the regulation the specific example of collecting a second composite sample with a redundant system. Such an approach would minimize the risk of shipping fuel without proper documentation for compliance, or alternatively avoid the burden of finding a different sampling method to demonstrate compliance.</P>
                    <P>A commenter suggested that the regulation identify a second, redundant compositor as an example of the contingency plan, rather than requiring the second compositor “where possible.” As discussed in RTC section 2.1, we agree that the regulation should simply identify the second compositor as an example of appropriate contingency planning and have changed the regulation accordingly.</P>
                    <HD SOURCE="HD3">4. Alternative Compliance Demonstration To Remedy Noncompliance</HD>
                    <P>
                        The current regulation contains a general requirement to demonstrate that a batch of fuel, fuel additive, or regulated blendstock meets all applicable per-gallon standards before any portion of the batch leaves the facility.
                        <SU>8</SU>
                        <FTREF/>
                         In-line blending waivers create an exception to that general requirement, with the understanding that the terms and conditions for a specific facility's blending process includes process controls to give adequate assurance that fuel from in-line blending will comply with all applicable per-gallon standards. The question of possible remedies by a fuel manufacturer arises when considering the possibility of test results showing that fuel coming out of an in-line blending process does not in fact meet all applicable per-gallon standards. To the extent that fuel has already left the facility, EPA would expect to take appropriate action to address the violation of failing to meet standards. However, fuel manufacturers may be able to take further measures before the blended fuel leaves the facility to demonstrate that the fuel meets all applicable per-gallon standards. Such remedies would involve additional testing, and it may also involve modifying or further blending the fuel to comply. Therefore, EPA is allowing fuel manufacturers to specify an alternative sampling demonstration in their contingency plan if an automatic sampling test result fails to meet an applicable per-gallon standard, as opposed to being subject to EPA action to address the violation of failing to meet standards.
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             40 CFR 1090.1310(b).
                        </P>
                    </FTNT>
                    <P>The amendment at 40 CFR 1090.1315(a)(12) identifies two example remedies that would be available as long as the fuel remains at the facility. First, we describe batch certification based on manual sampling in a tank if the fuel manufacturer collects the entire batch of blended fuel represented by the noncompliant test result in the tank before it leaves the fuel manufacturing facility gate. Second, we describe batch certification based on secondary automatic sampling as fuel comes out of a holding tank used to collect the fuel that failed to meet a per-gallon standard. Such approved alternative sampling demonstrations would allow the fuel manufacturer to disregard the earlier failing result if the subsequent valid measurements show that all shipped fuel meets all applicable per-gallon standards. Commenters did not object to the proposed requirement, but instead focused on proper wording for the new provision, which we address in RTC section 2.1.</P>
                    <HD SOURCE="HD2">C. Process for Amending In-Line Blending Waivers</HD>
                    <P>
                        Section II.B describes additional information for fuel manufacturers to include in in-line blending waivers. In most cases, fuel manufacturers already include this information in their approved in-line blending waivers. However, in some cases, fuel manufacturers will likely need to make updates to their approved in-line blending waivers to comport with these changes. We proposed an implementation date of March 31, 2025, for the new specifications for in-line blending waivers. Multiple commenters requested additional lead time to adjust to the new provisions. In response to these comments and as further discussed in RTC section 1.2, EPA agrees with commenters that additional lead time is appropriate and therefore is finalizing the requirement that all existing approved in-line blending waivers comply with the new specifications by January 1, 2026.
                        <SU>9</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             We note that fuel manufacturers must also comply with the associated attestation engagement requirements related to the new in-line blending waiver provisions starting with either the 2025 or 2026 compliance period, whichever is the earliest compliance period for which the waiver is in effect (
                            <E T="03">i.e.,</E>
                             fuel manufacturers that update or already have an approved in-line blending waiver that complies with 40 CFR 1090.1315(a)(7) through (13) by December 31, 2025, must comply with associated attestation engagement requirements in 1090.1850(b) as part of their attestation engagement report for the 2025 compliance period due June 1, 2026).
                        </P>
                    </FTNT>
                    <P>
                        To accommodate the timely review of these anticipated changes and other periodic updates to fuel manufacturers' in-line blending waivers, EPA is also finalizing the revised process for amending approved in-line blending waivers. Specifically, EPA is requiring that requests for an amended waiver include a description of the intended changes and a comparison document that comprehensively and clearly identifies the proposed changes to the waiver, and also include a statement attesting to the truthfulness of the submitted information, as described in section III.B. These specifications are intended to standardize the format and substance of the information submitted for the requested approval, with the intent of streamlining EPA review of the submitted material. As stated in the proposal, EPA believes that it is particularly important for the comparison document to include all 
                        <PRTPAGE P="4324"/>
                        intended changes to the approved in-line blending waiver so that EPA staff can focus their review on the suggested amendments to the waiver instead of previously approved elements of the waiver.
                    </P>
                    <P>While these specifications for requests to amend in-line blending waivers will facilitate timely review by EPA staff, we are aware that fuel manufacturers depend on timely processing of their requests even when circumstances lead to a protracted review period. EPA is therefore finalizing as proposed the provision deeming approval of a waiver amendment request to be effective 60 days after EPA acknowledges receiving the request if there is no further EPA response to the request. Keying the date to our acknowledgement is important to avoid a case where the fuel manufacturer submits the request in a way that does not come directly to our attention. An EPA response to the request may be in the form of denying the request, identifying deficiencies, or requiring additional information. Under this approach, if EPA identifies deficiencies or requires additional information, the deemed approval date would be 60 days after EPA acknowledges receipt of the subsequent submission that addresses the deficiencies or includes the requested information.</P>
                    <P>Considering the timing items together, fuel manufacturers can expect requests to amend their in-line blending waivers to comply with the new requirements to be deemed approved for the 2026 compliance period if the requests are submitted by November 1, 2025.</P>
                    <P>We received no comments opposing the creation of this automatic approval process for in-line blending waiver updates and are therefore finalizing this provision as proposed. Thus, as proposed, waiver amendment requests will be deemed to be approved effective 60 days after EPA acknowledges receiving the request if there is no further EPA response to the request.</P>
                    <P>Commenters requested that we clarify how to determine when various changes to blending and testing practices would trigger a need to submit a request for updating an approved waiver. As discussed in RTC section 2.1, we are amending the final rule at 40 CFR 1090.1315(c)(1) to address these concerns.</P>
                    <HD SOURCE="HD2">D. Changes to Manual Sampling Provisions</HD>
                    <P>
                        EPA is finalizing as proposed the option to collect spot samples or tap samples as a default method in addition to the currently specified “running” or “all-levels” sampling. In the streamlining rule, a fuel manufacturer was required to collect a “running” or “all-levels” sample from the top of the tank and could use tap sampling or spot sampling to collect upper, middle, and lower samples only “if a running or all-levels sample is impractical for a given storage configuration.” 
                        <SU>10</SU>
                        <FTREF/>
                         Since finalization of the streamlining rule, stakeholders expressed concern over the ambiguity of the term “impractical” and contended that tap or spot sampling is as robust as running or all-levels sampling. As stated in the proposal, EPA agrees that testing with spot samples or tap samples can be used to routinely collect tank samples for testing. Homogeneity requirements further ensure that spot samples and tap samples can properly represent the batch. EPA is therefore allowing spot sampling and tap sampling to be treated on par with running or all-levels sampling.
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             40 CFR 1090.1335(b).
                        </P>
                    </FTNT>
                    <P>We received no comments on the proposed change to the manual sampling provisions and are therefore finalizing this provision as proposed.</P>
                    <HD SOURCE="HD2">E. Homogeneity Samples Used for Batch Certification</HD>
                    <P>
                        The streamlining rule added provisions describing a much more detailed approach for demonstrating that a batch can be considered homogeneous when drawing manual samples for certification.
                        <SU>11</SU>
                        <FTREF/>
                         Industry efforts to comply with these more detailed specifications have led to requests for EPA to provide further clarification and adjustments to accommodate several specific circumstances. We address comments received on homogeneity samples used for batch certification in RTC section 2.2.
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             40 CFR 1090.1337.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Waivers From the Homogeneity Requirement</HD>
                    <P>
                        Under the current regulations, the homogeneity requirement is waived for several certain situations.
                        <SU>12</SU>
                        <FTREF/>
                         In this action, EPA is finalizing as proposed the waiver of the homogeneity requirement for three additional circumstances. First, as stated in the proposal, we recognize that homogeneity testing is impractical for horizontal tanks used for storing ethanol denaturant. EPA is therefore waiving the homogeneity requirement for horizontal tanks with a circular or elliptical cross section and with a volume less than 42,000 gallons to align with current practice for storing ethanol denaturant. This waiver includes a requirement to draw samples from the approximate mid-depth of the product level to ensure that the measured parameters best represent the batch. We received no comments on the proposed waiver of the homogeneity requirement under this circumstance and are therefore finalizing this provision as proposed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             40 CFR 1090.1337(a).
                        </P>
                    </FTNT>
                    <P>
                        Second, EPA is waiving the homogeneity requirement for certified butane and certified pentane. Certified butane and certified pentane are stored under pressure, which makes it impractical to collect homogeneity samples using the methods of ASTM D4057.
                        <SU>13</SU>
                        <FTREF/>
                         We received no comments on the proposed waiver of the homogeneity requirement under this circumstance and are therefore finalizing this provision as proposed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             ASTM D4057-22, “Standard Practice for Manual Sampling of Petroleum and Petroleum Products,” approved May 1, 2022.
                        </P>
                    </FTNT>
                    <P>
                        Third, as discussed in the proposal, we are aware that a small number of fuel tanks allow for tap sampling only at ground level, along with sampling from the roof. Homogeneity testing with such a tank configuration therefore depends on sampling from the roof. Section II.D describes how EPA allows tap sampling as a method that is equivalent to running or all-levels sampling. Based on those same concerns, we are aware that homogeneity testing is not possible with a tank that has only a single location for tap sampling when it is not an option to sample from the roof. EPA is allowing an alternative homogeneity demonstration when inclement weather prevents sampling from the roof for such a fuel tank based on prior approval of a mixing process that has been shown to achieve homogeneity. The mixing demonstration must apply for the specific tank configuration and include consideration of a range of product types, fill levels, and other relevant parameters to ensure that the specific circumstances that apply for a given certification support the conclusion that the mixed fuel would meet homogeneity specifications. Anyone relying on this waiver from the homogeneity requirement would be required to keep records documenting EPA approval of the mixing procedure, the specific actions taken to follow the approved mixing procedure, and the forcing weather event. We received no comments opposing the creation of provisions for an alternative homogeneity demonstration when inclement weather prevents roof sampling and are therefore finalizing this provision as proposed. However, one commenter suggested that we allow 
                        <PRTPAGE P="4325"/>
                        for additional flexibilities related to safety issues, which we are not finalizing for reasons discussed in RTC section 2.2.
                    </P>
                    <HD SOURCE="HD3">2. Homogeneity Testing Requirements</HD>
                    <P>
                        EPA is finalizing clarifications to the homogeneity testing requirements for special cases.
                        <SU>14</SU>
                        <FTREF/>
                         The first case addresses homogeneity test results that fall below the lower range for a given parameter. The homogeneity demonstration depends on showing that multiple samples collected in different places inside the tank have measured values that are consistent. As discussed in the proposal, test results are not helpful for comparing results across samples if measured values are at or below the lower limit of the test method. As proposed, EPA is disallowing using measurements for demonstrating homogeneity if multiple measured values are at or below the pooled limit of quantitation (PLOQ), laboratory limit of quantitation (LLOQ), or the valid range of the test method. In those cases, EPA is requiring that homogeneity testing instead be based on one of the following: (1) Testing with a different qualifying, valid test method for the same parameter; or (2) Testing a different parameter identified in 40 CFR 1090.1337(d) and (e). For example, if a fuel manufacturer tested a summer gasoline for both RVP (required) and sulfur, and multiple sulfur measurements using ASTM D2622 
                        <SU>15</SU>
                        <FTREF/>
                         were below the valid range of the test method, the fuel manufacturer could not use those values to demonstrate homogeneity. In this situation, the fuel manufacturer would need to perform homogeneity testing by one of the following methods: (1) Measuring sulfur with an approved alternative test method; (2) Measuring benzene with the referee test method or an approved alternative test method; or (3) Measuring density or API gravity using one of the test methods specified in 40 CFR 1090.1337(d)(1). Commenters suggested that EPA allow for parties to use test results outside of the valid range of the method for sulfur and benzene measured for homogeneity testing. We address these comments and describe why we are finalizing 40 CFR 1090.1337(f)(2) as proposed in RTC section 2.2.
                    </P>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             40 CFR 1090.1337(f).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             ASTM D2622-16, “Standard Test Method for Sulfur in Petroleum Products by Wavelength Dispersive X-ray Fluorescence Spectrometry,” approved January 1, 2016.
                        </P>
                    </FTNT>
                    <P>The second case relates to testing that includes results for more than the required number of parameters. Homogeneity testing for gasoline and transmix gasoline product (TGP) involves measurements of at least two parameters, while homogeneity testing for diesel fuel involves measurements of at least one parameter. A laboratory may have commercial or other reasons to perform measurements that include more than the minimum number of tests for demonstrating homogeneity. We proposed a provision that if more than the required parameters are tested, homogeneity testing fails when testing for any parameter other than density or API gravity does not meet the applicable homogeneity criterion. We did not receive any comments on this testing requirement and are therefore finalizing this provision as proposed.</P>
                    <P>
                        The third case is for density or API gravity results that fall above the current scope of ASTM D4052.
                        <SU>16</SU>
                        <FTREF/>
                         For valid testing, ASTM D4052 currently specifies an upper limit of 66° API. EPA is allowing the temporary option to use test results above 66° API for homogeneity testing with ASTM D4052. Calculations for samples that exceed 66° API would be based on the same equation that applies for results that are 51-66° API. This allowance applies for testing performed with ASTM D4052 through December 31, 2026. This temporary provision allows for continued testing for this commonly used test method, with the expectation that the ongoing ASTM process for updating the test method will allow for valid measurements above 66° API by the end of 2026. EPA is aware that ASTM has started the process to update the precision statements for ASTM D4052, which would allow for expanding the acceptable upper API gravity range in the specified timeframe. Commenters sought further clarification of the proposed provisions related to allowing for temporary expanded scope of ASTM D4052. In response to these comments and as further discussed in RTC section 2.2, we are finalizing two adjustments to the proposed provisions to more carefully address the transition to a revised test method with updated precision statements. First, parties may request to continue using the temporary expanded scope of ASTM D4052 beyond December 31, 2026, in case additional time is necessary for ASTM to update the test method. Second, parties may request to use the updated version of ASTM D4052 if it includes appropriately updated precision statements. Commenters also identified the need to accommodate a similar problem for the API gravity range of 45-51° for renewable diesel fuel. We note that this interim provision as proposed, and as modified for the final rule, applies for any fuel that has an API gravity that falls outside the range of the test method, including renewable diesel fuel.
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             ASTM D4052-18a, “Standard Test Method for Density, Relative Density, and API Gravity of Liquids by Digital Density Meter,” approved December 15, 2018.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">F. Retaining Samples</HD>
                    <P>
                        The streamlining rule required fuel manufacturers and oxygenate producers to retain untested (or less tested) samples for summer gasoline and tested (or most tested) samples for winter gasoline, diesel fuel, and oxygenate.
                        <SU>17</SU>
                        <FTREF/>
                         The requirement for such parties to retain tested samples (other than summer gasoline) was based on minimizing any test differences for cases involving EPA duplication of measurements already made to certify a batch. The requirement for retaining untested samples of summer gasoline was based on ASTM 5191,
                        <SU>18</SU>
                        <FTREF/>
                         which calls for RVP measurements to be from an aliquot that is the first test specimen withdrawn from a sample container.
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             40 CFR 1090.1345.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             ASTM D5191-22, “Standard Test Method for Vapor Pressure of Petroleum Products and Liquid Fuels (Mini Method),” approved July 1, 2022.
                        </P>
                    </FTNT>
                    <P>Prior to the proposal, industry stakeholders had expressed concern about the burden of complying with these sample retention requirements, and we acknowledged that the advantage of repeating a measurement on a tested sample is offset by the risk that the sampling process could introduce errors caused by changing the characteristics of the sample. Accordingly, we proposed to simplify the sample retention regulations by requiring parties to retain only an untested sample that is representative of the batch. A commenter requested that a single representative sample (tested or untested) be retained instead of an untested sample as proposed. They argued that the proposed approach would result in the collection of unnecessary samples resulting in an increased burden to industry. We believe that the commenter's approach is appropriate in all cases except for summer gasoline. Keeping a tested sample of summer gasoline would prevent any repeat testing for RVP because the RVP test methods require measurements with untested samples for a valid test result.</P>
                    <P>
                        Therefore, in response to these comments and as further discussed in RTC section 2.2, we are finalizing that fuel manufacturers must retain an untested sample that is representative of a batch of summer gasoline, and in other 
                        <PRTPAGE P="4326"/>
                        cases they must retain any (tested or untested) sample that represents the batch. This approach relies on the principle that demonstrating homogeneity allows for any sample from the batch to be used for measurements to establish test values to characterize the batch. Untested samples allow for testing summer gasoline for RVP, and any representative sample provides a useful starting point for measuring any other parameters.
                    </P>
                    <HD SOURCE="HD2">G. Homogeneity Testing of PCG</HD>
                    <P>
                        The regulations established by the streamlining rule specify requirements that apply for a refiner or blending manufacturer that adds blendstock to previously certified gasoline (PCG) to produce a new batch of gasoline.
                        <SU>19</SU>
                        <FTREF/>
                         Refiners and blending manufacturers can meet the requirements based on either “compliance by subtraction” or “compliance by addition.” The streamlining rule established that homogeneity requirements apply to the blendstocks and finished gasoline for compliance by addition but did not address homogeneity for compliance by subtraction for the PCG.
                        <SU>20</SU>
                        <FTREF/>
                         Compliance by subtraction in many cases does not depend on homogeneity testing because the relevant fuel parameters for the PCG are already known, as the PCG previously underwent certification testing consistent with the sampling and testing requirements in 40 CFR part 1090, subpart N. However, we proposed to clarify a requirement to apply homogeneity requirements for compliance by subtraction if a batch of PCG was mixed with other batches of PCG or if the batch of PCG was exempt from homogeneity testing under 40 CFR 1090.1337(a)(4). Homogeneity testing for these cases ensures that tested samples properly represent the batch after blending.
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             40 CFR 1090.1320.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             Note that the finished gasoline created in a PCG compliance by subtraction situation must meet the homogeneity requirements.
                        </P>
                    </FTNT>
                    <P>In response to a comment and as further discussed in RTC section 2.4, we are finalizing additional provisions to describe how homogeneity requirements apply uniquely for PCG sampled from a pipeline. Much like reduced spot sampling for small batches for in-line blending as described in section II.B.2, the final rule includes a provision waiving the homogeneity testing requirement for batch volumes less than 1 million gallons. We are similarly specifying that the homogeneity demonstration must be based on two samples for batch volumes between 1 million and 2 million gallons, and on three samples for batches with volume greater than 2 million gallons. Following a successful homogeneity demonstration, the multiple homogeneity samples must be composited for testing to measure sulfur, benzene, and oxygenate to represent the batch.</P>
                    <P>We are also finalizing the clarification that, for any blending or sampling scenario, 40 CFR 1090.1337(a)(4) allows for demonstrating compliance without meeting homogeneity requirements by relying on the worst-case test result, which in these cases would involve reporting the lowest value of each measured parameter to characterize the batch of blended fuel.</P>
                    <HD SOURCE="HD2">H. Precision and Accuracy Demonstration</HD>
                    <P>
                        The streamlining rule carried the principles for the Performance-based Measurement System (PBMS) from 40 CFR part 80 into 40 CFR part 1090. The streamlining rule added specifications to clarify how to apply quality-control testing requirements for meeting precision and accuracy requirements. As discussed in the proposal, demonstrating precision and accuracy is critical for ensuring that test results are valid and properly represent the sample.
                        <SU>21</SU>
                        <FTREF/>
                         In reviewing program implementation for quality-control testing, we recognized the need to address two shortcomings. First, while in-house testing for accuracy requires that test results meet specifications, the option to demonstrate compliance with accuracy requirements by periodically participating in a crosscheck program does not identify a “fail” condition for nonconforming test results. Second, for both precision and accuracy, the regulations do not describe the consequence for failing to meet requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             40 CFR 1090.1375.
                        </P>
                    </FTNT>
                    <P>EPA is finalizing a requirement that any of the following outcomes would result in a failed test result from a crosscheck program and thus are not valid for demonstrating compliance with accuracy requirements:</P>
                    <P>
                        • The crosscheck program does not have a robust accepted reference value (ARV) based on the check standard requirements in Section 6.2 of ASTM D6299.
                        <SU>22</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             ASTM D6299-23a, “Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance,” approved December 1, 2023.
                        </P>
                    </FTNT>
                    <P>• The difference between the test result and the ARV is greater than the maximum allowable difference for accuracy under 40 CFR 1090.1375.</P>
                    <P>
                        • The measured value lies outside of the three-sigma range for the data from the relevant inter-laboratory crosscheck program.
                        <SU>23</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             The three-sigma range, assuming a normal distribution, will contain 99.7 percent of the observations.
                        </P>
                    </FTNT>
                    <P>
                        We are adopting the first of these two criteria as proposed. We also proposed two additional fail criteria, both of which commenters described as being overly restrictive. The first of these proposed fail criteria was based on the difference between the test result and the ARV being greater than the method-defined limit for check standard accuracy. We agree that this criterion was too restrictive and have removed this criterion from the final rule. The second of these proposed fail criteria was based on the measured value lying outside of two Z-scores.
                        <SU>24</SU>
                        <FTREF/>
                         We also agree that this criterion was too restrictive; however, to preserve the principle of staying within a reasonable statistical boundary, we have revised the requirement for the final rule to stipulate that results must fall within the three-sigma range of the data from the relevant interlaboratory crosscheck program. This adjustment provides a clear standard for evaluating results, without being overly restrictive. We further discuss these issues in RTC section 2.5.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             The Z-score is a standardized dimensionless measure of the difference between an individual result in a data set and the sample arithmetic mean.
                        </P>
                    </FTNT>
                    <P>
                        If test results from a crosscheck program are found to be invalid for demonstrating compliance, EPA is finalizing the option for a laboratory to make timely corrections to avoid a compliance or enforcement consequence. Specifically, the laboratory would need to respond to a problematic test result by performing a root cause analysis and correcting the problem, which we understand to already be standard practice across the industry. The laboratory would need to document the findings of the root cause analysis and the steps taken to correct the problem. Under this approach, the laboratory would have a grace period to continue testing for 45 days without being out of compliance, an increase of 10 days from the proposed 35-day grace period. After that grace period, the laboratory would need to demonstrate that they again meet accuracy and precision requirements. The laboratory would be considered to continue to meet accuracy requirements if, after correcting the problems identified by the root cause analysis, in-house testing meets accuracy requirements using a check standard qualified by a third party. Alternatively, the laboratory 
                        <PRTPAGE P="4327"/>
                        could participate in the next crosscheck program and receive test results meeting specifications. We are also including a third option to demonstrate compliance based on a non-VCSB correlation program administered by a third party. We believe the deadline for correcting issues represents a reasonable timeframe for taking remedial action and getting new test results. Commenters suggested a longer grace period to resolve issues, and greater flexibility in demonstrating such a resolution. The extra 10 days for the compliance deadline and the option to demonstrate compliance based on a non-VCSB correlation program administered by a third party are intended to address those concerns. We discuss these changes from the proposed rule in RTC section 2.5.
                    </P>
                    <P>
                        As discussed in the proposal, failing to meet precision or accuracy requirements indicates that test instruments are not suitable for generating valid test results for certification. As a result, EPA is specifying that presumed fuel parameters 
                        <SU>25</SU>
                        <FTREF/>
                         would apply any time a laboratory fails to meet precision or accuracy requirements that prevent it from demonstrating compliance with standards using valid test results. For meeting accuracy requirements by participating in a crosscheck program, the presumed fuel parameters would apply only if the laboratory failed to correct the problems identified by the root cause analysis and repeat testing with valid test results within the specified timeframe. On the other hand, if corrective action is not taken to remedy the failing result within the specified timeframe, the presumed fuel parameters would apply relative to certification for parameter measurements with the test instruments failing to meet precision or accuracy requirements starting on the date the laboratory received the first failing report from the crosscheck program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             40 CFR 1090.1710(g).
                        </P>
                    </FTNT>
                    <P>One commenter suggested minor wording changes for the penalty-related provisions. A different commenter advocated for allowing a demonstration of appropriate parameter values for assessing penalties, rather than relying on the presumed values identified in 40 CFR 1090.1710(g). However, we note that the penalty provisions at 40 CFR 1090.1710(g) already include a process for EPA to approve alternative parameter values based on any relevant information. Since the regulation already addresses the concern, we are including minor wording changes, consistent with the comments, but are otherwise finalizing as proposed the penalty-related provisions at 40 CFR 1090.1375(e).</P>
                    <P>It bears noting that these final revisions narrowly address failures to meet precision and accuracy requirements in quality-control testing under 40 CFR 1090.1375. Any broader or different failure to meet testing specifications under 40 CFR part 1090 would be treated as its own violation based on the circumstances that apply.</P>
                    <HD SOURCE="HD2">I. Excluding SQC Data Points</HD>
                    <P>
                        EPA is finalizing provisions to address exclusion of certain outlier test results from statistical quality control (SQC) testing. The regulations currently incorporate by reference ASTM D6299-20; however, neither 40 CFR part 1090 nor ASTM D6299-20 clearly addresses how to handle suspected outlier results obtained as part of SQC testing.
                        <SU>26</SU>
                        <FTREF/>
                         Since the streamlining rule was promulgated in 2020, however, ASTM has updated this method to ASTM D6299-23a, which allows for the exclusion of outliers in SQC testing. Fuel manufacturers have asked EPA to update its incorporation by reference of ASTM D6299-20 in 40 CFR part 1090 to ASTM D6299-23a to also address outliers as part of SQC testing. EPA is finalizing as proposed the reference to the updated standard in the regulations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             40 CFR 1090.95(c)(30) and 1090.1375.
                        </P>
                    </FTNT>
                    <P>As discussed in the proposal, the purpose of SQC testing is to ensure that a fuel manufacturer or their third-party laboratory is conducting valid tests to ensure compliance with EPA's fuel quality requirements. Under ASTM D6299-23a, excluding an SQC test result can be appropriate under two scenarios:</P>
                    <P>• Scenario 1: When identified as an outlier using an appropriate statistical test, such as the Generalized Extreme Studentized Deviate (GESD), and evidence gathered from an investigation supports the exclusion. Supporting evidence could include a transcription error or other assignable cause that is not part of the normal process and needs to be properly documented.</P>
                    <P>• Scenario 2: During what is perceived to be normal operations of the SQC process, an SQC test result might fall outside of the Upper or Lower Control Limit, which is a strong indication of a system that is out-of-statistical-control (OOS). However, an immediate retest SQC sample should be performed to confirm the OOS event. If the retest indicates the system is in control as described in ASTM D6299-23a, then the OOS is not confirmed and the original SQC result might be excluded following further statistical analysis as addressed in section A1.5.4.1 of ASTM D6299-23a.</P>
                    <P>To provide clarity, EPA is finalizing as proposed the option for outliers to be excluded from SQC samples—but not certification samples—under the certain circumstances outlined in ASTM D6299-23a.</P>
                    <P>However, as discussed in the proposal, we are concerned that parties may dub certain test results as outliers even though the test result is valid and should be included as part of SQC simply because the party does not like the test result. Therefore, EPA is also finalizing as proposed recordkeeping requirements for exclusion events. If SQC data are excluded using the protocols outlined in ASTM D6299-23a, the laboratory would need to document the result as well as the assignable cause and justification for exclusion. EPA expects that SQC exclusions should be visible on the user's quality control chart while at the same time be excluded from ongoing SQC statistics. Under this approach, if EPA determines that the assignable cause for a test result treated as an outlier was not consistent with the circumstances described in ASTM D6299-23a, then such a test result would need to be retroactively included in the party's SQC. Furthermore, if documentation of the result as well as the assignable cause and justification are not maintained, EPA is finalizing the requirement that the test result also be included as part of the party's SQC.</P>
                    <P>We did not receive any comments on excluding SQC data points and are therefore finalizing this provision as proposed.</P>
                    <HD SOURCE="HD2">J. Testing for Oxygenates in PCG Under Compliance by Subtraction</HD>
                    <P>
                        EPA is finalizing as proposed a separate procedure for blending manufacturers that make a new batch of fuel with PCG that was a gasoline before oxygenate blending (BOB) and do not want to account for oxygenate added downstream under the compliance by subtraction provisions at 40 CFR 1090.1320(a)(1).
                        <SU>27</SU>
                        <FTREF/>
                         In the streamlining 
                        <PRTPAGE P="4328"/>
                        rule, a blending manufacturer certifying a batch using the PCG by subtraction procedures was required to create a hand blend of the PCG if the PCG was a BOB to determine the parameters of the PCG that would be used for the blending manufacturer's compliance calculations.
                        <SU>28</SU>
                        <FTREF/>
                         EPA established this requirement to ensure consistent accounting of sulfur and benzene levels of the PCG and believes that this approach is reasonable in the case where both the manufacturer of the PCG (a BOB in this case) and the manufacturer of the new finished fuel have accounted for oxygenate added downstream. However, after finalization of the streamlining rule, one stakeholder suggested that the creation of a hand blend for the PCG would not result in an accurate accounting of sulfur and benzene levels of the new finished fuel if the manufacturer of such fuel did not account for oxygenate added downstream. Rather, this stakeholder highlighted that testing both the PCG and the finished fuel without the addition of oxygenates would result in the correct sulfur and benzene levels of the reported sulfur and benzene values for average annual compliance if the manufacturer did not intend to account for oxygenate added downstream. Thus, in this circumstance there is no need to create a hand blend. EPA agrees with this assessment and as such is finalizing as proposed clarifications to the regulations to accommodate the scenario where a blending manufacturer complies by subtraction for PCG and does not account for oxygenate added downstream. Under this scenario, the blending manufacturer would test and report the sulfur and benzene values of the PCG and the finished fuel without the addition of oxygenates, which would be netted during the fuel manufacturer's annual compliance demonstration to report the correct sulfur and benzene values of the added blendstock. As discussed in the proposal, EPA still believes blending manufacturers that use the compliance by subtraction provisions to certify batches of fuels produced from PCG and elect to account for oxygenate added downstream should follow the existing requirement to create a hand blend of both the PCG and the finished fuel and are therefore not changing that requirement.
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             Under EPA's fuel quality regulations, a gasoline manufacturer may add additional blendstocks to PCG to create a new batch of gasoline so long as the gasoline manufacturer certifies the new batch as meeting all applicable per-gallon standards, and properly accounts for the sulfur and benzene levels of the gasoline manufacturer's annual average compliance calculations. The regulations at 40 CFR 1090.1320 provide two options for the certification of a new batch using PCG. First, the gasoline manufacturer may directly measure the gasoline and sulfur levels of the added blendstock and report those measurements and the volume as a positive batch thereby adding those values to the gasoline manufacturer's annual sulfur and benzene 
                            <PRTPAGE/>
                            compliance calculations; this procedure is called compliance by addition. The gasoline manufacturer may also determine the sulfur and benzene levels of the new blendstocks by measuring the sulfur and benzene levels of the PCG and the finished fuel then subtracting the PCG from the finished fuel to determine the values of the added blendstock; as such, this procedure is called compliance by subtraction. Gasoline manufacturers often use the compliance by subtraction method for PCG because it is often impractical to directly measure the sulfur and benzene values of blendstocks.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             40 CFR 1090.1320(a)(1).
                        </P>
                    </FTNT>
                    <P>We did not receive any comments on testing for oxygenates in PCG under compliance by subtraction provisions and are therefore finalizing this provision as proposed.</P>
                    <HD SOURCE="HD2">K. Noncompliant Certified Butane or Certified Pentane Test Results</HD>
                    <P>We proposed to clarify the treatment of certified butane or certified pentane when a certified butane or certified pentane blender obtains a test result under the quality assurance testing program that exceeds a per-gallon standard for certified butane or certified pentane in 40 CFR 1090.250 or 1090.255, respectively. We proposed that the volume of certified butane or certified pentane associated with the test result would be in violation of the per-gallon standard and that the certified butane or certified pentane blender would have to obtain sulfur or benzene credits calculated using the PCG by addition procedures in 40 CFR 1090.1320(a)(2) to offset any sulfur or benzene levels that exceeded the per-gallon standard.</P>
                    <P>Commenters requested that we further clarify which products and parties would be in violation when certified butane or certified pentane is found to be noncompliant with a per-gallon standard and that we allow for the use of both PCG by subtraction and PCG by addition procedures when this situation arises. In response to these comments and as further discussed in RTC section 2.4, we are finalizing clarified provisions and providing additional flexibility for the use of PCG by subtraction procedures to address the per-gallon exceedance.</P>
                    <HD SOURCE="HD1">III. Other Technical Amendments</HD>
                    <HD SOURCE="HD2">A. Definition of Batch</HD>
                    <P>
                        EPA is finalizing as proposed the modified definition of batch to better align with how the sampling and testing regulatory provisions establish the values for the regulated parameters for batches. Under the streamlining rule, a batch was defined as a “quantity of fuel, fuel additive, or regulated blendstock that has a homogeneous set of properties.” 
                        <SU>29</SU>
                        <FTREF/>
                         The definition notes further that “[t]his also includes fuel, fuel additive, or regulated blendstock for which homogeneity testing is not required under § 1090.1337(a).” Since this definition was promulgated in the streamlining rule, industry stakeholders have identified that the definition appears inconsistent because it says that a batch must be homogeneous, but the regulations also allow for certifying a batch without demonstrating homogeneity. It is also the case that fuel produced with in-line blending procedures is not subject to any homogeneity requirement. To address these concerns, EPA is revising the definition of batch to mean “a quantity of fuel, fuel additive, or regulated blendstock with properties that can be characterized by a single set of values using the measurement procedures in subpart N of this part.” We believe this framing better reflects our intent to have the values established through the sampling and testing provisions reflect the volume identified as the batch for manual sampling in cases where homogeneity has been determined and in cases where a party is allowed to certify a batch without demonstrating homogeneity. The revised definition also aligns with the requirement that fuel manufacturers using in-line blending must collect a single composite sample that represents the whole batch being certified.
                    </P>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             40 CFR 1090.80.
                        </P>
                    </FTNT>
                    <P>We did not receive any comments on the proposed revision to the definition of batch and are therefore finalizing this definition as proposed.</P>
                    <HD SOURCE="HD2">B. Truthful Reporting</HD>
                    <P>
                        EPA is finalizing as proposed clarifications to a requirement that applies to all information submitted to the Agency. Parties that submit information to EPA must, among other things, ensure that the information is complete, accurate, and not misleading according to the submitter's personal knowledge and belief. This requirement is codified at 18 U.S.C. 1001 and in several other statutory provisions. EPA's data systems—such as DCFuel and the EPA Moderated Transaction System (EMTS)—require the submitter to actively acknowledge this responsibility. For DCFuel, the submitter confirms that the information “meets all the requirements of the” applicable regulations by actively checking the certification box. Similarly, when information is submitted through EMTS, the submitter certifies that, “the information shown is a correct and accurate account of the transaction(s) that have taken place” or, “under penalty of law, that the information provided in this document is, to the best of [the submitter's] knowledge and belief, true, accurate, and complete. [The submitter is] aware that there are significant penalties for submitting false information, including the possibility of fines and 
                        <PRTPAGE P="4329"/>
                        imprisonment for knowing violations.” When information is submitted to EPA through email, however, there was no equivalent certification made, though the same requirement to submit complete, accurate, and not misleading information still applied. Therefore, EPA is finalizing the proposed statement in 40 CFR 1090.20(g) to ensure that the regulated community is aware that this obligation applies to all information submitted under 40 CFR part 1090, regardless of the form of that submission. We note that the statutory requirement to submit complete, accurate, and not misleading information applies with or without the regulatory clarification.
                    </P>
                    <P>We did not receive any comments on the proposed provision to require truthful reporting and are therefore finalizing this provision as proposed.</P>
                    <HD SOURCE="HD2">C. Clarification of RVP Standard in Federal 7.8 psi RVP Areas</HD>
                    <P>
                        EPA is finalizing as proposed a correction to the RVP standards for federal 7.8 psi RVP areas to allow for the use of 9.0 psi RVP summer gasoline in federal 7.8 psi RVP areas during the month of May. Prior to the streamlining rule, gasoline used in federal 7.8 psi RVP areas had to meet a 9.0 psi RVP standard during the month of May and a 7.8 psi RVP standard for the remainder of the summer season (
                        <E T="03">i.e.,</E>
                         June 1 to September 15). In the gasoline RVP standards specified in 40 CFR part 1090.215, EPA inadvertently modified the RVP standard for federal 7.8 psi RVP areas for the month of May in transcribing the previous RVP standards table in 40 CFR 80.27. This revision fixes that transcription error.
                    </P>
                    <P>We did not receive any comments on the proposed clarification of the RVP standard in Federal 7.8 psi RVP areas and are therefore finalizing this provision as proposed.</P>
                    <HD SOURCE="HD2">D. National Fuel Survey Program Notifications</HD>
                    <P>EPA is finalizing as proposed the requirement that independent surveyors include additional information in notifications to EPA and branded fuel manufacturers when the surveyor identifies potential non-compliance as part of the NFSP. Under the current NFSP requirements, the independent surveyor utilizes information about retail outlets to identify potential locations and ultimately randomly selects retail outlets for sampling. When the independent surveyor collects samples, it tests the sample to determine whether it meets the applicable fuel quality standards. If a test result exceeds one or more applicable standards, the independent surveyor is required to notify EPA, the retailer, and the branded fuel manufacturer (if applicable) within 24 hours of identifying the issue. The regulations in the streamlining rule did not specify that the surveyor indicate the contact information of the retail outlet in the notification provided to EPA or the branded fuel manufacturer (if applicable), even though the independent surveyor has this information readily available. Based on EPA's experience with the NFSP to date, we believe that including such information as part of the notifications for potentially non-compliant samples will help EPA and branded fuel manufacturers more expeditiously resolve these issues consistent with EPA's original intent in setting up the NFSP. As such, EPA is finalizing the requirement that any notification to EPA or a branded fuel manufacturer of a potential non-compliant sample include the retail outlet's contact information, including name, title, mailing address, telephone number, and email address of a representative of the retail outlet, if available.</P>
                    <P>We did not receive any comments on the proposed notifications under the NFSP and are therefore finalizing this provision as proposed.</P>
                    <HD SOURCE="HD2">E. Fuel Certification With Domestic Marine Vessels</HD>
                    <P>Several stakeholders requested flexibility to meet testing requirements for fuel certification when loading gasoline or diesel fuel onto domestic marine vessels, specifically by sampling and testing with the procedures that apply for importing fuel on marine vessels as specified in 40 CFR 1090.1605. EPA is finalizing this flexibility with minor edits subject to the stipulations that each vessel compartment is sampled and tested independently, and that no additional product loading or blending occurs after sampling and certification have been completed. The marine vessel is also not permitted to navigate beyond 15 miles from the fuel manufacturing facility or to discharge fuel until demonstrating compliance with all applicable per-gallon standards. This condition is intended to allow fuel manufacturers to free up dock space while waiting on test results. However, the fuel manufacturer is still accountable for any noncompliance and maintains responsibility for addressing any noncompliance before the fuel is discharged. EPA selected the 15-mile limit based on discussions with industry and believes this distance would be sufficient to allow for vessels to travel to free up dock space and still return to port to bring fuel back to the fuel manufacturing facility if an issue is identified with the fuel after it has left the dock.</P>
                    <P>In response to a comment and as further discussed in RTC section 2.6, we are finalizing this flexibility with minor edits to clarify the proposed language for fuel certification with domestic marine vessels.</P>
                    <HD SOURCE="HD2">F. Technical Corrections</HD>
                    <P>EPA is finalizing as proposed numerous technical amendments to 40 CFR part 1090. These amendments are being made to correct minor inaccuracies and clarify the current regulations. These changes are described in table III.F-1, and we address comments on these corrections and clarifications in RTC section 3.</P>
                    <BILCOD>BILLING CODE 6560-50-P</BILCOD>
                    <GPH SPAN="3" DEEP="235">
                        <PRTPAGE P="4330"/>
                        <GID>ER15JA25.003</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="4331"/>
                        <GID>ER15JA25.004</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="4332"/>
                        <GID>ER15JA25.005</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="4333"/>
                        <GID>ER15JA25.006</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="223">
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                    </GPH>
                    <GPH SPAN="3" DEEP="525">
                        <PRTPAGE P="4335"/>
                        <GID>ER15JA25.008</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 6560-50-C</BILCOD>
                    <HD SOURCE="HD1">IV. Updates to the Boutique Fuels List</HD>
                    <P>
                        We are using this final action to provide a current list of boutique fuels. Section 1541(b) of the Energy Policy Act of 2005 required EPA, in consultation with the Department of Energy (DOE), to determine the total number of fuels approved into all SIPs, under Clean Air Act (CAA) section 211(c)(4)(C), as of September 1, 2004, and publish a list of such fuels including the state and Petroleum Administration for Defense District (PADD) in which they are used for public review and comment. EPA originally published the required list on December 28, 2006.
                        <SU>31</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             71 FR 78192.
                        </P>
                    </FTNT>
                    <P>
                        Additionally, we are required to remove any fuels from the published list if the fuel either ceases to be included in a SIP or is identical to a federal fuel.
                        <SU>32</SU>
                        <FTREF/>
                         Since we last published an updated boutique fuel list on December 4, 2020, such a change has occurred.
                        <SU>33</SU>
                        <FTREF/>
                         Specifically, the requirements for the sale of gasoline with an RVP of 7.0 psi in the Kansas City, KS-MO area have been removed from the Kansas and Missouri state implementation plans.
                        <SU>34</SU>
                        <FTREF/>
                         We are also clarifying that the 
                        <PRTPAGE P="4336"/>
                        requirement for the sale of gasoline with an RVP of 7.0 psi in El Paso, TX extends until September 16th of each year. In table IV-1, we are providing an updated list of boutique fuels that includes all the boutique fuels that are currently in approved SIPs. We maintain a list of boutique fuels on our State Fuels website.
                        <SU>35</SU>
                        <FTREF/>
                         We will continue to update that website as changes to boutique fuels occur and periodically announce updates in the 
                        <E T="04">Federal Register</E>
                         for fuels that are either removed or added.
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             CAA section 211(c)(4)(C)(v)(III).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             85 FR 78412, 78427.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             EPA published a final rule on March 12, 2021 (86 FR 14000) that removed Kansas' gasoline rule. EPA published a second final rule on March 12, 2021 (86 FR 14007) that removed Missouri's gasoline rule. Both rules were effective on April 12, 2021.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             EPA's State Fuels website is available at 
                            <E T="03">https://www.epa.gov/gasoline-standards/state-fuels.</E>
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="202">
                        <GID>ER15JA25.009</GID>
                    </GPH>
                    <HD SOURCE="HD1">V. Statutory and Executive Order Reviews</HD>
                    <P>
                        Additional information about these statutes and Executive Orders can be found at 
                        <E T="03">https://www.epa.gov/laws-regulations/laws-and-executive-orders.</E>
                    </P>
                    <HD SOURCE="HD2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review</HD>
                    <P>This action is not a significant regulatory action as defined in Executive Order 12866, as amended by Executive Order 14094, and was therefore not subject to a requirement for Executive Order 12866 review.</P>
                    <HD SOURCE="HD2">B. Paperwork Reduction Act (PRA)</HD>
                    <P>This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0731.</P>
                    <HD SOURCE="HD2">C. Regulatory Flexibility Act (RFA)</HD>
                    <P>I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the agency is certifying that this rule will not have a significant economic impact on a substantial number of small entities because the rule has no net regulatory burden on the small entities subject to the rule.</P>
                    <P>The small entities directly regulated by EPA's fuel quality regulations are small refiners, which are defined at 13 CFR 121.201. This action makes relatively minor corrections and modifications to EPA's fuel quality regulations, and we do not anticipate that there will be any significant cost increases associated with these changes. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.</P>
                    <HD SOURCE="HD2">D. Unfunded Mandates Reform Act (UMRA)</HD>
                    <P>This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any state, local, or Tribal governments. Requirements for the private sector do not exceed $100 million in any one year.</P>
                    <HD SOURCE="HD2">E. Executive Order 13132: Federalism</HD>
                    <P>This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                    <HD SOURCE="HD2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</HD>
                    <P>This action does not have Tribal implications as specified in Executive Order 13175. This action will be implemented at the Federal level and potentially affects transportation fuel refiners, blenders, marketers, distributors, importers, exporters, and renewable fuel producers and importers. Tribal governments would be affected only to the extent they produce, purchase, and use regulated fuels. Thus, Executive Order 13175 does not apply to this action.</P>
                    <HD SOURCE="HD2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</HD>
                    <P>EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order.</P>
                    <P>
                        Therefore, this action is not subject to Executive Order 13045 because it does not concern an environmental health 
                        <PRTPAGE P="4337"/>
                        risk or safety risk. Since this action does not concern human health, EPA's Policy on Children's Health also does not apply.
                    </P>
                    <HD SOURCE="HD2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</HD>
                    <P>This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.</P>
                    <HD SOURCE="HD2">I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR Part 51</HD>
                    <P>This action involves technical standards. Except for the standards discussed in this section, the standards included in the regulatory text as incorporated by reference were all previously approved for incorporation by reference (IBR) and no change is included in this action.</P>
                    <P>
                        In accordance with the requirements of 1 CFR 51.5, we are incorporating by reference the use of attestation standards from the American Institute of Certified Public Accountants (AICPA). The referenced standards may be obtained from AICPA, 220 Leigh Farm Rd., Durham, NC 27707-8110, (919) 402-4500, or 
                        <E T="03">https://www.aicpa-cima.org.</E>
                         We are incorporating by reference the following standards from AICPA:
                    </P>
                    <BILCOD>BILLING CODE 6560-50-P</BILCOD>
                    <GPH SPAN="3" DEEP="349">
                        <GID>ER15JA25.010</GID>
                    </GPH>
                    <P>
                        In accordance with the requirements of 1 CFR 51.5, we are incorporating by reference the use of certain standards and test methods from ASTM International. The referenced standards and test methods may be obtained from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA, 19428-2959, (610) 832-9585, or 
                        <E T="03">https://www.astm.org.</E>
                         We are incorporating by reference the following standards from ASTM International:
                    </P>
                    <GPH SPAN="3" DEEP="154">
                        <PRTPAGE P="4338"/>
                        <GID>ER15JA25.011</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="4339"/>
                        <GID>ER15JA25.012</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 6560-50-C</BILCOD>
                    <PRTPAGE P="4340"/>
                    <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All</HD>
                    <P>EPA believes this type of action does not concern human health or environmental conditions and therefore cannot be evaluated with respect to potentially disproportionate and adverse effects on communities with environmental justice concerns. This action does not affect the level of protection provided to human health or the environment by applicable air quality standards. This action makes relatively minor corrections and modifications to EPA's existing fuel quality regulations and therefore will not cause emissions increases from these sources.</P>
                    <HD SOURCE="HD2">K. Congressional Review Act (CRA)</HD>
                    <P>This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).</P>
                    <HD SOURCE="HD1">VI. Amendatory Instructions</HD>
                    <P>
                        Amendatory instructions are the standard terms that OFR uses to give specific instructions to agencies on how to change the CFR. OFR's historical guidance was to include amendatory instructions accompanying each individual change that was being made (
                        <E T="03">e.g.,</E>
                         each sentence or individual paragraph). The piecemeal amendments served as an indication of changes EPA was making. Due to the extensive number of technical and conforming amendments included in this action, however, EPA is utilizing OFR's new amendatory instruction “revise and republish” for revisions that become effective in this action.
                        <SU>36</SU>
                        <FTREF/>
                         Therefore, instead of the past practice of piecemeal amendments for revisions to the CFR, EPA is using the “revise and republish” instruction to both revise regulatory text and republish in their entirety certain sections of 40 CFR part 1090 that contain the regulatory text being revised. To indicate those portions of provisions where changes are being revised, EPA has created a red-line version of 40 CFR part 1090 that incorporates the changes. This red-line version is available in the docket for this action, as well as on EPA's website at 
                        <E T="03">https://www.epa.gov/diesel-fuel-standards/fuels-regulatory-streamlining.</E>
                         This red-line version provides further context to assist the public in reviewing the regulatory text changes. As previously noted, EPA did not reopen those unchanged provisions for comment. Republishing provisions that are unchanged in this action is consistent with guidance from OFR.
                    </P>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             OFR's Document Drafting Handbook (Chapter 2, 2-38) explains that agencies “[u]se [r]epublish to set out unchanged text for the convenience of the reader, often to provide context for your regulatory changes.” 
                            <E T="03">https://www.archives.gov/federal-register/write/handbook.</E>
                             Additional information on OFR's mandatory use of “revise and republish” is available at 
                            <E T="03">https://www.archives.gov/federal-register/write/ddh/revise-republish.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">VII. Statutory Authority</HD>
                    <P>Statutory authority for this action comes from sections 114, 202, 203, 204, 205, 206, 207, 208, 209, 211, 213, 216, and 301 of the Clean Air Act, 42 U.S.C. 7414, 7521, 7522, 7523, 7524, 7525, 7541, 7542, 7543, 7545, 7547, 7550, and 7601.</P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 40 CFR Part 1090</HD>
                        <P>Environmental protection, Administrative practice and procedure, Air pollution control, Diesel fuel, Fuel additives, Gasoline, Imports, Incorporation by reference, Oil imports, Petroleum, Renewable fuel.</P>
                    </LSTSUB>
                    <SIG>
                        <NAME>Michael S. Regan,</NAME>
                        <TITLE>Administrator.</TITLE>
                    </SIG>
                    <P>For the reasons set forth in the preamble, EPA amends 40 CFR part 1090 as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 1090—REGULATION OF FUELS, FUEL ADDITIVES, AND REGULATED BLENDSTOCKS</HD>
                    </PART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>1. The authority citation for part 1090 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority: </HD>
                            <P>42 U.S.C. 7414, 7521, 7522-7525, 7541, 7542, 7543, 7545, 7547, 7550, and 7601.</P>
                        </AUTH>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart A—General Provisions</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>2. Amend § 1090.1 by revising and republishing paragraph (a) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1</SECTNO>
                            <SUBJECT>Applicability and relationship to other parts.</SUBJECT>
                            <P>(a) This part specifies fuel quality standards for gasoline and diesel fuel introduced into commerce in the United States. Additional requirements apply for fuel used in certain marine applications, as specified in paragraph (b) of this section.</P>
                            <P>(1) The regulations include standards for fuel parameters that directly or indirectly affect vehicle, engine, and equipment emissions, air quality, and public health. The regulations also include standards and requirements for fuel additives and regulated blendstocks that are components of any fuel regulated under this part.</P>
                            <P>(2) This part also specifies requirements for any person who engages in activities associated with the production, distribution, storage, and sale of any fuel, fuel additive, or regulated blendstock, such as collecting and testing samples for regulated parameters, reporting information to EPA to demonstrate compliance with fuel quality requirements, and performing other compliance measures to implement the standards. A party that produces and distributes other related products, such as heating oil, may need to meet certain reporting, recordkeeping, labeling, or other requirements of this part.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>3. Amend § 1090.5 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraphs (b)(3) and (c)(4); and</AMDPAR>
                        <AMDPAR>b. Adding paragraph (d).</AMDPAR>
                        <P>The revisions and addition read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.5</SECTNO>
                            <SUBJECT>Implementation dates.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(3) Unless otherwise specified, a regulated party must use the provisions of 40 CFR part 80 in 2021 to demonstrate compliance with regulatory requirements for the 2020 calendar year. This applies to calculating credits for the 2020 compliance period, and to any sampling, testing, reporting, or auditing related to any fuel, fuel additive, or regulated blendstock produced or imported in 2020.</P>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(4) The independent surveyor may collect only one summer or winter gasoline sample for each participating gasoline manufacturing facility instead of the minimum two samples required under § 1090.1450(c)(2)(i).</P>
                            <P>(d) The following requirements apply beginning with the 2025 or 2026 compliance period:</P>
                            <P>
                                (1) Fuel manufacturers operating under an approved in-line blending waiver under § 1090.1315 as of July 1, 2025, must have an approved in-line blending waiver that complies with all the provisions of § 1090.1315(a)(7) through (13) no later than January 1, 2026. Such fuel manufacturers must comply with the in-line blending waiver auditing requirements of § 1090.1850(b) starting with either the 2025 or 2026 compliance period, whichever is the earliest compliance period for which they have an approved in-line blending waiver that complies with all the provisions of § 1090.1315(a)(7) through (13).
                                <PRTPAGE P="4341"/>
                            </P>
                            <P>
                                (2) Gasoline manufacturers must comply with the batch reporting requirements in § 1090.905(c)(1)(viii)(A)(
                                <E T="03">2</E>
                                ), (c)(2)(viii)(A)(
                                <E T="03">2</E>
                                ), and (c)(8)(vii)(A)(
                                <E T="03">2</E>
                                ) beginning with the 2026 compliance period.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>4. Amend § 1090.15 by revising paragraph (e) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.15</SECTNO>
                            <SUBJECT>Confidential business information.</SUBJECT>
                            <STARS/>
                            <P>(e) EPA may disclose the information specified in paragraphs (b) through (d) of this section on its website, or otherwise make it available to interested parties, without additional notice, notwithstanding any claims that the information is entitled to confidential treatment under 40 CFR part 2, subpart B or 5 U.S.C. 552(b)(4).</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>5. Amend § 1090.20 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraph (f); and</AMDPAR>
                        <AMDPAR>b. Adding paragraph (g).</AMDPAR>
                        <P>The revision and addition read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.20</SECTNO>
                            <SUBJECT>Approval of submissions under this part.</SUBJECT>
                            <STARS/>
                            <P>(f) Any person who has an approval revoked or voided under this part is liable for any resulting violation of the requirements of this part.</P>
                            <P>(g) Submitting false, misleading, or incomplete information is a violation of law.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>6. Amend § 1090.50 by revising paragraph (a) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.50</SECTNO>
                            <SUBJECT>Rounding.</SUBJECT>
                            <P>(a) Unless otherwise specified, round values to the number of significant digits necessary to match the number of decimal places of the applicable standard or specification. Perform all rounding as specified in 40 CFR 1065.20(e)(1) through (6).</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>7. Amend § 1090.55 by revising and republishing paragraph (b) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.55</SECTNO>
                            <SUBJECT>Requirements for independent parties.</SUBJECT>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">Technical ability.</E>
                                 The third party must meet all the following requirements in order to demonstrate their technical capability to perform specified activities under this part:
                            </P>
                            <P>(1) An independent surveyor that conducts a survey under subpart O of this part must have personnel familiar with petroleum marketing, the sampling and testing of gasoline and diesel fuel at retail outlets, and the designing of surveys to estimate compliance rates for fuel parameters nationwide. The independent surveyor must demonstrate this technical ability in plans submitted under subpart O of this part.</P>
                            <P>(2) A laboratory attempting to qualify alternative procedures must contract with an independent third party to verify the accuracy and precision of measured values as specified in § 1090.1365. The independent third party must demonstrate work experience and a good working knowledge of the VCSB methods specified in §§ 1090.1335, 1090.1365, and 1090.1370, with training and expertise corresponding to a bachelor's degree in chemical engineering, or combined bachelor's degrees in chemistry and statistics.</P>
                            <P>(3) Any person auditing in-line blending operations must be familiar with the waiver provisions of § 1090.1315 and be proficient with the sampling procedures specified in § 1090.1335(c).</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>8. Amend § 1090.80 by:</AMDPAR>
                        <AMDPAR>a. Revising the definitions “Auditor”, “Automated detergent blending facility”, and “Batch”;</AMDPAR>
                        <AMDPAR>b. Removing the definition “California diesel”;</AMDPAR>
                        <AMDPAR>c. Adding the definition “California diesel fuel” in alphabetical order;</AMDPAR>
                        <AMDPAR>d. Revising the definitions “Certified ethanol denaturant producer”, “Detergent additive package”, “Detergent blender”, and “Diesel fuel manufacturer”;</AMDPAR>
                        <AMDPAR>e. Adding the definition “Distillate global marine fuel” in alphabetical order;</AMDPAR>
                        <AMDPAR>f. Revising the definitions “Downstream location”, “E0”, and “E85”;</AMDPAR>
                        <AMDPAR>g. Adding the definition “ECA associated area” in alphabetical order;</AMDPAR>
                        <AMDPAR>h. Revising the definition “ECA marine fuel”;</AMDPAR>
                        <AMDPAR>i. Adding the definition “Emission control area (ECA)” in alphabetical order;</AMDPAR>
                        <AMDPAR>j. Revising the definitions “Fuel additive” and “Fuel additive manufacturer”;</AMDPAR>
                        <AMDPAR>k. Adding the definition “Fuel additive manufacturing facility” in alphabetical order;</AMDPAR>
                        <AMDPAR>l. Revising the definitions “Fuel manufacturing facility”, “Gasoline before oxygenate blending (BOB)”, “Gasoline manufacturer”, “Global marine fuel”, “Marine engine”, “Non-automated detergent blending facility”, and “Reformulated gasoline (RFG)”;</AMDPAR>
                        <AMDPAR>m. Adding the definition “Regulated blendstock import facility” in alphabetical order;</AMDPAR>
                        <AMDPAR>n. Revising the definition “Regulated blendstock producer”;</AMDPAR>
                        <AMDPAR>o. Adding the definition “Regulated blendstock production facility” in alphabetical order;</AMDPAR>
                        <AMDPAR>p. Revising the definitions “Sampling strata” and “Transmix processor”;</AMDPAR>
                        <AMDPAR>q. Removing the definition “Volume Additive Reconciliation (VAR) Period”;</AMDPAR>
                        <AMDPAR>r. Adding the definition “Volume additive reconciliation (VAR) period” in alphabetical order; and</AMDPAR>
                        <AMDPAR>s. Revising the definition “Wholesale purchaser-consumer (WPC)”.</AMDPAR>
                        <P>The revisions and additions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.80</SECTNO>
                            <SUBJECT>Definitions.</SUBJECT>
                            <STARS/>
                            <P>
                                <E T="03">Auditor</E>
                                 means any person who conducts audits under subpart S of this part.
                            </P>
                            <P>
                                <E T="03">Automated detergent blending facility</E>
                                 means any facility (including, but not limited to, a truck or individual storage tank) at which detergent is blended with gasoline by means of an injector system calibrated to automatically deliver a specified amount of detergent.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Batch</E>
                                 means a quantity of fuel, fuel additive, or regulated blendstock with properties that can be characterized by a single set of values using the measurement procedures in subpart N of this part.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">California diesel fuel</E>
                                 means diesel fuel designated by a diesel fuel manufacturer as for use in California.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Certified ethanol denaturant producer</E>
                                 means any person who certifies ethanol denaturant as meeting the requirements in § 1090.275.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Detergent additive package</E>
                                 means an additive package containing detergent and may also contain carrier oils and other active components such as corrosion inhibitors, antioxidants, metal deactivators, and handling solvents.
                            </P>
                            <P>
                                <E T="03">Detergent blender</E>
                                 means any person who owns, leases, operates, controls, or supervises the blending operation of a detergent blending facility, or who imports detergent-additized gasoline.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Diesel fuel manufacturer</E>
                                 means a fuel manufacturer that owns, leases, operates, controls, or supervises a diesel fuel manufacturing facility.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Distillate global marine fuel</E>
                                 means global marine fuel that is distillate fuel.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Downstream location</E>
                                 means any point in the fuel distribution system other 
                                <PRTPAGE P="4342"/>
                                than a fuel manufacturing facility through which fuel passes after it leaves the fuel manufacturing facility gate at which it was certified (
                                <E T="03">e.g.,</E>
                                 fuel at facilities of distributors, pipelines, terminals, carriers, retailers, oxygenate blenders, and WPCs).
                            </P>
                            <P>
                                <E T="03">E0</E>
                                 means gasoline that contains no ethanol.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">E85</E>
                                 means a fuel that contains more than 50 and no more than 83 volume percent ethanol and is used, intended for use, or made available for use in flex-fuel vehicles or flex-fuel engines. E85 is not gasoline.
                            </P>
                            <P>
                                <E T="03">ECA associated area</E>
                                 has the meaning given in 40 CFR 1043.20.
                            </P>
                            <P>
                                <E T="03">ECA marine fuel</E>
                                 means diesel fuel, distillate fuel, or residual fuel used, intended for use, or made available for use in C3 marine vessels while the vessels are operating within an ECA, or an ECA associated area.
                            </P>
                            <P>
                                <E T="03">Emission control area (ECA)</E>
                                 has the meaning given in 40 CFR 1043.20.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Fuel additive</E>
                                 has the same meaning as 
                                <E T="03">additive</E>
                                 in 40 CFR 79.2(e).
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Fuel additive manufacturer</E>
                                 means any person who owns, leases, operates, controls, or supervises a fuel additive manufacturing facility.
                            </P>
                            <P>
                                <E T="03">Fuel additive manufacturing facility</E>
                                 means any facility where fuel additive is produced or imported.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Fuel manufacturing facility</E>
                                 means any facility where fuel is produced, imported, or recertified. Fuel manufacturing facilities include refineries, fuel blending facilities, transmix processing facilities, import facilities, and any facility where fuel is recertified.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Gasoline before oxygenate blending (BOB)</E>
                                 means gasoline for which a gasoline manufacturer has accounted for oxygenate added downstream under § 1090.710. BOB is subject to all the requirements and standards that apply to gasoline, unless subject to a specific alternative standard or requirement under this part.
                            </P>
                            <P>
                                <E T="03">Gasoline manufacturer</E>
                                 means a fuel manufacturer that owns, leases, operates, controls, or supervises a gasoline manufacturing facility.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Global marine fuel</E>
                                 means diesel fuel, distillate fuel, or residual fuel used, intended for use, or made available for use in steamships or Category 3 marine vessels while the vessels are operating in international waters or in any waters outside the boundaries of an ECA. Global marine fuel is subject to the provisions of MARPOL Annex VI. (Note: This part regulates only distillate global marine fuel.)
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Marine engine</E>
                                 has the meaning given in 40 CFR 1042.901.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Non-automated detergent blending facility</E>
                                 means any facility (including a truck or individual storage tank) at which detergent additive is blended using a hand-blending technique or any other non-automated method.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Reformulated gasoline (RFG)</E>
                                 means gasoline that is certified under § 1090.1000(b) and that meets the standards and requirements in § 1090.220.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Regulated blendstock import facility</E>
                                 means any facility where regulated blendstock is imported into the United States.
                            </P>
                            <P>
                                <E T="03">Regulated blendstock producer</E>
                                 means any person who produces or imports regulated blendstock in the United States, or any person who owns, leases, operates, controls, or supervises a facility where regulated blendstock is produced or imported.
                            </P>
                            <P>
                                <E T="03">Regulated blendstock production facility</E>
                                 means any facility where regulated blendstock is produced.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Sampling strata</E>
                                 means the following types of areas sampled during a survey:
                            </P>
                            <P>(1) Densely populated areas.</P>
                            <P>(2) Transportation corridors.</P>
                            <P>(3) Rural areas.</P>
                            <STARS/>
                            <P>
                                <E T="03">Transmix processor</E>
                                 means any person who owns, leases, operates, controls, or supervises a transmix processing facility in the United States. A transmix processor is a fuel manufacturer.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Volume additive reconciliation (VAR) period</E>
                                 means the following:
                            </P>
                            <P>(1) For an automated detergent blending facility, the VAR period is a time period lasting no more than 31 days or until an adjustment to a detergent concentration rate that increases the initial rate by more than 10 percent, whichever occurs first. The concentration setting for a detergent injector may be adjusted by more than 10 percent above the initial rate without terminating the VAR period, provided the purpose of the change is to correct a batch misadditization prior to the transfer of the batch to another party, or to correct an equipment malfunction and the concentration is immediately returned to no more than 10 percent above the initial rate of concentration after the correction.</P>
                            <P>(2) For a non-automated detergent blending facility, the VAR period constitutes the blending of one batch of gasoline.</P>
                            <STARS/>
                            <P>
                                <E T="03">Wholesale purchaser-consumer (WPC)</E>
                                 means any person who is an ultimate consumer of fuels and who purchases or obtains fuels for use in motor vehicles, nonroad vehicles, nonroad engines, or nonroad equipment, including locomotive or marine engines, and, in the case of liquid fuels, receives delivery of that product into a storage tank of at least 550-gallon capacity substantially under the control of that person.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>9. Amend § 1090.85 by adding paragraph (g) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.85</SECTNO>
                            <SUBJECT>Explanatory terms.</SUBJECT>
                            <STARS/>
                            <P>
                                (g) 
                                <E T="03">Generic terms.</E>
                                 Certain terms that are generically defined in this part (
                                <E T="03">e.g.,</E>
                                 “fuel manufacturing facility” or “importer”) may also be used to refer to a specific fuel, fuel additive, or regulated blendstock type (
                                <E T="03">e.g.,</E>
                                 “diesel fuel manufacturing facility” or “gasoline importer”).
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>10. Amend § 1090.90 by:</AMDPAR>
                        <AMDPAR>a. Revising the entry “PLOQ”; and</AMDPAR>
                        <AMDPAR>b. Adding the entry “VAR” in alphabetical order.</AMDPAR>
                        <P>The revision and addition read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.90</SECTNO>
                            <SUBJECT>Acronyms and abbreviations.</SUBJECT>
                            <PRTPAGE P="4343"/>
                            <GPOTABLE COLS="2" OPTS="L1,tp0,p1,8/9,i1" CDEF="s100,r100">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1"> </CHED>
                                    <CHED H="1"> </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="28">*         *         *         *         *         *         *</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">PLOQ</ENT>
                                    <ENT>pooled limit of quantitation.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="28">*         *         *         *         *         *         *</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">VAR</ENT>
                                    <ENT>volume additive reconciliation.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="28">*         *         *         *         *         *         *</ENT>
                                </ROW>
                            </GPOTABLE>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>11. Amend § 1090.95 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraphs (a), (b), and (c)(1), (3), and (6) through (8);</AMDPAR>
                        <AMDPAR>b. Removing paragraph (c)(9) and redesignating paragraphs (c)(10) through (37) as paragraphs (c)(9) through (36);</AMDPAR>
                        <AMDPAR>c. Revising newly redesignated paragraphs (c)(9), (10), (12) through (14), (17), (19), (20), (23), (24), (29), (31), and (35);</AMDPAR>
                        <AMDPAR>d. Removing paragraph (c)(38) and redesignating paragraphs (c)(39) and (40) as paragraphs (c)(37) and (38); and</AMDPAR>
                        <AMDPAR>e. In paragraph (d)(1), remove the text “May 17, 1999” and add, in its place, the text “May 17, 1999; IBR approved for § 1090.1395(b)”.</AMDPAR>
                        <P>The revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.95</SECTNO>
                            <SUBJECT>Incorporation by reference.</SUBJECT>
                            <P>
                                (a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the U.S. EPA and at the National Archives and Records Administration (NARA). Contact the U.S. EPA at: U.S. EPA, Air and Radiation Docket and Information Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20460; (202) 566-1742. For information on the availability of this material at NARA, visit 
                                <E T="03">www.archives.gov/federal-register/cfr/ibr-locations.html</E>
                                 or email 
                                <E T="03">fr.inspection@nara.gov.</E>
                                 The material may be obtained from the sources in the following paragraphs of this section.
                            </P>
                            <P>
                                (b) American Institute of Certified Public Accountants, 220 Leigh Farm Rd., Durham, NC 27707-8110; (919) 402-4500; 
                                <E T="03">www.aicpa-cima.org.</E>
                            </P>
                            <P>(1) AICPA Code of Professional Conduct, updated through December 2023; IBR approved for § 1090.1800(b).</P>
                            <P>(2) Statements on Quality Control Standards (SQCS) No. 8, QC Section 10: A Firm's System of Quality Control, current as of July 1, 2019; IBR approved for § 1090.1800(b).</P>
                            <P>(3) Statement on Quality Management Standards (SQMS) No. 1, A Firm's System of Quality Management, Issued June 2022; IBR approved for § 1090.1800(b).</P>
                            <P>(4) Statement on Quality Management Standards (SQMS) No. 2, Engagement Quality Reviews, Issued June 2022; IBR approved for § 1090.1800(b).</P>
                            <P>
                                (5) Statement on Quality Management Standards (SQMS) No. 3, 
                                <E T="03">Amendments to QM Sections 10,</E>
                                 A Firm's System of Quality Management, 
                                <E T="03">and 20,</E>
                                 Engagement Quality Reviews, Issued March 2023; IBR approved for § 1090.1800(b).
                            </P>
                            <P>(6) Statement on Standards for Attestation Engagements (SSAE) No. 19, Agreed-Upon Procedures Engagement, Issued December 2019; IBR approved for § 1090.1800(b).</P>
                            <P>(c) * * *</P>
                            <P>(1) ASTM D86-23ae1, Standard Test Method for Distillation of Petroleum Products and Liquid Fuels at Atmospheric Pressure, approved December 1, 2023 (“ASTM D86”); IBR approved for § 1090.1350(b).</P>
                            <STARS/>
                            <P>(3) ASTM D975-24a, Standard Specification for Diesel Fuel, approved August 1, 2024 (“ASTM D975”); IBR approved for § 1090.80.</P>
                            <STARS/>
                            <P>(6) ASTM D1319-20a, Standard Test Method for Hydrocarbon Types in Liquid Petroleum Products by Fluorescent Indicator Adsorption, approved August 1, 2020 (“ASTM D1319”); IBR approved for § 1090.1350(b).</P>
                            <P>(7) ASTM D2163-23e1, Standard Test Method for Determination of Hydrocarbons in Liquefied Petroleum (LP) Gases and Propane/Propene Mixtures by Gas Chromatography, approved March 1, 2023 (“ASTM D2163”); IBR approved for § 1090.1350(b).</P>
                            <P>(8) ASTM D2622-24, Standard Test Method for Sulfur in Petroleum Products by Wavelength Dispersive X-ray Fluorescence Spectrometry, approved July 1, 2024 (“ASTM D2622”); IBR approved for §§ 1090.1350(b); 1090.1360(d); 1090.1375(c).</P>
                            <P>(9) ASTM D3231-24, Standard Test Method for Phosphorus in Gasoline, approved March 1, 2024 (“ASTM D3231”); IBR approved for § 1090.1350(b).</P>
                            <P>(10) ASTM D3237-22, Standard Test Method for Lead in Gasoline by Atomic Absorption Spectroscopy, approved October 1, 2022 (“ASTM D3237”); IBR approved for § 1090.1350(b).</P>
                            <STARS/>
                            <P>(12) ASTM D4052-22, Standard Test Method for Density, Relative Density, and API Gravity of Liquids by Digital Density Meter, approved May 1, 2022 (“ASTM D4052”); IBR approved for § 1090.1337(d) and (f).</P>
                            <P>(13) ASTM D4057-22, Standard Practice for Manual Sampling of Petroleum and Petroleum Products, approved May 1, 2022 (“ASTM D4057”); IBR approved for §§ 1090.1335(b); 1090.1605(b).</P>
                            <P>(14) ASTM D4177-22e1, Standard Practice for Automatic Sampling of Petroleum and Petroleum Products, approved July 1, 2022 (“ASTM D4177”); IBR approved for §§ 1090.1315(a); 1090.1335(c).</P>
                            <STARS/>
                            <P>(17) ASTM D4814-24a, Standard Specification for Automotive Spark-Ignition Engine Fuel, approved July 1, 2024 (“ASTM D4814”); IBR approved for §§ 1090.80; 1090.1395(a).</P>
                            <STARS/>
                            <P>(19) ASTM D5186-24, Standard Test Method for Determination of the Aromatic Content and Polynuclear Aromatic Content of Diesel Fuels By Supercritical Fluid Chromatography, approved July 1, 2024 (“ASTM D5186”); IBR approved for § 1090.1350(b).</P>
                            <P>(20) ASTM D5191-22, Standard Test Method for Vapor Pressure of Petroleum Products and Liquid Fuels (Mini Method), approved July 1, 2022 (“ASTM D5191”); IBR approved for § 1090.1360(d).</P>
                            <STARS/>
                            <P>(23) ASTM D5599-22, Standard Test Method for Determination of Oxygenates in Gasoline by Gas Chromatography and Oxygen Selective Flame Ionization Detection, approved April 1, 2022 (“ASTM D5599”); IBR approved for § 1090.1360(d).</P>
                            <P>
                                (24) ASTM D5769-22, Standard Test Method for Determination of Benzene, Toluene, and Total Aromatics in Finished Gasolines by Gas Chromatography/Mass Spectrometry, approved July 1, 2022 (“ASTM D5769”); 
                                <PRTPAGE P="4344"/>
                                IBR approved for §§ 1090.1350(b); 1090.1360(d).
                            </P>
                            <STARS/>
                            <P>(29) ASTM D6299-23a, Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance, approved December 1, 2023 (“ASTM D6299”); IBR approved for §§ 1090.1300; 1090.1370(c); 1090.1375(a), (b), (c), and (d); and 1090.1450(c).</P>
                            <STARS/>
                            <P>(31) ASTM D6667-21, Standard Test Method for Determination of Total Volatile Sulfur in Gaseous Hydrocarbons and Liquefied Petroleum Gases by Ultraviolet Fluorescence, approved April 1, 2021 (“ASTM D6667”); IBR approved for §§ 1090.1360(d); 1090.1375(c).</P>
                            <STARS/>
                            <P>(35) ASTM D6751-24, Standard Specification for Biodiesel Fuel Blend Stock (B100) for Middle Distillate Fuels, approved March 1, 2024 (“ASTM D6751”); IBR approved for § 1090.1350(b).</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart B—General Requirements and Provisions for Regulated Parties</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>12. Amend § 1090.100 by revising the introductory text and paragraph (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.100</SECTNO>
                            <SUBJECT>General provisions.</SUBJECT>
                            <P>This subpart provides an overview of the general requirements and provisions applicable to any regulated party under this part. A person who meets the definition of more than one type of regulated party must comply with the requirements applicable to each of those types of regulated parties. For example, a fuel manufacturer that also transports fuel must meet the requirements applicable to a fuel manufacturer and a distributor. A regulated party is required to comply with all applicable requirements of this part, regardless of whether they are identified in this subpart. Any person who produces, sells, transfers, supplies, dispenses, or distributes fuel, fuel additive, or regulated blendstock must comply with all applicable requirements.</P>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">Importers.</E>
                                 In addition to the requirements of paragraphs (a) through (c) of this section and §§ 1090.105 and 1090.155, an importer must also comply with subpart Q of this part.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>13. Amend § 1090.105 by revising paragraphs (a)(1), (a)(8), (b)(4), and (b)(8) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.105</SECTNO>
                            <SUBJECT>Fuel manufacturers.</SUBJECT>
                            <STARS/>
                            <P>(a) * * *</P>
                            <P>
                                (1) 
                                <E T="03">Producing compliant gasoline.</E>
                                 A gasoline manufacturer must produce or import gasoline that meets the standards in subpart C of this part and must comply with the ABT requirements of subpart H of this part.
                            </P>
                            <STARS/>
                            <P>
                                (8) 
                                <E T="03">Annual attestation engagement.</E>
                                 A gasoline manufacturer must submit annual attestation engagement reports to EPA under subpart S of this part.
                            </P>
                            <P>(b) * * *</P>
                            <P>
                                (4) 
                                <E T="03">Certification and designation.</E>
                                 (i) A diesel fuel or ECA marine fuel manufacturer must certify and designate the diesel fuel or ECA marine fuel they produce under subpart K of this part.
                            </P>
                            <P>(ii) A distillate global marine fuel manufacturer must designate the distillate global marine fuel they produce under subpart K of this part.</P>
                            <STARS/>
                            <P>
                                (8) 
                                <E T="03">Distillate global marine fuel manufacturers.</E>
                                 A distillate global marine fuel manufacturer does not need to comply with the requirements of paragraphs (b)(1), (2), (3), and (6) of this section for distillate global marine fuel that is exempt from the standards in subpart D of this part, as specified in § 1090.650.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <SECTION>
                        <SECTNO>§ 1090.110</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>14. Amend § 1090.110 by removing paragraph (c) and redesignating paragraph (d) as paragraph (c).</AMDPAR>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>15. Amend § 1090.130 by revising paragraphs (d), (f), and (g) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.130</SECTNO>
                            <SUBJECT>Certified butane blenders.</SUBJECT>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">PTDs.</E>
                                 On each occasion when a certified butane blender transfers custody of or title to any gasoline blended with certified butane, the transferor must provide to the transferee PTDs under subpart L of this part.
                            </P>
                            <STARS/>
                            <P>
                                (f) 
                                <E T="03">Survey.</E>
                                 A certified butane blender may participate in the applicable fuel surveys under subpart O of this part.
                            </P>
                            <P>
                                (g) 
                                <E T="03">Annual attestation engagement.</E>
                                 A certified butane blender must submit annual attestation engagement reports to EPA under subpart S of this part.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>16. Amend § 1090.140 by revising paragraphs (d), (f), and (g) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.140</SECTNO>
                            <SUBJECT>Certified pentane blenders.</SUBJECT>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">PTDs.</E>
                                 On each occasion when a certified pentane blender transfers custody of or title to any gasoline blended with certified pentane, the transferor must provide to the transferee PTDs under subpart L of this part.
                            </P>
                            <STARS/>
                            <P>
                                (f) 
                                <E T="03">Survey.</E>
                                 A certified pentane blender may participate in the applicable fuel surveys under subpart O of this part.
                            </P>
                            <P>
                                (g) 
                                <E T="03">Annual attestation engagement.</E>
                                 A certified pentane blender must submit annual attestation engagement reports to EPA under subpart S of this part.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>17. Amend § 1090.145 by revising paragraph (g) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.145</SECTNO>
                            <SUBJECT>Transmix processors.</SUBJECT>
                            <STARS/>
                            <P>
                                (g) 
                                <E T="03">Annual attestation engagement.</E>
                                 A transmix processor must submit annual attestation engagement reports to EPA under subpart S of this part.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>18. Amend § 1090.155 by revising paragraphs (a)(1), (b)(1), and (b)(3) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.155</SECTNO>
                            <SUBJECT>Fuel additive manufacturers.</SUBJECT>
                            <STARS/>
                            <P>(a) * * *</P>
                            <P>
                                (1) 
                                <E T="03">Gasoline additive standards.</E>
                                 A gasoline additive manufacturer must comply with the applicable requirements of subpart C of this part.
                            </P>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>
                                (1) 
                                <E T="03">Diesel fuel additive standards.</E>
                                 A diesel fuel additive manufacturer must comply with the applicable requirements of subpart D of this part.
                            </P>
                            <STARS/>
                            <P>
                                (3) 
                                <E T="03">PTDs.</E>
                                 On each occasion when a diesel fuel additive manufacturer transfers custody of or title to any diesel fuel additive, the transferor must provide to the transferee PTDs under subpart L of this part.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>19. Amend § 1090.160 by revising paragraphs (a) and (b) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.160</SECTNO>
                            <SUBJECT>Distributors, carriers, and resellers.</SUBJECT>
                            <STARS/>
                            <P>
                                (a) 
                                <E T="03">Gasoline and diesel fuel standards.</E>
                                 A distributor, carrier, or reseller must comply with the applicable requirements of subparts C and D of this part.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Registration.</E>
                                 A distributor or carrier must register with EPA under subpart I of this part if they are part of the 500 ppm LM diesel fuel distribution chain in a compliance plan submitted under § 1090.515(g).
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>20. Amend § 1090.165 by revising paragraphs (a) and (c) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.165</SECTNO>
                            <SUBJECT>Retailers and WPCs.</SUBJECT>
                            <STARS/>
                            <PRTPAGE P="4345"/>
                            <P>
                                (a) 
                                <E T="03">Gasoline and diesel fuel standards.</E>
                                 A retailer or WPC must comply with the applicable requirements of subparts C and D of this part.
                            </P>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Fuels produced through fuel dispensers.</E>
                                 A retailer or WPC that produces gasoline (
                                <E T="03">e.g.,</E>
                                 E15) through a fuel dispenser with anything other than PCG and DFE is also a blending manufacturer and must comply with the applicable requirements in § 1090.105.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>21. Amend § 1090.175 by revising paragraphs (c) and (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.175</SECTNO>
                            <SUBJECT>Auditors.</SUBJECT>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Attestation engagements.</E>
                                 An auditor must conduct audits under subpart S of this part.
                            </P>
                            <P>
                                (d) 
                                <E T="03">Independence requirements.</E>
                                 In order to perform an annual attestation engagement under subpart S of this part, an auditor must meet the independence requirements in § 1090.55 unless they are a certified internal auditor under § 1090.1800(b)(1)(i).
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>22. Amend § 1090.180 by revising paragraphs (a) and (c) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.180</SECTNO>
                            <SUBJECT>Pipeline operators.</SUBJECT>
                            <STARS/>
                            <P>
                                (a) 
                                <E T="03">Gasoline and diesel fuel standards.</E>
                                 A pipeline operator must comply with the applicable requirements of subparts C and D of this part.
                            </P>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Transmix requirements.</E>
                                 A pipeline operator must comply with all applicable requirements of subpart F of this part.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart C—Gasoline Standards</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>23. Amend § 1090.200 by revising paragraph (c)(2)(i) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.200</SECTNO>
                            <SUBJECT>Overview and general requirements.</SUBJECT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(2) * * *</P>
                            <P>(i) Importers that import gasoline by rail or truck using the provisions of § 1090.1610 to meet the alternative per-gallon standards of §§ 1090.205(d) and 1090.210(c).</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>24. Amend § 1090.210 by revising paragraph (c)(1) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.210</SECTNO>
                            <SUBJECT>Benzene standards.</SUBJECT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(1) An importer that imports gasoline by rail or truck under § 1090.1610 must comply with a benzene per-gallon standard of 0.62 volume percent instead of the standards specified in paragraphs (a) and (b) of this section.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>25. Revise and republish § 1090.215 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.215</SECTNO>
                            <SUBJECT>Gasoline RVP standards.</SUBJECT>
                            <P>Except as specified in subpart G of this part and paragraph (d) of this section, all gasoline designated as summer gasoline or located at any location in the United States during the summer season is subject to a maximum RVP per-gallon standard in this section.</P>
                            <P>
                                (a)(1) 
                                <E T="03">Federal 9.0 psi maximum RVP per-gallon standard.</E>
                                 Gasoline designated as summer gasoline or located at any location in the United States during the summer season must meet a maximum RVP per-gallon standard of 9.0 psi unless the gasoline is subject to one of the lower maximum RVP per-gallon standards specified in paragraphs (a)(2) through (5) of this section.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Federal 7.8 maximum RVP per-gallon standard.</E>
                                 (i) Except as specified in paragraph (a)(2)(ii) of this section, gasoline designated as 7.8 psi summer gasoline, or located in the following areas during the summer season, must meet a maximum RVP per-gallon standard of 7.8 psi:
                            </P>
                            <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s50,r25,r100">
                                <TTITLE>
                                    Table 1 to Paragraph 
                                    <E T="01">(a)(2)(i)</E>
                                    —Federal 7.8 
                                    <E T="01">psi</E>
                                     RVP Areas
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Area designation</CHED>
                                    <CHED H="1">State</CHED>
                                    <CHED H="1">Counties</CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">Denver-Boulder-Greeley-Ft. Collins-Loveland</ENT>
                                    <ENT>Colorado</ENT>
                                    <ENT>
                                        Adams Arapahoe, Boulder, Broomfield, Denver, Douglas, Jefferson, Larimer,
                                        <SU>1</SU>
                                         Weld.
                                        <SU>2</SU>
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Reno</ENT>
                                    <ENT>Nevada</ENT>
                                    <ENT>Washoe.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Portland</ENT>
                                    <ENT>Oregon</ENT>
                                    <ENT>Clackamas (only the Air Quality Maintenance Area), Multnomah (only the Air Quality Maintenance Area), Washington (only the Air Quality Maintenance Area).</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Salem</ENT>
                                    <ENT>Oregon</ENT>
                                    <ENT>Marion (only the Salem Area Transportation Study), Polk (only the Salem Area Transportation Study).</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Beaumont-Port Arthur</ENT>
                                    <ENT>Texas</ENT>
                                    <ENT>Hardin, Jefferson, Orange.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Salt Lake City</ENT>
                                    <ENT>Utah</ENT>
                                    <ENT>Davis, Salt Lake.</ENT>
                                </ROW>
                                <TNOTE>
                                    <SU>1</SU>
                                     That portion of Larimer County, CO that lies south of a line described as follows: Beginning at a point on Larimer County's eastern boundary and Weld County's western boundary intersected by 40 degrees, 42 minutes, and 47.1 seconds north latitude, proceed west to a point defined by the intersection of 40 degrees, 42 minutes, 47.1 seconds north latitude and 105 degrees, 29 minutes, and 40.0 seconds west longitude, thence proceed south on 105 degrees, 29 minutes, 40.0 seconds west longitude to the intersection with 40 degrees, 33 minutes and 17.4 seconds north latitude, thence proceed west on 40 degrees, 33 minutes, 17.4 seconds north latitude until this line intersects Larimer County's western boundary and Grand County's eastern boundary. (Includes part of Rocky Mtn. Nat. Park.)
                                </TNOTE>
                                <TNOTE>
                                    <SU>2</SU>
                                     That portion of Weld County, CO that lies south of a line described as follows: Beginning at a point on Weld County's eastern boundary and Logan County's western boundary intersected by 40 degrees, 42 minutes, 47.1 seconds north latitude, proceed west on 40 degrees, 42 minutes, 47.1 seconds north latitude until this line intersects Weld County's western boundary and Larimer County's eastern boundary.
                                </TNOTE>
                            </GPOTABLE>
                            <P>(ii) Gasoline designated as 9.0 psi summer gasoline may be located in the areas specified in table 1 to paragraph (a)(2)(i) of this section between May 1 and May 31.</P>
                            <P>
                                (3) 
                                <E T="03">RFG maximum RVP per-gallon standard.</E>
                                 Gasoline designated as Summer RFG or located in an RFG covered area during the summer season must meet a maximum RVP per-gallon standard of 7.4 psi.
                            </P>
                            <P>
                                (4) 
                                <E T="03">California gasoline.</E>
                                 Gasoline designated as California gasoline or used in areas subject to the California reformulated gasoline regulations must comply with those regulations under Title 13, California Code of Regulations, sections 2250-2273.5.
                            </P>
                            <P>
                                (5) 
                                <E T="03">SIP-controlled gasoline.</E>
                                 Gasoline designated as SIP-controlled gasoline or used in areas subject to a SIP-approved state fuel rule that requires an RVP of less than 9.0 psi must meet the requirements of the federally approved SIP.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Ethanol 1.0 psi waiver.</E>
                                 (1) Except as specified in paragraph (b)(3) of this section, any gasoline subject to a federal 9.0 psi or 7.8 psi RVP standard in paragraph (a)(1) or (2) of this section that meets the requirements of paragraph (b)(2) of this section is not in violation of this section if its RVP does 
                                <PRTPAGE P="4346"/>
                                not exceed the applicable standard by more than 1.0 psi.
                            </P>
                            <P>(2) To qualify for the special regulatory treatment specified in paragraph (b)(1) of this section, gasoline must meet the applicable RVP standard in paragraph (a)(1) or (2) of this section prior to the addition of ethanol and must contain ethanol at a concentration of at least 9 volume percent and no more than 10 volume percent.</P>
                            <P>(3)(i) RFG and SIP-controlled gasoline that does not allow for the ethanol 1.0 psi waiver does not qualify for the special regulatory treatment specified in paragraph (b)(1) of this section.</P>
                            <P>(ii) Gasoline subject to the 9.0 psi RVP standard in paragraph (a)(1) of this section in the following areas is excluded from the special regulatory treatment specified in paragraph (b)(1) of this section:</P>
                            <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,r50,r50">
                                <TTITLE>
                                    Table 2 to Paragraph (
                                    <E T="01">b</E>
                                    )(3)(
                                    <E T="01">ii</E>
                                    )—Areas Excluded From the Ethanol 1.0 
                                    <E T="01">psi</E>
                                     Waiver
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">State</CHED>
                                    <CHED H="1">Counties</CHED>
                                    <CHED H="1">Effective date</CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">Illinois</ENT>
                                    <ENT>All</ENT>
                                    <ENT>April 28, 2025.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Iowa</ENT>
                                    <ENT>All</ENT>
                                    <ENT>April 28, 2025.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Minnesota</ENT>
                                    <ENT>All</ENT>
                                    <ENT>April 28, 2025.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Missouri</ENT>
                                    <ENT>All</ENT>
                                    <ENT>April 28, 2025.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Nebraska</ENT>
                                    <ENT>All</ENT>
                                    <ENT>April 28, 2025.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Ohio</ENT>
                                    <ENT>All</ENT>
                                    <ENT>April 28, 2025.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">South Dakota</ENT>
                                    <ENT>All</ENT>
                                    <ENT>April 28, 2025.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Wisconsin</ENT>
                                    <ENT>All</ENT>
                                    <ENT>April 28, 2025.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                (c) 
                                <E T="03">Gasoline subject to more than one RVP standard.</E>
                                 Gasoline located in an area of the United States subject to more than one RVP standard specified in paragraphs (a)(1) through (5) of this section must meet the most stringent standard.
                            </P>
                            <P>
                                (d) 
                                <E T="03">Exceptions.</E>
                                 The RVP standard in paragraph (a) of this section for the area in which the gasoline is located does not apply to that gasoline if the person(s) who produced, imported, sold, offered for sale, distributed, offered to distribute, supplied, offered for supply, dispensed, stored, transported, or introduced the gasoline into commerce can demonstrate one of the following:
                            </P>
                            <P>(1) The gasoline is designated as winter gasoline and was not sold, offered for sale, supplied, offered for supply, dispensed, or introduced into commerce for use during the summer season and was not delivered to any retail outlet or WPC during the summer season.</P>
                            <P>(2) The gasoline is designated as summer gasoline for use in an area other than the area in which it is located and was not sold, offered for sale, supplied, offered for supply, dispensed, or introduced into commerce in the area in which the gasoline is located. In this case, the standard that applies to the gasoline is the standard applicable to the area for which the gasoline is designated.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>26. Amend § 1090.220 by revising paragraph (e) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.220</SECTNO>
                            <SUBJECT>RFG standards.</SUBJECT>
                            <STARS/>
                            <P>
                                (e) 
                                <E T="03">Certified butane and certified pentane blending limitation.</E>
                                 Certified butane and certified pentane must not be blended with Summer RFG or Summer RBOB under § 1090.1320(b).
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>27. Revise and republish § 1090.230 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.230</SECTNO>
                            <SUBJECT>Limitation on use of gasoline-ethanol blends.</SUBJECT>
                            <P>
                                (a) No person may sell, introduce, cause, or permit the sale or introduction of gasoline containing greater than 10 volume percent ethanol (
                                <E T="03">e.g.,</E>
                                 E15) into any model year 2000 or older light-duty gasoline motor vehicle, any heavy-duty gasoline motor vehicle or engine, any highway or off-highway motorcycle, or any gasoline-powered nonroad engine, vehicle, or equipment.
                            </P>
                            <P>(b) Paragraph (a) of this section does not prohibit a person from producing, selling, introducing, causing, or allowing the sale or introduction of gasoline containing greater than 10 volume percent ethanol into any flex-fuel vehicle or flex-fuel engine.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>28. Amend § 1090.265 by revising paragraph (c) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.265</SECTNO>
                            <SUBJECT>Gasoline additive standards.</SUBJECT>
                            <STARS/>
                            <P>(c) Any person who blends any fuel additive that does not meet the requirements of paragraphs (a) and (b) of this section is a gasoline manufacturer and must comply with all the requirements applicable to a gasoline manufacturer under this part.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>29. Amend § 1090.285 by revising the introductory text to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.285</SECTNO>
                            <SUBJECT>RFG covered areas.</SUBJECT>
                            <P>The RFG covered areas are as follows:</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>30. Amend § 1090.290 by revising paragraph (d)(4) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.290</SECTNO>
                            <SUBJECT>Changes to RFG covered areas and procedures for opting out of RFG.</SUBJECT>
                            <STARS/>
                            <P>(d) * * *</P>
                            <P>
                                (4) EPA will publish a document in the 
                                <E T="04">Federal Register</E>
                                 announcing the approval of an RFG opt-out request and its effective date.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>31. Amend § 1090.295 by revising paragraph (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.295</SECTNO>
                            <SUBJECT>Procedures for relaxing the federal 7.8 psi RVP standard.</SUBJECT>
                            <STARS/>
                            <P>
                                (d) EPA will publish a document in the 
                                <E T="04">Federal Register</E>
                                 announcing the approval of any federal 7.8 psi gasoline relaxation request and its effective date.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart D—Diesel Fuel and ECA Marine Fuel Standards</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>32. Amend § 1090.300 by revising paragraph (h) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.300</SECTNO>
                            <SUBJECT>Overview and general requirements.</SUBJECT>
                            <STARS/>
                            <P>(h) No person may introduce used motor oil, or used motor oil blended with diesel fuel, into the fuel system of model year 2007 or later diesel fuel motor vehicles or engines or model year 2011 or later nonroad diesel fuel vehicles or engines (not including locomotive or marine engines).</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>33. Amend § 1090.310 by revising paragraph (c) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.310</SECTNO>
                            <SUBJECT>Diesel fuel additives standards.</SUBJECT>
                            <STARS/>
                            <P>(c) The provisions of this section do not apply to additives used in 500 ppm LM diesel fuel or ECA marine fuel.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>34. Revise and republish § 1090.315 to read as follows:</AMDPAR>
                        <SECTION>
                            <PRTPAGE P="4347"/>
                            <SECTNO>§ 1090.315</SECTNO>
                            <SUBJECT>Heating oil, kerosene, ECA marine fuel, and jet fuel provisions.</SUBJECT>
                            <P>Heating oil, kerosene, ECA marine fuel, or jet fuel must not be sold for use in motor vehicles or nonroad equipment and are not subject to the ULSD standards in § 1090.305 unless it is also designated as ULSD under § 1090.1015(a).</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>35. Amend § 1090.325 by revising paragraph (c)(1) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.325</SECTNO>
                            <SUBJECT>ECA marine fuel standards.</SUBJECT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(1) Residual fuel made available for use in a steamship or C3 marine vessel if the U.S. government exempts or excludes the vessel from MARPOL Annex VI fuel standards. Diesel fuel and other distillate fuel used in diesel fuel engines operated on such vessels is subject to the standards in this section instead of the standards in § 1090.305 or § 1090.320.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart F—Transmix and Pipeline Interface Provisions</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>36. Amend § 1090.500 by revising paragraph (c)(3)(ii) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.500</SECTNO>
                            <SUBJECT>Gasoline produced from blending transmix into PCG.</SUBJECT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(3) * * *</P>
                            <P>(ii) A letter signed by the RCO, or their delegate, stating that the information contained in the submission is true to the best of their belief must accompany the petition.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>37. Amend § 1090.510 by revising the section heading to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.510</SECTNO>
                            <SUBJECT>Diesel fuel and distillate fuel produced from TDP.</SUBJECT>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>38. Amend § 1090.515 by revising paragraph (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.515</SECTNO>
                            <SUBJECT>500 ppm LM diesel fuel produced from TDP.</SUBJECT>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">Use restrictions.</E>
                                 500 ppm LM diesel fuel may only be used in locomotive or marine engines that are not required to use ULSD under 40 CFR 1033.815 or 40 CFR 1042.660, respectively. No person may use 500 ppm LM diesel fuel in locomotive or marine engines that are required to use ULSD, in any other nonroad vehicle or engine, or in any motor vehicle engine.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>39. Amend § 1090.520 by revising paragraph (b) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.520</SECTNO>
                            <SUBJECT>Handling practices for pipeline interface that is not transmix.</SUBJECT>
                            <STARS/>
                            <P>(b) During the summer season, a pipeline operator must not cut pipeline interface from two batches of gasoline subject to different RVP standards that are shipped adjacent to each other by pipeline into the batch of gasoline that is subject to the more stringent RVP standard. For example, during the summer season, a pipeline operator must not cut pipeline interface from a batch of RFG shipped adjacent to a batch of conventional gasoline into the batch of RFG.</P>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart G—Exemptions</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>40. The heading of subpart G is revised to read as set forth above.</AMDPAR>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>41. Revise and republish § 1090.605 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.605</SECTNO>
                            <SUBJECT>Exemptions for national security and military use.</SUBJECT>
                            <P>(a) Fuel, fuel additive, or regulated blendstock that is produced, imported, sold, offered for sale, supplied, offered for supply, stored, dispensed, or transported for use in the following tactical military vehicles, engines, or equipment, including locomotive or marine engines, is exempt from the standards specified in this part:</P>
                            <P>(1) Tactical military vehicles, engines, or equipment, including locomotive or marine engines, that have an EPA national security exemption from the emission standards in this chapter. See 40 CFR part 85, subpart R, and 40 CFR 1068.225.</P>
                            <P>
                                (2) Tactical military vehicles, engines, or equipment, including locomotive or marine engines, that are not subject to a national security exemption from vehicle or engine emissions standards specified in paragraph (a)(1) of this section but, for national security purposes (
                                <E T="03">e.g.,</E>
                                 for purposes of readiness, including training, for deployment overseas), need to be fueled on the same fuel as the vehicles, engines, or equipment that EPA has granted such a national security exemption.
                            </P>
                            <P>(b) The exempt fuel, fuel additive, or regulated blendstock must meet all the following requirements:</P>
                            <P>(1) The fuel, fuel additive, or regulated blendstock must be accompanied by PTDs that meet the requirements of subpart L of this part.</P>
                            <P>(2) The fuel, fuel additive, or regulated blendstock must be segregated from non-exempt fuel, fuel additive, or regulated blendstock at all points in the distribution system.</P>
                            <P>(3) The fuel, fuel additive, or regulated blendstock must be dispensed from a fuel dispenser stand, fueling truck, or tank that is labeled with the appropriate designation of the exempt fuel, fuel additive, or regulated blendstock.</P>
                            <P>(4) The fuel, fuel additive, or regulated blendstock must not be used in any vehicles, engines, or equipment, including locomotive or marine engines, other than those specified in paragraph (a) of this section.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>42. Revise and republish § 1090.610 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.610</SECTNO>
                            <SUBJECT>Exemptions for temporary research, development, and testing.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Requests for an exemption.</E>
                                 (1) Any person may receive an exemption from the standards specified in this part for fuel, fuel additive, or regulated blendstock used for research, development, or testing (“R&amp;D”) purposes under paragraph (b) of this section by submitting the information specified in paragraph (c) of this section as specified in § 1090.10 and meeting the requirements of paragraph (d) of this section.
                            </P>
                            <P>(2) Any person who performs emissions certification testing for a motor vehicle or motor vehicle engine under 42 U.S.C. 7525 or nonroad engine or nonroad vehicle under 42 U.S.C. 7546 is exempt from the standards specified in this part for the fuel, fuel additive, or regulated blendstock they use for emissions certification testing if they have an exemption under 40 CFR parts 85 and 86 to perform such testing.</P>
                            <P>(3) Any person who performs research, development, or testing of a fuel additive is exempt from the standards specified in this part for such fuel additive if the fuel additive is exempt under 40 CFR 79.4(b)(2).</P>
                            <P>
                                (b) 
                                <E T="03">Criteria for an R&amp;D exemption.</E>
                                 For an R&amp;D exemption to be granted, the person requesting an exemption must do all the following:
                            </P>
                            <P>(1) Demonstrate that the exemption is for an appropriate R&amp;D purpose.</P>
                            <P>(2) Demonstrate that an exemption is necessary.</P>
                            <P>(3) Design an R&amp;D program that is reasonable in scope.</P>
                            <P>(4) Have a degree of control consistent with the purpose of the R&amp;D program and EPA's monitoring requirements.</P>
                            <P>(5) Meet the requirements specified in paragraphs (c) and (d) of this section.</P>
                            <P>
                                (c) 
                                <E T="03">Information required to be submitted.</E>
                                 To aid in demonstrating each of the elements in paragraph (b) of this section, the person requesting an exemption must include, at a minimum, all the following information:
                            </P>
                            <P>
                                (1) A concise statement of the purpose of the R&amp;D program demonstrating that 
                                <PRTPAGE P="4348"/>
                                the R&amp;D program has an appropriate R&amp;D purpose.
                            </P>
                            <P>(2) An explanation of why the stated purpose of the R&amp;D program is unable to be achieved in a practicable manner without meeting the requirements of this part.</P>
                            <P>(3) A demonstration of the reasonableness of the scope of the R&amp;D program, including all the following:</P>
                            <P>(i) An estimate of the R&amp;D program's duration in time (including beginning and ending dates).</P>
                            <P>(ii) An estimate of the maximum number of vehicles, engines, and equipment involved in the program, and the number of miles and engine hours that will be accumulated on each.</P>
                            <P>(iii) The manner in which the information on the vehicles, engines, or equipment used in the R&amp;D program will be recorded and made available to EPA upon request.</P>
                            <P>(iv) An estimate of the volume of fuel, fuel additive, or regulated blendstock expected to be used in the R&amp;D program that does not comply with the requirements of this part, as applicable.</P>
                            <P>(v) A list of how all applicable standards of this part would or would not apply to the fuel, fuel additive, or regulated blendstock expected to be used in the R&amp;D program.</P>
                            <P>(4) With regard to control, a demonstration that the R&amp;D program affords EPA a monitoring capability, including all the following:</P>
                            <P>(i) A description of the technical and operational aspects of the R&amp;D program.</P>
                            <P>(ii) The site of the R&amp;D program (including facility name, street address, city, county, state, and ZIP code).</P>
                            <P>(iii) The manner in which information on the vehicles, engines, or equipment used in the R&amp;D program will be recorded and made available to EPA upon request.</P>
                            <P>(iv) The manner in which information on the fuel, fuel additive, or regulated blendstock used in the R&amp;D program (including quantity, properties, name, address, telephone number, and contact person of the supplier, and the date received from the supplier) will be recorded and made available to EPA upon request.</P>
                            <P>(v) The manner in which the person will ensure that fuel, fuel additive, or regulated blendstock used in the R&amp;D program will be segregated from non-exempt fuel, fuel additive, or regulated blendstock and how fuel dispensers will be labeled to ensure that fuel, fuel additive, or regulated blendstock used in the R&amp;D program is not dispensed for use in motor vehicles or nonroad engines, vehicles, or equipment, including locomotive or marine engines, that are not part of the R&amp;D program.</P>
                            <P>(vi) The name, business address, telephone number, and title of the person in the organization requesting an exemption from whom further information on the application may be obtained.</P>
                            <P>(vii) The name, business address, telephone number, and title of the person in the organization requesting an exemption who is responsible for recording and making available the information specified in this paragraph (c), and the location where such information will be maintained.</P>
                            <P>(viii) Any other information requested by EPA to determine whether the R&amp;D program satisfies the criteria in paragraph (b) of this section.</P>
                            <P>
                                (d) 
                                <E T="03">Additional requirements.</E>
                                 (1) Fuel, fuel additive, or regulated blendstock used in the R&amp;D program must meet all the following requirements:
                            </P>
                            <P>(i) The fuel, fuel additive, or regulated blendstock must be accompanied by PTDs that meet the requirements of subpart L of this part.</P>
                            <P>(ii) The fuel, fuel additive, or regulated blendstock must be designated as exempt fuel, fuel additive, or regulated blendstock by the fuel, fuel additive, or regulated blendstock manufacturer or supplier, as applicable.</P>
                            <P>(iii) The fuel, fuel additive, or regulated blendstock must be segregated from non-exempt fuel, fuel additive, or regulated blendstock at all points in the distribution system.</P>
                            <P>(iv) The fuel, fuel additive, or regulated blendstock must not be sold, distributed, offered for sale or distribution, dispensed, supplied, offered for supply, transported to or from, or stored by a retail outlet or WPC facility, unless the WPC facility is associated with the R&amp;D program that uses the fuel, fuel additive, or regulated blendstock.</P>
                            <P>(2) At the completion of the R&amp;D program, any emission control systems or elements of design that are damaged or rendered inoperative must be replaced on vehicles, engines, or equipment remaining in service or the responsible person will be liable for a violation of 42 U.S.C. 7522(a)(3), unless sufficient evidence is supplied that the emission controls or elements of design were not damaged.</P>
                            <P>
                                (e) 
                                <E T="03">Approval of exemption.</E>
                                 EPA may grant an R&amp;D exemption upon a demonstration that the requirements of this section have been met. The R&amp;D exemption approval may include such terms and conditions as EPA determines necessary to monitor the exemption and to carry out the purposes of this part, including restoration of emission control systems.
                            </P>
                            <P>(1) The volume of fuel, fuel additive, or regulated blendstock used in the R&amp;D program must not exceed the amount estimated in paragraph (c)(3)(iv) of this section, unless EPA grants an approval for a greater amount.</P>
                            <P>(2) Any R&amp;D exemption granted under this section will expire at the completion of the R&amp;D program or 1 year from the date of approval, whichever occurs first, and may only be extended upon re-application consistent with the requirements of this section.</P>
                            <P>(3) If any information required in paragraph (c) of this section changes after approval of the R&amp;D exemption, the responsible person must notify EPA in writing immediately.</P>
                            <P>
                                (f) 
                                <E T="03">Notification of completion.</E>
                                 Any person with an approved R&amp;D exemption under this section must notify EPA in writing within 30 days after completion of the R&amp;D program.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>43. Revise and republish § 1090.615 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.615</SECTNO>
                            <SUBJECT>Exemptions for racing and aviation.</SUBJECT>
                            <P>Fuel, fuel additive, or regulated blendstock that is used in aircraft, or is used in racing vehicles or racing boats in sanctioned racing events, is exempt from the standards in subparts C and D of this part if all the following requirements are met:</P>
                            <P>(a) The fuel, fuel additive, or regulated blendstock must be identified on PTDs and on any fuel dispenser from which the fuel, fuel additive, or regulated blendstock is dispensed as restricted for use either in aircraft or in racing motor vehicles or racing boats that are used only in sanctioned racing events.</P>
                            <P>(b) The fuel, fuel additive, or regulated blendstock must be segregated from non-exempt fuel, fuel additive, or regulated blendstock at all points in the distribution system.</P>
                            <P>(c) The fuel, fuel additive, or regulated blendstock must not made available for use as gasoline or diesel fuel subject to the standards in subpart C or D of this part, respectively, or dispensed for use in motor vehicles or nonroad engines, vehicles, or equipment, including locomotive or marine engines, except for those used only in aircraft or in sanctioned racing events.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>44. Revise and republish § 1090.620 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.620</SECTNO>
                            <SUBJECT>Exemptions for Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.</SUBJECT>
                            <P>
                                Fuel that is produced, imported, sold, offered for sale, supplied, offered for supply, stored, dispensed, or 
                                <PRTPAGE P="4349"/>
                                transported for use in the territories of Guam, American Samoa, or the Commonwealth of the Northern Mariana Islands, is exempt from the standards in subparts C and D of this part if all the following requirements are met:
                            </P>
                            <P>(a) The fuel must be designated by the fuel manufacturer as gasoline, diesel fuel, or ECA marine fuel for use only in Guam, American Samoa, or the Commonwealth of the Northern Mariana Islands.</P>
                            <P>(b) The fuel must be used only in Guam, American Samoa, or the Commonwealth of the Northern Mariana Islands.</P>
                            <P>(c) The fuel must be accompanied by PTDs that meet the requirements of subpart L of this part.</P>
                            <P>(d) The fuel must be segregated from non-exempt fuel at all points from the point the fuel is designated as exempt fuel for use only in Guam, American Samoa, or the Commonwealth of the Northern Mariana Islands, while the exempt fuel is in the United States (including an ECA or an ECA associated area under 40 CFR 1043.20) but outside these territories.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>45. Amend § 1090.625 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraphs (b)(5) and (c)(1);</AMDPAR>
                        <AMDPAR>b. Revising and republishing paragraph (d)(2); and</AMDPAR>
                        <AMDPAR>c. Revising paragraph (e).</AMDPAR>
                        <P>The revisions and republication read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.625</SECTNO>
                            <SUBJECT>Exemptions for California gasoline and diesel fuel.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(5) Each transferor and transferee of California gasoline or diesel fuel produced outside the state of California must maintain copies of PTDs as specified in subpart M of this part.</P>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(1) Comply with the sampling and testing provisions specified in subpart N of this part, as applicable.</P>
                            <STARS/>
                            <P>(d) * * *</P>
                            <P>(2) Redesignates the California gasoline as gasoline under this part without recertification and does all the following:</P>
                            <P>(i) Demonstrates that the gasoline meets all applicable requirements for California reformulated gasoline under Title 13 of the California Code of Regulations.</P>
                            <P>(ii) Properly redesignates the gasoline under § 1090.1010(b)(2)(vi).</P>
                            <P>(iii) Generates PTDs under subpart L of this part.</P>
                            <P>(iv) Keeps records under subpart M of this part.</P>
                            <P>(v) Does not include the redesignated California gasoline in their average standard compliance calculations.</P>
                            <P>
                                (e) 
                                <E T="03">California diesel fuel used outside of California.</E>
                                 California diesel fuel may be used in any part of the United States outside of the state of California without recertification if the manufacturer or distributor of the California diesel fuel redesignates the California diesel fuel as diesel fuel under this part and does all the following:
                            </P>
                            <P>(1) Demonstrates that the diesel fuel meets all applicable requirements for California diesel fuel under Title 13 of the California Code of Regulations.</P>
                            <P>(2) Properly redesignates the diesel fuel under § 1090.1015(b)(3)(iii).</P>
                            <P>(3) Generates PTDs under subpart L of this part.</P>
                            <P>(4) Keeps records under subpart M of this part.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>46. Revise and republish § 1090.630 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.630</SECTNO>
                            <SUBJECT>Exemptions for Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands summer gasoline.</SUBJECT>
                            <P>Summer gasoline that is produced, imported, sold, offered for sale, supplied, offered for supply, stored, dispensed, or transported for use in Alaska, Hawaii, Puerto Rico, or the U.S. Virgin Islands is exempt from the RVP standards in § 1090.215 if all the following requirements are met:</P>
                            <P>(a) The summer gasoline must be designated by the fuel manufacturer as summer gasoline for use only in Alaska, Hawaii, Puerto Rico, or the U.S. Virgin Islands.</P>
                            <P>(b) The summer gasoline must be used only in Alaska, Hawaii, Puerto Rico, or the U.S. Virgin Islands.</P>
                            <P>(c) The summer gasoline must be accompanied by PTDs that meet the requirements of subpart L of this part.</P>
                            <P>(d) The summer gasoline must be segregated from non-exempt gasoline at all points from the point the summer gasoline is designated as exempt fuel for use only in Alaska, Hawaii, Puerto Rico, or the U.S. Virgin Islands, while the exempt summer gasoline is in the United States but outside these states or territories.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>47. Amend § 1090.635 by revising the section heading to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.635</SECTNO>
                            <SUBJECT>Exemptions for refinery extreme, unusual, and unforeseen hardship.</SUBJECT>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>48. Revise and republish § 1090.640 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.640</SECTNO>
                            <SUBJECT>Exemptions for E85.</SUBJECT>
                            <P>(a) Gasoline that is used to produce E85 is exempt from the gasoline deposit control requirements in § 1090.260.</P>
                            <P>(b) Any person who uses the exemption in paragraph (a) of this section must keep records to demonstrate that such exempt gasoline was used to produce E85 and was not distributed from a terminal for use as gasoline.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>49. Revise and republish § 1090.645 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.645</SECTNO>
                            <SUBJECT>Exemptions for exports of fuel, fuel additive, and regulated blendstock.</SUBJECT>
                            <P>(a) Fuel, fuel additive, or regulated blendstock that is exported for sale outside of the United States is exempt from the standards in subparts C and D of this part if all the following requirements are met:</P>
                            <P>(1) The fuel, fuel additive, or regulated blendstock must be designated for export by the fuel manufacturer, fuel additive manufacturer, or regulated blendstock producer.</P>
                            <P>(2) The fuel, fuel additive, or regulated blendstock designated for export must be accompanied by PTDs that meet the requirements of subpart L of this part.</P>
                            <P>(3) The fuel manufacturer, fuel additive manufacturer, or regulated blendstock producer must keep records that demonstrate that the fuel, fuel additive, or regulated blendstock was ultimately exported from the United States.</P>
                            <P>(4) The fuel, fuel additive, or regulated blendstock must be segregated from non-exempt fuel, fuel additive, or regulated blendstock at all points from the point the fuel, fuel additive, or regulated blendstock is designated for export to the point where it is ultimately exported from the United States.</P>
                            <P>(b) Fuel, fuel additive, or regulated blendstock certified and designated for export may be certified for use in the United States if all the applicable requirements of this part are met.</P>
                            <P>(c) Any fuel dispensed from a retail outlet within the geographic boundaries of the United States is not exempt under this section.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>50. Revise and republish § 1090.650 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.650</SECTNO>
                            <SUBJECT>Exemptions for distillate global marine fuel.</SUBJECT>
                            <P>(a) Distillate global marine fuel that is produced, imported, sold, offered for sale, supplied, offered for supply, stored, dispensed, or transported for use in steamships or Category 3 marine vessels is exempt from the standards in subpart D of this part when operating outside of ECA boundaries if all the following requirements are met:</P>
                            <P>
                                (1) The fuel must not exceed 0.50 weight percent sulfur (5,000 ppm).
                                <PRTPAGE P="4350"/>
                            </P>
                            <P>(2) The fuel must be accompanied by PTDs that meet the requirements of subpart L of this part.</P>
                            <P>(3) The fuel must be designated as distillate global marine fuel.</P>
                            <P>(4) The fuel must be segregated from non-exempt fuel at all points in the distribution system.</P>
                            <P>(5) The fuel must not be used in vehicles, engines, or equipment other than in steamships or Category 3 marine vessels.</P>
                            <P>(b)(1) Fuel that does not meet the requirements specified in paragraph (a) of this section is subject to the standards, requirements, and prohibitions that apply for ULSD under this part.</P>
                            <P>(2) Any person who produces, imports, sells, offers for sale, supplies, offers for supply, stores, dispenses, or transports distillate global marine fuel without meeting the applicable recordkeeping requirements of subpart M of this part must not claim the fuel is exempt from the standards, requirements, and prohibitions that apply for ULSD under this part.</P>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart H—Averaging, Banking, and Trading Provisions</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>51. Amend § 1090.700 by:</AMDPAR>
                        <AMDPAR>a. Revising and republishing paragraphs (a) and (b); and</AMDPAR>
                        <AMDPAR>b. Revising paragraphs (e)(7) and (8).</AMDPAR>
                        <P>The revisions and republications read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.700</SECTNO>
                            <SUBJECT>Compliance with average standards.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Compliance with the sulfur average standard.</E>
                                 For each of their facilities, a gasoline manufacturer must demonstrate compliance with the sulfur average standard in § 1090.205(a) by using the equations in paragraphs (a)(1) and (2) of this section.
                            </P>
                            <P>
                                (1) 
                                <E T="03">Compliance sulfur value calculation.</E>
                                 (i) The compliance sulfur value is determined as follows:
                            </P>
                            <P>Equation 1 to paragraph (a)(1)(i)</P>
                            <FP SOURCE="FP-2">
                                CSV
                                <E T="52">y</E>
                                 = S
                                <E T="52">tot,y</E>
                                 + D
                                <E T="52">s,(y−1)</E>
                                 + D
                                <E T="52">S_Oxy_Total,y</E>
                                 −C
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    CSV
                                    <E T="52">y</E>
                                     = Compliance sulfur value for compliance period y, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">tot,y</E>
                                     = Total amount of sulfur produced during compliance period y, per paragraph (a)(1)(ii) of this section, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Ds,
                                    <E T="52">(y−1)</E>
                                     = Sulfur deficit from compliance period y-1, per § 1090.715(a)(1), in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">S_Oxy_Total,y</E>
                                     = Total sulfur deficit from downstream BOB recertification during compliance period y, per § 1090.740(b)(1), in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    C
                                    <E T="52">S</E>
                                     = Sulfur credits used by the gasoline manufacturer, per § 1090.720, in ppm-gallons.
                                </FP>
                            </EXTRACT>
                            <P>(ii) The total amount of sulfur produced is determined as follows:</P>
                            <P>Equation 2 to paragraph (a)(1)(ii)</P>
                            <GPH SPAN="1" DEEP="26">
                                <GID>ER15JA25.014</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">tot,y</E>
                                     = Total amount of sulfur produced during compliance period y, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">i</E>
                                     = Volume of gasoline produced or imported in batch i, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">i</E>
                                     = Sulfur content of batch i, in ppm.
                                </FP>
                                <FP SOURCE="FP-2">i = Individual batch of gasoline produced or imported during the compliance period.</FP>
                                <FP SOURCE="FP-2">n = Number of batches of gasoline produced or imported during the compliance period.</FP>
                                <P>
                                    If the calculation of S
                                    <E T="52">tot,y</E>
                                     results in a negative number, replace it with zero.
                                </P>
                            </EXTRACT>
                            <P>
                                (2) 
                                <E T="03">Sulfur compliance calculation.</E>
                                 (i) Compliance with the sulfur average standard in § 1090.205(a) is achieved if the following equation is true:
                            </P>
                            <P>Equation 3 to paragraph (a)(2)(i)</P>
                            <FP SOURCE="FP-2">
                                CSV
                                <E T="52">y</E>
                                 ≤ V
                                <E T="52">tot</E>
                                 · S
                                <E T="52">std</E>
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    CSV
                                    <E T="52">y</E>
                                     = Compliance sulfur value for compliance period y, per paragraph (a)(1)(i) of this section, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">std</E>
                                     = Gasoline sulfur average standard, per § 1090.205(a), in ppm.
                                </FP>
                            </EXTRACT>
                            <P>(ii) Compliance with the sulfur average standard in § 1090.205(a) is not achieved if a deficit is incurred two or more consecutive years. A gasoline manufacturer incurs a deficit under § 1090.715 if the following equation is true:</P>
                            <P>Equation 4 to paragraph (a)(2)(ii)</P>
                            <FP SOURCE="FP-2">
                                CSV
                                <E T="52">y</E>
                                 &gt; V
                                <E T="52">tot</E>
                                 · S
                                <E T="52">std</E>
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    CSV
                                    <E T="52">y</E>
                                     = Compliance sulfur value for compliance period y, per paragraph (a)(1)(i) of this section, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">std</E>
                                     = Sulfur average standard, per § 1090.205(a), in ppm.
                                </FP>
                            </EXTRACT>
                            <P>
                                (b) 
                                <E T="03">Compliance with the benzene average standards.</E>
                                 For each of their facilities, a gasoline manufacturer must demonstrate compliance with the benzene average standard in § 1090.210(a) by using the equations in paragraphs (b)(1) and (2) of this section and with the maximum benzene average standard in § 1090.210(b) by using the equations in paragraphs (b)(3) and (4) of this section.
                            </P>
                            <P>
                                (1) 
                                <E T="03">Compliance benzene value calculation.</E>
                                 (i) The compliance benzene value is determined as follows:
                            </P>
                            <P>Equation 5 to paragraph (b)(1)(i)</P>
                            <FP SOURCE="FP-2">
                                CBV
                                <E T="52">y</E>
                                 = Bz
                                <E T="52">tot,y</E>
                                 + D
                                <E T="52">BZ,(y−1)</E>
                                 + D
                                <E T="52">BZ_OXy__Total,y</E>
                                 − C
                                <E T="52">BZ</E>
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    CBV
                                    <E T="52">y</E>
                                     = Compliance benzene value for compliance period y, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">tot,y</E>
                                     = Total amount of benzene produced during compliance period y, per paragraph (b)(1)(ii) of this section, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">Bz,(y−1)</E>
                                     = Benzene deficit from compliance period y−1, per § 1090.715(a)(2), in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">Bz_Oxy_Total,y</E>
                                     = Total benzene deficit from downstream BOB recertification during compliance period y, per § 1090.740(b)(3), in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    C
                                    <E T="52">Bz</E>
                                     = Benzene credits used by the gasoline manufacturer, per § 1090.720, in benzene gallons.
                                </FP>
                            </EXTRACT>
                            <P>(ii) The total amount of benzene produced is determined as follows:</P>
                            <P>Equation 6 to paragraph (b)(1)(ii)</P>
                            <GPH SPAN="1" DEEP="43">
                                <GID>ER15JA25.015</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">tot,y</E>
                                     = Total amount of benzene produced during compliance period y, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">i</E>
                                     = Volume of gasoline produced or imported in batch i, in gallons.
                                </FP>
                                <FP SOURCE="FP-2"/>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">i</E>
                                     = Benzene content of batch i, in volume percent.
                                </FP>
                                <FP SOURCE="FP-2">i = Individual batch of gasoline produced or imported during the compliance period.</FP>
                                <FP SOURCE="FP-2">n = Number of batches of gasoline produced or imported during the compliance period.</FP>
                                <FP SOURCE="FP-2">
                                    If the calculation of Bz
                                    <E T="52">tot,y</E>
                                     results in a negative number, replace it with zero.
                                </FP>
                            </EXTRACT>
                            <P>
                                (2) 
                                <E T="03">Benzene average compliance calculation.</E>
                                 (i) Compliance with the benzene average standard in § 1090.210(a) is achieved if the following equation is true:
                            </P>
                            <P>Equation 7 to paragraph (b)(2)(i)</P>
                            <GPH SPAN="1" DEEP="26">
                                <GID>ER15JA25.016</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    CBV
                                    <E T="52">y</E>
                                     = Compliance benzene value for compliance period y, per paragraph (b)(1)(i) of this section, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">avg_std</E>
                                     = Benzene average standard, per § 1090.210(a), in volume percent.
                                </FP>
                            </EXTRACT>
                            <P>(ii) Compliance with the benzene average standard in § 1090.210(a) is not achieved if a deficit is incurred two or more consecutive years. A gasoline manufacturer incurs a deficit under § 1090.715 if the following equation is true:</P>
                            <P>Equation 8 to paragraph (b)(2)(ii)</P>
                            <GPH SPAN="1" DEEP="26">
                                <PRTPAGE P="4351"/>
                                <GID>ER15JA25.017</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    CBV
                                    <E T="52">y</E>
                                     = Compliance benzene value for compliance period y, per paragraph (b)(1)(i) of this section, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">avg_std</E>
                                     = Benzene average standard, per § 1090.210(a), in volume percent.
                                </FP>
                            </EXTRACT>
                            <P>
                                (3) 
                                <E T="03">Average benzene concentration calculation.</E>
                                 The average benzene concentration is determined as follows:
                            </P>
                            <P>Equation 9 to paragraph (b)(3)</P>
                            <GPH SPAN="1" DEEP="29">
                                <GID>ER15JA25.018</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">avg,y</E>
                                     = Average benzene concentration for compliance period y, in volume percent.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">i</E>
                                     = Volume of gasoline produced or imported in batch i, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">i</E>
                                     = Benzene content of batch i, in volume percent.
                                </FP>
                                <FP SOURCE="FP-2">i = Individual batch of gasoline produced or imported during the compliance period.</FP>
                                <FP SOURCE="FP-2">n = Number of batches of gasoline produced or imported during the compliance period.</FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                            </EXTRACT>
                            <P>
                                (4) 
                                <E T="03">Maximum benzene average compliance calculation.</E>
                                 Compliance with the maximum benzene average standard in § 1090.210(b) is achieved if the following equation is true:
                            </P>
                            <P>Equation 10 to paragraph (b)(4)</P>
                            <FP SOURCE="FP-2">
                                BZ
                                <E T="52">avg,y</E>
                                 ≤ BZ
                                <E T="52">max_std</E>
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">avg,y</E>
                                     = Average benzene concentration for compliance period y, per paragraph (b)(3) of this section, in volume percent.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">max_std</E>
                                     = Maximum benzene average standard, per § 1090.210(b), in volume percent.
                                </FP>
                            </EXTRACT>
                            <P>
                                (5) 
                                <E T="03">Rounding and reporting benzene values.</E>
                                 (i) The total amount of benzene produced, as calculated in paragraph (b)(1)(ii) of this section, must be rounded to the nearest whole benzene gallon in accordance with § 1090.50.
                            </P>
                            <P>(ii) The average benzene concentration, as calculated in paragraph (b)(3) of this section, must be rounded and reported to two decimal places in accordance with § 1090.50.</P>
                            <STARS/>
                            <P>(e) * * *</P>
                            <P>(7) Gasoline imported by rail or truck using the provisions of § 1090.1610 to meet the alternative per-gallon standards of §§ 1090.205(d) and 1090.210(c).</P>
                            <P>
                                (8) Gasoline exempt under subpart G of this part from the average standards in subpart C of this part (
                                <E T="03">e.g.,</E>
                                 California gasoline, racing fuel, etc.).
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>52. Amend § 1090.710 by revising the introductory text to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.710</SECTNO>
                            <SUBJECT>Downstream oxygenate accounting.</SUBJECT>
                            <P>The requirements of this section apply to BOB for which a gasoline manufacturer accounts for the effects of the oxygenate blending that occurs downstream of the fuel manufacturing facility gate in the gasoline manufacturer's average standard compliance calculations under this subpart. This section also includes requirements for oxygenate blenders to ensure that oxygenate is added in accordance with the blending instructions specified by the gasoline manufacturer in order to ensure fuel quality standards are met.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>53. Amend § 1090.715 by revising and republishing paragraph (a) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.715</SECTNO>
                            <SUBJECT>Deficit carryforward.</SUBJECT>
                            <P>(a) A gasoline manufacturer incurs a compliance deficit if they exceed the average standard specified in subpart C of this part for a given compliance period. The deficit incurred must be determined as specified in paragraph (a)(1) of this section for sulfur and paragraph (a)(2) of this section for benzene.</P>
                            <P>(1) The sulfur deficit incurred is determined as follows:</P>
                            <FP SOURCE="FP-2">Equation 1 to paragraph (a)(1)</FP>
                            <FP SOURCE="FP-2">
                                D
                                <E T="52">s,y</E>
                                 = CSV−V
                                <E T="52">tot</E>
                                 · S
                                <E T="52">std</E>
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">S,y</E>
                                     = Sulfur deficit incurred for compliance period y, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    CSV
                                    <E T="52">y</E>
                                     = Compliance sulfur value for compliance period y, per § 1090.700(a)(1), in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">std</E>
                                     = Sulfur average standard, per § 1090.205(a), in ppm.
                                </FP>
                            </EXTRACT>
                            <P>(2) The benzene deficit incurred is determined as follows:</P>
                            <P>Equation 2 to paragraph (a)(2)</P>
                            <GPH SPAN="1" DEEP="26">
                                <GID>ER15JA25.019</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">Bz,y</E>
                                     = Benzene deficit incurred for compliance period y, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    CBV
                                    <E T="52">y</E>
                                     = Compliance benzene value for compliance period y, per § 1090.700(b)(1)(i), in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">avg_std</E>
                                     = Benzene average standard, per § 1090.210(a), in volume percent.
                                </FP>
                            </EXTRACT>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>54. Amend § 1090.720 by revising paragraphs (c)(5) and (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.720</SECTNO>
                            <SUBJECT>Credit use.</SUBJECT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(5) A gasoline manufacturer must only use credits that they own at the time of use.</P>
                            <P>
                                (d) 
                                <E T="03">Credit reporting.</E>
                                 A gasoline manufacturer that generates, transacts, or uses credits under this subpart must submit reports to EPA that include all information regarding credits as specified in § 1090.905 using forms and procedures specified by EPA.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>55. Amend § 1090.725 by revising paragraphs (a)(2)(vi), (c)(1), (d)(1), and (f) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.725</SECTNO>
                            <SUBJECT>Credit generation.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(2) * * *</P>
                            <P>(vi) Importation of gasoline by rail or truck using the alternative sampling and testing requirements in § 1090.1610.</P>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(1) The number of sulfur credits generated is determined as follows:</P>
                            <P>Equation 1 to paragraph (c)(1)</P>
                            <FP SOURCE="FP-2">
                                C
                                <E T="52">S,y</E>
                                 = V
                                <E T="52">tot</E>
                                 · S
                                <E T="52">std</E>
                                −CSV
                                <E T="52">y</E>
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    C
                                    <E T="52">S,y</E>
                                     = Sulfur credits generated for compliance period y, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">std</E>
                                     = Sulfur average standard, per § 1090.205(a), in ppm.
                                </FP>
                                <FP SOURCE="FP-2">
                                    CSV
                                    <E T="52">y</E>
                                     = Compliance sulfur value for compliance period y, per § 1090.700(a)(1), in ppm-gallons.
                                </FP>
                            </EXTRACT>
                            <STARS/>
                            <P>(d) * * *</P>
                            <P>(1) The number of benzene credits generated is determined as follows:</P>
                            <P>Equation 2 to paragraph (d)(1)</P>
                            <GPH SPAN="1" DEEP="26">
                                <GID>ER15JA25.020</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    C
                                    <E T="52">Bz,y</E>
                                     = Benzene credits generated for compliance period y, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Bz
                                    <E T="52">avg_std</E>
                                     = Benzene average standard, per § 1090.210(a), in volume percent.
                                </FP>
                                <FP SOURCE="FP-2">
                                    CBV
                                    <E T="52">y</E>
                                     = Compliance benzene value for compliance period y, per § 1090.700(b)(1)(i), in benzene gallons.
                                </FP>
                            </EXTRACT>
                            <STARS/>
                            <PRTPAGE P="4352"/>
                            <P>
                                (f) 
                                <E T="03">Credit generation reporting.</E>
                                 A gasoline manufacturer that generates credits under this section must submit reports to EPA that contain all information regarding credit generation as specified in § 1090.905 using forms and procedures specified by EPA.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>56. Amend § 1090.730 by revising paragraphs (f) and (h) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.730</SECTNO>
                            <SUBJECT>Credit transfers.</SUBJECT>
                            <STARS/>
                            <P>(f) No person may transfer credits if the transfer would cause them to incur a compliance deficit under § 1090.715.</P>
                            <STARS/>
                            <P>(h) The transferor and the transferee must submit reports to EPA that include all information regarding the transaction as specified in § 1090.905 using forms and procedures specified by EPA.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>57. Amend § 1090.735 by revising paragraph (a) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.735</SECTNO>
                            <SUBJECT>Invalid credits and remedial actions.</SUBJECT>
                            <STARS/>
                            <P>(a) Invalid credits must not be used to achieve compliance with an average standard specified in subpart C of this part, regardless of the good faith belief that the credits were validly generated.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>58. Amend § 1090.740 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraphs (a)(2) and (4); and</AMDPAR>
                        <AMDPAR>b. Revising and republishing paragraph (b).</AMDPAR>
                        <P>The revisions and republication read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.740</SECTNO>
                            <SUBJECT>Downstream BOB recertification.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(2) A gasoline manufacturer must comply with applicable requirements of this part and incur deficits to be included in their compliance calculations under § 1090.700 for each facility at which the gasoline manufacturer recertifies BOB.</P>
                            <STARS/>
                            <P>
                                (4) A party that only recertifies BOB that contains a greater amount of a specified oxygenate (
                                <E T="03">e.g.,</E>
                                 a party adds 15 volume percent ethanol instead of 10 volume percent ethanol to an E10 BOB) or a different oxygenate at an equal or greater amount (
                                <E T="03">e.g.,</E>
                                 a party adds 16 volume percent isobutanol instead of 10 volume percent ethanol to an E10 BOB) does not incur deficits under this section, does not need to submit reports under subpart J of this part, and does not need to arrange for an auditor to conduct an audit under subpart S of this part. The party must still comply with all other applicable provisions of this part (
                                <E T="03">e.g.,</E>
                                 register and keep records under subparts I and M of this part, respectively).
                            </P>
                            <P>(b) A gasoline manufacturer that recertifies a BOB under this section must calculate sulfur and benzene deficits for each batch and the total deficits for sulfur and benzene as follows:</P>
                            <P>
                                (1) 
                                <E T="03">Total sulfur deficit from downstream BOB recertification.</E>
                                 Calculate the total sulfur deficit from downstream BOB recertification for each facility as follows:
                            </P>
                            <P>Equation 1 to paragraph (b)(1)</P>
                            <GPH SPAN="3" DEEP="26">
                                <GID>ER15JA25.021</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">S_Oxy_Total,y</E>
                                     = Total sulfur deficit from downstream BOB recertification during compliance period y, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">S_Oxy_Batch,i</E>
                                     = Sulfur deficit for batch i of recertified BOB, per paragraph (b)(2) of this section, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">i = Individual batch of BOB recertified during compliance period y.</FP>
                                <FP SOURCE="FP-2">n = Number of batches of BOB recertified during compliance period y.</FP>
                            </EXTRACT>
                            <P>
                                (2) 
                                <E T="03">Sulfur deficits from downstream BOB recertification.</E>
                                 Calculate the sulfur deficit from BOB recertification for each individual batch of BOB recertified as follows:
                            </P>
                            <P>Equation 2 to paragraph (b)(2)</P>
                            <GPH SPAN="3" DEEP="31">
                                <GID>ER15JA25.022</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">S_Oxy_Batch,i</E>
                                     = Sulfur deficit for batch i of recertified BOB, in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">BOB</E>
                                     = Volume of BOB in the batch being recertified, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">PSV = Presumed sulfur value of recertified BOB, in ppm. For purposes of this equation, PSV equals 11 ppm.</FP>
                                <FP SOURCE="FP-2">
                                    PTD
                                    <E T="52">Oxy</E>
                                     = Volume fraction of oxygenate that would have been added to the BOB as specified on PTDs.
                                </FP>
                                <FP SOURCE="FP-2">
                                    ACTUAL
                                    <E T="52">Oxy</E>
                                     = Volume fraction of oxygenate that was actually added to the BOB. If no oxygenate was added to the BOB, then ACTUAL
                                    <E T="52">Oxy</E>
                                     equals 0.
                                </FP>
                            </EXTRACT>
                            <P>
                                (3) 
                                <E T="03">Total benzene deficit from downstream BOB recertification.</E>
                                 Calculate the total benzene deficit from downstream BOB recertification for each facility as follows:
                            </P>
                            <P>Equation 3 to paragraph (b)(3)</P>
                            <GPH SPAN="3" DEEP="26">
                                <GID>ER15JA25.023</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">Bz_Oxy_Total,y</E>
                                     = Total benzene deficit from downstream BOB recertification during compliance period y, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">Bz_Oxy_Batch,i</E>
                                     = Benzene deficit for batch i of recertified BOB, per paragraph (b)(4) of this section, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">i = Individual batch of BOB recertified during compliance period y.</FP>
                                <FP SOURCE="FP-2">n = Number of batches of BOB recertified during compliance period y.</FP>
                            </EXTRACT>
                            <P>
                                (4) 
                                <E T="03">Benzene deficits from downstream BOB recertification.</E>
                                 Calculate the benzene deficit from BOB recertification for each individual batch of BOB recertified as follows:
                            </P>
                            <P>Equation 4 to paragraph (b)(4)</P>
                            <GPH SPAN="3" DEEP="31">
                                <PRTPAGE P="4353"/>
                                <GID>ER15JA25.024</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    D
                                    <E T="52">Bz_Oxy_Batch,i</E>
                                     = Benzene deficit for batch i of recertified BOB, in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">BOB</E>
                                     = Volume of BOB in the batch being recertified, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">PBV = Presumed benzene value of recertified BOB, in volume percent. For purposes of this equation, PBV equals 0.68 volume percent.</FP>
                                <FP SOURCE="FP-2">
                                    PTD
                                    <E T="52">Oxy</E>
                                     = Volume fraction of oxygenate that would have been added to the BOB as specified on PTDs.
                                </FP>
                                <FP SOURCE="FP-2">
                                    ACTUAL
                                    <E T="52">Oxy</E>
                                     = Volume fraction of oxygenate that was actually added to the BOB. If no oxygenate was added to the BOB, then ACTUAL
                                    <E T="52">Oxy</E>
                                     equals 0.
                                </FP>
                            </EXTRACT>
                            <P>
                                (5) 
                                <E T="03">Deficit rounding.</E>
                                 The deficits calculated in paragraphs (b)(1) through (4) of this section must be rounded and reported to the nearest sulfur ppm-gallon or benzene gallon in accordance with § 1090.50, as applicable.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>59. Revise and republish § 1090.745 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.745</SECTNO>
                            <SUBJECT>Informational annual average calculations.</SUBJECT>
                            <P>(a) A gasoline manufacturer must calculate and report annual average sulfur and benzene concentrations for each of their facilities as specified in this section. The values calculated and reported under this section are not used to demonstrate compliance with average standards under this part.</P>
                            <P>(b) A gasoline manufacturer must calculate and report their unadjusted average sulfur concentration as follows:</P>
                            <P>Equation 1 to paragraph (b)</P>
                            <GPH SPAN="1" DEEP="29">
                                <GID>ER15JA25.025</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">avg,y</E>
                                     = Facility unadjusted average sulfur concentration for compliance period y, in ppm. Round and report S
                                    <E T="52">avg,y</E>
                                     to two decimal places.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">i</E>
                                     = Volume of gasoline produced or imported in batch i, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">i</E>
                                     = Sulfur content of batch i, in ppm.
                                </FP>
                                <FP SOURCE="FP-2">i = Individual batch of gasoline produced or imported during the compliance period.</FP>
                                <FP SOURCE="FP-2">n = Number of batches of gasoline produced or imported during the compliance period.</FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                            </EXTRACT>
                            <P>(c) A gasoline manufacturer must calculate and report their net average sulfur concentration as follows:</P>
                            <P>Equation 2 to paragraph (c)</P>
                            <GPH SPAN="1" DEEP="28">
                                <GID>ER15JA25.026</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    S
                                    <E T="52">net_avg,y</E>
                                     = Facility net average sulfur concentration for compliance period y, in ppm. Round and report S
                                    <E T="52">net_avg,y</E>
                                     to two decimal places.
                                </FP>
                                <FP SOURCE="FP-2">
                                    CSV
                                    <E T="52">y</E>
                                     = Compliance sulfur value for compliance period y, per § 1090.700(a)(1), in ppm-gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                            </EXTRACT>
                            <P>(d) A gasoline manufacturer must calculate and report their net average benzene concentration as follows:</P>
                            <P>Equation 3 to paragraph (d)</P>
                            <GPH SPAN="1" DEEP="28">
                                <GID>ER15JA25.027</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    B
                                    <E T="52">net_avg,y</E>
                                     = Facility net average benzene concentration for compliance period y, in volume percent. Round and report B
                                    <E T="52">net_avg,y</E>
                                     to two decimal places.
                                </FP>
                                <FP SOURCE="FP-2">
                                    CBV
                                    <E T="52">y</E>
                                     = Compliance benzene value for compliance period y, per § 1090.700(b)(1)(i), in benzene gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">tot</E>
                                     = Total volume of gasoline produced or imported during the compliance period, in gallons.
                                </FP>
                            </EXTRACT>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart I—Registration</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>60. Amend § 1090.800 by revising paragraph (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.800</SECTNO>
                            <SUBJECT>General provisions.</SUBJECT>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">RCO submission.</E>
                                 Registration information must be submitted by the RCO. The RCO may delegate responsibility to a person who is familiar with the requirements of this part and who is no lower in the organization than a fuel manufacturing facility manager, or equivalent.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>61. Amend § 1090.805 by revising and republishing paragraph (b) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.805</SECTNO>
                            <SUBJECT>Contents of registration.</SUBJECT>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">Additional information required for certified pentane producers.</E>
                                 In addition to the information in paragraph (a) of this section, a certified pentane producer must also submit the following information:
                            </P>
                            <P>(1) A description of the certified pentane production facility that demonstrates that the facility is capable of producing certified pentane that is compliant with the requirements of this part without significant modifications to the existing facility.</P>
                            <P>(2) A description of how certified pentane will be shipped from the certified pentane production facility to the certified pentane blender(s) and the associated quality assurance practices that demonstrate that contamination during distribution can be adequately controlled so as not to cause certified pentane to be in violation of the standards in this part.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>62. Amend § 1090.815 by revising paragraph (a)(4) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.815</SECTNO>
                            <SUBJECT>Deactivation (involuntary cancellation) of registration.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(4) Any required attestation engagement report has not been received within 30 days of the required submission date.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>63. Amend § 1090.820 by revising paragraph (b)(3) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.820</SECTNO>
                            <SUBJECT>Changes of ownership.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(3) A letter, signed by the RCO from the company that currently owns or will own the company or facility and, if possible, documentation from the company that previously registered the company or facility that details the effective date of the transfer of ownership of the company or facility and summarizes any changes to the registration information.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart J—Reporting</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>64. Amend § 1090.900 by revising paragraphs (c) and (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.900</SECTNO>
                            <SUBJECT>General provisions.</SUBJECT>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Report deadlines.</E>
                                 All annual, batch, and credit transaction reports required under this subpart, except attestation engagement reports, must be submitted by March 31 for the preceding compliance period (
                                <E T="03">e.g.,</E>
                                 reports covering the calendar year 2021 must be submitted to EPA by no later than March 31, 2022). Attestation engagement reports must be submitted by June 1 for the preceding compliance period (
                                <E T="03">e.g.,</E>
                                 attestation engagement reports covering calendar year 2021 must be submitted to EPA by no later than June 1, 2022). Independent survey 
                                <PRTPAGE P="4354"/>
                                quarterly reports must be submitted by the deadlines in table 1 to paragraph (a)(4) in § 1090.925.
                            </P>
                            <P>
                                (d) 
                                <E T="03">RCO submission.</E>
                                 Reports must be signed and submitted by the RCO or their delegate.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>65. Amend § 1090.905 by:</AMDPAR>
                        <AMDPAR>a. Revising the section heading;</AMDPAR>
                        <AMDPAR>b. Revising paragraphs (a)(2)(iv)(E), (b)(2)(vi)(E), (c)(1)(viii), and (c)(2)(ii), (iii), and (viii);</AMDPAR>
                        <AMDPAR>c. In paragraphs (c)(3)(i)(F) and (G), removing the text “BOB” and add, in its place, the text “BOB and the blending manufacturer is accounting for downstream oxygenate under § 1090.710”.</AMDPAR>
                        <AMDPAR>d. Removing paragraph (c)(3)(i)(H);</AMDPAR>
                        <AMDPAR>e. Redesignating paragraphs (c)(3)(i)(I) and (J) as paragraphs (c)(3)(i)(H) and (I); and</AMDPAR>
                        <AMDPAR>f. Revising paragraphs (c)(4) introductory text, (c)(5)(i)(E), and (c)(8)(vii)(A).</AMDPAR>
                        <P>The revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.905</SECTNO>
                            <SUBJECT>Reports by gasoline manufacturers.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(2) * * *</P>
                            <P>(iv) * * *</P>
                            <P>(E) The total sulfur deficit from downstream BOB recertification, per § 1090.740(b)(1).</P>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(2) * * *</P>
                            <P>(vi) * * *</P>
                            <P>(E) The total benzene deficit from downstream BOB recertification, per § 1090.740(b)(3).</P>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(1) * * *</P>
                            <P>(viii) For all batches of summer gasoline:</P>
                            <P>
                                (A)(
                                <E T="03">1</E>
                                ) The applicable RVP standard, as specified in § 1090.215.
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) Whether the ethanol 1.0 psi waiver under § 1090.215(b) applies.
                            </P>
                            <P>(B) The tested RVP of the batch, in psi, and the test method used to measure the RVP. If the gasoline is Summer RFG that is designated as “Intended for Oxygenate Blending” under § 1090.1010(a)(4), report the tested RVP of the hand blend.</P>
                            <STARS/>
                            <P>(2) * * *</P>
                            <P>(ii) The batch number.</P>
                            <P>(iii) The date the batch was produced or imported.</P>
                            <STARS/>
                            <P>(viii) For all batches of summer BOB:</P>
                            <P>
                                (A)(
                                <E T="03">1</E>
                                ) The applicable RVP standard, as specified in § 1090.215, for the neat CBOB or hand blend of RBOB and oxygenate prepared under § 1090.1340.
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) Whether the ethanol 1.0 psi waiver under § 1090.215(b) applies for the neat CBOB or hand blend of RBOB and oxygenate prepared under § 1090.1340.
                            </P>
                            <P>(B) The tested RVP of the neat CBOB or hand blend of RBOB and oxygenate prepared under § 1090.1340, in psi, and the test method used to measure the RVP.</P>
                            <STARS/>
                            <P>(4) For blendstock(s) added to PCG by a gasoline manufacturer complying by addition under § 1090.1320(a)(2), report each blendstock as a separate batch and all the following information:</P>
                            <STARS/>
                            <P>(5) * * *</P>
                            <P>(i) * * *</P>
                            <P>(E) The volume percentage of butane in batches of butane, or pentane in batches of pentane, provided by the certified butane or certified pentane supplier.</P>
                            <STARS/>
                            <P>(8) * * *</P>
                            <P>(vii) * * *</P>
                            <P>
                                (A)(
                                <E T="03">1</E>
                                ) The applicable RVP standard, as specified in § 1090.215.
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) Whether the ethanol 1.0 psi waiver under § 1090.215(b) applies.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>66. Amend § 1090.910 by:</AMDPAR>
                        <AMDPAR>a. Revising the section heading; and</AMDPAR>
                        <AMDPAR>b. Revising the introductory text and paragraphs (a)(1)(ix) and (x).</AMDPAR>
                        <P>The revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.910</SECTNO>
                            <SUBJECT>Reports by gasoline manufacturers that recertify BOB to gasoline.</SUBJECT>
                            <P>A gasoline manufacturer that recertifies BOB under § 1090.740 must report the information of this section, as applicable.</P>
                            <P>(a) * * *</P>
                            <P>(1) * * *</P>
                            <P>(ix) The sulfur deficit for the batch calculated under § 1090.740(b)(2).</P>
                            <P>(x) The benzene deficit for the batch calculated under § 1090.740(b)(4).</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>67. Amend § 1090.915 by revising the section heading and paragraph (c)(5) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.915</SECTNO>
                            <SUBJECT>Reports by oxygenate producers and importers.</SUBJECT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(5) The sulfur content of the batch, in ppm, and the method used to determine the sulfur content.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>68. Amend § 1090.925 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraph (b)(3) introductory text; and</AMDPAR>
                        <AMDPAR>b. Revising and republishing paragraph (c)(3).</AMDPAR>
                        <P>The revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.925</SECTNO>
                            <SUBJECT>Reports by independent surveyors.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(3) For each diesel fuel sample collected at a retail outlet by the independent surveyor:</P>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(3) Summary statistics for each identified geographic area, including the following:</P>
                            <P>(i) The number of samples collected and tested.</P>
                            <P>(ii) The mean, median, and range expressed in appropriate units for each measured fuel parameter.</P>
                            <P>(iii) The standard deviation for each measured fuel parameter.</P>
                            <P>(iv) The estimated compliance rate for each measured fuel parameter subject to a per-gallon standard in subpart C or D of this part.</P>
                            <P>(v) A summary of potential noncompliance issues.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>69. Revise and republish § 1090.930 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.930</SECTNO>
                            <SUBJECT>Reports by auditors.</SUBJECT>
                            <P>
                                (a) Attestation engagement reports required under subpart S of this part must be submitted by an independent auditor registered with EPA and associated with a company, or companies, through registration under subpart I of this part. Each attestation engagement report must clearly identify the company and compliance level (
                                <E T="03">e.g.,</E>
                                 facility), time period, and scope covered by the report. Attestation engagement reports covered by this section include those required under this part and those required under 40 CFR part 80, subpart M, beginning with the report due June 1, 2022.
                            </P>
                            <P>(b) An attestation engagement report must be submitted to EPA covering each compliance period by June 1 of the following calendar year. The auditor must make the attestation engagement report available to the company for which it was performed.</P>
                            <P>(c) The attestation engagement must comply with subpart S of this part and the attestation engagement report must clearly identify the methodologies followed and any findings, exceptions, and variances.</P>
                            <P>
                                (d) A single attestation engagement report submission by the auditor may include procedures performed under this part and under 40 CFR part 80, subpart M. If a single submission method is used, the auditor must clearly and separately describe the procedures and findings for each program.
                                <PRTPAGE P="4355"/>
                            </P>
                            <P>(e) The auditor must submit written acknowledgement from the RCO that the gasoline manufacturer has reviewed the attestation engagement report.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>70. Amend § 1090.935 by revising paragraphs (a)(1) introductory text and (a)(1)(i) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.935</SECTNO>
                            <SUBJECT>Reports by diesel fuel manufacturers.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(1) For each compliance period, a diesel fuel manufacturer that produces ULSD must submit the following information:</P>
                            <P>(i) The EPA-issued company and facility identifiers for the diesel fuel manufacturer.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart K—Batch Certification and Designation</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>71. Amend § 1090.1000 by revising paragraphs (b)(2)(ii), (b)(4) introductory text, (b)(5), (c)(2)(ii), and (e)(2)(i)(A) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1000</SECTNO>
                            <SUBJECT>Batch certification requirements.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(2) * * *</P>
                            <P>(ii) Ensure that each batch of gasoline meets the applicable requirements of subpart C of this part using the applicable procedures specified in subpart N of this part. A transmix processor must also meet all applicable requirements of subpart F of this part to ensure that each batch of gasoline meets the applicable requirements of subpart C of this part.</P>
                            <STARS/>
                            <P>(4) Any person who mixes summer gasoline with summer or winter gasoline that has a different designation must comply with one of the following:</P>
                            <STARS/>
                            <P>(5) Any person who mixes summer gasoline with winter gasoline to transition any storage tank from winter to summer gasoline is exempt from the requirement in paragraph (b)(4)(ii) of this section but must ensure that the gasoline meets the applicable RVP standard in § 1090.215.</P>
                            <P>(c) * * *</P>
                            <P>(2) * * *</P>
                            <P>(ii) Ensure that each batch of diesel fuel or ECA marine fuel meets the applicable requirements of subpart D of this part using the applicable procedures specified in subpart N of this part. A transmix processor must also meet all applicable requirements specified in subpart F of this part to ensure that each batch of diesel fuel or ECA marine fuel meets the applicable requirements of subpart D of this part.</P>
                            <STARS/>
                            <P>(e) * * *</P>
                            <P>(2) * * *</P>
                            <P>(i) * * *</P>
                            <P>(A) Testing must occur after the most recent delivery into the certified butane producer's storage tank, before transferring the certified butane batch for delivery.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>72. Amend § 1090.1005 by revising the section heading to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1005</SECTNO>
                            <SUBJECT>Designation of batches of fuel, fuel additive, and regulated blendstock.</SUBJECT>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>73. Amend § 1090.1010 by revising paragraph (c)(2) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1010</SECTNO>
                            <SUBJECT>Designation requirements for gasoline and regulated blendstocks.</SUBJECT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>
                                (2) The name of the specific oxygenate (
                                <E T="03">e.g.,</E>
                                 isobutanol).
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>74. Amend § 1090.1015 by:</AMDPAR>
                        <AMDPAR>a. Revising the section heading; and</AMDPAR>
                        <AMDPAR>b. Revising the paragraph heading of paragraph (a), and paragraphs (b) introductory text, and (b)(3)(iii) through (v).</AMDPAR>
                        <P>The revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1015</SECTNO>
                            <SUBJECT>Designation requirements for diesel fuel and distillate fuel.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Designation requirements for diesel fuel and distillate fuel manufacturers.</E>
                            </P>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">Designation requirements for distributors of diesel fuel and distillate fuel.</E>
                                 A distributor of diesel fuel or distillate fuel must accurately and clearly designate each batch of diesel fuel or distillate fuel for which they transfer custody as follows:
                            </P>
                            <STARS/>
                            <P>(3) * * *</P>
                            <P>(iii) California diesel fuel may be redesignated as ULSD if the requirements specified in § 1090.625(e) are met.</P>
                            <P>(iv) Heating oil, kerosene, ECA marine fuel, or jet fuel may be redesignated as ULSD if it meets the ULSD standards in § 1090.305 and was designated as ULSD under paragraph (a) of this section.</P>
                            <P>
                                (v) 500 ppm LM diesel fuel may be redesignated as ECA marine fuel, distillate global marine fuel, or heating oil. Any person who redesignates 500 ppm LM diesel fuel to ECA marine fuel or distillate global marine fuel must maintain records from the producer of the 500 ppm LM diesel fuel (
                                <E T="03">i.e.,</E>
                                 PTDs accompanying the fuel under § 1090.1115) to demonstrate compliance with the 500 ppm sulfur standard in § 1090.320(b).
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart L—Product Transfer Documents</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>75. Amend § 1090.1100 by revising paragraph (c) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1100</SECTNO>
                            <SUBJECT>General requirements.</SUBJECT>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Part 80 PTD requirements.</E>
                                 For any product subject to 40 CFR part 80, subpart M, a party must also include the applicable PTD information required under 40 CFR 80.1453.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>76. Revise and republish § 1090.1105 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1105</SECTNO>
                            <SUBJECT>PTD requirements for exempt fuel, fuel additive, and regulated blendstock.</SUBJECT>
                            <P>(a) In addition to the information required under § 1090.1100, on each occasion when any person transfers custody or title to any exempt fuel, fuel additive, or regulated blendstock under subpart G of this part, other than when the exempt fuel, fuel additive, or regulated blendstock is sold or dispensed to the ultimate end user at a retail outlet or WPC facility, the transferor must provide the transferee PTDs that include the following statements, as applicable:</P>
                            <P>
                                (1) 
                                <E T="03">National security exemption language.</E>
                                 For fuel, fuel additive, or regulated blendstock with a national security exemption specified in § 1090.605: “This fuel is for use in vehicles, engines, or equipment under an EPA-approved national security exemption only.”
                            </P>
                            <P>
                                (2) 
                                <E T="03">R&amp;D exemption language.</E>
                                 For fuel, fuel additive, or regulated blendstock used for an R&amp;D program specified in § 1090.610: “This fuel is for use in research, development, and test programs only.”
                            </P>
                            <P>
                                (3) 
                                <E T="03">Racing fuel language.</E>
                                 For fuel, fuel additive, or regulated blendstock used for racing purposes specified in § 1090.615: “This fuel is for racing purposes only.”
                            </P>
                            <P>
                                (4) 
                                <E T="03">Aviation fuel language.</E>
                                 For fuel, fuel additive, or regulated blendstock used in aircraft specified in § 1090.615: “This fuel is for aviation use only.”
                            </P>
                            <P>
                                (5) 
                                <E T="03">Territory fuel exemption language.</E>
                                 For fuel for use in American Samoa, Guam, or the Commonwealth of the Northern Mariana Islands specified in § 1090.620: “This fuel is for use only in Guam, American Samoa, or the Northern Mariana Islands.”
                                <PRTPAGE P="4356"/>
                            </P>
                            <P>
                                (6) 
                                <E T="03">California gasoline language.</E>
                                 For California gasoline specified in § 1090.625: “California gasoline”.
                            </P>
                            <P>
                                (7) 
                                <E T="03">California diesel fuel language.</E>
                                 For California diesel fuel specified in § 1090.625: “California diesel fuel”.
                            </P>
                            <P>
                                (8) 
                                <E T="03">Alaska, Hawaii, Puerto Rico, and U.S. Virgin Islands summer gasoline language.</E>
                                 For summer gasoline for use in Alaska, Hawaii, Puerto Rico, or the U.S. Virgin Islands specified in § 1090.630: “This summer gasoline is for use only in Alaska, Hawaii, Puerto Rico, or the U.S. Virgin Islands.”
                            </P>
                            <P>
                                (9) 
                                <E T="03">Exported fuel language.</E>
                                 For exported fuel, fuel additive, or regulated blendstock specified in § 1090.645: “This fuel is for export from the United States only.”
                            </P>
                            <P>
                                (b) In statements required by paragraph (a) of this section, where “fuel” is designated in a statement, the specific fuel, fuel additive, or regulated blendstock type (
                                <E T="03">e.g.,</E>
                                 “diesel fuel” or “gasoline”) may be used in place of the word “fuel”.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>77. Amend § 1090.1110 by revising paragraphs (b)(2)(i) introductory text, (c)(1)(i) introductory text, and (e) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1110</SECTNO>
                            <SUBJECT>PTD requirements for gasoline, gasoline additives, and gasoline regulated blendstocks.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(2) * * *</P>
                            <P>(i) Except as specified in paragraph (b)(2)(ii) of this section, for batches of summer BOB, identification of the product with one of the following statements indicating the applicable RVP standard, as specified in § 1090.215:</P>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(1) * * *</P>
                            <P>(i) Except as specified in paragraph (c)(1)(ii) of this section, for summer gasoline, identification of the product with one of the following statements indicating the applicable RVP standard, as specified in § 1090.215:</P>
                            <STARS/>
                            <P>
                                (e) 
                                <E T="03">Gasoline detergent language requirements.</E>
                                 (1) In addition to any other PTD requirements of this subpart, on each occasion when any person transfers custody or title to any gasoline detergent, the transferor must provide to the transferee PTDs that include the following information:
                            </P>
                            <P>(i) The identity of the product being transferred as detergent.</P>
                            <P>(ii) The name of the registered detergent must be used to identify the detergent additive package on its PTD and the LAC on the PTD must be consistent with the requirements in § 1090.260.</P>
                            <P>(2) In addition to any other PTD requirements of this subpart, on each occasion when any person transfers custody or title to any gasoline, the transferor must provide to the transferee PTDs that include the following information:</P>
                            <P>(i) The identify of the gasoline being transferred as detergent-additized gasoline or non-detergent-additized gasoline.</P>
                            <P>(ii) [Reserved]</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>78. Amend § 1090.1115 by revising the section heading and paragraph (a) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1115</SECTNO>
                            <SUBJECT>PTD requirements for distillate fuel and residual fuel.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">General requirements.</E>
                                 On each occasion when any person transfers custody or title of any distillate fuel or residual fuel, other than when fuel is sold or dispensed to the ultimate end user at a retail outlet or WPC facility, the transferor must provide the transferee PTDs that include the following information:
                            </P>
                            <P>
                                (1) The sulfur per-gallon standard that the transferor represents the distillate fuel or residual fuel to meet under subpart D of this part (
                                <E T="03">e.g.,</E>
                                 15 ppm sulfur for ULSD or 1,000 ppm sulfur for ECA marine fuel).
                            </P>
                            <P>
                                (2) An accurate and clear statement of the applicable designation(s) of the distillate fuel or residual fuel under § 1090.1015 (
                                <E T="03">e.g.,</E>
                                 “ULSD”, “500 ppm LM diesel fuel”, or “ECA marine fuel”).
                            </P>
                            <P>(3) If the distillate fuel or residual fuel does not meet the sulfur standard in § 1090.305(b) for ULSD, the following statement: “Not for use in highway vehicles or engines or nonroad, locomotive, or marine engines.”</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>79. Amend § 1090.1120 by revising paragraph (b)(3)(iii) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1120</SECTNO>
                            <SUBJECT>PTD requirements for diesel fuel additives.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(3) * * *</P>
                            <P>(iii) The contribution to the sulfur content of the diesel fuel, in ppm, that would result if the diesel fuel additive package is used at the maximum recommended concentration.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart M—Recordkeeping</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>80. Amend § 1090.1205 by revising paragraphs (c) introductory text and (c)(1) through (4) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1205</SECTNO>
                            <SUBJECT>Recordkeeping requirements for all regulated parties.</SUBJECT>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Sampling and testing.</E>
                                 Any party that performs any sampling and testing on any fuel, fuel additive, or regulated blendstock must keep records of the following information for each sample collected:
                            </P>
                            <P>(1) The date, time, location, and identification of the storage tank, railcar, truck, or vessel from which the sample was collected.</P>
                            <P>(2) The name of the person who collected the sample and the person who performed the test.</P>
                            <P>(3) The results of all tests, including where more than one test is performed, as originally printed by the testing apparatus, or where no printed result is produced, the results as originally recorded by the person that performed the test.</P>
                            <P>(4) The test methodology used.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>81. Amend § 1090.1210 by revising paragraphs (d)(1) and (d)(2)(i) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1210</SECTNO>
                            <SUBJECT>Recordkeeping requirements for gasoline manufacturers.</SUBJECT>
                            <STARS/>
                            <P>(d) * * *</P>
                            <P>(1) Records that reflect the storage and movement of the PCG or TGP and blendstock within the gasoline manufacturing facility to the point such PCG or TGP is used to produce gasoline or BOB.</P>
                            <P>(2) * * *</P>
                            <P>(i) The results of tests to determine the sulfur content, benzene content, oxygenate(s) content, and in the summer, RVP, for the PCG or TGP and volume of the PCG or TGP when received at the gasoline manufacturing facility.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>82. Amend § 1090.1215 by revising paragraphs (a), (b) introductory text, and (c) introductory text to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1215</SECTNO>
                            <SUBJECT>Recordkeeping requirements for diesel fuel, ECA marine fuel, and distillate global marine fuel manufacturers.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Overview.</E>
                                 In addition to the requirements in § 1090.1205, a diesel fuel, ECA marine fuel, or distillate global marine fuel manufacturer must keep records for each of their facilities that include the information in this section.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Diesel fuel and ECA marine fuel records.</E>
                                 For each batch of ULSD, 500 ppm LM diesel fuel, or ECA marine fuel, a diesel fuel or ECA marine fuel manufacturer must keep records of the following information:
                            </P>
                            <STARS/>
                            <PRTPAGE P="4357"/>
                            <P>
                                (c) 
                                <E T="03">Distillate global marine fuel records.</E>
                                 For distillate global marine fuel, a distillate global marine fuel manufacturer must keep records of the following information:
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>83. Amend § 1090.1230 by revising paragraph (b)(8) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1230</SECTNO>
                            <SUBJECT>Recordkeeping requirements for oxygenate producers.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(8) The neat ethanol production quality control records or the test results on the neat ethanol, as applicable.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>84. Amend § 1090.1240 by revising paragraphs (b)(2)(i), (b)(2)(ii)(B), and (b)(2)(vi) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1240</SECTNO>
                            <SUBJECT>Recordkeeping requirements for gasoline detergent blenders.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(2) * * *</P>
                            <P>(i) The dates of the VAR period.</P>
                            <P>(ii) * * *</P>
                            <P>(B) For a facility that uses a gauge to measure the inventory of the detergent storage tank, the total volume of detergent must be calculated as follows:</P>
                            <P>Equation 1 to paragraph (b)(2)(ii)(B)</P>
                            <FP SOURCE="FP-2">
                                V
                                <E T="52">D</E>
                                 = DI
                                <E T="52">i</E>
                                −DI
                                <E T="52">f</E>
                                 + DI
                                <E T="52">a</E>
                                −DI
                                <E T="52">w</E>
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    V
                                    <E T="52">D</E>
                                     = Volume of detergent, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    DI
                                    <E T="52">i</E>
                                     = Initial detergent inventory of the tank, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    DI
                                    <E T="52">f</E>
                                     = Final detergent inventory of the tank, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    DI
                                    <E T="52">a</E>
                                     = Sum of any additions to detergent inventory, in gallons.
                                </FP>
                                <FP SOURCE="FP-2">
                                    DI
                                    <E T="52">w</E>
                                     = Sum of any withdrawals from detergent inventory for purposes other than the additization of gasoline, in gallons.
                                </FP>
                            </EXTRACT>
                            <STARS/>
                            <P>(vi) If the detergent injector is set below the applicable LAC, or adjusted by more than 10 percent above the concentration initially set in the VAR period, documentation establishing that the purpose of the change is to correct a batch misadditization prior to the end of the VAR period and prior to the transfer of the batch to another party or to correct an equipment malfunction and the date and adjustments of the correction.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>85. Amend § 1090.1245 by revising paragraph (b)(2) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1245</SECTNO>
                            <SUBJECT>Recordkeeping requirements for independent surveyors.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(2) Records related to a geographically focused E15 survey program under § 1090.1420(b).</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>86. Amend § 1090.1250 by revising paragraph (b)(2) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1250</SECTNO>
                            <SUBJECT>Recordkeeping requirements for auditors.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(2) Copies of each attestation engagement report prepared and all related records developed to prepare each report.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>87. Amend § 1090.1255 by:</AMDPAR>
                        <AMDPAR>a. Revising the section heading; and</AMDPAR>
                        <AMDPAR>b. Revising paragraphs (a), (c)(4), and (d).</AMDPAR>
                        <P>The revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1255</SECTNO>
                            <SUBJECT>Recordkeeping requirements for transmix, 500 ppm LM diesel fuel, and pipeline interface.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Overview.</E>
                                 In addition to the requirements in § 1090.1205, a transmix processor, transmix blender, transmix distributor, manufacturer or distributor of 500 ppm LM diesel fuel using transmix, or pipeline operator must keep records that include the information in this section.
                            </P>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(4) Documents or information that demonstrates that the 500 ppm LM diesel fuel was only used in locomotive or marine engines that are not required to use ULSD under 40 CFR 1033.815 or 40 CFR 1042.660, respectively.</P>
                            <P>
                                (d) 
                                <E T="03">Pipeline interface.</E>
                                 A pipeline operator must keep records that demonstrate compliance with the pipeline interface handling practices in § 1090.520.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart N—Sampling, Testing, and Retention</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>88. Amend § 1090.1300 by revising paragraphs (b) and (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1300</SECTNO>
                            <SUBJECT>General provisions.</SUBJECT>
                            <STARS/>
                            <P>(b) If you need to meet requirements for a quality assurance program at a minimum frequency, the first shipment of product you receive from each distributor triggers the testing requirement for that distributor. Perform testing with the first shipment of product to demonstrate compliance for the testing period. The following example illustrates the requirements for testing based on sampling the more frequent of every 90 days or 500,000 gallons of certified butane you receive from each distributor:</P>
                            <P>(1) If you receive an initial shipment of certified butane from a distributor on March 1, perform testing on that batch to show that it meets standards. A passing result qualifies all further shipments of certified butane from that distributor until May 29, as long as you receive less than 500,000 gallons of certified butane from that distributor during those 90 days. In that case, the testing period ends May 29 and the next testing period starts when you receive another shipment of certified butane from that distributor on or after May 30.</P>
                            <P>(2) If you receive a shipment from that distributor before May 29 that that causes the total volume of certified butane from that distributor to exceed 500,000 gallons over the testing period, the date that batch is received represents the end of the testing period. The next testing period starts when you receive another shipment of certified butane from that distributor.</P>
                            <STARS/>
                            <P>(d) Anyone performing tests under this subpart must apply good laboratory practices for all sampling, measurement, and calculations related to testing required under this part. This requires performing these procedures in a way that is consistent with generally accepted scientific and engineering principles and properly accounting for all available relevant information. The following examples illustrate how to apply good laboratory practices:</P>
                            <P>(1) You may exclude outlier data points for quality testing under § 1090.1375 as specified in ASTM D6299 (incorporated by reference, see § 1090.95), subject to the following requirements:</P>
                            <P>(i) The justification for exclusion must be an assignable cause that is not part of the normal process and does not result from common causes.</P>
                            <P>(ii) You must meet requirements for documenting and supporting exclusion of data points as specified in § 1090.1375(a)(4).</P>
                            <P>(2) [Reserved]</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>89. Amend § 1090.1310 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraph (b) introductory text; and</AMDPAR>
                        <AMDPAR>b. Adding paragraph (f).</AMDPAR>
                        <P>The revision and addition read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1310</SECTNO>
                            <SUBJECT>Testing to demonstrate compliance with standards.</SUBJECT>
                            <STARS/>
                            <P>
                                (b) A fuel manufacturer, fuel additive manufacturer, or regulated blendstock producer must perform the following measurements before fuel, fuel additive, or regulated blendstock from a given 
                                <PRTPAGE P="4358"/>
                                batch leaves the facility, except as specified in paragraph (f) of this section and § 1090.1315:
                            </P>
                            <STARS/>
                            <P>(f) Refiners and blending manufacturers may meet the testing requirements of paragraph (b) of this section by loading gasoline or diesel fuel onto a marine vessel, subject to the following conditions:</P>
                            <P>(1) The marine vessel remains within 15 miles of the fuel manufacturing facility after loading.</P>
                            <P>(2) Each vessel compartment is sampled for meeting certification testing requirements as specified in § 1090.1605(b)(1).</P>
                            <P>(3) No additional loading or blending occurs after sampling and certification are complete.</P>
                            <P>(4) The refiner or blending manufacturer ensures that the fuel meets all applicable per-gallon standards before the fuel leaves the area specified in paragraph (f)(1) of this section.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>90. Amend § 1090.1315 by:</AMDPAR>
                        <AMDPAR>a. Revising the introductory text and paragraph (a) introductory text;</AMDPAR>
                        <AMDPAR>b. Adding paragraphs (a)(7) through (14); and</AMDPAR>
                        <AMDPAR>c. Revising paragraph (c).</AMDPAR>
                        <P>The revisions and additions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1315</SECTNO>
                            <SUBJECT>In-line blending.</SUBJECT>
                            <P>A fuel manufacturer using in-line blending equipment may qualify for a waiver from the requirement in § 1090.1310(b) to test every batch of fuel before the fuel leaves the fuel manufacturing facility. This section describes in-line blending waiver provisions that apply instead of or in addition to the requirements in § 1090.1335(c).</P>
                            <P>(a) Submit a request signed by the RCO, or their delegate, to EPA with the following information:</P>
                            <STARS/>
                            <P>(7) Describe which blendstock parameters you intend to measure for managing the blending process and the typical sampling frequency for those measurements.</P>
                            <P>(8) Describe any circumstances in which it is not possible to meet the requirements for sampling frequency as specified in § 1090.1335(c)(3). Also describe how you will adjust target values to account for the greater measurement variability. For example, if the greater margin of error corresponds to a 2 percent increase in measurement variability, adjust target values of all parameters subject to per-gallon and average standards downward by at least 2 percent.</P>
                            <P>(9) Describe an alternative sampling plan to meet requirements to test head, middle, and tail samples for small batches. Your alternative sampling plan may allow you to collect a single sample anytime during the blend for a batch involving up to 8 hours of blending or up to 1 million gallons of fuel, and it may allow you to collect two evenly distributed samples during the blend for a batch involving up to 16 hours of blending or up to 2 million gallons of fuel.</P>
                            <P>(10) Describe your plans to meet requirements to test head, middle, and tail samples in cases where unforeseen circumstances cause the batch to be complete before blending the anticipated batch volume. Any failure to perform required tests must not occur in more than 10 percent of in-line blending batches for the calendar year.</P>
                            <P>(11) Describe contingency plans for alternative sampling and testing in cases involving failure of the automatic compositor or other essential equipment. For example, the contingency play may identify collecting a second composite sample with a redundant system.</P>
                            <P>(12) Describe any contingency plans for an alternative sampling demonstration if an automatic sampling test result fails to meet a per-gallon standard. For example, the plan may include certifying the batch based on manual sampling in a tank if you collect the whole batch in the tank before it leaves the fuel manufacturing facility gate. As another example, as long as the fuel remains at the facility, you may certify the batch based on secondary automatic sampling as fuel comes out of a holding tank that you use to collect the fuel that failed to meet a per-gallon standard.</P>
                            <P>(13) In the case of in-line blending into a marine vessel, describe an alternative, equivalent method for meeting the requirement in § 1090.1335(c)(4) to collect head-middle-tail samples.</P>
                            <P>(14) Include the following statement: “The information in this submission is true, accurate, and complete to the best of my knowledge. I am aware that there are significant civil and criminal penalties for submitting false, misleading, or incomplete information.”</P>
                            <STARS/>
                            <P>(c) The following provisions apply for amending an approved waiver under this section:</P>
                            <P>(1) You must submit an updated waiver request to EPA 60 days before making any material change to your in-line blending process. Material changes generally include anything that causes the previously approved waiver to be incorrect or incomplete. Examples of material changes may include changing analyzer hardware or programming, changing the analyzer's location for drawing samples of blended fuel, changing the piping configuration, changing the mixing control hardware or programming logic, changing sample compositors or compositor settings, or expanding fuel blending capacity. Changing the name of the company or business unit is an example of a change that is not material.</P>
                            <P>(2) The request must include a description of the intended changes and a comparison document that clearly and comprehensively identifies the proposed changes to the waiver. The request must also include the statement in paragraph (a)(14) of this section.</P>
                            <P>(3) Your request to amend a waiver under this section is deemed to be approved effective 60 days after EPA acknowledges receiving the request if there is no EPA response to the request. Such a response may be in the form of denying the request, identifying deficiencies, or requiring additional information. If we require that you correct a deficiency or submit additional information, your waiver request is deemed to be approved effective 60 days after EPA acknowledges receiving the responsive submission.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>91. Amend § 1090.1320 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraph (a) introductory text;</AMDPAR>
                        <AMDPAR>b. Revising and republishing paragraph (a)(1)(i);</AMDPAR>
                        <AMDPAR>c. Revising paragraphs (b) introductory text and (b)(1);</AMDPAR>
                        <AMDPAR>d. Adding paragraphs (b)(5) and (6); and</AMDPAR>
                        <AMDPAR>e. Revising paragraph (c)(1).</AMDPAR>
                        <P>The revisions, republication, and additions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1320</SECTNO>
                            <SUBJECT>Adding blendstock to PCG.</SUBJECT>
                            <STARS/>
                            <P>(a) Sample and test using one of the following methods to exclude PCG from the compliance demonstration for sulfur content and benzene content:</P>
                            <P>(1) * * *</P>
                            <P>(i) Determine the sulfur content, benzene content, and oxygenate content of the PCG before blending blendstocks to produce a new batch of gasoline as follows:</P>
                            <P>
                                (A) Sample and test the sulfur content, benzene content, and oxygenate content of each batch of PCG using the procedures in § 1090.1350. Demonstrate homogeneity for the consolidated batch as specified in § 1090.1337 if blending involves multiple batches of PCG, or if 
                                <PRTPAGE P="4359"/>
                                a single batch of PCG was certified without demonstrating homogeneity under § 1090.1337(a)(4). The blending manufacturer does not need to test PCG for oxygenate content if they can demonstrate that the PCG does not contain oxygenates as specified in paragraph (a)(1)(i)(C) of this section or § 1090.1310(e)(1). For PCG sampled from a pipeline as specified in § 1090.1335(c), homogeneity provisions apply as specified in § 1090.1337, except that no homogeneity testing is required for a volume less than 1 million gallons. Evaluate homogeneity based on two evenly distributed samples if volume is between 1 million and 2 million gallons, and based on three evenly distributed samples if volume is greater than 2 million gallons. If multiple samples meet homogeneity requirements, composite the collected samples for testing sulfur, benzene, and oxygenate.
                            </P>
                            <P>(B) If the PCG is a BOB and the blending manufacturer is accounting for downstream oxygenate under § 1090.710, also prepare a hand blend under § 1090.1340 and test the hand blend for sulfur content and benzene content.</P>
                            <P>(C) The blending manufacturer may use the PCG manufacturer's certification test results if the PCG was received directly from the PCG manufacturer by an in-tank transfer or tank-to-tank transfer within the same terminal as long as the results are from the PCG that is being transferred.</P>
                            <P>(D) If multiple samples do not meet homogeneity requirements, demonstrate compliance based on the lowest measured values as specified in § 1090.1337(a)(4).</P>
                            <P>(E) If you are unable to measure a PCG parameter, you must comply using either the presumed value for the PCG volume or an EPA-approved alternative value as described in § 1090.1710(g).</P>
                            <STARS/>
                            <P>(b) A certified butane or certified pentane blender that blends certified butane or certified pentane into PCG, other than Summer RFG or Summer RBOB, to make a new batch of gasoline may comply with the following requirements instead of the requirements of paragraph (a) of this section:</P>
                            <P>(1) For summer gasoline, measure the RVP of the blended fuel. The fuel manufacturer may rely on test results from the certified butane or certified pentane producer for sulfur content and benzene content.</P>
                            <STARS/>
                            <P>(5) If the quality assurance testing under paragraph (b)(4) of this section shows that certified butane or certified pentane fails to meet one or more of the standards specified in § 1090.250 or § 1090.255, the certified butane or certified pentane received from that distributor at that butane blending facility or pentane blending facility during that testing period is deemed to be in violation of the relevant per-gallon standard. Any later shipment of certified butane or certified pentane received from that distributor at that butane blending facility or pentane blending facility will also be deemed to be in violation of the relevant per-gallon standard unless another quality assurance test is conducted demonstrating that certified butane or certified pentane received from that distributor meets the standards specified in § 1090.250 or § 1090.255.</P>
                            <P>(6) If certified butane or certified pentane is deemed to be in violation under paragraph (b)(5) of this section, the certified butane or certified pentane blender must calculate its compliance obligations using paragraph (a)(1) or (2) of this section using the test results from the quality assurance program and obtain any necessary sulfur or benzene credits. For purposes of averaging, banking, and trading, the certified butane or certified pentane deemed to be in violation will be subject to the sulfur and benzene standards in §§ 1090.205 and 1090.210, respectively.</P>
                            <P>(c) * * *</P>
                            <P>(1) Calculate and incur sulfur and benzene deficits under the BOB recertification provisions of § 1090.740.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>92. Revise and republish § 1090.1335 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1335</SECTNO>
                            <SUBJECT>Collecting, preparing, and testing samples.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">General provisions.</E>
                                 Use good laboratory practice to collect samples to represent the batch you are testing. For example, take steps to ensure that a batch is always well mixed before sampling. Also, always take steps to prevent sample contamination, such as completely flushing sampling taps and piping and pre-rinsing sample containers with the product being sampled. Follow the procedures in paragraph (b) of this section for manual sampling. Follow the procedures in paragraph (c) of this section for automatic sampling. Additional requirements for measuring RVP are specified in paragraph (d) of this section. A description of how to determine compliance based on single or multiple tests on single or multiple samples is specified in paragraph (e) of this section.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Manual sampling.</E>
                                 Perform manual sampling using one of the methods specified in ASTM D4057 (incorporated by reference; see § 1090.95) to demonstrate compliance with standards as follows:
                            </P>
                            <P>(1) Collect a “running” or “all-levels” sample from the top of the tank. Drawing a sample from a standpipe is acceptable only if it is slotted or perforated to ensure that the drawn sample properly represents the whole batch.</P>
                            <P>(2) Use tap sampling (or other spot sampling) to collect upper, middle, and lower samples. Collect samples that most closely match the recommendations in ASTM D4057. Adjust spot sampling for partially filled tanks as shown in Table 1, Table 5, or Table 6 of ASTM D4057, as applicable.</P>
                            <P>(3) If the procedures in paragraphs (b)(1) and (2) of this section are impractical for a given storage configuration, you may use alternative sampling procedures as specified in ASTM D4057. This applies primarily for sampling with railcars, trucks, retail outlets, and other downstream locations.</P>
                            <P>(4) Test results with manual sampling are valid only after you demonstrate homogeneity as specified in § 1090.1337. Once a batch meets homogeneity specifications, you may use any properly drawn sample to represent the batch, subject to the hand-blending provisions of § 1090.1340. The entire batch volume is noncompliant if a sample fails to meet any applicable per-gallon standard.</P>
                            <P>(5) Except as specified for marine vessels in § 1090.1605, you must not do certification testing with a composite sample from manual sampling.</P>
                            <P>
                                (c) 
                                <E T="03">Automatic sampling.</E>
                                 Perform automatic sampling as specified in ASTM D4177 (incorporated by reference; see § 1090.95), with the additional provisions specified in this paragraph (c). Automatic sampling is intended to apply for in-line blending, including configurations that involve a pipeline filling a tank that will be certified as compliant before it leaves the fuel manufacturing facility gate.
                            </P>
                            <P>(1) Follow all specifications for automatic sampling in this paragraph (c) unless EPA approves an in-line blending waiver that authorizes specific exceptions under § 1090.1315.</P>
                            <P>(2) Configure the system to ensure a well-mixed stream at the sampling point. Align the start and end of sampling with the start and end of creating the batch.</P>
                            <P>
                                (3) Set a sampling frequency to represent a batch by meeting one or more of the following specifications, 
                                <PRTPAGE P="4360"/>
                                keeping records to show that the sampling frequency meets specifications:
                            </P>
                            <P>(i) Collect 9,604 grabs.</P>
                            <P>(ii) Collect a number of grabs that achieves a margin of error of 0.01 or less as specified in Section 19.1.3 of ASTM D4177.</P>
                            <P>(iii) Collect grabs at regular intervals that do not exceed 20 seconds throughout the batch.</P>
                            <P>(4) Collect three samples for individual measurements in addition to the composite sample. Draw head, middle, and tail samples that come from the initial, middle, and final thirds of the estimated batch volume, respectively.</P>
                            <P>(5) If the composite sample fails to meet any applicable per-gallon standard, the entire batch volume is noncompliant. If one or more separate samples fail to meet any applicable per-gallon standard, the volume of noncompliant fuel is the volume starting with the last valid passing result before the failing result (or the start of the batch), up to the first valid passing result after the failing result (or the end of the batch).</P>
                            <P>(6) EPA may approve a different sampling strategy under an approved in-line blending waiver under § 1090.1315 if it is appropriate for a given facility or for a small-volume batch.</P>
                            <P>
                                (d) 
                                <E T="03">Sampling provisions related to measuring RVP of summer gasoline.</E>
                                 The following additional provisions apply for preparing samples to measure the RVP of summer gasoline:
                            </P>
                            <P>(1) Meet the additional specifications for manual and automatic sampling in ASTM D5842 (incorporated by reference; see § 1090.95).</P>
                            <P>(2) If you measure other fuel parameters for a given sample in addition to RVP testing, always measure RVP first.</P>
                            <P>
                                (e) 
                                <E T="03">Testing and reporting to demonstrate compliance with standards.</E>
                                 Perform testing as specified in this subpart and report values to demonstrate compliance with per-gallon and average standards as follows:
                            </P>
                            <P>(1) For parameters subject to per-gallon standards, report the highest measured value (or the lowest measured value for testing related to cetane index or other parameters that are subject to a standard representing a minimum value). This applies for repeat tests on a given sample and for testing multiple samples (including head, middle, and tail samples from automatic sampling).</P>
                            <P>(2) In the case of automatic sampling for parameters subject to average standards, report the result from the composite sample to represent the batch for demonstrating compliance with the average standard. For any repeat testing with the composite sample, calculate the arithmetic average from all tests to represent the batch.</P>
                            <P>(3) In the case of manual sampling for parameters subject to average standards, determine the value representing the batch as follows:</P>
                            <P>(i) For testing with only a single sample, report that value to represent the batch. If there are repeat tests with that sample, report the arithmetic average from all tests to represent the sample.</P>
                            <P>(ii) For testing with more than one sample, report the arithmetic average from all tested samples to represent the batch. If there are repeat tests for any sample, calculate the arithmetic average of those repeat tests to determine a single value to represent that sample before calculating the average value to represent the batch.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>93. Revise and republish § 1090.1337 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1337</SECTNO>
                            <SUBJECT>Demonstrating homogeneity.</SUBJECT>
                            <P>(a) Certification test results corresponding to manual sampling as specified in § 1090.1335(b) are valid only if collected samples meet the homogeneity specifications in this section, except that the homogeneity testing requirement does not apply in the following cases:</P>
                            <P>(1) There is only a single sample using the procedure specified in § 1090.1335(b)(2).</P>
                            <P>(2) Upright cylindrical tanks that have a liquid depth of less than 10 feet.</P>
                            <P>(3) Horizontal tanks with circular or elliptical cross section with a volume less than 42,000 gallons used for storing ethanol denaturant. Draw samples from the approximate mid-depth of the product level.</P>
                            <P>(4) You draw spot samples as specified in paragraph (c) of this section, test each sample for every parameter subject to a testing requirement, and use the worst-case test result for each parameter for purposes of reporting, meeting per-gallon and average standards, and all other aspects of compliance.</P>
                            <P>(5) Your tank configuration depends on roof sampling for homogeneity demonstration, but inclement weather prevents collecting roof samples and EPA has already approved a plan for a mixing procedure to ensure a homogeneous batch for your specific tank configuration. EPA approval of the mixing procedure will include consideration of product type, fill level, and other relevant parameters for specific tank configurations and batch characteristics. Keep records to document EPA approval of the mixing procedure, your actions to follow the approved mixing procedure, and the forcing weather event.</P>
                            <P>(6) Sampling occurs at a downstream location where it is not possible to collect separate samples and steps are taken to ensure that the batch is well mixed.</P>
                            <P>(7) The product being tested is certified butane or certified pentane.</P>
                            <P>(b) Any test to establish homogeneity is considered a certification test relative to a per-gallon standard for a given parameter if the test result is the worst-case value from all testing performed for the batch. Report the highest measured value as specified in § 1090.1335(e)(1).</P>
                            <P>(c) Use spot sampling as specified in § 1090.1335(b)(2) for homogeneity testing.</P>
                            <P>(d) Demonstrate homogeneity for gasoline and TGP using two of the procedures specified in this paragraph (d) with each sample. For summer gasoline, the homogeneity demonstration must include RVP measurement.</P>
                            <P>(1) Measure density or API gravity using ASTM D287, ASTM D1298, ASTM D4052, or ASTM D7777 (incorporated by reference, see § 1090.95).</P>
                            <P>(2) Measure the sulfur content as specified in § 1090.1360.</P>
                            <P>(3) Measure the benzene content as specified § 1090.1360.</P>
                            <P>(4) Measure the RVP as specified in § 1090.1360.</P>
                            <P>(e) Homogeneity requirements apply as follows for other products:</P>
                            <P>(1) Demonstrate homogeneity for diesel fuel using one of the procedures specified in paragraph (d)(1) or (2) of this section.</P>
                            <P>(2) Demonstrate homogeneity for certified ethanol denaturant and oxygenate based on measured sulfur content as specified in § 1090.1360, except that no homogeneity testing is required for DFE if you calculate sulfur content as specified in § 1090.1330.</P>
                            <P>
                                (f) Consider the batch to be homogeneous for a given parameter if the measured values for all tested samples vary by no more than the published reproducibility of the test method multiplied by 0.75 (R × 0.75). If reproducibility is a function of measured values, calculate reproducibility using the average value of the measured parameter representing all tested samples. Calculate using all meaningful significant figures as specified for the test method, even if § 1090.1350(c) describes a different precision. For cases that do not require a homogeneity demonstration under paragraph (a) of this section, the lack of homogeneity demonstration does not 
                                <PRTPAGE P="4361"/>
                                prevent a quantity of fuel, fuel additive, or regulated blendstock from being considered a batch for demonstrating compliance with the requirements of this part. The following additional provisions apply for special cases:
                            </P>
                            <P>(1) Do not use test results for a given test method for a parameter to demonstrate homogeneity if multiple measured values are at or below the test method's PLOQ, LLOQ, or valid range, as applicable. You may instead use a different test method as allowed under this subpart to get test results with the same parameter or with a different parameter.</P>
                            <P>(2) If you have homogeneity test results for more than the required number of parameters and not all parameters meet the criteria, all testing results except density or API gravity must meet applicable homogeneity criteria to demonstrate that the batch is homogeneous.</P>
                            <P>(3) If using ASTM D4052 (incorporated by reference; see § 1090.95) for measuring density or API gravity to demonstrate homogeneity through December 31, 2026, you may calculate the homogeneity criterion based on the reproducibility of the test method at the limit of the valid range for testing, even if measured results extend beyond the valid range. You may request to use an updated version of ASTM D4052 if the updated version has expanded the range of reproducibility to include your measured results. You may also request to use the provisions of this paragraph (f)(3) beyond December 31, 2026, if there is no updated version of ASTM D4052 with reproducibility that applies for your measured results.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>94. Amend § 1090.1340 by revising paragraphs (a) introductory text, (a)(1), and (a)(2)(iii) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1340</SECTNO>
                            <SUBJECT>Preparing a hand blend from BOB.</SUBJECT>
                            <P>(a) If you produce or import BOB and instruct downstream blenders to add oxygenate, you must meet the requirements of this subpart by blending oxygenate that reflects the anticipated sulfur content and benzene content of the oxygenate for blending into a BOB sample. To do this, prepare each hand blend by adding oxygenate to the BOB sample in a way that corresponds to your instructions to downstream blenders for the sampled batch of fuel. Prepare hand blends as follows:</P>
                            <P>(1) Take steps to avoid introducing high or low bias in sulfur content when selecting from available samples to prepare the hand blend. For example, if there are three samples with discrete sulfur content measurements, select the sample with the mid-range sulfur content. In other cases, randomly select the sample. If you omit the homogeneity demonstration under § 1090.1337(a)(4), prepare a single hand blend using the BOB sample that has the highest sulfur content.</P>
                            <P>(2) * * *</P>
                            <P>(iii) As an example, if you give instructions for a given batch of BOB to perform downstream blending to make E10, E15, and a blend that contains 8 volume percent butanol, prepare a hand blend for testing winter gasoline with 8 volume percent butanol, and prepare an E10 hand blend for testing summer gasoline.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>95. Amend § 1090.1345 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraph (a)(5);</AMDPAR>
                        <AMDPAR>b. Adding paragraphs (a)(6) and (7); and</AMDPAR>
                        <AMDPAR>c. Redesignating paragraphs (c) through (e) as paragraphs (b) through (d).</AMDPAR>
                        <P>The revision and additions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1345</SECTNO>
                            <SUBJECT>Retaining samples.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(5) The nominal volume of retained liquid samples must be at least 330 ml.</P>
                            <P>(6) If you have only a single sample for testing, keep that sample after testing is complete. If you collect multiple samples from a single batch, keep any sample that represents the batch, except that samples of summer gasoline must be untested.</P>
                            <P>(7) If you test a hand blend under § 1090.1340, keep a sample of the BOB and a sample representative of the oxygenate used to prepare the hand blend.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>96. Amend § 1090.1350 by revising paragraphs (c)(4) and (5) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1350</SECTNO>
                            <SUBJECT>Overview of test procedures.</SUBJECT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(4) Record oxygenate content to the nearest 0.01 mass percent for each measured oxygenate.</P>
                            <P>(5) Record diesel fuel aromatic content to the nearest 0.1 volume percent, or record cetane index to the nearest whole number.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>97. Amend § 1090.1355 by revising paragraphs (a), (b)(1), and (2) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1355</SECTNO>
                            <SUBJECT>Calculation adjustments and corrections.</SUBJECT>
                            <STARS/>
                            <P>(a) Adjust measured values for total vapor pressure as follows:</P>
                            <P>Equation 1 to paragraph (a)</P>
                            <FP SOURCE="FP-2">
                                RVP = 0.946 .P
                                <E T="52">total</E>
                                −0.347
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">RVP = Reid vapor pressure, in psi.</FP>
                                <FP SOURCE="FP-2">
                                    P
                                    <E T="52">total</E>
                                     = Measured total vapor pressure, in psi.
                                </FP>
                            </EXTRACT>
                            <P>(b) * * *</P>
                            <P>(1) If your test method involves a published procedure with a Pooled Limit of Quantitation (PLOQ), treat the PLOQ as your final result if your measured result is below the PLOQ.</P>
                            <P>(2) If your test method involves a published procedure with a limited scope but no PLOQ, treat the lower bound of the scope as your final result if your measured result is less than that value.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>98. Amend § 1090.1360 by revising paragraph (b)(1)(i) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1360</SECTNO>
                            <SUBJECT>Performance-based Measurement System.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(1) * * *</P>
                            <P>(i) Sulfur.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>99. Amend § 1090.1365 by:</AMDPAR>
                        <AMDPAR>a. Revising the introductory text and paragraphs (a)(3) and (4);</AMDPAR>
                        <AMDPAR>b. Revising and republishing paragraphs (b) and (c)(3);</AMDPAR>
                        <AMDPAR>c. Revising paragraphs (f)(2) and (5).</AMDPAR>
                        <P>The revisions and republication read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1365</SECTNO>
                            <SUBJECT>Qualifying criteria for alternative measurement procedures.</SUBJECT>
                            <P>This section specifies how to qualify alternative procedures for measuring absolute and method-defined fuel parameters under the Performance-based Measurement System specified in § 1090.1360.</P>
                            <P>(a) * * *</P>
                            <P>(3) Except as specified in paragraph (d) of this section, testing to demonstrate compliance with the precision and accuracy specifications in this section apply only for the laboratory where the testing occurred. At a given laboratory, qualifying a test method applies for all associated instruments used for testing to certify fuel.</P>
                            <P>(4) If a procedure for measuring benzene or sulfur in gasoline has no published PLOQ and no published scope with a lower bound, you must establish a LLOQ.</P>
                            <STARS/>
                            <P>
                                (b) All alternative procedures must meet precision criteria based on a calculated maximum allowable standard deviation for a given fuel parameter as specified in this paragraph (b). The precision criteria apply for measuring 
                                <PRTPAGE P="4362"/>
                                the parameters and fuels specified in paragraph (b)(4) of this section. Take the following steps to qualify the measurement procedure for measuring a given fuel parameter:
                            </P>
                            <P>(1) The fuel must meet the parameter specifications in table 1 to paragraph (b)(4) of this section. This may require that you modify the fuel you typically produce to be within the specified range. Absent a specification (maximum or minimum), select a fuel representing values that are typical for your testing. Store and mix the fuel to maintain a homogenous mixture throughout the measurement period to ensure that each fuel sample drawn from the batch has the same properties.</P>
                            <P>(2) Measure the fuel parameter from a homogeneous fuel batch at least 20 times. Record each result in sequence. Do not omit any valid results unless you use good engineering judgment to determine that the omission is necessary and you document those results and the reason for excluding them. Perform this analysis over a 20-day period. You may make up to 4 separate measurements in a 24-hour period, as long as the interval between measurements is at least 4 hours. Do not measure RVP more than once from a single sample.</P>
                            <P>(3) An alternative procedure for measuring oxygenate in gasoline must account for every type of oxygenate covered by the referee method.</P>
                            <P>(4) Calculate the maximum allowable standard deviation as follows:</P>
                            <HD SOURCE="HD3">Equation 1 to Paragraph (b)(4)</HD>
                            <GPH SPAN="1" DEEP="25">
                                <GID>ER15JA25.028</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    σ
                                    <E T="52">max</E>
                                     = Maximum allowable standard deviation.
                                </FP>
                                <FP SOURCE="FP-2">
                                    x
                                    <E T="52">1</E>
                                    , x
                                    <E T="52">2</E>
                                    , and x
                                    <E T="52">3</E>
                                     have the values from the following table:
                                </FP>
                            </EXTRACT>
                            <GPOTABLE COLS="8" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,r50,r50,10,xs60,10,10,xs60">
                                <TTITLE>
                                    Table 1 to Paragraph 
                                    <E T="01">(b)(4)</E>
                                    —Precision Criteria for Qualifying Alternative Procedures
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Fuel, fuel additive, or regulated blendstock</CHED>
                                    <CHED H="1">Fuel parameter</CHED>
                                    <CHED H="1">Range</CHED>
                                    <CHED H="1">
                                        x
                                        <E T="0732">1</E>
                                    </CHED>
                                    <CHED H="1">
                                        x
                                        <E T="0732">2</E>
                                        <LI>repeatability</LI>
                                        <LI>(r) or</LI>
                                        <LI>reproducibility</LI>
                                        <LI>
                                            (R) 
                                            <SU>1</SU>
                                        </LI>
                                    </CHED>
                                    <CHED H="1">
                                        x
                                        <E T="0732">3</E>
                                    </CHED>
                                    <CHED H="1">
                                        Fixed
                                        <LI>values of</LI>
                                        <LI>
                                            σ
                                            <E T="0732">max</E>
                                        </LI>
                                    </CHED>
                                    <CHED H="1">
                                        Source 
                                        <SU>2</SU>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">ULSD</ENT>
                                    <ENT>Sulfur</ENT>
                                    <ENT>5 ppm minimum</ENT>
                                    <ENT>1.5</ENT>
                                    <ENT>r = 1.33</ENT>
                                    <ENT>2.77</ENT>
                                    <ENT>0.72</ENT>
                                    <ENT>ASTM D3120-08.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">500 ppm LM diesel fuel</ENT>
                                    <ENT>Sulfur</ENT>
                                    <ENT>350 ppm minimum</ENT>
                                    <ENT>1.5</ENT>
                                    <ENT>r = 21.3</ENT>
                                    <ENT>2.77</ENT>
                                    <ENT>11.5</ENT>
                                    <ENT>ASTM D2622-16.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">ECA marine fuel</ENT>
                                    <ENT>Sulfur</ENT>
                                    <ENT>700 ppm minimum</ENT>
                                    <ENT>1.5</ENT>
                                    <ENT>r = 37.1</ENT>
                                    <ENT>2.77</ENT>
                                    <ENT>20.1</ENT>
                                    <ENT>ASTM D2622-16.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Butane</ENT>
                                    <ENT>Sulfur</ENT>
                                    <ENT/>
                                    <ENT>1.5</ENT>
                                    <ENT>r = 0.1152 · x</ENT>
                                    <ENT>2.77</ENT>
                                    <ENT/>
                                    <ENT>ASTM D6667-14.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Gasoline</ENT>
                                    <ENT>Sulfur</ENT>
                                    <ENT/>
                                    <ENT>1.5</ENT>
                                    <ENT>
                                        r = 0.4998 · x
                                        <SU>0.54</SU>
                                    </ENT>
                                    <ENT>2.77</ENT>
                                    <ENT/>
                                    <ENT>ASTM D7039-15a.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Gasoline</ENT>
                                    <ENT>Oxygenate</ENT>
                                    <ENT/>
                                    <ENT>0.3</ENT>
                                    <ENT>
                                        R = 0.13 · x
                                        <SU>0.83</SU>
                                    </ENT>
                                    <ENT>1</ENT>
                                    <ENT/>
                                    <ENT>ASTM D5599-18.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Gasoline</ENT>
                                    <ENT>
                                        RVP 
                                        <SU>3</SU>
                                    </ENT>
                                    <ENT/>
                                    <ENT>0.3</ENT>
                                    <ENT>R = 0.40</ENT>
                                    <ENT>1</ENT>
                                    <ENT>0.12</ENT>
                                    <ENT>ASTM D5191-15</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Gasoline</ENT>
                                    <ENT>Benzene</ENT>
                                    <ENT/>
                                    <ENT>0.15</ENT>
                                    <ENT>
                                        R = 0.221 · x
                                        <SU>0.67</SU>
                                    </ENT>
                                    <ENT>1</ENT>
                                    <ENT/>
                                    <ENT>ASTM D5769-20.</ENT>
                                </ROW>
                                <TNOTE>
                                    <SU>1</SU>
                                     Calculate repeatability and reproducibility using the average value determined from testing. Use units as specified in § 1090.1350(c).
                                </TNOTE>
                                <TNOTE>
                                    <SU>2</SU>
                                     Note that the listed procedure may be different than the referee procedure identified in § 1090.1360(d), or it may be an older version of the referee procedure.
                                </TNOTE>
                                <TNOTE>
                                    <SU>3</SU>
                                     Use only 1-liter containers for testing to qualify alternative methods.
                                </TNOTE>
                            </GPOTABLE>
                            <P>(c) * * *</P>
                            <P>(3) The measurement procedure meets the accuracy requirement as follows:</P>
                            <P>(i) Demonstrate accuracy for measuring sulfur in gasoline and butane using samples to represent sulfur values from 1 to 10 ppm, 11 to 20 ppm, and 21 to 95 ppm. You may omit any of these ranges if you do not perform testing with fuel in that range. Calculate the maximum allowable difference between the average measured value and the ARV for each applicable range as follows:</P>
                            <HD SOURCE="HD3">Equation 2 to Paragraph (c)(3)(i)</HD>
                            <FP SOURCE="FP-2">
                                Δ
                                <E T="52">max</E>
                                 = 0.75 · σ
                                <E T="52">max</E>
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    Δ
                                    <E T="52">max</E>
                                     = Maximum allowable difference.
                                </FP>
                                <FP SOURCE="FP-2">
                                    σ
                                    <E T="52">max</E>
                                     = Maximum allowable standard deviation, per paragraph (b)(4) of this section, using the sulfur content represented by the ARV.
                                </FP>
                            </EXTRACT>
                            <P>(ii) Demonstrate accuracy for measuring sulfur in diesel fuel using test fuels meeting the specifications in table 2 to this section. For testing diesel fuel-related blendstocks and additives, use representative test samples meeting the appropriate sulfur specification. Table 2 to this paragraph also identifies the maximum allowable difference between average measured value and the ARV corresponding to the ARV at the upper end of each specified range. These values are based on calculations with the equation in paragraph (c)(3)(i) of this section, with parameter values set equal to the standard.</P>
                            <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12,12">
                                <TTITLE>
                                    Table 2 to Paragraph 
                                    <E T="01">(c)(3)(ii)</E>
                                    —Accuracy Criteria for Qualifying Alternative Procedures With Diesel Fuel and Diesel Fuel-Related Blendstocks and Additives
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Fuel</CHED>
                                    <CHED H="1">
                                        Sulfur content
                                        <LI>(ppm)</LI>
                                    </CHED>
                                    <CHED H="1">
                                        Illustrated
                                        <LI>maximum</LI>
                                        <LI>allowable</LI>
                                        <LI>difference</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">ULSD</ENT>
                                    <ENT>10-20</ENT>
                                    <ENT>0.54</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">500 ppm LM diesel fuel</ENT>
                                    <ENT>450-500</ENT>
                                    <ENT>8.65</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">ECA marine fuel</ENT>
                                    <ENT>900-1,000</ENT>
                                    <ENT>15.1</ENT>
                                </ROW>
                            </GPOTABLE>
                            <STARS/>
                            <P>(f) * * *</P>
                            <P>(2) Test with a range of fuels that are typical of those you will analyze at your laboratory. Use either consensus-named fuels or locally named reference materials. Consensus-named fuels are homogeneous fuel quantities sent around to different laboratories for analysis, which results in a “consensus name” representing the average value of the parameter for all participating laboratories. Locally named reference materials are fuel samples analyzed using the reference test method, either at your laboratory or at a reference installation, to establish an estimated value for the fuel parameter; locally named reference materials usually come from the fuel you produce.</P>
                            <STARS/>
                            <PRTPAGE P="4363"/>
                            <P>(5) Perform testing at your laboratory as specified in paragraph (b) of this section to establish the repeatability of the alternative procedure. The repeatability must be as good as or better than that specified in paragraph (b)(4) of this section.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>100. Amend § 1090.1370 by revising paragraph (b) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1370</SECTNO>
                            <SUBJECT>Qualifying criteria for reference installations.</SUBJECT>
                            <STARS/>
                            <P>(b) You may qualify a reference installation for VCSB procedures by participating in an inter-laboratory crosscheck program with at least 16 separate measurements that are not identified as outliers. This presumes that the results for the candidate reference installation are not outliers.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>101. Amend § 1090.1375 by:</AMDPAR>
                        <AMDPAR>a. Redesignating paragraph (a)(4) as (a)(5) and adding new paragraph (a)(4);</AMDPAR>
                        <AMDPAR>b. Revising paragraphs (c) introductory text, (c)(2), and (c)(4); and</AMDPAR>
                        <AMDPAR>c. Adding paragraphs (d) and (e).</AMDPAR>
                        <P>The additions and revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1375</SECTNO>
                            <SUBJECT>Quality control procedures.</SUBJECT>
                            <STARS/>
                            <P>(a) * * *</P>
                            <P>(4) Keep records to document any test results excluded for being out of control under Section 8.5 and A1.5.4.1 of ASTM D6299. Identify the assignable cause and include any appropriate additional supporting justification.</P>
                            <STARS/>
                            <P>
                                (c) 
                                <E T="03">Accuracy demonstration.</E>
                                 For absolute fuel parameters (VCSB and non-VCSB) and for method-defined fuel parameters using non-VCSB methods, you must show that you meet accuracy criteria as specified in this paragraph (c). For method-defined VCSB procedures, you may meet accuracy requirements as specified in this paragraph (c) or by comparing your results to the accepted reference value in an inter-laboratory crosscheck program as specified in paragraph (d) of this section.
                            </P>
                            <STARS/>
                            <P>(2) Except as specified in paragraph (c)(3) of this section, test every instrument using a check standard meeting the specifications of ASTM D6299. Select a fuel sample with an ARV representing fuel that is typical for your testing.</P>
                            <STARS/>
                            <P>(4) You meet accuracy requirements under this section if the difference between your measured value for the check standard and the ARV is less than the value from the following equation:</P>
                            <P>Equation 1 to paragraph (c)(4)</P>
                            <GPH SPAN="3" DEEP="40">
                                <GID>ER15JA25.029</GID>
                            </GPH>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">
                                    Δ
                                    <E T="52">max</E>
                                     = Maximum allowable difference.
                                </FP>
                                <FP SOURCE="FP-2">L = Total number of test results used to determine the ARV of a consensus-named fuel. For testing locally named fuels for which no consensus-based ARV applies, use L equal to ∞.</FP>
                                <FP SOURCE="FP-2">R = Reproducibility of the referee procedure identified in § 1090.1360(d), as noted in table 1 to § 1090.1365(b)(4) or in the following table:</FP>
                            </EXTRACT>
                            <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s200,r50,r50">
                                <TTITLE>
                                    Table 1 to Paragraph (
                                    <E T="01">c</E>
                                    )(4)—Criteria for Qualifying Alternative Procedures
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Tested product</CHED>
                                    <CHED H="1">
                                        Referee
                                        <LI>
                                            procedure 
                                            <SU>1</SU>
                                        </LI>
                                    </CHED>
                                    <CHED H="1">
                                        Reproducibility (R) 
                                        <SU>2</SU>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">ULSD, 500 ppm diesel fuel, ECA marine fuel, diesel fuel additive, gasoline, gasoline regulated blendstock, and gasoline additive</ENT>
                                    <ENT>ASTM D2622</ENT>
                                    <ENT>
                                        R = 0.4273 · x
                                        <SU>0.8015</SU>
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">Butane</ENT>
                                    <ENT>ASTM D6667</ENT>
                                    <ENT>R = 0.3130 · x</ENT>
                                </ROW>
                                <TNOTE>
                                    <SU>1</SU>
                                     ASTM specifications are incorporated by reference, see § 1090.95.
                                </TNOTE>
                                <TNOTE>
                                    <SU>2</SU>
                                     Calculate reproducibility using the average value determined from testing. Use units as specified in § 1090.1350(c).
                                </TNOTE>
                            </GPOTABLE>
                            <P>
                                (d) 
                                <E T="03">Demonstrating accuracy by participating in crosscheck programs.</E>
                                 You may meet accuracy requirements under paragraph (c) of this section by comparing your results to the accepted reference value in an inter-laboratory crosscheck program sponsored by ASTM International or another VCSB at least three times per year (two times per year for RVP), subject to the following provisions:
                            </P>
                            <P>(1) Your results from the crosscheck program are not valid for demonstrating compliance with accuracy requirements for a test instrument under this section if any of the following apply:</P>
                            <P>(i) The crosscheck program does not have a robust ARV based on the check standard requirements in Section 6.2 of ASTM D6299.</P>
                            <P>(ii) The difference between the test result and the ARV is greater than the maximum allowable difference in paragraph (c)(4) of this section.</P>
                            <P>(iii) The measured value lies outside of the three-sigma range for the data from the relevant inter-laboratory crosscheck program.</P>
                            <P>(2) If your results from the crosscheck program are not valid under paragraph (a)(1) of this section, perform a root cause analysis and document your findings and the steps you take to correct the problem. You continue to meet accuracy requirements under this section for the affected parameter only if you correct the problem and demonstrate compliance with the accuracy requirements of this section within 45 days after learning of a failure under paragraph (d)(1) of this section. The compliance demonstration may be based on in-house testing using a check standard qualified by a third party, on a non-VCSB correlation program administered by a third party, or on testing in the next crosscheck program.</P>
                            <P>
                                (e) 
                                <E T="03">Failure to meet precision or accuracy requirements.</E>
                                 The presumed values specified in § 1090.1710(g) apply relative to certification for parameter measurements with test instruments failing to meet precision or accuracy requirements under this section. If you fail to meet the deadlines for resolving crosscheck-related issues under paragraph (d)(2) of this section, the presumed values apply relative to certification for parameter measurements with the test instruments failing to meet precision or accuracy 
                                <PRTPAGE P="4364"/>
                                requirements starting at the point of learning of a failure under paragraph (d)(1) of this section.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>102. Amend § 1090.1390 by revising the section heading to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1390</SECTNO>
                            <SUBJECT>Requirement for automated detergent blending equipment calibration.</SUBJECT>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>103. Amend § 1090.1395 by revising paragraphs (a) introductory text, (a)(1)(i), and (b) introductory text to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1395</SECTNO>
                            <SUBJECT>Gasoline deposit control test procedures.</SUBJECT>
                            <STARS/>
                            <P>
                                (a) 
                                <E T="03">Top Tier-based test method.</E>
                                 Use the procedures specified in ASTM D6201 (incorporated by reference, see § 1090.95), as follows:
                            </P>
                            <P>(1) * * *</P>
                            <P>(i) 8.0-10.0 volume percent ethanol that meets the requirements in § 1090.270 and conforms to the specifications of ASTM D4806 (incorporated by reference, see § 1090.95).</P>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">CARB test method.</E>
                                 Use the procedures specified by CARB in Title 13, California Code of Regulations, section 2257 (incorporated by reference, see § 1090.95).
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart O—Survey Provisions</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>104. Amend § 1090.1400 by revising paragraph (a)(2) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1400</SECTNO>
                            <SUBJECT>General provisions.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(2) The program plan must be signed by the RCO of the independent surveyor conducting the program.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>105. Amend § 1090.1405 by revising paragraphs (a)(1) and (b)(2) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1405</SECTNO>
                            <SUBJECT>National fuels survey program.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(1) A gasoline manufacturer that elects to account for oxygenate added downstream under § 1090.710 must participate in the national fuels survey program (NFSP) specified in paragraph (b) of this section.</P>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(2) The survey program must be conducted by collecting samples representative of retail outlets in the United States as specified in § 1090.1415.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>106. Amend § 1090.1410 by revising paragraphs (b)(1), (2), (c)(3), (5), (d), and (e) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1410</SECTNO>
                            <SUBJECT>Independent surveyor requirements.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(1) Obtain samples representative of the gasoline and diesel fuel (including diesel fuel made available at retail outlets to nonroad vehicles, engines, and equipment) offered for sale separately from all retail outlets in accordance with the survey program plan approved by EPA, or immediately notify EPA of any refusal of a retailer to allow samples to be taken.</P>
                            <P>(2) Obtain the number of samples representative of the number of retail outlets offering E15.</P>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(3) Diesel fuel samples must be analyzed for sulfur content.</P>
                            <STARS/>
                            <P>(5) All testing must be completed by an EPA-approved laboratory within 10 business days after receipt of the sample.</P>
                            <P>(d) Verify E15 labeling requirements at retail outlets that offer E15 for sale.</P>
                            <P>(e)(1) Using procedures specified in an EPA-approved plan under § 1090.1415, notify EPA, the retailer, and the branded fuel manufacturer (if applicable) within 24 hours after an EPA-approved laboratory has completed analysis when any of the following occur:</P>
                            <P>(i) A test result for a gasoline sample yields a sulfur content result that exceeds the downstream sulfur per-gallon standard in § 1090.205(c).</P>
                            <P>(ii) A test result for a gasoline sample yields an RVP result that exceeds the applicable RVP standard in § 1090.215.</P>
                            <P>(iii) A test result for a diesel fuel sample yields a sulfur content result that exceeds the sulfur standard in § 1090.305(b).</P>
                            <P>(iv) A test result for a gasoline sample identified as “E15” yields an ethanol content result that exceeds 15 volume percent.</P>
                            <P>(v) A test result for a gasoline sample not identified as “E15” yields an ethanol content of more than 10 volume percent ethanol.</P>
                            <P>(2) Any notification to EPA or a branded fuel manufacturer under paragraph (e)(1) of this section must include the retail outlet's contact information, including name, title, mailing address, telephone number, and email address of a representative of the retail outlet, if available.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>107. Amend § 1090.1415 by:</AMDPAR>
                        <AMDPAR>a. Revising and republishing paragraph (d); and</AMDPAR>
                        <AMDPAR>b. Revising paragraphs (e)(2) and (f) introductory text.</AMDPAR>
                        <P>The revisions and republication read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1415</SECTNO>
                            <SUBJECT>Survey program plan design requirements.</SUBJECT>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">Retail outlet selection.</E>
                                 (1) Retail outlets to be sampled in a sampling area must be selected from among all gasoline retail outlets in the United States with the probability of selection proportionate to the volume of gasoline sold at the retail outlet. The sample of retail outlets must also include gasoline retail outlets with different brand names as well as those gasoline retail outlets that are unbranded.
                            </P>
                            <P>(2) For any retail outlet from which a sample of gasoline or diesel fuel was collected during a survey and was reported to EPA under § 1090.1410(e), that retail outlet must be included in the subsequent survey.</P>
                            <P>(3) At least one sample of a product dispensed as E15 must be collected at each gasoline retail outlet when E15 is present, and separate samples must be taken that represent the gasoline contained in each storage tank at the gasoline retail outlet unless collection of separate samples is not practicable.</P>
                            <P>(4) At least one sample of diesel fuel must be collected at each retail outlet when diesel fuel is present. Samples of diesel fuel may be collected at retail outlets that sell gasoline.</P>
                            <P>(e) * * *</P>
                            <P>(2) The minimum number of samples to be included in the survey program plan for each calendar year is calculated as follows:</P>
                            <P>Equation 1 paragraph (e)(2)</P>
                            <GPH SPAN="3" DEEP="37">
                                <GID>ER15JA25.030</GID>
                            </GPH>
                            <EXTRACT>
                                <PRTPAGE P="4365"/>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">n = Minimum number of samples in a year-long survey series. However, n must be greater than or equal to 2,000 for the number of diesel fuel samples or 5,000 for the number of gasoline samples.</FP>
                                <FP SOURCE="FP-2">
                                    Z
                                    <E T="7334">α</E>
                                     = Upper percentile point from the normal distribution to achieve a one-tailed 95 percent confidence level (5 percent α-level). For purposes of this survey program, Z
                                    <E T="7334">α</E>
                                     equals 1.645.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Z
                                    <E T="7334">β</E>
                                     = Upper percentile point to achieve 95 percent power. For purposes of this survey program, Z
                                    <E T="7334">β</E>
                                     equals 1.645.
                                </FP>
                                <FP SOURCE="FP-2">
                                    φ
                                    <E T="52">1</E>
                                     = Maximum proportion of noncompliant outlets for a region to be deemed compliant. This parameter needs to be 5 percent or greater (
                                    <E T="03">i.e.,</E>
                                     5 percent or more of the outlets, within a stratum such that the region is considered noncompliant).
                                </FP>
                                <FP SOURCE="FP-2">
                                    φ
                                    <E T="52">0</E>
                                     = Underlying proportion of noncompliant outlets in a sample. For the first survey program plan, φ
                                    <E T="52">0</E>
                                     will be 2.3 percent. For subsequent survey program plans, φ
                                    <E T="52">0</E>
                                     will be the average of the proportion of outlets found to be noncompliant over the previous 4 surveys.
                                </FP>
                                <FP SOURCE="FP-2">
                                    F
                                    <E T="52">a</E>
                                     = Adjustment factor for the number of extra samples required to compensate for samples that could not be included in the survey (
                                    <E T="03">e.g.,</E>
                                     due to technical or logistical considerations), based on the number of additional samples required during the previous 4 surveys. F
                                    <E T="52">a</E>
                                     must be greater than or equal to 1.1.
                                </FP>
                                <FP SOURCE="FP-2">
                                    F
                                    <E T="52">b</E>
                                     = Adjustment factor for the number of samples required to resample each retail outlet with test results reported to EPA under § 1090.1410(e), based on the rate of resampling required during the previous 4 surveys. F
                                    <E T="52">b</E>
                                     must be greater than or equal to 1.1.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Su
                                    <E T="52">n</E>
                                     = Number of surveys per year. For purposes of this survey program, Su
                                    <E T="52">n</E>
                                     equals 4.
                                </FP>
                                <FP SOURCE="FP-2">
                                    St
                                    <E T="52">n</E>
                                     = Number of sampling strata. For purposes of this survey program, St
                                    <E T="52">n</E>
                                     equals 3.
                                </FP>
                            </EXTRACT>
                            <STARS/>
                            <P>
                                (f) 
                                <E T="03">Laboratory designation.</E>
                                 Any laboratory that the independent surveyor intends to use to test samples collected as part of the NFSP must be approved annually as part of the survey program plan approval process under § 1090.1400(a). In the survey program plan submitted to EPA, the independent surveyor must include the following information regarding any laboratory they intend to use to test samples:
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>108. Amend § 1090.1420 by revising and republishing paragraph (a) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1420</SECTNO>
                            <SUBJECT>Additional requirements for E15 misfueling mitigation surveying.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">E15 misfueling mitigation survey requirement.</E>
                                 (1) Any gasoline manufacturer, oxygenate blender, or oxygenate producer that produces, introduces into commerce, sells, or offers for sale gasoline, BOB, DFE, or gasoline-ethanol blended fuel that is intended for use in or as E15 must comply with either survey program Option 1 (as specified in paragraph (b) of this section) or Option 2 (as specified in paragraph (c) of this section).
                            </P>
                            <P>(2) For an oxygenate producer that produces or imports DFE, the DFE is deemed as intended for use in E15 unless the oxygenate producer demonstrates that it was not intended for such use. The oxygenate producer may demonstrate, at a minimum, that DFE is not intended for use in E15 by including language on PTDs stating that the DFE is not intended for use in E15, entering into contracts with oxygenate blenders to limit the use of their DFE to gasoline-ethanol blended fuels of no more than 10 volume percent ethanol, and limiting the concentration of their DFE to no more than 10 volume percent ethanol in their fuel additive registration under 40 CFR part 79.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>109. Amend § 1090.1450 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraph (c)(2)(v);</AMDPAR>
                        <AMDPAR>b. Revising and republishing paragraph (c)(3); and</AMDPAR>
                        <AMDPAR>c. Revising paragraphs (c)(4) introductory text, (c)(10) introductory text, (c)(10)(iii), (d)(2)(i), (d)(3)(ii), (d)(4) introductory text, (d)(4)(iv), and (d)(5).</AMDPAR>
                        <P>The revisions and republication read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1450</SECTNO>
                            <SUBJECT>National sampling and testing oversight program.</SUBJECT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>(2) * * *</P>
                            <P>(v) Samples collected must be shipped via ground service within 2 business days from when the samples are collected to an EPA-approved laboratory as established in an approved NSTOP plan under this section. A random subset of collected samples must also be shipped to the EPA National Vehicle and Fuel Emissions Laboratory as established in an approved NSTOP plan under this section.</P>
                            <P>(3) Test, or arrange to be tested, samples collected under paragraph (c)(2) of this section as follows:</P>
                            <P>(i) Winter gasoline samples must be analyzed for oxygenate content, sulfur content, benzene content, distillation parameters, aromatics, and olefins.</P>
                            <P>(ii) Summer gasoline samples must be analyzed for oxygenate content, sulfur content, benzene content, distillation parameters, aromatics, olefins, and RVP, except that samples of exempt gasoline under § 1090.630 do not need to be analyzed for RVP.</P>
                            <P>(iii) All samples must be tested by an EPA-approved laboratory using test methods specified in subpart N of this part.</P>
                            <P>(iv) All analyses must be completed by an EPA-approved laboratory within 10 business days after receipt of the sample.</P>
                            <P>(v) A gasoline manufacturer must analyze gasoline samples for sulfur content, benzene content, and for summer gasoline, RVP, except that samples of exempt gasoline under § 1090.630 do not need to be analyzed for RVP.</P>
                            <P>(4) Using procedures specified in an EPA-approved NSTOP plan under this section, notify EPA and the gasoline manufacturer within 24 hours after an EPA-approved laboratory has completed analysis when any of the following occur:</P>
                            <STARS/>
                            <P>(10) Review the test performance index and precision ratio for each method and instrument the laboratory used to test gasoline samples collected under this section as follows:</P>
                            <STARS/>
                            <P>(iii) A gasoline manufacturer must supply copies of the necessary information to the independent surveyor to review the TPI and PR for each method and instrument used to test gasoline samples collected under this section.</P>
                            <STARS/>
                            <P>(d) * * *</P>
                            <P>(2) * * *</P>
                            <P>(i) Each participating gasoline manufacturing facility must be sampled at least once during each season they produce fuel. The NSTOP plan must demonstrate how these facilities will be randomly selected within the summer and winter seasons.</P>
                            <STARS/>
                            <P>(3) * * *</P>
                            <P>(ii) The minimum number of samples to be included in the NSTOP plan for each calendar year is calculated as follows:</P>
                            <P>Equation 1 to paragraph (d)(3)(ii)</P>
                            <FP SOURCE="FP-2">
                                n = R · F
                                <E T="52">a</E>
                                 · F
                                <E T="52">b</E>
                                 · Su
                                <E T="52">n</E>
                            </FP>
                            <EXTRACT>
                                <FP SOURCE="FP-2">Where:</FP>
                                <FP SOURCE="FP-2">n = Minimum number of samples in a year.</FP>
                                <FP SOURCE="FP-2">R = Number of participating gasoline manufacturing facilities.</FP>
                                <FP SOURCE="FP-2">
                                    F
                                    <E T="52">a</E>
                                     = Adjustment factor for the number of extra samples required to compensate for samples that could not be included in the NSTOP (
                                    <E T="03">e.g.,</E>
                                     due to technical or logistical considerations), based on the number of additional samples required during the previous 2 calendar years. F
                                    <E T="52">a</E>
                                     must be greater than or equal to 1.1.
                                </FP>
                                <FP SOURCE="FP-2">
                                    F
                                    <E T="52">b</E>
                                     = Adjustment factor for the number of samples required to ensure oversight. For purposes of this program, F
                                    <E T="52">b</E>
                                     equals 1.25.
                                </FP>
                                <FP SOURCE="FP-2">
                                    Su
                                    <E T="52">n</E>
                                     = Number of samples required per participating facility per year. For purposes of this program, Su
                                    <E T="52">n</E>
                                     equals 2.
                                </FP>
                            </EXTRACT>
                            <PRTPAGE P="4366"/>
                            <P>
                                (4) 
                                <E T="03">Laboratory designation.</E>
                                 Any laboratory that the independent surveyor intends to use to test samples collected as part of the NSTOP must be approved annually as part of the NSTOP plan approval process in § 1090.1400(a). The independent surveyor must include the following information regarding each laboratory it intends to use to test samples:
                            </P>
                            <STARS/>
                            <P>(iv) Records demonstrating the laboratory's performance in a laboratory crosscheck program for the most recent 12 months prior to submission of the NSTOP plan.</P>
                            <P>
                                (5) 
                                <E T="03">Sampling procedure.</E>
                                 The NSTOP plan must include a detailed description of the sampling procedures used to collect samples at participating gasoline manufacturing facilities.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart P—Retailer and Wholesale Purchaser-Consumer Provisions</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>110. Amend § 1090.1515 by revising the section heading to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1515</SECTNO>
                            <SUBJECT>Diesel fuel sulfur labeling provisions.</SUBJECT>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart Q—Importer and Exporter Provisions</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>111. Amend § 1090.1600 by revising paragraphs (b) and (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1600</SECTNO>
                            <SUBJECT>General provisions for importers.</SUBJECT>
                            <STARS/>
                            <P>(b)(1) Except as specified in paragraph (b)(2) of this section, all applicable standards in subparts C and D of this part apply to imported gasoline and diesel fuel, respectively.</P>
                            <P>(2) An importer that imports gasoline at multiple import facilities must comply with the gasoline average standards in §§ 1090.205(a) and 1090.210(a) as specified in § 1090.705(b), unless the importer complies with the provisions of § 1090.1610 to meet the alternative per-gallon standards for rail or truck imports specified in §§ 1090.205(d) and 1090.210(c).</P>
                            <STARS/>
                            <P>(d) Alternative testing requirements for an importer that imports fuel, fuel additive, or regulated blendstock by rail or truck are specified in § 1090.1610.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>112. Amend § 1090.1605 by revising and republishing paragraph (b)(1) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1605</SECTNO>
                            <SUBJECT>Importation by marine vessel.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(1) The importer must sample each compartment of the vessel and use one of the following methods to meet testing requirements:</P>
                            <P>(i) Treat each compartment as a separate batch. Each individual compartment is deemed to meet the homogeneity requirements in § 1090.1337.</P>
                            <P>(ii) For summer gasoline, measure the RVP of a sample collected from each compartment. In the case of blending oxygenate with imported gasoline, collect samples and measure RVP before or after blending as described in § 1090.1310(c)(1) and (2). For testing all other products, combine samples from separate compartments into a single, vessel-volumetric composite sample using the procedures in Section 9.2.4 of ASTM D4057 (incorporated by reference, see § 1090.95). Test results from the composite sample are valid only if single samples collected from each affected compartment together meet the homogeneity requirements in § 1090.1337.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>113. Revise and republish § 1090.1610 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1610</SECTNO>
                            <SUBJECT>Importation by rail or truck.</SUBJECT>
                            <P>(a) An importer that imports fuel, fuel additive, or regulated blendstock by rail or truck must meet the sampling and testing requirements of subpart N of this part by sampling and testing each compartment of the railcar or truck unless they do one of the following:</P>
                            <P>
                                (1) 
                                <E T="03">Use supplier results.</E>
                                 The importer may rely on test results from the supplier for fuel, fuel additive, or regulated blendstock imported by rail or truck if the importer meets all the following requirements:
                            </P>
                            <P>(i) The importer obtains documentation of test results from the supplier for each batch of fuel, fuel additive, or regulated blendstock in accordance with the following requirements:</P>
                            <P>(A) The testing includes measurements for all the parameters specified in § 1090.1310 using the measurement procedures specified in § 1090.1350.</P>
                            <P>(B) Testing for a given batch occurs after the most recent delivery into the supplier's storage tank and before transferring the fuel, fuel additive, or regulated blendstock to the railcar or truck.</P>
                            <P>(ii) The importer conducts testing to verify test results from each supplier as follows:</P>
                            <P>(A) Collect a sample at least once every 30 days or every 50 rail or truckloads from a given supplier, whichever is more frequent. Test the sample as specified in paragraphs (a)(1)(i)(A) and (B) of this section.</P>
                            <P>(B) Treat importation of each fuel, fuel additive, or regulated blendstock separately, but treat railcars or truckloads together if the fuel, fuel additive, or regulated blendstock is imported from a given supplier by rail or truck.</P>
                            <P>
                                (2) 
                                <E T="03">Certify in a storage tank.</E>
                                 The importer may transfer the fuel, fuel additive, or regulated blendstock imported by rail or truck into storage tanks that also contain the same product if the importer meets the following requirements:
                            </P>
                            <P>(i) For gasoline, the importer transfers gasoline into one or more empty tanks or tanks containing PCG that the importer owns.</P>
                            <P>(A) If the importer transfers gasoline into one or more empty tanks, they must sample and test the sulfur content, benzene content, and for summer gasoline, RVP, of each tank into which the gasoline was transferred.</P>
                            <P>(B) If the importer transfers gasoline into one or more tanks containing PCG, they must sample the PCG already in the tank prior to transferring gasoline from the train or truck, test the sulfur content and benzene content, and report this PCG as a negative batch as specified in § 1090.905(c)(3)(i). After transferring the gasoline into the tanks, the importer must sample and test the sulfur content, benzene content, and for summer gasoline, RVP, of each tank into which the gasoline was transferred and report the volume, sulfur content, and benzene content as a positive batch.</P>
                            <P>(C) Include the PCG in the tank before transferring and the volume and properties after transferring in compliance calculations as specified in § 1090.700(d)(4)(i).</P>
                            <P>(D) The sample retention requirements in § 1090.1345 apply to the samples taken prior to transferring and those taken after transferring.</P>
                            <P>(ii) For all other fuel, fuel additive, or regulated blendstock, the importer must sample and test the fuel, fuel additive, or regulated blendstock in each tank into which it was transferred. The importer must ensure that all applicable per-gallon standards are met before the fuel, fuel additive, or regulated blendstock is shipped from the tank.</P>
                            <P>
                                (b) If an importer that elects to comply with paragraph (a)(1) or (2) of this section fails to meet the applicable requirements, they must meet the sampling and testing requirements of subpart N of this part for each compartment of the railcar or truck until EPA determines that the importer has 
                                <PRTPAGE P="4367"/>
                                adequately addressed the cause of the failure.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>114. Amend § 1090.1615 by revising and republishing paragraph (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1615</SECTNO>
                            <SUBJECT>Gasoline treated as a blendstock.</SUBJECT>
                            <STARS/>
                            <P>(d)(1) The importer must treat the GTAB as if it were imported gasoline and complete all the requirements for a gasoline manufacturer under § 1090.105(a) (except for the sampling, testing, and sample retention requirements in § 1090.105(a)(6)) for the GTAB at the time it is imported.</P>
                            <P>
                                (2) Any GTAB that ultimately is not used to produce gasoline (
                                <E T="03">e.g.,</E>
                                 a tank bottom of GTAB) must be treated as newly imported gasoline and must meet all applicable requirements for imported gasoline.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart R—Compliance and Enforcement Provisions</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>115. Amend § 1090.1710 by revising paragraph (g) introductory text to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1710</SECTNO>
                            <SUBJECT>Penalties.</SUBJECT>
                            <STARS/>
                            <P>(g) The presumed fuel parameter values in this paragraph (g) apply for cases in which any person fails to comply with the sampling or testing requirements and must be reported, unless EPA, in its sole discretion, approves a different value. Any person requesting the use of alternative test values must submit their request to EPA as specified in § 1090.10 within 30 days of discovering failure to comply with sampling and testing requirements, except that the request will be considered timely if the sampling and testing violation is self-disclosed under EPA's audit policy and the request is submitted by the certification deadline for the self-disclosure.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>116. Amend § 1090.1715 by:</AMDPAR>
                        <AMDPAR>a. Revising paragraph (c); and</AMDPAR>
                        <AMDPAR>b. Revising and republishing paragraph (e).</AMDPAR>
                        <P>The revisions and republication read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1715</SECTNO>
                            <SUBJECT>Liability provisions.</SUBJECT>
                            <STARS/>
                            <P>(c) Any parent corporation is liable for any violation committed by any of its wholly owned subsidiaries.</P>
                            <STARS/>
                            <P>(e)(1) Any person who produced, imported, sold, offered for sale, dispensed, supplied, offered for supply, stored, transported, caused the transportation or storage of, or introduced into commerce fuel, fuel additive, or regulated blendstock that is in the storage tank containing fuel, fuel additive, or regulated blendstock that is found to be in violation of a per-gallon standard is liable for the violation.</P>
                            <P>(2) In order for a carrier to be liable under paragraph (e)(1) of this section, EPA must demonstrate by reasonably specific showing, by direct or circumstantial evidence, that the carrier caused the violation.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart S—Attestation Engagements</HD>
                    </SUBPART>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>117. Amend § 1090.1800 by:</AMDPAR>
                        <AMDPAR>a. Adding paragraph (a)(3); and</AMDPAR>
                        <AMDPAR>b. Revising paragraphs (b)(1)(ii) and (d)(1).</AMDPAR>
                        <P>The addition and revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 1090.1800</SECTNO>
                            <SUBJECT>General provisions.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(3) A gasoline manufacturer that transacts sulfur or benzene credits under this part.</P>
                            <P>(b) * * *</P>
                            <P>(1) * * *</P>
                            <P>
                                (ii) The auditor may be a certified public accountant, or firm of such accountants, that is independent of the gasoline manufacturer. Such an auditor must comply with the AICPA 
                                <E T="03">Code of Professional Conduct,</E>
                                 including its independence requirements, the AICPA 
                                <E T="03">Statements on Quality Control Standards (SQCS) No. 8, A Firm's System of Quality Control,</E>
                                 the AICPA 
                                <E T="03">Statement on Quality Management Standards (SQMS) No. 1, No. 2, and No. 3</E>
                                 (all incorporated by reference, see § 1090.95), and applicable rules of state boards of public accountancy. Such an auditor must also perform the attestation engagement in accordance with the AICPA 
                                <E T="03">Statement on Standards for Attestation Engagements (SSAE) No. 19, Agreed-Upon Procedures Engagements,</E>
                                 especially as noted in sections AT-C 105, 215, and 315 (incorporated by reference, see § 1090.95).
                            </P>
                            <STARS/>
                            <P>(d) * * *</P>
                            <P>(1) The auditor must prepare an attestation engagement report identifying the applicable procedures specified in this subpart along with the auditor's corresponding findings for each procedure. The auditor must submit the attestation engagement report electronically to EPA by June 1 of the year following the compliance period.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>118. Amend § 1090.1805 by revising paragraph (a)(3) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1805</SECTNO>
                            <SUBJECT>Representative samples.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(3) Determine sample size using an alternate method that is equivalent to or better than the methods specified in paragraphs (a)(1) and (2) of this section with respect to strength of inference and freedom from bias. An auditor that determines a sample size using an alternate method must describe and justify the alternate method in the attestation engagement report.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>119. Revise and republish § 1090.1810 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1810</SECTNO>
                            <SUBJECT>General procedures for gasoline manufacturers.</SUBJECT>
                            <P>An auditor must perform the procedures specified in this section for a gasoline manufacturer that produces gasoline in the United States.</P>
                            <P>
                                (a) 
                                <E T="03">Registration and reports.</E>
                                 An auditor must review registration and reports as follows:
                            </P>
                            <P>(1) Obtain copies of the gasoline manufacturer's registration information submitted under subpart I of this part and all reports (except batch reports) submitted by the gasoline manufacturer under subpart J of this part.</P>
                            <P>(2) For each gasoline manufacturing facility, confirm that the facility's registration is accurate based on the activities reported during the compliance period, including that the registration for the facility and any related updates were completed prior to conducting regulated activities at the facility and report any discrepancies.</P>
                            <P>(3) Confirm that the gasoline manufacturer submitted all reports required under subpart J of this part for activities they performed during the compliance period and report any exceptions.</P>
                            <P>(4) Obtain a written statement from the gasoline manufacturer's RCO that the submitted reports are complete and accurate.</P>
                            <P>(5) Report the name of any commercial computer program used to track any data required under this part.</P>
                            <P>
                                (b) 
                                <E T="03">Inventory reconciliation analysis.</E>
                                 An auditor must review an inventory reconciliation analysis as follows:
                            </P>
                            <P>
                                (1) Obtain an inventory reconciliation analysis from the gasoline manufacturer for each gasoline type produced at each facility (
                                <E T="03">e.g.,</E>
                                 RFG, CG, RBOB, CBOB), including the inventory at the beginning and end of the compliance period and inventory records (
                                <E T="03">e.g.,</E>
                                 receipts, production volumes, shipments, transfers, and gain/loss).
                                <PRTPAGE P="4368"/>
                            </P>
                            <P>(2) Foot and cross-foot the volumes by gasoline type.</P>
                            <P>(3) Compare the beginning and ending inventory to the inventory records for each gasoline type and report any variances.</P>
                            <P>(4) Report the total volume of each gasoline type.</P>
                            <P>
                                (c) 
                                <E T="03">Listing of gasoline tenders.</E>
                                 An auditor must review a listing of gasoline tenders as follows:
                            </P>
                            <P>(1) Obtain a detailed listing of gasoline tenders from the gasoline manufacturer, by gasoline type.</P>
                            <P>(2) Foot the tender volumes by gasoline type.</P>
                            <P>(3) Compare the total volume from the tenders to the inventory reconciliation analysis obtained under paragraph (b) of this section for each gasoline type and report any variances.</P>
                            <P>
                                (d) 
                                <E T="03">Listing of gasoline batches.</E>
                                 An auditor must review a listing of gasoline batches as follows:
                            </P>
                            <P>(1) Obtain the gasoline batch reports submitted by the gasoline manufacturer under subpart J of this part.</P>
                            <P>(2) Foot the batch volumes by gasoline type.</P>
                            <P>(3) Compare the total volume from the batch reports to the inventory reconciliation analysis obtained under paragraph (b) of this section for each gasoline type and report any variances.</P>
                            <P>(4) Report as a finding any batch with a reported value that does not meet a per-gallon standard in subpart C of this part.</P>
                            <P>
                                (e) 
                                <E T="03">Test methods.</E>
                                 An auditor must follow the procedures specified in § 1090.1845 to determine whether the gasoline manufacturer complies with the applicable quality control requirements specified in § 1090.1375.
                            </P>
                            <P>
                                (f) 
                                <E T="03">Detailed testing of BOB tenders.</E>
                                 An auditor must review a detailed listing of BOB tenders as follows:
                            </P>
                            <P>(1) Select a representative sample of BOB tenders from the listing of tenders obtained under paragraph (c) of this section.</P>
                            <P>(2) Obtain the associated PTD for each selected tender.</P>
                            <P>(3) Using a unique identifier, confirm that the correct PTDs are obtained for the selected tenders.</P>
                            <P>(4) Compare the volume on the listing for each selected tender to the associated PTD and report any exceptions.</P>
                            <P>(5) Confirm that the PTD associated with each selected tender contains all the applicable language required under subpart L of this part and report any exceptions.</P>
                            <P>
                                (g) 
                                <E T="03">Detailed testing of BOB batches.</E>
                                 An auditor must review a detailed listing of BOB batches as follows:
                            </P>
                            <P>(1) Select a representative sample of BOB batches from the batch reports obtained under paragraph (d) of this section.</P>
                            <P>(2) Obtain the volume documentation and laboratory analysis for each selected batch.</P>
                            <P>(3) Compare the reported volume for each selected batch to the volume documentation and report any exceptions.</P>
                            <P>(4) Compare the reported properties for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(5) Compare the reported test methods used for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(6) Determine each oxygenate type and amount that was required for blending with each selected batch.</P>
                            <P>(7) Confirm that each oxygenate type and amount included in the BOB hand blend agrees with the gasoline manufacturer's blending instructions for each selected batch and report any exceptions.</P>
                            <P>(8) Confirm that the gasoline manufacturer participates in the NFSP under § 1090.1405, if applicable.</P>
                            <P>
                                (9)(i) For a blending manufacturer, confirm that the laboratory analysis includes test results for oxygenate content, if applicable, and distillation parameters (
                                <E T="03">i.e.,</E>
                                 T10, T50, T90, final boiling point, and percent residue).
                            </P>
                            <P>(ii) For a blending manufacturer not required to measure oxygenate content, confirm that records demonstrate that the PCG or blendstock contained no oxygenate, no oxygenate was added to the final gasoline batch, and the blending manufacturer did not account for oxygenate added downstream under § 1090.710.</P>
                            <P>
                                (h) 
                                <E T="03">Detailed testing of finished gasoline tenders.</E>
                                 An auditor must review a detailed listing of finished gasoline tenders as follows:
                            </P>
                            <P>(1) Select a representative sample of finished gasoline tenders from the listing of tenders obtained under paragraph (c) of this section.</P>
                            <P>(2) Obtain the associated PTD for each selected tender.</P>
                            <P>(3) Using a unique identifier, confirm that the correct PTDs are obtained for the selected tenders.</P>
                            <P>(4) Compare the volume on the listing for each selected tender to the associated PTD and report any exceptions.</P>
                            <P>(5) Confirm that the PTD associated with each selected tender contains all the applicable language required under subpart L of this part and report any exceptions.</P>
                            <P>
                                (i) 
                                <E T="03">Detailed testing of finished gasoline batches.</E>
                                 An auditor must review a detailed listing of finished gasoline batches as follows:
                            </P>
                            <P>(1) Select a representative sample of finished gasoline batches from the batch reports obtained under paragraph (d) of this section.</P>
                            <P>(2) Obtain the volume documentation and laboratory analysis for each selected batch.</P>
                            <P>(3) Compare the reported volume for each selected batch to the volume documentation and report any exceptions.</P>
                            <P>(4) Compare the reported properties for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(5) Compare the reported test methods used for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>
                                (6)(i) For a blending manufacturer, confirm that the laboratory analysis includes test results for oxygenate content, if applicable, and distillation parameters (
                                <E T="03">i.e.,</E>
                                 T10, T50, T90, final boiling point, and percent residue).
                            </P>
                            <P>(ii) For a blending manufacturer not required to measure oxygenate content, confirm that records demonstrate that the PCG or blendstock contained no oxygenate, no oxygenate was added to the final gasoline batch, and the blending manufacturer did not account for oxygenate added downstream under § 1090.710.</P>
                            <P>
                                (j) 
                                <E T="03">Detailed testing of blendstock batches.</E>
                                 In the case of adding blendstock to TGP or PCG under § 1090.1320(a)(2), an auditor must review a detailed listing of blendstock batches as follows:
                            </P>
                            <P>(1) Select a representative sample of blendstock batches from the batch reports obtained under paragraph (d) of this section.</P>
                            <P>(2) Obtain the volume documentation and laboratory analysis for each selected batch.</P>
                            <P>(3) Compare the reported volume for each selected batch to the volume documentation and report any exceptions.</P>
                            <P>(4) Compare the reported properties for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(5) Compare the reported test methods used for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(6) For a blending manufacturer not required to measure oxygenate content, confirm that records demonstrate that the PCG or blendstock contained no oxygenate, no oxygenate was added to the final gasoline batch, and the blending manufacturer did not account for oxygenate added downstream under § 1090.710.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>120. Revise and republish § 1090.1815 to read as follows:</AMDPAR>
                        <SECTION>
                            <PRTPAGE P="4369"/>
                            <SECTNO>§ 1090.1815</SECTNO>
                            <SUBJECT>General procedures for gasoline importers.</SUBJECT>
                            <P>An auditor must perform the procedures specified in this section for a gasoline importer.</P>
                            <P>
                                (a) 
                                <E T="03">Registration and reports.</E>
                                 An auditor must review registration and reports for the importer as specified in § 1090.1810(a).
                            </P>
                            <P>
                                (b) 
                                <E T="03">Listing of gasoline imports.</E>
                                 An auditor must review a listing of gasoline imports as follows:
                            </P>
                            <P>(1) Obtain a detailed listing of gasoline imports from the importer, by gasoline type.</P>
                            <P>(2) Foot the import volumes from the importer by gasoline type.</P>
                            <P>(3) Obtain a detailed listing of gasoline imports directly from the third-party customs broker, by gasoline type.</P>
                            <P>(4) Foot the import volumes from the third-party customs broker by gasoline type.</P>
                            <P>(5) Compare the total volume from the listing of imports supplied by the importer to the listing of imports supplied by the third-party customs broker for each gasoline type and report any variances.</P>
                            <P>(6) Report the total imported volume of each gasoline type.</P>
                            <P>
                                (c) 
                                <E T="03">Listing of gasoline batches.</E>
                                 An auditor must review a listing of gasoline batches as follows:
                            </P>
                            <P>(1) Obtain the gasoline batch reports submitted by the importer under subpart J of this part.</P>
                            <P>(2) Foot the batch volumes by gasoline type.</P>
                            <P>(3) Compare the total volume from the batch reports to the listing of imports supplied by the importer under paragraph (b) of this section for each gasoline type and report any variances.</P>
                            <P>(4) Report as a finding any batch with a reported value that does not meet a per-gallon standard in subpart C of this part.</P>
                            <P>
                                (d) 
                                <E T="03">Test methods.</E>
                                 An auditor must follow the procedures specified in § 1090.1845 to determine whether the importer complies with the applicable quality control requirements specified in § 1090.1375.
                            </P>
                            <P>
                                (e) 
                                <E T="03">Detailed testing of BOB imports.</E>
                                 An auditor must review a detailed listing of BOB imports as follows:
                            </P>
                            <P>(1) Select a representative sample of BOB imports from the listing of imports supplied by the importer under paragraph (b) of this section.</P>
                            <P>(2) Obtain the associated U.S. Customs Entry Summary and PTD for each selected import.</P>
                            <P>(3) Using a unique identifier, confirm that the correct U.S. Customs Entry Summaries are obtained for the selected imports.</P>
                            <P>(4) Compare the volume and location the import arrived in the United States on the listing for each selected import to the associated U.S. Customs Entry Summary and report any exceptions.</P>
                            <P>(5) Using a unique identifier, confirm that the correct PTDs are obtained for the selected imports.</P>
                            <P>(6) Compare the volume on the listing for each selected import to the associated PTD and report any exceptions.</P>
                            <P>(7) Confirm that the PTD associated with each selected import contains all the applicable language required under subpart L of this part and report any exceptions.</P>
                            <P>
                                (f) 
                                <E T="03">Detailed testing of BOB batches.</E>
                                 An auditor must review a detailed listing of BOB batches as follows:
                            </P>
                            <P>(1) Select a representative sample of BOB batches from the batch reports obtained under paragraph (c) of this section.</P>
                            <P>(2) Obtain the volume inspection report and laboratory analysis for each selected batch.</P>
                            <P>(3) Compare the reported volume for each selected batch to the volume inspection report and report any exceptions.</P>
                            <P>(4) Compare the reported properties for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(5) Compare the reported test methods used for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(6) Determine each oxygenate type and amount that was required for blending with each selected batch.</P>
                            <P>(7) Confirm that each oxygenate type and amount included in the BOB hand blend agrees with the importer's blending instructions for each selected batch and report any exceptions.</P>
                            <P>(8) Confirm that the importer participates in the NFSP under § 1090.1405, if applicable.</P>
                            <P>
                                (g) 
                                <E T="03">Detailed testing of finished gasoline imports.</E>
                                 An auditor must review a detailed listing of finished gasoline imports as follows:
                            </P>
                            <P>(1) Select a representative sample of finished gasoline imports from the listing of imports supplied by the importer under paragraph (b) of this section.</P>
                            <P>(2) Obtain the associated U.S. Customs Entry Summary and PTD for each selected import.</P>
                            <P>(3) Using a unique identifier, confirm that the correct U.S. Customs Entry Summaries are obtained for the selected imports.</P>
                            <P>(4) Compare the volume and location the import arrived in the United States on the listing for each selected import to the associated U.S. Customs Entry Summary and report any exceptions.</P>
                            <P>(5) Using a unique identifier, confirm that the correct PTDs are obtained for the selected imports.</P>
                            <P>(6) Compare the volume on the listing for each selected import to the associated PTD and report any exceptions.</P>
                            <P>(7) Confirm that the PTD associated with each selected import contains all the applicable language required under subpart L of this part and report any exceptions.</P>
                            <P>
                                (h) 
                                <E T="03">Detailed testing of finished gasoline batches.</E>
                                 An auditor must review a detailed listing of finished gasoline batches as follows:
                            </P>
                            <P>(1) Select a representative sample of finished gasoline batches from the batch reports obtained under paragraph (c) of this section.</P>
                            <P>(2) Obtain the volume inspection report and laboratory analysis for each selected batch.</P>
                            <P>(3) Compare the reported volume for each selected batch to the volume inspection report and report any exceptions.</P>
                            <P>(4) Compare the reported properties for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(5) Compare the reported test methods used for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>
                                (i) 
                                <E T="03">Additional procedures for gasoline imported by rail or truck.</E>
                                 An auditor must perform the following additional procedures for an importer that imports gasoline into the United States by rail or truck under § 1090.1610:
                            </P>
                            <P>(1)(i) Select a representative sample of gasoline batches from the batch reports obtained under paragraph (c) of this section.</P>
                            <P>(ii) Obtain the tank activity records for each selected batch from the party that supplied the gasoline to the importer.</P>
                            <P>(iii) Identify the point of sampling and testing associated with each selected batch in the tank activity records.</P>
                            <P>(iv) Confirm that the sampling and testing for each selected batch occurred after the most recent delivery into the supplier's storage tank and before transferring gasoline to the railcar or truck.</P>
                            <P>(2)(i) Obtain a detailed listing of the importer's quality assurance program sampling and testing results.</P>
                            <P>(ii) Determine whether the frequency of sampling and testing meets the requirements in § 1090.1610(a)(2) and report any discrepancies.</P>
                            <P>(iii)(A) Select a representative sample of gasoline batches from the sampling and testing results.</P>
                            <P>(B) Obtain the laboratory analysis for each selected batch.</P>
                            <P>
                                (C) Determine whether the importer analyzed the test sample for each 
                                <PRTPAGE P="4370"/>
                                selected batch, and report as a finding any batch where the importer failed to perform the analysis using the methods specified in subpart N of this part.
                            </P>
                            <P>(D) Obtain and review any terminal test results corresponding to the time of collecting the quality assurance test samples.</P>
                            <P>(E) Compare the terminal test results to the test results from the quality assurance program. Report as a finding any test result with a difference that is greater than the reproducibility of the applicable method specified in subpart N of this part.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>121. Revise the section heading and revise and republish § 1090.1820 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1820</SECTNO>
                            <SUBJECT>Additional procedures for GTAB.</SUBJECT>
                            <P>In addition to any other procedure required under this subpart, an auditor must perform the procedures specified in this section for a gasoline manufacturer that imports GTAB under § 1090.1615.</P>
                            <P>
                                (a) 
                                <E T="03">Listing of GTAB imports.</E>
                                 An auditor must review a listing of GTAB imports as follows:
                            </P>
                            <P>(1) Obtain a detailed listing of GTAB imports from the importer.</P>
                            <P>(2) Foot the import volumes from the importer.</P>
                            <P>(3) Obtain a detailed listing of GTAB imports directly from the third-party customs broker.</P>
                            <P>(4) Foot the import volumes from the third-party customs broker.</P>
                            <P>(5) Compare the total volume from the listing of imports supplied by the importer to the listing of imports supplied by the third-party customs broker and report any variances.</P>
                            <P>(6) Report the total imported volume of GTAB and the corresponding facilities at which the GTAB was blended.</P>
                            <P>
                                (b) 
                                <E T="03">Listing of GTAB batches.</E>
                                 An auditor must review a listing of GTAB batches as follows:
                            </P>
                            <P>(1) Obtain the GTAB batch reports submitted by the importer under subpart J of this part.</P>
                            <P>(2) Foot the batch volumes.</P>
                            <P>(3) Compare the total volume from the batch reports to the listing of imports supplied by the importer under paragraph (a) of this section and report any variances.</P>
                            <P>
                                (c) 
                                <E T="03">Detailed testing of GTAB imports.</E>
                                 An auditor must review a detailed listing of GTAB imports as follows:
                            </P>
                            <P>(1) Select a representative sample of GTAB imports from the listing of imports supplied by the importer under paragraph (a) of this section.</P>
                            <P>(2) Obtain the associated U.S. Customs Entry Summary for each selected import.</P>
                            <P>(3) Using a unique identifier, confirm that the correct U.S. Customs Entry Summaries are obtained for the selected imports.</P>
                            <P>(4) Compare the volume and location the import arrived in the United States on the listing for each selected import to the associated U.S. Customs Entry Summary and report any exceptions.</P>
                            <P>
                                (d) 
                                <E T="03">Detailed testing of GTAB batches.</E>
                                 An auditor must review a detailed listing of GTAB batches as follows:
                            </P>
                            <P>(1) Select a representative sample of GTAB batches from the batch reports obtained under paragraph (b) of this section.</P>
                            <P>(2) Obtain the volume inspection report for each selected batch.</P>
                            <P>(3) Compare the reported volume for each selected batch to the volume inspection report and report any exceptions.</P>
                            <P>
                                (e) 
                                <E T="03">GTAB tracing.</E>
                                 An auditor must trace and review the movement of GTAB from importation to gasoline production as follows:
                            </P>
                            <P>(1) Compare the total volume from the batch reports obtained under paragraph (b) of this section to the inventory reconciliation analysis obtained under § 1090.1810(b).</P>
                            <P>(2)(i) Obtain tank activity records that describe the movement of each selected batch under paragraph (d) of this section from importation to gasoline production.</P>
                            <P>(ii) Identify each selected batch in the tank activity records and trace each selected batch to subsequent reported batches of BOB or finished gasoline and report any exceptions.</P>
                            <P>(iii) Match the location of the facility where gasoline was produced from each selected batch to the location where each selected batch arrived in the United States, or to the facility directly receiving the selected batch from the import facility.</P>
                            <P>
                                (iv) Determine the status of the tank(s) before receiving each selected batch (
                                <E T="03">e.g.,</E>
                                 empty tank, tank containing blendstock, tank containing GTAB, tank containing PCG).
                            </P>
                            <P>(v) If the tank(s) contained PCG before receiving the selected batch, take the following additional steps:</P>
                            <P>(A) Obtain and review a copy of the documented tank mixing procedures.</P>
                            <P>(B) Determine the volume and properties of the tank bottom that was PCG before adding GTAB.</P>
                            <P>(C) Confirm that the gasoline manufacturer determined the volume and properties of the BOB or finished gasoline produced using GTAB by excluding the volume and properties of any PCG, and that the gasoline manufacturer separately reported the PCG volume and properties under subpart J of this part and report any discrepancies.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>122. Revise and republish § 1090.1825 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1825</SECTNO>
                            <SUBJECT>Additional procedures for PCG used to produce gasoline.</SUBJECT>
                            <P>In addition to any other procedure required under this subpart, an auditor must perform the procedures specified in this section for a gasoline manufacturer that produces gasoline from PCG under § 1090.1320.</P>
                            <P>
                                (a) 
                                <E T="03">Listing of PCG batches.</E>
                                 An auditor must review a listing of PCG batches as follows:
                            </P>
                            <P>(1) Obtain the PCG batch reports submitted by the gasoline manufacturer under subpart J of this part.</P>
                            <P>(2) Foot the batch volumes.</P>
                            <P>(3) Compare the total volume from the batch reports to the inventory reconciliation analysis obtained under § 1090.1810(b) and report any variances.</P>
                            <P>
                                (b) 
                                <E T="03">Detailed testing of PCG batches.</E>
                                 An auditor must review a detailed listing of PCG batches as follows:
                            </P>
                            <P>(1) Select a representative sample of PCG batches from the batch reports obtained under paragraph (a) of this section.</P>
                            <P>(2) Obtain the volume documentation, laboratory analysis, associated PTD, and tank activity records for each selected batch.</P>
                            <P>(3) Identify each selected batch in the tank activity records and trace each selected batch to subsequent reported batches of BOB or finished gasoline and report any exceptions.</P>
                            <P>(4) For each selected batch, report as a finding any instance where the reported volume was adjusted from the original receipt volume, such as for exported PCG.</P>
                            <P>(5) Compare the reported volume for each selected batch to the volume documentation and report any exceptions.</P>
                            <P>(6) Compare the reported gasoline type for each selected batch to the associated PTD and report any exceptions.</P>
                            <P>(7) Compare the reported properties for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(8) Compare the reported test methods used for each selected batch to the laboratory analysis and report any exceptions.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>123. Revise and republish § 1090.1830 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1830</SECTNO>
                            <SUBJECT>Alternative procedures for certified butane blenders.</SUBJECT>
                            <P>
                                An auditor must perform the procedures specified in this section instead of or in addition to the applicable procedures in § 1090.1810 for 
                                <PRTPAGE P="4371"/>
                                a certified butane blender that blends certified butane into PCG under § 1090.1320(b).
                            </P>
                            <P>
                                (a) 
                                <E T="03">Registration and reports.</E>
                                 An auditor must review registration and reports as follows:
                            </P>
                            <P>(1) Obtain copies of the certified butane blender's registration information submitted under subpart I of this part and all reports submitted by the certified butane blender under subpart J of this part, including the batch reports for the certified butane received and blended.</P>
                            <P>(2) For each butane blending facility, confirm that the facility's registration is accurate based on the activities reported during the compliance period, including that the registration for the facility and any related updates were completed prior to conducting regulated activities at the facility and report any discrepancies.</P>
                            <P>(3) Confirm that the certified butane blender submitted all reports required under subpart J of this part for activities they performed during the compliance period and report any exceptions.</P>
                            <P>(4) Obtain a written statement from the certified butane blender's RCO that the submitted reports are complete and accurate.</P>
                            <P>(5) Report the name of any commercial computer program used to track any data required under this part.</P>
                            <P>
                                (b) 
                                <E T="03">Inventory reconciliation analysis.</E>
                                 An auditor must review an inventory reconciliation analysis as follows:
                            </P>
                            <P>(1) Obtain an inventory reconciliation analysis from the certified butane blender for each butane blending facility related to all certified butane movements, including the inventory at the beginning and end of the compliance period, receipts, blending/production volumes, shipments, transfers, and gain/loss.</P>
                            <P>(2) Foot and cross-foot the volumes.</P>
                            <P>(3) Compare the beginning and ending inventory to the certified butane blender's inventory records and report any variances.</P>
                            <P>(4) Compare the total volume of certified butane received from the inventory reconciliation analysis to the batch reports obtained under paragraph (a) of this section and report any variances.</P>
                            <P>(5) Compare the total volume of certified butane blended from the inventory reconciliation analysis to the batch reports obtained under paragraph (a) of this section and report any variances.</P>
                            <P>(6) Report the total volume of certified butane received and blended.</P>
                            <P>
                                (c) 
                                <E T="03">Listing of certified butane receipts.</E>
                                 An auditor must review a listing of certified butane receipts as follows:
                            </P>
                            <P>(1) Obtain a detailed listing of certified butane receipts for certified butane received at each butane blending facility from the certified butane blender.</P>
                            <P>(2) Foot the receipt volumes.</P>
                            <P>(3) Compare the total volume from the receipts to the batch reports obtained under paragraph (a) of this section and report any variances.</P>
                            <P>
                                (d) 
                                <E T="03">Detailed testing of certified butane batches.</E>
                                 An auditor must review a detailed listing of certified butane batches as follows:
                            </P>
                            <P>(1) Select a representative sample of certified butane batches from the batch reports obtained under paragraph (a) of this section.</P>
                            <P>(2) Obtain the volume documentation and laboratory analysis for each selected batch.</P>
                            <P>(3) Compare the reported volume for each selected batch to the volume documentation and report any exceptions.</P>
                            <P>(4) Compare the reported properties for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(5) Compare the reported test methods used for each selected batch to the laboratory analysis and report any exceptions.</P>
                            <P>(6) Report as a finding any batch with a reported value that does not meet a standard for certified butane in subpart C of this part.</P>
                            <P>
                                (e) 
                                <E T="03">Quality assurance program review.</E>
                                 An auditor must review a certified butane blender's quality assurance program as follows:
                            </P>
                            <P>(1) Obtain a detailed listing of the certified butane blender's quality assurance program sampling and testing results.</P>
                            <P>(2) Determine whether the frequency of sampling and testing meets the requirements in § 1090.1320(b)(4) and report any discrepancies.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>124. Amend § 1090.1835 by revising paragraph (a) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1835</SECTNO>
                            <SUBJECT>Alternative procedures for certified pentane blenders.</SUBJECT>
                            <P>(a) An auditor must perform the procedures specified in this section instead of or in addition to the applicable procedures in § 1090.1810 for a certified pentane blender that blends certified pentane into PCG under § 1090.1320(b).</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>125. Revise and republish § 1090.1840 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1840</SECTNO>
                            <SUBJECT>Additional procedures related to compliance with gasoline average standards.</SUBJECT>
                            <P>In addition to any other procedure required under this subpart, an auditor must perform the procedures specified in this section for a gasoline manufacturer that complies with the standards in subpart C of this part using the procedures specified in subpart H of this part.</P>
                            <P>
                                (a) 
                                <E T="03">Annual compliance demonstration review.</E>
                                 An auditor must review annual compliance demonstrations as follows:
                            </P>
                            <P>(1) Obtain the annual compliance reports for sulfur and benzene and associated batch reports submitted by the gasoline manufacturer under subpart J of this part.</P>
                            <P>(2)(i) For a gasoline refiner or gasoline blending manufacturer, compare the total volume of gasoline produced at each facility from the annual compliance report to the inventory reconciliation analysis obtained under § 1090.1810(b) and report any variances.</P>
                            <P>(ii) For a gasoline importer, compare the total volume of gasoline imported from the annual compliance report to the listing of imports supplied by the importer under § 1090.1815(b) and report any variances.</P>
                            <P>(3) For each facility, recalculate and report the following values:</P>
                            <P>(i) Compliance sulfur value, per § 1090.700(a)(1), and compliance benzene value, per § 1090.700(b)(1)(i).</P>
                            <P>(ii) Unadjusted average sulfur concentration, per § 1090.745(b), and average benzene concentration, per § 1090.700(b)(3).</P>
                            <P>(iii) Number of credits generated during the compliance period, or number of banked or traded credits needed to meet standards for the compliance period.</P>
                            <P>(iv) Number of credits from the preceding compliance period that are expired or otherwise no longer available for the compliance period being reviewed.</P>
                            <P>(v) Net average sulfur concentration, per § 1090.745(c), and net average benzene concentration, per § 1090.745(d).</P>
                            <P>(4) Compare the recalculated values under paragraph (a)(3) of this section to the reported values in the annual compliance reports and report any exceptions.</P>
                            <P>(5) Report whether the gasoline manufacturer had a deficit for both the compliance period being reviewed and the preceding compliance period.</P>
                            <P>
                                (b) 
                                <E T="03">Credit transaction review.</E>
                                 An auditor must review credit transactions as follows:
                            </P>
                            <P>
                                (1) Obtain the credit transaction reports submitted by the gasoline manufacturer under subpart J of this part and contracts or other information that documents all credit transfers. Also obtain records that support intracompany transfers.
                                <PRTPAGE P="4372"/>
                            </P>
                            <P>(2) For each reported transaction, compare the supporting documentation with the credit transaction reports for the following elements and report any exceptions:</P>
                            <P>(i) Compliance period of creation.</P>
                            <P>
                                (ii) Credit type (
                                <E T="03">i.e.,</E>
                                 sulfur or benzene) and number of times traded.
                            </P>
                            <P>(iii) Quantity.</P>
                            <P>(iv) The name of the other company participating in the credit transfer.</P>
                            <P>(v) Transaction type.</P>
                            <P>
                                (c) 
                                <E T="03">Facility-level credit reconciliation.</E>
                                 Except as specified in paragraph (c)(4) of this section, an auditor must perform a facility-level credit reconciliation separately for each gasoline manufacturing facility as follows:
                            </P>
                            <P>(1) Obtain the credits remaining or the credit deficit from the previous compliance period from the credit transaction reports obtained under paragraph (b) of this section.</P>
                            <P>(2) Calculate and report as a finding the net credits remaining at the end of the compliance period.</P>
                            <P>(3) Compare the ending balance of credits or credit deficit recalculated under paragraph (c)(2) of this section to the corresponding value from the annual compliance report obtained under paragraph (a) of this section and report any variances.</P>
                            <P>(4) For an importer, the procedures of this paragraph (c) apply at the company level.</P>
                            <P>
                                (d) 
                                <E T="03">Company-level credit reconciliation.</E>
                                 An auditor must perform a company-level credit reconciliation as follows:
                            </P>
                            <P>(1) Obtain a credit reconciliation listing company-wide credits aggregated by facility for the compliance period.</P>
                            <P>(2) Foot and cross-foot the credit quantities.</P>
                            <P>(3) Compare and report the beginning balance of credits, the ending balance of credits, the associated credit activity at the company level in accordance with the credit reconciliation listing, and the corresponding credit balances and activity submitted by the gasoline manufacturer under subpart J of this part.</P>
                            <P>
                                (e) 
                                <E T="03">Procedures for gasoline manufacturers that recertify BOB.</E>
                                 An auditor must perform the following procedures for a gasoline manufacturer that recertifies BOB under § 1090.740 and incurs a deficit:
                            </P>
                            <P>(1) Perform the procedures specified in § 1090.1810(a) to review the gasoline manufacturer's registration and reports.</P>
                            <P>(2)(i) Obtain the recertified BOB batch reports submitted by the gasoline manufacturer under subpart J of this part.</P>
                            <P>(ii) Select a representative sample of recertified BOB batches from the batch reports.</P>
                            <P>
                                (iii) Obtain supporting documentation (
                                <E T="03">e.g.,</E>
                                 PTDs, bills of lading, etc.) for each selected batch.
                            </P>
                            <P>(iv) Compare the information on the batch reports to the supporting documentation and report any exceptions.</P>
                            <P>(v) Recalculate the deficits in accordance with the provisions of § 1090.740 and report any discrepancies.</P>
                            <P>(vi) Confirm that the deficits are included in the annual compliance report and report any exceptions.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>126. Revise and republish § 1090.1845 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1845</SECTNO>
                            <SUBJECT>Procedures related to meeting performance-based measurement and statistical quality control for test methods.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">General provisions.</E>
                                 (1) In addition to any other procedure required under this subpart, an auditor must perform the procedures specified in this section for a gasoline manufacturer.
                            </P>
                            <P>(2) The auditor performing the procedures in this section must meet the laboratory experience requirements specified in § 1090.55(b)(2).</P>
                            <P>(3) In cases where the auditor employs, contracts, or subcontracts an external specialist, all the requirements in § 1090.55 apply to the external specialist. The auditor is responsible for overseeing the work of the specialist, consistent with applicable professional standards specified in § 1090.1800.</P>
                            <P>(4) In the case of quality control testing at a third-party laboratory, the auditor may perform a single attestation engagement on the third-party laboratory for multiple gasoline manufacturers if the auditor directly reviewed the information from the third-party laboratory. The third-party laboratory may also arrange for the auditor to perform a single attestation engagement on the third-party laboratory and make that available to gasoline manufacturers that have testing performed by the third-party laboratory.</P>
                            <P>
                                (b) 
                                <E T="03">Non-referee method qualification review.</E>
                                 For each test method used to measure a gasoline parameter as specified in a report submitted under subpart J of this part that is not one of the referee procedures listed in § 1090.1360(d), the auditor must review the following:
                            </P>
                            <P>(1) Obtain supporting documentation showing that the laboratory has qualified the alternative test method by meeting the precision and accuracy criteria specified under § 1090.1365.</P>
                            <P>(2) Report a list of the alternative test methods used.</P>
                            <P>(3) Confirm that the gasoline manufacturer supplied the supporting documentation for each alternative test method and report any exceptions.</P>
                            <P>(4) If the auditor has previously reviewed supporting documentation under this paragraph (b) for an alternative test method at the laboratory, the auditor does not have to review the supporting documentation again.</P>
                            <P>
                                (c) 
                                <E T="03">Reference installation review.</E>
                                 For each reference installation used by the gasoline manufacturer during the compliance period, the auditor must review the following:
                            </P>
                            <P>(1) Obtain supporting documentation demonstrating that the reference installation followed the qualification procedures specified in § 1090.1370(c)(1) and (2) and the quality control procedures specified in § 1090.1370(c)(3).</P>
                            <P>(2) Confirm that the laboratory completed the qualification procedures and report any exceptions.</P>
                            <P>
                                (d) 
                                <E T="03">Instrument control review.</E>
                                 For each test instrument used to measure gasoline parameters for batches selected as part of a representative sample under § 1090.1810, the auditor must review whether test instruments were in control as follows:
                            </P>
                            <P>(1) Obtain a listing from the laboratory of the instruments and period when the instruments were used to measure gasoline parameters during the compliance period for batches selected as part of the representative sample under § 1090.1810.</P>
                            <P>(2) Obtain statistical quality assurance data and control charts demonstrating ongoing quality testing to meet the accuracy and precision requirements specified in § 1090.1375 or 40 CFR 80.47, as applicable.</P>
                            <P>(3) Confirm that the laboratory performed statistical quality assurance monitoring of its instruments under § 1090.1375 and report any exceptions.</P>
                            <P>(4) Report as a finding any test result that was excluded for being out of control and the laboratory did not have an assignable cause with appropriate supporting justification.</P>
                            <P>(5) Report as a finding the listing of instruments obtained under paragraph (d)(1) of this section and the compliance period when the instrument control review was completed.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="1090">
                        <AMDPAR>127. Revise and republish § 1090.1850 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 1090.1850</SECTNO>
                            <SUBJECT>Procedures related to in-line blending waivers.</SUBJECT>
                            <P>
                                In addition to any other procedure required under this subpart, an auditor must perform the procedures specified in this section for a gasoline manufacturer that relies on an in-line blending waiver under § 1090.1315.
                                <PRTPAGE P="4373"/>
                            </P>
                            <P>(a)(1) Obtain a copy of the gasoline manufacturer's in-line blending waiver submission and EPA's approval letter.</P>
                            <P>(2) Confirm that the sampling procedures and composite calculations conform to the specifications in § 1090.1315(a)(2).</P>
                            <P>(3) Review the gasoline manufacturer's procedure for defining a batch for compliance purposes. Review available test data demonstrating that the test results from in-line blending correctly characterize the fuel parameters for the designated batch.</P>
                            <P>(4) Confirm that the gasoline manufacturer corrected their operations because of previous audits, if applicable.</P>
                            <P>(5) Confirm that the equipment and procedures have not materially changed from the gasoline manufacturer's in-line blending waiver. In cases of material change in equipment or procedure, confirm that the gasoline manufacturer updated their in-line blending waiver and report any exceptions.</P>
                            <P>(6) Perform any additional procedures unique to the blending operation, as specified in the in-line blending waiver, and report any findings, variances, or exceptions, as applicable.</P>
                            <P>(7) Confirm that the gasoline manufacturer has complied with all provisions related to their in-line blending waiver and report any exceptions.</P>
                            <P>(b)(1) Obtain test data, including head, middle, and tail results, for each batch produced under the gasoline manufacturer's in-line blending waiver.</P>
                            <P>(2) Review the alternative sampling plan to meet requirements to test head, middle, and tail samples for small batches under § 1090.1315(a)(9).</P>
                            <P>(3) Report as a finding any instance where only a single sample was taken for a small batch involving more than 8 hours of blending or more than 1 million gallons of fuel.</P>
                            <P>(4) Report as a finding any instance where two samples were unevenly distributed for a small batch or where only two samples were taken for a small batch involving more than 16 hours of blending or up to 2 million gallons of fuel.</P>
                            <P>(5) Determine and report the percentage of in-line blending batches where the gasoline manufacturer failed to perform the required head, middle, and tail samples due to unforeseen circumstances. Report as a finding if this percentage is greater than 10 percent of in-line blending batches for the calendar year.</P>
                            <P>(6) Determine and report each instance where a contingency plan for alternative sampling was utilized under § 1090.1315(a)(12).</P>
                        </SECTION>
                    </REGTEXT>
                </SUPLINF>
                <FRDOC>[FR Doc. 2024-31218 Filed 1-14-25; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 6560-50-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4375"/>
            <PARTNO>Part VIII</PARTNO>
            <AGENCY TYPE="PNR">Department of Defense</AGENCY>
            <AGENCY TYPE="PNR">General Services Administration</AGENCY>
            <AGENCY TYPE="P">National Aeronautics and Space Administration</AGENCY>
            <CFR>48 CFR Parts 1, 2, 3, et al.</CFR>
            <TITLE>Federal Acquisition Regulation: Preventing Organizational Conflicts of Interest in Federal Acquisition; Proposed Rule</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="4376"/>
                    <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                    <AGENCY TYPE="O">GENERAL SERVICES ADMINISTRATION</AGENCY>
                    <AGENCY TYPE="O">NATIONAL AERONAUTICS AND SPACE ADMINISTRATION</AGENCY>
                    <CFR>48 CFR Parts 1, 2, 3, 7, 8, 9, 10, 11, 12, 13, 15, 16, 17, 18, 37, 42, 50, and 52</CFR>
                    <DEPDOC>[FAR Case 2023-006, Docket No. FAR-2023-0006, Sequence No. 1]</DEPDOC>
                    <RIN>RIN 9000-AO54</RIN>
                    <SUBJECT>Federal Acquisition Regulation: Preventing Organizational Conflicts of Interest in Federal Acquisition</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Proposed rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement the Preventing Organizational Conflicts of Interest in Federal Acquisition Act. The statute requires the FAR to provide and update definitions, guidance, and examples related to organizational conflicts of interest, including the creation of solicitation provisions and contract clauses to avoid or mitigate organizational conflicts of interest. The statute also requires the FAR to permit contracting officers to consider professional standards and procedures to prevent organizational conflicts of interest to which an offeror or contractor is subject.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>Interested parties should submit written comments to the Regulatory Secretariat Division at the address shown below on or before March 17, 2025 to be considered in the formation of the final rule.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            Submit comments in response to FAR Case 2023-006 to the Federal eRulemaking portal at 
                            <E T="03">https://www.regulations.gov</E>
                             by searching for “FAR Case 2023-006”. Select the link “Comment Now” that corresponds with “FAR Case 2023-006”. Follow the instructions provided on the “Comment Now” screen. Please include your name, company name (if any), and “FAR Case 2023-006” on your attached document. If your comment cannot be submitted using 
                            <E T="03">https://www.regulations.gov,</E>
                             call or email the points of contact in the 
                            <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                             section of this document for alternate instructions.
                        </P>
                        <P>
                            <E T="03">Instructions:</E>
                             Please submit comments only and cite “FAR Case 2023-006” in all correspondence related to this case. Comments received generally will be posted without change to 
                            <E T="03">https://www.regulations.gov,</E>
                             including any personal and/or business confidential information provided. Public comments may be submitted as an individual, as an organization, or anonymously (see frequently asked questions at 
                            <E T="03">https://www.regulations.gov/faq).</E>
                             To confirm receipt of your comment(s), please check 
                            <E T="03">https://www.regulations.gov,</E>
                             approximately two to three days after submission to verify posting.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            For clarification of content, contact Ms. Mahruba Uddowla, Procurement Analyst, at 703-605-2868 or by email at 
                            <E T="03">Mahruba.Uddowla@gsa.gov.</E>
                             For information pertaining to status, publication schedules, or alternate instructions for submitting comments if 
                            <E T="03">https://www.regulations.gov</E>
                             cannot be used, contact the Regulatory Secretariat at 202-501-4755 or 
                            <E T="03">GSARegSec@gsa.gov.</E>
                             Please cite “FAR Case 2023-006.”
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">I. Background</HD>
                    <P>DoD, GSA, and NASA are proposing to revise the FAR to implement the Preventing Organizational Conflicts of Interest in Federal Acquisition Act (Pub. L. 117-324, 41 U.S.C. 2303 note), enacted December 27, 2022. The statute directs the Federal Acquisition Regulatory Council to revise the FAR to provide and update—</P>
                    <P>• Definitions, to include those related to specific types of organizational conflicts of interest (OCIs), including unequal access to information, impaired objectivity, and biased ground rules;</P>
                    <P>• Guidance and illustrative examples related to relationships of contractors with public, private, domestic, and foreign entities that may result in OCIs;</P>
                    <P>• Illustrative examples of situations related to the potential for OCIs.</P>
                    <P>The statute also requires that the FAR be revised to provide agencies with tailorable solicitation provisions and contract clauses to avoid or mitigate organizational conflicts. The statute provides agencies the ability to take agency-specific needs into consideration when addressing risk that may be unique to the agency.</P>
                    <P>The statute instructs the Federal Acquisition Regulatory Council to require executive agencies to establish or update agency conflict of interest procedures to implement these revisions to the FAR. Agencies will be instructed to develop or update procedures to reflect the requirements of this new regulatory coverage when it is finalized.</P>
                    <P>DoD, GSA, and NASA published a proposed rule under FAR Case 2011-001, Organizational Conflicts of Interest, on April 26, 2011 (76 FR 23236) intended to amend the FAR coverage of OCIs and provide additional coverage regarding unequal access to nonpublic information. However, given the amount of time that had passed since publication of the proposed rule, and potential changed circumstances, a decision was made not to proceed with finalization of that rule. As a result, the proposed rule was withdrawn and the case was closed on March 19, 2021 (86 FR 14863).</P>
                    <HD SOURCE="HD1">II. Discussion and Analysis</HD>
                    <P>This rule proposes to create a new FAR subpart 3.12, Organizational Conflicts of Interest, to reflect the direction of the statute. A summary of the proposed changes follows:</P>
                    <HD SOURCE="HD2">A. Placement of OCI Coverage</HD>
                    <P>This rule proposes to move OCI coverage from FAR subpart 9.5 to a new subpart in FAR part 3. Part 9 addresses contractor qualifications. While the ability to provide impartial advice and assistance is an important qualification of a Government contractor, the larger issues that underlie efforts to identify and address OCI are more directly associated with some of the business practice topics discussed in FAR part 3. Part 3 is already the home of coverage on personal conflicts of interest. As a result, FAR subpart 9.5 is proposed to be marked “reserved” and the coverage of OCIs in 9.000, Scope of part, is removed.</P>
                    <P>To reflect the broader scope of part 3, this rule proposes to change the title from “Improper Business Practices and Personal Conflicts of Interest” to “Business Ethics and Conflicts of Interest.” As a result, the proposed rule also revises section 3.000, Scope of part, to reflect the new scope.</P>
                    <HD SOURCE="HD2">B. Definitions</HD>
                    <P>The proposed rule updates definitions and creates several new definitions. The definition of OCI in FAR part 2 is revised to address “unequal access to information, impaired objectivity, and biased ground rules,” in accordance with the statute. For clarity, a definition of “entity” is created for the context of OCIs. The definition is refined to clearly reflect the two types of situations that result in OCI concerns: impaired objectivity and unfair competitive advantage.</P>
                    <P>
                        A new definition is added for impaired objectivity, which is a type of OCI in which an entity or its affiliate has or may have financial or other interests or an incentive to provide other than impartial advice to the 
                        <PRTPAGE P="4377"/>
                        Government, or the entity or its affiliate's objectivity in performing the contract work is or might be otherwise impaired. In the context of these definitions related to OCIs, “entity” can mean an individual, a corporation or other organization.
                    </P>
                    <P>Unfair competitive advantage in turn can result from biased ground rules or unequal access to information. The proposed rule adds a definition for “biased ground rules” that describes a situation in which an entity or its affiliate, as part of its performance of a Government contract, has or may have materially influenced the development of the requirement, evaluation criteria, or other source selection procedures for another Government contract. The primary concern is that the entity could skew the future competition, whether intentionally or not, in favor of itself.</P>
                    <P>A new definition for “unequal access to information” describes situations in which an entity or its affiliate has or may have an unfair competitive advantage because they have access to Government-provided information that all potential offerors do not have. That information may assist the entity in obtaining the contract.</P>
                    <P>The proposed rule also adds a definition of “firewall” to new section 3.1201 since the term reflects an important mitigation strategy for addressing OCI resulting from unequal access to information in the new subpart.</P>
                    <HD SOURCE="HD2">C. General Policy</HD>
                    <P>The new OCI coverage at FAR subpart 3.12 provides updated statutory citations and a more concise depiction of the applicability of the requirements. While the requirements are applicable to most procurements, acquisitions below the simplified acquisition threshold (SAT) and those for commercial products are exempt, as well as subcontracts for commercial products or commercial services.</P>
                    <P>Within the new policy section at FAR 3.1203, the proposed rule explains the two types of harm that OCIs may cause to the procurement system: harm from impaired objectivity and harm to the integrity of the competitive acquisition process. The discussion provides the actions that the Government and agency contracting officers should take to address or prevent harm.</P>
                    <P>
                        The rule describes the role a contractor's advantage can play in OCIs. Proposed language clarifies that the mere fact that a contractor has a competitive advantage in an acquisition on the basis of having previously performed work for the Government (
                        <E T="03">i.e.,</E>
                         “natural advantage”) does not mean that the contractor has an OCI or that the contractor's advantage is unfair. Guidance is provided to contracting officers on the hard facts needed (vs. innuendo and supposition) to determine the presence of OCIs in a procurement.
                    </P>
                    <P>The new section directs contracting officers to address situations where one or more offerors hold an unfair competitive advantage due to unequal access to information. The rule directs contracting officers to explore all available methods to address an OCI based upon unequal access to information before selecting disqualification of an offeror to alleviate unfair competitive advantage. Language in this section contains general principles for determining when access to information is “unequal,” constitutes an OCI, and needs to be addressed.</P>
                    <HD SOURCE="HD2">D. Examples</HD>
                    <P>As required by the statute, the proposed rule provides “illustrative examples” of potential OCIs that could result from “relationships of contractors with public, private, domestic, and foreign entities” at section 3.1204. The rule also provides examples of potential OCIs that result from a “Federal regulatory agency” awarding a contract for consulting services to a contractor in which “employees of the contractor performing work under such contract are permitted by the contractor to simultaneously perform work under a contract for a private sector client under the regulatory purview of such agency.”</P>
                    <P>For clarity, the examples are broken out by the two sources of OCIs: impaired objectivity and unfair competitive advantage. The examples of impaired objectivity include situations in which a firm's relationships with other entities can create undue influence or otherwise impair their performance on a Government contract. The examples of unfair competitive advantage are broken out by when the advantage is created from biased ground rules and from unequal access to information.</P>
                    <HD SOURCE="HD2">E. Methods of Addressing OCIs</HD>
                    <P>The proposed rule provides guidance at 3.1205 on the various methods for addressing OCIs. Agencies are advised that OCIs and their associated risks may be addressed by means of avoidance; limitations on future contracting; mitigation; and/or the Government's assessment that the risk inherent in the conflict is acceptable.</P>
                    <P>The rule explains the methods of avoiding OCIs at 3.1205-1 and advises contracting officers to work with the program office or requiring activity early in the acquisition process to successfully implement an avoidance strategy. Similar to current FAR 9.505-2 language, the rule lists techniques for avoidance such as developing a statement of work that does not require contractors to utilize subjective judgment and, when required, soliciting advice from more than one contractor rather than relying on the advice of a single contractor. The coverage recognizes that the available tools and appropriate use of avoidance by disqualification of an offeror depend on the circumstances involved.</P>
                    <P>The rule also provides guidance at 3.1205-2 for addressing OCIs by using a limitation on future contracting. Such limitations apply when the contractor's work on a current contract could be impaired by virtue of its expectation of future work or could jeopardize the integrity of the competitive process. As a result, a contractor and its affiliates may be precluded from entering into certain future contracts, either as a prime contractor or subcontractor. Similar to current FAR 9.507-2 language, the rule directs contracting officers to place a reasonable duration for the limitation that is sufficient to neutralize the OCI. Contracting officers are advised to provide a specific end date for the limitation or indicate that the limitation would end upon occurrence of an identifiable event.</P>
                    <P>The rule provides guidance at 3.1205-3 on techniques that can reduce, or mitigate, OCI risk. These techniques may require Government action, contractor action, or a combination of both. The new text requires that, when mitigation is used to address OCIs, the offeror-submitted and Government-approved mitigation plan be incorporated into the contract. The mitigation plan must reflect all actions the offeror has agreed to take to mitigate OCIs. The proposed rule describes several mitigation techniques and explains when the techniques should be used.</P>
                    <P>
                        The proposed rule provides direction at 3.1205-4 for instances in which the Government determines that the risk of harm from impaired objectivity is an acceptable performance risk. In making such a determination, the contracting officer will assess whether some or all of the performance risk is acceptable because the risk is outweighed by the expected benefit of having the offeror perform the contract, and whether the performance risk is manageable. The rule provides agencies the flexibility to set approval levels for such determinations above the contracting officer in agency procedures. When making a determination that the risk is acceptable, contracting officers should 
                        <PRTPAGE P="4378"/>
                        use a combination of methods to address OCIs, particularly mitigation.
                    </P>
                    <P>The proposed rule adds new FAR section 3.1206 to provide guidance on waivers, much of which is similar to the coverage currently in FAR 9.503. Agencies have the authority to pursue a waiver from a preexisting limitation on future contracting or from the requirements to address OCIs in a particular acquisition when certain circumstances exist. The new text provides the minimum requirements for each waiver and specifies that the approval authority is the agency head, without delegation below the head of the contracting activity.</P>
                    <HD SOURCE="HD2">F. Contracting Officer Responsibilities</HD>
                    <P>The proposed rule consolidates the discussion of contracting officer responsibilities to identify, analyze, and address OCIs at FAR 3.1207. The new text provides more detailed guidance than the current coverage at FAR 9.504.</P>
                    <P>FAR 3.1207-2 requires contracting officers to identify whether an acquisition has the potential to result in an OCI during the presolicitation phase of the acquisition process to decide whether to include an appropriate provision in the solicitation.</P>
                    <P>New text at section 3.1207-3 provides guidance on analyzing information from the offeror and other sources to determine if an OCI is present during the evaluation phase.</P>
                    <P>New text at section 3.1207-4 describes the contracting officer's responsibilities in implementing the selected method or methods to reduce or eliminate the risks associated with a particular OCI. Part of addressing, for example, could include negotiating an acceptable mitigation plan. The responsibility to “address” is similar to the requirement to “resolve” in current FAR subpart 9.5 prior to award of a contract or issuance of an order under a contract. The new term reflects the range of flexibilities that are allowed under the new, risk-based approach to OCIs. While existing case law requires the contracting officer to determine that a conflict has been adequately mitigated, the proposed rule allows the contracting officer to accept a risk when the conflict results from impaired objectivity and the risk to performance is low (see proposed FAR 3.1205-4).</P>
                    <P>New text at FAR 3.1207-5 is similar to current direction at FAR 9.504(e), which requires contracting officers to award to the apparent successful offeror after all OCIs have been addressed or waived. Contracting officers are required to notify the offeror, provide the reason for withholding award, and allow the offeror a reasonable opportunity to respond prior to withholding award due to OCIs.</P>
                    <P>FAR 3.1207-6 requires contracting officers to consider OCI at the time of award and again when issuing an order. For interagency acquisitions where the ordering (customer) agency places an order directly under another agency's contract (a “direct acquisition”), the ordering agency is responsible for addressing OCIs on that order. For interagency acquisitions where the servicing agency performs acquisition activities on the requesting agency's behalf (an “assisted acquisition”), the interagency agreement between the servicing and requesting agency to establish the terms and conditions of the assisted acquisition would need to identify which party is responsible for carrying out these responsibilities.</P>
                    <HD SOURCE="HD2">G. New Provisions and Clauses</HD>
                    <P>The proposed rule adds 2 new solicitation provisions and 3 new contract clauses related to OCIs in FAR part 52. Existing FAR coverage anticipates appropriate handling of OCI issues through solicitation provisions and contract clauses, but does not provide a standard format (see FAR 9.507). The statute requires that the FAR provide contracting officers with standard language that can be used or tailored as appropriate. The proposed rule combines the requirements at FAR 9.506 and 9.507 with the statutory direction that the clauses and provisions “require contractors to disclose information relevant to potential organizational conflicts of interest and limit future contracting,” in the development of one proposed provision and all the clauses on OCI.</P>
                    <P>The proposed rule adds a new provision at FAR 52.203-XX, Potential Organizational Conflict of Interest—Disclosure and Representation, to provide notice to offerors that the nature of the work described in the solicitation is such that OCIs may result from contract performance. When using this provision, contracting officers may identify contractors that are disqualified from participation and types of client or industry relationships that may present OCIs for the work to be performed under a contract resulting from that solicitation. This provision requires an offeror, as part of its proposal, to—</P>
                    <P>(1) Disclose all relevant information regarding any OCI (including active limitations on future contracting and specific clients or industry relationships that may create OCI if identified by the contracting officer);</P>
                    <P>(2) Disclose any professional standards to which it is subject, or any procedures it has in place, to prevent OCIs;</P>
                    <P>(3) Represent, to the best of its knowledge and belief, that it has disclosed all relevant information regarding any OCI;</P>
                    <P>
                        (4) Explain the actions it intends to use to address any OCI (
                        <E T="03">e.g.,</E>
                         submit a mitigation plan if it believes an OCI may exist or agree to a limitation on future contracting); and
                    </P>
                    <P>(5) Update their disclosure(s) for new information not previously disclosed or if there is a change to any relevant facts relating to a previously disclosed OCI.</P>
                    <P>The proposed rule adds a new clause at FAR 52.203-DD, Postaward Disclosure of Organizational Conflict of Interest, which requires the contractor to make a prompt and full disclosure of any new or newly discovered OCI. The clause is intended to address scenarios in which events occur during the performance of a contract that result in a new OCI, or an OCI is discovered after award. The contractor is informed that in certain circumstances, the newly reported OCI may result in termination of the contract. The clause is required to flow down to subcontracts exceeding the SAT where the work includes or may include tasks that may result in an OCI, except subcontracts for commercial products or commercial services.</P>
                    <P>The proposed rule adds a new clause at FAR 52.203-MM, Mitigation of Organizational Conflicts of Interest, for contracts that may involve an OCI that can be addressed by an acceptable offeror-submitted mitigation plan prior to contract award. The clause incorporates the mitigation plan in the contract; addresses changes to the mitigation plan; and addresses noncompliance with the clause or with the mitigation plan. The clause is required to flow down to subcontracts exceeding the SAT where the work is addressed in the mitigation plan, except subcontracts for commercial products or commercial services.</P>
                    <P>
                        The proposed rule adds a new clause at FAR 52.203-LL, Limitation on Future Contracting, for use when the contracting officer decides to address a potential conflict of interest through a limitation on future contracting. The contracting officer must fill in the nature of the limitation on future contractor activities and the length of any such limitation. The clause provides explicit terms with which the contractor would comply regarding future competitions that would create an OCI. The clause is required to flow down to subcontracts exceeding the SAT for which the work includes tasks that are encompassed by the description of work the contracting officer identified 
                        <PRTPAGE P="4379"/>
                        as subject to a limitation, except subcontracts for commercial products or commercial services.
                    </P>
                    <P>The proposed rule adds a new provision at FAR 52.203-AA, Unequal Access to Information—Representation, which requires the offeror to identify, prior to submission of its offer, whether it or any of its affiliates had unequal access to any information that could provide an unfair competitive advantage. If so, the offeror is required to advise the contracting officer of any actions that the offeror proposes to take to resolve the OCI. The provision also requires offerors to represent, by submission of an offer, that they effectively implemented any agreed-to mitigation measures and that any firewall that was used to mitigate the OCI has not been breached. The provision requires offerors to check a box if any planned firewall was not implemented or was breached. In the event an offeror checks that box, the provision requires the offeror to provide additional explanatory information.</P>
                    <P>New prescriptions for the provisions and clauses are added at FAR 3.1208. FAR provision 52.203-XX is prescribed for use in solicitations exceeding the SAT, other than solicitations for commercial products, when the contracting officer identifies the work may have the potential to result in an OCI.</P>
                    <P>FAR clause 52.203-DD is prescribed for use when provision 52.203-XX is included. Contracting officers are instructed to fill in paragraph (b)(1)(iii) of the clause if they identified specific contractor client and industry relationships that may present a conflict of interest.</P>
                    <P>FAR clause 52.203-MM is prescribed for use in solicitations exceeding the SAT, other than solicitations for commercial products, when the resulting contract may involve an OCI that can be addressed by an acceptable offeror-submitted mitigation plan. Contracting officers are instructed to only include the clause in the resulting contract if the offeror submits an organizational conflict of interest mitigation plan that will be incorporated into the contract.</P>
                    <P>FAR clause 52.203-LL is prescribed for use in solicitations exceeding the SAT, other than solicitations for commercial products, when the contracting officer expects that the method of addressing the OCI will involve a limitation on future contracting. The clause is to be included in the resulting contract only if a limitation on future contracting is to be placed on the contractor. In the event the clause is to be included in the contract, prior to award the contracting officer must fill in the clause with the nature and duration of the limitation on future contracting or contractor activities, based on communications with the apparent successful offeror. Contracting officers are instructed to establish a duration sufficient to neutralize the projected organizational conflict of interest, but no longer than necessary.</P>
                    <P>FAR provision 52.203-AA is prescribed for use in solicitations exceeding the SAT, other than solicitations for commercial products.</P>
                    <HD SOURCE="HD2">H. Conforming and Other Minor Edits</HD>
                    <P>FAR part 1 is proposed to be amended at 1.106 to reflect the OMB control number associated with the new FAR clauses and provisions that contain an information collection, requiring approval under the Paperwork Reduction Act.</P>
                    <P>Conforming edits are made to part 2, subpart 3.6, parts 11, 15, 17, 18, 37, 42, and 50 to reflect the movement of OCI coverage from FAR subpart 9.5 to new subpart 3.12. This includes moving the definition of “contractor team arrangement” out of FAR 9.6 to part 2, since the term will be used in the OCI coverage in part 3, in addition to part 9.</P>
                    <P>Language flagging applicability of OCI procedures to task orders is added to FAR 8.405, Ordering procedures for Federal Supply Schedules, and FAR 16.505, Ordering.</P>
                    <P>Revisions to part 12 are proposed to reflect the Federal Acquisition Regulatory Council's determination that it would be in the best interest of the Federal Government to not exempt contracts for the acquisition of commercial services from the statute. Revisions to part 13 are proposed to reflect that the statute does not apply to all acquisitions at or below the SAT in accordance with 41 U.S.C. 1905. See section III of the preamble below for further details.</P>
                    <P>Language is added to FAR 15.306, Exchanges with offerors after receipt of proposals, to clarify that exchanges about OCIs are not necessarily considered discussions. Exchanges on an offeror's OCI mitigation plan are similar to responsibility determinations when OCI is not an evaluation factor. However, the language requires discussions if the other parts of the technical proposal and/or cost proposal are changed due to the exchanges. The language creates clear direction for both the Government and offerors regarding the extent to which an OCI mitigation plan may be changed without triggering the requirement to conduct discussions.</P>
                    <HD SOURCE="HD1">III. Applicability to Contracts at or Below the Simplified Acquisition Threshold (SAT) and for Commercial Products (Including Commercially Available Off-The-Shelf (COTS) Items) or for Commercial Services</HD>
                    <P>This rule proposes to add new provisions and clauses at—</P>
                    <P>• FAR 52.203-XX, Potential Organizational Conflict of Interest— Disclosure and Representation;</P>
                    <P>• FAR 52.203-DD, Postaward Disclosure of Organizational Conflict of Interest;</P>
                    <P>• FAR 52.203-MM, Mitigation of Organizational Conflicts of Interest;</P>
                    <P>• FAR 52.203-LL, Limitation on Future Contracting; and</P>
                    <P>• FAR 52.203-AA, Unequal Access to Information—Representation.</P>
                    <P>These new provisions and clauses implement the requirements of the Preventing Organizational Conflicts of Interest in Federal Acquisition Act (Pub. L. 117-324). The provisions and clauses are prescribed at FAR 3.1208 for use in acquisitions exceeding the SAT, and for acquisitions of commercial services, where OCIs are anticipated. The provisions and clauses are not prescribed for acquisitions of commercial products (including COTS).</P>
                    <HD SOURCE="HD2">A. Applicability to Contracts at or Below the Simplified Acquisition Threshold</HD>
                    <P>41 U.S.C. 1905 governs the applicability of laws to acquisitions at or below the SAT. Section 1905 generally limits the applicability of new laws when agencies are making acquisitions at or below the SAT, but provides that such acquisitions will not be exempt from a provision of law under certain circumstances, including when the Federal Acquisition Regulatory Council makes a written determination and finding that it would not be in the best interest of the Federal Government to exempt contracts and subcontracts in amounts not greater than the SAT from the provision of law.</P>
                    <P>
                        At this time, the Federal Acquisition Regulatory Council does not intend to make a determination to apply this statute to contracts or subcontracts at or below the SAT. However, the Federal Acquisition Regulatory Council may decide for the final rule to make a determination to apply this statute to certain contracts at or below the SAT, specifically those contracts that subsequently lead to future contracts in amounts greater than the SAT, where OCIs are anticipated. Public comments are welcome on whether it would be in the best interest of the Federal Government to apply this statute to the subset of contracts at or below the SAT.
                        <PRTPAGE P="4380"/>
                    </P>
                    <HD SOURCE="HD2">B. Applicability to Contracts for the Acquisition of Commercial Products (Including Commercially Available Off-The-Shelf (COTS) Items) and Commercial Services</HD>
                    <P>41 U.S.C. 1906 governs the applicability of laws to contracts for the acquisition of commercial products and commercial services, and is intended to limit the applicability of laws to contracts for the acquisition of commercial products and commercial services. Section 1906 provides that if the Federal Acquisition Regulatory Council makes a written determination that it is not in the best interest of the Federal Government to exempt commercial contracts, the provision of law will apply to contracts for the acquisition of commercial products and commercial services.</P>
                    <P>41 U.S.C. 1907 states that acquisitions of COTS items will be exempt from certain provisions of law unless the Administrator for Federal Procurement Policy makes a written determination and finds that it would not be in the best interest of the Federal Government to exempt contracts for the procurement of COTS items.</P>
                    <P>The Federal Acquisition Regulatory Council intends to make a determination to apply this statute to acquisitions for commercial services, but not commercial products. The Administrator for Federal Procurement Policy does not intend to make a determination to apply this statute to acquisitions for COTS items.</P>
                    <HD SOURCE="HD2">C. Determination</HD>
                    <P>As defined in this rule in accordance with the statute, OCI occurs when an entity has impaired objectivity or an unfair competitive advantage. Impaired objectivity could result in the Government acquiring products and services that are not the best value or for which the contractor's performance is biased against the Government's interest. Unfair competitive advantage, which is caused by either biased ground rules or unequal access to information, jeopardizes the Government's ability to solicit competitive proposals and removes integrity and fairness from the Federal acquisition process.</P>
                    <P>Application of Public Law 117-324 to acquisitions of commercial services is in the best interest of the Government. Many of the situations in which the Government is vulnerable to OCI occur when it acquires services from the commercial sector. One such situation explicitly called out in the statute occurs when a “regulatory” agency acquires consulting services—which is a commercial service—from a contractor, and the contractor has the same employees perform both under the agency's contract as well as on a contract with a private sector client that is regulated by said agency. Further, due to the preference of the Government to acquire commercial products and commercial services (41 U.S.C. 3307), a significant portion of the Government's spend is on these categories; and between the two, commercial services are acquired more often than commercial products. According to data from the Federal Procurement Data System, 61% of the contracts over the SAT awarded in fiscal year 2023 using commercial acquisition procedures were for services.</P>
                    <P>Given the statute's explicit requirement to protect particular acquisitions of commercial services against OCIs and the prevalence of the Government's acquisition of commercial services, exempting acquisitions of commercial services from application of the statute would result in a failure to completely implement the statute and greatly limit the implementation of the remainder of the statute.</P>
                    <P>Based on these findings, the Federal Acquisition Regulatory Council intends to determine that it would not be in the best interest of the Federal Government to exempt contracts for the acquisition of commercial services from the applicability of Public Law 117-324.</P>
                    <P>Considering the nature of commercial products and the fact that protections will be applied against OCIs at the prime contract level for commercial services, it is not in the best interest of the Government to apply Public Law 117-324 to acquisitions of commercial products or to subcontracts for commercial services.</P>
                    <HD SOURCE="HD1">IV. Expected Impact of the Rule</HD>
                    <HD SOURCE="HD2">A. Summary of the Rule</HD>
                    <P>This rule proposes to update the FAR coverage related to OCI. The revisions include moving the coverage from a FAR part that addresses contractor qualifications to a FAR part that addresses contractor business practices. While the ability to provide impartial advice and assistance is an important qualification of a Government contractor, the larger issues that underlie efforts to identify and address OCIs are more directly associated with business practice issues.</P>
                    <P>
                        The rule also proposes to revise the definition of OCI. Currently, the FAR definition of OCI is at a high level and only mentions that it can cause impaired objectivity or unfair competitive advantage. This rule proposes to provide more details on how OCIs could cause an unfair competitive advantage (
                        <E T="03">i.e.,</E>
                         through biased ground rules or unequal access to information) and further defines key terms used in the OCI definition. It is expected that the new definition will clarify what constitutes an OCI for both the acquisition workforce and industry. The rule provides a definition of “firewall” to provide more context to the new coverage related to mitigation strategies for various types of OCIs.
                    </P>
                    <P>The rule strengthens the OCI coverage by providing updated illustrative examples of what constitutes an OCI, offering an additional way of addressing OCIs, presenting a consolidated discussion of contracting officer responsibilities that provides more detailed guidance, establishing standardized FAR OCI clauses and provisions, and adding guidance related to situations in which OCI causes an unfair competitive advantage due to someone having unequal access to information. The illustrative examples are updated to reflect current acquisition scenarios and are broken out by the two sources of OCIs: impaired objectivity and unfair competitive advantage. This new coverage is expected to provide clarity and assist contracting officers in identifying the existence of OCIs in their procurement and therefore, take steps to appropriately address OCIs.</P>
                    <P>
                        The rule provides contracting officers with a new risk-based method of addressing OCIs, 
                        <E T="03">i.e.,</E>
                         the ability to determine whether an OCI risk involving impaired objectivity is an acceptable risk in certain circumstances.
                    </P>
                    <P>The new guidance is structured according to the steps a contracting officer must take during the different phases of an acquisition to identify and address OCIs. The more detailed structure in this proposed rule is expected to help contracting officers more effectively identify, analyze, and address OCI for their procurements.</P>
                    <P>
                        Instead of directing contracting officers to create an OCI provision and a clause that will implement a limitation on future contracting, this rule proposes to establish a FAR provision that includes OCI disclosure requirements and provides OCI notices to industry as well as a FAR clause that implements limitations on future contracting. In addition, the proposed rule establishes FAR clauses related to postaward OCI disclosures and mitigation plans as well as a FAR provision addressing representations related to an unfair competitive advantage due to unequal access to information. By creating FAR clauses and provisions, it is expected that there 
                        <PRTPAGE P="4381"/>
                        will be greater use of standardized OCI terms and conditions across Government procurements. The new guidance related to unequal access to information provides more complete OCI coverage.
                    </P>
                    <HD SOURCE="HD2">B. Benefits</HD>
                    <P>Benefits of this rule, for both the Government and the public, include ensuring fair competition, maintaining integrity of the procurement process, avoiding unfair advantage, protecting Government interests, furthering legal compliance, maintaining public trust, enhancing efficient contract performance, standardizing terms and conditions, and protecting against contract termination.</P>
                    <P>By revising the OCI coverage, the Government expects to enable fair competition among contractors. Fair competition encourages industry to focus on innovation and quality to stand out among competitors. This emphasis on excellence can result in better project outcomes and reduced costs associated with addressing issues that may arise from suboptimal performance.</P>
                    <P>Revising the OCI coverage is expected to help maintain the integrity of the procurement process by furthering the Government's requirement that Federal procurements are conducted impartially and without undue influence. The revised coverage is expected to help the Government identify and address conflicts prior to the receipt of offers. Furthermore, effective OCI management can prevent legal challenges and bid protests related to perceived improprieties in the procurement process. Litigation can be time-consuming and costly for contractors and the Government and avoiding them contributes to overall cost savings for both parties.</P>
                    <P>The proposed FAR OCI provisions and clauses are intended to prevent contractors from gaining an unfair advantage in current or future acquisitions. When used, potential offerors are notified of reasons for exclusion from receiving a contract award. Cost savings can result from:</P>
                    <P>(1) Supporting fair competition, which—promotes an even playing field allowing all eligible contractors to compete;</P>
                    <P>(2) Avoiding preferential treatment, which—prevents bid protests, saving legal fees, delays, and re-solicitation costs;</P>
                    <P>(3) Preventing biased decision making;</P>
                    <P>(4) Protecting proprietary information to prevent contractors with unfair advantages, such as access to sensitive information through conflicts of interest, from gaining insights into their competitors, which could allow those contractors' to affect pricing; and</P>
                    <P>(5) Preventing postaward issues—by addressing OCI before the award of a contract, which helps prevent postaward issues that could arise if conflicts are discovered later. Timely management of OCI reduces the risk of protests, disputes, or legal challenges that can disrupt the contract execution phase.</P>
                    <P>The revised OCI coverage may assist the Government in protecting its own interests by requiring its contractors to act in the best interest of the Government without compromising the effectiveness of the work. If the effectiveness of a contract is compromised, the contractor may be susceptible to price adjustments, delays, litigation, or contract termination. By ensuring the Government's interests are protected, the contractor's interests are protected as well.</P>
                    <P>The updated OCI coverage is expected to help the Government comply with relevant laws, regulations, and procurement policies designed to promote fairness, competition, and ethical conduct in the procurement process. Compliance prevents costly litigation for both the Government and industry and allows the Government to avoid the possibility of unintended contract delays.</P>
                    <P>The revised OCI coverage may contribute to building and maintaining public trust in the Government's procurement processes. It demonstrates a commitment to ethical practices and fairness in awarding contracts. Public trust is closely tied to perceptions of ethical conduct. Contractors with a reputation for ethical conduct are more likely to be trusted by the Government. A positive reputation can lead to increased business opportunities and a higher likelihood of contract awards, reducing the costs associated with extensive marketing efforts to secure contracts.</P>
                    <P>The proposed OCI provision and clauses provide uniformity in direction across all Federal agencies, which helps to avoid ambiguity, making it easier for each agency to understand the terms and obligations. Standardization helps prospective contractors comply with applicable laws and regulations, reducing the likelihood of legal disputes and noncompliance issues. Standardization of OCI clauses and provisions may streamline the proposal development process. Industry may reuse or modify previous responses to the standardized provisions and clauses across multiple offers. This may result in reductions in the time and resources associated with customizing proposals for each solicitation.</P>
                    <P>The proposed FAR OCI provisions and clauses provide a clear, comprehensive, and unambiguous description of the rights, responsibilities, and obligations of all parties intended to avoid conditions for termination and resulting consequences. Contract terminations can be costly to contractors as well as the Government.</P>
                    <HD SOURCE="HD2">C. Costs</HD>
                    <P>The proposed revisions in this rule create costs for both the public and the Government, though it is anticipated that the costs will be de minimis considering that many of the new procedures and requirements in this rule will take the place of existing procedures and requirements spread out across the Government such as in agencies' supplements to the FAR. As directed in the Preventing Organizational Conflicts of Interest in Federal Acquisition Act, agencies are required to update their conflict of interest procedures to implement these revisions to the FAR as appropriate. It is expected that since the FAR allows agencies to tailor certain coverage to address risks that are unique to the agency, the FAR coverage will ultimately replace much of the agency-specific OCI requirements that currently exist.</P>
                    <P>
                        The compliance requirements explicitly proposed in this rule for industry involve mitigation plans and disclosures. While this rule proposes to create a requirement for contractors to comply with any OCI mitigation plan that has been incorporated into their contract, these contractors are already subject to comparable mitigation plan requirements when contracting with certain agencies, 
                        <E T="03">e.g.,</E>
                         Defense FAR Supplement 209.571-4(b), Department of Homeland Security's clause 3052.209-72. Similarly, while this rule proposes to create a requirement for contractors to constantly monitor to ensure new OCIs or overlooked OCIs are discovered, these contractors are already subject to comparable disclosure requirements when contracting with certain agencies, 
                        <E T="03">e.g.,</E>
                         Environmental Protection Agency's clause 1552.209-71, Department of Energy's clause 952.209-72. This rule also proposes to create a number of reporting requirements; see section VII of this preamble. However, since industry is already subject to similar reporting requirements via various agency-specific clauses and provisions, it is expected that the net reporting cost of this proposed rule is less than the estimate in section VII of this preamble.
                        <PRTPAGE P="4382"/>
                    </P>
                    <P>The proposed rule provides more detailed guidance to the acquisition workforce on OCIs. Current FAR coverage directs contracting officers to “identify,” “evaluate,” “[a]void, neutralize, [and] mitigate,” OCIs; however, there are not many specific procedures provided for contracting officers to follow. The current FAR coverage directs contracting officers to use a provision that addresses OCIs and, when appropriate, to use a clause that can implement a limitation on future contracting; however, no provision or clause text is provided. For example, the proposed new disclosure and unequal access to information provisions will provide contracting officers with the data necessary to best “identify” and “evaluate” OCIs. The proposed clause regarding a limitation on future contracting will help the contracting officer “avoid” potential OCIs. The proposed mitigation plan clause will help the contracting officer “neutralize” and “mitigate” OCIs.</P>
                    <P>While this rule is proposing to create new clauses and provisions for contracting officers to use and specific actions for contracting officers to take, the costs associated with these revisions should be offset by the current cost of the FAR coverage: cost of contracting officers having to determine the specific actions to take or write their own clauses and provisions, both of which places the Government at a greater degree of OCI risk. The costs associated with these revisions are also expected to replace the current costs associated with contracting officers following agency-specific guidance instead of contracting officers across the Government using a set of standardized and uniform procedures and terms and conditions.</P>
                    <HD SOURCE="HD1">V. Executive Orders 12866 and 13563</HD>
                    <P>Executive Orders (E.O.s) 12866 (as amended by E.O. 14094) and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action and, therefore, was subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.</P>
                    <HD SOURCE="HD1">VI. Regulatory Flexibility Act</HD>
                    <P>The proposed rule, if finalized, may have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act 5 U.S.C. 601-612. The Initial Regulatory Flexibility Analysis (IRFA) is as follows:</P>
                    <EXTRACT>
                        <P>
                            <E T="03">1. Reasons for the action.</E>
                        </P>
                        <P>The Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) are proposing to revise the Federal Acquisition Regulation (FAR) to implement a statute, which directs the Federal Acquisition Regulatory Council to revise the FAR to provide and update—</P>
                        <P>• Definitions related to specific types of organizational conflicts of interest;</P>
                        <P>• Definitions, guidance, and illustrative examples related to relationships of contractors with public, private, domestic, and foreign entities that may cause contract support to be subject to potential organizational conflicts; and</P>
                        <P>• Illustrative examples of situations related to the potential organizational conflicts identified.</P>
                        <P>The statute also directs that the FAR be revised to—</P>
                        <P>• Provide agencies with solicitation provisions and contract clauses to avoid or mitigate organizational conflicts, for agency use as needed, that require contractors to disclose information relevant to potential organizational conflicts and limit future contracting with respect to potential conflicts with the work to be performed under awarded contracts;</P>
                        <P>• Allow agencies to tailor such solicitation provisions and contract clauses as necessary to address risks associated with conflicts of interest and other considerations that may be unique to the agency; and</P>
                        <P>• Permit contracting officers to take into consideration professional standards and procedures to prevent organizational conflicts of interest to which an offeror or contractor is subject.</P>
                        <P>
                            <E T="03">2. Objectives of, and legal basis for, the rule.</E>
                        </P>
                        <P>The objective of this rule is to implement the updates to the FAR as required by the statute.</P>
                        <P>The legal basis for the rule is the Preventing Organizational Conflicts of Interest in Federal Acquisition Act (Pub. L. 117-324, 41 U.S.C. 2303 note). The promulgation of the FAR is authorized by 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.</P>
                        <P>
                            <E T="03">3. Description of and an estimate of the number of small entities to which the rule will apply.</E>
                        </P>
                        <P>The proposed rule is expected to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601-612.</P>
                        <P>The rule is proposed to apply to acquisitions exceeding the simplified acquisition threshold (SAT). The rule is also proposed to apply to the acquisition of commercial services. The rule is not proposed to apply to commercial products, which includes commercially available off-the-shelf (COTS) items.</P>
                        <P>
                            DoD, GSA, and NASA do not have data on the number of acquisitions that may be affected by organizational conflicts of interest. As of December 3, 2023, there were 361,685 small business registrants (
                            <E T="03">i.e.,</E>
                             entities that are small for any North American Industry Classification System code) in the System for Award Management. These registrants may be required to complete the new FAR provisions that are proposed to be created in this rule.
                        </P>
                        <P>
                            <E T="03">4. Description of projected reporting, recordkeeping, and other compliance requirements of the rule.</E>
                        </P>
                        <P>This proposed rule includes both preaward and postaward reporting requirements. In terms of preaward requirements, offerors are required to disclose—</P>
                        <P>• Any relevant limitations on future contracting, the term of which has not yet expired, to which the offeror or potential subcontractor(s) agreed;</P>
                        <P>
                            • All relevant information of which the offeror is aware regarding financial or other interests that could give rise to an organizational conflict of interest, including information about affiliates and potential subcontracts, except where such disclosure would constitute a violation of law (
                            <E T="03">e.g.,</E>
                             the Securities Exchange Act of 1934, 15 U.S.C. 78a 
                            <E T="03">et seq.</E>
                            );
                        </P>
                        <P>• Information withheld pursuant to the previous paragraph as soon as the law no longer prohibits disclosure;</P>
                        <P>• Any professional standards to which the offeror is subject, or any procedures the Offeror has in place, to prevent organizational conflicts of interest;</P>
                        <P>
                            • To the extent that either the offeror or the Government identifies any financial or other interests that could give rise to an organizational conflict of interest on the contract resulting from a solicitation, the offeror shall explain the actions it intends to use to address such organizational conflicts of interest, 
                            <E T="03">e.g.,</E>
                             by submitting a mitigation plan and/or accepting a limitation on future contracting;
                        </P>
                        <P>• Whether an offeror or any of its affiliates had unequal access to any information that could provide an unfair competitive advantage;</P>
                        <P>• Any actions that the offeror proposes to take to resolve a situation in which it or its affiliates had unequal access to information that could provide an unfair competitive advantage; and</P>
                        <P>• Whether any firewall it planned to put in place to mitigate the impact of an unfair competitive advantage due to unequal access to information was not implemented or was breached.</P>
                        <P>
                            In terms of postaward reporting requirements, contractors are required to make a full disclosure in writing within 5 days to the contracting officer if the contractor identifies financial or other interests that could result in an organizational conflict of interest that was not previously addressed and for which a waiver has not been granted, or a change to any relevant facts relating to a previously 
                            <PRTPAGE P="4383"/>
                            identified organizational conflict of interest. The disclosure shall include a description of—
                        </P>
                        <P>• The organizational conflict(s) of interest in sufficient detail for agency evaluation; and</P>
                        <P>• Actions to address the organizational conflict(s) of interest that—</P>
                        <P>○ The contractor has taken or proposes to take; or</P>
                        <P>○ The contractor recommends that the Government take.</P>
                        <P>Other postaward reporting requirements include—</P>
                        <P>• Proposing updates to any mitigation plan incorporated into the contract within 30 days of—</P>
                        <P>○ Any changes to the legal construct of a contractor's organization, any subcontractor changes, or any significant management or ownership changes; or</P>
                        <P>○ A change to the contract requirements that impacts the mitigation plan; and</P>
                        <P>• Reporting to the contracting officer any noncompliance with the clause governing mitigation plans or with the mitigation plan itself, whether by the contractor's own personnel, those of the Government, other contractors, or subcontractors.</P>
                        <P>In addition to the reporting requirements listed above, the rule establishes the following compliance requirements for offerors and contractors:</P>
                        <P>• If an offeror submits a mitigation plan, the resulting contract will include the Government-approved mitigation plan with which that contractor will be required to comply.</P>
                        <P>• Contractors must flow down the clauses pertaining to postaward disclosures, mitigation plans, and limitation on future contracting to certain subcontracts for which the work includes or may include tasks that may give rise to an organizational conflict of interest.  </P>
                        <P>• Offerors must determine, to the best of their knowledge and belief, whether they or any of their affiliates had unequal access to any information that could provide an unfair competitive advantage.</P>
                        <P>The proposed revisions in this rule create costs for industry, though it is anticipated that the costs will be de minimis considering that many of the new procedures and requirements in this rule will take the place of existing procedures and requirements spread out across the Government such as in agencies' supplements to the FAR. As directed in the Preventing Organizational Conflicts of Interest in Federal Acquisition Act, agencies are required to update their conflict of interest procedures to implement these revisions to the FAR as appropriate. It is expected that since the FAR allows agencies to tailor certain coverage to address risks that are unique to the agency, the FAR coverage will ultimately replace much of the agency-specific OCI requirements that currently exist.</P>
                        <P>
                            5. 
                            <E T="03">Relevant Federal rules which may duplicate, overlap, or conflict with the rule.</E>
                        </P>
                        <P>The statute requires agencies to establish or update agency conflict of interest procedures to implement these revisions to the FAR made under the statute and periodically assess and update such procedures as needed to address agency-specific conflict issues. As such, the rule does not duplicate, overlap, or conflict with any other Federal rules.</P>
                        <P>
                            6. 
                            <E T="03">Description of any significant alternatives to the rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the rule on small entities.</E>
                        </P>
                        <P>There are no exemptions from the rule for small entities, because the law does not provide for any such exemption. To minimize impact on small entities, the rule exempts actions at or below the SAT; the rule only applies to those actions above the SAT.</P>
                        <P>The rule also exempts acquisitions of commercial products, which includes COTS items.</P>
                    </EXTRACT>
                    <P>The Regulatory Secretariat Division has submitted a copy of the IRFA to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the Regulatory Secretariat Division. DoD, GSA, and NASA invite comments from small business concerns and other interested parties on the expected impact of this proposed rule on small entities.</P>
                    <P>DoD, GSA, and NASA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FAR Case 2023-006), in correspondence.</P>
                    <HD SOURCE="HD1">VII. Paperwork Reduction Act</HD>
                    <P>The Paperwork Reduction Act (44 U.S.C. 3501-3521) applies because the proposed rule contains information collection requirements. Accordingly, the Regulatory Secretariat Division has submitted a request for approval of a new information collection requirement concerning “Preventing Organizational Conflicts of Interest in Federal Acquisition” to the Office of Management and Budget (OMB).</P>
                    <HD SOURCE="HD2">A. Public Reporting Burden</HD>
                    <P>Public reporting burden for this information collection includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.</P>
                    <P>1. The annual reporting burden estimated for the OCI disclosure and representation provision requirements is as follows:</P>
                    <P>
                        <E T="03">Respondents:</E>
                         1,781.
                    </P>
                    <P>
                        <E T="03">Total annual responses:</E>
                         3,562.
                    </P>
                    <P>
                        <E T="03">Hours/response:</E>
                         × 1.
                    </P>
                    <P>
                        <E T="03">Total burden hours:</E>
                         3,562.
                    </P>
                    <P>2. The annual reporting burden estimated for the OCI disclosure clause requirements is as follows:</P>
                    <P>
                        <E T="03">Respondents:</E>
                         891.
                    </P>
                    <P>
                        <E T="03">Total annual responses:</E>
                         2,673.
                    </P>
                    <P>
                        <E T="03">Hours/response:</E>
                         × 1.
                    </P>
                    <P>
                        <E T="03">Total burden hours:</E>
                         2,673.
                    </P>
                    <P>3. The annual reporting burden estimated for OCI mitigation plans is estimated as follows:</P>
                    <P>
                        <E T="03">Respondents:</E>
                         1,114.
                    </P>
                    <P>
                        <E T="03">Total annual responses:</E>
                         3,342.
                    </P>
                    <P>
                        <E T="03">Hours/response:</E>
                         × 0.5.
                    </P>
                    <P>
                        <E T="03">Total Burden Hours:</E>
                         1,671.
                    </P>
                    <P>4. The annual reporting burden estimated for the unequal access to information provision requirements is as follows:</P>
                    <P>
                        <E T="03">Respondents:</E>
                         357.
                    </P>
                    <P>
                        <E T="03">Total annual responses:</E>
                         357.
                    </P>
                    <P>
                        <E T="03">Hours/response:</E>
                         × 0.5.
                    </P>
                    <P>
                        <E T="03">Total Burden Hours:</E>
                         178.5.
                    </P>
                    <HD SOURCE="HD2">B. Request for Comments Regarding Paperwork Burden</HD>
                    <P>
                        Submit comments on this collection of information no later than March 17, 2025 through 
                        <E T="03">https://www.regulations.gov</E>
                         and follow the instructions on the site. All items submitted must cite OMB Control No. 9000-XXXX, Organizational Conflicts of Interest. Comments received generally will be posted without change to 
                        <E T="03">https://www.regulations.gov,</E>
                         including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check 
                        <E T="03">https://www.regulations.gov,</E>
                         approximately two to three days after submission to verify posting. If there are difficulties submitting comments, contact the GSA Regulatory Secretariat Division at 202-501-4755 or 
                        <E T="03">GSARegSec@gsa.gov.</E>
                    </P>
                    <P>Public comments are particularly invited on:</P>
                    <P>• The necessity of this collection of information for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility;</P>
                    <P>• The accuracy of the estimate of the burden of this collection of information;</P>
                    <P>• Ways to enhance the quality, utility, and clarity of the information to be collected; and</P>
                    <P>• Ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.</P>
                    <P>
                        Requesters may obtain a copy of the supporting statement from the General Services Administration, Regulatory Secretariat Division by calling 202-501-4755 or emailing 
                        <E T="03">GSARegSec@gsa.gov.</E>
                         Please cite OMB Control Number 9000-XXXX, Organizational Conflicts of Interest.
                    </P>
                    <LSTSUB>
                        <PRTPAGE P="4384"/>
                        <HD SOURCE="HED">List of Subjects in 48 CFR Parts 1, 2, 3, 7, 8, 9, 10, 11, 12, 13, 15, 16, 17, 18, 37, 42, 50, and 52</HD>
                        <P>Government procurement.</P>
                    </LSTSUB>
                    <SIG>
                        <NAME>William F. Clark,</NAME>
                        <TITLE>Director, Office of Government-wide Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy.</TITLE>
                    </SIG>
                    <P>Therefore, DoD, GSA, and NASA propose amending 48 CFR parts 1, 2, 3, 7, 8, 9, 10, 11, 12, 13, 15, 16, 17, 18, 37, 42, 50, and 52 as set forth below:</P>
                    <AMDPAR>1. The authority citation for 48 CFR parts 1, 2, 3, 7, 8, 9, 10, 11, 12, 13, 15, 16, 17, 18, 37, 42, 50, and 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 40 U.S.C. 121(c); 10 U.S.C. chapter 4 and 10 U.S.C. chapter 137 legacy provisions (see 10 U.S.C. 3016); and 51 U.S.C. 20113.</P>
                    </AUTH>
                    <PART>
                        <HD SOURCE="HED">PART 1—FEDERAL ACQUISITION REGULATIONS SYSTEM</HD>
                    </PART>
                    <AMDPAR>2. In section 1.106 amend the table by adding in numerical order entries for “52.203-XX”, “52.203-DD,” “52.203-MM,” and “52.203-AA” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>1.106 </SECTNO>
                        <SUBJECT>OMB approval under the Paperwork Reduction Act.</SUBJECT>
                        <STARS/>
                        <GPOTABLE COLS="2" OPTS="L1,tp0,i1" CDEF="s25,14">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">FAR segment</CHED>
                                <CHED H="1">OMB control No.</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*    *    *    *    *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">52.203-XX</ENT>
                                <ENT>9000-xxxx</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">52.203-DD</ENT>
                                <ENT>9000-xxxx</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">52.203-MM</ENT>
                                <ENT>9000-xxxx</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">52.203-AA</ENT>
                                <ENT>9000-xxxx</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*    *    *    *    *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 2—DEFINITIONS OF WORDS AND TERMS</HD>
                    </PART>
                    <AMDPAR>3. Amend section 2.101 by—</AMDPAR>
                    <AMDPAR>a. Removing from the definition of “advisory and assistance services” the phrase “(see 9.505-1(b))”;</AMDPAR>
                    <AMDPAR>b. Adding in alphabetical order the definition “contractor team arrangement”; and</AMDPAR>
                    <AMDPAR>c. Revising the definition of “organizational conflict of interest”.</AMDPAR>
                    <P>The addition and revision read as follows:</P>
                    <SECTION>
                        <SECTNO>2.101 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Contractor team arrangement</E>
                             means an arrangement in which—
                        </P>
                        <P>(1) Two or more companies form a partnership or joint venture to act as a potential prime contractor; or  </P>
                        <P>(2) A potential prime contractor agrees with one or more other companies to have them act as its subcontractors under a specified Government contract or acquisition program.</P>
                        <STARS/>
                        <P>
                            <E T="03">Organizational conflict of interest</E>
                             means that an entity or its affiliate(s) has impaired objectivity or an unfair competitive advantage as a result of other activities or relationships with other entities or their affiliates, including with public, private, domestic, and foreign entities. An entity or its affiliate may have an unfair competitive advantage as a result of biased ground rules or through unequal access to information. As used in this definition—
                        </P>
                        <P>
                            (1) 
                            <E T="03">Biased ground rules</E>
                             means a situation in which an entity or its affiliate, as part of its performance of a Government contract, has or may have materially influenced the development of the requirement, evaluation criteria, or other source selection procedures for another Government contract. The primary concern is that the entity could skew the future competition, whether intentionally or not, in favor of itself;
                        </P>
                        <P>
                            (2) 
                            <E T="03">Entity</E>
                             means an individual, corporation, or other organization;
                        </P>
                        <P>
                            (3) 
                            <E T="03">Impaired objectivity</E>
                             means a situation in which an entity or its affiliate has or may have financial or other interests or an incentive to provide other than impartial advice to the Government, or the entity or its affiliate's objectivity in performing the contract work is or might be otherwise impaired; and
                        </P>
                        <P>
                            (4) 
                            <E T="03">Unequal access to information</E>
                             means a situation in which an entity or its affiliate has or may have an unfair competitive advantage because—
                        </P>
                        <P>
                            (i) Access to the information was provided to the entity or its affiliate by the Government. Such information may include proprietary and source selection information, 
                            <E T="03">e.g.,</E>
                             proposals, financial information;
                        </P>
                        <P>(ii) The information is not available to all potential offerors; and</P>
                        <P>(iii) Having access to the information would assist the entity in obtaining the contract.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 3—BUSINESS ETHICS AND CONFLICTS OF INTEREST</HD>
                    </PART>
                    <AMDPAR>4. Revise the heading for part 3 to read as set forth above.</AMDPAR>
                    <AMDPAR>5. Revise section 3.000 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>3.000 </SECTNO>
                        <SUBJECT>Scope of part.</SUBJECT>
                        <P>This part prescribes policies and procedures for addressing issues regarding business ethics and conflicts of interest.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>3.603 </SECTNO>
                        <SUBJECT> [Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>6. Amend section 3.603 in paragraph (b) by removing “subpart 9.5” and adding “subpart 3.12” in its place.</AMDPAR>
                    <AMDPAR>7. Add subpart 3.12 to read as follows:</AMDPAR>
                    <CONTENTS>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart 3.12—Organizational Conflicts of Interest</HD>
                            <SECHD>Sec.</SECHD>
                            <SECTNO>3.1200</SECTNO>
                            <SUBJECT>Scope of subpart.</SUBJECT>
                            <SECTNO>3.1201</SECTNO>
                            <SUBJECT>Definition.</SUBJECT>
                            <SECTNO>3.1202</SECTNO>
                            <SUBJECT>Applicability.</SUBJECT>
                            <SECTNO>3.1203</SECTNO>
                            <SUBJECT>Policy.</SUBJECT>
                            <SECTNO>3.1204</SECTNO>
                            <SUBJECT>Examples.</SUBJECT>
                            <SECTNO>3.1205</SECTNO>
                            <SUBJECT>Methods of addressing organizational conflicts of interest.</SUBJECT>
                            <SECTNO>3.1205-1</SECTNO>
                            <SUBJECT>Avoidance.</SUBJECT>
                            <SECTNO>3.1205-2</SECTNO>
                            <SUBJECT>Limitation on future contracting.</SUBJECT>
                            <SECTNO>3.1205-3</SECTNO>
                            <SUBJECT>Mitigation.</SUBJECT>
                            <SECTNO>3.1205-4</SECTNO>
                            <SUBJECT>Determination of acceptable risk.</SUBJECT>
                            <SECTNO>3.1206 </SECTNO>
                            <SUBJECT>Waiver.</SUBJECT>
                            <SECTNO>3.1207 </SECTNO>
                            <SUBJECT>Contracting officer responsibilities.</SUBJECT>
                            <SECTNO>3.1207-1</SECTNO>
                            <SUBJECT>General.</SUBJECT>
                            <SECTNO>3.1207-2</SECTNO>
                            <SUBJECT>Identification of organizational conflicts of interest.</SUBJECT>
                            <SECTNO>3.1207-3</SECTNO>
                            <SUBJECT>Analyzing organizational conflicts of interest.</SUBJECT>
                            <SECTNO>3.1207-4</SECTNO>
                            <SUBJECT>Addressing organizational conflicts of interest.</SUBJECT>
                            <SECTNO>3.1207-5</SECTNO>
                            <SUBJECT>Award requirements.</SUBJECT>
                            <SECTNO>3.1207-6</SECTNO>
                            <SUBJECT>Task-order or delivery-order contracts, blanket purchase agreements, basic ordering agreements, and interagency acquisitions.</SUBJECT>
                            <SECTNO>3.1208 </SECTNO>
                            <SUBJECT>Solicitation provisions and contract clauses.</SUBJECT>
                        </SUBPART>
                    </CONTENTS>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart 3.12—Organizational Conflicts of Interest</HD>
                        <SECTION>
                            <SECTNO>3.1200 </SECTNO>
                            <SUBJECT> Scope of subpart.</SUBJECT>
                            <P>(a) This subpart prescribes policies and procedures, and provides illustrative examples, for identifying, analyzing, and addressing organizational conflicts of interest.</P>
                            <P>(b) This subpart implements—</P>
                            <P>(1) 41 U.S.C. 2304;</P>
                            <P>(2) Section 841(b)(2) of the Duncan Hunter National Defense Authorization Act for Fiscal Year 2009 (Pub. L. 110-417); and</P>
                            <P>(3) The Preventing Organizational Conflicts of Interest in Federal Acquisition Act (Pub. L. 117-324, 41 U.S.C. 2303 note).</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1201 </SECTNO>
                            <SUBJECT> Definition.</SUBJECT>
                            <P>
                                <E T="03">Firewall</E>
                                 means a barrier against the unauthorized flow of information. Firewalls may consist of a variety of elements, including organizational and physical separation; facility and workspace access restrictions; information system access restrictions; independent compensation systems; and individual and organizational nondisclosure agreements.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1202 </SECTNO>
                            <SUBJECT> Applicability.</SUBJECT>
                            <P>
                                (a)(1) Except as provided in paragraphs (a)(2) and (b) of this section, this subpart applies to—
                                <PRTPAGE P="4385"/>
                            </P>
                            <P>(i) Contracts, subcontracts, task orders, delivery orders, blanket purchase agreements, basic ordering agreements, and modifications for new work; and</P>
                            <P>(ii) For-profit and nonprofit organizations, including nonprofit organizations created largely or wholly with Government funds.</P>
                            <P>(2) This subpart does not apply to—</P>
                            <P>(i) Contracts and subcontracts at or below the simplified acquisition threshold;</P>
                            <P>(ii) Contracts for commercial products; or</P>
                            <P>(iii) Subcontracts for commercial products or commercial services.</P>
                            <P>(b) Contracting officers shall not apply this subpart where it conflicts with an agency-specific conflict-of-interest statute.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1203 </SECTNO>
                            <SUBJECT> Policy.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">General.</E>
                                 It is the Government's policy to identify, analyze, and address organizational conflicts of interest in order to maintain the integrity and fairness of the Federal acquisition system. Organizational conflicts of interest undermine the public's trust in the Federal acquisition system because they can result in the following:
                            </P>
                            <P>
                                (1) 
                                <E T="03">Impaired objectivity.</E>
                                 The Government's interests are to ensure that—
                            </P>
                            <P>(i) It acquires products and services that provide the best value to the Government; and</P>
                            <P>(ii) The contractor's performance fulfills the Government's requirements without bias (see 3.1204(a)).</P>
                            <P>
                                (2) 
                                <E T="03">Unfair competitive advantage.</E>
                                 Protection against biased ground rules and unequal access to information—
                            </P>
                            <P>(i) Preserves the Government's ability to solicit competitive proposals; and</P>
                            <P>(ii) Provides prospective offerors an opportunity to compete for Government requirements, free from organizational conflicts of interest as governed by this subpart (see 3.1204(b)).</P>
                            <P>
                                (b) 
                                <E T="03">Contractor advantage.</E>
                                 (1) The fact that a contractor may, on the basis of work previously performed, have a natural advantage in competing for a particular Government requirement does not necessarily mean that the advantage is unfair or that it creates an organizational conflict of interest. Although incumbent contractors will often have a natural advantage based on their experience, insights, and expertise, this situation must be distinguished from situations in which an incumbent contractor also has had access to information that could provide an unfair competitive advantage. For example—
                            </P>
                            <P>(i) Incumbent contractors may have a natural advantage that is not unfair when competing for follow-on contracts because of knowledge and expertise developed during contract performance; and  </P>
                            <P>(ii) Development contractors may have a natural advantage that is not unfair when they have done the most advanced work in a field and may be able to start production earlier, or offer products of a higher quality.</P>
                            <P>
                                (2) A contracting officer should not disqualify a contractor based on mere innuendo and supposition unsupported by the record (
                                <E T="03">i.e.,</E>
                                 no hard facts), or when the contractor's advantage is speculative and too remote from the present procurement to establish an organizational conflict of interest. Additionally, any allegation that a contractor could theoretically act in bad faith while performing on a contract is not a basis for a finding of a conflict of interest and therefore not a basis to disqualify an offeror from a competition.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Unequal access to information.</E>
                                 The Government shall address situations in which it has reason to believe an offeror has obtained or is attempting to obtain an unfair competitive advantage because of its unequal access to information.
                            </P>
                            <P>(1) Unequal access to information only covers situations in which access to information was provided by the Government either—</P>
                            <P>(i) Directly, through, or in connection with, performance on another Government contract; or</P>
                            <P>(ii) Indirectly, through sources such as former Government employees as described in 3.1204(b)(2)(ii) or employees of other contractors or subcontractors who received the nonpublic information from the Government.</P>
                            <P>(2) Offerors and the Government should take action early to avoid situations where an unfair competitive advantage could be created because of unequal access to information. These actions, for example, may include implementing firewalls or, when appropriate, sharing the information with other interested parties.</P>
                            <P>(3) The Government shall not disqualify the offeror from a competition on the basis of unequal access to information unless no other method of resolution is appropriate (see 3.1207-4(b)).</P>
                            <P>(4) An offeror could gain unequal access to information that does not constitute an organizational conflict of interest such as through the offeror's own market research efforts or its private-sector business contacts.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1204 </SECTNO>
                            <SUBJECT> Examples.</SUBJECT>
                            <P>The examples in this section are intended to help the contracting officer identify potential organizational conflicts of interest. They are not all inclusive.</P>
                            <P>
                                (a) 
                                <E T="03">Impaired objectivity.</E>
                                 The following contractual tasks illustrate certain situations likely to create an organizational conflict of interest that could impair or influence the contractor's performance under a Government contract:
                            </P>
                            <P>(1) A contractor is reviewing or evaluating, for Government approval, the delivery of products or performance of services under an existing contract, when the products or services are its own products or services or those of an affiliate or of a competitor.</P>
                            <P>(2) A contractor is providing systems engineering or technical direction involving a major system or components thereof when the same contractor or one of its affiliates will be furnishing the same major system or components (or will be a subcontractor or consultant to the contractor furnishing the major system or component).</P>
                            <P>(3) A contractor is providing systems engineering or technical direction involving a major system or components thereof when the same contractor or one of its affiliates will be testing or verifying the system or a component (or will be a subcontractor or consultant to the contractor furnishing or testing the major system or component).</P>
                            <P>(4) A contractor is assisting an agency in developing policies or regulatory procedures and the contractor or one of its affiliates may, at some future point, be governed by or subject to (or be a subcontractor or consultant to an entity governed by or subject to) such policies or regulatory procedures.</P>
                            <P>(5) A contractor is providing consulting services to an agency that is responsible for regulating an industry and the contractor is performing work under a contract for a public or private sector client that is regulated by that agency. Organizational conflict of interest is more likely to occur if the contractor's employees are simultaneously performing work under both contracts.</P>
                            <P>
                                (6) A contractor is providing support to an agency involving a subject area or issue while it is also performing work for other entities with a competing interest involving the same subject area or issue. For example, a contractor assisting an agency with implementing legislation or regulations may have a conflict if the contractor is also assisting industry with compliance on that same legislation or regulations.
                                <PRTPAGE P="4386"/>
                            </P>
                            <P>
                                (7) A contractor is providing enforcement support to an agency (
                                <E T="03">e.g.,</E>
                                 cost recovery, litigation) while also assisting or representing parties subject to those activities. In addition, when a contractor supports enforcement activities for an agency, and those enforcement activities continue beyond the life of the contract, such conflicting client relationships could continue to jeopardize enforcement actions for a time even after the contract ends, especially if the contractor had access to sensitive information about the agency's enforcement or litigation strategy.
                            </P>
                            <P>(8) A contractor is conducting research for an agency, but that contractor or its researchers has financial or non-financial ties to a foreign entity that seeks capability or advantage related to the topic of that research and is likely to exert undue influence on the contractor. Undue influence in this context describes a situation in which an entity that is not party to a contract, through financial support, position of authority, or other ties, persuades the contractor to take actions that it would not have taken otherwise, such as taking the research in a certain direction or engaging in unauthorized information-sharing with other parties.</P>
                            <P>
                                (9) A contractor is providing services to an agency related to national security or foreign policy matters, but that contractor is also providing similar services to a foreign government or other foreign entity (
                                <E T="03">e.g.,</E>
                                 foreign state-owned or private enterprise) with a competing or opposing interest in those matters, which could result in the foreign entity having undue influence on the contractor's performance on the contract.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Unfair competitive advantage.</E>
                                 (1) The following contractual tasks illustrate situations likely to create an organizational conflict of interest due to unfair competitive advantage through biased ground rules:
                            </P>
                            <P>(i) A contractor is writing specifications, preparing the Government estimate of cost, or providing draft evaluation criteria or a draft evaluation plan for a competitive solicitation, and it or one of its affiliates may be in a position to compete for (or perform as a subcontractor) the relevant requirement.</P>
                            <P>(ii) A contractor is assisting the Government with acquisition planning activities, and the contractor or one of its affiliates or clients may be in a position to compete for (or perform as a subcontractor) the future requirement.</P>
                            <P>(iii) A contractor is assisting the Government in evaluating technical proposals submitted in response to a competitive solicitation, and one of the contractor's affiliates or clients is among the competitors.</P>
                            <P>(iv) A contractor is providing advice that could result in a recommendation to purchase particular goods or services, and the contractor or one of its affiliates is a potential supplier of such goods or services (whether as a prime contractor or subcontractor).</P>
                            <P>(v) A contractor is providing a product or service to the Government and employs a former Government employee who was involved in developing the requirement for the product or service as part of such employee's Government job.</P>
                            <P>(2)(i) Unequal access to information could provide an offeror with an unfair competitive advantage with respect to a particular competition.</P>
                            <P>(ii) Unequal access to information could involve information in the possession of a former Government employee when—</P>
                            <P>(A) The information was obtained by the former Government employee while working for the Government;</P>
                            <P>(B) The information is, for example, contractor proprietary information or is source selection information; and</P>
                            <P>
                                (C) The former Government employee is in a position in which use of the information could provide an unfair competitive advantage to an offeror, 
                                <E T="03">e.g.,</E>
                                 working on or being a consultant to a team preparing a proposal in response to a competitive solicitation.
                            </P>
                            <P>(iii) Unequal access to information may involve a contractor assisting in the closeout of completed contracts gaining access to another contractor's proprietary information.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1205 </SECTNO>
                            <SUBJECT> Methods of addressing organizational conflicts of interest.</SUBJECT>
                            <P>Contracting officers may address organizational conflicts of interest, and their associated risks, using avoidance (3.1205-1), limitations on future contracting (3.1205-2), mitigation (3.1205-3), or the Government may assess and determine that the risk associated with the conflict is acceptable (3.1205-4). Contracting officers may address the risks using a combination of these methods. (See 3.1207-4).  </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1205-1 </SECTNO>
                            <SUBJECT> Avoidance.</SUBJECT>
                            <P>Avoidance consists of Government action taken in one acquisition that is intended to prevent an organizational conflict of interest from arising in the current acquisition or in a future acquisition. In order to successfully implement an avoidance strategy, the contracting officer should work with the program office or requiring activity early in the acquisition process. Techniques of avoidance include, but are not limited to, the following:</P>
                            <P>(a) Developing statements of work and performance work statements that do not require contractors to utilize subjective judgment. Tasks that could require subjective judgment include—</P>
                            <P>(1) Making recommendations;</P>
                            <P>(2) Providing analysis, evaluation, planning, or studies; and</P>
                            <P>(3) Preparing requirements or solicitation documents.</P>
                            <P>(b) Obtaining advice from more than one contractor, so that the Government does not rely solely on the advice of any one contractor.</P>
                            <P>(c) Disqualifying an offeror or offerors from receiving a contract award. Use of this technique may be appropriate when the contracting officer concludes that—</P>
                            <P>(1)(i) The offeror could have an unfair competitive advantage because of its—</P>
                            <P>
                                (A) Prior involvement in acquisition planning for the procurement (
                                <E T="03">e.g.,</E>
                                 developing the solicitation);
                            </P>
                            <P>(B) Work on a Government contract that places the offeror in a position to influence the acquisition; or</P>
                            <P>(C) Unequal access to information that cannot be mitigated.</P>
                            <P>(ii) In such cases, if the offeror is not already disqualified through a limitation on future contracting (see 3.1205-2), disqualification may be the only appropriate means of addressing the organizational conflict of interest;</P>
                            <P>(2)(i) The offeror could have an unfair competitive advantage because of an affiliate's—</P>
                            <P>
                                (A) Prior involvement in acquisition planning for the procurement (
                                <E T="03">e.g.,</E>
                                 developing the solicitation); or
                            </P>
                            <P>(B) Work on a Government contract that places the affiliate in a position to influence the acquisition.</P>
                            <P>(ii) In such cases, the contracting officer should consider the relationship between the offeror and the affiliate in determining whether disqualification of the offeror is appropriate (see 3.1207-4(c)(2) and (d)(2)); or</P>
                            <P>(3) The risk that an offeror's impaired objectivity poses to the Government's interest is more than the Government is willing to accept, because the substance of the work has the potential to affect current or future activities or interests of the offeror (or its affiliates or clients). In such cases, disqualification may be used only if less restrictive techniques for addressing the organizational conflict of interest will not adequately protect the Government's interests (see 3.1207-4(b)(2)).</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1205-2 </SECTNO>
                            <SUBJECT> Limitation on future contracting.</SUBJECT>
                            <P>
                                (a) A limitation on future contracting allows a contractor to perform on the 
                                <PRTPAGE P="4387"/>
                                current contract but precludes the contractor and its affiliates from entering into or participating as a contractor or subcontractor in certain future contracts. This method applies when the contractor's work on the current contract could be impaired by virtue of its expectation of future work or could jeopardize the integrity of the competitive process. Use this method to address an unfair competitive advantage or to address the risk to the Government's interest posed by impaired objectivity when the risk is greater than the Government is willing to accept.
                            </P>
                            <P>(b) Restrict limitations on future contracting to a reasonable duration that is sufficient to neutralize the organizational conflict of interest. The restriction shall end on a specific date or upon the occurrence of an identifiable event.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1205-3 </SECTNO>
                            <SUBJECT> Mitigation.</SUBJECT>
                            <P>(a)(1) Mitigation is an action taken to reduce the risk from an organizational conflict of interest.</P>
                            <P>(2) Mitigation may require Government action, contractor action, or a combination of both.</P>
                            <P>(b) When this method is utilized, contracting officers shall incorporate into the contract a Government-approved mitigation plan, that reflects the actions an offeror has agreed to take to mitigate an organizational conflict of interest. The mitigation plan should provide sufficient details commensurate with the complexity of the organizational conflict of interest and the value of the acquisition. While implementation of a mitigation plan is the contractor's responsibility, the Government retains the right to review implementation of the plan.</P>
                            <P>(c) Possible techniques for mitigating organizational conflicts of interest include, but are not limited to, the following:</P>
                            <P>(1) Requiring a subcontractor or member of a contractor team arrangement that is free of an organizational conflict of interest to perform the portion of the work that involves an organizational conflict of interest on the current contract. This technique will not reduce the risk associated with an organizational conflict of interest unless it is used in conjunction with controls to ensure that the entity with the organizational conflict of interest has no input or influence on how the party without the organizational conflict of interest performs the work.</P>
                            <P>(2) Requiring the contractor to implement structural or behavioral barriers, internal controls, or both.</P>
                            <P>(i) Barriers and internal controls may reduce the risk that potentially conflicting financial or other interests of an affiliate will influence the contractor's exercise of judgment during contract performance. When appropriate, contracting officers may use barriers and controls to prevent corporate officials with a direct interest in an affiliate's performance from participating in or influencing contract performance. Contracting officers should select specific barriers or controls based on an analysis of the facts and circumstances of each case.</P>
                            <P>(ii) When appropriate, use a firewall to implement the controls in paragraph (c)(2)(i) of this section. However, a firewall intended to limit the sharing of information may not adequately address an organizational conflict of interest regarding an affiliate.</P>
                            <P>(iii)(A) For example, if an affiliate anticipates competing for a future related contract, the parties may negotiate a mitigation plan that requires the contractor and its affiliates to implement structural or behavioral barriers, internal controls, or both. The contracting officer for the future contract will determine whether these mitigation measures were sufficient to allow the affiliate to compete for that contract, in accordance with 3.1207-4(d)(2)(ii).</P>
                            <P>
                                (B) Since the mitigation techniques in paragraph (c)(2)(iii)(A) of this section are resource intensive, use the techniques when appropriate to allow the affiliate to compete for the future contract when this offers a benefit to the Government (
                                <E T="03">e.g.,</E>
                                 increased competition in a narrow industry field). Absent such benefit, contracting officers should address this type of organizational conflict of interest using a limitation on future contracting (see 3.1205-2).
                            </P>
                            <P>(3) Disseminating the information to all potential offerors when there is an organizational conflict of interest as a result of unequal access to information (see 3.1204(b)(2)).</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1205-4 </SECTNO>
                            <SUBJECT> Determination of acceptable risk.</SUBJECT>
                            <P>(a) Contracting officers shall not determine any risk is acceptable when an organizational conflict of interest involves unfair competitive advantage (see 3.1204(b)).</P>
                            <P>(b)(1) Contracting officers may determine that some or all of the performance risk associated with an organizational conflict of interest resulting from impaired objectivity is acceptable when—</P>
                            <P>(i) The risk is outweighed by the expected benefit from having the offeror with an organizational conflict of interest perform the contract; and</P>
                            <P>
                                (ii) The performance risk is manageable, 
                                <E T="03">i.e.</E>
                                —
                            </P>
                            <P>(A) The performance risk after implementing mitigation measures is minimal; or</P>
                            <P>(B) The agency has sufficient oversight controls (see 3.1207-3(b)(3)).</P>
                            <P>(2) The contracting officer determination may require approval by a higher authority in accordance with agency procedures.</P>
                            <P>(c) Contracting officers should use this method to address organizational conflicts of interests in combination with other methods, such as mitigation. For example, the contracting officer may require a mitigation plan and elect to accept the remaining risk if the contracting officer determines that the mitigation plan does not remove all of the performance risk associated with the organizational conflict of interest.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1206 </SECTNO>
                            <SUBJECT> Waiver.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Authority.</E>
                                 (1) The agency head may waive—
                            </P>
                            <P>
                                (i) The requirement to address an organizational conflict of interest in a particular acquisition if methods of addressing the organizational conflict of interest are not adequate or feasible (
                                <E T="03">e.g.,</E>
                                 the agency cannot assess the remaining risk as acceptable because the organizational conflict of interest involves an unfair competitive advantage); or  
                            </P>
                            <P>(ii) A preexisting limitation on future contracting.</P>
                            <P>(2) The agency head shall not delegate this waiver authority below the head of the contracting activity.</P>
                            <P>
                                (b) 
                                <E T="03">Requirements.</E>
                                 (1) All waivers shall—
                            </P>
                            <P>(i) Be in writing;</P>
                            <P>(ii) Not include a class of contracts;</P>
                            <P>(iii) Describe the extent of the organizational conflict of interest;</P>
                            <P>(iv) Explain why other methods of addressing the organizational conflict of interest are not feasible or not adequate; and</P>
                            <P>(v) Explain why the waiver is in the Government's interest.</P>
                            <P>(2) The contracting officer shall include the waiver documentation in the contract file.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1207 </SECTNO>
                            <SUBJECT> Contracting officer responsibilities.</SUBJECT>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1207-1 </SECTNO>
                            <SUBJECT> General.</SUBJECT>
                            <P>(a) The contracting officer shall—</P>
                            <P>(1) Identify as early as possible in the acquisition process whether the facts of an acquisition may result in an organizational conflict of interest;</P>
                            <P>
                                (2) Analyze the financial and other interests of the offerors and their affiliates to determine whether an organizational conflict of interest exists (see 3.1207-3(a));
                                <PRTPAGE P="4388"/>
                            </P>
                            <P>(3) Determine whether an organizational conflict of interest exists and whether the organizational conflict of interest can be adequately addressed; and</P>
                            <P>(4) Address any such organizational conflicts of interest, giving proper consideration to decisions of a prior contracting officer when such decisions are known.</P>
                            <P>(b) Contracting officers should obtain the assistance of the program office, appropriate technical specialists, and legal counsel in carrying out the responsibilities of this subpart.</P>
                            <P>(c) Contracting officers are encouraged to consult with potential offerors early in the process (see 3.1207-2(b)).</P>
                            <P>(d) The contracting officer shall identify, analyze, and address organizational conflicts of interest throughout all phases of the acquisition as required in this subpart.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1207-2 </SECTNO>
                            <SUBJECT> Identification of organizational conflicts of interest.</SUBJECT>
                            <P>(a)(1) The contracting officer shall review the nature of the work to be performed to decide whether performance by a contractor is likely to result in an organizational conflict of interest. In addition to evaluating the nature of the work to be performed on the current contract, the contracting officer should also consider whether performance of the current contract is likely to cause the contractor to have an organizational conflict of interest in an anticipated future contract.</P>
                            <P>(2) During acquisition planning (see 7.105(b)(18)), the contracting officer shall ask the relevant contracting activity and requiring activity (as appropriate) to examine whether any potential offerors may have had unequal access to information relevant to the acquisition that could provide an unfair competitive advantage (see 3.1204(b)(2)).</P>
                            <P>
                                (3) The contracting officer shall identify specific contractor client and industry relationships (
                                <E T="03">e.g.,</E>
                                 named organization, named industry) that may present a conflict with the work to be performed, especially when the contractor will be providing advisory and assistance services to the agency, or when the work will involve supporting policymaking or adjudicatory functions, assisting with regulatory enforcement and compliance, or performing work related to national security or foreign policy matters. See 3.1204(a) for examples of relationships that may present impaired objectivity. The contracting officer should use the fill-ins at paragraphs (c)(1)(ii) of the provision at 52.203-XX, Potential Organizational Conflict of Interest—Disclosure and Representation, and at paragraph (b)(1)(iii) of the clause at 52.203-DD, Postaward Disclosure of Organizational Conflict of Interest, to identify these contractor relationships and require offerors to disclose them for review and decision by the agency.
                            </P>
                            <P>(b) When initially announcing an acquisition, the contracting officer shall ask potential offerors if they had unequal access to any information relevant to the acquisition that could provide an unfair competitive advantage as described in 3.1204(b)(2).</P>
                            <P>(1) For contract actions, this inquiry should be included in the sources sought notification or the presolicitation notice.</P>
                            <P>(2) For orders placed against multiple-award contracts, blanket purchase agreements, or basic ordering agreements, this inquiry shall be included in the first announcement to contract holders regarding the order.</P>
                            <P>(3) For Federal Supply Schedule orders, this inquiry shall also be included in the request for quotations.</P>
                            <P>(c) If the contracting officer decides that contractor performance of the contemplated work is likely to result in an organizational conflict of interest, the contracting officer should consult with the program office or requiring activity to determine whether avoidance could be used (see 3.1205-1).</P>
                            <P>(d) Efforts supporting the development of a solicitation that could create an organizational conflict of interest include assistance in preparation of the statement of work or other requirements or the development of cost or budget estimates. If avoiding organizational conflicts of interest is not feasible during the development of the requirement, the contracting officer shall—</P>
                            <P>(1) Require the program office or requiring activity to identify any contractors that participated in acquisition planning, including development of the solicitation, that do not have a preexisting limitation on future contracting; and</P>
                            <P>(2) Review the nature and scope of the work performed to determine whether there was adequate mitigation before listing a contractor at paragraph (b)(3) of 52.203-XX, Potential Organizational Conflict of Interest—Disclosure and Representation, in accordance with 3.1205-1(c).</P>
                            <P>(e)(1) Contracting officers shall identify, to the extent known, any contractors prohibited from competing as a prime contractor or a subcontractor due to an applicable preexisting limitation on future contracting. See 52.203-XX.</P>
                            <P>(2) To identify applicable preexisting limitations on future contracting, the contracting officer may contact the program office and examine prior acquisition history.</P>
                            <P>(f) If the contracting officer has not identified the likelihood of an organizational conflict of interest in accordance with this section, the contracting officer shall document the contract file.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1207-3 </SECTNO>
                            <SUBJECT> Analyzing organizational conflicts of interest.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Sources of information</E>
                                —(1) 
                                <E T="03">Information from offerors.</E>
                                 (i) Contracting officers shall use information provided in response to 52.203-XX to determine whether an offeror's financial or other interests could result in an organizational conflict of interest. In the absence of conflicting information, the contracting officer may rely on the information provided by an offeror.
                            </P>
                            <P>(ii) Contracting officers may request additional information from an offeror or obtain information from other sources, if there is reason to believe that the offeror omitted relevant financial or other interests from its disclosure.</P>
                            <P>
                                (2) 
                                <E T="03">Other sources of information—</E>
                                (i) 
                                <E T="03">Governmental sources.</E>
                                 Governmental sources include, but are not limited to, the files and the knowledge of personnel within—
                            </P>
                            <P>(A) The contracting office;</P>
                            <P>(B) Other contracting offices;  </P>
                            <P>(C) The cognizant contract administration, finance, and audit activities; and</P>
                            <P>(D) The requiring activity.</P>
                            <P>
                                (ii) 
                                <E T="03">Nongovernmental sources.</E>
                                 Nongovernmental sources include, but are not limited to—
                            </P>
                            <P>(A) Offeror's websites;</P>
                            <P>(B) Trade and financial journals;</P>
                            <P>(C) Business directories and registers; and</P>
                            <P>(D) Annual corporate shareholder reports.</P>
                            <P>
                                (b) 
                                <E T="03">Factors to consider.</E>
                                 When analyzing the nature and scope of any organizational conflicts of interest and the associated risks that may arise during contract performance and considering how best to address any such organizational conflicts of interest, the contracting officer should weigh at least the following factors:
                            </P>
                            <P>(1) The extent to which the contract requires the contractor to exercise subjective judgment and provide advice.</P>
                            <P>
                                (2) The extent and severity of the expected impact of the organizational conflict of interest (
                                <E T="03">e.g.,</E>
                                 whether it is expected to occur only once or twice during performance or to impact performance throughout the entire contract).
                                <PRTPAGE P="4389"/>
                            </P>
                            <P>
                                (3) The extent to which the agency has effective oversight controls to prevent an organizational conflict of interest from influencing the contractor's actions during contract performance (
                                <E T="03">e.g.,</E>
                                 postaward monitoring plans).
                            </P>
                            <P>(4) Whether the organizational conflict of interest involves a risk to the integrity of the competitive process (see 3.1204(b)).</P>
                            <P>(5) The extent that the risk can be effectively mitigated through the offeror's proposed mitigation plan.</P>
                            <P>(6) The degree to which any impairment of the contractor's objectivity may impact the agency mission or reduce the value of its services to the agency, and the agency's willingness to accept the performance risk of that impairment. For instance, the performance risk of awarding to a contractor with significant financial ties to or other interests in that same industry could be significant and jeopardize the mission (see examples at 3.1204(a)(4) through (6)). In another example (see 3.1204(a)(9)), an agency involved in addressing certain foreign issues may have significant performance risk awarding to a contractor that also provides advice or assistance to certain foreign entities on the same or similar issues. Significant performance risks such as these may not be acceptable to the agency, regardless of mitigation measures proposed.</P>
                            <P>(7) Whether the offeror or contractor is required to adhere to certain professional standards or has internal operating procedures intended to prevent conflicts of interest. Contracting officers may consider how professional standards or the contractor's operating procedures will prevent or address organizational conflicts of interest during contract performance. However, an offeror or contractor having professional standards or procedures in place related to organizational conflicts of interest is not, by itself, a mitigation strategy.</P>
                            <P>
                                (c) 
                                <E T="03">Unequal access to information.</E>
                                 If the contracting officer is aware that one or more offerors had unequal access to information relevant to the acquisition, the contracting officer shall—
                            </P>
                            <P>(1) Address the situation if access to the information could provide any offeror with an unfair competitive advantage (see 3.1203 and 3.1204(b)(2)); or</P>
                            <P>(2) Document the file, if the contracting officer does not need to address the situation.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1207-4 </SECTNO>
                            <SUBJECT> Addressing organizational conflicts of interest.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">General.</E>
                                 (1) Consistent with 3.1207-3(a), the contracting officer should consider relevant information regarding an offeror's financial or other interests in determining how to address any organizational conflicts of interest (see 3.1205). When determining what method or methods of addressing the organizational conflict of interest will be appropriate, contracting officers shall consider the specific facts and circumstances of the contracting situation and the nature and potential extent of the risks associated with an organizational conflict of interest.
                            </P>
                            <P>(2)(i) When organizational conflict of interest is not an evaluation factor (see 15.304) in a competitive solicitation, exchanges between the Government and an offeror regarding the offeror's mitigation plan or limitation on future contracting are not considered discussions.</P>
                            <P>(ii) If the exchanges (see 15.306) result in a change to other parts of an offeror's technical proposal or cost proposal, the contracting officer shall either—</P>
                            <P>(A) Open discussions;</P>
                            <P>(B) Reopen discussions; or</P>
                            <P>(C) Eliminate the offeror from further consideration.</P>
                            <P>
                                (iii) The contracting officer should conduct these exchanges as early as possible in the acquisition process so major changes to a mitigation plan that significantly affect proposed performance can be evaluated; 
                                <E T="03">e.g.,</E>
                                 having a member of a contractor team arrangement that is free of an organizational conflict of interest perform the portion of the work that involves an organizational conflict of interest.
                            </P>
                            <P>(3) Use of a firewall may address an unfair competitive advantage resulting from unequal access to information. If no firewall was previously required, or an existing firewall was breached, and the offeror has already received an unfair competitive advantage, the contracting officer should explore other methods such as information sharing or a combination of methods.</P>
                            <P>
                                (b) 
                                <E T="03">Avoidance by disqualifying offerors.</E>
                                 Contracting officers shall refer to the standards for determining when disqualification of an offeror from participation in a competition is appropriate (see 3.1205-1(c)).
                            </P>
                            <P>
                                (1) 
                                <E T="03">Unfair competitive advantage.</E>
                                 (i) Consistent with 3.1205-1(c), disqualification of an offeror from participation in a contract award is appropriate where there is a risk to the integrity of the competitive process. These organizational conflicts of interest involve the contractor or its affiliates' prior work on a Government contract that places it in a position to influence the acquisition when a limitation on future contracting was not included in the prior contract.
                            </P>
                            <P>(ii) The contracting officer shall disqualify the offeror or potential offeror from consideration for the contract if the contracting officer determines that—</P>
                            <P>(A) Evidence exists that an offeror or potential offeror had an unfair competitive advantage in accordance with 3.1204(b)(2); and</P>
                            <P>(B) No mitigation strategy will protect the integrity of the competition.</P>
                            <P>
                                (2) 
                                <E T="03">Impaired objectivity.</E>
                                 Consistent with 3.1205-1(c)(3), when an organizational conflict of interest presents a risk to the Government's interests, the contracting officer shall prepare a written determination that less restrictive techniques for addressing the organizational conflict of interest will not adequately protect the Government's interests before disqualifying an offeror. The contracting officer determination may require approval by a higher authority in accordance with agency procedures.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Limitation on future contracting.</E>
                                 (1) Contracting officers shall include a limitation on future contracting, when the contemplated work requires the contractor to exercise subjective judgment and provide advice, if the advice may create an unfair competitive advantage or result in impaired objectivity by virtue of the contractor's expectation of future work (see 3.1205-2 and 3.1208(d)).
                            </P>
                            <P>(2)(i) An offeror that is subject to a preexisting limitation on future contracting as an affiliate can request the agency waive the limitation in accordance with section 3.1206. If the contracting officer determines that the offeror's request has merit, the contracting officer shall process the waiver request.</P>
                            <P>(ii) In determining whether to process a waiver to remove an affiliate from an existing future limitation on contracting, the contracting officer should analyze the nature of the relationship between the entities to determine whether the risk associated with the organizational conflict of interest should preclude the affiliate from competing. This analysis may include but is not limited to—</P>
                            <P>(A) Controls put in place, either as the result of other Government contracts or the offeror's own initiative;</P>
                            <P>(B) The financial relationships, or lack thereof, between the two entities;</P>
                            <P>
                                (C) The information sharing framework, or barriers to information sharing, between the two entities;
                                <PRTPAGE P="4390"/>
                            </P>
                            <P>(D) The work performed by the two entities, and whether there is overlap in the areas in which they work; and</P>
                            <P>(E) The general corporate and control structure between the two entities.</P>
                            <P>(iii) The contracting officer may also use this analysis with regard to affiliates' participation in situations in which a future limitation on contracting should have been included in the earlier contract.</P>
                            <P>
                                (d) 
                                <E T="03">Mitigation</E>
                                —(1) 
                                <E T="03">General.</E>
                                 Consistent with 3.1205-3, when the acquisition involves offeror-submitted mitigation plans, the contracting officer shall analyze the feasibility of mitigation of the organizational conflict of interest, including the expected effectiveness of the proposed mitigation plan and the Government's ability to review implementation of the provisions of the plan.  
                            </P>
                            <P>
                                (2) 
                                <E T="03">Mitigation to avoid an affiliate's organizational conflicts of interest on future contracts.</E>
                                 Contracting officers may negotiate a mitigation plan, which requires the contractor and its affiliates to implement structural or behavioral barriers, internal controls, or a combination of methods.
                            </P>
                            <P>(i) This technique is intended to provide a basis for the contracting officer of the future contract to determine whether the organizational conflict of interest has been effectively mitigated with regard to the affiliate on the future contract. Therefore, the contracting officer for the current contract shall document the file regarding how the mitigation plan is intended to address any organizational conflict of interest such that the affiliate may compete for a future contract.</P>
                            <P>(ii) The contracting officer of the future contract shall consider the decisions of the contracting officer for the earlier contract when determining whether the risk associated with the organizational conflict of interest has been effectively reduced or eliminated. This analysis may include the factors in 3.1207-4(c)(2)(ii). If the contracting officer determines that the earlier mitigation measures are sufficient to allow the affiliate to participate, then the contracting officer shall prepare a written determination. The contracting officer determination may require approval by a higher authority in accordance with agency procedures.</P>
                            <P>(iii) This technique is only available for an affiliate.</P>
                            <P>
                                (3) 
                                <E T="03">Mitigation to avoid unfair competitive advantage resulting from unequal access to information</E>
                                —(i) 
                                <E T="03">Information sharing.</E>
                                 Contracting officers may use information sharing to avoid an unfair competitive advantage, which results from unequal access to information. Information sharing consists of disseminating the information in question to all potential offerors, either in the solicitation, in a solicitation amendment, or through some other method, such as posting it online. When using this technique, contracting officers shall—
                            </P>
                            <P>(A) Obtain permission to disseminate information that belongs to a third party; and</P>
                            <P>(B) Provide such information to potential offerors early enough in the acquisition process to allow those offerors to effectively utilize the information.</P>
                            <P>
                                (ii) 
                                <E T="03">Use of a firewall.</E>
                                 When some of an offeror's employees or an affiliate had access to the relevant information, the contracting officer may consider the use of a firewall to prevent those employees from sharing that information with employees involved in the competition.
                            </P>
                            <P>(A) The contracting officer has discretion to approve or reject an offeror's proposed firewall.</P>
                            <P>(B) If an offeror's proposal includes use of a preexisting firewall as mitigation, the contracting officer shall require the offeror to—</P>
                            <P>
                                (
                                <E T="03">1</E>
                                ) Provide a representation that, to the best of its knowledge and belief, there were no breaches of the firewall during preparation of the proposal; or
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) Explain any breach that occurred (provided in paragraph (b) at 52.203-AA, Unequal Access to Information-Representation).
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Safeguarding of proprietary information.</E>
                                 When a contractor gains access to proprietary information of another entity as a result of its performance on a Government contract, the contracting officer shall require the contractor to execute nondisclosure agreements with each affected entity. Each nondisclosure agreement shall—
                            </P>
                            <P>(A) Provide protection for each entity's information from unauthorized use or disclosure for as long as it remains proprietary;</P>
                            <P>(B) Prevent the use of such information for any purpose other than that for which it was furnished; and</P>
                            <P>(C) Be submitted to the contracting officer for inclusion in the contract file.</P>
                            <P>
                                (4) 
                                <E T="03">Mitigation to avoid impaired objectivity through use of a firewall.</E>
                                 When impaired objectivity may result in significant performance risk to the agency (see 3.1207-3(b)(6)), contracting officers should not accept use of a firewall as a contractor or its affiliate's sole mitigation strategy. Contracting officers should consider combining additional methods to adequately address the organizational conflict of interest.
                            </P>
                            <P>
                                (5) 
                                <E T="03">Mitigation plans.</E>
                                 If the contracting officer approves any changes to the mitigation plan after award, the contracting officer shall incorporate the revised plan into the contract (see 52.203-MM(c)).
                            </P>
                            <P>
                                (e) 
                                <E T="03">Assessment that the risk is acceptable.</E>
                                 (1) If the contracting officer determines that the performance risk resulting from impaired objectivity is acceptable, the contracting officer shall document the file to—
                            </P>
                            <P>(i) Describe the extent of the organizational conflict of interest;</P>
                            <P>(ii) Explain how it meets the conditions of 3.1205-4; and</P>
                            <P>(iii) Discuss the reasons it is in the best interest of the Government to accept the risk associated with the organizational conflict of interest.</P>
                            <P>(2) If the contracting officer identifies a performance risk associated with an organizational conflict of interest but cannot make a determination consistent with 3.1205-4, the head of the agency may waive the requirement to address the conflict of interest in accordance with 3.1206, prior to contract award.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1207-5 </SECTNO>
                            <SUBJECT> Award requirements.</SUBJECT>
                            <P>(a) Except as provided in 3.1207-6(a), the contracting officer shall award the contract to the apparent successful offeror after all organizational conflicts of interest have been addressed or the requirement to address the organizational conflict of interest has been waived in writing in accordance with 3.1206.</P>
                            <P>(b) Before withholding award from the apparent successful offeror based on organizational conflict of interest considerations, the contracting officer shall—</P>
                            <P>(1) Notify the offeror in writing;</P>
                            <P>(2) Provide the reasons for withholding award; and</P>
                            <P>(3) Allow the offeror a reasonable opportunity to respond.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1207-6 </SECTNO>
                            <SUBJECT>Task-order or delivery-order contracts, blanket purchase agreements, basic ordering agreements, and interagency acquisitions.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Task-order or delivery-order contracts, blanket purchase agreements, or basic ordering agreements.</E>
                                 The contracting officer shall make a reasonable attempt to identify all organizational conflicts of interest prior to award of the task-order or delivery-order contract or establishment of the blanket purchase agreement or basic ordering agreement. The contracting officer shall address the organizational conflict of interest in the base contract or agreement, to the extent that an organizational conflict of interest can be identified prior to award, using the tools discussed at 3.1205.
                                <PRTPAGE P="4391"/>
                            </P>
                            <P>
                                (b) 
                                <E T="03">Issuance of task or delivery orders or orders under a blanket purchase agreement or basic ordering agreement.</E>
                                 Before placing an order, the contracting officer shall—
                            </P>
                            <P>(1) Consider whether the work involved has a potential for an organizational conflict of interest, consistent with the requirements in 3.1207-1 through 3.1207-5;</P>
                            <P>(2) Supplement, in the order, the procedures for addressing an organizational conflict of interest in the task-order or delivery-order contract, blanket purchase agreement, or basic ordering agreement, as necessary, to reflect the nature and scope of the order being placed;</P>
                            <P>(3) Address organizational conflicts of interest or obtain a waiver; and</P>
                            <P>(4) For orders expected to exceed the simplified acquisition threshold, include terms substantially the same as those found in the provision at 52.203-AA in the—</P>
                            <P>(i) Notice of fair opportunity under a multiple-award contract (see 16.505(b)(1)(iii)(B));</P>
                            <P>(ii) Request for quotation provided under a multiple-award blanket purchase agreement (see 8.405-3(c)(2)(iii); or</P>
                            <P>(iii) Order under a basic ordering agreement (see 16.703(d)).</P>
                            <P>
                                (c) 
                                <E T="03">Interagency acquisitions.</E>
                                 (1) If the order is placed as a direct acquisition (see 17.502-1), the contracting officer for the requesting agency is responsible for addressing organizational conflicts of interest associated with the order.
                            </P>
                            <P>(2) If an agency acquires supplies or services by means of an assisted acquisition, the servicing agency and requesting agency shall identify which agency is responsible for the actions identified in 3.1207 and reflect this understanding in the interagency agreement.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>3.1208</SECTNO>
                            <SUBJECT> Solicitation provisions and contract clauses.</SUBJECT>
                            <P>(a)(1) If the contracting officer has identified the likelihood of an organization conflict of interest (see 3.1207-2), include in solicitations exceeding the simplified acquisition threshold, except for solicitations for commercial products, a provision substantially the same as 52.203-XX, Potential Organizational Conflict of Interest—Disclosure and Representation.</P>
                            <P>(2) The contracting officer shall fill in paragraph (b)(2) of the provision as instructed in the provision to identify contractors who have a known preexisting limitation on future contracting and that preexisting limitation has not been waived.</P>
                            <P>(3) The contracting officer shall fill in paragraph (b)(3) of the provision, if any contractors have been identified as having participated in the development of the solicitation (see 3.1207-2(d)), and do not have a preexisting limitation on future contracting, but have been disqualified from the competition.</P>
                            <P>(4) The contracting officer shall fill in paragraph (c)(1)(ii)(B) of the provision if the contracting officer has identified specific contractor client and industry relationships that may present a conflict with the work to be performed.</P>
                            <P>(b)(1) Include in solicitations and contracts a clause substantially the same as 52.203-DD, Postaward Disclosure of Organizational Conflict of Interest, when the solicitation includes the provision at 52.203-XX, Potential Organizational Conflict of Interest—Disclosure and Representation.</P>
                            <P>(2) The contracting officer shall fill in paragraph (b)(1)(iii) of the clause if the contracting officer has identified specific contractor client and industry relationships that may present a conflict of interest.</P>
                            <P>(c)(1) Include in solicitations exceeding the simplified acquisition threshold, except for solicitations for commercial products, a clause that is substantially the same as 52.203-MM, Mitigation of Organizational Conflicts of Interest, when the resulting contract may involve an organizational conflict of interest that can be addressed by an acceptable offeror-submitted mitigation plan prior to contract award.</P>
                            <P>(2) Include in the resulting contract a clause that is substantially the same as 52.203-MM, Mitigation of Organizational Conflicts of Interest, only if the offeror submits an organizational conflict of interest mitigation plan that will be incorporated into the contract.</P>
                            <P>(d)(1) Include in solicitations exceeding the simplified acquisition threshold, except for solicitations for commercial products, a clause that is substantially the same as 52.203-LL, Limitation on Future Contracting, when the contracting officer expects that the method of addressing the organizational conflict of interest will involve a limitation on future contracting (see 3.1207-4(c)).</P>
                            <P>(i) The contracting officer shall establish a duration sufficient to neutralize the projected organizational conflict of interest, but no longer than necessary (see 3.1205-2(b)).</P>
                            <P>(ii) Prior to contract award, the contracting officer shall fill in the nature and duration of the limitation on future contracting or contractor activities in paragraph (a) of the clause for incorporation into the contract, based on communications with the apparent successful offeror.</P>
                            <P>(2) Include in the resulting contract a clause that is substantially the same as 52.203-LL, Limitation on Future Contracting, when a limitation on future contracting is used to address an organizational conflict of interest.</P>
                            <P>(e) Include in solicitations that exceed the simplified acquisition threshold, except for solicitations for commercial products, a provision that is substantially the same as 52.203-AA, Unequal Access to Information—Representation.</P>
                        </SECTION>
                    </SUBPART>
                    <PART>
                        <HD SOURCE="HED">PART 7—ACQUISITION PLANNING</HD>
                    </PART>
                    <AMDPAR>8. Amend section 7.105 by—</AMDPAR>
                    <AMDPAR>a. Redesignating paragraphs (b)(18) through (b)(22) as paragraphs (b)(19) through (b)(23); and</AMDPAR>
                    <AMDPAR>b. Adding a new paragraph (b)(18).</AMDPAR>
                    <P>The addition reads as follows:</P>
                    <SECTION>
                        <SECTNO>7.105 </SECTNO>
                        <SUBJECT>Contents of written acquisition plans.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>
                            (18) 
                            <E T="03">Organizational conflicts of interest.</E>
                             (i) Discuss the potential for organizational conflicts of interest (see 2.101 and 3.1207-2) that may—
                        </P>
                        <P>(A) Exist at time of contract award;</P>
                        <P>(B) Occur during contract performance; or</P>
                        <P>(C) Occur in a future acquisition.</P>
                        <P>(ii) Discuss the proposed method or methods of addressing these organizational conflicts of interest. Also address unequal access to information (see 3.1207-2 through 3.1207-4). Identify any solicitation provisions and contract clauses that would be used.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 8—REQUIRED SOURCES OF SUPPLIES AND SERVICES</HD>
                    </PART>
                    <AMDPAR>9. Amend section 8.404 by—</AMDPAR>
                    <AMDPAR>a. Removing from the end of paragraph (c)(2) “and”;</AMDPAR>
                    <AMDPAR>b. Redesignating paragraph (c)(3) as paragraph (c)(4);</AMDPAR>
                    <AMDPAR>c. Adding a new paragraph (c)(3); and</AMDPAR>
                    <AMDPAR>d. Removing from newly redesignated paragraph (c)(4) “Must” and adding “Shall” in its place.</AMDPAR>
                    <P>The addition reads as follows:</P>
                    <SECTION>
                        <SECTNO>8.404 </SECTNO>
                        <SUBJECT>Use of Federal Supply Schedules.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(3) Shall comply with the requirements on organizational conflicts of interest (see subpart 3.12); and</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>10. Amend section 8.405-1 by—</AMDPAR>
                    <AMDPAR>
                        a. Redesignating paragraphs (d)(3) and (4) as paragraphs (d)(4) and (5) respectively; and
                        <PRTPAGE P="4392"/>
                    </AMDPAR>
                    <AMDPAR>b. Adding a new paragraph (d)(3).</AMDPAR>
                    <P>The addition reads as follows:</P>
                    <SECTION>
                        <SECTNO>8.405-1 </SECTNO>
                        <SUBJECT>Ordering procedures for supplies, and services not requiring a statement of work.</SUBJECT>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(3) When ordering services, the ordering activity contracting officer shall require schedule contractors planning on submitting a quote to disclose if they had unequal access to any information relevant to the acquisition that could provide an unfair competitive advantage (see 3.1207-2(b)).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>11. Amend section 8.405-2 by revising paragraph (c)(3)(ii) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>8.405-2 </SECTNO>
                        <SUBJECT>Ordering procedures for services requiring a statement of work.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(3) * * *</P>
                        <P>(ii) The ordering activity contracting officer shall provide an RFQ that includes a statement of work, the evaluation criteria, and a request that schedule contractors planning on submitting a quote indicate as early as possible whether they had unequal access to any information relevant to the acquisition that could provide an unfair competitive advantage (see 3.1207-2(b)).</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 9—CONTRACTOR QUALIFICATIONS</HD>
                    </PART>
                    <AMDPAR>12. Revise section 9.000 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>9.000 </SECTNO>
                        <SUBJECT> Scope of part.</SUBJECT>
                        <P>This part prescribes policies, standards, and procedures pertaining to prospective contractors' responsibility; debarment, suspension, and ineligibility; qualified products; first article testing and approval; contractor team arrangements; and defense production pools and research and development pools.</P>
                    </SECTION>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart 9.5 [Removed and Reserved]</HD>
                    </SUBPART>
                    <AMDPAR>13. Remove and reserve subpart 9.5.</AMDPAR>
                    <SECTION>
                        <SECTNO>9.601 </SECTNO>
                        <SUBJECT> [Removed and Reserved]</SUBJECT>
                    </SECTION>
                    <AMDPAR>14. Remove and reserve section 9.601.</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 10—MARKET RESEARCH</HD>
                    </PART>
                    <AMDPAR>15. Amend section 10.001 by—</AMDPAR>
                    <AMDPAR>a. Removing from paragraph (a)(3)(viii) “and”;</AMDPAR>
                    <AMDPAR>b. Removing the period from the end of paragraph (a)(3)(ix) and adding “; and” in its place; and</AMDPAR>
                    <AMDPAR>c. Adding paragraph (a)(3)(x).</AMDPAR>
                    <P>The addition reads as follows:</P>
                    <SECTION>
                        <SECTNO>10.001 </SECTNO>
                        <SUBJECT>Policy.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(3) * * *</P>
                        <P>(x) Determine if potential offerors had unequal access to any information relevant to the acquisition that could provide an unfair competitive advantage (see 3.1207-2(b)).</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 11—DESCRIBING AGENCY NEEDS</HD>
                        <SECTION>
                            <SECTNO>11.002 </SECTNO>
                            <SUBJECT> [Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>16. Amend section 11.002 by removing from paragraph (c) “subpart 9.5” and adding “subpart 3.12” in its place.</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 12—ACQUISITION OF COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES</HD>
                    </PART>
                    <AMDPAR>17. Amend section 12.301 by—</AMDPAR>
                    <AMDPAR>a. Redesignating paragraphs (d)(1) through (d)(14) as paragraphs (d)(3) through (d)(16); and</AMDPAR>
                    <AMDPAR>b. Adding new paragraphs (d)(1) and (2).</AMDPAR>
                    <P>The additions read as follows:</P>
                    <SECTION>
                        <SECTNO>12.301 </SECTNO>
                        <SUBJECT>Solicitation provisions and contract clauses for the acquisition of commercial products and commercial services.</SUBJECT>
                        <P>(d) * * *</P>
                        <P>(1) Insert a provision substantially the same as 52.203-XX, Potential Organizational Conflict of Interest—Disclosure and Representation, as prescribed in 3.1208(a).</P>
                        <P>(2) Insert a provision substantially the same as 52.203-AA, Unequal Access to Information—Representation, as prescribed in 3.1208(e).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>18. Amend section 12.504 by adding paragraph (a)(3) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>12.504 </SECTNO>
                        <SUBJECT>Applicability of certain laws to subcontracts for the acquisition of commercial products and commercial services.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(3) 41 U.S.C. 2303 note, Preventing Organizational Conflicts of Interest in Federal Acquisition (Pub. L. 117-324) (see 52.203-XX, 52.203-DD, 52.203-MM, 52.203-LL, and 52.203-AA).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>19. Amend section 12.505 by adding paragraph (d) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>12.505 </SECTNO>
                        <SUBJECT>Applicability of certain laws to contracts for the acquisition of COTS items.</SUBJECT>
                        <STARS/>
                        <P>(d) 41 U.S.C. 2303 note, Preventing Organizational Conflicts of Interest in Federal Acquisition (Pub. L. 117-324) (see 52.203-XX, 52.203-DD, 52.203-MM, 52.203-LL, and 52.203-AA).</P>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 13—SIMPLIFIED ACQUISITION PROCEDURES</HD>
                    </PART>
                    <AMDPAR>20. Amend section 13.005 by redesignating paragraph (a)(7) as paragraph (a)(8) and adding new paragraph (a)(7) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>13.005 </SECTNO>
                        <SUBJECT>List of laws inapplicable to contracts and subcontracts at or below the simplified acquisition threshold.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(7) 41 U.S.C. 2303 note, Preventing Organizational Conflicts of Interest in Federal Acquisition (Pub. L. 117-324) (see 52.203-XX, 52.203-DD, 52.203-MM, 52.203-LL, and 52.203-AA).</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 15—CONTRACTING BY NEGOTIATION</HD>
                        <SECTION>
                            <SECTNO>15.206 </SECTNO>
                            <SUBJECT> [Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>21. Amend section 15.206 by removing from paragraph (d) introductory text “15.306(e)” and adding “15.306(f)” in its place.</AMDPAR>
                    <AMDPAR>22. Amend section 15.306 by—</AMDPAR>
                    <AMDPAR>a. Removing from paragraph (d)(3) the phrase “and (e)” and adding “and (f)” in its place;</AMDPAR>
                    <AMDPAR>b. Redesignating paragraph (e) as paragraph (f); and</AMDPAR>
                    <AMDPAR>c. Adding a new paragraph (e).</AMDPAR>
                    <P>The addition reads as follows:</P>
                    <SECTION>
                        <SECTNO>15.306 </SECTNO>
                        <SUBJECT>Exchanges with offerors after receipt of proposals.</SUBJECT>
                        <STARS/>
                        <P>(e) Exchanges with offerors to address organizational conflicts of interest. Exchanges between the Government and an offeror regarding an offeror's mitigation plan or limitation on future contracting do not constitute discussions as long as—</P>
                        <P>(1) The organizational conflict of interest is not an evaluation factor; and</P>
                        <P>(2) The exchanges did not result in a change to other parts of the offeror's technical or cost proposal (see 3.1207-4(a)(2)).</P>
                        <STARS/>
                    </SECTION>
                    <SECTION>
                        <SECTNO>15.604 </SECTNO>
                        <SUBJECT> [Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>23. Amend section 15.604 in paragraph (a)(2) by removing “subpart 9.5” and adding “subpart 3.12” in its place.</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 16—TYPES OF CONTRACTS</HD>
                    </PART>
                    <AMDPAR>24. Amend section 16.505 by—</AMDPAR>
                    <AMDPAR>
                        a. Removing from the end of paragraph (b)(1)(iii)(B)(
                        <E T="03">1</E>
                        ) “and”;
                    </AMDPAR>
                    <AMDPAR>
                        b. Redesignating paragraph (b)(1)(iii)(B)(
                        <E T="03">2</E>
                        ) as paragraph (b)(1)(iii)(B)(
                        <E T="03">3</E>
                        ); and
                        <PRTPAGE P="4393"/>
                    </AMDPAR>
                    <AMDPAR>
                        c. Adding new paragraph (b)(1)(iii)(B)(
                        <E T="03">2</E>
                        ).
                    </AMDPAR>
                    <P>The addition reads as follows:</P>
                    <SECTION>
                        <SECTNO>16.505 </SECTNO>
                        <SUBJECT>Ordering.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) * * *</P>
                        <P>(iii) * * *</P>
                        <P>(B) * * *</P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) If appropriate, follow the procedures for addressing unequal access to information (see 3.1207-6); and
                        </P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 17—SPECIAL CONTRACTING METHODS</HD>
                        <SECTION>
                            <SECTNO>17.605 </SECTNO>
                            <SUBJECT> [Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>25. Amend section 17.605 by removing from the third sentence in paragraph (a) “adequately covered” and adding “addressed” in its place.</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 18—EMERGENCY ACQUISITIONS</HD>
                        <SECTION>
                            <SECTNO>18.000 </SECTNO>
                            <SUBJECT> [Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>26. Amend section 18.000 by removing from paragraph (b) “FAR Part 3, Improper Business Practices and Personal Conflicts of Interest” and adding “part 3” in its place.</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 37—SERVICE CONTRACTING</HD>
                        <SECTION>
                            <SECTNO>37.102 </SECTNO>
                            <SUBJECT> [Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>27. Amend section 37.102 in paragraph (g) by adding (see subparts 3.11 and 3.12)” after “conflicts of interest”.</AMDPAR>
                    <SECTION>
                        <SECTNO>37.110 </SECTNO>
                        <SUBJECT> [Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>28. Amend section 37.110 by removing paragraph (d) and redesignating paragraph (e) as paragraph (d).</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 42—CONTRACT ADMINISTRATION AND AUDIT SERVICES</HD>
                    </PART>
                    <AMDPAR>29. Amend section 42.1204 by revising paragraph (d) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>42.1204 </SECTNO>
                        <SUBJECT> Applicability of novation agreements.</SUBJECT>
                        <STARS/>
                        <P>(d) When considering whether to recognize a third party as a successor in interest to Government contracts, the responsible contracting officer shall identify, analyze, and address any organizational conflicts of interest in accordance with subpart 3.12. If the responsible contracting officer determines that an organizational conflict of interest cannot be addressed in accordance with 3.1207-4, but that it is in the best interest of the Government to approve the novation request, a request for a waiver may be submitted in accordance with the procedures at 3.1206.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 50—EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT</HD>
                        <SECTION>
                            <SECTNO>50.205-1 </SECTNO>
                            <SUBJECT> [Amended]</SUBJECT>
                        </SECTION>
                    </PART>
                    <AMDPAR>30. Amend section 50.205-1 by removing from paragraph (b) “7.105(b)(20)(v)” and adding “7.105(b)(21)(v)” in its place.</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 52—SOLICITATION PROVISIONS AND CONTRACT CLAUSES</HD>
                    </PART>
                    <AMDPAR>31. Add sections 52.203-XX, 52.203-DD, 52.203-LL, 52.203-MM, and 52.203-AA to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>52.203-XX </SECTNO>
                        <SUBJECT> Potential Organizational Conflict of Interest—Disclosure and Representation.</SUBJECT>
                        <P>As prescribed in 3.1208(a), insert a provision substantially the same as the following:</P>
                        <EXTRACT>
                            <HD SOURCE="HD1">Potential Organizational Conflict of Interest—Disclosure and Representation (Date)</HD>
                            <P>
                                (a) 
                                <E T="03">Definition.</E>
                                 “Organizational conflict of interest,” as used in this provision, is defined in Federal Acquisition Regulation (FAR) clause 52.203-DD, Postaward Disclosure of Organizational Conflict of Interest.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Notice.</E>
                                 (1) The Contracting Officer has determined that the nature of the work to be performed under the contract resulting from this solicitation is such that it may result in organizational conflicts of interest (see FAR section 3.1204, Examples).
                            </P>
                            <P>(2) The following entities are disqualified from competing as a prime contractor or a subcontractor, due to an applicable preexisting limitation on future contracting (see FAR 3.1205-2):</P>
                            <P>
                                [
                                <E T="03">Contracting Officer shall insert entity name(s), if applicable.</E>
                                ]
                            </P>
                            <P>(3) The following entities do not have an applicable preexisting limitation on future contracting. However, they participated in the preparation of the statement of work or other requirements documents, including cost or budget estimates, or otherwise participated in development of the solicitation. These prior activities result in an organizational conflict of interest due to an unfair competitive advantage. As a result, the Contracting Officer has determined the following entities are disqualified from competing as a prime contractor or a subcontractor:</P>
                            <P>
                                [
                                <E T="03">Contracting Officer shall insert entity name(s), if applicable.</E>
                                ]
                            </P>
                            <P>
                                (c) 
                                <E T="03">Proposal requirements</E>
                                —(1) 
                                <E T="03">Disclosure.</E>
                                 The Offeror shall—
                            </P>
                            <P>(i) Describe any relevant limitations on future contracting, the term of which has not yet expired, to which the Offeror or potential subcontractor(s) agreed;</P>
                            <P>
                                (ii) Disclose all relevant information of which the Offeror is aware regarding past (within the past twelve months), present, or currently planned financial or other interests that could result in an organizational conflict of interest, including information about affiliates, clients, and potential subcontracts, except where such disclosure would constitute a violation of law (
                                <E T="03">e.g.,</E>
                                 the Securities Exchange Act of 1934, 15 U.S.C. 78a 
                                <E T="03">et seq.</E>
                                ). At a minimum, such disclosure must include—
                            </P>
                            <P>(A) The name of the client(s) and a description of the services rendered or planned to be rendered;</P>
                            <P>(B) Specific client and industry relationships, if identified by the Contracting Officer, that may present a conflict with the work to be performed:</P>
                            <P>
                                [
                                <E T="03">Contracting Officer shall insert entity name(s) and relationship(s), if applicable</E>
                                ]; and
                            </P>
                            <P>(C) The nature and extent of the financial or other interest and any entity or entities involved in the relationship;</P>
                            <P>(iii) Disclose information withheld pursuant to paragraph (c)(1)(ii) of this provision as soon as the law no longer prohibits disclosure; and</P>
                            <P>(iv) Describe any professional standards to which the Offeror is subject, or any procedures the Offeror has in place, to prevent organizational conflicts of interest.</P>
                            <P>
                                (2) 
                                <E T="03">Representation.</E>
                                 The Offeror represents, by submission of its offer, that to the best of its knowledge and belief it has disclosed all relevant information of which the Offeror is aware regarding any organizational conflicts of interest as required in paragraph (c)(1) of this provision.
                            </P>
                            <P>
                                (3) To the extent that either the Offeror or the Government identifies any financial or other interests that could result in an organizational conflict of interest on the contract resulting from this solicitation, the Offeror shall explain the actions it intends to take to address such organizational conflicts of interest, 
                                <E T="03">e.g.,</E>
                                 by submitting a mitigation plan and/or accepting a limitation on future contracting. The Offeror shall include information on planned flowdown to subcontracts of clauses 52.203-MM, Mitigation of Organizational Conflicts of Interest, or 52.203-LL, Limitation on Future Contracting.
                            </P>
                            <P>(4) The Contracting Officer will determine whether an organizational conflict of interest exists and whether the organizational conflict of interest has been adequately addressed. The Contracting Officer may withhold award if an organizational conflict of interest cannot be adequately addressed.</P>
                            <P>
                                (d) 
                                <E T="03">Disclosure update.</E>
                                 The Offeror shall make a full disclosure in writing to the Contracting Officer within 5 days, if the Offeror identifies, after receipt of proposals but before contract award—
                            </P>
                            <P>(1) Financial or other interests that could result in an organizational conflict of interest that was not previously disclosed in its proposal in accordance with paragraph (c) of this provision; or</P>
                            <P>(2) A change to any relevant facts relating to a previously disclosed organizational conflict of interest.</P>
                            <P>
                                (e) 
                                <E T="03">Resulting contract.</E>
                                 (1) If the Offeror submits a mitigation plan, the Contracting 
                                <PRTPAGE P="4394"/>
                                Officer will include the Government-approved mitigation plan and a clause substantially the same as 52.203-MM, Mitigation of Organizational Conflicts of Interest, in the contract resulting from this solicitation.
                            </P>
                            <P>(2) If a limitation on future contracting is used, the Contracting Officer will include a clause substantially the same as 52.203-LL, Limitation on Future Contracting in the resultant contract.</P>
                        </EXTRACT>
                        <FP>(End of provision)</FP>
                    </SECTION>
                    <SECTION>
                        <SECTNO>52.203-DD </SECTNO>
                        <SUBJECT> Postaward Disclosure of Organizational Conflict of Interest.</SUBJECT>
                        <P>As prescribed in 3.1208(b), insert the following clause:</P>
                        <EXTRACT>
                            <HD SOURCE="HD1">Postaward Disclosure of Organizational Conflict of Interest (Date)</HD>
                            <P>
                                (a) 
                                <E T="03">Definition.</E>
                                 “Organizational conflict of interest,” as used in this clause, means that an entity or its affiliate(s) has impaired objectivity or an unfair competitive advantage as a result of other activities or relationships with other entities or their affiliates, including with public, private, domestic, and foreign entities. An entity or its affiliate may have an unfair competitive advantage as a result of biased ground rules or through unequal access to information. As used in this definition—
                            </P>
                            <P>(1) “Biased ground rules” means a situation in which an entity or its affiliate, as part of its performance of a Government contract, has or may have materially influenced the development of the requirement, evaluation criteria, or other source selection procedures for another Government contract. The primary concern is that the entity could skew the future competition, whether intentionally or not, in favor of itself;</P>
                            <P>(2) “Entity” means an individual, corporation, or other organization;</P>
                            <P>(3) “Impaired objectivity” means a situation in which an entity or its affiliate has or may have financial or other interests or an incentive to provide other than impartial advice to the Government, or the entity or its affiliate's objectivity in performing the contract work is or might be otherwise impaired; and</P>
                            <P>(4) “Unequal access to information” means a situation in which an entity or its affiliate has or may have an unfair competitive advantage because—</P>
                            <P>
                                (i) Access to the information was provided to the entity or its affiliate by the Government. Such information may include proprietary and source selection information, 
                                <E T="03">e.g.,</E>
                                 proposals, financial information;
                            </P>
                            <P>(ii) The information is not available to all potential offerors; and</P>
                            <P>(iii) Having access to the information would assist the entity in obtaining the contract.</P>
                            <P>
                                (b) 
                                <E T="03">Disclosures.</E>
                                 (1) Except as provided in paragraph (b)(3) of this clause, the Contractor shall provide the Contracting Officer a full disclosure in writing within 5 days if the Contractor identifies—
                            </P>
                            <P>(i) Financial or other interests that could result in an organizational conflict of interest that was not previously addressed and for which a waiver has not been granted;</P>
                            <P>(ii) A change to any relevant facts relating to a previously identified organizational conflict of interest; or</P>
                            <P>(iii) Specific client and industry relationships, if identified by the Contracting Officer, that may present a conflict with the work to be performed:</P>
                            <P>
                                [
                                <E T="03">Contracting Officer shall insert entity name(s), if applicable</E>
                                ].
                            </P>
                            <P>(2) The Contractor shall disclose organizational conflicts of interest identified during performance of the contract, as well as newly discovered organizational conflicts of interest that existed before contract award. This disclosure shall include a description of—</P>
                            <P>(i) The organizational conflict(s) of interest in sufficient detail for agency evaluation; and</P>
                            <P>(ii) Actions to address the organizational conflict(s) of interest that—</P>
                            <P>(A) The Contractor has taken or proposes to take; or</P>
                            <P>(B) The Contractor recommends that the Government take.</P>
                            <P>
                                (3) Where such disclosure would constitute a violation of law (
                                <E T="03">e.g.,</E>
                                 the Securities Exchange Act of 1934, 15 U.S.C. 78a 
                                <E T="03">et seq.</E>
                                ), the Contractor shall withhold information only until the law no longer prohibits disclosure.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Termination.</E>
                                 If, in compliance with this clause, the Contractor reports financial or other interests that the Contracting Officer identifies as an organizational conflict of interest that cannot be addressed in a manner acceptable to the Government, the Contracting Officer may terminate the contract, one or more orders, the blanket purchase agreement, or the basic ordering agreement.
                            </P>
                            <P>
                                (d) 
                                <E T="03">Subcontracts.</E>
                                 The Contractor shall include the substance of this clause, including this paragraph (d), in subcontracts exceeding the simplified acquisition threshold where the work includes or may include tasks that may result in an organizational conflict of interest, other than subcontracts for commercial products, commercial services, and commercially available off-the-shelf items. The Contractor shall modify the terms “Contractor” and “Contracting Officer” appropriately to reflect the change in parties.
                            </P>
                        </EXTRACT>
                        <FP>(End of clause)</FP>
                    </SECTION>
                    <SECTION>
                        <SECTNO>52.203-MM </SECTNO>
                        <SUBJECT> Mitigation of Organizational Conflicts of Interest.</SUBJECT>
                        <P>As prescribed in 3.1208(c), insert a clause substantially the same as the following:</P>
                        <EXTRACT>
                            <HD SOURCE="HD1">Mitigation of Organizational Conflicts of Interest (Date)</HD>
                            <P>
                                (a) 
                                <E T="03">Definition.</E>
                                 “Organizational conflict of interest,” as used in this clause, is defined in the clause 52.203-DD, Postaward Disclosure of Organizational Conflict of Interest.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Mitigation plan.</E>
                                 The Government-approved organizational conflict of interest mitigation plan (mitigation plan) and its obligations are hereby incorporated as an attachment to the contract. While implementation of a mitigation plan is the Contractor's responsibility, the Government retains the right to review implementation of the plan.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Changes.</E>
                                 (1) Either the Contractor or the Government may propose changes to the mitigation plan. Such changes are subject to the mutual agreement of the parties and will become effective only upon written approval of the revised mitigation plan by the Contracting Officer and incorporation into the contract.
                            </P>
                            <P>(2) The Contractor shall propose an update to the mitigation plan within 30 days of—</P>
                            <P>(i) Any changes to the legal construct of its organization, any subcontractor changes, or any significant management or ownership changes that impact the mitigation plan; or</P>
                            <P>(ii) A change to the contract requirements that impacts the mitigation plan.</P>
                            <P>
                                (d) 
                                <E T="03">Noncompliance.</E>
                                 (1) The Contractor shall report to the Contracting Officer any noncompliance with this clause or with the mitigation plan, whether by its own personnel, those of the Government, other contractors, or subcontractors.
                            </P>
                            <P>(2) The report shall describe the noncompliance and the actions the Contractor has taken or proposes to take to cure and mitigate such noncompliance and avoid repetition of the noncompliance.</P>
                            <P>(3) After conducting such further inquiries and communications as may be necessary, the Contracting Officer and the Contractor shall agree on appropriate corrective action, if any, or the Contracting Officer will direct corrective action, subject to the terms of this contract.</P>
                            <P>
                                (e) 
                                <E T="03">Subcontracts.</E>
                                 (1) The Contractor shall include the substance of this clause, including this paragraph (e), in subcontracts exceeding the simplified acquisition threshold where the subcontract work is addressed in the mitigation plan, other than subcontracts for commercial products, commercial services, and commercially available off-the-shelf items.
                            </P>
                            <P>(2) The Contractor shall modify the terms “Contractor” and “Contracting Officer” appropriately to reflect the change in parties.</P>
                            <P>(3) The Contractor shall provide the Contracting Officer with information on the flowdown of this clause upon request.</P>
                        </EXTRACT>
                        <FP>(End of clause)</FP>
                    </SECTION>
                    <SECTION>
                        <SECTNO>52.203-LL</SECTNO>
                        <SUBJECT>Limitation on Future Contracting.</SUBJECT>
                        <P>As prescribed in 3.1208(d), insert a clause substantially the same as the following:</P>
                        <EXTRACT>
                            <HD SOURCE="HD1">Limitation on Future Contracting (Date)</HD>
                            <P>
                                (a) 
                                <E T="03">Limitation.</E>
                                 The Contractor and any of its affiliates shall be disqualified from performing ___ 
                                <E T="03">[Before contract award, Contracting Officer to describe the work that the Contractor will be disqualified from performing]</E>
                                 as a contractor or as a subcontractor. The disqualification will last until ___. 
                                <E T="03">[Before contract award, Contracting Officer to determine appropriate length of prohibition or identify the appropriate ending event for the limitation on future contracting.]</E>
                            </P>
                            <P>
                                (b) 
                                <E T="03">Subcontracts.</E>
                                 (1) The Contractor shall include the substance of this clause, including this paragraph (b), in subcontracts exceeding the simplified acquisition threshold where the work includes tasks that 
                                <PRTPAGE P="4395"/>
                                are encompassed by the description of work provided in paragraph (a) of this clause, other than subcontracts for commercial products, commercial services, and commercially available off-the-shelf items. The Contractor shall modify the terms “Contractor” and “Contracting Officer” appropriately to reflect the change in parties.
                            </P>
                            <P>(2) Upon request, the Contractor shall provide information to the Contracting Officer with regard to flowdown of this clause.</P>
                        </EXTRACT>
                        <FP>(End of clause)</FP>
                    </SECTION>
                    <SECTION>
                        <SECTNO>52.203-AA </SECTNO>
                        <SUBJECT>Unequal Access to Information—Representation.</SUBJECT>
                        <P>As prescribed in 3.1208(e), insert a provision substantially the same as the following:</P>
                        <EXTRACT>
                            <HD SOURCE="HD1">Unequal Access to Information—Representation (Date)</HD>
                            <P>
                                (a) 
                                <E T="03">Preproposal requirements.</E>
                                 The Offeror shall determine, to the best of its knowledge and belief, whether it or any of its affiliates had unequal access to any information that could provide an unfair competitive advantage as described in Federal Acquisition Regulation (FAR) 3.1204(b)(2). If so, the Offeror shall inform the Contracting Officer of such access prior to the submission of its offer. The Offeror shall also advise the Contracting Officer of any actions that the Offeror proposes to take to address the situation pursuant to FAR 3.1207-4(d).
                            </P>
                            <P>
                                (b) 
                                <E T="03">Representation.</E>
                                 (1) By submission of its offer, the Offeror represents, to the best of its knowledge and belief, that—
                            </P>
                            <P>(i) No firewall was necessary because the Offeror did not have an unfair competitive advantage due to unequal access to information; or</P>
                            <P>(ii) If a firewall was planned to mitigate the impact of an unfair competitive advantage due to unequal access to information, the firewall was implemented and was not breached during the preparation of this offer; or</P>
                            <P>(2) By checking this box □, the Offeror represents, to the best of its knowledge and belief, that the planned firewall was not implemented or was breached, and additional explanatory information is attached.</P>
                        </EXTRACT>
                        <FP>(End of provision)</FP>
                    </SECTION>
                    <AMDPAR>32. Amend section 52.212-3 by—</AMDPAR>
                    <AMDPAR>a. Revising the date of the provision; and</AMDPAR>
                    <AMDPAR>b. Removing from paragraph (t) introductory text “12.301(d)(1)” and adding “12.301(d)(3)” in its place.</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <SECTION>
                        <SECTNO>52.212-3</SECTNO>
                        <SUBJECT>Offeror Representations and Certifications—Commercial Products and Commercial Services.</SUBJECT>
                        <STARS/>
                        <EXTRACT>
                            <HD SOURCE="HD1">Offeror Representations and Certifications—Commercial Products and Commercial Services (Date)</HD>
                        </EXTRACT>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>33. Amend section 52.212-5 by—</AMDPAR>
                    <AMDPAR>a. Revising the date of the clause;</AMDPAR>
                    <AMDPAR>b. Redesignating paragraphs (c)(1) through (10) as paragraphs (c)(4) through (13); and</AMDPAR>
                    <AMDPAR>c. Adding new paragraphs (c)(1) through (3).</AMDPAR>
                    <P>The revision and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>52.212-5</SECTNO>
                        <SUBJECT>Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services.</SUBJECT>
                        <STARS/>
                        <EXTRACT>
                            <HD SOURCE="HD1">Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Date)</HD>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>__(1) 52.203-DD, Postaward Disclosure of Organizational Conflict of Interest (Pub. L. 117-324)(41 U.S.C. 2303 note).</P>
                            <P>__(2) 52.203-MM, Mitigation of Organizational Conflicts of Interest (Pub. L. 117-324)(41 U.S.C. 2303 note).</P>
                            <P>__(3) 52.203-LL, Limitation on Future Contracting (Pub. L. 117-324)(41 U.S.C. 2303 note).</P>
                        </EXTRACT>
                        <STARS/>
                    </SECTION>
                </SUPLINF>
                <FRDOC>[FR Doc. 2024-31561 Filed 1-14-25; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 6820-EP-P</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4397"/>
            <PARTNO>Part IX</PARTNO>
            <AGENCY TYPE="P">Department of Homeland Security</AGENCY>
            <CFR>6 CFR Part 139</CFR>
            <TITLE>Protection of Federal Property; Proposed Rule</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="4398"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                    <CFR>6 CFR Part 139</CFR>
                    <DEPDOC>[Docket ID No. DHS-2024-0033]</DEPDOC>
                    <RIN>RIN 1601-AB17</RIN>
                    <SUBJECT>Protection of Federal Property</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Department of Homeland Security.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Notice of proposed rulemaking.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>The Department of Homeland Security (DHS), in consultation with the U.S. General Services Administration (GSA), proposes to promulgate regulations for the protection of Federal property. Within DHS, Federal Protective Service (FPS) maintains responsibility for the protection of buildings, grounds, and property owned, occupied, or secured by the Federal government. The proposed rule would adopt and revise the language of related-GSA regulations, consistent with DHS' statutory authority, to provide charging options for violations occurring on and adjacent to Federal property, update prohibited conduct to incorporate advancing technology, provide clearer public notice, and apply the regulations uniformly to all Federal property.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>Written comments must be submitted on or before March 17, 2025. The electronic Federal Docket Management System will accept comments before midnight eastern time at the end of that day.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            You may send comments on this notice, identified by Docket Number DHS-2024-0033, through the Federal e-Rulemaking portal at 
                            <E T="03">https://www.regulations.gov</E>
                            . Follow the website instructions for submitting comments. Comments submitted in a manner other than those discussed in this proposal will not be considered by DHS. Please note that DHS cannot accept any comments that are hand-delivered or couriered. In addition, DHS cannot accept any comments contained on any form of digital media storage devices, such as CDs/DVDs and USB drives. DHS is also not accepting mailed comments. If you cannot submit your comment using 
                            <E T="03">https://www.regulations.gov</E>
                            , please contact David Hess by email at 
                            <E T="03">FPSNPRM@fps.dhs.gov</E>
                            . For additional instructions regarding submitting comments, see Section I of this notice, “Public Participation” in the 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             Section of this document.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            Mr. David Hess, Deputy Director, FPS Policy, Communications and Engagement, 202-447-0800, 
                            <E T="03">FPSNPRM@fps.dhs.gov</E>
                            .
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Public Participation</FP>
                        <FP SOURCE="FP-2">II. Background</FP>
                        <FP SOURCE="FP1-2">A. Statutory Authority</FP>
                        <FP SOURCE="FP1-2">B. History of Federal Facility Protection</FP>
                        <FP SOURCE="FP1-2">1. Federal Works Agency</FP>
                        <FP SOURCE="FP1-2">2. U.S. General Services Administration</FP>
                        <FP SOURCE="FP1-2">3. U.S. Department of Homeland Security</FP>
                        <FP SOURCE="FP1-2">C. Federal Protective Service Today</FP>
                        <FP SOURCE="FP-2">III. Comparison to GSA's Federal Management Regulations</FP>
                        <FP SOURCE="FP-2">IV. Proposed Rule</FP>
                        <FP SOURCE="FP1-2">Subpart A—General</FP>
                        <FP SOURCE="FP1-2">Subpart B—Personal Conduct Affecting Federal Property</FP>
                        <FP SOURCE="FP-2">V. Regulatory Analyses</FP>
                        <FP SOURCE="FP1-2">A. Executive Order 12866 and Executive Order 13563</FP>
                        <FP SOURCE="FP1-2">B. Regulatory Flexibility Act</FP>
                        <FP SOURCE="FP1-2">C. Paperwork Reduction Act</FP>
                        <FP SOURCE="FP1-2">D. Executive Order 13132 (Federalism)</FP>
                        <FP SOURCE="FP1-2">E. Unfunded Mandates Reform Act</FP>
                        <FP SOURCE="FP1-2">F. National Environmental Policy Act</FP>
                        <FP SOURCE="FP1-2">G. Executive Order 13175</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">Table of Acronyms</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                        <FP SOURCE="FP-1">DHS Department of Homeland Security</FP>
                        <FP SOURCE="FP-1">FSC Facility Security Committee</FP>
                        <FP SOURCE="FP-1">FMR Federal Management Regulations</FP>
                        <FP SOURCE="FP-1">FPS Federal Protective Service</FP>
                        <FP SOURCE="FP-1">FPS LEOs Federal Protective Service Law Enforcement Officers</FP>
                        <FP SOURCE="FP-1">FR Federal Register</FP>
                        <FP SOURCE="FP-1">GSA U.S. General Services Administration</FP>
                        <FP SOURCE="FP-1">HSA Homeland Security Act</FP>
                        <FP SOURCE="FP-1">ISC Interagency Security Committee</FP>
                        <FP SOURCE="FP-1">MOU Memorandum of Understanding</FP>
                        <FP SOURCE="FP-1">NARA National Archives and Records Administration</FP>
                        <FP SOURCE="FP-1">NPRM Notice of Proposed Rulemaking</FP>
                        <FP SOURCE="FP-1">PSO Protective Security Officer</FP>
                        <FP SOURCE="FP-1">UMRA Unfunded Mandates Reform Act</FP>
                        <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Public Participation</HD>
                    <P>Interested persons are invited to participate in this rulemaking by submitting written comments, data, or views. DHS also invites comments relating to the economic, environmental, energy, or federalism considerations that might result from this proposed rulemaking action. Comments that will provide the most assistance to DHS in developing this proposed rule will refer to a specific provision of the NPRM, explain the reason for any comments, and include other information or authority that supports such comments.</P>
                    <P>
                        <E T="03">Instructions:</E>
                         If you submit a comment, you must submit it to DHS Docket Number 
                        <E T="03">DHS-2024-0033.</E>
                         All submissions may be posted, without change, to the Federal eRulemaking Portal at 
                        <E T="03">https://www.regulations.gov,</E>
                         and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary public comment submission you make. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy and Security Notice available at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         For access to the docket and to read background documents or comments received, go to 
                        <E T="03">https://www.regulations.gov,</E>
                         referencing the docket number listed above. You may also sign up for email alerts on the online docket to be notified when comments are posted or another 
                        <E T="04">Federal Register</E>
                         document is published.
                    </P>
                    <HD SOURCE="HD1">II. Background</HD>
                    <HD SOURCE="HD2">A. Statutory Authority</HD>
                    <P>
                        In response to the terrorist attacks on September 11, 2001, Congress enacted the Homeland Security Act of 2002, Public Law 107-296, 116 Stat 2135 (Nov. 25, 2002) (the Act) to better protect the assets and critical infrastructure of the United States. The Act expressly transfers the authority for law enforcement and related security functions for Federal properties from the GSA to the Secretary of DHS.
                        <SU>1</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Section 403(3) of the Homeland Security Act, Public Law 107-296, 116 Stat. 2315 (2002), codified at 6 U.S.C. 203(3) (transferred all law enforcement and related security functions of the Federal Protective Service from the Administrator of General Services to the Secretary of Homeland Security).
                        </P>
                    </FTNT>
                    <P>
                        The Act requires the Secretary to “protect the buildings, grounds, and property that are owned, occupied, or secured by the Federal Government (including any agency, instrumentality, or wholly owned or mixed-ownership corporation thereof) and the persons on the property.” 40 U.S.C. 1315(a). The Act further authorizes the Secretary to designate officers and agents “for duty in connection with the protection of property owned or occupied by the Federal Government and persons on the property, including duty in areas outside the property to the extent necessary to protect the property and persons on the property.” 40 U.S.C. 1315(b)(1). Thus, in addition to moving the protective mission into DHS, the statute further expanded DHS's protective coverage to include duties in areas outside federal property to the extent necessary to protect federal property and persons thereon, as well as authorizing off-property investigations related to the protection of federal 
                        <PRTPAGE P="4399"/>
                        property and the individuals on that property. 40 U.S.C. 1315(b)(2)(E).
                        <SU>2</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             
                            <E T="03">See</E>
                             40 U.S.C. 318 (2000) (authorizing appointment of special policeman for GSA in connection with the policing of federal property with authority as sheriffs and constables upon that property.)
                        </P>
                    </FTNT>
                    <P>In addition, as directly related to this proposed rule, the statute authorizes the Secretary, in consultation with the Administrator of GSA, to “prescribe regulations necessary for the protection and administration of property owned or occupied by the Federal Government and persons on the property.” 40 U.S.C. 1315(c)(1).</P>
                    <HD SOURCE="HD2">B. History of Federal Facility Protection</HD>
                    <HD SOURCE="HD3">1. Federal Works Agency</HD>
                    <P>
                        On June 1, 1948, Congress authorized the Administrator of the Federal Works Agency to appoint uniformed guards to police federal buildings and other areas within the jurisdiction of the Federal Works Agency. Public Law 80-566, 62 Stat. 281. The special police were given the same responsibility on federal property as sheriffs and constables to enforce the laws enacted for the protection of persons and property, to prevent breaches of peace, and to address disturbances and unlawful assemblies. The Federal Works Agency published the original rules governing personal conduct at federal facilities in the 
                        <E T="04">Federal Register</E>
                         on May 26, 1949. 
                        <E T="03">See</E>
                         14 FR 2799 (May 27, 1949).
                    </P>
                    <HD SOURCE="HD3">2. U.S. General Services Administration</HD>
                    <P>One year after the establishment of the Federal Works Agency, Congress abolished it and transferred all its functions, including the protection of federal buildings, to GSA. Public Law 81-152, 63 Stat. 377. In September 1961, Congress authorized the GSA Administrator to appoint non-uniformed special police to conduct investigations to protect property under the control of GSA, enforce federal law to protect persons and property, and make arrests without a warrant for any offense committed upon Federal property if a police officer had reason to believe the offense was a felony and the person to be arrested was guilty of the felony. Public Law 87-275, 75 Stat. 574.</P>
                    <P>
                        Pursuant to Public Law 87-275, the GSA Administrator formally established the FPS in January 1971 through GSA Administrative Order 5440.46.
                        <SU>3</SU>
                        <FTREF/>
                         FPS, as a component of GSA, continued to protect federal property and buildings with both uniformed and non-uniformed officers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             
                            <E T="03">See</E>
                             Shawn Reese, Cong. Rsch. Serv., RS22706, The Federal Protective Service and Contract Security Guards: A Statutory History and Current Status (2009).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. U.S. Department of Homeland Security</HD>
                    <P>As mentioned above, in 2002 Congress transferred FPS from GSA to DHS with enactment of the Homeland Security Act of 2002 (Pub. L. 107-296). 6 U.S.C. 203. It further authorized the Secretary to designate officers and agents “for duty in connection with the protection of property owned or occupied by the Federal Government and persons on the property, including duty in areas outside the property to the extent necessary to protect the property and persons on the property.” 40 U.S.C. 1315(b)(1).</P>
                    <P>
                        Thereafter, in 2009, the DHS Secretary transferred FPS from Immigration and Customs Enforcement to the National Protection and Programs Directorate.
                        <SU>4</SU>
                        <FTREF/>
                         In 2018, Congress passed the Cybersecurity and Infrastructure Security Agency Act, Public Law 115-278, renaming the National Protection and Programs Directorate to the Cybersecurity and Infrastructure Security Agency and authorizing the Secretary of Homeland Security to coordinate a transfer or realignment of FPS within DHS.
                        <SU>5</SU>
                        <FTREF/>
                         In 2019, FPS was transferred to the DHS Management Directorate.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             
                            <E T="03">See</E>
                             Press Release, Secretary Napolitano Announces Transfer of Federal Protective Service to National Protection and Programs Directorate (
                            <E T="03">https://www.dhs.gov/news/2009/10/29/transfer-federal-protective-service-national-protection-and-programs-directorate</E>
                            ) (Oct. 29, 2009) (last accessed July 15, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             
                            <E T="03">See</E>
                             6 U.S.C. 452, note (directing reassignment of FPS within DHS). Effective October 1, 2019, the Secretary internally realigned FPS under the Department's Management Directorate.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">C. Federal Protective Service Today</HD>
                    <P>
                        Over the past decade, DHS has encountered a myriad of criminal misconduct directed at and occurring on federal property, including violent acts committed by active shooters, assaults and disturbances committed by competing and conflicting individuals or groups, and increased threats, harassment, and hazards perpetrated or presented by bad-faith actors.
                        <SU>6</SU>
                        <FTREF/>
                         DHS acts to mitigate these threats through the authority of 40 U.S.C. 1315 to protect Federal property owned, occupied, or secured by the Federal government and the persons thereon, and conducts enforcement operations commensurate with threats to this mission. Additionally, DHS partners with other federal, state, local, and tribal law enforcement agencies. FPS provides guidance to building owners and tenant agencies on physical security measures to promote public safety at Federal facilities, such as FPS's involvement in the development of a facility's Occupancy Emergency Plan and active shooter trainings. FPS also provides crime prevention education for agencies and individuals and recommends strategies to promote safety.
                        <SU>7</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             
                            <E T="03">See e.g.</E>
                             Rosana Hughes, 
                            <E T="03">Guilty plea after Molotov cocktail damages federal building in Atlanta in 2020,</E>
                             The Atlanta Journal-Constitution (Oct. 27, 2022), 
                            <E T="03">https://www.ajc.com/news/crime/guilty-plea-after-molotov-cocktail-damages-federal-building-in-atlanta-in-2020/IJQEHRPXX5FD5MUPSOGPISXB24/</E>
                            (last accessed Sept. 10, 2024); 
                            <E T="03">see also, e.g.,</E>
                             Aaron Katersky, Josh Margolin, and Meredith Deliso, 
                            <E T="03">Standoff ends after armed man allegedly tried to break into Cincinnati FBI office</E>
                            , ABC News (Aug. 12, 2022), 
                            <E T="03">https://abcnews.go.com/US/suspect-chased-break-fbis-cincinnati-office-police/story?id=88246982</E>
                             (last accessed Sept. 10, 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             
                            <E T="03">See</E>
                             Cline Testimony, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <P>
                        Specifically, to accomplish the federal property protection mandate prescribed by Congress, the Secretary, through the delegation of 40 U.S.C. 1315 authorities and police powers, relies upon the law enforcement and protective security services provided primarily by FPS.
                        <SU>8</SU>
                        <FTREF/>
                         FPS employs nearly 900 Federal law enforcement officers designated under the Secretary's authority to protect over 8,500 Federal non-military properties and the roughly 1.4 million people who work, visit, or conduct business on those properties across the United States and its territories. FPS officers utilize the police powers prescribed at 40 U.S.C. 1315(b)(2), including enforcement of federal law and regulations, for the protection of property and persons on the property.
                        <SU>9</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             
                            <E T="03">See</E>
                             DHS Delegations 0002, Rev. No. 00.4, approved on 10/11/2022, and 02500, Rev. No. 00.1, approved on 11/23/2022. Additionally, pursuant to DHS Delegation 12000, Rev. No. 00.1, law enforcement officers of DHS's Office of the Chief Security Officer, the Federal Law Enforcement Training Center, and the Federal Emergency Management Agency Mt. Weather Police Department may also be delegated enforcement under 40 U.S.C 1315.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             See 
                            <E T="03">Hearing on Examining the Security of Federal Facilities</E>
                             (Nov. 29, 2023) (Testimony of Richard K. Cline, Director, FPS, Management Directorate, DHS), 
                            <E T="03">https://www.hsgac.senate.gov/hearings/examining-the-security-of-federal-facilities/</E>
                            (last accessed July 18, 2024).
                        </P>
                    </FTNT>
                    <P>
                        As noted, in accomplishing this security mission, FPS currently has authority to enforce GSA regulations at protected GSA facilities. The enforcement activities related to GSA regulations include but are not limited to: inspecting items subject to inspection; admitting persons to property; preserving property; controlling vehicular and pedestrian traffic in accordance with signs and directions; and enforcing regulations that prohibit disturbances, possession and use of narcotics and other drugs, use of alcoholic beverages, soliciting, vending, debt collection, posting and 
                        <PRTPAGE P="4400"/>
                        distributing materials, taking photographs for news, advertising or commercial purposes; bringing dogs and other animals on Federal property; and possession of weapons and explosives on Federal property. 
                        <E T="03">See generally</E>
                         41 CFR Part 102-74, Subpart C.
                    </P>
                    <P>FPS executes its mission by providing integrated security, law enforcement, and protective intelligence capabilities to ensure the Federal Government functions securely. For example, during Fiscal Year (FY) 2022, FPS:</P>
                    <P>• Responded to, investigated, and mitigated more than 1,292 threats and assaults directed towards federal facilities and their occupants.</P>
                    <P>• Conducted 58,084 Protective Security Officer (PSO) post inspections, including 47,086 facility security checks.</P>
                    <P>• Stopped more than 189,462 weapons/prohibited items including knives, brass knuckles, pepper spray, and other items that could be used as weapons or are contraband such as illegal drugs, from entering federal facility entrances during routine checks.</P>
                    <P>• Made 505 arrests.</P>
                    <P>• Responded to 17,168 incidents involving people or property.</P>
                    <P>In addition to enforcing GSA regulations, FPS has criminal jurisdiction that varies based on the jurisdiction of the facility. The Federal government obtains jurisdiction over Federal property through various methods resulting in three types of legislative jurisdiction discussed below: exclusive, concurrent, or proprietary. When a criminal incident occurs, the response and the applicable criminal laws depend on the facility's legislative jurisdiction: (1) Exclusive Jurisdiction—Federal government has sole law enforcement authority over these lands and only Federal criminal law applies; (2) Concurrent Jurisdiction—Both Federal and state governments have law enforcement authority over the area and both may prosecute those who violate their respective laws; and (3) Proprietary Jurisdiction—States have primary jurisdiction, but Federal laws of general application and agency regulations still apply. For criminal acts, FPS may enforce all Federal laws and regulations and the type of Federal charge is dependent on the type of legislative jurisdiction where the offense occurred. For example, although FPS may enforce all Federal criminal statutory laws, FPS most frequently enforces Title 18 of the U.S. Code, which covers “Crimes and Criminal Procedure.” Title 18 of the U.S. Code covers both general crimes, such as murder and narcotics use, and restrictions particular to Federal facilities, such as prohibitions on weapons and explosives. FPS enforces these laws across all three jurisdictions, with the exception of Title 18 offenses pertinent to special maritime and territorial jurisdiction of the United States. These offenses can only be charged in exclusive and concurrent legislative jurisdictions and cannot be charged in proprietary jurisdictions. The proposed rule would not affect this statutory jurisdiction.</P>
                    <P>In some circumstances, FPS may enforce state law under the Assimilative Crimes Act (ACA). 18 U.S.C. 13. The ACA applies state law to conduct occurring on Federal lands when the following three criteria are met: (1) the United States has exclusive or concurrent jurisdiction, (2) there is no Federal law covering the conduct, and (3) there is an applicable state law under the jurisdiction in which the lands are located. However, fewer than 10 percent of GSA facilities are under known concurrent or exclusive jurisdictions, limiting the applicability of the ACA in supporting FPS's mission. FPS may also enforce State and/or Local law via a Memorandum of Understanding or Agreement (MOU or MOA) where such agreements have been entered into with the jurisdictions. In summary, FPS enforces the GSA regulations and Federal law and regulations across jurisdictions. FPS enforces certain state law through the ACA in exclusive and concurrent jurisdictions, or through relevant MOUs or MOAs in concurrent or proprietary jurisdictions.</P>
                    <P>In further executing this vital mission, FPS LEOs exercise their jurisdictional authority off Federal property to the extent necessary to protect federal property and persons on the property. This off-property enforcement is spatially limited by the requirement of a nexus between the off-property enforcement action and the nature of the criminal offense directed at the federal property or persons on that property. In other words, FPS LEOs are authorized to take enforcement action for off-property conduct that affects the federal property. For example, FPS LEOs may take enforcement action where a person, located off of federal property, fires a weapon at a federal building. 40 U.S.C. 1315(b)(1). Relatedly, FPS LEOs may act without geographical limitation where conducting investigations of off-property offenses that may have nevertheless been committed against property owned or occupied by the Federal government or persons on the property. For example, FPS LEOs may investigate a threat against a government employee without regard to whether the threat occurred on federal property. 40 U.S.C. 1315(b)(2)(E). In sum, FPS is authorized, and does, make arrests for off-property federal offenses committed against federal property or persons located thereon.</P>
                    <P>
                        The charging options available to FPS LEOs, however, vary for off-property conduct. Specifically, as noted above, the GSA regulations cannot be used as they only apply when the prohibited activity is on the GSA property, in which case persons who commit low-level offenses on federal property may be cited and released under the GSA regulations (also referred to as the “Federal Management Regulation (FMR)”). To illustrate the difference in charging options between off-property and on-property conduct, consider the case of two individuals who both throw a brick at a Federal building causing damage to the Federal property. The charging options will differ based on where the individuals were standing. If one of the individuals is standing on Federal (GSA) property, the government has the option to charge that individual under the FMR or under 18 U.S.C. 1361. In comparison, an individual who commits the same conduct one foot off Federal property cannot be cited under the FMR; instead, charging options are limited to 18 U.S.C. 1361 (or under state law where appropriate).
                        <SU>10</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             Non-federal charges are either a result of FPS enforcing local laws through a Memorandum of Understanding (MOU), or by local authorities bring charges. 
                            <E T="03">See</E>
                             40 U.S.C. 1315(e).
                        </P>
                    </FTNT>
                    <P>In sum, through its protection mission, DHS ensures the continuity and resilience of important government capabilities and functions. FPS law enforcement officers and contract security personnel support the enforcement of laws and regulations governing Federal buildings, maintain law and order, and protect life and property in workplaces controlled by the Federal Government.</P>
                    <HD SOURCE="HD1">III. Comparison to GSA's Federal Management Regulations</HD>
                    <P>
                        The General Service Administration (GSA)'s Federal Management Regulations (FMR) currently include provisions in Title 41 of the Code of Federal Regulations (CFR) Part 102-74, Subpart C, Conduct on Federal Property, that function as Class C Misdemeanor crimes subject to maximum penalties of 30-days' imprisonment, $5,000 fine, or both, consistent with 40 U.S.C. 1315(c)(2), 18 U.S.C. 3559(a)(8) (term of imprisonment), and 18 U.S.C. 3571(b)(6) (fines). FPS charges these FMR provisions by issuing a written citation akin to a traffic ticket. The FMR provisions provide FPS officers low-
                        <PRTPAGE P="4401"/>
                        level charging authority for the types of criminal misconduct routinely encountered while protecting federal property and occupants on the property across the Nation, as discussed in section II.C.
                    </P>
                    <P>
                        DHS is proposing to mirror the requirements in part 102-74, 
                        <E T="03">Federal Management Regulations,</E>
                         in a new Part 139, 
                        <E T="03">Conduct on Federal Property,</E>
                         in Title 6 to ensure the protection of federal property under the Secretary's purview and the responsibility for such protection is clearly communicated to employees and visitors at Federal property. DHS welcomes comments on all the proposed changes set out in this proposed rule.
                    </P>
                    <P>For purposes of comparison and ease of reference, DHS provides the following distribution table listing the proposed rule and, as relevant, the current GSA FMR governing conduct for the protection of federal property as located in Title 41 of the Code of Federal Regulations (CFR).</P>
                    <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s50,r50">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">DHS Title 6 Section</CHED>
                            <CHED H="1">FMR Section</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">6 CFR 139.1 (Purpose)</ENT>
                            <ENT>N/A</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.5(a)</ENT>
                            <ENT>41 CFR 102-74.5</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.5(a)</ENT>
                            <ENT>41 CFR 102-74.365</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.5(b)</ENT>
                            <ENT>41 CFR 102-74.455</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.5(c)</ENT>
                            <ENT>41 CFR 102-74.15</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139. 5(d)</ENT>
                            <ENT>41 CFR 102-74.365</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.10 (Assessments)</ENT>
                            <ENT>N/A</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.15</ENT>
                            <ENT>41 CFR 102-71.20</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.20</ENT>
                            <ENT>41 CFR 102-74.370</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.20</ENT>
                            <ENT>41 CFR 102-74.375</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.25</ENT>
                            <ENT>41 CFR 102-74.380</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.30</ENT>
                            <ENT>41 CFR 102-74.385</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.35</ENT>
                            <ENT>41 CFR 102-74.390</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.40</ENT>
                            <ENT>41 CFR 102-74.395</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.45</ENT>
                            <ENT>41 CFR 102-74.400</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.50</ENT>
                            <ENT>41 CFR 102-74.405</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.55</ENT>
                            <ENT>41 CFR 102-74.410</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.60</ENT>
                            <ENT>41 CFR 102-74.415</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.65</ENT>
                            <ENT>41 CFR 102-74.420</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.70</ENT>
                            <ENT>41 CFR 102-74.430</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.75(a)</ENT>
                            <ENT>41 CFR 102-74.440</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.75(b)</ENT>
                            <ENT>41 CFR 102-74.435</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.80</ENT>
                            <ENT>41 CFR 102-74.425</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6 CFR 139.85</ENT>
                            <ENT>41 CFR 102-74.450</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">IV. Proposed Rule</HD>
                    <P>
                        To better execute the Secretary's statutory mission to protect federal property and persons on and off the property pursuant to 40 U.S.C. 1315, the proposed rule would create new DHS regulations that conform with the Secretary's statutory authority at 40 U.S.C. 1315. DHS developed this proposed rule in consultation with GSA and by using the current criminal regulations governing personal conduct on federal property found in 41 CFR Part 102-74, Subpart C, of the FMR as a guidepost.
                        <SU>11</SU>
                        <FTREF/>
                         The current FMR, however, is applicable only to GSA property (rather than all property protected by FPS), and applies only when the conduct is committed on the property itself and not adjacent thereto. Accordingly, the current regulations are not as comprehensive as contemplated by 40 U.S.C. 1315 in accomplishing DHS's statutory mission to protect federal buildings. The proposed rulemaking is meant to close these enforcement gaps. Informed by lessons learned from terrorist attacks and other criminal misconduct, the proposed rule is also intended to address the day-to-day criminal activity encountered by DHS on Federal property by proposing responsive updates to the personal conduct regulations that provide a more current, flexible, and consistent law enforcement tool.
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             DHS's proposed rule would not include non-criminal rules; specifically, 41 CFR 102-74.426 (permitting breastfeeding on federal property) and 41 CFR 102-74.445 (“Federal agencies must not discriminate by segregation or otherwise against any person or persons because of race, creed, religion, age, sex, color, disability, or national origin in furnishing or by refusing to furnish to such person or persons the use of any facility of a public nature, including all services, privileges, accommodations, and activities provided on the property.”). As these two rules do not relate to DHS' mission of protecting federal property, and remain under GSA's mission of maintaining federal property, they are not included in the proposed rule.
                        </P>
                    </FTNT>
                    <P>
                        The primary changes brought about by the proposed rule would bring the criminal regulations out from GSA and under DHS; expand charging options for offenses committed on non-GSA property and promote charging consistency across federal facilities protected by DHS; modernize the personal conduct regulations to address current societal and technological advances, 
                        <E T="03">e.g.,</E>
                         electronic cigarettes and unmanned aircraft systems (UAS); provide clearer guidance and notice of prohibited conduct to the public; and permit the charging of regulatory violations occurring near or adjacent to federal property.
                    </P>
                    <P>
                        By expanding the scope of the regulations to off-property conduct and non-GSA buildings, FPS is able to meet several enforcement needs while adhering to its statutory authority under 40 U.S.C. 1315.
                        <SU>12</SU>
                        <FTREF/>
                         First, DHS can more effectively effectuate crowd management by citing and releasing criminal actors rather than requiring an arrest and detention, thus permitting officers to respond to more serious criminal activity and preserve limited detention resources. Second, regulatory charges serve to fill the void where there is no applicable federal statutory charge applicable to the conduct and no MOU permitting DHS to charge state or local offenses. Further, regulatory charges serve as a lower-level charging option for subjects whose criminal conduct is less significant and does not warrant higher level charges under Title 18. These proposed revisions would also promote equity by allowing the same charging options for individuals committing the same conduct regardless of whether they are standing on or merely adjacent to the property.
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             DHS is statutorily authorized to protect areas outside the federal property to the extent necessary to protect the property and persons on the property, 40 U.S.C 1315(b)(1), and the proposed rule would facilitate that protective mission by providing the charging authority to be commensurate with DHS's statutory enforcement authority.
                        </P>
                    </FTNT>
                    <P>Relatedly, the proposed regulations would provide updated criminal regulatory charging violations that are directly targeted, relevant, and applicable to the criminal misconduct encountered by FPS in the regular course of enforcement and operational efforts to protect the federal property and persons on the property.</P>
                    <P>
                        Furthermore, while the rule also covers non-GSA facilities, the proposed rule is limited in that it would only apply to the federal property protected by DHS pursuant to the Secretary's authority under 40 U.S.C. 1315. Nothing in the proposed rule would alter the current landscape of authorities that permit federal agencies with their own realty authority to seek security and law enforcement services outside DHS. 
                        <E T="03">See</E>
                         40 U.S.C. 1315(g). In particular, the provisions in this proposed rule would not be imposed upon federal agencies that do not otherwise procure security and law enforcement services from DHS. For example, under 38 U.S.C. 901, the Secretary of Veterans' Affairs has authority to prescribe regulations to provide for the maintenance of law and order and the protection of persons and property on VA property. These rules do not limit or alter the ability of VA or other agencies to maintain security not currently under FPS protection.
                    </P>
                    <HD SOURCE="HD1">Subpart A—General</HD>
                    <P>Proposed Subpart A would establish the purpose, applicability, assessments, and definitions relevant to FPS's proposed regulations. Proposed Subpart A corresponds to GSA regulations, as set out in the distribution table, which describe the purpose, applicability, assessments, and definitions related to the existing FMR governing personal conduct on GSA-operated Federal property.</P>
                    <P>
                        Proposed Subpart A shifts the focus of these provisions from more general provisions outlining conduct on federal property to detailing the criminal nature 
                        <PRTPAGE P="4402"/>
                        of the prohibited conduct as well as modernizing definitions to meet the expanded mission prescribed in 40 U.S.C. 1315, and corresponding operational needs. Congress expanded the DHS mission-set from the limited protection of property under the authority of GSA to directing the Secretary of Homeland Security to protect the buildings, grounds, and property that are owned, occupied, or secured by the Federal Government (including any agency, instrumentality, or wholly owned or mixed-ownership corporation thereof) and the persons on the property.
                    </P>
                    <P>
                        The Secretary accomplishes this statutorily-mandated federal property protection mission, in large part, by and through the delegation of authorities and duties to designated officers and agents of the FPS. FPS protects approximately 8,500 federal facilities, including both GSA-operated facilities and other non-GSA federal property such as DHS and HHS Federal properties.
                        <SU>13</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             
                            <E T="03">See</E>
                             Cline Testimony, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <P>
                        Under the existing FMR, FPS is limited to charging the misconduct proscribed in the regulations only for conduct occurring in or on GSA-operated property even though FPS protects both non-GSA federal property and responds to criminal misconduct that occurs off-property but directly affects, threatens, or endangers the federal property and its occupants (
                        <E T="03">i.e.,</E>
                         persons standing across the street or sidewalk from federal property throwing objects at the property and its occupants, or persons blocking access to federal property while standing a few feet off the property line). 
                        <E T="03">See</E>
                         41 CFR 102-74.365 (“The rules in this subpart apply to all property under the authority of GSA and to all persons entering in or on such property.”).
                        <SU>14</SU>
                        <FTREF/>
                         Additionally, there are circumstances where, because the property is not leased or owned by GSA, the FMR rules are inapplicable despite being protected by FPS.
                    </P>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             
                            <E T="03">See United States</E>
                             v. 
                            <E T="03">Holdsworth,</E>
                             990 F. Supp. 1274 (D. Col, Jan. 21, 1998) (GSA regulation prohibiting conduct that impeded or disrupted the performance official duties inapplicable to defendant who sent repetitive and threatening faxes from his home and off federal property.).
                        </P>
                    </FTNT>
                    <P>
                        Subpart A would allow DHS to provide FPS protection to all property protected by FPS, not just GSA-operated property. 6 CFR 139.5 (proposed). The proposed regulations would also fill a critical enforcement gap by providing additional charging options when responding to criminal misconduct that occurs on the federal property 
                        <E T="03">and</E>
                         adjacent off-property misconduct that otherwise affects, threatens, or endangers the federal property and its occupants consistent with 40 U.S.C. 1315(b)(1) and 40 U.S.C. 1315(b)(2)(E). 6 CFR 139.5 (proposed). The above is consistent with the statute, which does not distinguish between GSA and non-GSA federal property; authorizes DHS enforcement in areas outside the property to the extent necessary to protect the property and persons on the property; and permits off-property investigations for offenses that may have been committed against federal property or persons on the property. 40 U.S.C. 1315(a)-(b), (b)(2)(E).
                    </P>
                    <HD SOURCE="HD2">Section 139.1 Purpose</HD>
                    <P>Section 139.1 would establish that the purpose of new part 139 is the protection of federal property and persons located on the property. It mirrors the statutory authorization from Congress in 40 U.S.C. 1315(a), which directs the Secretary, by and through designated law enforcement officers, to protect federal property and persons on the property.</P>
                    <HD SOURCE="HD2">Section 139.5 Scope, Applicability, and Agency Cooperation</HD>
                    <P>Section 139.5(a) would set forth the scope and applicability, establishing to whom and on what properties the regulations would apply. Specifically, it proposes to apply to all federal property under the protection responsibility of the Secretary and all persons on such property. As described above and pursuant to the authority granted in 40 U.S.C. 1315(b)(1), these proposed regulations would also apply to non-GSA properties and areas outside the Federal property to the extent necessary to protect the property and its occupants.</P>
                    <P>The existing FMR, located in 41 CFR, Subpart C, are, as stated in 41 CFR 102-74.365, limited in application to property under the authority of GSA and to persons entering in or on such property. The limited applicability of the existing FMR creates an inconsistency with the enabling statutory authority in 40 U.S.C. 1315 and leads to operational enforcement deficiencies. Specifically, as described previously, under the current regulations, DHS cannot readily utilize the FMR as charging authority either when protecting non-GSA Federal property, as authorized by 40 U.S.C. 1315(a), or when responding to misconduct that occurs off the federal property yet affects, threatens, or endangers the property and/or its occupants. Thus, the charging decisions under the current regulatory scheme may depend upon the nature of the property (GSA vs. non-GSA) or whether the individual is on the property, rather than the nature and effect of the criminal violation.</P>
                    <P>
                        The existing FMR, violations of which function as comparatively low-level Class C Misdemeanor crimes that can be charged through issuance of a written citation or the functional equivalent of issuing a traffic ticket, provides the most relevant charging authority for the types of misconduct FPS typically encounters during these incidents, including trespass, failure to follow lawful directions, and creating disturbances. The FMR's current limited application creates, at the very least, the potential for inconsistency in charging authority. For example, on GSA-operated property FPS may charge FMR violations as misdemeanor crimes; for non-GSA operated property, however, FPS must look to Title 18 of the U.S. Code or available state and local charging authority, including felony crimes, for the same or similar violations on non-GSA property.
                        <SU>15</SU>
                        <FTREF/>
                         By contrast, the proposed regulations would allow FPS to charge under the regulations regardless of whether the individual committed the offense on non-GSA federal property protected by FPS, off the property, or on GSA property, lending to consistency for charging options.
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             In these instances, DHS can enforce state and local laws where there is an applicable MOU with local authorities allowing FPS to charge under state/local laws. 
                            <E T="03">See</E>
                             40 U.S.C. 1315(e). Alternatively, DHS may contact local authorities, wait for an officer to respond to the scene, and request the local authorities charge the individuals.
                        </P>
                    </FTNT>
                    <P>
                        For example, FPS has encountered situations where individuals gathered on the city street or sidewalk immediately adjacent to federal property protected by FPS and formed human barricades, strategically placed spike-boards (
                        <E T="03">i.e.,</E>
                         plywood with nails protruding), and thrown objects at the federal property and/or occupants. While FPS LEOs conducted investigations of this off-property criminal activity consistent with 40 U.S.C. 1315(b)(2)(E), available charging authority was an operational issue as the misconduct did not occur “in or on” the federal property as required by 41 CFR 102-74.365.
                        <SU>16</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             
                            <E T="03">See</E>
                             Arun Gupta, 
                            <E T="03">How Portland Occupies Shut Down ICE,</E>
                             In These Times (Jul. 2, 2018), 
                            <E T="03">https://inthesetimes.com/article/how-portland-occupiers-shut-down-ice</E>
                             (last accessed July 18, 2024); 
                            <E T="03">see also</E>
                             Dirk VanderHart, 
                            <E T="03">ICE Temporarily Shutters Portland Facility Due to `Occupy' Protest, OPB</E>
                             (Jun. 20, 2018), 
                            <E T="03">https://www.opb.org/news/article/portland-occupy-ice-building-closed/</E>
                            (last accessed July 18, 2024).
                        </P>
                    </FTNT>
                    <P>
                        This proposed provision would address both the operational inconsistency between the scope of the Secretary's statutory 40 U.S.C. 1315 
                        <PRTPAGE P="4403"/>
                        authority and applicability of the corresponding regulatory authority, and the operational deficiencies caused by the limited applicability of the FMR. Section 139.5(a) would extend application of the proposed regulations to match the scope of the statutory authority provided by Congress in 40 U.S.C. 1315. The expanded applicability in proposed § 139.5(a) is both contemplated by the language of the statute and necessary for the protection and administration of all federal property under the Secretary's protection responsibility. In addition, it would both ensure the most relevant charging authority is readily available for when crimes occur which affect Federal property.
                    </P>
                    <P>
                        As guidance for the application of this proposed rule to areas outside federal property, DHS looks to the Department of Agriculture's Forest Service's similar rulemaking that covers protection of forests. Just as 40 U.S.C. 1315(c) authorizes the Secretary of DHS to “prescribe regulations necessary for the protection and administration of property owned or occupied by the Federal Government and persons on the property,” the Department of Agriculture's Forest Service is authorized to “make such rules and regulations and establish such service as will insure the objects of such reservations, namely, to regulate their occupancy and use and to preserve the forests thereon from destruction.” 
                        <E T="03">See</E>
                         16 U.S.C. 551. In 36 CFR 261.1(a), the Forest Service's implementing regulatory provisions, the Forest Service expressly extends the scope of application to both prohibited conduct that occurs in the or on the National Forest System, as well as misconduct that “affects, threatens, or endangers” Federal property administered by the Forest Service. In 2014, the U.S. Court of Appeals for the Ninth Circuit affirmed the constitutional validity of this analogous Forest Service regulation in 
                        <E T="03">U.S.</E>
                         v. 
                        <E T="03">Parker,</E>
                         761 F.3d 986, 990-991 (9th Cir. 2014). The Court specifically recognized that regulations extending to activities that “affect, threaten, or endanger” property administered by the Forest Service fit within the agency's statutory authority at 16 U.S.C. 551 to make needful rules and regulations for federal property protection. Here, the proposed rule would similarly extend FPS's ability to charge conduct that affects, threatens, or endangers federal property protected by FPS consistent with 40 U.S.C. 1315(c).
                    </P>
                    <P>Section 139.5(b) would establish the applicability of the proposed part by affirming that these regulations may not be interpreted to invalidate any other federal, state, or local law or regulation applicable to the property. To that end, § 139.5(b) specifically states that nothing in the proposed part restricts the authority of GSA or another relevant government entity to promulgate regulations related to federal property under its jurisdiction, custody, or control. Section 139.5(b) would be functionally identical to the existing provision in GSA's FMR, codified at 41 CFR 102-74.455. The only textual changes that § 139.5(b) are to affirm GSA's regulatory authority.</P>
                    <P>Section 139.5(c) would state the cooperation responsibilities of Federal agencies that operate or otherwise occupy space as tenants at Federal property under the Secretary's protection responsibility. Cooperation responsibilities include following all relevant provisions of the proposed rule, reporting all crimes and suspicious circumstances, providing training to employees regarding protection and emergency-situation responses, making recommendations for improved security, and posting all notices requested by DHS. Proposed § 139.5(c) is substantively identical to the existing provision in GSA's FMR at 41 CFR 102-74.15. Cooperation is important because federal tenant agencies and their employees, customers, and visitors provide vital, first-hand information and insight regarding activities that trigger security concerns or otherwise warrant law enforcement responses. For instance, federal employees regularly report incidents of suspicious loitering, harassment, or unattended items left on federal property, as well as express interest in active shooter and other emergency response training.</P>
                    <P>Section 139.5(d) would state the notice requirement in the proposed rule. It would require the Facility Security Committee (FSC) or the highest-ranking official of the sole federal agency occupant or designee to post a Notice of the rules governing personal conduct affecting federal property in a conspicuous place at each federal property under the Secretary's protection. A conspicuous place is any location on federal property where persons entering the property will likely see it. The notice would be approximately 11 inches by 14 inches and describe generally the rules and regulations governing personal conduct contained in new Part 139, and would be similar to the existing notice provision in GSA's FMR at 41 CFR 102-74.365. The notice would ensure federal stakeholders and the general public are aware of the substantive content of this proposed part, including specific definitions, rules of behavior, prohibited conduct, and potential penalties for violations. The text of § 139.5(d) would reflect the realignment of the general applicability provisions and emphasize the responsibility of the FSC or the highest-ranking official of the sole federal agency occupant or designee to ensure written notice is posted.</P>
                    <P>
                        Section 139.5(d) would also provide that DHS prescribe the notice on its website so that it can be updated to reflect the most user-friendly content for the public. DHS is considering the use of a QR code, weblink or other uses of technology to ensure the information is easily available to visitors of federal facilities. The notice requirement in § 139.5(d) is necessary for the protection and administration of federal property under the Secretary's protection to ensure the substance of the regulations, including prescribed penalties, in the proposed part is clearly communicated and otherwise imparted to employees and visitors at federal property.
                        <SU>17</SU>
                        <FTREF/>
                         DHS notes that the burden to post such notice falls on the Federal agency.
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             In addition to this notice requirement found in 40 U.S.C. 1315(c)(1) that addresses rules governing personal conduct affecting federal property, see 41 CFR part 102-81 that assigns responsibility to an occupant agency, if it is the only Federal occupant agency in the building, or the Facility Security Committee, for determining and enacting countermeasures and other security-related actions.
                        </P>
                    </FTNT>
                    <P>
                        Section 139.5(e) proposes that the operational implementation date for the regulations would occur six months after publication of the final rule in the 
                        <E T="04">Federal Register</E>
                        . During this period, GSA would conduct a review of its FMR in-light-of the newly published DHS regulations in this proposed rule, and GSA may consider eliminating, realigning, or otherwise modifying their FMR to avoid confusion or duplication between the two sets of regulations. In addition, DHS would undertake officer training and publication of written signage specific to the requirements of the new part to ensure both DHS officers and agents designated under 40 U.S.C. 1315 are trained on enforcement of the newly published regulations, and written signage is provided for posting at federal property under DHS protection. DHS specifically requests comments on whether a six-month delay in effective date is appropriate.
                    </P>
                    <HD SOURCE="HD2">Section 139.10 Assessments for Protective Services</HD>
                    <P>
                        Section 139.10 would state the Secretary's authority to charge federal agencies under the Secretary's protection for the law enforcement and protective security services provided to those agencies by FPS. The FPS security fees charged to federal tenant agencies 
                        <PRTPAGE P="4404"/>
                        are authorized in accordance with the Secretary's statutory authority, codified at 40 U.S.C. 586(c), which authorizes any federal executive-branch agency to charge for services provided to other agencies receiving the services. Section 139.10 would also be consistent with the Secretary's statutory authority, codified at 6 U.S.C. 203(3) and 232(a) and 40 U.S.C. 1315, to protect federal property and persons on the property utilizing FPS personnel and assets.
                    </P>
                    <P>
                        FPS is a fee-funded law enforcement entity, meaning FPS is entirely funded by the security fees collected from the federal tenant agencies FPS protects.
                        <SU>18</SU>
                        <FTREF/>
                         FPS collected security fees through GSA while the two entities were organizationally aligned. In 2003, Congress expressly transferred GSA's law enforcement and protective security functions, including personnel, assets, and liabilities of FPS, to the Secretary of Homeland Security with the passage of sections 403 and 422 of the Homeland Security Act (6 U.S.C. 203(3) and 232(a)). Section 232(a) specifies that nothing in the statute shall affect GSA's functions or authorities, with the exception of law enforcement and related security functions which were transferred to the Secretary. Accordingly, Congress vested the Secretary with the authority to assess and collect fees for the law enforcement and protective security services provided by FPS in furtherance of the Secretary's statutory responsibility to protect federal property and its occupants.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             Congress originally prescribed statutory authority, codified at 40 U.S.C. 121 (formerly cited as 40 U.S.C. 486), for the GSA Administrator to prescribe regulations necessary for the administration of GSA-operated Federal property, and authority at 40 U.S.C. 586 authorizing Federal agencies other than GSA to impose fees for services at such Federal property. Consistent with these statutory authorities, GSA prescribed a regulation in the FMR at 41 CFR 102-85.135 that authorizes DHS (and other Federal agencies besides GSA) to charge for services furnished to Federal tenant agencies, including law enforcement and protective security services furnished by FPS.
                        </P>
                    </FTNT>
                    <P>FPS remains entirely fee funded; FPS relies upon the collection of security fees to execute the Secretary's statutory law enforcement mission under 40 U.S.C. 1315 by providing law enforcement and protective security services at approximately 8,500 federal facilities nationwide, including both GSA-operated and non-GSA Federal properties. Accordingly, the assessments provision in § 139.10 provides federal stakeholders a direct, unambiguous statement of the Secretary's authority to assess and collect security fees from the federal tenant agencies that utilize FPS law enforcement and protective security services.</P>
                    <HD SOURCE="HD2">Section 139.15 Definitions</HD>
                    <P>Section 139.15 would state the definitions of key words and phrases used throughout the substantive provisions in the proposed part. In developing the definitions in the proposed rule, DHS sought guidance from other federal agency regulations, comparable statutory definitions in the U.S. Code, existing definitions in the GSA FMR, or relevant policy guidance related to the protection of federal property.</P>
                    <P>GSA's FMR definitions section at 41 CFR 102-71.20 is largely specific to key words and phrases related to GSA's mission of administering the business and logistical aspects associated with Federal real estate, as opposed to key words and phrases related to the Secretary's law enforcement and protective security mission. For, example, the current FMR do not define the terms “facility security committee,” “protective security officer,” and “security personnel,” all of which are defined in proposed § 139.15 and integral to understanding the protective security and law enforcement services provided at Federal property protected by the Secretary. The proposed rule also includes definitions for “crime of violence,” “tobacco product,” “unmanned aircraft,” and “unmanned aircraft system” to add meaning and clarity to new substantive provisions in the prohibited conduct provisions described in § 139.35.</P>
                    <P>For a starting point in drafting the proposed rule, DHS utilized as guidance other statutory and regulatory definitions, or logical derivatives thereof, that relate to the same or substantially similar subject matter that is included in the proposed rule. To that end, proposed § 139.15 defines the following terms using the same or substantially similar definitions from GSA's existing FMR at 41 CFR 102-71.20: “building manager/property manager/facility manager” (referred to as “Federal agency buildings manager” in FMR), “designated official,” “emergency,” and “public area.” Section 139.15 also uses the same definition of “gambling per se” as found in the FMR at 102-74.395(b) and derives the definition of “nuisance” from the disturbances provision in the FMR at 41 CFR 102-74.390.</P>
                    <P>Section 139.15 would also include language from the authority in 40 U.S.C. 1315(a) to define “Secretary” as specific to the Department of Homeland Security Secretary and “Federal Government” as inclusive of any agency, instrumentality, or wholly owned or mixed-ownership corporation thereof. DHS derived the definitions of “federal property,” “federal grounds,” and “federal facility” from 40 U.S.C. 1315 to clarify that Congress authorized the Secretary to protect federal property, which is an umbrella term that includes both federal facilities (buildings and physical structures) and federal grounds (the land operated by GSA or another Federal agency). DHS also derived the definition of “security personnel” from 40 U.S.C. 1315(b), which authorizes the Secretary to designate specific officers and agents, including FPS personnel, for duties in connection to the protection of federal property and persons on the property.</P>
                    <P>
                        In addition, Section 139.15 would define the following terms with the same or substantially similar definition from an analogous statutory authority: “aircraft,” “unmanned aircraft,” and “unmanned aircraft system,” which appear in the prohibited conduct provisions in § 139.35(k), (l), with the same definitions used in Federal aviation law at 49 U.S.C. 40102(6) (defining aircraft) and 44801(12) (and the implementing regulation at 14 CFR 1.1 ((defining unmanned aircraft system))); “crime of violence,” which appears in the criminal threats prohibition in § 139.35(f), with the same definition in the elements clause at 18 U.S.C. 16(a); “dangerous weapon,” which appears in the prohibited carriage and possession provision at § 139.75(a), with the same definition in Federal firearms law codified at 18 U.S.C. 930(g)(2); “labor organization,” which appears in § 139.55(b) as one of the categories of persons exempt from the general prohibition on soliciting, with the same definition in the Civil Service Reform Act codified at 5 U.S.C. 7103(a)(4); “service animal,” which appears in the animals provision in § 139.80, with the same definition as the Department of Justice regulation at 28 CFR 36.104 that implements the Americans with Disabilities Act, Public Law 101-336, 104 Stat. 327; 
                        <SU>19</SU>
                        <FTREF/>
                         and 
                        <PRTPAGE P="4405"/>
                        “tobacco product,” which appears in the prohibited conduct provision in § 139.35(j), with substantially the same definition as the Food, Drug, and Cosmetics Act codified at 21 U.S.C. 321.
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             Other species of animals, whether wild or domestic, trained or untrained, are not service animals for the purposes of this definition. The work or tasks performed by a service animal must be directly related to the individual's disability. Examples of work or tasks include, but are not limited to, assisting individuals who are blind or have low vision with navigation and other tasks, alerting individuals who are deaf or hard of hearing to the presence of people or sounds, providing non-violent protection or rescue work, pulling a wheelchair, assisting an individual during a seizure, alerting individuals to the presence of allergens, retrieving items such as medicine or the telephone, providing physical support and assistance with balance and stability to individuals with mobility disabilities, and helping persons with 
                            <PRTPAGE/>
                            psychiatric and neurological disabilities by preventing or interrupting impulsive or destructive behaviors. The crime deterrent effects of an animal's presence and the provision of emotional support, well-being, or comfort or companionship do not constitute work for purposes of this definition. Proposed § 139.80 is similar to the Department of Justice (DOJ) definition at 28 CFR 36.104 of service animal as limited to trained dogs. This modification to the definition of service animal is made to provide uniformity and ensure operational consistency with DOJ's implementation of the Americans with Disabilities Act. It is noted that while the DOJ definition is limited to dogs, Titles II and III of the ADA include a requirement of modification of polices, practices or procedures to permit the 
                            <E T="03">use</E>
                             of miniature horses when certain requirements are met. 
                            <E T="03">See</E>
                             Legal Brief: Service Animals and Individuals with Disabilities Under the Americans with Disabilities Act (ACA) 
                            <E T="03">adala.org</E>
                            ) (2019)(last accessed July 18, 2024).
                        </P>
                    </FTNT>
                    <P>DHS also reviewed regulations promulgated by other federal agencies with similarly aligned law enforcement entities or statutory law enforcement authority, such as the Department of Interior's National Park Service, Department of Agriculture's Forest Service, and Department of Defense's Army Corps of Engineers as guidance. Section 139.15 derives the definitions of “camping” and “open container” from analogous provisions in the Park Service regulations at 36 CFR 1.4 (camping), and 4.14 (open container). Section 139.15 would use a substantially similar definition for “damaging” as found in the Forest Service regulation at 36 CFR 261.2. The proposed definitions of “littering” and “vehicles” are similar to definitions in the Army Corps of Engineers regulations at 36 CFR 327.2 (vehicles) and 327.9 (sanitation).</P>
                    <P>
                        Section 139.15 also would include definitions of “audio recording” and “image recording” that are similar to the “audiovisual” class of definitions found in the National Archives and Records Administration (NARA) regulation at 36 CFR 1237.4(b). The definition of “commercial purpose” is similar to the Rules for Filming, Photographing, or Videotaping on NARA Property or in NARA facilities at 36 CFR 1280.40. The term “tobacco product” would be defined in proposed § 139.15 as any item made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product. This definition of tobacco product in the proposed rule is consistent with the definition in Federal Food, Drug, and Cosmetic Act (FFDCA) at 21 U.S.C. 321(rr), which is incorporated into the FDA regulations at 21 CFR 1140.3 and 1140.2 and includes electronic nicotine delivery systems (ENDS), including e-cigarettes, e-hookah, e-cigars, e-pipes, personal vaporizers, and vape pens. 
                        <E T="03">See</E>
                         81 FR 28974 (May 10, 2016). However, the FFDCA definition of “tobacco product” includes “any product made or derived from tobacco, 
                        <E T="03">or containing nicotine from any source,</E>
                         that is intended for human consumption, including any component, part, or accessory of a tobacco product.” 21 U.S.C. 321(rr) (italics added). The definition of tobacco products proposed at § 139.15 would not include accessories that merely facilitate the use of tobacco products such as ashtrays, spittoons, and clips, as the mere possession of these items without use of nicotine does not impact the safety or security of the federal building or its occupants.
                    </P>
                    <P>
                        Finally, § 139.15 would utilize relevant federal property protection and security policy to define the following terms: “building,” “facility security committee,” “Federal tenant,” “personal property,” “protective security officer,” and “secure area.” Section 139.15 would use definitions for these terms from policy guidance and standards established either by FPS, or the DHS Interagency Security Committee. 
                        <E T="03">See</E>
                         Executive Orders 14111 and 13286; 
                        <SU>20</SU>
                        <FTREF/>
                          
                        <E T="03">see also</E>
                         CISA, ISC Standard: Risk Management Process, 
                        <E T="03">https://www.cisa.gov/resources-tools/resources/isc-standard-risk-management-process,</E>
                         (2024)(last accessed April 15, 2024).
                        <SU>21</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             E.O. 14111, 
                            <E T="03">Interagency Security Committee</E>
                             (88 FR 83809 (Nov. 27, 2023)) and E.O. 13286, 
                            <E T="03">Amendment of Executive Orders, and Other Actions, in Connection with the Transfer of Certain Functions to the Secretary of Homeland Security</E>
                             (68 FR 10617 (Mar. 5, 2003)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             Definition of Facility Security Committee: A committee that is responsible for addressing facility-specific security issues and approving the implementation of security measures and practices. The Facility Security Committee (FSC) consists of representatives of all Federal tenants in the facility, the security organization, and the owning or leasing department or agency. In the case of new construction or pending lease actions, the FSC will also include the project team and the planned tenant(s). The FSC was formerly known as the Building Security Committee “BSC.”
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">Subpart B—Personal Conduct Affecting Federal Property</HD>
                    <P>Proposed Subpart B would contain sections related to specific personal conduct affecting Federal property protected by the Secretary to be codified at 6 CFR 139.20-85. Proposed Subpart B corresponds to GSA regulations, currently codified at 41 CFR 102-74.370-450, which describe the rules, prohibitions, and exceptions associated with inspections, admissions, preservation of property, conformity with written and verbal instructions, disturbances, gambling, narcotics, alcoholic beverages, solicitation, distribution and posting, photography and recording, animals, vehicular traffic, weapons possession, and the associated penalties for violations.</P>
                    <P>Based upon the jurisdictional authority outlined in 40 U.S.C. 1315, proposed Subpart B would contain more preservation of property and prohibited conduct sections, and more precise sections on admissions and animals, posting and distribution, recording, and weapons, than existing GSA regulations that have not been updated to include specific definitions for prohibited conduct. This is in recognition of both the evolving landscape of threats and security risks directed at Federal property and its occupants, and corresponding operational needs to detect, prevent, mitigate, and respond to threats at Federal property. The sections in Subpart B would also be revised to reflect updates in and consistency with relevant case law, federal statutes and regulations, and policy guidance related to federal property protection.</P>
                    <P>Accordingly, the proposed sections in Subpart B would provide updates, consistent with the authorizing statutory authority in 40 U.S.C. 1315(c), necessary for the protection and administration of federal property under the Secretary's protection. The sections in Subpart B would move away from ministerial real estate oversight equities and focus expressly on the law enforcement and protective security equities related to personal conduct affecting federal property protected by the Secretary.</P>
                    <P>
                        Proposed Subpart B would fill critical enforcement gaps by addressing prohibitions on emerging areas of criminal threats (for example, electronic threats to commit a crime of violence (§ 139.35(f)), drone activity (§ 139.35(k)-(l)), and impersonation of security personnel (§ 139.35(n))). Compared to the current GSA regulations, Subpart B would also better inform and protect Federal stakeholders and the general public who work on and visit federal property by expressly and plainly stating the parameters associated with admitting, inspecting, and otherwise policing persons on federal property in accordance with and in recognition of First and Fourth Amendment considerations. For instance, the distribution (§ 139.60) and recording (§ 139.65) provisions are revised to reflect updates in relevant case law and policy regarding First Amendment equities related to assembly, expression, 
                        <PRTPAGE P="4406"/>
                        and speech. Likewise, the admissions and inspection provision (proposed § 139.20) is revised to more precisely state the operational prerequisites and parameters in light of Fourth Amendment equities related to searches and seizures. The sections in proposed Subpart B are described and otherwise explained in detail below.
                    </P>
                    <HD SOURCE="HD2">Section 139.20 Admissions and Inspections Related to Federal Property</HD>
                    <P>Proposed § 139.20 would state the requirements for admissions and inspections related to Federal property under the Secretary's protection responsibility. Section 139.20 would provide a statement of the inspection requirements and consequences for non-compliance with the screening procedures.</P>
                    <P>The current FMR at 41 CFR 102-74.370 states that Federal agencies have discretionary authority to inspect items in the immediate possession of persons arriving on, working at, visiting, or departing from Federal property, and agencies may conduct a full search of a person and his/her vehicle upon arrest. Section 139.20 of the proposed rule would update this inspection authority in 41 CFR 102-74.370 by making substantive textual changes to more precisely state the parameters of inspections occurring on federal property protected by the Secretary.</P>
                    <P>
                        Specifically, proposed § 139.20 would state the FSC or the highest-ranking official of the sole federal agency occupant or designee may determine who must be screened. Once the FSC requires inspections, § 139.20 states that designated security personnel would screen and inspect individuals and all accessible personal property and vehicles for dangerous items that would pose a security and safety risk, 
                        <E T="03">i.e.,</E>
                         for firearms, explosives, dangerous weapons, and the component parts thereof. Section 139.20 also clarifies that once an inspection of a person, article of personal property, or associated vehicle starts, the inspection process would not terminate until completed by designated security personnel, 
                        <E T="03">i.e.,</E>
                         the visitor may not leave the screening process once it has begun.
                    </P>
                    <P>Consistent with Fourth Amendment protections against unreasonable searches and seizures, § 139.20 would balance the Secretary's security mission in ensuring the security of federal property and the persons thereon, with the Fourth Amendment privacy interests by limiting inspections to examinations for firearms, explosives, dangerous weapons, and component parts. Security personnel may not use administrative inspections with the principal purpose of detecting contraband or evidence of crimes unrelated to the protection of federal property. However, as currently conducted in accordance with Fourth Amendment constraints, security personnel may report and take appropriate law enforcement action if unlawful items, such as contraband, are detected during an otherwise lawful inspection for firearms, explosives, dangerous weapons, and component parts. Moreover, nothing in § 139.20 would alter the established legal precedent on Fourth Amendment requirements and exceptions relating to administrative inspections.</P>
                    <P>The current FMR at 41 CFR 102-74.375 states the policy on admitting persons to GSA-operated Federal property. The substance of 41 CFR 102-74.375 is focused on the administrative rules regarding hours of operation, registration upon entry, and presenting identification. Section 139.20 of the proposed rule would make substantive textual changes to focus on the law enforcement and protective security aspect of admitting persons on federal property as opposed to the existing emphasis on administration. Section 139.20 would streamline the existing admissions provision in 41 CFR 102-74.375 by merging it with the administrative inspection authority in 41 CFR 102-74.370 to emphasize the precise security requirements, such as administrative inspection, for persons entering a secure area on federal property protected by the Secretary. Nothing in § 139.20 impedes the authority of GSA or other federal tenant agencies to retain or establish administrative policies regarding hours of operation, sign-in, or identification requirements specific to their property.</P>
                    <HD SOURCE="HD2">Section 139.25 Preservation of Federal Property</HD>
                    <P>Proposed § 139.25 includes seven categories of conduct that would be prohibited to preserve federal property under the Secretary's protection. Section 139.25 would incorporate the six existing categories of prohibited conduct related to preserving GSA-operated property in the current FMR at 41 CFR 102-74.380: littering, destruction, theft, hazards, throwing articles, and climbing, and add a seventh category to prohibit the unauthorized use, operation, parking, locking, or storage of vehicles or other personal transportation devices on federal property. Overall, the proposed categories of prohibited conduct are consistent with and derived from either the existing prohibitions in GSA's FMR, or the operational and security challenges presented in relation to preserving federal property in-light-of technology and threat developments across the modern landscape.</P>
                    <P>Section 139.25(a), in comparison to the existing FMR at 41 CFR 102-74.380(a), would prohibit “littering” as defined in § 139.15, to include the same prohibited behavior currently described as “improperly disposing of rubbish on property” in 41 CFR 102-74.380(a). Section 139.25(b) would prohibit damaging or unauthorized changing of the appearance of federal property, which mirrors the prohibition in 41 CFR 102-74.380(b) against destroying or damaging property. Section 139.25(b) would omit “willfully,” a reference to the required intent or state-of-mind, in recognition of the fact that all violations of the regulations in the proposed rule require some degree of intent—as opposed to accidental or mistaken incidents—and the degree of intent is best interpreted by a Federal court of jurisdiction consistent with other Class C Misdemeanor crimes in the jurisdiction.</P>
                    <P>Section 139.25(c) would prohibit the unauthorized removal of federal property, which is functionally identical to the prohibition in 41 CFR 102-74.380(c) against stealing property. Section 139.25(d) would build on the prohibition in 41 CFR 102-74.380(d) against creating any hazard to persons or things on federal property by also prohibiting the creation of any threat of such a hazard. Consistent with the Secretary's statutory authority to protect federal property and the persons thereon, § 139.25 would add the provision for creating a threat of hazard to address operational and security concerns that arise when individuals or groups of individuals erect temporary structures or displays, such as ladders and elevated platforms, that may damage or impede property or harm persons on the property. Section 139.25(e) and (f), respectively, would prohibit the same behavior of either throwing articles of any kind at/from federal property, or climbing structures (fountains, statues, etc.) on federal property as currently prohibited in 41 CFR 102-74.380(e).</P>
                    <P>
                        Proposed § 139.25(g) would add a seventh and final category of prohibited conduct concerning the preservation of property with a prohibition on unauthorized use, operation, parking, locking, or storage of any vehicle or other personal transportation device, with exceptions allowed for personal transportation devices used as required by individuals with mobility impairments or when specifically allowed in designated areas. FPS has 
                        <PRTPAGE P="4407"/>
                        proposed this prohibition due to the security threat that vehicles and other transportation devices can pose. For example, such devices/vehicles may be used to block entrance and exit to federal facilities, and individuals may use them to ram or crash into federal facilities or immediately adjacent courtyards or plazas. They can also be outfitted with improvised explosive devices or other dangerous weapons to vehicles and personal transportation devices as means of damaging and harming federal property and its occupants. Accordingly, DHS believes that including this prohibition in the proposed rule is an important tool to ensure the Secretary fulfills his mission of securing federal property.
                    </P>
                    <P>
                        DHS has also observed the threat of vehicles and transportation devices left unattended for extended periods of time while parked or stored on or immediately adjacent to federal property.
                        <SU>22</SU>
                        <FTREF/>
                         For instance, much of the federal property protected by the Secretary through FPS security personnel is geographically located in large, urban city-centers where there is an increase in the use of personal transportation devices for mobility purposes as technology and enterprise continue to develop. In addition, parking, whether on Federal property or adjacent thereto, is typically situated in-the-midst of these densely populated city-centers. Consequently, DHS remains vigilant for the threat posed by attaching improvised explosive devices or other dangerous weapons to vehicles and personal transportation devices as means of damaging and harming federal property and its occupants. FPS has therefore proposed including § 139.25(g) in the proposed rule to reasonably ensure the use, operation, parking, locking, and storage of vehicles and transportation devices does not harm, destroy, or otherwise compromise the security of federal property and its occupants.
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             
                            <E T="03">See Oklahoma City Bombing, History.com</E>
                             (Apr. 19, 2023), 
                            <E T="03">https://www.history.com/topics/1990s/oklahoma-city-bombing</E>
                             (last accessed July 18, 2024).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">Section 139.30 Conformance With Signs and Directions</HD>
                    <P>Section 139.30 would require individuals on federal property protected by the Secretary to comply with official signage that is prohibitory, regulatory, or directive in nature and with the lawful verbal directions of security personnel. This proposed provision would ensure the orderly passage of federal stakeholders and the general public while traversing federal property, to include passing through any security or screening stations, and would ensure the ability of security personnel to direct persons on federal property regarding conduct that impacts the security of the property and its occupants. For example, security personnel regularly direct persons through the security screening checkpoints and direct visitors as to closed or restricted access areas on federal property. Proposed § 139.30 would be both functionally identical and textually similar to the existing provision in GSA's FMR at 41 CFR 102-74.385.</P>
                    <HD SOURCE="HD2">Section 139.35 Prohibited Conduct</HD>
                    <P>Section 139.35 would prohibit certain types of conduct that adversely affect or compromise the safety and security of federal property protected by the Secretary, people working at or visiting the property, and Government functions occurring on the property. Proposed § 139.35 is functionally similar to, and largely derived from, the existing disturbances provision in GSA's FMR at 41 CFR 102-74.390 with notable additions to enhance federal property and occupant protection and security.</P>
                    <P>Consistent with the discussion earlier in the preamble, proposed § 139.5(a) would state that the section applies to all federal property protected by the Secretary, as well as all areas outside such property to the extent necessary to protect the property and its occupants. The introductory paragraph would explain that persons are prohibited from engaging in the specified forms of conduct both on federal property itself as well in areas outside federal property.</P>
                    <P>
                        Enforcement in areas outside federal property, as contemplated by 40 U.S.C. 1315 for prohibited conduct that affects, threatens, or endangers federal property and occupants, would be similar to the approach taken by other federal land management agencies, 
                        <E T="03">e.g.,</E>
                         United State Forest Service, and is operationally necessary to implement the security mission envisioned in section 1315. This proposed change is necessary to address situations where individuals commit criminal acts off property that affect the federal property, such as obstructing access to federal property with the placement of spike-boards or throwing objects at federal property while physically standing off, but immediately adjacent to, federal property. This limitation compromises the immediate safety of federal employees and efficient operations of the Federal Government as well as consistency by limiting the use of otherwise applicable charging authority when criminal acts are physically committed off federal property, but directed at and otherwise meant to endanger federal property and occupants. In such instances, absent an applicable statutory Federal charge, the Secretary's ability to execute the statutorily prescribed law enforcement duties in 40 U.S.C. 1315 is unnecessarily hampered by a lack of readily available charging authority, and federal property and occupant protection becomes reliant on the availability and willingness of applicable state/local authorities, 
                        <E T="03">e.g.,</E>
                         spike boards placed off of GSA property but blocking entrances to the building.
                    </P>
                    <P>In total, § 139.35 would include 14 categories of prohibited conduct, including five categories of disturbances currently prohibited by 41 CFR 102-74.390, as described in greater detail below.</P>
                    <P>Section 139.35(a) would prohibit disorderly conduct, which would expressly include assaulting, fighting, harassing, intimidating, threatening or other violent behavior, lewd acts, or the inappropriate disposal of feces, urine, and other bodily fluids. Section 139.35(a) would be functionally identical to but substantively more precise than the existing prohibition on “exhibiting disorderly conduct” stated in the opening line of the FMR at 41 CFR 102-74.390. Notably, § 139.35(a) would make textual changes to the disorderly conduct prohibition by specifically identifying the types of behavior subject to the prohibition to better notify Federal stakeholders and the general public as to what behavior constitutes prohibited disorderly conduct.</P>
                    <P>Federal property and persons on the property remain high-profile targets of criminal activity, such as fights, harassment, and intimidation. FPS and other relevant security personnel continue to use the disorderly conduct prohibition in the FMR regulations to address instances of violent and lewd behavior while protecting federal property and its occupants. Accordingly, the disorderly conduct prohibition is necessary for the protection and administration of property under the Secretary's protection and to continue addressing operational needs in responding to actual, real-life threats posed by persons causing harm to/on federal property and its occupants.</P>
                    <P>
                        Section 139.35(b) would introduce a new category of prohibited conduct that prohibits wearing masks and other articles to avoid detection when committing crimes to address instances where criminal actors intentionally hide their identity through face masks or 
                        <PRTPAGE P="4408"/>
                        facial attire when committing a crime against federal property or persons on the property. The concealed identity prohibition in § 139.35(b) is modeled after existing municipality codes, 
                        <E T="03">e.g.,</E>
                         Code of the District of Columbia Section 22-3312.03, 
                        <E T="03">Wearing hoods or masks,</E>
                         and would be expressly limited to instances when a person is concealing his/her identity to avoid detection while violating an applicable law.
                        <SU>23</SU>
                        <FTREF/>
                         Nothing in § 139.35(b) would prohibit a law-abiding citizen from wearing a mask or concealing his/her identity as part of a peaceful assembly, demonstration, disease prevention, religious observance, or other exercise of speech absent some indicia of criminal activity. Instead, the concealed identity prohibition in § 139.35(b) would address operational needs to protect against the actual, real-life crimes committed by criminal actors seeking to avoid detection.
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             There are many jurisdictions that contain analogous prohibitions, including, among others, California, Connecticut, and Delaware. 
                            <E T="03">See generally Cal. Penal Code sect. 185; Conn. Gen. Stat. Ann. sect. 53-37a; Del. Code Ann. tit. 11, sect. 1239; Fla. Stat. Ann. sect. 876.12; Ga. Code Ann. sect. 16-11-38; La. Stat. Ann. sect. 14:313; Mich. Comp. Laws Ann. sect. 750.396; Minn. Stat. Ann. sect. 609.735; N.M. Stat. Ann. sect. 30-22-3.</E>
                        </P>
                    </FTNT>
                    <P>
                        Section 139.35(c) would prohibit creating loud or unusual noises, noxious odors, or other nuisances that affect the safety of persons on Federal property, or otherwise disrupts Government functions on the property. Section 139.35(c) would be functionally identical and textually similar to the existing provision in 41 CFR 102-74.390(a). However, proposed § 139.35(c) would differ from 41 CFR 102-74.390(a) because it includes a prohibition of noxious odors as a specific type of prohibited nuisance. The inclusion of odors is a result of real-world, operational incidents whereby individuals place or release stink-bombs or other odor-emitting devices in such a manner as to adversely impact Federal property and its occupants.
                        <SU>24</SU>
                        <FTREF/>
                         The existing prohibition against loud or unusual noises remains necessary to ensure persons, particularly through use of bullhorns, megaphones, or other audio equipment, do not disturb or otherwise interfere with the performance of official Government functions, particularly the provision of services to the general public.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             
                            <E T="03">See</E>
                             “Irritating Substance”; York, Peel and Toronto Police Investigating After 3 Movie Theaters Evacuated Following Release of “Unknown” Spray Into Air, 
                            <E T="03">www.toronto.com</E>
                             (Dec. 6, 2023) (last accessed July 24, 2024).
                        </P>
                    </FTNT>
                    <P>Proposed § 139.35(d) would prohibit obstructing the usual use, enjoyment, or access to a federal facility, including entrances, exits, offices, courtyards, parking garages, other common areas, and areas closed during an emergency. Section 139.35(d) would be functionally identical and textually similar to the existing disturbances provision at 41 CFR 102-74.390(b). Proposed § 139.35(d) would include additional examples of common areas subject to the obstruction prohibition, such as exterior areas, plazas, and areas designated as closed during an emergency to reflect a more precise and accurate accounting of the physical spaces on federal property where obstruction would be prohibited. This would ensure the safety and security of persons on the property, especially during emergency situations including fires, active shooters, or other natural or man-made disasters. For example, federal property is often structured to accommodate multiple federal tenant entities, and obstruction in common areas directed at one federal tenant may, if unchecked, quickly devolve into obstruction of and safety hazards for another federal tenant. This prohibition would also apply to blocking stairwells, elevators, and escalators. Accordingly, the obstruction provision in § 139.35(d) would ensure both the free flow of vehicular and pedestrian traffic on and through federal property for orderly operations and the unimpeded ability to exit or otherwise navigate federal property during any emergency circumstances.</P>
                    <P>Section 139.35(e) proposes to prohibit impeding or disrupting the security inspection process administered by security personnel, the performance of official duties by federal employees, or the ability of the general public to obtain government services. Section 139.35(e) would be functionally identical and textually similar to the existing provisions at 41 CFR 102-74.390(c) and (d). To that end, § 139.35(e) would streamline and consolidate the existing prohibitions on impeding the performance of official duties by government employees in 41 CFR 102-74.390(c) and preventing the public from obtaining administrative services in 41 CFR 102-74.390(d) into a single provision. Proposed § 139.35(e) would also add a prohibition on the impediment or disruption of the security inspection process, which is detailed above in § 139.20 regarding admission and inspections related to federal property.</P>
                    <P>The added prohibition on impeding/disrupting the security inspection process in § 139.35(e) is operationally necessary to ensure the integrity and effectiveness of security screening performed in furtherance of detecting firearms, explosives, dangerous weapons, and component parts before these items enter or cause harm to Federal property and persons on the property. As noted, § 139.20 administrative inspection or screening is a security countermeasure that federal agencies use to better ensure safety at/on federal property. While the current FMR at 41 CFR 102-74.370 authorizes administrative inspections, there is no express prohibition under 41 CFR 102-74.390 for impeding or disrupting the inspection process. Rather, security personnel must rely on the more generic charging authority under 41 CFR 102-74.385 for failure to follow directions. Reliance on generic charging authority in the context of executing a critical security countermeasure is counterproductive as the generic charge fails to clearly notify the public that impeding or disrupting the inspection process is prohibited.</P>
                    <P>Moreover, executing effective inspections necessarily involves some degree of waiting or delay on the part of persons subject to inspection. When an individual disrupts or impedes the inspection process by failing to comply with instructions, providing unclear or evasive answers to security personnel questions, or otherwise attempting to evade detection of unlawful items, the security risks and wait-time or delays increase, which disrupts the overall safety and orderly operations on the federal property. Accordingly, the prohibited impediment and disruption provision at § 139.35(e) is necessary to ensure the Federal Government functions properly and without unnecessary risk to safety or delay to operations through the unimpeded performance of security inspections, execution of government duties, and receipt of government services.</P>
                    <P>
                        While FPS has the authority to investigate and charge, 
                        <E T="03">e.g.,</E>
                         18 U.S.C. 115, individuals who threaten government employees regardless of where the threat is made, § 139.35(f) would allow another charging option by prohibiting threatening by any means, including mail, facsimile, telephone, or electronic communication, to commit any crime of violence. The companion term “crime of violence” would be defined in § 139.15, and mirror the definition found in 18 U.S.C. 16(a), to wit, as an offense that has as an element the use, attempted use, or threatened use of physical force against the person or property of another, such as assaultive acts. Proposed § 139.35(f) is a prohibition added to address operational incidents of individuals off federal property who deliver, transmit, or otherwise direct violent threats 
                        <PRTPAGE P="4409"/>
                        towards federal employees and other visitors or customers on federal property. This provision would allow DHS to fully perform the protection duties authorized by 40 U.S.C. 1315(b)(2)(e) by allowing regulatory charging authority for off property commission of crimes against federal property or persons on federal property. The proposed violent threats prohibition is analogous to statutory provisions such as the criminal threats provision at 18 U.S.C. 115 (specific to federal officials and their family members), 18 U.S.C. 875 (threats by interstate communications), and 42 U.S.C. 1320a-8b (threats of force specific to designated Social Security Administration personnel). Enforcement of these analogous statutory provisions often involves competing resource constraints and other prosecutorial considerations, whereas under the proposed rule the offender can be cited with a comparatively lesser offense (Class C Misdemeanor) that is charged through issuance of a written citation, penalized through payment of a fine or imprisonment of not more than 30 days (or both), and, all the while, remains subject to judicial review and other due process protections without implicating more time consuming processes associated with felony or higher-grade misdemeanor charges.
                    </P>
                    <P>Proposed § 139.35(f) is necessary because in the modern landscape of federal property protection, there is greater ease and opportunity with relatively accessible technology, such as email, social media, and text/direct messaging, for individuals to make violent threats that intimidate and harass federal employees and visitors or customers at federal property. For example, FPS has observed increased threats over the last several years at federal property where monetary Government services or benefits are provided or processed, or where the federal entity performs official functions associated which may be subject to public controversy or heightened public interest. Violent threats, at the very least, cause panic or insecurity that destabilizes and disrupts the Federal Government, and, at the very worst, escalates into assault or other harmful acts that cause injury, loss of life, or significant property damage or destruction. Accordingly, the violent threats provision at § 139.35(f) is necessary to ensure readily available charging authority exists to address violent threats that directly undermine the safe and effective administration of the Federal Government.</P>
                    <P>
                        Proposed § 139.35(g) would prohibit unauthorized bathing, wading, or swimming in or polluting any water areas, to include fountains, basins, or reservoirs. This new prohibition is necessary because the presence of water areas may attract unauthorized use of the area and require additional security considerations for the general safety of federal property and its occupants. Such unauthorized use includes bathing, wading, or swimming in water areas on federal property. Additionally, prohibiting unauthorized use would address public safety concerns related to polluting or damaging the water area, 
                        <E T="03">e.g.,</E>
                         urinating or defecating in the pools or fountains on federal property. The existing disturbances provision at 41 CFR 102-74.390 does not expressly prohibit unauthorized use of water areas, which leaves security personnel with the comparatively generic failure to follow directions provision at 41 CFR 102-74.385 for enforcement purposes. Accordingly, the prohibition against the unauthorized use of water areas puts the public on notice and ensures readily available charging authority exists to address such unauthorized use for the safety of federal property and occupants.
                    </P>
                    <P>Section 139.35(h) would prohibit unauthorized camping on federal property. The companion term “camping” would be defined in § 139.15, in pertinent part, as the use of federal property for living accommodations, to include sleeping activities, storing personal property, or altering the federal property for shelter. Section 139.35(h) would be added to address operational incidents of unauthorized camping that occurs at federal property on both interior and exterior spaces. Such unauthorized camping degrades the preservation of federal property, impedes public access for lawful business on federal property, and presents unnecessary security risks in the form of potentially hidden or obstructed persons and items that may be used to disrupt or harm Federal property and occupants.</P>
                    <P>Section 139.35(h) is consistent with other federal land management agency regulations, such as the National Park Service (36 CFR 2.10) and U.S. Forest Service (36 CFR 261.16, and 261.58), that similarly prohibit unauthorized camping in non-designated areas. The unauthorized camping provision better informs federal stakeholders and the general public of the express prohibition on camping without authorization on federal property, including interior and exterior areas, and ensures a readily available charging authority exists to address such unauthorized camping for the safety of federal property and occupants.</P>
                    <P>Section 139.35(i) would prohibit trespassing, entering, or remaining in or on areas of Federal property closed to the public. Section 139.35(i) is a new prohibition directly derived from the hours of operation language in the existing admissions provision at 41 CFR 102-74.375. Persons who engage in trespassing pose a security risk to federal property and occupants, and as such, DHS proposes to expressly prohibit such conduct, instead of the current and comparatively cumbersome reference to the general hours of operation and admissions to Federal property in 41 CFR 102-74.375. Accordingly, the trespassing provision in § 139.35(i) would better inform federal stakeholders and the general public of the express prohibition on trespassing, entering, or remaining in or on closed areas of federal property, and would ensure readily available charging authority exists to address such unauthorized trespassing for the safety of federal property and occupants.</P>
                    <P>
                        Section 139.35(j) would prohibit consuming a tobacco product in all interior space owned, rented, or leased by the Federal Government, as well as all courtyards, terraces, and plazas within 25 feet of doorways and air intake ducts under the custody, control, or jurisdiction of the Federal Government. This new paragraph would add a new category of expressly prohibited conduct that is directly derived from existing federal authorities. While there is signage stating that no smoking is allowed, and violators might be cited for failing to follow the written signage, there is no specific criminal charge related to smoking on Federal property. Instead, DHS must rely on other charges to address smoking on Federal property. Specifically, E.O. 13058, Protecting Federal Employees and the Public from Exposure to Tobacco Smoke in the Federal Workplace,
                        <SU>25</SU>
                        <FTREF/>
                         establishes a smoke-free environment for federal employees and members of the public visiting or using Federal facilities by expressly prohibiting the smoking of tobacco products. The 1997 Executive Order also authorizes agencies to establish more protective policies. GSA subsequently implemented the Order with promulgation of the FMR provisions at 41 CFR 102-74.315-351, including the addition of “within 25 feet of doorways and air intake ducts” in 41 CFR 102-74.330. Then, in 2016, the FDA promulgated a rule to deem 
                        <PRTPAGE P="4410"/>
                        ENDS as covered within the definition of tobacco products.
                        <SU>26</SU>
                        <FTREF/>
                         Given this sequence of events, the existing landscape of applicable authorities supports the proposed rule definition for tobacco products, as well as the prohibition on the use or consumption of these products while on or near federal property protected by the Secretary as stated in § 139.35(j).
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             Executive Order, 13058, Protecting Federal Employees and the Public from Exposure to Tobacco Smoke in the Federal Workplace, 62 FR 43451 (Aug. 13, 1997).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             FDA, Final Rule: Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 FR 28974 (May 10, 2016).
                        </P>
                    </FTNT>
                    <P>While the category of prohibited conduct in § 139.35(j) would be new, the prohibition on tobacco products is not. Smoking tobacco products is currently prohibited through the posting of written signage stating the prohibition, consistent with 41 CFR 102-74.315-351, and follow-on enforcement by security personnel, consistent with 41 CFR 102-74.385, for failure to comply with lawful signage of a prohibitory nature. Accordingly, the consumption of tobacco products prohibition in § 139.35(j) is necessary for the protection and administration of federal property protected by the Secretary. This prohibition would both better inform federal stakeholders and the general public of the express prohibition and parameters associated with the prohibition on consuming tobacco products on or near federal property, inclusive of all forms of smoking and the use of ENDS and ensure readily available charging authority exists to address unauthorized consumption of tobacco products for the safety of federal property and occupants.</P>
                    <P>
                        Section 139.35(k) would prohibit causing an unmanned aircraft to take off or land on federal property without authorization from designated officials. The provision explicitly prohibits take-offs and landings on or from federal property without permission from the Facility Security Committee, Designated Official, or another federal agency responsible for the property. The proposed rule does not regulate lawful overflights of unmanned aircraft over federal property. Overflights are exclusively regulated by the Federal Aviation Administration (FAA). 
                        <E T="03">See</E>
                         14 CFR part 107.
                    </P>
                    <P>Section 139.35(k) is necessary to address operational concerns because DHS has observed an increase in unmanned aircraft activity on, near, and around federal property, and there is no existing authority in the FMR that expressly prohibits unauthorized unmanned aircraft take-offs and landings, which leaves security personnel with the comparatively generic preservation of property or creating a hazard provision at 41 CFR 102-74.380 for enforcement purposes. Accordingly, the unauthorized unmanned aircraft take-offs and landing provision in § 139.35(k) is necessary for the protection and administration of Federal property protected by the Secretary to both better inform federal stakeholders and the general public of the express prohibition and parameters associated with the take-offs and landings of unmanned aircraft on federal property, and ensure readily available charging authority exists to address such unauthorized use of unmanned aircraft for the safety of federal property and occupants.</P>
                    <P>
                        This regulation would address the launch or retrieval of unmanned aircrafts while on federal property. Securing air domain awareness and defense from unmanned aircraft system (UAS) threats at federal facilities is addressed by 6 U.S.C. 124n and through civil enforcement authority retained by FAA. However, this statutory construct does not provide criminal charging options for UAS activity that threatens the safety and security of federal property and persons on the property. The proposed rule would not infringe upon the FAA's regulatory authority, as the prohibition only addresses the impact unlawful UAS conduct has on federal real property. The regulation does not address the prohibitions on operating UAS in certain airspace or other prohibited areas which remain in the bailiwick of FAA. 
                        <E T="03">See, e.g.,</E>
                         14 CFR 107.41 and 107.45.
                    </P>
                    <P>Section 139.35(l) would prohibit using an unmanned aircraft to cause damage, destruction, harm, or a hazard to Federal property or persons on the property. Similar to § 139.35(k), the prohibition in § 139.35(l) would be added to address operational instances of unsafe usage of unmanned aircrafts on Federal property. For example, DHS has observed instances of unmanned aircraft operated in such a manner as to fly low enough to the ground to come into contact with persons or objects on federal property. Such usage of unmanned aircraft presents a direct threat to the safety of persons and preservation of structures and objects on federal property. There is no existing prohibition on the unsafe usage or operation of unmanned aircraft on federal property, which leaves security personnel with the comparatively generic causing a disturbance provision at 41 CFR 102-74.390 for enforcement purposes. Accordingly, the unauthorized unmanned aircraft usage provision in § 139.35(l) is necessary for the protection and administration of Federal property protected by the Secretary to both better inform Federal stakeholders and the general public of the express prohibition associated with using unmanned aircraft to cause damage, destruction, harm, or a hazard to Federal property or persons thereon, and ensure readily available charging authority exists to address such prohibited use of unmanned aircraft for the safety of Federal property and occupants.</P>
                    <P>Section 139.35(m) would prohibit tampering with, accessing, damaging, or interfering with the operation of a computer, digital network, industrial control system or Supervisory Control and Data Acquisition (SCADA) system without proper authorization. Section 139.35(m) would be added to address emerging operational needs to thwart unauthorized use or interference with functional electronic systems on Federal property. Many HVAC and electrical systems that operate on internet connectivity and control the electricity, heating, air conditioning, and overall air flow within federal facilities and also power security alarms, door locking mechanisms, elevators, and escalators.</P>
                    <P>
                        The emerging operational need for § 139.35(m) is supported by the findings in the U.S. Government Accountability Office July 2019 Report to Congressional Requesters, 
                        <E T="03">Cybersecurity, Agencies Need to Fully Establish Risk Management Programs and Address Challenges,</E>
                        <SU>27</SU>
                        <FTREF/>
                         which put Congress on notice that “federal agencies face cyber threats that continue to grow in number and sophistication.” There is no existing provision in GSA's FMR that expressly prohibits the unauthorized use or interference with electronic operating systems on federal property, which leaves security personnel with the comparatively less descriptive, and potentially inapplicable, prohibitions on destroying or damaging property or creating a hazard on property under 41 CFR 102-74.380(b), (d). Section 139.35(m) would provide a more precise and targeted means to respond to emerging cyber threats that affect the security and functionality of Federal facilities protected by DHS.
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             
                            <E T="03">https://www.gao.gov/assets/gao-19-384.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Proposed § 139.35(n) would prohibit impersonating security personnel. Section 139.35(n) would be a new prohibition added to address the use of fake or unauthorized security badges, insignia, identification cards, etc., to gain unauthorized entry into Federal facilities and workspace.
                        <PRTPAGE P="4411"/>
                    </P>
                    <P>
                        Section 139.35(n) is necessary to address an ongoing issue, the use of fake law enforcement badges and credentials to gain entry into federal facilities. First identified in a 2002 Senate Report, 
                        <E T="03">Phony Identification and Credentials Via the Internet,</E>
                         Report 107-133, 107th Congress (2d Session),
                        <SU>28</SU>
                        <FTREF/>
                         the report highlighted the ability of investigators in the General Accounting Office to breach numerous Federal agency facilities utilizing fake law enforcement badges and credentials. Additionally, in 2015, DHS reiterated the threat of individuals impersonating first responders such as law enforcement in public messaging to emergency services sections.
                        <SU>29</SU>
                        <FTREF/>
                         Most states recognize this threat through criminalizing the use of fake law enforcement badges and credentials.
                        <SU>30</SU>
                        <FTREF/>
                         However, there is currently a gap in GSA's FMR and there is no express prohibition of the impersonation of security personnel. This deficiency is challenging where an individual attempts to pose as security personnel to access federal property with weapons or other tools with the intent to cause damage or do harm to occupants. Section 139.35(n) is thus necessary to ensure readily available charging authority exists to address the impersonation of security personnel and to better inform Federal stakeholders and the general public of the express prohibition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             
                            <E T="03">www.congress.gov/congressional-report/107th-congress/senate-report/133/1.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             U.S. Dep't of Homeland Sec., Impersonation of First Responders (2015), available at 
                            <E T="03">https://www.hsdl.org/c/view?docid=800800.</E>
                              
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Fla. Stat. sect. 843.08 (2024) (False Personation); 
                            <E T="03">see also, e.g.,</E>
                             S.C. Code Ann. sect. 16-17-720 (Impersonating law enforcement officer) (2023); 
                            <E T="03">see also, e.g.,</E>
                             Iowa Code sect. 718.2 (2024) (Impersonating a public official).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">Section 139.40 Gambling</HD>
                    <P>
                        Section 139.40 proposes, with limited exceptions, a prohibition on gambling activities on federal property. This section would be similar to the current prohibition on gambling in the GSA regulations, codified at 41 CFR 102-74.395. Notably, § 139.40 would not alter the statutory exceptions provided in the Randolph-Sheppard Act, as codified at 20 U.S.C. 107 
                        <E T="03">et seq.,</E>
                         or prize drawings for personal property at otherwise permitted functions on federal property. Rather, this proposed section would continue the existing general prohibitions on games for money or other personal property, operating gambling devices, conducting a lottery or pool, and purchasing/selling gambling tickets on Federal property.
                    </P>
                    <HD SOURCE="HD2">Section 139.45 Narcotics, Other Drugs, and Drug Paraphernalia</HD>
                    <P>Section 139.45 would establish the prohibition on using, possessing, operating a vehicle while under the influence of, or being under the influence of narcotics, or possessing illegal drug paraphernalia on Federal property. This section would be functionally identical and textually similar to the existing provision in the GSA regulations, codified at 41 CFR 102-74.400</P>
                    <P>The unlawful use of narcotics continues to present security risks associated with elevated, delayed, or otherwise impaired behavior of visitors to federal property. Section 139.45 is reasonable and necessary to address the illegal use or possession of controlled substances on federal property as federal misdemeanor offenses instead of defaulting to prosecution under the Controlled Substances Act found in Title 21, United States Code. Specifically, this proposed provision would provide that an individual in violation of this section is temporarily detained, issued a citation, and released on his/her own recognizance rather than experiencing a formal arrest. Without the option of charging a narcotics offense as a Class C misdemeanor, DHS would have to look to the statutory counterpart and charge the individual with either a higher-level misdemeanor or felony under the code.</P>
                    <HD SOURCE="HD2">Section 139.50 Alcoholic Beverages</HD>
                    <P>
                        Section 139.50 would prohibit individuals from consuming or being under the influence of alcoholic beverages, except where authorized by the head of an agency or the agency head's designee. This provision would not alter the written exemption or related procedures for obtaining an exemption to the prohibition against the consumption of alcoholic beverages on federal property in the current regulation.
                        <SU>31</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             41 CFR 102-74.405.
                        </P>
                    </FTNT>
                    <P>This proposed section would also prohibit the possession of an “open container” on property owned, occupied, or secured by the federal government. “Open container” would be defined in proposed § 139.15 as a bottle, can, or any other receptable containing an alcoholic beverage that is open, has a broken seal, or from which the contents are partially removed. The prohibition on possessing open containers would address operational concerns with security risks posed by instances of elevated or otherwise altered behavior by intoxicated persons. Finally, the proposed section would prohibit the operation of a motor vehicle under the influence of alcohol. Accordingly, the alcoholic beverage provision in § 139.50 is necessary for the protection and administration of federal property protected by the Secretary to continue prohibiting the unauthorized use of alcohol for the security and safety of federal property and occupants.</P>
                    <HD SOURCE="HD2">Section 139.55 Soliciting, Vending, and Debt Collection</HD>
                    <P>
                        Section 139.55 would prohibit soliciting, vending merchandise, displaying or distributing commercial advertising, and engaging in debt collection activities on federal property, except under certain conditions. This section would be functionally identical and textually similar to the existing FMR provision at 41 CFR 102-74.410. Notably, all six categories of permissible activity currently listed in 41 CFR 102-74.410 would be included in the exceptions for § 139.55, to include Government sponsored or approved activities.
                        <SU>32</SU>
                        <FTREF/>
                         Accordingly, FPS believes this proposed section prohibiting solicitation, vending, and debt collection strikes the appropriate balance between activities that could disrupt or distract the orderly administration of government functions and approved activities that do not compromise or otherwise degrade the administration of government.
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             41 CFR 102.74.410(c)-(d) have been merged and are now reflected in proposed rule § 139.55(b)(3).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">Section 139.60 Posting and Distributing Materials</HD>
                    <P>Proposed § 139.60 would prohibit the posting and distribution of printed materials on federal property, except as specifically authorized. Although this proposed section is functionally identical to the GSA regulations, codified at 41 CFR 102-74.415, it would provide better clarity and notice to the public of the precise nature of prohibited conduct for the preservation and safety of property and occupants through more precise terminology. Proposed § 139.60 would not disturb the current exceptions for the lawful exercise of distributing materials during permitted events on public areas of federal property in furtherance of free speech and assembly.</P>
                    <P>
                        The unauthorized distribution of materials can create significant problems for the maintenance and security of federal property. For example, in the Fall of 2019, an individual in Portland, Oregon, threw 
                        <PRTPAGE P="4412"/>
                        hundreds of pamphlets on the grounds of a federal plaza in protest. The pamphlets covered the entire plaza affecting the plaza water drainage system. The individual did so without a permit. It was then left to FPS as the security provider and GSA as the federal landlord to secure the area and remove the pamphlets. This effort diverted both FPS law enforcement personnel and GSA employees over 8 hours from their normal duties.
                    </P>
                    <P>The prohibition in proposed § 139.60 would also help prevent individuals or groups from interfering with the judicial process and the jurors by precluding the unauthorized distribution of materials that may be the subject of litigation to jurors on the Federal property, which undermines the fair administration of justice during trials at Federal courthouse facilities.</P>
                    <HD SOURCE="HD2">Section 139.65 Photography and Recording</HD>
                    <P>Proposed § 139.65(a) would establish that image and audio recording of federal facilities and grounds is prohibited if conducted in a manner that either impedes or disrupts access to or operations on federal property, or if it is prohibited by any federal security regulation, rule, order, or directive. For example, if the image or audio recording prevents or disrupts security screening, or the provision of services by the federal government.</P>
                    <P>Proposed § 139.65(b) would provide exceptions to prohibitions on photographing and video or audio recording in proposed § 139.65(a). Specifically, proposed § 139.65(b) would allow image and audio recording of the publicly accessible exterior of federal properties from outdoor public areas when not impeding or disrupting access to or operations on federal property. Recording still and motion images and audio would also be allowed in the entrance and common areas of federal facilities open to the public, provided the recording does not disrupt access to or operations on the federal property. Image and audio recording within interior areas occupied by federal agencies would be prohibited except with the express permission of the tenant agency, and written permission would be required for any photography or recording done for a commercial purpose.</P>
                    <P>
                        This section would mirror, though not replicate, a similar provision in the GSA regulations, codified at 41 CFR 102-74.420. By comparison to the existing provision, § 139.65 would be restructured stylistically to state the general rule and three applicable exceptions. The proposed substantive language would provide better clarity and notice to the public of the precise nature of prohibited and permitted recording conduct and ensure consistency with corresponding First Amendment case law related to photography and recording at/on Federal property.
                        <SU>33</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             The public has the right to photograph/videotape officials carrying out public duties. 
                            <E T="03">Glik</E>
                             v. 
                            <E T="03">Cunniffe,</E>
                             655 F.3d 78, 82 (1st Cir.2011). However, content neutral restrictions on photography regulating time/manner or in non-public fora (
                            <E T="03">e.g.,</E>
                             polling place or courtroom) for privacy or to maintain order are consistent with the First Amendment. 
                            <E T="03">Silberberg</E>
                             v. 
                            <E T="03">Board of Election of New York,</E>
                             272 F. Supp. 3d (S.D. N.Y. 2017).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">Section 139.70 Vehicle Operations and Removal</HD>
                    <P>Section 139.70 would require persons to operate vehicles in a safe manner, possess a valid operator's license, comply with signs and directions by security personnel and obey traffic and safety signals and posted signage. The section additionally prohibits certain conduct such as blocking driveways and sidewalks and parking on federal property without a permit or authorization in restricted parking areas. This section would also state that vehicles determined to be in violation of this section are subject to seizure and removal with the owner of the vehicle responsible for associated costs in removal.</P>
                    <P>This section is derived from similar provisions in the GSA regulations, codified at 41 CFR 102-74.370 and 430, but, significantly, this proposed section would allow LEOs to enforce these traffic concerns adjacent to the federal property where the conduct, while off federal property, affects the security of the property or the persons on the property as envisioned by 40 U.S.C. 1315. Overall, the vehicle operation and removal provision in § 139.70 would provide clarity and notice to the public of the precise nature of prohibited conduct with plainly stated parameters for safe operation, prohibited operations, specific responsibilities, and authority for enforcement, removal, and seizure.</P>
                    <HD SOURCE="HD2">Section 139.75 Firearms, Dangerous Weapons, and Explosives</HD>
                    <P>Section 139.75 would prohibit the possession and carrying of firearms, dangerous weapons and explosives. This section would streamline and combine the existing GSA regulations on weapons and explosives in Federal facilities, codified at 41 CFR 102-74.435, 440. Notably, § 139.75 would cross-reference both the definitions of the companion term “firearm” and “dangerous weapon” found in federal firearms laws in 18 U.S.C. 921 and 930(g), respectively, and the same three categories of persons eligible to possess weapons on Federal property as stated in 18 U.S.C. 930(d). Section 139.75 would also cross-reference the definition of explosives found in 18 U.S.C. 841. The real-world threats posed by active shooters, improvised explosive devices, and other dangerous weapons remains a top concern for the security of federal property and occupants. Accordingly, proposed § 139.75 would ensure readily available charging authority for instances of unlawful possession of firearms, dangerous weapons, and explosives.</P>
                    <HD SOURCE="HD2">Section 139.80 Animals</HD>
                    <P>Section 139.80 would prohibit any person from bringing animals in or on federal property for other than official purposes with the limited exception of service animals for persons with disabilities. The companion term “service animal” would be defined in proposed § 139.15 to mean any dog that is individually trained to do work or perform tasks for the benefit of an individual with a disability, including a physical, sensory, psychiatric, intellectual, or other mental disability.</P>
                    <P>The substance of § 139.80 would be like the existing provision in the FMR at 41 CFR 102-74.425 with the notable exclusion of “other animals” as qualifying service animals. This is consistent with the Department of Justice's definition of “service animal”. 28 CFR 35.104. Accordingly, proposed § 139.80 regarding the prohibition of animals on federal property, with one limited exception, is proposed to ensure the definition of a service animal is consistent with other agencies' definitions of “service animal,” in compliance with the Americans with Disability Act of 1990, and ensure proper order and security is maintained on federal property while allowing the lawful presence of service animals.</P>
                    <HD SOURCE="HD2">Section 139.85 Penalties</HD>
                    <P>
                        Proposed § 139.85 would establish the penalties for violating the rules and regulations in the proposed rule in accordance with the maximum penalties set forth in 40 U.S.C. 1315(c)(2). Section 139.85 would establish that violations of proposed subpart B may be punished by a fine in accordance with title 18 U.S.C. 3571, imprisonment for not more than 30 days, or both. DHS has updated the language of proposed § 139.85 slightly but has maintained the same penalties as established in GSA's FMR at 41 CFR 102-74.450. In other words, the rule would maintain that a conviction for a violation of the proposed rule's 
                        <PRTPAGE P="4413"/>
                        provisions would be a Class C misdemeanor. 
                        <E T="03">See</E>
                         18 U.S.C. 3559(a)(8). This proposed section would ensure that the appropriate penalties and sanctions are available to address minor criminal misconduct not warranting prosecution under Title 18, United States Code, and provides a degree of deterrence for minor criminal violations that cause damage or harm to Federal property and occupants.
                    </P>
                    <HD SOURCE="HD1">V. Regulatory Analyses</HD>
                    <HD SOURCE="HD2">A. Executive Order 12866, Regulatory Planning and Review</HD>
                    <P>Executive Orders 12866 (Regulatory Planning and Review), as amended by Executive Order 14094 (Modernizing Regulatory Review), and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying costs and benefits, reducing costs, harmonizing rules, and promoting flexibility.</P>
                    <P>The Office of Management and Budget (OMB) has not designated this proposed rule a significant regulatory action under section 3(f) of Executive Order 12866, as amended by Executive Order 14094. Accordingly, OMB has not reviewed this proposed rule.</P>
                    <P>Below is FPS's assessment of the benefits and costs of this regulatory action. A detailed discussion of FPS's approach and assumptions is provided separately in the regulatory impact analysis (RIA) included in the docket for this proposed rule.</P>
                    <P>OMB's Circular A-4 provides guidance to Federal agencies on the development of regulatory analyses estimating the benefits and costs of regulatory actions. It asks Federal agencies to analyze alternative regulatory approaches for achieving the desired outcome. At a minimum, agencies should evaluate the preferred alternative, a more stringent option, and a less stringent option. FPS evaluates the following regulatory alternatives:</P>
                    <P>
                        <E T="03">Proposed Rule:</E>
                         This proposed rule implements the authority of the Federal Protective Services for the protection of buildings, grounds, and property that are owned, occupied, or secured by the federal Government with the specific revisions discussed in this preamble. 40 U.S.C. 1315, specifically authorizes the Secretary of DHS to protect property owned, leased, or secured by the Federal government and the persons on that property. This authority also authorizes off property enforcement to the extent necessary to protect the Federal property or the persons thereon and for DHS LEOs to conduct investigations off property of offenses that may have been committed against property owned or occupied by the Federal government or persons on the property. Additionally, 40 U.S.C. 1315 permits the Secretary of DHS, in consultation with GSA, to prescribe regulations necessary for the protection and administration of Federal property and to include reasonable penalties.
                    </P>
                    <P>
                        <E T="03">Alternative 1 (less stringent):</E>
                         Under the less stringent alternative, in order to accomplish its goal of aligning regulations under DHS authority, DHS would incorporate the existing GSA regulations governing personal conduct on federal property from Title 41 with no changes in the language or content of those regulations. Specifically, DHS would copy each GSA provision to the proposed rule and re-issue the posted rules and regulations relating to and governing conduct on Federal property identifying DHS as the regulatory authority. Thus, the posted rules and regulations would display the DHS seal instead of the GSA logo. Incorporating the existing GSA rules and regulations to DHS would not result in any other changes in current law enforcement practices at Federal facilities. Alternative 1 would not expand upon the prohibited conduct outlined in existing GSA provisions nor modify the charging options for non-GSA property.
                    </P>
                    <P>
                        <E T="03">Alternative 2 (more stringent):</E>
                         Under the more stringent alternative, DHS would incorporate and update the existing GSA rules and regulations to DHS as in the proposed rule. In addition, Alternative 2 would further improve protection of Federal facilities and persons thereon through enforcement of state and local laws by authorizing FPS to apply state and local laws relating to the security of Federal property or the people thereon where there is no applicable Federal law or regulation. Unlike the application of the Assimilative Crimes Act, 18 U.S.C. 13, which allows prosecution of state law criminal violations in federal court under certain circumstances, this alternative would incorporate state laws into the federal regulation by reference. In other words, state laws would be incorporated into federal law. DHS LEOS would not be enforcing state laws. Instead, federal LEOs would thereby apply Federal law that incorporates State law by reference. The approach would be similar to that of the National Park Service regulation that incorporates state boat safety laws into the federal regulation.
                        <SU>34</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             
                            <E T="03">See U.S.</E>
                             v. 
                            <E T="03">Bohn,</E>
                             622 F.3d 1129 (9th Cir. 2010) (upholding conviction under NPS regulation that adopts substantive provisions of state law; Property Clause power of Constitution extends to conduct threatening designated purpose of federal lands whether than conduct occurs on or off federal land); 
                            <E T="03">see also</E>
                             U.S. CONST. art. IV, sec. 3, cl.2 (The Property Clause) (“Congress shall have Power to dispose of and make all needful Rules and Regulations respecting the Territory or other Property belonging to the United States.”); 40 U.S.C. 1315(c) (DHS required by Congress to create regulations necessary for the protection and administration of property owned or occupied by the Federal government and the persons thereon).
                        </P>
                    </FTNT>
                    <P>For each alternative, a cost/benefit analysis would ideally compare the monetized costs of implementing the regulations to the monetized estimates of the resulting reduction in security risk at Federal facilities. However, data limitations make it challenging to quantify the incremental change in risks likely to result from the proposed rule. Instead, DHS provides a qualitative discussion of the likely benefits of the proposed rule.</P>
                    <P>The economic costs associated with the proposed rule include one-time and ongoing costs incurred by FPS to implement the proposed rule, one-time costs incurred by GSA to comply with the requirements of the proposed rule, and ongoing costs incurred by U.S. district courts to implement and comply with the requirements of the proposed rule.</P>
                    <P>These economic costs represent the incremental costs above and beyond those that would already be incurred absent the proposed regulation in order to protect Federal property and persons located on or within those properties. The incremental costs of the proposed rule are estimated over a 5-year analysis period (2024 to 2028) and calculated on a present value basis.</P>
                    <P>
                        Under the analytic baseline, FPS issues citations for regulatory violations under 41 CFR 102-74 Subpart C and charges for statutory violations under Title 18 of the U.S. Code. In 2021 and 2022, FPS issued approximately 900 citations annually on average that were processed by the Central Violation Bureau (CVB). A number of citations within the baseline are issued under “All Other Charges,” which represent FPS enforcement of criminal charges under statutory Federal law, primarily Title 18 of the U.S. Code. Many of the GSA regulations do not apply to incidences that occur adjacent to Federal property, including regulations pertaining to throwing objects, wearing disguises, obstructing federal property, and operating unmanned aircrafts without authorization. FPS responds to 
                        <PRTPAGE P="4414"/>
                        threatening incidents and conducts full investigations, which may result in issuing a citation for criminal misconduct, detaining, or arresting individuals making such threats. However, FPS LEOs do not have regulatory authority to issue citations for off-property incidents that do not rise to the level of a U.S. Code violation. Building managers are also required to maintain and replace signage as needed under 41 CFR 102-74.365. The RIA in the docket provides additional discussion and analysis of potential changes to enforcement and the issuance of citations under the proposed rule compared to the baseline.
                    </P>
                    <P>Table 1 summarizes the estimated costs of the proposed rule. As shown in the exhibit, the present value costs of the proposed rule are estimated to be approximately $1,186,310 during the next 5 years, or approximately $251,686 annualized (discounted at two percent). The majority of the incremental costs of the proposed rule are associated with replacing signage at all Federal facilities protected by FPS (§ 139.5(d)); the associated costs of which would be shared roughly equally between FPS and GSA. FPS would also incur initial training costs for LEOs to become familiar with the proposed regulatory changes. Furthermore, FPS and U.S. district courts may experience an increase in labor and administrative costs, respectively, associated with an increase in the number of citations issued by FPS (§§ 139.25 and 139.35).</P>
                    <GPOTABLE COLS="7" OPTS="L2,p7,7/8,i1" CDEF="s50,12,12,12,12,12,12">
                        <TTITLE>Table 1—Summary of Costs of the Proposed Rule by Section</TTITLE>
                        <TDESC>[2023 Dollars]</TDESC>
                        <BOXHD>
                            <CHED H="1">Year</CHED>
                            <CHED H="1">Training costs</CHED>
                            <CHED H="1">
                                § 139.5(d) 
                                <LI>Notice</LI>
                                <LI>requirement</LI>
                                <LI>costs</LI>
                            </CHED>
                            <CHED H="1">
                                § 139.25
                                <LI>Preservation</LI>
                                <LI>of Federal property costs</LI>
                            </CHED>
                            <CHED H="1">
                                § 139.35
                                <LI>Prohibited conduct costs</LI>
                            </CHED>
                            <CHED H="1">Undiscounted total</CHED>
                            <CHED H="1">
                                Present
                                <LI>value total</LI>
                                <LI>(2% discount</LI>
                                <LI>rate)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2024</ENT>
                            <ENT>$364,198</ENT>
                            <ENT>$722,570</ENT>
                            <ENT>$1,084</ENT>
                            <ENT>$24,555</ENT>
                            <ENT>$1,112,408</ENT>
                            <ENT>$1,090,596</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2025</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>1,084</ENT>
                            <ENT>24,555</ENT>
                            <ENT>25,640</ENT>
                            <ENT>24,644</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2026</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>1,084</ENT>
                            <ENT>24,555</ENT>
                            <ENT>25,640</ENT>
                            <ENT>24,161</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2027</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>1,084</ENT>
                            <ENT>24,555</ENT>
                            <ENT>25,640</ENT>
                            <ENT>23,687</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">2028</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>1,084</ENT>
                            <ENT>24,555</ENT>
                            <ENT>25,640</ENT>
                            <ENT>23,223</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="03">Total</ENT>
                            <ENT>364,198</ENT>
                            <ENT>722,570</ENT>
                            <ENT>5,421</ENT>
                            <ENT>122,777</ENT>
                            <ENT>1,214,966</ENT>
                            <ENT>1,186,310</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Annualized</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>251,686</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Table Note:</E>
                             Totals may not sum due to rounded values in the table.
                        </TNOTE>
                    </GPOTABLE>
                    <P>Under Alternative 1, DHS would replicate the rules relating to and governing personal conduct on Federal property from GSA, and would leave in place the existing GSA language and requirements. FPS would print new signs and coordinate with GSA to have them posted at Federal facilities to comply with the proposed regulations. However, replicating the existing GSA rules and regulations to DHS would not result in any other changes in current law enforcement practices at Federal facilities. Thus, the costs of the less stringent alternative would only include the one-time costs of replacing existing signage at Federal facilities, $708,402, annualized discounted at two percent.</P>
                    <P>Under Alternative 2, DHS would be the same as the proposed rule with modifications to improve protection of Federal facilities and persons thereon through enforcement of state and local laws by authorizing FPS to apply state and local laws relating to the security of Federal property or the people thereon where there is no applicable Federal statutory law or regulation. Table 2 compares the costs of the two quantified regulatory alternatives. While the costs of Alternative 2 are not quantified, FPS anticipates the costs to be substantially higher than the proposed rule.</P>
                    <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s50,12">
                        <TTITLE>Table 2—Cost of Regulatory Alternatives for Proposed FPS Rule </TTITLE>
                        <TDESC>[2023 Dollars]</TDESC>
                        <BOXHD>
                            <CHED H="1">Alternative</CHED>
                            <CHED H="1">
                                5-year 
                                <LI>total cost</LI>
                                <LI>(2 percent </LI>
                                <LI>discount </LI>
                                <LI>rate)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Proposed Rule</ENT>
                            <ENT>$1,186,310</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Alternative 1 (less stringent)</ENT>
                            <ENT>708,402</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>With respect to benefits, the primary purpose of the proposed rule is to improve security at Federal properties. Increased enforcement and successful prosecution of misconduct is intended to reduce the risk of future incidents of misconduct, thereby avoiding adverse consequences such as injuries, property damage and loss, and temporary workplace closures.</P>
                    <P>Ideally, the evaluation of the proposed rule would compare the monetized values for all benefits arising from the proposed rule to the cost of implementing the proposed rule. Estimating benefits requires information about (1) the incremental change in security risk at Federal facilities and (2) the value individuals place on such risk reductions. In practice, precise quantification and valuation of such risk reductions is difficult.</P>
                    <P>As discussed in the RIA, this analysis of benefits includes a review of published academic literature evaluating the linkages between increased enforcement and clearer regulations and reduced misconduct. The literature generally suggests that increased enforcement is likely to result in decreased misconduct. Based on this literature, DHS expects that implementing the proposed rule, which DHS expects to lead to increased enforcement, is likely to reduce the incidence of misconduct at Federal properties; however, the literature does not provide a strong basis to quantify likely reductions in such incidents. DHS also reviews studies providing monetary estimates of the value of reductions in various types of misconduct. This literature does not provide a sufficient basis to monetize all the types of misconduct that might be affected by the proposed rule. Thus, this analysis provides a qualitative discussion of the potential benefits of each element of the proposed rule. The benefits broadly fall into three categories:</P>
                    <P>• Extending FPS's regulatory enforcement authority, which would allow FPS LEOs to prevent incidents of misconduct;</P>
                    <P>• Removing ambiguities in current regulations, leading to higher rates of successful prosecution and therefore greater deterrence of repeat offenses; and;</P>
                    <P>
                        • Clarifying the language of prohibited activities and behavior, which would increase compliance by 
                        <PRTPAGE P="4415"/>
                        raising the public's awareness of prohibited activities and behavior.
                    </P>
                    <P>
                        DHS has concluded that the proposed rule would best balance the security needs for Federal properties with the potential costs imposed on DHS and other Federal agencies as well as facility occupants and visitors. By incorporating GSA regulations and adding definitions to further clarify the regulations relating to and governing personal conduct on Federal properties, the proposed rule would increase the enforcement (
                        <E T="03">e.g.,</E>
                         for certain off-property misconduct) and successful prosecution of misconduct (
                        <E T="03">e.g.,</E>
                         due to higher specificity of the regulations), which in turn is expected to reduce the risk of future incidents, thereby avoiding adverse consequences such as injuries, property damage and loss, and temporary workplace closures.
                    </P>
                    <P>DHS determined that Alternative 1 (the less stringent alternative) would have the lowest costs, but would also yield the fewest benefits. By establishing the regulations under DHS, this alternative resolves the legal ambiguity of FPS's enforcement of the GSA regulations on prohibited conduct at Federal properties. Alternative 1, however, would not enhance security measures at Federal facilities because it does not clarify the language of regulations relating to and governing personal conduct on Federal property or include new, more detailed provisions. Therefore, DHS believes that Alternative 1 is unlikely to reduce incidents involving prohibited conduct relative to existing levels.</P>
                    <P>DHS determined that Alternative 2 (more stringent alternative) would have higher costs than the other regulatory alternatives, but may also provide additional benefits. Under this alternative, FPS would issue additional citations related to state and local laws. In addition to providing the same benefits as the proposed rule, Alternative 2 may further reduce incidence of misconduct by providing FPS another mechanism for charging violations of misconduct that fall under state law. However, DHS recognized that the administrative and oversight burden for Alternative 2 (more stringent alternative) would not be possible with FPS's current funding and manpower level. First, this alternative would require significant resources to implement, adding an expanded training requirement for all FPS LEOs and requiring FPS attorneys to undertake extensive research to understand the laws potentially applicable to each Federal facility in all 50 states and many local jurisdictions. Second, it would require FPS attorneys to constantly monitor state and local law to identify and interpret changes in such laws, which may then necessitate changes in officer procedures, guidance, and associated training materials.</P>
                    <P>In evaluating these alternatives, FPS recognized uncertainty in the estimates of the costs and benefits. For a complete discussion of the analysis, see the complete RIA provided in the docket.</P>
                    <HD SOURCE="HD2">B. Regulatory Flexibility Act</HD>
                    <P>Under the requirements of the Regulatory Flexibility Act (RFA), the Small Business Regulatory Enforcement Fairness Act (SBREFA) and E.O. 13272, entitled “Proper Consideration of Small Entities in Agency Rulemaking,” agencies must consider the potential impact of regulations on small businesses, small governmental jurisdictions, and small organizations during the development of their rules. As discussed above, costs are likely to be incurred by FPS, other Federal agencies (including tenants of Federal facilities), and U.S. district courts. The Federal Government is not considered to be a small entity. Thus, FPS certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.</P>
                    <HD SOURCE="HD2">C. Paperwork Reduction Act</HD>
                    <P>
                        The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3507(d) requires that DHS consider the impact of paperwork and other information collection burdens imposed on the public. According to the Paperwork Reduction Act, an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid OMB control number. DHS has determined that the proposed rule would not result in a new collection nor modify an existing collection of information. The proposed rule is amending prohibited conduct on and adjacent to federal property. The proposed rule places burden on the Federal Government and not directly on the public. In accordance with the authority vested in the Secretary of DHS under 18 U.S.C. 1315, this rulemaking would establish regulations governing conduct on federal property and establish additional Federal charging options off of Federal property to the extent necessary to protect that property or the persons thereon. The proposed rule does not impose any additional burden on the public for the collection of information, so the provisions of the PRA do not apply to this rule and no new collection of information is warranted.
                        <SU>35</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             Insofar as DHS may collect information from individuals charged under statute or with regulatory violations under the proposed rule, the PRA exempts from its provisions the collection of information during the conduct of a Federal criminal investigation or prosecution or administrative action or investigation involving an agency against specific individuals or entities. 44 U.S.C. 3518(c)(1)(A), (c)(1)(B)(ii).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">D. Executive Order 13132, Federalism</HD>
                    <P>Executive Order 13132, 64 FR 43255 (Aug. 10, 1999), sets forth principles and criteria that agencies must adhere to in formulating and implementing policies that have federalism implications, that is, regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Federal agencies must closely examine the statutory authority supporting any action that would limit the policymaking discretion of the States, and to the extent practicable, must consult with state and local officials before implementing any such action.</P>
                    <P>
                        DHS has reviewed this proposed rule under Executive Order 13132 and has concluded that it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, this proposed rule does not have federalism implications as defined by the Executive Order. This rulemaking would not significantly affect the rights, roles, and responsibilities of States, and involves no preemption of State law. In accordance with the authority vested in the Secretary of DHS under 18 U.S.C. 1315, this rulemaking would establish regulations governing conduct on federal property and establish additional Federal charging options off of Federal property to the extent necessary to protect that property or the persons thereon. The rule does not usurp or otherwise effect existing state or local law enforcement authority on or adjacent to federal property. Specifically, DHS rejected the alternative of authorizing FPS to apply state and local laws where there is no applicable Federal law or regulation (see discussion on Alternative 2 in Section V.A. (“Executive Order 12866, Regulatory Planning and Review”)). Instead, the proposed rule merely mirrors DHS's current statutory enforcement authority under 40 U.S.C. 
                        <PRTPAGE P="4416"/>
                        1315 and does not adopt state laws or otherwise affect State or local enforcement authority. The proposed rule similarly does not affect or alter DHS's jurisdictional requirements under the Assimilative Crimes Act or DHS's current ability to enter into agreements with State or local authorities for enforcement of State or local laws.
                    </P>
                    <P>Therefore, under Executive Order 13132, DHS analyzed this proposed rule and determined that the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.</P>
                    <HD SOURCE="HD2">E. Unfunded Mandates Reform Act</HD>
                    <P>The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538, requires Federal agencies to assess the effects of their discretionary regulatory actions. The Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100 million (adjusted for inflation) or more in any one year. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100 million (adjusted for inflation) or more in any one year) an identification of the provision of Federal law under which the rule is being promulgated. The proposed rule does not require action or costs by State, local, and tribal governments or the private sector, nor does it affect the health, safety, and the natural environment of these entities. The proposed rule establishes the regulations governing the conduct on Federal property, and off property to the extent that there is a nexus to that Federal property under 40 U.S.C. 1315. Because the rule does not result in expenditures by a State, local, or tribal government, DHS does not need to assess the effects of this proposed rule.</P>
                    <HD SOURCE="HD2">F. National Environmental Protection Act (NEPA)</HD>
                    <P>
                        Section 102 of the National Environmental Policy Act of 1969 (NEPA), Public Law 91-190, 83 Stat. 852 (Jan. 1, 1970) (42 U.S.C. 4321 
                        <E T="03">et seq.</E>
                        ), as amended, requires Federal agencies to evaluate the impacts of a proposed major Federal action that may significantly affect the human environment, consider alternatives to the proposed action, provide public notice and opportunity to comment, and properly document its analysis. DHS and its agency components analyze proposed actions to determine whether NEPA applies to them and, if so, what level of documentation and analysis is required.
                    </P>
                    <P>DHS Directive 023-01, Rev. 01 and DHS Instruction Manual 023-01-001-01, Rev. 01 (Instruction Manual) establish the policies and procedures DHS and its component agencies use to comply with NEPA and the Council on Environmental Quality (CEQ) regulations for implementing NEPA codified in 40 CFR parts 1500-1508. The CEQ regulations allow Federal agencies to establish, in their implementing procedures, with CEQ review and concurrence, categories of actions (“categorical exclusions”) that experience has shown do not, individually or in the aggregate, have a significant effect on the human environment and, therefore, do not require preparation of an environmental assessment or environmental impact statement. 40 CFR 1501.4, 1507.3(e)(2)(ii). Appendix A of the Instruction Manual lists the DHS categorical exclusions. Under DHS NEPA implementing procedures, for an action to be categorically excluded, it must satisfy each of the following three conditions: (1) the entire action clearly fits within one or more categorical exclusions; (2) the action is not a piece of a larger action; and (3) no extraordinary circumstances exist that create the potential for a significant environmental effect. This proposed rule would establish DHS regulations for permissible and prohibited conduct on property owned, operated, or secured by the Federal government. Additionally, pursuant to the authority granted in 18 U.S.C. 1315, the rule would provide additional charging authority for LEOs for conduct occurring off property which affects the Federal property or the persons thereon. DHS has analyzed the proposed rule in accordance with its NEPA implementing procedures and has determined that no extraordinary circumstances are present that may create a potential for significant environmental effects. DHS has analyzed this proposed rule and has determined it clearly fits within categorical exclusion A3 because it is a rule is a standalone rulemaking that is not part of a larger DHS action. The conclusion, when the three criteria are met, is that the action is categorically excluded and that no further review or documentation is necessary. DHS has determined that the proposed rule does not constitute a major Federal action significantly affecting the quality of the human environment. DHS has also determined that the proposed rule does not involve any of the extraordinary circumstances that require further NEPA analysis. Therefore, DHS has determined preparation of an environmental assessment or impact statement is not required in promulgating this proposed rule.</P>
                    <HD SOURCE="HD2">G. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments</HD>
                    <P>
                        The 2000 Executive Order 13175 directs Federal agencies to coordinate and consult with Indian tribal governments whose interests might be directly and substantially affected by activities on federally administered lands.
                        <SU>36</SU>
                        <FTREF/>
                         Of the 8,520 Federal facilities protected by FPS, the agency identified 21 such Federal facilities located on tribal lands. As discussed in Chapter 3, the costs of implementing the proposed rule would be incurred solely by the Federal government, including FPS, other Federal agencies that are tenants of Federal facilities protected by FPS, and U.S. district courts. Accordingly, the proposed rule would not impose any costs on local or tribal governments. As discussed in Chapter 4, data limitations prevent the quantification of the incremental improvement in security resulting from the proposed rule. However, this improvement is focused on Federal facilities and persons thereon. Thus, DHS certifies that the proposed rule does not directly and substantially affect tribal government interests as specified in E.O. 13175.
                    </P>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             E.O. No. 13175, 64 FR 67249 (Nov. 10, 2000), 
                            <E T="03">https://www.gpo.gov/fdsys/pkg/FR-2000-11-09/pdf/00-29003.pdf.</E>
                        </P>
                    </FTNT>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 6 CFR Part 139</HD>
                        <P>Aircraft, Alcohol and alcoholic beverages, Animals, Buildings and facilities, Civil disorders, Crime, Explosives, Federal buildings and facilities, Firearms, Gambling, Government employees, Government property, Government property management, Homeland Security, Law enforcement, Law enforcement officers, Penalties, Public buildings, Safety, Search warrants, Security measures, Terrorism, Tobacco, Unmanned aircraft.</P>
                    </LSTSUB>
                    <P>For the reasons set forth in the preamble, DHS proposes to add part 139, under the authority of 40 U.S.C. 1315(c), to chapter I of title 6 of the Code of Federal Regulations as set forth below:</P>
                    <AMDPAR>1. Add part 139 to read as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 139—CONDUCT ON FEDERAL PROPERTY</HD>
                        <CONTENTS>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart A—General</HD>
                                <SECHD>Sec.</SECHD>
                                <SECTNO>139.1</SECTNO>
                                <SUBJECT>Purpose.</SUBJECT>
                                <SECTNO>139.5</SECTNO>
                                <SUBJECT>
                                    Scope, applicability, and agency cooperation.
                                    <PRTPAGE P="4417"/>
                                </SUBJECT>
                                <SECTNO>139.10</SECTNO>
                                <SUBJECT>Assessments for protective services.</SUBJECT>
                                <SECTNO>139.15</SECTNO>
                                <SUBJECT>Definitions.</SUBJECT>
                            </SUBPART>
                            <SUBPART>
                                <HD SOURCE="HED">Subpart B—Personal Conduct Affecting Federal Property</HD>
                                <SECTNO>139.20</SECTNO>
                                <SUBJECT>Admissions and inspections related to federal property.</SUBJECT>
                                <SECTNO>139.25</SECTNO>
                                <SUBJECT>Preservation of federal property.</SUBJECT>
                                <SECTNO>139.30</SECTNO>
                                <SUBJECT>Conformance with signs and directions.</SUBJECT>
                                <SECTNO>139.35</SECTNO>
                                <SUBJECT>Prohibited conduct.</SUBJECT>
                                <SECTNO>139.40</SECTNO>
                                <SUBJECT>Gambling.</SUBJECT>
                                <SECTNO>139.45</SECTNO>
                                <SUBJECT>Narcotics, other drugs, and drug paraphernalia.</SUBJECT>
                                <SECTNO>139.50</SECTNO>
                                <SUBJECT>Alcoholic beverages.</SUBJECT>
                                <SECTNO>139.55</SECTNO>
                                <SUBJECT>Soliciting, vending, and debt collection.</SUBJECT>
                                <SECTNO>139.60</SECTNO>
                                <SUBJECT>Posting and distributing materials.</SUBJECT>
                                <SECTNO>139.65</SECTNO>
                                <SUBJECT>Photography and recording.</SUBJECT>
                                <SECTNO>139.70</SECTNO>
                                <SUBJECT>Vehicle operation and removal.</SUBJECT>
                                <SECTNO>139.75</SECTNO>
                                <SUBJECT>Firearms, dangerous weapons, and explosives</SUBJECT>
                                <SECTNO>139.80</SECTNO>
                                <SUBJECT>Animals.</SUBJECT>
                                <SECTNO>139.85</SECTNO>
                                <SUBJECT>Penalties.</SUBJECT>
                            </SUBPART>
                        </CONTENTS>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P> 6 U.S.C. 203(3) and 232(a); 40 U.S.C. 586(c) and 1315.</P>
                        </AUTH>
                    </PART>
                    <PART>
                        <HD SOURCE="HED">PART 139—CONDUCT ON FEDERAL PROPERTY</HD>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—General</HD>
                            <SECTION>
                                <SECTNO>§ 139.1</SECTNO>
                                <SUBJECT>Purpose.</SUBJECT>
                                <P>The regulations in this part provide for the protection and administration of the buildings, grounds, and property or portions thereof that are owned, occupied, or secured by the federal Government (including any agency, instrumentality, or wholly owned or mixed-ownership corporation thereof) and the persons on the property.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.5</SECTNO>
                                <SUBJECT>Scope, applicability, and agency cooperation.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Scope.</E>
                                     This part applies to all federal property under the protection responsibility of the Secretary of Homeland Security and all persons on such property, as well as areas outside such federal property to the extent necessary to protect the property and persons on the property.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Applicability.</E>
                                     This part shall not be construed to nullify any other federal, state, or local laws or regulations applicable to any area in which federal property is situated; preclude or limit the authority of any federal law enforcement agency; or restrict the authority of the Administrator of General Services or other federal government entity to promulgate regulations affecting property under its jurisdiction, custody, or control.
                                </P>
                                <P>
                                    (c) 
                                    <E T="03">Cooperation.</E>
                                     Federal tenants must cooperate to the fullest extent possible with all applicable provisions set out in this part; promptly report all crimes and suspicious circumstances occurring on federal property first to the Federal Protective Service MegaCenter at 1-877-4FPS-411, and, as appropriate, the local responding law enforcement authority; provide training to employees regarding protection and responses to emergency situations; and make recommendations for improving the effectiveness of protection on federal property.
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Notice.</E>
                                     The Facility Security Committee or highest-ranking official of the sole federal agency occupant or a designee must ensure a Notice is posted in a conspicuous place at each federal facility under the protection responsibility of the Secretary of Homeland Security. The posted notice:
                                </P>
                                <P>(1) Shall be 11 inches by 14 inches;</P>
                                <P>(2) Shall describe the rules and regulations governing personal conduct contained in this part; and</P>
                                <P>
                                    (3) Shall be prescribed in accordance with directions provided by DHS and found on its website at: 
                                    <E T="03">https://www.dhs.gov/fps-visitors</E>
                                    .
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Effective Date.</E>
                                     The regulations in this part are effective [INSERT DATE SIX MONTHS AFTER PUBLICATION OF THE FINAL RULE IN THE 
                                    <E T="04">FEDERAL REGISTER</E>
                                    ].
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.10</SECTNO>
                                <SUBJECT>Assessments for protective services.</SUBJECT>
                                <P>The Secretary of Homeland Security is authorized to charge federal agencies under the Secretary's protection responsibility for security services provided by the Federal Protective Service.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.15</SECTNO>
                                <SUBJECT>Definitions.</SUBJECT>
                                <P>For purposes of this part—</P>
                                <P>
                                    <E T="03">Aircraft</E>
                                     means any contrivance invented, used, or designed to navigate, or fly in, the air.
                                </P>
                                <P>
                                    <E T="03">Audio recording</E>
                                     means the use of any microphone, device, material, or equipment to capture a sound, including any tape recorder, digital recorder, or other recording device.
                                </P>
                                <P>
                                    <E T="03">Building</E>
                                     means an enclosed structure (above or below grade).
                                </P>
                                <P>
                                    <E T="03">Building Manager/Property Manager/Facility Manager</E>
                                     means the individual employed by or through contract with a federal agency that has real property management and operations authority.
                                </P>
                                <P>
                                    <E T="03">Camping</E>
                                     means the use of federal property for living accommodation purposes. The following activities constitute camping when it reasonably appears, based on the totality of the circumstances, that the participant, in conducting these activities, is in fact using the area as a living accommodation: sleeping or preparing to sleep, including the laying down of bedding for the purpose of sleeping; storing personal belongings; making any fire; using a tent, shelter, other structure, or vehicle for sleeping; doing any digging or earth breaking; or carrying on cooking activities.
                                </P>
                                <P>
                                    <E T="03">Commercial purpose</E>
                                     means to undertake an activity with the objective of furthering, promoting, or selling a good or service regardless of whether the activity is intended to produce a profit.
                                </P>
                                <P>
                                    <E T="03">Crime of violence</E>
                                     means any offense that has as an element the use, attempted use, or threatened use of physical force against the person or property of another.
                                </P>
                                <P>
                                    <E T="03">Damaging</E>
                                     means injuring, mutilating, defacing, destroying, or impairing the use of any property owned, occupied, or secured by the federal government without the consent of the federal government.
                                </P>
                                <P>
                                    <E T="03">Dangerous weapon</E>
                                     means a weapon, device, instrument, material, or substance, animate or inanimate, that is used for, or is readily capable of causing, death or serious bodily injury, except that a pocketknife with a blade of less than two and a half inches in length is not a dangerous weapon.
                                </P>
                                <P>
                                    <E T="03">Designated official</E>
                                     is the highest-ranking official of the primary federal occupant agency of a federal facility, or, alternatively, a designee selected by agreement of federal occupant agency officials.
                                </P>
                                <P>
                                    <E T="03">Emergency</E>
                                     means a situation that causes or has the potential to cause imminent danger to life or property, including, but not limited to, terrorist attacks, bombings and bomb threats, shootings, civil disturbances, fires, explosions, electrical failures, loss of water pressure or other critical infrastructure failures, chemical and gas leaks, medical emergencies, natural disasters, or other threats to public safety and security.
                                </P>
                                <P>
                                    <E T="03">Facility Security Committee</E>
                                     means a group of representatives from federal tenants in the facility responsible for addressing facility-specific security issues and approving the implementation of security measures and practices. The Facility Security Committee (FSC) consists of representatives of all federal tenants in the facility, the federal Protective Service or the Government agency or internal agency component responsible for physical security for the specific facility, and the owning or leasing department or agency with jurisdiction, custody, or control over the property. In the case of new construction or pending lease actions, the FSC will also include the project team and the planned tenant(s).
                                </P>
                                <P>
                                    <E T="03">Federal facility</E>
                                     means a federally owned or leased building, structure, or 
                                    <PRTPAGE P="4418"/>
                                    the land it resides on, in whole or in part, that is regularly occupied by Federal employees or Federal contractor workers for nonmilitary activities. The term “Federal facility” also means any building or structure acquired by a contractor through ownership or leasehold interest, in whole or in part, solely for the purpose of executing a nonmilitary Federal mission or function under the direction of an agency. The term “Federal facility” does not include public domain land, including improvements thereon; withdrawn lands; or buildings or facilities outside of the United States.
                                </P>
                                <P>
                                    <E T="03">Federal Government</E>
                                     means the United States Government, including any agency, instrumentality, or wholly owned or mixed-ownership corporation thereof.
                                </P>
                                <P>
                                    <E T="03">Federal grounds</E>
                                     mean all parts outside a federal facility (
                                    <E T="03">e.g.,</E>
                                     lands, walkways, and roadways) that are owned, occupied, or secured by the federal Government.
                                </P>
                                <P>
                                    <E T="03">Federal property</E>
                                     means any facility, grounds, or other property, to include vehicles, equipment, and any movable article, that is owned, occupied, or secured by the federal Government and under the protection responsibility of the Secretary of Homeland Security.
                                </P>
                                <P>
                                    <E T="03">Federal tenant</E>
                                     means a federal department or agency that occupies space and pays rent on space in any federal facility under the protection responsibility of the Secretary of Homeland Security.
                                </P>
                                <P>
                                    <E T="03">Gambling per se</E>
                                     means a game of chance where the participant risks something of value for the chance to gain or win a prize.
                                </P>
                                <P>
                                    <E T="03">Image recording</E>
                                     means use of any camera, device, material, or equipment to capture an image, including any photograph, sketch, picture, drawing, map, or graphical representation.
                                </P>
                                <P>
                                    <E T="03">Labor organization</E>
                                     means an organization composed in whole or in part of employees, in which employees participate and pay dues, and which has as a purpose the dealing with an agency concerning grievances and conditions of employment, but does not include—an organization that, by its constitution, bylaws, tacit agreement among its members, or otherwise, denies membership because of race, color, creed, national origin, sex, age, preferential or non-preferential civil service status, political affiliation, marital status, or handicapping condition; an organization that advocates the overthrow of the constitutional form of government of the United States; an organization sponsored by an agency; or an organization that participates in the conduct of a strike against the Government or any agency thereof or imposes a duty or obligation to conduct, assist, or participate in such a strike.
                                </P>
                                <P>
                                    <E T="03">Littering</E>
                                     means discarding wastepaper, cans, bottles, or other refuse or rubbish on the ground or in any other area not designated for disposal.
                                </P>
                                <P>
                                    <E T="03">Nuisance</E>
                                     means a condition, activity, or situation, to include a loud noise or foul odor, that interferes with the use or enjoyment of federal property.
                                </P>
                                <P>
                                    <E T="03">Open container</E>
                                     means a bottle, can, or any other receptacle containing an alcoholic beverage that is open, has a broken seal, or from which the contents are partially removed.
                                </P>
                                <P>
                                    <E T="03">Personal property</E>
                                     means any article or item, including but not limited to outer clothing, purses, backpacks, briefcases, suitcases, packages, and other containers within the possession, custody, or control of a person.
                                </P>
                                <P>
                                    <E T="03">Personal transportation device</E>
                                     means any method of conveyance, whether motorized or non-motorized, including but not limited to any personal transportation vehicle, skateboards, roller skates (including inline skates), roller shoes, roller skis, scooters, bicycles, non-medical use personal transporters, and similar devices or vehicles.
                                </P>
                                <P>
                                    <E T="03">Protective Security Officer</E>
                                     means a security guard employed by a private security contractor who provides contract security services to the Federal Protective Service (FPS). The contract security services provided by a Protective Security Officer include, but are not limited to, the performance of security screenings and inspections of persons, personal property, and vehicles entering federal property; confronting individuals who have violated or are suspected of violating building rules and regulations; and reporting all such security-related information to FPS.
                                </P>
                                <P>
                                    <E T="03">Public area</E>
                                     means any part or section on federal property that is ordinarily open to members of the public.
                                </P>
                                <P>
                                    <E T="03">Secretary</E>
                                     means the Secretary of the Department of Homeland Security or any person, officer, or entity within the Department to whom the Secretary's authority under 40 U.S.C. 1315 is delegated.
                                </P>
                                <P>
                                    <E T="03">Secure area</E>
                                     means any part or section on federal property marked by signage where persons present themselves to enter the property and submit to the security inspection and screening process.
                                </P>
                                <P>
                                    <E T="03">Security personnel</E>
                                     means persons authorized to ensure compliance with this Part, including FPS law enforcement officers, protective security officers, court security officers, or other security personnel charged by the federal Government with security duties under this Part such as other DHS component armed security guards performing similar duties as contract PSOs.
                                </P>
                                <P>
                                    <E T="03">Service animal</E>
                                     means any dog that is individually trained to do work or perform tasks for the benefit of an individual with a disability, including a physical, sensory, psychiatric, intellectual, or other mental disability. Other species of animals, whether wild or domestic, trained or untrained, are not service animals for the purposes of this definition.
                                </P>
                                <P>
                                    <E T="03">Tobacco product</E>
                                     means any item made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Tobacco product does not mean any item specifically excluded by the Food, Drug, and Cosmetic Act, 21 U.S.C. 301 
                                    <E T="03">et seq.</E>
                                     [ add the devices listed in the preamble to this definition.]
                                </P>
                                <P>
                                    <E T="03">Unmanned Aircraft</E>
                                     means an aircraft that is operated without the possibility of direct human intervention from within or on the aircraft.
                                </P>
                                <P>
                                    <E T="03">Unmanned Aircraft System</E>
                                     means an unmanned aircraft and associated elements (including communication links and components that control the unmanned aircraft) that are required for the operator to operate safely and efficiently in the national airspace system.
                                </P>
                                <P>
                                    <E T="03">Vehicle</E>
                                     means any method of conveyance, whether motorized or non-motorized, including but not limited to any motorcycle, automobile, truck, tractor, bus, motorhome, agricultural machinery, construction equipment, and other similar vehicle, even if autonomously operated.
                                </P>
                                <P>
                                    <E T="03">Water Area</E>
                                     means any area where water is retained or collected such as a fountain, basin, pool, pond, septic or sewer, reservoir, or other manmade water feature maintained on federal property.
                                </P>
                            </SECTION>
                        </SUBPART>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart B—Personal Conduct Affecting Federal Property</HD>
                            <SECTION>
                                <SECTNO>§ 139.20</SECTNO>
                                <SUBJECT>Admissions and inspections related to federal property.</SUBJECT>
                                <P>
                                    When a Facility Security Committee (FSC) or the highest-ranking official of the sole federal agency occupant or designee requires inspections at a federal facility, then no person required to be screened may enter a secure area without submitting to the screening and inspection of that person and all accessible personal property or vehicles. 
                                    <PRTPAGE P="4419"/>
                                    Security personnel shall conduct inspections and screening as follows:
                                </P>
                                <P>(a) Security personnel shall inspect any person, article of personal property, or vehicle, when entering in or present on federal property, for firearms, explosives, dangerous weapons, and the component parts thereof.</P>
                                <P>(b) Once a person, article of personal property, or vehicle enters a secure area, the inspection process will not terminate until completed by security personnel.</P>
                                <P>(c) Security personnel may deny admission, remove, or take other appropriate law enforcement action with respect to any person, article of personal property, or vehicle that fails to comply with security procedures, delays or impairs the inspection process, or presents a threat to either security personnel or other persons in or on federal property.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.25</SECTNO>
                                <SUBJECT>Preservation of federal property.</SUBJECT>
                                <P>All persons are prohibited from the following conduct affecting federal property:</P>
                                <P>(a) Littering;</P>
                                <P>(b) Damaging or otherwise changing the appearance of federal property in any way except through authorized normal and customary use;</P>
                                <P>(c) Removing federal property without proper authority;</P>
                                <P>(d) Creating any hazard or threat of hazard on federal property to persons or things;</P>
                                <P>(e) Throwing articles of any kind from or at federal property;</P>
                                <P>(f) Climbing on any statue, fountain, or part of a federal facility, or any tree, shrub, or plant on federal property;</P>
                                <P>(g) Using, operating, parking, locking, or storing any vehicle or personal transportation device on federal property, except as either required by individuals with mobility impairments, or otherwise specifically allowed in designated areas.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.30</SECTNO>
                                <SUBJECT>Conformance with signs and directions.</SUBJECT>
                                <P>Any person on federal property must at all times comply with official signs of a prohibitory, regulatory, or directive nature and with the lawful direction of security personnel.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.35</SECTNO>
                                <SUBJECT>Prohibited conduct.</SUBJECT>
                                <P>All persons are prohibited from engaging in the following conduct, on federal property or in areas outside federal property, that affects, threatens, or endangers federal property or persons on the federal property—</P>
                                <P>(a) Disorderly conduct, which includes, but is not limited to, assaulting, fighting, harassing, intimidating, threatening or other violent behavior, lewd acts, or the inappropriate disposal of feces, urine, and other bodily fluids.</P>
                                <P>(b) Wearing a mask, hood, disguise, or device that conceals the identity of the wearer when attempting to avoid detection or identification while violating any federal, state, or local law, ordinance, or regulation.</P>
                                <P>(c) Creating a loud or unusual noise, noxious odor, or other nuisance.</P>
                                <P>(d) Obstructing the usual use, enjoyment, or access to federal property, including but not limited to use of entrances, exits, exterior areas, plazas, courtyards, foyers, lobbies, corridors, offices, elevators, escalators, stairways, parking areas, garages, loading docks, and areas on federal property designated as closed during an emergency.</P>
                                <P>(e) Impeding or disrupting the security inspection process administered by security personnel, the performance of official duties by federal employees, or the ability of the general public to obtain services provided by the federal Government.</P>
                                <P>(f) Threatening by any means, including but not limited to by mail, facsimile, telephone, or electronic communications, to commit any crime of violence.</P>
                                <P>(g) Bathing, wading, or swimming in or polluting any water area, except where authorized by the federal agency responsible for the property.</P>
                                <P>(h) Camping, except in designated areas and as expressly authorized by the Facility Security Committee, Designated Official, or federal agency responsible for the property.</P>
                                <P>(i) Trespassing, entering, or remaining in or upon areas of federal property closed to the public.</P>
                                <P>(j) Consuming a tobacco product in all interior space owned, rented, or leased by the federal Government, as well as all courtyards, terraces, and plazas within 25 feet of doorways and air intake ducts under the custody, control, or jurisdiction of the federal Government.</P>
                                <P>(k) Causing an unmanned aircraft to take off or land on federal property without express permission from the Facility Security Committee, Designated Official, or federal agency responsible for the property.</P>
                                <P>(l) Using an unmanned aircraft to cause interference, damage, destruction, harm, or a hazard to federal property or persons on the property.</P>
                                <P>(m) Tampering with, accessing, damaging, or interfering with the operation of a computer, digital network, industrial control system or Supervisory Control and Data Acquisition (SCADA) system without proper authorization.</P>
                                <P>(n) No person, except authorized security personnel or sworn law enforcement officers, may wear, display, present, or possess any indicia of law enforcement or security authority, to include any badge, insignia, emblem, identification card, uniform or part of a uniform, or any imitation thereof.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.40</SECTNO>
                                <SUBJECT>Gambling.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">General Rule.</E>
                                     Any person on federal property is prohibited from—
                                </P>
                                <P>(1) Participating in games for money or other personal property;</P>
                                <P>(2) Operating gambling devices;</P>
                                <P>(3) Conducting a lottery or pool; or</P>
                                <P>(4) Selling or purchasing gambling tickets.</P>
                                <P>
                                    (b) 
                                    <E T="03">Exceptions.</E>
                                     This provision is not intended to prohibit:
                                </P>
                                <P>
                                    (1) Vending or exchange of chances by licensed blind operators of vending facilities for any lottery set forth in a State law and authorized by section 2(a)(5) of the Randolph-Sheppard Act (20 U.S.C. 107 
                                    <E T="03">et seq.</E>
                                    ); and
                                </P>
                                <P>(2) Prize drawings for personal property at otherwise permitted functions on federal property, provided that the game or drawing does not constitute gambling per se.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.45</SECTNO>
                                <SUBJECT>Narcotics, other drugs, and drug paraphernalia.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Narcotics and Other Drugs.</E>
                                     Except when a patient uses a narcotic or drug as prescribed by a licensed health care provider in accordance with federal law, any person on federal property is prohibited from being under the influence of, using, possessing, or operating a vehicle while under the influence of any controlled substance as defined in 21 U.S.C. 802, 812, 841.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Drug Paraphernalia.</E>
                                     Any person on federal property is prohibited from possessing drug paraphernalia as defined in 21 U.S.C. 863.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.50</SECTNO>
                                <SUBJECT>Alcoholic beverages.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">General Rule.</E>
                                     Any person on federal property is prohibited from either consuming, or otherwise being under the influence of alcoholic beverages, possessing an open container of alcohol, or operating a vehicle while under the influence of alcohol.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Exception.</E>
                                     The head of the occupant agency for the designee in the space where the alcohol is to be served may grant a written exemption to the prohibition against the consumption of alcoholic beverages on federal property. A copy of any granted exemption must be provided to the building manager and the officials responsible for the security of the property before the event at which alcohol will be consumed is held.
                                </P>
                            </SECTION>
                            <SECTION>
                                <PRTPAGE P="4420"/>
                                <SECTNO>§ 139.55</SECTNO>
                                <SUBJECT>Soliciting, vending, and debt collection.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">General Rule.</E>
                                     Soliciting, begging, or demanding gifts, money, goods, or services on federal property is prohibited, unless otherwise provided in paragraph (b) of this section. Any person on federal property is specifically prohibited from:
                                </P>
                                <P>(1) Soliciting on behalf of:</P>
                                <P>(i) Charitable organizations.</P>
                                <P>(ii) Political campaigns.</P>
                                <P>(iii) Commercial enterprises.</P>
                                <P>(2) Vending merchandise of any kind.</P>
                                <P>(3) Displaying or distributing commercial advertising.</P>
                                <P>(4) Collecting private debts, including repossession of vehicles.</P>
                                <P>
                                    (b) 
                                    <E T="03">Exceptions.</E>
                                     The following activities are allowed:
                                </P>
                                <P>(1) Soliciting on behalf of charitable organizations as authorized by 5 CFR part 950, Solicitation of Federal Civilian and Uniformed Service Personnel for Contributions to Private Voluntary Organizations and sponsored or approved by the occupant agency.</P>
                                <P>(2) Posting concessions or personal notices by employees on authorized bulletin boards.</P>
                                <P>(3) Soliciting on behalf of labor organizations authorized by federal occupant agencies and/or labor organizations representing or seeking to represent contractors working in Federal Government facilities.</P>
                                <P>(4) Lessee, or its agents and employees, with respect to space leased for commercial, cultural, educational, or recreational use under 40 U.S.C. 581(h). Public areas of GSA-controlled property may be used for other activities in accordance with 41 CFR part 102-74, Subpart D, Occasional Use of Public Buildings.</P>
                                <P>(5) Collection of non-monetary items that are sponsored or approved by the federal occupant agencies.</P>
                                <P>(6) Commercial activities sponsored by recognized federal employee associations and on-site childcare centers.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.60</SECTNO>
                                <SUBJECT>Posting and distributing materials.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">General Rule.</E>
                                     Any person on federal property is prohibited from the following activities:
                                </P>
                                <P>(1) Posting or affixing materials, such as pamphlets, handbills, or flyers on federal property, including vehicles, bulletin boards, and other equipment.</P>
                                <P>(2) Distributing materials, such as pamphlets, handbills or flyers, or free samples, including samples of tobacco products.</P>
                                <P>
                                    (b) 
                                    <E T="03">Exceptions.</E>
                                     (1) The posting or distribution of materials is allowed when conducted as part of an authorized federal activity.
                                </P>
                                <P>(2) An individual may distribute materials in public areas on federal property, provided the person first obtains a permit from the building manager, as specified in 42 CFR 102.74 subpart D, and the person does not leave behind any of the materials.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.65</SECTNO>
                                <SUBJECT>Photography and recording.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">General.</E>
                                     Any person on federal property may not photograph or create video, image, or audio recordings of federal facilities and grounds in a manner that either impedes or disrupts access to or operations on federal property, or is prohibited by a security regulation, rule, order, or directive. Photography and recording on federal property are allowed as provided paragraph (b) of this section.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Exceptions.</E>
                                     The following activities are allowed:
                                </P>
                                <P>(1) Any person, including persons affiliated with the media and commercial entities, may photograph or record video, images, and audio of publicly accessible exterior areas of federal facilities and grounds from public areas, including public streets, sidewalks, parks, and plazas, when not impeding or disrupting access to or operations on the federal property.</P>
                                <P>(2) Any person, including persons affiliated with the media and commercial entities, may photograph or record video, images, and audio of publicly accessible interior areas of federal facilities and grounds from public areas, including public entrances, lobbies, foyers, corridors, or auditoriums, when not impeding or disrupting access to or operations on the federal property.</P>
                                <P>(3) Any person, including persons affiliated with the media and commercial entities, may only photograph or record video, images, and audio of interior areas occupied by a federal tenant with the express permission of the occupying tenant. Persons must obtain written permission in advance from the occupying tenant when photographing or recording tenant-occupied space for a commercial purpose.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.70</SECTNO>
                                <SUBJECT>Vehicle operation and removal.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Safe operation.</E>
                                     All vehicle operators on federal property must:
                                </P>
                                <P>(1) Drive/operate in a careful and safe manner at all times;</P>
                                <P>(2) Possess a valid driver's/operator's license;</P>
                                <P>(3) Comply with the lawful signals and directions of security personnel; and</P>
                                <P>(4) Comply with traffic and safety signals and posted signs.</P>
                                <P>
                                    (b) 
                                    <E T="03">Prohibited operations.</E>
                                     All vehicle operators on federal property or in areas outside federal property that affect, threaten, or endanger federal property or persons on the property, are prohibited from:
                                </P>
                                <P>(1) Blocking entrances, driveways, walks, loading platforms, fire hydrants, docking areas, or other passageways; and</P>
                                <P>(2) Parking on or adjacent to federal property in unauthorized locations, or contrary to the direction of posted signs consistent with 41 CFR 102-74.265-102-74.310.</P>
                                <P>
                                    (c) 
                                    <E T="03">Responsibility.</E>
                                     Registered vehicle owners will be responsible for violations of this regulation when the vehicle operator is not present.
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Enforcement.</E>
                                     Security personnel may stop any vehicle that is observed operating on federal property in violation of this section.
                                </P>
                                <P>
                                    (e) 
                                    <E T="03">Removal and Seizure.</E>
                                     Any vehicle used in violation of these regulations may be seized, removed, immobilized, towed, stored, marked with warning tags or notices, and booted in addition to any law enforcement actions or citations. All expenses incurred because of any seizure, removal, immobilization, towing, storage, marking, booting, or other law enforcement actions will be the responsibility of the owner, driver, operator, or other person using or operating the vehicle that is in violation of these regulations.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.75</SECTNO>
                                <SUBJECT>Firearms, dangerous weapons, and explosives.</SUBJECT>
                                <P>(a) Any person on federal property is prohibited from knowingly carrying or otherwise possessing a firearm or other dangerous weapon, as defined by 18 U.S.C. 921 and 930, whether carried or otherwise possessed either openly or concealed, unless authorized by 18 U.S.C. 930(d).</P>
                                <P>(b) Any person on federal property is prohibited from knowingly carrying or otherwise possessing explosives, as defined by 18 U.S.C. 841, or items intended to be used to fabricate an explosive or incendiary device, whether carried or otherwise possessed either openly or concealed, except for official purposes as authorized by the Facility Security Committee, Designated Official, FPS, or other primary law enforcement agency responsible for the security of the federal property.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.80</SECTNO>
                                <SUBJECT>Animals.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">General Rule.</E>
                                     All persons are prohibited from bringing animals in or on federal property for other than official purposes.
                                </P>
                                <P>
                                    (b) 
                                    <E T="03">Exception.</E>
                                     Persons with disabilities, as defined under the Americans with Disabilities Act of 1990, may bring a service animal that is 
                                    <PRTPAGE P="4421"/>
                                    trained to do work or perform tasks for the benefit of that individual. The work or tasks performed by a service animal must be directly related to the individual's disability. Examples of work or tasks include, but are not limited to, assisting individuals who are blind or have low vision with navigation and other tasks, alerting individuals who are deaf or hard of hearing to the presence of people or sounds, providing non-violent protection or rescue work, pulling a wheelchair, assisting an individual during a seizure, alerting individuals to the presence of allergens, retrieving items such as medicine or the telephone, providing physical support and assistance with balance and stability to individuals with mobility disabilities, and helping persons with psychiatric and neurological disabilities by preventing or interrupting impulsive or destructive behaviors. The crime deterrent effects of an animal's presence and the provision of emotional support, well-being, comfort, or companionship do not constitute work or tasks for purposes of this exception. Persons with disabilities may be required to state whether the animal is a service animal required because of a disability.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 139.85</SECTNO>
                                <SUBJECT>Penalties.</SUBJECT>
                                <P>A person who violates any provision of Subpart B of this Part may be punished by a fine under title 18, United States Code, imprisoned for not more than 30 days, or both.</P>
                            </SECTION>
                        </SUBPART>
                        <SIG>
                            <NAME>Alejandro Mayorkas,</NAME>
                            <TITLE>Secretary, Department of Homeland Security.</TITLE>
                        </SIG>
                    </PART>
                </SUPLINF>
                <FRDOC>[FR Doc. 2024-31206 Filed 1-10-25; 4:15 pm]</FRDOC>
                <BILCOD>BILLING CODE 9111-CC-P</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4423"/>
            <PARTNO>Part X</PARTNO>
            <AGENCY TYPE="P">Department of Health and Human Services</AGENCY>
            <CFR>45 CFR Parts 153, 155, 156, et al.</CFR>
            <TITLE>Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="4424"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                    <SUBAGY>Office of the Secretary</SUBAGY>
                    <CFR>45 CFR Parts 153, 155, 156, and 158</CFR>
                    <DEPDOC>[CMS-9888-F]</DEPDOC>
                    <RIN>RIN 0938-AV41</RIN>
                    <SUBJECT>Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Centers for Medicare &amp; Medicaid Services (CMS), Department of Health and Human Services (HHS).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2026 benefit year user fee rates for issuers that participate in the HHS-operated risk adjustment program and the 2026 benefit year user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes requirements related to modifications to the calculation of the Basic Health Program (BHP) payment; and changes to the Initial Validation Audit (IVA) sampling approach and Second Validation Audit (SVA) pairwise means test for HHS-RADV. It also addresses HHS' authority to engage in compliance reviews of and take enforcement action against lead agents of insurance agencies for violations of HHS' Exchange standards and requirements; HHS' system suspension authority to address noncompliance by agents and brokers; an optional fixed-dollar premium payment threshold; permissible plan-level adjustment to the index rate to account for cost-sharing reductions (CSRs); reconsideration standards for certification denials; changes to the approach for conducting Essential Community Provider (ECP) certification reviews; a policy to publicly share aggregated, summary-level Quality Improvement Strategy (QIS) information on an annual basis; and revisions to the medical loss ratio (MLR) reporting and rebate requirements for qualifying issuers that meet certain standards.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>These regulations are effective on January 15, 2025.</P>
                    </EFFDATE>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P/>
                        <P>Jeff Wu, (301) 492-4305, Rogelyn McLean, (301) 492-4229, Grace Bristol, (410) 786-8437, for general information.</P>
                        <P>Ayesha Anwar, (301) 492-4000 or Joshua Paul, (301) 492-4347 for matters related to HHS-operated risk adjustment.</P>
                        <P>Leanne Scott, (410) 786-1045 or Ayesha Anwar, (301) 492-4000 for matters related to HHS-operated risk adjustment data validation.</P>
                        <P>Preeti Juturu, (301) 450-3234 or Leanne Scott, (410) 786-1045, for matters related to user fees.</P>
                        <P>Lisa Cuozzo (410) 786-1746, for matters related to the single risk pool.</P>
                        <P>Brian Gubin, (410) 786-1659, for matters related to agent, broker, and web-broker guidelines.</P>
                        <P>Zarin Ahmed, (301) 492-4400, for matters related to enrollment of qualified individuals into QHPs and termination of Exchange enrollment or coverage for qualified individuals.</P>
                        <P>Christina Whitefield, (301) 492-4172, for matters related to the medical loss ratio program.</P>
                        <P>Preeti Hans, (301) 492-5144, for matters related to Quality Improvement Strategy.</P>
                        <P>Ken Buerger, (410) 786-1190, for matters related to certification standards for QHPs.</P>
                        <P>Nikolas Berkobien, (667) 290-9903, for matters related to standardized plan options, non-standardized plan option limits and exceptions, and financial requirements for issuers of QHPs on the FFEs.</P>
                        <P>Adelaide Balenger, (667) 414-0691, for matters related to the Actuarial Value Calculator.</P>
                        <P>Mary Evans, (470) 890-4113, for matters related to the Failure to File and Reconcile process.</P>
                        <P>Chris Truffer, (410) 786-1264, for matters related to the Basic Health Program (BHP) provision.</P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Executive Summary</FP>
                        <FP SOURCE="FP-2">II. Background</FP>
                        <FP SOURCE="FP1-2">A. Legislative and Regulatory Overview</FP>
                        <FP SOURCE="FP1-2">B. Summary of Major Provisions</FP>
                        <FP SOURCE="FP-2">III. Summary of the Provisions of the Proposed Regulations and Analysis of and Responses to Public Comments</FP>
                        <FP SOURCE="FP1-2">A. 42 CFR Part 600—BHP Methodology Regarding the Value of the Premium Adjustment Factor (PAF)</FP>
                        <FP SOURCE="FP1-2">B. 45 CFR Part 153—Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment</FP>
                        <FP SOURCE="FP1-2">C. 45 CFR Part 155—Exchange Establishment Standards and Other Related Standards Under the Affordable Care Act</FP>
                        <FP SOURCE="FP1-2">D. 45 CFR Part 156—Health Insurance Issuer Standards Under the Affordable Care Act, Including Standards Related to Exchanges</FP>
                        <FP SOURCE="FP1-2">E. 45 CFR Part 158—Issuer Use of Premium Revenue: Reporting and Rebate Requirements</FP>
                        <FP SOURCE="FP1-2">F. Severability</FP>
                        <FP SOURCE="FP-2">IV. Waiver of Delay in Effective Date</FP>
                        <FP SOURCE="FP-2">V. Collection of Information Requirements</FP>
                        <FP SOURCE="FP1-2">A. Wage Estimates</FP>
                        <FP SOURCE="FP1-2">B. ICRs Regarding the Initial Validation Audit (IVA) Sample—Enrollees Without HCCs, Removal of the FPC, and Neyman Allocation (§ 153.630(b))</FP>
                        <FP SOURCE="FP1-2">C. ICRs Regarding Engaging in Compliance Reviews and Taking Enforcement Actions Against Lead Agents for Insurance Agencies (§ 155.220)</FP>
                        <FP SOURCE="FP1-2">D. ICRs Regarding Agent and Broker System Suspension Authority (§ 155.220(k))</FP>
                        <FP SOURCE="FP1-2">E. ICRs Regarding Updating the Model Consent Form (§ 155.220)</FP>
                        <FP SOURCE="FP1-2">F. ICRs Regarding Notification of 2-Year Failure To File and Reconcile Population (§ 155.305)</FP>
                        <FP SOURCE="FP1-2">G. ICRs Regarding General Program Integrity and Oversight Requirements (§ 155.1200)</FP>
                        <FP SOURCE="FP1-2">H. ICRs Regarding Essential Community Provider Certification Reviews (§ 156.235)</FP>
                        <FP SOURCE="FP1-2">I. ICRs Regarding Quality Improvement Strategy Information (§ 156.1130)</FP>
                        <FP SOURCE="FP1-2">J. ICRs Regarding Medical Loss Ratio (§§ 158.103, 158.140, 158.240)</FP>
                        <FP SOURCE="FP1-2">K. Summary of Annual Burden Estimates for Finalized Requirements</FP>
                        <FP SOURCE="FP1-2">L. Submission of PRA-Related Comments</FP>
                        <FP SOURCE="FP-2">VI. Regulatory Impact Analysis</FP>
                        <FP SOURCE="FP1-2">A. Statement of Need</FP>
                        <FP SOURCE="FP1-2">B. Overall Impact</FP>
                        <FP SOURCE="FP1-2">C. Impact Estimates of the Payment Notice Provisions and Accounting Table</FP>
                        <FP SOURCE="FP1-2">D. Regulatory Alternatives Considered</FP>
                        <FP SOURCE="FP1-2">E. Regulatory Flexibility Act (RFA)</FP>
                        <FP SOURCE="FP1-2">F. Unfunded Mandates Reform Act (UMRA)</FP>
                        <FP SOURCE="FP1-2">G. Federalism</FP>
                        <FP SOURCE="FP1-2">H. Congressional Review Act</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Executive Summary</HD>
                    <P>
                        We are finalizing changes to the provisions and parameters implemented through prior rulemaking to implement the ACA.
                        <SU>1</SU>
                        <FTREF/>
                         These requirements are published under the authority granted to the Secretary by the ACA and the Public Health Service (PHS) Act.
                        <SU>2</SU>
                        <FTREF/>
                         In this final rule, we are finalizing changes related to some of the ACA provisions and parameters we previously 
                        <PRTPAGE P="4425"/>
                        implemented and are finalizing new provisions. Our goal with these requirements is to provide quality, affordable coverage to consumers while minimizing administrative burden and ensuring program integrity. The changes in this final rule are intended to help advance health equity, mitigate health disparities, and alleviate discrimination.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             The Patient Protection and Affordable Care Act (Pub. L. 111-148, 124 Stat. 119) was enacted on March 23, 2010. The Healthcare and Education Reconciliation Act of 2010 (Pub. L. 111-152, 124 Stat. 1049), which amended and revised several provisions of the Patient Protection and Affordable Care Act, was enacted on March 30, 2010. In this rulemaking, the two statutes are referred to collectively as the “Patient Protection and Affordable Care Act,” “Affordable Care Act,” or “ACA.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             See sections 1301, 1302, 1311, 1312, 1313, 1321, 1331, and 1343 of the ACA and sections 2718 and 2792 of the PHS Act.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">II. Background</HD>
                    <HD SOURCE="HD2">A. Legislative and Regulatory Overview</HD>
                    <P>Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) added a new title XXVII to the PHS Act to establish various reforms to the group and individual health insurance markets. These provisions of the PHS Act were later augmented by other laws, including the ACA. Subtitles A and C of title I of the ACA reorganized, amended, and added to the provisions of part A of title XXVII of the PHS Act relating to group health plans and health insurance issuers in the group and individual markets. The term “group health plan” includes both insured and self-insured group health plans.</P>
                    <P>Below, we summarize sections of the PHS Act and ACA that are relevant to this final rule.</P>
                    <P>Section 2718 of the PHS Act, as added by the ACA, generally requires health insurance issuers offering group or individual health insurance coverage to submit an annual medical loss ratio (MLR) report to HHS and provide rebates to enrollees if the issuers do not achieve specified MLR thresholds.</P>
                    <P>Section 1301(a)(1)(B) of the ACA directs all issuers of qualified health plans (QHPs) to cover the essential health benefits (EHB) package described in section 1302(a) of the ACA, including coverage of the services described in section 1302(b) of the ACA, adherence to the cost-sharing limits described in section 1302(c) of the ACA, and meeting the Actuarial Value (AV) levels established in section 1302(d) of the ACA. Section 2707(a) of the PHS Act, which is effective for plan or policy years beginning on or after January 1, 2014, extends the requirement to cover the EHB package to non-grandfathered individual and small group health insurance coverage, irrespective of whether such coverage is offered through an Exchange. In addition, section 2707(b) of the PHS Act directs non-grandfathered group health plans to ensure that cost sharing under the plan does not exceed the limitations described in section 1302(c)(1) of the ACA.</P>
                    <P>Section 1302 of the ACA provides for the establishment of an EHB package that includes coverage of EHBs (as defined by the Secretary of HHS), cost-sharing limits, and AV requirements. The law directs that EHBs be equal in scope to the benefits provided under a typical employer plan, and that they cover at least the following 10 general categories: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.</P>
                    <P>Sections 1302(b)(4)(A) through (D) of the ACA establish that the Secretary must define EHB in a manner that: (1) reflects appropriate balance among the 10 categories; (2) is not designed in such a way as to discriminate based on age, disability, or expected length of life; (3) takes into account the health care needs of diverse segments of the population; and (4) does not allow denials of EHBs based on age, life expectancy, disability, degree of medical dependency, or quality of life.</P>
                    <P>Section 1302(d) of the ACA describes the various levels of coverage based on AV. Consistent with section 1302(d)(2)(A) of the ACA, AV is calculated based on the provision of EHB to a standard population. Section 1302(d)(3) of the ACA directs the Secretary of HHS to develop guidelines that allow for de minimis variation in AV calculations.</P>
                    <P>Section 1311(c) of the ACA provides the Secretary the authority to issue regulations to establish criteria for the certification of QHPs. Section 1311(c)(1)(B) of the ACA requires, among the criteria for certification that the Secretary must establish by regulation, that QHPs ensure a sufficient choice of providers. Section 1311(d)(4)(A) of the ACA requires the Exchange to implement procedures for the certification, recertification, and decertification of health plans as QHPs, consistent with guidelines developed by the Secretary under section 1311(c) of the ACA. Section 1311(e)(1) of the ACA grants the Exchange the authority to certify a health plan as a QHP if the health plan meets the Secretary's requirements for certification issued under section 1311(c) of the ACA, and the Exchange determines that making the plan available through the Exchange is in the interests of qualified individuals and qualified employers in the State. Section 1311(c)(6)(C) of the ACA directs the Secretary of HHS to require an Exchange to provide for special enrollment periods and section 1311(c)(6)(D) of the ACA directs the Secretary of HHS to require an Exchange to provide for a monthly enrollment period for Indians, as defined by section 4 of the Indian Health Care Improvement Act.</P>
                    <P>Section 1311(d)(3)(B) of the ACA permits a State, at its option, to require QHPs to cover benefits in addition to EHB. This section also requires a State to make payments, either to the individual enrollee or to the issuer on behalf of the enrollee, to defray the cost of these additional State-required benefits.</P>
                    <P>Section 1312(c) of the ACA generally requires a health insurance issuer to consider all enrollees in all health plans (except grandfathered health plans) offered by such issuer to be members of a single risk pool for each of its individual and small group markets. States have the option to merge the individual and small group market risk pools under section 1312(c)(3) of the ACA.</P>
                    <P>Section 1312(e) of the ACA provides the Secretary with the authority to establish procedures under which a State may allow agents or brokers to (1) enroll qualified individuals and qualified employers in QHPs offered through Exchanges and (2) assist individuals in applying for advance payments of the premium tax credit (APTC) and CSRs for QHPs sold through an Exchange.</P>
                    <P>Section 1312(f)(1)(B) of the ACA provides that an individual shall not be treated as a qualified individual for enrollment in a QHP if, at the time of enrollment, the individual is incarcerated, other than incarceration pending the disposition of charges.</P>
                    <P>Sections 1313 and 1321 of the ACA provide the Secretary with the authority to oversee the financial integrity of State Exchanges, their compliance with HHS standards, and the efficient and non-discriminatory administration of State Exchange activities. Section 1313(a)(5)(A) of the ACA provides the Secretary with the authority to implement any measure or procedure that the Secretary determines is appropriate to reduce fraud and abuse in the administration of the Exchanges. Section 1321 of the ACA provides for State flexibility in the operation and enforcement of Exchanges and related requirements.</P>
                    <P>
                        Section 1321(a) of the ACA provides broad authority for the Secretary to establish standards and regulations to implement the statutory requirements related to Exchanges, QHPs and other components of title I of the ACA, 
                        <PRTPAGE P="4426"/>
                        including such other requirements as the Secretary determines appropriate. When operating an FFE under section 1321(c)(1) of the ACA, HHS has the authority under sections 1321(c)(1) and 1311(d)(5)(A) of the ACA to collect and spend user fees. Office of Management and Budget (OMB) Circular A-25 Revised establishes Federal policy regarding user fees and specifies that a user charge will be assessed against each identifiable recipient for special benefits derived from Federal activities beyond those received by the public.
                    </P>
                    <P>Section 1321(d) of the ACA provides that nothing in title I of the ACA must be construed to preempt any State law that does not prevent the application of title I of the ACA. Section 1311(k) of the ACA specifies that Exchanges may not establish rules that conflict with or prevent the application of regulations issued by the Secretary.</P>
                    <P>Section 1331 of the ACA provides States with an option to establish a Basic Health Program (BHP). In the States that elect to operate a BHP, the BHP makes affordable health benefits coverage available for individuals under age 65 with household incomes between 133 percent and 200 percent of the Federal poverty level (FPL) who are not otherwise eligible for Medicaid, the Children's Health Insurance Program (CHIP), or affordable employer-sponsored coverage, or for individuals whose income is equal to or below 200 percent of FPL but are lawfully present non-citizens ineligible for Medicaid. For those States that have expanded Medicaid coverage under section 1902(a)(10)(A)(i)(VIII) of the Social Security Act (the Act), the lower income threshold for BHP eligibility is effectively 138 percent of the FPL due to the application of a required 5 percent income disregard in determining the upper limits of Medicaid income eligibility (section 1902(e)(14)(I) of the Act).</P>
                    <P>
                        Section 1343 of the ACA establishes a permanent risk adjustment program to provide payments to health insurance issuers that attract higher-than-average risk populations, such as those with chronic conditions, funded by charges collected from those issuers that attract lower-than-average risk populations, thereby reducing incentives for issuers to avoid higher-risk enrollees. Section 1343(b) of the ACA provides that the Secretary, in consultation with States, shall establish criteria and methods to be used in carrying out the risk adjustment activities under this section. Consistent with section 1321(c) of the ACA, the Secretary is responsible for operating the HHS risk adjustment program in any State that fails to do so.
                        <SU>3</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             In the 2014 through 2016 benefit years, HHS operated the risk adjustment program in every State and the District of Columbia, except Massachusetts. Beginning with the 2017 benefit year, HHS has operated the risk adjustment program in all 50 States and the District of Columbia.
                        </P>
                    </FTNT>
                    <P>Section 1401(a) of the ACA added section 36B to the Internal Revenue Code (the Code), which, among other things, requires that a taxpayer reconcile APTC for a year of coverage with the amount of the premium tax credit (PTC) the taxpayer is allowed for the year.</P>
                    <P>Section 1402 of the ACA provides for, among other things, reductions in cost sharing for EHB for qualified low- and moderate-income enrollees in silver level QHPs offered through the individual market Exchanges. This section also provides for reductions in cost sharing for Indians enrolled in QHPs at any metal level.</P>
                    <P>Section 1411(f) of the ACA requires the Secretary, in consultation with the Secretary of the Treasury and the Secretary of Homeland Security, and the Commissioner of Social Security, to establish procedures for hearing and making decisions governing appeals of Exchange eligibility determinations. Section 1411(f)(1)(B) of the ACA requires the Secretary to establish procedures to redetermine eligibility on a periodic basis, in appropriate circumstances, including eligibility to purchase a QHP through the Exchange and for APTC and CSRs.</P>
                    <P>Section 1411(g) of the ACA allows the use of applicant information only for the limited purpose of, and to the extent necessary for, ensuring the efficient operation of the Exchange, including by verifying eligibility to enroll through the Exchange and for APTC and CSRs, and limits the disclosure of such information.</P>
                    <P>Section 1413 of the ACA directs the Secretary to establish, subject to minimum requirements, a streamlined enrollment process for enrollment in QHPs and all insurance affordability programs.</P>
                    <P>Section 5000A of the Code, as added by section 1501(b) of the ACA, requires individuals to have minimum essential coverage (MEC) for each month, qualify for an exemption, or make an individual shared responsibility payment. Under the Tax Cuts and Jobs Act, which was enacted on December 22, 2017, the individual shared responsibility payment is reduced to $0, effective for months beginning after December 31, 2018. Notwithstanding that reduction, certain exemptions are still relevant to determine whether individuals aged 30 and above qualify to enroll in catastrophic coverage under §§ 155.305(h) and 156.155(a)(5).</P>
                    <P>Section 1902(r)(2)(A) of the Act permits States to apply less restrictive methodologies than cash assistance program methodologies in determining eligibility for certain eligibility groups.</P>
                    <HD SOURCE="HD3">1. Premium Stabilization Programs</HD>
                    <P>
                        The premium stabilization programs refer to the risk adjustment, risk corridors, and reinsurance programs established by the ACA.
                        <SU>4</SU>
                        <FTREF/>
                         For past rulemaking, we refer readers to the following rules:
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             See section 1341 of the ACA (transitional reinsurance program), section 1342 of the ACA (risk corridors program), and section 1343 of the ACA (risk adjustment program).
                        </P>
                    </FTNT>
                    <P>
                        • In the March 23, 2012 
                        <E T="04">Federal Register</E>
                         (77 FR 17219) (Premium Stabilization Rule), we implemented the premium stabilization programs.
                    </P>
                    <P>
                        • In the March 11, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 15409) (2014 Payment Notice), we finalized the benefit and payment parameters for the 2014 benefit year to expand the provisions related to the premium stabilization programs and set forth payment parameters in those programs.
                    </P>
                    <P>
                        • In the October 30, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 65046), we finalized the modification to the HHS risk adjustment methodology related to community rating States.
                    </P>
                    <P>
                        • In the November 6, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 66653), we issued a correcting amendment to the 2014 Payment Notice to address how an enrollee's age for the risk score calculation would be determined under the HHS risk adjustment methodology.
                    </P>
                    <P>
                        • In the March 11, 2014 
                        <E T="04">Federal Register</E>
                         (79 FR 13743) (2015 Payment Notice), we finalized the benefit and payment parameters for the 2015 benefit year to expand the provisions related to the premium stabilization programs, set forth certain oversight provisions, and establish payment parameters in those programs.
                    </P>
                    <P>
                        • In the May 27, 2014 
                        <E T="04">Federal Register</E>
                         (79 FR 30240), we announced the fiscal year 2015 sequestration rate for the HHS-operated risk adjustment program.
                    </P>
                    <P>
                        • In the February 27, 2015 
                        <E T="04">Federal Register</E>
                         (80 FR 10749) (2016 Payment Notice), we finalized the benefit and payment parameters for the 2016 benefit year to expand the provisions related to the premium stabilization programs, set forth certain oversight provisions, and establish the payment parameters in those programs.
                    </P>
                    <P>
                        • In the March 8, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 12203) (2017 Payment 
                        <PRTPAGE P="4427"/>
                        Notice), we finalized the benefit and payment parameters for the 2017 benefit year to expand the provisions related to the premium stabilization programs, set forth certain oversight provisions, and establish the payment parameters in those programs.
                    </P>
                    <P>
                        • In the December 22, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 94058) (2018 Payment Notice), we finalized the benefit and payment parameters for the 2018 benefit year, added the high-cost risk pool parameters to the HHS risk adjustment methodology, incorporated prescription drug factors in the adult models, established enrollment duration factors for the adult models, and finalized policies related to the collection and use of enrollee-level External Data Gathering Environment (EDGE) data.
                    </P>
                    <P>
                        • In the April 17, 2018 
                        <E T="04">Federal Register</E>
                         (83 FR 16930) (2019 Payment Notice), we finalized the benefit and payment parameters for the 2019 benefit year, created the State flexibility framework permitting States to request a reduction in risk adjustment State transfers calculated by HHS, and adopted a new error rate methodology for HHS-RADV adjustments to transfers.
                    </P>
                    <P>
                        • In the May 11, 2018 
                        <E T="04">Federal Register</E>
                         (83 FR 21925), we issued a correction to the 2019 HHS risk adjustment coefficients in the 2019 Payment Notice.
                    </P>
                    <P>
                        • On July 27, 2018, consistent with 45 CFR 153.320(b)(1)(i), we updated the 2019 benefit year final HHS risk adjustment model coefficients to reflect an additional recalibration related to an update to the 2016 enrollee-level EDGE data set.
                        <SU>5</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             CMS. (2018). 
                            <E T="03">Updated 2019 Benefit Year Final HHS Risk Adjustment Model Coefficients. https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/2019-Updtd-Final-HHS-RA-Model-Coefficients.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • In the July 30, 2018 
                        <E T="04">Federal Register</E>
                         (83 FR 36456), we adopted the 2017 benefit year HHS risk adjustment methodology as established in the final rules issued in the March 23, 2012 (77 FR 17220 through 17252) and March 8, 2016 (81 FR 12204 through 12352) editions of the 
                        <E T="04">Federal Register</E>
                        . The final rule set forth an additional explanation of the rationale supporting the use of Statewide average premium in the State payment transfer formula for the 2017 benefit year, including the reasons why the program is operated by HHS in a budget-neutral manner. The final rule also permitted HHS to resume 2017 benefit year HHS risk adjustment payments and charges. HHS also provided guidance as to the operation of the HHS-operated risk adjustment program for the 2017 benefit year in light of the publication of the final rule.
                    </P>
                    <P>
                        • In the December 10, 2018 
                        <E T="04">Federal Register</E>
                         (83 FR 63419), we adopted the 2018 benefit year HHS risk adjustment methodology as established in the final rules issued in the March 23, 2012 (77 FR 17219) and the December 22, 2016 (81 FR 94058) editions of the 
                        <E T="04">Federal Register</E>
                        . In the rule, we set forth an additional explanation of the rationale supporting the use of Statewide average premium in the State payment transfer formula for the 2018 benefit year, including the reasons why the program is operated by HHS in a budget-neutral manner.
                    </P>
                    <P>
                        • In the April 25, 2019 
                        <E T="04">Federal Register</E>
                         (84 FR 17454) (2020 Payment Notice), we finalized the benefit and payment parameters for the 2020 benefit year, as well as the policies related to making the enrollee-level EDGE data available as a limited data set for research purposes and expanding the HHS uses of the enrollee-level EDGE data, approval of the request from Alabama to reduce HHS risk adjustment transfers by 50 percent in the small group market for the 2020 benefit year, and updates to HHS-RADV program requirements.
                    </P>
                    <P>
                        • On May 12, 2020, consistent with § 153.320(b)(1)(i), we issued the 2021 Benefit Year Final HHS Risk Adjustment Model Coefficients on the CCIIO website.
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             CMS. (2020). Final 2021 Benefit Year Final HHS Risk Adjustment Model Coefficients. 
                            <E T="03">https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Final-2021-Benefit-Year-Final-HHS-Risk-Adjustment-Model-Coefficients.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • In the May 14, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 29164) (2021 Payment Notice), we finalized the benefit and payment parameters for the 2021 benefit year, as well as adopted updates to the HHS risk adjustment models' hierarchical condition categories (HCCs) to transition to the 10th revision of the International Classification of Diseases (ICD-10) codes, approved the request from Alabama to reduce HHS risk adjustment transfers by 50 percent in the small group market for the 2021 benefit year, and modified the outlier identification process under the HHS-RADV program.
                    </P>
                    <P>
                        • In the December 1, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 76979) (Amendments to the HHS-Operated Risk Adjustment Data Validation Under the Patient Protection and Affordable Care Act's HHS-Operated Risk Adjustment Program (2020 HHS-RADV Amendments Rule)), we adopted the creation and application of Super HCCs in the sorting step that assigns HCCs to failure rate groups, finalized a sliding scale adjustment in HHS-RADV error rate calculation, and added a constraint for negative error rate outliers with a negative error rate. We also established a transition from the prospective application of HHS-RADV adjustments to apply HHS-RADV results to risk scores from the same benefit year as that being audited.
                    </P>
                    <P>
                        • In the September 2, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 54820), we issued an interim final rule containing certain policy and regulatory revisions in response to the COVID-19 public health emergency (PHE), wherein we set forth HHS risk adjustment reporting requirements for issuers offering temporary premium credits in the 2020 benefit year.
                    </P>
                    <P>
                        • In the May 5, 2021 
                        <E T="04">Federal Register</E>
                         (86 FR 24140) (part 2 of the 2022 Payment Notice), we finalized a subset of proposals from the December 4, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 78572) (the 2022 Payment Notice proposed rule), including policy and regulatory revisions related to the HHS-operated risk adjustment program, finalization of the benefit and payment parameters for the 2022 benefit year, and approval of the request from Alabama to reduce HHS risk adjustment transfers by 50 percent in the individual and small group markets for the 2022 benefit year. In addition, this final rule established a revised schedule of collections for HHS-RADV and updated the provisions regulating second validation audit (SVA) and initial validation audit (IVA) entities.
                    </P>
                    <P>
                        • On July 19, 2021, consistent with § 153.320(b)(1)(i), we released Updated 2022 Benefit Year Final HHS Risk Adjustment Model Coefficients on the CCIIO website, announcing some minor revisions to the 2022 benefit year final HHS risk adjustment adult model coefficients.
                        <SU>7</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             CMS. (2021). 2022 Benefit Year Final HHS Risk Adjustment Model Coefficients. 
                            <E T="03">https://www.cms.gov/files/document/updated-2022-benefit-year-final-hhs-risk-adjustment-model-coefficients-clean-version-508.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • In the May 6, 2022 
                        <E T="04">Federal Register</E>
                         (87 FR 27208) (2023 Payment Notice), we finalized revisions related to the HHS-operated risk adjustment program, including the benefit and payment parameters for the 2023 benefit year, HHS risk adjustment model recalibration, and policies related to the collection and extraction of enrollee-level EDGE data. We also finalized the adoption of the interacted HCC count specification for the adult and child models, along with modified enrollment duration factors for the adult models, beginning with the 2023 benefit year.
                        <FTREF/>
                        <SU>8</SU>
                          
                        <PRTPAGE P="4428"/>
                        We also repealed the ability for States, other than prior participants, to request a reduction in HHS risk adjustment State transfers starting with the 2024 benefit year. In addition, we approved a 25 percent reduction to 2023 benefit year HHS risk adjustment transfers in Alabama's individual market and a 10 percent reduction to 2023 benefit year HHS risk adjustment transfers in Alabama's small group market. We also finalized further refinements to the HHS-RADV error rate calculation methodology beginning with the 2021 benefit year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             CMS (2022). 2023 Benefit Year Final HHS Risk Adjustment Model Coefficients. 
                            <E T="03">
                                https://
                                <PRTPAGE/>
                                www.cms.gov/files/document/2023-benefit-year-final-hhs-risk-adjustment-model-coefficients.pdf
                            </E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        • In the April 27, 2023 
                        <E T="04">Federal Register</E>
                         (88 FR 25740) (2024 Payment Notice), we finalized the benefit and payment parameters for the 2024 benefit year, amended the EDGE discrepancy materiality threshold and data collection requirements, and reduced the risk adjustment user fee. For the 2024 benefit year, we approved 50 percent reductions to HHS risk adjustment transfers for Alabama's individual and small group markets and repealed prior participant States' ability to request reductions of their risk adjustment transfers for the 2025 benefit year and beyond. We finalized several refinements to HHS-RADV program requirements, such as shortening the window to confirm SVA findings or file a discrepancy report, changing the HHS-RADV materiality threshold for random and targeted sampling, and no longer exempting exiting issuers from adjustments to risk scores and HHS risk adjustment transfers when they are negative error rate outliers. We also announced the discontinuance of the Lifelong Permanent Condition List (LLPC) and Non-EDGE Claims (NEC) in HHS-RADV beginning with the 2022 benefit year.
                    </P>
                    <P>
                        • In the April 15, 2024 
                        <E T="04">Federal Register</E>
                         (89 FR 26218) (2025 Payment Notice), we finalized the benefit and payment parameters for the 2025 benefit year, including the 2025 risk adjustment models and updated the adjustment factors for the receipt of CSRs for the American Indian and Alaska Native (AI/AN) subpopulation who are enrolled in zero and limited cost-sharing plans to improve prediction in the HHS risk adjustment models. In addition, we finalized that in certain cases, we may require a corrective action plan (CAP) to address an observation identified in an HHS risk adjustment program audit.
                    </P>
                    <HD SOURCE="HD3">2. Program Integrity</HD>
                    <P>
                        We have finalized program integrity standards related to the Exchanges and premium stabilization programs in two rules: the “first Program Integrity Rule” issued in the August 30, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 54069), and the “second Program Integrity Rule” issued in the October 30, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 65045). We also refer readers to the 2019 Patient Protection and Affordable Care Act; Exchange Program Integrity final rule (2019 Program Integrity Rule) issued in the December 27, 2019 
                        <E T="04">Federal Register</E>
                         (84 FR 71674).
                    </P>
                    <P>
                        In the April 27, 2023 
                        <E T="04">Federal Register</E>
                         (88 FR 25740) (2024 Payment Notice), we finalized a policy to implement improper payment pre-testing and assessment (IPPTA) requirements for State Exchanges to ensure adherence to the Payment Integrity Information Act of 2019. In addition, we finalized allowing additional time for HHS to review evidence submitted by agents and brokers to rebut allegations pertaining to Exchange Agreement suspensions or terminations. We also introduced consent and eligibility application documentation requirements for agents, brokers, and web-brokers that assist Exchange consumers in FFE and SBE-FP States.
                    </P>
                    <HD SOURCE="HD3">3. Market Rules</HD>
                    <P>
                        In the February 27, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 13406), we issued the health insurance market rules, including provisions related to the single risk pool. We amended requirements related to index rates under the single risk pool provision in a final rule issued in the July 2, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 39870). In the October 30, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 65046), we clarified when issuers may establish and update premium rates. In the March 8, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 12203), we clarified single risk pool provisions related to student health insurance coverage. We finalized minor adjustments to the single risk pool regulations in the 2018 Payment Notice, issued in the December 22, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 94058).
                    </P>
                    <HD SOURCE="HD3">4. Exchanges</HD>
                    <P>
                        We requested comment relating to Exchanges in the August 3, 2010 
                        <E T="04">Federal Register</E>
                         (75 FR 45584). We issued initial guidance to States on Exchanges on November 18, 2010. In the March 27, 2012 
                        <E T="04">Federal Register</E>
                         (77 FR 18310) (Exchange Establishment Rule), we implemented the Affordable Insurance Exchanges (Exchanges), consistent with title I of the ACA, to provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options based on price, quality, and other factors. This included implementation of components of the Exchanges and standards for eligibility for Exchanges, as well as network adequacy and ECP certification standards.
                    </P>
                    <P>
                        In the August 17, 2011 
                        <E T="04">Federal Register</E>
                         (76 FR 51201), we issued a proposed rule regarding eligibility determinations, including the regulatory requirement to verify incarceration status. In the March 27, 2012 
                        <E T="04">Federal Register</E>
                         (77 FR 18310), we finalized the regulatory requirement to verify incarceration attestation using an approved electronic data source that is current and accurate, and to resolve the inconsistency when attestations are not reasonably compatible with information in an approved data source. We also established requirements regarding accessible communications for individuals with disabilities and those with LEP.
                    </P>
                    <P>
                        In the 2014 Payment Notice and the Amendments to the HHS Notice of Benefit and Payment Parameters for 2014 interim final rule, issued in the March 11, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 15541), we set forth standards related to Exchange user fees. We established an adjustment to the FFE user fee in the Coverage of Certain Preventive Services under the Affordable Care Act final rule, issued in the July 2, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 39869) (Preventive Services Rule).
                    </P>
                    <P>
                        In the 2016 Payment Notice, we also set forth the ECP certification standard at § 156.235, with revisions in the 2017 Payment Notice in the March 8, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 12203) and the 2018 Payment Notice in the December 22, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 94058).
                    </P>
                    <P>
                        In the 2018 Payment Notice, issued in the December 22, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 94058), we set forth the standards for the request for reconsideration of denial of certification specific to the FFEs at § 155.1090.
                    </P>
                    <P>
                        In an interim final rule, issued in the May 11, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 29146), we made amendments to the parameters of certain special enrollment periods (2016 Interim Final Rule). We finalized these in the 2018 Payment Notice, issued in the December 22, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 94058).
                    </P>
                    <P>
                        In the Market Stabilization final rule, issued in the April 18, 2017 
                        <E T="04">Federal Register</E>
                         (82 FR 18346), we amended standards relating to special enrollment periods and QHP certification. In the 2019 Payment Notice, issued in the April 17, 2018 
                        <E T="04">Federal Register</E>
                         (83 FR 16930), we modified parameters around certain special enrollment periods. In the April 25, 2019 
                        <E T="04">Federal Register</E>
                         (84 FR 17454), the 2020 Payment Notice 
                        <PRTPAGE P="4429"/>
                        established a new special enrollment period.
                    </P>
                    <P>
                        In the May 14, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 29164) (2021 Payment Notice), we finalized revisions to the parameters of special enrollment periods and the quality rating information display standards for State Exchanges and amended the periodic data matching requirements.
                    </P>
                    <P>
                        In the January 19, 2021 
                        <E T="04">Federal Register</E>
                         (86 FR 6138) (part 1 of the 2022 Payment Notice), we finalized only a subset of the proposals in the 2022 Payment Notice proposed rule. In the May 5, 2021 
                        <E T="04">Federal Register</E>
                         (86 FR 24140), we issued part 2 of the 2022 Payment Notice. In part 3 of the 2022 Payment Notice, issued in the September 27, 2021 
                        <E T="04">Federal Register</E>
                         (86 FR 53412), in conjunction with the Department of the Treasury, we finalized amendments to certain policies in part 1 of the 2022 Payment Notice.
                    </P>
                    <P>
                        In the May 6, 2022 
                        <E T="04">Federal Register</E>
                         (87 FR 27208), we finalized changes to maintain the user fee rate for issuers offering plans through the FFEs and maintain the user fee rate for issuers offering plans through the SBE-FPs for the 2023 benefit year. We also finalized various policies to address certain agent, broker, and web-broker practices and conduct. We also finalized updates to the requirement that all Exchanges conduct special enrollment period verifications.
                    </P>
                    <P>
                        In the 2024 Payment Notice, issued in the April 27, 2023 
                        <E T="04">Federal Register</E>
                         (88 FR 25740), we revised Exchange Blueprint approval timelines, lowered the user fee rate for QHPs in the FFEs and SBE-FPs, and amended re-enrollment hierarchies for enrollees. We also finalized policies to update FFE and SBE-FP standardized plan options; reduce the risk of plan choice overload on the FFEs and SBE-FPs by limiting the number of non-standardized plan options that issuers may offer through Exchanges on the Federal platform to four for Plan Year (PY) 2024 and to two for PY 2025 and subsequent years; and ensure correct QHP information. In addition, we amended coverage effective date rules, lengthened the special enrollment period from 60 to 90 days for those who lose Medicaid coverage, and prohibited QHPs on FFEs and SBE-FPs from terminating coverage mid-year for dependent children who reach the applicable maximum age. We also finalized policies on verifying consumer income and permitting door-to-door assisters to solicit consumers. To ensure provider network adequacy, we finalized provider network and ECP policies for QHPs. We revised the failure to file and reconcile process to ensure enrollees would not lose APTC eligibility until they or their tax filer failed to file their Federal income taxes and reconcile APTC for 2 consecutive tax years.
                    </P>
                    <P>
                        In the 2025 Payment Notice, issued in the April 15, 2024 
                        <E T="04">Federal Register</E>
                         (89 FR 26218), we required a State seeking to operate a State Exchange to first operate an SBE-FP for at least one PY, revised Exchange Blueprint requirements for States transitioning to a State Exchange, established additional minimum standards for Exchange call center operations, required an Exchange to operate a centralized eligibility and enrollment platform on its website, and finalized various policies for web-brokers and direct enrollment entities. In addition, we required State Exchanges and State Medicaid agencies to remit payment to HHS for their use of certain income data, amended re-enrollment hierarchies for enrollees enrolled in catastrophic coverage, revised the parameters around a State Exchange adopting an alternative open enrollment period, and extended the availability of a special enrollment period for APTC-eligible qualified individuals with a projected annual household income no greater than 150 percent of the Federal Poverty Level (FPL). To ensure provider network adequacy in State Exchanges and SBE-FPs, we finalized provider network adequacy policies applicable to such Exchanges for PY 2026 and subsequent plan years. We also further lowered the user fee rate for QHPs in the FFEs and SBE-FPs. In addition, we finalized the policy to maintain FFE and SBE-FP standardized plan option metal levels from the 2024 Payment Notice and finalized an exceptions process to the limitation on non-standardized plan options in FFEs and SBE-FPs. We also finalized the requirement for Exchanges to provide notification to enrollees or their tax filers who have failed to file their Federal income taxes and reconcile APTC for 1 tax year.
                    </P>
                    <HD SOURCE="HD3">5. Essential Health Benefits</HD>
                    <P>
                        We established requirements relating to EHBs in the Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation Final Rule, which was issued in the February 25, 2013 
                        <E T="04">Federal Register</E>
                         (78 FR 12834) (EHB Rule). We established at § 156.135(a) that AV is generally to be calculated using the AV Calculator developed and made available by HHS for a given benefit year. In the 2015 Payment Notice (79 FR 13743), we established at § 156.135(g) provisions for updating the AV Calculator in future plan years. In the 2017 Payment Notice (81 FR 12349), we amended the provisions at § 156.135(g) to allow for additional flexibility in our approach and options for updating of the AV Calculator.
                    </P>
                    <P>
                        In the 2025 Payment Notice, issued in the April 15, 2024 
                        <E T="04">Federal Register</E>
                         (89 FR 26218), we revised § 155.170(a) to codify that benefits covered in a State's EHB-benchmark plan are not considered in addition to EHB, even if they had been required by State action taking place after December 31, 2011, other than for purposes of compliance with Federal requirements. We finalized three revisions to the standards for State selection of EHB-benchmark plans for benefit years beginning on or after January 1, 2026: we revised the typicality standard at § 156.111 for States to demonstrate that their new EHB-benchmark plan provides a scope of benefits that is equal to that of a typical employer plan in the State and removed the generosity standard; removed the requirement for States to submit a formulary drug list as part of their application unless they are changing their prescription drug EHBs; and consolidated the options for States to change their EHB-benchmark plans. We also removed the regulatory prohibition at § 156.115(d) on issuers from including routine non-pediatric dental services as an EHB beginning with PY 2027.
                    </P>
                    <P>In addition, we revised § 156.122 to codify that prescription drugs in excess of those covered by a State's EHB-benchmark plan are considered EHB. We also stated that the 2025 Payment Notice does not address the application of this policy to large group market health plans and self-insured group health plans, and that HHS and the Departments of Labor and the Treasury intend to propose rulemaking that would align the standards applicable to large group market health plans and self-insured group health plans with those applicable to individual and small group market plans, so that all group health plans and health insurance coverage subject to sections 2711 and 2707(b) of the PHS Act, as applicable, would be required to treat prescription drugs covered by the plan or coverage in excess of the applicable EHB-benchmark plan as EHB for purposes of the prohibition of lifetime and annual limits and the annual limitation on cost sharing, which would further strengthen the consumer protections in the ACA.</P>
                    <HD SOURCE="HD3">6. Medical Loss Ratio (MLR)</HD>
                    <P>
                        We requested comment on section 2718 of the PHS Act in the April 14, 2010 
                        <E T="04">Federal Register</E>
                         (75 FR 19297) 
                        <PRTPAGE P="4430"/>
                        and issued an interim final rule with a 60-day comment period relating to the MLR program on December 1, 2010 (75 FR 74864). A final rule with a 30-day comment period was issued in the December 7, 2011 
                        <E T="04">Federal Register</E>
                         (76 FR 76573). An interim final rule with a 60-day comment period was issued in the December 7, 2011 
                        <E T="04">Federal Register</E>
                         (76 FR 76595). A final rule was issued in the 
                        <E T="04">Federal Register</E>
                         on May 16, 2012 (77 FR 28790). The MLR program requirements were amended in final rules issued in the March 11, 2014 
                        <E T="04">Federal Register</E>
                         (79 FR 13743), the May 27, 2014 
                        <E T="04">Federal Register</E>
                         (79 FR 30339), the February 27, 2015 
                        <E T="04">Federal Register</E>
                         (80 FR 10749), the March 8, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 12203), the December 22, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 94183), the April 17, 2018 
                        <E T="04">Federal Register</E>
                         (83 FR 16930), the May 14, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 29164), the May 5, 2021 
                        <E T="04">Federal Register</E>
                         (86 FR 24140), the May 6, 2022 
                        <E T="04">Federal Register</E>
                         (87 FR 27208), and an interim final rule that was issued in the September 2, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 54820).
                    </P>
                    <HD SOURCE="HD3">7. Quality Improvement Strategy</HD>
                    <P>
                        We issued regulations in § 155.200(d) to direct Exchanges to evaluate quality improvement strategies, and § 156.200(b) to direct QHP issuers to implement and report on a quality improvement strategy or strategies consistent with section 1311(g) standards as QHP certification criteria for participation in an Exchange. In the 2016 Payment Notice, issued in the February 27, 2015 
                        <E T="04">Federal Register</E>
                         (80 FR 10749), we finalized regulations at § 156.1130 to establish standards and the associated timeframe for QHP issuers to submit the necessary information to implement quality improvement strategy standards for QHPs offered through an Exchange.
                    </P>
                    <HD SOURCE="HD3">8. Basic Health Program</HD>
                    <P>
                        In the March 12, 2014, 
                        <E T="04">Federal Register</E>
                         (79 FR 14111), we issued a final rule entitled the “Basic Health Program: State Administration of Basic Health Programs; Eligibility and Enrollment in Standard Health Plans; Essential Health Benefits in Standard Health Plans; Performance Standards for Basic Health Programs; Premium and Cost Sharing for Basic Health Programs; Federal Funding Process; Trust Fund and Financial Integrity” (hereinafter referred to as the BHP final rule) implementing section 1331 of the ACA, which governs the establishment of BHPs. The BHP final rule established the standards for State and Federal administration of BHPs, including provisions regarding eligibility and enrollment, benefits, cost-sharing requirements and oversight activities. In the BHP final rule, we specified that the BHP Payment Notice process would include the annual publication of both a proposed and final BHP payment methodology.
                    </P>
                    <P>
                        On October 11, 2017, the Attorney General of the United States provided HHS and the Department of the Treasury (the Departments) with a legal opinion 
                        <SU>9</SU>
                        <FTREF/>
                         indicating that the permanent appropriation at 31 U.S.C. 1324, from which the Departments had historically drawn funds to make CSR payments, cannot be used to fund CSR payments to insurers. In light of this opinion—and in the absence of any other appropriation that could be used to fund CSR payments—HHS directed CMS to discontinue CSR payments to issuers until Congress provides for an appropriation. As a result of this opinion, CMS discontinued CSR payments to issuers in the States operating a BHP (that is, New York and Minnesota). The States then sued the Secretary for declaratory and injunctive relief in the United States District Court for the Southern District of New York.
                        <SU>10</SU>
                        <FTREF/>
                         On May 2, 2018, the parties filed a stipulation requesting a stay of the litigation so that HHS could issue an administrative order revising the 2018 BHP payment methodology. After consideration of the States' comments on the administrative order revising the payment methodology, we issued a Final Administrative Order on August 24, 2018 (Final Administrative Order) setting forth the payment methodology that would apply to the 2018 BHP program year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             Sessions, J. (2017, Oct. 11). 
                            <E T="03">Legal Opinion Re: Payments to Issuers for Cost Sharing Reductions (CSRs).</E>
                             Office of the Attorney General. 
                            <E T="03">https://www.hhs.gov/sites/default/files/csr-payment-memo.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             See Complaint, 
                            <E T="03">New York</E>
                             v. 
                            <E T="03">U.S. Dep't of Health &amp; Human Servs.,</E>
                             No. 1:18-cv-00683 (RJS) (S.D.N.Y. filed Jan. 26, 2018).
                        </P>
                    </FTNT>
                    <P>
                        In the November 5, 2019 
                        <E T="04">Federal Register</E>
                         (84 FR 59529) (hereinafter referred to as the November 2019 final BHP Payment Notice), we finalized the payment methodologies for BHP program years 2019 and 2020.
                        <SU>11</SU>
                        <FTREF/>
                         The 2019 payment methodology is the same payment methodology described in the Final Administrative Order. The 2020 payment methodology is the same methodology as the 2019 payment methodology with one additional adjustment to account for the impact of individuals selecting different metal tier level plans in the Exchange, referred to as the Metal Tier Selection Factor (MTSF).
                        <SU>12</SU>
                        <FTREF/>
                         In the August 13, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 49264) (hereinafter referred to as the August 2020 final BHP Payment Notice), we finalized the payment methodology for BHP program year 2021. The 2021 payment methodology is the same methodology as the 2020 payment methodology, with one adjustment to the income reconciliation factor (IRF). In the July 7, 2021 
                        <E T="04">Federal Register</E>
                         (86 FR 35615) (hereinafter referred to as the July 2021 final BHP Payment Notice), we finalized the payment methodology for BHP program year 2022. The 2022 payment methodology is the same as the 2021 payment methodology, with the exception of the removal of the Metal Tier Selection Factor.
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             BHP program year means a calendar year for which a standard health plan provides coverage for BHP enrollees. 
                            <E T="03">See</E>
                             42 CFR 600.5.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             “Metal tiers” refer to the different actuarial value plan levels offered on the Exchanges. Bronze-level plans generally must provide 60 percent actuarial value; silver-level 70 percent actuarial value; gold-level 80 percent actuarial value; and platinum-level 90 percent actuarial value. See 45 CFR 156.140.
                        </P>
                    </FTNT>
                    <P>
                        In the December 20, 2022 
                        <E T="04">Federal Register</E>
                         (87 FR 77722) (hereafter referred to as the 2023 final BHP Payment Notice), we finalized the payment methodology for BHP program year 2023. The 2023 payment methodology is the same as the 2022 payment methodology, except for the addition of a factor to account for a State operating a BHP and implementing an approved State Innovation Waiver under section 1332 of the ACA; this is the section 1332 waiver factor (WF). In the 2023 final BHP Payment Notice (87 FR 77722), we also revised the schedule for issuance of payment notices and allowed payment notices to be effective for 1 or multiple program years, as determined by and subject to the direction of the Secretary, beginning with the 2023 payment methodology. In the 2025 Payment Notice, issued in the April 15, 2024 
                        <E T="04">Federal Register</E>
                         (89 FR 26218), we finalized that States may start BHP applicants' effective date of eligibility on the first day of the month following the date of application. In addition, we finalized that, subject to HHS approval, a State may establish its own effective date of eligibility for enrollment policy.
                    </P>
                    <HD SOURCE="HD2">B. Summary of Major Provisions</HD>
                    <P>The regulations outlined in the final rule are codified in 42 CFR part 600 and 45 CFR parts 153, 155, 156, and 158.</P>
                    <HD SOURCE="HD3">1. 42 CFR Part 600</HD>
                    <P>
                        We are finalizing changes to the methodology regarding the premium adjustment factor (PAF), which is used to calculate the adjusted reference 
                        <PRTPAGE P="4431"/>
                        premium (ARP) for BHP payment. We are finalizing maintaining the PAF value at 1.188 for States that have fully implemented BHP and are using Second Lowest Cost Silver Plan (SLCSP) premiums from a year in which BHP was fully implemented. As previously clarified, for States in their first year of implementing BHP and choosing to use prior year SLCSP premiums to determine BHP payment, the PAF value will be set to 1.00. We are finalizing that if a State is using SLCSP premiums from a year in which BHP was not fully implemented, the PAF is calculated by determining the CSR adjustment that QHP issuers included in the SLCSP premiums, reporting the CSR adjustments for the SLCSP for each region in the State to CMS, and then CMS calculating the PAF as 1.20 divided by 1 plus the adjustment. Additionally, we are finalizing a technical clarification for BHP payment rates in cases of multiple SLCSP premiums in an area.
                    </P>
                    <HD SOURCE="HD3">2. 45 CFR Part 153</HD>
                    <P>
                        In accordance with the OMB Report to Congress on the Joint Committee Reductions for Fiscal Year 2025, the HHS-operated risk adjustment program is subject to the fiscal year 2025 sequestration.
                        <SU>13</SU>
                        <FTREF/>
                         Therefore, the HHS-operated risk adjustment program will sequester payments made from fiscal year 2025 resources (that is, funds collected during the 2025 fiscal year) at a rate of 5.7 percent.
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             OMB. (2024). OMB Report to 
                            <E T="03">the</E>
                             Congress on 
                            <E T="03">the</E>
                             BBEDCA 
                            <E T="03">251A</E>
                             Sequestration for 
                            <E T="03">Fiscal Year</E>
                             2025. 
                            <E T="03">https://www.whitehouse.gov/wp-content/uploads/2024/03/BBEDCA_251A_Sequestration_Report_FY2025.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>We are unable to complete the calculations for the final coefficients for the 2026 benefit year in time to publish them in this final rule. Therefore, consistent with § 153.320(b)(1)(i), we are finalizing the datasets to be used to calculate the final coefficients in this rule and will publish the final coefficients for the 2026 benefit year in guidance after the publication of this final rule. Starting with the 2026 benefit year, we are finalizing the proposal to begin phasing out the market pricing adjustment to the plan liability associated with Hepatitis C drugs in the HHS risk adjustment models (see, for example, 84 FR 17463 through 17466). We are also finalizing the incorporation of pre-exposure prophylaxis (PrEP) as a separate, new type of factor called an Affiliated Cost Factor (ACF) in the HHS risk adjustment adult and child models starting with the 2026 benefit year. We are finalizing a risk adjustment user fee for the 2026 benefit year of $0.20 per member per month (PMPM).</P>
                    <P>Beginning with the 2025 benefit year of HHS-RADV, we are finalizing the proposals to exclude enrollees without HCCs, which includes adult enrollees with only prescription drug categories (RXCs), from the IVA sample, remove the Finite Population Correction (FPC) from the IVA sampling methodology, and replace the source of the Neyman allocation data used for HHS-RADV sampling with the most recent 3 consecutive years of HHS-RADV data. In addition, beginning with the 2024 benefit year of HHS-RADV, we are finalizing the proposals to modify the SVA pairwise means test, which tests for statistically significant differences between the IVA and SVA results, to use a bootstrapped 90 percent confidence interval methodology and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees.</P>
                    <HD SOURCE="HD3">3. 45 CFR Part 155</HD>
                    <P>We address our authority to investigate and undertake compliance reviews and enforcement actions in response to misconduct or noncompliance with applicable agent, broker, and web-broker Exchange requirements or standards occurring at the insurance agency level and how we intend to hold lead agents of insurance agencies accountable for such misconduct or noncompliance.</P>
                    <P>We are finalizing revisions at § 155.220(k)(3) to reflect our authority to suspend an agent's or broker's ability to transact information with the Exchange in instances where HHS discovers circumstances that pose unacceptable risk to accuracy of Exchange eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) and the privacy and security standards under § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction.</P>
                    <P>
                        We are finalizing updates to the model consent form that agents, brokers, and web-brokers can use to obtain and document consumer consent.
                        <SU>14</SU>
                        <FTREF/>
                         The updates expand the resource to include a standardized form that agents, brokers, and web-brokers can use to document the consumer's review and confirmation of the accuracy of information in their Exchange eligibility application, which is a new standard of conduct that was also implemented as part of the 2024 Payment Notice (88 FR 25809 through 25814). The updates also add scripts that agents, brokers, and web-brokers may utilize to meet the consumer consent and eligibility application review requirements finalized in the 2024 Payment Notice via an audio recording.
                    </P>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             CMS. (2022, December 14). 
                            <E T="03">CMS Model Consent Form for Marketplace Agents and Brokers.</E>
                             PRA package (CMS-10840, OMB Control Number 0938-1438). 
                            <E T="03">https://www.cms.gov/files/document/cms-model-consent-form-marketplace-agents-and-brokers.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>We are finalizing, in connection with the failure to file and reconcile process at § 155.305(f)(4), that Exchanges are required to send notices to tax filers or their enrollees for the second year in which they have been determined to have failed to reconcile APTC explaining that they risk being determined ineligible for APTC. A notice to the tax filer may specifically explain that if they fail to file and reconcile for a second consecutive year, they risk being determined ineligible for APTC. Alternatively, an Exchange may send a more general notice to the enrollee or their tax filer explaining that they are at risk of losing APTC, without the additional detail that the tax filer has failed to file and reconcile APTC.</P>
                    <P>
                        We are finalizing the addition of § 155.400(d)(1) to codify HHS' guidance that requires that, within 60 calendar days after a State Exchange receives a data inaccuracy from an issuer operating in an State Exchange that includes a description of an inaccuracy that meets the requirements at § 156.1210(a) through (c) and all the information that the State Exchange requires or requests to properly assess the inaccuracy, State Exchanges must review and resolve the State Exchange issuer's enrollment data inaccuracies and submit to HHS a description of the resolution of any inaccuracies described by the State Exchange issuer that the State Exchange confirms to be inaccuracies in a format and manner specified by HHS.
                        <SU>15</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             OMB Control No: 0938-1312 and 0938-1341.
                        </P>
                    </FTNT>
                    <P>
                        We are finalizing a provision at § 155.400(g) to allow issuers to adopt a fixed-dollar payment threshold of $10 or less, to be adjusted for inflation by annual agency guidance, under which issuers would not be required to trigger a grace period or terminate enrollment for enrollees who fail to pay the full amount of their portion of premium owed, provided they do not owe more than the threshold amount. We are also finalizing a provision allowing issuers to adopt a gross percentage-based premium threshold of 98 percent or higher, which similarly would not require issuers to trigger a grace period 
                        <PRTPAGE P="4432"/>
                        or terminate enrollment for enrollees who fail to pay the full amount of their portion of premium owed, provided they do not owe more than the threshold amount. In addition, we are finalizing a provision that permits issuers to set the premium payment threshold based on net premium owed by the enrollee at 95 percent or higher of the net premium, rather than providing for a “reasonable” standard as is currently set forth in regulation. We are finalizing a policy limiting application of the fixed-dollar payment threshold and gross premium percentage-based threshold to premium payments after coverage is effectuated. Issuers will be allowed to apply the fixed-dollar payment threshold and/or one of two percentage-based thresholds (but not both percentage-based thresholds). Issuers will be required to apply all chosen premium payment thresholds uniformly to all enrollees and without regard to their health status.
                    </P>
                    <P>We are finalizing a provision at § 155.505(b) to codify an option for application filers as defined under § 155.20 to file appeals on behalf of applicants and enrollees on the application filer's Exchange application.</P>
                    <P>We are finalizing amendments at § 155.1000 to state explicitly that an Exchange may deny certification to any plan that does not meet the general certification criteria at § 155.1000(c). We also finalize amending § 155.1090 with refinements to the standards for a request for the reconsideration of a denial of certification specific to the FFEs.</P>
                    <P>We are finalizing that in addition to collecting the information and data currently provided by State Exchanges under § 155.1200 to monitor performance and compliance, we would use the information and data that State Exchanges submit to increase transparency into Exchange operations and to promote program improvements. We anticipate publicly releasing the State Exchange spending on outreach (including Navigators), Open Enrollment call center metrics (call center volume, average wait time, average call abandonment rate), and website visits and visitors. We are stating in this final rule that we no longer intend to publicly release the State Exchanges' annual State-based Marketplace Annual Reporting Tools (SMARTs). In addition, we intend to only post those metrics for which we also have reasonably comparable data from Exchanges on the Federal platform.</P>
                    <HD SOURCE="HD3">4. 45 CFR Part 156</HD>
                    <P>
                        We are finalizing 2026 benefit year FFE and SBE-FP user fee rates of 2.5 percent and 2.0 percent of total monthly premiums, respectively. We are also finalizing alternative 2026 benefit year FFE and SBE-FP user fee rates of 2.2 percent and 1.8 percent of total monthly premiums, respectively, if enhanced PTC subsidies,
                        <SU>16</SU>
                        <FTREF/>
                         at the level currently enacted or at a higher level, are extended through the 2026 benefit year by July 31, 2025.
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             ARP, Public Law  117-2, 135 Stat. 4 (2021). These enhanced subsidies were extended under the IRA, Public Law  117-169, 136 Stat. 1818 (2022) and are scheduled to expire after the 2025 calendar year.
                        </P>
                    </FTNT>
                    <P>We are finalizing amendments to § 156.80(d)(2)(i) to affirm that CSR loading practices that are permitted by State regulators are permissible under Federal law to the extent that they are actuarially justified and provided the issuer does not otherwise receive reimbursement for such CSR amounts.</P>
                    <P>We are finalizing changes to the method for updating the AV Calculator, starting with the 2026 AV Calculator. Under this approach, for a plan year, we will only release a single, final version of the AV Calculator.</P>
                    <P>
                        We are finalizing minor updates to the standardized plan option designs for PY 2026 to ensure these plans continue to have AVs within the permissible 
                        <E T="03">de minimis range</E>
                         for each metal level and to maintain a high degree of continuity with the approaches to standardized plan options finalized in the 2023, 2024, and 2025 Payment Notices. In response to comments requesting the expanded bronze metal level designs revert to the 50 percent coinsurance rate used in previous years, we have revised this plan design to maintain this consistency, instead of raising it to 60 percent for PY 2026, as proposed. We made several additional modifications to both sets of plan designs at the expanded bronze metal.
                    </P>
                    <P>In addition, we are finalizing amendments at § 156.201 to require issuers that offer multiple standardized plan options within the same product network type, metal level, and service area to meaningfully differentiate these plans from one another in terms of included benefits, provider networks, included prescription drugs, or a combination of some or all these factors.</P>
                    <P>We are finalizing amendments at § 156.202(b) and (d) to properly reflect the flexibility that issuers have been operationally permitted since these requirements were introduced to vary the inclusion of the distinct adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage categories under the non-standardized plan option limit in accordance with § 156.202(c)(1) through (3).</P>
                    <P>We are finalizing conducting ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions, beginning in PY 2026.</P>
                    <P>We are finalizing the proposal to share aggregated, summary-level QIS information publicly on an annual basis beginning on January 1, 2026, with information QHP issuers submit during the PY 2025 QHP Application Period.</P>
                    <P>We are finalizing an amendment to § 156.1220(a) to introduce a new materiality threshold for HHS-RADV appeals, such that we will rerun HHS-RADV results and adjust HHS-RADV adjustments to State transfers in response to a successful appeal when the impact of that appeal to the filer's HHS-RADV adjustments to State transfers is greater than or equal to $10,000.</P>
                    <HD SOURCE="HD3">5. 45 CFR Part 158</HD>
                    <P>We are finalizing amendments to § 158.140(b)(4)(ii) to allow qualifying issuers to not adjust incurred claims by the net payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes beginning with the 2026 MLR reporting year (MLR reports due in 2027), with certain modifications. Specifically, we are finalizing that at the option of qualifying issuers, earned premium would account for net risk adjustment receipts by simply adding these net receipts to total premium, without subsequently subtracting them from adjusted earned premium, such that these net receipts would impact the MLR denominator rather than MLR numerator. We are also finalizing an amendment to § 158.103 to add a definition of “qualifying issuer,” with certain clarifications.</P>
                    <P>
                        We also are finalizing amendments to § 158.240(c) to add an illustrative example of how qualifying issuers that opt to apply risk adjustment transfer amounts as described in § 158.140(b)(4)(ii) will calculate the amount of rebate owed to each enrollee to accurately reflect how such issuers will incorporate the net risk adjustment transfer amounts into the MLR and rebate calculations differently from other issuers, as well as a conforming amendment to clarify that the current illustrative example in paragraph (c)(2) will apply to issuers that are not qualifying issuers and to qualifying issuers that do not opt to apply risk 
                        <PRTPAGE P="4433"/>
                        adjustment transfer amounts as described in § 158.140(b)(4)(ii).
                    </P>
                    <HD SOURCE="HD1">III. Summary of the Provisions of the Proposed Regulations and Analysis of and Responses to Public Comments</HD>
                    <HD SOURCE="HD2">A. 42 CFR Part 600—BHP Methodology Regarding the Value of the Premium Adjustment Factor (PAF)</HD>
                    <HD SOURCE="HD3">1. Overview of the Payment Methodology and Calculation of the Payment Amount</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82317), we proposed to make a change to the calculation of the PAF starting in program year 2026. Section 1331(d)(3) of the ACA directs the Secretary to consider several factors when determining the Federal BHP payment amount, which, as specified in the statute, must equal 95 percent of the value of the PTC under section 36B of the Code and CSRs under section 1402 of the ACA that would have been paid on behalf of BHP enrollees had they enrolled in a QHP through an Exchange. Thus, the BHP payment methodology is designed to calculate the PTC and CSRs as consistently as possible and in general alignment with the methodology used by Exchanges to calculate advance payments of the PTC (APTC) and CSRs, and the methodology used to reconcile APTC with the amount of the PTC allowed for the tax year under section 36B of the Code. In accordance with section 1331(d)(3)(A)(iii) of the ACA, the final payment methodology must be certified by the Chief Actuary of CMS, in consultation with the Office of Tax Analysis (OTA) of the Department of the Treasury, as having met the requirements of section 1331(d)(3)(A)(ii) of the ACA.</P>
                    <P>Section 1331(d)(3)(A)(ii) of the ACA specifies that the payment determination shall take into account all relevant factors necessary to determine the value of the PTC and CSRs that would have been paid on behalf of eligible individuals, including but not limited to, the age and income of the enrollee, whether the enrollment is for self-only or family coverage, geographic differences in average spending for health care across rating areas, the health status of the enrollee for purposes of determining risk adjustment payments and reinsurance payments that would have been made if the enrollee had enrolled in a QHP through an Exchange, and whether any reconciliation of APTC and CSR would have occurred if the enrollee had been enrolled. Under all previous payment methodologies, the total Federal BHP payment amount has been calculated using multiple rate cells in each BHP State. Each rate cell represents a unique combination of age range (if applicable), geographic area, coverage category (for example, self-only or two-adult coverage through the BHP), household size, and income range as a percentage of FPL, and there is a distinct rate cell for individuals in each coverage category within a particular age range who reside in a specific geographic area and are in households of the same size and income range. The BHP payment rates developed are also consistent with the State's rules on age rating. Thus, in the case of a State that does not use age as a rating factor on an Exchange, the BHP payment rates would not vary by age.</P>
                    <P>Under the methodology finalized in the July 2021 final BHP Payment Notice, the rate for each rate cell is calculated in two parts. The first part is equal to 95 percent of the estimated PTC that would have been allowed if a BHP enrollee in that rate cell had instead enrolled in a QHP in an Exchange. The second part is equal to 95 percent of the estimated CSR payment that would have been made if a BHP enrollee in that rate cell had instead enrolled in a QHP in an Exchange. These two parts are added together and the total rate for that rate cell would be equal to the sum of the PTC and CSR rates. As noted in the July 2021 final BHP Payment Notice, we currently assign a value of zero to the CSR portion of the BHP payment rate calculation, because there is presently no available appropriation from which we can make the CSR portion of any BHP payment.</P>
                    <P>The 2023 final BHP Payment Notice provides a detailed description of the structure of the BHP payments, including the equations, factors, and the values of the factors used to calculate the BHP payments. We proposed one change to the methodology regarding the premium adjustment factor (PAF).</P>
                    <P>The PAF is used to calculate the adjusted reference premium (ARP) that is used to calculate the BHP payment. The ARP is used to calculate the BHP payment. The ARP is used to calculate the estimated PTC that would be allowed if BHP-eligible individuals enrolled in QHPs through an Exchange and is based on the premiums for the applicable second lowest cost silver plan during the applicable plan year. The PAF considers the premium increases in other States that took effect after we discontinued payments to issuers for CSRs provided to enrollees in QHPs offered through Exchanges. Despite the discontinuance of Federal payments for CSRs, QHP issuers are required to provide CSRs to eligible enrollees. As a result, many QHP issuers increased the silver-level plan premiums to account for those additional costs; these premium adjustments and how they were applied (for example, to only silver-level plans or to all metal tier plans) varied across States. For the States operating BHPs in 2018, the increases in premiums were relatively minor, because the majority of enrollees eligible for CSRs (and all who were eligible for the largest CSRs) were enrolled in the BHP and not in QHPs on the Exchanges, and therefore, issuers in BHP States did not significantly raise premiums to cover costs related to HHS not making CSR payments.</P>
                    <P>
                        In the Final Administrative Order and the 2019 through 2023 final BHP Payment Notices, we incorporated the PAF into the BHP payment methodologies to capture the impact of how other States responded to HHS ceasing to make CSR payments.
                        <SU>17</SU>
                        <FTREF/>
                         We also reserved the right that in the case an appropriation for CSR payments is made for a future year, to determine whether and how to modify the PAF in the payment methodology.
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             
                            <E T="03">https://www.medicaid.gov/sites/default/files/2019-11/final-admin-order-2018-revised-payment-methodology.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Under the Final Administrative Order, we calculated the PAF by using information sought from QHP issuers in each State and the District of Columbia and determined the premium adjustment that the responding QHP issuers made to each silver level plan in 2018 to account for the discontinuation of CSR payments to QHP issuers. Based on the data collected, we estimated the median adjustment for silver level QHPs nationwide (excluding those in the two BHP States). To the extent that QHP issuers made no adjustment (or the adjustment was zero), this was counted as zero in determining the median adjustment made to all silver level QHPs nationwide. If the amount of the adjustment was unknown—or we determined that it should be excluded for methodological reasons (for example, the adjustment was negative, an outlier, or unreasonable)—then we did not count the adjustment towards determining the median adjustment.
                        <SU>18</SU>
                        <FTREF/>
                         The median adjustment for silver level QHPs is referred to as the nationwide median adjustment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             Some examples of outliers or unreasonable adjustments include (but are not limited to) values over 100 percent (implying the premiums doubled or more because of the adjustment), values more than double the otherwise highest adjustment, or non-numerical entries.
                        </P>
                    </FTNT>
                    <P>
                        For each of the two BHP States, we determined the median premium adjustment for all silver level QHPs in that State, which we refer to as the State 
                        <PRTPAGE P="4434"/>
                        median adjustment. The PAF for each BHP State equaled one plus the nationwide median adjustment divided by one plus the State median adjustment for the BHP State. In other words,
                    </P>
                    <FP SOURCE="FP-2">PAF = (1 + Nationwide Median Adjustment) ÷ (1 + State Median Adjustment).</FP>
                    <P>To determine the PAF described above, we sought to collect QHP information from QHP issuers in each State and the District of Columbia to determine the premium adjustment those issuers made to each silver level plan offered through the Exchange in 2018 to account for the end of CSR payments. Specifically, we sought information showing the percentage change that QHP issuers made to the premium for each of their silver level plans to cover benefit expenditures associated with the CSRs, given the lack of CSR payments in 2018. This percentage change was a portion of the overall premium increase from 2017 to 2018.</P>
                    <P>According to our 2018 records, there were 1,233 silver-level QHPs operating on Exchanges in 2018. Of these 1,233 QHPs, 318 QHPs (25.8 percent) responded to our request for the percentage adjustment applied to silver-level QHP premiums in 2018 to account for the discontinuance of HHS making CSR payments. These 318 QHPs operated in 26 different States, with 10 of those States running State Exchanges (while we requested information only from QHP issuers in States serviced by an FFE, many of those issuers also had QHPs in State Exchanges and submitted information for those States as well). Thirteen of these 318 QHPs were in New York (and none were in Minnesota). Excluding these 13 QHPs from the analysis, the nationwide median adjustment was 20.0 percent. Of the 13 QHPs in New York that responded, the State median adjustment was 1.0 percent. We believed that this was an appropriate adjustment for QHPs in Minnesota, as well, based on the observed changes in New York's QHP premiums in response to the discontinuance of CSR payments (and the operation of the BHP in that State) and our analysis of expected QHP premium adjustments for States with BHPs. We calculated the proposed PAF as (1 + 20 percent) ÷ (1 + 1 percent) (or 1.20/1.01), which results in a value of 1.188.</P>
                    <P>
                        We set the value of the PAF to 1.188 for all program years for 2018 through 2024, with limited exceptions.
                        <SU>19</SU>
                        <FTREF/>
                         We believe that this value for the PAF continues to reasonably account for the increase in silver-level premiums experienced in non-BHP States that took effect after the discontinuance of the CSR payments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             See the 
                            <E T="03">Federal Funding Methodology for Program Year 2023 and Changes to the Basic Health Program Payment Notice Process</E>
                             at 87 FR 77722, 77731, 77737.
                        </P>
                    </FTNT>
                    <P>
                        Starting in 2023, we made one limited exception in setting the value of the PAF as part of the 2023 final BHP Payment Notice.
                        <SU>20</SU>
                        <FTREF/>
                         In the case of a State in the first year of implementing a BHP, if the State chooses to use prior year second lowest cost silver plan (SLCSP) premiums to determine the BHP payment (for example, the 2025 premiums for the 2026 program year), we set the value of the PAF to 1.00. In this case, we believe that adjustment to the QHP premiums to account for the discontinuation of CSR payments would be included fully in the prior year premiums, and no further adjustment would be necessary.
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             Id. at 77731-32.
                        </P>
                    </FTNT>
                    <P>We proposed to make a change to the calculation of the PAF starting in program year 2026. There are cases in which a State may not have fully implemented BHP for a full program year. For example, a State may operate BHP for only a portion of the year (in other words, less than 12 months); there may be other such cases in which a State would be deemed to have partially implemented BHP for a program year.</P>
                    <P>For a State that initially only partially implemented BHP, it is likely that, in the year (or years) when the BHP is only partially implemented, the percentage adjustment to the premiums for the program year to account for the discontinuation of CSR payments may be significantly higher than the 1 percent adjustment we determined for BHP States in 2018. In these cases, it is probable that QHP issuers would include a larger premium adjustment (that is, greater than 1 percent) because more individuals would be eligible for CSRs (and individuals eligible for relatively larger CSRs) would be enrolled in a QHP on the Exchange, for part or all of the initial implementation year. If premiums with a larger CSR adjustment are used as a basis for calculating the BHP payments and the current value of the PAF (1.188) is used, it is likely that this would “double count” a portion of the adjustment and lead to an effective CSR adjustment over 20 percent.</P>
                    <P>For example, assume a State implements BHP for only 6 months in a program year. As a result, QHP issuers may include a 10 percent adjustment to the premiums to account for the discontinuation of the CSR for the portion of the year when CSR eligible individuals would have QHP coverage. The issuers would be liable for roughly half of the CSR amounts they would have had to provide if there was no BHP in place. Under the previous BHP payment methodology, if these premiums that already partially account for CSRs are used to calculate the BHP payment, we would increase the reference premium by 18.8 percent for the PAF, leading to an effective increase of 30.68 percent (1.188 multiplied by 1.10 minus 1). This is significantly larger than the 20 percent adjustment we determined as the basis for the PAF for States that have operated their BHP for more than 2 full program years.</P>
                    <P>
                        Under the Secretary's general authority to account for all relevant factors necessary to determine the value of the premium and cost-sharing reductions that would have been provided to eligible individuals now enrolled in BHP coverage 
                        <SU>21</SU>
                        <FTREF/>
                         and to avoid such an overpayment, we proposed the following changes to the PAF:
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             Section 1331(d)(3)(A)(ii) of the PHS Act.
                        </P>
                    </FTNT>
                    <P>(1) If a State has fully implemented BHP and is using SLSCP premiums for a year in which the BHP was fully implemented, then the value of the PAF would remain 1.188, as described above.</P>
                    <P>(2) If a State is in the first year of implementing a BHP and the State chooses to use prior year SLCSP premiums to determine the BHP payment (for example, the 2025 premiums for the 2026 program year), we set the value of the PAF to 1.00. This is the same approach described in the 2023 final BHP Payment Notice.</P>
                    <P>(3) If a State is using SLCSP premiums from a year in which BHP was not fully implemented, then the PAF is calculated as follows:</P>
                    <P>
                        First, the State must determine the CSR adjustment that QHP issuers included in the SLSCP premiums for individual market Exchange plans. The State should identify the SLSCP in each region, as defined for the Exchange. For each SLSCP, the State should determine the CSR adjustment that the QHP issuer included in the premium. This may be done by (1) reviewing any materials submitted by the QHP issuer describing the calculation of the premium; or (2) requesting that the QHP issuer provide the adjustment, or an estimate of the adjustment used in calculating the premium. Second, the State should report the CSR adjustments for the SLCSP for individual market Exchange 
                        <PRTPAGE P="4435"/>
                        plans for each region in the State to CMS. Third, CMS will take this percentage adjustment and calculate the PAF as 1.20 divided by 1 plus the adjustment. For example, if the percentage adjustment for the CSR is 5 percent, the PAF would be (1.20 ÷ 1.05), or 1.143. The maximum value of the PAF would be 1.188, and the minimum value of the PAF would be 1.00.
                    </P>
                    <P>We noted in the proposed rule (89 FR 82319) that this approach would apply based on the premium year, not necessarily the program year. If the State has fully implemented BHP but is using the prior year premiums and BHP was not fully implemented in that year, this modified approach would still apply. For example, if a State partially implemented BHP in 2026 and fully implemented BHP in 2027, when determining the BHP payments for 2027, we would then use 1.188 for the value of the PAF if the State elected to use 2027 QHP premiums to determine the payment; if the State elected to use the 2026 QHP premiums, then we would use the modified PAF calculation described in this section. CMS would make a determination of whether or not a BHP was fully implemented based on a review of the Blueprint and provide that determination to the State.</P>
                    <P>We also noted in the proposed rule (89 FR 82319) that we considered other approaches to the modified PAF. We considered whether or not CMS would collect data on the underlying CSR adjustment in the SLCSP premiums; however, we believe that such activities fall within States roles as BHP administrators and States are better able to work with QHP issuers to administer this data collection process. We also considered if States should survey all QHP issuers (not just those with the SLSCP premium). We believe that only using the CSR adjustment from individual market Exchange plans with the SLCSPs would be a more reasonable approach and would minimize the burden on States and QHP issuers by only requiring the State to work with one issuer in each region, as opposed to all issuers in each region. We also considered whether or not we should make further changes to the PAF, but we believe that this approach balances maintaining accurate BHP payments with stability and limited burden for BHP States. We requested comments on this approach or alternative approaches to calculating the PAF.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing the approach to calculating the PAF as proposed. We summarize and respond to public comments received on the proposed change to the calculation of the PAF below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters were supportive of the change to adjust the PAF for BHP in program years in which States have not fully implemented BHP.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these comments in support of the proposed change.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted “relying on silver CSR loads from 2018 in the development of the population adjustment factor may not reflect actual silver loads because these 2018 premiums are based on experience from a time when CSRs were fully funded,” while also acknowledging there are other factors “including state-specified loads, the impact of States' 1332 waivers, the effects of the COVID-19 pandemic and related Medicaid coverage policies, and other factors” that may affect these adjustments in States.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We acknowledge that there are limitations to relying on the 2018 CSR loads for calculation of the PAF. We also agree that other factors that may affect CSR loads and these factors complicate updating the PAF. We did not propose and are not making any changes to the standard calculation of the PAF in this final rule.
                    </P>
                    <HD SOURCE="HD3">2. Technical Clarification for Calculation of BHP Payment Rates in Cases of Multiple Second Lowest Cost Silver Plan Premiums in an Area</HD>
                    <P>The BHP payment rates are based on the second lowest cost silver plan premium among individual market QHPs operating on the Exchanges in each rating area (or county) in a State. This is the basis for the reference premium (or RP) in the BHP payment methodology.</P>
                    <P>In general, we expect that each county would have a unique second lowest cost silver plan premium, which is used to calculate the payment rates for residents of that county for the BHP payment. However, in some cases, we have found that States may have more than one second lowest cost silver plan within a county. This may occur in cases where the State has allowed QHPs to operate in only a portion of the county instead of the entire county on the Exchange.</P>
                    <P>
                        In our previous BHP payment methodologies, we do not describe how such a case would be handled for calculating BHP payments. In our technical guidance to States,
                        <SU>22</SU>
                        <FTREF/>
                         we have instructed States to report the premiums for the second lowest cost silver plan operating in the largest part of the county as measured by total population.
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             CMS. (September 15, 2023). 
                            <E T="03">Basic Health Program; Federal Funding Methodology for Program Year 2024.</E>
                             Accessed at: 
                            <E T="03">https://www.medicaid.gov/federal-policy-guidance/downloads/cib091523.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Under the Secretary's general authority to account for all relevant factors necessary to determine the value of the premium and cost-sharing reductions that would have been provided to eligible individuals now enrolled in BHP coverage,
                        <SU>23</SU>
                        <FTREF/>
                         for the 2026 payment methodology and all subsequent years, we proposed to clarify that in cases where there are more than one second lowest cost silver plans in a county, the BHP payment would be based on the premium of the second lowest cost silver plan applicable to the largest portion of the county as measured by total population. We sought comment on this approach.
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             Section 1331(d)(3)(A)(ii) of the PHS Act.
                        </P>
                    </FTNT>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy as proposed. We summarize and respond to public comments received on the proposed clarification of the correct premiums to use below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters were supportive of the clarification for which second lower cost silver plan premiums to use in these cases for the purposes of calculating the Federal BHP payment.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these comments in support of the proposed change.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Two commenters noted that in one State that has operated a BHP, the State is using a different silver plan premium (the third lowest cost silver plan premium) in cases when there are two or more second lowest cost silver plan premiums in an area. Commenters noted that using the proposed approach would present operational challenges for the State. The commenters requested flexibility on this in the BHP payment methodology.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the comments and understand that there may be some operational issues; however, we believe that these issues can be easily addressed, and we note that other BHP States have been able to determine premiums in accordance with these requirements. In addition, we do not believe there is any basis to use any premiums other than the second lowest cost silver plans (even if there are two or more in an area) for the purposes of the BHP payment methodology.
                        <PRTPAGE P="4436"/>
                    </P>
                    <HD SOURCE="HD2">B. 45 CFR Part 153—Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment</HD>
                    <P>
                        In subparts A, B, D, G, and H of part 153, we established standards for the administration of the risk adjustment program. The risk adjustment program is a permanent program created by section 1343 of the ACA that transfers funds from issuers of lower-than-average risk, risk adjustment covered plans to issuers of higher-than-average risk, risk adjustment covered plans in the individual, small group markets, or merged markets, inside and outside the Exchanges. In accordance with § 153.310(a), a State that is approved or conditionally approved by the Secretary to operate an Exchange may establish a risk adjustment program or have HHS do so on its behalf.
                        <SU>24</SU>
                        <FTREF/>
                         HHS did not receive any requests from States to operate risk adjustment for the 2026 benefit year. Therefore, HHS will operate risk adjustment in every State and the District of Columbia for the 2026 benefit year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             See also 42 U.S.C. 18041(c)(1).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Sequestration</HD>
                    <P>
                        In accordance with the OMB Report to Congress on the Joint Committee Reductions for Fiscal Year 2025, the HHS-operated risk adjustment program is subject to the fiscal year 2025 sequestration.
                        <SU>25</SU>
                        <FTREF/>
                         The Federal Government's 2025 fiscal year began on October 1, 2024. Therefore, the HHS-operated risk adjustment program is sequestered at a rate of 5.7 percent for payments made from fiscal year 2025 resources (that is, funds collected during the 2025 fiscal year).
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             OMB. (2024). OMB Report to the Congress on the BBEDCA 251A Sequestration for Fiscal Year 2025. 
                            <E T="03">https://www.whitehouse.gov/wp-content/uploads/2024/03/BBEDCA_251A_Sequestration_Report_FY2025.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        HHS, in coordination with OMB, has determined that, under section 256(k)(6) of the Balanced Budget and Emergency Deficit Control Act of 1985 (BBEDCA),
                        <SU>26</SU>
                        <FTREF/>
                         as amended, and the underlying authority for the HHS-operated risk adjustment program, the funds that are sequestered in fiscal year 2025 from the HHS-operated risk adjustment program will become available for payment to issuers in fiscal year 2026 without further Congressional action. If the Congress does not enact deficit reduction provisions that replace the Joint Committee reductions, the program would be sequestered in future fiscal years, and any sequestered funding would become available in the fiscal year following that in which it was sequestered.
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             Public Law 99-177, 99 Stat. 1037 (1985).
                        </P>
                    </FTNT>
                    <P>
                        Additionally, we note that the Infrastructure Investment and Jobs Act 
                        <SU>27</SU>
                        <FTREF/>
                         amended section 251A(6) of the BBEDCA and extended sequestration for the HHS-operated risk adjustment program through fiscal year 2031 at a rate of 5.7 percent per fiscal year.
                        <SU>28</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             Public Law 117-58, 135 Stat. 429 (2021).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             2 U.S.C. 901a.
                        </P>
                    </FTNT>
                    <P>One comment was received on this section of the proposed rule that acknowledges the fiscal year 2025 sequestration rate. Therefore, after consideration of this comment and for reasons outlined in the proposed rule and this final rule, the HHS-operated risk adjustment program will sequester payments made from fiscal year 2025 resources at a rate of 5.7 percent.</P>
                    <HD SOURCE="HD3">2. HHS Risk Adjustment (§ 153.320)</HD>
                    <P>
                        The HHS risk adjustment models predict plan liability for an average enrollee based on that person's age, sex, and diagnoses (also referred to as HCCs) producing a risk score. The State payment transfer formula 
                        <SU>29</SU>
                        <FTREF/>
                         that is part of the HHS Federally certified risk adjustment methodology utilizes separate models for adults, children, and infants to account for clinical and cost differences in each age group. In the adult and child models, the relative risk assigned to an individual's age, sex, and diagnoses are added together to produce an individual risk score. Additionally, to calculate enrollee risk scores in the adult models, we added enrollment duration factors beginning with the 2017 benefit year,
                        <SU>30</SU>
                        <FTREF/>
                         and prescription drug categories (RXCs) beginning with the 2018 benefit year.
                        <SU>31</SU>
                        <FTREF/>
                         Starting with the 2023 benefit year, we removed the severity illness factors in the adult models and added interacted HCC count factors (that is, additional factors that express the presence of a severity or transplant HCC in combination with a specified number of total payment HCCs or HCC groups on the enrollee's record) to the adult and child models 
                        <SU>32</SU>
                        <FTREF/>
                         applicable to certain severity and transplant HCCs.
                        <SU>33</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             The State payment transfer formula refers to part of the Federally certified risk adjustment methodology that applies in States where HHS is responsible for operating the program. The formula calculates payments and charges at the State market risk pool level (prior to the calculation of the high-cost risk pool payment and charge terms that apply beginning with the 2018 benefit year). See, for example, 81 FR 94080.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             For the 2017 through 2022 benefit years, there was a set of 11 binary enrollment duration factors in the adult models that decreased monotonically from 1 to 11 months, reflecting the increased annualized costs associated with fewer months of enrollments. See, for example, 81 FR 94071 through 94074. These enrollment duration factors were replaced beginning with the 2023 benefit year with HCC-contingent enrollment duration factors for up to 6 months in the adult models. See, for example, 87 FR 27228 through 27230.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             For the 2018 benefit year, there were 12 RXCs, but starting with the 2019 benefit year, the two severity-only RXCs were removed from the adult models. See, for example, 83 FR 16941.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             See Table 4 in the proposed rule for a list of draft factors in the adult models, and Table 5 in the proposed rule for a list of draft factors in the child models.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             See 87 FR 27224-28. Also see Table 6 in the proposed rule.
                        </P>
                    </FTNT>
                    <P>Infant risk scores are determined by inclusion in one of 25 mutually exclusive groups, based on the infant's maturity and the severity of diagnoses. If applicable, the risk score for adults, children, or infants is multiplied by a CSR adjustment factor. The enrollment-weighted average risk score of all enrollees in a particular risk adjustment covered plan (also referred to as the plan liability risk score (PLRS)) within a geographic rating area is one of the inputs into the State payment transfer formula, which determines the State transfer payment or charge that an issuer will receive or be required to pay for that plan for the applicable State market risk pool for a given benefit year. Thus, the HHS risk adjustment models predict average group costs to account for risk across plans, in keeping with the Actuarial Standards Board's Actuarial Standards of Practice for risk classification.</P>
                    <HD SOURCE="HD3">a. Data for HHS Risk Adjustment Model Recalibration for the 2026 Benefit Year</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82320 through 82321), we proposed to recalibrate the 2026 benefit year HHS risk adjustment models with the 2020, 2021, and 2022 enrollee-level EDGE data. In the proposed rule, we noted the history of recalibrating the risk adjustment models, the transition to use of enrollee-level EDGE data for this purpose, and why we use 3 years of blended data for recalibration.
                        <SU>34</SU>
                        <FTREF/>
                         Given this history and reasoning, we proposed to determine coefficients for the 2026 benefit year based on a blend of separately solved coefficients from the 2020, 2021, and 2022 benefit years' enrollee-level EDGE data, with the costs of services identified from the data trended between the relevant year of data and the 2026 benefit year.
                        <SU>35</SU>
                        <FTREF/>
                         We sought 
                        <PRTPAGE P="4437"/>
                        comment on the proposal to determine 2026 benefit year coefficients for the HHS risk adjustment models based on a blend of separately solved coefficients from the 2020, 2021, and 2022 enrollee-level EDGE data.
                    </P>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             See 89 FR 82308, 82320-21.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             As described in the 
                            <E T="03">2016 Risk Adjustment White Paper</E>
                             (
                            <E T="03">https://www.cms.gov/cciio/resources/forms-reports-and-other-resources/downloads/ra-march-31-white-paper-032416.pdf</E>
                            ) and the 2017 Payment Notice (81 FR 12218), we subdivide expenditures into traditional drugs, specialty drugs, medical services, and preventive services and 
                            <PRTPAGE/>
                            determine trend factors separately for each category of expenditure. In determining these trend factors, we consult our actuarial experts, review relevant Unified Rate Review Template submission data, analyze multiple years of enrollee-level EDGE data, and consult National Health Expenditure Accounts (NHEA) data as well as external reports and documents published by third parties. In this process, we aim to determine trends that reflect changes in cost of care rather than gross growth in expenditures. As such, we believe the trend factors we used for each expenditure category for the 2026 benefit year models are appropriate for the most recent changes in cost of care that we have seen.
                        </P>
                    </FTNT>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing the approach to use the 2020, 2021 and 2022 enrollee-level EDGE data to calculate the 2026 benefit year coefficients as proposed. We summarize and respond to public comments received on the proposed enrollee-level EDGE data to be used for HHS risk adjustment model recalibration for the 2026 benefit year below. Because we were unable to complete the calculations for the final coefficients in time to publish them in this final rule, we will publish the final 2026 benefit year coefficients in guidance after the publication of this final rule consistent with § 153.320(b)(1)(i). We will release this guidance by the spring of 2025, in time for rate setting for the 2026 benefit year.</P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters supported utilizing the 2020, 2021, and 2022 enrollee-level EDGE data to recalibrate the HHS risk adjustment models for the 2026 benefit year as proposed. Other commenters opposed or noted concern about using these years of enrollee-level EDGE data due to concerns about the potential impact of the COVID-19 PHE on 2020 and 2021 benefit year enrollee-level EDGE data.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are finalizing the use of the 2020, 2021, and 2022 enrollee-level EDGE data to recalibrate the 2026 benefit year HHS risk adjustment models as proposed. As described in the proposed rule (89 FR 82308, 82320) and detailed further below, our analyses found the 2020 and 2021 benefit year enrollee-level EDGE data is sufficiently similar to prior years of enrollee-level EDGE data such that exclusion of these data years from the risk adjustment model recalibration is not warranted.
                    </P>
                    <P>
                        We recognize that if a benefit year of enrollee-level EDGE data has significant changes that differentially impact certain conditions or populations relative to others or is sufficiently anomalous relative to expected future patterns of care, we should carefully consider what impact that benefit year of data could have if it is used in the annual recalibration of the HHS risk adjustment models.
                        <SU>36</SU>
                        <FTREF/>
                         This includes consideration of whether to exclude or adjust that benefit year of data to increase the models' predictive validity or otherwise limit the impact of anomalous trends. For this reason, as described in the 2026 Payment Notice proposed rule,
                        <SU>37</SU>
                        <FTREF/>
                         we conducted extensive analysis on the 2020 benefit year enrollee-level EDGE data to consider its inclusion in the recalibration of the 2024 benefit year risk adjustment models. For example, in the 2024 Payment Notice proposed rule 
                        <SU>38</SU>
                        <FTREF/>
                         and final rule 
                        <SU>39</SU>
                        <FTREF/>
                         we discussed our analysis of the 2020 benefit year data to identify possible impacts of the COVID-19 PHE.
                        <SU>40</SU>
                        <FTREF/>
                         Likewise, when we conducted recalibration of the 2025 benefit year risk adjustment models, we conducted similar analyses on the 2021 benefit year enrollee-level EDGE data as we did to the 2020 benefit year enrollee-level EDGE data to examine the potential impact of the COVID-19 PHE.
                        <SU>41</SU>
                        <FTREF/>
                         We did not find any notable anomalous trends, and determined that deviations identified in 2020 or 2021 benefit year data were within the expected level for any individual data year. Further, we believe the blending of the coefficients from the separately solved models for benefit years 2020 and 2021 with benefit year 2022 for purposes of the 2026 benefit year model recalibration sufficiently stabilizes any differences resulting from the COVID-19 PHE in the 2020 or 2021 datasets. As the 2020 and 2021 benefit years' enrollee-level EDGE data used to recalibrate the 2025 benefit year risk adjustment models are identical to the 2020 and 2021 enrollee-level EDGE data used to recalibrate the 2026 benefit year risk adjustment models, the analyses and conclusions discussed in prior rulemaking equally apply to the recalibration of the risk adjustment models for the 2026 benefit year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             Since the start of model calibration for the HHS risk adjustment models in benefit year 2014, the COVID-19 PHE has been the only such situation to date. Other events and policy changes have not risen to the same level of uniqueness or potential impact.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             89 FR 82308, 82320.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             87 FR 78214-18.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             88 FR 25749-54.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             This analysis included assessing how the 2020 benefit year enrollee-level EDGE recalibration data compares to 2019 benefit year enrollee-level EDGE recalibration data.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             See the 2025 Payment Notice Final Rule, 89 FR 26218, 26236-37.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted decreases in the risk adjustment model R-squared values for the 2022 benefit year enrollee-level EDGE data relative to prior benefit years as presented in Table 10 of the proposed rule.
                        <SU>42</SU>
                        <FTREF/>
                         This commenter requested information regarding any analysis HHS has conducted concerning the reduction in this model performance statistic.
                    </P>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             89 FR 82308, 82347.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Response:</E>
                         First, as demonstrated by Table 10 of the proposed rule,
                        <SU>43</SU>
                        <FTREF/>
                         each individually solved model that contributes to the blended HHS risk adjustment models has an R-squared statistic within the expected range for concurrent claims-based risk scoring models 
                        <SU>44</SU>
                        <FTREF/>
                         such as the models used for the HHS-operated risk adjustment program. Nevertheless, we are aware of and intend to continue monitoring the slight decrease in the R-squared values for the HHS risk adjustment models over the past few years of enrollee-level EDGE data which indicates that the models are explaining slightly less of the variation in plan liability for the 2022 benefit year enrollee-level EDGE data compared to prior benefit years of enrollee-level EDGE data. In our quality control assessments of the recalibration process for the proposed draft 2026 benefit year coefficients, we explored two possible explanations for this decrease in R-squared values—a shift in enrollment and the presence of outlier enrollees with very high costs in the enrollee-level EDGE data.
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             See 89 FR 82308, 82347.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             See Hileman, G., &amp; Steele, S. (2016). Accuracy of Claims-Based Risk Scoring Models. Society of Actuaries. 
                            <E T="03">https://www.soa.org/4937b5/globalassets/assets/files/research/research-2016-accuracy-claims-based-risk-scoring-models.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Our analysis found that the largest percentage decreases in R-squared values between the 2022 benefit year and the 2019 (or 2020) 
                        <SU>45</SU>
                        <FTREF/>
                         benefit year of enrollee-level EDGE data for adult enrollees were for enrollees without HCCs, enrollees with only 1 month of enrollment, and new enrollees (that is, enrollees new to an issuer, whose system identifier was not present for the issuer in the prior year).
                        <SU>46</SU>
                        <FTREF/>
                         We interpret these results to be consistent with a hypothesis that new enrollees and a greater proportion of relatively healthier enrollees in 2022 were partially 
                        <PRTPAGE P="4438"/>
                        responsible for a decrease in model R-squared values between the 2022 benefit year and the 2019 through 2021 benefit years of enrollee-level EDGE data, in that the R-squared value decreases are largest for subgroups that are likely to contain more new enrollees or are difficult to predict, for example, new enrollees to an issuer and enrollees without HCCs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             HHS was unable to incorporate an analysis of new enrollees for the 2019 benefit year of enrollee-level of EDGE data at the time of the analysis of R-squared changes. As such, R-squared changes for new enrollees only considered the difference between 2020 benefit year and 2022 benefit year R-squared values.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>Likewise, our analysis found that the removal of outlier enrollees always resulted in an increase in R-squared values and the impacts were notably higher for 2020, 2021, and 2022 enrollee-level EDGE data than for 2019 enrollee-level EDGE data. We interpret these results to imply that recent data years have exhibited more influential high-cost enrollees. However, we do not see the presence of cost outliers in the enrollee-level EDGE data to be problematic at this time because we generally expect the number of cost outliers to vary from year to year, and we did not find evidence that suggests a clear data error exists related to any of these outliers.</P>
                    <P>In short, although we were able to identify likely contributing factors to the observed slight decrease in R-squared values and will continue to monitor the R-squared values in the future, the R-squared values for 2026 benefit year risk adjustment model recalibration remain high and within the expected range of R-squared values for the type of model used for the HHS-operated risk adjustment program. We remain confident the HHS risk adjustment models continue to operate effectively and appropriately predict plan liability for an average enrollee.</P>
                    <P>
                        After consideration of comments and for the reasons outlined in the proposed rule, this final rule, the 2024 Payment Notice, the 2025 Payment Notice,
                        <SU>47</SU>
                        <FTREF/>
                         and our responses to comments above, we are finalizing this approach as proposed. However, to account for the incorporation of the human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) affiliated cost factor (ACF) with the generic drug exclusion and hierarchy specifications finalized in this rule, we were unable to complete the calculations for the final coefficients in time to publish them in this final rule. Therefore, consistent with § 153.320(b)(1)(i), we are finalizing the use of the 2020, 2021 and 2022 enrollee-level data to calculate the 2026 benefit year coefficients and will publish the final coefficients for the 2026 benefit year in guidance after the publication of this final rule. We will release this guidance in time for rate setting for the 2026 benefit year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             See, supra, notes 22-24, and 26.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Pricing Adjustment for the Hepatitis C Drugs</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82321), we proposed that beginning with the 2026 benefit year, we would begin phasing out the market pricing adjustment 
                        <SU>48</SU>
                        <FTREF/>
                         to the plan liability associated with Hepatitis C drugs in the HHS risk adjustment models and start trending Hepatitis C drugs consistent with the other drugs 
                        <SU>49</SU>
                        <FTREF/>
                         in the HHS risk adjustment models. Since the 2020 benefit year HHS risk adjustment models, we have included a market pricing adjustment to the plan liability associated with Hepatitis C drugs to reflect future market pricing prior to solving for coefficients for the models.
                        <SU>50</SU>
                        <FTREF/>
                         The purpose of this market pricing adjustment was to account for significant pricing changes between the data years used for recalibrating the models and the applicable benefit year of risk adjustment as a result of the introduction of new and generic Hepatitis C drugs.
                        <SU>51</SU>
                        <FTREF/>
                         For the reasons and history described in the proposed rule, we proposed to adopt a multi-year phase out approach to transition the Hepatitis C drugs' trending to move away from the current unique market pricing adjustment for these drugs and align Hepatitis C drugs' trending with the trending approach for specialty drugs.
                        <SU>52</SU>
                        <FTREF/>
                         To begin this transition for the 2026 benefit year HHS risk adjustment models, we proposed to apply the specialty drug trend to 1 year of trending Hepatitis C treatment costs (that is, the trend from 2025 to 2026) for all 3 years of enrollee-level EDGE data used in recalibration (that is, 2020, 2021, and 2022 enrollee-level EDGE data). As such, 2026 benefit year recalibration data for Hepatitis C would reflect 1 year of growth in the cost of treatment at the same rate as other specialty drugs. To continue the transition of phasing out the Hepatitis C drug pricing adjustment in future benefit years' annual model recalibration, we proposed to annually increase the number of years for which we would use the specialty drug trend and decrease the number of years that would use the unique market pricing adjustment for Hepatitis C drugs. We proposed to continue this approach until such time as all enrollee-level EDGE data years used for the recalibration of the HHS risk adjustment models are from benefit year 2025 or later, at which time the specialty drug cost trend would be fully applied to Hepatitis C drug costs consistent with other specialty drugs in the HHS risk adjustment models and we would stop applying the separate market pricing adjustment for Hepatitis C drugs as part of the annual model recalibration.
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             For discussion relating to the Hepatitis C Pricing Adjustment for previous benefit years, 
                            <E T="03">see,</E>
                             for example, 89 FR 26218, 26237-38.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             See 81 FR 12204, 12218-19.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             The Hepatitis C drugs market pricing adjustment to plan liability is applied for all enrollees taking Hepatitis C drugs in the data used for recalibration.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             See Milligan, J. (2018). A perspective from our CEO: Gilead Subsidiary to Launch Authorized Generics to Treat HCV. Gilead. 
                            <E T="03">https://www.gilead.com/news-and-press/company-statements/authorized-generics-for-hcv.</E>
                             See also AbbVie. (2017). AbbVie Receives U.S. FDA Approval of MAVYRETTM (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT 1-6) in as Short as 8 Weeks. Abbvie. 
                            <E T="03">https://news.abbvie.com/news/abbvie-receives-us-fda-approval-mavyret-glecaprevirpibrentasvir-for-treatment-chronic-hepatitis-c-in-all-major-genotypes-gt-1-6-in-as-short-as-8-weeks.htm.</E>
                             See also Silseth, S., &amp; Shaw, H. (2021). Analysis of prescription drugs for the treatment of hepatitis C in the United States [White paper]. Milliman. 
                            <E T="03">https://www.milliman.com/-/media/milliman/pdfs/2021-articles/6-11-21-analysis-prescription-drugs-treatment-hepatitis-c-us.ashx.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             See 89 FR 82308, 82321-23.
                        </P>
                    </FTNT>
                    <P>We sought comment on our proposal to begin to phase out the Hepatitis C drugs market pricing adjustment and trend Hepatitis C drugs consistent with other specialty drugs starting with the annual recalibration of the 2026 benefit year HHS risk adjustment models.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy as proposed. We summarize and respond to public comments received on the proposal to begin to phase out the market pricing adjustment for Hepatitis C drugs starting with the 2026 benefit year below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the proposal to begin to phase out the market pricing adjustment and trend Hepatitis C drugs consistent with other specialty drugs starting with the annual recalibration of the 2026 benefit year HHS risk adjustment models. Many of these commenters agreed with HHS' assessment that the cost trend for Hepatitis C drugs has begun to rise alongside the expected cost of other specialty drugs. A couple of commenters recommended close monitoring of costs and utilization of Hepatitis C drugs to ensure that access to these drugs is not interrupted for enrollees.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are finalizing the phasing out of the market pricing adjustment for Hepatitis C drugs starting with the 2026 benefit year as proposed. We agree with commenters that the cost 
                        <PRTPAGE P="4439"/>
                        trend for Hepatitis C drugs has changed and resulted in the need to reexamine the treatment of these drugs in the HHS risk adjustment models, including consideration of phasing out the market pricing adjustment for these drugs. We also note that the policy adopted in this final rule to phase out the market pricing adjustment for these drugs will allow Hepatitis C drug costs to increase as appropriate alongside other specialty drugs in the simulation of plan liability used for annual HHS risk adjustment model recalibration. Starting this transition beginning with the 2026 benefit year and appropriately accounting for price increases of Hepatitis C drugs in the HHS risk adjustment models alongside other specialty drugs in the simulation of plan liability responds to these observed emerging trends and will better reflect the actuarial risk of an issuer's population, especially for issuers that attract a large number of enrollees using Hepatitis C drugs, helping to prevent adverse selection and the associated perverse incentives. As such, we are finalizing the policy to begin phasing out of the Hepatitis C market pricing adjustment starting with the 2026 benefit year recalibration of the HHS risk adjustment models as proposed, but we will also continue to monitor costs and utilization of drugs, including Hepatitis C drugs, as part of our ongoing efforts to examine ways to continually improve the HHS risk adjustment models for future benefit years.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that HHS continue to review the costs associated with specialty drugs and consider whether market pricing adjustments may be warranted for GLP-1 drugs, gene therapies, or other unique, high-cost drugs that may drive the cost of treating a particular condition in a given benefit year significantly higher than those reflected in the enrollee-level EDGE data years used in recalibration for that benefit year. One commenter noted recently available expensive gene therapies for sickle cell disease as an example of this phenomenon and requested that HHS consider a market pricing adjustment for sickle cell disease treatments.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not propose to change the treatment of high-cost drugs, such as GLP-1 drugs, sickle cell disease treatments, or other gene and cellular therapies, in the 2026 benefit year HHS risk adjustment models and are not finalizing such updates in this final rule. As we discussed in the 2022 Payment Notice 
                        <SU>53</SU>
                        <FTREF/>
                         and 2025 Payment Notice,
                        <SU>54</SU>
                        <FTREF/>
                         we recognize that the data used to recalibrate the HHS risk adjustment models lag by several benefit years behind the applicable benefit year for risk adjustment and therefore may not account for the costs of new, expensive drugs, such as gene therapy drugs, that are expected to be available in the market by the applicable benefit year of risk adjustment. Thus, we continue to consider ways that we could better account for high-cost drugs in the risk adjustment models and, as part of this effort, analyze new data as they become available.
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             See 86 FR 24140, 24163.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             See 89 FR 26218, 26247-48.
                        </P>
                    </FTNT>
                    <P>
                        With specific regard to new gene therapies for sickle cell disease, when we were previously analyzing the changes to the sickle cell disorder related HCCs in the 2025 benefit year risk adjustment models,
                        <SU>55</SU>
                        <FTREF/>
                         we considered whether to add an RXC for existing high-cost sickle cell drugs and new gene therapy treatments, but determined that we need to continue to analyze the evolution and availability of drug treatments for sickle cell disease. Specifically, the new gene therapy drugs for sickle cell disease were not approved for the market until December 2023.
                        <SU>56</SU>
                        <FTREF/>
                         Therefore, the first full year of claims data in which these new sickle cell disease treatments may be reflected will not be available until the 2024 benefit year enrollee-level EDGE data is available. We therefore continue to find that we do not have enough information at the present time to account for these treatments in the HHS risk adjustment models because of the general lack of data on the utilization and cost of gene therapy drugs for sickle cell disease in the individual, small group, and merged markets. We are committed to continuing to analyze new data as they become available and, consistent with § 153.320(b)(1), we would propose the addition of any market pricing adjustments or other changes to the risk adjustment models to account for these treatments through notice-and-comment rulemaking, as appropriate. We also note that if an enrollee in an issuer's risk adjustment covered plan has claims for gene therapy, other high-cost drugs, or other expensive treatments, that enrollee would be eligible for the high-cost risk pool payments if claims for that enrollee are over $1 million.
                        <SU>57</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             See 
                            <E T="03">https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             For example, the new sickle cell gene therapy treatments are expected to exceed the high-cost risk pool payment threshold. See, DeMartino P, Haag MB, Hersh AR, Caughey AB, Roth JA. A Budget Impact Analysis of Gene Therapy for Sickle Cell Disease: The Medicaid Perspective. JAMA Pediatr. 2021 Jun 1;175(6):617-623. doi: 10.1001/jamapediatrics.2020.7140. Erratum in: JAMA Pediatr. 2021 Jun 1;175(6):647. PMID: 33749717; PMCID: PMC7985816. Accessed at 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985816/.</E>
                        </P>
                    </FTNT>
                    <P>Considering the absence of adequate data, we did not propose and are not finalizing a new market pricing adjustment or other model adjustments for sickle cell gene therapy drugs for the 2026 benefit year. We intend to continue to assess sickle cell gene therapy drugs and other high-cost drugs to consider whether model updates for future benefit years are warranted.</P>
                    <P>We also intend to work with interested parties to continue to analyze plan liability for sickle cell disease and the impact of gene and cell therapy treatments, as well as explore the availability of alternative data sources that could be used to monitor utilization and costs outside of currently available enrollee-level EDGE data.</P>
                    <P>
                        As explained in the 2025 Payment Notice (89 FR 26249), we also recently examined the treatment of GLP-1 drugs in the HHS risk adjustment models using the 2022 benefit year enrollee-level EDGE data and found that, at this time, a change was not warranted to the current mapping of GLP-1 drugs to RXC 07 (Anti Diabetic Agents, Except Insulin and Metformin Only).
                        <SU>58</SU>
                        <FTREF/>
                         We understand GLP-1 drug utilization patterns are changing and will continue to assess these trends as additional benefit years of enrollee-level EDGE data become available for potential targeted refinements to the HHS risk adjustment models in future benefit years, as appropriate.
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             As background, RXC 07 (Anti Diabetic Agents, Except Insulin and Metformin Only) is a pharmacotherapeutic class of drugs, which contains a broad array of anti-diabetic medications that vary in cost. RXC 07 (Anti Diabetic Agents, Except Insulin and Metformin Only) does not include all GLP-1 drugs currently on the market; drugs that carry an FDA indication for chronic weight management are excluded from RXC 07 (Anti Diabetic Agents, Except Insulin and Metformin Only). The RXC 07 (Anti Diabetic Agents, Except Insulin and Metformin Only) coefficient in the HHS risk adjustment adult models is meant to reflect the average enrollee cost for individuals being treated by any of the drugs in this class.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested additional information on how HHS defines generic and specialty drugs and what trend assumptions HHS uses for each of these two categories, asserting that this information would help interested parties better evaluate the proposal to begin to phase out the Hepatitis C market pricing adjustment against costs experienced by issuers.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Since the 2017 benefit year, we have subdivided expenditures into traditional drugs, specialty drugs, medical services, and preventive 
                        <PRTPAGE P="4440"/>
                        services and determine trend factors separately for each category of expenditure.
                        <SU>59</SU>
                        <FTREF/>
                         In determining these trend factors, we consult our actuarial experts, review relevant URRT submission data, analyze multiple years of enrollee-level EDGE data, and consult NHEA data as well as external reports and documents 
                        <SU>60</SU>
                        <FTREF/>
                         published by third parties. As described in the 2024 Payment Notice,
                        <SU>61</SU>
                        <FTREF/>
                         in this process, we aim to determine trends that reflect changes in cost of care rather than gross growth in expenditures. We believe the trend factors we used for each expenditure category for the 2026 benefit year are appropriate for the most recent changes in cost of care that we have seen in the market. We further note that, for the purposes of annual risk adjustment model recalibration activities, our definitions of what drugs qualify as either traditional (for example, low-cost and generic drugs) or specialty are also informed by consultations with actuarial experts and by reviewing price data for these drugs. Specific thresholds and criteria may vary according to the class of drugs or the conditions they are intended to treat, but we generally use the Part D specialty-tier cost threshold, which is updated periodically, to differentiate between traditional and specialty drugs.
                        <SU>62</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             See 81 FR 12218. See also the 2016 Risk Adjustment White Paper, available at: 
                            <E T="03">https://www.cms.gov/cciio/resources/forms-reports-and-other-resources/downloads/ra-march-31-white-paper-032416.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             See, for example, “How much is health spending expected to grow?” by the Peterson-Kaiser Family Foundation, available at 
                            <E T="03">https://www.healthsystemtracker.org/chart-collection/how-much-is-health-spending-expected-to-grow/.</E>
                             See also “Medical cost trend: Behind the numbers 2024” by PwC Health Research Institute, available at 
                            <E T="03">https://www.pwc.com/us/en/industries/health-industries/library/assets/pwc-behind-the-numbers-2024.pdf.</E>
                             See also “MBB Health Trends 2024” by MercerMarsh Benefits, available at 
                            <E T="03">https://www.marsh.com/na/services/employee-health-benefits/insights/health-trends-report.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             See 88 FR 25740, 25754-55.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             For example, the specialty-tier cost threshold specified in the Contract Year (CY) 2023 Final Part D Bidding Instructions (available at: 
                            <E T="03">https://www.cms.gov/files/document/2023partdbiddinginstructions.pdf</E>
                            ) will be used to divide prescription drug claims into traditional versus specialty drugs for 2023 enrollee-level EDGE data when they become available.
                        </P>
                    </FTNT>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments above, we are finalizing the proposal to begin phasing out the market pricing adjustment for Hepatitis C drugs starting with the 2026 benefit year, as proposed. However, to account for the incorporation of the PrEP ACF with the generic drug exclusion and hierarchy specifications finalized in this final rule, we were unable to complete the calculations for the final coefficients in time to publish them in this final rule. Therefore, consistent with § 153.320(b)(1)(i), we will publish the final coefficients for the 2026 benefit year in guidance after the publication of this final rule. We will release this guidance in time for rate setting for the 2026 benefit year.</P>
                    <HD SOURCE="HD3">c. Inclusion of Pre-Exposure Prophylaxis (PrEP) in the HHS Risk Adjustment Adult and Child Models as an Affiliated Cost Factor (ACF)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82323), we proposed to incorporate human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) as a separate, new type of factor called an Affiliated Cost Factor (ACF) in the HHS risk adjustment adult and child models starting with the 2026 benefit year. As proposed, the change would reflect an evolution in our approach to defining the factors used in the HHS risk adjustment models to include a factor that is not indicative of an active medical condition and would change our current policy that models the costs of PrEP alongside other preventive services.</P>
                    <P>
                        As explained in the proposed rule (89 FR 82324), as a general principle, we currently incorporate preventive services (including PrEP 
                        <SU>63</SU>
                        <FTREF/>
                        ) into the HHS risk adjustment models to ensure that 100 percent of the cost of those services are reflected in the simulation of plan liability. In the simulation of plan liability, services are only counted as preventive when they occur in the recommended circumstances (for example, age) to the extent we can identify such circumstances from enrollee-level EDGE data. In addition to PrEP drugs, like other preventive services,
                        <SU>64</SU>
                        <FTREF/>
                         ancillary services related to PrEP care (for example, HIV screenings) qualify as preventive services and as such are also currently calibrated at 100 percent plan liability in the recalibration of the HHS risk adjustment adult and child models.
                        <SU>65</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             See 85 FR 28164, 29185-87.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             For example, colonoscopies typically require a combination of several services between the drugs needed for the colonoscopy and the professional and institutional claims for the visit and procedure itself. Likewise, contraception coverage often requires a doctor's visit to obtain a prescription for the contraception.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             See 86 FR 24140, 24164.
                        </P>
                    </FTNT>
                    <P>
                        However, as a part of our commitment to consider ways to continually improve the HHS risk adjustment models, we continued to monitor and assess different ways to more accurately assess the actuarial risk and costs associated with PrEP in the HHS risk adjustment models. In this regard, we stated in the proposed rule (89 FR 82324) that because of PrEP's high costs relative to other preventive services, PrEP services can pose a unique risk of adverse selection to the extent that utilization of PrEP services differs between plans. Our analysis of 2022 benefit year enrollee-level data 
                        <SU>66</SU>
                        <FTREF/>
                         found that the costs of PrEP services remained high, in contrast to our initial assumptions about expected pricing decreases as generics entered the market, and that there are statistically significant, substantial differences in PrEP prevalence between issuers in rating areas where PrEP use is most common, indicating that the addition of a PrEP factor in the adult and child risk adjustment models would be appropriate and would have a meaningful impact on risk adjustment State transfers. Our analysis also found that other considerations that helped inform the current approach (such as the expected decrease in costs as generics entered the market and gained market share) have not addressed the uniquely high costs of PrEP as a preventive service as we previously expected. For these reasons, we proposed to incorporate a non-RXC and non-HCC model factor for PrEP in the HHS risk adjustment adult and child models to capture differences in costs for PrEP utilizers relative to the average enrollee. To signify that the proposed new factor would not indicate the presence of a specific active medical condition, we referred to the proposed new type of factor as an “affiliated cost factor” (ACF), thereby distinguishing this new type of factor from RXCs and HCCs. Furthermore, we proposed a set of seven principles to guide our development of any new ACF variable.
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             Prior to the 2021 Benefit Year, Plan ID and Rating Area were not included as part of the enrollee-level data extracted from issuers' EDGE data submissions. As finalized in the 2023 Payment Notice (87 FR 27208, 27241-51), we now extract these fields as part of the enrollee-level EDGE dataset and are able to include them in our analyses. As such, this recent analysis reflects our earliest opportunity to reliably detect differences in prevalence within rating areas for any medical and prescription drug expenditures, including PrEP.
                        </P>
                    </FTNT>
                    <P>
                        We stated in the proposed rule (89 FR 82324) that in developing an ACF variable reflecting PrEP, we considered whether PrEP satisfies those principles and what approaches were necessary to appropriately balance all seven principles. As described in the proposed rule, a PrEP ACF would easily satisfy the principles of clinical meaningfulness and specificity, 
                        <PRTPAGE P="4441"/>
                        meaningful and predictable costs,
                        <SU>67</SU>
                        <FTREF/>
                         sufficient sample size, and low risk of inappropriate prescribing. However, we also stated in the proposed rule that that the creation of a PrEP ACF variable would require further careful consideration in assessing the other three proposed principles: specifically, the principles of hierarchical factor definitions, monotonicity, and mutually exclusive classification.
                    </P>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             As discussed later in this section, it may be appropriate to remove generic drugs to ensure homogeneity of costs within a PrEP ACF.
                        </P>
                    </FTNT>
                    <P>We stated in the proposed rule (89 FR 82327) that to address the HHS risk adjustment adult modeling concerns we identified regarding these three principles; we considered two alternative approaches. First, we could modify the current definition of RXC 1 (Anti-HIV Agents) by treating PrEP NDCs as RXC 1 NDCs in limited circumstances based on individual enrollee characteristics. Operationally, to capture these cases, the adult enrollees with a PrEP prescription claim would receive the RXC 1 flag instead of the ACF only in cases where the enrollee has both a PrEP prescription claim and an HIV diagnosis but does not have a typical RXC 1 prescription claim because the enrollee did not begin treatment for HIV, or because their treatment medication was provided at no cost to the issuer and therefore no claim was submitted to the issuer's EDGE server. Alternatively, we explained we could place the PrEP ACF in a hierarchy with RXC 1 but define no hierarchical restrictions between PrEP and HCC 1 (HIV/AIDS). This alternative would allow adult enrollees without RXC 1 to receive the PrEP ACF along with HCC 1 in cases where the enrollee has both a PrEP prescription claim and an HCC 1 diagnosis in their medical records for the benefit year. We solicited comments on addressing these hierarchy, monotonicity, and mutual exclusivity concerns, and both alternative approaches designed to address those concerns.</P>
                    <P>
                        We also sought comment on our proposal to create a new ACF category of model factors for incorporation into the HHS risk adjustment models to account for unique medical expenses or services (such as PrEP) that do not meet the criteria to qualify as HCC or RXC factors, but impact the actuarial risk presented to issuers of risk adjustment covered plans. In addition, we sought comment on our proposal to modify the treatment of PrEP in the HHS risk adjustment adult and child models beginning with the 2026 benefit year, as well as how to methodologically define a potential ACF category of model factors that accounts for PrEP (or other unique medical expenses or services) and what other considerations should be part of the analysis and modeling for this proposed new category of model factors (such as the availability of drug rebates 
                        <SU>68</SU>
                        <FTREF/>
                         or differences in medication adherence for PrEP). Furthermore, we sought comment regarding the principles to guide inclusion of potential ACF factors and the alternative approaches for defining a PrEP ACF's hierarchical relationship to HCC 1 and RXC1 to address the concerns related to hierarchical factor definitions, violations of monotonicity, and violations of mutually exclusive classification in the HHS risk adjustment adult models.
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             For example, we believe there are likely substantial rebates for Descovy that are not captured in issuers' EDGE data submissions. See, for example, Dickson, S., Gabriel, N., and Hernandez, I. Estimated changes in price discounts for tenofovir-inclusive HIV treatments following introduction of tenofovir alafenamide. AIDS. 2022 Dec 1;36(15):2225-2227. doi: 10.1097/QAD.0000000000003401. See, also, Krakower, D. and Marcus, J.L. Commercial Determinants of Access to HIV Preexposure Prophylaxis. 
                            <E T="03">JAMA Network Open.</E>
                             2023;6(11):e2342759. doi: 
                            <E T="03">10.1001/jamanetworkopen.2023.42759.</E>
                             See, also, McManus, K.A., et al. Geographic Variation in Qualified Health Plan Coverage and Prior Authorization Requirements for HIV Preexposure Prophylaxis. 
                            <E T="03">JAMA Network Open.</E>
                             2023;6(11):e2342781. doi: 
                            <E T="03">10.1001/jamanetworkopen.2023.42781.</E>
                        </P>
                    </FTNT>
                    <P>
                        Additionally, we solicited comments on whether generic versions of PrEP medication should be excluded from the definition of the proposed ACF for PrEP. As we stated in the proposed rule (89 FR 82326), we found that a large disparity exists between the costs of generic PrEP medication and the costs of brand name PrEP medication.
                        <SU>69</SU>
                        <FTREF/>
                         We explained that due to this disparity, if we include all PrEP medications in the definition of an ACF, the estimated coefficient would likely lead to overprediction for enrollees receiving generic medications and underprediction for enrollees receiving brand name medications. Therefore, an exclusion of low-cost generics from the PrEP ACF could improve predictions for enrollees receiving either generic or brand name PrEP medication and has precedent in our adoption of other factors in the HHS risk adjustment models.
                        <SU>70</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             See, supra, note 53.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             We previously excluded generic drugs from RXC 9, Immune Suppressants and Immunomodulators, due to concern over patient access and health plan selection behavior. See the 2019 Payment Notice (83 FR 16942).
                        </P>
                    </FTNT>
                    <P>Lastly, we sought comment concerning whether there are any similar medical expenses or services that we should consider for potential new ACFs alongside PrEP.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing the addition of PrEP as an ACF in the HHS risk adjustment adult and child models, but are excluding generic versions of PrEP from the ACF at this time, and are placing the PrEP ACF in the adult models in a hierarchy below RXC 1 (Anti-HIV Agents) without defining any hierarchical relationship between the PrEP ACF and HCC 1 (HIV/AIDS). In the child models, which do not contain RXCs, we are finalizing the placement of the PrEP ACF in a hierarchy with HCC 1. We summarize and respond to public comments received on the proposed addition of PrEP as an ACF in the HHS risk adjustment adult and child models starting with the 2026 benefit year below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the proposal to add PrEP to the HHS risk adjustment adult and child models as an ACF. Many of these commenters noted agreement with HHS' determination that PrEP presents a unique risk of adverse selection among preventive services and that the addition of PrEP to the HHS risk adjustment adult and child models would mitigate perverse incentives for issuers to minimize their exposure to enrollees who can benefit from PrEP despite the mandate to cover preventive services with no enrollee cost sharing. Several commenters stated that this addition to the HHS risk adjustment adult and child models will better align issuers' incentives with the public health benefit of preventing HIV transmission. A few commenters acknowledged that PrEP may be appropriate to include in the HHS risk adjustment adult and child models but noted doubt that a new class of factors (that is, ACFs) was necessary.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that PrEP should be properly represented in the HHS risk adjustment adult and child models to mitigate the potential for adverse selection and appreciate the support for the addition of a new PrEP ACF to these models beginning with the 2026 benefit year. As explained in the proposed rule (89 FR 82308, 82323-24), we believe that creating a new class of factors is necessary and appropriate at this time to capture actuarial risks and costs that may contribute to adverse selection but are not indicative of an active medical condition, as is the case with PrEP, and therefore would not be reflected in the 
                        <PRTPAGE P="4442"/>
                        HCC and RXC factors used in the HHS risk adjustment models.
                    </P>
                    <P>
                        Although this new ACF class of model factors is guided by similar principles 
                        <SU>71</SU>
                        <FTREF/>
                         for inclusion as the existing RXC class of model factors,
                        <SU>72</SU>
                        <FTREF/>
                         we feel that it is conceptually appropriate to distinguish between these two classes. As stated in the 2018 Payment Notice,
                        <SU>73</SU>
                        <FTREF/>
                         RXCs were specifically incorporated into the HHS risk adjustment models as separate factors from HCCs (which indicate the presence of a diagnosis directly) to impute a missing diagnosis or indicate severity of a diagnosis. Because the PrEP ACF (and any potential future ACFs) are not intended to be related to a diagnosis for any medical condition, we believe it is appropriate to distinguish such model factors from RXCs and HCCs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             See 89 FR 82308, 82324-31.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             See 81 FR 94058, 94074-80. See also the 2016 HHS Risk Adjustment White Paper. Available at 
                            <E T="03">https://www.cms.gov/cciio/resources/forms-reports-and-other-resources/downloads/ra-march-31-white-paper-032416.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             Ibid. See also the March 31, 2016, 
                            <E T="03">HHS-Operated Risk Adjustment Methodology Meeting Questions &amp; Answers.</E>
                             June 8, 2016. Available at 
                            <E T="03">https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/RA-OnsiteQA-060816.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter opposed the proposal to add PrEP to the HHS risk adjustment adult and child models as an ACF on the basis that the commenter believes including PrEP in the HHS risk adjustment adult and child models is discriminatory, expressing a belief that risk adjustment and the assignment of risk scores to enrollees based on health conditions is discriminatory in general.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         HHS takes seriously our obligation to protect individuals from discrimination and generally disagrees that the use of factors based on enrollees' age, sex, and health conditions or utilization of services and treatments in risk adjustment is inappropriate. Consistent with section 1343 of the ACA, the HHS-operated risk adjustment program reduces the incentives for issuers to avoid higher-than-average risk enrollees, such as those with chronic conditions, by using charges collected from issuers that attract lower-than-average risk enrollees to provide payments to health insurance issuers that attract higher-than-average risk enrollees. The ACA limits issuers' ability to establish or charge premiums on the basis of age and prohibits issuers' ability to do so on the basis of sex or any individual health characteristic other than tobacco use.
                        <SU>74</SU>
                        <FTREF/>
                         However, the cost of care for and actuarial risk of enrollees is, in part, correlated with their age, sex, health conditions (or severity thereof), and likelihood to utilize services and treatments. As such, without the inclusion of factors related to age, sex, health conditions, and use of services and treatments in the HHS risk adjustment models, some issuers would be incentivized to design plans that are less attractive to potential enrollees whose age-sex category, health conditions, or use of services and treatments is predicted to create a higher liability for the issuer. The various factors in the HHS risk adjustment models help alleviate this incentive by ensuring that the actuarial risk of an issuers' enrollee population in a State market risk pool, including issuers that enroll a higher-than-average proportion of enrollees who fall into a high-cost age-sex category or are likely utilizers of high-cost preventive services (PrEP, for example), are appropriately assessed as part of the calculations under the State payment transfer formula. The use of factors associated with age, sex, health conditions, and the use of services and treatments (including expensive preventive services, such as PrEP) in the HHS risk adjustment models is therefore necessary, appropriate, and helps reduce the likelihood that discrimination based on any of these factors will occur with respect to health insurance coverage issued or renewed in the individual and small group (including merged) markets.
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             See section 2701 of the Public Health Service Act (42 U.S.C. 300gg) as amended by section 1201 of the ACA. See also the Market Rules and Rate Review final rule (78 FR 13406, 13411-13).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter opposed the proposal due to concerns that the addition of ACFs would increase risk adjustment model complexity. A few commenters urged caution in implementing the proposal or requested that HHS implement the addition of the PrEP ACF on a pilot basis. A few commenters requested a technical paper be published on the ACF concept.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate commenters' interest in carefully considering the impact of the addition of a PrEP ACF to the HHS risk adjustment adult and child models. We will continue to monitor the performance of the HHS risk adjustment models, including the impact of the new PrEP ACF. Although the HHS risk adjustment models are made more complex by the addition of any new model factor, we believe that the seven principles for considering new ACFs discussed in the proposed rule,
                        <SU>75</SU>
                        <FTREF/>
                         as well as the existing principles for consideration of HCCs 
                        <SU>76</SU>
                        <FTREF/>
                         and RXCs,
                        <SU>77</SU>
                        <FTREF/>
                         are sufficient to ensure that new model factors are only added when appropriate. In particular, we note that the addition of the PrEP ACF satisfies the principles of clinical meaningfulness and specificity, meaningful and predictable costs, sufficient sample size, and low risk of inappropriate prescribing. Therefore, we determined that the addition of the PrEP ACF is likely to improve the predictive validity of the models with respect to the portion of the enrollee population that are eligible for PrEP. With the specifications finalized in this rule to address the principles of hierarchical factor definitions, monotonicity, and mutually exclusive factor definitions, we believe that the benefits of adding a new PrEP ACF outweighs the concerns about model complexity. In addition, our recent analysis of 2022 benefit year enrollee-level EDGE data confirmed there is sufficiently robust data to justify the addition of the PrEP ACF and calculate its coefficients for the HHS risk adjustment adult and child models beginning with the 2026 benefit year such that a pilot period for the PrEP ACF is unnecessary.
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             See 89 FR 82308, 82325-27.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             See the 2014 Payment Notice Proposed Rule (77 FR 73118, 73128) and the 2014 Payment Notice Final Rule (78 FR 15410, 15420). See also Kautter, J. et al (2014). The HHS-HCC Risk Adjustment Model for Individual and Small Group Markets under the Affordable Care Act. 
                            <E T="03">Medicare and Medicaid Research Review, 4</E>
                            (3). Available at: 
                            <E T="03">https://www.cms.gov/mmrr/Downloads/MMRR2014_004_03_a03.pdf.</E>
                             See also the 2016 HHS Risk Adjustment White Paper (available at: 
                            <E T="03">https://www.cms.gov/cciio/resources/forms-reports-and-other-resources/downloads/ra-march-31-white-paper-032416.pdf</E>
                            ) and the 2021 RA Technical Paper (available at: 
                            <E T="03">https://www.cms.gov/files/document/2021-ra-technical-paper.pdf</E>
                            ).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             See the 2018 Payment Notice Proposed Rule (81 FR 61456, 61470-71) and the 2018 Payment Notice Final Rule (81 FR 94058, 94075-80).
                        </P>
                    </FTNT>
                    <P>
                        As always, as part of our ongoing efforts to continually improve the precision of the HHS risk adjustment models, we will seek input from interested parties through notice-and-comment rulemaking or other appropriate vehicles (including technical papers, as appropriate) on potential changes to the HHS risk adjustment models, including any potential new ACFs we may consider in the future. However, in light of the rationale and data discussed in the proposed rule, and in response to the comments in support of adding the PrEP ACF to the HHS risk adjustment adult and child models beginning with the 2026 benefit year, we do not believe a technical paper is warranted before finalizing the addition of the PrEP ACF to the HHS risk adjustment adult and child models.
                        <PRTPAGE P="4443"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters expressed a preference for excluding generic drugs from the definition of the PrEP ACF, noting the vast difference in prices between brand name and generic drugs. One commenter noted that their experience showed that prices for brand name PrEP drugs can be as much as 100 times the cost of generic PrEP drugs. A few commenters stated that excluding generics would better support patients as advances in PrEP come to market, with a few commenters specifically noting that newer branded forms of PrEP drugs that are more effective, more tolerable, and long-acting will likely be the predominant form of PrEP in the near future. Furthermore, a few commenters were concerned that including generics in the PrEP ACF definition would overcompensate plans that prescribe more generics than average or would otherwise contribute to adverse selection incentives.
                    </P>
                    <P>Several other commenters noted a preference for generic drugs to be included in the definition of the PrEP ACF on the basis that excluding generics may incentivize prescription of brand name drugs and inefficient care patterns. A few of these commenters noted that issuers are likely receiving considerable manufacturer rebates for PrEP that may not be reflected in the enrollee-level EDGE data that HHS uses for risk adjustment model recalibration.</P>
                    <P>One commenter who supported the exclusion of generics requested that step-therapy requirements be instituted for PrEP drugs that have both a generic and brand name formulation. A few commenters noted an interest in splitting the PrEP ACF into two ACFs according to brand name/generic status or based on oral/injectable form.</P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the comments and agree with the position that the vast difference in costs between brand name and generic PrEP drugs warrants an exclusion for generic drugs from the definition of the PrEP ACF. Although excluding generic drugs from the definition of a model factor may, in many cases, encourage the prescription of brand name drugs over generic drugs and encourage inefficient care patterns, we do not believe this is especially likely in the case of PrEP due to the very large difference in price between the only generic form of PrEP available on the market and the multiple brand name forms available. Moreover, we are concerned that the inclusion of generic drugs would lead to an overpayment for coverage of generic drugs and an underpayment for coverage of brand name drugs, potentially incentivizing issuers to limit access to brand name drugs. Because there is presently only one form of generic PrEP available on the market (a daily oral regimen), barriers to accessing brand name drugs, including step-therapy requirements, would only limit access to newer and more tolerable formulations, including long-acting injectable forms of PrEP. Additionally, step-therapy requirements would be inconsistent with recently released guidance relating to coverage of preventive services under section 2713 of the PHS Act specifying that issuers must cover, without cost sharing, all three FDA-approved PrEP formulations (two oral and one injectable) and are not permitted to use medical management techniques to direct individuals prescribed PrEP to utilize one formulation over another.
                        <SU>78</SU>
                        <FTREF/>
                         As such, to further limit the influence of perverse incentives, to align with the recent guidance, and in recognition of the very large difference in price between generic and brand name forms of PrEP, beginning with the 2026 benefit year, we are finalizing the addition of the PrEP ACF to the HHS risk adjustment adult and child models with an exclusion of generic versions of PrEP medication from the definition of the PrEP ACF. We will continue to monitor the impact of the new PrEP ACF, as well as the cost and utilization of PrEP drugs in the market, and may consider alterations to the new PrEP ACF if the prices of generic and brand name forms of PrEP become more comparable, additional generic forms of PrEP enter the market, or we observe market distortions or other impacts resulting from the addition of the new PrEP ACF to the adult and child models that should be addressed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             See 
                            <E T="03">https://www.cms.gov/files/document/faqs-implementation-part-68.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We may also consider the potential addition of a separate generic drug PrEP ACF in the future, but would need to consider whether the inclusion of an ACF for generic drugs would satisfy the principles finalized in this rule to guide the adoption of potential additional ACFs in the future. In particular, we would need to consider whether a generic drug PrEP ACF would satisfy the principle of meaningful and predictable costs (Principle 2), as the cost of the generic version of PrEP currently available on the market is fairly low and may not produce a meaningful coefficient if incorporated into the HHS risk adjustment adult and child models. As part of this future analysis, we may also consider whether a distinction between oral and injectable PrEP is warranted. However, we note that the annual costs of brand name oral and injectable forms are currently similar and that the only generic form of PrEP currently available is an oral form. Therefore, the splitting of the PrEP ACF into oral and injectable forms may still necessitate the exclusion of generic PrEP due to the cost disparity between the generic and brand name oral forms, which would continue to lead to overprediction for the generic form, incentivizing issuers to use medical management techniques to direct individuals prescribed oral PrEP to utilize the generic oral formulation over other branded oral forms that may have fewer side effects or otherwise be more appropriate for the enrollee. We would seek input from interested parties through notice-and-comment rulemaking or other appropriate vehicles on any such potential changes.</P>
                    <P>
                        Regarding the comments related to manufacturer rebates, we acknowledge that manufacturer rebates are common and may impact drug prices for a wide variety of prescription drugs.
                        <SU>79</SU>
                        <FTREF/>
                         We note that issuers are currently instructed that they do not need to adjust the reported Plan Paid Amount to reflect manufacturer rebates in the data made available to HHS through issuers' EDGE servers.
                        <SU>80</SU>
                        <FTREF/>
                         As such, using enrollee-level EDGE data to precisely account for manufacturer rebates for any prescription drugs in the HHS risk adjustment adult and child models may necessitate changes to issuers' data submission practices. We continue to consider these issues and different ways to potentially account for these rebates in the HHS risk adjustment models in future benefit years.
                    </P>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             See, for example, Shepherd, Joanna. (2020). Pharmacy benefit managers, rebates, and drug prices: conflicts of interest in the market for prescription drugs. 
                            <E T="03">Yale Law &amp; Policy Review, 38(2),</E>
                             360-396. Available at: 
                            <E T="03">https://heinonline.org/HOL/P?h=hein.journals/yalpr38&amp;i=390.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             See the EDGE Server Business Rules, Version 25 (December 2024). Available at: 
                            <E T="03">https://regtap.cms.gov/reg_librarye.php?i=3765</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         All commenters on the two hierarchy options set forth in the proposed rule preferred the alternative approach in which HHS would allow adult enrollees with HIV to receive credit for PrEP and place the PrEP ACF in the adult models in a hierarchy below RXC 1 (Anti-HIV Agents). Commenters noted that this approach is the most straightforward approach, that it maintains a strong adherence to the seven principles for developing a new ACF factor set forth in the proposed rule, and that it ensures that the HHS risk adjustment models can distinguish between preventive use of PrEP and treatment of active HIV infection, thus mitigating overlap issues and preserving the integrity of the classification system.
                        <PRTPAGE P="4444"/>
                    </P>
                    <P>One commenter suggested that if the ACF for PrEP is added to the HHS risk adjustment child models, RXC 1 (Anti-HIV Agents) should also be added to the child models with the same hierarchy specifications as the adult models. This commenter asserted that without this modification, it may be difficult to differentiate enrollees subject to the child models who are on PrEP from those who are taking antiretrovirals to manage active HIV infections.</P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the alternative hierarchy approach for the adult models set forth in the proposed rule is straightforward and would appropriately address the hierarchy concerns identified in the proposed rule with regards to the adult models, namely the violations of the hierarchical factor definitions principle (Principle 4), the monotonicity principle (Principle 5), and the mutually exclusive classification system principle (Principle 6).
                        <SU>81</SU>
                        <FTREF/>
                         Because we are able to appropriately address these violations through the adoption of the alternative hierarchy approach, we also agree that the adult models will be able to appropriately distinguish between the preventive use of PrEP and the treatment of an active HIV infection. Therefore, in the HHS risk adjustment adult models we are finalizing the hierarchy option that places the PrEP ACF below RXC 1 in a hierarchy without defining any hierarchical relationship between the PrEP ACF and HCC 1 (HIV/AIDS). Under this approach, adult enrollees without RXC 1 will receive the PrEP ACF along with HCC 1 in cases where the enrollee has both a PrEP prescription claim and an HCC 1 diagnosis in their medical records for the benefit year. Further, under this approach, an adult enrollee with a PrEP prescription claim in their medical records for the benefit year who later tests positive for HIV in the same benefit year would have an increase in their risk score for that year as a result of the additional diagnosis, appropriately satisfying the principles of additivity (Principle 4) and monotonicity (Principle 5).
                    </P>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             This alternative hierarchy approach satisfies the intent of Principle 6 (mutually exclusive classification) by using similar considerations and filtering steps to those we currently use in our simulation of plan liability for PrEP.
                        </P>
                    </FTNT>
                    <P>
                        Regarding the comment requesting the addition of RXC 1 to the child models with the same hierarchy specifications as the adult models, we did not propose and are not finalizing the addition of any RXCs to the HHS risk adjustment child models. Currently, only the HHS risk adjustment adult models include RXCs. Determining whether it is appropriate to add any RXCs to the child models would require careful analysis and consideration, and we would want to solicit public comment on such analysis, which was not possible between the receipt of these comments and publication of this final rule. For example, similar to the development of the RXC-HCC pairs for the HHS risk adjustment adult models, we would need to work with clinicians to analyze, select, and tailor the RXCs that could be used to impute diagnoses and to indicate the severity of diagnoses otherwise indicated through medical coding as appropriate for the child models.
                        <SU>82</SU>
                        <FTREF/>
                         We would also need to propose and solicit comments on such potential draft factors in the applicable HHS notice of benefit and payment parameters.
                    </P>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             For information on the development of the RXC-HCC pairs for the adult models, including the guiding principles and other considerations, see the 2018 Payment Notice Proposed Rule (81 FR 61456, 61470-71), the 2018 Payment Notice Final Rule (81 FR 94058, 94075-80), and the 2019 Payment Notice Final Rule (83 FR 16930, 16941-43). Also see Chapter 4, 2016 HHS Risk Adjustment White Paper, available at: 
                            <E T="03">https://www.cms.gov/cciio/resources/forms-reports-and-other-resources/downloads/ra-march-31-white-paper-032416.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        However, we agree with the commenter that there is an important issue with the hierarchy specification(s) related to the addition of the PrEP ACF in the child models that needs to be addressed when finalizing these new factors for the models. To explain, we first note that because the HHS risk adjustment child models do not contain RXCs, the costs of HIV treatment (inclusive of the HIV treatment medication regimens captured in RXC 1 in the adult models) are accounted for in the HCC 1 coefficient in the child models. As such, in contrast to the adult models, where the RXC 1 coefficient is generally larger than the PrEP ACF or HCC 1 coefficient, with the HCC 1 coefficient having the smallest coefficient of the three adult model factors, the absence of RXC 1 in the child models generally results in a higher coefficient for HCC 1 than the PrEP ACF coefficient. As such, without a hierarchy specification limiting the application of the PrEP ACF in the child models, an enrollee subject to the child models who was on PrEP for part of a benefit year, but was later diagnosed with HIV (and would therefore likely be prescribed treatment for an active HIV infection instead) would receive a large increase to their risk score (approximately 3.993, per the draft silver coefficient for HCC 1 in the child models as reflected in Table 5 of the proposed rule) 
                        <SU>83</SU>
                        <FTREF/>
                         because the enrollee would be receiving risk score components associated with both prevention and treatment of HIV. However, in the context of the adult model PrEP ACF and hierarchy specification finalized in this rule, a similar enrollee subject to the adult models who was on PrEP for part of a benefit year, but was later diagnosed with HIV and started to take an RXC 1 drug for treatment would receive a much smaller increase to their risk score (approximately 1.962 per the silver coefficients for the adult models as reflected in Tables 2 and 4 of the proposed rule) 
                        <SU>84</SU>
                        <FTREF/>
                         because the enrollee's risk score would only reflect the difference in cost associated with treatment relative to prevention.
                    </P>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             See 89 FR 82308, 82328-41. Note that these values are approximate and presented here only for illustrative purposes. We note that the proposed rule estimates included generic drugs in the definition of the PrEP ACF but in this rule we are finalizing that generic drugs will be excluded from PrEP ACF definition for both the adult and child models. As such, these values should be taken only as rough estimates of the impact of the hierarchy specification on the example enrollee.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        Pending further research and consideration on the impact of adding RXCs (such as RXC 1) to the child models, to better align the representation of risk between the adult and child models and more appropriately reflect the cost of enrollees who receive both PrEP and HIV treatment in the same benefit year in the child models, we believe that an appropriate approach would be to place the PrEP ACF below HCC 1 in a hierarchy in the child models. This would allow the risk score of an enrollee subject to the child models who was on PrEP for part of a benefit year but was later diagnosed with HIV to reflect only the difference in cost associated with treatment relative to prevention (approximately 2.719 per the silver coefficients for the child models as reflected in Tables 3 and 5 of the proposed rule) 
                        <SU>85</SU>
                        <FTREF/>
                         rather than the whole cost of both treatment and prevention.
                    </P>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        We are finalizing as proposed the addition of a new PrEP ACF to the child models and, in response to comments, we will place the PrEP ACF in a hierarchy below HCC 1 in the child models to ensure that child enrollees who have both a PrEP prescription claim and an HCC 1 (HIV/AIDS) diagnosis reflected in their medical records for a benefit year (and are therefore likely receiving active treatment) will receive an appropriate increase to their risk score relative to enrollees in the child models without an 
                        <PRTPAGE P="4445"/>
                        HCC 1 diagnosis who have a PrEP prescription claim in their medical records for that year.
                    </P>
                    <P>We will consider if any additional changes to the child models are necessary as we continue to monitor the impact of the new PrEP ACF and consider potential refinements to the ACF framework in future benefit years. As always, as part of our ongoing efforts to continually improve the precision of the HHS risk adjustment models, we will seek input from interested parties through notice-and-comment rulemaking or other appropriate vehicles on potential changes to the models in future benefit years.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters offered ideas for additional ACFs to be added to the HHS risk adjustment models in the future. These included ACFs for biologic drugs, GLP-1 drugs, and cellular and gene therapies. Other commenters' suggestions requested the use of the ACF framework to restructure how childbirth, organ transplants, end stage renal disease (ESRD), dialysis, respirator dependance, amputations, autism spectrum disorder, moderate forms of psychiatric illness, and prophylactic interventions such as prophylactic mastectomy are accounted for in the HHS-operated risk adjustment program.
                    </P>
                    <P>A few commenters requested changes to the risk adjustment specifications for one or more of these conditions without specifying that the ACF framework was the proper vehicle for addressing their concerns.</P>
                    <P>
                        <E T="03">Response:</E>
                         We did not propose and therefore are not finalizing the adoption of additional ACFs at this time. However, we are finalizing the adoption of the ACF framework and the proposed principles to guide any potential development of additional ACFs to the HHS risk adjustment models in the future. We appreciate the suggestions regarding other conditions or diagnoses for which it may be appropriate to leverage the ACF framework to restructure or refine the treatment of the other identified clinically meaningful enrollee characteristics in the HHS risk adjustment models. As we consider potential refinements to the ACF structure and other changes to the HHS risk adjustment models in the future, we may further consider these suggestions and the structure of related HCCs. As always, as part of our ongoing efforts to continually improve the precision of the HHS risk adjustment models, if we were to make changes to the ACF structure or other changes to the HHS risk adjustment models in the future, we will seek input from interested parties through notice-and-comment rulemaking or other appropriate vehicles on such potential changes.
                    </P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments above, we are finalizing the addition of PrEP as an ACF in the adult and child risk adjustment models beginning with the 2026 benefit year. Furthermore, we are finalizing the exclusion of generic versions of PrEP from the PrEP ACF and are finalizing the placement of the PrEP ACF in the adult models in a hierarchy below RXC 1 (Anti-HIV Agents) without defining any hierarchical relationship between the PrEP ACF and HCC 1 (HIV/AIDS). In the child models, which do not contain RXCs, we are finalizing the placement of the PrEP ACF in a hierarchy below HCC 1. Additionally, we are finalizing the proposed ACF framework and principles used to determine whether it is appropriate to add a new ACF to the HHS risk adjustment models, and how the hierarchy structure associated with an ACF should be defined.</P>
                    <P>We were unable to complete the calculations for the final coefficients in time to publish them in this final rule because additional time is needed to complete the calculations needed to account for the incorporation of the PrEP ACF with the generic drug exclusions and hierarchy specifications finalized in this rule. Therefore, consistent with § 153.320(b)(1)(i), we will publish the final coefficients for the 2026 benefit year in guidance after the publication of this final rule. We will release this guidance by the spring of 2025 in time for rate setting for the 2026 benefit year.</P>
                    <HD SOURCE="HD3">d. List of Factors To Be Employed in the HHS Risk Adjustment Models (§ 153.320)</HD>
                    <P>
                        Consistent with § 153.320(b)(1)(i), we are finalizing the use of the 2020, 2021 and 2022 enrollee-level EDGE data to calculate the 2026 benefit year coefficients and will publish the final coefficients for the 2026 benefit year in guidance after the publication of this final rule, as we were unable to complete the calculations to finalize them in time to publish them in this final rule,
                        <SU>86</SU>
                        <FTREF/>
                         due to the additional calculations needed to account for the incorporation of the PrEP ACF with the generic drug exclusions and hierarchy specifications as finalized in this rule. The proposed 2026 benefit year HHS risk adjustment model factors resulting from the equally weighted (averaged) blended factors from separately solved models using 2020, 2021, and 2022 enrollee-level data are shown in Tables 2 through 9 of the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82328 through 46). As we have done for certain prior benefit years,
                        <SU>87</SU>
                        <FTREF/>
                         we will release the final 2026 benefit year coefficients in guidance after publication of this final rule by the spring of 2025 in time for rate setting for the 2026 benefit year. We received several comments requesting additional changes to the HHS risk adjustment models that we did not consider or propose in the proposed rule. We respond to these comments below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             See 45 CFR 153.320(b)(1)(i).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             For example, the final 2018 benefit year HHS risk adjustment model coefficients were not published in the 2018 Payment Notice final rule (81 FR 94058, 81 FR 94084) but were instead published on the CMS website and are available at 
                            <E T="03">https://www.cms.gov/cciio/programs-and-initiatives/premium-stabilization-programs/downloads/2018-benefit-year-final-hhs-risk-adjustment-model-coefficients.pdf.</E>
                             See also, for example, the final 2021 benefit year HHS risk adjustment model coefficients, which were not published in the 2023 Payment Notice final rule (85 FR 29164, 29190) but were instead published on the CMS website and are available at 
                            <E T="03">https://www.cms.gov/cciio/resources/regulations-and-guidance/downloads/final-2021-benefit-year-final-hhs-risk-adjustment-model-coefficients.pdf.</E>
                        </P>
                        <P>
                            See also, for example, the final 2023 benefit year HHS risk adjustment model coefficients, which were not published in the 2023 Payment Notice final rule (87 FR 27208, 27235) but were instead published on the CMS website and are available at 
                            <E T="03">https://www.cms.gov/files/document/2023-benefit-year-final-hhs-risk-adjustment-model-coefficients.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that HHS update the risk adjustment models to incorporate Tepezza and Graves Disease/Hyperthyroidism.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not propose and are not finalizing changes to add an RXC to the HHS risk adjustment adult models for Tepezza, which treats thyroid eye disease, or to add a payment HCC for Graves Disease/Hyperthyroidism. We recently discussed the approach to the treatment of Tepezza and Graves Disease/Hyperthyroidism in the HHS risk adjustment models in the 2025 Payment Notice final rule,
                        <SU>88</SU>
                        <FTREF/>
                         explaining that thyroid eye disease (thyrotoxicosis) is currently categorized in a condition category (Other Endocrine/Metabolic/Nutritional Disorders) that is not a payment HCC in the HHS risk adjustment models. Further, all RXCs in the HHS adult risk adjustment models are associated with a payment HCC. We therefore generally have concerns about adding thyroid eye disease to the HHS risk adjustment models at this time as it is currently not categorized as a payment HCC and we would need to perform further analysis to consider whether it is appropriate and how best 
                        <PRTPAGE P="4446"/>
                        to incorporate this condition into the models given these concerns. For these reasons, HHS did not propose and is not finalizing any changes with respect to the treatment of Tepezza for thyroid eye disease in the 2026 benefit year risk adjustment models. However, HHS intends to continue analysis of Graves Disease/Hyperthyroidism and thyrotoxicosis and the use of Tepezza as more data becomes available and consider potential changes to the treatment of this condition and drug in the HHS risk adjustment models for future benefit years.
                    </P>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             See 89 FR 26218, 26248-49.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters identified certain conditions that they believe are undercompensated in the risk adjustment models. These conditions included autism spectrum disorder, ESRD, and maternal and newborn care. These commenters requested that HHS reconsider how these conditions and their associated costs are accounted for in the HHS risk adjustment models. Additionally, one commenter requested that HHS revisit the analysis in the 2021 RA Technical Paper,
                        <SU>89</SU>
                        <FTREF/>
                         expressing concern that the risk associated with the lowest-risk enrollees remains underpredicted by the HHS risk adjustment models. One commenter recommended that HHS study the impact of calibrating the HHS risk adjustment models separately for the individual and small group markets due to differences in the characteristics of the enrollee population between the two markets. Furthermore, one commenter recommended that HHS consider ways to account for plan design generosity as more generous plans tend to attract enrollees with expensive chronic conditions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             See 
                            <E T="03">https://www.cms.gov/files/document/2021-ra-technical-paper.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the suggestions regarding conditions that commenters identified for review of how they are accounted for in the HHS risk adjustment models. Although we did not propose and are not finalizing changes to the treatment of the identified conditions in the 2026 benefit year risk adjustment models, we generally note that we consistently monitor the performance of the risk adjustment models, including through out-of-sample analysis of predictive ratios associated with each model factor, as additional years of enrollee-level EDGE data become available. Results of these monitoring activities were a key impetus for several risk adjustment model changes finalized in the 2023 Payment Notice 
                        <SU>90</SU>
                        <FTREF/>
                         to address the adult and child models' underprediction for enrollees with many HCCs. Specifically, we finalized the interacted HCC counts and HCC-contingent enrollment duration factor model specifications to improve model prediction for higher risk enrollees and ensure that issuers are being accurately compensated for these enrollees. As such, the potential for underprediction or overprediction in the HHS risk adjustment models is an area that HHS is consistently monitoring and addressing as needed and will continue to monitor and address in the future as part of our ongoing efforts to continually improve the HHS risk adjustment models. We also note that the conditions or diagnoses identified in these comments show strong overlap with the conditions that some commenters identified as being appropriate to be addressed by the ACF framework and that, as stated in our response to comments about those conditions in that section of this final rule, we will take these comments into consideration as we consider potential refinements to the HHS risk adjustment models in future benefit years.
                    </P>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             87 FR 27208, 27221-30.
                        </P>
                    </FTNT>
                    <P>
                        In regard to the request to revisit the analysis in the 2021 RA Technical Paper, we appreciate the commenter's concern. As noted in the 2023 Payment Notice,
                        <SU>91</SU>
                        <FTREF/>
                         our analysis of the addition of the interacted HCC counts factors in the adult and child models, the removal of the former adult model severity illness factors, and the replacement of the former enrollment duration factors with the HCC-contingent enrollment duration factors in the adult models found that the combined impact of these changes would significantly improve predictions across most deciles and HCC counts for the very highest-risk enrollees, as well as the lowest-risk enrollees without HCCs.
                        <SU>92</SU>
                        <FTREF/>
                         These model specification updates were implemented starting with the 2023 benefit year HHS risk adjustment models and we intend to monitor the impact of these updates as part of future benefit years' model recalibrations using additional years of available enrollee-level EDGE data.
                    </P>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             Ibid. See also Figure 4.2. HHS-Operated Risk Adjustment Technical Paper on Possible Model Changes. (2021, October 26). CMS. 
                            <E T="03">https://www.cms.gov/files/document/2021-ra-technical-paper.pdf.</E>
                        </P>
                    </FTNT>
                    <P>As we consider potential refinements to the HHS risk adjustment models in the future, we will also continue to monitor the specific conditions identified by commenters, along with the structure of related model factors, and the impact of recent model specification updates on the ability of the models to predict risk across all subgroups of enrollees and enrollees with chronic conditions who are more likely to enroll in plans with more generous coverage. We also will continue to study whether differences in the characteristics of the enrollee population between the individual and small groups markets would warrant calibrating the HHS risk adjustment models separately for the individual and small group markets. As always, as part of our ongoing efforts to continually improve the precision of the HHS risk adjustment models, if we were to pursue changes to the risk adjustment models in the future, we will seek input from interested parties through notice-and-comment rulemaking or other appropriate vehicles.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested clarification regarding how medically administered injectable drugs are accounted for in the HHS risk adjustment models. These commenters were concerned that these drugs appear to be filtered out of enrollee claims data for the purpose of calculating risk scores.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate commenters bringing this concern to our attention. Although not expressly stated by commenters, we believe these concerns stem from the commenters' interpretation of language in guidance document(s) such as the Risk Adjustment DIY Software Instructions.
                        <SU>93</SU>
                        <FTREF/>
                         To clarify, for RXC eligibility (including medically administered injectable claims), a professional or outpatient medical claim does not need to have a risk adjustment eligible service code or bill type code. Instead, the professional or outpatient claim simply needs to have a service code that maps to an RXC for selection and inclusion in enrollee claims data for purposes of calculating risk scores. We intend to update language in these guidance document(s) in future releases to clarify this point.
                    </P>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             For example, see the 2024 Benefit Year Risk Adjustment Updated HHS-Developed Risk Adjustment Model Algorithm “Do It Yourself (DIY)” Software Instructions, available at: 
                            <E T="03">https://www.cms.gov/files/document/cy2024-diy-instructions-09062024.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">e. Cost-Sharing Reduction Adjustments</HD>
                    <P>
                        In the 2025 Payment Notice (89 FR 26252 through 26254), we finalized the updated CSR adjustment factors for American Indian/Alaska Native (AI/AN) zero-cost sharing and limited cost sharing CSR plan variant enrollees for the 2025 benefit year, and for all future benefit years, unless changed through notice-and-comment rulemaking. In the 2025 Payment Notice (89 FR 26252 through 26254), we also finalized maintaining the existing CSR 
                        <PRTPAGE P="4447"/>
                        adjustment factors for silver plan variant enrollees (70 percent, 73 percent, 87 percent, and 94 percent AV plan variants) 
                        <SU>94</SU>
                        <FTREF/>
                         for the 2025 benefit year and beyond, unless changed through notice-and-comment rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             See 83 FR 16930, 16953; 84 FR 17454, 17478-79; 85 FR 29164, 29190; 86 FR 24140, 24181; 87 FR 27208, 27235-36; 88 FR 25740, 25772-74; and 89 FR 26218, 26252-54.
                        </P>
                    </FTNT>
                    <P>
                        For the 2026 benefit year, we did not propose to change the CSR adjustment factors as finalized in the 2025 Payment Notice and we will maintain the existing CSR adjustment factors for the 2026 benefit year.
                        <SU>95</SU>
                        <FTREF/>
                         We summarize and respond to the public comments received on the CSR adjustment factors for the 2026 benefit year below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             See CSR adjustment factors finalized in the 2025 Payment Notice at 89 FR 26252 through 26254.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         We received a few comments asking that HHS revisit the CSR factors for Massachusetts wraparound plans, specifically for wrap-around plans with AVs above 94 percent. These commenters stated that the wrap-around plans with AVs above 94 percent warrant higher CSR factors than the current 1.12 values. One of these commenters compared the current CSR factor used for Massachusetts wrap-around plans with AVs above 94 percent to those used in Arkansas for plans the commenter identified as having similar AVs.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         For all plan liability risk score calculations under the State payment transfer formula, we use the CSR adjustment factor that aligns with the AV of the applicable plan for the enrollee. Thus, for unique State-specific plans, we apply the CSR adjustment factors that correspond to each plan's AV. As we identify unique State-specific plans that have higher plan liability than the standard plan variants, such as those in Massachusetts and Arkansas, we work with the relevant State Departments of Insurance and other relevant State agencies to identify the applicable CSR adjustment factor that corresponds to the unique State-specific plan's AV.
                    </P>
                    <P>Regarding the comparison between Massachusetts' wrap-around plans and Arkansas' Medicaid expansion plans, Arkansas Medicaid expansion plans are identical to other 94 percent and 100 percent AV CSR plan variants offered on the Exchange and are distinguished from these identical plans only in their sources of funding and eligibility criteria. As such, we presently direct issuers in Arkansas who provide Medicaid expansion plans with AVs of 94 percent and 100 percent to use specified plan variant codes for their Medicaid expansion plans only to differentiate the sources of funding and to differentiate between populations eligible for the Medicaid expansion plans from those who are eligible for standard 94 percent and 100 percent AV CSR plan variants. In contrast, in Massachusetts, the higher cost sharing wrap-around plans are variations of lower cost sharing plans and do not have the same AVs as their comparable plans.</P>
                    <P>We will continue to follow this approach, working with the State to identify the applicable CSR adjustment factor that corresponds to that State's unique State-specific plan's AV. As of the release of this final rule, the Massachusetts Division of Insurance, which is the regulating body for the State, has not identified changes to the AVs of the State's wrap-around plans. As such, we are maintaining our general approach to determining the CSR factors for State-specific plans, including Massachusetts wrap-around plans, for the 2026 benefit year.</P>
                    <HD SOURCE="HD3">f. Model Performance Statistics</HD>
                    <P>Each benefit year, to evaluate the HHS risk adjustment model performance, we examine each model's R-squared statistic and predictive ratios (PRs). The R-squared statistic, which calculates the percentage of individual variation noted by a model, measures the predictive accuracy of the model overall. The PR for each of the HHS risk adjustment models is the ratio of the weighted mean predicted plan liability for the model sample population to the weighted mean actual plan liability for the model sample population. The PR represents how well the model does on average at predicting plan liability for that subpopulation.</P>
                    <P>
                        A subpopulation that is predicted perfectly would have a PR of 1.0. For each of the current and proposed HHS risk adjustment models, the R-squared statistic and the PRs are in the range of published estimates for concurrent HHS risk adjustment models.
                        <SU>96</SU>
                        <FTREF/>
                         Because we are finalizing a blend the coefficients from separately solved models based on the 2020, 2021 and 2022 benefit years' enrollee-level EDGE data, we publish the R-squared statistic for each model separately to verify their statistical validity. We will include the R-squared statistics for the final 2026 benefit year models when we publish the final coefficients for the 2026 benefit year in guidance after publication of this final rule. We will release this guidance by the spring of 2025, in time for rate setting for the 2026 benefit year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             Hileman, G., &amp; Steele, S. (2016). 
                            <E T="03">Accuracy of Claims-Based Risk Scoring Models.</E>
                             Society of Actuaries. 
                            <E T="03">https://www.soa.org/4937b5/globalassets/assets/files/research/research-2016-accuracy-claims-based-risk-scoring-models.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We received one comment noting the decreases in the risk adjustment model R-squared values for the 2022 enrollee-level EDGE data relative to prior benefit years as presented in Table 10 of the proposed rule and provide a response to that comment in the section on Data for HHS Risk Adjustment Model Recalibration for the 2026 Benefit Year above.</P>
                    <HD SOURCE="HD3">3. Overview of the HHS Risk Adjustment Methodology: State Payment Transfer Formula</HD>
                    <P>In part 2 of the 2022 Payment Notice (86 FR 24183 through 24186), we finalized the proposal to continue to use the State payment transfer formula finalized in the 2021 Payment Notice for the 2022 benefit year and beyond, unless changed through notice-and-comment rulemaking. We did not propose any changes to the formula in the proposed rule, and therefore, did not republish the formulas in the proposed rule. We therefore will continue to apply the formula as finalized in the 2021 Payment Notice (86 FR 24183 through 24186) in the States where HHS operates the risk adjustment program in the 2026 benefit year.</P>
                    <P>
                        Additionally, as finalized in the 2020 Payment Notice (84 FR 17466 through 17468), we will maintain the high-cost risk pool parameters for the 2020 benefit year and beyond, unless amended through notice-and-comment rulemaking. We did not propose any changes to the high-cost risk pool parameters for the 2026 benefit year; therefore, we will maintain the $1 million threshold and 60 percent coinsurance rate.
                        <SU>97</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             See 81 FR 94058, 94081. See also 84 FR 17454, 17467.
                        </P>
                    </FTNT>
                    <P>We did not receive any comments in response to the overview of the HHS risk adjustment methodology applicable to the 2026 benefit year.</P>
                    <HD SOURCE="HD3">4. Solicitation of Comments—Time Value of Money in HHS-Operated Risk Adjustment Program</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters 2026 proposed rule (89 FR 82347, 82348), HHS solicited comments on the impact of the time value of money on the HHS-operated risk adjustment program, including the impact of the time value of money on issuers' assessment of actuarial risk and the incentives for adverse selection, and what possible solutions or mitigating steps we should consider to address the impact of the time value of money on 
                        <PRTPAGE P="4448"/>
                        the HHS-operated risk adjustment program in future rulemaking. HHS noted in the proposed rule that it received feedback in the past from some interested parties that issuers of risk adjustment covered plans were more impacted by the time value of money for benefit year 2023 than in any previous benefit years. Therefore, HHS solicited comment on the impact of the 8-to-10-month gap between the end of the benefit year when claims are incurred and the issuance of risk adjustment charges and allocation of payments for that benefit year. We thank commenters for their feedback and will take these comments into consideration in future rulemaking as applicable.
                    </P>
                    <HD SOURCE="HD3">5. HHS Risk Adjustment User Fee for the 2026 Benefit Year (§ 153.610(f))</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82348), we proposed an HHS risk adjustment user fee for the 2026 benefit year of $0.18 PMPM. Section 153.610(f)(2) provides that, where HHS operates a risk adjustment program on behalf of a State, an issuer of a risk adjustment covered plan must remit a user fee to HHS equal to the product of its monthly billable member enrollment in the plan and the PMPM risk adjustment user fee specified in the annual HHS notice of benefit and payment parameters for the applicable benefit year.</P>
                    <P>
                        For the 2026 benefit year, HHS proposed to use the same methodology used in the 2025 Payment Notice (89 FR 26218) to estimate our administrative expenses to operate the program. These costs cover development of the models and methodology, collections, payments, account management, data collection, data validation, program integrity and audit functions, operational and fraud analytics, interested parties training, operational support, and administrative and personnel costs dedicated to HHS-operated risk adjustment program activities. To calculate the risk adjustment user fee, we divided HHS' projected total costs for administering the program on behalf of States by the expected number of BMMs in risk adjustment covered plans in States where the HHS-operated risk adjustment program will apply in the 2026 benefit year.
                        <SU>98</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             HHS did not receive any requests from States to operate risk adjustment for the 2026 benefit year. Therefore, HHS will operate risk adjustment in every State and the District of Columbia for the 2026 benefit year.
                        </P>
                    </FTNT>
                    <P>We estimated that the total costs for HHS to operate the risk adjustment program on behalf of States within the 2026 calendar year will be approximately $65 million, roughly the same as the amount estimated for the 2025 calendar year. Based on these costs and because we did not estimate increased enrollment in the 2026 benefit year beyond the 2024 benefit year level, we proposed an HHS risk adjustment user fee of $0.18 PMPM for the 2026 benefit year. We sought comment on the proposed HHS risk adjustment user fee for the 2026 benefit year.</P>
                    <P>After consideration of comments and updating our projections based on the most recent available data, which impacted our enrollment estimates, we are finalizing a risk adjustment user fee rate of $0.20 PMPM for the 2026 benefit year. We summarize and respond to public comments received on the proposed 2026 benefit year risk adjustment user fee rate below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters supported the proposed 2026 benefit year risk adjustment user fee rate but noted that the user fee rate may require modification if enhanced premium tax credit (PTC) subsidies are not extended into the 2026 benefit year. A few commenters requested more information on the assumptions we made if enhanced PTC subsidies expire or are extended.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are finalizing an HHS risk adjustment user fee rate for the 2026 benefit year of $0.20 PMPM. We proposed a risk adjustment user fee rate of $0.18 PMPM for the 2026 benefit year based on our estimates at the time in the proposed rule (89 FR 82348), and we explained that we may modify the risk adjustment user fee rate in the final rule if there were events resulting in larger than expected enrollment growth or some other deviation from our expectations of current conditions that would significantly change our estimates around costs, enrollment projections or the finalization of the proposed risk adjustment policies between the proposed and final rule. The final 2026 benefit year risk adjustment user fee rate adopted in this final rule assumes that, consistent with current law, the enhanced PTC subsidies will expire at the end of 2025. Though we project a similar budget to operate the HHS-operated risk adjustment program, the final user fee rate reflects updates to enrollment projections in individual, small group, and merged market risk pools based on the latest data available that was not available at the time of the proposed rule, such as PY 2025 open enrollment data 
                        <SU>99</SU>
                        <FTREF/>
                         and estimated health insurance coverage changes 
                        <SU>100</SU>
                        <FTREF/>
                         due to the expiration of enhanced PTC subsidies. We explained the assumptions used when determining the risk adjustment user fee in the 2026 Payment Notice proposed rule (89 FR 82349).
                    </P>
                    <FTNT>
                        <P>
                            <SU>99</SU>
                             See Marketplace 2025 Open Enrollment Period Report National Snapshot, as of December 4, 2024: 
                            <E T="03">https://www.cms.gov/newsroom/fact-sheets/marketplace-2025-open-enrollment-period-report-national-snapshot-0</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>100</SU>
                             See CBO June 2024 projections of health insurance coverage via 
                            <E T="03">https://www.cbo.gov/system/files/2024-06/51298-2024-06-healthinsurance.pdf.</E>
                        </P>
                    </FTNT>
                    <P>As we noted in the proposed rule (89 FR 82348), similar to prior benefit years, we projected risk adjustment enrollment scenarios for the 2026 benefit year, considered the impact of the expiration of the enhanced PTC subsidies established in section 9661 of the ARP and extended in section 12001 of the IRA through the 2025 benefit year on enrollment in the individual, small group, and merged market risk pools for the 2026 benefit year of risk adjustment, and used those estimates to calculate the proposed 2026 benefit year HHS risk adjustment user fee rate. While our updated projections show a decrease in enrollment in risk adjustment covered plans in States where the HHS-operated risk adjustment program will apply in the 2026 benefit year, we continue to estimate that the total costs for HHS to operate the risk adjustment program on behalf of States within the 2026 benefit year will be approximately $65 million. Therefore, we are finalizing a risk adjustment user fee rate for benefit year 2026 of $0.20 PMPM to ensure adequate funding for the HHS-operated risk adjustment program.</P>
                    <HD SOURCE="HD3">6. Risk Adjustment Data Validation Requirements When HHS Operates Risk Adjustment (HHS-RADV) (§§ 153.350 and 153.630)</HD>
                    <P>
                        HHS conducts risk adjustment data validation under §§ 153.350 and 153.630 in any State where HHS is responsible for operating the risk adjustment program.
                        <SU>101</SU>
                        <FTREF/>
                         The purpose of risk adjustment data validation is to ensure issuers are providing accurate high-quality information to HHS, which is crucial for the proper functioning of the HHS-operated risk adjustment program. HHS-RADV also ensures that risk adjustment transfers calculated under the State payment transfer formula reflect verifiable actuarial risk differences among issuers, rather than risk score calculations that are based on poor quality data, thereby helping to ensure that the HHS-operated risk adjustment program assesses charges to 
                        <PRTPAGE P="4449"/>
                        issuers with plans with lower-than-average actuarial risk while making payments to issuers with plans with higher-than-average actuarial risk. HHS-RADV consists of an initial validation audit (IVA) and a second validation audit (SVA).
                    </P>
                    <FTNT>
                        <P>
                            <SU>101</SU>
                             Since the 2017 benefit year, HHS has operated the risk adjustment program in all 50 States and the District of Columbia.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">a. Initial Validation Audit (IVA) Sampling Methodology—Enrollees Without HCCs, Finite Population Correction, and Neyman Allocation (§ 153.630(b))</HD>
                    <P>
                        To better align the IVA sampling methodology with the HHS-RADV error estimation methodology that estimates HCC error rates and to improve overall sampling precision, in the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82349), we proposed to exclude enrollees without HCCs 
                        <SU>102</SU>
                        <FTREF/>
                         from IVA sampling, to remove the FPC, and to replace the source of the Neyman allocation 
                        <SU>103</SU>
                        <FTREF/>
                         data used for IVA sampling purposes with 3 years of available HHS-RADV data beginning with benefit year 2025 HHS-RADV.
                        <SU>104</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             As explained in the proposed rule, adult enrollees with only RXCs do not have any HCCs, and therefore would be excluded from IVA sampling under this policy. See 89 FR 82308 at 82351.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             Neyman allocation is a method to allocate samples to strata based on the strata variances. A Neyman allocation scheme provides the most precision for estimating a population mean given a fixed total sample size. See 
                            <E T="03">http://methods.sagepub.com/reference/encyclopedia-of-survey-research-methods/n324.xml.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>104</SU>
                             Activities related to the 2025 benefit year of HHS-RADV will generally begin in Spring 2026, when issuers can start selecting their IVA entity, and IVA entities can start electing to participate in HHS-RADV for the 2025 benefit year. Changes to the IVA sampling methodology need to be finalized before HHS-RADV activities begin; therefore, we proposed these IVA sampling changes begin with 2025 benefit year HHS-RADV due to the timing of this rulemaking. For the most recently published annual HHS-RADV timeline, see the 
                            <E T="03">2023 Benefit Year HHS-RADV Activities Timeline. https://regtap.cms.gov/uploads/library/2023_RADV_Timeline_5CR_072424.pdf.</E>
                             We note that there were delays in the 2023 Benefit Year HHS-RADV Activities Timeline in recognition of issuers facing challenges related to EDGE server operations after the Change Healthcare Cybersecurity Incident.
                        </P>
                    </FTNT>
                    <P>For a discussion of the background of the HHS-RADV IVA sampling methodology and the proposed changes to the IVA sampling methodology, see the proposed rule (89 FR 82308, 82349). We summarize and respond to public comments on each of these three IVA sampling methodology changes below.</P>
                    <HD SOURCE="HD3">1. Proposal To Exclude Enrollees Without HCCs From IVA Sampling</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82351), we proposed to modify IVA sampling to exclude stratum 10 enrollees, which would exclude enrollees that do not have HCCs nor RXCs, and adult enrollees in strata 1 through 3 that have RXCs only, from IVA sampling beginning with benefit year 2025 HHS-RADV. For a full discussion of the proposed changes to exclude enrollees without HCCs from the HHS-RADV IVA sampling methodology, see the proposed rule (89 FR 82308, 82351). We sought comment on this proposal to exclude enrollees without HCCs from IVA sampling.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy as proposed. We summarize and respond to public comments received on the proposal to exclude enrollees without HCCs from IVA sampling beginning with benefit year 2025 HHS-RADV below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the proposal to exclude enrollees without HCCs from IVA sampling with several of these commenters suggesting that the proposal would enhance the accuracy of HHS-RADV. A few commenters agreed that excluding enrollees without HCCs would ensure that the IVA sample reflects enrollees who most directly impact risk scores and HHS-RADV error rates, and one commenter suggested that including only enrollees with HCCs in the IVA sample would streamline the IVA validation and medical record retrieval processes, making the IVA less resource intensive.
                    </P>
                    <P>Other commenters agreed that excluding enrollees without HCCs would better align the IVA sampling methodology with the HHS-RADV error estimation methodology and the policies finalized in the 2024 Payment Notice to discontinue the use of the lifelong permanent condition (LLPC) list and non-EDGE claims in HHS-RADV. One commenter noted concern that stratum 10 enrollees were included under the current IVA sampling methodology and suggested that these enrollees have no variance of error and therefore cannot have Neyman allocation-calculated sample sizes.</P>
                    <P>
                        <E T="03">Response:</E>
                         We are finalizing the exclusion of enrollees without HCCs from IVA sampling, which excludes stratum 10 enrollees that do not have HCCs nor RXCs and adult enrollees in strata 1 through 3 that have RXCs only, beginning with benefit year 2025 HHS-RADV as proposed. We agree with commenters that finalizing this change, in combination with the other IVA and SVA methodological changes finalized in this rule, will improve the accuracy of HHS-RADV results. Moreover, finalizing the exclusion of enrollees without HCCs will better align our IVA sampling methodology with the error estimation methodology established in the 2019 Payment Notice, which calculates HCC-associated error rates and applies these error rates to the HCC-related portion of issuers' plan liability risk scores. Finalizing this policy will also better align our IVA sampling methodology with the HHS-RADV policies finalized in the 2024 Payment Notice to discontinue the LLPC list and no longer allow non-EDGE claims beginning with the 2022 benefit year of HHS-RADV, which emphasize HHS-RADV's focus on validating enrollee HCCs on EDGE.
                        <SU>105</SU>
                        <FTREF/>
                         We also agree with commenters that excluding enrollees without HCCs will ensure that issuers, IVA Entities, and the SVA Entity (as applicable) focus audit resources on enrollees who have a more direct impact on Super HCC failure rates, issuers' group failure rates, and issuers' error rates in HHS-RADV.
                    </P>
                    <FTNT>
                        <P>
                            <SU>105</SU>
                             See 88 FR 25790 through 88 FR 25798.
                        </P>
                    </FTNT>
                    <P>
                        We disagree with commenters' concerns about stratum 10 enrollees being included under the current IVA sampling methodology as stratum 10 enrollees have stratum sample sizes calculated with the Neyman allocation in the current HHS-RADV IVA sampling methodology.
                        <SU>106</SU>
                        <FTREF/>
                         The current methodology assumes that the variance of net risk score error for stratum 10 used in the Neyman allocation is equal to the variance of net risk score error for the low-risk strata, which is a non-zero variance. Moreover, if we were to remove this assumption, it would still be possible to calculate a non-zero variance of net risk score errors for these stratum 10 enrollees because net risk score error is measured as the difference between the enrollee's calculated risk score using the HCCs validated during audit and the enrollee's calculated risk score using HCCs on EDGE. Therefore, the proposed change to exclude enrollees in stratum 10 was not driven by being unable to calculate stratum 10's variance of net risk score error or sample size. Rather, the change was driven by the desire to continue to make incremental improvements to the HHS-operated risk adjustment program, including HHS-RADV, and make IVA sampling more targeted and efficient. As previously noted, this change also better 
                        <PRTPAGE P="4450"/>
                        aligns the IVA sampling methodology with the error estimation methodology and the policies finalized in the 2024 Payment Notice to discontinue the use of the LLPC list and no longer allow non-EDGE claims in HHS-RADV.
                        <SU>107</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             In the initial years of HHS-RADV, we constrained the “10th stratum” of the IVA sample—that is, enrollees without HCCs selected for the IVA sample—to be one-third of the sampled IVA enrollees. In the 2020 Payment Notice, we finalized the extension of the Neyman allocation sampling methodology to the 10th stratum to improve sample precision and permit for a larger portion of the sample to be allocated to the HCC strata. See 84 FR 17494 through 17495.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             See 88 FR 25790 through 88 FR 25798.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters that supported the proposal to exclude enrollees without HCCs from the IVA sampling methodology suggested that HHS should not include enrollees without HCCs in IVA sampling because audits should investigate whether issuers are overstating sickness in their population and enrollees without HCCs do not have sickness reflected in their risk adjustment risk scores. Another commenter suggested that including enrollees without HCCs in the IVA sample advantages lower-risk issuers that have more enrollees without HCCs and will face less administrative burden in the medical record retrieval and review process. This commenter expressed concerns that these lower-risk issuers get more opportunities for HCCs to be found while also getting fewer opportunities to fail to validate HCCs under the current methodology, which could limit HHS-RADV's ability to identify lower-risk issuers that are engaging in upcoding and therefore undermine the accuracy of HHS-RADV adjustments to risk adjustment State transfers. Another commenter similarly suggested that the proposal to exclude enrollees without HCCs from IVA sampling would help prevent upcoding.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The purpose of HHS-RADV is to ensure that issuers are submitting accurate, high-quality information to their EDGE servers to be used in the risk adjustment State transfer calculations. We recognize that lower-risk issuers may face less administrative burden than higher-risk issuers when performing HHS-RADV under the current IVA sampling methodology if these issuers have more enrollees without HCCs, and therefore more enrollees without medical records proportionately affecting the Neyman allocation and stratum 10's sample size. However, lower-risk issuers may continue to have less burden than higher-risk issuers under the revised IVA sampling methodology finalized in this rule that excludes enrollees without HCCs. This is because the Neyman allocation will continue to calculate the optimal number to be sampled from each stratum, proportional to each stratum's contribution to the total standard deviation of risk score error in the issuer's population. Each stratum's contribution to the total standard deviation of risk score error in the issuer's population is determined by the stratum's population size, mean risk score, and variance of net risk score error. Therefore, compared to lower-risk issuers, higher-risk issuers may still have relatively more enrollees selected for higher-risk strata if the higher-risk strata contribute relatively more to the total standard deviation of risk score error in the issuer's population. Conversely, lower-risk issuers may still have relatively more enrollees in their IVA samples from lower-risk strata with less HCCs to validate or medical records to review if the lower-risk strata contribute relatively more to the total standard deviation of risk score error in the issuer's population, and therefore would experience a lower burden than higher-risk issuers with respect to medical record retrieval and review. As we explain in more detail later in this final rule, we estimate that issuer burden will decrease on average across all issuers as a result of the finalized changes to the IVA sampling methodology.
                    </P>
                    <P>
                        In addition, we agree that excluding enrollees without HCCs from the IVA sampling methodology will further ensure that issuers are submitting accurate, high-quality information to their EDGE servers to be used in the risk adjustment State transfer calculations and disincentivize inaccurate coding practices, such as upcoding. However, we note that we have not seen conclusive evidence of upcoding on EDGE. We also believe that the HHS-RADV program serves as a safeguard against upcoding by auditing the issuer's EDGE data and reviewing the supporting medical records to validate enrollee health status. In addition, we note that there are risk adjustment model specifications to mitigate the potential for upcoding, such as the HCC coefficient estimation groups, which reduce risk score additivity within disease groups and limit the sensitivity of the risk adjustment models to upcoding,
                        <SU>108</SU>
                        <FTREF/>
                         and we have developed HHS-RADV's error estimation methodology to appropriately account for these model specifications (such as., the HCC coefficient estimation groups).
                        <SU>109</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             See, for example, Section 2.3 of the Potential Updates to HHS-HCCs for the HHS-operated Risk Adjustment Program White Paper (June 17, 2019) available at: 
                            <E T="03">https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Potential-Updates-to-HHS-HCCs-HHS-operated-Risk-Adjustment-Program.pdf.</E>
                             Note that “HCC Group constraints” is synonymous with “HCC coefficient estimation groups.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             The 2020 HHS-RADV Amendments Rule finalized a policy to ensure that HCCs that share a coefficient estimation group used in the risk adjustment models are sorted into the same failure rate groups by first aggregating any HCCs that share a coefficient estimation group into Super HCCs before applying the HHS-RADV failure rate group sorting algorithm beginning with benefit year 2019 HHS-RADV. See 85 FR 76984 through 76989. The 2023 Payment Notice finalized to extend the application of Super HCCs to also apply to coefficient estimation groups throughout the HHS-RADV error rate calculation beginning with benefit year 2021 HHS-RADV. See 2023 Payment Notice, 87 FR 27208, 27253 through 27256.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters opposed the proposal to exclude enrollees without HCCs from IVA sampling and some commenters disagreed with or questioned whether the proposal would improve the accuracy of HHS-RADV results. Some of these commenters noted that enrollees without HCCs may be under-coded and HHS-RADV should validate appropriate coding by issuers for all diagnoses—including diagnoses that were not originally submitted to issuers' EDGE servers or supplemental files or HCCs that were not on EDGE—in the sampled enrollees' medical records to appropriately adjust issuers' risk scores. A few commenters suggested that the accurate assessment of a plan's risk score depends on sampling from the issuer's full population during HHS-RADV. One of these commenters noted that many enrollees in issuers' populations have no documented HCCs and noted concern that removing enrollees without HCCs would lead to greater volatility or even increase the number of outlier issuers. One commenter expressed concern that HHS-RADV was only validating HCCs and excluding other components of the risk score, such as RXCs, from validation. Another commenter suggested that removing enrollees without HCCs from HHS-RADV could encourage upcoding and inaccurate risk adjustment coding because issuers would not be able to get failure rate credit for diagnoses identified in HHS-RADV but unreported on EDGE. This commenter also suggested that HHS-RADV encourages coding to the industry average rather than coding with accuracy and noted that if issuers engage in upcoding at similar rates, industry failure rates will increase, coding accuracy will decrease, but HHS-RADV results could remain the same. Other commenters who opposed the proposal suggested that excluding enrollees without HCCs from the IVA sample could unfairly penalize or reward plans based on the risk profile of their high-cost patients and may be short-sighted, as HHS-RADV should help ensure that the actuarial risk and risk scores for both high-risk and low-risk plans are appropriately calculated 
                        <PRTPAGE P="4451"/>
                        and reflected in risk adjustment State transfers.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As explained in the proposed rule (89 FR 82308, 82351), we anticipate that excluding enrollees without HCCs from IVA sampling will improve the precision of issuers' group failure rates for any given sample size by increasing the number of observations used to make statistical inferences. The precision of group failure rates is important as we identify outliers in HHS-RADV based on whether their group failure rates are statistically different from the national benchmarks. As previously noted, the purpose of HHS-RADV is to ensure that issuers are submitting accurate, high-quality information to their EDGE servers as that data is used to calculate risk adjustment State transfers. While it is possible that enrollees without HCCs may be missing diagnoses, issuers are responsible for submitting data to EDGE in accordance with the EDGE Server Business Rules for the applicable benefit year by the established deadline.
                        <E T="51">110 111</E>
                        <FTREF/>
                         The validation of HCCs in HHS-RADV aligns with the policies in the EDGE Server Business Rules stating that a risk adjustment eligible diagnosis must be supported by appropriate medical record documentation and linked to a risk adjustment eligible claim accepted by the issuer's EDGE server to validate an HCC in HHS-RADV. Since we finalized discontinuing the use of the LLPC list and non-EDGE claims beginning with 2022 benefit year HHS-RADV, IVA and SVA Entities cannot abstract diagnoses that are not linked to an accepted risk adjustment eligible claim on issuers' EDGE servers. Therefore, it is unlikely that HHS-RADV would identify any missing HCCs for enrollees without HCCs if these enrollees remained in the IVA sample. Furthermore, we clarify that the changes finalized to the IVA sampling methodology in this rule will not affect the review of demographic and enrollment information, as we will continue to validate demographic and enrollment information for a subsample of up to 50 enrollees from the IVA sample, or RXC review, as the HHS-RADV requires review of RXCs for all adult enrollees in the IVA sample with at least one RXC, and we continue to assume that a review will be performed on approximately 50 RXCs per issuer.
                        <SU>112</SU>
                        <FTREF/>
                         As explained in the proposed rule (89 FR 82308, 82351), an analysis of available enrollee-level EDGE data from benefit years 2019 through 2022 shows that on average less than 12 percent of an issuer's adult enrollee population with RXCs has no HCCs. Therefore, the vast majority of adult enrollees with RXCs also have HCCs and will therefore still be captured in strata 1 through 3 in the IVA sample and eligible for inclusion in the HHS-RADV RXC validation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>110</SU>
                             As explained in 45 CFR 153.730, issuers of risk adjustment covered plans must submit data to be considered for risk adjustment payments and charges for the applicable benefit year by April 30 of the year following the applicable benefit year or, if such date is not a business day, the next applicable business day.
                        </P>
                        <P>
                            <SU>111</SU>
                             Issuers of risk adjustment covered plans remain responsible for ensuring the completeness and accuracy of the data submitted to their respective EDGE servers by the data submission deadline. CMS does not permit issuers to submit additional data or correct data already submitted to their EDGE servers after the applicable benefit year's data submission deadline.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             In the 2020 Payment Notice, we finalized piloting the incorporation of RXCs into the HHS-RADV process in the 2018 benefit year, which was the first year that RXCs were incorporated into the risk adjustment models. We also finalized incorporating RXC validation into HHS-RADV as a method of discovering materially incorrect EDGE server data submissions in a manner similar to how we address demographic, and enrollment errors discovered during HHS-RADV beginning with the 2019 benefit year. See 84 FR 17501. We later extended the pilot years of incorporating RXCs into HHS-RADV to the 2019 and 2020 benefit years of HHS-RADV to increase consistency between the operations of these benefit years' HHS-RADV and facilitate the combination of the HHS-RADV adjustments for these benefit years as we transitioned to a concurrent application of HHS-RADV results. See 85 FR 77002 through 77005.
                        </P>
                    </FTNT>
                    <P>
                        Under the finalized methodology, any enrollees inappropriately coded with diagnoses that map to payment HCCs would fall within the population of enrollees with HCCs and may be selected in the IVA sample. Therefore, we believe this policy ensures that HHS-RADV remains focused on ensuring issuers submit accurate, high-quality information to their EDGE servers to be used in the risk adjustment State transfer calculations and further disincentivizes inaccurate coding practices, such as upcoding. However, as previously noted, we have not seen conclusive evidence of upcoding on EDGE and believe that the HHS-RADV program serves as a safeguard against upcoding by auditing the issuer's EDGE data and reviewing the supporting medical records to validate enrollee health status. In addition, while we acknowledge that issuers are compared to industry coding averages when comparing issuer group failure rates to national benchmarks, issuers with statistically significant group failure rates that are below these national benchmarks may receive negative group adjustment factors to calculate IVA sampled enrollees' adjusted risk scores in error estimation and may be assigned negative error rates such that their more accurate coding practices are reflected in their HHS-RADV results.
                        <SU>113</SU>
                        <FTREF/>
                         We therefore continue to believe that the HHS-RADV program encourages accurate coding in issuer EDGE data. In addition, we also believe that some variation and error should be expected in the compilation of data for risk scores, because providers' documentation of enrollee health status varies across provider types and groups, so it may not be reasonable to assume that issuers can achieve group failure rates equal to zero. As such, the primary purpose of identifying statistically meaningful differences between issuers' group failure rates and national benchmarks in HHS-RADV is to avoid the unwarranted application of risk score adjustments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>113</SU>
                             We also note that the 2020 HHS-RADV Amendments Rule adopted a negative failure rate constraint to mitigate the impact of adjustments that result from outlier issuers with negative failure rates that are driven by newly identified Super HCCs (rather than by high validation rates) beginning with 2019 benefit year HHS-RADV. See 85 FR 76994 through 76998. The 2023 Payment Notice expanded the application of the negative failure rate constraint to constrain the failure rate of any failure rate group in which an issuer is a negative failure rate outlier to zero when calculating the group adjustment factor, regardless of whether the outlier issuer has a negative or positive error rate, beginning with 2021 benefit year HHS-RADV. See 87 FR 27255 through 27256.
                        </P>
                    </FTNT>
                    <P>We also disagree that excluding enrollees without HCCs from the IVA sampling methodology would lead to unfair HHS-RADV results based on the risk profile of issuers' high-cost patients as enrollees with HCCs in the issuer-specific low-risk and medium-risk strata will continue to be sampled and included in the IVA. Moreover, we anticipate that the average proportion of issuers' IVA samples from low-risk strata will generally increase from finalizing the policy to use HHS-RADV data rather than MA-RADV data as the source for the Neyman allocation for IVA sampling.</P>
                    <P>
                        Finally, we note that the refinements to the IVA sampling methodology, including the policy to exclude enrollees without HCCs, further advance program integrity goals of validating the actuarial risk of enrollees in risk adjustment covered plans to ensure that the HHS-operated risk adjustment program accurately assesses charges to issuers with plans with lower-than-average actuarial risk while making payments to issuers with plans with higher-than-average actuarial risk. We therefore believe that HHS-RADV will continue to help ensure that the risk scores and risk adjustment State transfers for issuers of high-risk and low-risk plans are calculated consistent with the established methodology and 
                        <PRTPAGE P="4452"/>
                        requirements based on the data made available to HHS by the applicable benefit year's deadline.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters requested clarification on how this change would impact the error rate calculation. One of these commenters requested HHS further investigate the impact of this policy as the commenters believed the impact would vary across issuers depending on the proportion of their enrollee population with HCCs. This commenter requested HHS apply the error rate such that only the plan liability risk score associated with enrollees with HCCs, and not with the total enrollee population, would be adjusted.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Excluding enrollees without HCCs from the IVA sampling methodology does not impact the formula used to calculate issuers' HCC-associated error rates during error estimation. As described in the HHS-RADV protocols, HHS estimates an issuer's HCC-associated error rate using sampled enrollees' adjusted HCC-associated risk scores and HCC-associated EDGE risk scores.
                        <SU>114</SU>
                        <FTREF/>
                         Although enrollees without HCCs are currently included in issuers' audit samples, these enrollees have HCC-associated EDGE risk scores equal to zero and cannot have adjusted HCC-associated risk scores. Therefore, enrollees without HCCs are already excluded from the calculation of the HCC-associated error rate, which was explained as one of the reasons for implementing this IVA sampling change in the proposed rule (89 FR 82351).
                    </P>
                    <FTNT>
                        <P>
                            <SU>114</SU>
                             See Section 13.3.1.3.3 Calculate Error Rates of the BY23 HHS-RADV Protocols available at 
                            <E T="03">https://regtap.cms.gov/uploads/library/HHS-RADV_2023_Benefit_Year_Protocols_v1_5CR_060424.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        However, we also note that excluding enrollees without HCCs from IVA sampling will have an impact on the steps in the error estimation methodology during which HCC-associated error rates are applied to adjust issuers' plan liability risk scores. Under the current error estimation methodology finalized in the 2019 Payment Notice 
                        <SU>115</SU>
                        <FTREF/>
                         and the 2020 HHS-RADV Amendments Rule,
                        <SU>116</SU>
                        <FTREF/>
                         and as described in the HHS-RADV Protocols,
                        <SU>117</SU>
                        <FTREF/>
                         the HCC-associated error rate, which only describes the proportion of the HCC-related components of the risk score that are believed to be in error, is scaled to apply only to the HCC portion of an issuer's total plan liability risk score, which includes non-HCC and HCC components. To accomplish this, HHS uses the issuer's audit sample, which includes enrollees with and without HCCs under the current IVA sampling methodology, to calculate an HCC-associated PLRS weight and estimate how much of the issuer's plan liability risk score is HCC-related in the issuer population. Therefore, removing enrollees without HCCs from IVA sampling beginning with 2025 benefit year HHS-RADV implies that issuers' audit samples can no longer be used to calculate the appropriate HCC-associated PLRS weight according to the existing formula. As such, before 2025 benefit year HHS-RADV error estimation begins,
                        <SU>118</SU>
                        <FTREF/>
                         we intend to continue to consider the impact of the IVA sampling methodology changes in this rule on the HHS-RADV error estimation methodology and will seek comments from interested parties on potential modifications to the intermediate steps in the error estimation methodology to ensure that the HCC-associated error rate continues to apply to only the proportion of the total plan liability risk score that is associated with HCC-components of EDGE risk scores.
                    </P>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             See the Notice of Benefit and Payment Parameters for 2019; Final Rule, 83 FR 16930 at 16961-16965 (April 17, 2018) (2019 Payment Notice).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>116</SU>
                             See the Amendments to the HHS-Operated Risk Adjustment Data Validation (HHS-RADV) Under the Patient Protection and Affordable Care Act's HHS-Operated Risk Adjustment Program; Final Rule; 85 FR 76979 at 76998-77001 (December 1, 2020) (2020 HHS-RADV Amendments Rule).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>117</SU>
                             See Section 13.3.1.3.3 Calculate Error Rates of the BY23 HHS-RADV Protocols available at 
                            <E T="03">https://regtap.cms.gov/uploads/library/HHS-RADV_2023_Benefit_Year_Protocols_v1_5CR_060424.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>118</SU>
                             Error estimation for 2025 benefit year HHS-RADV is anticipated to begin in Spring 2027 after IVA and SVA Entities submit audit findings for the 2025 benefit year.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that HHS allot additional time for issuers to complete HHS-RADV, as excluding enrollees without HCCs from the IVA sample will require issuers to validate more HCCs and RXCs, impacting operational resources and capacity.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not anticipate that excluding enrollees without HCCs from IVA sampling will prevent issuers from meeting the current timeline associated with HHS-RADV activities. Issuers have complied with the timeline for HHS-RADV activities under the current IVA sampling methodology and should be able to maintain compliance under the finalized IVA sampling methodology where issuer burden is estimated to decrease on average. As discussed in the proposed rule, under the revised IVA sampling methodology, we estimate that issuers will have to submit approximately 2 medical records per enrollee in the IVA sample for IVA review, which is a decrease from the current burden estimates under the existing IVA sampling methodology of 5 medical record requests per enrollee in the IVA sample. In addition, as explained in the Collection of Information section of this rule, we do not anticipate that these changes will affect RXC review, as HHS-RADV requires review of RXCs for all adult enrollees in the IVA sample with at least one RXC, and we continue to assume that a review will be performed on approximately 50 RXCs per issuer.
                        <SU>119</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>119</SU>
                             For more details on RXC validation, see Section 10.4 Validation of the BY23 HHS-RADV Protocols available at 
                            <E T="03">https://regtap.cms.gov/uploads/library/HHS-RADV_2023_Benefit_Year_Protocols_v1_5CR_060424.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Proposal To Remove the Finite Population Correction (FPC)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82351), we proposed to remove the FPC from the IVA sampling methodology such that, with the exclusion of enrollees without HCCs from IVA sampling, all issuers with at least 200 enrollees with HCCs in their enrollee population would have an IVA sample size of 200. Under this proposal, all issuers with fewer than 200 enrollees with HCCs would have an IVA sample size equal to their population of enrollees with HCCs. See the proposed rule (89 FR 82308, 82351) for a full discussion of the proposal to remove the FPC from the IVA sampling methodology.</P>
                    <P>As noted in the proposed rule (89 FR 82308, 82352), by including more enrollees with HCCs in these smaller issuers' IVA samples, we would increase these issuers' probability of meeting the 30 Super HCC constraint and improve the precision of group failure rates during error estimation, as well as improve the precision of net risk score error as discussed below. In addition, for small issuers that meet the 30 Super HCC threshold, this proposal would further allow these issuers' risk scores to be appropriately adjusted if they are identified as outliers, and it would allow them to gain additional insights from a richer set of data elements reported in their HHS-RADV results to improve coding practices and EDGE data submission procedures (as applicable). For these reasons, we proposed to remove the FPC beginning with 2025 benefit year HHS-RADV.</P>
                    <P>We sought comment on the proposal to remove the FPC from the IVA sampling methodology.</P>
                    <P>
                        After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our 
                        <PRTPAGE P="4453"/>
                        responses to comments, we are finalizing this proposal as proposed. We summarize and respond to public comments received on the proposal to remove the FPC from the IVA sampling methodology beginning with 2025 benefit year HHS-RADV below.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the proposal to remove the FPC from IVA sampling. Several of these commenters suggested that this proposal would contribute to improving sampling precision and the accuracy and integrity of HHS-RADV.
                    </P>
                    <P>A few commenters were opposed the proposal to remove the FPC. One of these commenters expressed concern that the combined impact of this policy and the policy to exclude enrollees without HCCs from IVA sampling would significantly disadvantage smaller issuers. This commenter noted that smaller issuers are already burdened by a significantly higher per member per month audit cost than larger issuers and stated that these changes would not apply the same audit standard equitably and consistently across issuers. This commenter suggested that a smaller issuer with a total population of 600 enrollees with HCCs could end up with 33 percent of their enrollee population with HCCs sampled for audit by sampling 200 enrollees whereas a larger issuer in the same market might have a total population of 37,000 enrollees with HCCs and end up with less than 1 percent of their enrollee population of HCCs sampled for audit. Another commenter noted that the proposal would likely burden smaller issuers that currently have modified IVA sample sizes less than 200 enrollees by increasing the number of sampled enrollees and medical records.</P>
                    <P>
                        <E T="03">Response:</E>
                         We are finalizing the proposal to remove the FPC from IVA sampling as proposed and anticipate that this policy will improve the precision of net risk score error and group failure rates. We disagree that the removal of the FPC, combined with the finalization of the proposals to exclude enrollees without HCCs from IVA sampling and replace the source of the Neyman allocation data, will disadvantage smaller issuers over larger issuers. While we recognize that smaller issuers incur costs to hire an IVA Entity and undergo the HHS-RADV, there are other HHS-RADV provisions intended to limit administrative and cost burden on small issuers. Specifically, at § 153.630(g)(1) and (2), we established exemptions from HHS-RADV for issuers with 500 or fewer billable member months (BMMs) Statewide and we established random and targeted sampling for issuers at or below a materiality threshold 
                        <SU>120</SU>
                        <FTREF/>
                         for the benefit year being audited.
                        <SU>121</SU>
                        <FTREF/>
                         For issuers at or below the HHS-RADV materiality threshold, which is set at 30,000 total BMMs Statewide, these costs are only realized for the benefits years that the smaller issuer is selected for HHS-RADV, which is approximately once every 3 years (barring any risk-based triggers that would warrant more frequent audits) under the materiality threshold provision at § 153.630(g)(2).
                        <SU>122</SU>
                        <FTREF/>
                         Under the very small issuer exemption at § 153.630(g)(1), an issuer that has 500 or fewer BMMs of enrollment in the individual, small group, and merged market (as appliable) for the applicable benefit year, calculated on a Statewide basis, and elects to establish and submit data to an EDGE server is not subject to the requirement to hire an IVA Entity or submit IVA audits for that benefit year.
                        <SU>123</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>120</SU>
                             Beginning with the 2022 benefit year of HHS-RADV, the materiality threshold under § 153.630(g)(2) was defined as 30,000 total BMMs Statewide, calculated by combining an issuer's enrollment in the individual non-catastrophic, catastrophic, small group, and merged markets (as applicable), in the benefit year being audited. See the 2024 Payment Notice, 88 FR 25740, 25788 through 25790.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>121</SU>
                             See § 153.630(g)(1) and (2). Also see 81 FR 94058 at 94104, 83 FR 16930, 16966, and 84 FR 17454, 17508.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>122</SU>
                             An issuer who meets the criteria and is exempt from the IVA requirements for a benefit year of HHS-RADV under the materiality threshold for random and targeted sampling may be required to make their records available for review and comply with an audit by the Federal Government under § 153.620.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>123</SU>
                             45 CFR 153.630(g)(1).
                        </P>
                    </FTNT>
                    <P>
                        To further explain, we adopted these policies in response to concerns regarding the regulatory burden and costs associated with HHS-RADV, particularly for smaller issuers. For example, we explained in prior rulemakings that HHS was adopting a materiality threshold for HHS-RADV to ease the burden of annual audit requirements for small issuers of risk adjustment covered plans.
                        <SU>124</SU>
                        <FTREF/>
                         We further explained that we believed this provision was appropriate because the fixed costs associated with hiring an IVA Entity and conducting the audit may be disproportionately high for smaller issuers, and may even constitute a large portion of their administrative costs.
                        <SU>125</SU>
                        <FTREF/>
                         Also, we estimated that issuers of risk adjustment covered plans at or below this threshold would represent less than 1.5 percent of enrollment in risk adjustment covered plans nationally, so the effect of the provision on HHS-RADV would not be material. We similarly explained that exempting very small issuers under § 153.630(g)(1) is appropriate because they will have a disproportionally high operational burden for compliance with HHS-RADV.
                        <E T="51">126 127</E>
                        <FTREF/>
                         These provisions remain applicable.
                    </P>
                    <FTNT>
                        <P>
                            <SU>124</SU>
                             See the 2020 Payment Notice, 84 FR 17508 through 17511. Also see the 2019 Payment Notice, 83 FR 16966 through 19697, and the 2018 Payment Notice, 81 FR 94104 through 94105.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>125</SU>
                             See the 2020 Payment Notice, 84 FR 17510. Also see the 2018 Payment Notice, 81 FR 94104 through 94105, and the 2019 Payment Notice, 83 FR 16966 through 19697.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>126</SU>
                             See the 2019 Payment Notice, 83 FR 16966. Also see the 2020 Payment Notice, 84 FR 17508.
                        </P>
                        <P>
                            <SU>127</SU>
                             These very small issuers who are eligible for the exemption under § 153.630(g)(1) are also not subject to random sampling under the materiality threshold, and therefore would continue to not be subject to the requirement to hire an IVA Entity or submit IVA results for that benefit year. See the 2020 Payment Notice, 84 FR 17508. Issuers who qualify for this exemption are not subject to enforcement action for noncompliance with HHS-RADV requirements and are not assessed the default data validation charge under § 153.630(b)(10) for the applicable benefit year.
                        </P>
                    </FTNT>
                    <P>
                        In addition, we believe the removal of the FPC will benefit smaller issuers by giving them a better opportunity to increase the count of Super HCCs reviewed in HHS-RADV and gain additional insights from more informative HHS-RADV results to improve coding practices and EDGE data submission procedures. As explained in the proposed rule, we found in recent years of HHS-RADV results that issuers with IVA sample sizes less than 200 enrollees are less likely to meet the 30 Super HCC constraint for outlier identification in a failure rate group. This constraint was first established in the 2021 Payment Notice 
                        <SU>128</SU>
                        <FTREF/>
                         as standard statistical practice states that sample sizes below 30 observations could result in violations of the assumptions of statistical testing or lead to the detection of more apparent outliers than would be desirable. Because the requirements to participate in HHS-RADV do not depend on issuers' count of Super HCCs, issuers selected for HHS-RADV may incur the costs to participate without having sufficient Super HCCs to make statistical inferences. By increasing the count of Super HCCs, we 
                        <PRTPAGE P="4454"/>
                        increase the precision of the group failure rates that are used to determine national benchmarks and the probability that issuers will be able to meaningfully compare their calculated group failure rates to the national benchmarks. More specifically, as noted in the proposed rule (89 FR 82308, 82352) we estimate that any issuers receiving the FPC under the current methodology and whose IVA sample sizes would increase under the finalized IVA sampling methodology would see a 35 percent increase in Super HCC count in their IVA samples and a 26 percent increase in group failure rate precision on average across all three failure rate groups.
                    </P>
                    <FTNT>
                        <P>
                            <SU>128</SU>
                             Under the outlier identification policy finalized in the 2021 Payment Notice, when HCCs were the unit of analysis of failure rates, an issuer could not be identified as an outlier in any failure rate group in which that issuer had fewer than 30 Super HCCs. See 85 FR 29196 through 29198. In the 2023 Payment Notice, when the unit of analysis of failure rates was altered to de-duplicated Super HCCs, we finalized the policy to not consider an issuer as an outlier in any failure rate group in which that issuer has fewer than 30 de-duplicated EDGE Super HCCs. Issuers with fewer than 30 de-duplicated EDGE Super HCCs in a failure rate group may still be considered an outlier in other failure rate groups in which they have 30 or more de-duplicated EDGE Super HCCs. See 87 FR 27254.
                        </P>
                    </FTNT>
                    <P>
                        We also recognize that because IVA sample sizes are limited to 200 enrollees, larger issuers will inherently have smaller proportions of their populations subject to audit, but we disagree that this creates an unequal application of audit standards across issuers. Given the variance in issuer size across issuers of risk adjustment covered plans, it would not be possible to audit equal proportions of issuers' populations. The IVA sampling methodology recognizes this by using the Neyman allocation to optimally allocate each issuer's IVA sample across strata. In addition, while it is possible that a smaller issuer may be burdened by an increased number of sampled enrollees under the finalized policy to remove the FPC, we estimate a decrease in aggregate issuer burden across all issuers as the total estimated number of medical records reviewed per sampled enrollee will decrease, and we note that sample size will not increase for all issuers currently subject to the FPC as some of these issuers have a smaller population of enrollees with HCCs than their previously assigned modified IVA sample sizes that included enrollees without HCCs. For example, an issuer with a total enrollee population of 1,000 would be assigned a sample size of 160 enrollees under the current methodology and using the FPC formula. If this issuer only has a population of 100 enrollees with HCCs, then, under the methodology being finalized in this rule, the issuer's IVA sample size would decrease to 100 enrollees. In addition, we anticipate that the vast majority of issuers who would see increased IVA sample sizes after the removal of the FPC are at or below the materiality threshold for random and targeted sampling and would therefore only be selected for audit approximately once every 3 benefit years (barring any risk-based triggers based on experience that will warrant more frequent audits).
                        <E T="51">129 130</E>
                        <FTREF/>
                         Therefore, we believe that the benefits a smaller issuer gains from increased group failure rate precision, as described above, outweigh potential increases in IVA sample size.
                    </P>
                    <FTNT>
                        <P>
                            <SU>129</SU>
                             45 CFR 153.630(g)(2).
                        </P>
                        <P>
                            <SU>130</SU>
                             Beginning with the 2022 benefit year of HHS-RADV, the materiality threshold under § 153.630(g)(2) is defined as 30,000 total BMMs Statewide, calculated by combining an issuer's enrollment in the individual non-catastrophic, catastrophic, small group, and merged markets (as applicable), in the benefit year being audited. See the 2024 Payment Notice, 88 FR 25740, 25788 through 25790.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Proposal To Source the IVA Sampling Neyman Allocation With HHS-RADV Data</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82352), we also proposed to change the current IVA sampling methodology to replace the source of the Neyman allocation data with HHS-RADV data to determine IVA sample strata allocation. To do this, we proposed to no longer use MA-RADV data to calculate the standard deviation of risk score error(
                        <E T="03">S</E>
                        <E T="54">i,h</E>
                        ) for use in the Neyman allocation and instead use a 3-year rolling-window of available HHS-RADV data beginning with 2025 benefit year HHS-RADV.
                    </P>
                    <P>
                        As noted in the proposed rule, under this proposal, for a given benefit year of HHS-RADV, we would use the 3 most recent consecutive years of HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin as the source data for the Neyman allocation and would continue to combine enrollees in each stratum across all issuers to create a national variance of net risk score error to calculate the standard deviation of risk score error (
                        <E T="03">S</E>
                        <E T="54">i,h</E>
                        ).
                        <E T="51">131 132</E>
                        <FTREF/>
                         We proposed to continue calculating 
                        <E T="03">S</E>
                        <E T="54">i,h</E>
                         with a national variance of net risk score error, but to use a 3-year rolling window of HHS-RADV data rather than the MA-RADV data as the source data for the Neyman allocation. Under the proposed approach, we would re-calculate 
                        <E T="03">S</E>
                        <E T="54">i,h</E>
                         during each benefit year of HHS-RADV to use the 3 most recent consecutive years of HHS-RADV data with results that have been released before each benefit year's HHS-RADV activities begin. In the context of HHS-RADV, a 3-year rolling window would capture population changes that occur over time while promoting stability in the estimates of 
                        <E T="03">S</E>
                        <E T="54">i,h</E>
                         in HHS-RADV year over year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>131</SU>
                             A new benefit year of HHS-RADV activities generally begins in the spring the year following the applicable benefit year when issuers can start selecting their IVA entity and IVA entities can start electing to participate in HHS-RADV for that benefit year. See, for example, the 2023 Benefit Year HHS-RADV Activities Timeline. 
                            <E T="03">https://regtap.cms.gov/uploads/library/2023_RADV_Timeline_5CR_072424.pdf.</E>
                             We note that there were delays in the 2023 Benefit Year HHS-RADV Activities Timeline in recognition of issuers facing challenges related to EDGE server operations after the Change Healthcare Cybersecurity Incident.
                        </P>
                        <P>
                            <SU>132</SU>
                             As an example, finalizing this policy as proposed, we anticipate using HHS-RADV data from benefit years 2021, 2022 and 2023 for the Neyman allocation for benefit year 2025 HHS-RADV.
                        </P>
                    </FTNT>
                    <P>In the proposed rule (89 FR 82353), we noted that the proposal to use HHS-RADV data rather than the MA-RADV data as the source data for the Neyman allocation would decrease burden on issuers and IVA Entities. More specifically, our analysis found that the MA-RADV data yields considerably different sample sizes for each stratum than the HHS-RADV data, and that using the HHS-RADV data rather than the MA-RADV data is likely to increase the proportion of the sample in the lower-risk groups and decrease the proportion of the sample in the high-risk group. The estimated change in sampled enrollees means that, under this proposal, issuers would have relatively fewer medical records to review because of the increase in the proportion of sampled enrollees in the lower-risk strata and the decrease in the proportion of enrollees in higher-risk strata. To further explain, this decrease in estimated medical record review would occur because higher-risk enrollees tend to have relatively more medical records to review than lower-risk enrollees. Issuers and their IVA Entities spend time and resources on retrieving, reviewing, and submitting medical records and documentation for HHS-RADV, so the estimated decrease in the average number of medical records reviewed per enrollee in the IVA sample that our analysis found would result from replacing MA-RADV data with HHS-RADV data is expected to lead to a decrease in issuer burden. We further address the estimated aggregate burden impact of all IVA sampling policies being finalized in section III.B.6.a.4 below and the Collection of Information section of this rule.</P>
                    <P>We sought comment on the proposal to replace the source of the Neyman allocation data for IVA sampling source with HHS-RADV data.</P>
                    <P>
                        After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this proposal as proposed. We summarize and respond to public comments received on the proposal to replace the MA-RADV data used in the Neyman allocation for IVA sampling purposes with HHS-RADV data below.
                        <PRTPAGE P="4455"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the proposal to replace the MA-RADV data used in the Neyman allocation for IVA sampling purposes with HHS-RADV data and suggested that the proposal would improve sampling precision or the accuracy of HHS-RADV. A few commenters agreed that using the HHS-RADV data for this purpose would lead to the stratum allocation shifts described in the proposed rule and suggested that the MA-RADV data may lead to oversampling enrollees from the high-risk score groups relative to other groups. One of these commenters stated that the shift to lower-risk strata will be more reflective of the true population and another commenter noted that this shift may reduce administrative burden for issuers with a greater volume of HCCs to validate in their IVA samples. One commenter suggested that this shift may incentivize issuers to focus chart reviews on enrollees with lower risk scores but also recognized that the timing of HHS-RADV may make it difficult for issuers to determine whether these are effective strategies for chart reviews. One commenter expressed general opposition to the proposal to replace the MA-RADV data with HHS-RADV data in the Neyman allocation for IVA sampling.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that replacing the MA-RADV data used to calculate the standard deviation of risk score error (
                        <E T="03">S</E>
                        <E T="54">i,h</E>
                        ) in the Neyman allocation for IVA sampling with HHS-RADV data would increase sampling precision, and we are finalizing this change as proposed beginning with 2025 benefit year HHS-RADV. Under this new approach, for a given benefit year of HHS-RADV, we will use the 3 most recent consecutive years of HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin to calculate a national variance of net risk score error and issuer's standard deviation of risk score error in the Neyman allocation for IVA sampling purposes. For example, for 2025 benefit year HHS-RADV sampling, we anticipate using the 2021, 2022 and 2023 benefit years of HHS-RADV data for this purpose as they would represent the 3 most recent consecutive years of HHS-RADV whose results would be released before that benefit year's HHS-RADV activities began.
                        <SU>133</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>133</SU>
                             Activities related to the 2025 benefit year of HHS-RADV will generally begin in Spring 2026, when issuers can start selecting their IVA entity, and IVA entities can start electing to participate in HHS-RADV for the 2025 benefit year. For the most recently published annual HHS-RADV timeline, see the 
                            <E T="03">2023 Benefit Year HHS-RADV Activities Timeline. https://regtap.cms.gov/uploads/library/2023_RADV_Timeline_5CR_072424.pdf.</E>
                             Note that there were delays in the 2023 Benefit Year HHS-RADV Activities Timeline in recognition of the challenges some issuers were facing related to EDGE server operations after the Change Healthcare Cybersecurity Incident.
                        </P>
                    </FTNT>
                    <P>
                        As explained in the proposed rule (89 FR 82308, 82350), we initially chose to use MA-RADV data when calculating a national variance of net risk score error and issuers' standard deviation of risk score error because HHS-RADV data was not available and the MA-RADV program utilizes a similar HCC-based methodology. We reconsidered the use of MA-RADV data in the IVA sampling methodology in the 2019 HHS-RADV White Paper, but we only had data from 1 year of non-pilot HHS-RADV at the time, and we determined that we would need to gather more data from future years of HHS-RADV to perform further analysis.
                        <SU>134</SU>
                        <FTREF/>
                         Now, as noted in the proposed rule, we have several years of HHS-RADV data and our recent analysis found that the MA-RADV data yields considerably different sample sizes for each stratum than the HHS-RADV data and using the HHS-RADV data would better capture the true variance in net risk score error in the risk adjustment population. The HHS-RADV data supports sampling low-risk strata more intensely than the MA-RADV data because the HHS-RADV data estimates a greater variance for these groups than the MA-RADV data, so a relatively smaller proportion of the IVA sample will be assigned to the higher-risk strata. Consequentially, we anticipate this change to the source data used for the Neyman allocation for IVA sampling would result in relatively fewer HCCs to validate and medical records to review per enrollee during the IVA for all issuers, on average. We also note that while the Neyman allocation optimizes strata sample size by sampling strata with greater variance more intensely, the number of enrollees sampled from each stratum also depends on each stratum's relative size in the issuer's population. Enrollees will continue to be sampled from low, medium and high-risk strata as we calculate non-zero national variances of net risk score error for strata 1-9.
                        <SU>135</SU>
                        <FTREF/>
                         Therefore, issuers should continue to focus on the appropriate coding of all enrollees regardless of enrollee risk score as the purpose of HHS-RADV is to ensure that issuers are providing accurate, high-quality information to their EDGE servers to be used in the risk adjustment State transfer calculations. While HHS sets the standards for HHS-RADV and validates IVA results through the SVA, issuers have different structures, systems and contracts with their IVA Entities which may determine how they prioritize chart retrievals and reviews.
                    </P>
                    <FTNT>
                        <P>
                            <SU>134</SU>
                             See Chapter 2: HHS-RADV Initial Validation Audit (IVA) Sampling of the HHS Risk Adjustment Data Validation (HHS-RADV) White Paper (December 6, 2019).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>135</SU>
                             As noted above, we are also finalizing the proposal to exclude enrollees without HCCs from IVA sampling.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters expressed concerns with difficulty retrieving documentation to validate newborn birthweight and noted that this may impact calculating the variance of net risk score error for infant strata in HHS-RADV. One of these commenters requested HHS to exclude the newborn birthweight HCCs when calculating the variance of error for infant strata.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we recognize commenters' concerns with retrieving documentation to validate newborn birthweight, issuers are required to have the appropriate documentation to substantiate any risk adjustment eligible diagnoses submitted to EDGE. Moreover, we disagree with excluding the newborn birthweight HCCs when calculating the variance of infant strata. The average number of infant enrollees selected in the IVA sample is relatively low and excluding birthweight HCCs could artificially reduce the variance in the infant low, medium and high-risk strata, which in turn would further reduce the representation of infant enrollees in the IVA sample. We believe that using HHS-RADV data to derive stratum variance without excluding any HCCs will ensure that issuers' IVA sample sizes best reflect the relevant risk adjustment population. We therefore decline to exclude the newborn birthweight HCCs when calculating the variance of error for infant strata.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter who supported the general proposal to no longer use MA-RADV data and begin using HHS-RADV data opposed using a 3-year rolling average and requested HHS instead use the most recent year of HHS-RADV data. This commenter suggested that HHS-RADV policy goals should not aim to make HHS-RADV audits predictable year-to-year and using the most recent year of HHS-RADV data available would help identify any evolving data integrity issues before they lead to competitive disequilibrium. This commenter also stated that continuing to use the MA-RADV data in the Neyman allocation may reduce transfer accuracy and requested HHS to recalibrate IVA sampling using the HHS-RADV data as soon as possible rather than waiting to the 2025 benefit year of HHS-RADV.
                        <PRTPAGE P="4456"/>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are finalizing the proposal to replace MA-RADV data as the source data for the Neyman allocation for IVA sampling and use of the 3 most recent consecutive years of HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities to calculate the standard deviation of risk score error ) in the Neyman allocation starting with the 2025 benefit year of HHS-RADV. As explained in the proposed rule (89 FR 82308, 82353), the purpose of using 3 years of HHS-RADV data is to capture population changes that occur over time while promoting stability in the estimates of the standard deviation of risk score error in HHS-RADV year over year and to ensure that all issuers, including smaller issuers that are at or below the materiality threshold at § 153.630(g)(2) that are generally subject to HHS-RADV approximately once every 3 years, are captured when estimating strata variance. The 3-year rolling average for sample design is not intended to make HHS-RADV predictable. Furthermore, using a rolling-window of the 3 most recent consecutive years of HHS-RADV data means that the set of 3 years informing the calculation of stratum variance would change from one benefit year of HHS-RADV to the next. Predicting these annually calculated stratum variance values years in advance would be more difficult under the finalized methodology than the current methodology, which relies on a static year of MA-RADV data to estimate the variance of net risk score error.
                        <SU>136</SU>
                        <FTREF/>
                         In addition, the stratum variance would continue to be calculated at a national level, so the impact of any one issuer's behavior on stratum variance is limited. Moreover, using this 3-year rolling-window should capture any new trends in variance that could reflect data integrity issues without immediately abandoning the trends in variance observed in the recent past.
                    </P>
                    <FTNT>
                        <P>
                            <SU>136</SU>
                             The HHS-RADV protocols include an estimate for the stratum variance calculated from MA-RADV data and used in the Neyman allocation. See, for example, Section 8.3.3 Validating the IVA Sample Generated by CMS in the 2023 Benefit Year HHS-RADV Protocols.
                        </P>
                    </FTNT>
                    <P>While we anticipate the transition to HHS-RADV data in the Neyman allocation to better reflect the relevant risk adjustment population, we disagree with concerns that continuing to use the MA-RADV data before the 2025 benefit year of HHS-RADV will reduce transfer accuracy. Our analysis of the current HHS-RADV methodology supports acceptable levels of error rate precision, and we are finalizing improvements to the IVA sampling methodology in this final rule to further our program integrity goals of validating the actuarial risk of enrollees in risk adjustment covered plans to ensure that the HHS-operated risk adjustment program accurately assess charges to issuers with plans with lower-than-average actuarial risk while making payments to issuers with plans with higher-than-average actuarial risk. In addition, the finalized changes to use HHS-RADV data in the Neyman allocation for IVA sampling will require sufficient lead time for HHS to derive coding changes to calculate the national variance of net risk score error for each stratum and issuers' standard deviations of risk score error for each stratum, which are used as an input to the Neyman allocation formula, and to perform testing and quality reviews of the calculations. In addition, as we explained in the proposed rule (89 FR 82406), we considered implementing the change to use HHS-RADV data in the Neyman allocation without the other proposed IVA sampling modifications, and we found that making these modifications in combination would lead to greater improvements in sampling precision and would allow more than 95 percent of issuers to pass the 10 percent sampling precision target at a two-sided 95 percent confidence level. Therefore, we need sufficient lead time to build all changes to the IVA sampling methodology finalized in this rule before issuers' IVA samples can be generated under the methodology finalized in this rule. There would be insufficient time to complete these tasks and implement this change to generate 2024 benefit year IVA samples as 2024 benefit year HHS-RADV activities will generally begin in early 2025. We therefore are finalizing the proposed applicability date and will implement this change beginning with the 2025 benefit year HHS-RADV.</P>
                    <HD SOURCE="HD3">4. Impact of IVA Sampling Proposals</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82353) we noted that in preparation for these proposed changes to HHS-RADV IVA sampling, HHS conducted several analyses to evaluate the impact of these proposals. Our analyses revealed that the proposed modifications to switch data for the Neyman allocation to use the 3 most recent consecutive years of HHS-RADV data with results that have been released before HHS-RADV activities begin for the given benefit year, combined with the proposals to remove enrollees without HCCs from IVA sampling and to remove the FPC from the IVA sampling methodology, would improve our ability to reach the 10 percent sampling precision target for net risk score error for a greater proportion of issuers in HHS-RADV.
                        <SU>137</SU>
                        <FTREF/>
                         More specifically, when we evaluated the proposed IVA sampling methodology reflecting the changes outlined in the proposed rule, which excludes enrollees without HCCs, removes the FPC, and replaces the MA-RADV data with available HHS-RADV data as the source data for the Neyman allocation, using HHS-RADV data from the 2022 benefit year, we found that more than 99 percent of issuers met the 10 percent sampling precision target for net risk score error at a two-sided 95 percent confidence level.
                    </P>
                    <FTNT>
                        <P>
                            <SU>137</SU>
                             The precision of net risk score error reflects the ability of the IVA sampling methodology to consistently estimate the percent difference between enrollees' audit risk scores and EDGE risk scores. We provided details on how the 10 percent sampling target was derived in the proposed rule. See 89 FR 82349 through 82350.
                        </P>
                    </FTNT>
                    <P>Our analyses also focused on the impact of the policies on group failure rate precision. Under the proposed changes to the IVA sampling methodology in the proposed rule, our analysis found that approximately 91 percent of all issuers in HHS-RADV would meet the 10 percent group failure rate precision in all three Super HCC groups. Moreover, approximately 87 percent of issuers with IVA sample sizes less than 200 would also meet the 10 percent group failure rate precision target in all three Super HCC groups.</P>
                    <P>In addition, we anticipated that the proposed changes to the IVA sampling methodology in the proposed rule would result in an overall decrease in the number of medical records reviewed by IVA Entities. Although every enrollee sampled for the IVA would have HCCs, the proportion of enrollees sampled from strata 1 through 9 would change such that enrollees that generally have more medical records are sampled less intensely due to the replacement of MA-RADV data with HHS-RADV data for the Neyman allocation. As mentioned in the proposed rule, the median sample proportion of high-risk adult enrollees, who have more medical records to review on average, could decrease from 39 percent of the sample to 19 percent under the updated IVA sampling methodology reflecting the proposed changes in the proposed rule. We described our estimates of the proposed methodology on issuer burden in more detail in the Collection of Information section of the proposed rule.</P>
                    <P>
                        As noted in the proposed rule (89 FR 82308, 82354), removing enrollees without HCCs and the FPC, and updating the source of the IVA sampling Neyman allocation data to use HHS-
                        <PRTPAGE P="4457"/>
                        RADV data, leads to an IVA sample that improves sampling precision while decreasing burden on issuers and IVA Entities on average. Therefore, we proposed to exclude enrollees without HCCs from IVA sampling such that each enrollee in an issuer's IVA sample must have at least one HCC, remove the FPC, and change the source of the Neyman allocation data used to calculate the standard deviation of risk score error from MA-RADV data to the 3 most recent consecutive years of HHS-RADV data with results that have been released before HHS-RADV activities for the benefit year begin.
                    </P>
                    <P>We sought comment on the estimated impact of all proposed changes to the IVA sampling methodology. After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments below and on the proposals to exclude enrollees without HCCs from IVA sampling, remove the FPC from the IVA sampling methodology, and replace the source of data in the Neyman allocation from MA-RADV data with HHS-RADV data, we are finalizing all proposed IVA sampling policies as proposed. We summarize and respond to public comments received on the estimated impact of these proposals below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested that the three proposed changes to the IVA sampling methodology would improve the overall accuracy and precision of HHS-RADV results. In addition, several commenters agreed that all proposed changes to the IVA sampling methodology would improve sampling and group failure rate precision. One of these commenters suggested that finalizing the proposed changes would provide a more accurate and inclusive threshold for outlier identification. Another commenter suggested that the IVA sampling proposals would improve the predictability of HHS-RADV.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these comments in support of the three proposed changes to the IVA sampling methodology and are finalizing all of these proposed changes as proposed to align sampling with the error estimation methodology and improve sampling precision. We anticipate that the changes will also improve the precision of group failure rates, the national benchmarks used to determine outlier status in each failure rate group, the net risk score error calculations, and will therefore improve the precision of HHS-RADV results used to adjust risk adjustment State transfers. Improving the precision of the IVA sampling methodology with the adoption of the changes finalized in this rule will also further promote the overall integrity of HHS-RADV and confidence in the HHS-operated risk adjustment program.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter agreed with HHS' assessment that issuer and IVA Entity burden would decrease as a result of the proposed changes to the IVA sampling methodology. However, a few commenters questioned HHS' assessment of burden associated with the proposed changes. One of these commenters suggested that the proposals would unnecessarily increase the administrative burden for issuers and another commenter suggested that there would be a significant burden increase associated with collecting more records from enrollees in lower-risk strata as these enrollees will likely be more heavily sampled if the proposed changes are finalized. This commenter noted that enrollees in lower-risk strata are more likely to see providers who do not provide issuers with direct access to medical records, which could make it more burdensome for issuers to retrieve medical records for these enrollees, especially for smaller issuers. Another commenter noted concern that compliance with the added HHS-RADV audit requirements could place a greater burden on smaller issuers without clarity on how these proposed changes would help patients. One commenter urged HHS to monitor the impact of these changes on burden and consider future changes if there is an undesired impact on HHS-RADV adjustments to risk adjustment State transfers.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As noted in the proposed rule, we estimate that the impact of finalizing all proposed modifications to the IVA sampling methodology will decrease issuer burden on average. Although every enrollee sampled for the IVA would have HCCs, the proportion of enrollees sampled from strata 1 through 9 would change such that enrollees with more medical records are sampled less intensely, and we estimate this would lead to an average decrease in the number of HCCs and medical records reviewed per enrollee. We recognize the commenter's concern that some providers for enrollees from lower-risk strata may provide issuers with less direct access to medical records, but we note that enrollees in lower risk strata are enrollees with fewer HCCs or relatively lower-risk HCCs, for whom issuers should be able to provide supporting medical records for risk adjustment eligible diagnoses submitted to EDGE as required by the EDGE Server Business Rules.
                        <SU>138</SU>
                        <FTREF/>
                         The principles for including an HCC in the risk adjustment models require that each HCC represents a well-specified, clinically significant, chronic or systematic medical condition, and therefore, any enrollees with HCCs, regardless of if they are in a lower-risk stratum or higher risk stratum, have conditions that should have supporting medical records.
                        <SU>139</SU>
                        <FTREF/>
                         Furthermore, if it is more burdensome to retrieve medical records for enrollees from lower-risk strata, any increase in burden from retrieving these medical records would be offset, at least in part, by the decrease in burden from retrieving fewer medical records for enrollees from higher-risk strata. We also note that enrollees from low, medium, and high-risk strata will continue to be sampled for the IVA and the actual number of enrollees sampled from each stratum will depend on that stratum's contribution to the total standard deviation of net risk score error in the issuer's population.
                    </P>
                    <FTNT>
                        <P>
                            <SU>138</SU>
                             See, for example, the EDGE Server Business Rules (ESBR) Version 25.0 (December 2024) available at 
                            <E T="03">https://regtap.cms.gov/uploads/library/DDC-ESBR-v25-5CR-120624.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>139</SU>
                             See CMS. (2021). 
                            <E T="03">HHS-Operated Risk Adjustment Technical Paper on Possible Model Changes.</E>
                             Section 1.2.1 (Principles of Risk Adjustment). 
                            <E T="03">https://www.cms.gov/files/document/2021-ra-technical-paper.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        In addition, we estimate that smaller issuers whose IVA sample sizes may increase under the IVA sampling methodology finalized in this rule are also likely to see the greatest increases in Super HCC counts and group failure rate precision on average across all three failure rate groups. Overall, this contributes to more precise HHS-RADV results and ensures that risk adjustment State transfers reflect verifiable actuarial risk differences between issuers. Moreover, as explained in section III.3.B.6.a.2 above, we anticipate that the vast majority of issuers who would see increased IVA sample sizes after the removal of the FPC are at or below the materiality threshold for random and targeted sampling and would only be selected for audit approximately once every 3 benefit years (barring any risk-based triggers based on experience that will warrant more frequent audits). Therefore, we believe that the benefits a smaller issuer gains from increased group failure rate precision and the estimated overall average decrease in the number of HCCs and medical records reviewed per enrollee outweigh any potential increases in IVA sample size. We also clarify that HHS-RADV does not directly impact patients. The HHS-RADV program helps ensure the integrity of data used in the HHS-operated risk adjustment program to calculate risk adjustment State transfers. The risk adjustment program helps 
                        <PRTPAGE P="4458"/>
                        stabilize premiums across the individual, merged, and small group markets, and thereby helps provide consumers with affordable health insurance coverage options. As with any finalized modifications to HHS-RADV, we will monitor the implementation and impact of these policies. While these changes to the IVA sampling methodology could affect the adjustments to risk adjustment State transfers for an individual issuer, we anticipate that any changes to HHS-RADV adjustments will reflect more accurate actuarial risk differences between issuers.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested HHS to apply the proposed IVA sampling methodology changes to the 2024 benefit year of HHS-RADV and stated that waiting to implement these changes until the 2025 benefit year would allow issuers to adjust their strategies in advance of the audit which would undermine the impact of the audit on data integrity. This commenter also suggested that the typical one-year delay between the year in which HHS-RADV changes are proposed and the applicable benefit year of HHS-RADV should not apply as HHS-RADV adjustments are not relevant to rate setting.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We proposed the IVA sampling methodology changes to apply beginning with the 2025 benefit year of HHS-RADV to reflect the timeline for HHS-RADV activities and the anticipated time needed to test and implement these changes. We disagree that waiting to implement these changes beginning with 2025 benefit year HHS-RADV would undermine the impact of the audit on data integrity. While issuers and their IVA Entities may vary in how they choose to approach changes to HHS-RADV, we believe these policies maintain HHS-RADV's focus on ensuring issuers submit accurate, high-quality information to their EDGE servers to be used in the risk adjustment State transfer calculations. We also clarify that we are not delaying the implementation of these policies to benefit year 2025 because of issuers' timelines for rate setting. Rather, the finalized changes to exclude enrollees without HCCs and use HHS-RADV data in the Neyman allocation for IVA sampling will require sufficient lead time for HHS to derive coding changes to generate samples from EDGE server data that exclude enrollees without HCCs and coding changes to calculate the national variance of net risk score error for each stratum and issuers' standard deviations of risk score error for each stratum, which are used as inputs to the Neyman allocation formula. These IVA sampling changes will also require HHS to update the Audit Tool and perform testing before issuers' IVA samples can be generated under the IVA sampling methodology finalized in this rule. In addition, as we explained in Section III.B.6.a.3 above, we found that making the IVA sampling modifications to exclude enrollees without HCCs, remove the FPC, and replace the MA-RADV data used in the Neyman allocation in unison would lead to greater improvements in sampling precision. Therefore, we need sufficient lead time to build all changes to the IVA sampling methodology finalized in this rule before issuers' IVA samples can be generated under the methodology finalized in this rule. There would be insufficient time to complete these tasks and implement these changes to generate 2024 benefit year IVA samples as 2024 benefit year HHS-RADV activities will generally begin in early 2025. We therefore are finalizing the proposed applicability date and will implement this change beginning with the 2025 benefit year HHS-RADV.
                    </P>
                    <HD SOURCE="HD3">b. Second Validation Audit (SVA) Pairwise Means Test (§ 153.630(c))</HD>
                    <P>
                        To improve the sensitivity of the SVA pairwise means test, in the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82354), we proposed to modify the test, which currently uses a paired sample t-test methodology, to use a bootstrapping methodology, and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV.
                        <SU>140</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>140</SU>
                             These changes to the SVA framework do not impact or change issuer or IVA Entity obligations or requirements; therefore, we proposed to implement the proposed changes to the SVA pairwise means test starting with the 2024 benefit year HHS-RADV. Activities related to the 2024 benefit year of HHS-RADV will generally begin in March 2025, when issuers can start selecting their IVA entity, and IVA entities can start electing to participate in HHS-RADV for the 2024 benefit year. The SVA typically starts the January 2 years after the applicable benefit year (January 2026 for the 2024 benefit year of HHS-RADV) once issuers' IVA results have been submitted. See HHS. (2024, March 27). For the most recently published annual HHS-RADV timeline, see the 
                            <E T="03">2023 Benefit Year HHS-RADV Activities Timeline. https://regtap.cms.gov/uploads/library/2023_RADV_Timeline_5CR_072424.pdf.</E>
                             We note that there were delays in the 2023 Benefit Year HHS-RADV Activities Timeline in recognition of the challenges some issuers were facing related to EDGE server operations after the Change Healthcare Cybersecurity Incident.
                        </P>
                    </FTNT>
                    <P>
                        As noted in the proposed rule (89 FR 82354), based on our experience operating HHS-RADV for the past several benefit years, we have reassessed the sensitivity of our pairwise means testing procedure, meaning the ability of the statistical test to identify statistically significant differences between IVA and SVA risk scores when they exist, to see whether changes are needed. Based on our reassessment, we noted that we believe the pairwise means testing procedure should be modified to use a 90 percent bootstrapped confidence interval, rather than a t-test with a 95 percent confidence interval, and to increase the initial SVA subsample level from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV to improve the sensitivity of the pairwise means test, improve the false negative rate and promote the integrity of HHS-RADV.
                        <SU>141</SU>
                        <FTREF/>
                         For a full discussion of the proposed changes to the SVA pairwise means test, see the proposed rule (89 FR 82308, 82354).
                    </P>
                    <FTNT>
                        <P>
                            <SU>141</SU>
                             As explained in the proposed rule, “false negatives” are a detection error that occurs when there are significant differences between IVA and SVA results, but the statistical test does not identify a statistically significant difference between IVA and SVA enrollee risk scores. The conventional minimum power desired for most research settings is 80 percent, which implies a false negative rate of 20 percent. See Cohen, Jacob (1988). 
                            <E T="03">Statistical Power Analysis for the Behavioral Sciences.</E>
                             Routledge. ISBN 978-1-134-74270-7. pp. 25-27.
                        </P>
                    </FTNT>
                    <P>
                        As we explained in the proposed rule (89 FR 82308, 82355), at a given SVA subsample level, the proposed pairwise bootstrapping methodology would perform 10,000 iterations of resampling with replacement from the enrollees in the issuer's SVA subsample at that level. The average difference between enrollees' IVA and SVA risk scores would be calculated for each resample to build an issuer-specific confidence interval for statistical testing of enrollee's IVA and SVA risk scores. Like the current pairwise means test, if the bootstrapped confidence interval contains zero, the bootstrapping procedure would show non-significant differences between IVA and SVA risk scores, and the issuer would pass pairwise means testing at that SVA subsample level and IVA results would be used in error estimation. If the bootstrapped confidence interval does not include zero, the differences between IVA and SVA risk scores identified would be statistically significant, and the issuer would fail pairwise means testing at that SVA subsample level. In these circumstances, the SVA subsample would be expanded and the pairwise means test conducted at that new SVA subsample level. If the issuer continues to fail the pairwise means test at the SVA 100-level, a precision analysis would be performed to determine whether the SVA audit results from the SVA 100 subsample can 
                        <PRTPAGE P="4459"/>
                        be used in error estimation or if the SVA sample needs to expand to the full IVA sample of 200 enrollees with the SVA 200 results used in error estimation.
                        <E T="51">142 143</E>
                        <FTREF/>
                         We sought comment on the proposal to modify the SVA pairwise means testing procedure to use a bootstrapped 90 percent confidence interval and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV.
                    </P>
                    <FTNT>
                        <P>
                            <SU>142</SU>
                             See Section 11.6.2 Pairwise Means Test to Determine Accepted Results (IVA vs. SVA) of the 2023 Benefit Year PPACA HHS Risk Adjustment Data Validation (HHS-RADV) Protocols (June 4, 2024) available at 
                            <E T="03">https://regtap.cms.gov/uploads/library/HHS-RADV_2023_Benefit_Year_Protocols_v1_5CR_060424.pdf.</E>
                        </P>
                        <P>
                            <SU>143</SU>
                             As explained in the proposed rule (89 FR 82308, 82354), all issuers are subject to the same SVA subsample sizes, but the maximum SVA subsample for pairwise testing is one half of the issuer's IVA sample size. Under the IVA policies finalized in this rule beginning with benefit year 2025 HHS-RADV, issuers with less than 200 enrollees with HCCs would continue to follow the standard SVA subsample sizes with a maximum SVA subsample size for pairwise testing equal to one half of the issuer's IVA sample size. If the issuer fails at the maximum SVA subsample size for pairwise testing, a precision analysis is performed to determine whether the SVA audit results from that maximum SVA subsample size can be used in error estimation or if the SVA sample needs to expand to the full IVA sample.
                        </P>
                    </FTNT>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing the modification to the SVA pairwise means test to use a bootstrapped 90 percent confidence interval and to increase the initial SVA subsample size to 24 enrollees beginning with the 2024 benefit year HHS-RADV as proposed. We summarize and respond to public comments received on modifying the SVA pairwise means testing procedure and increasing the SVA sample size below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters supported the proposal to modify the SVA pairwise means test to use a bootstrapping methodology and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees. Two commenters suggested these modifications would improve the accuracy and precision of HHS-RADV results. One of these commenters stated that the modelling assumptions under the proposed methodology would produce more accurate statistics when the underlying distribution is unknown. This commenter also recognized the effort to balance false negatives and false positives to increase the overall integrity of HHS-RADV.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the comments in support of this proposal and are finalizing the proposal to modify the SVA pairwise means testing procedure to use a bootstrapped 90 percent confidence interval and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV to improve the sensitivity of the SVA pairwise means test, reduce the false negative rate, and further promote the overall integrity of HHS-RADV. We agree that building confidence intervals using bootstrapping rather than t-intervals is better suited for the SVA pairwise means test as issuers' population distribution of IVA and SVA risk score differences is unknown when conducting the test at any SVA subsample level. As noted in the proposed rule (89 FR 82308, 82355), there is a tradeoff between decreasing the false negative rate and the false positive rate when reducing the size of the confidence interval from 95 percent to 90 percent, but we believe that the benefits in achieving an acceptable rate of false negatives outweighs the potential impacts for any increase in the false positive rate. This is because the SVA methodology provides the opportunity for false positives to be addressed at a later stage of the SVA review process as an issuer failing the SVA pairwise at a given subsample size results in an incremental increase in that issuer's SVA subsample size for further review by the SVA Entity whereas false negatives result in the issuer passing the SVA pairwise test at the subsample size where no significant differences are detected between IVA and SVA results.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters opposed the proposed changes to the SVA pairwise means test. One commenter noted that the current SVA methodology has provided consistent results and noted concern that changing the methodology would create unpredictability in HHS-RADV. Another commenter stated that they could not appropriately evaluate the impact of the proposed changes because issuers and IVA entities have little transparency into SVA outcomes because issuers who pass pairwise do not receive SVA results. A few commenters also urged HHS to provide more transparency by releasing SVA results to issuers and their IVA entities when there is sufficient agreement between the IVA and SVA in the SVA pairwise means test. One of these commenters suggested that the current process prevents IVA entities from evaluating their own coding practices and specifically requested that HHS release calculated z-scores with SVA results so that issuers can understand where coding differences occurred that triggered additional levels of SVA review. A few commenters requested that HHS and interested parties take additional time to evaluate the impact of the IVA sampling methodology changes before pursuing changes to the SVA pairwise means testing procedure and sample size approach.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are finalizing the modifications to the SVA pairwise means test to use a bootstrapped 90 percent confidence interval and to increase the SVA subsample size from 12 to 24 enrollees beginning with benefit year 2024 HHS-RADV as proposed. In the proposed rule (89 FR 82355), we recognized that the increased sensitivity of the bootstrapping methodology could result in more issuers being expanded to larger SVA subsample sizes during pairwise means testing. However, issuers with IVA entities that continue to code according to the relevant coding guidelines and validate HCCs in accordance with the EDGE Server Business Rules and for whom the current pairwise test correctly identifies no significant differences between IVA and SVA results should continue to pass pairwise testing under the modified pairwise testing procedure and SVA subsample size approach finalized in this rule. We encourage all issuers to coordinate with their IVA Entities to study and learn from their HHS-RADV results and experience. In particular, issuers that fail pairwise testing should work with their IVA entities to review the IVA diagnosis abstraction and identify differences from SVA results.
                    </P>
                    <P>
                        Thus, we also disagree that issuers and IVA entities have insufficient transparency into SVA outcomes to evaluate the impact of the proposed changes to the SVA pairwise testing procedure or their own coding practices. In the proposed rule (89 FR 82308, 82355), we explained the impact of the proposed modifications to increase the initial SVA subsample size to 24 enrollees and use a bootstrapped 90 percent confidence interval on the false negative rate, false positive rate and the overall sensitivity of the pairwise means test, and we sought comment on these proposals. In addition, we disagree that issuers have insufficient transparency into SVA outcomes. HHS does not provide SVA results to issuers or IVA entities that pass pairwise testing because passing signifies that the SVA findings do not significantly differ from IVA findings and that the IVA findings, which issuers review and sign off on, can be used during error estimation as issuers' final accepted audit results. 
                        <PRTPAGE P="4460"/>
                        Issuers and IVA Entities that pass pairwise testing and do not receive an SVA findings report are still able to review key SVA findings, such as the most commonly miscoded HCCs for SVA reviewed sampled enrollees, from each benefit year of HHS-RADV in the results memo.
                        <SU>144</SU>
                        <FTREF/>
                         Issuers that do not pass pairwise testing receive SVA findings reports that include details on the enrollee-level HCCs that differed between IVA and SVA review.
                    </P>
                    <FTNT>
                        <P>
                            <SU>144</SU>
                             See, for example, Table 1 of the 2022 Benefit Year HHS-RADV Results Memo (May 14, 2024) available at 
                            <E T="03">https://www.cms.gov/files/document/by22-hhs-radv-results-memo-appendix-pdf.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Lastly, we note that in finalizing these changes to the SVA processes, we recognize that the paired t-test with a 95 percent confidence interval has been consistently used as the SVA pairwise testing procedure since we started conducting HHS-RADV, but we also note that the consistency or predictability of an issuer's SVA pairwise means test results from one benefit year to the next is not indicative of the effectiveness of the methodology. The SVA pairwise means test is intended to identify whether significant differences exist between an issuer's IVA and SVA results in a given benefit year of HHS-RADV and to determine which audit results should be used for that year's error estimation. We also further clarify that HHS does not calculate z-scores during the current SVA pairwise testing methodology as the current statistical test is a paired t-test.
                        <SU>145</SU>
                        <FTREF/>
                         HHS will not calculate z-scores under the finalized SVA pairwise testing methodology beginning with benefit year 2024 HHS-RADV as this statistical test will build bootstrapped confidence intervals.
                        <SU>146</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>145</SU>
                             For more information on the paired t-test, see Section 11.6.2 Pairwise Means Test to Determine Accepted Results (IVA vs. SVA) of the 2023 Benefit Year PPACA HHS Risk Adjustment Data Validation (HHS-RADV) Protocols (June 4, 2024) available at 
                            <E T="03">https://regtap.cms.gov/uploads/library/HHS-RADV_2023_Benefit_Year_Protocols_v1_5CR_060424.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>146</SU>
                             As explained above, the pairwise bootstrapping methodology would perform 10,000 iterations of resampling with replacement from the enrollees in the issuer's SVA subsample at that level. The average difference between enrollees' IVA and SVA risk scores would be calculated for each resample to build an issuer-specific confidence interval for statistical testing of enrollee's IVA and SVA risk scores. If the bootstrapped confidence interval contains zero, the issuer would pass pairwise means testing at that SVA subsample level. If the bootstrapped confidence interval does not include zero, the issuer would fail pairwise means testing at that SVA subsample level. More detail on the pairwise bootstrapping methodology will be provided in the applicable benefit year's HHS-RADV protocols.
                        </P>
                    </FTNT>
                    <P>For these reasons, we disagree with delaying the finalization of changes to the SVA methodology after the finalized changes to the IVA methodology take place as the changes to the SVA methodology are intended to improve the sensitivity of the pairwise means test and the finalized changes to the IVA methodology are specific to IVA sampling and do not address the pairwise means test.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter inquired about how the estimated costs and estimated improvement in the false negative rate were attributed to modifying the SVA subsample size as opposed to modifying the pairwise means testing procedure. This commenter noted concern that bootstrapping would not address underlying issues associated with smaller sample sizes or could create a false sense of precision at smaller sample sizes and stated that the current t-test is better suited to handle small sample size uncertainty. However, this commenter also suggested that bootstrapping may be appropriate if CMS observes that the rate of false negatives reliably decreases when switching from the t-test to bootstrapping and keeping the confidence interval and sample size constant.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We estimate that approximately 20 percent of the estimated improvement in the false negative rate will be attributable to modifying the initial SVA subsample size to 24 enrollees and approximately 80 percent will be attributable to modifying to pairwise means test to a bootstrapped 90 percent confidence interval.
                        <SU>147</SU>
                        <FTREF/>
                         We also estimate that approximately 33 percent of the costs associated with making these changes in 2024 benefit year HHS-RADV will be attributed to transitioning from the current t-test pairwise means testing procedure to the bootstrapped procedure and coding the changes to test and execute the bootstrapping methodology, and the remaining costs will be attributed to increasing the initial SVA subsample size to 24 enrollees.
                    </P>
                    <FTNT>
                        <P>
                            <SU>147</SU>
                             The rate of improvement in the false negative rate and how this is attributed to the initial SVA subsample size or the statistical methodology differs depending on the effect size, or the magnitude of the true difference between IVA and SVA results. For these estimates, we use the Cohen's D effect size measure and assume a small effect size. See Cohen, Jacob (1988). Statistical Power Analysis for the Behavioral Sciences. Routledge. ISBN 978-1-134-74270-7. pp 25-27.
                        </P>
                    </FTNT>
                    <P>We are not concerned with a false sense of precision at smaller sample sizes because we are increasing the initial SVA subsample size from 12 to 24 enrollees and our analysis comparing the updated SVA pairwise means test to the current test indicates a lower incidence of false negatives at smaller sample sizes. Moreover, if there is an increase in false positives at smaller sample sizes, the incremental review structure of the SVA allows the opportunity for those false positives to be corrected and for issuers to pass SVA pairwise testing at larger sample sizes such that their IVA results could be used for error estimation.</P>
                    <HD SOURCE="HD3">c. HHS-RADV Materiality Threshold for Rerunning HHS-RADV Results (§ 156.1220(a)(2))</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82356), we proposed to amend § 156.1220(a) to codify a new materiality threshold for HHS-RADV appeals, hereafter referred to as the materiality threshold for rerunning HHS-RADV results.
                        <SU>148</SU>
                        <FTREF/>
                         We proposed to amend § 156.1220 to add a new paragraph (a)(2)(i) to provide that HHS would rerun HHS-RADV results in response to a successful appeal when the impact to the issuer who submitted the appeal (that is, the filer's) HHS-RADV adjustments to State transfers is greater than or equal to $10,000. We are finalizing these amendments as proposed; the discussion of comments pertaining to this proposal are below in part 156 (§ 156.1220).
                    </P>
                    <FTNT>
                        <P>
                            <SU>148</SU>
                             For purposes of this proposal, rerunning HHS-RADV results involves recalculating all national program benchmarks and issuers' error rate results, reissuing issuers' error rate results, conducting discrepancy reporting and appeal windows for the reissued results, applying the reissued error rates to the applicable benefit year's State transfers, and invoicing, collecting, and distributing any additional changes to the HHS-RADV adjustments to State transfers.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">C. Part 155—Exchange Establishment Standards and Other Related Standards</HD>
                    <HD SOURCE="HD3">1. Solicitation of Comments—Navigator, Non-Navigator Assistance Personnel, and Certified Application Counselor Program Standards (§§ 155.210, 155.215, and 155.225)</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82356), we solicited comment regarding how assisters who perform their assister duties in a hospital and hospital system may, within the bounds of the statute, refer consumers to programs designed to reduce medical debt. We thank commenters for their feedback and will take comments into consideration in future rulemaking.
                        <PRTPAGE P="4461"/>
                    </P>
                    <HD SOURCE="HD3">2. Ability of States To Permit Agents and Brokers and Web-Brokers To Assist Qualified Individuals, Qualified Employers, or Qualified Employees Enrolling in QHPs (§ 155.220)</HD>
                    <HD SOURCE="HD3">a. Engaging in Compliance Reviews and Taking Enforcement Actions Against Lead Agents for Insurance Agencies</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82357), we addressed our authority under § 155.220 to address misconduct or noncompliance occurring at an agency-level,
                        <SU>149</SU>
                        <FTREF/>
                         by undertaking compliance reviews of and enforcement action against an insurance agency's (agency's) lead agent(s), and discussed how we propose to utilize this authority to hold agencies accountable for misconduct or noncompliance with applicable HHS Exchange standards and requirements under § 155.220. We noted that the term lead agent generally refers to any person who registers or maintains a business within a State and/or any person who registers a business NPN with the Exchange, who typically is an executive or person with a leadership role within an agency.
                    </P>
                    <FTNT>
                        <P>
                            <SU>149</SU>
                             For purposes of this policy, “agency-level” misconduct or noncompliance refers to misconduct or noncompliance with HHS Exchange standards and requirements under § 155.220 associated with an eligibility application or enrollment transaction that lists an agency's National Producer Number (NPN) or that the agency was involved in or facilitated the submission of, or misconduct or noncompliance with HHS Exchange standards and requirements under § 155.220 that involves the agency's lead agent(s) or that the agency endorsed or is otherwise involved in.
                        </P>
                    </FTNT>
                    <P>
                        Section 155.220 currently applies to an agent, broker, or web-broker that assists with or facilitates enrollment of qualified individuals, qualified employers, or qualified employees in a QHP in a manner that constitutes enrollment through the Exchange or assists individuals in applying for APTC and CSRs for coverage offered through an Exchange. “Web-broker” is defined in § 155.20 as an individual agent or broker, group of agents or brokers, or business entity registered with an Exchange under § 155.220(d)(1) that develops and hosts a non-Exchange website that interfaces with an Exchange to assist consumers with direct enrollment in QHPs offered through the Exchange as described in § 155.220(c)(3) or § 155.221.
                        <SU>150</SU>
                        <FTREF/>
                         Section 155.20 defines “agent or broker” as a person or entity licensed by the State as an agent, broker or insurance producer.
                    </P>
                    <FTNT>
                        <P>
                            <SU>150</SU>
                             The term also includes an agent or broker direct enrollment technology provider. See § 155.20.
                        </P>
                    </FTNT>
                    <P>In the proposed rule (89 FR 82357), we did not propose amendments to our existing regulations to codify our approach to hold agencies, through their lead agents, accountable for misconduct or noncompliance with applicable standards and requirements in § 155.220 because they can reasonably be interpreted to apply to agencies that are involved in Exchange enrollment transactions, since agencies are entities licensed by a State as an agent, broker, or insurance producer. As such, agencies fall under the current definitions of “agent or broker” and “web-broker” under § 155.20.</P>
                    <P>
                        We proposed to rely on the same authorities under § 155.220 to address misconduct or noncompliance occurring at an agency-level, by undertaking compliance reviews of and enforcement action against an insurance agency's lead agent(s). These authorities subject agents, brokers, and web-brokers to compliance reviews and enforcement actions under § 155.220, which allow HHS to periodically monitor and audit an agent, broker, or web-broker to assess their compliance with the applicable requirements of § 155.220.
                        <SU>151</SU>
                        <FTREF/>
                         This means that agencies, through their lead agents, would also be subject to section 155.220(g), which sets forth standards for suspension and termination of an agent's, broker's, or web-broker's Exchange Agreements for cause, which ends their participation in the FFEs.
                        <SU>152</SU>
                        <FTREF/>
                         These enforcement actions may be taken in three situations: (1) for specific findings or patterns of noncompliance,
                        <SU>153</SU>
                        <FTREF/>
                         (2) failure to maintain proper licensure in all States where the agent, broker, or web-broker is assisting consumers,
                        <SU>154</SU>
                        <FTREF/>
                         and (3) for engaging in fraud or abusive conduct.
                        <SU>155</SU>
                        <FTREF/>
                         Likewise, through their lead agents, agencies would be subject to section 155.220(k), which sets forth penalties other than suspension or termination of the agent's, broker's, or web-broker's Exchange Agreements for the current plan year. If an agent, broker, or web-broker fails to comply with the requirements of § 155.220, HHS may deny an agent, broker, or web-broker the right to enter into Exchange Agreements in future years 
                        <SU>156</SU>
                        <FTREF/>
                         or impose a civil money penalty as described in § 155.285.
                        <SU>157</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>151</SU>
                             45 CFR 155.220(c)(5).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>152</SU>
                             We notify State Departments of Insurance when we suspend or terminate the Exchange Agreement(s) of an agent, broker, or web-broker under § 155.220(g), per § 155.220(g)(6). We also maintain and publish the Agent and Broker Federally-facilitated Marketplace (FFM) Registration Termination List, which allows QHP issuers, consumers, and other interested parties to search for NPNs associated with agents, brokers, and web-brokers whose Exchange Agreement(s) have been terminated or suspended. See 
                            <E T="03">https://data.healthcare.gov/ab-suspension-and-termination-list.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>153</SU>
                             45 CFR 155.220(g)(1).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>154</SU>
                             45 CFR 155.220(g)(3)(ii).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>155</SU>
                             45 CFR 155.220(g)(5).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>156</SU>
                             45 CFR 155.220(k)(1)(i).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>157</SU>
                             45 CFR 155.220(k)(1)(ii).
                        </P>
                    </FTNT>
                    <P>
                        Lastly, HHS may immediately impose a system suspension against an agent or broker if HHS discovers circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems.
                        <E T="51">158 159</E>
                        <FTREF/>
                         We explained that under this proposal agencies, through their lead agents, would be subject to these enforcement actions too.
                    </P>
                    <FTNT>
                        <P>
                            <SU>158</SU>
                             45 CFR 155.220(k)(3). HHS also authority to temporarily suspend the ability of a web-broker to make its non-Exchange website available to transact information with HHS, if HHS discovers a security and privacy incident or breach, for the period in which HHS begins to conduct an investigation and until the incident or breach is remedied to HHS' satisfaction. See 45 CFR 155.220(c)(4)(ii).
                        </P>
                        <P>
                            <SU>159</SU>
                             As detailed in III.C.2.b. of this rule, we are finalizing the proposal to amend § 155.220(k)(3) such that an agent's or broker's ability to transact information with the Exchange in instances in which HHS discovers circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction.
                        </P>
                    </FTNT>
                    <P>
                        The NPN is a unique identifier for an agent, broker, web-broker, or agency that the National Association of Insurance Commissioners assigns during the State licensing application process. The NPN can be recorded as part of the consumer's Exchange eligibility application and is used to track which individual agents, brokers, or web-brokers and agencies assisted Exchange consumers. QHP issuers use the NPN to identify the agent, broker, web-broker, or agency for compensation purposes. Either the NPN of the individual agent, broker, or web-broker assisting the consumer, or the business NPN of the agency, may be listed on the consumer's eligibility application submitted to an FFE or SBE-FP. In the most recent Open Enrollment survey, approximately 4 percent of respondents attested to using a business NPN for all their enrollments.
                        <SU>160</SU>
                        <FTREF/>
                         That means at least 640,000 enrollments 
                        <SU>161</SU>
                        <FTREF/>
                         contained an NPN that did not belong to an individual agent, broker, or web-broker. The NPN, when provided, is a key identifying element in any compliance review under § 155.220(c)(5) or enforcement action by HHS under 
                        <PRTPAGE P="4462"/>
                        § 155.220(c)(4)(ii), (g)(1), (g)(3)(ii), (g)(5), (k)(1)(i), (k)(1)(ii), and (k)(3).
                    </P>
                    <FTNT>
                        <P>
                            <SU>160</SU>
                             Open Enrollment Survey, conducted between January 29, 2024, and February 14, 2024.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>161</SU>
                             Based on the PY 2024 enrollment total of 16 million consumers.
                        </P>
                    </FTNT>
                    <P>Under the approach described in the proposed rule (89 FR 82358), when information suggests there is agency-level misconduct or noncompliance, an investigation or compliance review would occur, and enforcement action may be taken. Any such compliance review, or enforcement action would be directed at the agency's lead agent(s), and any other agent, broker, or web-broker who is discovered to be involved in the misconduct or noncompliant activity. When the misconduct or noncompliant activity is occurring at the agency-level, as stated in the proposed rule (89 FR 82358), we believe it is appropriate for the lead agents to be subject to the compliance review, or enforcement action, in addition to the agents, brokers, or web-brokers working at or for an agency that may have been involved in the misconduct or noncompliant activity, as those lead agents are the individuals responsible for directing and/or overseeing their employees' and contractors' behavior and activity. Engaging in compliance reviews and taking enforcement actions against lead agents in these circumstances would ensure that the individuals who are directing and/or overseeing the misconduct or noncompliance are held accountable.</P>
                    <P>We sought comment on these proposals. In particular, we solicited comments from States as to the specific or unique characteristics of their agency oversight policies and procedures, including how they define or describe the term “lead agent,” or whatever term of art each State uses to capture the same individuals who would fall under our definition of “lead agent” in this preamble, as well as suggestions from States for ways to enhance collaboration and alignment of our oversight and enforcement of agencies that assist consumers applying for and enrolling in QHPs through the FFEs and SBE-FPs. We also solicited comments from Classic DE and EDE partners, issuers, and other interested parties regarding whether we should consider an agent, broker, or web-broker that allows their NPN to be used by other agents, brokers, or web-brokers to be a lead agent and potentially held responsible for misconduct or noncompliant behavior or activities committed by another agent, broker, or web-broker using their NPN.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this approach as proposed. We summarize and respond to public comments received on the proposed approach to address misconduct or noncompliance occurring at an agency-level by undertaking compliance reviews of and enforcement action against agencies through their lead agents below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters stated this change would protect consumers from noncompliant and fraudulent behavior and support the integrity of the Exchange.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that this change will better protect consumers and support the integrity of the Exchange. This change will allow HHS to undertake targeted actions—compliance reviews and enforcement actions—against lead agents to address misconduct or noncompliance occurring at an agency-level. Engaging in compliance reviews and taking enforcement actions against lead agents in these circumstances will ensure that the individuals who are directing and/or overseeing the misconduct or noncompliance are held accountable. This, in turn, will help protect consumers on the FFEs and SBE-FPs (Exchanges), reduce fraud and other misconduct and noncompliance on the Exchanges, and improve public trust in the Exchanges as a whole.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received one comment noting that a single complaint of potential fraud or misconduct by an agent, broker, or web-broker should be enough to trigger an investigation.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with the commenter in that, depending on the nature of and facts underlying a complaint, one complaint of misconduct or noncompliance by an agent, broker, or web-broker could be enough to warrant an investigation and possible enforcement action under our existing authorities at § 155.220. We have also had conversations with interested parties, including State Departments of Insurance (DOIs), that share that view. We currently investigate and may take enforcement actions in situations where there was only a single complaint of misconduct or noncompliance by an individual agent, broker, or web-broker. For example, we use our authority under § 155.220(g)(3)(ii) to terminate the Exchange Agreements of agents, brokers, and web-brokers where there has only been one licensure complaint directed at them.
                        <SU>162</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>162</SU>
                             Sections 155.220(g)(3)(ii) and (l) allow HHS to immediately terminate the Exchange Agreements of an agent, broker, or web-broker for cause if they fail to maintain the appropriate license under State law as an agent, broker, or insurance producer in every State they actively assist consumers with applying for APTC or CSRs or with enrolling in QHPs through the Exchanges.
                        </P>
                    </FTNT>
                    <P>We note that our proposal in the proposed rule concerned when we would engage in compliance reviews and take enforcement actions against lead agents for agency-level misconduct and noncompliance, as well as any other individual agents, brokers, and web-brokers involved in that agency-level misconduct and noncompliance. We refer readers to discussion in the proposed rule (89 FR 82358 through 82360) for a more detailed explanation of how we determine whether to engage in compliance reviews and take enforcement actions in these circumstances.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern about taking enforcement actions against lead agents and the implications this would have on downline agents, including downline agents' ability to receive commissions and complete enrollments. These commenters requested that CMS only engage in enforcement actions against lead agents when CMS is sure they were involved in the agency-level misconduct or noncompliance.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are mindful of the impact that enforcement actions under this proposal may have on an agency's downline agents.
                        <SU>163</SU>
                        <FTREF/>
                         We understand that there are different structures and relationships between agencies and their downline agents, brokers, and web-brokers, including single-level call centers, multi-level call centers, as well as agents, brokers, and web-brokers who work for multiple agencies, and that investigating and taking an enforcement action against a lead agent may disrupt some of these relationships.
                        <SU>164</SU>
                        <FTREF/>
                         Our goal is not to disrupt these structures, but we understand there may be impact on downline agents, brokers, and web-brokers, including single-level call centers, multi-level call centers, as well as agents, brokers, and web-brokers who work for multiple agencies, while we investigate and potentially suspend and terminate the Exchange Agreements of lead agents engaged in agency-level misconduct or noncompliance. However, as we explained in the proposed rule (89 FR 82357), we believe this enforcement framework is necessary to protect the integrity of the Exchanges, as well as to protect 
                        <PRTPAGE P="4463"/>
                        consumers from agency-level misconduct that threatens their PII, Exchange coverage, and trust in the Exchanges and the many compliant agents, brokers, and web-brokers who operate on them.
                    </P>
                    <FTNT>
                        <P>
                            <SU>163</SU>
                             In this context, “downline agents” refers to agents, brokers, and web-brokers who are working for, or with, a lead agent against whom we take an enforcement action, and who may be impacted by that compliance action.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>164</SU>
                             Such disruptions may include forcing an agent, broker, or web-broker to change agencies if the agency stopped working on the Exchanges due to a compliance action, or requiring an agent, broker, or web-broker to use their NPN on instead of an agency's NPN when actively assisting Exchange consumers with enrollment.
                        </P>
                    </FTNT>
                    <P>In addition, we note that even if we took enforcement action against an agency's lead agent(s) and terminated their Exchange Agreements, agents, brokers, and web-brokers employed by that lead agent's agency would still be able to assist consumers with Exchange enrollment using their own NPNs or their agency's NPN, assuming the licenses associated with those NPNs have not been suspended or revoked.</P>
                    <P>We appreciate the commenter's suggestion that we only take enforcement actions against lead agents when we are certain they were involved in the agency-level misconduct or noncompliance at issue. Under the approach we are finalizing, we will take enforcement action against a lead agent when we determine that the lead agent was involved in the misconduct or noncompliance at issue—whether by directing, overseeing, or otherwise participating in it. In addition, we will take enforcement action against a lead agent when we determine that there was agency-level endorsement of or involvement in the misconduct or noncompliance issue. We refer readers to the proposed rule (89 FR 82357) for discussion about why we believe it is appropriate to do so. In either case, we will only consider taking enforcement action against a lead agent when we have discovered information or evidence that indicates the lead agent's involvement in the misconduct or noncompliant behavior or activity at issue.</P>
                    <P>We will not permit a lead agent to engage in agency-level misconduct or noncompliant behavior or activity merely because there are downline agents or entities that may be impacted by their Exchange Agreement suspension or termination or other enforcement action against them. Doing so would run counter to the consumer protection and program integrity goals that underlie many of our agent, broker, and web-broker enforcement policies, including under § 155.220(g) and (k) in particular. See for example, the 2017 Payment Notice (81 FR 12259), which codified our ability to suspend and terminate an agent, broker, or web-broker's Exchange Agreements under § 155.220(g)(5)(i) “in cases involving potential fraud or abusive conduct,” and the 2020 Payment Notice (84 FR 17553), which codified our authority to system-suspend agents and brokers in instances where “. . . there is a need to take immediate action to protect sensitive consumer data or Exchange systems and operations” under § 155.220(k)(3). Similar to this proposal, we finalized these policies to protect consumers, their PII, and the integrity of the Exchanges.</P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter recommended that CMS consider the volume of consumer complaints submitted to CMS about an agency relative to the volume of Exchange consumer enrollments that the agency is associated with before taking enforcement action against the agency's lead agent.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate commenter's input. Under our approach, we will consider the volume and subject matter of consumer complaint(s) and other complaints that name or are directed at a lead agent as we determine whether to engage in enforcement action against or a compliance review of the lead agent. In particular, complaints that name an agency's lead agent(s), especially for unauthorized enrollments or other potentially fraudulent or noncompliant activity, could trigger a compliance review or enforcement action against the lead agent(s), as they could indicate agency endorsement of or involvement in misconduct or noncompliant behavior or activities, including inaction by the agency to try to curb the misconduct or noncompliant behavior or activities. We will also look to see if complaints against a lead agent are similar to complaints received against the agency's other agents, brokers, or web-brokers, which could indicate agency-level endorsement of or involvement in the misconduct or noncompliant behavior or activities. We refer readers to the proposed rule (89 FR 82357) for further discussion on the criteria we will consider as we determine whether to initiate a compliance review of or enforcement action against a lead agent and why we believe these criteria are appropriate.
                    </P>
                    <P>With respect to considering the volume of complaints submitted against an agency relative to the volume of Exchange consumer enrollments the agency is associated with prior to investigating and taking compliance action against a lead agent, we decline to adopt this approach at this time. We currently investigate and take enforcement actions in situations where there was only a single complaint made about an agency or its agents, brokers, and web-brokers, including agencies associated with relatively few Exchange enrollments. We have consistently found that many of these cases involve serious risks to Exchange consumer coverage and PII and the integrity of the Exchange that require immediate action by CMS. We note that ignoring complaints against an agency because the volume of complaints is small relative to the agency's total book of business would be a disservice to consumers and not achieve our program integrity goals of promoting a safe and secure Exchange and reducing fraud and abuse. However, as we develop experience implementing this enforcement framework, we will further consider the commenter's recommendation in future rulemaking as applicable.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters expressed concern that we are no longer allowing agents, brokers, and web-brokers to assist consumers with enrolling in Exchange coverage and are allowing unlicensed persons to enroll consumers in Exchange coverage. These commenters were also concerned that we are eliminating the ability of an agent, broker, or web-broker to assist consumers with enrollment face-to-face. Commenters noted that agents, brokers, and web-brokers play a crucial role in helping consumers enroll in Exchange coverage and answering complicated health insurance questions consumers may have.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that agents, brokers, and web-brokers play a crucial role in helping to enroll consumers in Exchange coverage. Agents, brokers, and web-brokers guide consumers through the Exchange enrollment process, answer questions, and build personal relationships with consumers along the way. Accordingly, as we explain earlier in this final rule, our approach with respect to compliance review and enforcement actions against agencies through their lead agents will not limit the ability of an agent, broker, or web-broker to assist consumers with enrolling in Exchange coverage, including face-to-face whether through a DE pathway or the “Exchange Pathway” (whereby an agent, broker, or web-broker sits “side-by-side” to assist the consumer with enrollment using the 
                        <E T="03">HealthCare.gov</E>
                         website).
                    </P>
                    <P>
                        Instead, this approach clarifies that our current standards and requirements in § 155.220 can reasonably be interpreted to apply to agencies that are involved in Exchange enrollment transactions, since these agencies are entities licensed by the State as an agent, broker, or insurance producer and fall under the current definitions of “agent or broker” and “web-broker” in § 155.20. Addressing these issues in this rulemaking also clarifies and provides notice to interested parties that we will rely on those same authorities under § 155.220 to address misconduct or 
                        <PRTPAGE P="4464"/>
                        noncompliance occurring at an agency-level by undertaking compliance reviews of and enforcement actions against an insurance agency's lead agent(s).
                    </P>
                    <P>
                        Similarly, this approach will not allow unlicensed persons to enroll consumers in Exchange coverage. Consistent with § 155.220(a) and the definitions of “agent or broker” and “web-broker” in § 155.20, agents, brokers, and web-brokers can assist consumers with enrolling in Exchange coverage in a manner that constitutes enrollment through the Exchange only if they are properly licensed in any State they are conducting business as an agent, broker, or insurance producer. Likewise, consistent with the definition of “web-broker” in § 155.20 and § 155.221(a)(2), web-brokers who are agents or brokers can only assist consumers with direct enrollment if they are properly licensed in any State they are conducting business as an agent, broker, or insurance producer in and meet the applicable requirements of §§ 155.220 and 155.221.
                        <SU>165</SU>
                        <FTREF/>
                         We will continue to monitor consumer enrollments on the Exchange to ensure that agents, brokers, and web-brokers who assist consumers with enrollment in Exchange coverage are properly licensed, and we will continue to leverage our authority under § 155.220(g)(3)(ii) to promptly terminate the Exchange Agreements of any such unlicensed individuals.
                    </P>
                    <FTNT>
                        <P>
                            <SU>165</SU>
                             This framework will not directly impact the existing abilities of issuer and direct enrollment entity application assisters to assist individuals in the individual market with applying for a determination or redetermination of eligibility for coverage through the Exchange or for insurance affordability programs. See 45 CFR 155.20. Those assisters remain subject to regulatory requirements at §§ 155.221(d) and 155.415(b). See also Patient Protection and Affordable Care Act; Program Integrity: Exchange, SHOP, and Eligibility Appeals final rule (78 FR 54074 through 54075, 54086 through 54087, and 54125 through 54126); and 2020 Payment Notice (84 FR 17525 through 17526).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested CMS expand the definition of “lead agent” to include any agent, broker or web-broker who willingly allows another agent, broker, or web-broker to use their NPN.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate receiving this comment but have elected not to expand our proposed definition of “lead agent” to include agents, brokers, and web-brokers who allow another agent, broker, or web-broker to use their NPN at this time.
                    </P>
                    <P>The definition of lead agent we are finalizing in this rule includes persons who register and/or maintains a business with a State and/or any person who registers a business NPN with the Exchanges. We developed this definition to identify agents, brokers, and web-brokers at an agency who are typically an executive or in a leadership role. We believe expanding the definition of lead agent as the commenter suggests will expand the pool of potential lead agents subject to compliance reviews and enforcement actions under this framework too greatly; we have observed that it is common for agents, brokers, and web-brokers to allow other agents, brokers, and web-brokers at their agencies to use their NPNs, such as where multiple agents, brokers, and web-brokers actively assist a consumer but use the NPN of the writing agent (one of the aforementioned agents, brokers, or web-brokers) on the eligibility application. Potentially subjecting such a high volume of lead agents to compliance reviews or enforcement actions to address agency-level misconduct or noncompliance may unduly interfere with agency operations and the ability of compliant agents, brokers, and web-brokers to assist consumers with Exchange enrollment, which would run counter to our goals of consumer protection and encouraging Exchange enrollment.</P>
                    <HD SOURCE="HD3">b. System Suspension Authority</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82360), we proposed to amend § 155.220(k)(3), which currently outlines our authority to immediately suspend an agent's or broker's ability to transact information with the Exchange if we discover circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems until the incident or breach is remedied or sufficiently mitigated to HHS' satisfaction.
                        <SU>166</SU>
                        <FTREF/>
                         Specifically, we proposed to add language to reflect that § 155.220(k)(3) system suspensions may be imposed in instances in which we discover circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260,
                        <SU>167</SU>
                         
                        <SU>168</SU>
                        <FTREF/>
                         until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction. As stated in the proposed rule (89 FR 82360), we believe these amendments are necessary and appropriate Exchange program integrity measures to support the efficient administration of Exchange activities, reduce fraud and abuse, and protect Exchange applicant or enrollee's PII. We also explained in the proposed rule (89 FR 82361) that we were pursuing these amendments in the interest of transparency regarding when HHS may invoke this authority.
                    </P>
                    <FTNT>
                        <P>
                            <SU>166</SU>
                             We did not propose to add a reference to web-brokers in § 155.220(k)(3) as part of these amendments because as DE entities, web-brokers are subject to the system suspension authority at § 155.221(e). See § 155.221(a)(2). As amended in this final rule, § 155.220(k)(3) will be similar to the authority captured at § 155.221(e) that applies to DE entities and permits HHS to immediately suspend the DE entity's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, or Exchange information technology systems until the incident or breach is remedied or sufficiently mitigated to HHS' satisfaction.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>167</SU>
                             Section 155.220(d)(3) requires agents, brokers, and web-brokers to enter into a Privacy and Security Agreement pursuant to which they agree to comply with Exchange privacy and security standards adopted consistent with § 155.260. There are two Privacy and Security Agreements between CMS and the agent, broker, and web-broker for FFEs and SBE-FPs: (1) one is for the individual market FFEs and SBE-FPs, and (2) one is for the FF-SHOPs and SBE-FP-SHOPs.
                        </P>
                        <P>
                            <SU>168</SU>
                             When consumers call the Marketplace Call Center to report unauthorized enrollments, we resolve their complaints through a combination of the following: (1) we review the complaint to verify that the consumer's plan switch was unauthorized and identify the plan that the consumer wants to be enrolled in; (2) we instruct the issuer offering the plan the consumer wants to be enrolled in to reinstate the consumer's enrollment in that plan as if it had not been terminated. The issuer is instructed to cover all eligible claims incurred and accumulate all cost sharing toward applicable deductibles and annual limits on cost sharing; and/or (3) consumers receive information via an IRS Form 1095-A that is generated by HHS and which the enrollee may send to the IRS to prevent adverse tax implications as a result of the unauthorized plan switch activity.
                        </P>
                    </FTNT>
                    <P>
                        In the proposed rule (89 FR 82360), we stated that we continuously monitor for behaviors or activities related to Exchange operations or access to Exchange systems and Exchange enrollee or applicant PII that we believe, based on our experience overseeing agents and brokers on the FFEs and SBE-FPs, may be indicative of misconduct or noncompliance with applicable HHS Exchange standards or requirements. Our experience overseeing agents and brokers on the FFEs and SBE-FPs includes past completed agent, broker, and web-broker investigations and enforcement actions, and observations of behavior by agents and brokers that may not comply with the standards of conduct at § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260 and that could endanger the accuracy of Exchange eligibility 
                        <PRTPAGE P="4465"/>
                        determinations, applicant or enrollee PII, or Exchange operations or systems in a number of ways.
                    </P>
                    <P>Consistent with the existing framework, in circumstances where we would impose a system suspension under the proposed amendments to § 155.220(k)(3), in the proposed rule, we explained that we would notify the agent or broker of the suspension and they would have an opportunity to submit evidence and information or to demonstrate that the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction to warrant lifting the suspension to reinstate their system access. We further noted that we would review such evidence and information submitted by the agent or broker to determine if the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to warrant lifting the suspension to reinstate their system access. For example, we anticipate receiving documentation of consumer consent and/or review and confirmation of the accuracy of the Exchange eligibility application information and assessing whether the documentation complies with § 155.220(j)(2)(ii) and (iii) for consumers cited in the suspension notice from agents and brokers whose system access we would suspend under § 155.220(k)(3). If such evidence or information remedies or sufficiently mitigates the incident, breach, or noncompliance to our satisfaction, we explained that we would lift the suspension and reinstate Exchange system access for the agent or broker.</P>
                    <P>In cases where such evidence and information does not remedy or sufficiently mitigate the circumstances of the incident, breach or noncompliance to HHS' satisfaction (including situations where there is no response from the agent or broker), we explained that we would not lift the suspension under § 155.220(k)(3) to reinstate the agent's or broker's system access and would pursue a suspension or termination of the agent's or broker's Exchange Agreements under § 155.220(g). We also noted that agents and brokers whose ability to transact information with the Exchange is suspended under § 155.220(k)(3) remain registered with the FFEs and are authorized to assist consumers using the Exchange (or side-by-side) pathway and the Marketplace Call Center, unless and until their Exchange Agreements are suspended or terminated under § 155.220(f) or (g).</P>
                    <P>We stated in the proposed rule (89 FR 82362) that we are pursuing these amendments at this time in light of recent increases in behavior and activity by agents and brokers that indicate potential violations of § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260 and endangers applicant or enrollee PII or Exchange program integrity in a manner that poses unacceptable risk to the accuracy of Exchange eligibility determinations, Exchange operations, applicants, enrollees, or Exchange information technology systems.</P>
                    <P>
                        At the beginning of PY 2024 Open Enrollment, we saw an increase in complaints from enrollees, applicants, and other individuals and entities to the Agent/Broker Help Desk regarding enrollments submitted without enrollee or applicant consent, enrollee or applicant eligibility applications submitted with incorrect information and without enrollee or applicant review or confirmation of the eligibility application information, and changes to enrollee or applicant eligibility applications made without enrollee or applicant consent. These complaints continued to be submitted at a high volume until we implemented system changes targeted at preventing these issues.
                        <SU>169</SU>
                        <FTREF/>
                         A significant portion of these complaints have involved unauthorized changes to the plans in which enrollees or applicants were enrolled, impacting the ability of enrollees or applicants to utilize their desired coverage and access care.
                        <SU>170</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>169</SU>
                             CMS. (2024, July 19). 
                            <E T="03">CMS Statement on System Changes to Stop Unauthorized Agent and Broker Marketplace Activity. https://www.cms.gov/newsroom/press-releases/cms-statement-system-changes-stop-unauthorized-agent-and-broker-marketplace-activity.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>170</SU>
                             When consumers call the Marketplace Call Center to report unauthorized enrollments, we resolve their complaints through a combination of the following: (1) we review the complaint to verify that the consumer's plan switch was unauthorized and identify the plan that the consumer wants to be enrolled in; (2) we instruct the issuer offering the plan the consumer wants to be enrolled in to reinstate the consumer's enrollment in that plan as if it had not been terminated. The insurer is instructed to cover all eligible claims incurred and accumulate all cost sharing toward applicable deductibles and annual limits on cost sharing; and/or (3) consumers receive information via an updated IRS Form 1095-A that is generated by HHS and which the enrollee may send to the IRS to prevent adverse tax implications as a result of the unauthorized plan switch activity.
                        </P>
                    </FTNT>
                    <P>Unauthorized plan changes may harm enrollees or applicants by removing them from their selected plan and placing them in another plan that may not provide coverage that meets their needs (for example, different plans can have different formularies and provider networks). Unauthorized enrollments can also involve situations where individuals are enrolled in an Exchange plan without having an existing Exchange plan. Being enrolled in an Exchange plan, including in the case of an unauthorized enrollment, may impact a consumer's future ability to enroll in health insurance through the Exchange or enroll in Medicare or Medicaid, as a consumer generally may not enroll in more than one plan simultaneously. Unauthorized enrollments may also create premium costs for the consumer if the unauthorized enrollment is in a non-zero-dollar premium plan. Unauthorized plan changes and enrollments cost the consumer time to learn about and resolve the discrepancy and either (1) unenroll from a plan they did not want, or (2) change the plan to one that better meets their needs.</P>
                    <P>Additionally, submission of eligibility applications with inaccurate enrollee or applicant data, such as an incorrect income, may cause harm by providing the enrollee or applicant with an incorrect APTC amount. For example, an incorrect APTC amount can result in a consumer erroneously receiving a zero-dollar monthly premium. Because the consumer does not receive monthly billing notifications due to the zero-dollar premiums, they may not know they were enrolled or that their eligibility application information was incorrect. However, once the consumer files their taxes, a reconciliation may reveal that the consumer must repay the incorrect APTC amount they were receiving. By their nature, these unauthorized enrollments and plan changes, as well as inaccurate eligibility application information submissions, also involve the misuse of enrollee or applicant PII, and they threaten the efficient administration of the Exchange and the accuracy of Exchange eligibility determinations.</P>
                    <P>
                        Our experience monitoring compliance with the new requirements in § 155.220(j)(2)(i), (ii), and (iii) has also shown that some agents, brokers, and web-brokers 
                        <SU>171</SU>
                        <FTREF/>
                         are engaging in misconduct or noncompliant behavior or activities. For example, their consumer consent and eligibility application information review documentation often lacks the required content specified in § 155.220(j)(2)(ii) or (iii) that demonstrates the applicant or enrollee has taken an action to provide consent or confirm the accuracy of the eligibility application information prior to submission to the Exchange. For example, we have seen consent documentation that solely lists numbers 
                        <PRTPAGE P="4466"/>
                        that the agent, broker, or web-broker claims tie back to the consumer's IP address, which we cannot verify and does not meet the consent documentation requirements of § 155.220(j)(2)(iii). Additionally, we have received consent documentation that is merely a name, typed using a cursive script, with no indication or evidence demonstrating the consumer took an action to confirm their consent to the assistance provided by the agent, broker, or web-broker, such as a text message response, email response, or signature.
                        <SU>172</SU>
                        <FTREF/>
                         The proposed amendments to § 155.220(k)(3) to permit immediate system suspensions would support HHS' efforts to take immediate action to prevent further enrollee, applicant, Exchange operational, Exchange information technology, or Exchange program integrity harm caused by agents and brokers engaged in these types of misconduct or noncompliant behaviors or activities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>171</SU>
                             We did not propose to add a reference to web-brokers as part of the amendments to § 155.220(k)(3) because web-brokers are subject to the system suspension authority at § 155.221(e) applicable to DE entities. See § 155.221(a)(2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>172</SU>
                             A typed name using a cursive script, alone, makes it impossible for HHS to determine if the consumer, or their authorized representative, provided consent and typed the signature. In these situations, supplemental documentation is required for CMS to assess compliance with the consent requirements of § 155.220(j)(2)(iii).
                        </P>
                    </FTNT>
                    <P>Though, as stated in the proposed rule (89 FR 82362), we believe our current authority in § 155.220(k)(3) allows HHS to implement system suspensions broadly based on circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems, in light of the increasing complaints about unauthorized enrollments, we proposed amendments to § 155.220(k)(3) to increase transparency concerning the reach and application of system suspensions and capture in regulation when HHS may invoke this authority. These proposed amendments would allow HHS to immediately respond to circumstances discovered by HHS that pose unacceptable risks to the accuracy of Exchange eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems. They would also provide agents and brokers with an increased understanding of our approach to implement system suspensions. The proposed amendments would also better encapsulate the original intent of the § 155.220(k)(3) suspension authority, which included protecting against unacceptable risk to consumer Exchange data.</P>
                    <P>
                        We noted in the proposed rule (89 FR 82363) that the types of misconduct or noncompliant behaviors or activities that could lead to a system suspension under § 155.220(k)(3) could also lead to an enforcement action under § 155.220(g). However, there are important distinctions between these authorities. For example, system suspensions under § 155.220(k)(3) allow HHS to immediately suspend an agent or broker's system access. These system suspensions differ from agreement suspensions or terminations under § 155.220(g) because system suspensions do not suspend or terminate the agent's or broker's Exchange Agreement(s).
                        <SU>173</SU>
                        <FTREF/>
                         Rather, system suspensions prevent agents or brokers from submitting Exchange applications and enrollments through the Direct Enrollment Pathways, whether Classic DE or EDE. However, while a system suspension is in place, the agent or broker remains registered with the FFEs, unless and until their Exchange Agreements are suspended or terminated under § 155.220(f) or (g). As such, a system suspension does not prohibit the agent or broker from assisting FFE and SBE-FP enrollees or applicants via the Marketplace Call Center on a three-way call with the enrollees or applicants or side-by-side with an enrollee or applicant on 
                        <E T="03">HealthCare.gov</E>
                         (also known as the “Exchange Pathway”).
                        <SU>174</SU>
                        <FTREF/>
                         In cases where there is imminent danger to applicants' or enrollees' PII or to Exchange program integrity in such a manner that poses unacceptable risk to the accuracy of Exchange eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems from the misconduct or noncompliant behaviors or activities of agents or brokers, system suspensions under the proposed amendments to § 155.220(k)(3) would provide a more immediate action to protect applicants' or enrollees' PII and the efficient administration of the Exchange, as well as reduce potential fraud, abuse, and consumer harm.
                    </P>
                    <FTNT>
                        <P>
                            <SU>173</SU>
                             Consistent with § 155.220(d), there are currently three Exchange Agreements with CMS that extend to agents or brokers assisting consumers in the FFEs and SBE-FPs: (1) the Agent Broker General Agreement for Individual Market FFEs and SBE-FPs, (2) the Agent Broker Privacy and Security Agreement for Individual Market FFEs and SBE-FPs, and (3) the Agent Broker SHOP Privacy and Security Agreement. Web-brokers assisting consumers in the FFEs and SBE-FPs are required to sign the Web-broker General Agreement, and web-brokers who are primary Enhanced Direct Enrollment (EDE) entities that assist consumers in the FFEs and SBE-FPs are required to sign the EDE Business Agreement and the Interconnection Security Agreement. In addition, each individual agent or broker who wishes to include the business entity NPN on Exchange eligibility applications must also complete the annual registration process, take the required trainings, and sign the applicable Exchange Agreements with CMS for the applicable plan year using their individual NPN.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>174</SU>
                             In this pathway, registered agents and brokers help a consumer obtain an eligibility determination and select a plan directly on 
                            <E T="03">HealthCare.gov.</E>
                             The consumer creates an account, logs in to the 
                            <E T="03">HealthCare.gov</E>
                             website with a consumer account, and “drives” the process; the agent or broker does not log in to 
                            <E T="03">HealthCare.gov.</E>
                             Generally, the Exchange Pathway requires the agent or broker to be sitting side-by-side with the consumer because the consumer must sign in to 
                            <E T="03">HealthCare.gov</E>
                             without sharing their log-in credentials with the agent or broker.
                        </P>
                    </FTNT>
                    <P>
                        In contrast, an enforcement action under § 155.220(g) to suspend or terminate an agent's, broker's, or web-broker's Exchange Agreement(s) results in the agent, broker, or web-broker no longer being registered with the FFEs.
                        <SU>175</SU>
                        <FTREF/>
                         When an agent's, broker's, or web-broker's Exchange Agreements are suspended, or following the termination of the agent's, broker's, or web-broker's Exchange Agreements, the agent, broker, or web-broker is also no longer permitted to assist with or facilitate enrollment of qualified individuals, qualified employers, or qualified employees in coverage in a manner that constitutes enrollment through an FFE or SBE-FP, or assist individuals in applying for APTC and CSRs for QHPs. As such, these agents, brokers, and web-brokers cannot submit Exchange applications and enrollments through any of the available pathways—through Classic DE, EDE, the Marketplace Call Center, and/or through the Exchange pathway.
                    </P>
                    <FTNT>
                        <P>
                            <SU>175</SU>
                             See § 155.220(g)(4) and (5)(iii).
                        </P>
                    </FTNT>
                    <P>
                        Though we would only initiate system suspensions under § 155.220(k)(3) against agents and brokers based on data or other information that suggest noncompliance or misconduct, we stated in the proposed rule (89 FR 82363) that we recognize that data or other information could suggest there is noncompliance or misconduct by a compliant agent or broker. For example, in some instances, this could occur if an agent or broker works largely or exclusively with a specific group of consumers, including those who live in low-income communities, communities where life changes necessitating eligibility application changes may be more common, or communities where some consumers may not have Social Security Numbers (SSNs) but are nonetheless eligible for Exchange coverage. Consistent with the existing framework, when pursuing system suspensions, agents and brokers would be notified of the system suspension and would have an opportunity to submit evidence or other information (such as documentation of consumer consent, or documentation demonstrating consumer review and confirmation of the accuracy of the eligibility application information 
                        <PRTPAGE P="4467"/>
                        that was created before the application was submitted to the Exchange that is compliant with § 155.220(j)(2)(ii) and (iii)) to demonstrate that the circumstances of the incident, breach, or noncompliance concerns are remedied or sufficiently mitigated to HHS' satisfaction to merit reinstatement of their system access. We noted that where there is clear evidence of compliance, compliant agents and brokers would be able to quickly respond to or otherwise remediate the risks identified by HHS that led to the system suspension under § 155.220(k)(3) such that their system access could be reinstated more swiftly than the lifting of a suspension or reinstatement of an agent's or broker's Exchange Agreement(s) following an enforcement action under § 155.220(g).
                    </P>
                    <P>We sought comment on this proposal.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing the amendments to the system suspension authority under § 155.220(k)(3) as proposed. We summarize and respond to public comments received on these proposed amendments below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported expanding § 155.220(k)(3) as it would reduce noncompliant behavior and protect consumers.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters who supported these proposed amendments and agree it would help reduce noncompliant behavior and protect consumers. As we explained in the 2020 Payment Notice (84 FR 17517),
                        <SU>176</SU>
                        <FTREF/>
                         to promote information technology system security in the FFEs and SBE-FPs, including the protection of consumer data, we codified § 155.220(k)(3) to capture HHS' authority to immediately suspend an agent's or broker's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems until the incident or breach is remedied or sufficiently mitigated to HHS' satisfaction. We explained this provision was necessary and appropriate to ensure that HHS can take immediate action to stop unacceptable risks to Exchange operations or systems posed by agents and brokers, as well as take immediate action to protect sensitive consumer data.
                        <SU>177</SU>
                        <FTREF/>
                         Finalizing the proposed amendments to the system suspension authority in this final rule at § 155.220(k)(3) more closely aligns with this original intent and will better allow us to implement system suspensions in situations that pose unacceptable risk to consumer PII. The amendments to § 155.220(k)(3), which we are finalizing in this rule, will also allow HHS to impose a system freeze suspension in situations where there is noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii), or (iii) and the privacy and security standards under § 155.260, as well as when there is risk to the accuracy of Exchange eligibility determinations, operations, applications, enrollees, or information technology systems. Each of these different situations may cause consumer harm, impact the efficient administration of Exchange activities, and reduce public trust in the Exchange itself.
                    </P>
                    <FTNT>
                        <P>
                            <SU>176</SU>
                             Also see the 2020 Payment Notice proposed rule, 84 FR 272.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>177</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters suggested we consider changing the data metrics and analytics used to engage in system suspensions under § 155.220(k)(3), be more transparent in the process, and resolve these suspensions more quickly. Commenters also expressed concern about the impact our data metrics may have on minority groups and minority agents and brokers, citing potential equity issues and biases in the system.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As explained in the proposed rule (89 FR 82361), we continuously monitor for behaviors or activities related to Exchange operations or access to Exchange systems and enrollee or applicant PII that we believe, based on our experience overseeing agents and brokers on the FFEs and SBE-FPs, may be indicative of misconduct or noncompliance with applicable HHS Exchange standards or requirements. In the interest of transparency, we also shared a non-exhaustive list of data that we currently use to monitor and identify behaviors or activities that may be indicative of misconduct or noncompliance with applicable HHS Exchange standards or requirements, which includes: (1) the number of Exchange transactions submitted to the FFEs or SBE-FPs to change enrollee or applicant eligibility application information or plan selections, (2) the volume of unsuccessful person search activities, (3) the number of submitted eligibility applications with missing SSNs, (4) the number of enrollments submitted within a specified time-frame, and (5) the volume of submitted eligibility applications with NPN changes. We also review and consider complaints from enrollees, applicants, and other individuals or entities concerning agent and broker activities.
                        <SU>178</SU>
                        <FTREF/>
                         While none of these items alone may ultimately indicate misconduct or noncompliant behavior or activities, each represents a piece of evidence that we currently utilize to identify behaviors or activities that may be indicative of misconduct or noncompliance and help decide whether a system suspension or other enforcement action is warranted in a particular circumstance. Furthermore, our history of investigations has revealed these data points are good indicators of noncompliant behavior and circumstances that pose unacceptable risk to Exchange operations or Exchange information technology systems. For example, a high volume of submissions made during a short timeframe is sometimes the result of scripting or automation, which is prohibited by regulation unless approved in advance by CMS.
                        <SU>179</SU>
                        <FTREF/>
                         Allowing agents or brokers to utilize scripting or automation may cause risk to the Exchange information technology systems. Unauthorized activity may cause the system to lag or present security risks to consumer PII. These same data points also offer good indicators of noncompliant behavior and circumstances that pose unacceptable risks to the accuracy of Exchange eligibility determinations, as well as Exchange applicants or enrollees. For example, a high volume of submissions made during a short timeframe may indicate unauthorized enrollments because it is not feasible to discuss this volume of enrollments with that many consumers during this period of time. This could lead to unauthorized enrollments for consumers or cause the consumer to incur future tax liabilities due to incorrect eligibility determinations and an incorrect APTC being applied to their application and enrollment. While the specific data points used would evolve over time in response to changes in the behaviors and activities that create circumstances that pose unacceptable risk to Exchange consumers, Exchange operations, and Exchange systems, we continue to believe that use of these types of data metrics and analytics are necessary and appropriate to protect consumers, reduce fraud and abuse, and support the efficient administration of Exchange activities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>178</SU>
                             Complaints may be submitted to the Marketplace Call Center. See 
                            <E T="03">https://www.cms.gov/files/document/agent/broker-help-desks.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>179</SU>
                             See 45 CFR 155.220(j)(2)(vi).
                        </P>
                    </FTNT>
                    <P>
                        Our experience monitoring and investigating agent and broker noncompliance on the Exchanges that use the Federal platform has shown that 
                        <PRTPAGE P="4468"/>
                        minority or disadvantaged groups are more likely to be targeted by agents and brokers engaged in misconduct or noncompliant activities, including in circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems. For example, noncompliant agents and brokers may target a population segment that does not speak English as a first language and use this language barrier to their advantage. This inevitably can lead to system suspensions against agents and brokers working with these groups.
                    </P>
                    <P>We further note that we strive to resolve all system suspensions under § 155.220(k)(3) in a timely manner and are committed to expeditiously reviewing the response and information provided by agents and brokers to demonstrate compliance or explain the remedial or mitigation steps taken to address the circumstances identified by HHS that pose unacceptable risks. When a system suspension is imposed under § 155.220(k)(3), the agent or broker receives a notification outlining the circumstances and reasons for the system suspension, as well as offering details on how they may submit a response to remedy or mitigate the identified concerns. As with the existing framework, when pursuing system suspensions under § 155.220(k)(3), as amended, we would continue to notify an agent or broker if a system suspension is imposed and the notice would include information on the circumstances and reasons for the system suspension, as well as their opportunity to submit evidence or other information to remedy or mitigate the circumstances of the incident, breach, or noncompliance concerns. The agent or broker may then submit evidence and information (such as, for example, documentation of consumer consent and documentation of consumer review and confirmation of the eligibility application information that is compliant with § 155.220(j)(2)(ii) and (iii)) to HHS to show that the incident, breach, or noncompliance is remedied or sufficiently mitigated such that reinstatement of system access is warranted.</P>
                    <P>
                        In addition, we expect that compliant agents and brokers would be able to quickly respond and provide compelling evidence that demonstrates compliance or otherwise offer information on remedial or mitigation steps that address the circumstances identified by HHS that pose the unacceptable risks that led to the system suspension under § 155.220(k)(3) such that their system access would be reinstated swiftly and the length of the system freeze suspension would be relatively short. We also encourage the timely submission of a response with evidence demonstrating compliance or offering information on the remedial or mitigation steps taken to address the circumstances identified by HHS that pose the unacceptable risks to help limit the length of the suspension period. We also remind readers that, as detailed above, system suspensions under § 155.220(k)(3) only restrict an agent's or broker's access to the Classic DE and EDE pathways and the system suspended agent or broker may still help enroll consumers in Exchange coverage using the Marketplace Call Center on a three-way call with the enrollees or applicants, or side-by-side with an enrollee or applicant on 
                        <E T="03">HealthCare.gov.</E>
                    </P>
                    <P>After consideration of comments, we are finalizing these amendments as proposed. We continue to believe that system suspensions under § 155.220(k)(3) are a necessary and appropriate program integrity measure that strikes the appropriate balance among the competing interests. Under this framework, the agent or broker has an opportunity to respond and can continue to assist FFE and SBE-FP consumers with the submission of Exchange applications and enrollments during the suspension period, and HHS has the ability to take immediate action to address circumstances that pose unacceptable risks to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems. This oversight and enforcement provision will be used to stop further FFE and SBE-FP enrollments through the Classic DE and EDE pathways to protect consumers and their data, as well as Exchange operations and systems.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters suggested we allow agents and brokers to provide evidence prior to initiating system suspensions.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not propose and decline to adopt changes to our system suspension process to allow an agent or broker to provide evidence prior to imposing a system suspension under § 155.220(k)(3) as that would defeat the purpose of this temporary enforcement measure that provides HHS the ability to immediately respond to circumstances HHS discovers that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems.
                    </P>
                    <P>
                        As previously explained, the original intent behind § 155.220(k)(3) was to promote Exchange information technology system security and protect consumer data. The proposed amendments, which we are finalizing in this rule as proposed, help further achieve these goals by allowing system suspensions to be immediately implemented when we discover circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260.
                        <SU>180</SU>
                         
                        <SU>181</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>180</SU>
                             Section 155.220(d)(3) requires agents, brokers, and web-brokers to enter into a Privacy and Security Agreement pursuant to which they agree to comply with Exchange privacy and security standards adopted consistent with § 155.260. There are two Privacy and Security Agreements between CMS and the agent, broker, and web-broker for FFEs and SBE-FPs: (1) one is for the individual market FFEs and SBE-FPs, and (2) one is for the FF-SHOPs and SBE-FP-SHOPs.
                        </P>
                        <P>
                            <SU>181</SU>
                             When consumers call the Marketplace Call Center to report unauthorized enrollments, we resolve their complaints through a combination of the following: (1) we review the complaint to verify that the consumer's plan switch was unauthorized and identify the plan that the consumer wants to be enrolled in; (2) we instruct the issuer offering the plan the consumer wants to be enrolled in to reinstate the consumer's enrollment in that plan as if it had not been terminated. The issuer is instructed to cover all eligible claims incurred and accumulate all cost sharing toward applicable deductibles and annual limits on cost sharing; and/or (3) consumers receive updated information via an IRS Form1095-A that is generated by HHS and which the enrollee may send to the IRS to prevent adverse tax implications as a result of the unauthorized plan switch activity.
                        </P>
                    </FTNT>
                    <P>
                        Offering an opportunity to provide evidence prior to a system suspension being implemented would leave consumers and the Exchanges that use the Federal platform vulnerable in situations where HHS has identified circumstances that pose unacceptable risk to consumers and the Exchanges that use the Federal platform. System suspensions under § 155.220(k)(3) allow HHS to immediately suspend an agent's or broker's system access and prevents the agent or broker from utilizing the Classic DE or EDE pathways to assist with FFE and SBE-FP applications and enrollments. As previously explained, this program integrity measure offers an enforcement tool that permits HHS to immediately respond to circumstances HHS identifies that pose unacceptable risks as soon as they are discovered. While the option to assist FFE and SBE-FP consumers to apply for or enroll in Exchange coverage using the 
                        <PRTPAGE P="4469"/>
                        Marketplace Call Center or 
                        <E T="03">HealthCare.gov</E>
                         would continue to be available to system suspended agents and brokers, these enrollment avenues have additional safeguards against misconduct and noncompliant behavior and activities, as the Marketplace Call Center requires the consumer to be on the call with the agent or broker and the agent or broker would need to be sitting with the consumer when using the Exchange pathway.
                    </P>
                    <P>We believe our system suspension process is efficient, provides sufficient due process to the system suspended agent or broker, and strikes the appropriate balance by allowing the agent or broker to continue to assist FFE and SBE-FP consumers with the submission of Exchange applications and enrollments during the suspension period while also providing HHS authority to take immediate action to address circumstances HHS identifies that pose unacceptable risks to consumers and the Exchanges that use the Federal platform until the circumstances of the breach, incident, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction. When a suspension under § 155.220(k)(3) is imposed, the agent or broker will receive a notice informing them of the suspension and providing information on the circumstances and reasons for the suspension, as well as the process for submitting evidence or other information to show that the circumstances of the incident, breach, or noncompliance concerns are remedied or sufficiently mitigated such that reinstatement of their system access is warranted. Our system suspension process is designed to be a narrowly tailored and temporary enforcement approach that stops further FFE and SBE-FP enrollments through the Classic DE and EDE pathways during the suspension period to protect consumers and their data, as well as Exchange operations and systems.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter expressed concern that system suspensions are not a good enforcement method. The commenter explained that system suspending an innocent agent or broker would cause them harm even though enrollments are permissible using 
                        <E T="03">HealthCare.gov</E>
                         or by calling the Marketplace Call Center. The commenter further explained their concern was that it is more burdensome to work through these alternative enrollment channels.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that working with a consumer using 
                        <E T="03">HealthCare.gov</E>
                         or by calling the Marketplace Call Center may require more coordination, time, and effort than the Classic DE and EDE pathways, however, we continue to believe this trade-off is necessary and appropriate in the context of system suspensions. Section 155.220(k)(3) is designed as a narrowly tailored and temporary enforcement approach that allows HHS in certain circumstances to take immediate action and stop further FFE and SBE-FP enrollments through the Classic DE and EDE pathways during the suspension period to protect consumers and their data, as well as Exchange operations and systems, until such time that the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction. We continue to believe it is an important program integrity and consumer protection measure that strikes the appropriate balance between the agent's and broker's interests and desire to continue working with FFE and SBE-FP consumers, and HHS' interests in reducing fraud and abuse, protecting Exchange consumers and their data, and promoting Exchange information technology system security. In addition, as noted above, we expect that compliant agents and brokers would be able to quickly respond and provide compelling evidence that demonstrates compliance or offers information on how they addressed the circumstances identified by HHS that pose unacceptable risks that led to the system suspension under § 155.220(k)(3) such that their system access would be reinstated swiftly and the length of the system freeze suspension would be relatively short.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters expressed concern that allowing a noncompliant agent or broker to continue to assist FFE and SBE-FP consumers submit application and enrollments during the suspension period allows them to continue committing further misconduct or noncompliant behavior or activity using the Marketplace Call Center.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We believe the system suspension framework under § 155.220(k)(3), which allows HHS to take immediate action in response to circumstances HHS identifies that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, is a necessary and appropriate program integrity approach that strikes the appropriate balance between the different interests involved. It is designed as a narrowly tailored and temporary enforcement approach that stops further FFE and SBE-FP enrollments through the Classic DE and EDE pathways during the suspension period to protect consumers and their data, as well as Exchange operations and systems, until such time that the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction. While the option to assist FFE and SBE-FP consumers to apply for or enroll in Exchange coverage using the Marketplace Call Center or the Exchange pathway remains available to system suspended agents and brokers, these enrollment avenues have additional safeguards against misconduct and noncompliant behavior and activities. For example, the Marketplace Call Center requires the consumer to be on the call for the agent or broker to be able to assist the consumer with the Exchange application or enrollment. Similarly, the Exchange pathway requires the agent or broker to be working side-by-side with the consumer to assist with an Exchange application or enrollment. These enrollment avenues therefore do not pose the same risks to consumers and their data, the accuracy of the Exchange eligibility determinations, or Exchange operations and systems.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters stated we need to protect agents who report noncompliant behavior from being suspended themselves.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We encourage any agent, broker, agency, or other entity to report fraud, abuse, and noncompliant behavior or activities that occurs with respect to applications or enrollments to 
                        <E T="03">HealthCare.gov</E>
                         Exchanges to the Agent and Broker Help Desk, as well as their State DOI, or its equivalent.
                        <SU>182</SU>
                        <FTREF/>
                         We take tips seriously and investigate claims of fraud, abuse, and noncompliant behavior or activities involving the 
                        <E T="03">HealthCare.gov</E>
                         Exchanges. We affirm that we do not engage in compliance actions against individuals for submitting such reports.
                    </P>
                    <FTNT>
                        <P>
                            <SU>182</SU>
                             The agent broker help desk email is: 
                            <E T="03">FFMProducer-AssisterHelpDesk@cms.hhs.gov.</E>
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters stated we should leave all oversight and enforcement of agents and brokers to States and QHP issuers unless we have clear authority from Congress to conduct such oversight and enforcement.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The proposed amendments to § 155.220(k)(3) that we are finalizing in this rule pertains to an agent's or broker's ability to use the Classic DE and EDE pathways to assist consumers with enrollments through the FFEs and SBE-FPs. These proposed amendments are rooted in the authority provided to HHS under the ACA, including section 1312(e), which provides HHS the 
                        <PRTPAGE P="4470"/>
                        authority to establish procedures under which a State may allow agents or brokers to (1) enroll qualified individuals and qualified employers in QHPs offered through Exchanges and (2) assist individuals in applying for APTC and CSRs for QHPs sold through an Exchange. This enforcement tool and regulatory provision is also authorized by section 1313(a)(5)(A) of the ACA, which provides the Secretary with the authority to implement any measure or procedure that the Secretary determines is appropriate to reduce fraud and abuse in the administration of the Exchanges, and section 1321(a) of the ACA, which provides the Secretary authority to establish standards and regulations to implement the statutory requirements related to Exchanges, QHPs and other components of title I of the ACA, including such other requirements as the Secretary determines appropriate. As previously detailed, we continue to believe the system suspension framework in § 155.220(k)(3), including the amendments finalized in this rule, is a necessary and appropriate program integrity measure for HHS to adopt and apply in Exchanges that use the Federal platform. It strikes the appropriate balance between the different interests involved and is narrowly tailored to protect consumers and their data, as well as Exchange operations and systems, until such time that the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction. We affirm that it does not otherwise interfere with State authority to oversee or monitor compliance and take enforcement actions with respect to agents and brokers who are licensed to do business in their jurisdiction. However, HHS is responsible for protecting Exchange consumers and promoting Exchange information technology system security, which extends to ensuring compliance with applicable HHS Exchange standard and requirements by agents and brokers participating in the FFEs and SBE-FPs. We therefore generally disagree with the comments suggesting that we should leave all oversight and enforcement of agents and brokers to the States, but we intend to continue to conduct our investigations and enforcement related to the conduct of agents and brokers with respect to applications and enrollments submitted to the FFEs and SBE-FPs in coordination with States.
                    </P>
                    <P>In response to the comment about QHP issuer responsibility with respect to their affiliated agents and brokers, we affirm that, consistent with § 156.340, each QHP issuer maintains responsibility for its compliance and the compliance of any of its delegated or downstream entities with all applicable Federal standards related to the Exchanges. For QHP issuers participating in Exchanges that use the Federal platform, this includes being responsible for their downstream and delegated entities' compliance with the standards of § 155.220. Section 156.430(b)(5) also makes it clear that downstream and delegated entity are obligated to maintain Exchange-related records and comply with the relevant Exchange authority's demand to receive the entity's books, contracts, computers or other electronic systems relating to the QHP issuer's obligations in accordance with applicable Federal Exchange standards. Similar to our approach with the States, we intend to continue to coordinate with QHP issuers participating in Exchanges and share information, as appropriate, regarding our agent and broker enforcement and oversight activities.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters recommended that we should report system suspensions to State DOIs, QHP issuers, and the public. Commenters also recommended mandating that agents and brokers who are system suspended disclose this to consumers they are working with.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these comments and are committed to coordinating with the States and QHP issuers with respect to enforcement and oversight of agents and brokers, as well as sharing information with the public about these activities, as appropriate. Our regulations currently require HHS to notify to the State DOIs or equivalent State licensing authorities in cases of Exchange agreements suspensions or terminations under § 155.220(g).
                        <SU>183</SU>
                        <FTREF/>
                         Information on the status of an agent or broker's registration and Exchange Agreements is also made available to the public, updated on a monthly basis, and may be used or disclosed for certain limited purposes.
                        <SU>184</SU>
                        <FTREF/>
                         Our regulatory framework, however, does not currently provide for the sharing of information on system suspensions under § 155.220(k)(3).We further note that we currently work closely with State DOIs to coordinate our enforcement activities when we identify an agent's or broker's behavior or activities that poses unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants or enrollees, or Exchange information technology systems. Furthermore, if the agent or broker does not respond to our outreach or their response does not sufficiently mitigate the circumstances that led to the system suspension, we would likely move to terminate or suspend the agent's or broker's Agreements under § 155.220(g)(1) or (g)(5), respectively. If the issue is not resolved to HHS' satisfaction after sending the notice of intent to terminate under § 155.220(g)(1), or at the time we send the Exchange Agreement suspension or termination notice under § 155.220(g)(5), we would notify the State DOIs or other equivalent State licensing authorities as required by § 155.220(g)(6).
                    </P>
                    <FTNT>
                        <P>
                            <SU>183</SU>
                             45 CFR 155.220(g)(6).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>184</SU>
                             The Suspension and Termination List can be found here: 
                            <E T="03">https://data.healthcare.gov/ab-suspension-and-termination-list.</E>
                        </P>
                    </FTNT>
                    <P>
                        We respectfully disagree with commenters who believe agents or brokers who are system suspended should be required to disclose this fact to consumers. Requiring such disclosure at this point in the process may confuse consumers or cause unwarranted concerns. By system suspending the agent or broker, we have helped reduce the risk of noncompliant behavior by requiring the agent or broker to assist consumers working side-by-side through the consumer pathway on 
                        <E T="03">HealthCare.gov</E>
                         or via a three-way call with the Marketplace call center. We believe restricting access to the Classic DE and EDE pathways during the suspension period mitigates the concern sufficiently while we investigate the circumstances that led to the system suspension. Since these agents and brokers are still permitted to assist consumers with enrolling in coverage through the FFEs and SBE-FPs through the consumer pathway on 
                        <E T="03">HealthCare.gov</E>
                         and a three-way call with the Marketplace call center, it would be confusing for consumers to be notified about the system suspension. Furthermore, if the agent or broker does not respond to our outreach or their response does not sufficiently mitigate the circumstances that led to the system suspension, we would likely move to terminate or suspend the agent's or broker's Exchange Agreements under § 155.220(g)(1) or (g)(5), respectively. If the issue is not resolved to HHS' satisfaction after sending the notice of intent to terminate under § 155.220(g)(1), or at the time we send the Exchange Agreement suspension or termination notice under § 155.220(g)(5), we would notify the State DOIs or other equivalent State licensing authorities as required by § 155.220(g)(6).
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments stating that when an agent is system suspended under § 155.220(k)(3), we 
                        <PRTPAGE P="4471"/>
                        should ensure they are unable to utilize State Exchanges.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these comments and generally encourage State Exchanges that elect to operate a DE program, as part of their oversight of the agents and brokers assisting consumers in their respective States apply for and enroll in coverage in a manner that constitutes enrollment through their Exchange, to adopt a system suspension framework similar to § 155.220(k)(3). It is one of the important features of HHS' oversight of agents and brokers participating in the FFEs and SBE-FPs that protects consumers data, safeguards Exchange operations and systems, and helps reduce fraud and abuse. When HHS imposes a system suspension under § 155.220(k)(3), a system suspended agent or broker is unable to utilize the Classic DE or EDE pathways available in FFE and SBE-FP States to enroll consumers in coverage in a manner that constitutes enrollment through the Exchange. State Exchanges that do not use the Federal platform utilize their own systems and are responsible for overseeing and ensuring compliance by the agents and brokers assisting Exchange consumers in their State, including participation in any DE program the State Exchange elects to establish.
                        <SU>185</SU>
                        <FTREF/>
                         We therefore did not propose and are not finalizing the extension of the system suspension framework under § 155.220(k)(3) to State Exchanges that do not use the Federal platform; however, we continue to encourage adoption of a similar framework if a State Exchanges that does not use the Federal platform elects to establish a DE program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>185</SU>
                             In the 2025 Payment Notice, we finalized the extension of certain HHS minimum standards governing web-broker and DE entities across all Exchanges to newly apply them to State Exchanges that do not use the Federal platform. See 89 FR 26276 through 26298. The framework adopted in the 2025 Payment Notice also provided State Exchanges with continued flexibility and discretion to decide whether and how to structure their respective web-broker and direct enrollment programs. Ibid. It also affirmed the State Exchange's role with respect to oversight and enforcement with respect to the entities it permits to assist its consumers, and HHS' role overseeing the Exchange's compliance with the applicable Federal requirements. See 89 FR 26276 through 26298.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters expressed concern that suspensions may prevent them from being paid commissions and that we should keep any withheld commissions in a trust that would be payable to the agent or broker upon the suspension being lifted.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these comments and generally note that the system suspensions implemented under § 155.220(k)(3) do not result in the suspension or termination of the agent's or broker's Exchange Agreements. As such, a system suspension by HHS under § 155.220(k)(3) should not have an impact on the agent's or broker's ability to receive commissions for FFE and SBE-FP enrollments. In addition, HHS does not set compensation levels or pay commissions to agents or brokers for assistance provided to Exchange consumers. Agents and brokers who participate in the Exchanges receive compensation directly from the QHP issuers they are affiliated with in accordance with their agreements with those issuers and any applicable State-specific requirements. Agents and brokers should work directly with their QHP issuers to resolve any questions or concerns with respect to commissions or other compensation they believe they are owed. We did not propose and decline to adopt an approach whereby we would start collecting and holding in trust commissions withheld by QHP issuers.
                    </P>
                    <HD SOURCE="HD3">c. Model Consent Form Updates</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82363), we proposed to modify the model consent form that was created as part of the 2024 Payment Notice (88 FR 25809 through 25811).
                        <SU>186</SU>
                        <FTREF/>
                         Our proposed modifications included updating the model consent form to include a section for documentation of consumer review and confirmation of the accuracy of their Exchange eligibility application information under § 155.220(j)(2)(ii)(A)(1)-(2), as well as scripts agents, brokers, and web-brokers could use when meeting the requirements codified at § 155.220(j)(2)(ii)(A) and (j)(2)(iii)(A)-(C) via an audio recording.
                    </P>
                    <FTNT>
                        <P>
                            <SU>186</SU>
                             CMS. (2022, December 14). CMS model consent form for Marketplace Agents and Brokers. PRA package (CMS-10840, OMB 0938-1438). 
                            <E T="03">https://www.cms.gov/files/document/cms-model-consent-form-marketplace-agents-and-brokers.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Agents, brokers, and web-brokers are required to obtain consumer consent prior to assisting with and facilitating enrollment in coverage through FFEs and SBE-FPs or assisting an individual with applying for APTC and CSRs for QHPs. Until we finalized new requirements related to consumer consent in the 2024 Payment Notice, there was no mandate to document the receipt of consent of the consumer or their authorized representative, or to maintain such documentation. The absence of a consent documentation requirement led to disputes between consumers and agents, brokers, and web-brokers that were difficult for us to adjudicate because neither party had documentary proof of consent. In the 2024 Payment Notice (88 FR 25809 through 25811), we finalized regulations requiring receipt of consent of the consumer or their authorized representative to be documented.
                        <SU>187</SU>
                        <FTREF/>
                         Under these regulations, the consent documentation must contain certain minimum elements as enumerated in § 155.220(j)(2)(iii)(B) and must be retained by the assisting agent, broker, or web-broker for a minimum of 10 years and produced to HHS upon request in response to monitoring, audit, and enforcement activities pursuant to § 155.220(j)(2)(iii)(C). Our goal in codifying these consent documentation requirements was to minimize the risk of fraudulent activities, such as unauthorized enrollments, and help us resolve disputes and adjudicate claims related to the provision of consumer consent.
                    </P>
                    <FTNT>
                        <P>
                            <SU>187</SU>
                             45 CFR 155.220(j)(2)(iii).
                        </P>
                    </FTNT>
                    <P>
                        We also finalized regulations in the 2024 Payment Notice (88 FR 25804 through 25809) requiring agents, brokers, and web-brokers assisting with and facilitating enrollment in coverage through FFEs and SBE-FPs or assisting an individual with applying for APTC and CSRs for QHPs to document that eligibility application information has been reviewed by and confirmed to be accurate by the consumer or their authorized representative prior to application submission.
                        <SU>188</SU>
                        <FTREF/>
                         Under these regulations, this documentation must contain certain minimum elements as enumerated in § 155.220(j)(2)(ii)(A)(1) and must be retained by the assisting agent, broker, or web-broker for a minimum of 10 years and produced to HHS upon request in response to monitoring, audit, and enforcement activities pursuant to § 155.220(j)(2)(ii)(A)(2). Our goal in codifying these requirements was to minimize the risk of fraudulent activities, such as providing false information to the Exchange, help us resolve disputes and DMIs and adjudicate claims related to inaccurate eligibility information on submitted applications, and ensure consumers receive accurate eligibility determinations and do not receive incorrect APTC determinations, which may result in consumers owing money during tax reconciliation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>188</SU>
                             See § 155.220(j)(2)(ii).
                        </P>
                    </FTNT>
                    <P>
                        The model consent form 
                        <SU>189</SU>
                        <FTREF/>
                         created and provided to agents, brokers, and 
                        <PRTPAGE P="4472"/>
                        web-brokers on June 30, 2023, has been used by agents, brokers, and web-brokers, either as is or as a starting point for creating their own consent documentation. However, no model consent form was created for agents, brokers, and web-brokers to use to meet the documentation of consumer review and confirmation of the accuracy of the eligibility application information requirements enumerated in § 155.220(j)(2)(ii)(A)(1). Since the 2024 Payment Notice requirements went into effect, agents, brokers, and web-brokers have asked us to provide a model documentation that they could use to meet these requirements under § 155.220(j)(2)(ii). In the proposed rule, (89 FR 82364), we proposed to update the model consent form to include a section for documentation of consumer review and confirmation of the accuracy of their Exchange eligibility application information in response to these requests. This addition to the model consent form is meant to provide clarity to agents, brokers, and web-brokers on how to meet the regulatory requirements under § 155.220(j)(2)(ii) and help them comply with this regulation by providing a standardized form they may use to do so. Furthermore, we stated in the proposed rule (89 FR 82364) that we believe providing a clearly written model consent form would provide more consumer clarity and assurance that the agent, broker, or web-broker they are working with is complying with § 155.220(j)(2)(ii).
                    </P>
                    <FTNT>
                        <P>
                            <SU>189</SU>
                             CMS. (2022, December 14). 
                            <E T="03">CMS model consent form for Marketplace Agents and Brokers.</E>
                             PRA package (CMS-10840, OMB 0938-1438). 
                            <E T="03">https://www.cms.gov/files/document/cms-model-consent-form-marketplace-agents-and-brokers.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Because the requirements of § 155.220(j)(2)(ii)(A) and (j)(2)(iii) can be met via an audio recording, we also proposed (89 FR 82364) to create appendices to the model consent form that would contain scripts agents, brokers, and web-brokers may use to document compliance with these requirements via an audio recording. We stated in the proposed rule (89 FR 82364) that our goal is to provide agents, brokers, and web-brokers who assist consumers verbally with guidance on meeting the consent and eligibility application review documentation requirements contained in § 155.220(j)(2)(iii) and (j)(2)(ii)(A), respectively, similar to how the current model consent form helps agents, brokers, and web-brokers documenting consent via a physical document with handwritten signatures demonstrate compliance with the new consent documentation requirements.</P>
                    <P>In the proposed rule (89 FR 82364), we stated that the proposed scripts, to the extent they are utilized by agents, brokers, and web-brokers, would help ensure agents, brokers, and web-brokers are following the regulatory requirements when enrolling consumers. We further stated that we believe this would reduce consumer harm by reducing unauthorized enrollments, which can result in financial harm if a consumer receives an improper APTC amount upon enrollment. We also stated that we believe this proposal would clarify and simplify how regulated entities can meet regulatory requirements. The proposal did not involve any revisions to § 155.220(j)(2)(ii)(A) and (j)(2)(iii)(A) through (C). Lastly, we stated that if finalized as proposed, it would not be mandatory for agents, brokers, or web-brokers to use the amended model consent form or new scripts to comply with the requirements set forth in § 155.220(j)(2)(ii)(A) and (j)(2)(iii)(A) through (C).</P>
                    <P>We sought comment on these proposals.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing the modifications to the model consent form as proposed. We summarize and respond to public comments received on the modifications to the model consent form below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters supported updating the model consent form, stating this would provide clarity to agents, brokers, and web-brokers, and help ensure consumers' enrollment applications include correct information.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that these updates will provide more clarity and assurance to agents, brokers, web-brokers, and agencies on how to meet the applicable regulatory requirements and more consumer clarity and assurance that the agent, broker, or web-broker they are working with is complying with the applicable regulatory requirements.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters stated that we should not mandate audio recording of enrollments and should not require agents, brokers, or web-brokers to use our scripts as this would be especially burdensome to smaller agents, brokers, web-brokers, or agencies.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While agents, brokers, and web-brokers can meet the requirements of § 155.220(j)(2)(ii)(A) and (j)(2)(iii) via an audio recording, this is just one type of documentation that is considered to be acceptable under these sections, and there is no mandate that an audio recording be used to meet these requirements. Agents, brokers, and web-brokers may use any method they wish to meet the consent documentation requirement and review and confirmation of the accuracy of eligibility application information requirement, provided the minimum information required by the regulations is captured in this documentation and the documentation can be maintained for a minimum of 10 years and produced to CMS upon request. In addition, as noted in the proposed rule (89 FR 82364), it would not be mandatory for agents, brokers, or web-brokers to use the amended model consent form or new scripts to comply with the requirements set forth in § 155.220(j)(2)(ii)(A) and (j)(2)(iii)(A) through (C).
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A commenter requested clarification on whether the updated model consent form, if finalized, would invalidate consumer consent obtained and documented using the previous model consent form.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         If an agent, broker, or web-broker obtained consumer consent using the previously released model consent form, the consent and the documentation of such consent would still be valid if the consent documentation complies with the regulatory requirements at § 155.220(j)(2)(iii) and the consent has not expired or been rescinded.
                    </P>
                    <HD SOURCE="HD3">3. Requirement for Notification of Tax Filers and Consumers Who Have Failed To File and Reconcile APTC for 2 Consecutive Tax Years (§ 155.305)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (88 FR 82308 through 82411), we proposed changes and updates to the failure to file and reconcile (FTR) process at § 155.305(f)(4). Specifically, we proposed that all Exchanges, including State Exchanges, would be required to send notices to tax filers or their enrollees for the second, consecutive tax year in which they or their tax filer failed to reconcile APTC. This notice, when sent to the tax filer, would serve as an additional warning to inform and educate tax filers that they need to file their Federal income taxes and reconcile their APTC or risk being determined ineligible for APTC if they fail to file and reconcile for a second consecutive tax year. The notice, when sent to enrollees, would indicate the importance of filing Federal income taxes and reconciling APTC on Form 8962 in order to remain eligible for APTC, without disclosing tax information about an individual tax filer. We are finalizing this policy as proposed.</P>
                    <P>
                        As part of the 2024 Payment Notice (88 FR 25814 through 25816), we changed the FTR process such that an Exchange may only determine enrollees 
                        <PRTPAGE P="4473"/>
                        ineligible for APTC due to their FTR status after a tax filer (or a tax filer's spouse, if married) has failed to file a Federal income tax return and reconcile their APTC for 2 consecutive years (specifically, years for which tax data will be utilized for verification of household income and family size). In the 2025 Payment Notice (89 FR 26218 through 26426), we imposed a requirement for Exchanges to send direct or indirect notices for the first year in which the tax filer was determined to have failed to file and reconcile. A direct notice to the tax filer provides a warning to inform and educate the tax filer that they need to file and reconcile, or risk being determined ineligible for APTC if they fail to file and reconcile for a second consecutive tax year. An indirect notice, also sometimes referred to as a “combined notice,” contains general, broad language regarding FTR that complies with the prohibition on sending Federal tax information (FTI) in circumstances where the household contact or enrollee is not the tax filer. However, in the 2025 Payment Notice, we did not impose a requirement for Exchanges to send a direct or indirect notice enrollees or their tax filer about the second consecutive year that the applicable tax filer failed to file and reconcile. In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82364), we proposed to revise § 155.305(f)(4) to require Exchanges to send a direct or indirect notice to enrollees or their tax filer who have not filed their Federal income tax return and reconciled their APTC for 2 consecutive tax years.
                    </P>
                    <P>Under the policy finalized in this rule, Exchanges on the Federal platform will continue to send notices to enrollees or their tax filers for the second consecutive tax year in which the tax filer has failed to reconcile APTC. State Exchanges that operate their own eligibility and enrollment platforms will be required to send either one of these notices and may send an indirect notice to the tax filer if desired. Our policy to codify this practice for Exchanges on the Federal platform and require State Exchanges to notify either an enrollee or their tax filer as described above, ensures that tax filers who have been determined to have FTR status for 2 consecutive tax years are adequately educated on the file and reconcile requirement, and have ample opportunity to file their Federal taxes and reconcile APTC before they lose APTC. This policy supports compliance with the filing and reconciling requirement under section 36B(f) of the Code and its implementing regulations at 26 CFR 1.36B-4(a)(1)(i) and (a)(1)(ii)(A), minimizes the potential for APTC recipients to incur large tax liabilities over time, and supports eligible enrollees' continuous enrollment in Exchange coverage with APTC by avoiding situations where enrollees become uninsured when their APTC is terminated because they were unaware of the requirement to file and reconcile. Additionally, this policy better aligns State Exchanges' FTR processes with that of the Exchanges on the Federal platform by ensuring that consumers will receive at least one FTR notice per year before being found ineligible for APTC. We sought comment on this proposal.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and our responses to comments, we are finalizing this provision as proposed at § 155.305(f)(4)(ii) to require all Exchanges to send direct notices to a tax filer alerting them of their FTR status, or to send informative indirect notices that do not contain FTI either to the enrollee or their tax filer, if through the income verification processes described in § 155.320, they have been found to have failed to reconcile their APTC for 2 consecutive tax years. Section 155.305(f)(4)(ii)(A) describes the requirements for sending the direct notice to the tax filer, including that Exchanges must send the notice consistent with the standards applicable to the protection of FTI. Section 155.305(f)(4)(ii)(B) describes the requirements for sending the indirect notice, which must not convey FTI. We summarize and respond to public comments received on the proposed policy below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         The majority of commenters supported the proposal requiring an Exchange to notify enrollees and their tax filers of their FTR status when they are identified as having failed to reconcile for 2 consecutive tax years. Several of these commenters cited its positive impact on continuity of coverage for consumers enrolled in Exchange coverage.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that the proposed FTR policy will have a positive impact on enrollee retention of APTC and Exchange coverage by ensuring enrollees and their tax filers are informed of the tax reconciliation requirement or of a potential FTR status.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters opposed the proposal requiring Exchanges to send FTR notices to enrollees who have a 2-year FTR status. These commenters believe that it is not the role of Exchanges, but rather of the Internal Revenue Service (IRS), to conduct FTR because the IRS has the ability to send direct notices that more specifically address a tax filer's FTR status. These commenters stated that indirect notices are less effective because they cannot disclose FTI.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree with commenters that the IRS is the correct agency to provide FTR notifications. Exchanges are well-suited to send FTR notices because they already send a variety of notices about Exchange coverage to QHP enrollees, both through mail and Exchange portals, including direct and indirect notices to enrollees or their tax filer who have failed to file and reconcile for 1 tax year. These notices sent by the Exchange have proven effective, as, historically, the majority of consumers identified in the failure to file and reconcile process have successfully filed and reconciled to prevent the loss of their APTC. State Exchanges are afforded the flexibility to choose to send direct notices in certain situations, but also can choose to send indirect notices in situations where sending a direct notice that protects FTI is not feasible.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters supported the proposal but stated that the FTR process overall is flawed, overly punitive to consumers by removing APTC, and a threat to continuity of coverage. They also stated that the IRS already has the adequate tax enforcement tools and, as such, these commenters recommended repealing the FTR process entirely.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We acknowledge the concerns that commenters have raised that FTR is overly punitive to consumers. However, the changes that HHS has implemented in this rule, as well as the changes finalized in the 2024 Payment Notice and the 2025 Payment Notice, properly balance consumer protections and program integrity protections. Therefore, we maintain that we should continue to improve the FTR process rather than repeal FTR entirely.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters stated that HHS should fully repeal FTR processes because there is no statutory authority for it.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree with commenters that there is no statutory authority for Exchanges to conduct FTR. Consumers who receive APTC are required to file income taxes pursuant to § 6011(a) of the Code and regulations prescribed by the Secretary of Treasury. Section 36B(f) of the Code requires taxpayers to reconcile their APTC under section 1412 of the ACA with their PTC allowed under section 36B of the Code. FTR regulations, implemented pursuant to the Secretary's general rulemaking authority under section 1321(a) of the 
                        <PRTPAGE P="4474"/>
                        ACA, facilitate compliance with those requirements.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters stated that requiring Exchanges to provide a direct FTR notification to their consumers would be overly burdensome.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We understand the concern raised by commenters regarding increased burden for Exchanges to provide these FTR notifications. However, States have flexibility under § 155.305(f)(4)(ii)(B) to provide either a direct notice that discloses FTI or an indirect notice that does not disclose FTI to their consumers, and we are not requiring Exchanges to provide direct notices in this final rule.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that HHS provide technical guidance on developing indirect notices for Exchanges that do not want to store any FTI. In addition, the commenter also requested HHS to consider a phased implementation approach that accounts for varying State capabilities and resources.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are allowing Exchanges to choose whether they want to send direct or indirect notices and have provided Exchanges with technical guidance and sample notice for both types of notices. These are available at 
                        <E T="03">https://www.cms.gov/marketplace/in-person-assisters/applications-forms-notices/notices.</E>
                         Additionally, Exchanges have experience sending direct and indirect notices for consumers whose tax filer has failed to file and reconcile APTC for 1 tax year, so they should have the capability to send notices as required in this final rule. For these reasons, we have provided sufficient time for Exchanges to implement the notice required described in this final rule and will not be providing a phased implementation.
                    </P>
                    <HD SOURCE="HD3">4. Timeliness Standard for State Exchanges To Review and Resolve Enrollment Data Inaccuracies § 155.400(d)(1)</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82365 through 82366), we proposed to add § 155.400(d)(1) to codify HHS guidance 
                        <SU>190</SU>
                        <FTREF/>
                         that, within 60 calendar days after a State Exchange receives a data inaccuracy from an issuer operating in an State Exchange (hereinafter referred to as “State Exchange issuer”) that includes a description of an inaccuracy that meets the requirements at § 156.1210(a)-(c) and all the information that the State Exchange requires or requests to properly assess the inaccuracy, the State Exchange must review and resolve the State Exchange issuer's enrollment data inaccuracies and submit to HHS a description of the resolution of any inaccuracies described by the State Exchange issuer that the State Exchange confirms to be inaccuracies in a format and manner specified by HHS.
                        <SU>191</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>190</SU>
                             CMS. (2024, Aug. 14). 
                            <E T="03">Reporting and Reviewing Data Inaccuracy Reports in State-based Exchanges (SBE) Frequently Asked Questions (FAQs). https://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/downloads/faqs-SBE-reporting-enrollment-data-inaccuracies.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>191</SU>
                             OMB Control No: 0938-1312 and 0938-1341.
                        </P>
                    </FTNT>
                    <P>In the proposed rule, we explained that, under existing rules, the State Exchange issuer must work with its State Exchange to ensure resolution of any inaccuracy impacting APTC payment. If a State Exchange issuer is directed by its State Exchange to submit inaccuracies directly to HHS, the State Exchange issuer should follow those submission instructions, but any information HHS shares in response to the submission is informational. If the inaccuracy remains unresolved, the State Exchange issuer must follow up with its State Exchange to identify and rectify the reason for non-resolution. In accordance with § 155.400(b), a State Exchange must submit all enrollment data that HHS then uses to calculate APTC payments to State Exchange issuers. Therefore, in instances when a State Exchange does not address State Exchange issuer data inaccuracies in a timely manner, HHS cannot directly assist the State Exchange issuer in addressing these data inaccuracies.</P>
                    <P>
                        In accordance with this policy, the proposed rule (89 FR 82308, 82365 through 82366) proposed to codify the guidance titled 
                        <E T="03">Reporting and Reviewing Data Inaccuracy Reports in State-based Exchanges (SBE) Frequently Asked Questions (FAQs).</E>
                         This guidance directs State Exchanges to review descriptions of data inaccuracies submitted by State Exchange issuers, resolve them, and submit to HHS a description of the resolution of the inaccuracies when the State Exchange issuer submits a description of a data inaccuracy within the 90-calendar day deadline, or reasonably after the 90-calendar day deadline but before the 3-year deadline pursuant to § 156.1210(b) and (c).
                        <SU>192</SU>
                        <FTREF/>
                         The guidance directs State Exchanges to submit the resolution of these inaccuracies to HHS via the State Based Marketplace Inbound File (SBMI) within 60 calendar days after receiving from a State Exchange issuer a description of a data inaccuracy that includes all the information that the State Exchange requires or requests to properly assess the inaccuracy.
                    </P>
                    <FTNT>
                        <P>
                            <SU>192</SU>
                             CMS. (2024, Aug. 14). 
                            <E T="03">Reporting and Reviewing Data Inaccuracy Reports in State-based Exchanges (SBE) Frequently Asked Questions (FAQs). https://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/downloads/faqs-SBE-reporting-enrollment-data-inaccuracies.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We stated in the proposed rule (89 FR 82308, 82365 through 82366) that this proposed timeline for resolution of enrollment data inaccuracies would require State Exchanges to timely review and resolve enrollment data inaccuracies; clarify the resolution process for State Exchange issuers; and ensure the accurate payment of APTCs, as enrollment data is the basis of APTC payments to State Exchange issuers in the automated policy-based payments (PBP) system. We will monitor State Exchanges' efforts to implement the policy and continue to consider whether modifying the State-based Marketplace Annual Reporting Tool (SMART) to have State Exchanges outline their process for timely resolving data inaccuracies in accordance with the requirement may be appropriate for tracking State Exchanges' efforts to meet the 60-calendar day requirement for submission inaccuracies to HHS.</P>
                    <P>We sought comments on this proposal.</P>
                    <P>
                        After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy as proposed. We summarize and respond to public comments received on the codification that, within 60 calendar days after a State Exchange receives a data inaccuracy from a State Exchange issuer that includes a description of an inaccuracy that meets the requirements at § 156.1210(a)-(c) and all the information that the State Exchange requires or requests to properly assess the inaccuracy, the State Exchange must review and resolve the State Exchange issuer's enrollment data inaccuracies and submit to HHS a description of the resolution of any inaccuracies described by the State Exchange issuer that the State Exchange confirms to be inaccuracies in a format and manner specified by HHS.
                        <SU>193</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>193</SU>
                             OMB Control No: 0938-1312 and 0938-1341.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters supported the proposal, noting that enrollment inaccuracies impact consumers, and ensuring timely resolution of data inaccuracies will minimize impacts on consumers' APTC payments. Other commenters opposed the policy, expressing various operational and financial concerns for State Exchanges. These concerns 
                        <PRTPAGE P="4475"/>
                        included: system restrictions and limitations; limited resources; the anticipated need to divert staff from essential functions like outreach, enrollment assistance, and plan certification; being held accountable for a timeframe based on required actions by issuers, which are outside of State Exchanges' direct control; increased risk of errors or incomplete reviews in resolving disputes resulting from rushed decision-making to meet the 60-calendar day requirement; and other unforeseen circumstances. Some commenters requested that this regulation be effective no earlier than PY 2026 and the 60-calendar day window restart when State Exchanges need additional information from issuers to resolve inaccuracies. Some commenters suggested that HHS allow extensions and in doing so sought clarification on the difference between responding to versus resolving data inaccuracies.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We acknowledge commenters' concerns regarding operational and financial burdens such as system, human capital, procedural constraints, and other unforeseen circumstances. However, we do not believe codifying a timeliness standard represents a significant increase in operational and financial burden given this policy aligns with existing guidance 
                        <SU>194</SU>
                        <FTREF/>
                         and, as stated in the proposed rule (89 FR 82365 through 82366), builds on the existing requirement at § 155.400(d) that a State Exchange must reconcile enrollment information with issuers and HHS no less than on a monthly basis. Further, because State Exchanges provide the enrollment data that HHS uses as the basis of APTC payments to State Exchange issuers, timely and accurate resolution between State Exchanges and State Exchange issuers is necessary for accurate payment of Federal dollars. This policy also provides certainty for State Exchange issuers by providing a timeline for State Exchanges to act upon enrollment data inaccuracies submitted to the State Exchange by a State Exchange issuer that meets the requirements at § 156.1210(a)-(c). As such, we believe that any potential operational or financial burden faced by State Exchanges is outweighed by the benefits of ensuring more timely and more accurate APTC payments, and for these same reasons, we are finalizing this policy to be effective as of the effective date of this final rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>194</SU>
                             CMS. (2024, Aug. 14). 
                            <E T="03">Reporting and Reviewing Data Inaccuracy Reports in State-based Exchanges (SBE) Frequently Asked Questions (FAQs). https://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/downloads/faqs-SBE-reporting-enrollment-data-inaccuracies.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Further, we are clarifying in this rule that there are generally no exceptions to the 60-calendar day window for State Exchanges to review, resolve, and submit data inaccuracies to HHS. However, as described in the proposed rule (89 FR 82365 through 82366) and in the guidance,
                        <SU>195</SU>
                        <FTREF/>
                         the 60-calendar day window begins after the receipt of a complete inaccuracy submission from a State Exchange issuer that includes all the information that a State Exchange requires or requests to properly assess the amount of APTC paid to the issuer.
                        <SU>196</SU>
                        <FTREF/>
                         If a State Exchange requires additional information needed to address the APTC payment or enrollment data inaccuracy after a State Exchange issuer reports the inaccuracy to the State Exchange or HHS (as required by the State Exchanges), the State Exchange may respond to the State Exchange issuer to request that information. The 60-calendar day window to review, resolve, and submit the data inaccuracy to HHS would start only after the State Exchange receives all necessary information. Resolving inaccuracies, as opposed to responding to inaccuracies, includes taking any warranted action to address the inaccuracy and submit to HHS as described in the guidance.
                        <SU>197</SU>
                        <FTREF/>
                         Because the 60-calendar day time period does not begin until the State Exchange has all the information it needs (that is, a complete inaccuracy submission), we have not identified any situations that warrant an extension of this deadline.
                    </P>
                    <FTNT>
                        <P>
                            <SU>195</SU>
                             Id.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>196</SU>
                             Id.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>197</SU>
                             Id.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters sought clarification regarding the separate 90-calendar days for issuers to report inaccuracies and the 60-calendar day requirement in this rule for State Exchanges to address disputes.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We clarify that these are two separate time frames. State Exchange issuers must submit enrollment data and APTC payment inaccuracies to the State Exchange or HHS (as required by the State Exchanges) within 90 calendar days after the date HHS sends a payment and collections report to State Exchanges and State Exchange issuers 
                        <SU>198</SU>
                        <FTREF/>
                         or, in limited circumstances, within 15 calendar days of identifying the inaccuracy, within the 3-year period beginning at the end of the plan year to which the inaccuracy relates.
                        <SU>199</SU>
                        <FTREF/>
                         This timeframe is unaffected by this final rule. The policy being finalized in this rule requires State Exchanges to review and resolve data inaccuracies and send them to HHS within 60 calendar days after receipt of a complete inaccuracy submission from a State Exchange issuer. HHS reiterates the 90-calendar day window applies to issuers and the 60-calendar day window applies to State Exchanges.
                    </P>
                    <FTNT>
                        <P>
                            <SU>198</SU>
                             45 CFR 156.1210(a).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>199</SU>
                             45 CFR 156.1210(c).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. Establishment of Optional Fixed-Dollar Premium Payment Threshold and Total Premium Threshold (§ 155.400(g))</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82366), we proposed to codify a provision related to the premium payment threshold policies under § 155.400(g) that would allow additional issuer flexibility to decide when amounts collected from an enrollee would be considered to satisfy their obligation to pay the enrollee-responsible portion of the premium for certain purposes. Specifically, this would provide issuers with additional flexibility to not place an enrollee in a grace period for failure to pay the full amount of their portion of premiums due, and to not terminate enrollment through the Exchange after the applicable grace period ends without outstanding premiums being paid in full. We stated in the proposed rule (89 FR 82366) that this proposal would reduce the number of coverage terminations for enrollees who owe only a small amount of premium within the threshold. Specifically, we proposed that issuers be permitted to set a fixed-dollar threshold of $5 or less, which would be adjusted for inflation by annual agency guidance. In the proposed rule (89 FR 82366), we stated that we were also considering permitting issuers to adopt a threshold that is based on the gross premium owed by the enrollee, rather than net premium. We also proposed to modify the threshold of the existing premium payment threshold policy at § 155.400(g) from a reasonable amount to 95% for clarity. We further proposed to allow issuers to adopt only one of the three thresholds. Finally, we proposed to limit application of the fixed-dollar premium payment threshold and gross premium-payment threshold to payments made after coverage is effectuated, so that it could not apply to the binder payment. Based on comments received, we are finalizing this policy with the following modifications: we are increasing the fixed-dollar threshold to $10, adjusted annually for inflation, from $5 as proposed; decreasing the gross premium percentage-based threshold to 98 
                        <PRTPAGE P="4476"/>
                        percent, from 99 percent as proposed; and allowing issuers to select a fixed-dollar threshold in tandem with one of the two percentage-based thresholds.
                    </P>
                    <P>
                        Currently, issuers have the option under § 155.400(g) to adopt a percentage-based premium payment threshold which allows issuers to effectuate coverage in accordance with binder payment rules at § 155.400(e) for enrollees who pay an amount of the enrollee-responsible portion of the premium that is less than 100 percent but within the threshold, provided that the level is reasonable and that the level and the policy are applied in a uniform manner to all enrollees (we have historically recommended a percentage equal to or greater than 95 percent).
                        <SU>200</SU>
                        <FTREF/>
                         This permits an issuer to avoid triggering a grace period for non-payment under § 156.270(d) or a grace period under State rules, and to avoid terminating enrollment for non-payment of premiums. Under this policy, if the total amount of premium owed by an enrollee (including aggregate amounts over multiple months) exceeds the threshold set by the issuer, the issuer is required to place the enrollee in a grace period: either the grace period for enrollees receiving APTC described at § 156.270(d), or a grace period under State authority, as applicable. Any amount that is unpaid but within the reasonable premium payment threshold established by an issuer remains an amount owed by the enrollee and cannot be forgiven by the issuer.
                        <SU>201</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>200</SU>
                             See CMS. (2024, Aug. 19). 
                            <E T="03">Federally-facilitated Exchange (FFE) Enrollment Manual.</E>
                             Section 6.2, pp. 92-94. 
                            <E T="03">https://www.cms.gov/files/document/ffe-enrollment-manual-2024-5cr-082024.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>201</SU>
                             2017 Payment Notice, 81 FR 12203, 12272.
                        </P>
                    </FTNT>
                    <P>In the 2017 Payment Notice (81 FR 12271 through 12272), in which HHS established the option for issuers to implement a percentage-based premium payment threshold, we received a comment requesting that issuers be allowed to establish a flat dollar amount threshold. At that time, we stated that we did not consider implementing such a threshold because there may be cases in which even a low flat dollar amount may represent a large percentage of an enrollee's portion of the premium less APTC (81 FR 12272).</P>
                    <P>However, after implementation of the percentage-based threshold, we have realized that the percentage-based premium threshold policy does not always adequately enable enrollees who owe small amounts of premium to avoid triggering a grace period or termination of enrollment through the Exchange. For example, an enrollee whose portion of the premium was $1 after APTC, and who failed to make a premium payment, would be placed into a grace period even if the issuer had adopted a 95 percent payment threshold, despite being delinquent by only $1. In an analysis of Exchange data for PY 2023, we found that there were 81,383 total policies terminated for non-payment in which $5 or less was owed by the enrollee, representing approximately 5.4 percent of the total number of policies terminated for non-payment that year. In addition, 102,728 policies in which enrollees owed premiums of $5.01 to $10 were terminated for non-payment, representing approximately 6.84 percent of the total number of policies terminated for non-payment. Even though $5 may represent a large percentage of an enrollee's portion of the premium less APTC, we stated in the proposed rule (89 FR 82367) that we believe that triggering a grace period or terminating enrollment through the Exchange is too severe a consequence for non-payment of such limited dollar amounts.</P>
                    <P>In the proposed rule (89 FR 82367), we noted our concern about situations in which an issuer would be willing to avoid termination of enrollment through the Exchange if the enrollee owed only small amounts of premium but are prevented from doing so by the lack of flexibility in the current regulation. In addition, many of the enrollees who enter a grace period because they owe de minimis amounts of premium are likely low or moderate-income enrollees and thus might be especially hurt by disruptions in coverage. We stated in the proposed rule (89 FR 82367) that we recognize that issuers have historically implemented various premium payment thresholds, and we believe there is value in providing flexibility to issuers regarding whether to adopt a fixed-dollar payment threshold and the amount of the threshold.</P>
                    <P>
                        We thus proposed to modify § 155.400(g) to allow issuers to adopt a fixed-dollar premium payment threshold of $5 or less, adjusted for inflation by annual agency guidance, under which they could provide additional flexibility to enrollees who fail to pay the full amount of their portion of premium owed. We proposed to limit the fixed-dollar premium threshold to $5 or less because, unlike the current percentage-based threshold, a fixed-dollar threshold would allow enrollees, in some cases, to pay $0 in premium without the issuer triggering a grace period or terminating enrollment through the Exchange. Such a limit would ensure that enrollees who owe large amounts of premium do not remain enrolled in coverage through the Exchange and would serve to limit the number of times an enrollee may fail to pay premium and avoid triggering a grace period or termination of enrollment through the Exchange. As we stated in the proposed rule (89 FR 82367), we believe that a limit of $5 is sufficiently large to enable issuers to allow enrollees who owe 
                        <E T="03">de minimis</E>
                         amounts of premium to remain enrolled, while ensuring that enrollees do not accumulate excessive amounts of premium owed prior to triggering a grace period or termination of enrollment through the Exchange. We also stated that we recognize that this amount might be lower than the threshold enrollees might be afforded under a percentage-based threshold. However, we also stated that we recognize that within a percentage-based threshold, the enrollee must pay a certain amount of their premium to avoid triggering a grace period or termination of enrollment through the Exchange, whereas with a fixed-dollar threshold, an enrollee may not have paid any other amount than the binder payment. Other factors such as the amount the enrollee has paid for their premium to date is not considered when applying the fixed-dollar payment threshold. We requested comment on whether this is a reasonable limit for the fixed-dollar threshold, or whether an alternative amount (such as $10) would be more appropriate and in line with our goal of enabling enrollees who owe small amounts of premiums, while avoiding excessive accumulation of premium debt, to avoid triggering a grace period or termination of enrollment through the Exchange. In the proposed rule (89 FR 82367), we stated that if adopted, we would publish annual updates through subregulatory guidance to this $5 limit to adjust for inflation, using the National Health Expenditure Forecast published annually by CMS' Office of the Actuary.
                        <SU>202</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>202</SU>
                             See CMS. (n.d.). National health expenditure data—Projected. 
                            <E T="03">https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data/projected.</E>
                        </P>
                    </FTNT>
                    <P>
                        Issuers that adopt such a policy could permit enrollees who owe less than the specified amount of premium to avoid triggering a grace period and termination of enrollment through the Exchange. However, we proposed to limit application of this threshold to premium payments made after coverage is effectuated, so that it could not apply to the binder payment. Issuers have the option under the current percentage threshold policy at § 155.400(g)(1) of applying a percentage-based threshold 
                        <PRTPAGE P="4477"/>
                        to the binder payment, but under that policy, enrollees are required to pay some amount of premium, even if it less than the total. By contrast, under a fixed-dollar premium payment threshold, enrollees could have their coverage effectuated without making any payment if their portion of the binder payment is under the threshold amount. Due to concerns about program integrity, we stated in the proposed rule (89 FR 82367) that we believe it is important to ensure that, when a binder payment is required, enrollees must always pay some amount of premium to effectuate coverage as an important signal that the coverage is desired by the enrollee. In addition, as under the current policy (81 FR 12272), any amount that is unpaid but within the reasonable premium payment threshold established by an issuer remains an amount owed by the enrollee and cannot be forgiven by the issuer. This remains true whether the premium payment threshold is utilized for any of the following payments: binder payments, regularly billed payments, or amounts owed by an enrollee while in a grace period.
                    </P>
                    <P>To illustrate how a fixed-dollar premium threshold would work, we provided the following example in the proposed rule (82368):</P>
                    <P>
                        <E T="03">Example 1:</E>
                         During the annual Open Enrollment Period, a consumer selects a QHP with a total monthly premium amount of $300, and the consumer is determined eligible for $299 in APTC and elects to receive the entire amount. The consumer's enrollee-responsible portion of premium will thus be $1. The QHP issuer has adopted a fixed-dollar premium payment threshold policy under which it will not terminate enrollment of enrollees who owe $5 or less of the enrollee-responsible portion of premium. The issuer has set a binder payment deadline of January 30, and the consumer sends the binder payment of $1 ahead of the deadline and effectuates coverage effective January 1. Subsequently, the consumer does not make a payment for February, March, April, May, or June, and, as a result, the enrollee owes $5 in outstanding premiums. Because the issuer has adopted a $5 premium payment threshold, the issuer would not put the consumer into a grace period, since the total amount owed does not exceed $5. However, the issuer would not be permitted to write off the $5 owed, and if the consumer does not pay the premium for July in full, the issuer must put the consumer into a 3-month grace period since the total amount of premium owed would exceed the threshold set by the issuer. However, if within the grace period the consumer paid the full amount owed or a portion of the full amount owed that brings the amount owed under $5, the issuer could terminate the grace period without terminating enrollment through the Exchange.
                    </P>
                    <P>Finally, under the current percentage-based threshold policy, the percentage is calculated based on the percentage paid of the enrollee's portion of the premium (that is, the total premium minus any APTC). In the proposed rule (89 FR 82368), we stated that we were considering whether to further amend § 155.400(g) to also permit issuers to set a threshold that is a percentage of the policy's total premium and not just the enrollee's portion of premium, thus allowing APTC paid on the consumer's behalf to count toward the threshold.</P>
                    <P>In the 2017 Payment Notice (81 FR 12271 through 12272), we established the option for issuers to adopt a premium payment threshold based on net premium owed by the enrollee. At that time, we did not consider establishing a threshold based on gross premium, nor have we done so since then. We stated in the proposed rule (89 FR 82368) that we now recognize that this option may provide issuers with an alternative method of keeping consumers enrolled in coverage that issuers may prefer, either because it is simpler to implement or because it is percentage-based and therefore more similar to the premium payment threshold that is currently allowed under § 155.400(g).</P>
                    <P>
                        Establishing an option for issuers to adopt a percentage threshold based on gross premium owed by the enrollee with APTC counting toward the threshold would, in some cases, allow enrollees to remain enrolled in coverage or avoid triggering a grace period or termination of enrollment through the Exchange for owing small amounts of the enrollee-responsible portion of the premium. For example, an enrollee whose gross premium was $600, and was receiving $595 in APTC, could avoid triggering a grace period or termination of enrollment through the Exchange or termination of coverage even without paying the $5 enrollee-responsible portion of the premium if the issuer had adopted a 99 percent premium threshold based on gross premium because 99 percent of the gross premium ($594) would have been paid on the enrollee's behalf in the form of APTC. With the current 95 percent threshold based on net premium, by contrast, the enrollee would be required to pay at least $4.75 to avoid triggering a grace period or termination of enrollment through the Exchange. While historically we have not defined a specific threshold for the premium threshold based on net premium, we stated in the proposed rule (89 FR 82368) that we would implement a threshold for the premium threshold based on gross premium that is 99 percent or more of the gross premium. We stated that we believe the gross premium threshold should be higher than the net premium threshold to avoid the enrollee accumulating a much larger amount of premium debt, and to keep to a similar 
                        <E T="03">de minimis</E>
                         amount of premium owed as the net premium percentage-based and fixed-dollar thresholds allow. Because this threshold would also, in some circumstances, allow enrollees to temporarily avoid paying any premium, we also proposed to limit application of this threshold to premium payments made after coverage is effectuated, so that it could not apply to the binder payment (due to operational and program integrity concerns, as discussed earlier in this section).
                    </P>
                    <P>
                        A percentage threshold based on gross premium may be simpler to implement, since it is similar to the type of threshold issuers are already allowed to adopt. However, in the proposed rule (89 FR 82368), we stated that we recognize that there may also be drawbacks to this approach, including that enrollees could accumulate more than $5 in premium debt, which the enrollee would continue to owe even if coverage were eventually terminated due to non-payment of premiums. Based on our experience with the current, net premium-based payment threshold, we stated that we do not believe this would result in significant premium debts accumulated by enrollees, since we would be limiting the gross percentage-based threshold to be 99 percent or more of the gross premium. We further stated that we recognize that a gross premium amount higher than the average gross premium (which was $604.78 in February 2023) 
                        <SU>203</SU>
                        <FTREF/>
                         might allow enrollees to accrue more than the $5 debt that could be accrued under the fixed-dollar threshold, but this is true under the existing net premium payment threshold as well. We also noted in the proposed rule (89 FR 82368) that issuers are prohibited from attributing premiums owed to prior debts and not to binder payments, and thus issuers may not refuse to enroll enrollees in coverage based on failure to 
                        <PRTPAGE P="4478"/>
                        pay their binder payment by attributing binder payments to prior debts.
                    </P>
                    <FTNT>
                        <P>
                            <SU>203</SU>
                             See CMS (2024). 
                            <E T="03">Effectuated Enrollment: Early 2024 Snapshot and Full Year 2023 Average. https://www.cms.gov/files/document/early-2024-and-full-year-2023-effectuated-enrollment-report.pdf.</E>
                        </P>
                    </FTNT>
                    <P>To illustrate how a premium threshold based on gross premium would work, we provided the following example in the proposed rule (89 FR 82368):</P>
                    <P>
                        <E T="03">Example 2:</E>
                         During the annual Open Enrollment Period, a consumer selects a QHP with a total monthly premium amount of $500, and the consumer is determined eligible for $495 in APTC and elects to receive the entire amount. The consumer's enrollee-responsible portion of premium will thus be $5. The QHP issuer has adopted a percentage-based premium payment threshold policy under which it will not trigger a grace period or termination of enrollment through the Exchange for enrollees who pay at least 99 percent of gross premium (including payments of APTC made on the enrollee's behalf), which here would be $5. The issuer has set a binder payment deadline of January 30, and the consumer sends the binder payment of $5 ahead of the deadline and effectuates coverage effective January 1. Subsequently, the consumer pays $1 in February and owes $4 in past due premium; because the consumer's payment is within the 99 percent threshold established by the issuer, the issuer would not place the enrollee in a grace period. The following month, the consumer does not pay any premium, and now owes $9 in past due premium. Since the $9 now owed after application of the $495 APTC paid on the consumer's behalf for March represents more than 1 percent of the $500 gross premium, the issuer must put the consumer into a 3-month grace period starting March 1. The issuer would not be permitted to write off the $9 owed, and the consumer must pay all outstanding premium owed before the end of the grace period (May 31) to avoid exhaustion of the grace period and remain enrolled in coverage.
                    </P>
                    <P>We sought comments on this proposal. Specifically, we requested comment on whether a fixed-dollar threshold, as proposed, or a percentage threshold based on gross premium, would better meet our goal of providing flexibility to issuers to allow enrollees to avoid triggering a grace period or termination of enrollment through the Exchange for owing small amounts of premium.</P>
                    <P>We also proposed changing the premium payment threshold based on net premium owed by the enrollee from being a “reasonable” standard to a specifically defined threshold of 95 percent or higher of the net premium. We stated in the proposed rule (89 FR 82369) that we believe this would provide clarity for issuers and Exchanges.</P>
                    <P>We also proposed limiting issuers to utilize one premium payment threshold, such that a fixed-dollar threshold cannot be adopted and utilized in tandem with a percentage-based policy, either net or gross. We stated in the proposed rule (89 FR 82369) that we believe that limiting this flexibility would allow issuers to choose and apply the threshold that works best for their payment operations but prevents complex situations that may arise from allowing multiple thresholds to be used simultaneously. We sought comment on whether we should allow issuers to adopt both a fixed-dollar and percentage-based threshold and requested commenters to consider the administrative feasibility of applying both thresholds, and how such a policy could be applied uniformly and consistently across enrollees.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy with the following modifications: we are increasing the fixed-dollar threshold to $10, lowering the gross premium percentage-based threshold to 98 percent, and allowing issuers to select multiple thresholds: a fixed-dollar threshold in tandem with one of the two percentage-based thresholds. We summarize and respond to public comments received on the proposed premium payment thresholds below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the proposal overall and stated that providing additional flexibilities to issuers would allow consumers who owe small premium amounts, especially those with lower incomes, to keep their coverage and prevent disruptions in care.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the additional flexibilities would allow issuers to implement a premium payment threshold that meets the needs of their enrollees and allow enrollees to maintain their coverage when they owe minimal premium.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The majority of commenters supported the premium payment threshold but recommended that the fixed-dollar threshold be increased from the proposed $5 limit. Most recommended that it be increased to $10 and stated that the proposed $5 limit would be too low to afford consumers the desired protection from triggering a grace period or termination over a minor payment issue. One commenter stated that $10 was less than 2 percent of the average premium in their State, which operates a State Exchange, and that carriers in their State had higher fixed-dollar thresholds for non-Exchange plans. One commenter, an issuer, stated that a fixed-dollar threshold of $5 was too low as it translated to approximately 99.9 percent of their premiums, which they stated is a very high bar for underpayments.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that a fixed-dollar threshold of $10, adjusted for inflation by annual agency guidance, would provide more protection to consumers who owe small amounts of premium. We also note that $10 would represent less than 2 percent of the average monthly premium across all Exchanges. Based on FFE data from PY 2023, 102,728 policies in which enrollees owed premiums of $5.01 to $10 were terminated for non-payment, representing approximately 6.84 percent of the total number of policies terminated for non-payment. Increasing the maximum fixed-dollar threshold to $10 would allow more consumers to avoid termination of their coverage, while ensuring that most enrollees will still be required to pay the majority of their premium to maintain coverage. While we maintain that the fixed-dollar threshold should remain at a 
                        <E T="03">de minimis</E>
                         amount to prevent enrollees from accruing too much debt, based on comments received, we believe that the additional $5 an enrollee could accrue would not place them in substantially more debt.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters stated that the fixed-dollar threshold and gross premium percentage-based thresholds should also apply to the binder payment. Some commenters stated that expanding the proposal in this way would allow issuers to maintain enrollment for consumers, many of whom are living paycheck to paycheck. One commenter stated that applying the proposed policy to binder payments was unlikely to have a meaningful effect on the number of fraudulent enrollments: many plans already have a $0 premium for consumers at certain income levels, and a broker willing to engage in fraud could simply choose a plan and fabricate an income estimate to get a $0 enrollment. Another commenter suggested that the fixed-dollar and gross premium payment thresholds should be applied to the binder payment, but only for policies with an enrollee responsible amount, which would help maintain effectuation rates. Finally, one commenter supported our proposal to not apply the fixed-dollar and gross premium percentage-based thresholds to the binder payment and stated that enrollees should continue to be required to pay a premium to effectuate coverage.
                        <PRTPAGE P="4479"/>
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we understand that some enrollees will have a difficult time paying the binder payment, we believe that when a premium is required, it is best practice to require consumers to pay some portion of it to indicate their desire to effectuate coverage to promote the integrity of the Exchanges and to reduce the potential for fraud and abuse. This policy may also minimize the opportunities for agents, brokers, and web-brokers to enroll consumers in an Exchange plan without their consent because all consumers who owe a premium would be required to pay some of their binder payment if the issuer adopted a net premium percentage-based threshold, or all of their binder payment if the issuer adopted a fixed-dollar or gross premium percentage-based threshold in order to effectuate coverage. We have found that some agents, brokers, and web brokers may target consumers who do not have to make a binder payment because it is harder for those consumers to detect the unauthorized enrollment when they do not have to pay to effectuate coverage. Given the pattern of unauthorized enrollments and our efforts to curb them,
                        <SU>204</SU>
                        <FTREF/>
                         we think it is prudent to further protect consumers and the Exchanges by making it harder for agents, brokers, and web-brokers to enroll consumers in Exchange coverage without their consent, to the extent possible. As such, at this time we are finalizing that the binder payment will be excluded from the fixed-dollar and gross premium-based thresholds.
                    </P>
                    <FTNT>
                        <P>
                            <SU>204</SU>
                             See CMS (2024). 
                            <E T="03">CMS Update on Actions to Prevent Unauthorized Agent and Broker Marketplace Activity. https://www.cms.gov/newsroom/press-releases/cms-statement-system-changes-stop-unauthorized-agent-and-broker-marketplace-activity.</E>
                             See also the revisions in this final rule to § 155.220, “Ability of States to Permit Agents and Brokers and Web-Brokers to Assist Qualified Individuals, Qualified Employers, or Qualified Employees Enrolling in QHPs.”
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters stated that issuers should be able to apply more than one threshold to improve continuity of coverage, as long as the issuer applied both thresholds consistently and in a non-discriminatory manner. Commenters also disagreed that allowing issuers to implement more than one threshold would introduce too much complexity for both issuers and consumers. Commenters stated that if an issuer was concerned about the complexity of implementing two thresholds, they have the option to only apply one threshold, or none at all. Lastly, some commenters noted that while consumers may be confused about the existence of multiple thresholds, the benefit of avoiding being put into a grace period would outweigh any potential confusion.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that allowing issuers to apply multiple thresholds would allow more consumers to avoid being placed into a grace period and thereby avoid termination of their coverage for owing nominal amounts of premium, which would increase the effectiveness of the proposed policy. We also agree that if an issuer is concerned about the complexity of implementing multiple thresholds, they have the option to only implement one threshold or none at all. As such, we are finalizing the option for issuers to implement multiple thresholds: a fixed-dollar threshold and either the net premium or gross premium percentage-based threshold. We would limit an issuer to only applying one of the percentage-based thresholds to ensure that the implementation and application of the premium payment threshold does not become too operationally complex for issuers and for CMS in reviewing audits of premium payment activity. To illustrate how a fixed-dollar and percentage-based threshold might be implemented, we are providing the following example: During the annual Open Enrollment Period, a consumer selects a QHP with a total monthly premium amount of $200. The consumer is determined ineligible for APTC and thus responsible for paying the full amount of the premium. The QHP issuer has adopted both a fixed-dollar premium payment threshold policy, under which it will not terminate coverage of enrollees who owe $8 or less of the enrollee-responsible portion of premium, and a net premium percentage-based threshold policy, under which it will not terminate coverage of enrollees who pay at least 95 percent of the enrollee-responsible portion of the premium. The issuer has set a binder payment deadline of January 30, and the consumer sends the binder payment of $200 ahead of the deadline and effectuates coverage effective January 1. Subsequently, the consumer makes a payment of $190 for February's premium, only 95 percent of the total amount owed. Although the remainder of the amount owed, $10, is above the issuer's fixed-dollar premium payment threshold of $8, it falls within the percentage-based threshold of 95 percent set by the issuer, and thus the enrollee's coverage would not be terminated. If the enrollee makes another payment of $190 for March's premium, the issuer would then terminate coverage, subject to a State's grace period if applicable, because the premium owed would exceed both the 95 percent and $8 thresholds.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some issuers, while supportive of the premium payment threshold proposal, specifically opposed the gross premium percentage-based threshold and stated that it could be confusing for consumers who likely consider the premium payment to be the individual responsibility amount, rather than the premium amount owed before the application of APTC. One commenter stated that more time was needed to review the gross premium percentage-based threshold.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we agree that most consumers likely consider the net premium (their portion of the premium after APTC) to be their premium amount, we encourage issuers who adopt the gross premium percentage-based threshold to include the full premium amount and the applied APTC on member invoices so that the enrollee is made aware of the gross premium amount and whether they have paid enough of their portion due to avoid being placed into a grace period. Because establishment of a premium payment threshold is optional, issuers that are concerned about implementation of a gross premium percentage-based threshold could wait or opt not to implement one.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters opposed the premium payment threshold policy entirely. One commenter was concerned that implementation of the proposal may lead to unintended consequences, particularly if the threshold is set by the issuer, such as issuers undermining the rate review process and providing an incentive for issuers to take more credit risks and incorporate the additional costs into premiums. The commenter was also concerned that the fixed-dollar threshold could incentivize fraudulent activity directed at the most flexible premium payment threshold policies, and that a flexible threshold would also lead to brokers leveraging these unique carrier-specific policies as a marketing lever. One commenter was concerned that the proposal would modify the grace period because consumers would be allowed to continue coverage without making any of their premium payments, which the commenter stated would extend grace period coverage. Additionally, the commenter stated this would lead to a costly tax bill for consumers who expected their coverage to terminate for non-payment.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree that the additional flexibilities provided in the premium payment threshold proposal might drive issuers to take additional credit risks since all of the premium 
                        <PRTPAGE P="4480"/>
                        payment thresholds allow enrollees to owe a 
                        <E T="03">de minimis</E>
                         amount of debt. In addition, issuers that do not want to take on the risk associated with adopting a premium payment threshold would not have to, since the policy is optional. We also disagree that any premium payment threshold policy set by an issuer would undermine the rate review process, because there is already a current existing net premium percentage-based threshold which is optional for issuers to implement and must currently be set at a reasonable 
                        <E T="03">de minimis</E>
                         level, and which has not, to our knowledge, impacted the rate review process. We also disagree that the fixed-dollar threshold would incentivize fraudulent activity directed at the most flexible premium payment threshold policies and that a flexible threshold would lead to agents, brokers, or web-brokers leveraging these unique carrier-specific policies as a marketing lever. The commenter seems to suggest that agents, brokers, or web-brokers would be incentivized to enroll consumers in an Exchange plan with a generous premium policy threshold(s) to secure a commission. However, we are not convinced that consumers would be persuaded to enroll in an Exchange plan, or to enroll in a specific Exchange plan over another, because of a 
                        <E T="03">de minimis</E>
                         premium payment threshold, especially when any unpaid amounts remain a debt owed to the issuer. If the commenter is suggesting that an agent, broker, or web-broker might pay a binder payment on a consumer's behalf in order to secure an unauthorized enrollment, we note that the fixed-dollar and gross premium percentage-based thresholds will not apply to the binder payment, and that the current net percentage-based threshold, which does apply to the binder payment, has not, to our knowledge, induced unauthorized enrollments. With regard to the comment that the proposal would modify the grace period, we clarify that the premium payment threshold, which already exists as the net premium percentage-based threshold, would not extend the grace period. Per § 156.270(g), and issuer guidance, a consumer must pay the full amount due once they are placed into the grace period, and the grace period does not reset if partial payments are made.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters recommended a lower threshold for the gross premium percentage-based threshold.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that the gross premium percentage-based threshold should be lowered, and as such, we are finalizing a 98 percent or above threshold for the gross premium percentage-based threshold. Since we are also increasing the fixed-dollar threshold to $10, which is almost 2 percent of the average premium in the FFE, increasing the allowed gross premium percentage-based threshold would allow more consistency to the definition of a 
                        <E T="03">de minimis</E>
                         amount, though we note that any percentage-based threshold may be higher than $10 if the gross premium is higher than the average premium.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters stated that CMS should establish clear guidelines for issuers on how the premium payment threshold should be implemented uniformly across all plans.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Issuers that select any threshold must apply it in the same manner to all enrollees in a plan. For example, an issuer may not impose a $10 threshold for some enrollees and a $5 threshold for others, even though both thresholds would be within the permitted fixed-dollar threshold of $10. We note that we already provide guidelines for implementing the current net premium percentage-based threshold through the 
                        <E T="03">FFE Enrollment Manual</E>
                         and will also do so for the fixed-dollar and gross premium percentage-based thresholds in the same manner in a future revision of the 
                        <E T="03">FFE Enrollment Manual.</E>
                        <SU>205</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>205</SU>
                             CMS. (2024, Aug. 19). 
                            <E T="03">Federally-facilitated Exchange (FFE) Enrollment Manual.</E>
                             Section 6.2, pp. 92-94. 
                            <E T="03">https://www.cms.gov/files/document/ffe-enrollment-manual-2024-5cr-082024.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters requested clarification on whether State Exchanges would be limited to permitting only the premium payment threshold options specifically described in the proposed regulation, or whether State Exchanges have the authority to permit issuers in their State to offer additional flexibility.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         State Exchanges have the option to permit their issuers to implement only the flexibilities available after finalization of this rule. Similar to the current premium payment rules, State Exchanges would not be permitted to provide additional flexibility. Consistent with the current rules on premium payment thresholds, the FFE and SBE-FPs will provide the flexibilities specified in the regulation.
                    </P>
                    <HD SOURCE="HD3">6. General Eligibility Appeals Requirements (§ 155.505)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82369), we proposed revising § 155.505(b) to codify an option for application filers to file appeals on behalf of applicants and enrollees on the application filer's Exchange application.</P>
                    <P>
                        The Exchanges on the Federal platform allow application filers as defined under § 155.20 to file applications on behalf of an applicant. However, the appeals regulation at § 155.505(b) states that only applicants and enrollees may submit appeal requests to the HHS appeals entity or a State Exchange appeals entity. Appeal requests submitted online to the HHS appeals entity are linked to a consumer's 
                        <E T="03">HealthCare.gov</E>
                         account, which is controlled by the application filer. Thus, an application filer who has authority to apply for coverage through 
                        <E T="03">HealthCare.gov</E>
                         on behalf of an applicant under § 155.20, does not have parallel authority under § 155.505(b) to appeal a contested eligibility determination on behalf of that applicant through the same 
                        <E T="03">HealthCare.gov</E>
                         account.
                    </P>
                    <P>In the proposed rule (89 FR 82369), we stated that this limitation under § 155.505(b) puts a burden on consumers, as appeals filed by application filers who are neither an applicant or enrollee are considered invalid based on lack of standing, requiring either that the applicant or enrollee resubmit their appeal or that they designate the application filer as an authorized representative in writing. These extra steps not only add unnecessary complications for the applicant or enrollee, but also serve to delay an appeal resolution that may grant or restore QHP coverage and financial assistance.</P>
                    <P>The proposed change would allow application filers to file appeals through the HHS appeals entity or a State Exchange appeals entity on behalf of applicants and enrollees on their Exchange application, streamlining the appeals process and ensuring operational consistency throughout the application and appeals processes. In the proposed rule (89 FR 82369), we stated that we did not anticipate that this would impose any additional substantial burden on any Exchanges, including State Exchanges that operate their own platform, as this should not materially increase the number of appeals filed, or add complexity to appeals processes.</P>
                    <P>We sought comment on this proposal.</P>
                    <P>
                        After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy as proposed. We summarize and respond to public comments received on the proposed policy to allow application filers to file appeals on behalf of applicants and enrollees below.
                        <PRTPAGE P="4481"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The majority of commenters supported allowing application filers to file appeals on behalf of applicants and enrollees on the application filer's Exchange application. Several commenters noted that application filers have the authority to apply for coverage in the Exchange on behalf of applicants and that this change ensures operational consistency throughout the application and appeals process while reducing burden on appellants. One commenter noted that the change will particularly help reduce the burden on those appellants with disabilities and limited English proficiency who rely on household members to assist them. A few commenters stated that health center staff are already knowledgeable in navigating 
                        <E T="03">HealthCare.gov</E>
                         and the appeals process, and that this proposed change would benefit the patients they serve. Lastly, one commenter noted that the proposed regulation would support continuous health insurance coverage and prevent unnecessary gaps in coverage by removing administrative hurdles faced by applicants and enrollees.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that this change ensures operational consistency throughout the application and appeals process while reducing burden on consumers.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that CMS clarify that the regulation applies only to FFEs, noting that if a consumer needs assistance filing an appeal with a State Exchange appeals entity, the appeal form provides a space in which the consumer can appoint an authorized representative. The commenter stated that allowing application filers to file appeals rather than attempting to resolve the appeal through customer support pathways may increase the number of appeals filed for issues that could be resolved without an appeal. The commenter also stated that appeals may be delayed in the State Exchange system if the system does not recognize application filer data.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We clarify that the change to § 155.505(b) applies to State Exchanges as well. We agree that it is important to not make a change that may unnecessarily delay the appeals process for a consumer. However, we believe that the current process requiring the consumer to designate the application filer as an authorized representative in writing creates a burden that potentially delays adjudicating and resolving an appeal. We appreciate that a State Exchange may need to make adjustments to accommodate application filers, however we expect these adjustments to be minimal and ultimately in the best interest of the consumer and the efficiency of the appeals process. Finally, we acknowledge that State Exchanges may have multiple paths to resolve eligibility determination issues, but we note that this change should not hinder consumers' use of those alternative paths or incentivize consumers to pursue a formal appeal over an informal resolution.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested CMS include additional appeal consent language confirming that the applicant gives consent to have the application filer file an appeal on their behalf. The commenter noted concern that application filers may file appeals on behalf of applicants that do not wish to appeal.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We acknowledge the concern that an application filer may file an appeal on behalf of an applicant who does not wish to appeal. However, Exchanges allow application filers, as defined under § 155.20, to file applications on an applicant's behalf and therefore it is consistent to allow an application filer to appeal an eligibility determination related to such application on the applicant's behalf. While there is a low risk that an application filer may submit an application for coverage or appeal the eligibility determination created in response to that application without the consumer's consent, the application and appeal request are both submitted under penalty of perjury to guard against any misuse of authority. We further believe that the benefit created for both the application filer and consumer in streamlining these processes and providing operational consistency outweighs such a risk.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that CMS provide guidance on the scope and role of the application filer after filing an appeal and that CMS explore the ramifications of this change further before making it.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As per the proposed regulation, the application filer would have the same standing to file an appeal and participate in the adjudicatory process as an applicant or enrollee. We have considered, but have not identified, any unintended consequences of this policy.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that CMS expand the language to allow agents and brokers to file appeals on behalf of consumers, stating it would be consistent with other actions they perform.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We clarify that an agent, broker, or web-broker would have authority to file an appeal on behalf of a consumer if the agent, broker, or web-broker has been designated as an authorized representative by the consumer (or if the agent, broker, or web-broker is acting in their personal capacity and otherwise meets the definition of application filer). Given our efforts to address misconduct and noncompliance by agents, brokers, and web-brokers, as described in more detail in section III.C.2. of this final rule, we decline to further extend the authority for agents, brokers, and web-brokers to file consumer appeals.
                    </P>
                    <HD SOURCE="HD3">7. Certification Standards for QHPs (§ 155.1000)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82369), we proposed to amend § 155.1000 by adding a new paragraph (e) stating that an Exchange may deny certification of any health plan as a QHP that does not meet the general certification criteria at § 155.1000(c).</P>
                    <P>
                        Section 1311(e)(1) of the ACA grants an Exchange the authority to certify a health plan as a QHP if the health plan meets the requirements for certification promulgated by the Secretary under section 1311(c)(1) of the ACA, and the Exchange determines that making the plan available through the Exchange is in the interests of qualified individuals and qualified employers in the State.
                        <SU>206</SU>
                        <FTREF/>
                         In the Exchange Establishment Rule (77 FR 18310, 18404 through 18405), we codified the responsibilities of an Exchange to certify QHPs at § 155.1000 and, § 155.1000(b), required Exchanges to only offer health plans which have in effect a certification issued or are recognized as health plans deemed certified for participation in an Exchange as a QHP. In that final rule, we also codified general certification criteria, consistent with section 1311(e)(1)(A) and (B) of the ACA, at § 155.1000(c): an Exchange may certify a plan as a QHP if: (1) the health insurance issuer provides evidence during the certification process that it complies with the applicable minimum certification requirements outlined in subpart C, part 156 of our regulations; and (2) the Exchange determines that making the health plan available through the Exchange is in the interest 
                        <PRTPAGE P="4482"/>
                        of qualified individuals and qualified employers.
                        <SU>207</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>206</SU>
                             Section 1311(c)(1)(B) of the ACA and § 155.1000(c)(2) further provide that an Exchange may not exclude a health plan (i) on the basis that such plan is a fee-for-service plan, (ii) through the imposition of premium price controls, or (iii) on the basis that the plan provides treatments necessary to prevent patients' deaths in circumstances the Exchange determines are inappropriate or too costly.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>207</SU>
                             In that rule, we outlined a number of non-exhaustive strategies an Exchange may employ to determine whether the offering of a health plan is in the interest of qualified individuals and qualified employers (77 FR 18406).
                        </P>
                    </FTNT>
                    <P>However, an Exchange's authority to deny certification is not explicitly referenced in 45 CFR part 155. Several regulations, including §§ 155.1000(c) and 155.1090, illustrate that an Exchange may deny certification of a health plan that does not meet the requirements of § 155.1000(c). Moreover, a plain reading of section 1311(e)(1) of the ACA makes clear that an Exchange, as the entity statutorily responsible for determining whether a plan meets the minimum QHP certification standards, has the implied authority to deny certification of plans that do not meet these standards. Any contrary read of section 1311(e)(1) of the ACA would mean that an Exchange does not have any statutory authority to take any action for plans that do not meet minimum certification standards, which is not a reasonable result and would be contrary to congressional intent.</P>
                    <P>We sought in the proposed rule (89 FR 82369) to revise our regulations so that they more fully and accurately reflect the discretion that Exchanges have to deny certification of any plan that does not meet the general certification criteria at § 155.1000(c). Accordingly, we proposed to use the authorities under section 1311(c) of the ACA (which gives HHS the authority to establish criteria for the certification of health plans as QHPs), section 1311(d)(4)(A) (which provides that Exchanges shall implement procedures for the certification, recertification, and decertification of QHPs consistent with the guidelines HHS develops under section 1311(c)), and section 1321(a)(1)(B) (which provides HHS with broad rulemaking authority to issue regulations setting standards for meeting the requirements under title I of the ACA (which includes section 1311) for the establishment and operation of Exchanges and the offering of QHPs through the Exchanges) to add new paragraph (e) to § 155.1000 to formalize the implicit authority that an Exchange, including State Exchanges and SBE-FPs, may deny certification to any plan that does not meet the general certification criteria at § 155.1000(c). We proposed that an Exchange may deny certification if the issuer does not provide evidence during the certification process in § 155.1010 that it complies with the minimum certification requirements (under § 155.1000(c)(1)), or if the Exchange determines that making the health plan available is not in the interest of the qualified individuals and qualified employers (under § 155.1000(c)(2)).</P>
                    <P>In the proposed rule (89 FR 82370), we stated that we were not proposing to require Exchanges, including State Exchanges and SBE-FPs, to implement any specific procedures or processes for the denial of a QHP certification application. We stated that we did not intend for this proposal to amend the existing, implied authority of an Exchange to deny certification. We stated that we only intended this proposal to make that authority more explicit in our regulations, which would provide greater certainty to Exchanges, issuers, and consumers on an Exchange's role, which we expected would only improve the efficiency of the Exchanges.</P>
                    <P>We sought comment on this proposal.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy as proposed. We summarize and respond to public comments received on the proposal to amend § 155.1000 below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a small number of comments on the proposal, with most commenters supporting and agreeing with HHS that the proposal is consistent with the text of the ACA and that it provides a clear articulation of an Exchange's existing authority. These commenters noted the proposal is imperative to ensuring that plans that do not meet the certification criteria at § 155.1000(c) are denied certification.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate these commenters' support of the proposal and of the rationale that we provided in the proposed rule.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter opposed the proposal as unnecessary, stating the current regulations provide no uncertainty with respect to an Exchange's authority to not certify plans that do not meet the certification criteria at § 155.1000(c). This commenter maintains that HHS should not expand certification regulations without due cause and, in this case, current regulations have served all Exchanges well in providing authority to certify or not certify plans as QHPs. Finally, this commenter stated that the proposed regulatory text providing that an Exchange may deny certification “if the Exchange determines that making the health plan available is not in the interest of the qualified individuals and qualified employers” introduces subjectivity and therefore ambiguity for certification denial that does not currently exist in QHP certification criteria.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate this commenter's position that the current regulatory text already encompasses the implied authority of an Exchange to deny certification of any plan that does not meet the general certification criteria at § 155.1000(c). To HHS' knowledge, no Exchanges have interpreted § 155.1000(c) to preclude them from denying certification to plans that do not meet the general certification criteria. The proposed rule (89 FR 82369) explained that this proposal is intended to codify an Exchange's existing and implicit certification denial authority. This revision is not without due cause, as it provides a reader of this regulatory text, including Exchanges, issuers, and consumers, greater certainty with respect to an Exchange's role, which we continue to expect will only improve the efficiency of the Exchanges. In addition, we disagree with this commenter's characterization that the proposal introduces subjectivity that does not currently exist in the QHP certification criteria with reference to the “interest standard.” This proposal did not seek to revise the QHP certification criteria at § 155.1000(c), which include a determination by the Exchange that making the health plan available is in the interest of the qualified individuals and qualified employers. Given this, we do not expect any change in an Exchange's approach in assessing whether plans meet certification criteria, including for States with an FFE.
                        <SU>208</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>208</SU>
                             
                            <E T="03">See</E>
                             the discussion in the 2017 Payment Notice (81 FR 12289) for more information on HHS' approach for the denial of certification on the FFEs (stating “HHS expects to continue to certify the vast majority of plans that meet certification standards. HHS will focus denials of certification in the FFEs based on the ‘interest of the qualified individuals and qualified employers’ standard on cases involving the integrity of the FFEs and the plans offered through them.”)
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">8. Request for the Reconsideration of Denial of Certification Specific to the FFEs (§ 155.1090)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82370), we proposed to amend § 155.1090 to revise the standards for an issuer to request the reconsideration of denial of certification as a QHP specific to the FFEs.</P>
                    <P>
                        Section 1311(e)(1) of the ACA grants an Exchange the authority to certify a health plan as a QHP if the health plan meets the requirements for certification promulgated by the Secretary under section 1311(c)(1) of the ACA, and the Exchange determines that making the plan available through the Exchange is 
                        <PRTPAGE P="4483"/>
                        in the interests of qualified individuals and qualified employers in the State.
                        <SU>209</SU>
                        <FTREF/>
                         In the 2018 Payment Notice (81 FR 94137), we finalized § 155.1090 to allow an issuer to request the reconsideration of a denial of certification of a plan as a QHP for sale through an FFE.
                    </P>
                    <FTNT>
                        <P>
                            <SU>209</SU>
                             Section 1311(c)(1)(B) of the ACA and § 155.1000(c)(2) further provide that an Exchange may not exclude a health plan (i) on the basis that such plan is a fee-for-service plan, (ii) through the imposition of premium price controls, or (iii) on the basis that the plan provides treatments necessary to prevent patients' deaths in circumstances the Exchange determines are inappropriate or too costly.
                        </P>
                    </FTNT>
                    <P>HHS, as operator of the FFEs, is responsible for ensuring that health plans offered through the FFEs meet all Federal requirements for certification as QHPs under § 155.1000(c). Starting with PY 2014, HHS has certified numerous health plans as QHPs on the FFEs. During this time, HHS has also determined that a small number of applications submitted by issuers for the certification of health plans as QHPs on the FFEs did not meet minimum certification criteria under § 155.1000(c), and HHS denied certification to these plans. Some of these issuers submitted reconsideration requests to HHS under § 155.1090(a)(1). HHS ultimately sustained its denial determinations for these issuers' certification applications upon reconsideration review.</P>
                    <P>Based on our experience reviewing these certification application reconsideration requests, we stated in the proposed rule (89 FR 82370) that we believe that it would be appropriate to amend § 155.1090 to codify more structure for the FFEs' process for conducting a reconsideration of denial of certification. Accordingly, we proposed to use the authorities under section 1311(c) of the ACA (which gives HHS the authority to establish criteria for the certification of health plans as QHPs), section 1311(d)(4)(A) (which provides that Exchanges shall implement procedures for the certification, recertification, and decertification of QHPs consistent with the guidelines HHS develops under section 1311(c)), and section 1321(a)(1)(B) (which provides HHS with broad rulemaking authority to issue regulations setting standards for meeting the requirements under title I of the ACA (which includes section 1311) for the establishment and operation of Exchanges and the offering of QHPs through the Exchanges) to require that an issuer's reconsideration request meet a specified burden of proof. Specifically, we proposed revising § 155.1090(a)(2) to state that the burden is on an issuer that is denied certification to provide evidence that HHS' determination that the plan does not meet the certification criteria at § 155.1000(c) was in error.</P>
                    <P>
                        As we stated in the Exchange Establishment Rule (76 FR 41891), offering only QHPs through an Exchange assures consumers that the coverage options presented through the Exchange meet certain minimum Federal standards. Given the voluntary nature of QHP certification, the FFEs utilize a process for QHP certification whereby the burden of proof is on issuers to provide sufficient evidence that they comply with those minimum Federal standards to obtain certification.
                        <SU>210</SU>
                        <FTREF/>
                         Consistent with this general approach towards QHP certification, we stated in the proposed rule (89 FR 82370) that we believe it is appropriate to propose formalizing that the burden of proof involved in a reconsideration request is also on issuers. Under this proposal, we stated that an issuer that is denied certification on an FFE would be responsible for submitting a request to HHS, as operator of the FFEs, for reconsideration of a denial determination.
                    </P>
                    <FTNT>
                        <P>
                            <SU>210</SU>
                             See § 155.1000(c)(1): “The health insurance issuer provides evidence during the certification process in § 155.1010 that it complies with the minimum certification requirements outlined in subpart C of part 156, as applicable.”
                        </P>
                    </FTNT>
                    <P>In the proposed rule, we also proposed to revise § 155.1090(a)(2) to require that, as part of a reconsideration request, an issuer would be required to submit clear and convincing evidence that HHS' determination that the plan does not meet the general certification criteria at § 155.1000(c) was in error. We noted in the 2017 Payment Notice (81 FR 12289) that HHS expects to certify the vast majority of plans that meet the certification standards. To maximize this amount of time for health plans to prepare, submit, and revise QHP applications to the FFEs, HHS provides as much time as it can for issuers to demonstrate that they comply with the certification standards. In the proposed rule, we explained that the FFE's QHP certification timeline provides at least three opportunities for issuers to submit application materials to demonstrate that it meets minimum certification standards for a given plan year (four opportunities, if the issuer avails itself of an optional early bird submission). As such, by the time it issues a denial of certification, HHS will have typically already received substantial factual information from the issuer over the period of several months upon which it will have based its denial determination. It is unlikely that any additional evidence that the issuer would seek to provide upon reconsideration request that they had not already provided during the three or four rounds of application submissions would meaningfully weigh in favor of certification unless it clearly and convincingly establishes that HHS' determination that the plan does not meet the general certification criteria at § 155.1000(c) was in error.</P>
                    <P>In the proposed rule (89 FR 82370), we stated that under this proposal, we would expect evidence to be clear and convincing that HHS' determination was in error if the issuer demonstrates that HHS clearly misunderstood or misinterpreted facts or data already provided by the issuer in previously submitted application materials (such as network adequacy calculation errors). We stated that we would not expect evidence to be clear and convincing in this regard if it is substantially based on new information (such as the inclusion of new ECPs that the issuer did not include in previously submitted application materials) or is comprised of disputes of HHS' authority to ensure compliance with certification standards (such as a determination that making the plan available is not in the interest of the qualified individuals and qualified employers, under section 1311(e)(1)(B) of the ACA and § 155.1000(c)(2)) that would require HHS to perform de novo analysis before open enrollment.</P>
                    <P>Finally, we proposed to revise the title of § 155.1090 to state, “Request for the reconsideration of a denial of certification” and the subtitle of § 155.1090(a) to state, “Request for the reconsideration of a denial of certification specific to a Federally-facilitated Exchange.”</P>
                    <P>We sought comment on this proposal.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy as proposed. We summarize and respond to public comments received on the proposal to revise the standards for an issuer to request reconsideration of denial of certification as a QHP specific to the FFEs below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         We received a small number of comments on this proposal. Most commenters were in support, agreeing that the burden should be on the issuer receiving a denial of certification to provide HHS with “clear and convincing” evidence that its determination was in error.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are appreciative of these commenters' support of the proposal and of the rationale that we provided in the proposed rule.
                        <PRTPAGE P="4484"/>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter opposed the proposal due to the complexity of the QHP certification process and requirements and stated consumers are best served from increased issuer participation, and therefore, HHS should create more lenient certification standards to allow for the certification of plans with more innovative benefit designs.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with this commenter that increased issuer participation and innovation on the Exchanges serves consumers generally. However, the certification criteria are minimum requirements established by the ACA and CMS regulations for a plan to be offered on an Exchange, and innovation is not a substitute for compliance with these minimum requirements. Permitting issuers to offer Exchange plans that do not meet those requirements would run counter to our goal of ensuring that all QHPs provide essential health benefits, maintain reasonable cost-sharing limits, include adequate provider networks, and meet other requirements that help ensure Exchange consumers have access to a range of quality, affordable plans meeting their health needs.
                    </P>
                    <P>
                        With respect to the commenter's point that the QHP certification process is complex, the proposed rule noted that, in addition to providing robust technical guidance to issuers,
                        <SU>211</SU>
                        <FTREF/>
                         HHS provides as much time as it can for issuers to demonstrate that they comply with the certification standards. For example, HHS provides issuers with three separate opportunities to submit certification application materials to demonstrate that their plan meets minimum certification standards for a given plan year.
                        <SU>212</SU>
                        <FTREF/>
                         These opportunities have proven more than sufficient for issuers to demonstrate compliance with minimum certification requirements while still having the ability to innovate, as only a small number of issuers have been denied certification of all of the plans they submitted for certification on the FFEs since 2014. The denial of certification of a small fraction of plans that HHS has certified since 2014 has not had a material negative impact on consumers, as they had many other QHP options on the impacted FFEs to choose from that offered benefits comparable to the plans that were not certified.
                    </P>
                    <FTNT>
                        <P>
                            <SU>211</SU>
                             See, for example, 
                            <E T="03">https://www.qhpcertification.cms.gov/s/QHP.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>212</SU>
                             The proposed rule (89 FR 82370) explained that issuers have four opportunities (instead of three) to submit certification application materials to demonstrate that their plan meets minimum certification standards if the issuer avails itself of an optional early bird submission opportunity. HHS is planning to enhance the application submission process in order to provide more contemporaneous results to issuers as soon as they submit their applications. As a result, HHS no longer intends to offer an early bird submission deadline in the certification process for PY 2026 or future plan years.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">9. General Program Integrity and Oversight Requirements (§ 155.1200)</HD>
                    <P>We currently collect certain information and data from State Exchanges and SBE-FPs under § 155.1200 to monitor their performance and compliance. In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82369), we proposed under our authority under section 1321(a)(1)(D) of the ACA to promulgate appropriate requirements related to Exchanges, to also use this information and data to increase transparency into State Exchange operations and to promote program improvements.</P>
                    <P>Under § 155.1200, State Exchanges must report to HHS on certain Exchange-related activities and performance monitoring data. State Exchanges must also engage an independent qualified auditing entity which follows generally accepted government auditing standards (GAGAS) to annually compile a financial statement and conduct a financial audit and a programmatic audit.</P>
                    <P>
                        To meet these requirements, under section 1313(a)(1) of the ACA, State Exchanges and SBE-FPs are required to submit a State Marketplace Annual Reporting Tool (SMART) to CMS, which CMS uses to monitor and evaluate State Exchange compliance with Exchange requirements under Title I of the ACA.
                        <SU>213</SU>
                        <FTREF/>
                         Through the SMART, State Exchanges and SBE-FPs attest to compliance with specific regulations, provide supporting documentation including, if applicable, a redetermination plan for the upcoming plan year, an oversight and monitoring plan with fraud, waste, and abuse policies and procedures, nondiscrimination policies and standards, and an operating budget with a financial statement. Additionally, the Exchanges submit the financial and programmatic audits with corrective action plans for any identified audit or findings. Following review, we provide State Exchanges and SBE-FPs with a SMART summary letter based on the observations and action items identified and monitor State Exchange completion of any open findings.
                    </P>
                    <FTNT>
                        <P>
                            <SU>213</SU>
                             
                            <E T="03">State-based Marketplace Annual Reporting Tool (SMART).</E>
                             OMB Control Number: 0938-1244. 
                            <E T="03">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/smart_2017_5.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        State Exchanges that operate their own eligibility and enrollment platform also report enrollment and Exchange activity data to CMS weekly during Open Enrollment and twice a year outside of Open Enrollment.
                        <SU>214</SU>
                        <FTREF/>
                         We publish Exchange Open Enrollment data annually.
                        <SU>215</SU>
                        <FTREF/>
                         We utilize the programmatic data received from State Exchanges to identify program risks and provide technical assistance to State Exchanges on corrective actions or strategies to mitigate risks, as well as to inform the development of new or updated policies as part of our annual rule-making processes to address known risks.
                    </P>
                    <FTNT>
                        <P>
                            <SU>214</SU>
                             OMB Control Number: 0938-1119.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>215</SU>
                             See, for example, CMS. (2024, March 22). 
                            <E T="03">2024 Marketplace Open Enrollment Period Public Use Files. https://www.cms.gov/data-research/statistics-trends-reports/marketplace-products/2024-marketplace-open-enrollment-period-public-use-files.</E>
                        </P>
                    </FTNT>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule we explained our intention to use the information and data that State Exchanges and Exchanges on the Federal platform (SBE-FPs) submit to HHS under § 155.1200 to increase transparency into State Exchanges and to promote program improvements. Specifically, we described our plan to publicly release the State Exchange and SBE-FP annual State Marketplace Annual Reporting Tool (SMART) submitted to CMS annually and to expand on current Open Enrollment data reporting by publishing additional metrics on State Exchange operations and functionality that we currently collect from State Exchanges but do not currently report to external audiences. We also stated our intention that any public reporting of State Exchange operations and functionality would include the public release of comparable metrics for the FFE and SBE-FPs.</P>
                    <P>
                        After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy with a modification. Commenters expressed support for increased transparency in Exchanges and agreement that any data released should include comparable data from the Exchanges on the Federal platform. State Exchange commenters raised challenges with posting the SMARTs since they contain non-public operational and business processes employed by Exchanges to maintain program integrity and combat fraud, such as procedures used for verifying consumer information. State Exchange 
                        <PRTPAGE P="4485"/>
                        commenters described the value the SMARTs provide as an oversight tool through which they are held to meeting Federal Exchange requirements but also receive technical assistance. They were concerned that restricting their responses to protect the release of sensitive operational issues would devalue the SMARTs and limit its effectiveness as an oversight mechanism. Commenters also questioned the value of indiscriminately releasing data in the format of individual SMARTs and instead encouraged us to identify standard metrics that could be presented to meaningfully compare across all Exchanges.
                    </P>
                    <P>After further consideration, we will not release the SMARTs. Commenters raised valid concerns and we do not want to inadvertently expose Exchange system operations that could be susceptible to misuse or to constrain the efficacy of the SMARTs. We also recognize that there may be better ways to provide Exchange data than posting individual reports. For that reason, as proposed, we intend to expand our current Open Enrollment data reporting by publishing additional metrics on State Exchange operations and functionality. We intend, as resources permit, to proceed with preparing for the release of additional customer service data elements already described. Specifically, we will, at a minimum, publish the following data elements that we currently collect from State Exchanges but do not currently report to external audiences:</P>
                    <P>• Exchange actual expenditures on consumer marketing, education, and outreach for the most recent fiscal year available,</P>
                    <P>• Exchange actual expenditures on Navigator program, total allocation and per grantee,</P>
                    <P>• Exchange call center metrics during Open Enrollment:</P>
                    <P>++ Total number of incoming calls received by the call center.</P>
                    <P>++ The average wait time for each incoming call to the call center.</P>
                    <P>++ The number of incoming calls terminated while waiting to speak to a call center representative.</P>
                    <P>++ The average amount of time spent by call center representative on each individual call.</P>
                    <P>• Exchange website (eligibility and enrollment application and/or consumer) visitors during Open Enrollment:</P>
                    <P>++ Number of website and mobile application visits.</P>
                    <P>++ Number of unique visitors requesting the website and mobile application.</P>
                    <P>We will work with States in advance to evaluate the metric definitions and methodologies and provide technical assistance prior to publishing this data. We reaffirm that we will also publish reasonably comparable customer metrics from Exchanges on the Federal platform if data is available. This data will be released publicly by CMS.</P>
                    <P>We summarize and respond to public comments received on the proposed public release of Exchange data below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Generally, all commenters supported increased transparency of Exchange operations; however, several commenters expressed concerns about the scope and breadth of the information to be published. Specifically, several State Exchanges cited concerns over potential fraud or security risks if certain operational data, particularly the information that is collected in the SMARTs, is made public.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that increased transparency is necessary to monitor the performance of Exchanges and promote program improvements. However, because of these concerns raised by State Exchanges, we will not be releasing the SMARTs.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters were split on what data should or should not be included and how the data should be presented. Several commenters believed the data State Exchanges currently make public is sufficient for current oversight requirements. Many commenters, however, recommended identifying standard metrics across both State Exchanges and the Exchanges on the Federal platform to meaningfully compare across all Exchanges rather than indiscriminately releasing data we currently collect, and that any State Exchange information or data released should include comparable FFE data from Exchanges on the Federal platform. Many commenters recommended specific metrics that they would like to see reported by State Exchanges and the Exchanges on the Federal platform. A few commenters recommended ways CMS could display data including creating a centralized reporting website; developing an Exchange performance measurement tool to assess Exchange quality and consumer experience; working with interested parties to identify set metrics and publish a joint State Exchange/Exchanges on the Federal platform data report; and adding data elements to the current PUF files.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We recognize that regulations exist requiring State Exchanges to make certain data public and that some State Exchanges offer data above and beyond the regulatory requirements in various formats. We believe, however, that releasing additional data metrics will increase the public's understanding of State Exchanges and provide more transparency into our compliance activities. We also appreciate the recommendations on what specific data metrics could be identified, and how we should present data to the public. We will take these recommendations into consideration when it is time to publish data in the future. Initially, we intend to post most data through public communication channels to be determined by CMS. We intend to release the metrics originally proposed, if data from the Exchanges on the Federal platform is also available, and we will work with States through technical assistance to further identify and refine the additional metrics for public reporting that will be released for both State Exchanges and Exchanges on the Federal platform.
                    </P>
                    <HD SOURCE="HD2">D. Part 156—Health Insurance Issuer Standards Under the Affordable Care Act, Including Standards Related to Exchanges</HD>
                    <HD SOURCE="HD3">1. Solicitation of Comments—Reducing the Risk That Issuer Insolvencies Pose to the Integrity of the FFEs</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82371), we solicited comments on methods that HHS, as operator of the FFEs, could potentially employ, in partnership with State regulators, to reduce the risk that issuer insolvencies pose to the integrity of the FFEs. We will take comments received into consideration in future rulemaking.</P>
                    <HD SOURCE="HD3">2. FFE and SBE-FP User Fee Rates for the 2026 Benefit Year (§ 156.50)</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82373), we proposed an FFE user fee rate of 2.5 percent of total monthly premiums and an SBE-FP user fee rate of 2.0 percent of total monthly premiums for the 2026 benefit year. We also proposed a 2026 benefit year FFE user fee rate range between 1.8 and 2.2 percent of total monthly premiums and an SBE-FP user fee rate range between 1.4 and 1.8 percent of total monthly premiums, with each of these ranges to be set at a single rate in this final rule, if the enhanced PTC subsidies at the level currently enacted 
                        <SU>216</SU>
                        <FTREF/>
                         or at a higher level are extended through the 2026 benefit year by March 31, 2025. We sought comment 
                        <PRTPAGE P="4486"/>
                        on whether March 31, 2025 would provide sufficient time and whether we should select an earlier or later date.
                    </P>
                    <FTNT>
                        <P>
                            <SU>216</SU>
                             ARP, Public Law 117-2, 135 Stat. 4 (2021). These enhanced subsidies were extended under the IRA, Public Law 117-169, 136 Stat. 1818 (2022) and are scheduled to expire after the 2025 calendar year.
                        </P>
                    </FTNT>
                    <P>
                        Section 1311(d)(5)(A) of the ACA permits an Exchange to charge assessments or user fees on participating health insurance issuers as a means of generating funding to support its operations. If a State does not elect to operate an Exchange or does not have an approved Exchange, section 1321(c)(1) of the ACA directs HHS to operate an Exchange within the State. Accordingly, in § 156.50(c), we provide that a participating issuer offering a plan through an FFE or SBE-FP must remit a user fee to HHS each month that is equal to the product of the annual user fee rate specified in the annual HHS notice of benefit and payment parameters for FFEs and SBE-FPs for the applicable benefit year and the monthly premium charged by the issuer for each policy where enrollment is through an FFE or SBE-FP. OMB Circular A-25 established Federal policy regarding user fees and what the fees can be used for.
                        <SU>217</SU>
                        <FTREF/>
                         OMB Circular A-25 provides that a user fee charge will be assessed against each identifiable recipient of special benefits derived from Federal activities beyond those received by the general public.
                    </P>
                    <FTNT>
                        <P>
                            <SU>217</SU>
                             See OMB. (n.d.) Circular No. A-25 Revised. 
                            <E T="03">https://www.whitehouse.gov/wp-content/uploads/2017/11/Circular-025.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">a. FFE User Fee Rates for the 2026 Benefit Year</HD>
                    <P>Section 156.50(c)(1) provides that, to support the functions of FFEs, an issuer offering a plan through an FFE must remit a user fee to HHS, in the timeframe and manner established by HHS, equal to the product of the monthly user fee rate specified in the annual HHS notice of benefit and payment parameters for the applicable benefit year and the monthly premium charged by the issuer for each policy where enrollment is through an FFE. As in benefit years 2014 through 2025, issuers seeking to participate in an FFE in the 2026 benefit year will receive two special benefits not available to issuers offering plans in State Exchanges: (1) the certification of their plans as QHPs; and (2) the ability to sell health insurance coverage through an FFE to individuals determined eligible for enrollment in a QHP. For the 2026 benefit year, issuers participating in an FFE will receive special benefits from the following Federal activities:</P>
                    <P>• Provision of consumer assistance tools;</P>
                    <P>• Consumer outreach and education;</P>
                    <P>• Management of a Navigator program;</P>
                    <P>• Regulation of agents and brokers;</P>
                    <P>• Eligibility determinations;</P>
                    <P>• Enrollment processes; and</P>
                    <P>• Certification processes for QHPs (including ongoing compliance verification, recertification, and decertification).</P>
                    <P>Activities performed by the Federal Government that do not provide issuers participating in an FFE with a special benefit are not covered by the FFE user fee.</P>
                    <P>As discussed in detail in the proposed rule (89 FR 82373 through 82375), the proposed user fee rate reflected our estimates for the 2026 benefit year of costs for operating the FFEs, premiums, enrollment, and transitions in Exchange models from the FFE and SBE-FP models to either the SBE-FP or State Exchange models. We proposed a 2026 benefit year FFE user fee rate of 2.5 percent of total monthly premiums, which is greater than the 2025 benefit year fee rate of 1.5 percent of total monthly premiums. We noted that if any events occurred between the proposed rule and the final rule that significantly changed our estimated costs to operate the FFEs or the Federal platform or our projections of premiums or enrollment, we may finalize FFE and SBE-FP user fee rates that differ from the proposed rates to reflect those changes.</P>
                    <P>In addition to proposing a FFE user fee rate that assumed the expiration of enhanced PTC subsidies, we proposed a 2026 benefit year FFE user fee rate range between 1.8 and 2.2 percent of total monthly premiums, to be set at a single rate in this final rule, if the current level or a higher level of enhanced PTC subsidies is extended through the 2026 benefit year by March 31, 2025. We sought comment on the proposed 2026 benefit year FFE user fee rate of 2.5 percent of total monthly premiums and the alternative proposed 2026 benefit year FFE user fee rate range between 1.8 and 2.2 percent of total monthly premiums.</P>
                    <P>We refer readers to the proposed rule (89 FR 82373 through 82376) for further discussion of the proposed 2026 benefit year FFE user fee rate and the alternative proposed 2026 benefit year FFE user fee rate range, including the factors considered in developing the proposed user fee rates and the rationale for our proposals.</P>
                    <HD SOURCE="HD3">b. SBE-FP User Fee Rates for the 2026 Benefit Year</HD>
                    <P>Section 156.50(c)(2) requires that an issuer offering a plan through an SBE-FP must remit a user fee to HHS, in the timeframe and manner established by HHS, equal to the product of the monthly user fee rate specified in the annual HHS notice of benefit and payment parameters for the applicable benefit year and the monthly premium charged by the issuer for each policy where enrollment is through an SBE-FP. SBE-FPs enter into a Federal platform agreement with HHS to leverage the systems established for the FFEs to perform certain Exchange functions and enhance efficiency and coordination between State and Federal programs. The benefits provided to issuers in SBE-FPs by the Federal Government include use of the FFE information technology and call center infrastructure used in connection with eligibility determinations for enrollment in QHPs and other applicable State health subsidy programs, as defined at section 1413(e) of the ACA, and QHP enrollment functions under 45 CFR part 155, subpart E. The user fee rate for SBE-FPs is calculated based on the proportion of total FFE costs associated with Federal activities that provide these benefits to the SBE-FP issuers.</P>
                    <P>To calculate the proposed SBE-FP rates for the 2026 benefit year, we used the same assumptions related to contract costs, enrollment, and premiums as we used for the proposed FFE user fee rates. Based on this methodology, we proposed a 2026 benefit year SBE-FP user fee rate of 2.0 percent of total monthly premiums, which is greater than the user fee rate of 1.2 percent of total monthly premiums that we established for the 2025 benefit year. As discussed in the proposed rule (89 FR 82373 through 82376), we also proposed an alternative SBE-FP user fee range between 1.4 percent and 1.8 percent of total monthly premiums, to be set at a single rate in this final rule, if the current level or a higher level of enhanced PTC subsidies is extended through the 2026 benefit year by March 31, 2025. We sought comment on the proposed 2026 benefit year SBE-FP user fee rate of 2.0 percent of total monthly premiums and the alternative proposed 2026 benefit year SBE-FP user fee rate range between 1.4 percent and 1.8 percent of total monthly premiums.</P>
                    <P>We refer readers to the proposed rule (89 FR 82373 through 82376) for further discussion of the proposed 2026 benefit year SBE-FP user fee rate and the alternative proposed 2026 benefit year SBE-FP user fee rate range, including the factors considered in developing the proposed user fee rates and the rationale for our proposals.</P>
                    <P>
                        We are finalizing two sets of FFE and SBE-FP user fee rates accounting for the 
                        <PRTPAGE P="4487"/>
                        expiration and extension of enhanced PTC subsidies. If enhanced PTC subsidies expire as currently set forth in the IRA,
                        <SU>218</SU>
                        <FTREF/>
                         we are finalizing as proposed the 2026 benefit year user fee rate for all issuers offering QHPs through an FFE to be 2.5 percent of the monthly premium charged by the issuer for each policy under FFE plans, and the 2026 benefit year user fee rate for all issuers offering QHPs through an SBE-FP to be 2.0 percent of the monthly premium charged by the issuer for each policy under SBE-FP plans. If enhanced PTC subsidies at the level currently enacted 
                        <SU>219</SU>
                        <FTREF/>
                         or at a higher level, are extended through the 2026 benefit year by July 31, 2025, we are finalizing an alternative set of 2026 benefit year FFE and SBE-FP user fee rates of 2.2 percent and 1.8 percent of total monthly premiums, respectively, which are both within the range set forth in the final rule. Both sets of user fee rates have been finalized after consideration of comments, and for the reasons outlined in the proposed rule and this final rule, including our responses to comments. The finalized, alternative user fee rates were informed by updates to our projected enrollment 
                        <SU>220</SU>
                        <FTREF/>
                         and premium growth estimates based on the most recent data (along with our latest budget projections). Additionally, after consideration of the comments, we are finalizing July 31, 2025, as the date by which the enhanced subsidies must be extended in order to trigger the alternate user fees, instead March 31, 2025, as proposed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>218</SU>
                             ARP, Public Law 117-2 (2021). These enhanced subsidies were extended under the IRA, Public Law 117-169 (2022) and are scheduled to expire after the 2025 calendar year.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>219</SU>
                             ARP, Public Law 117-2 (2021). These enhanced subsidies were extended under the IRA, Public Law 117-169 (2022) and are scheduled to expire after the 2025 calendar year.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>220</SU>
                             As described in the proposed rule (89 FR 82373 through 82376), user fee rates are based, in part, on projected enrollment during the 2025 open enrollment period and may change between the publication of the proposed rule and final rule. At the time of this final rule, more data is available about the 2025 open enrollment period and about the projected 2025 open enrollment numbers to determine user fee rates than we had for the proposed rule. Thus, after accounting for updated open enrollment data, we have finalized single FFE and SBE-FP user fee rates within the proposed ranges if enhanced PTC subsidies are extended at the level currently enacted or at a higher level and finalized the proposed FFE and SBE-FP user fee rates if enhanced PTC subsidies expire as enacted. See Marketplace 2025 Open Enrollment Period Report National Snapshot, as of December 4, 2024: 
                            <E T="03">https://www.cms.gov/newsroom/fact-sheets/marketplace-2025-open-enrollment-period-report-national-snapshot-0</E>
                            .
                        </P>
                    </FTNT>
                    <P>We summarize and respond to public comments received on the proposed 2026 benefit year FFE and SBE-FP user fee rates below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Most commenters supported the 2026 benefit year user fee rates, with several of these commenters supporting user fee rates that adequately fund Federal programs. Some commenters supported maintaining the 2025 user fee rates or lowering the proposed 2026 user fee rates. These commenters stated that a higher user fee rate could lead to increased premiums and affect competitiveness of Exchange plans compared to off-Exchange plans, thereby impacting the affordability of health insurance.
                    </P>
                    <P>Many commenters also expressed concern about the impact of the expiration of enhanced PTC subsidies on user fees and Exchange enrollment, as well as specifically how the expiration may impact enrollment projections or other factors used to determine 2026 benefit year user fee rates. One commenter stated that the proposed 2026 benefit year user fee rates may be lower than required to sufficiently fund costs if enrollment declines more than expected as a result of the expiration of enhanced PTC subsidies.</P>
                    <P>
                        <E T="03">Response:</E>
                         We are finalizing the 2026 benefit year FFE and SBE-FP user fee rates as proposed. While we acknowledge that FFE and SBE-FP user fee rates impact the costs of plans offered in the FFEs and SBE-FPs, and by extension may impact premiums, we continue to calculate and set these FFE and SBE-FP user fee rates annually in a manner that ensures sufficient funding for operations of the FFEs and SBE-FPs.
                    </P>
                    <P>We recognize commenters' concerns about the expiration of enhanced PTC subsidies, and in the proposed rule (89 FR 82373 through 82376), we noted the uncertainty around the expiration or extension of these enhanced subsidies and the potential impact on enrollment and premium growth in the Exchanges. In the proposed rule (89 FR 82375), we explained that if enhanced PTC subsidies expire, we project that the total enrollment through FFEs and SBE-FPs would decrease, and in turn, issuers would likely rate for the uncertainty associated with the expected decreased enrollment in the risk pool and increased premiums for 2026. We maintain this projection, and anticipate a decrease in enrollment beginning in 2026, which may exert upward pressure on premiums. Despite this uncertainty, we must set user fee rates that will allow us to sufficiently fund and operate the FFEs and the Federal platform based on the latest budget projections. Our data suggests that the user fees being finalized in this rule—which account for the possibility that enhanced PTC subsidies may expire or be extended—would do so.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters had mixed opinions regarding the proposed March 31, 2025 deadline to apply a set of alternative user fee rates if enhanced PTC subsidies are extended. Some of these commenters wanted final user fee rates to be known by or before March 31, 2025 to allow sufficient time for issuers to set premiums and comply with State and Federal filing deadlines. Other commenters suggested the deadline could be later than March 31, 2025, as all States do not need to submit 2026 benefit year rate filings until August 2025. One commenter suggested that HHS should put the user fee rates in guidance or allow for multiple rate filing submissions.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After considering comments, we are finalizing a revised deadline of July 31, 2025, for determining whether the alternative FFE and SBE-FP user fee rates will apply. The alternative 2026 benefit year user fee rates finalized in this rule will only take effect if enhanced PTC subsidies are extended through the 2026 benefit year at the current level or a higher level by July 31, 2025. While we proposed a March 31, 2025, deadline to provide issuers sufficient time to request rates and States sufficient time to review rate requests, we agree with commenters that the proposed March 31, 2025 deadline could be later, as issuers can submit changes to their benefit year 2026 QHP Applications, including updated rate data in the Rates Table Template of an issuer's QHP Application, as late as August 13. In finalizing the July 31, 2025, deadline, we recognize that many States allow issuers to file multiple rate filings to justify proposed rate increases depending on the uncertainty of factors applicable to the filing under review. In addition, we have previously provided flexibility on filing deadlines to allow States to account for rating changes in response to uncertain circumstances. For example, when issuers of silver-level QHPs were facing increased liability for enrollees in cost-sharing reduction plan variations after HHS stopped making cost-sharing reduction payments to issuers, we accounted for this change in single risk pool rate setting by extending the issuer filing deadline for QHPs and non-QHPs. Similarly, to provide the latest possible deadline that would allow issuers sufficient time to account for the uncertainty surrounding the expiration of enhanced PTC subsidies and allow issuers and States to set and approve rates under the existing filing deadlines, we are finalizing this revised July 31, 2025, deadline to establish the 
                        <PRTPAGE P="4488"/>
                        alternative user fee rates. We believe this deadline will also help reduce uncertainty, and by extension any upward pressure on premiums, and help ensure that we do not impose higher user fees than necessary to fund the operations of the FFEs and the Federal platform.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters suggested that HHS should adopt a PMPM user fee structure, stating that administrative costs do not track with premium changes and a PMPM user fee would avoid higher fee amounts based solely on premium increases.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not propose any changes to the user fee structure; as such, the user fee rates will continue to be set as a percent of the premium. We note that we propose and finalize user fee rates each benefit year and can adjust the user fee rates to avoid higher fee amounts based solely on premium increases. However, we will continue to engage with interested parties regarding how the FFE and SBE-FP user fee policies can best support consumer access to affordable, quality health insurance coverage through the Exchanges that use the Federal platform.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested increased transparency on user fees and wanted additional information on how user fee collections support HHS' policy goals for the Exchanges. The same commenter requested enumerated costs of providing Federal eligibility and enrollment platform service and infrastructure to each State.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         HHS collects user fees in accordance with Section 1311(d)(5)(A) of the ACA which permits an Exchange to charge assessments or user fees on participating health insurance issuers as a means of generating funding to support its operations. Therefore, our goal in collecting user fees is to collect user fees at a rate that will allow us to sustain the operations of the FFEs and SBE-FPs. In the proposed rule (89 FR 82373 through 82376, 82402), we provided information on the assumptions used to calculate the 2026 benefit year user fee rates.
                    </P>
                    <HD SOURCE="HD3">3. CSR Loading (§ 156.80)</HD>
                    <P>
                        In response to the termination of CSR payments to issuers in 2017,
                        <SU>221</SU>
                        <FTREF/>
                         State DOIs generally permitted or instructed their issuers to increase premiums only, or primarily, on silver-level QHPs, to compensate for the cost of offering CSRs, since the vast majority of eligible enrollees receiving CSRs are enrolled in silver plans. The proposed rule (89 FR 82376) reiterated that practices to increase premiums to offset amounts of unpaid CSRs 
                        <SU>222</SU>
                        <FTREF/>
                         that are permitted by State regulators are permissible under Federal law to the extent that they are reasonable and actuarially justified. We further stated that we were considering codifying this by amending the single risk pool regulations at § 156.80(d)(2)(i) to state that the plan-specific factors by which issuers may adjust the market-wide index rate include adjustments that reflect the costs associated with providing CSRs to the eligible enrollee population, to the extent that such adjustments are reasonable and actuarially justified. We sought comment on whether and how to codify this policy at § 156.80. We refer readers to the proposed rule (89 FR 82376 through 82377) for a detailed discussion, including the history of CSR payments to QHP issuers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>221</SU>
                             See discussion in the proposed rule of the history of CSR payments to QHP issuers (89 FR 82376). As discussed in the proposed rule, on October 11, 2017, the Attorney General of the United States provided HHS and the Department of the Treasury with a legal opinion indicating that the permanent appropriation at 31 U.S.C. 1324 could not be used to fund CSR payments to issuers.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>222</SU>
                             Rating practices to increase premiums to offset amounts of unpaid CSRs are referred to as “silver loading” (if premiums are increased on silver-level plans only), “broad loading” (if premiums are increased on all plans in the relevant State market, not just silver-level plans), or “CSR loading” generally. For purposes of this preamble, we use the term “CSR loading” to refer to any rating practices to increase premiums to offset amounts of unpaid CSRs.
                        </P>
                    </FTNT>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing amendments to § 156.80(d)(2)(i) to specify that the actuarially justified plan-specific factors by which an issuer may vary premium rates for a particular plan from its market-wide index rate include the actuarial value and cost-sharing design of the plan, including, if permitted by the applicable State authority, accounting for CSR amounts provided to eligible enrollees under § 156.410, provided the issuer does not otherwise receive reimbursement for such amounts. We summarize and respond below to public comments received on the amendments considered in the proposed rule.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Most commenters generally supported amending § 156.80(d)(2)(i) to explicitly note that plan-specific adjustments to the market-wide index rate that account for CSR loading, as permitted by State regulators, are permissible, stating that codifying this would promote market stability and provide greater clarity for issuers. One commenter supported the continuation of the practice of CSR loading but noted that codifying the allowability of this practice in regulation may not be necessary, as it is not altering the position that CMS has already provided in written guidance. In contrast, one commenter opposed codifying language regarding the practice of CSR loading in § 156.80(d)(2)(i), stating that CSR loading is a temporary measure that creates significant market distortions and increases Federal PTC spending.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that supported codifying language specifying in § 156.80(d)(2)(i) that CSR loading is permissible under Federal premium rating requirements. We agree that the practice of CSR loading has helped to promote market stability, as evidenced by the adoption of CSR loading in most States.
                        <SU>223</SU>
                        <FTREF/>
                         While we understand that many States intended to permit loading practices that specifically reimburse issuers for unpaid CSRs, we recognize that CSR loading practices vary and may not be critical to promoting market stability under all market conditions. For this reason, we have consistently deferred to States, as the traditional regulators of insurance and rating practices, to provide issuers with pricing guidance on how to account for unpaid CSRs in an actuarially-justified manner. This codification does not change our deference to States.
                    </P>
                    <FTNT>
                        <P>
                            <SU>223</SU>
                             Uccello, CE, American Academy of Actuaries, “Considerations for Calculating Cost-Sharing Reduction Load Factors,” Society of Actuaries Virtual Health Meeting Session 3C, available at 
                            <E T="03">https://www.actuary.org/sites/default/files/2023-07/2023_SOA_Session_3C_Uccello.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        States have provided guidance to issuers absent express language in § 156.80(d)(2) for years. We have concluded that it is appropriate to codify language regarding CSR loading in regulatory text because such amendments will provide greater clarity. Since the cessation of CSR payments in 2017, States and issuers have requested that we clarify how the single risk pool rules at § 156.80 apply with regard to CSR loading. We released guidance responsive to such requests in 2018 
                        <SU>224</SU>
                        <FTREF/>
                         and have consistently repeated that the ACA permits States' rating practices for CSR loading, as long as the resulting rate adjustments are actuarially justifiable pursuant to § 156.80. Because we continue to receive questions about permissible CSR loading practices, we have determined it is appropriate to codify that CSR loading is permitted under Federal 
                        <PRTPAGE P="4489"/>
                        rules, provided any such adjustments are actuarially justified and the issuer does not otherwise receive reimbursement for such amounts.
                    </P>
                    <FTNT>
                        <P>
                            <SU>224</SU>
                             
                            <E T="03">See,</E>
                             CMS. (2018, Aug. 3). Center for Consumer Information &amp; Insurance Oversight, Insurance Standards Bulletin Series—Information, Offering of plans that are not QHPs without CSR “loading,” 
                            <E T="03">https://www.cms.gov/cciio/resources/regulations-and-guidance/downloads/offering-plans-not-qhps-without-csr-loading.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We also recognize that CSR loading leads to higher PTCs and other pricing impacts that can alter how markets function. However, in light of the continued absence of Congressional action to fund CSRs, CSR loading continues to promote market stability, and we are codifying Federal policy that permits such premium rating under Federal premium rating requirements.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters encouraged CMS to affirm deference to State regulators to determine if and how CSR loading practices exist in their State, and other commenters, while supporting amendments to § 156.80(d)(2)(i), recommended against adoption of any further requirements on State approaches to CSR loading. Several commenters that supported amending § 156.80 encouraged HHS to avoid language that may, inadvertently or otherwise, limit State flexibilities, roll back State progress in pursuing innovative solutions, or undermine State methodologies to lower the cost of care. One commenter was concerned that a strict interpretation of the changes discussed in the proposed rule may require States to make significant changes to their strategic health policy initiatives related to CSR loading, which may have a destabilizing impact on the individual market. That commenter sought clarification regarding whether HHS intends to impose a test of reasonableness or actuarial justification that may override existing CSR loading practices permitted by States. Another commenter requested that CMS amend regulations to recognize the existing authority of States to establish rating rules for their markets. One commenter, who appears to have interpreted the discussion in the proposed rule to suggest that HHS was considering codifying a requirement that issuers use CSR loading when setting rates,
                        <SU>225</SU>
                        <FTREF/>
                         noted concern that codifying the practice of CSR loading in Federal regulation would undermine State authority to regulate insurance and stated that unfunded CSRs should be addressed through a Congressional appropriation, not regulatory codification of a workaround.
                    </P>
                    <FTNT>
                        <P>
                            <SU>225</SU>
                             Nothing in this final rule requires a State to allow CSR loading.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Response:</E>
                         Recognizing States' traditional role in regulating insurance and rating practices, this final rule codifies longstanding statements that, in light of the continued absence of Congressional action to fund CSRs and given States' well-established role as the primary regulators of insurance, the ACA permits States' rating practices for CSR loading, as long as the resulting rate adjustments are actuarially justifiable and otherwise comply with the requirements in § 156.80. The final rule codifies this deference to State regulators to determine if and how CSR loading practices exist in their State by permitting CSR loading “if permitted by the applicable State authority (as defined in § 144.103 of this subchapter).”
                    </P>
                    <P>
                        States may determine how to implement CSR loading in their State. However, there is no requirement for States to do so. Likewise, in those States that have an Effective Rate Review Program,
                        <SU>226</SU>
                        <FTREF/>
                         the State has the responsibility to determine whether an issuer's adjustments to the market-wide index rate for plan-specific factors (including accounting for CSR amounts) are actuarially justified.
                    </P>
                    <FTNT>
                        <P>
                            <SU>226</SU>
                             State authority to maintain an Effective Rate Review Program, including establishing rating rules for their markets, is codified in 45 CFR 154.210(b), 154.225(b) and 154.301.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters that supported the regulatory codification made recommendations regarding amendatory language in § 156.80(d)(2)(i). For example, some commenters suggested adding “including cost-sharing reductions under subpart E of this part 156 if not paid for under § 156.430,” while another commenter suggested adding “including adjustments for CSRs if not otherwise reimbursed.” One commenter, noting that HHS uses both “CSR loading” and “actuarial loading” to describe the premium loads arising due to the lack of Federal funding for CSRs, suggested that the term “CSR loading” is more appropriate because it is more specific. The commenter noted that “actuarial loading” could refer to a broader range of premium loads, including those related to new benefits or administrative expenses. Another commenter that supported the regulatory codification noted that current requirements for plan-level adjustments in § 156.80(d) require all such adjustments to be “actuarially justified,” but not “reasonable,” and therefore, urged HHS to define “reasonable” if included in amendments to § 156.80(d).
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 156.80(d)(2)(i) provides that an issuer may vary premium rates for a particular plan from its market-wide index rate for a relevant State market based on the actuarial value and cost-sharing design of the plan. We are finalizing amendments to § 156.80(d)(2)(i) specifying that adjustments related to the actuarial value and cost-sharing design of the plan may include, if permitted by the applicable State authority (as defined in § 144.103 of this subchapter), accounting for CSR amounts provided to eligible enrollees under § 156.410, provided the issuer does not otherwise receive reimbursement for such amounts. We note that these amendments do not use the shorthand terms “CSR loading,” “silver loading” or “actuarial loading.” With respect to the comments regarding the use of the term “reasonable” in regulatory text, § 156.80(d) requires all permitted plan-level adjustments to be “actuarially justified” and does not apply a separate “reasonableness” standard to permitted plan-level adjustments. We therefore have not included the word “reasonable” in the amendments to § 156.80(d)(2)(i). We note that States with an Effective Rate Review Program or CMS will continue to review rates to determine whether rate increases subject to review are unreasonable, pursuant to section 2794 of the PHS Act and 45 CFR part 154.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted concern that the discussion in the preamble of the proposed rule could be read to require the portion of silver premiums associated with CSRs to be experience-rated. The commenter therefore requested that HHS clarify that however a State approaches CSR loading, metal-level pricing must meet single risk pool requirements, and rates for individual plans must be set using methods that are actuarially justified.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Section 156.80(d)(2)(i), as amended, does not require States or issuers to follow a specific methodology when accounting for unpaid CSRs, so long as any such adjustments are actuarially justified. When we issued guidance regarding CSR loading in 2018, we confirmed that, under Federal law, States may allow or require their issuers to apply a premium load that would cover the cost of amounts of unpaid CSRs. We recognize that States have directed or permitted issuers to adjust rates to reflect unreimbursed CSRs using a range of methodologies.
                        <SU>227</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>227</SU>
                             Uccello, CE, American Academy of Actuaries, “Considerations for Calculating Cost-Sharing Reduction Load Factors,” Society of Actuaries Virtual Health Meeting Session 3C, available at 
                            <E T="03">https://www.actuary.org/sites/default/files/2023-07/2023_SOA_Session_3C_Uccello.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters recommended actions HHS should take in recognition of the absence of an appropriation to pay CSRs, the existence of the practice of CSR loading, and the attendant impact of CSR loading on the 
                        <PRTPAGE P="4490"/>
                        level of APTC paid. For example, one commenter recommended further action, such as the authorization of a pooled CSR fund, to address market distortions. A few commenters recommended further consideration of how silver loading interacts with risk adjustment, including potential modifications to the risk adjustment State payment transfer formula to account for the impact of CSR loading. One commenter noted that CSR loading will result in higher APTCs and requested that CMS allow consumers to apply such higher APTC amounts toward adult and pediatric dental care when included in silver-level QHPs as well as premiums for stand-alone dental plans (SADPs).
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate commenters' recommendations. We lack a specific appropriation to create a pooled CSR fund to address market distortions as one commenter recommended.
                    </P>
                    <P>We recognize that the HHS-operated risk adjustment program serves as an important market stabilizing tool, but we did not propose and are not adopting in this final rule any changes to the risk adjustment State payment transfer formula that applies in States where HHS is responsible for operating the program to account for the impact of CSR loading. Instead, we are continuing to study these issues and their impact on HHS-operated risk adjustment to consider whether potential updates are needed to risk adjustment, including changes to the State payment transfer formula and the CSR adjustment factors discussed in section III.B.2.e of this final rule. If any updates are needed, we would propose them through notice-and-comment rulemaking.</P>
                    <P>
                        With respect to the comment regarding permitting consumers to use excess APTC to pay for dental benefits, this is permitted to the extent that dental care is an EHB.
                        <SU>228</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>228</SU>
                             Pediatric dental benefits are an EHB. Beginning in PY 2027, States can choose to make adult dental care an EHB when updating their EHB-benchmark plan. In States that update their EHB-benchmark plan to include adult dental care, it will be an EHB and therefore APTC can go towards that benefit. APTCs cannot go toward adult dental SADP premiums at this time.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters requested that issuers no longer be required to notify the Secretary of any reduced CSR amounts for QHPs.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In accordance with § 156.430(d), in the absence of an appropriation for HHS to make advance CSR payments to issuers, the submission of CSR data under § 156.430 is optional.
                    </P>
                    <HD SOURCE="HD3">4. Publication of the 2026 Premium Adjustment Percentage, Maximum Annual Limitation on Cost Sharing, Reduced Maximum Annual Limitation on Cost Sharing, and Required Contribution Percentage in Guidance (§ 156.130(e))</HD>
                    <P>
                        As established in part 2 of the 2022 Payment Notice (86 FR 24238), for benefit years in which we are not making changes to the methodology to calculate the premium adjustment percentage, the required contribution percentage, and maximum annual limitations on cost sharing and reduced maximum annual limitation on cost sharing, we will publish these parameters in guidance annually starting with the 2023 benefit year. Therefore, because we did not propose to change the methodology for calculating these parameters for the 2026 benefit year, these parameters are not included in this rulemaking. Instead, on October 8, 2024, we published these 2026 benefit year parameters 
                        <SU>229</SU>
                        <FTREF/>
                         in guidance in accordance with our 2022 Payment Notice regulations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>229</SU>
                             Available at 
                            <E T="03">https://www.cms.gov/files/document/2026-papi-parameters-guidance-2024-10-08.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. AV Calculation for Determining Level of Coverage (§ 156.135)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82377), we stated that we intend to revise the method for updating the AV Calculator, starting with the 2026 AV Calculator.</P>
                    <P>Section 2707(a) of the PHS Act and section 1302 of the ACA direct issuers of non-grandfathered individual and small group health insurance coverage, including QHPs, to ensure that plans meet a level of coverage, or metal tier, specified in section 1302(d)(1) of the ACA. Each level of coverage corresponds to an AV calculated based on the cost-sharing features of the plan. On February 25, 2013, HHS published the EHB Rule (78 FR 12834), implementing section 1302(d) of the ACA, which requires at subsection (d)(2)(A) that, to determine the level of coverage for a given metal tier, the calculation of AV be based upon the provision of EHB to a standard population. Section 156.135(a), as finalized in the EHB Rule, provides that an issuer must use the AV Calculator developed and made available by HHS for the given benefit year to calculate the AV of a health plan, subject to the exception in paragraph (b).</P>
                    <P>In the 2015 Payment Notice (79 FR 13744), we established at § 156.135(g) provisions for updating the AV Calculator in future plan years. We stated in the preamble of the 2015 Payment Notice that we intend to release a draft version of the AV Calculator and AV Calculator Methodology through guidance for public comment each plan year before releasing the final version. In that same rule, we noted that interested parties could submit feedback on changes to the AV Calculator, and that we would consult as needed with the American Academy of Actuaries and the National Association of Insurance Commissioners on changes to the AV Calculator.</P>
                    <P>In the 2017 Payment Notice (81 FR 12204), we reiterated this approach and amended § 156.135(g) to allow for additional flexibility in our approach and options for updating the AV Calculator each year, which include trend factor updates, algorithms changes, user interface changes, updates to the claims data and demographic distribution being used in the AV Calculator, and an update to the AV Calculator's annual limitation on cost sharing. We also stated that we intend to release the final AV Calculator for a respective plan year no later than the end of the first quarter of the preceding plan year.</P>
                    <P>Since this time, we have largely fulfilled this intention. However, we have received feedback that we should strive to release the final version of the AV Calculator even sooner, in anticipation of State filing deadlines. SBE-FPs have also provided feedback explaining that they could benefit from an earlier release of the final version of the AV Calculator to design standardized plan options that satisfy the AV de minimis ranges. We stated in the proposed rule that we believe these requests are reasonable and that we can accommodate them in most years when there are no material changes between the draft and final versions of an AV Calculator for a respective plan year.</P>
                    <P>
                        Therefore, in the proposed rule (89 FR 82377), we stated that we intend to revise the current method whereby we release a draft version of the AV Calculator for a respective plan year through guidance for public comment and then release the final version of the AV Calculator for that plan year no later than the end of the first quarter of the preceding plan year after considering any comments received. We stated that we intend to only release the single, final version of the AV Calculator for a respective plan year. We noted that under this approach, we would still solicit public comments on the AV Calculator for a plan year generally, but we would only plan to incorporate this 
                        <PRTPAGE P="4491"/>
                        feedback into the development and release of the following plan year's AV Calculator, rather than to specifically inform the potential revision of the final version of the upcoming plan year's AV Calculator. We noted that this approach would allow us to release the final AV Calculator sooner and that we anticipated issuers would have the final version of the AV Calculator 3 to 6 months sooner than the end of the first quarter of the preceding plan year.
                    </P>
                    <P>We also noted that this approach would not sacrifice the quality of the AV Calculator. We stated that the stability and functionality of the AV Calculator has improved every year, and that we believe there are diminishing returns to receiving public comments on specific versions of it at this time. We noted that this is particularly evident given that we receive fewer than 10 comments on average each year on the draft AV Calculator. In addition, we noted that since the first AV Calculator was released for PY 2014, we have never made substantive changes in a final version of the AV Calculator for a plan year based on comments received on the draft version for that plan year, though this feedback is valuable to us and informs our decisions to update the AV Calculator in subsequent plan years. We added that this decision to not make substantive changes to the final version of the AV Calculator is also partly influenced by the limited timeframe we would have to make substantive changes to the final AV Calculator.</P>
                    <P>Thus, changes from the draft to the final version of the AV Calculator have historically only included non-substantive amendments to correct and clarify language in the AV Calculator Methodology or to add frequently asked questions to the AV Calculator User Guide. We stated that since these changes have historically been so minor, we believe the time delay required to effectuate those changes and release the final AV Calculator by the end of the first quarter of the preceding plan year is less valuable to issuers than releasing the final version sooner. We noted that under this approach, we would leave open the rare possibility that we could reissue another final version of the AV Calculator for a plan year if we discover the AV Calculator contains an error that materially impacts the functionality or accuracy of that version of the AV Calculator. We noted that although this has never happened to date, under the current framework of releasing both a draft and final version of the AV Calculator, if we had discovered a material error in the final version, we also would have reissued a corrected, final version.</P>
                    <P>We also noted that under this approach, we would still seek public comment on the AV Calculator for a plan year generally and would still consult with the American Academy of Actuaries, as well as the National Association of Insurance Commissioners. We further stated that we would consider this feedback for incorporation into the following year's AV Calculator.</P>
                    <P>In addition, we stated that to maximize the benefits of this approach, we intended to make this change effective starting with the release of the 2026 AV Calculator. We noted that we believe there would be minimal effect in effectuating this change with the 2026 AV Calculator because we intend to base the 2026 AV Calculator substantially on the final 2025 AV Calculator, and do not plan to make any material changes to it.</P>
                    <P>We sought comment on this approach.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this approach to release only the single, final version of the AV Calculator for a respective plan year. We summarize and respond to public comments received on this approach below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the approach to release only the single, final version of the AV Calculator for a respective plan year. These commenters noted that an earlier release of the final AV Calculator provides States and issuers with additional time to prepare plan designs ahead of rate and form filing deadlines. Several commenters mentioned that this earlier release will give Exchanges more time to finalize their State-specific standardized plan designs. A few commenters also noted that this revised approach is more efficient and reduces duplicative work and administrative burden for issuers.
                    </P>
                    <P>Some commenters provided feedback on the timing of the release of the final AV Calculator. One commenter requested that the final AV Calculator be released in October in future years, on a similar timeline to this year. Other commenters requested that the final AV Calculator be released no later than 13 or 14 months before the applicable plan year, while several commenters requested that the AV Calculator be released as early as possible. Lastly, a commenter requested we clarify that once the final version of the AV Calculator is released, issuers and States will have certainty that it is the final version.</P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that finalizing this revised approach for releasing the AV Calculator will create efficiencies and reduce administrative burden for issuers, States, and Exchanges.
                    </P>
                    <P>While we cannot commit to specific timeframes for the release of future final AV Calculators, we stated in the proposed rule (89 FR 82377) that we expect to release the final version of the AV Calculator 3 to 6 months sooner than when we have historically published the final AV Calculator for the forthcoming plan year. In connection with this rule, we released the final 2026 AV Calculator on October 16, 2024, more than 14 months before the plans that use it would become effective.</P>
                    <P>Once we release the final version of the AV Calculator for a particular plan year, issuers, States, and Exchanges can expect that, except in rare circumstances, we would not thereafter release a subsequent version of the AV Calculator for that plan year. As stated in the proposed rule (89 FR 82377 through 82378), we leave open the rare possibility that we could reissue another final version of the AV Calculator for a plan year if we discover the AV Calculator contains an error that materially impacts the functionality or accuracy of that version of the AV Calculator. However, this has never happened to date. Under the current framework of releasing both a draft and final version of the AV Calculator, if we had discovered a material error in the final version, we also would have reissued a corrected, final version, so this revised approach is in line with precedent.</P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters suggested that we could achieve the same goal of releasing the final version of the AV Calculator sooner by releasing the draft version earlier as well. One commenter specifically requested that the draft AV Calculator be released in the spring, while two others requested that the draft AV Calculator generally be released earlier to provide even more time to analyze changes to that plan year's AV Calculator.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Releasing a draft version of the AV Calculator in the spring is not technically possible. As discussed in the 2015 Payment Notice (79 FR 13811), certain updates to the AV Calculator are dependent on the timeline of availability of the necessary data elements. These data elements are unavailable in the spring for the plan year 2 years in the future (for example, spring 2024 for PY 2026). This includes the trend factors based on data collected through the Unified Rate Review 
                        <PRTPAGE P="4492"/>
                        Templates and the maximum annual limitation on cost sharing, published annually in the PAPI parameters guidance. Both these data elements are unavailable until late summer or early fall. So, we cannot release the draft AV Calculator in the spring or even the summer. The earliest we could release a draft AV Calculator is in the fall as we have in previous years. It is not technically possible for us to receive and analyze this data, incorporate it into the next build of the AV Calculator, perform quality assurance, release a draft version, solicit public feedback, and make revisions to the final AV Calculator based on that feedback and still release a final version 13 or 14 months before the plans that use it would become effective.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters noted the ongoing importance of collecting and incorporating public feedback on the AV Calculator, despite no longer releasing the draft version. A few commenters agreed with our rationale to condense this process since we have received fewer than 10 comments on average each year on the draft AV Calculator and agreed that eliminating the draft version to release the final version earlier is an acceptable tradeoff to gain access to the final AV Calculator earlier.
                    </P>
                    <P>Several commenters provided feedback on the process to collect input on the AV Calculator. One commenter noted that this change will allow issuers to provide feedback throughout the year. Conversely, several commenters requested that HHS establish a formal AV Calculator comment period that does not overlap with the Payment Notice comment period. The commenters stated that establishing a comment period would ensure that we receive input from all interested parties before starting work on the next year's AV Calculator, and creating a comment period distinct from the Payment Notice comment period would give interested parties more time to thoughtfully prepare feedback. In addition, one commenter distinguished between minor updates to the AV Calculator, such as updating the maximum out-of-pocket limits, that may not necessitate a formal comment period, versus more material changes when a comment and response period would be more appropriate.</P>
                    <P>
                        <E T="03">Response:</E>
                         Public feedback on the AV Calculator is essential to its accuracy and functionality. Under this revised approach, we will still solicit public comments on the AV Calculator but will only seek to incorporate this feedback into the development and release of the following plan year's AV Calculator, rather than into the development of the same plan year's AV Calculator. As we noted in the proposed rule (89 FR 82379), this revised approach is justified given that the stability and functionality of the AV Calculator has improved every year, and we believe there are diminishing returns to receiving public comments on a draft version for incorporation into a final version for a particular plan year. We also noted that we receive fewer than 10 comments on average each year on the draft AV Calculator. We agree that collecting and incorporating public feedback on the AV Calculator is valuable, and we encourage and welcome feedback from all interested parties on the 2026 final AV Calculator and future final AV Calculators.
                    </P>
                    <P>Given this revised approach, we do not believe it is necessary to set a specific deadline by which public comments on a particular version of the AV Calculator must be submitted, so we will accept public comments on a continuous rolling basis until the following plan year's AV Calculator is released. Without a specific deadline, interested parties can review the final AV Calculator without a timing constraint or competing priorities, such as reviewing and commenting on that year's Payment Notice.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters noted significant concerns with eliminating the draft version of the AV Calculator as a mechanism to solicit feedback. Several of these commenters urged CMS to continue a formal process to solicit feedback on the AV Calculator. A few commenters opposed our implementation of this approach for the 2026 AV Calculator, stating it was inappropriate to go forward with this approach without first seeking public comment. Another commenter stated that this approach introduces a dangerous precedent if applied to other guidance.
                    </P>
                    <P>One commenter stated that reviewing the draft version of the AV Calculator is the only opportunity to provide feedback. This commenter stated that the receipt of a small number of comments in prior years does not justify doing away with the draft version of the AV Calculator and that we ignored the comments on the draft version in prior years. This commenter also found the process of accepting rolling comments impractical and pointed out that the 2026 AV Calculator did not provide instructions on how to submit comments.</P>
                    <P>
                        <E T="03">Response:</E>
                         We reiterate our commitment to collecting feedback from all interested parties on the AV Calculator. In fact, we adopted this revised approach directly in response to consistent feedback we have received over the years to provide issuers, States, and Exchanges with access to the AV Calculator sooner. Releasing only the final version of the AV Calculator fulfills this request without jeopardizing its accuracy or functionality.
                    </P>
                    <P>We believe it is reasonable to move forward with this revised approach for the final 2026 AV Calculator given the AV Calculator's stability over the last few years. Considering the many process improvements in recent years, including the switch to the masked enrollee-level EDGE data starting with the 2025 AV Calculator and other changes to make the standard population more representative of the individual and small group markets, the AV Calculator has improved every year, so we believe it has achieved a mature state. Given this stability, the benefit of releasing a draft version of the AV Calculator no longer outweighs the corresponding delay to release the final AV Calculator after the draft version.</P>
                    <P>Although we will no longer receive feedback on a draft version to incorporate into the final AV Calculator, the same process to submit feedback on the AV Calculator remains available throughout the year. Since this process is the same as previous years when we have collected feedback on the AV Calculator, but without a specific deadline to submit comments, we disagree that accepting comments on the final AV Calculator on a rolling basis is impractical.</P>
                    <P>We disagree that it was inappropriate to move forward with this revised approach before seeking public comment, since this revised approach was in response to numerous public comments that we have received in the past. We also disagree that this revised approach introduces a dangerous precedent of no longer seeking public comment on draft versions of guidance. As stated, we revised the approach to release only a final version of the AV Calculator in response to specific feedback on the timing of the release of the AV Calculator, and as such, we clarify that this revised approach applies only to the AV Calculator and to no other guidance.</P>
                    <P>In addition, as we noted in the proposed rule (89 FR 82379), we believe there will be minimal effect in effectuating this change with the 2026 AV Calculator because we based the 2026 AV Calculator substantially on the final 2025 AV Calculator, and did not make any material changes to it.</P>
                    <P>
                        We note that the 2026 AV Calculator Methodology erroneously omitted a contact method for interested parties to 
                        <PRTPAGE P="4493"/>
                        submit comments on the final 2026 AV Calculator, but all prior draft AV Calculators have included the same contact information, which has remained available. We apologize for this oversight. Interested parties may submit comments to HHS via email at 
                        <E T="03">PMPolicy@cms.hhs.gov.</E>
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters mentioned other ideas for soliciting feedback on the AV Calculator, such as forming an advisory work group, seeking input from Navigators, community-based organizations, regulators, and patients, publishing a white paper and/or hosting a webinar, and reporting on how we incorporate feedback into future versions of the AV Calculator.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We again emphasize that feedback on the AV Calculator from all interested parties is essential. We appreciate the commenters' suggestions on other strategies to solicit feedback on the AV Calculator. We note that we already share updates and invite discussion on the AV Calculator at several venues, including at an annual webinar hosted for issuers and at the annual American Academy of Actuaries meeting. We will continue to do so, as well as explore other avenues and meetings throughout the year to engage with interested parties. However, a white paper explaining changes to the AV Calculator would be duplicative of the AV Calculator Methodology already published. The AV Calculator Methodology describes in detail all changes to that year's AV Calculator, as well as changes that were considered but not made. We will continue to use the AV Calculator Methodology document to describe such changes and considerations.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters opposed the proposed approach, stating that eliminating the draft version of the AV Calculator would not provide enough time to prepare plan designs. They stated that having earlier access to the draft version of the AV Calculator enabled them to plan ahead, and eliminating the draft version would make it difficult to meet key deadlines.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         These commenters misunderstood the primary goal of this revised approach. We want to clarify that this revised approach will not shorten the time that users have access to the AV Calculator. Rather, the revised approach will enable earlier access to the final AV Calculator. It is our understanding that having the final AV Calculator 3 to 6 months sooner than we have historically released it will only benefit plan design preparation.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters provided technical feedback on the 2026 final AV Calculator.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We thank commenters for providing this feedback on the 2026 final AV Calculator. We have noted this feedback and will consider it in the development of the 2027 AV Calculator.
                    </P>
                    <HD SOURCE="HD3">6. Standardized Plan Options (§ 156.201)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82378), we proposed to exercise our authority under sections 1311(c)(1) and 1321(a)(1)(B) of the ACA to make minor updates to the standardized plan options for PY 2026. We also proposed to amend § 156.201 by adding paragraph (c) to provide that an issuer that offers multiple standardized plan options within the same product network type, metal level, and service area must meaningfully differentiate these plans from one another in terms of included benefits, provider networks, and/or formularies.</P>
                    <P>
                        In the proposed rule (89 FR 82378), we proposed minor updates to the plan designs for PY 2026 to ensure these plans continue to have AVs within the permissible 
                        <E T="03">de minimis</E>
                         range for each metal level. We proposed to otherwise generally maintain continuity regarding the approach to standardized plan options finalized in the 2023, 2024, and 2025 Payment Notices. Our proposed updates to plan designs for PY 2026 were detailed in Tables 11 and 12 in the proposed rule.
                    </P>
                    <P>We proposed to maintain this high degree of continuity in standardized plan options for several reasons. We stated that primarily, we believe maintaining a high degree of continuity will reduce the risk of disruption for all involved interested parties, including issuers, agents, brokers, States, and consumers. We further stated that we continue to believe that making major departures from the standardized plan option designs finalized in the 2023, 2024, and 2025 Payment Notices could result in significant changes that may create undue burden for interested parties.</P>
                    <P>We refer readers to the proposed rule (89 FR 82378 through 82382) for further discussion of the background and rationale regarding our proposed approach to standardized plan options, and to the preambles of the 2023, 2024, and 2025 Payment Notices discussing § 156.201 (87 FR 27310 through 27322, 88 FR 25847 through 25855, and 89 FR 26357 through 26362, respectively) for a detailed discussion regarding the approaches to standardized plan options finalized in those Payment Notices.</P>
                    <P>In addition, we proposed a meaningful difference standard for PY 2026 and subsequent plan years at § 156.201(c) because several issuers in recent years have offered indistinguishable standardized plan options, and we believe issuers may continue to do so in future plan years partly because the number of non-standardized plan options that issuers can offer is limited in accordance with § 156.202(b). We stated that we do not believe it benefits consumers for issuers to offer identical standardized plan options, or standardized plan options that do not differ in meaningful ways, within the same product network type, metal level, and service area. In addition, we noted that permitting issuers to offer identical standardized plan options or standardized plan options that do not differ in meaningful ways runs counter to our goals of enhancing the consumer experience, increasing consumer understanding, and simplifying the plan selection process. We also stated that allowing issuers to offer duplicative standardized plan options could cause significant consumer confusion and unnecessary plan proliferation if the trend continues unabated.</P>
                    <P>As such, we stated that under this proposal, although issuers would continue to be permitted to offer multiple standardized plan options within the same product network type, metal level, and service area, these standardized plan options would be required to have meaningfully different benefit coverage, provider networks, and/or formularies. For the purposes of the proposed standard, for PY 2026 and subsequent plan years, we stated that we would consider a standardized plan option with a different product, provider network, and/or formulary ID to be meaningfully different, similar to the version of the standard from the 2017 Payment Notice (81 FR 12312 and 12331).</P>
                    <P>
                        In the proposed rule (89 FR 82380), we stated that if an issuer submitted two standardized plan options within the same product network type, metal level, and service area both with the same product, provider network, and formulary IDs, we would not certify both of these plans. We explained that we anticipated we would seek feedback from the issuer regarding which plan to certify, assuming the issuer meets all other certification requirements. We also noted that for the purposes of the proposed standard, we would not consider differences in plan variant marketing names, the availability of different language access features, or the administration of the plan by different 
                        <PRTPAGE P="4494"/>
                        vendors in determining whether two or more standardized plan options are meaningfully different, similar to the version of the standard from the 2017 Payment Notice.
                    </P>
                    <P>We further stated that if this policy were finalized as proposed, we would monitor whether issuers are seeking certification of plans that technically meet this standard but are nearly identical. We noted that if we determined that issuers were attempting to circumvent this standard in this manner, we would consider proposing in future rulemaking a version of this meaningful difference standard that would require greater variation among plans beyond product, provider network, and/or formulary IDs. We noted that we were not proposing such a standard for PY 2026 and subsequent plan years at that time because, assuming issuers do not attempt to circumvent this standard as noted above, we believe that the proposed policy would likely be sufficient to ensure that issuers' standardized plan options continue to support our goals of enhancing the consumer experience, increasing consumer understanding, and simplifying the plan selection process.</P>
                    <P>We refer readers to the proposed rule (89 FR 82378 through 82380) for further discussion of the background and rationale regarding our proposal to require an issuer that offers multiple standardized plan options within the same product network type, metal level, and service area to meaningfully differentiate these plans from one another in terms of included benefits, provider networks, and/or formularies.</P>
                    <P>We sought comment on our proposed approach to standardized plan options for PY 2026, including amending § 156.201 to add paragraph (c).</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="440">
                        <GID>ER15JA25.053</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="451">
                        <PRTPAGE P="4495"/>
                        <GID>ER15JA25.054</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing our proposed approach with respect to standardized plan options, with several modifications to both sets of plan designs at the expanded bronze metal level.</P>
                    <P>In particular, for both sets of plan designs at the expanded bronze metal level, we reduced the coinsurance rate for all benefit categories that had coinsurance subject to the deductible as the form of cost sharing from 60 percent to 50 percent. We also reduced the copayments exempt from the deductible for the primary care visit benefit category from $60 to $50; for the urgent care benefit category from $90 to $75; for the specialist visit benefit category from $120 to $100; for the mental health and substance use disorder outpatient office visit benefit category from $60 to $50; for the speech therapy benefit category from $60 to $50; and for the occupational and physical therapy benefit category from $60 to $50. To counterbalance this subsequent increase in AV, we increased the annual limitation on cost sharing value from $9,200 to $10,000. Altogether, these modifications resulted in a reduction in AV from 64.42 percent in the proposed plan designs to 64.12 percent in the plan designs finalized in this rule.</P>
                    <P>We made these modifications primarily to maintain continuity in plan designs, to minimize the risk of coverage disruption and unexpected financial costs for consumers already enrolled in these plans, and to allow issuers to design standardized plans in a manner that conforms to State laws. We are otherwise finalizing the plan designs as proposed. There were no other modifications to any of the other benefit categories in either set of plan designs at the expanded bronze metal level. There were similarly no modifications to either set of plan designs at any of the other metal levels. Our finalized plan designs for PY 2026 are detailed in Tables 1 and 2 of this final rule.</P>
                    <P>
                        After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are also finalizing, with minor modification, our proposal that an issuer that offers multiple standardized plan options 
                        <PRTPAGE P="4496"/>
                        within the same product network type, metal level, and service area must meaningfully differentiate these plans from one another in terms of included benefits, provider networks, and/or formularies.
                    </P>
                    <P>In particular, we modified the language at § 156.201(c) to state that an issuer that offers multiple standardized plan options within the same product network type, metal level, and service area must meaningfully differentiate these plans from one another in terms of included benefits, provider networks, included prescription drugs, or a combination of some or all these factors. For the purposes of this standard, a standardized plan option with a different product ID, provider network ID, drug list ID, or some combination of or all these factors, will be considered meaningfully different.</P>
                    <P>We modified the portion of the proposed standard stating that a difference in formularies (which is defined as a difference in formulary IDs) would constitute a meaningful difference to instead state that a difference in included prescription drugs (which is defined as a difference in drug list IDs) would constitute a meaningful difference. We made this modification to ensure that minor differences in prescription drug cost sharing (which would be reflected by differences in formulary IDs) would not constitute a meaningful difference under this framework, consistent with our goal of ensuring that standardized plan options differ in meaningful ways. This is similar to how differences in included benefits (which is defined as a difference in product IDs) would constitute a meaningful difference, but differences in the cost sharing for those medical benefits would not. Additionally, we made this modification to further clarify the flexibility that issuers are permitted.</P>
                    <P>We summarize and respond to public comments received on the proposed approach to standardized plan options below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported continuing to require FFE and SBE-FP QHP issuers to offer standardized plan options. Some of these commenters described standardized plan options as helping to reduce consumer confusion by simplifying the plan selection process and by allowing consumers to draw meaningful comparisons between plan options more easily. Many commenters noted that consumers continue to risk experiencing plan choice overload as they navigate the plan selection process and that standardized plan options continue to play an important role in reducing the number of variables that consumers need to compare as part of the selection process. Other comments encouraged CMS to make further improvements to the 
                        <E T="03">HealthCare.gov</E>
                         shopping experience by refining tools that help consumers navigate and manage plan choices more easily, including by enhancing the differential display of standardized plan options. Some commenters also requested that CMS create a pathway for issuers to submit both English and Spanish marketing plan variant names for all plans to enhance accessibility for Spanish-speaking consumers using 
                        <E T="03">CuidadoDeSalud.gov.</E>
                    </P>
                    <P>
                        Many commenters supported our approach to the design of these standardized plan options for PY 2026. Specifically, commenters supported taking a consistent approach to the design of standardized plan options and only making minor adjustments to ensure the plans continue to have AVs within the permissible 
                        <E T="03">de minimis</E>
                         ranges at each metal level, particularly because of the consistency this provides enrollees for anticipating their health care costs. Conversely, a few commenters opposed continuing to require issuers to offer standardized plan options. These commenters noted that continuing to subject issuers to these requirements reduces consumer choice and makes it harder for consumers to find plan options that best meet their individual health care needs.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that standardized plan options continue to serve as one important facet of our multifaceted strategy of reducing the rate of plan proliferation, the risk of plan choice overload, and the frequency of suboptimal plan selection. We are also engaged in ongoing work to improve consumers' decision-making through enhancing choice architecture and the user experience on 
                        <E T="03">HealthCare.gov,</E>
                         and we will consider additional ways to do so in the future.
                    </P>
                    <P>
                        For the comments requesting that we create a pathway for issuers to submit both English and Spanish marketing plan variant names for all plans to enhance accessibility for Spanish-speaking consumers using 
                        <E T="03">CuidadoDeSalud.gov,</E>
                         we note that we are currently working on modifications to 
                        <E T="03">HealthCare.gov</E>
                         to improve the user experience, including with respect to language accessibility. We also note that we will consider revising the submission website to allow issuers to submit plan variant marketing names in Spanish or other languages in future plan years. For the purposes of the meaningful difference standard that we are finalizing in this rule for PY 2026 and subsequent plan years, we reiterate our explanation in the proposed rule (89 FR 82380) that we would not consider differences in plan variant marketing names, the availability of different language access features, or the administration of the plan by different vendors in determining whether two or more standardized plan options are meaningfully different.
                    </P>
                    <P>We agree that maintaining a high degree of continuity in our standardized plan options from year to year is desirable for several reasons. Specifically, we agree that having consistent year-to-year plan designs allows consumers enrolled in these plans to become better acquainted with these plans, increasing both consumer understanding and financial certainty. We also agree that drastically modifying the plan designs from year to year could potentially result in avoidable financial harm if the cost sharing for benefits that consumers depend upon increases unexpectedly, which could also result in consumers forgoing obtaining medical care. Although we believe that, today, the benefits that may arise from making major modifications to these plan designs are outweighed by the risk that doing so could result in undue burden for issuers and consumers, we may consider making major modifications to the design of these standardized plan options in future rulemakings if this assessment changes.</P>
                    <P>
                        We disagree that continuing to require issuers in the FFEs and SBE-FPs to offer standardized plan options makes it harder for consumers to access plans that meet their unique health needs, even with the additional requirement we are finalizing in this rule for meaningfully differentiating standardized plan options when an issuer chooses to offer multiple standardized plan options within the same product network type, metal level, and service area. We note that, as clarified in section III.E.7 of this rule, issuers are permitted to offer two non-standardized plan options per product network type, metal level (excluding catastrophic plans), inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage, and service area, as well as additional non-standardized plan options per product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage, and service area, so long as these additional plans substantially benefit consumers with chronic and high-cost conditions and meet the other criteria for the exceptions process under § 156.202(d) and (e).
                        <PRTPAGE P="4497"/>
                    </P>
                    <P>As we explained in the 2025 Payment Notice (89 FR 26367), we believe the fact that issuers continue to be permitted to offer these non-standardized plan options ensures that consumers will continue to have access to a sufficiently broad range of plan designs that meet their diverse needs and that issuers can continue to offer innovative plan designs. We further believe that continuing to require issuers to offer standardized plan options, as well as reducing the non-standardized plan option limit and implementing the exceptions process for this limit (as discussed in section III.E.7. of this rule), strikes an appropriate balance between limiting the risk of plan choice overload while simultaneously continuing to permit issuers a sufficient degree of flexibility to offer innovative plan designs.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters expressed support for various features of the proposed plan designs. In particular, commenters supported standardized plan options for improving affordability by providing greater access to pre-deductible coverage and requiring copayments instead of coinsurance rates for certain benefit categories. Commenters also noted that the use of copayments and pre-deductible coverage in standardized plan options promotes predictable and affordable cost sharing for essential care, thereby reducing barriers and enhancing access for these services.
                    </P>
                    <P>However, some commenters recommended further reducing enrollees' out-of-pocket costs, such as by exempting additional drug tiers from the deductible, or by capping monthly out-of-pocket costs for particular prescription drugs. Several commenters recommended lowering the coinsurance rate for both sets of plan designs at the expanded bronze metal level from 60 percent to 50 percent in order to allow issuers to design plans compliant with State laws that prohibit coinsurance rates over 50 percent. Another commenter recommended including health savings account (HSA)-compliant high-deductible health plan (HDHP) designs in both sets of standardized plan options.</P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate commenters' support for various features of the proposed plan designs. We acknowledge that a high annual limitation on cost sharing values, high deductibles, and limited pre-deductible coverage can sometimes act as barriers that prevent consumers, including those with chronic and high-cost conditions, from obtaining the health care they need. We also acknowledge that coinsurance rates, as well as subjecting particular benefit categories and prescription drug tiers to the deductible, can potentially increase consumer uncertainty regarding how much particular items and services may cost.
                    </P>
                    <P>
                        However, due to AV constraints arising from the permissible 
                        <E T="03">de minimis</E>
                         range restriction for each metal level in accordance with § 156.140(c)(2), we are unable to substantially lower the annual limitation on cost sharing or deductible values, expand pre-deductible coverage to include additional benefit categories, or include copayments as the form of cost sharing for a broader range of benefit categories without a corresponding increase in the AV of each plan. Making some combination of these modifications would increase the generosity of these plans, potentially to the point of each plan's AV exceeding the permissible 
                        <E T="03">de minimis</E>
                         range for its respective metal level. Furthermore, even if making some combination of these changes would result in an AV within the permissible 
                        <E T="03">de minimis</E>
                         range for each metal level, there would still be a corresponding increase in premiums that would render these plans costlier for consumers and potentially uncompetitive.
                    </P>
                    <P>
                        We further note that although it may be possible to make some combination of these modifications to these plan designs while maintaining an AV near the floor of the 
                        <E T="03">de minimis</E>
                         range for each metal level, doing so would require a corresponding increase in cost sharing for other benefits or subjecting additional benefits to the deductible to offset this increase in generosity. Since the benefits that we have exempted from the deductible as well as the benefits for which we have reduced cost sharing in the standardized plan options finalized in this rule are some of the most frequently utilized benefits, we believe that the disadvantages of subjecting these benefits to the deductible or increasing the cost sharing for these benefits would outweigh the benefit that may arise from exempting other benefits from the deductible or reducing cost sharing for other benefits. The disadvantages include the risk that these plans would become uncompetitive and that consumers would forego obtaining medical services covered by these frequently utilized benefits which would be newly subject to the deductible or have increased cost sharing.
                    </P>
                    <P>We also note that we are not standardizing the cost sharing for additional benefit categories beyond those already included in these plan designs since EHB-benchmark plans vary significantly by State, and we do not wish to standardize the cost sharing for benefits that issuers may not be required to offer in particular States.</P>
                    <P>However, we agree with commenters who recommended reducing the expanded bronze plan coinsurance rate from 60 percent in both sets of plan designs, as proposed, to 50 percent in order to allow issuers to design plans in a manner that conforms with State laws and to maintain continuity with plan designs from previous years. Requiring issuers to offer standardized plan options that fail to conform with State laws may inadvertently lead issuers to become subject to State enforcement and other legal actions, which could endanger their licensure and ability to continue offering QHPs, and cause coverage disruptions for consumers enrolled in noncompliant standardized plan options that are terminated during the plan year. Accordingly, we have finalized coinsurance rates of 50 percent for all benefit categories subject to a coinsurance rate in the expanded bronze plan design in both sets of plan designs.</P>
                    <P>
                        In addition to modifying the default coinsurance rates for both sets of plan designs at the expanded bronze metal level, we also reduced the copayments exempt from the deductible for the primary care visit benefit category from $60 to $50; for the urgent care benefit category from $90 to $75; for the specialist visit benefit category from $120 to $100; for the mental health and substance use disorder outpatient office visit benefit category from $60 to $50; for the speech therapy benefit category from $60 to $50; and for the occupational and physical therapy benefit category from $60 to $50. To counterbalance this subsequent increase in AV and help ensure both sets of plan designs at the expanded bronze metal level have AVs within the permissible 
                        <E T="03">de minimis</E>
                         range for that level, we increased the annual limitation on cost sharing value from $9,200 to $10,000. Altogether, these modifications resulted in a reduction in AV from 64.42 percent in the proposed plan designs to 64.12 percent in the plan designs finalized in this rule.
                    </P>
                    <P>
                        We made these changes primarily to maintain consistent year-to-year plan designs, which allows enrollees to become better acquainted with these plans, increasing both consumer understanding and financial certainty, similar to our approach in previous years and consistent with the goals outlined in the proposed rule (89 FR 82379), to minimize the risk of coverage disruption for consumers already enrolled in these plans, and to allow issuers to design standardized plans in a manner that conforms to State laws.
                        <PRTPAGE P="4498"/>
                    </P>
                    <P>Finally, we note that we have not included an HSA-eligible HDHP in these sets of plan designs due to decreased enrollment in these plans in the last several plan years, which suggests they may be less competitive and in-demand than traditional health insurance plans. We thus declined to include HSA-eligible HDHPs in these sets of plan designs because, as we explained when we reintroduced standardized plan options in the 2023 Payment Notice (87 FR 27319), our approach is to design standardized plan options that reflect the most popular QHPs offered through the Exchanges. We also declined to include an HSA-eligible HDHP in these sets of plan designs because we have not included these types of plans in the sets of standardized plan options for PY 2023, PY 2024, or PY 2025, and we want to maintain a high degree of continuity with the standardized plan option policies and designs finalized in the 2023, 2024 and 2025 Payment Notices. However, we note that QHP issuers in the FFEs and SBE-FPs continue to be permitted to offer HSA-eligible HDHPs as non-standardized plan options, if so desired.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the proposal to allow QHP issuers to offer more than one standardized plan option within the same product network type, metal level, and service area if the plans conform to the proposed meaningful difference standard. These commenters appreciated the effort to reduce duplicative plan offerings and to help consumers better understand included benefits, provider networks, and included prescription drugs when making plan selections and comparisons. They described the adoption of the meaningful difference standard as a critical step toward simplifying plan selection, preventing confusion, and promoting better consumer decision-making. Commenters noted that the adoption of the meaningful difference standard aligns with the broader aims of standardized plan options—reducing the number and complexity of the variables that consumers must consider when comparing plans.
                    </P>
                    <P>Some commenters noted their approval of relying on product, provider network, and formulary IDs to determine whether standardized plan options are meaningfully different, while other commenters noted concern that the proposed standard would not be strict enough to reduce the risk of issuers offering duplicative standardized plan options. One such commenter recommended that CMS consider requiring a particular quantitative difference between the standardized plan options' provider networks and formularies to ensure plans are meaningfully different from one another. Many commenters similarly recommended making the meaningful difference requirement more stringent by reducing the number of factors that would qualify a plan as meaningfully different. Several commenters recommended applying the meaningful difference standard to the non-standardized plan options instead of standardized plan options. Some commenters encouraged CMS to monitor whether allowing issuers to offer multiple standardized plan options in the same service area would result in unnecessary complexity for consumers shopping for health plans.</P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that requiring issuers to meaningfully differentiate between multiple standardized plans within the same product network type, metal level, and service area will improve the consumer experience by increasing consumer understanding, simplifying the plan selection process, and limiting unnecessary plan proliferation. We share commenters' concerns about consumer confusion when comparing identical-appearing standardized plan options, and, as we explained in the proposed rule (89 FR 82380), we will monitor whether issuers are seeking certification of standardized plans that technically meet the meaningful difference standard but are nearly identical.
                    </P>
                    <P>We note that, in this final rule, we are finalizing a modification to our proposed meaningful difference standard. Instead of providing that a difference in formularies (which is defined as a difference in formulary IDs) would constitute a meaningful difference, we are finalizing that a difference in included prescription drugs (which is defined as a difference in drug list IDs) will constitute a meaningful difference. We made this modification to ensure that minor differences in prescription drug cost sharing (which would be reflected by differences in formulary IDs) would not constitute a meaningful difference. This is similar to how differences in included benefits (which is defined as a difference in product IDs) would constitute a meaningful difference, but differences in the cost sharing for those medical benefits would not.</P>
                    <P>If we determine that issuers are attempting to circumvent this standard, or that it is otherwise not strict enough, we will consider proposing in future rulemaking a version of this meaningful difference standard that would require greater variation among plans beyond product ID, provider network ID, drug list ID, or a combination of some or all these factors. We did not propose such a standard for PY 2026 and subsequent plan years in the proposed rule because, assuming issuers do not attempt to circumvent this standard as noted above, we believe that this proposed policy would likely be sufficient to ensure that issuers' standardized plan offerings support our goals of enhancing the consumer experience, increasing consumer understanding, and simplifying the plan selection process. We will monitor whether the standard we are finalizing in this rule effectively enhances the consumer experience, reduces plan proliferation, and encourages plan diversity in the individual market.</P>
                    <P>We appreciated comments that shared specific recommendations about how to craft this standard in a manner that would ensure that the standardized plan options offered under this standard yield meaningfully different plan design features for consumers—such as by requiring particular quantitative differences in provider networks or formularies. Again, if we determine that the standardized plan options that issuers are offering within the same product network type, metal level, and service area that have different product IDs, provider network IDs, drug list IDs, or a combination of some or all these factors, fail to yield meaningful and distinguishable differences in plans for consumers, we may consider proposing a quantitative version of the standard in a future plan year.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters requested clarification on how issuers could vary benefit coverage in standardized plan options within the same product network type, metal level, and service area under this proposed standard. Several commenters recommended relaxing this standard, such as by allowing plans to be considered meaningfully different based on differences in cost sharing for non-standardized benefit categories or differences in tiered provider networks (in addition to differences in product, provider network, and drug list IDs)—similar to the previous meaningful difference standard finalized in the 2018 Payment Notice. Another commenter recommended providing issuers with the opportunity to make their case for how two proposed, seemingly indistinguishable standardized plan options meaningfully differ from one another before CMS decides whether to not certify one of these plans (assuming the issuer meets all other certification requirements).
                        <PRTPAGE P="4499"/>
                    </P>
                    <P>A few commenters opposed allowing issuers to offer multiple standardized plan options within the same product network type, metal level, and service area—regardless of whether they are deemed to be meaningfully different—primarily due to concerns regarding plan proliferation. These commenters explained that permitting issuers to offer multiple standardized plan options within the same product network type, metal level, and service area but with different included benefit coverage, provider networks, or included prescription drugs could cause confusion for consumers—since these standardized plan options would not be standardized in every regard.</P>
                    <P>
                        <E T="03">Response:</E>
                         In response to the commenters who requested clarification regarding how standardized plan options can vary benefit coverage outside of the benefit categories with standardized cost sharing in order to satisfy the requirements of this standard, we note that issuers may differentiate their standardized plan options from one another by varying the included benefit coverage, such as non-EHBs, or in how the plan covers EHB, consistent with the EHB requirements in the applicable State. For example, when reviewing if two standardized plan options within the same product network type, metal level, and service area are meaningfully different, we will consider the plans to be meaningfully different from one another if they do not share the same product ID.
                    </P>
                    <P>However, we note that varying non-standardized benefit category cost sharing parameters (such as for those benefit categories that do not have standardized cost sharing parameters specified in Tables 1 and 2 of this rule) would not constitute a meaningful difference for the purpose of this standard. This is because we do not believe that minute differences in cost sharing (such as a $5 difference in the copayment amount for a relatively infrequently utilized benefit) would provide a meaningful or discernible difference for consumers. The same is true for minor differences in cost sharing for prescription drugs (which would be reflected in differences in formulary IDs)—which is why we modified the standard we are finalizing to instead state that differences in included prescription drugs (which is defined as differences in drug list IDs) would constitute a meaningful difference.</P>
                    <P>Furthermore, permitting issuers to vary standardized plan options in this regard could increase the risk of circumvention of the standard (such as by permitting issuers to offer one standardized plan option with a $20 copayment for an infrequently utilized benefit, another with a $15 copayment for the same benefit, and another with a $10 copayment for the same benefit)—within the same product network type, metal level, and service area and with the same product, provider network, and drug list ID. Such an approach would exacerbate the risk of plan proliferation and choice overload.</P>
                    <P>In response to commenters who recommended that we allow standardized plan options to be considered meaningfully different based on tiered provider networks, similar to our stance when we reintroduced the requirement for issuers to offer standardized plan options in the 2023 Payment Notice (87 FR 27311), we reiterate that we continue to design these standardized plan options to be similar to the most popular QHPs in FFEs and SBE-FPs in terms of cost sharing parameters, annual limitation on cost sharing values, and deductibles in order to ensure these plans are similar to plans that most consumers are already currently enrolled in, thereby reducing the risk of disruption for both consumers and issuers.</P>
                    <P>Given that most consumers continue to not be enrolled in plans with tiered provider networks, we believe that permitting issuers to offer standardized plan options with tiered provider networks under this standard would unnecessarily increase the risk of plan proliferation for consumers. Permitting issuers to offer standardized plan options with tiered provider networks would also mark a departure from our aim of maintaining continuity in plan designs from year to year, since we have not designed such plans as standardized plans to date. Adopting such an approach would also increase the number of factors that consumers must consider when selecting a plan—which runs counter to our goal of simplifying the plan selection process to reduce the risks of consumer confusion and plan choice overload. We also note that issuers are permitted to offer non-standardized plan options with tiered provider networks, if they so desire.</P>
                    <P>In response to the commenter who recommended that we provide issuers with an opportunity to make their case that their two proposed, seemingly indistinguishable standardized plan options are meaningfully different from one another before deciding not to certify one, we refer the commenter to discussion on this point in the proposed rule (89 FR 82380). In particular, in the proposed rule, we explained that, if an issuer submitted two standardized plan options within the same product network type, metal level, and service area, both with the same product, provider network, and formulary IDs, we would not certify both of these plans. We explained that before deciding which plan to certify, assuming the issuer meets all other certification requirements, we would seek feedback from the issuer regarding which plan to certify. Under the standard finalized in this rule, we will consider the issuer's explanation of how the plans differ based on their benefit coverage, provider networks, included prescription drugs, or a combination of some or all these factors, as part of this process.</P>
                    <P>We appreciate the concern of commenters who opposed allowing multiple standardized plan options within the same product network type, metal level, and service area due to this approach increasing the risk of plan proliferation. We acknowledge that this standard could permit issuers to offer multiple standardized plan options where consumers struggle to discern how the plans differ. However, as we explained in the proposed rule (89 FR 82380), we believe this is unlikely, and we will monitor whether issuers seek certification of standardized plan options that technically meet the meaningful difference standard but are nearly identical.</P>
                    <P>Further, if we determine that issuers are attempting to circumvent this standard in this manner, we will consider proposing in future rulemaking a version of this meaningful difference standard that would require greater variation between plans beyond requiring differences in product, provider network, and drug list IDs. As we explained in the proposed rule (89 FR 82380), we did not propose such a standard for PY 2026 and subsequent plan years because, assuming issuers do not attempt to circumvent this standard as noted above, we believe that the proposed policy would likely be sufficient to ensure that issuers' standardized plan options support our goals of enhancing the consumer experience, increasing consumer understanding, and simplifying the plan selection process.</P>
                    <P>
                        Finally, we acknowledge the concern that allowing standardized plan options to have varied benefit coverage, provider networks, and included prescription drugs could potentially increase the risk of consumer confusion—since these standardized plan options would not be standardized in every regard. However, we note that that we wish to permit issuers a sufficient degree of flexibility to design plans that accommodate a broad and 
                        <PRTPAGE P="4500"/>
                        diverse range of unique health care needs, which we do by permitting issuers to offer a range of standardized plan options, subject to the meaningful difference standard, as well as non-standardized plan options.
                    </P>
                    <P>The benefit categories that we standardize within these plans are the most frequently utilized—and they are all required to be offered by QHP issuers as EHB. We do not wish to standardize the cost sharing for every possible benefit category within these plans since there are benefit categories that are less frequently utilized—as well as benefit categories that may not be required to be offered as EHB in particular States—and we do not wish to give the impression that such benefit coverage must be included in these plans even if they are not EHB in particular States. We further believe the standard we are finalizing in this rule will ensure that issuers that offer multiple standardized plan options within a product network type, metal level, and service area will yield meaningful differences in coverage for consumers while still providing a sufficient degree of standardization and minimizing the risk of consumer confusion. At the same time, we want to take steps to simplify and streamline the plan selection process for consumers, which, for the reasons explained in this final rule and in the proposed rule, we believe this policy does.</P>
                    <P>Altogether, we believe that requiring issuers to offer these standardized plan options, reintroducing this meaningful difference standard, limiting the number of non-standardized plan options that issuers can offer, and permitting exceptions to the non-standardized plan option limit for plans that have specific design features that would substantially benefit consumers with chronic and high-cost conditions strikes an appropriate balance between allowing issuers to innovate in plan designs, maintaining a sufficient degree of choice for consumers, and simplifying and streamlining the plan selection process to reduce the risk of choice overload.</P>
                    <HD SOURCE="HD3">7. Non-Standardized Plan Option Limits (§ 156.202)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82382), we proposed to exercise our authority under sections 1311(c)(1) and 1321(a)(1)(B) of the ACA to amend § 156.202(b) and (d) to properly reflect the flexibility that issuers have operationally been permitted since the introduction of non-standardized plan option limits to vary the inclusion of distinct adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage categories under the non-standardized plan option limit in accordance with § 156.202(c)(1) through (3).</P>
                    <P>Section 1311(c)(1) of the ACA directs the Secretary to establish criteria for the certification of health plans as QHPs. Section 1321(a)(1)(B) of the ACA directs the Secretary to issue regulations that set standards for meeting the requirements of title I of the ACA, which includes section 1311, for, among other things, the offering of QHPs through such Exchanges.</P>
                    <P>In the 2024 Payment Notice (88 FR 25855 through 25865), we finalized requirements under § 156.202(a) and (b) limiting the number of non-standardized plan options that issuers of QHPs can offer through Exchanges on the Federal platform (including SBE-FPs) to four non-standardized plan options per product network type (as described in the definition of “product” at § 144.103), metal level (excluding catastrophic plans), inclusion of dental and/or vision benefit coverage, and service area for PY 2024, and two non-standardized plan options for PY 2025 and subsequent years.</P>
                    <P>In the 2025 Payment Notice (89 FR 26362 through 26375), we finalized an exceptions process under § 156.202(d) and (e) permitting FFE and SBE-FP issuers to offer more than two non-standardized plan options per product network type, metal level, inclusion of dental and/or vision benefit coverage, and service area for PY 2025 and subsequent plan years, if issuers demonstrate that these additional non-standardized plans offered beyond the limit at § 156.202(b) have specific design features that would substantially benefit consumers with chronic and high-cost conditions and meet certain other requirements.</P>
                    <P>In the 2025 Payment Notice (88 FR 26365 through 26366), we also clarified that the example included in the 2024 Payment Notice that illustrated issuers' flexibility to vary the inclusion of dental and/or vision benefit coverage in accordance with § 156.202(c) under the non-standardized plan option limits at § 156.202(a) and (b) failed to properly distinguish between the adult and pediatric dental benefit coverage categories.</P>
                    <P>In particular, in the 2024 Payment Notice (88 FR 25858), we stated that for PY 2025, for example, an issuer would be permitted to offer two non-standardized gold HMOs with no additional dental or vision benefit coverage, two non-standardized gold HMOs with additional dental benefit coverage, two non-standardized gold HMOs with additional vision benefit coverage, and two non-standardized gold HMOs with additional dental and vision benefit coverage, as well as two non-standardized gold PPOs with no additional dental or vision benefit coverage, two non-standardized gold PPOs with additional dental benefit coverage, two non-standardized gold PPOs with additional vision benefit coverage, and two non-standardized gold PPOs with additional dental and vision benefit coverage, in the same service area.</P>
                    <P>However, in the 2025 Payment Notice, we clarified that in PY 2024, issuers had the ability to vary the inclusion of dental and/or vision benefit coverage (including varying the inclusion of the distinct adult and pediatric dental benefit coverage categories), such that issuers could offer plans in the manner reflected in Table 3, instead of in the more limited manner reflected in the incomplete example in the 2024 Payment Notice.</P>
                    <P>In the 2025 Payment Notice, we affirmed that issuers continued to retain this flexibility for PY 2025 and subsequent years. We thus noted that under the non-standardized plan option limit of two for PY 2025 and subsequent years, if an issuer desired to offer the theoretical maximum number of non-standardized plans, and if that issuer varied the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage in these plans in accordance with the flexibility provided for at § 156.202(c)(1) through (3), that issuer could offer a theoretical maximum of 16 plans in a given product network type, metal level, and service area in the manner demonstrated in Table 3. Furthermore, we noted that if an issuer offered QHPs with two product network types (for example, HMO and PPO), that issuer could offer a theoretical maximum of 32 plans in a given metal level and service area in the manner demonstrated in Table 3.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="446">
                        <PRTPAGE P="4501"/>
                        <GID>ER15JA25.055</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>In the proposed rule, we proposed to amend the regulation text at § 156.202(b) and (d) to properly reflect the flexibility that issuers have been operationally permitted since we introduced non-standardized plan option limits to vary the inclusion of the distinct adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage under the non-standardized plan option limit at § 156.202(b) in accordance with § 156.202(c)(1) through (3) for PY 2025 and subsequent plan years.</P>
                    <P>In particular, we proposed to amend § 156.202(b) to properly distinguish between adult dental benefit coverage at § 156.202(c)(1) and pediatric dental benefit coverage at § 156.202(c)(2), such that an issuer offering QHPs in an FFE or SBE-FP, for PY 2025 and subsequent plan years, is limited to offering two non-standardized plan options per product network type, as the term is described in the definition of “product” at § 144.103 of this subchapter, metal level (excluding catastrophic plans), and inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of § 156.202), in any service area.</P>
                    <P>
                        Consistent with our proposed amendment of § 156.202(b), we further proposed a conforming amendment to § 156.202(d) to provide that, for PY 2025 and subsequent plan years, an issuer may offer additional non-standardized plan options for each product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of § 156.202), and service area if it demonstrates that these additional plans' cost sharing for benefits pertaining to the treatment of chronic and high-cost conditions (including benefits in the form of prescription drugs, if pertaining to the treatment of the condition(s)) is at least 25 percent lower, as applied without restriction in scope throughout the plan year, than the cost sharing for the same corresponding benefits in the issuer's other non-standardized plan option offerings in the same product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and/or adult vision benefit coverage, and service area.
                        <PRTPAGE P="4502"/>
                    </P>
                    <P>
                        In the proposed rule, we stated that we proposed these modifications to align the regulation text of § 156.202(b) and (d) with the existing flexibility that issuers have been operationally permitted since the non-standardized plan option limit was introduced in the 2024 Payment Notice.
                        <SU>230</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>230</SU>
                             CMS. (2024, April 10). 2025 Final Letter to Issuers in the Federally-facilitated Exchanges. 
                            <E T="03">https://www.cms.gov/files/document/2025-letter-issuers.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        We sought comment on these proposed modifications. After consideration of comments, and for the reasons outlined in the proposed rule and in this final rule, including our responses to comments, we are finalizing these provisions as proposed, with one minor modification. In particular, we are modifying the language at both § 156.202(b) and (d) to state that issuers may vary the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, 
                        <E T="03">and</E>
                         adult vision benefit coverage, instead of adult dental benefit coverage, pediatric dental benefit coverage, 
                        <E T="03">and/or</E>
                         adult vision benefit coverage—to enhance clarity and minimize risk of confusion.
                        <SU>231</SU>
                        <FTREF/>
                         We summarize and respond below to public comments received on the proposed modifications to § 156.202(b) and (d).
                    </P>
                    <FTNT>
                        <P>
                            <SU>231</SU>
                             Antonin Scalia &amp; Bryan A. Garner, 
                            <E T="03">Reading Law: The Interpretation of Legal Texts</E>
                             125 (2012) (collecting “experts” that “warn against” use of the “hybrid” and/or); Kenneth A. Adams, 
                            <E T="03">Know Your Enemy: Sources of Uncertain Meaning in Contracts,</E>
                             Mich. B.J. 40, 42 (Oct. 2016) (discussing the “ambiguity of the part versus the whole” presented by the words “and” and “or”).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters supported the modifications to clarify the permissibility of varying the inclusion of the distinct adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage categories under the non-standardized plan option limit and the associated exceptions process. These commenters stated that clarifying that flexibility would ensure that issuers have a clearer understanding of the operational parameters of the existing non-standardized plan option limit and exceptions process and establish more uniform market rules for all issuers in FFE and SBE-FP States that are subject to the policy.
                    </P>
                    <P>Many commenters expressed general support for continuing to limit the number of non-standardized plan options that issuers can offer. These commenters noted that in recent years, consumers have been confronted with too many health plan choices and thus may be more likely to make suboptimal plan selections. In some instances, commenters noted that consumers run the risk of forgoing enrollment altogether in instances where they cannot easily identify a plan that meets their needs due to choice overload. Several of these commenters also noted the chilling effect that choice overload can have on consumers with chronic and high-cost conditions or other significant health care demands.</P>
                    <P>Similarly, several commenters expressed general support for continuing to allow issuers to offer additional non-standardized plan options under the exceptions process so that they can provide targeted coverage specifically for populations with chronic and high-cost conditions. Commenters noted that permitting issuers to offer these additional non-standardized plan options continues to support health equity and allows for more targeted innovation by issuers, while still simultaneously achieving the reduction in plan proliferation HHS has sought. Many of these commenters noted that individuals with chronic and high-cost conditions are especially price sensitive, and that these individuals often encounter significantly higher out-of-pocket costs associated with the higher rates of utilization of the benefits required to treat these conditions.</P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that clarifying how the non-standardized plan option limit and exceptions process are operationalized enhances issuer understanding of the policy. We reiterate that we are not permitting issuers a novel flexibility to vary the inclusion of the distinct adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage categories—nor are we permitting a novel flexibility in the exceptions process with the conforming modification to the regulation text language. Instead, we are amending § 156.202(b) and (d) to clarify the flexibility that issuers have been operationally permitted since we implemented the non-standardized plan option limit in PY 2024, as we explained in greater detail in the 2025 Payment Notice (89 FR 26365 through 26366). Thus, in PY 2026 and subsequent plan years, issuers will continue to retain that same flexibility.
                    </P>
                    <P>We also agree that providing additional clarity in our regulations helps to educate issuers about their existing options for designing their product and plan offerings within and—when justified—above the non-standardized plan option limit. Ensuring issuers understand their non-standardized plan design flexibility may encourage more coverage of vision and dental benefits by non-standardized plans and more uniform plan offerings by issuers across States.</P>
                    <P>We also agree that the number of plan choices available to consumers continues to complicate the plan selection process, and that plan proliferation and the risk of plan choice overload persist. We further agree that this increased risk of plan choice overload also increases the risk of suboptimal plan selection and unexpected financial harm for those least able to afford it. Thus, we agree that continuing to limit the number of non-standardized plan options that issuers can offer in conjunction with permitting issuers to offer additional non-standardized plan options that facilitate the treatment of chronic and high-cost conditions under the exceptions process continues to reduce plan proliferation and the risk of choice overload while simultaneously permitting issuers a sufficient degree of flexibility to innovate.</P>
                    <P>We continue to recognize the advantages that innovation imparts upon consumers by supporting the ability of QHP issuers to offer them a diverse range of plan offerings from which to select. We also continue to believe that excepted non-standardized plans that reduce cost sharing for benefits pertaining to the treatment of chronic and high-cost conditions can significantly reduce the out-of-pocket costs for consumers with these conditions experience and ultimately increase treatment adherence and improve health outcomes.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters opposed continuing to limit the number of non-standardized plan options that issuers can offer. Some commenters suggested that the market conditions that may necessitate a restriction on the number of non-standardized plan options may not apply uniformly across all States. These commenters explained that States differ in their rates of issuer participation and the unique needs of each State's population, among other factors.
                    </P>
                    <P>
                        Several of these commenters further suggested that that individual FFE and SBE-FP States themselves should be given the ability to exercise discretion on how best to address issues of plan proliferation and choice overload. Some of these commenters suggested that States could then choose how best to structure a non-standardized plan option limit or pursue an alternative approach altogether. One commenter suggested that all SBE-FP States should be exempted from the non-standardized plan option limit. Another commenter suggested allowing SBE-FP States to seek blanket exceptions for individual 
                        <PRTPAGE P="4503"/>
                        issuers in their State to be exempted from the non-standardized plan option limit.
                    </P>
                    <P>Some commenters opposed allowing issuers to offer excepted plans beyond the non-standardized plan option limit, citing concerns that additional exceptions could exacerbate the risk of plan choice overload and suboptimal plan selection. These commenters noted that the intent of the non-standardized plan option limit is to mitigate the risk of uncontrolled plan proliferation that leads to consumer confusion, and that to permit each issuer the opportunity to receive exceptions to the numerical limit counteracts this intent.</P>
                    <P>
                        <E T="03">Response:</E>
                         We reiterate that we did not propose and are not finalizing any changes to the applicability of the non-standardized plan option limit or exceptions process under § 156.202(b) and (d). Instead, we are only making modifications to those regulations to more clearly align their text with the flexibility that issuers have been operationally permitted since we implemented the non-standardized plan option limit. As we previously noted in the 2024 Payment Notice (88 FR 25856 and 25864), we continue to believe it is appropriate to apply the non-standardized plan option limit equally to issuers in FFE and SBE-FP States given their shared platform. We also reiterate that States with SBE-FPs that do not wish to be subject to these requirements may investigate the feasibility of transitioning to a State Exchange. We continue to believe the financial and operational burden to HHS outweighs the benefit of changing the platform to permit distinction on this policy between FFEs and SBE-FPs.
                    </P>
                    <P>We also acknowledge that different States and counties have differing rates of issuer participation, and thus, differing numbers of available plans. We still believe the limit of two non-standardized plan options and the permissible exceptions strike an appropriate balance in reducing the risk of plan choice overload and preserving a sufficient degree of consumer choice, even for consumers in counties with lower rates of issuer participation. For a more detailed example of the number of plan choices that we described as a likely scenario for consumers who have access to one QHP issuer where they live, we refer readers to the 2024 Payment Notice (88 FR 25862 through 258623). Except for the modifications we are making in this final rule, we are maintaining the non-standardized plan option limit and accompanying exceptions process and the applicability of these requirements as previously finalized.</P>
                    <P>We also recognize the potential concerns associated with an uncontrolled exceptions process. However, as we explained in the 2025 Payment Notice (89 FR 26363 through 26364), we did not set a numerical limit on the permitted exceptions per issuer, product network type, metal level, inclusion of dental and vision benefit coverage, and service area (for example, allowing exceptions for only two such plans) to ensure that issuers are not restricted in the number of innovative plans they can offer. We noted that this approach would help ensure that a greater portion of consumers with chronic and high-cost conditions have access to plans that reduce barriers to access to care for services critical to the treatment of their conditions.</P>
                    <P>We continue to believe the exceptions process finalized in the 2025 Payment Notice (alongside the modification we are finalizing in this rule to clarify the flexibility associated with varying the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage) that limits issuers to one exception per chronic and high-cost condition in each product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage, and service area sufficiently mitigates the risk of contributing to choice overload.</P>
                    <P>
                        Furthermore, similar to what we explained in the 2025 Payment Notice (89 FR 26364), although issuers are not limited in the total number of exceptions they may be granted from the non-standardized plan option limit (provided all such exceptions meet the criteria at § 156.202), we continue to anticipate that most issuers would determine that the burden of creating and certifying additional non-standardized plan options intended to benefit a comparatively small population of consumers would outweigh the benefit of doing so. In PY 2025, we certified only 120 plans as excepted plans, and we do not expect that those plans' availability on 
                        <E T="03">HealthCare.gov</E>
                         will create a colorable risk of plan proliferation or choice overload.
                    </P>
                    <P>Additionally, we continue to believe that limiting the total number of excepted non-standardized plan options issuers can offer could harm consumers who have a comparatively less common chronic and high-cost condition that issuers may choose to not target with this exceptions process, which would hinder efforts to advance health equity.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters noted general support for the existing flexibility, clarified in the proposed rule, that issuers are permitted to offer additional plans within the non-standardized plan option limit by varying the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage. These commenters noted that the flexibility allows issuers the opportunity to design a sufficient number of plan offerings that cater to the individualized needs of consumers on the Exchange while maintaining guardrails on the rate of plan proliferation.
                    </P>
                    <P>Some commenters also noted specific support for the benefit coverage categories that are subject to the existing flexibility afforded to issuers under the non-standardized plan option limit, namely adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage. These commenters further noted that ensuring that issuers' plan offerings include a variety of these dental and vision benefits encourages consumer access to these services and ensures that these services are integrated into the marketplace in a way that benefits both consumers and issuers.</P>
                    <P>Conversely, several commenters opposed the existing flexibility allowing issuers to offer non-standardized plans beyond the plan limit by varying the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage. Some commenters cited concerns that the flexibility to offer non-standardized plans beyond the plan limit by varying the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage could result in additional plan proliferation and ultimately exacerbate existing concerns with plan choice overload. One commenter noted that the existence of plans with variations solely based on dental or vision benefit coverage could complicate plan selection and the consumer shopping experience.</P>
                    <P>
                        <E T="03">Response:</E>
                         We reiterate that the flexibility afforded to issuers to offer non-standardized plans within the plan limit by varying the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage has been operationally permitted since the non-standardized plan option limit was introduced in the 2024 Payment Notice. In this final rule, we are maintaining continuity across all operational requirements associated with the non-standardized plan option limit for PY 2026, including that we are only finalizing modifications to align 
                        <PRTPAGE P="4504"/>
                        the regulation text of § 156.202(b) and (d) with that existing flexibility.
                    </P>
                    <P>We agree that the flexibility given to issuers to offer non-standardized plan options within the plan limit by varying the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage affords them the opportunity to design their non-standardized plan options enough to cater to the individualized needs of consumers while keeping the overall number of plans low.</P>
                    <P>In the 2024 Payment Notice (88 FR 25862), we expressed our belief that this combination of limiting issuers' non-standardized plan options and allowing flexibility to vary adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage within non-standardized plans within the limit strikes a sufficient balance between minimizing the extent of plan proliferation and maximizing choice of plans among distinguishable plan options. </P>
                    <P>We also agree that the vision and dental benefits are appropriate for distinguishing among non-standardized plan options within the existing flexibility offered under the non-standardized plan option limit opposed to other additional benefits. As previously noted in the 2024 Payment Notice (88 FR 25959), issuers have frequently offered dental and vision as additional benefits in otherwise identical plan options. Furthermore, when two plans are offered by the same issuer in the product network type, metal level, and service area with different product IDs, the plans are most often distinguished by their coverage of vision or dental benefits.</P>
                    <P>We share commenters' concerns about the negative consumer impact of plan proliferation. However, we note that nothing compels issuers to offer nearly identical plans that vary solely by the plans' coverage of vision and dental benefits. In our experience, we have found that issuers often choose to offer non-standardized plan options that vary in terms of more parameters (such as the plans' formularies or provider networks, among other factors)—in addition to the inclusion of dental and vision benefit coverage—within the limit of two non-standardized plan options per product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage, and service area.</P>
                    <P>We disagree with commenters who suggested that the flexibility permitting issuers to vary the inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage would result in issuers offering virtually indistinguishable plans that may confuse consumers and render them unable to make meaningful comparisons when attempting to select a plan that best meets their needs. This is because the inclusion of dental and vision benefit coverage represents meaningful coverage variations for consumers.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested other modifications to the non-standardized plan option limit. Some commenters recommended expanding the criteria considered under the limit beyond those already included under § 156.202(b) to further relax the standard and allow issuers to vary plans along a greater number of parameters. Some commenters suggested adopting a meaningful difference standard for non-standardized plan options in conjunction with the non-standardized plan option limit to ensure that any two plans are not duplicative across all plan parameters, taking into account differences such as differences in product packages, differences in cost sharing (including whether particular services are available pre-deductible), differences in provider network (such as if there is a reasonable difference in the size of each plan's network), differences in provider network ID, differences in product network type, and differences in whether a plan is an HSA-eligible HDHP.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Similar to our stance in the 2024 Payment Notice (88 FR 25863), we continue to believe that the current structure of the non-standardized plan option limit (as well as the criteria currently considered under the limit) strikes an appropriate balance that allows for issuers to innovate across a sufficiently broad number of plan attributes (including but not limited to provider network, benefit coverage, and benefit cost sharing) while further preventing the likelihood of unabated plan proliferation and plan choice overload. Furthermore, similar to our stance in the 2024 Payment Notice (88 FR 25864), we continue to believe that directly limiting the number of non-standardized plan options issuers can offer under the non-standardized plan option limit is a more effective mechanism than applying a meaningful difference standard at this particular time to reduce plan proliferation and the risk of plan choice overload.
                    </P>
                    <P>We note that the current structure of the non-standardized plan option limit does not restrict issuers' ability to innovate by differentiating plans on the basis of parameters that are not explicitly identified in the limit—which allows issuers to vary non-standardized plan options' included benefit coverage, cost sharing parameters, and provider networks, among other factors, while still complying with the limit. Additionally, we note that the harm of identical or near-identical plans to the consumer experience is particularly salient for standardized plan options since there is no limit on the maximum allowable number of standardized plan options that an issuer can offer. However, we believe this harm is sufficiently mitigated for non-standardized plan options due to the existence of the non-standardized plan option limit. This is because under the limit, issuers are incentivized to offer plans with meaningful differences to consumers to attract a broader portion of the market. Offering duplicative plans under the non-standardized plan option limit would result in an issuer targeting the same market segments with two different plans.</P>
                    <P>
                        As we explained in the preceding section addressing standardized plan options, we will monitor whether issuers seek certification of nearly identical plans, including by assessing whether there are plans that would appear identical to consumers shopping on 
                        <E T="03">HealthCare.gov.</E>
                         If we observe this kind of plan proliferation, we may consider proposing stricter standards in future rulemaking.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters also suggested modifications to the current exceptions process. They suggested considering additional metrics beyond cost sharing on which issuers might choose to innovate as grounds for granting an exception, such as deductibles, additional benefit coverage, provider networks, formularies, telehealth availability, or HSA-eligibility.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we agree that different benefit packages, deductibles, provider networks, formularies, the inclusion of telehealth services, and HSA-eligibility are all important factors that pertain to the treatment of chronic and high-cost conditions, we maintain that restricting eligibility for this exceptions process based solely on a reduction in cost sharing for benefits pertaining to the treatment of chronic and high-cost conditions is the most appropriate approach. We continue to believe that the inclusion of any additional factors, including the aforementioned factors and HSA-eligibility, may compromise how precisely tailored the current standard is in ensuring that excepted plans indeed target the unique health care needs of consumers with high-cost and chronic conditions. As we explained in the 2025 Payment Notice (89 FR 26371), one of 
                        <PRTPAGE P="4505"/>
                        our goals with the exceptions process is to ensure that excepted plans substantially benefit consumers with chronic and high-cost conditions.
                    </P>
                    <P>Specifically, considering these additional criteria in determining eligibility for an exception may allow issuers to offer excepted plans that only slightly vary included provider networks, formularies, deductible amounts, the inclusion of telehealth services, HSA-eligibility, or additional benefits unrelated to the unique health care needs of consumers with high-cost and chronic conditions. This could result in excepted plans differing slightly but failing to provide meaningfully different coverage between excepted plans or failing to provide coverage that is tailored to meet the health care needs of consumers with high-cost and chronic conditions. We maintain that including one different provider in a plan's network, for example, should not result in that plan being permitted an exception on that basis alone.</P>
                    <P>We reiterate that such an approach would weigh against our goals of reducing plan proliferation, choice overload, and consumer confusion. We refer readers to the 2025 Payment Notice (89 FR 26368) for additional discussion about why we believe that restricting eligibility for this exceptions process based solely on a reduction in cost sharing for benefits pertaining to the treatment of chronic and high-cost conditions remains the most appropriate approach.</P>
                    <HD SOURCE="HD3">8. Essential Community Provider Reviews for States Performing Plan Management (§ 156.235)</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82385), we proposed, under § 156.235, to conduct Essential Community Provider (ECP) certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions effective beginning in PY 2026.
                        <SU>232</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>232</SU>
                             Twelve FFEs operate in States performing plan management functions: Delaware, Hawaii, Iowa, Kansas, Michigan, Montana, Nebraska, New Hampshire, Ohio, South Dakota, Utah, and West Virginia.
                        </P>
                    </FTNT>
                    <P>Section 1311(c)(1)(C) of the ACA directs HHS to establish by regulation certification criteria for QHPs, including criteria that require QHPs to include within health insurance plan networks those ECPs, where available, that serve predominately low-income, medically-underserved individuals. Federal ECP standards were first detailed in the Exchange Establishment Rule (77 FR 18310) and codified at § 156.235. ECP certification reviews under § 156.235 ensure medical QHP and stand-alone dental plan (SADP) issuers include in their provider networks a sufficient number and geographic distribution of ECPs, where available.</P>
                    <P>
                        HHS has relied on State ECP certification reviews for the certification of QHPs in FFEs in States that perform plan management functions since PY 2015 due to system limitations in the Systems for Electronic Rates &amp; Forms Filing (SERFF),
                        <SU>233</SU>
                        <FTREF/>
                         which does not have unique network and service area IDs reliably associated with issuers' ECP data. From PY 2015 to PY 2024, prior to HHS' implementation of the user interface logic for ECPs in the Health Insurance Oversight System (HIOS) Marketplace Plan Management System (MPMS),
                        <SU>234</SU>
                        <FTREF/>
                         HHS received ECP data via the ECP/Network Adequacy (NA) Template 
                        <SU>235</SU>
                        <FTREF/>
                         and SERFF. The ECP/NA Template was an Excel template created by HHS to provide to FFE issuers for collection and submission of both ECP and NA data. While issuers in FFE States would submit the ECP/NA Template with ECP data to HHS directly, issuers in FFEs in States performing plan management functions would not use the ECP/NA Template, but rather submit the ECP data to SERFF.
                        <SU>236</SU>
                        <FTREF/>
                         Since there was no reliable mechanism for HHS to convert ECP data received from SERFF back into the ECP/NA Template for review and analysis of the data, HHS could not conduct ECP reviews for issuers in FFEs in States performing plan management functions and therefore relied on States to perform those ECP certification reviews. In the SERFF data, each plan has its own ECP template with its own set of ECPs and networks. The SERFF data does not allow HHS to conduct accurate ECP evaluations of each issuer's networks because multiple networks can share the same sequence of numbers (sometimes referred to as “sequence numbers”) within the SERFF data, making them indistinguishable from each other in the issuer's SERFF binder. For example, since network IDs are not required to be unique across binders, an issuer may have a multiple network ID 001; then when SERFF data is transferred to HHS, it is not possible to distinguish if “Network 001” is applied to the issuer's individual market QHPs or small business health option program (SHOP) SADPs. Initially, HHS designed a workaround to merge the SERFF issuer templates across each plan and remove duplicate entries to allow HHS to conduct the review at the plan level; but this workaround still did not allow for independent evaluation of each issuer's provider networks that share the same sequence number or network IDs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>233</SU>
                             Systems for Electronic Rates &amp; Forms Filing (SERFF) is a portal utilized by States for form submittal, document management, and review.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>234</SU>
                             HIOS MPMS is a web application where users can validate plan data as well as submit their QHPs and SADPs to CMS for annual review and certification.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>235</SU>
                             OMB Control Number 0938-1415: Essential Community Provider-Network Adequacy (ECP/NA) Data Collection to Support QHP Certification (CMS-10803).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>236</SU>
                             For PY 2025 there were 13 FFEs that operate in States performing plan management functions: Delaware, Hawaii, Illinois, Iowa, Kansas, Michigan, Montana, Nebraska, New Hampshire, Ohio, South Dakota, Utah, and West Virginia.
                        </P>
                    </FTNT>
                    <P>As we stated in the proposed rule (89 FR 82385), as a result of HHS' system design enhancements via MPMS, HHS is now able to collect ECP data directly from issuers in States performing plan management functions, enabling HHS to conduct ECP evaluations of each issuer's network. Starting with certification reviews for PY 2025, all issuers seeking certification of plans as medical QHPs and SADPs in FFEs, including in States performing plan management functions, can now enter their ECP data in the HIOS MPMS using the ECP user interface. We noted that because ECP data can now be collected directly in MPMS from all issuers applying for certification of plans as QHPs in FFEs, including in States performing plan management functions, HHS will now be able to independently review the ECP data for such issuers.</P>
                    <P>In addition, we noted that now, the MPMS ECP user interface also allows issuers in FFEs, including in States performing plan management functions, to validate data before submission to their States, improving data submission to the State as well as providing HHS with each issuer's provider network. We stated that, therefore, HHS will now be able to assess validated ECP data, improving the accuracy and efficiency of the QHP certification process.</P>
                    <P>
                        We further noted that it was always HHS' intent to implement operational capabilities that would allow for more efficient and accurate ECP reviews. As a result, we proposed to harness the flexibilities afforded by MPMS to conduct Federal ECP certification reviews of medical and dental plans for which issuers submit QHP certification applications in FFEs in States that perform plan management functions beginning with certification reviews for PY 2026. We stated that this proposal would allow HHS to review, evaluate, analyze, and compare provider networks across various FFE States. We added that HHS would also consider challenges FFE issuers face across 
                        <PRTPAGE P="4506"/>
                        various provider networks and ECP categories, such as provider shortages or facility closures. As proposed, issuers applying for certification of plans as QHPs in FFEs, including in States performing plan management functions, would be evaluated against the same requirements and standards. We stated that FFE issuers in States with limited plan management staff or resources would be given the same ECP support, guidance, and monitoring of ECP deficiencies as other FFE issuers.
                    </P>
                    <P>We noted that this proposal would provide more consistent oversight of ECP data across all FFEs. We further noted that Federal ECP reviews would help ensure all medical QHP and SADP issuers applying for certification of plans as QHPs in FFEs, including in States performing plan management functions, include sufficient provider networks. We stated that this proposal would allow HHS to strengthen ECP data integrity in the FFEs by validating all ECP data before they are submitted and displayed on the FFEs, thereby supporting consumer access to vitally important medical and dental services and health equity for low-income and medically underserved consumers.</P>
                    <P>We sought comment on this proposal. After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy as proposed. We summarize and respond below to public comments received on the proposed policy to conduct ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions beginning in PY 2026.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported this proposal to conduct ECP certification reviews of plans submitted by QHP issuers in FFEs in States performing plan management functions, expressing that this proposal would allow greater consistency, improve data integrity, streamline data transfers that result in an overall operational improvement, and improve consumer access to ECPs. One commenter that supported this proposal asked that we extend this review to SADPs as these plans are also subject to the ECP requirement under the ACA.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree that conducting ECP certification reviews for QHPs, both medical QHPs and SADPs, in all FFEs, including in States performing plan management functions, would allow greater consistency, improve data integrity, and support consumer access to qualified ECPs. We clarify that QHPs include medical QHPs and SADPs, and ECP certification reviews include medical QHPs and SADPs for which issuers submit QHP certification applications in FFEs, including in States performing plan management functions.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters opposed the proposal to expand Federal ECP review to certification applications submitted by issuers in FFE States performing plan management functions. These commenters stated that CMS does not have the authority to conduct these reviews as written in the Payment Notice.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Although we have relied on the State for ECP certification review of QHPs in FFEs in States that perform plan management functions since PY 2015 due to system limitations in SERFF, these issuers are still applying for QHP certification in FFEs. We remind commenters that Section 1311(c)(1)(C) of the ACA, part of Title I of the statute, directs HHS to establish by regulation certification criteria for QHPs, including criteria that require QHPs to include within health insurance plan networks those ECPs, where available, that serve predominately low-income, medically-underserved individuals. In addition, Section 1321(a)(1)(B) of the ACA directs the Secretary to issue regulations setting standards for meeting the requirements of Title I with respect to the offering of QHPs through the Exchanges.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters submitted comments related to the use of MPMS for the purpose of providing ECP data to HHS via the ECP user interface. One of the commenters was confused by HHS' explanation of the associated network ID and service area ID data within SERFF prior to MPMS and asked, “What is a `sequence' number? Is it by a different name in the templates?” Another commenter expressed concern over the level of personal information required to be disclosed for the multifactor identification for MPMS registration for users and the administrative burden on issuers. Another commenter suggested HHS provide year-round access to the ECP user interface and encouraged HHS to continue to provide transparent communications regarding timeframes for ECP reviews in MPMS and the frequency of updates made to the ECP list in MPMS.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In response to the questions about sequence numbers, we clarify that the term “sequence numbers” was used to reference multiple provider networks that may share the same number sequence within SERFF data. Furthermore, we add that issuers in FFEs, including in States performing plan management functions, are not required to provide a unique sequence of numbers for their network IDs across SERFF binders. A SERFF binder submitted by an issuer contains a collection of various templates and plan data,
                        <SU>237</SU>
                        <FTREF/>
                         and an issuer may have multiple binders in SERFF. However, since an issuer could submit multiple SERFF binders for different types of plans (
                        <E T="03">e.g.,</E>
                         SHOP SADPs, individual market medical QHPs, etc.) with potentially identical network IDs, this made it difficult for HHS to distinguish and evaluate how a network was applied to the issuer's plan. We used a workaround to merge the SERFF data at a plan level, but this workaround still did not allow for independent evaluation of each issuer's provider networks; therefore, we relied on States to certify ECP review results. Due to variations in ECP data transfers across SERFF submitting States, this network ID barrier to evaluating ECP data may not have applied to all SERFF submitting States.
                    </P>
                    <FTNT>
                        <P>
                            <SU>237</SU>
                             
                            <E T="03">https://login.serff.com/Appendix%20II.pdf.</E>
                        </P>
                    </FTNT>
                    <P>In response to concerns about MPMS' registration requirements, we note that the implementation of the MPMS ECP user interface was the start of our efforts to drive innovation and tackle challenges during QHP certification. We continue to provide technical enhancements to help reduce burden on issuers while providing a secure environment to protect the sensitive data provided by MPMS users to HHS. By using HIOS to access a CMS system, MPMS, users are accessing a Federal Government information system which has system requirements that ensure only authorized/registered users can access protected information and systems through the CMS Enterprise Portal. New users are required to complete the Remote Identity Proofing process, which requires users to answer questions related to their personal information; as well as Multi-Factor Authentication (MFA), which requires users to provide more than one form of verification in order to access the CMS Enterprise Portal. Once an MFA device is registered for their account, users must use this device to log into the CMS Enterprise Portal. All users must complete this registration process, but we will continue to enhance our operational processes to minimize duplicative administrative steps for issuers.</P>
                    <P>
                        We appreciate the suggestion that we provide year-round access to the ECP user interface. At this time, the ECP user interface is available for QHP certification; but issuers can access the Final PY 2025 ECP List or the HHS 
                        <PRTPAGE P="4507"/>
                        Rolling Draft ECP List year-round to view the current list of available ECPs. We will continue to provide issuers with technical support and communication around QHP certification timeframes and provide the frequency of updates to the ECP list through our published guidance and other communications.
                    </P>
                    <HD SOURCE="HD3">9. Quality Improvement Strategy (§ 156.1130)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82385), we proposed to share aggregated, summary-level Quality Improvement Strategy (QIS) information publicly on an annual basis beginning on January 1, 2026, with information QHP issuers submit during the PY 2025 QHP Application Period. We did not propose any revisions to the regulation text to codify this proposal.</P>
                    <P>
                        Section 1311(c)(1)(E) of the ACA specifies that to be certified as a QHP for participation on an Exchange, each health plan must implement a QIS described in section 1311(g)(1) of the ACA. Section 1311(g)(1) of the ACA describes this strategy as a payment structure that provides increased reimbursement or other incentives for improving health outcomes of plan enrollees, and the implementation of activities to prevent hospital readmissions, improve patient safety and reduce medical errors, promote wellness and health, and reduce health and health care disparities. Section 1311(g)(2) of the ACA requires the Secretary to develop guidelines associated with the QIS in consultation with health care quality experts and interested parties, including periodic reporting to the applicable Exchange of the activities that the plan has conducted to implement the QIS, as described in section 1311(g)(3) of the ACA. In the 2016 Payment Notice (80 FR 10844 through 10845), we issued regulations at § 156.1130(a) and (c) to direct eligible QHP issuers to implement and report on their QIS for each QHP offered in an Exchange, and to submit data annually to evaluate compliance with the standards for a QIS in a manner and timeline specified by the Exchange, respectively.
                        <SU>238</SU>
                        <FTREF/>
                         In addition, in the Exchange Establishment Rule (77 FR 18324 and 18415), we finalized regulations at § 155.200(d) that direct Exchanges to evaluate each QIS, and § 156.200(b)(5) that direct QHP issuers to implement and report on a QIS consistent with ACA section 1311(g) standards as QHP certification criteria for participation in an Exchange.
                    </P>
                    <FTNT>
                        <P>
                            <SU>238</SU>
                             Refer to OMB control number 0938-1286.
                        </P>
                    </FTNT>
                    <P>
                        The CMS National Quality Strategy,
                        <SU>239</SU>
                        <FTREF/>
                         launched in 2022, builds on previous efforts to improve quality across the health care system. As we noted in the proposed rule (89 FR 82386), we continue to use a variety of levers across the agency, including but not limited to quality measurement, public reporting, and quality improvement programs, to improve health care quality for all. One of the four priority areas of the CMS National Quality Strategy is to promote alignment and coordination across programs and care settings and to improve quality and health outcomes across the care journey.
                        <SU>240</SU>
                        <FTREF/>
                         We stated that by developing aligned approaches across quality programs, we can improve coordination and comparisons across programs and across the continuum of care and build the evidence base for quality interventions to support identifying disparities in care. We noted that across Medicare, Medicaid, and Exchange quality programs and initiatives, we promote sharing health care quality information with consumers, providers, researchers and others using different methods, such as program experience reports. Specifically, for the Quality Rating System (QRS) program, we share a summary of quality ratings for each plan year in an annual Results at a Glance report.
                        <SU>241</SU>
                        <FTREF/>
                         Additionally, we share information pertaining to both the QRS and QHP Enrollee Experience Survey programs with the public annually through the same report.
                        <SU>242</SU>
                        <FTREF/>
                         We noted that our proposal to share aggregated, summary-level QIS information publicly is consistent with the goal of these Marketplace Quality Initiatives (MQIs) to share information publicly and is in alignment with agency efforts to drive innovation and advance quality improvement across the Exchanges.
                    </P>
                    <FTNT>
                        <P>
                            <SU>239</SU>
                             The CMS National Quality Strategy for Quality Improvement in Health Care available at 
                            <E T="03">http://www.cms.gov/medicare/quality/meaningful-measures-initiative/cms-quality-strategy.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>240</SU>
                             Id.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>241</SU>
                             See, for example, Health Insurance Exchanges Quality Rating System (QRS) for Plan Year (PY) 2024: Results at a Glance, available at 
                            <E T="03">https://www.cms.gov/files/document/health-insurance-exchanges-qrs-program-plan-year-2024-results-glance.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>242</SU>
                             Id.
                        </P>
                    </FTNT>
                    <P>
                        Since 2017, we have been collecting QIS information from QHP issuers on the FFEs. We stated in the proposed rule (89 FR 82386) that over the years, we have received feedback from issuers, States, and Technical Expert Panel (TEP) representatives about the benefits of sharing QIS data more broadly to promote transparency, improve engagement of best practices across QHP issuers, and provide consumers with useful information about quality improvement efforts by QHP issuers on the FFEs. Therefore, recognizing the general interest in this information, and consistent with the general authority set forth in section 1701(a)(8) of the PHS Act,
                        <SU>243</SU>
                        <FTREF/>
                         we proposed to release annually, in a report format, the following aggregated, summary-level QHP issuer data: (1) value-based payment models used in QHPs offered by the issuer; (2) QIS topic area; (3) QIS market-based incentive types; (4) clinical areas addressed by QIS; (5) QIS activities; and (6) QRS measures used in QIS. We stated that we do not receive QIS data from State Exchanges or SBE-FPs and would not collect QIS data from State Exchanges or SBE-FPs or their respective issuers under this proposal. As such, we stated that the report would provide information on QIS programs adopted by issuers offering QHPs in the FFEs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>243</SU>
                             Section 1701(a)(8) of the PHS Act, codified at 42 U.S.C. 300u(a)(8), provides general authority to the Secretary of HHS to foster exchange of health-related information to consumers and others.
                        </P>
                    </FTNT>
                    <P>We noted that we believe this proposal would promote transparency of data and drive innovation and quality improvement across Exchanges. We stated that sharing QIS data publicly would also strengthen alignment across CMS quality reporting and value-based incentive programs, including the MQI programs, and would encourage learning to inform best practices for quality improvement across Exchanges, QHP issuers, researchers, and health care quality communities. Additionally, we stated that we believe this proposal would increase accountability for QHP issuers through transparency of quality improvement goals, encourage State Exchanges to share QIS information from their State Exchange issuers publicly, and support HHS' mission to achieve optimal health and well-being for all individuals.</P>
                    <P>
                        We acknowledged there may be concerns related to the potential sharing of proprietary and/or confidential information. However, we stated that we do not intend to share confidential or proprietary information from a QHP issuer and would only share QIS data that is de-identified and in summary and aggregate form. We further stated that we would maintain compliance with CMS privacy policies, and to address potential confidentiality concerns, we would carefully redact and omit confidential data when data are released aggregately and in a summary format.
                        <PRTPAGE P="4508"/>
                    </P>
                    <P>We sought comment on this proposal. In particular, we sought comment on the types of QHP issuer QIS data to release in an annual report, on the proposed approach and timeline for release of a QIS summary report with aggregated QIS data, and other potential mechanisms to present QIS information publicly in a manner that is informative to issuers and consumers.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing this policy as proposed. We summarize and respond below to public comments received on our proposal to share aggregated, summary-level QIS information publicly on an annual basis beginning on January 1, 2026.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters supported the proposal to release aggregated, summary-level QIS information publicly in a report format beginning in 2026. Specifically, these commenters noted support for releasing aggregated, summary-level QIS data and our goals of promoting transparency and encouraging learning to inform best practices for quality improvement across Exchanges, health plan issuers, researchers, and health care quality communities, which they stated will provide consumers with useful information about quality improvement efforts by QHP issuers on the FFEs.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate commenters' support of the proposal to publicly share aggregated, summary-level QIS information annually in a report format. As noted in the proposed rule (89 FR 82386), this policy is in alignment with the goal of the MQIs to share information publicly and is in alignment with agency efforts to drive innovation and advance quality improvement across Federal programs including Medicare, Medicaid as well as the Exchanges.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters recommended we develop specific formats for data collection and reporting to ensure consistency, reliability of the data, and to reduce issuers' reporting burden. Other commenters encouraged CMS to develop a uniform standardized reporting format sample for use by QHP issuers in both the FFEs and the State Exchanges, to allow QHP issuers operating in State Exchanges to submit their data for inclusion in the summary-level QIS data CMS plans to share publicly. One commenter recommended we add demographic data to the aggregated, summary-level QHP issuer data we proposed to release annually, while another commenter suggested we add consensus-based entity endorsed measure information, if applicable. One commenter requested additional clarification with respect to what “summary level data” includes.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the feedback and suggestions regarding the format for QIS data collection and reporting. We intend to leverage data collected from QHP issuers in FFEs through the current QIS forms for the annual aggregated, summary-level QIS data and will consider opportunities to improve the consistency and reliability of data that is included in the aggregated, summary-level QIS data that we will release publicly. This will not increase issuer burden since issuers are already submitting this information on their current QIS forms. Prior to release of the first annual public report of QIS data, we plan to seek feedback from our TEP and will provide definitions, a summary, and clarifications to existing data elements in the associated technical guidance documents. As we stated in the proposed rule (89 FR 82386), we do not currently receive QIS data from State Exchanges or SBE-FPs and do not intend to collect QIS data from State Exchanges or SBE-FPs or their respective issuers under this proposal. We stated in the proposed rule (89 FR 82386) that over the years, we have received feedback from issuers, States, and TEP representatives about the benefits of sharing QIS data more broadly to promote transparency, and the types of data to release in an annual report to provide consumers with useful information about quality improvement efforts by QHP issuers on the FFEs. We will also consider and gain input from our TEP regarding adding demographic data and endorsement data, which refers to measure data that has been reviewed using a standard set of evaluation criteria by the Consensus-Based Entity. We clarify that we anticipate the summary-level QIS data we share publicly will be similar to the summary-level data contained in the QRS Results at a Glance report. Summary-level QRS data includes high-level overviews of health plan quality information such as percent and number of reporting units that scored three stars or more in their overall rating. Summary-level QIS data may include the percent and number of reporting units that used a specific market-based incentive type, addressed a specific clinical topic area, or used a QRS measure(s). We believe sharing such data allows consumers, researchers and policymakers to assess key trends, performance, and comparisons across QHP issuers.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters provided recommendations on specific approaches for release of an annual report with aggregated, summary-level QIS data. These commenters suggested we share a sample of an annual report for issuer review and feedback prior to the release of an official report, so that plans have an opportunity to review and comment to ensure QIS data is consistent across all plans, on which data points are made available to the public, and how the data will be presented and displayed. One commenter suggested that the publicly reported information be available in digital formats and physical formats to ensure access to information.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate commenters' feedback, and consistent with section 1311(g)(2) of the ACA, which requires consultation with experts in health care quality and interested parties, we intend to seek feedback on approaches for the public display of the aggregated, summary-level QIS data, including meeting with TEP representatives and engagement with interested parties. We will take the comments summarized above into consideration in doing so. Although we do not routinely publish MQI sample reports solely for issuer review and feedback, we intend to gain thorough input from interested parties including representatives from issuer organizations, State Exchanges, the health care quality community, and consumer advocates. We will adhere to our processes of utilizing the TEP and above-mentioned parties to seek feedback on the timing of the report being released, types of data for inclusion, and approaches to sharing the data. We will also request input from our TEP as to the feasibility of reporting the QIS data in physical and digital formats.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters suggested that CMS allow for one full year of data collection prior to release of an annual report with aggregated, summary-level QIS data or limit the included data to a specific timeframe, to allow issuers to use information from the Healthcare Effectiveness Data and Information Set (HEDIS®) and any related QRS metrics in issuers' reporting. A few commenters recommended that CMS limit its public reporting to the information included in the QIS implementation plans submitted in the first year because different health plans may be operating on different timelines, and this may lead to ambiguity if data on plan performance is combined for reporting purposes. One commenter recommended CMS delay the public release of aggregated, summary-level QIS data until 2027 and use the interim period to clarify reporting requirements and release more detail on what data will be released. These commenters 
                        <PRTPAGE P="4509"/>
                        stated that these steps will allow issuers to align their data submission processes with a standardized format fostering uniformity in the reporting of the data across issuers while avoiding duplication, and ensuring clear, consistent public information on QHP quality improvements.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the feedback and note the timeline being finalized will allow for one full year of data collection prior to release of the first annual report. One full year of data collection will ensure that issuers can capture comprehensive and reliable information from relevant sources such as HEDIS® and QRS metrics. One full year of data collection also ensures that the data used for reporting reflects a complete cycle of care and improvements. With a year of data, issuers can compare their performance against industry standards, which can identify areas for improvement. With respect to the comment related to the use of data from the QIS Implementation Plan form, CMS will extract and aggregate a majority of data fields from the Implementation Plan form, and may supplement information from an issuer's Modification Summary Supplement form, as needed. CMS may extract the performance measures from an issuer's Modification Summary Supplement form if that issuer has modified their measures. We currently do not aggregate nor publicly report data collected via Progress Report forms due to the timing of QIS data collection, which may result in unvalidated data. We are finalizing in this rule that aggregated, summary-level QIS information will be shared publicly on an annual basis beginning on January 1, 2026, with information QHP issuers submit during the PY 2025 QHP Application Period. We believe that January 1, 2026, is the appropriate time to begin sharing this QIS data publicly because, for the reasons stated above, we need one full year of data collection prior to the release of the annual report. QHP issuers have been submitting QIS data to HHS since 2017 and since that time, we have received feedback from issuers, States, and TEP representatives about the benefits of sharing QIS data more broadly. We intend to leverage data collected from issuers through current QIS reporting tools and believe that sharing the QIS data publicly beginning in 2026, instead of 2027, allows opportunities for interested parties to understand trends and potential issues by viewing interim data. Sharing interim data promotes transparency and helps foster trust even if the data is not yet complete. The collaborative approach from interested parties on review of the data can improve the quality of the final report. Additionally, regular data sharing can address quality improvement efforts where enhancements need to be made to processes throughout the year. Specifically, best practices in quality improvement activities across QHP issuers can be made apparent, improving engagement of QHP issuers to potentially refine approaches to their QIS, and provide consumers with useful information about quality improvement efforts by QHP issuers on the FFEs. We will continue to assess and enhance the public-facing report to help ensure that clear, consistent QIS information is being provided. Since we intend to use QIS information already submitted by QHP issuers on the FFEs through current, annual reporting tools, there would be no duplication of information.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested we ensure plain language experts review the QIS information that is publicly displayed to make this data accessible to a wider audience, which will empower interested parties to make informed decisions. One commenter recommended that the data be published in a manner that is simplified for consumers to easily understand and in multiple languages. Another commenter suggested we comply with ADA accessibility standards when presenting data. One commenter suggested the report be housed on the QIS website instead of 
                        <E T="03">HealthCare.gov</E>
                         because it will be most meaningful to policymakers and researchers with expertise in quality work and value-based care, and likely will be too much information and detail for a consumer. Another commenter recommended HHS disseminate publicly diverse sets of educational resources including webinars, fliers, and FAQs relevant to the aggregated, summary-level QIS data that will be publicly shared.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We will make efforts to incorporate plain language and ensure that the QIS information that will be publicly shared complies with ADA standards. We will also consider making MQI reports, including the annual QIS report, available in multiple languages and align them as consistently as possible with other quality initiatives. We acknowledge the recommendation to post the QIS report on the QIS website as well as the recommendation regarding dissemination of information relevant to the aggregated, summary-level QIS information that will be publicly shared through various educational resources. As noted above, we intend to conduct activities to receive feedback for the public display of the information, including meeting with interested parties pursuant to section 1311(g) of the ACA.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters noted concern regarding the confidentiality of the aggregated, summary-level QIS information that will be displayed publicly on an annual basis because of accidental data breaches. One commenter suggested that we include de-identified data to address information security and privacy concerns.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We acknowledged in the proposed rule (89 FR 82386) that there may be concerns related to the potential sharing of proprietary and/or confidential information. However, as we stated in the proposed rule, we do not intend to share confidential or proprietary information from a QHP issuer and will only share QIS data that is de-identified and in summary and aggregate form. We will maintain compliance with CMS privacy policies, and to address potential confidentiality concerns, we will carefully redact and omit confidential data when data are released aggregately and in a summary format.
                    </P>
                    <HD SOURCE="HD3">10. HHS-RADV Materiality Threshold for Rerunning HHS-RADV Results (§ 156.1220(a)(2))</HD>
                    <P>
                        In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82386), we proposed to amend § 156.1220(a) to codify a new materiality threshold for HHS-RADV appeals,
                        <SU>244</SU>
                        <FTREF/>
                         hereafter referred to as the materiality threshold for rerunning HHS-RADV results.
                        <SU>245</SU>
                        <FTREF/>
                         We stated that this proposal would codify a standard for when HHS would take action to rerun HHS-RADV results and adjust HHS-RADV adjustments to State transfers in response to a successful appeal. We proposed to make amendments to § 156.1220 to add a new paragraph (a)(2)(i) to provide that HHS would rerun HHS-RADV results in response to an appeal when the impact to the filing issuer's (that is, the issuer who submitted the appeal) HHS-RADV adjustments to State transfers is greater than or equal to $10,000, and we 
                        <PRTPAGE P="4510"/>
                        proposed to apply this new materiality threshold for rerunning HHS-RADV results beginning with the 2023 benefit year HHS-RADV.
                        <SU>246</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>244</SU>
                             For the purposes of this proposal, “appeals” refers to all three steps of the administrative appeals process as listed in § 156.1220, which includes the request for reconsideration, informal hearing, and review by the Administrator of CMS.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>245</SU>
                             For purposes of this proposal, rerunning HHS-RADV results involves recalculating all national program benchmarks and issuers' error rate results, reissuing issuers' error rate results, conducting discrepancy reporting and appeal windows for the reissued results, applying the reissued error rates to the applicable benefit year's State transfers, and invoicing, collecting, and distributing any additional changes to the HHS-RADV adjustments to State transfers.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>246</SU>
                             The appeal window for 2023 benefit year HHS-RADV is expected to open in July 2025, after the publication of the Summary Report of 2023 Benefit Year HHS-RADV Adjustments to 2023 Benefit Year Risk Adjustment Transfers, which is tentatively scheduled for release in July 2025. See the 
                            <E T="03">2023 Benefit Year HHS-RADV Activities Timeline. https://regtap.cms.gov/uploads/library/2023_RADV_Timeline_5CR_072424.pdf.</E>
                             Therefore, we proposed to adopt and apply the materiality threshold for rerunning HHS-RADV results in response to a successful appeal beginning with the 2023 benefit year HHS-RADV.
                        </P>
                    </FTNT>
                    <P>
                        We noted that this materiality threshold would promote the stability of HHS-RADV and avoid considerable expenditures to rerun HHS-RADV results in situations where the filing issuer only accrues a very minor financial benefit (in this case defined as less than $10,000), if any, and where there is a non-material impact on State transfers in a State market risk pool. As we stated in the proposed rule (89 FR 82387), we believe the adoption of this additional materiality threshold to codify a standard for when HHS would rerun HHS-RADV results is necessary and appropriate because HHS-RADV is unique in comparison to other ACA financial programs, such as APTC, where the outcome of a successful appeal only impacts the filing issuer because an issuer's amount of APTC does not impact other issuers.
                        <SU>247</SU>
                        <FTREF/>
                         We noted that instead, an HHS-RADV appeal has the potential to impact all issuers nationwide who participated in the applicable benefit year's HHS-RADV.
                        <SU>248</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>247</SU>
                             The EDGE data discrepancies that can arise in States where the HHS-operated risk adjustment program applies have a more limited reach and only impact the State market risk pool with the discrepancy.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>248</SU>
                             The impact of successful HHS-RADV requests for reconsideration or appeals on HHS-RADV results and HHS-RADV adjustments to risk adjustment State transfers on all participating issuers also differs from that of high-cost risk pool audits, discrepancies, and appeals. Any high-cost risk pool funds HHS recoups as a result of audits of risk adjustment covered plans, actionable discrepancies, or successful appeals are used to reduce high-cost risk pool charges for that national high-cost risk pool in the next applicable benefit year for which high-cost risk pool payments have not already been calculated. See the 2023 Payment Notice (87 FR 27253).
                        </P>
                    </FTNT>
                    <P>We refer readers to the proposed rule (89 FR 82386 through 82388) for further discussion of the background and rationale for this proposal.</P>
                    <P>We solicited comments on the proposed materiality threshold for rerunning HHS-RADV results, including the proposed dollar amount for the materiality threshold and whether that dollar amount should be higher or lower or subject to an annual inflation adjustment amount, as well as the proposed applicability of this threshold beginning with 2023 benefit year HHS-RADV.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing, as proposed, the amendments to add § 156.1220(a)(2)(i) to codify a new materiality threshold for rerunning HHS-RADV results such that we will not rerun HHS-RADV results if the appeal's financial impact on the filing issuer was less than $10,000, beginning with the 2023 benefit year of HHS-RADV. For purposes of this new materiality threshold, “appeals” refers to all three steps of the process in § 156.1220, which includes the request for reconsideration, informal hearing, and review by the Administrator of CMS. We summarize and respond below to public comments received on the proposed materiality threshold for rerunning HHS-RADV results.</P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters supported the proposal to codify a dollar threshold to specify when HHS would rerun HHS-RADV results based on a successful appeal. A few commenters noted that the proposal would improve predictability and ensure that adjustments to State transfers as the result of a successful HHS-RADV appeal are limited to situations with significant impacts on HHS-RADV adjustments to risk adjustment transfers. One commenter noted that the policy would limit the burden that rerunning HHS-RADV results has historically disproportionately placed on smaller issuers.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that this new materiality threshold to rerun HHS-RADV results, which we are finalizing as proposed in this final rule, will ensure appeals are limited to situations with significant State transfer impacts. We also agree that this materiality threshold will improve predictability and limit the administrative burden associated with HHS-RADV, including for smaller issuers.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters suggested that the proposed threshold of $10,000 was too low, with one suggesting an alternative threshold of $100,000. These commenters noted concern that a low threshold would result in HHS rerunning HHS-RADV results too frequently. Another commenter suggested that the threshold be set at a certain percentage of statewide average premium.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We are finalizing the proposed materiality threshold for rerunning HHS-RADV results in response to a successful appeal such that we will not rerun HHS-RADV results if the appeal's financial impact on the filing issuer was less than $10,000. We are finalizing this $10,000 threshold because the current materiality threshold applicable to risk adjustment discrepancies set forth in § 153.710(e) is $100,000, and we have found based on our years of experience with HHS-RADV that the magnitude of HHS-RADV adjustments is generally at least one order of magnitude smaller than that of risk adjustment transfers calculated by HHS under the State payment transfer formula, as HHS-RADV adjustments are adjustments to the original risk adjustment State transfer amounts for a benefit year. For these reasons, we believe the proposed lower materiality threshold of $10,000 is roughly proportional to the risk adjustment discrepancy materiality threshold of $100,000.
                        <SU>249</SU>
                        <FTREF/>
                         Therefore, we maintain that this is an appropriate materiality threshold for rerunning HHS-RADV results in response to a successful appeal.
                    </P>
                    <FTNT>
                        <P>
                            <SU>249</SU>
                             Please note that the risk adjustment discrepancy materiality threshold is the lesser of either $100,000 or 1% of State risk pool transfers.
                        </P>
                    </FTNT>
                    <P>
                        As for setting a materiality threshold based on a percentage of statewide average premium, we are concerned that this approach would be overly complex for the purposes of rerunning HHS-RADV results in response to a successful appeal as all issuers would be held to different dollar thresholds under the percentage of statewide average premium standard. While this would ensure a consistent proportional threshold by State market risk pool to account for the correlation of State transfers and statewide average premium, we note that it would likely advantage issuers whose risk adjustment State payments or charges were a larger percent of statewide average premium in meeting the materiality threshold and disadvantage issuers whose State transfers were a lower proportion of the statewide average premium. In this situation, two issuers with the same dollar impact could have their appeals treated differently based on different statewide average premiums. Use of a percentage of statewide average premium could also lead to more frequent re-running of national HHS-RADV results in response to a successful appeal, with associated burden but minimal impact on national results, based on appeals in smaller States with lower statewide average premium. Therefore, in the interest of ensuring that HHS-RADV appeals 
                        <PRTPAGE P="4511"/>
                        measure the impact to HHS-RADV adjustments at a certain dollar threshold, we did not propose and decline to finalize a materiality threshold based on a percentage of statewide average premium at this time.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that the proposed threshold may impact the accuracy of the HHS-RADV results if HHS identifies a methodological error and limits recalculation and reissuance of the HHS-RADV results only to situations where the filing issuer meets the proposed materiality threshold. This commenter requested HHS clarify that the Department would recalculate and reissue HHS-RADV results in response to a successful appeal when an HHS error impacting many or all issuers is identified, regardless of how the error was identified.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we will not rerun HHS-RADV results in response to a successful appeal resulting in an impact of less than $10,000 to a filing issuer's HHS-RADV adjustments to State transfers, the materiality threshold finalized in this rule does not prevent HHS from taking appropriate action, outside of an individual appeal, which could include recalculation and reissuance of HHS-RADV results for a given benefit year, as a result of an identified HHS methodological error. With the adoption of § 156.1220(a)(2)(i), we aim to balance the importance of having accurate HHS-RADV results with the administrative burden of rerunning HHS-RADV when the impact on the filing issuer's HHS-RADV adjustments to transfers is not material.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that as an alternative to a materiality threshold, HHS could reduce the broad impact of HHS-RADV successful appeals by limiting the application of the result of a successful appeal to the State market risk pool in which the appeal is filed, or adopt a policy to not make changes to group failure rate classifications or bounds if appeals are submitted after HHS-RADV adjustments to State transfers for a given benefit year are posted.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We did not propose and are not finalizing the alternatives suggested by this commenter. We believe that the materiality threshold for determining when we will rerun HHS-RADV results in response to a successful appeal that we are finalizing in this final rule will best mitigate the administrative burden associated with re-running HHS-RADV results when there is a small financial impact both inside and outside of the State market risk pool in which the appeal was filed, and that the finalized materiality threshold to rerun HHS-RADV results ensures appeals are limited to situations with significant program impacts relative to the burdens incurred by issuers and HHS in rerunning HHS-RADV results.
                    </P>
                    <P>We disagree that we could limit the scope of an HHS-RADV appeal to the applicable State market risk pool. HHS-RADV appeals have national impacts in that successful appeals can affect and change the national confidence intervals and group failure rates used to calculate issuers' error rates. This process cannot be disaggregated from the calculation of HHS-RADV adjustments, which applies issuers' error rates to all plan level risk scores and recalculates risk adjustment transfers at the State market risk pool level. We also do not believe this approach would be methodologically justifiable as disaggregating the processes of recalculating error rates from the application of error rates for HHS-RADV adjustments to State market risk pool level risk adjustment transfers would imply using two different sets of HHS-RADV results for a single benefit year.</P>
                    <P>We also do not agree with the comment that we should not make any changes to the group failure rates or confidence interval bounds in response to appeals submitted after the publication of the Summary Report of HHS-RADV Adjustments to Risk Adjustment State Transfers. First, all appeals occur after the publication of the Summary Report of HHS-RADV Adjustments to Risk Adjustment State Transfers. Second, this approach would not take into consideration the true impact of any successful appeal as appeals can result in necessary and methodologically justifiable updates to the group failure rates or confidence interval bounds. Lastly, due to the budget neutrality of risk adjustment transfers, a change to one issuer's risk score error rate or HHS-RADV adjustment due to a successful appeal impacts all other issuers' HHS-RADV adjustments in the filing issuer's State market risk pool; therefore, we do not believe the suggested approach to develop a policy that ignores the impact of a successful appeal on group failure rates and confidence interval bounds is a reasonable option.</P>
                    <HD SOURCE="HD2">E. Part 158—Issuer Use of Premium Revenue: Reporting and Rebate Requirements</HD>
                    <HD SOURCE="HD3">1. Definitions (§ 158.103)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82388), we proposed to amend § 158.103 by adding a definition of “qualifying issuer.” See subsection E.2 below for the discussion of this proposal.</P>
                    <HD SOURCE="HD3">2. Reimbursement for Clinical Services Provided to Enrollees (§§ 158.140, 158.240)</HD>
                    <P>In the HHS Notice of Benefit and Payment Parameters for 2026 proposed rule (89 FR 82308, 82388), we proposed to amend § 158.140(b)(4)(ii) to allow qualifying issuers to not adjust incurred claims by the net payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes beginning with the 2026 MLR reporting year (MLR reports due in 2027). We also proposed to amend § 158.240(c) to add an illustrative example of how qualifying issuers would calculate the amount of rebate owed to each enrollee to accurately reflect how such issuers would incorporate the net risk adjustment transfer amounts into the MLR and rebate calculations differently from other issuers, as well as to make a conforming amendment to clarify that the current illustrative example in paragraph (c)(2) would apply to issuers that are not qualifying issuers.</P>
                    <P>Section 2718 of the PHS Act and the implementing regulations at 45 CFR part 158 require health insurance issuers offering group or individual health insurance coverage to submit an annual report to the Secretary of HHS concerning their MLR and issue an annual rebate to enrollees if the issuer's MLR is less than the applicable MLR standard established in sections 2718(b)(1)(A)(i) and (ii) of the PHS Act. Under section 2718 of the PHS Act, an issuer's MLR is defined as the ratio of (a) incurred claims and quality improvement activity expenses, to (b) premium revenue after subtracting taxes and licensing and regulatory fees and accounting for payments or receipts for risk adjustment, risk corridors, and reinsurance under sections 1341, 1342, and 1343 of the ACA. The statute also defines the total amount of an issuer's annual rebate as an amount equal to the product of the amount by which the applicable MLR standard exceeds the issuer's MLR, multiplied by the issuer's premium revenue after subtracting taxes and licensing and regulatory fees and accounting for payments or receipts for risk adjustment, risk corridors, and reinsurance under sections 1341, 1342, and 1343 of the ACA.</P>
                    <P>
                        In contrast, section 1342(c) of the ACA provides that allowable costs shall be reduced by any risk adjustment payments in the numerator of the risk 
                        <PRTPAGE P="4512"/>
                        corridors calculation.
                        <SU>250</SU>
                        <FTREF/>
                         To preserve consistency between these two programs, we finalized an approach in the 2014 Payment Notice (78 FR 15504) that accounted for all premium stabilization program 
                        <SU>251</SU>
                        <FTREF/>
                         amounts, other than reinsurance contribution fees, in a way that would not have a net impact on the adjusted earned premium revenue used in the calculation of the MLR denominator as defined in § 158.130. Specifically, in the 2014 Payment Notice, we noted that to account for premium stabilization program amounts as an adjustment to earned premium under § 158.130(b)(5), net risk adjustment program receipts, net risk corridors program receipts, and reinsurance program payments would be added to total premium and then subtracted from adjusted earned premium. Section 158.140(b)(4) also provided that premium stabilization amounts, other than reinsurance contribution fees, must adjust incurred claims in the numerator of the MLR calculation defined in § 158.221, in a manner similar to the adjustment of allowable costs in the risk corridors formula set forth in § 153.500. As stated in the 2014 Payment Notice, we found that this approach adhered to the statutory construct of the MLR formula in section 2718 of the PHS Act, which we believe provides flexibility as to whether to account for the effects of collections or receipts for the premium stabilization programs in determining revenue (the denominator) or costs (the numerator) of the MLR formula, while also aligning with the treatment of risk adjustment transfer amounts and reinsurance payments in the calculation of risk corridors payments and charges under section 1342 of the ACA.
                    </P>
                    <FTNT>
                        <P>
                            <SU>250</SU>
                             Section 1342 of the ACA and the implementing regulations at 45 CFR part 153 established a temporary risk corridors program applicable to QHP issuers in the individual and small group (or merged) markets for the 2014, 2015, and 2016 benefit years.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>251</SU>
                             The premium stabilization programs refer to the reinsurance, risk corridors, and risk adjustment programs established by the ACA. See section 1341 of the ACA (transitional reinsurance program), section 1342 of the ACA (risk corridors program), and section 1343 of the ACA (risk adjustment program).
                        </P>
                    </FTNT>
                    <P>In the proposed rule (89 FR 82389), we noted that while many complex factors influence an issuer's underwriting position, our internal analysis suggests that issuers with unusual business models characterized by ratios of risk adjustment payments to earned premium that are approximately 50 percent or higher may owe disproportionately large MLR rebates that could impact solvency. We stated that in these circumstances, we believe that the way the current MLR methodology functions is misaligned with one of the primary statutory goals of the program, which is to ensure that consumers receive value for their premium dollars, as issuers with especially high-risk populations spend a significant proportion of their revenue paying medical claims and may nonetheless also owe rebates that make continued operation in their current markets untenable. Consistent with section 2718(c) of the PHS Act, the standardized methodologies for calculating an issuer's MLR “shall be designed to take into account the special circumstances of smaller plans, different types of plans, and newer plans.” We stated that we believe modifying the treatment of risk adjustment transfer amounts in the MLR and rebate calculations for these issuers such that these amounts have a net impact on the MLR denominator rather than on MLR numerator would mitigate the solvency and stability concerns for this small subset of issuers that offer different types of plans with unique business models, namely the issuers that focus on underserved communities with significant rates of serious health conditions and that may disproportionately rely on risk adjustment payments, as opposed to premiums, for revenue.</P>
                    <P>Therefore, we proposed to exercise our authority to account for the special circumstances of this small subset of issuers. Specifically, we proposed to amend § 158.103 to add a definition of “qualifying issuer” to mean an issuer whose ratio of net payments related to the risk adjustment program under section 1343 of the ACA to earned premiums, prior to accounting for the net payments or receipts related to the risk adjustment, risk corridors, and reinsurance programs (as described in § 158.130(b)(5)) in a relevant State and market, is greater than or equal to 50 percent. We also proposed to modify § 158.140(b)(4)(ii) to no longer apply net risk adjustment receipts as an adjustment to the incurred claims amount that is used to calculate the MLR numerator defined in § 158.221(b) for such qualifying issuers. We did not propose to make any changes to the definition of premium revenue in § 158.130.</P>
                    <P>We stated in the proposed rule (89 FR 82390) that under this proposal, we would modify the calculation of the MLR denominator and rebates as described in the 2014 Payment Notice such that for qualifying issuers, earned premium would account for net risk adjustment receipts by simply adding these net receipts to total premium, without subsequently subtracting them from adjusted earned premium. We noted that the effect of the proposed changes would be to remove these offsetting adjustments (the addition and the subtraction that offset each other) to earned premium in the MLR denominator and rebate calculations, such that these qualifying issuers' risk adjustment transfer amounts would have a net impact on the MLR denominator and rebate calculations in § 158.221(c) and § 158.240(c), respectively. We also proposed to make a conforming amendment to § 158.240(c) to clarify that the existing illustrative example in paragraph (c)(2) would apply to issuers that are not qualifying issuers, and to add an illustrative example in a new paragraph (c)(3) of how qualifying issuers would determine the amount of rebate owed to each enrollee, to accurately reflect how qualifying issuers would incorporate the net risk adjustment transfer amounts into the MLR and rebate calculations differently from other issuers.</P>
                    <P>In summary, we proposed that for qualifying issuers, risk adjustment transfer amounts would be a net adjustment to the denominator, rather than the numerator, of the MLR calculation as follows:</P>
                    <FP SOURCE="FP-2">If (ra/p) &gt; or = 50%;</FP>
                    <FP SOURCE="FP-2">Adjusted MLR = [(i + q−s + nc−rc)/{(p + s−nc + rc)−t−f−(s−nc + rc)−na + ra}] + c </FP>
                    <EXTRACT>
                        <FP SOURCE="FP-2">Where,</FP>
                        <FP SOURCE="FP-2">i = incurred claims</FP>
                        <FP SOURCE="FP-2">q = expenditures on quality improving activities</FP>
                        <FP SOURCE="FP-2">p = earned premiums</FP>
                        <FP SOURCE="FP-2">t = Federal and State taxes</FP>
                        <FP SOURCE="FP-2">f = licensing and regulatory fees including transitional reinsurance contributions</FP>
                        <FP SOURCE="FP-2">s = issuer's transitional reinsurance receipts</FP>
                        <FP SOURCE="FP-2">na = issuer's risk adjustment related payments</FP>
                        <FP SOURCE="FP-2">nc = issuer's risk corridors related payments</FP>
                        <FP SOURCE="FP-2">ra = issuer's risk adjustment related receipts</FP>
                        <FP SOURCE="FP-2">rc = issuer's risk corridors related receipts</FP>
                        <FP SOURCE="FP-2">c = credibility adjustment, if any</FP>
                    </EXTRACT>
                    <P>For a qualifying issuer whose MLR falls below the minimum MLR standard in a State and market, we proposed to calculate the MLR rebate in § 158.240(c) as follows:</P>
                    <FP SOURCE="FP-2">If (ra/p) &gt; or = 50%;</FP>
                    <FP SOURCE="FP-2">Rebates = (m−a) * [(p + s−nc + rc)−t−f−(s−nc + rc)−na + ra]</FP>
                    <EXTRACT>
                        <FP SOURCE="FP-2">Where,</FP>
                        <FP SOURCE="FP-2">m = the applicable minimum MLR standard for a particular State and market</FP>
                        <FP SOURCE="FP-2">a = issuer's MLR for a particular State and market.</FP>
                    </EXTRACT>
                    <P>
                        We proposed that these amendments would be applicable beginning with the 2026 MLR reporting year (MLR reports 
                        <PRTPAGE P="4513"/>
                        due in 2027), to enable issuers that are, or may be able to meet the definition of, a qualifying issuer to reflect the amendments in their premium rates. We requested comment on all aspects of the proposal, including the definition of “qualifying issuer” and whether issuers should satisfy additional criteria to qualify for this flexibility, whether the proposed MLR and rebate methodologies would create any inappropriate incentives for issuers that are unable to accurately price their products or reduce administrative costs, as well as impacts to other issuers that are not “qualifying issuers” and potential market distortions that may arise if the proposed flexibility for MLR and rebate calculations is not extended to all issuers in applicable markets.
                    </P>
                    <P>We also considered an alternative approach that would modify the treatment of net risk adjustment transfer amounts such that these amounts would have a net impact on the MLR denominator and rebate calculations in § 158.221(c) and § 158.240(c), respectively, instead of the MLR numerator defined in § 158.221(b), for all issuers subject to MLR requirements, rather than only for qualifying issuers. We noted that we did not propose this alternative approach as we believe that the more narrow, tailored proposal to provide this flexibility only for qualifying issuers is sufficient to maximize availability of coverage options while remaining consistent with the statutory objective of section 2718 of the PHS Act, which is to ensure that consumers receive value for their premium dollars. We stated that the more narrow, tailored proposal would also produce a smaller reduction in rebate payments to consumers than the alternative approach and would cause less disruption to the industry. We requested comment on all aspects of this alternative approach, including on ways that this alternative approach could potentially influence issuers' rebate positions, plan composition, and pricing decisions, and potential impacts of this alternative approach on consumers.</P>
                    <P>We refer readers to the proposed rule (89 FR 82388 through 82391) for further discussion of our proposal as well as the alternative approach we considered.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing our proposal, with modification, effective beginning with the 2026 MLR reporting year. First, we are finalizing our proposed amendment to § 158.103 to add a definition of “qualifying issuer,” with a modification to clarify that the new definition of “qualifying issuer” is based on an issuer's 3-year aggregate ratio of net payments related to the risk adjustment program under section 1343 of the ACA to earned premiums as defined in § 158.130, but prior to and excluding the adjustments in § 158.130(b)(5) that account for the net payments or receipts related to the risk adjustment, risk corridors, and reinsurance programs, in a relevant State and market. Second, we are finalizing our proposed amendment to § 158.140(b)(4)(ii) to allow qualifying issuers to not adjust incurred claims by the net payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes, with a modification to specify that we are allowing qualifying issuers to modify the treatment of risk adjustment transfer amounts in the manner described above at their option, rather than making this change mandatory for qualifying issuers. Finally, we are finalizing our proposed amendments to § 158.240(c) to (1) add an illustrative example at § 158.240(c)(3) of how qualifying issuers that choose to apply risk adjustment transfer amounts as described in § 158.140(b)(4)(ii) would calculate the amount of rebate owed to each enrollee to accurately reflect how such issuers would incorporate the net risk adjustment transfer amounts into the MLR and rebate calculations differently from other issuers, with a modification to clarify that qualifying issuers “opt” to apply risk adjustment transfer amounts as described in § 158.140(b)(4)(ii), and (2) to clarify that the current illustrative example in § 158.240(c)(2) would apply to issuers that are not qualifying issuers or that are qualifying issuers that do not opt to apply risk adjustment transfer amounts as described in § 158.140(b)(4)(ii). We summarize and respond to public comments received on our proposal below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         We received several comments of general support for the proposal.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We thank commenters for their support of the proposal.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters supported the proposal's applicability to only the narrow subset of qualifying issuers, on the basis that doing so would minimize any rebate reduction that would be a result of the proposal and would avoid harming issuers whose premium rates are relatively low in proportion to the coverage provided and that incur risk adjustment program payments.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with these commenters and thank them for their support of the proposal.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested CMS to clarify whether, when determining if an issuer is a “qualifying issuer,” the issuer should use a single year, or 3-years' aggregate ratio of net risk adjustment payments to earned premiums. Another commenter requested CMS to state more clearly and explicitly that the definition of “qualifying issuer” is based on billed premium, rather than premium that reflects the impact of risk adjustment transfer amounts.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We confirm that the definition of “qualifying issuer” at § 158.103 is based on an issuer's 3-year aggregate ratio of net payments related to the risk adjustment program under section 1343 of the ACA to earned premiums as defined in § 158.130, but prior to and excluding the adjustments in § 158.130(b)(5) that account for the net payments or receipts related to the risk adjustment, risk corridors, and reinsurance programs, in a relevant State and market. We are modifying the proposed definition of “qualifying issuer” at § 158.103 accordingly.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that we allow all issuers that receive risk adjustment payments to reflect these amounts in the MLR denominator, while continuing to allow issuers that make risk adjustment payments (pay risk adjustment charges) to reflect these amounts in the MLR numerator. The commenter stated that they believe this approach eliminates any potential incentive to misprice premiums, is straightforward to implement, and is fair and equitable for all issuers, regardless of their share of claims from high- and low-risk enrollees.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We decline to adopt this commenter's suggestion as the statute does not provide for a different means of accounting for risk adjustment payments and receipts in the MLR calculation. This approach is also inconsistent with generally accepted accounting principles that provide for a consistent accounting of transfers regardless of their direction. Additionally, the suggested approach would significantly reduce total net rebates to consumers without a justifiable benefit, contrary to the goals of the MLR program.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter recommended making the proposal optional for qualifying issuers.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the comment and agree that qualifying issuers should have the option to elect whether to take advantage of modifying the treatment of risk adjustment program transfer amounts in their MLR and rebate calculations. Making the modification optional will allow issuers 
                        <PRTPAGE P="4514"/>
                        that are part of a holding company system, and that operate in many States and markets, to maintain the consistent MLR reporting practices that they have implemented across companies. Such companies might find having one reporting approach to be simpler than determining which issuers, and in which States and markets, in the holding company system are “qualifying issuers” and changing their MLR reporting process only for those issuers. Additionally, issuers that meet the definition of a “qualifying issuer” but do not owe MLR rebates may not want to change their established reporting processes when the change would not create any benefit for them.
                    </P>
                    <P>We are modifying the amendments to § 158.140(b)(4)(ii) and § 158.240(c)(2) and (3) to give qualifying issuers the option to elect whether to take advantage of modifying the treatment of risk adjustment program transfer amounts in their MLR and rebate calculations.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested that we add a maximum threshold of 25,000 enrollees in order for an issuer to qualify as a qualifying issuer, to serve as a guardrail to ensure that the proposal targets the specific issuers whose risk adjustment payments exceed 50 percent of their earned premium and does not cause unintended consequences for other issuers.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we appreciate the commenter's suggestion, we decline to adopt a maximum enrollment threshold of 25,000 enrollees, as we believe that it is possible for an issuer to have a unique business model and corresponding challenges targeted by this policy even if its enrollment exceeds 25,000. Based on our estimates that extremely few issuers would meet the definition of a qualifying issuer and also owe rebates, we do not believe that proposal, as finalized, is likely to cause unintended consequences for other issuers.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters declined to offer support or opposition to the proposal, but pointed out the potential benefits of, as well as noted concerns with, the proposal. A few commenters requested that if CMS does finalize the proposal, that it carefully monitor the impact on the affected enrollees in underserved communities. These commenters noted that the proposal could potentially benefit enrollees with chronic conditions by stabilizing their issuers, reducing premium increases, and promoting consistent access to care. On the other hand, commenters noted that the proposal could result in lower rebates, and that limiting the proposal to only qualifying issuers could result in market imbalances and lead to higher costs or fewer coverage options. These commenters noted concern that the proposal could unintentionally incentivize issuers to reduce their costs by reducing benefit quality.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' perspectives and agree that the policy will have a number of beneficial impacts. We agree that the policy could benefit enrollees in underserved communities, particularly those with chronic conditions and those with lower incomes that are served by issuers that receive large risk adjustment payments in proportion to their revenue. We believe that allowing qualifying issuers the flexibility to account for risk adjustment transfers in the denominator of the MLR calculation will enable them to continue to serve these communities and provide continuity of care to enrollees. We intend to monitor the impact of the finalized policy to the extent resources are available. While we acknowledge commenters' concern that the finalized policy could reduce rebates, we note that any rebate reduction is expected to come from issuers whose business models put them at risk of being financially unviable and unable to continue to provide coverage or pay any rebates, and thus any rebate reduction would be outweighed by the benefit to enrollees of being able to continue their current health coverage, or access higher quality health coverage that might not otherwise be available. We do not agree that the policy would incentivize issuers to reduce benefit quality, raise costs, or reduce coverage options as such coverage changes would not attract higher-risk enrollees for which the issuer would receive risk adjustment payment. For the reasons described in more detail in the response to the comment below, we also do not believe that the rule is likely to cause significant market imbalances or precipitate issuer insolvencies. However, we intend to monitor and analyze the impact of this provision after it is implemented for the 2026 and later MLR reporting years to evaluate whether it operates as intended and continues to be appropriate.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that CMS provide the number of impacted issuers as well as additional data on the impact of the proposal to enable interested parties to fully evaluate the proposal.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As noted in the Regulatory Impact Analysis section of this final rule, since the proposal as finalized is not mandatory for qualifying issuers, CMS cannot, at this time, provide the number of impacted issuers. However, based on 2023 MLR data, we estimate that fewer than half a dozen issuers would meet the new definition of “qualifying issuer” and, if all of them choose to modify the treatment of risk adjustment transfer amounts in the manner described and finalized in this rule, would experience a total combined reduction in rebates of approximately $35 million, out of approximately 180 issuers that owed approximately $946 million in combined total rebates for 2023.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters opposed the proposal. The majority of these commenters advocated for the alternative approach described in the proposed rule that would apply the risk adjustment transfer amounts in a manner that has a net impact on the MLR denominator instead of numerator for all issuers, rather than only “qualifying issuers.” In contrast, a few commenters who opposed the proposal stated that if CMS nevertheless did finalize the proposal, they would prefer the proposed narrow approach, rather than the alternative approach, as it would be less harmful. These commenters were particularly concerned with the potential negative impacts of the alternative approach on the lower-cost issuers that tend to offer more affordable plans designed to target low utilization, generally owe risk adjustment payments, and sometimes face solvency concerns of their own. One commenter opposed both the proposal and the alternative approach. Several commenters noted concern that the proposal would exacerbate pricing uncertainty and market distortion for non-qualifying issuers. One commenter stated that they were unable to conclusively determine whether risk adjustment should be reflected in the MLR numerator or denominator, while two commenters stated they consider payments or receipts related to the HHS-operated risk adjustment program to be more appropriate as an adjustment to premium rather than claims, as this would be consistent with both generally accepted accounting practices and State statutory accounting.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Given the wide range of views among commenters, including conflicting views regarding whether payments or receipts related to the risk adjustment program are generally more appropriate as an adjustment to premium in the MLR denominator or claims in the MLR numerator, we are declining to adopt the alternative approach described in the proposed rule and are finalizing the narrower proposal that applies the changes only to “qualifying issuers,” rather than all issuers, with the modification discussed 
                        <PRTPAGE P="4515"/>
                        above to allow qualifying issuers to opt into taking advantage of modifying the treatment of risk adjustment transfer amounts in their MLR and rebate calculations. We agree with commenters who favored limiting this option to qualified issuers as a means of reducing the possibility of an adverse impact on issuers that owe risk adjustment charges and that may have lower administrative costs and premiums. Given the very small number of issuers that we estimate will meet the definition of a “qualifying issuer” and also owe rebates, we believe that finalizing the narrower proposal will have minimal possibility of disrupting the market and exacerbating pricing uncertainty, and we share some commenters' concerns regarding the potential negative impact of higher MLR rebates under the alternative approach on issuers that owe risk adjustment payments.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters who opposed the proposal stated that the proposed 50 percent threshold to become a “qualifying issuer” is arbitrary, inequitable, and would create an unlevel playing field. These commenters stated that the proposal could incentivize issuers to set inadequate rates to meet the new definition of a qualifying issuer, and that if actual risk adjustment receipts were to be lower than expected, an issuer could face both inadequate premium and risk adjustment revenue, as well as have to pay higher than expected rebates, which could ultimately increase, rather than prevent, market instability and issuer insolvencies.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We acknowledge commenters' concerns. However, we believe that this hypothetical scenario, under which an issuer that is close to the threshold of “qualifying issuer” and close to or under the MLR rebate threshold would purposely and significantly underprice, would greatly increase the risk of insolvency, and is therefore unlikely. Our analysis of 2023 MLR data shows that fewer than half a dozen additional issuers have aggregate ratios of risk adjustment receipts to premium between 20 and 50 percent. Further, our analysis of 2023 MLR data also shows that very few issuers nationwide would currently meet the threshold to qualify as a “qualifying issuer” and also owe rebates, and thus it is unlikely that providing the option for these issuers to modify the treatment of risk adjustment transfer amounts in the manner described and finalized in this rule would cause significant or widespread market uncertainty, distortion, or instability that would outweigh the benefits of codifying this narrow flexibility for qualifying issuers that opt to utilize it. For the same reason, we disagree that the 50 percent threshold is arbitrary or would create an uneven playing field, as it was chosen to capture a small number of issuers that are clear outliers relative to the prevalent positioning in the industry, and whose risk adjustment transfer amounts and premium revenue indicate business models that are fundamentally different from those of most issuers.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted skepticism that the proposal validly asserts that risk adjustment overcompensates issuers whose premiums are below statewide average premium and that they should be entitled to retain that overcompensation. One commenter also noted that the proposal is unnecessary since any issuer whose risk adjustment program payments are large enough to result in it owing MLR rebates is being overcompensated by the risk adjustment program for its enrollees, depriving those enrollees of an MLR rebate.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The policy being finalized in this final rule is designed to target issuers that rely on risk adjustment receipts for revenue to such a disproportionate degree that it distorts the results of the MLR and rebate calculations, and that are consequently also unable to reduce enrollees' premiums any further without jeopardizing solvency. Therefore, we do not agree that the policy would enable such issuers to be overcompensated or that it would improperly deprive their enrollees of the benefit of MLR rebates.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters urged CMS to explore alternative vehicles other than MLR to address the stated policy concerns, such as addressing issues with the HHS-operated risk adjustment program or focusing on other policies that directly impact issuers' long-term financial stability and actuarily sound pricing practices.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenters' suggestions. We have analyzed the HHS risk adjustment methodology in numerous white papers, have refined the HHS risk adjustment methodology as new data become available, and have finalized modifications and improvements to it as necessary, including in this final rule. However, the modifications we are finalizing in part 158 do not impact the HHS-operated risk adjustment program, and the comment regarding changes to the HHS-operated risk adjustment program to address issuers' financial stability and pricing practices is out of scope of this proposal. As stated in the proposed rule, the change to the MLR and rebate calculations is intended to specifically address concerns that, for certain issuers with risk adjustment payments that are greater than half of their premium revenue, these calculations might require large rebate payments that impact solvency—a scenario that we believe is contrary to the goals of the MLR program. As such, we believe that finalizing the proposed change to the MLR and rebate calculations for qualifying issuers, at their option, is appropriate.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter supported making the proposal effective beginning with the 2026 MLR reporting year.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We thank the commenter for their support of the proposed effective date and are finalizing this proposal, with modification, effective beginning with the 2026 MLR reporting year.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter suggested CMS postpone finalizing the proposal to study its potential impact in greater depth and to receive additional feedback from interested parties.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we appreciate the commenter's suggestion, we decline to postpone finalizing the proposal. We received many detailed and thorough comments from interested parties that addressed the full spectrum of the potential benefits and drawbacks of the proposal, and that are sufficient to inform the decision to finalize the proposal. However, as noted above, we intend to monitor and analyze the impact of this policy after it is implemented for the 2026 and later MLR reporting years to evaluate whether it operates as intended and continues to be appropriate.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter urged CMS to investigate how issuers and PBMs are using vertically integrated systems to circumvent the intent of the MLR reporting and rebate rules by shifting profits from an issuer to an affiliated entity that is not subject to the MLR requirements, or inflating clinical reimbursement payments to affiliated providers. One commenter recommended that we change the definition of a “health plan” to include stand-alone dental coverage.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While we appreciate the commenters' recommendations, these comments are out of scope of this proposal.
                    </P>
                    <HD SOURCE="HD2">F. Severability</HD>
                    <P>
                        As demonstrated by the number of distinct programs addressed in this rulemaking and the structure of this final rule in addressing them independently, HHS generally intends this rule's provisions to be severable from each other. For example, the final rule outlines payment parameters and 
                        <PRTPAGE P="4516"/>
                        provisions for the HHS-operated risk adjustment and risk adjustment data validation programs, 2026 user fee rates for issuers in these programs, and changes to the BHP payment calculations. It includes modifications to the initial and second validation audit processes that are part of the HHS-RADV program and addresses HHS' authority to take enforcement action against lead agents at insurance agencies for violations of HHS' Exchange standards and requirements. The rule also addresses certification standards, ECP reviews, public sharing of aggregated, summary-level QIS information on an annual basis, and revisions to the MLR reporting and rebate requirements for qualifying issuers that meet certain standards. It is HHS' intent that if any provision of this final rule is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, the rule shall be construed so as to continue to give maximum effect as permitted by law. In the event a provision is found to be utterly invalid or unenforceable, HHS intends that that provision to be severable.
                    </P>
                    <HD SOURCE="HD1">IV. Waiver of Delay in Effective Date</HD>
                    <P>
                        We ordinarily provide a minimum 60-day delay in the effective date of the provisions of a rule in accordance with the Administrative Procedure Act (APA) (5 U.S.C. 553(d)), which usually requires a 30-day delayed effective date, and the Congressional Review Act (CRA) (5 U.S.C. 801(a)(3)), which usually requires a 60-day delayed effective date for major rules. However, we can waive the APA and CRA delay in effective date requirements for good cause (5 U.S.C. 553(d)(3) waiver available when “provided by the agency for good cause found and published with the rule”; 5 U.S.C. 808(2) (waiver available when “an agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rule issued that notice and public procedure thereon are impactable, unnecessary, or contrary to the public interest”). The Secretary has determined that it is appropriate to issue this final rule effective immediately from the date this rule appears in the 
                        <E T="04">Federal Register</E>
                        . The provisions are necessary to address imminent threats to the health and safety of Exchange enrollees presented by unauthorized changes to a consumer's health coverage.
                    </P>
                    <P>Prompt action is necessary to provide for certain critical changes to our monitoring of agents and brokers for 2025 to protect consumers, insurers, and agents and brokers from non-compliant actors. Over the past year, HHS has observed inappropriate behavior by a small population of agents and brokers in the Exchanges that significantly impacts and endangers consumers. The non-compliant actions of these agents and brokers have placed the health and safety of consumers at risk, led to consumer financial harm, and undermined trust in the Exchanges and the healthcare system.</P>
                    <P>HHS has observed enrollment practices where agents and brokers switch individuals' plans without their consent or enroll them in a plan without their consent. This has led to dangerous gaps in coverage that kept consumers from obtaining medications for chronic conditions and placed at risk their ability to receive medically necessary procedures and services because of the disruption to their coverage. Making this final rule effectively immediately will help to mitigate the significant health and safety risk that consumers will go without necessary medical care and services due to gaps in coverage that are no fault of their own.</P>
                    <P>
                        As reported, from January to August of 2024 there were 90,863 unauthorized plan switches and 183,553 unauthorized enrollments attributed to agent and broker misconduct.
                        <SU>252</SU>
                        <FTREF/>
                         Such actions not only harm consumers, but also place sensitive consumer information at risk, disrupting the integrity of the Exchanges. The oversight policies in this final rule are integral to combatting agent and broker misuse of sensitive consumer information. Privacy violations pose a significant risk, as unauthorized use or sharing of personal consumer information can lead to identity theft and other privacy breaches. In response to the proposed rule, interested parties requested speedy changes in oversight to protect consumers from noncompliant and fraudulent behavior to protect consumers and maintain the integrity of the Exchanges.
                    </P>
                    <FTNT>
                        <P>
                            <SU>252</SU>
                             CMS, 
                            <E T="03">CMS Update on Actions to Prevent Unauthorized Agent and Broker Marketplace Activity, https://www.cms.gov/newsroom/press-releases/cms-update-actions-prevent-unauthorized-agent-and-broker-marketplace-activity#:~:text=consumers%20who%20believe%20they%20may,resolve%20any%20coverage%20issues%20promptly.</E>
                             Oct. 17, 2024.
                        </P>
                    </FTNT>
                    <P>Consumers also have faced financial harm after being inappropriately lured into a plan by misleading agent/broker advertisements that promise non-existent cash benefits, as well as concerning behavior involving the use of high-pressure sales tactics. Such tactics have caused consumers to enroll in QHPs with no premium responsibility when they are already enrolled in Medicaid or employer sponsored coverage that qualifies as minimum essential coverage that disqualifies them from receiving APTCs to support QHP premium payments. This has exposed affected consumers to liability to repay APTCs once they discover they were enrolled in a plan without their knowledge or consent.</P>
                    <P>Prompt action is also necessary to provide for certain critical changes to our programs for 2025—including a policy to allow issuers to voluntarily adopt multiple premium payment thresholds to support continuous coverage of consumers; an amendment to the medical loss ratio (MLR) calculation to account for risk adjustment; updates to user fees for issuers offering qualified health plans (QHPs) through an FFE or SBE-FP and those participating in the HHS-RADV program; amendments to adjust the premium adjustment factor (PAF) in the Basic Health Program (BHP); a clarification to the BHP payment methodology to address ambiguities when multiple second lowest cost silver plans exist in one county; risk adjustment data validation policies that remove enrollees without HCCs from the IVA sampling methodology and remove the finite population correction (FPC) factor; and timeliness standards for State Exchanges to review and resolve enrollment data inaccuracies. We seek an immediate effective date to allow issuers ample time to prepare for the 2025 plan year and help stabilize the Exchanges for issuers and consumers. We believe consumers' confidence in the Exchanges is especially important this time of year when they are making enrollment decisions, with Open Enrollment in the individual market ongoing and the Medicare General Enrollment period about to begin on January 1. States, issuers, and other interested parties have also requested that this rule become effective earlier to establish rates for 2026 in a timely fashion.</P>
                    <P>
                        HHS has determined that implementation of these changes beginning early in 2025 is necessary to protect against imminent threats to the health and safety of Exchange applicants and enrollees, maintain robust participation on the Exchanges, and to encourage affordability of coverage for enrollees and the continuity of care that is supported by the continued availability of plans on the Exchanges. HHS has therefore found good cause to waive the APA's and CRA's delayed effective date requirements and determined that the rule will become effective immediately 
                        <PRTPAGE P="4517"/>
                        on the date this rule appears in the 
                        <E T="04">Federal Register</E>
                         January 15, 2025.
                    </P>
                    <HD SOURCE="HD1">V. Collection of Information Requirements</HD>
                    <P>
                        Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide a 60-day notice in the 
                        <E T="04">Federal Register</E>
                         and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. To fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comments on the following issues:
                    </P>
                    <P>• The need for the information collection and its usefulness in carrying out the proper functions of the agency.</P>
                    <P>• The accuracy of our estimate of the information collection burden.</P>
                    <P>• The quality, utility, and clarity of the information to be collected.</P>
                    <P>• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.</P>
                    <P>We solicited public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs). The public comments and our responses appear in this section, and in the applicable ICR sections that follow.</P>
                    <HD SOURCE="HD2">A. Wage Estimates</HD>
                    <P>
                        To derive wage estimates, we generally use data from the Bureau of Labor Statistics to derive average labor costs (including a 100 percent increase for the cost of fringe benefits and overhead) for estimating the burden associated with the ICRs.
                        <SU>253</SU>
                        <FTREF/>
                         Table 4 presents the median hourly wage, the cost of fringe benefits and overhead, and the adjusted hourly wage.
                    </P>
                    <FTNT>
                        <P>
                            <SU>253</SU>
                             See Department of Labor. (2024, April 3). Bureau of Labor Statistics, Occupational Employment 
                            <E T="03">and Wage</E>
                             Statistics, 
                            <E T="03">May 2023 Occupation Profiles</E>
                            . 
                            <E T="03">https://www.bls.gov/oes/current/oes_stru.htm.</E>
                        </P>
                    </FTNT>
                    <P>As indicated, employee hourly wage estimates have been adjusted by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly across employers, and because methods of estimating these costs vary widely across studies. Nonetheless, there is no practical alternative, and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.</P>
                    <GPH SPAN="3" DEEP="119">
                        <GID>ER15JA25.056</GID>
                    </GPH>
                    <HD SOURCE="HD2">B. ICRs Regarding the Initial Validation Audit (IVA) Sample—Enrollees Without HCCs, Removal of the FPC, and Neyman Allocation (§ 153.630(b))</HD>
                    <P>
                        Beginning with the 2025 benefit year of HHS-RADV, we are finalizing under § 153.630(b) excluding enrollees without HCCs from the IVA sampling methodology, removing the FPC from IVA sampling,
                        <SU>254</SU>
                        <FTREF/>
                         and replacing the source of the Neyman allocation data with the most recent 3 years of consecutive HHS-RADV data with results that have been released before HHS-RADV activities for the benefit year begin. Specifically, these amendments will exclude enrollees without HCCs (stratum 10 enrollees that do not have HCCs nor RXCs and RXC-only enrollees in strata 1 through 3) from IVA sampling, remove the FPC such that issuers with 200 or more enrollees in strata 1 through 9 will have IVA sample sizes of 200 enrollees and issuers with less than 200 enrollees in strata 1 through 9 will have IVA sample sizes equal to their population of enrollees with HCCs, and change the source of the Neyman allocation data used to calculate the standard deviation of risk score error from MA-RADV data to HHS-RADV data. By removing enrollees without HCCs from IVA sampling, the Neyman allocation will only apply to enrollees with HCCs in strata 1 through 9 in the IVA sample.
                    </P>
                    <FTNT>
                        <P>
                            <SU>254</SU>
                             In the current IVA sampling methodology, a Finite Population Correction factor is used to calculate a target IVA sample size less than 200 enrollees for issuers with less than 4,000 enrollees.
                        </P>
                    </FTNT>
                    <P>These amendments are intended to improve the validity of our IVA sampling assumptions and sampling precision and will decrease aggregate burden across all issuers when implemented in combination. As noted in section III.B.6.a of this final rule, the finalized changes to the IVA sampling methodology will result in increased sample sizes for some smaller issuers that are subject to the FPC and currently assigned modified IVA sample sizes less than 200 enrollees under the current methodology. However, sample size is not necessarily indicative of issuer burden in HHS-RADV, as the driving factor of burden is the number of enrollee medical records that must be retrieved and reviewed for the IVA sample. Overall, the amended IVA sampling methodology in this final rule alters the allocation of strata sample sizes within the IVA sample, ultimately resulting in relatively smaller proportions of enrollees from high-risk strata, who generally have more medical records to review, being selected for the IVA sample, on average. Consequently, with these amendments, the average number of medical records reviewed per enrollee in the IVA sample and the average number of medical records reviewed per issuer will decrease.</P>
                    <P>
                        The currently approved information collection (OMB Control Number 0938-1155) for conducting the IVA takes into account that the issuer must review the IVA sample and determine which enrollees will require medical records to validate their HCCs and details the processes the issuer must undertake to obtain medical records for their enrollees selected for the IVA sample. In the currently approved information 
                        <PRTPAGE P="4518"/>
                        collection, we estimate an upper limit of 650 issuers submitting samples of 200 enrollees for HHS-RADV for any given benefit year, five medical record requests per enrollee in the IVA sample size and three HCCs to be reviewed by a certified medical coder per enrollee with HCCs, which leads to an aggregate burden of conducting IVAs of approximately 1,663,729 hours and $116,963,821.
                        <SU>255</SU>
                        <FTREF/>
                         Given the changes to the IVA sample under the policies in this final rule and recent HHS-RADV data, we estimate an upper limit of 600 issuers submitting samples of 200 enrollees for HHS-RADV for any given benefit year.
                        <SU>256</SU>
                        <FTREF/>
                         We estimate an approximate average of two medical records reviewed and two HCCs reviewed per enrollee in the IVA sample under the revised IVA sampling methodology.
                    </P>
                    <FTNT>
                        <P>
                            <SU>255</SU>
                             OMB Control No: 0938-1155 (exp. April 30, 2025). 
                            <E T="03">https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202308-0938-015.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>256</SU>
                             A total of 605 issuers participated in the HHS-operated risk adjustment program for the 2023 benefit year. However, some of these issuers are subject to exemptions from HHS-RADV under 45 CFR 153.630(g) and would not submit IVA samples for HHS-RADV. For example, any issuers at or below the materiality threshold for random and targeted sampling only participate in HHS-RADV approximately once every 3 years. Therefore, we use 600 issuers as a conservative upper limit of the number of issuers that could participate in a given benefit year of HHS-RADV. See the Summary Report on Individual and Small Group Market Risk Adjustment Transfers for the 2023 Benefit Year (July 22, 2024) available at 
                            <E T="03">https://www.cms.gov/cciio/programs-and-initiatives/premium-stabilization-programs/downloads/ra-report-by2023pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        For our monetary and hourly burden estimates, we are incorporating labor and wage costs from the most recent premium stabilization programs information collection, “Standards Related to Reinsurance, Risk Corridors, Risk Adjustment, and Payment Appeals” (OMB Control Number 0938-1155). Based on an analysis that applies the amendments to remove enrollees without HCCs from IVA sampling, remove the FPC, and use HHS-RADV data as the source for the Neyman allocation beginning with 2025 benefit year HHS-RADV, approximately 200 enrollees in an issuer sample will require medical records to validate HCCs, with approximately two medical record requests per enrollee (approximately 400 medical record requests per issuer).
                        <SU>257</SU>
                        <FTREF/>
                         We estimate it will take a business operations specialist (occupation title “Business Operations Specialists, All Other” at an hourly wage rate of $76.52) approximately 1 hour to complete, review, and conduct follow-up on each medical record request (20 minutes each to complete each medical record request, review the response to each medical record request, and to conduct further follow-up on each medical record request). For each issuer, we anticipate the burden will be approximately 400 hours at a cost of $30,608. For an estimated 600 issuers required to submit samples for HHS-RADV for any given benefit year, we anticipate that the aggregate burden of completing medical record reviews will be approximately 240,000 hours and $18,364,800.
                    </P>
                    <FTNT>
                        <P>
                            <SU>257</SU>
                             This estimate is a decrease from the estimate of medical record requests per enrollee in the currently approved information collection because the finalized changes to the IVA sampling methodology in this rule will generally result in relatively fewer enrollees sampled from higher-risk strata, which are generally composed of enrollees with more medical records, thereby reducing our estimated number of medical records for review.
                        </P>
                    </FTNT>
                    <P>Based on a review of enrollee-level EDGE data for the 2017-2022 benefit years and the finalized changes to the IVA sampling methodology in this final rule, we have determined that for enrollees with HCCs, the average number of HCCs to be reviewed by a certified medical coder per enrollee will be approximately two HCCs. Additionally, based on HHS-RADV audit experience, we estimate that it may cost approximately $272.52 ($60.56 per hour for 4.5 hours on average) for a certified medical coder to review the medical record documentation for one enrollee with roughly two HCCs. For 200 enrollees with HCCs in an issuer's IVA sample, the total cost to each issuer will be $54,504 (for 900 hours). In some cases, a secondary review by a senior certified medical coder (occupation title “Health Information Technologists and Medical Registrars” at an hourly wage rate of $60.56 per hour) will be needed to re-review approximately one-third of the medical record documentation required during the first review. Thus, a senior certified medical coder will need to review medical documentation for the equivalent of approximately 66 enrollees with HCCs in an issuer sample. We estimate that the total cost to each issuer will be approximately $17,986.32 ($60.56 per hour for 4.5 hours per enrollee). For this review and secondary review, the total cost to each issuer will be approximately $72,490.32 (1,197 total hours).</P>
                    <P>These changes will not affect the review of demographic and enrollment information, as we will continue to validate demographic and enrollment information for a subsample of up to 50 enrollees from the audit sample, or the RXC review, as the audit entity must review RXCs for all adult enrollees in the audit sample with at least one RXC, and we continue to assume that a review will be performed on approximately 50 RXCs per issuer. As such, we are only changing our burden estimates of demographic and enrollment or RXC review to use the most recent median hourly wage estimates. We estimate that it may cost approximately $20.19 per enrollee ($60.56 per hour for 20 minutes) to validate demographic information for 50 enrollees in each audit sample totaling $1,009.33 per issuer. Similarly, we estimate that RXC validation for 50 enrollees will cost approximately $20.19 per RXC ($60.56 per hour for 20 minutes), totaling $1,009.33 per issuer. In addition, for each issuer, we expect it will require a compliance officer working 40 hours at $72.76 per hour, and two operations managers working a total of 80 hours at $97.38 per hour to make available to external medical coders associated with the IVA entity claims documents for review of demographic information and RXC review (120 hours at a combined cost of $10,701).</P>
                    <P>For each issuer submitting audit findings for HHS-RADV in a given benefit year, the total burden for reporting, coding, and administration will be approximately 1,750.33 hours at a cost of $115,817.79 per issuer. For an estimated 600 issuers required to submit audit findings for HHS-RADV for any given benefit year, we anticipate that the aggregate burden of conducting IVAs will be approximately 1,050,200 hours and $69,490,672 beginning in 2025. This reflects an aggregate burden decrease of 613,529 hours and $47,473,149 from the existing aggregate burden estimate of approximately 1,663,729 hours and $116,963,821.</P>
                    <P>We sought comment on these assumptions.</P>
                    <P>We did not receive any comments in response to the proposed burden estimates for this policy. We received comments on the general impacts of this policy on issuer and IVA Entity burden and respond to those comments in section III.B.6.a. and the Regulatory Impact Analysis section of this rule. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates as proposed.</P>
                    <HD SOURCE="HD2">C. ICRs Regarding Engaging in Compliance Reviews and Taking Enforcement Actions Against Lead Agents for Insurance Agencies (§ 155.220)</HD>
                    <P>
                        This finalized policy addresses HHS' authority to engage in compliance reviews of and take enforcement action against lead agents of insurance agencies in both FFE and SBE-FP States for misconduct or noncompliant activity 
                        <PRTPAGE P="4519"/>
                        at the agency level. We did not propose any amendments to our existing regulations as the current regulatory framework and definitions supports this approach. Furthermore, this finalized policy only envisions collecting agency-level documentation, including, but not limited to, training manuals, onboarding material, and marketing materials, from lead agents, in addition to the existing documentation collection 
                        <SU>258</SU>
                        <FTREF/>
                         for agents, brokers, or web-brokers, to investigate potential misconduct or noncompliant behavior or activities. Therefore, this collection will fall under 5 CFR 1320.4(a)(2), stating collections of information “. . . during the conduct of an [. . .] investigation” are exceptions to the ICR requirements.
                        <SU>259</SU>
                        <FTREF/>
                         The documentation that will be collected will solely relate to investigations of potential misconduct or noncompliant behavior or activities such that this exception will apply.
                    </P>
                    <FTNT>
                        <P>
                            <SU>258</SU>
                             This includes documentation of consumer review and confirmation of the accuracy of eligibility application information in compliance with 45 CFR 155.220(j)(2)(ii)(A)(2) and consumer consent documentation in compliance with 45 CFR 155.220(j)(2)(iii)(c).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>259</SU>
                             5 CFR 1320.4(a)(2).
                        </P>
                    </FTNT>
                    <P>We sought comment on these assumptions.</P>
                    <P>We did not receive any public comments regarding this ICR, and the assumptions made. For the reasons outlined in the proposed rule and this final rule, we are finalizing these assumptions for this policy as proposed.</P>
                    <HD SOURCE="HD2">D. ICRs Regarding Agent and Broker System Suspension Authority (§ 155.220(k))</HD>
                    <P>
                        We are finalizing an amendment to expand HHS' authority to suspend system access for agents and brokers under § 155.220(k)(3) in instances in which we discover circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii), or (iii) or the privacy and security standards at § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction. Since this amendment will entail providing an opportunity for agents and brokers to submit evidence and information to demonstrate that the circumstances of the incident, breach, or noncompliance have been remedied or sufficiently mitigated to HHS' satisfaction, it will involve collecting documents from agents and brokers participating in the FFEs and SBE-FPs whose system access has been suspended. Depending on the circumstances leading to the system suspension, we anticipate receiving documentation of consumer consent and/or review and confirmation of the accuracy of the Exchange eligibility application information and assessing whether the documentation complies with § 155.220(j)(2)(ii) and (iii) for consumers cited in the suspension notice from agents and brokers we system suspend under § 155.220(k)(3). The system suspension authority in § 155.220(k)(3) is part of HHS' oversight and enforcement framework applicable to agents and brokers who participate in the FFEs and SBE-FPs. Therefore, this collection will fall under 5 CFR 1320.4(a)(2), stating collections of information “. . . during the conduct of an [. . .] investigation” are exceptions to the ICR requirements.
                        <SU>260</SU>
                        <FTREF/>
                         The documentation that will be collected will solely relate to investigations and responses to system suspensions, meaning this exception would apply.
                    </P>
                    <FTNT>
                        <P>
                            <SU>260</SU>
                             Id.
                        </P>
                    </FTNT>
                    <P>We sought comment on these assumptions.</P>
                    <P>We did not receive any public comments regarding this ICR, and the assumptions made. For the reasons outlined in the proposed rule and this final rule, we are finalizing these assumptions for this policy as proposed.</P>
                    <HD SOURCE="HD2">E. ICRs Regarding Updating the Model Consent Form (§ 155.220)</HD>
                    <P>We are finalizing amendments to the model consent form created as part of the 2024 Payment Notice (88 FR 25809 through 25811). The existing model consent form only provides a template for meeting the consent documentation and retention requirements of § 155.220(j)(2)(iii)(A)-(C). We are finalizing an update such that the model consent form will also include a template to meet the requirements under § 155.220(j)(2)(ii), which requires agents, brokers, and web-brokers to document that eligibility application information has been reviewed by and confirmed to be accurate by the consumer or their authorized representative prior to submission of the application to the FFE or SBE-FP. This amendment will only update the optional model consent form that was created as part of the 2024 Payment Notice and adopted on June 30, 2023. The 2024 Payment Notice (88 FR 25890 through 25891) considered the additional time it would take the assisting agent, broker, or web-broker to process and submit each consumer's eligibility application, and those assumptions remain valid and are unchanged. We believe these assumptions remain valid as none of the regulatory requirements established by the 2024 Payment Notice are being changed and no new requirements are being added with this amendment. Therefore, this finalized policy will not impart extra time or costs to the assisting agent, broker, or web-broker. Agents, brokers, and web-brokers are already required to meet the requirements of § 155.220(j)(2)(ii) and (iii), meaning the time required to gather the documentation required by the 2024 Payment Notice is already a part of every agent's, broker's, and web-broker's enrollment process. We do not believe the updated model consent form will impose any additional burden on agents, brokers, web-brokers, or consumers, because usage of this model consent form remains optional and this updated model consent form is simply intended to provide a useable example of how agents, brokers, web-brokers, and agencies may compliantly meet the documentation requirements already required by the 2024 Payment Notice. If agents, brokers, agencies, or web-brokers elect to use this form, we do not anticipate that the updated model consent form will take any longer to fill out than agent, broker, web-broker, or agency-created forms or other methods being already being utilized currently, as the requirements for documentation are not changing from the documentation requirements that agents, brokers, agencies, and web-brokers are already required to meet in their current agent, broker, web-broker, or agency-created forms or methods.</P>
                    <P>
                        The amended model consent form will also include scripts agents, brokers, and web-brokers can utilize to meet the consumer consent and eligibility application review requirements finalized in the 2024 Payment Notice when assisting consumers via an audio recording. The scripts will ensure agents, brokers, and web-brokers having verbal, recorded conversations with consumers discuss all the regulatory requirements with consumers. We do not anticipate these scripts will increase burden on any assisting agent, broker, web-broker, or consumer as no regulatory requirements have been changed. As agents, brokers, and web-brokers should already be complying with these requirements, no additional costs will be borne by the agent, broker, or web-broker if using the updated model consent form scripts. The scripts are merely meant to provide agents, 
                        <PRTPAGE P="4520"/>
                        brokers, and web-brokers with guidance and clarification on how the consent documentation and eligibility application review documentation requirements can be met when having a verbal, recorded conversation with a consumer. The scripts in the updated model consent form are not mandatory and are not intended to limit or otherwise impact the agent, broker, or web-broker's ability to answer consumer questions about plan selection or other matters.
                    </P>
                    <P>Finally, there is no anticipated increase in documentation collection burden on HHS based on the updated model consent form. We currently request documentation of consumer consent and eligibility application review for compliance reviews and, assuming agents, brokers, and web-brokers use the updated model consent form, that will not meaningfully impact the documentation collection or review by HHS.</P>
                    <P>The updated model consent form discussed in this section will be submitted for OMB review and approval in the amended PRA package (OMB Control No. 0938-1438/Expiration date: June 30, 2026).</P>
                    <P>We sought comment on these assumptions.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing these assumptions for this policy as proposed. We summarize and respond to public comments received on the proposed assumptions below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters stated we should not mandate audio recording of enrollments and should not require agents, brokers, or web-brokers to use our scripts as this would be especially burdensome to smaller agents, brokers, web-brokers, or agencies.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While agents, brokers, and web-brokers can meet the requirements of § 155.220(j)(2)(ii)(A) and (j)(2)(iii) via an audio recording, this is just one type of documentation that is considered to be acceptable under these sections, and there is no mandate that an audio recording be used to meet these requirements. Agents, brokers, and web-brokers may use any method they wish to meet the consent documentation requirement and review and confirmation of the accuracy of eligibility application information requirement, provided the minimum information required by the regulations is captured in this documentation and the documentation can be maintained for a minimum of 10 years and produced to CMS upon request. In addition, as noted in the proposed rule (89 FR 82364), it would not be mandatory for agents, brokers, or web-brokers to use the amended model consent form or new scripts to comply with the requirements set forth in § 155.220(j)(2)(ii)(A) and (j)(2)(iii)(A)-(C).
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Numerous commenters noted concern that this proposal would impose more burdens on agents, brokers, and web-brokers, especially smaller entities. Commenters stated that agents, brokers, and web-brokers would have less time to spend with each consumer, people would be deterred from enrolling, and agents and brokers would be deterred from participating in the Exchange.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We respectfully disagree with commenters that this proposal will require an agents, broker, or web-broker to spend more time with each consumer, that smaller agents or agencies will be impacted more severely, or that agents, brokers, web-brokers, or consumers will stop participating in the Exchange.
                    </P>
                    <P>The proposal to update the model consent form does not involve a regulatory change or add requirements to the current enrollment process. The proposal expands the model consent form to include means to meet requirements that were established in the 2024 Payment Notice, namely, the requirement to document the consumer reviewed and confirmed their eligibility application information. The proposal also provides scripts an agent, broker, or web-broker may utilize to meet these requirements, along with the consent documentation requirements, if working with a consumer via a spoken method.</P>
                    <P>The requirements established in the 2024 Payment Notice remain in effect and are unchanged. Therefore, we do not anticipate any new burden or impact to consumers', agents', brokers', or web-brokers' participation in the Exchange that will be associated with the updated model consent Form and use of this form will remain optional.</P>
                    <HD SOURCE="HD2">F. ICRs Regarding Notification of 2-Year Failure To File and Reconcile Population (§ 155.305)</HD>
                    <P>We are finalizing an amendment to current regulation at § 155.305(f)(4) under which an Exchange needs to provide notification to either an enrollee or their tax filer (or both) who have been identified as having failed to file their Federal income taxes and reconcile their APTC after 2 consecutive tax years. This notification provides an additional opportunity to educate the enrollee or their tax filer of their responsibility to file their Federal income taxes and reconcile their APTC and that they are at risk for losing their eligibility for APTC. This finalized rule will ensure that State Exchanges will provide notifications, similar to how Exchanges on the Federal platform currently do, and that tax filers with a 2 year FTR status on State Exchanges receive adequate education on the requirement to file and reconcile. It will also impact State Exchanges' FTR processing notices for PY 2026 and subsequent years, although HHS-published guidance has already recommended States implement noticing procedures for PY 2025 similar to what is being required in this final rule. We anticipate that the finalized amendment will not impact the information collection (OMB Control Number 0938-1207) burden for Exchanges because, in practice, the majority of Exchanges are already sending notifications to consumers who have been identified as at risk for losing APTC due to failing to file their Federal income taxes and reconcile their APTC for 2 consecutive years, as discussed in further detail in section VI.C.9 of this final rule and section V.C.9 the proposed rule.</P>
                    <P>We sought comment on these assumptions.</P>
                    <P>We did not receive any public comments regarding this ICR and the assumptions made. For the reasons outlined in the proposed rule and this final rule, we are finalizing these assumptions as proposed.</P>
                    <HD SOURCE="HD2">G. ICRs Regarding General Program Integrity and Oversight Requirements (§ 155.1200)</HD>
                    <P>As discussed in the preamble of this final rule, we proposed to increase transparency into Exchange operations by publishing annual State Exchange and SBE-FP SMARTs, programmatic and financial audits, Blueprint applications, and additional data points in the Open Enrollment data reports. We are finalizing this proposal with a modification to not publish the SMARTs. We estimate that there will be no additional costs or burdens on Exchanges associated with this finalized policy since this data is already collected through the Blueprint application (OMB Control No.: 0938-1172), SMART (OMB Control No.: 0938-1244), and Enrollment Metrics PRA packages (OMB Control No.: 0938-1119).</P>
                    <P>We sought comment on these assumptions.</P>
                    <P>
                        We did not receive any public comments regarding this ICR and the assumptions made. For the reasons outlined in the proposed rule and this final rule, we are finalizing these assumptions as proposed.
                        <PRTPAGE P="4521"/>
                    </P>
                    <HD SOURCE="HD2">H. ICRs Regarding Essential Community Provider Certification Reviews (§ 156.235)</HD>
                    <P>The finalized policy to conduct ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions effective beginning in PY 2026 continues our ECP data collection as permitted under the currently approved information collection (OMB Control No.: 0938-1187/Expiration date: June 30, 2025).</P>
                    <P>
                        To satisfy the ECP requirement under § 156.235, medical QHP and SADP issuers must complete and submit ECP data as part of their QHP application, in which they must list the names and geographic locations of ECPs with whom they have contracted to provide health care services to low-income, medically underserved individuals in their service areas. These issuers must contract with a certain percentage, as determined by HHS, of the available ECPs in the plan's service area. This finalized policy will not significantly change the burden currently approved under OMB Control No. 0938-1415,
                        <SU>261</SU>
                        <FTREF/>
                         because the ECP data collected remains the same. Only the format in which the ECP information is submitted will be different. As described in the preamble of this final rule, issuers in FFEs, including in States performing plan management functions, can now submit ECP data to HHS via MPMS. As a result of HHS system design enhancements via MPMS, HHS is now able to collect ECP data directly from issuers in FFEs in States performing plan management functions, enabling HHS to conduct independent ECP evaluations of each issuers' network.
                    </P>
                    <FTNT>
                        <P>
                            <SU>261</SU>
                             OMB Control No. 0938-1415: Essential Community Provider-Network Adequacy (ECP/NA) Data Collection to Support QHP Certification (CMS-10803).
                        </P>
                    </FTNT>
                    <P>We sought comment on these assumptions.</P>
                    <P>We did not receive any public comments regarding this ICR and the assumptions made. For the reasons outlined in the proposed rule and this final rule, we are finalizing these assumptions as proposed.</P>
                    <HD SOURCE="HD2">I. ICRs Regarding Quality Improvement Strategy Information (§ 156.1130)</HD>
                    <P>There is no information collection associated with this finalized policy and no changes were proposed to the QIS data collection requirements applicable to QHP issuers. QIS data collection from QHP issuers to the Exchange has been approved under OMB Control Number 0938-1286.</P>
                    <HD SOURCE="HD2">J. ICRs Regarding Medical Loss Ratio (§§ 158.103, 158.140, 158.240)</HD>
                    <P>We are finalizing adding a definition of “qualifying issuer” to § 158.103, with certain clarifications, amending § 158.140(b)(4)(ii) to no longer adjust incurred claims by the net payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes for, and at the option of, qualifying issuers, making conforming amendments to the rebate calculation example in § 158.240(c)(2), and adding § 158.240(c)(3) to provide a rebate calculation example for qualifying issuers that choose to apply risk adjustment transfer amounts as described in § 158.140(b)(4)(ii). To the extent issuers currently report their risk adjustment transfer amounts on their Annual MLR Reporting Form(s), we do not expect there to be any impact on the reporting burden, as the affected issuers will continue to report the same risk adjustment transfer amounts but will include them on different lines of the MLR Annual Reporting Form. The burden related to this information collection is currently approved under OMB Control No.: 0938-1164. </P>
                    <P>We sought comment on these assumptions.</P>
                    <P>We did not receive any public comments regarding this ICR and the assumptions made. For the reasons outlined in the proposed rule and this final rule, we are finalizing these assumptions as proposed.</P>
                    <HD SOURCE="HD2">K. Summary of Annual Burden Estimates for Finalized Requirements</HD>
                    <GPH SPAN="3" DEEP="107">
                        <GID>ER15JA25.057</GID>
                    </GPH>
                    <HD SOURCE="HD2">L. Submission of PRA-Related Comments</HD>
                    <P>We have submitted a copy of the final rule to OMB for its review of the rule's information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB.</P>
                    <P>
                        To obtain copies of the supporting statement and any related forms for the finalized proposed collections discussed above, please visit CMS' website at 
                        <E T="03">www.cms.hhs.gov/PaperworkReductionActof1995,</E>
                         or call the Reports Clearance Office at 410-786-1326.
                    </P>
                    <HD SOURCE="HD1">VI. Regulatory Impact Analysis</HD>
                    <HD SOURCE="HD2">A. Statement of Need</HD>
                    <P>
                        This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation programs, as well as 2026 user fee rates for issuers offering QHPs through FFEs and SBE-FPs. This final rule also includes finalized requirements related to modifications to the calculation of the BHP payment, changes to the IVA sampling approach and SVA pairwise means test for HHS-RADV, as well as finalized compliance reviews of and enforcement action against lead agents, updates to the model consent form, and the authority for HHS to suspend agent and broker access to Exchange systems. Additionally, this rule includes finalized policies related to consumer notification requirements, standards for an issuer to request the reconsideration of denial of certification as a QHP specific to the FFEs, changes to the approach for conducting ECP certification reviews of plans for which issuers submit QHP certification 
                        <PRTPAGE P="4522"/>
                        applications in FFEs in States performing plan management functions, and revisions to the MLR reporting and rebate requirements for qualifying issuers. Lastly, this final rule includes finalized amendments to specify that the actuarially justified plan-specific factors by which an issuer may vary premium rates for a particular plan from its market-wide adjusted index rate include the actuarial value and cost-sharing design of the plan, including, if permitted by the applicable State authority, accounting for CSR amounts provided to eligible enrollees under § 156.410, provided the issuer does not otherwise receive reimbursement for such amounts.
                    </P>
                    <HD SOURCE="HD2">B. Overall Impact</HD>
                    <P>We have examined the impacts of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), Executive Order 14094 entitled “Modernizing Regulatory Review” (April 6, 2023), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354, 94 Stat. 1164), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4, 109 Stat. 48), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).</P>
                    <P>
                        Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 14094 
                        <SU>262</SU>
                        <FTREF/>
                         amends section 3(f) of Executive Order 12866 and defines a “significant regulatory action” as an action that is likely to result in a rule that may: (1) have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of OMB's Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product), or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or Tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impacts of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the Executive Order, as specifically authorized in a timely manner by the Administrator of OIRA in each case.
                    </P>
                    <FTNT>
                        <P>
                            <SU>262</SU>
                             Office of the White House. (2023, April 6). 
                            <E T="03">Executive Order on Modernizing Regulatory Review. https://www.whitehouse.gov/briefing-room/presidential-actions/2023/04/06/executive-order-on-modernizing-regulatory-review/.</E>
                        </P>
                    </FTNT>
                    <P>A regulatory impact analysis (RIA) must be prepared for significant rules. OMB's OIRA has determined that this rulemaking is “significant” as measured by the $200 million threshold under section 3(f)(1). We have prepared an RIA that to the best of our ability presents the costs and benefits of the rulemaking. OMB has reviewed these regulations, and the Department has provided the following assessment of their impact.</P>
                    <HD SOURCE="HD2">C. Impact Estimates of the Payment Notice Provisions and Accounting Table</HD>
                    <P>
                        Consistent with OMB Circular A-4 (available at 
                        <E T="03">https://www.whitehouse.gov/wp-content/uploads/2023/11/CircularA-4.pdf</E>
                        ), we have prepared an accounting statement in Table 6 showing the classification of the impact associated with the provisions of this final rule.
                    </P>
                    <P>This final rule implements standards for programs that will have numerous effects, including providing consumers with access to affordable health insurance coverage, reducing the impact of adverse selection, and stabilizing premiums in the individual and small group health insurance markets and in Exchanges. We are unable to quantify all the benefits and costs of this final rule. The effects in Table 6 reflect qualitative assessment of impacts and estimated direct monetary costs and transfers resulting from the provisions of this final rule for health insurance issuers and consumers. The annual monetized transfers described in Table 7 include changes to costs associated with the risk adjustment user fee paid to HHS by issuers.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="295">
                        <PRTPAGE P="4523"/>
                        <GID>ER15JA25.058</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="4524"/>
                        <GID>ER15JA25.059</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="153">
                        <PRTPAGE P="4525"/>
                        <GID>ER15JA25.060</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">
                        1. BHP Methodology Regarding the Value of the Premium Adjustment Factor (PAF) (42 CFR Part 600)
                        <FTREF/>
                    </HD>
                    <FTNT>
                        <P>
                            <SU>263</SU>
                             Reinsurance collections ended in FY 2018 and outlays in subsequent years reflect remaining payments, refunds, and allowable activities.
                        </P>
                    </FTNT>
                    <P>The aggregate economic impact of the finalized changes to the BHP payment methodology is estimated to be $0 in transfers for calendar year 2026 and all subsequent years. For the purposes of this analysis, we have assumed that two States will operate BHPs in 2026 since currently only two States operate BHPs, and we do not assume any more States will do so.</P>
                    <P>For the States currently operating BHPs, we do not anticipate these finalized changes to the payment methodology will affect future payments. We expect that these States will have fully implemented programs by 2026, and thus these changes will not change the value of the PAF used in the payment methodologies for these States in 2026 and beyond. If other States implement a BHP and do so on a partial basis, the finalized changes would be expected to reduce Federal BHP payments compared to what they would be under current law. The changes in payments would depend on the number of people enrolled in BHP in the State, the QHP premiums in the State, and the level of adjustments added to the premiums to account for the CSRs.</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates as proposed.</P>
                    <HD SOURCE="HD3">2. Incorporation of PrEP Affiliated Cost Factor (ACF) in the HHS Risk Adjustment Adult and Child Models (§ 153.320)</HD>
                    <P>We are finalizing the incorporation of PrEP into the HHS risk adjustment adult and child models as part of a new class of factors that reflect the costs associated with care that is not related to active medical conditions. This finalized class of factors, called the Affiliated Cost Factors (ACFs), which are detailed in the preamble discussion under 45 CFR part 153, will not result in any additional reporting burden for issuers. Because it will have some impact on risk adjustment State transfers, some issuers' State transfers will be impacted, either in a positive or in a negative manner, consistent with the budget-neutral nature of the HHS-operated risk adjustment program. As HHS is responsible for operating the risk adjustment program in all 50 States and the District of Columbia, we do not expect these policies to place any additional burden on State governments. The finalized model specifications in this final rule result in limited changes to the number and type of risk adjustment model factors; therefore, we do not expect these changes to impact issuer burden beyond the current burden for the HHS-operated risk adjustment program. This change will help mitigate risk of adverse selection and issuers' associated perverse incentives for coverage of PrEP users, resulting in increased health equity among this population.</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these assumptions as proposed.</P>
                    <HD SOURCE="HD3">3. Initial Validation Audit (IVA) Sampling Methodology Changes (§ 153.630(b))</HD>
                    <P>We are finalizing several changes to the IVA sampling methodology. Beginning with the 2025 benefit year of HHS-RADV, we are finalizing under § 153.630(b) excluding enrollees without HCCs (enrollees in stratum 10 without HCCs nor RXCs and RXC-only enrollees in strata 1 through 3) from IVA sampling, removing the FPC such that issuers with 200 or more enrollees in strata 1 through 9 would have IVA sample sizes of 200 enrollees and issuers with less than 200 enrollees in strata 1 through 9 would have IVA sample sizes equal to their EDGE population of enrollees with HCCs, and changing the source of the Neyman allocation data used to calculate the standard deviation of risk score error from MA-RADV data to the 3 most recent consecutive years of HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin, beginning with benefit year 2025 HHS-RADV.</P>
                    <P>
                        Although issuers are already required to provide the IVA Entities with all documentation necessary to complete HHS-RADV, these finalized changes to the IVA sample will ensure all enrollees in the IVA sample have at least one HCC on EDGE and therefore will have associated medical records that will need to be submitted. In the Collection of Information section of this final rule, we estimate the aggregate decrease in administrative burden that will result from the finalized policies to modify the IVA sample as the average number of medical records reviewed per enrollee in the IVA sample and the average number of medical records reviewed per issuer will decrease. We estimate that the aggregate burden of conducting IVAs will be approximately 1,050,200 hours and $69,490,672 beginning with 2025 benefit year HHS-RADV, which is an aggregate burden decrease of 613,529 
                        <PRTPAGE P="4526"/>
                        hours and $47,473,149 from the existing aggregate burden estimate of approximately 1,663,729 hours and $116,963,821. We believe that these finalized changes to the IVA sampling methodology will result in more precise HHS-RADV results which are used to adjust risk scores and associated risk adjustment State transfers.
                    </P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing these impact estimates for this policy as proposed. We summarize and respond to public comments received on the proposed estimates below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         A few commenters agreed that the proposed changes to the IVA sampling methodology would contribute to reduced administrative burden among issuers and IVA entities. One commenter specifically suggested that administrative burden could decrease for issuers with a greater volume of HCCs to validate in their IVA samples if the proposed changes to the IVA sampling methodology were finalized. However, a few commenters questioned HHS' assessment of burden associated with the proposed changes to the IVA sampling methodology. Some commenters suggested that the proposals would increase administrative burden for issuers, specifically for smaller issuers or lower-risk issuers with more enrollees without HCCs in their population. One commenter suggested that issuers' operational resources and capacity will be significantly impacted because issuers will have to perform more HCC and RXC validations under the proposed IVA sampling methodology. Another commenter noted that smaller issuers that currently have modified IVA sample sizes of fewer than 200 enrollees under the FPC factor would be burdened by increasing the number of sampled enrollees and medical records. Another commenter suggested that there would be a significant burden increase associated with collecting more records from enrollees in lower-risk strata as these enrollees are more likely to see providers who do not provide issuers with direct access to medical records, which could make it more burdensome for issuers to retrieve medical records for these enrollees, especially for smaller issuers. Another commenter suggested concern that compliance with the added HHS-RADV audit requirements could place a greater burden on smaller issuers without clarity on how these proposed changes would help patients. One commenter requested HHS to monitor the impact of these changes on burden and consider future changes if there is an untenable increase in burden or an undesired impact on HHS-RADV adjustments to risk adjustment transfers.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As explained in section III.B.6.a of this rule, we are finalizing the proposed changes to the IVA sampling methodology to exclude enrollees without HCCs, remove the FPC, and use the 3 most recent consecutive years of HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin to calculate the standard deviation of risk score error (
                        <E T="03">S</E>
                        <E T="54">i,h</E>
                        ) in the Neyman allocation as proposed to align sampling with the error estimation methodology and improve sampling precision. We anticipate that these changes will also improve the precision of group failure rates, the national benchmarks used to determine outlier status in each failure rate group, the net risk score error calculations, and will therefore improve the precision of HHS-RADV results used to adjust risk adjustment State transfers. Improving the precision of the IVA sampling methodology with the adoption of the changes finalized in this rule will also further promote the overall integrity of HHS-RADV and confidence in the HHS-operated risk adjustment program.
                    </P>
                    <P>
                        As explained in the section III.B.6.a of this final rule, we anticipate a decrease in the aggregate average burden associated with conducting IVAs as the average number of medical records reviewed per enrollee in the IVA sample and the average total number of medical records reviewed per issuer will generally decrease. We disagree that all issuers will have to perform more HCC and RXC validations under the IVA sampling methodology finalized in this rule that incorporates all three of the proposed changes and, as described in the proposed rule and in section III.B.6.a of this final rule, we estimate an approximate average of two medical records reviewed and two HCCs reviewed per enrollee in the IVA sample under the revised IVA sampling methodology, which is a decrease from the previous burden estimates under the existing IVA sampling methodology of an approximate average of five medical record requests per enrollee in the IVA sample size and three HCCs to be reviewed by a certified medical coder per enrollees with HCCs. In addition, as explained in section III.B.6.a. and the Collection of Information section of this rule, we do not anticipate that these changes will affect RXC review, as HHS-RADV requires review of RXCs for all adult enrollees in the IVA sample with at least one RXC, and we continue to assume that a review will be performed on approximately 50 RXCs per issuer.
                        <SU>264</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>264</SU>
                             For more details on RXC validation, see Section 10.4 Validation of the BY23 HHS-RADV Protocols available at: 
                            <E T="03">https://regtap.cms.gov/uploads/library/HHS-RADV_2023_Benefit_Year_Protocols_v1_5CR_060424.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        We recognize that the IVA sampling methodology finalized in this rule will result in increased sample sizes for some smaller issuers that are currently subject to the FPC and assigned modified IVA sample sizes of fewer than 200 enrollees under the current IVA sampling methodology. However, we note that sample size will not increase for all issuers currently subject to the FPC as some of these issuers have a smaller population of enrollees with HCCs than their previously assigned modified IVA sample sizes that included enrollees without HCCs. For example, an issuer with a total enrollee population of 1,000 would be assigned a sample size of 160 enrollees under the current methodology and using the FPC formula. If this issuer only has a population of 100 enrollees with HCCs, then, under the revised IVA sampling methodology being finalized in this rule, the issuer's IVA sample size would decrease to 100 enrollees. In addition, based on an analysis of historical HHS-RADV data, we estimate that the vast majority of issuers who would see increased IVA sample sizes after the removal of the FPC are at or below the materiality threshold for random and targeted sampling and would therefore only be selected to participate in HHS-RADV approximately once every 3 benefit years (barring any risk-based triggers based on experience that will warrant more frequent audits).
                        <E T="51">265 266</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>265</SU>
                             45 CFR 153.630(g)(2).
                        </P>
                        <P>
                            <SU>266</SU>
                             Beginning with the 2022 benefit year of HHS-RADV, the materiality threshold under § 153.630(g)(2) is defined as 30,000 total billable member months Statewide, calculated by combining an issuer's enrollment in the individual non-catastrophic, catastrophic, small group, and merged markets (as applicable), in the benefit year being audited. See the 2024 Payment Notice, 88 FR 25740, 25788 through 25790.
                        </P>
                    </FTNT>
                    <P>
                        We also recognize the commenter's concern that some providers of enrollees from lower-risk strata may provide issuers with less direct access to medical records for enrollees from lower-risk strata, but we note that that enrollees in lower-risk strata are enrollees with fewer HCCs or relatively lower-risk HCCs, for whom issuers should be able to provide supporting medical records for risk adjustment eligible diagnoses submitted to EDGE as required by the EDGE Server Business 
                        <PRTPAGE P="4527"/>
                        Rules.
                        <SU>267</SU>
                        <FTREF/>
                         The principles for including an HCC in the risk adjustment models require that each HCC represents a well-specified, clinically significant, chronic or systematic medical condition, and therefore, any enrollees with HCCs, regardless of if they are in a lower-risk stratum or higher-risk stratum, have conditions that should have supporting medical records.
                        <SU>268</SU>
                        <FTREF/>
                         Furthermore, if it is more burdensome to retrieve medical records for enrollees from lower-risk strata, any increase in burden from retrieving these medical records would be offset, at least in part, by the decrease in burden from retrieving fewer medical records for enrollees from higher-risk strata. We also note that enrollees from low, medium, and high-risk strata will continue to be sampled for the IVA and the actual number of enrollees sampled from each stratum will depend on that stratum's contribution to the total standard deviation of net risk score error in the issuer's population.
                    </P>
                    <FTNT>
                        <P>
                            <SU>267</SU>
                             See, for example, the EDGE Server Business Rules (ESBR) Version 25.0 (December 2024) available at: 
                            <E T="03">https://regtap.cms.gov/uploads/library/DDC-ESBR-v25-5CR-120624.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>268</SU>
                             See CMS. (2021). 
                            <E T="03">HHS-Operated Risk Adjustment Technical Paper on Possible Model Changes.</E>
                             Section 1.2.1 (Principles of Risk Adjustment). 
                            <E T="03">https://www.cms.gov/files/document/2021-ra-technical-paper.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Moreover, as explained in section III.B.6.a of this rule, we estimate that any smaller issuers receiving the FPC under the current methodology and whose IVA sample sizes would increase under the finalized IVA sampling methodology would see a 35 percent increase in Super HCC count in their IVA samples and a 26 percent increase in group failure rate precision on average across all three failure rate groups. Therefore, we believe that the benefits a smaller issuer gains from increased group failure rate precision and the estimated overall average decrease in the number of HCCs and medical records reviewed per enrollee outweigh any potential increases in IVA sample size.</P>
                    <P>We also clarify that while HHS-RADV does not directly impact patients, HHS-RADV is an issuer audit that helps ensure the integrity of data used in the HHS-operated risk adjustment program to calculate risk adjustment State transfers. The risk adjustment program helps stabilize premiums across the individual, merged, and small group markets, and thereby helps provide consumers with affordable health insurance coverage options.</P>
                    <P>HHS will continue to monitor the impact of the finalized changes to the IVA sampling methodology once implemented. While these changes to the IVA sampling methodology could affect the adjustments to risk adjustment State transfers for an individual issuer, we anticipate that any changes to HHS-RADV adjustments will reflect more accurate actuarial risk differences between issuers.</P>
                    <HD SOURCE="HD3">4. Second Validation Audit (SVA) Pairwise Means Test (§ 153.630(c))</HD>
                    <P>We are finalizing modifications to the pairwise means test to use a 90 percent confidence interval bootstrapping methodology and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV. Because issuers are already required to provide the IVA and SVA Entities with all documentation necessary to complete the audits, the finalized changes to the pairwise means test that will increase the initial SVA subsample size to 24 enrollees and transition to a bootstrapping methodology using a 90 percent confidence interval will not directly increase burden on issuers. We believe that these changes will increase the burden and costs to the Federal Government of conducting the SVA. We estimate that increasing the initial SVA sample size from 12 to 24 enrollees will increase the annual costs of SVA medical review by approximately $1.5 million and that transitioning from the current t-test pairwise means testing procedure to a bootstrapped procedure will increase the annual cost of SVA medical review by approximately $500,000 as more issuers will be expanded to larger SVA sample sizes under a more sensitive pairwise means testing procedure. In addition, there will be a one-time cost of approximately $250,000 to code these modifications to the existing SVA pairwise means test in the Audit Tool. Any increase in SVA costs will increase the costs to the Federal Government associated with HHS-RADV program activities, which are covered through the risk adjustment user fees that are charged to issuers. While issuers will indirectly cover these costs through the risk adjustment user fee, we do not anticipate that this policy alone will increase the risk adjustment user fee as the costs are relatively small compared to the entirety of the budget to operate the HHS-operated risk adjustment program. We believe that the benefits from improving the SVA process for validating the IVA results and determining the appropriate audit results to use in error estimation will outweigh the increased costs to the Federal Government and better ensure the integrity of the risk adjustment program.</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing these impact estimates for this policy as proposed. We summarize and respond to public comments received on the proposed estimates below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested how the estimate costs and estimated improvement in the false negative rate are attributed to modifying the SVA subsample size as opposed to modifying the statistical methodology. Another commenter stated that they could not appropriately evaluate the impact of the proposed changes because issuers and IVA entities have little transparency into SVA outcomes as issuers who pass pairwise do not receive SVA results.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As previously noted in section III.B.6.b of this rule, we estimate that approximately 20 percent of the estimated improvement in the false negative rate will be attributable to modifying the initial SVA subsample size to 24 enrollees and approximately 80 percent will be attributable to modifying the pairwise means test to a bootstrapped 90 percent confidence interval.
                        <SU>269</SU>
                        <FTREF/>
                         We also estimate that approximately 33 percent of the costs associated with making these changes in 2024 benefit year HHS-RADV will be attributed to transitioning from the current t-test pairwise means testing procedure to the bootstrapped procedure and coding the changes to test and execute the bootstrapping methodology, and the remaining costs will be attributed to increasing the initial SVA subsample size to 24 enrollees.
                    </P>
                    <FTNT>
                        <P>
                            <SU>269</SU>
                             The rate of improvement in the false negative rate and how this is attributed to the initial SVA subsample size or the statistical methodology differs depending on the effect size, or the magnitude of the true difference between IVA and SVA results. For these estimates, we use the Cohen's D effect size measure and assume a small effect size. See Cohen, Jacob (1988). Statistical Power Analysis for the Behavioral Sciences. Routledge. ISBN 978-1-134-74270-7. pp 25-27.
                        </P>
                    </FTNT>
                    <P>
                        We disagree that issuers and IVA entities have insufficient transparency into SVA outcomes to evaluate the impact of the proposed changes to the SVA pairwise testing procedure. In the proposed rule (89 FR 82308, 82355), we explained the impact of the proposed modifications to increase the initial SVA subsample size to 24 enrollees and use a bootstrapped 90 percent confidence interval on the false negative rate, false positive rate and the overall sensitivity of the pairwise means test, and we sought comment on these proposals. As explained in section 
                        <PRTPAGE P="4528"/>
                        III.B.6.b of this final rule, we are finalizing the proposed modifications to the SVA pairwise means testing procedure beginning with 2024 benefit year HHS-RADV to improve the sensitivity of the SVA pairwise means test, reduce the false negative rate and promote the integrity of HHS-RADV. In addition, we disagree that issuers have insufficient transparency into SVA outcomes. HHS does not provide SVA results to issuers or IVA entities that pass pairwise testing because passing signifies that the SVA findings do not significantly differ from IVA findings and that the IVA findings, which issuers review and sign off on, can be used during error estimation as issuers' final accepted audit results for that benefit year of HHS-RADV. Issuers and IVA Entities that pass pairwise testing and do not receive an SVA findings report are still able to review key SVA findings, such as the most commonly miscoded HCCs for SVA reviewed sampled enrollees, from each benefit year of HHS-RADV in the results memo.
                        <SU>270</SU>
                        <FTREF/>
                         Issuers that do not pass pairwise testing receive SVA findings reports that include details on the enrollee-level HCCs that differed between IVA and SVA review.
                    </P>
                    <FTNT>
                        <P>
                            <SU>270</SU>
                             See, for example, Table 1 of the 2022 Benefit Year HHS-RADV Results Memo (May 14, 2024) available at 
                            <E T="03">https://www.cms.gov/files/document/by22-hhs-radv-results-memo-appendix-pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. HHS Risk Adjustment User Fee for the 2026 Benefit Year (§ 153.610(f))</HD>
                    <P>For the 2026 benefit year, HHS will operate risk adjustment in every State and the District of Columbia. As described in the 2014 Payment Notice (78 FR 15416 through 15417), HHS' operation of risk adjustment under section 1343 of the ACA on behalf of States is funded through a risk adjustment user fee. For the 2026 benefit year, we are finalizing using the same methodology to estimate our administrative expenses to operate the HHS risk adjustment program as was used in the 2025 Payment Notice (89 FR 26218).</P>
                    <P>We expect that the finalized risk adjustment user fee for the 2026 benefit year of $0.20 PMPM would increase the amount transferred from issuers of risk adjustment covered plans to the Federal Government by approximately $6.6 million compared to maintaining the 2025 benefit year risk adjustment user fee of $0.18 PMPM. We continue to estimate that the total costs for HHS to operate the risk adjustment program on behalf of all States and the District of Columbia within the 2026 calendar year will be approximately $65 million, roughly the same as the amount estimated for the 2025 calendar year, and are finalizing the risk adjustment user fee for the 2026 benefit year at $0.20 PMPM to sufficiently fund these costs.</P>
                    <HD SOURCE="HD3">6. Engaging in Compliance Reviews and Taking Enforcement Actions Against Lead Agents for Insurance Agencies (§ 155.220)</HD>
                    <P>As discussed in the preamble to this final rule, we address our authority to investigate, engage in compliance reviews of, and take enforcement actions against lead agents of insurance agencies who are engaging in potential misconduct or noncompliant behavior or activities in FFE and SBE-FP States. This will better align our oversight and enforcement approach with how States regulate agencies. This will also ensure enhanced consumer protections from agency-level misconduct or noncompliance facilitated at the agency level, which similarly impacts consumers negatively as misconduct or noncompliance by individual agents, brokers, and web-brokers. This finalized policy is also designed to reduce consumer harm associated with unauthorized enrollments or bad-acting agents, brokers, or web-brokers entering incorrect income information on eligibility applications which may cause harm by providing the enrollee or applicant with an incorrect APTC amount. For example, an incorrect APTC amount can result in a consumer having a zero-dollar monthly premium. Because the consumer does not receive monthly billing notifications due to the zero-dollar premiums, they may not know they were enrolled or that their eligibility application information was incorrect. However, once the consumer files their taxes, a reconciliation may reveal that the consumer must repay the incorrect APTC amount they were receiving. By their nature, these unauthorized enrollments and plan changes, as well as inaccurate eligibility application information submissions, also involve the misuse of enrollee or applicant PII, and they threaten the efficient administration of the Exchange and the accuracy of Exchange eligibility determinations.</P>
                    <P>This finalized policy is also designed to reduce consumer harm associated with unauthorized enrollments or unauthorized plan switches which can lead to the consumer receiving a DMI. Upon application submission, certain consumer data is checked against trusted data sources to ensure a match between what is in the application submission and the information HHS receives from the trusted data source(s). If the trusted data source does not have the consumer data or the data is inconsistent with the information provided on the application, a DMI is generated. A non-exhaustive list of DMIs include the Annual Income DMI, Citizenship/Immigration DMI, and American Indian/Alaskan Native Status DMI. Certain DMIs may lead to loss of Exchange coverage, including a Citizenship/Immigration DMI, which occurs when the consumer is unable to verify an eligible citizenship or lawful presence status.</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing these impact estimates for this policy as proposed. We summarize and respond to public comments received on the proposed estimates below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments that we should remove or limit the 150 percent SEP and implement pre-enrollment SEP verification that are vulnerable to fraud, such as income.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While this comment touches on issues that potentially relate to noncompliant agents and brokers or fraudulent behavior, these comments are outside the scope of this proposal.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments stating this change would protect consumers from noncompliant and fraudulent behavior and maintain the integrity of the Exchange.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that this change would better protect consumers. This change would allow HHS to take targeted action against lead agents found to be involved in noncompliant or fraudulent behavior. Removing noncompliant individuals and entities from the Exchanges that use the Federal platform reduces fraud and improves public trust of these Exchanges as a whole. We continue to encourage State Exchanges that do not use the Federal platform to adopt a similar enforcement approach to enable it to also take immediate action when circumstances that pose unacceptable risk to their Exchange operations.
                    </P>
                    <HD SOURCE="HD3">7. Agent and Broker System Suspension Authority (§ 155.220(k))</HD>
                    <P>
                        We believe the impact related to the finalized changes to § 155.220(k)(3) will be positive. These changes will allow HHS to take swift action for misconduct and noncompliance with existing standards and requirements by expanding the bases on which § 155.220(k)(3) system suspensions may be implemented. This finalized policy will enhance consumer protection and 
                        <PRTPAGE P="4529"/>
                        promote program integrity by allowing HHS to immediately suspend an agent's or broker's access to Exchange systems when HHS discovers circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii), or (iii) or the privacy and security standards at § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction. This will help reduce future consumer harm by allowing HHS to quickly suspend system access for agents or brokers who are engaged in misconduct or noncompliant behavior that impacts Exchange consumers, operations, and systems. This finalized policy will also increase transparency by informing agents and brokers of the full suite of HHS enforcement actions that may be leveraged in response to noncompliance or misconduct, which may help curb such activities and behaviors. We do not anticipate negative feedback from the entities impacted by this, such as agents and brokers, as these changes are meant to more quickly system suspend bad-acting agents and brokers. This will help build consumer trust in compliant agents and brokers who work with consumers on the FFEs and SBE-FPs.
                    </P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing these impact estimates for this policy as proposed. We summarize and respond to public comments received on the proposed estimates below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Commenters suggested we allow agents and brokers to provide evidence to us prior to initiating system suspensions.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We do not agree with commenters that we should change our system suspension process to allow for agent or broker response prior to engaging in a system suspension.
                    </P>
                    <P>
                        The purpose of § 155.220(k)(3) is to maintain the integrity of the Exchange and individual consumers. Adding language to allow system suspensions to be implemented when we discover circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under § 155.220(j)(2)(i), (ii) or (iii) or the privacy and security standards at § 155.260,
                        <SU>271</SU>
                        <FTREF/>
                         helps achieve these goals.
                    </P>
                    <FTNT>
                        <P>
                            <SU>271</SU>
                             Section 155.220(d)(3) requires agents and brokers to enter into a Privacy and Security Agreement pursuant to which they agree to comply with Exchange privacy and security standards adopted consistent with § 155.260. There are two Privacy and Security Agreements between CMS and the agent, broker, and web-broker for FFEs and SBE-FPs: (1) one is for the individual market FFEs and SBE-FPs, and (2) one is for the FF-SHOPs and SBE-FP-SHOPs.
                        </P>
                    </FTNT>
                    <P>
                        Providing an opportunity to provide evidence prior to a system suspension being implemented would leave consumers vulnerable to potential harm as the agent or broker would have full use of all avenues to enroll consumers. System suspensions allow HHS to “immediately” prevent an agent or broker from utilizing the DE/EDE pathways, protecting consumers. The use of the word “immediate” in § 155.220(k)(3) means this enforcement tool is intended to reduce risk of noncompliance as soon as it is discovered. Allowing an agent or broker to respond prior to implementing the system suspension would defeat the intention of the regulation. While the option to enroll using the call center or 
                        <E T="03">HealthCare.gov</E>
                         exists, these are safer options for the consumer as the call center requires the consumer to be on the call and the agent or broker would need to be sitting with the consumer if using 
                        <E T="03">HealthCare.gov.</E>
                    </P>
                    <P>We believe our process allowing an agent or broker to respond to a system suspension is efficient and provides sufficient due process to the system-suspended agent or broker. Agents or brokers may respond with exculpatory evidence immediately after receiving a system suspension, which would reduce the amount of time the system suspension is in place, provided the submitted evidence mitigates the situation to HHS' satisfaction.</P>
                    <P>Furthermore, we do not engage in compliance actions, such as system suspensions, without reviewing all the evidence at our disposal and determining there is a high likelihood the agent or broker has been engaging in noncompliant behavior.</P>
                    <P>
                        <E T="03">Comment:</E>
                         We received comments in support of expanding § 155.220(k)(3) as it would reduce noncompliant behavior and protect consumers.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters who supported this proposal and agree it would reduce noncompliant behavior and protect consumers.
                    </P>
                    <P>The original intent of § 155.220(k)(3) included protecting against unacceptable risk to consumer Exchange data. Clarifying this in regulatory text will allow us to implement system suspensions in situations involving consumer PII while making agents and brokers aware of this authority. We believe violations of the standards of conduct under 155.220(j)(2)(i), (ii), or (iii), risk to the accuracy of Exchange eligibility determinations, operations, applications, enrollees, or information technology systems all warrant system suspensions as each may cause consumer harm or reduce public trust in the Exchange itself.</P>
                    <HD SOURCE="HD3">8. Updating the Model Consent Form (§ 155.220)</HD>
                    <P>We are finalizing an update to the model consent form to include a section for documentation of consumer review and confirmation of the accuracy of their Exchange eligibility application information under § 155.220(j)(2)(ii)(A)(1)-(2), as well as scripts agents, brokers, and web-brokers could use when meeting the requirements codified at § 155.220(j)(2)(ii)(A) and (j)(2)(iii)(A)-(C) via an audio recording.</P>
                    <P>These finalized policies will update the optional model consent form that was created as part of the 2024 Payment Notice and adopted on June 18, 2023. The 2024 Payment Notice (88 FR 25890 through 25892) considered the additional time it would take to process and submit each consumer's eligibility application and those assumptions remain valid and are unchanged. We believe these assumptions remain valid because we are not changing the regulatory requirements established by the 2024 Payment Notice, we are not adding requirements with this finalized policy, and we are not making the use of the model consent form mandatory. The time required to gather the documentation required by the 2024 Payment Notice requirements is already a part of every agent's, broker's, and web-broker's enrollment process. We do not believe the updated model consent form will impose any additional burden on agents, brokers, web-brokers, or consumers. We do not anticipate that the updated model consent form will take any longer to fill out than agent, broker, web-broker, or agency-created forms already being utilized. The use of the updated model consent form will not be mandatory. Therefore, this finalized policy will not impart extra time or costs to the assisting agent or broker.</P>
                    <P>
                        This updated model consent form will provide agents, brokers, and web-brokers with clarity on how to meet the regulatory requirements under § 155.220(j)(2)(ii) and help them comply 
                        <PRTPAGE P="4530"/>
                        with this regulation by providing a standardized form they may use to do so. Furthermore, we believe providing a clearly written model consent form will provide more consumer clarity and assurance that the agent, broker, or web-broker they are working with is complying with § 155.220(j)(2)(ii). The finalized scripts, to the extent they are utilized by agents, brokers, and web-brokers, will help ensure they are following the regulatory requirements when enrolling consumers. We believe this will reduce consumer harm by reducing unauthorized enrollments, which can result in financial harm if a consumer receives an improper APTC amount upon enrollment, and DMIs, which may lead to cancellation of coverage if the DMIs are not resolved in a timely manner. We also believe this finalized policy will clarify and simplify how regulated entities can meet regulatory requirements.
                    </P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing these impact estimates for this policy as proposed. We summarize and respond to public comments received on the proposed estimates below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters stated we should not mandate audio recording of enrollments and should not require agents or brokers to use our scripts as this would be especially burdensome to smaller agents, brokers, web-brokers, or agencies.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While agents, brokers, and web-brokers can meet the requirements of § 155.220(j)(2)(ii)(A) and (j)(2)(iii) via an audio recording, this is just one type of documentation that is considered to be acceptable under these sections, and there is no mandate that an audio recording be used to meet these requirements. Agents, brokers, and web-brokers may use any method they wish to meet the consent documentation requirement and review and confirmation of the accuracy of eligibility application information requirement, provided the minimum information required by the regulations is captured in this documentation and the documentation can be maintained for a minimum of 10 years and produced to CMS upon request.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters supported updating the model consent form, stating this would provide clarity to agents, brokers, and web-brokers, and help ensure consumers' enrollment applications have correct information.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with commenters that these updates will provide more clarity and assurance to agents, brokers, web-brokers, and agencies on how to meet the applicable regulatory requirements and more consumer clarity and assurance that the agent, broker, or web-broker they are working with is complying with the applicable regulatory requirements.
                    </P>
                    <HD SOURCE="HD3">9. Requirement for Notification of Tax Filers and Consumers Who Have Failed To File and Reconcile APTC for 2 Consecutive Tax Years (§ 155.305)</HD>
                    <P>We anticipate a small financial impact related to our finalized updates to § 155.305(f)(4)(i)(A)(1)-(2). Prior to pausing the FTR process during the COVID-19 PHE, Exchanges provided notice to enrollees or their tax filers (or both) who were identified as at risk of losing their APTC due to their failure to file their Federal income taxes and reconcile their APTC using Form 8962 prior to the FTR Recheck process. The 2025 Payment Notice (89 FR 26299) codified the requirement to send notices in the first tax year a tax filer was identified as having FTR status. The policy finalized in this rule will require sending either direct or indirect notices to tax filers or their enrollees when the tax filer is identified as having an FTR status for a second consecutive tax year, which we estimated in the 2024 Payment Notice (88 FR 25902) to represent 20 percent of the total FTR population. We sought comments on these impacts and assumptions, including regarding additional costs, burdens, and benefits to issuers, consumers, and Exchanges.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates with the following modifications to our initial cost estimates for these new FTR notice requirements.</P>
                    <P>
                        Since the publication of the proposed rule, HHS has sent out FTR notices regarding APTC eligibility for the 2025 coverage year to enrollees or their tax filers, and we wish to update our initial cost projections for this policy change. Due to increases in enrollment in Exchanges on the Federal platform, the volume of FTR notices sent to enrollees or their tax filers was higher than we originally estimated, which increased the cost of providing FTR direct notices to tax filers. The revised cost for Exchanges on the Federal platform to provide FTR direct notices that protect FTI to tax filers will be approximately $292,000 annually for fiscal years 2025 through 2029, revised from $134,000 as proposed. These cost estimates may fluctuate in future years due to unknown factors, such as increases in the cost of postage and inflation in future years. We expect that the cost of providing notices would decrease in 2026 and the subsequent years if the enhanced PTC subsidies provided by the Inflation Reduction Act are not extended past 2025 because consumers may terminate their Exchange coverage if they become ineligible for financial assistance. However, because it is currently unknown whether the enhanced PTC subsidies will expire or be extended, we have not factored this into our cost estimate. While HHS did not receive any comments related to our estimates regarding the cost of print notices for FTR, we would like to provide more context on why we are not providing more details regarding the contract pricing. We did not publish the cost per print notice because this is proprietary information. Furthermore, HHS will not publish specific future contract estimates in this final rule because the data underlying those estimates could undermine future contract procurements. For example, if HHS were to publish the projected future cost of the contracts used to provide print notifications, the Federal Government would be meaningfully disadvantaged in future contract negotiations related to Federal notice printing activities, as bidders would know how much HHS anticipates such a future contract is worth. Although current contract awards are published and publicly available,
                        <SU>272</SU>
                        <FTREF/>
                         these award amounts do not necessarily reflect the future value of the contract, as there may be future changes in policy and operations and the scope of the work.
                    </P>
                    <FTNT>
                        <P>
                            <SU>272</SU>
                             Available at 
                            <E T="03">https://sam.gov.</E>
                        </P>
                    </FTNT>
                    <P>
                        Our finalized regulations give flexibility to Exchanges to choose to send the required notices to enrollees or tax filers, or both. While most State Exchanges have noted a preference to provide indirect notices to their consumers, there is uncertainty about how State Exchanges would choose to provide notices to their enrollees (for example, mail or electronic) as well as the proportion of enrollees on State Exchanges who fail to file their Federal income taxes and reconcile their APTC for 2 consecutive tax years, and therefore we are unable to provide exact estimates of the cost of providing these notices. We believe that if State Exchanges chose to provide direct mailing notices, the approximate cost could be $0.84 per notice for FY 2025 based on the cost for the Exchanges on the Federal platform to send an average notice and would likely grow with 
                        <PRTPAGE P="4531"/>
                        postage and inflation costs in future years. We anticipate approximately 110,000 total notices across State Exchanges based on updated FTR data from the Exchanges on the Federal platform, and so in total, the updated estimated cost to State Exchanges to send these notices will be approximately $92,400 yearly for fiscal years 2025 through 2029. However, we still believe this is likely an overestimate based on conversations with interested parties because many State Exchanges may prefer to provide indirect notices that can be emailed, which would substantially reduce costs to the State Exchanges. There could be some cost related to creation of the notice, but State Exchanges could also choose to use either the language that Exchanges on the Federal platform already use or the language previously used in FTR notices.
                    </P>
                    <HD SOURCE="HD3">10. Timeliness Standard for State Exchanges To Review and Resolve Enrollment Data Inaccuracies (§ 155.400(d)(1))</HD>
                    <P>
                        We are finalizing the addition of § 155.400(d)(1) to codify HHS' guidance document titled, 
                        <E T="03">Reporting and Reviewing Data Inaccuracy Reports in State-based Exchanges (SBE) Frequently Asked Questions (FAQs),</E>
                        <SU>273</SU>
                        <FTREF/>
                         which provides that, within 60 calendar days after a State Exchange receives a data inaccuracy from an issuer operating in an State Exchange (hereinafter referred to as “State Exchange issuer”) that includes a description of an inaccuracy that meets the requirements at § 156.1210(a)-(c) and all the information that the State Exchange requires or requests to properly assess the inaccuracy, the State Exchange must review and resolve the State Exchange issuers' enrollment data inaccuracies and submit to HHS a description of the resolution of any inaccuracies described by the State Exchange issuer that the State Exchange confirms to be inaccuracies in a format and manner specified by HHS.
                        <SU>274</SU>
                        <FTREF/>
                         This finalized policy aligns with existing guidance 
                        <SU>275</SU>
                        <FTREF/>
                         and builds on the existing requirement at § 155.400(d) that a State Exchange must reconcile enrollment information with issuers and HHS no less than on a monthly basis. It also provides certainty for State Exchange issuers by providing a timeline for State Exchanges to act upon an enrollment data inaccuracy submitted to the State Exchange by a State Exchange issuer that meets the requirements at § 156.1210(a)-(c).
                    </P>
                    <FTNT>
                        <P>
                            <SU>273</SU>
                             CMS. (2024, Aug. 14). 
                            <E T="03">Reporting and Reviewing Data Inaccuracy Reports in State-based Exchanges (SBE) Frequently Asked Questions (FAQs). https://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/downloads/faqs-SBE-reporting-enrollment-data-inaccuracies.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>274</SU>
                             OMB Control No.: 0938-1312 and 0938-1341.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>275</SU>
                             CMS. (2024, Aug. 14). 
                            <E T="03">Reporting and Reviewing Data Inaccuracy Reports in State-based Exchanges (SBE) Frequently Asked Questions (FAQs). https://www.cms.gov/cciio/programs-and-initiatives/health-insurance-marketplaces/downloads/faqs-SBE-reporting-enrollment-data-inaccuracies.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We do not believe that the finalized amendment will impose substantial additional costs to HHS, State Exchanges, or State Exchanges issuers beyond the costs that are already accounted for as part of the existing issuers' enrollment data inaccuracies description process and existing State Exchange enrollment data reconciliation requirements. The existing process already requires State Exchange issuers to submit enrollment inaccuracies and the State Exchanges to resolve those inaccuracies and reconcile enrollment information with both State Exchange issuers and HHS on no less than a monthly basis. We have no reason to believe that codifying a timeliness standard will materially increase burden.</P>
                    <P>Furthermore, this finalized policy to codify a timeliness standard for resolution of enrollment data inaccuracies will clarify to issuers in State Exchanges the process for timely reviewing and resolving enrollment data inaccuracies and will ensure the accurate and timely payment of APTCs as this enrollment data is the basis of APTC payments to State Exchange issuers in the automated PBP system.</P>
                    <P>Therefore, we anticipate that this finalized policy will streamline the existing issuers' enrollment data inaccuracies process and benefit consumers by ensuring accurate payment of APTCs.</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates as proposed.</P>
                    <HD SOURCE="HD3">11. Establishment of Optional Fixed-Dollar Premium Payment Threshold and Total Premium Threshold (§ 155.400(g))</HD>
                    <P>
                        We anticipate that the finalized policy to allow issuers to implement a fixed-dollar premium payment threshold, adjusted for inflation by annual agency guidance, will benefit enrollees who may otherwise have been unable to maintain enrollment due to owing 
                        <E T="03">de minimis</E>
                         amounts of premium. The finalized modification will likely be especially beneficial to enrollees who have low incomes, who might be disproportionately impacted by disruptions in coverage. In addition, we believe that issuers that choose to implement a fixed-dollar premium payment threshold will benefit by being able to continue enrollment for enrollees who owe small amounts of premium. We anticipate that there will be some costs associated with implementing a fixed-dollar threshold for those issuers that choose to do so, as well as State Exchanges that choose to allow issuers to do so.
                    </P>
                    <P>
                        Since the finalized policy will be optional for issuers to adopt, and some may choose not to adopt a payment threshold at all, it is challenging to quantify the impact on APTC payments. In the proposed rule, assuming a fixed-dollar threshold of $5 or less, based on PY 2023 counts of 79,612 QHP policies terminated for non-payment where the enrollee had a member responsibility amount of $0.01-$5.00, with an average monthly APTC of $604.78 per enrollee (for PY 2023), we estimated that this at most would result in $481,477,453.60 in APTC payments for 10 months that excludes the binder payment and first month of the grace period (for which the issuer already received APTC and would not have to return) that issuers would retain, rather than being returned to the Federal Government.
                        <SU>276</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>276</SU>
                             See CMS (2024) 
                            <E T="03">Effectuated Enrollment: Early 2024 Snapshot and Full Year 2023 Average. https://www.cms.gov/files/document/early-2024-and-full-year-2023-effectuated-enrollment-report.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We sought comment on these impacts and assumptions, including quantifying a lower limit, and whether there are additional costs for other interested parties that have not been considered here.</P>
                    <P>
                        We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates with the following modifications: since we are finalizing a fixed-dollar threshold of $10 or less, based on PY2023 counts of 135,185 QHP policies terminated for non-payment where the enrollee had a member responsibility amount of $0.01-$10.00, with an average monthly APTC of $604.78 per enrollee (for PY 2023), we estimate that this at most will result in $817,571,843.00 in APTC payments for 10 months that excludes the binder payment and first month of the grace period (for which the issuer already received APTC and would not have to return) that issuers would retain, rather than being returned to the Federal 
                        <PRTPAGE P="4532"/>
                        Government. This would allow such consumers to remain in coverage, rather than having their policy terminated and health care coverage terminated for owing 
                        <E T="03">de minimis</E>
                         amounts of premium.
                    </P>
                    <HD SOURCE="HD3">12. General Eligibility Appeals Requirements (§ 155.505)</HD>
                    <P>This finalized modification will allow application filers to file appeals through the HHS appeals entity or a State Exchange appeals entity on behalf of applicants and enrollees on their Exchange application, streamlining the appeals process and ensuring operational consistency between the Exchanges on the Federal platform and appeals entities. We do not anticipate any material financial impact related to our proposed change at § 155.505(b).</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates as proposed.</P>
                    <HD SOURCE="HD3">13. Amendments to Certification Standards for QHPs, Request for the Reconsideration of Denial of Certification, and Non-Certification and Decertification of QHPs (§§ 155.1000 and 155.1090)</HD>
                    <P>We are finalizing an amendment to § 155.1000 by codifying that an Exchange may deny certification to any plan that does not meet the general certification criteria at § 155.1000 and amending § 155.1090 with refinements to the standards for the request for the reconsideration of a denial of certification specific to the FFEs. We anticipate no appreciable changes in impact because of these modifications. We expect that the FFEs will deny certification to one or fewer certification applications on average each year, so we expect the number of affected entities to be small. In addition, the finalized revisions to §§ 155.1000 and 155.1090 do not substantively alter the responsibilities of affected issuers or the content of reconsideration requests. As a result, there is no material impact on regulated entities because of these finalized policies.</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates as proposed.</P>
                    <HD SOURCE="HD3">14. General Program Integrity and Oversight Requirements (§ 155.1200)</HD>
                    <P>As part of § 155.1200, we proposed to increase transparency in Exchanges by publishing annual State Exchange and SBE-FP SMARTs, programmatic and financial audits, Blueprint applications, and additional data points in the Open Enrollment data reports. We are finalizing this proposal with a modification to not publish the SMARTs. We anticipate no appreciable change in impact with this finalized policy since this data is already collected through the Blueprint application (OMB Control Number: 0938-1172), SMART (OMB Control Number: 0938-1244), and Enrollment Metrics PRA packages (OMB Control Number: 0938-1119). We expect that this policy will increase the public's understanding of State Exchanges, promote program improvements, and better evaluate Exchange quality.</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these assumptions as proposed.</P>
                    <HD SOURCE="HD3">15. FFE and SBE-FP User Fee Rates for the 2026 Benefit Year (§ 156.50)</HD>
                    <P>We are finalizing an updated FFE user fee rate of 2.5 percent of monthly premiums for the 2026 benefit year, which is greater than the FFE user fee rate finalized in the 2025 Payment Notice (89 FR 26336 through 26338) of 1.5 percent of total monthly premiums. We are also finalizing an SBE-FP user fee rate of 2.0 percent for the 2026 benefit year, which is greater than the SBE-FP user fee rate finalized in the 2025 Payment Notice of 1.2 percent of total monthly premiums. We are also finalizing an alternative FFE user fee rate of 2.2 percent of total monthly premiums and an alternative SBE-FP user fee rate of 1.8 percent of total monthly premiums, which would take effect if enhanced PTC subsidies were extended at their current level, or higher, by July 31, 2025. We recognize that the expiration of the enhanced PTC subsidies at the end of the 2025 benefit year creates a significant amount of uncertainty in the ACA markets and despite this uncertainty, we maintain that the amount collected under these user fee rates will adequately fund all user fee-eligible Exchange and Federal platform functions based on the latest budget estimates.</P>
                    <P>We provided estimates of FFE and SBE-FP user fee transfers from issuers to the Federal Government in the proposed rule based on the proposed FFE and SBE-FP user fee rates of 2.5 and 2.0 percent of total monthly premiums, respectively, and alternative FFE and SBE-FP user fee rate range between 1.8 and 2.2 percent and between 1.4 and 1.8 percent of total monthly premiums, respectively, and our projections of enrollment and premium growth at the time. We are finalizing the FFE and SBE-FP user fee rates of 2.5 and 2.0 percent of total monthly premiums, respectively, as proposed and finalizing modified alternative FFE and SBE-FP user fee rates of 2.2 percent and 1.8 percent of total monthly premiums, respectively. Therefore, we are updating our estimates of transfers from issuers to the Federal Government in this final rule as follows.</P>
                    <P>We estimate an increase in FFE and SBE-FP user fee transfers from issuers to the Federal Government of $732 million for benefit year 2026 compared to if the user fee rates from the prior benefit year were maintained in 2026. We estimate additional increases in FFE and SBE-FP user fee transfers from issuers to the Federal Government of $937 million in 2027, $958 million in 2028, and $997 million in 2029 if the finalized 2026 benefit year user fee rates were maintained in subsequent years. Under the alternate FFE and SBE-FP user fee rates, which reflect different enrollment assumptions, we estimate increases in FFE and SBE-FP user fee transfers compared to if the 2025 benefit year user fee rates were maintained for 2026 and beyond from issuers to the Federal Government of $620 million in 2026, $854 million in 2027, $885 million in 2028, and $918 million in 2029 if the alternate user fee rates were maintained in subsequent years.</P>
                    <P>
                        We anticipate that these finalized user fee rates, along with the impact of the expiration of the enhanced PTCs on enrollment in ACA markets, will exert upward pressure on premiums compared to the 2025 benefit year. However, we believe these user fee rate increases from the 2025 user fee rates are necessary to provide financial stability to the Exchanges on the Federal platform, ensure continuity of special benefits to issuers, and maintain access to QHPs for enrollees. We sought comment on the impacts and assumptions included in the proposed rule, and we responded to all comments received on the FFE and SBE-FP user fees in the preamble section titled FFE and SBE-FP User Fee Rates for the 2026 Benefit Year (§ 156.50). After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our 
                        <PRTPAGE P="4533"/>
                        responses to comments, we are finalizing the impact estimates for this policy as discussed in the preceding paragraphs.
                    </P>
                    <HD SOURCE="HD3">16. CSR Loading (§ 156.80)</HD>
                    <P>While we anticipate that codifying the permissibility of CSR loading will provide greater clarity and generally promote market stability, we do not expect that it will have a substantive economic impact, as it will continue to allow States' existing actuarially justified practices of determining whether and how CSR loading occurs.</P>
                    <HD SOURCE="HD3">17. Amendments to AV Calculator Update Methodology (§ 156.135)</HD>
                    <P>This approach to revise the method for updating the AV Calculator, starting with the 2026 AV Calculator, resulting in an earlier release of the final AV Calculator for a given plan year, will benefit both issuers and States. Issuers have previously provided feedback that HHS should strive to release the final version of the AV Calculator sooner, and this approach addresses such requests. An earlier release of the final AV Calculator benefits issuers by providing additional time to develop plan designs ahead of State filing deadlines. In addition, States could benefit from an earlier release of the final version of the AV Calculator to ensure their EHB-benchmark plans comply with EHB requirements, and States that design their own standardized plan options could benefit from an earlier release to ensure they satisfy the AV de minimis ranges. This approach will have no impact on consumers.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates as proposed.</P>
                    <HD SOURCE="HD3">18. Standardized Plan Options (§ 156.201)</HD>
                    <P>
                        We are finalizing updates to the standardized plan options for PY 2026 to ensure these plans continue to have AVs within the permissible 
                        <E T="03">de minimis</E>
                         range for each metal level, and we are revising both sets of plan designs at the expanded bronze metal level to conform more closely to the corresponding plan designs for PY 2025. These modifications are discussed in detail in the § 156.201 of the preamble to this rule. We believe maintaining a high degree of continuity in the approach to standardized plan options year over year minimizes the risk of disruption for interested parties, including issuers, agents, brokers, States, and enrollees.
                    </P>
                    <P>We continue to believe that making major departures from the approach to standardized plan options set forth in the 2023, 2024, and 2025 Payment Notices could result in changes that may cause undue burden for interested parties. For example, if the standardized plan options vary significantly from year to year, those enrolled in these plans could experience unexpected financial harm if the cost sharing for services they rely upon differs substantially from the previous year. Ultimately, we believe consistency in standardized plan options is important to allow both issuers and enrollees to become accustomed to these plan designs.</P>
                    <P>Thus, similar to the approach taken in the 2023, 2024, and 2025 Payment Notices, we are finalizing standardized plan options that continue to resemble the most popular QHP offerings that millions of consumers are already enrolled in. As such, these finalized standardized plan options are based on updated cost sharing and enrollment data to ensure that these plans continue to reflect the most popular offerings in the Exchanges. By finalizing an approach to standardized plan options similar to that taken in the 2023, 2024, and 2025 Payment Notices, issuers will continue to be able to utilize many existing benefit packages, networks, and formularies, including those paired with standardized plan options for PY 2025. Further, issuers will continue to not be required to extend plan offerings beyond their existing service areas.</P>
                    <P>We do not anticipate that the modification we are finalizing at § 156.201(c) that will require an issuer that offers multiple standardized plan options within the same product network type, metal level, and service area to meaningfully differentiate these plans from one another in terms of included benefits, networks, included prescription drugs, or a combination of some or all these factors, will have a significant impact on issuers. This is because most issuers have not offered multiple standardized plan options within the same product network type, metal level, and service area since these requirements were introduced in PY 2023. In fact, current QHP certification submission data indicates that only three issuers offered multiple standardized plan options within the same product network type, metal level, and service area in PY 2025.</P>
                    <P>However, we acknowledge that those issuers that do offer multiple standardized plan options in the same product network type, metal level, and service area will either have to modify certain offerings (such as by modifying included benefits, provider networks, included prescription drugs, or a combination of some or all these factors) or choose to discontinue certain plans to the extent they are not meaningfully different. That said, given that issuers will retain the discretion to choose between modifying or discontinuing plans, and given that making these modifications to plans are a routine part of the annual plan design process, we do not anticipate significant burden for affected issuers related to this proposed requirement.</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates as proposed.</P>
                    <HD SOURCE="HD3">19. Non-Standardized Plan Option Limits (§ 156.202)</HD>
                    <P>We are finalizing an amendment to § 156.202(b) and (d) to properly reflect the flexibility that issuers have been operationally permitted since the introduction of these requirements to vary the inclusion of the distinct adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage categories under the non-standardized plan option limit at § 156.202(b) in accordance with § 156.202(c)(1) through (3).</P>
                    <P>In particular, we are finalizing an amendment to § 156.202(b) to properly distinguish between adult dental benefit coverage at § 156.202(c)(1) and pediatric dental benefit coverage at § 156.202(c)(2), such that an issuer offering QHPs in an FFE or SBE-FP, for PY 2025 and subsequent plan years, is limited to offering two non-standardized plan options per product network type, as the term is described in the definition of “product” at § 144.103 of this subchapter, metal level (excluding catastrophic plans), and inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of § 156.202), in any service area.</P>
                    <P>
                        We are finalizing a similar conforming amendment to § 156.202(d), such that for PY 2025 and subsequent plan years, an issuer may offer additional non-standardized plan options for each product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of § 156.202), and service area if it demonstrates that these additional plans' cost sharing for 
                        <PRTPAGE P="4534"/>
                        benefits pertaining to the treatment of chronic and high-cost conditions (including benefits in the form of prescription drugs, if pertaining to the treatment of the condition(s)) is at least 25 percent lower, as applied without restriction in scope throughout the plan year, than the cost sharing for the same corresponding benefits in an issuer's other non-standardized plan option offerings in the same product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage, and service area.
                    </P>
                    <P>
                        We are finalizing these modifications to align the regulation text with the existing flexibility that issuers have been operationally permitted since the non-standardized plan option limit was introduced in the 2024 Payment Notice.
                        <SU>277</SU>
                        <FTREF/>
                         Given that issuers have had this flexibility since the non-standardized plan option limit was first introduced PY 2024, we do not anticipate any impact on relevant interested parties.
                    </P>
                    <FTNT>
                        <P>
                            <SU>277</SU>
                             CMS. (2024, April 10). 
                            <E T="03">2025 Final Letter to Issuers in the Federally-facilitated Exchanges. https://www.cms.gov/files/document/2025-letter-issuers.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates as proposed.</P>
                    <HD SOURCE="HD3">20. Essential Community Provider Certification Review for States Performing Plan Management Functions (§ 156.235)</HD>
                    <P>This finalized policy to conduct ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions beginning in PY 2026 will not have a significant financial impact on the Federal Government. HHS continues to perform ECP certification reviews for plans in the FFEs, so the financial burden to conduct the certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions using the existing data infrastructure is a marginal increase within the annual programming for QHP certifications. For PY 2025, HHS will use MPMS for ECP reviews for plans seeking QHP certification in FFEs, and HHS has all the necessary data infrastructure and operational processes to conduct reviews for States performing plan management functions for PY 2026 as finalized. While the Federal Government will undertake additional administrative work to review the ECP data from QHP certification applications submitted by issuers seeking certification of their plans as QHPs in FFEs in States performing plan management functions, the transfer of administrative impact from the State that had been performing these reviews to the Federal Government is marginal, as the Federal Government already has in place processes and procedures to conduct the ECP certification reviews. HHS will continue ECP QHP certification reviews in all other FFE States.</P>
                    <P>
                        This finalized policy will reduce the administrative burden for these States as they will no longer be responsible for ECP data review. We estimate a cost savings of $148,212.12 per State annually for each of the 12 FFE States performing plan management functions in PY 2026.
                        <SU>278</SU>
                        <FTREF/>
                         This is calculated by taking the median hourly wage for a compliance officer of $36.38, according to the Occupational Employment and Wage Statistics,
                        <SU>279</SU>
                        <FTREF/>
                         and adding 100 percent fringe benefits to total $72.76. We estimate the operations and maintenance costs for the ECP QHP data collection and the QHP data collection support to equal 485 hours for 4.2 full-time equivalents,
                        <SU>280</SU>
                        <FTREF/>
                         totaling $148,212.12. The total cost across the 12 FFE States performing plan management functions will be $1,778,545.44. This cost associated with ECP enforcement/compliance reviews will be transferred from the States performing plan management functions to the Federal Government. We further estimate an annual cost of $8,155 associated with ECP compliance reviews that will be transferred from the States performing plan management functions to the Federal Government based on current contract costs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>278</SU>
                             Twelve FFEs operate in States performing plan management functions for PY 2026: Delaware, Hawaii, Iowa, Kansas, Michigan, Montana, Nebraska, New Hampshire, Ohio, South Dakota, Utah, and West Virginia.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>279</SU>
                             Occupational Employment and Wage Statistics from the US Bureau of Labor Statistics for job code 13-1041 Compliance Officer from 
                            <E T="03">https://www.bls.gov/oes/current/oes131041.htm.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>280</SU>
                             We estimated 485 hours for 4.2 full time equivalents similar to the administrative burden cost for the Federal Government as indicated in cost estimate of the Supporting Statement for Continuation of Data Collection to Support QHP Certification and other Financial Management and Exchange Operations OMB control number: 0938-1187.
                        </P>
                    </FTNT>
                    <P>Further, this finalized policy should not lead to increased burden for issuers in the FFE in States performing plan management functions as they will still have to submit ECP data to HHS regardless of whether it is the State or HHS conducting the QHP certification review. In previous years, these issuers were required to submit ECP data to HHS via the SERFF binders, whereas these issuers are now required to submit their ECP data to HHS in MPMS beginning with the PY 2025 QHP application submission season, making it now possible for HHS to begin reviewing these ECP data going forward.</P>
                    <P>
                        In addition, this finalized policy will not financially impact providers on the HHS ECP list.
                        <SU>281</SU>
                        <FTREF/>
                         There is no fee to be included in the HHS ECP list, and the administrative burden to complete the petition continues to be the same. The finalized policy will support consumer access to vitally important medical and dental services, enhancing health equity for low-income and medically underserved consumers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>281</SU>
                             A non-exhaustive list of available ECPs that primarily serve low-income and medically underserved populations which can be counted toward an issuer's satisfaction of the ECP standard as part of the issuer's QHP application.
                        </P>
                    </FTNT>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>We did not receive any comments in response to the proposed impact estimates for this policy. For the reasons outlined in the proposed rule and this final rule, we are finalizing these estimates as proposed.</P>
                    <HD SOURCE="HD3">21. HHS-RADV Materiality Threshold for Rerunning HHS-RADV Results (§ 156.1220(a)(2))</HD>
                    <P>
                        We are finalizing an amendment to § 156.1220(a)(2) to codify a materiality threshold for when HHS will rerun HHS-RADV results in response to a successful HHS-RADV appeal. We believe that this amendment supports providing stability for issuers that participate in risk adjustment because it limits the potential for issuers to reopen their books for small changes to their State transfers because of a successful HHS-RADV appeal. This finalized policy will avoid situations where HHS is required to rerun HHS-RADV results and all issuers are required to reopen their books, when the impact for the filer of a successful HHS-RADV appeal is less than $10,000. Because this approach is limited to small dollar amounts, we do not believe that the finalized policy will materially impact issuers or their premiums and it will provide stability to issuers by limiting the situations where their books will need to be reopened. We believe that this finalized amendment, when applicable, will reduce Federal costs by an estimated $75,000 due to the estimated 575 hours of contractor work. 
                        <PRTPAGE P="4535"/>
                        We also believe that this amendment, when applicable, will reduce Federal costs through a decrease in HHS staff work hours. These HHS staff are funded by the risk adjustment user fee, therefore there is no cost impact. Rerunning HHS-RADV results requires HHS to recalculate all national metrics, reissue all issuers' error rate results, and then apply all of those revised error rates to State transfers for the applicable benefit year before going through the process to net, invoice, collect, and redistribute the changes to the HHS-RADV adjustments to State transfers.
                    </P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>After consideration of comments and for the reasons outlined in the proposed rule and this final rule, including our responses to comments, we are finalizing the impact estimates for this policy as proposed. We summarize and respond to public comments received on the proposed estimates below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter noted that this policy would reduce the burden on smaller issuers, who are disproportionately impacted when HHS-RADV is rerun.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We agree with this commenter. This policy should provide stability to the HHS-operated risk adjustment markets by limiting the potential for HHS-RADV results to be rerun for a particular benefit year when the financial impact on the filer falls below the materiality threshold and thereby reduce burden on all issuers of risk adjustment covered plans, including smaller issuers, by reducing the situations where there are additional adjustments to the HHS-RADV adjustments to State transfers for any given benefit year.
                    </P>
                    <HD SOURCE="HD3">22. Medical Loss Ratio (§§ 158.103, 158.140, 158.240)</HD>
                    <P>We are finalizing (1) the addition of a definition of “qualifying issuer” to § 158.103 with a modification to clarify that the new definition of “qualifying issuer” is based on an issuer's 3-year aggregate ratio of net payments related to the risk adjustment program under section 1343 of the ACA to earned premiums as defined in § 158.130, but prior to and excluding the adjustments in § 158.130(b)(5) that account for the net payments or receipts related to the risk adjustment, risk corridors, and reinsurance programs, in a relevant State and market, and (2) amending § 158.140(b)(4)(ii) to allow qualifying issuers, at their option, to not adjust incurred claims by the net payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes beginning with the 2026 MLR reporting year. This rule also amends § 158.240(c) to add an illustrative example of how qualifying issuers that opt to apply risk adjustment transfer amounts as described in § 158.140(b)(4)(ii) would determine the amount of rebate owed to each enrollee, and makes a conforming amendment to § 158.240(c) to clarify that the current illustrative example in paragraph (c)(2) would apply to issuers that are not qualifying issuers and to qualifying issuers that do not choose to apply risk adjustment transfer amounts as described in § 158.140(b)(4)(ii). These finalized policies, which will extend only to qualifying issuers (that is, issuers whose aggregate ratio of net payments related to the risk adjustment program under section 1343 of the ACA to earned premiums as defined in § 158.130, but prior to and excluding the adjustments in § 158.130(b)(5) that account for the net payments or receipts related to the risk adjustment, risk corridors, and reinsurance programs, based on 3 consecutive years of data in a relevant State and market, is greater than or equal to 50 percent), will result in transfers to such issuers from their enrollees in the form of lower rebates or higher premiums. Based on MLR data for 2023, these finalized policies will reduce rebates paid by issuers to consumers or increase premiums collected by issuers from consumers by a total of approximately $35 million per year.</P>
                    <P>We sought comment on these impacts and assumptions.</P>
                    <P>After consideration of comments and updated estimates based on the more recent 2023 MLR data, and for the reasons outlined in the proposed rule and this final rule, including our response to comments, we are finalizing these impact estimates. We summarize and respond to public comments received on the proposed estimates below.</P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested that we provide information regarding the number of issuers that will be impacted by the proposal to enable interested parties to evaluate whether it would in fact be a “small subset,” and the magnitude of the impact on MLR calculations.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Since the proposal as finalized is not mandatory for qualifying issuers, CMS cannot, at this time, provide the exact number of impacted issuers. However, based on 2023 MLR data, we estimate that fewer than half a dozen issuers would meet the new definition of “qualifying issuer” and, if all of them choose to apply risk adjustment transfer amounts as described and finalized in this rule, would experience a reduction in rebates in a combined total amount of approximately $35 million, out of approximately 180 issuers that owed approximately $946 million in combined total rebates.
                    </P>
                    <HD SOURCE="HD3">23. Regulatory Review Cost Estimation</HD>
                    <P>If regulations impose administrative costs on private entities, such as the time needed to read and interpret this final rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that a range of between the total number of unique commenters on the 2026 Payment Notice proposed rule (266) and the total number of page views on the 2026 Payment Notice proposed rule (about 13,000) will include the actual number of reviewers of this final rule. We therefore use an average number of approximately 6,600 reviewers of this final rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this final rule. It is possible that not all commenters reviewed the proposed rule in detail, and it is also possible that some page viewers will not actually read the final rule. For these reasons, we believe that the approximate average of the number of commenters and number of page viewers on the proposed rule will be a fair estimate of the number of reviewers of this final rule. We sought comments on the approach in estimating the number of entities which will review the proposed rule and did not receive any such comments.</P>
                    <P>We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this final rule, and therefore, for the purposes of our estimate we assume that each reviewer reads approximately 55 percent of the rule (an average of the range from 10 percent to 100 percent of the rule). We sought comments on this assumption and did not receive any such comments.</P>
                    <P>
                        Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this final rule is $106.42 per hour, including overhead and fringe benefits.
                        <SU>282</SU>
                        <FTREF/>
                         Assuming an average reading speed of 250 words per minute, we estimate that it will take approximately 4.75 hours for the staff to review 55 percent of this final rule. For each entity that reviews the rule, the 
                        <PRTPAGE P="4536"/>
                        estimated cost is $505.50 (4.75 hours × $106.42 per hour). Therefore, we estimate that the total cost of reviewing this regulation is approximately $3,336,300 ($505.50 per reviewer × 6,600 reviewers).
                    </P>
                    <FTNT>
                        <P>
                            <SU>282</SU>
                             U.S. Bureau of Labor Statistics. (2024, April 9). 
                            <E T="03">Occupational Employment and Wage Statistics. https://www.bls.gov/oes/current/oes_nat.htm.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">D. Regulatory Alternatives Considered</HD>
                    <P>We are finalizing under § 153.630(b) excluding enrollees without HCCs, removing the FPC, and changing the source of the Neyman allocation data used to calculate the standard deviation of risk score error from MA-RADV data to HHS-RADV data beginning with the 2025 benefit year of HHS-RADV.</P>
                    <P>
                        The finalized IVA sampling methodology will use the most recent 3 consecutive years of HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin to calculate a national variance of net risk score error to calculate each issuer's standard deviation of risk score error used in the Neyman allocation formula, whereas the current IVA sampling methodology relies on MA-RADV data to calculate this national variance of net risk score error.
                        <SU>283</SU>
                        <FTREF/>
                         When investigating the impact of switching the Neyman allocation data source to the most recent 3 consecutive years of HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin, we considered creating an issuer-specific variance of net risk score error to calculate each issuer's standard deviation of risk score error used in the Neyman allocation formula. However, it would not be possible to calculate an issuer-specific variance of net risk score error for all issuers participating in a given benefit year of HHS-RADV as some issuers would not have 3 consecutive years of HHS-RADV data. As explained in the proposed rule (89 FR 82308, 82353), these issuers would have to rely on fewer years of HHS-RADV data under an issuer-specific calculation, meaning significantly fewer data points compared to other issuers that participated in all years, which could result in large variations in IVA sample stratum size and increased uncertainty in HHS-RADV. Therefore, for this reason and the reasons noted in section III.B.6.a.3 of this final rule, we are finalizing continuing to calculate each issuer's standard deviation of risk score error using a national variance of net risk score error, but to use a three-year rolling window of HHS-RADV data rather than the MA-RADV data as the source data for the Neyman allocation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>283</SU>
                             As noted in the preamble of this final rule, a new benefit year of HHS-RADV activities generally begins in the spring when issuers can start selecting their IVA entity and IVA entities can start electing to participate in HHS-RADV for that benefit year. We would use data from the 3 most recent consecutive years of HHS-RADV where results have been released. For the most recently published annual HHS-RADV timeline, see the 
                            <E T="03">2023 Benefit Year HHS-RADV Activities Timeline. https://regtap.cms.gov/uploads/library/2023_RADV_Timeline_5CR_072424.pdf.</E>
                             Note that there were delays in the 2023 Benefit Year HHS-RADV Activities Timeline in recognition of the challenges some issuers were facing related to EDGE server operations after the Change Healthcare Cybersecurity Incident.
                        </P>
                    </FTNT>
                    <P>
                        We considered proposing to replace the source of the Neyman allocation data while continuing to include enrollees without HCCs in IVA sampling and retaining the FPC.
                        <SU>284</SU>
                        <FTREF/>
                         However, this would result in sampling a greater proportion of enrollees without HCCs, who do not have risk scores to adjust when calculating issuers' error rates during HHS-RADV. In addition, keeping the FPC while excluding enrollees without HCCs from IVA sampling and replacing the source data for the Neyman allocation with available HHS-RADV data would lead to a dramatic increase in the number of issuers subject to the FPC and therefore decrease the total count of Super HCCs in issuers' IVA samples. For example, we estimate that the average Super HCC count for issuers currently subject to the FPC would decrease by 26 percent by retaining the FPC, which would increase the proportion of issuers that fail to meet the 30 Super HCC constraint in HHS-RADV.
                        <SU>285</SU>
                        <FTREF/>
                         In contrast, removing the FPC would increase the average Super HCC count for these same issuers by 30 percent, which would improve issuers' probability of meeting the 30 Super HCC constraint. Overall, our analyses found that making these modifications in combination will lead to the greater improvements in sampling precision and will allow more than 95 percent of issuers to pass the 10 percent sampling precision target at a two-sided 95 percent confidence level.
                    </P>
                    <FTNT>
                        <P>
                            <SU>284</SU>
                             As noted in the preamble of this final rule, enrollees without HCCs include stratum 10 enrollees that do not have HCCs nor RXCs and RXC-only enrollees in strata 1 through 3.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>285</SU>
                             As noted earlier in this preamble, this estimate is based on the combined impact of all finalized changes to the IVA sampling methodology.
                        </P>
                    </FTNT>
                    <P>We also considered only excluding stratum 10 enrollees from the IVA sampling methodology and retaining RXC-only enrollees in strata 1 through 3. However, we believe removing all enrollees without HCCs (both stratum 10 enrollees and RXC-only enrollees) is the preferred approach so issuers and IVA Entities are not spending resources on enrollees who do not have risk scores to adjust when calculating issuers' error rates during HHS-RADV. In addition, our analysis revealed the greatest improvements in precision and greatest decreases in the average medical records reviewed per enrollee, and therefore the greatest decreases in issuer and IVA Entity burden, when excluding RXC-only enrollees and stratum 10 enrollees from the IVA sampling methodology.</P>
                    <P>
                        As an alternative respect to the SVA pairwise means test proposal, we considered only changing the pairwise means testing procedure from the 95 percent confidence interval paired t-test to the 90 percent confidence interval bootstrapped test without increasing the initial SVA subsample size to 24. However, our analysis found that maintaining an initial SVA subsample size of 12 under the bootstrapping methodology did not achieve an optimal target false negative rate of approximately 20 percent at various effect sizes. Therefore, we are finalizing a modification to the pairwise means test to use a 90 percent confidence interval bootstrapping methodology and to increase the initial SVA subsample size from 12 enrollees to 24 enrollees beginning with 2024 benefit year HHS-RADV.
                        <SU>286</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>286</SU>
                             A standard IVA sample size is 200 enrollees, and it applies to the majority of issuers of risk adjustment covered plans. CMS calculates a smaller IVA sample sizes for issuers for smaller populations by using a Finite Population Correction (FPC) factor. All issuers are subject to the same SVA subsample sizes, but the maximum SVA subsample for pairwise testing is one half of the issuer's IVA sample size. As discussed in section II.B.5.a., we are finalizing changes to the IVA sampling methodology that will exclude enrollees without HCCs from IVA sampling and remove the FPC factor such that all IVA samples will consist of 200 enrollees with HCCs or the issuer's total EDGE population of enrollees with HCCs if they have less than 200 enrollees with HCCs beginning with the 2025 benefit year of HHS-RADV. Under this policy, the SVA subsample size expansion for issuers with less than 200 enrollees with HCCs will continue to follow the standard SVA subsample sizes with a maximum SVA subsample for pairwise testing equal to one half of the issuer's IVA sample size. If the issuer fails at the maximum SVA subsample size for pairwise testing, a precision analysis if performed to determine whether the SVA audit results from that maximum SVA subsample size can be used in error estimation or if the SVA sample needs to expand to the full IVA sample.
                        </P>
                    </FTNT>
                    <P>We considered taking no action regarding the changes at § 155.305(f)(4)(ii) and instead relying on the guidance released by CMS to inform Exchanges of noticing best practices as was previously done, but instead decided to codify this as a requirement to ensure that tax filers or their enrollees receive multiple educational notices regarding the requirement to file their Federal income taxes and reconcile their APTC.</P>
                    <P>
                        We considered taking no action regarding modifications to § 155.400(g) to allow issuers to adopt a fixed-dollar premium payment threshold or a gross 
                        <PRTPAGE P="4537"/>
                        premium-based percentage payment threshold. However, the finalized policy will provide important flexibility to issuers that wish to allow enrollees who owe de minimis amounts of premium to maintain their enrollment. This flexibility is limited under current regulation, and as a result enrollees who owe small amounts of premium are sometimes unable to remain enrolled. We solicited feedback from interested parties on whether a fixed-dollar threshold, or a percentage threshold based on gross premium, would better meet our goal of providing flexibility to issuers to allow enrollees to avoid triggering a grace period and termination of enrollment through the Exchange for owing small amounts of premium. For the fixed-dollar premium payment threshold, we also considered whether to implement a $5 or $10 cap on the fixed-dollar threshold because while we believe the $5 cap is sufficient to help many enrollees avoid termination, CMS data on non-payment terminations also indicate that there are a considerable number of policies that were terminated in PY2023 with a member responsibility amount of $10 or less. We solicited feedback from interested parties to determine what the appropriate cap should be on the fixed-dollar threshold and received comments supporting a $10 threshold, which we are finalizing in this rule. We also considered keeping the existing net premium-based threshold at a “reasonable” limit, which we recommended to be 95 percent or higher, but we are finalizing specifically defining the threshold at 95 percent or higher, to provide clarity for issuers and Exchanges. We also considered whether it would be administratively feasible to allow issuers to adopt both a fixed-dollar and percentage-based threshold but restricted issuers to choosing one threshold method. We solicited feedback from interested parties on whether we should allow this flexibility and received comments supporting this flexibility, which we are finalizing in this rule.
                    </P>
                    <P>For the 2026 benefit year FFE and SBE-FP user fees, we considered only proposing one FFE user fee rate and one SBE-FP user fee rate as we have done in previous years. However, we recognize that the expiration of the enhanced PTC subsidies at the end of the 2025 benefit year creates a significant amount of uncertainty in the ACA markets and despite this uncertainty, we maintain our interest in ensuring that we collect user fees at a rate that will allow us to sustain the operations of the FFEs. Therefore, we are finalizing two sets of user fee rates to account for both the expiration and extension of enhanced PTC subsidies.</P>
                    <P>We are finalizing an updated FFE user fee rate of 2.5 percent of total monthly premiums and an SBE-FP user fee rate of 2.0 percent of total monthly premiums for the 2026 benefit year, which account for the expiration of enhanced PTC subsidies at the end of the 2025 benefit year. The 2026 benefit year FFE and SBE-FP user fee rates are greater than the FFE and SBE-FP user fee rates of 1.5 and 1.2 percent of total monthly premiums, respectively, that were finalized in the 2025 Payment Notice (89 FR 26336 through 26338). We are also finalizing an alternative FFE user fee rate of 2.2 percent of total monthly premiums and an alternative SBE-FP user fee rate of 1.8 percent of total monthly premiums for the 2026 benefit year, which would take effect if enhanced PTC subsidies are extended at their current level, or at a higher level, by July 31, 2025.</P>
                    <P>We considered taking no action on conducting ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs in States performing plan management functions under § 156.235. Not conducting reviews as finalized would maintain current certification operations for issuers in FFE States that perform plan management functions and continue to provide States with the ability to use a similar approach to Federal ECP certification reviews of plans for which issuers submit QHP certification applications in FFEs. However, due to the implementation of the MPMS and enhancement of the ECP user interface, issuers seeking QHP certification in FFEs, including States performing plan management functions, can now submit ECP data to HHS for data integrity of the Federal platform regardless of whether it is the State or HHS conducting the review.</P>
                    <P>We are finalizing an amendment § 156.1220(a)(2) to codify when HHS will take action in response to a successful HHS-RADV appeal. We considered several ways to design the new materiality threshold to rerun HHS-RADV results. For example, we considered setting the second materiality threshold to rerun HHS-RADV results to include a percentage of HHS-RADV adjustments and applying a 1 percent test to align with the EDGE materiality threshold in § 153.710(e). However, considering that the HHS-RADV adjustments to State risk adjustment transfer charges and State risk adjustment transfer payments are orders of magnitude smaller than those of the initial State risk adjustment transfer amounts, we were concerned that we would see situations where 1 percent of the applicable payment or charge could be as little as $10 based on our experience running HHS-RADV for the past few years. Specifically, we believe that structuring the threshold, as finalized, to the financial impact of the filer and applying a threshold of equal to or greater than $10,000 amount will balance the need for ensuring that HHS-RADV results are accurate with the desire for ensuring that changes in HHS-RADV results actually have a meaningful financial impact. This finalized new materiality threshold to rerun HHS-RADV results takes into consideration the existing materiality threshold for filing a request for reconsideration, which applies to a number of different program appeals. To remain consistent with this existing threshold and recognizing that HHS-RADV adjustments are significantly smaller in magnitude than risk adjustment transfers, we believe that $10,000 is a reasonable threshold, but we solicited comment on this dollar amount and whether it should be higher or lower or whether we should consider including an inflation adjustment rate to this amount. This new finalized materiality threshold to rerun HHS-RADV results also considers the fact that it costs HHS approximately $75,000 to rerun HHS-RADV and re-release results. Reducing the number of times HHS-RADV needs to be rerun and HHS-RADV adjustments need to be re-released also helps maintain the stability of the market, as there are fewer instances of adjustments after the initial release of HHS-RADV adjustments.</P>
                    <HD SOURCE="HD2">E. Regulatory Flexibility Act (RFA)</HD>
                    <P>
                        The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that small businesses, nonprofit organizations, and small governmental jurisdictions are small entities as that term is used in the RFA. The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the Small Business Administration (SBA) definition of a small business (having revenues of less than $8.0 million to $41.5 million in any 1 year). We do not anticipate that providers will be directly impacted by the provisions in this final rule. Individuals and States are not included in the definition of a small entity. The provisions in this final rule will affect Exchanges and QHP issuers.
                        <PRTPAGE P="4538"/>
                    </P>
                    <P>
                        For purposes of the RFA, we believe that health insurance issuers will be classified under the NAICS code 524114 (Direct Health and Medical Insurance Carriers). According to SBA size standards, entities with average annual receipts of $47 million or less would be considered small entities for these NAICS codes. Issuers could possibly be classified in 621491 (HMO Medical Centers) and, if this is the case, the SBA size standard will be $44.5 million or less.
                        <SU>287</SU>
                        <FTREF/>
                         We believe that few, if any, insurance companies underwriting comprehensive health insurance policies (in contrast, for example, to travel insurance policies or dental discount policies) fall below these size thresholds. Based on data from MLR annual report submissions for the 2023 MLR reporting year, approximately 82 out of 475 issuers of health insurance coverage nationwide had total premium revenue of $47 million or less.
                        <SU>288</SU>
                        <FTREF/>
                         This estimate may overstate the actual number of small health insurance issuers that may be affected, since over 80 percent of these small issuers belong to larger holding groups, and many, if not all, of these small companies are likely to have non-health lines of business that will result in their revenues exceeding $47 million. Therefore, although it is likely that fewer than 82 issuers are considered small entities, for the purposes of this analysis, we assume 82 small issuers will be impacted by this final rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>287</SU>
                             SBA. (n.d.). 
                            <E T="03">Table of size standards. https://www.sba.gov/document/support--table-size-standards.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>288</SU>
                             CMS. (n.d.). 
                            <E T="03">Medical Loss Ratio Data and System Resources. https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.html.</E>
                        </P>
                    </FTNT>
                    <P>The finalized policies that will result in an increased burden to small entities are described below.</P>
                    <P>We are finalizing an update to the IVA sampling methodology, including the removal of enrollees without HCCs (including RXC-only enrollees), removing the FPC, and replacing the source of the Neyman allocation data with the most recent 3 years of consecutive HHS-RADV data with results that have been released before that benefit year's HHS-RADV activities begin, beginning with benefit year 2025 HHS-RADV. The total cost savings associated with this finalized policy will be approximately $79,121.92 per issuer audited per year. For more details, please refer to the Regulatory Impact Analysis section associated with this policy in this final rule.</P>
                    <P>
                        We are finalizing in this final rule amendments to add a definition of “qualifying issuer” and to give such issuers an option to modify the treatment of payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes beginning with the 2026 MLR reporting year. If every qualifying issuer chooses to take advantage of the option to modify the treatment of the payments or receipts related to the risk adjustment program for MLR reporting and rebate calculation purposes, then this finalized policy will reduce rebates paid by these issuers to consumers or increase premiums collected by these issuers from consumers by approximately $35 million annually. The cost savings per issuer will therefore be approximately $73,684.21.
                        <SU>289</SU>
                        <FTREF/>
                         For more details, please refer to the Regulatory Impact Analysis section associated with this policy in this final rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>289</SU>
                             $35 million/475 issuers subject to the MLR requirements = approximately $73,684.21.
                        </P>
                    </FTNT>
                    <P>Thus, the per-entity estimated annual cost savings for small issuers is $152,806.13, and the total estimated annual cost savings for small issuers is $13,294,133.31. See Tables 8 and 9.</P>
                    <GPH SPAN="3" DEEP="73">
                        <GID>ER15JA25.061</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="64">
                        <GID>ER15JA25.062</GID>
                    </GPH>
                    <P>We sought comment on this analysis and sought information on the number of small issuers that may be affected by the provisions in these final rules. We did not receive any comments on this analysis and are therefore finalizing the estimates as proposed.</P>
                    <P>
                        As its measure of significant economic impact on a substantial number of small entities, HHS uses a change in revenue of more than 3 to 5 percent. We do not believe that this threshold will be reached by the requirements in this final rule, given that the annual per-entity cost savings of $152,806.13 per small issuer represents approximately 0.07 percent of the average annual receipts for a small issuer.
                        <SU>290</SU>
                        <FTREF/>
                         Therefore, the Secretary has certified that this final rule will not have a significant economic impact on a substantial number of small entities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>290</SU>
                             United States Census Bureau (2020, March). 
                            <E T="03">2017 SUSB Annual Data Tables by Establishment Industry, Data by Enterprise Receipt Size. https://www.census.gov/data/tables/2020/econ/susb/2020-susb-annual.html.</E>
                        </P>
                    </FTNT>
                    <P>
                        In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For the purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. While this final rule is not subject to section 1102 of the Act, we have determined that this final rule will not affect small rural hospitals. Therefore, the Secretary has certified that this final 
                        <PRTPAGE P="4539"/>
                        rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
                    </P>
                    <HD SOURCE="HD2">F. Unfunded Mandates Reform Act (UMRA)</HD>
                    <P>Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2024, that threshold is approximately $183 million. Although we have not been able to quantify all costs, we expect that the combined impact on State, local, or Tribal governments and the private sector does not meet the UMRA definition of an unfunded mandate.</P>
                    <HD SOURCE="HD2">G. Federalism</HD>
                    <P>Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications.</P>
                    <P>In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have Federalism implications or limit the policy making discretion of the States, we have engaged in efforts to consult with and work cooperatively with affected States, including participating in conference calls with and attending conferences of the NAIC, and consulting with State insurance officials on an individual basis.</P>
                    <P>While developing this final rule, we attempted to balance the States' interests in regulating health insurance issuers with the need to ensure market stability. By doing so, we complied with the requirements of Executive Order 13132.</P>
                    <P>Because States have flexibility in designing their Exchange and Exchange-related programs, State decisions will ultimately influence both administrative expenses and overall premiums. States are not required to establish an Exchange or risk adjustment program. For States that elected previously to operate an Exchange, those States had the opportunity to use funds under Exchange Planning and Establishment Grants to fund the development of data. Accordingly, some of the initial cost of creating programs was funded by Exchange Planning and Establishment Grants. After establishment, Exchanges must be financially self-sustaining, with revenue sources at the discretion of the State. Current State Exchanges charge user fees to issuers.</P>
                    <P>In our view, while this final rule will not impose substantial direct requirement costs on State and local governments, this regulation has Federalism implications due to potential direct effects on the distribution of power and responsibilities among the State and Federal governments relating to determining standards relating to health insurance that is offered in the individual and small group markets. For example, the finalized policy to conduct ECP certification reviews of plans for issuers in FFEs in States performing plan management functions effective beginning in PY 2026 may have Federalism implications, given that HHS has not conducted Federal ECP certification reviews of plans in FFEs in States performing plan management functions since PY 2015. However, these Federalism implications may be balanced by enabling HHS to align standards in these States with Federal review standards, and thereby increasing consumer access in these States and improving efficiency of the QHP certification process. Additionally, we do not believe that the finalized amendment to codify the timeliness guidance for State Exchanges to review and resolve the State Exchange issuers enrollment data inaccuracies within 60 calendar days will have significant Federalism implications because this finalized policy is merely codifying a timeline for an existing data submission requirement. Likewise, we do not believe that codifying the permissibility of CSR loading has significant Federalism implications because it continues to allow States to determine whether to allow and how to implement actuarially justified CSR loading in their State, as discussed in section III.D.3 of this preamble.</P>
                    <HD SOURCE="HD2">H. Congressional Review Act</HD>
                    <P>
                        Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act, 5 U.S.C 801 
                        <E T="03">et seq.</E>
                        ), OIRA has determined that this rule meets the criteria set forth in 5 U.S.C. 804(2). Therefore, this rule shall be submitted to each House of the Congress and to the Comptroller General as part of a report containing a copy of the rule along with other information specified in 5 U.S.C. 801(a)(1). Chiquita Brooks-LaSure, Administrator of the Centers for Medicare &amp; Medicaid Services, approved this document on December 20, 2024.
                    </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects</HD>
                        <CFR>
                            <E T="03">45 CFR Part 155</E>
                        </CFR>
                        <P>Administrative practice and procedure, Advertising, Brokers, Conflict of interests, Consumer protection, Grants administration, Grant programs—health, Health care, Health insurance, Health maintenance organizations (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Intergovernmental relations, Loan programs—health, Medicaid, Organization and functions (Government agencies), Public assistance programs, Reporting and recordkeeping requirements, Technical assistance, Women and youth.</P>
                        <CFR>
                            <E T="03">45 CFR Part 156</E>
                        </CFR>
                        <P>Administrative practice and procedure, Advertising, Advisory committees, Brokers, Conflict of interests, Consumer protection, Grant programs—health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs—health, Medicaid, Organization and functions (Government agencies), Public assistance programs, Reporting and recordkeeping requirements, State and local governments, Sunshine Act, Technical assistance, Women, and Youth.</P>
                        <CFR>
                            <E T="03">45 CFR Part 158</E>
                        </CFR>
                        <P>Administrative practice and procedure, Claims, Health care, Health insurance, Penalties, Reporting and recordkeeping requirements.</P>
                    </LSTSUB>
                    <P>For the reasons set forth in the preamble, under the authority at 5 U.S.C. 301, the Department of Health and Human Services amends 45 CFR subtitle A, subchapter B, as set forth below.</P>
                    <PART>
                        <HD SOURCE="HED">PART 155—EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED STANDARDS UNDER THE AFFORDABLE CARE ACT</HD>
                    </PART>
                    <REGTEXT TITLE="45" PART="155">
                        <AMDPAR>1. The authority citation for part 155 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P> 42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 18081-18083.</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="155">
                        <AMDPAR>2. Section 155.220 is amended by revising paragraph (k)(3) to read as follows:</AMDPAR>
                        <SECTION>
                            <PRTPAGE P="4540"/>
                            <SECTNO>§ 155.220</SECTNO>
                            <SUBJECT>Ability of States to permit agents, brokers, web-brokers, and agencies to assist qualified individuals, qualified employers, or qualified employees enrolling in QHPs.</SUBJECT>
                            <STARS/>
                            <P>(k) * * *</P>
                            <P>(3) HHS may immediately suspend the agent's or broker's ability to transact information with the Exchange if HHS discovers circumstances that pose unacceptable risk to the accuracy of the Exchange's eligibility determinations, Exchange operations, applicants, or enrollees, or Exchange information technology systems, including but not limited to risk related to noncompliance with the standards of conduct under paragraph (j)(2)(i), (ii), or (iii) of this section and the privacy and security standards under § 155.260, until the circumstances of the incident, breach, or noncompliance are remedied or sufficiently mitigated to HHS' satisfaction.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="155">
                        <AMDPAR>3. Section 155.305 is amended by adding paragraph (f)(4)(ii) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 155.305</SECTNO>
                            <SUBJECT>Eligibility Standards.</SUBJECT>
                            <STARS/>
                            <P>(f) * * *</P>
                            <P>(4) * * *</P>
                            <P>(ii) If HHS notifies the Exchange as part of the process described in § 155.320(c)(3) that APTC payments were made on behalf of either the tax filer or their spouse, if the tax filer is a married couple, for 2 consecutive tax years for which tax data would be utilized for verification of household income and family size in accordance with § 155.320(c)(1)(i), and the tax filer or the tax filer's spouse did not comply with the requirement to file an income tax return for both years as required by 26 U.S.C. 6011, 6012, and their implementing regulations and reconcile APTC for that period (“file and reconcile”), the Exchange must:</P>
                            <P>(A) Send a direct notification to the tax filer, consistent with the standards applicable to the protection of Federal Tax Information, that explicitly informs the tax filer that the Exchange has determined that the tax filer or the tax filer's spouse, if the tax filer is married, has failed to file their Federal income taxes and reconcile APTC, and educate the tax filer of the need to file and reconcile or risk being determined ineligible for APTC after 2 consecutive years of failing to file and reconcile; or</P>
                            <P>(B) Send an indirect notification to either the tax filer or their enrollee, that informs the tax filer or enrollee that they may be at risk of being determined ineligible for APTC after 2 years of failing to file and reconcile. These notices must educate tax filers or their enrollees on the requirement to file and reconcile, while not directly stating that the Internal Revenue Service indicates the tax filer or the tax filer's spouse, if the tax filer is married, has failed to file and reconcile.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="155">
                        <AMDPAR>4. Section 155.400 is amended by adding paragraphs (d)(1) and (2) and revising paragraph (g) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 155.400</SECTNO>
                            <SUBJECT>Enrollment of qualified individuals into QHPs.</SUBJECT>
                            <STARS/>
                            <P>(d) * * *</P>
                            <P>
                                (1) 
                                <E T="03">Timeliness standard for State Exchanges to review, resolve, and report data inaccuracies submitted by a State Exchange issuer.</E>
                                 Within 60 calendar days after a State Exchange receives a data inaccuracy from an issuer operating in the State Exchange that includes a description of a data inaccuracy in accordance with § 156.1210 and all the information that the State Exchange requires or requests to properly assess the inaccuracy, the State Exchange must review and resolve the State Exchange issuer's data inaccuracies and submit to HHS a description of the resolution of the inaccuracies in a format and manner specified by HHS.
                            </P>
                            <P>(2) [Reserved]</P>
                            <STARS/>
                            <P>
                                (g) 
                                <E T="03">Premium payment threshold.</E>
                                 Exchanges may, and the Federally-facilitated Exchanges and State-Based Exchanges on the Federal platform will, allow issuers to implement a percentage-based premium payment threshold policy (which can be based on either the net premium after application of advance payments of the premium tax credit or gross premium) and/or a fixed-dollar premium payment threshold policy, provided that the threshold and policy is applied in a uniform manner to all applicants and enrollees.
                            </P>
                            <P>(1) Under a net premium percentage-based premium payment threshold policy, issuers can consider applicants or enrollees to have paid all amounts due for the following purposes, if the applicants or enrollees pay an amount sufficient to maintain a percentage of total premium paid out of the total premium owed equal to or greater than 95 percent of the net monthly premium amount owed by the enrollees. If an applicant or enrollee satisfies the percentage-based premium payment threshold policy, the issuer may:</P>
                            <P>(i) Effectuate an enrollment based on payment of the binder payment under paragraph (e) of this section.</P>
                            <P>(ii) Avoid triggering a grace period for non-payment of premium, as described by § 156.270(d) of this subchapter or a grace period governed by State rules.</P>
                            <P>(iii) Avoid terminating the enrollment for non-payment of premium as, described by §§ 156.270(g) of this subchapter and 155.430(b)(2)(ii)(A) and (B).</P>
                            <P>(2) Under a gross premium percentage-based premium payment threshold policy, issuers can consider enrollees to have paid all amounts due for the following purposes, if the enrollees pay an amount sufficient to maintain a percentage of the gross premium of the policy before the application of advance payments of the premium tax credit that is equal to or greater than 98 percent of the gross monthly premium owed by the enrollees. If an enrollee satisfies the gross premium percentage-based premium payment threshold policy, the issuer may:</P>
                            <P>(i) Avoid triggering a grace period for non-payment of premium, as described by § 156.270(d) of this subchapter or a grace period governed by State rules.</P>
                            <P>(ii) Avoid terminating the enrollment for non-payment of premium as, described by §§ 156.270(g) of this subchapter and 155.430(b)(2)(ii)(A) and (B).</P>
                            <P>(3) Under a fixed-dollar premium payment threshold policy, issuers can consider enrollees to have paid all amounts due for the following purposes, if the enrollees pay an amount that is less than the total premium owed, the unpaid remainder of which is equal to or less than a fixed-dollar amount of $10 or less, adjusted for inflation, as prescribed by the issuer. If an enrollee satisfies the fixed-dollar premium payment threshold policy, the issuer may:</P>
                            <P>(i) Avoid triggering a grace period for non-payment of premium, as described by § 156.270(d) of this subchapter or a grace period governed by State rules.</P>
                            <P>(ii) Avoid terminating the enrollment for non-payment of premium as, described by §§ 156.270(g) of this subchapter and 155.430(b)(2)(ii)(A) and (B).</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="155">
                        <AMDPAR>5. Section 155.505 is amended by revising paragraph (b) introductory text to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 155.505</SECTNO>
                            <SUBJECT>General Eligibility Appeals Requirements.</SUBJECT>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">Right to appeal.</E>
                                 An applicant, enrollee, or application filer must have the right to appeal:
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="155">
                        <PRTPAGE P="4541"/>
                        <AMDPAR>6. Section 155.1000 is amended by adding paragraph (e) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 155.1000</SECTNO>
                            <SUBJECT>Certification standards for QHPs.</SUBJECT>
                            <STARS/>
                            <P>
                                (e) 
                                <E T="03">Denial of certification.</E>
                                 The Exchange may deny certification to any plan that does not meet the general certification criteria under § 155.1000(c).
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="155">
                        <AMDPAR>7. Section 155.1090 is amended by revising the section heading, the paragraph (a) heading, and paragraphs (a)(2) and (3) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 155.1090</SECTNO>
                            <SUBJECT>Request for the reconsideration of a denial of certification.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Request for the reconsideration of a denial of certification specific to a Federally-facilitated Exchange</E>
                                —
                            </P>
                            <STARS/>
                            <P>
                                (2) 
                                <E T="03">Form and manner of request.</E>
                                 An issuer submitting a request for reconsideration under paragraph (a)(1) of this section must submit a written request for reconsideration to HHS, in the form and manner specified by HHS, within 7 calendar days of the date of the written notice of denial of certification. The issuer must include any and all documentation the issuer wishes to provide in support of its request with its request for reconsideration. The request for reconsideration must provide clear and convincing evidence that HHS' determination that the plan does not meet the general certification criteria at § 155.1000(c) was in error.
                            </P>
                            <P>
                                (3) 
                                <E T="03">HHS reconsideration decision.</E>
                                 HHS will review the reconsideration request to determine whether the issuer's reconsideration request provided clear and convincing evidence that HHS' determination that the plan does not meet the general certification criteria at § 155.1000(c) was in error. HHS will provide the issuer with a written notice of the reconsideration decision. The decision will constitute HHS' final determination.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 156—HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES</HD>
                    </PART>
                    <REGTEXT TITLE="45" PART="156">
                        <AMDPAR>8. The authority citation for part 156 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P> 42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, and 26 U.S.C. 36B.</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="156">
                        <AMDPAR>9. Section 156.80 is amended by revising paragraph (d)(2)(i) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 156.80</SECTNO>
                            <SUBJECT>Single risk pool.</SUBJECT>
                            <STARS/>
                            <P>(d) * * *</P>
                            <P>(2) * * *</P>
                            <P>(i) The actuarial value and cost-sharing design of the plan, including, if permitted by the applicable State authority (as defined in § 144.103 of this subchapter), accounting for cost-sharing reduction amounts provided to eligible enrollees under § 156.410, provided the issuer does not otherwise receive reimbursement for such amounts.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="156">
                        <AMDPAR>10. Section 156.201 is amended by adding paragraph (c) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 156.201</SECTNO>
                            <SUBJECT>Standardized plan options.</SUBJECT>
                            <STARS/>
                            <P>(c) For plan year 2026 and subsequent plan years, an issuer that offers multiple standardized plan options within the same product network type, metal level, and service area must meaningfully differentiate these plans from one another in terms of included benefits, provider networks, included prescription drugs, or a combination of some or all these factors. For the purposes of this standard, a standardized plan option with a different product ID, provider network ID, drug list ID, or a combination of some or all these factors, would be considered meaningfully different.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="156">
                        <AMDPAR>11. Section 156.202 is amended by revising paragraph (b) and paragraph (d) introductory text to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 156.202</SECTNO>
                            <SUBJECT>Non-standardized plan option limits.</SUBJECT>
                            <STARS/>
                            <P>(b) For plan year 2025 and subsequent plan years, is limited to offering two non-standardized plan options per product network type, as the term is described in the definition of “product” at § 144.103 of this subchapter, metal level (excluding catastrophic plans), and inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of this section), in any service area.</P>
                            <STARS/>
                            <P>(d) For plan year 2025 and subsequent plan years, an issuer may offer additional non-standardized plan options for each product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage (as defined in paragraphs (c)(1) through (3) of this section), and service area if it demonstrates that these additional plans' cost sharing for benefits pertaining to the treatment of chronic and high-cost conditions (including benefits in the form of prescription drugs, if pertaining to the treatment of the condition(s)) is at least 25 percent lower, as applied without restriction in scope throughout the plan year, than the cost sharing for the same corresponding benefits in the issuer's other non-standardized plan option offerings in the same product network type, metal level, inclusion of adult dental benefit coverage, pediatric dental benefit coverage, and adult vision benefit coverage, and service area.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="156">
                        <AMDPAR>12. Section 156.1220 is amended by adding paragraphs (a)(2)(i) and (ii) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 156.1220</SECTNO>
                            <SUBJECT>Administrative appeals.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(2) * * *</P>
                            <P>(i) Notwithstanding paragraphs (a)(1) and (2) of this section, for appeals related to HHS-RADV under paragraphs (a)(1)(vii) and (viii) of this section, HHS will only take action to adjust risk adjustment State payments and charges for an issuer in response to an appeal decision when the impact of the decision to the filer's HHS-RADV adjustments to risk adjustment State transfers is greater than or equal to $10,000.</P>
                            <P>(ii) [Reserved]</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 158—ISSUER USE OF PREMIUM REVENUE: REPORTING AND REBATE REQUIREMENTS</HD>
                    </PART>
                    <REGTEXT TITLE="45" PART="158">
                        <AMDPAR>13. The authority citation for part 158 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P> 42 U.S.C. 300gg-18.</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="158">
                        <AMDPAR>14. Section 158.103 is amended by adding a definition for “Qualifying issuer” in alphabetical order to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 158.103</SECTNO>
                            <SUBJECT>Definitions.</SUBJECT>
                            <STARS/>
                            <P>
                                <E T="03">Qualifying issuer</E>
                                 means an issuer whose aggregate ratio of net payments related to the risk adjustment program under section 1343 of the Patient Protection and Affordable Care Act, 42 U.S.C. 18063, to earned premiums as defined in § 158.130, but prior to and excluding the adjustments in § 158.130(b)(5) that account for the net payments or receipts related to the risk adjustment, risk corridors, and reinsurance programs, based on three consecutive years of data in a relevant State and market, is greater than or equal to 50 percent.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="45" PART="158">
                        <PRTPAGE P="4542"/>
                        <AMDPAR>15. Section 158.140 is amended by revising paragraph (b)(4)(ii) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 158.140</SECTNO>
                            <SUBJECT>Reimbursement for clinical services provided to enrollees.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(4) * * *</P>
                            <P>(ii) Beginning with the 2026 MLR reporting year, for qualifying issuers (as defined in § 158.103), at such issuers' option, receipts related to the transitional reinsurance program and net payments or receipts related to the risk corridors program (calculated using an adjustment percentage, as described in § 153.500 of this subchapter, equal to zero percent) under sections 1341 and 1342 of the Patient Protection and Affordable Care Act, 42 U.S.C. 18061, 18062. For all other issuers, receipts related to the transitional reinsurance program and net payments or receipts related to the risk adjustment and risk corridors programs (calculated using an adjustment percentage, as described in § 153.500 of this subchapter, equal to zero percent) under sections 1341, 1342, and 1343 of the Patient Protection and Affordable Care Act, 42 U.S.C. 18061, 18062, 18063.</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <AMDPAR>16. Section 158.240 is amended by revising paragraph (c)(2) and adding paragraph (c)(3) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 158.240</SECTNO>
                        <SUBJECT>Rebating premium if the applicable medical loss ratio standard is not met.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(2) For example, an issuer must rebate a pro rata portion of premium revenue if it does not meet an 80 percent MLR for the individual market in a State that has not set a higher MLR. If an issuer has a 75 percent MLR for the coverage it offers in the individual market in a State that has not set a higher MLR, the issuer must rebate 5 percent of the premium paid by or on behalf of the enrollee for the MLR reporting year after subtracting a pro rata portion of taxes and fees and accounting for payments or receipts related to the reinsurance, risk adjustment and risk corridors programs (calculated using an adjustment percentage, as described in § 153.500 of this subchapter, equal to zero percent). If the issuer is not a qualifying issuer (defined in § 158.103), or is a qualifying issuer that does not opt to apply risk adjustment transfer amounts as described in § 158.140(b)(4)(ii), the issuer's total earned premium for the MLR reporting year in the individual market in the State is $200,000, incurred claims are $121,250, the issuer received transitional reinsurance payments of $2,500, and made net payments related to risk adjustment and risk corridors of $20,000 (calculated using an adjustment percentage, as described in § 153.500 of this subchapter, equal to zero percent), then the issuer's gross earned premium in the individual market in the State would be $200,000 plus $2,500 minus $20,000, for a total of $182,500. If the issuer's Federal and State taxes and licensing and regulatory fees, including reinsurance contributions, that may be excluded from premium revenue as described in §§ 158.161(a), 158.162(a)(1), and 158.162(b)(1), allocated to the individual market in the State are $15,000, and the net payments related to risk adjustment and risk corridors, reduced by reinsurance receipts, that must be accounted for in premium revenue as described in §§ 158.130(b)(5), 158.221, and 158.240, are $17,500 ($20,000 reduced by $2,500), then the issuer would subtract $15,000 and add $17,500 to gross premium revenue of $182,500, for a base of $185,000 in adjusted premium. The issuer would owe rebates of 5 percent of $185,000, or $9,250 in the individual market in the State. In this example, if an enrollee of the issuer in the individual market in the State paid $2,000 in premiums for the MLR reporting year, or 1/100 of the issuer's total premium in that State market, then the enrollee would be entitled to 1/100 of the total rebates owed by the issuer, or $92.50.</P>
                        <P>(3) As another example, if an issuer is a qualifying issuer (defined in § 158.103) that opts to apply risk adjustment transfer amounts as described in § 158.140(b)(4)(ii), the issuer's total earned premium for the MLR reporting year in the individual market in the State is $90,000, incurred claims are $151,250, and the issuer received transitional reinsurance payments of $12,500 and net receipts related to risk adjustment of $110,000, then the issuer's gross earned premium in the individual market in the State would be $90,000 plus $12,500, for a total of $102,500. If the qualifying issuer's Federal and State taxes and licensing and regulatory fees, including reinsurance contributions, that may be excluded from premium revenue as described in §§ 158.161(a), 158.162(a)(1), and 158.162(b)(1), allocated to the individual market in the State are $15,000, and the reinsurance payments that must be accounted for in premium revenue as described in §§ 158.130(b)(5), 158.221, and 158.240 are $12,500, then the qualifying issuer would subtract $15,000 and $12,500 from gross premium revenue of $102,500, for a subtotal of $75,000. The qualifying issuer would then add $110,000 in net receipts related to risk adjustment, for a base of $185,000 in adjusted premium. The qualifying issuer would owe rebates of 5 percent of $185,000, or $9,250 in the individual market in the State. In this example, if an enrollee of the issuer in the individual market in the State paid $900 in premiums for the MLR reporting year, or 1/100 of the issuer's total premium in that State market, then the enrollee would be entitled to 1/100 of the total rebates owed by the issuer, or $92.50.</P>
                        <STARS/>
                    </SECTION>
                    <SIG>
                        <NAME>Xavier Becerra,</NAME>
                        <TITLE>Secretary, Department of Health and Human Services.</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2025-00640 Filed 1-13-25; 4:15 pm]</FRDOC>
                <BILCOD>BILLING CODE 4120-01-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>90</VOL>
    <NO>9</NO>
    <DATE>Wednesday, January 15, 2025</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="4543"/>
            <PARTNO>Part XI</PARTNO>
            <AGENCY TYPE="P"> Department of Commerce</AGENCY>
            <SUBAGY> Bureau of Industry and Security</SUBAGY>
            <HRULE/>
            <CFR>15 CFR Parts 732, 734, 740, et al.</CFR>
            <TITLE>Framework for Artificial Intelligence Diffusion; Interim Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="4544"/>
                    <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                    <SUBAGY>Bureau of Industry and Security</SUBAGY>
                    <CFR>15 CFR Parts 732, 734, 740, 742, 744, 748, 750, 762, 772, and 774</CFR>
                    <DEPDOC>[Docket No. 250107-0007]</DEPDOC>
                    <RIN>RIN 0694-AJ90</RIN>
                    <SUBJECT>Framework for Artificial Intelligence Diffusion</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Bureau of Industry and Security, Department of Commerce.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Interim final rule; request for comments.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>With this interim final rule, the Commerce Department's Bureau of Industry and Security (BIS) revises the Export Administration Regulations' (EAR) controls on advanced computing integrated circuits (ICs) and adds a new control on artificial intelligence (AI) model weights for certain advanced closed-weight dual-use AI models. In conjunction with the expansion of these controls, which BIS has determined are necessary to protect U.S. national security and foreign policy interests, BIS is adding new license exceptions and updating the Data Center Validated End User authorization to facilitate the export, reexport, and transfer (in-country) of advanced computing (ICs) to end users in destinations that do not raise national security or foreign policy concerns. Together, these changes will cultivate secure ecosystems for the responsible diffusion and use of AI and advanced computing ICs.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P/>
                        <P>
                            <E T="03">Effective date:</E>
                             This rule is effective January 13. 2025.
                        </P>
                        <P>
                            <E T="03">Compliance date:</E>
                             As explained in the 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             section, exporters, reexporters, and transferors are not required to comply with the changes made in this rule until May 15, 2025, except that paragraphs 14, 15, and 18 of supplement no. 10 to part 748 have a delayed compliance date of January 15, 2026.
                        </P>
                        <P>
                            <E T="03">Comment due date:</E>
                             Comments on revisions and additions in this rule are strongly encouraged and must be received by BIS no later than May 15, 2025.
                        </P>
                        <P>
                            <E T="03">Saving clause:</E>
                             Shipments of items removed from eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export, reexport, or transfer (in-country), on May 15, 2025, pursuant to actual orders for export, reexport, or transfer (in-country) to or within a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR), provided the export, reexport, or transfer (in-country) is completed no later than on June 16, 2025.
                        </P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            Comments on this rule may be submitted to the Federal rulemaking portal (
                            <E T="03">www.regulations.gov</E>
                            ). The 
                            <E T="03">regulations.gov</E>
                             ID for this rule is: BIS-2025-0001. Please refer to RIN 0694-AJ90 in all comments.
                        </P>
                        <P>All filers using the portal should use the name of the person or entity submitting the comments as the name of their files, in accordance with the instructions below. Anyone submitting business confidential information should clearly identify the business confidential portion at the time of submission, file a statement justifying nondisclosure and referring to the specific legal authority claimed, and provide a non-confidential version of the submission.</P>
                        <P>
                            For comments submitted electronically containing business confidential information, the file name of the business confidential version should begin with the characters “BC.” Any page containing business confidential information must be clearly marked “BUSINESS CONFIDENTIAL” on the top of that page. The corresponding non-confidential version of those comments must be clearly marked “PUBLIC.” The file name of the non-confidential version should begin with the character “P.” Any submissions with file names that do not begin with either a “BC” or a “P” will be assumed to be public and will be made publicly available through 
                            <E T="03">https://www.regulations.gov</E>
                            . Commenters submitting business confidential information are encouraged to scan a hard copy of the non-confidential version to create an image of the file, rather than submitting a digital copy with redactions applied, to avoid inadvertent redaction errors which could enable the public to read business confidential information.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P/>
                        <P>
                            <E T="03">For general questions contact:</E>
                             Hillary Hess at 202-482-2440 or 
                            <E T="03">RPD2@bis.doc.gov</E>
                            .
                        </P>
                        <P>
                            <E T="03">For technical questions contact:</E>
                        </P>
                        <P>
                            <E T="03">Category 2:</E>
                             Sean Ghannadian at 202-482-3429 or 
                            <E T="03">Sean.Ghannadian@bis.doc.gov</E>
                            .
                        </P>
                        <P>
                            <E T="03">Category 3:</E>
                             Carlos Monroy at 202-482-3246 or 
                            <E T="03">Carlos.Monroy@bis.doc.gov</E>
                            .
                        </P>
                        <P>
                            <E T="03">Category 4:</E>
                             Aaron Amundson at 202-482-0707 or 
                            <E T="03">Aaron.Amundson@bis.doc.gov</E>
                            ].
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">I. Background</HD>
                    <P>BIS is amending the EAR to enhance and refine its framework for applying export controls to regulate the global diffusion of the most advanced artificial intelligence (AI) models and large clusters of advanced computing integrated circuits (ICs) to protect U.S. national security and foreign policy interests. Specifically, BIS is expanding existing controls on advanced computing ICs controlled under ECCNs 3A090.a and 4A090.a and the corresponding .z items and imposing new controls on the model weights of certain advanced closed-weight dual-use AI models controlled under newly created ECCN 4E091. Background on these changes, which follow extensive U.S. government consideration of the impact of advanced dual-use AI models on U.S. national security and foreign policy interests, is detailed below.</P>
                    <P>
                        The Export Control Reform Act of 2018 (ECRA), 15 U.S.C. 4801, 
                        <E T="03">et seq.,</E>
                         emphasizes that national security “requires that the United States maintain its leadership in the science, technology, engineering, and manufacturing sectors, including foundational technology that is essential to innovation.” ECRA also commands that BIS's rules be “transparent, predictable, and timely,” and have “the flexibility to be adapted” in light of evolving circumstances. Given that this rule imposes new global requirements on a rapidly developing industry that is central to innovation, BIS has determined that it can best further the United States's technological leadership, and provide transparency and predictability to affected stakeholders, by delaying the compliance date of this rule, as outlined in the 
                        <E T="02">DATES</E>
                         section. Such delay will allow stakeholders time to familiarize themselves with the rule, and to provide comment on it, before compliance is required.
                    </P>
                    <HD SOURCE="HD2">a. Risks and Benefits of Advanced AI Models</HD>
                    <P>
                        Over the past decade, AI models have shown striking performance improvements across many domains, including reasoning, coding, and image and voice recognition and creation. These performance improvements create numerous direct applications, such as text generation and computer code-assistance, and can increasingly support AI agents that are able to interact with digital and physical systems, increasing the ability of laypeople to, for example, write code or use scientific tools that previously required specialized skills. 
                        <PRTPAGE P="4545"/>
                        Performance improvements may continue as AI developers increase the scale and efficiency of their models.
                    </P>
                    <P>
                        Experts from across the U.S. government have determined that as the capabilities of these models continue to improve, they will enable malicious actors to engage in activities that pose profound risks to U.S. national security and foreign policy objectives. As the Office of the Director of National Intelligence has assessed, AI models have the potential to enable advanced military and intelligence applications; lower the barriers to entry for non-experts to develop weapons of mass destruction (WMD); support powerful offensive cyber operations; and assist in human rights violations, such as through mass surveillance. 
                        <E T="03">See</E>
                         Feb 5, 2024, Office of the Director of National Intelligence, Annual Threat Assessment of the U.S. Intelligence Community. For example, a dual-use AI model trained on data describing the functions and mechanics of chemical compounds or biological sequences could lower barriers to the development of chemical or biological weapons by providing protocols and troubleshooting information that would enable non-experts to design and produce such weapons at low cost. Similarly, the Department of Homeland Security has determined that advancements in AI may lower the barriers to entry for WMD development for both state and non-state actors and thus enhance malicious actors' ability to conduct attacks that threaten U.S. national security. 
                        <E T="03">See</E>
                         April 26, 2024, Department of Homeland Security Report on Reducing the Risks at the Intersection of Artificial Intelligence and Chemical, Biological, Radiological, and Nuclear Threats.
                    </P>
                    <P>
                        At the same time, experts from across the U.S. government have determined that, in the hands of validated entities operating under secure conditions, dual-use AI models have the potential to create significant economic and social benefits in the United States and across the globe. As BIS explained in a previous rule, dual-use AI models hold the potential to increase access to healthcare, education, and food and assist with combatting complex problems such as climate change. 
                        <E T="03">See</E>
                         Expansion of Validated End User Authorization: Data Center Validated End User Authorization, 89 FR 80,080 (Oct. 2, 2024). For example, under the right conditions, advanced AI models could be an enabler toward achieving Sustainable Development Goals, such as by boosting productivity in the pharmaceutical industry, strengthening climate resilience by improving climate modelling, and helping expand access to education by providing personalized tutors in a wide range of subjects. The United States is committed to the full implementation of the 2030 Agenda for Sustainable Development and Sustainable Development Goals.
                    </P>
                    <P>In other words, advanced AI models both pose unique threats to U.S. national security and foreign policy and have the potential to unlock unique economic and social benefits. As President Biden explained in remarks made to the United Nations General Assembly on September 24, 2024, AI will transform “our ways of life, our ways of work, and our ways of war.” As well as profound benefits, President Biden noted, AI brings “profound risks,” from “disinformation to novel pathogens to bioweapons.” President Biden's National Security Memorandum on Advancing the United States' Leadership in Artificial Intelligence; Harnessing Artificial Intelligence to Fulfill National Security Objectives; and Fostering the Safety, Security, and Trustworthiness of Artificial Intelligence, issued on October 24, 2024, similarly explained the promise and perils of AI. “AI,” it stated, “if used appropriately and for its intended purpose, can offer great benefits. If misused, AI could threaten United States national security, bolster authoritarianism worldwide, undermine democratic institutions and processes, facilitate human rights abuses, and weaken the rules-based international order.” Importantly, such “harmful outcomes could occur even without malicious intent if AI systems and processes lack sufficient protections.”</P>
                    <HD SOURCE="HD2">b. AI Diffusion Policy Review</HD>
                    <P>
                        Recognizing both the benefits and the risks of advanced AI models, the Department of Commerce (Commerce) has engaged in an extensive and ongoing policy process with partners across the U.S. Government to consider strategic, tailored, and effective controls on the diffusion of advanced AI technology to entities and destinations around the world. In October 2022, BIS imposed a first set of controls to certain destinations with the aim of preventing certain foreign military and intelligence services from obtaining the ability to indigenously develop advanced weapons modeling and advanced AI capabilities, by imposing restrictions on their access to advanced computing ICs and certain semiconductor manufacturing equipment (SME) used to manufacture advanced computing ICs and other advanced-node ICs. BIS determined that those foreign military and intelligence services would use advanced AI to improve the speed and accuracy of their military decision making, planning, and logistics, as well as their autonomous military systems, such as those used for cognitive electronic warfare, radar, signals intelligence, and jamming. 
                        <E T="03">See</E>
                         Implementation of Additional Export Controls: Certain Advanced Computing and Semiconductor Manufacturing Items; Supercomputer and Semiconductor End Use; Entity List Modification, 87 FR 62,186 (Oct. 13, 2022). BIS also determined that those military and intelligence services would use advanced AI surveillance tools, enabled by efficient processing of huge amounts of data, to monitor, track, and surveil citizens, among other purposes, without regard for human rights. 
                        <E T="03">See id.</E>
                         Accordingly, BIS controlled both the advanced computing ICs and the SME used to manufacture the controlled ICs.
                    </P>
                    <P>Since then, BIS has continuously evaluated and updated BIS's controls to ensure that they remain as targeted and effective as possible to protect U.S. national security and foreign policy In 2023, BIS updated the technological parameters on its advanced computing controls and broadened the scope of destinations to which those controls apply to cover countries of concern not captured by the 2022 controls. BIS also imposed worldwide license requirements for advanced computing ICs and certain semiconductor end-uses when conducted on behalf of entities headquartered in Country Group D:5 or Macau. In 2024, BIS made clarifications to the scope of the AI and SME controls and, recognizing the importance of facilitating the responsible diffusion of advanced AI technology, expanded Authorization Validated End User (VEU) to enable data centers to receive VEU authorizations, which allow entities in locations subject to license requirements to receive controlled items through a streamlined process subject to security conditions. BIS's work in this area is consistent with U.S. foreign policy to support global development.</P>
                    <P>
                        Over the past year, BIS has engaged with national security and foreign policy experts from across the U.S. Government—including interagency export control partners in the Departments of Defense, Energy, and State, as well as the Intelligence Community—to study whether and how additional controls on advanced AI technologies would advance U.S. national security and foreign policy. As explained below, they began by studying the risks and benefits that would arise if the most advanced AI models or the items necessary for developing them were allowed to diffuse through destinations across the 
                        <PRTPAGE P="4546"/>
                        world. Simultaneously, they engaged with technical experts to understand the most effective means for controlling the diffusion of those items to address the risks. This rule details a multi-part control structure aiming to both reduce the risk that countries of concern (Country Group D:5 and Macau) obtain the most advanced AI models and enable validated entities to access the benefits of those models, while protecting national security.
                    </P>
                    <HD SOURCE="HD3">i. Impact of AI Diffusion on National Security and Foreign Policy</HD>
                    <P>The proliferation of advanced AI models throughout the world will affect U.S. national security and foreign policy interests in three fundamental ways.</P>
                    <P>First, exporting advanced AI models, or the means to produce them, to any destination outside the United States increases the risk of theft or diversion to countries and end users of concern. Although the degree of risk varies between different destinations and end users, there is risk even when the end user is a validated entity and the destination is a U.S. ally with a robust export control system. These risks may be most acute at the constantly advancing frontier of AI development—the largest and most advanced models available at any given time.</P>
                    <P>Second, it will be impossible to realize the full economic and social benefits of advanced AI models unless validated entities outside the United States are able to obtain large quantities of advanced computing ICs or advanced AI models themselves. Such entities may be able to discover beneficial applications that U.S. firms alone will not, and they may increase the likelihood that the benefits of advanced AI models reach people across the world. The Export Control Reform Act of 2018 (ECRA) states that export controls should be “tailored to focus on those core technologies . . . capable of being used to pose a serious national security threat to the United States,” so BIS considered the need to appropriately tailor potential controls to address national security concerns without unduly burdening the economic and social benefits of access by foreign entities to advanced AI models and advanced computing ICs. 50 U.S.C. 4811(2)(G) and (5). In cases in which such entities are located in destinations that present a risk of diversion or misuse, BIS and its interagency export control partners can account for that risk with appropriate mitigation measures.</P>
                    <P>Third, U.S. national security requires that the United States maintain technological leadership in the global AI industry. Specifically, ECRA notes that maintaining technological leadership is a core national security interest and that the impact of export controls on technology leadership must be continuously evaluated (50 U.S.C. 4811(3)). BIS has determined that to maintain U.S. leadership in the field of AI, U.S. developers of advanced AI models may need to build large clusters of advanced computing ICs outside the United States. They may also need to store their models at facilities abroad to ensure that they can provide high quality services to validated foreign customers.</P>
                    <P>Therefore, BIS determined that U.S. national security and foreign policy require the regulation of the global diffusion of advanced AI models. However, such controls must be tailored to enable economically and socially beneficial uses of advanced AI models and to maintain U.S. technological leadership as described above.</P>
                    <HD SOURCE="HD3">ii. Means for Responsibly Controlling AI Diffusion</HD>
                    <P>AI models are software programs that comprise a series of mathematical operations. When a user enters data into the program, the program executes those operations on the input data to produce outputs—information, analysis, or media. The design of these operations and their arrangement (known as the model's architecture) determines the nature and quality of the model's outputs.</P>
                    <P>The first step in developing an AI model is to design the model's architecture and write it into computer code. However, the initial structure does not transform inputs into meaningful outputs. This means that before the model has been exposed to a high volume of real-world data, its outputs will be largely meaningless.</P>
                    <P>The next step is to “train” the model. Training involves feeding large quantities of data into the model while using optimization algorithms to evaluate the quality of the program's outputs and improve its performance. These algorithms systematically adjust numerical parameters called “model weights” that weight the results of certain operations more or less heavily than others. As the training progresses, these weights are gradually optimized to allow the model to produce higher quality outputs for its intended tasks. The weights that result from the training process are valuable intellectual property, because basic model architectures and supporting code are often either publicly documented or subject to reverse engineering through a process that may be significantly easier than training a new set of model weights.</P>
                    <P>Training today's most advanced AI models, including Large Language Models (LLMs), requires large clusters of advanced computing ICs capable of handling large quantities of data and models containing large numbers of parameters. Progress in AI models has resulted partly from dramatic increases in the computing power and training data used to develop the largest AI models. Leading AI developers have increased the computing power and data used to produce their largest models by many orders of magnitude over the last decade and continue to increase their scale by several multiples each year. By the end of this decade, leading AI developers plan to construct clusters of advanced ICs many times larger than those that exist today to train AI models using many times more computational operations than the largest AI models yet released.</P>
                    <P>The structure of AI models and these industry trends suggest that export controls can effectively regulate the global diffusion of advanced AI models through: (1) an expansion of existing controls on the export, reexport, and transfer (in-country) of advanced computing ICs that are necessary to construct large clusters for training advanced AI models; and (2) new controls on the export, reexport, and transfer (in-country) of the model weights of the most advanced AI models.</P>
                    <HD SOURCE="HD3">iii. Framework for the Diffusion of Advanced AI Technologies</HD>
                    <P>This rule details a tailored strategic approach to controlling the proliferation of advanced AI models. At a high level, this strategy aims to ensure that the model weights of the most advanced U.S. AI models are stored outside the United States only under stringent security conditions and the large clusters of advanced ICs necessary to train those models are built in destinations that pose comparatively low risks of diversion or misuse.</P>
                    <P>
                        This rule requires a license to export, reexport, or transfer (in-country) advanced computing ICs or the model weights of the most advanced AI models to any end user in any destination. The U.S. Government will review applications for such exports, reexports, and transfers (in-country) based on the sensitivity of the destination, the quantity of compute power or performance of the AI model, and the security requirements agreed to by the recipient. This global licensing requirement is crucial to ensuring that these items are not diverted to 
                        <PRTPAGE P="4547"/>
                        destinations or end users of concern. Credible open-source reporting has identified People's Republic of China (PRC) companies that have used foreign subsidiaries in a range of uncontrolled destinations to buy ICs subject to EAR controls. The risk is even greater with AI model weights, which, once exfiltrated by malicious actors, can be copied and sent anywhere in the world instantaneously. Accordingly, U.S. national security and foreign policy require that BIS scrutinize any transaction involving a destination or end user that presents an elevated risk of diversion or misuse. To reinforce this general requirement, BIS will set a licensing policy of a presumption of denial for certain large quantities of advanced computing ICs needed to train advanced AI models. For destinations and end users that present a comparatively low risk of diversion or misuse, a global licensing requirement will enable BIS to impose conditions that reduce the overall risk. A global licensing requirement is the most effective way to ensure that BIS can address the various risks associated with exporting large quantities of advanced computing ICs and the model weights of the most advanced AI models.
                    </P>
                    <P>
                        To help ease the burden on destinations and end users that pose a comparatively low risk of diversion or misuse and to facilitate economically beneficial activities, BIS is including flexibility within its global licensing requirements. For example, BIS will provide license exceptions—conditioned on compliance with certain security measures—for validated end users or particularly low-risk destinations. BIS will also provide a mechanism for other end users in other destinations to achieve validated status, which will allow them to obtain advanced computing ICs more easily. Additionally, consistent with its general practice, BIS will not require a license for the export of the model weights of open-weight models (
                        <E T="03">see</E>
                         July 30, 2024, Dual-Use Foundation Models with Widely Available Model Weights Report, National Telecommunications and Information Administration). These elements of the strategy will ensure that BIS's controls address only the starkest risks identified at the frontier of AI development and do not affect the vast majority of AI technology. This is consistent with ECRA's policy goals, which direct BIS to restrict the export of items that would “make a significant contribution to the military potential of any other country or combination of countries which would prove detrimental to the national security of the United States” while simultaneously maintaining U.S. “leadership in the science, technology, engineering, and manufacturing sectors, including foundational technology that is essential to innovation.” 50 U.S.C. 4811(3).
                    </P>
                    <P>As a third and final part of the strategy, BIS will impose security conditions to safeguard the storage of the most advanced models in destinations that pose heightened risks of diversion and to mitigate the risk of diversion for advanced ICs. Such conditions will protect U.S. national security by ensuring that where advanced models are stored, and large IC clusters are built, outside the United States, they are safeguarded from diversion or misuse.</P>
                    <P>As explained further below, BIS is implementing this three-part strategy by:</P>
                    <P>(1) adding a new control for AI model weights under new Export Control Classification Number (ECCN) 4E091;</P>
                    <P>(2) revising the license requirements and review policy for ECCNs 3A090.a, 4A090.a, and corresponding .z items;</P>
                    <P>(3) expanding the country scope of License Exception Advanced Computing Authorized (ACA);</P>
                    <P>(4) adding new License Exceptions Artificial Intelligence Authorization (AIA), Advanced Compute Manufacturing (ACM), and Low Processing Performance (LPP) that apply to advanced computing integrated circuits, AI model weights, and related items;</P>
                    <P>(5) adding new red flag guidance related to AI model weights;</P>
                    <P>(6) bifurcating the Data Center Validated End-User Authorization into Universal and National Validated End-User Authorizations; and</P>
                    <P>(6) updating License Exception Notified Advanced Computing (NAC) notification procedures to improve its efficiency.</P>
                    <P>Ultimately, ensuring the staged, responsible diffusion of advanced AI in these ways has several benefits. First, it reduces the risk that countries or end users of concern obtain the most advanced AI models or the ability to develop them. Second, it will allow a fuller understanding of the risks posed by each generation of AI models and the development of safety mitigations before the most advanced model weights and largest IC clusters diffuse globally. Third, a highly focused scope on frontier AI will allow commerce in AI models and advanced ICs to continue largely unimpeded. And finally, a strategy that focuses on the physical locations of model weights and large clusters of advanced ICs will allow continued global access to the capabilities of even the most advanced AI models through structured mechanisms, including through user applications and application programming interfaces (APIs), for which this rule imposes no new restrictions.</P>
                    <HD SOURCE="HD1">II. Expanded Advanced Computing Integrated Circuit Controls</HD>
                    <P>As explained above, large clusters of advanced computing ICs are essential to the development of advanced AI models. Accordingly, BIS can reduce the risk that malicious state and non-state actors gain access to advanced AI models by imposing controls that allow exports, reexports, and transfers (in-country) of large quantities of advanced computing ICs only to certain destinations and end users. At the same time, BIS can ensure that destinations and end users that meet robust security and safety standards will be able to obtain large quantities of advanced computing ICs.</P>
                    <P>Controls focused on the construction of large clusters of advanced computing ICs are a logical extension of BIS's previous controls, which have focused on the risk to U.S. national security and foreign policy from allowing even small numbers of advanced ICs, and associated SME, to be exported or reexported to certain destinations of concern. Those previous controls were based on BIS's determination that military and intelligence services in such destinations could use even small quantities of advanced computing ICs to further their military capabilities, contrary to U.S. national security and foreign policy interests. Accordingly, BIS imposed controls on these items in October 2022 (87 FR 62186, October 13, 2022), October 2023 (88 FR 73458, October 25, 2023 and 88 FR 73424, October 25, 2023), and further clarified such controls in April 2024 (89 FR 23876, April 4, 2024). In October 2024, BIS expanded the Validated End-User (VEU) Authorization in § 748.15 to facilitate the export of advanced computing ICs and related items to qualified data centers (89 FR 80080, October 2, 2024). Mostly recently, BIS updated these controls in December 2024 (89 FR 96790, December 5, 2024).</P>
                    <P>
                        Specifically, in October 2022, BIS published an interim final rule (87 FR 62186) which made critical changes to the EAR in two areas. First, the rule imposed additional export controls on certain advanced computing ICs, computer commodities that contain such ICs, and certain SME and parts and components needed to produce those and other advanced ICs. Specifically, 
                        <PRTPAGE P="4548"/>
                        the controls required a license before exporting or reexporting those items to the PRC or to certain entities on the Entity List (supplement no. 4 to part 744). BIS explained that these controls were aimed at limiting the PRC's ability to engage in activities that would pose significant threats to U.S. national security and foreign policy. Specifically, BIS found that certain advanced computing ICs and related computing items—many of which originated in the United States or were produced with U.S. technology, software, or tools—could enable the PRC to develop certain enhanced data processing and analysis capabilities, including through AI applications. Additionally, BIS found that the capability to produce advanced computing ICs through the use of certain SME presented significant national security and foreign policy concerns. These capabilities could be used by the PRC to further its military modernization efforts; to improve calculations in weapons design and testing, including for weapons of mass destruction (WMD); and to violate human rights through comprehensive surveillance programs.
                    </P>
                    <P>Thereafter, in October 2023, BIS broadened the scope of advanced computing controls to cover other destinations of concern (Country Groups D:1, D:4, and D:5). Similarly, BIS imposed worldwide license requirements for certain advanced computing ICs and specified semiconductor manufacturing and supercomputing end-uses when conducted on behalf of entities headquartered in, or with an ultimate parent company headquartered in, Macau or a destination in Country Group D:5. Due to the rapid nature of technological change in AI, BIS has been closely studying these developments and updating its rules accordingly to ensure that they remain as targeted and effective as possible.</P>
                    <P>BIS has also modified its controls to facilitate the export of advanced computing ICs and related items to certain end users who agree to use those items in secure ecosystems. Specifically, in October 2024, BIS expanded the Validated End-User (VEU) Authorization in § 748.15 to expand Authorization VEU for data centers 89 FR 80080, October 2, 2024. BIS explained that data centers are vital to global AI development, and that the United States is committed to facilitating international AI development in a way that minimizes risk to U.S. national security. Accordingly, BIS expanded Authorization VEU to facilitate the export or reexport of items necessary for a data center to preapproved validated end users in destinations (other than D:5 countries) that require a license for items classified under ECCNs 3A090.a, 4A090.a, and .z items in Categories 3, 4, and 5. The Data Center VEU Authorization adopted much of the framework of the existing Authorization VEU, with additional requirements appropriate for a data center environment.</P>
                    <P>
                        Effective December 2, 2024, BIS expanded controls on advanced computing ICs that could enable AI applications of national security concern, as well as the SME, software, and technology needed to produce such ICs. Specifically, BIS imposed new controls on certain high-bandwidth memory (HBM) commodities, which are critical to AI training and inference at scale and a key component of advanced computing ICs. BIS also imposed controls on additional SME capable of producing advanced computing ICs (
                        <E T="03">e.g.,</E>
                         certain etch, deposition, lithography tools, etc.) and on software that can enhance the capabilities of such SME or can be used to design advanced computing ICs.
                    </P>
                    <P>These previous controls reflect BIS's determination—made in conjunction with experts from across the U.S. government—that the export of even small quantities of advanced computing ICs to specific destinations and end users of concern pose significant risks to U.S. national security and foreign policy interests. Having imposed controls that address those risks, BIS and its interagency partners have evaluated how sales of large quantities of advanced computing ICs to other destinations and end users affect U.S. national security and foreign policy. BIS has determined that it is necessary to restrict the export of quantities of advanced ICs sufficient to train such models in order to protect U.S. national security and foreign policy interests.</P>
                    <P>To that end, this rule imposes a global license requirement for the export of advanced ICs classified under ECCNs 3A090.a, 4A090.a, and related .z items in § 742.6(a)(6)(iii)(A), and then creates several exceptions and pathways to authorization to facilitate transactions that pose a low risk of diversion or would otherwise advance U.S. national security or foreign policy interests, including technological leadership. As noted elsewhere in this rule, these provisions also are consistent with U.S. foreign policy regarding global development.</P>
                    <P>First, this rule creates an exception in new § 740.27 for all transactions involving certain types of end users in certain low-risk destinations. Specifically, these are destinations in which: (1) the government has implemented measures to prevent diversion of advanced technologies, and (2) there is an ecosystem that will enable and encourage firms to use advanced AI models to advance the common national security and foreign policy interests of the United States and its allies and partners. Those destinations, which are listed in paragraph (a) to Supplement No. 5 to Part 740, are Australia, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Japan, the Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Taiwan, the United Kingdom, and the United States. For these destinations, this IFR makes minimal changes: companies in these destinations generally will be able to obtain the most advanced ICs without a license as long as they certify compliance with specific requirements provided in § 740.27.</P>
                    <P>Second, BIS makes no changes to the strict rules governing provision of these items to Country Group D:5 destinations and Macau.</P>
                    <P>
                        Third, for all other destinations—in other words, destinations that are not Macau, Country Group D:5, or those listed in paragraph (a) to Supplement No. 5 to Part 740—this rule creates a multi-part framework that takes into account the compute power of the transaction and, in certain cases, security measures agreed to by the recipient. To start, BIS is establishing a license exception for limited quantities of advanced ICs, 
                        <E T="03">i.e.,</E>
                         quantities well below the amount necessary to train the most advanced AI models. This license exception can ensure that transactions not intended to contribute to the development of advanced AI models can continue unimpeded, so long as the exporter provides BIS with notice. Transactions involving larger quantities of controlled ICs will be subject to a new licensing policy that enables the export of ICs up to a specified country allocation. To provide predictability, BIS is specifying this allocation for the time period from 2025 to 2027. This licensing policy will enable end users in these destinations to develop any AI models short of the frontier, thereby allowing them to access the economic benefits of those models while simultaneously protecting the United States from the most significant threats.
                    </P>
                    <P>
                        At the same time, this rule enables entities in these destinations to gain validated status to obtain significantly larger quantities of ICs under Authorization VEU. Authorization VEU advances U.S. national security and foreign policy by allowing entities that 
                        <PRTPAGE P="4549"/>
                        have agreed to enact concrete, verifiable, and robust security measures to access large clusters of advanced ICs. For end users in these destinations—not Macau, Country Group D:5, or those listed in paragraph (a) to supplement no. 5 to Part 740—that do not meet eligibility criteria for the National VEU Authorization, BIS is implementing uniform default country allocations of advanced ICs. Exports and reexports of advanced ICs will be counted against these allocations starting on the effective date of this rule. These allocations will limit the risk of diversion of advanced ICs and encourage such entities to meet the conditions to qualify for VEU Authorization. In this way, Authorization VEU will also buttress U.S. foreign policy to support global development.
                    </P>
                    <HD SOURCE="HD2">A. New Worldwide License Requirements</HD>
                    <P>With this IFR, BIS establishes a worldwide license requirement for ECCNs 3A090.a, 4A090.a, and corresponding .z items in new § 742.6(a)(6)(iii)(A). A worldwide license requirement for these items, which includes those items subject to the EAR's jurisdiction through the advanced computing foreign direct product rule (FDPR), will protect U.S. national security and foreign policy interests by allowing BIS to scrutinize any transaction that presents an elevated risk of diversion or misuse and by providing the U.S. government with visibility into the locations, end users, and end uses of advanced ICs. Further, as discussed below, diffusion of AI compute through the Data Center VEU Authorization will allow for companies around the world to benefit from allocations of AI compute in validated, protected environments.</P>
                    <P>ECCN 3A090.a controls integrated circuits with one or more digital processing units having either: (1) a `total processing performance' of 4800 or more; or (2) a `total processing performance' of 1600 or more and a `performance density' of 5.92 or more. ECCN 3A090.b controls integrated circuits with one or more digital processing units having either: (1) a `total processing performance' of 2400 or more and less than 4800 and a `performance density' of 1.6 or more and less than 5.92; or (2) a `total processing performance' of 1600 or more and a `performance density' of 3.2 or more and less than 5.92.</P>
                    <P>ECCN 4A090.a controls computers, “electronic assemblies,” and “components” containing integrated circuits, any of which meets or exceeds the limits in 3A090.a. ECCN 4A090.b controls computers, “electronic assemblies,” and “components” containing integrated circuits, any of which meets or exceeds the limits in 3A090.b.</P>
                    <P>To adopt this new control, BIS is revising the Regional Stability control in § 742.6 by amending paragraph (a)(6)(iii) and bifurcating it into paragraphs (A) and (B). Section (a)(6)(iii)(A) will implement a worldwide license requirement on 3A090.a, 4A090.a and corresponding .z commodities, software, and technology. Section (a)(6)(iii)(B) implements license requirements on 3A090.b, 4A090.b, and corresponding .z commodities, software, and technology to or within destinations specified in Country Groups D:1, D:4, and D:5, excluding destinations also specified in Country Groups A:5 or A:6. Imposition of this RS control will make License Exception GBS unavailable for 3A001.z.1.a items, because they will be subject to a worldwide license requirement that is imposed for other than national security reasons. GBS will still be available for 3A001.z.1.b items for destinations in Country Group B that are not also listed in Country Groups D:1, D:4, or D:5. Additionally, consistent with the imposition of expanded RS controls for such items, this rule removes existing LVS eligibility for all 3A001.z items to ensure they may not be exported or reexported under this license exception to destinations in Country Group B without being subject to the volume restrictions, certification requirements, and reporting requirements of the new license exceptions added for such items in this rule. (See also restrictions on license exceptions, § 740.2(a)(9)(ii).)</P>
                    <P>In addition to expanding the country scope of controls on ECCN 3A090.a and 4A090.a items, BIS is also expanding the destination scope of the advanced computing foreign direct product rule in § 734.9(h)(2)(i). BIS is replacing references to Country Groups D:1, D:4, and D:5 and exclusions of A:5 and A:6 with the word “worldwide.” Accordingly, the language now provides that a foreign-produced item meets the destination scope of this paragraph (h)(2) if there is “knowledge” that the foreign-produced item is destined worldwide or will be incorporated into any “part,” “component,” “computer,” or “equipment” not designated EAR99 to any destination worldwide.</P>
                    <HD SOURCE="HD2">B. License Exceptions for 3A090, 4A090, Corresponding .z Items, and 4E091</HD>
                    <P>With this rule, BIS is adding three new license exceptions to the EAR that will be applicable to advanced compute ICs: § 740.27 License Exception AIA, § 740.28 License Exception ACM, and § 740.29 License Exception LPP. In addition, it is updating the destination scope of License Exception Advanced Compute Authorization (ACA). BIS also is updating the NAC process to facilitate more efficient processing. As part of this updated process, BIS and the interagency are seeking additional information from NAC users.</P>
                    <HD SOURCE="HD3">1. License Exception Artificial Intelligence Authorization (AIA)</HD>
                    <P>
                        This new license exception authorizes the export, reexport, or transfer (in-country) of eligible advanced computing ICs and associated software and technology to entities located in a destination listed in paragraph (a) of supplement no. 5 to part 740, unless the entity either is headquartered outside of a destination specified in paragraph (a) of the supplement or has an ultimate parent company that is headquartered outside of a destination specified in paragraph (a) of the supplement. 
                        <E T="03">See</E>
                         § 740.27(a).
                    </P>
                    <P>
                        To use the license exception for eligible items (
                        <E T="03">e.g.,</E>
                         3A090.a, 4A090.a, or corresponding .z items and 4E091), the exporter, reexporter, or transferor must furnish the ECCN to the ultimate consignee. In addition, for advanced computing ICs eligible for this license exception, the exporter, reexporter, or transferor must also obtain a prior certification from the ultimate consignee and, for certain large orders, provide the certification to BIS pursuant to certain reporting requirements. For purposes of License Exception AIA, the ultimate consignee is the entity that has ownership over the eligible items. The certification must state that, without BIS authorization: (1) the items received will not be used to provide Infrastructure-as-a-Service (IaaS) access sufficient to train an AI model classified under ECCN 4E091 to entities headquartered or located outside of, or whose ultimate parent company is headquartered outside of destinations listed in paragraph (a) of supplement no. 5 to Part 740; (2) the ultimate consignee will not export, reexport, or transfer the items to any end use or end user prohibited pursuant to Part 744 of the EAR; and (3) the ultimate consignee will not export, reexport, or transfer (in-country) the items to an entity headquartered or located outside of, or whose ultimate parent company is headquartered outside of paragraph(a) of supplement no. 5 to Part 740. Once the certification is received from the ultimate consignee, and prior to the initial export, reexport, or transfer, the exporter, reexporter, or transferor must 
                        <PRTPAGE P="4550"/>
                        submit the certification to 
                        <E T="03">EARReports@bis.doc.gov</E>
                         with the Subject AIA Certification. The ultimate consignee must also submit the certification to the exporter, reexporter, or transferor. The certification is a one-time certification provided by each ultimate consignee that will be using License Exception AIA. With each shipment under License Exception AIA, the exporter, reexporter, or transferor, must notify the ultimate consignee in writing that: (1) the shipment is being made pursuant to License Exception AIA; (2) specify which items are subject to License Exception AIA or state that the entire shipment is made pursuant to License Exception AIA; and (3) it has certified to the certification in § 740.27(b)(2). This reporting requirement is only applicable if the ultimate consignee is receiving items identified in paragraphs (a)(1) with a cumulative total processing performance (TPP) of 253,000,000.
                    </P>
                    <HD SOURCE="HD3">2. License Exception Advanced Compute Manufacturing (ACM)</HD>
                    <P>New License Exception ACM authorizes the export, reexport, and transfer (in-country) of eligible items (ECCNs 3A090, 4A090, and related .z commodities, software, and technology) to a `private sector end user' that is located in a destination not listed in Country Group D:5 or Macau, provided it is not headquartered in and does not have an ultimate parent company headquartered in Macau or a destination specified in Country Group D:5, if the ultimate end use is the “development,” “production,” or storage (in a warehouse or other similar facility) of such eligible items. An entity may not use this exception if the ultimate end use of the items is training an AI model or any other activity not related to the “development,” “production,” or storage (in a warehouse or other similar facility) of such eligible items. For the purposes of this license exception, `private sector end user' is an individual who is not acting on behalf of any government (other than the U.S. government); or a commercial firm (including its subsidiary and parent firms, and other subsidiaries of the same parent) that is not wholly owned by, or otherwise controlled by any government (other than the U.S. government). The items produced must be ultimately destined to customers outside of Macau or destinations specified in Country Group D:5. Although License Exception ACM shipments do not count toward country caps, exporters, reexporters, and transferors must maintain a system of distribution that allows them to account for the number of controlled items transferred to, and subsequently out, of the facility. Such accounting should be done for each facility, with records updated every six months or more frequently. This license exception is intended to minimize the impact of this rule on supply chains.</P>
                    <HD SOURCE="HD3">3. License Exception Low Processing Performance (LPP)</HD>
                    <P>New License Exception LPP, set forth in new § 740.29, authorizes the export and reexport of low amounts of compute that do not present significant national security risks, up to 26,900,000 Total Processing Performance (TPP) of advanced computing ICs per-calendar year to any individual ultimate consignee. For purposes of this license exception, ultimate consignee means the entity that has ownership over the items. This license exception is available to exporters or reexporters who export or reexport eligible items (ECCNs 3A001.z.1.a, z.2.a, z.3.a, z.4.a; 3A090.a; 4A003.z.1.a, z.2.a; 4A004.z.1; 4A005.z.1; 4A090.a; 5A004.z.1.a, z.2.a; and 5A992.z.1) directly to ultimate consignees in eligible destinations. It is not available for exports or reexports made through distributors or for in-country transfers. Eligible destinations are those located outside of destinations in Country Group D:5 or Macau, provided the ultimate consignee is not headquartered in, and does not have an ultimate parent company headquartered in, Macau or Country Group D:5. In addition, the license exception cannot be used to export or reexport to prohibited end uses or end users in part 744 of the EAR.</P>
                    <P>The license exception provides for an annual TPP volume restriction on LPP orders set forth in paragraph (d) of the new license exception. The total TPP volume of exports and reexports per calendar year by all exporters and reexporters to any individual ultimate consignee may not exceed the 26,900,000 TPP volume limit; however, there is no restriction on the number of shipments from any exporters or reexporters, provided the volume limit is not exceeded. This annual TPP limit applies to shipments to any individual ultimate consignee even if the shipments are made by multiple exporters or reexporters or through more than one intermediate consignee. Before using License Exception LPP, under paragraph (f) of new § 740.29, the exporter or reexporter must obtain a certification from the ultimate consignee that the ultimate consignee has not received a cumulative of 26,900,000 TPP during the relevant calendar year under License Exception LPP from all exporters and reexporters and that the requested TPP for the specific transaction will not result in the ultimate consignee exceeding the TPP limit. The exporter or reexporter must also provide this certificate to BIS within 30 days of the date on which the export or reexport of eligible items occurs. Cumulative TPP is the total amount of TPP of the eligible commodities in paragraph (b) of § 740.29 that are provided to the ultimate consignee in all shipments by all exporters and reexporters in a calendar year under License Exception LPP. Pursuant to paragraph (g), the exception also provides that ultimate consignees receiving eligible items under License Exception LPP must notify BIS once they have received a cumulative total of 26,900,000 TPP in a calendar year. Under paragraph (g), the exception also provides that the exporter must notify BIS of all shipments under the exception with an aggregate TPP of more than 3,200,000.</P>
                    <HD SOURCE="HD3">4. Updates to License Exception Notified Advanced Computing and Advanced Computing Authorized for ECCNs 3A090, 4A090, and Corresponding .z Items</HD>
                    <P>
                        Currently, under § 740.8(a), License Exceptions Notified Advanced Computing (NAC) and Advanced Computing Authorized (ACA) are available for items classified in ECCNs 3A090, 4A090, 3A001.z, 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, 5A992.z, 5D002.z, or 5D992.z, except for items designed or marketed for use in a data center and meeting the parameters of 3A090.a. License Exception NAC authorizes the export and reexport of specified items to Macau and destinations specified in Country Group D:5 and entities headquartered in, or with an ultimate parent headquartered in, Macau or a destination specified in Country Group D:5 wherever located, that require a notification to BIS. License Exception ACA authorizes the export and reexport of any item classified in ECCN 3A090, 4A090, 3A001.z, 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, 5A992.z, 5D002.z, or 5D992.z (except for items designed or marketed for use in a datacenter and meeting the parameters of 3A090.a) to or within any destination specified in Country Groups D:1 and D:4 (except Macau, a destination in Country Group D:5, or an entity headquartered in, or with an ultimate parent headquartered in, Macau or a destination specified in Country Group D:5, wherever located), as well as transfers (in-country) within Macau and destinations in Country Group D:5. The destination scope of License Exception ACA in § 740.8(a) is amended by striking to D:1 or D:4 and 
                        <PRTPAGE P="4551"/>
                        replacing with “any destination worldwide.” Accordingly, the regulatory text now states, “to or within any destination worldwide (except Macau, a destination specified in Country Group D:5, or an entity headquartered in, or with an ultimate parent headquartered in, Macau or a destination specified in Country Group D:5, wherever located), as well as transfers (in-country) within Macau and destinations specified in Country Group D:5”.
                    </P>
                    <P>
                        In addition to the changes to License Exception ACA, BIS is amending the NAC notification procedures by seeking additional information as set forth in § 740.8(c). License Exception NAC established a notification process for exports and reexports to Macau or destinations specified in Country Group D:5 to provide BIS and interagency partners the opportunity to evaluate the national security risk posed by ICs that fall within this parameter. Since initial implementation, BIS and its interagency partners have revisited NAC to implement a faster internal review process. Specifically, during the evaluation process, interagency partners will be reviewing: (1) whether the export is NAC eligible; (2) whether the end-user has ties to a military or intelligence organization that prompt national security or human rights concerns; (3) if the technical parameters of the ICs are &gt;2800 TPP or if the ICs have &gt;1,000 GB/s memory bandwidth; (4) whether the ICs will be aggregated with other ICs into a datacenter cluster, or be used as a sample or in a standalone configuration (
                        <E T="03">e.g.,</E>
                         workstation); (5) if the ICs are going into the datacenter, the size of the data center; and (6) if the ICs will be used internally by a company headquartered in the United States or a company headquartered in Country Group A:5 or A:6. Exporters and reexporters utilizing License Exception NAC must provide this information to ensure efficient processing. BIS believes the use of this new review criteria will result in overall faster processing of all NAC notifications, as well as a greater percentage of NAC notifications being approved during the initial review period.
                    </P>
                    <P>
                        Moreover, to deploy this process, BIS is amending § 740.8(c) to add the following to the existing list of required information: (1) all NAC and license approvals to the end-user in the past 12 months under ECCN 3A090, 4A090, 3A001.z, 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, 5A992.z, 5D002.z, or 5D992.z (except for items designed or marketed for use in a datacenter and meeting the parameters of 3A090.a)
                        <E T="03">;</E>
                         (2) memory bandwidth of the item(s) requested; and (3) whether the items are destined to be aggregated into a datacenter or computing cluster, and, if so: (i) the computing power of the computing cluster, measured in the aggregate TPP of all chips used in the cluster once the cluster is complete; and (ii) whether the cluster will be (a) exclusively for internal use by a company headquartered in the United States or a member of Country Group A:5 or A:6, or (b) used by any other companies not headquartered in A:5 or A:6, or by external parties such as through cloud services.
                    </P>
                    <HD SOURCE="HD2">C. Data Center Validated End-Users (DC VEUs): Universal and National VEUs</HD>
                    <P>In October 2024, BIS amended the EAR to expand Authorization VEU to include Data Center VEU (DC VEU). As noted in that rule, data centers play a vital role in global AI development, and the United States is committed to facilitating international AI development in a way that minimizes risk to national security. With this rule, BIS further expands the DC VEU Authorization by bifurcating it into a universal VEU (UVEU) and a national VEU (NVEU) Authorization. Companies headquartered in, or whose ultimate parent is headquartered in destinations specified in paragraph (a) of supplement no. 5 to part 740 may apply for the UVEU Authorization. With certain limitations, companies headquartered in, or whose ultimate parent is headquartered in, all destinations worldwide except Macau or destinations specified in Country Group D:5, that would like to qualify for exports, reexports, or transfers (in-country) of large amounts of advanced computing integrated circuits, may apply for the NVEU Authorization.</P>
                    <P>BIS recognizes that advanced compute data centers (DCs) may involve corporate relationships in which different parties own the data center, provide physical security, own the advanced compute assemblies, provide logical security, and are able to access the compute. To clarify the September 2024 DC VEU rule, BIS notes that the party that has ownership of the advanced compute should submit the DC VEU application. If such party cannot directly certify to all of the application information requested in § 748.15, it must inform BIS of the identities of other entities involved in the DC operations. Applicants may be required to obtain written assurances from those other entities during the application review process. If the operator of the advanced compute is different from the owner of the advanced compute, both the advanced compute owner and the advanced compute operator must have a VEU authorization.</P>
                    <P>
                        As specified in paragraph 6 of Supplement No. 10 to Part 748, all UVEUs will be subject to limitations on where they can geographically allocate their AI computing power, measured by the aggregate TPP of chips that meet or exceed the scope of ECCN 3A090.a. Specifically, a UVEU headquartered in a country listed in paragraph (a) to Supplement no. 5 to Part 740 cannot transfer or install more than 25% of its total AI computing power
                        <E T="03">—i.e.,</E>
                         the AI computing power owned by the entity all its subsidiary and parent entities—to or in locations outside of countries listed in paragraph (a) to Supplement No. 5 to Part 740, and cannot transfer or install more than 7% of its total AI computing power to or in any single country outside of those listed in paragraph (a) to Supplement No. 5 to Part 740. Additionally, a UVEU headquartered in the United States cannot transfer or install more than 50% of its total AI computing power outside of the United States.
                    </P>
                    <P>For all NVEUs, as described in new paragraph (a)(2)(iii)(B) of § 748.15, a per-company, per-country installed base allocation of TPP, as measured by the collective computing power of items subject to ECCNs 3A090.a, 4A090.a, or corresponding .z paragraphs, will apply as follows:</P>
                    <GPOTABLE COLS="02" OPTS="L2,tp0,i1" CDEF="s25,14">
                        <BOXHD>
                            <CHED H="1">Quarter</CHED>
                            <CHED H="1">
                                Cumulative TPP per-company per-country
                                <LI>allocation</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">2025 Q1</ENT>
                            <ENT>633,000,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2025 Q2</ENT>
                            <ENT>949,500,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2025 Q3</ENT>
                            <ENT>1,266,000,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2025 Q4</ENT>
                            <ENT>1,582,500,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2026 Q1</ENT>
                            <ENT>1,899,000,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2026 Q2</ENT>
                            <ENT>2,690,250,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2026 Q3</ENT>
                            <ENT>3,481,500,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2026 Q4</ENT>
                            <ENT>4,272,750,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2027 Q1-4</ENT>
                            <ENT>5,064,000,000</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        These TPP allocations were identified through an extensive analysis of the size of AI compute clusters necessary to train the largest AI models, and the rate at which those clusters are likely to grow over the next three years. These allocations represent clusters approximately 12 months, or one generation, behind the cluster size BIS believes will be needed to train the most advanced dual-use AI models. By providing a three-year roadmap, BIS aims to give predictability to industry while reducing the risks posed by the unchecked proliferation of the most advanced AI models and largest clusters 
                        <PRTPAGE P="4552"/>
                        at any given time. These TPP allocations represent permitted cumulative installed base during a given quarter, not newly available TPP in addition to previous-quarter installed bases, and do not count towards or impact country allocations. Additionally, multiple NVEUs may operate in a single country, with each NVEU subject to the quarterly allocations above. Advanced computing ICs that suffer attrition due to factors such as loss, damage, failure, relocation, and resale will no longer count toward allocations. BIS is not identifying specific TPP allocations for future years at this time given the evolving nature of national security requirements, the geopolitical landscape, and the AI industry.
                    </P>
                    <P>Together with the Departments of State, Energy, and Defense, BIS will review allocations for subsequent years on an annual basis to determine future allocations.</P>
                    <HD SOURCE="HD3">1. Data Center VEU: Universal Validated End User</HD>
                    <P>The UVEU Authorization is available to companies headquartered in the countries listed in paragraph (a) to supplement no. 5 to Part 740. As described in new paragraph (a)(2)(ii)(A) of § 748.15, under the UVEU Application Overview, the UVEU Authorization provides the data centers that own their advanced computing capacity with a single authorization that will allow a UVEU to build DCs around the world, except in Macau or destinations specified in Country Group D:5, provided that the UVEU maintains its status by following the guidelines in supplement no. 10 to part 748. The UVEU is responsible for ensuring it complies with the applicable AI TPP geographic allocations. To receive UVEU status, a DC that owns its advanced computing capacity must certify that it will follow the guidelines outlined in supplement no. 10 to part 748 and go through an intensive application process. As previously noted, if the owner of the advanced compute cannot directly certify to all of the application information requested in § 748.15, it must include in its VEU application to BIS the identities of other entities involved in the DC operations. Through this process, BIS and its interagency partners will be able to assess whether the UVEU applicant meets the guidelines and resolve national security concerns.</P>
                    <P>Approved applicants for the UVEU authorization will be listed in the EAR as UVEUs along with each authorized address identified in the UVEU application. As new DCs are brought online by the UVEU, it is required to notify BIS 180 days prior to any exports, reexports, or transfers (in-country) to the new DC so that the EAR may be updated to include the new location(s). This notification will allow BIS to update supplement no. 7 to part 748 with the new data center's address to notify exporters and reexporters of the UVEU location address that can receive exports and reexports under this authorization. The UVEU may choose whether to list a corporate address or a physical address of the new data center location. Otherwise, or in the period between notification to BIS and EAR amendment, UVEUs may furnish their BIS authorization letters to exporters and reexporters to enable continuity of exports and reexports to the new country and/or new DC.</P>
                    <HD SOURCE="HD3">A. Data Center VEU: National Validated End-User</HD>
                    <P>
                        A National Validated End-User (NVEU) Authorization is available to all entities headquartered in or located in a destination in Country Groups A, B, or D:1-D:4, except Macau or destinations specified in Country Group D:5, as described in revised § 748.15(b)(2). New paragraph (a)(2)(iii) of § 748.15 describes the requirements to obtain an NVEU. In order to receive NVEU Authorization, a data center operator that owns its advanced computing capacity must apply to BIS and go through an intensive application process that will be subject to interagency review. Information required to be submitted to become a VEU is described in supplement no. 8 to part 748, some provisions of which are revised by this rule, including an update to paragraph (B)(2) of the supplement to require information about business activities and corporate relationships with government or military organizations in Macau and destinations specified Country Group D:5, 
                        <E T="03">e.g.,</E>
                         direct sales to or contracts with such entities.
                    </P>
                    <P>Approved applicants for the NVEU Authorization will be listed in the EAR as NVEUs in supplement no. 7 to part 748. This listing will serve to notify exporters and reexporters that the NVEU location can receive exports and reexports under this authorization. The NVEU may choose whether to list a corporate address or a physical address of the new data center location. NVEUs will be subject to the cumulative TPP allocations identified above.</P>
                    <HD SOURCE="HD2">D. License Applications</HD>
                    <P>For transactions that do not meet the terms and conditions for use of license exceptions, and for which the end user does not participate in the DC VEU Authorization, the traditional license application process is available under part 748 of the EAR.</P>
                    <P>As explained in additional detail below, BIS is instituting specific country allocations of total processing performance (TPP) in new paragraph (b)(10) of § 742.6. As with Authorization VEU allocations, exports and reexports of advanced ICs will be counted against the following country allocation beginning on the effective date of this rule. From 2025 to 2027, countries will be subject to a cumulative maximum installed base allocation of 790,000,000 TPP. This TPP allocation represents permitted cumulative installed base for the entire period to and inclusive of 2027. Advanced computing ICs that suffer attrition due to factors such as loss, damage, failure, relocation, and resale will no longer count toward the allocation.</P>
                    <P>Accordingly, license applications for 3A090.a, 4A090.a, or corresponding .z items must be accompanied by a purchase order or equivalent firm contractual agreement reflecting the actual volume amount that the applicant seeks to export, reexport, or transfer (in-country). The purchase order requirement is found in paragraph (c) of supplement no. 2 to part 748. The purchase order must be for the fulfilment of actual items to be sold, although it may be contingent on license approval. In addition, licenses for these items generally will carry a one-year validity period during which the items must be exported, re-exported, or transferred (in country), pursuant to the revision to § 750.7(g) made in this rule. Should a lengthier validity period be required, such information must be provided with the license application or a request for extension must be filed in accordance with § 750.7(g)(1) or (2).</P>
                    <P>BIS is not identifying specific TPP allocations for future years at this time given the evolving nature of national security requirements, the geopolitical landscape, and the AI industry.</P>
                    <P>Together with the Departments of State, Energy, and Defense, BIS will review allocations for subsequent years on an annual basis.</P>
                    <HD SOURCE="HD3">1. Revision of License Review Policy</HD>
                    <P>
                        To implement the new license review policy for § 742.6(a)(6)(iii)(A), BIS is updating the license review policy in § 742.6(b)(10). Section 742.6(b)(10)(iii)(A)(1) provides that a presumption of denial will apply to applications for Macau, destinations specified in Country Group D:5, and any entity headquartered in, or whose ultimate parent is headquartered in, 
                        <PRTPAGE P="4553"/>
                        Macau or a destination specified in Country Group D:5.
                    </P>
                    <P>For end users headquartered or located in destinations listed in paragraph (a) of supplement no. 5 to Part 740, license applications will be reviewed under a presumption of approval under new § 742.6(b)(10)(iii)(A)(2).</P>
                    <P>Under certain circumstances when destination governments assure the U.S. Government of a commitment to protect advanced computing ICs consistent with U.S. national security interests, these TPP allocations may be increased up to 100% for a given destination. Once the U.S. Government has determined that a country has provided appropriate national security assurances, BIS will list that country in paragraph (b) to supplement no. 5 to Part 740. In such a case, the licensing policies pursuant to new § 742.6(b)(10)(iii)(B), would apply with an upward adjustment to country TPP allocations. While the U.S. Government—led by the Departments of State and Commerce—may pursue such government-to-government assurances independently to advance U.S. national security and foreign policy interests, in cases where BIS has not applied an allocation increase to a particular destination, license applicants seeking an upward departure from country TPP allocations should identify such interest in their license applications, along with the contact information for appropriate foreign government officials with whom BIS and interagency partners should engage on such assurances.</P>
                    <P>For end users headquartered, or whose ultimate parent is headquartered, outside of destinations listed in paragraph (a) or (b) of supplement no. 5 to Part 740, Macau, and Country Group D:5, license applications for 3A090.a, 4A090.a, and corresponding .z items will be subject to a presumption of approval up to specific country allocations in TPP, as described in new § 742.6(b)(10)(iii)(B)(1). BIS will calculate progress toward country allocations by totaling the TPP of 3A090.a, 4A090.a, and corresponding .z items licensed to each destination in a given calendar year. When country allocations have been met for a specific country, licenses will be reviewed under a policy of denial, consistent with new § 742.6(b)(10)(iii)(B)(2).</P>
                    <P>Together with the Departments of State, Energy, and Defense, BIS will review allocations for subsequent years on an annual basis. Moreover, absent regulatory changes, the licensing policies outlined in § 742.6(a)(6)(iii) will continue to apply.</P>
                    <P>
                        To keep the public informed on country allocations, BIS will use purchase orders provided in license applications to track fulfillment of country allocations and will provide timely updates to the public on these allocations in aggregate at 
                        <E T="03">http://www.bis.gov/advanced-compute-resources</E>
                        .
                    </P>
                    <HD SOURCE="HD3">2. Information Required in License Application</HD>
                    <P>Applicants are required to submit the total aggregated TPP volume of each export item on their license application. This information, consistent with new paragraph (c)(4) in supp. no. 2 to Part 748, should be included in block 22(j) in SNAP-R. If applicants are submitting a license for items destined to a country that is subject to a per-country TPP allocation, the applicant must fill out an individual license for each country and calculate the TPP per individual country. Applicants must submit relevant purchase orders and are encouraged to include additional information to support their TPP calculation in their Letter of Explanation (LOE). Calculate the aggregate TPP for each export item by adding the TPP for each integrated circuit. For additional information on calculating TPP, please refer to the Technical Notes to 3A090.</P>
                    <HD SOURCE="HD1">III. Overview of New Controls for AI Model Weights</HD>
                    <P>As of the effective date of this rule on January 13, 2025, in addition to expanding its controls on advanced computing ICs, BIS is imposing new controls on the model weights of the most advanced AI models. Model weights are “numerical parameter[s] within an AI model” that “help determine the model's outputs in response to inputs.” Executive Order 14110 on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. An AI model that lacks trained model weights produces meaningless outputs. Additionally, the developers of the most advanced AI models typically incorporate technical safeguards that help to prevent applications based on the model, such as chatbots or those served through APIs, from completing certain dangerous tasks, such as assisting in the development of nuclear, chemical, biological, or cyber weapons. With access to the model weights, it is easier to remove these safeguards. Model weights for advanced AI models can, moreover, be produced only by training the model on vast quantities of data using thousands of advanced computing ICs over a period of several months or more. Accordingly, model weights can be the most valuable and closely guarded elements of an AI model.</P>
                    <P>
                        Given the importance of model weights to the functioning of advanced AI models, BIS has determined that, in order to protect U.S. national security and foreign policy interests, it is necessary to impose a global licensing requirement on the model weights of the most advanced AI models. Even if countries and end users of concern are able to obtain or reverse engineer the other elements of an advanced AI model—
                        <E T="03">e.g.,</E>
                         the architecture or ancillary code—those actors will be unable to use the model for activities that threaten U.S. national security and foreign policy unless they have the corresponding model weights. And crucially, they will not be able to train their own model weights unless they have access to thousands of advanced computing ICs. Thus, by imposing global controls on the model weights of the most advanced AI models, BIS will make it significantly more difficult for countries and end users of concern to access those models and their functions.
                    </P>
                    <P>
                        In conjunction with technical experts from across the U.S. government, BIS has determined that a reasonable proxy for the performance of an AI model is the amount of compute—
                        <E T="03">i.e.,</E>
                         the number of computational operations—used to train the model. This determination is supported by empirical evidence compiled by leading AI researchers, which shows that the performance of an AI model depends in large part on the number of parameters in the model, the size of the dataset used to train the model, and the amount of compute used to train the model. Although there is disagreement about whether it is more important to maximize the number of parameters or the size of the dataset, there is a general consensus that, given a fixed model architecture, the amount of compute positively correlates with the performance of the model. Accordingly, at the outset of the training process, developers of advanced AI models set a “compute budget,” 
                        <E T="03">i.e.,</E>
                         a fixed number of operations on which the model will be trained. It is possible, however, that better measures of model capabilities may become available over time. BIS will consider alternative approaches as they become available.
                    </P>
                    <P>
                        Using this measure, BIS is requiring a license to export, reexport, or transfer (in-country) the model weights of any closed-weight AI model—
                        <E T="03">i.e.,</E>
                         a model with weights that are not published—that has been trained on more than 10
                        <SU>26</SU>
                         computational operations. Because the model weights of models trained with fewer than 10
                        <SU>26</SU>
                         computational 
                        <PRTPAGE P="4554"/>
                        operations are already stored at locations across the globe, and such models are available from foreign sources, imposing controls on such models would be ineffective. These models have shown concerning capabilities, however, and technical experts from across the U.S. government agree that the next generation of models—
                        <E T="03">i.e.,</E>
                         those trained on 10
                        <SU>26</SU>
                         computational operations—will significantly reduce the barriers to enabling activities that threaten U.S. national security and foreign policy. To ensure that the licensing process consistently accounts for the risks associated with the most advanced AI models, BIS has decided to apply a presumption of denial review policy (implemented in § 742.6(a)(12)) to every license application involving the model weights of those models. This policy is necessary for two interrelated reasons. First, the potential risks to U.S. national security from even one case of diversion are extreme. For example, if a terrorist organization were to obtain the model weights of an advanced AI model, it could potentially gain permanent access to the full range of capabilities of that model. Second, because model weights can be stored, copied, and transferred using basic computer technologies, the risk of diversion is elevated. And if a particular set of model weights is diverted even once, it would be difficult to prevent further dissemination across the world. Accordingly, BIS must scrutinize every license application involving model weights to ensure that the end user does not present a risk of diversion and has adequate security measures in place. A presumption of denial review policy can ensure this consistent level of scrutiny.
                    </P>
                    <P>
                        In addition to applying to U.S.-origin model weights, this licensing requirement applies to the model weights of certain closed-weight models produced in foreign destinations. As discussed, training an AI model on more than 10
                        <SU>26</SU>
                         computational operations is not possible without advanced computing ICs and other related advanced computing items. BIS has found that many foreign entities that are training advanced AI models or intend to train such models are using advanced computing ICs and related items that were directly produced with U.S. technology. To reduce the risk that such U.S. technology contributes to models that are diverted to malicious actors and used for activities that threaten U.S. national security and foreign policy interests, this IFR creates a new Foreign Direct Product (FDP) rule (implemented in new § 734.9(l)) for the model weights of closed-weight models trained using more than more than 10
                        <SU>26</SU>
                         computational operations.
                    </P>
                    <P>As with advanced computing ICs, however, BIS is providing a license exception (License Exception AIA, implemented in new § 740.27) for the export or reexport of model weights to certain end users in certain destinations. As discussed, BIS and its interagency partners have identified a set of destinations where (1) the government has implemented measures with a view to preventing diversion of advanced AI technologies, and (2) there is an ecosystem that will enable and encourage firms to use advanced AI models activities that may have significant economic benefits. Those destinations, which are listed in paragraph (a) to Supplement No. 5 to Part 740, are Australia, Belgium, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Republic of Korea, Spain, Sweden, Taiwan, the United Kingdom, and the United States. For end users headquartered in these destinations, listed in paragraph (a) of supplement no. 5 to Part 740, BIS is providing a license exception for export or reexport to entities located in all destinations except Macau and those in Country Group D:5. However, exporters and reexporters may not take advantage of this exception unless they ensure that the end user has instituted specific security measures that will reduce the risk of diversion, specified in paragraphs 14, 15, and 18 of supplement no. 10 to Part 748.</P>
                    <P>
                        Additionally, BIS is not imposing controls on the model weights of open-weight models. At present, there are no open-weight models known to have been trained on more than 10
                        <SU>26</SU>
                         computational operations. Moreover, Commerce and its interagency partners assess that the most advanced open-weight models are currently less powerful than the most advanced closed-weight models, in part because the most advanced open-weight models have been trained on less computing power and because proprietary algorithmic advances have allowed closed-weight model developers to produce more advanced capabilities with the same computational resources. BIS has also determined that, for now, the economic and social benefits of allowing the model weights of open-weight models to be published without a license currently outweigh the risks posed by those models. Specifically, making model weights open ensures that many actors seeking to use the models for economically and socially beneficial activities can do so. This includes small, independent research groups that are seeking to research model safety and trustworthiness, as well as defenses against AI risk, such as cyberattacks. It also includes small commercial entities that are pursuing applications of AI models that require expertise not possessed by leading AI developers; for example, many of the premier foreign language translation applications have been developed by small entities using open-weight models. Wide availability also allows governments and independent researchers to assess the risks posed by these models and develop mitigations. By comparison, the actors that can take advantage of the capabilities of “closed weight” models—
                        <E T="03">i.e.,</E>
                         models with weights that have not been made publicly available—are the original developer, actors who negotiate directly with original developers or deployers, and malicious actors that have stolen the weights. In practice, the most advanced closed weight models are, BIS assesses, closely held by their developers.
                    </P>
                    <P>Accordingly, BIS and its interagency partners are not today imposing controls on open-weight models. BIS also recognizes that users of open-weight models may need to perform additional training operations to fine tune open-weight models for beneficial uses. Accordingly, this IFR makes clear that training an open-weight model with a relatively small amount of additional computational operations does not subject that model to BIS's controls. But as noted in the National Telecommunications and Information Administration's report “Dual-Use Foundation Models with Widely Available Model Weights” published on July 30, 2024, the U.S. Government will continue to actively monitor risks that could arise from open-weight models and assess what actions might need to be taken if heightened risks emerge.</P>
                    <P>
                        To reduce the economic impact on developers of closed models, BIS will also not require a license for the export, reexport, or transfer (in-country) of the model weights of closed models that are less powerful than the most powerful open-weight model (as determined by the AI Safety Institute and the U.S. Department of Energy). Because the model weights of the most powerful open-weight model will be available to all entities across the world, any entity seeking to use advanced AI models for activities that threaten U.S. national security and foreign policy will have no incentive to divert the model weights of less powerful closed models.
                        <PRTPAGE P="4555"/>
                    </P>
                    <P>In sum, BIS's new controls for the model weights of the most advanced AI models reflects both BIS's focus on the risks posed by the frontier of AI development and BIS's expectation that increasingly powerful models will continue to be available from foreign sources, rendering controls on general purpose models behind the frontier ineffective. BIS's controls will assist in the responsible management of the risks to national security and public safety posed by technological development at the frontier by ensuring that such models are diffused more broadly in a structured, staged manner. Additionally, restricting the export of model weights, while allowing access to the most advanced AI models through other methods, such as application programming interfaces, can unlock the beneficial uses of AI for users across the world while mitigating the national security and public safety risks posed by these models. Below, BIS explains its controls in more detail.</P>
                    <HD SOURCE="HD2">A. AI Model Weights Technology Controls</HD>
                    <P>
                        In the Commerce Control List (CCL), this rule adds new ECCN 4E091 for `parameters' for advanced AI models, which are defined as having been trained utilizing 10
                        <SU>26</SU>
                         or more `operations.' `Parameters' refers to any value learned during training (
                        <E T="03">e.g.,</E>
                         network weights, biases, etc.). `Operations' include any subsequent training, such as fine-tuning the pre-trained model, but does not include the collection and curation of the input training data.
                    </P>
                    <P>
                        This ECCN is controlled for regional stability (RS) reasons for exports, reexports, and transfers (in-country) to and within all destinations worldwide through new § 742.6(a)(13). The ECCN is also controlled for anti-terrorism (AT) reasons when destined to a country that has an AT:1 license requirement (
                        <E T="03">i.e.,</E>
                         Iran in § 742.8, Syria in § 742.9, or North Korea in § 742.19). 
                        <E T="03">See also</E>
                         parts 744 and 746 of the EAR for additional controls. License applications for items controlled under this RS control will be reviewed under a presumption of denial for all destinations other than those listed in paragraph (a) of supplement no. 5 to part 740, as established in new § 742.6(b)(14) of the EAR. License applications for destinations listed in paragraph (a) of supplement no. 5 to part 740 will be reviewed under a presumption of approval. The license requirements in § 742.6(a)(13) do not apply to deemed exports or deemed reexports for persons employed by entities headquartered in or with an ultimate parent headquartered in the United States or a destination specified in paragraph (a) of supplement no. 5 to Part 740.
                    </P>
                    <P>
                        As explained above, ECCN 4E091 excludes from the control any open-weight models. Note 1 to the ECCN states that ECCN 4E091 does not control the `parameters' of any artificial intelligence model that has been “published” as defined in § 734.7(a), or that were subject to additional training `operations' applied to “published” `parameters,' such that the additional training `operations' constitute no more than 2x10
                        <SU>25</SU>
                         `operations' or no more than 25 percent of the training `operations' defined in Note 2, whichever is higher. ECCN 4E091 also excludes from the control models that are less powerful than the most powerful open-weight model (as determined by the AI Safety Institute and the U.S. Department of Energy). Note 2 to the ECCN states that ECCN 4E091 does not control the `parameters' of any artificial intelligence model trained utilizing fewer `operations' than the number needed to train an artificial intelligence model as capable, according to an aggregate of widely used benchmarks, as the most advanced artificial intelligence model that has been “published” as defined in § 734.7(a) of the EAR.
                    </P>
                    <P>
                        As described in Note 2 to ECCN 4E091, to determine if an AI model is excluded from ECCN 4E091, an exporter may either self-classify its model or obtain guidance from BIS. Self-classification may rely on guidance published on BIS's website 
                        <E T="03">http://www.bis.gov/advanced-compute-resources</E>
                         or a technical opinion issued by the U.S. AI Safety Institute and the Department of Energy. For a BIS classification, exporters should submit a classification request in accordance with the procedures in §§ 748.1 and 748.3 of the EAR.
                    </P>
                    <HD SOURCE="HD2">B. Foreign-Direct Product Rule for AI Model Weights</HD>
                    <P>As described above, access to the model weights of advanced AI models may enable malicious actors to advance military end uses, develop WMD, the deploy offensive cyber operations, and carry out human right abuses. Direct access to the model weights may, for example, enable malicious actors to use the model to provide step-by-step instructions for the creation of chemical or biological weapons, or to develop AI agents capable of conducting advanced cyberattacks. This risk applies with equal force to model weights produced outside the United States using U.S. technology as it does to model weights produced inside the United States. To address the national security and foreign policy risk associated with the production of AI model weights outside of the United States, this rule applies a new Foreign Direct Product Rule (FDPR) in § 734.9(l). Under this new AI model weights FDPR, an item classified under new ECCN 4E091 is subject to the EAR based on product scope criteria to any location, worldwide. License requirements and license review policy are the same as those for ECCN 4E091, meaning that a license is not necessarily required just because this new FDPR establishes jurisdiction over the model. The applicable license requirements depend on the license requirements for 4E091 items, as well as end use and end user license requirements described in part 744 of the EAR.</P>
                    <P>To meet the new FDPR's product scope, the 4E091 item must be produced by a complete plant or `major component' of a plant that is located outside the United States, when the complete plant or `major component' of a plant, whether made in the United States or a foreign country, is subject to the EAR and specified in ECCN 3A001.z, 3A090, 4A003.z, 4A004.z, 4A005.z, 4A090, 5A002.z, 5A004.z, or 5A992.z. The ICs, servers, and other electronic equipment described in those ECCNs, which would be considered `major components' of a plant under this FDPR, are critical to producing model weights specified in 4E091. The FDPR also includes a note specifying that ECCN 4E091 includes any foreign-produced item that is further trained, including through techniques that follow on initial training, such as fine-tuning and quantization. Thus, the use of items not specified in ECCN 3A001.z, 3A090, 4A003.z, 4A004.z, 4A005.z, 4A090, 5A002.z, 5A004.z, or 5A992.z to conduct further training of a foreign-produced 4E091 item would not impact whether the 4E091 item is subject to the EAR.</P>
                    <HD SOURCE="HD2">C. License Exception Eligibility for AI Model Weights</HD>
                    <P>
                        The only license exception available for new ECCN 4E091 is newly-created License Exception AIA in § 740.27. License Exception AIA authorizes the export, reexport, and transfer (in-country) of ECCN 4E091 to entities located within the destinations listed in paragraph (a) of supplement no. 5 to Part 740. This license exception also authorizes the export, reexport, and transfer (in-country) of AI model weights, including the most advanced AI models specified in ECCN 4E091, to entities headquartered in, or whose ultimate parent company is headquartered in, the destinations listed in paragraph (a) of supplement no. 5 to 
                        <PRTPAGE P="4556"/>
                        Part 740 and located in any destination other than Macau or destinations listed in Country Group D:5. As discussed below, License Exception AIA also is available for certain eligible commodities, software, and technology. License Exception AIA cannot be used to export, reexport or transfer (in-country) ECCN 4E091 or other specified ECCNs to an entity headquartered outside of, or whose ultimate parent company is headquartered outside of, a destination specified in paragraph (a) of supplement no. 5 to Part 740.
                    </P>
                    <HD SOURCE="HD2">D. Red Flag Guidance on AI Model Weights</HD>
                    <P>In supplement no. 3 to part 732—BIS's “Know Your Customer” Guidance and Red Flags—this IFR adds a new red flag to provide compliance guidance to assist exporters, re-exporters, and transferors of AI model weights in complying with BIS's controls. New red flag 28 will help U.S. Infrastructure as a Service (IaaS) cloud computing providers located in the United States identify when training an advanced AI model for a customer that is a U.S. subsidiary of a foreign entity—and transferring the resulting model weights to that customer—creates a potential diversion concern. Under some circumstances, there is a substantial risk that the model weights will be exported from the United States in violation of BIS's controls. New red flag 28 specifies that in scenarios where a U.S. subsidiary of an entity headquartered in destinations other than those listed in paragraph (a) of supplement no. 5 to Part 740 uses a U.S. IaaS provider's products or services to train an AI model that falls within ECCN 4E091 raises a red flag under the EAR that the model weights may be exported to the connected entity without the necessary authorization. For example, if a U.S. IaaS provider provides infrastructure, in the form of clusters of advanced ICs, to train an AI model for a separate AI development organization, once the training run is complete, the model weights of the resulting AI model are transferred to the AI development organization. If a U.S. IaaS provider performs this service for a U.S. subsidiary of a foreign corporation headquartered in a destination to which a license requirement for ECCN 4E091 applies, the performance of the training run and the transfer of model weights creates a substantial risk that the model weights will be diverted to the entity's ultimate parent in violation of the EAR and that the IaaS provider may have aided and abetted a violation of the EAR.</P>
                    <P>BIS encourages exporters, reexporters, and transferors, as well as IaaS providers serving domestic customers, to take additional steps as part of their compliance programs to determine whether the model weights in question will be exported, reexported, or transferred to a destination subject to a license requirement and, if so, either to apply for a license or inform their customers of the obligation to do so prior to export.</P>
                    <HD SOURCE="HD1">IV. New Definition</HD>
                    <P>Section 772.1 is amended by adding a definition for “model weights.” This term is added to § 772.1 to assist the public to easily find the definition, because it is used in multiple parts of the EAR.</P>
                    <HD SOURCE="HD2">Export Control Reform Act of 2018</HD>
                    <P>On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (codified, as amended, at 50 U.S.C. 4801-4852). ECRA provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule. In particular, and as noted elsewhere, Section 1753 of ECRA (50 U.S.C. 4812) authorizes the regulation of exports, reexports, and transfers (in-country) of items subject to U.S. jurisdiction. Further, Section 1754(a)(1)-(16) of ECRA (50 U.S.C. 4813(a)(1)-(16)) authorizes, inter alia, the establishment of a list of controlled items; the prohibition of unauthorized exports, reexports, and transfers (in-country); the requirement of licenses or other authorizations for exports, reexports, and transfers (in-country) of controlled items; apprising the public of changes in policy, regulations, and procedures; and any other action necessary to carry out ECRA that is not otherwise prohibited by law. Pursuant to Section 1762(a) of ECRA (50 U.S.C. 4821(a)), these changes can be imposed in a final rule without prior notice and comment.</P>
                    <HD SOURCE="HD2">Rulemaking Requirements</HD>
                    <P>1. Executive Orders 12866, 13563, and 14094 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects and distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits and of reducing costs, harmonizing rules, and promoting flexibility.</P>
                    <P>This interim final rule has been designated a “significant regulatory action” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094.</P>
                    <P>
                        2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                        ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. Although this rule makes important changes to the EAR for items controlled for national security reasons, BIS believes that the overall increases in burdens and costs associated with the following information collections due to this rule are estimated to increase the number of submissions by 800 which is not expected to exceed the current approved estimates.
                    </P>
                    <P>• 0694-0088, “Simplified Network Application Processing System,” which carries a burden-hour estimate of 29.6 minutes for a manual or electronic submission;</P>
                    <P>• 0694-0137 “License Exceptions and Exclusions,” which carries a burden-hour estimate average of 1.5 hours per submission (Note: submissions for License Exceptions are rarely required);</P>
                    <P>• 0694-0096 “Five Year Records Retention Period,” which carries a burden-hour estimate of less than 1 minute; and</P>
                    <P>• 0607-0152 “Automated Export System (AES) Program,” which carries a burden-hour estimate of 3 minutes per electronic submission.</P>
                    <P>
                        Additional information regarding these collections of information—including all background materials—can be found at 
                        <E T="03">https://www.reginfo.gov/public/do/PRAMain</E>
                         and using the search function to enter either the title of the collection or the OMB Control Number.
                    </P>
                    <P>3. This rule does not contain policies with federalism implications as that term is defined in Executive Order 13132.</P>
                    <P>4. Pursuant to section 1762 of ECRA (50 U.S.C. 4821), this action is exempt from the Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation and delay in effective date.</P>
                    <P>
                        5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or 
                        <PRTPAGE P="4557"/>
                        by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, 
                        <E T="03">et seq.,</E>
                         are not applicable. Accordingly, no regulatory flexibility analysis is required, and none has been prepared.
                    </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects</HD>
                        <CFR>15 CFR Parts 732 and 750</CFR>
                        <P>Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.</P>
                        <CFR>15 CFR Part 734</CFR>
                        <P>Administrative practice and procedure, Exports, Inventions and patents, Research, Science and technology.</P>
                        <CFR>15 CFR Parts 740</CFR>
                        <P>Administrative practice and procedure, Exports, Reporting and recordkeeping.</P>
                        <CFR>15 CFR Part 742</CFR>
                        <P>Exports, Terrorism.</P>
                        <CFR>15 CFR Part 744</CFR>
                        <P>Exports, Reporting and recordkeeping requirements, Terrorism.</P>
                        <CFR>15 CFR Part 748</CFR>
                        <P>Administrative practice and procedure, Exports, Reporting and recordkeeping requirements, Terrorism.</P>
                        <CFR>15 CFR Part 762</CFR>
                        <P>Administrative practice and procedure, Business and industry, Confidential business information, Exports, Reporting and recordkeeping requirements.</P>
                        <CFR>15 CFR Part 772</CFR>
                        <P>Exports.</P>
                        <CFR>15 CFR Part 774</CFR>
                        <P>Exports, Reporting and Recordkeeping Requirements.</P>
                    </LSTSUB>
                    <P>Accordingly, parts 732, 734, 740, 742, 744, 748, 750, 762, 772, and 774 of the Export Administration Regulations (15 CFR parts 730 through 774) are amended as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 732—STEPS FOR USING THE EAR</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="732">
                        <AMDPAR>1. The authority citation for part 732 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783.
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="732">
                        <AMDPAR>2. Supplement No. 3 to part 732 is amended by adding paragraph 28 under “Red Flags” to read as follows:</AMDPAR>
                        <HD SOURCE="HD1">Supplement No. 3 to Part 732—BIS's “Know Your Customer” Guidance and Red Flags</HD>
                        <EXTRACT>
                            <STARS/>
                            <HD SOURCE="HD1">Red Flags</HD>
                            <STARS/>
                            <P>28. You will be providing Infrastructure-as-a-Service (IaaS) products or services, or other computing products or services, to assist in training an AI model with model weights captured by ECCN 4E091 for an entity headquartered, or whose ultimate parent is headquartered, in any destination other than those listed in paragraph (a) of supplement no. 5 to part 740 of the EAR. Such assistance creates a substantial risk that such AI model weights, due to their digital nature, will be exported or reexported to a destination for which a license is required and, if a license is not obtained, that the IaaS provider will have aided and abetted in a violation of the EAR. In such cases, the IaaS provider should inquire if the customer intends to export the model and if so, apply for a license as required or inform the customer of their obligation to do so prior to export.</P>
                        </EXTRACT>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 734—SCOPE OF THE EXPORT ADMINISTRATION REGULATIONS</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="734">
                        <AMDPAR>3. The authority citation for part 734 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; Notice of November 7, 2024, 89 FR 88867 (November 8, 2024); Pub. L. 118-50.
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="734">
                        <AMDPAR>4. Section 734.9 is amended by:</AMDPAR>
                        <AMDPAR>a. Revising paragraph (h); and</AMDPAR>
                        <AMDPAR>b. Adding paragraph (l).</AMDPAR>
                        <P>The addition and revision read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 734.9 </SECTNO>
                            <SUBJECT>Foreign-Direct Product (FDP) Rules.</SUBJECT>
                            <STARS/>
                            <P>
                                (h) 
                                <E T="03">Advanced computing FDP rule.</E>
                                 A foreign-produced item is subject to the EAR if it meets both the product scope in paragraph (h)(1) of this section and the destination scope in paragraph (h)(2) of this section. See § 742.6(a)(6) of the EAR for license requirements and license exceptions and § 742.6(b)(10) for license review policy applicable to foreign-produced items that are subject to the EAR under this paragraph (h).
                            </P>
                            <P>
                                (1) 
                                <E T="03">Product scope of advanced computing FDP rule.</E>
                                 The product scope applies if a foreign-produced item meets the conditions of either paragraph (h)(1)(i) or (ii) of this section.
                            </P>
                            <P>
                                (i) 
                                <E T="03">“Direct product” of “technology” or “software.”</E>
                                 A foreign-produced item meets the product scope of this paragraph (h) if it meets both of the following conditions:
                            </P>
                            <P>(A) The foreign-produced item is the “direct product” of “technology” or “software” subject to the EAR and specified in 3D001, 3D901, 3D991, 3D992, 3D993, 3D994, 3E001, 3E002, 3E003, 3E901, 3E991, 3E992, 3E993, 3E994, 4D001, 4D090, 4D993, 4D994, 4E001, 4E992, 4E993, 5D001, 5D002, 5D991, 5E001, 5E991, or 5E002 of the CCL; and</P>
                            <P>(B) The foreign-produced item is:</P>
                            <P>
                                (
                                <E T="03">1</E>
                                ) Specified in ECCN 3A090, 3E001 (for 3A090), 4A090, or 4E001 (for 4A090) of the CCL; or
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) An integrated circuit, computer, “electronic assembly,” or “component” specified in ECCN 3A001.z, 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, or 5A992.z.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Product of a complete plant or 'major component' of a plant that is a “direct product.”</E>
                                 A foreign-produced item meets the product scope of this paragraph (h) if it meets both of the following conditions:
                            </P>
                            <P>(A) The foreign-produced item is produced by any complete plant or 'major component' of a plant that is located outside the United States, when the plant or 'major component' of a plant, whether made in the United States or a foreign country, itself is a “direct product” of U.S.-origin “technology” or “software” that is specified in ECCN 3D001, 3D901, 3D991, 3D992, 3D993, 3D994, 3E001, 3E002, 3E003, 3E901, 3E991, 3E992, 3E993, 3E994, 4D001, 4D090, 4D993, 4D994, 4E001, 4E992, 4E993, 5D001, 5D991, 5E001, 5E991, 5D002, or 5E002 of the CCL; and</P>
                            <P>(B) The foreign-produced item is:</P>
                            <P>
                                (
                                <E T="03">1</E>
                                ) Specified in ECCN 3A090, 3E001 (for 3A090), 4A090, or 4E001 (for 4A090) of the CCL; or
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) An integrated circuit, computer, “electronic assembly,” or “component” specified in ECCN 3A001.z, 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, or 5A992.z.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Destination or end use scope of the advanced computing FDP rule.</E>
                                 A foreign-produced item meets the destination scope of this paragraph (h)(2) if there is “knowledge” that the foreign-produced item is:
                            </P>
                            <P>(i) Destined to any location worldwide or will be incorporated into any “part,” “component,” “computer,” or “equipment” not designated EAR99 destined to any location worldwide; or</P>
                            <P>
                                (ii) “Technology” “developed” by an entity headquartered in, or whose ultimate parent company is headquartered in, either Macau or a destination specified in Country Group 
                                <PRTPAGE P="4558"/>
                                D:5, for the “production” of a mask or an integrated circuit wafer or die.
                            </P>
                            <NOTE>
                                <HD SOURCE="HED">Note to 5 paragraph (h)(2)(ii):</HD>
                                <P>
                                      
                                    <E T="03">These end-use requirements under paragraph (h) apply when any entity headquartered in, or whose ultimate parent company is headquartered in, either Macau or a destination specified in Country Group D:5, is a party to any transaction involving the foreign-produced item, e.g., as a “purchaser,” “intermediate consignee,” “ultimate consignee,” or “end-user.”</E>
                                </P>
                            </NOTE>
                            <STARS/>
                            <P>
                                (l) 
                                <E T="03">AI Model weights FDP rule.</E>
                                 A foreign-produced item is subject to the EAR if it meets both the product scope in paragraph (l)(1) of this section and the destination scope in paragraph (l)(2) of this section. See § 742.6(a)(13) of the EAR for license requirements and § 742.6(b)(10) for license review policy applicable to foreign-produced items that are subject to the EAR under this paragraph (l).
                            </P>
                            <P>
                                (1) 
                                <E T="03">Product scope.</E>
                                 The product scope applies if a foreign-produced item is specified in ECCN 4E091 and is produced by a complete plant or `major component' of a plant that is located outside the United States, when the complete plant or `major component' of a plant, whether made in the United States or a foreign country, is subject to the EAR and specified in ECCN 3A001.z, 3A090, 4A003.z, 4A004.z, 4A005.z, 4A090, 5A002.z, 5A004.z, or 5A992.z.
                            </P>
                            <NOTE>
                                <HD SOURCE="HED">Note 7 to paragraph (l)(1):</HD>
                                <P> A foreign-produced item specified in ECCN 4E091 includes any foreign produced item that is further trained or modified via post-training techniques such as fine-tuning, quantization, or other techniques.</P>
                            </NOTE>
                            <P>
                                (2) 
                                <E T="03">Destination scope.</E>
                                 A foreign-produced 4E091 item meets the destination scope of this paragraph (l)(2) if the foreign-produced item is destined to any location worldwide.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 740—LICENSE EXCEPTIONS</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="740">
                        <AMDPAR>5. The authority citation for part 740 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 22 U.S.C. 7201 
                                <E T="03">et seq.;</E>
                                 E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783.
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="740">
                        <AMDPAR>6. Section 740.2 is amended by revising paragraph (a)(9)(ii) introductory text and paragraph (a)(9)(ii)(A) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 740.2 </SECTNO>
                            <SUBJECT>Restrictions on all License Exceptions.</SUBJECT>
                            <STARS/>
                            <P>(a) * * *</P>
                            <P>(9) * * *</P>
                            <P>(ii) The item is identified in paragraph (a)(9)(ii)(A) or (B) of this section and is being exported, reexported, or transferred (in-country) to or within a destination specified in Country Group D:1, D:4, or D:5, excluding any destination also specified in Country Groups A:5 or A:6, or to an entity headquartered in or whose ultimate parent is headquartered in, Macau or a destination specified in Country Group D:5, wherever located, and the license exception is other than: TMP, restricted to eligibility under the provisions of § 740.9(a)(6); NAC/ACA, under the provisions of § 740.8; RPL, under the provisions of § 740.10; GOV, restricted to eligibility under the provisions of § 740.11(b); TSU under the provisions of § 740.13(a) and (c); HBM under the provisions of § 740.25; AIA under the provisions of § 740.27 (for ECCN 4E091 to entities headquartered in countries listed in paragraph (a) of supplement no. 5 to part 740 and located in destinations other than Macau or Country Group D:5); or ACM under the provisions of § 740.28. Items restricted to eligibility only for the foregoing license exceptions are:</P>
                            <P>(A) Controlled under ECCNs 3A090, 4A090, 4E091, or associated software and technology in 3D001, 3E001, 4D090, and 4E001;</P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="740">
                        <AMDPAR>7. Section 740.8 is amended by revising the introductory text of paragraph (a) and paragraph (c)(1) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 740.8 </SECTNO>
                            <SUBJECT>Notified Advanced Computing (NAC) and Advanced Computing Authorized (ACA).</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Eligibility requirements.</E>
                                 License Exception NAC authorizes the export and reexport of any item classified in ECCN 3A090 (except for 3A090.c), 4A090, 3A001.z, 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, 5A992.z, 5D002.z, or 5D992.z, except for items designed or marketed for use in a datacenter and meeting the parameters of 3A090.a, to Macau and Country Group D:5 or an entity headquartered in or whose ultimate parent is headquartered in, Macau or a destination specified in Country Group D:5, wherever located. License Exception ACA authorizes the export, reexport, and transfer (in-country) of any item classified in ECCN 3A090 (except for 3A090.c), 4A090, 3A001.z, 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, 5A992.z, 5D002.z, or 5D992.z, except for items designed or marketed for use in a datacenter and meeting the parameters of 3A090.a, to or within any destination worldwide (except Macau, a destination specified in Country Group D:5, or an entity headquartered in, or whose ultimate parent is headquartered in, Macau or a destination specified in Country Group D:5, wherever located), as well as transfers (in-country) within Macau and destinations specified in Country Group D:5. These license exceptions may be used provided the export, reexport, or transfer (in-country) meets all of the applicable criteria identified under this paragraph (a) and none of the restrictions in paragraph (b) of this section.
                            </P>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>
                                (1) 
                                <E T="03">Procedures.</E>
                                 At least twenty-five calendar days prior to exports or reexports using License Exception NAC, you must provide prior notification under License Exception NAC by submitting a completed application in SNAP-R in accordance with § 748.1 of the EAR. The following blocks must be completed, as appropriate: Blocks 1, 2, 3, 4, 5 (by marking box 5 export license or reexport license), 9, 14, 16, 17, 18, 19, 21, 22(a), (d), (e), (f), (g), (h), (i), (j), 23, 24, and 25 according to the instructions described in supplement no. 1 to part 748 of the EAR. Box 9 under special purpose must include NAC. The application must include certain information to allow for BIS to determine if the item in question otherwise meets the criteria for an item eligible for License Exception NAC. Required information to include in the NAC submission is as follows:
                            </P>
                            <P>(i) Total Processing Performance of the item, as defined in ECCN 3A090;</P>
                            <P>(ii) Performance density of the item, as defined in ECCN 3A090;</P>
                            <P>(iii) Data sheet or other documentation showing how the item is designed and marketed (in particular, whether it is designed or marketed for datacenter use);</P>
                            <P>(iv) All NAC and license approvals to the end-user in the past 12 months;</P>
                            <P>(v) Memory bandwidth of the item(s); and</P>
                            <P>(vi) Whether the items are destined for use in a computing cluster, and, if so:</P>
                            <P>(A) The computing power of the computing cluster, measured in the aggregate TPP of all chips used in the cluster once the cluster is complete; and</P>
                            <P>(B) Whether the cluster will be:</P>
                            <P>
                                (
                                <E T="03">1</E>
                                ) Exclusively for internal use by a company headquartered in the United States or a destination specified in Country Group A:5 or A:6, or
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) Used by any other companies not headquartered in A:5 or A:6, or by external parties such as through cloud services.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="740">
                        <PRTPAGE P="4559"/>
                        <AMDPAR>8. Add §§ 740.27, 740.28, and 740.29 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 740.27 </SECTNO>
                            <SUBJECT>License Exception Artificial Intelligence Authorization (AIA).</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Scope.</E>
                                 This license exception authorizes the export, reexport, and transfer (in-country) of the items identified in paragraphs (a)(1) and (a)(2)(i) of this section to entities located within destinations listed in paragraph (a) of supplement no. 5 to this part, unless the entity is headquartered outside of, or has an ultimate parent company headquartered outside of, a destination specified in paragraph (a) of supplement no. 5 to this part, with an additional authorization for certain model weights in paragraph (a)(3) of this section, subject to additional conditions. This license exception cannot be used to provide items identified in paragraph (a)(1) of this section to entities headquartered outside of or located outside of paragraph (a) in supplement no. 5 to this part for training AI models specified in ECCN 4E091. Prior to export, reexport, or transfer (in-country) of eligible items in paragraph (a)(1) of this section, the exporter, reexporter, or transferor must obtain the certification described in (b)(2) of this section and submit it to BIS. 
                            </P>
                            <P>(1) Eligible commodities for this exception are: ECCNs 3A001.z.1.a, z.2.a, z.3.a, z.4.a; 3A090.a; 4A003.z.1.a, z.2.a; 4A004.z.1; 4A005.z.1; 4A090.a; 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a; 5A004.z.1.a, z.2.a; 5A992.z.1; 5A004.z.1.a, z.2.a; and 5A992.z.1.</P>
                            <P>(2) Eligible software and technology for this exception are:</P>
                            <P>(i) Advanced Integrated Circuits: 3D001 (for “software” for commodities controlled by 3A001.z.1.a, z.2.a, z.3.a, z.4.a and 3A090.a); 4D001 (for “software” for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, and 4A005.z.1); 4D090 (for “software” for commodities controlled by 4A090.a); 4E001 (for “technology” for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, 4A005.z.1, 4A090.a or “software” specified by 4D001 (for 4A003.z.1.a, z.2.a 4A004.z.1, and 4A005.z.1) or 4D090.a); ; 5D002.z.1.a z.2.a, z.3.a, z.4.a, z.5.a, z.6.a, z.7.a, z.8.a, and z.9.a, or 5D992.z.1; 5E002 (for “technology” for commodities controlled by 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a or 5A004.z.1.a, z.2.a or “software” specified by 5D002 (for 5A002. z.1.a, z.2.a, z.3.a, z.4.a, z.5.a or 5A004.z.1.a, z.2.a commodities)); and 5E992 (for “technology” for commodities controlled by 5A992.z.1 or “software” controlled by 5D992.z.1.)</P>
                            <P>(ii) AI Model Weights specified by ECCN 4E091, subject to the additional requirements in paragraph (a)(3) of this section.</P>
                            <P>(3) Additional authorization for AI model weights. For items identified in paragraph (a)(2)(ii) of this section only, this license exception also authorizes the export, reexport, and transfer (in-country) to entities headquartered, or whose ultimate parent company is headquartered, in the destinations listed in paragraph (a) of supplement no. 5 to this part 740, as long as:</P>
                            <P>(i) The entities obtaining the items are located outside Macau or destinations specified in Country Group D:5, and</P>
                            <P>(ii) These items will be stored in a facility that complies with paragraphs 14, 15 and 18 of the guidelines outlined in supplement no. 10 to part 748 (regardless of whether the facility is designated as a VEU).</P>
                            <P>
                                (b) 
                                <E T="03">Requirements prior to use of this license exception for eligible commodities, software, and technology identified in paragraphs (a)(1) and (a)(2)(i) of this section—</E>
                                (1) 
                                <E T="03">Furnish ECCN.</E>
                                 The exporter, reexporter, or transferor must furnish to the ultimate consignee the ECCN of each item to be exported, reexported, or transferred (in-country) pursuant to this section. Once furnished to a particular ultimate consignee, the ECCN need not be refurnished to that same ultimate consignee at the time the same exporter, reexporter, or transferor makes an additional export, reexport, or transfer (in-country) of the same item, if the ECCN(s) remains accurate at the time of the additional export, reexport, or transfer (in-country). For purposes of this license exception, the ultimate consignee is the entity that has ownership over the eligible item(s) in paragraph (a)(1) or (a)(2)(ii).
                            </P>
                            <P>
                                (2) 
                                <E T="03">Ultimate consignee certification.</E>
                                 Prior to use of this license exception for items identified in (a)(1) only, the exporter, reexporter, or transferor must obtain a certification from the ultimate consignee. The certification is a one-time certification provided by each ultimate consignee that will be receiving items through the use of this license exception. The certification should provide that: [INSERT NAME(S) OF ULTIMATE CONSIGNEE(S)]:
                            </P>
                            <P>
                                (i) Is aware that [INSERT GENERAL DESCRIPTION AND APPLICABLE ECCN(S) OF ITEMS TO BE SHIPPED (
                                <E T="03">e.g.,</E>
                                 Boards classified under ECCN 4A090.a)) will be shipped pursuant to License Exception Artificial Intelligence Authorization (AIA) of the Export Administration Regulations (EAR), 15 CFR parts 730-774;
                            </P>
                            <P>(ii) Agrees not to export, reexport, or transfer (in-country) these items to any end use or end user prohibited pursuant to Part 744 of the EAR without BIS authorization;</P>
                            <P>(iii) Agrees items received under this license exception are not, without prior authorization from the U.S. Department of Commerce's Bureau of Industry and Security (BIS), to be used to provide Infrastructure-as-a-Service (IaaS) access for training AI models specified in ECCN 4E091 for entities headquartered or located outside of, or whose ultimate parent company is headquartered outside of destinations listed in paragraph (a) of Supplement No. 5 to part 740;</P>
                            <P>(iv) Agrees that the items received under this license exception will not be exported, reexported, or transferred (in-country) to an entity headquartered or located outside of, or whose ultimate parent company is headquartered outside of paragraph (a) of Supplement No. 5 to Part 740 without prior authorization from BIS; and</P>
                            <P>(v) Inserts [NAME(S), SIGNATURE(S), AND TITLE(S) OF PERSON(S) AUTHORIZED TO SIGN THIS DOCUMENT ON BEHALF OF THE ULTIMATE CONSIGNEE, AND DATE(S) DOCUMENT IS SIGNED].</P>
                            <P>
                                (3) 
                                <E T="03">Notification to ultimate consignee of AIA shipment.</E>
                                 With each shipment under License Exception AIA, the exporter (or reexporter or transferor as applicable), must notify the ultimate consignee in writing that the shipment is made pursuant to License Exception AIA. The notice must either specify which items are subject to License Exception AIA or state that the entire shipment is made pursuant to License Exception AIA. The notice must clearly identify the shipment to which it applies. The written notice may be conveyed by paper documents or by electronic methods such as facsimile or email.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Reporting requirement.</E>
                                 Once the exporter, reexporter, or transferor obtains the certification from the ultimate consignee for items identified in paragraph (a)(1) only, prior to the initial export, reexport or transfer (in-country), the exporter, reexporter, or transferor must submit the certification to 
                                <E T="03">EARReports@bis.doc.gov,</E>
                                 with the subject line: AIA Certification. Following submission of the certification, exporters, reexporters and in-country transferors are not required to sign or provide a subsequent certification if the notification described in (b)(4) is provided to the ultimate consignee. This reporting requirement is only applicable if the ultimate consignee is receiving items identified in paragraph (a)(1) with a cumulative total processing performance (TPP) of 253,000,000.
                            </P>
                        </SECTION>
                        <SECTION>
                            <PRTPAGE P="4560"/>
                            <SECTNO>§ 740.28</SECTNO>
                            <SUBJECT> License Exception Advanced Compute Manufacturing (ACM).</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Scope.</E>
                                 License Exception ACM authorizes the export, reexport, and transfer (in-country) of eligible items specified in paragraph (b) to `private sector end users' for the “development,” “production,” or storage (in a warehouse or other similar facility) prior to export, reexport, or transfer (in country) to the ultimate end user of eligible items specified in paragraph (b) for items that are ultimately destined to customers outside of Macau or destinations specified in Country Group D:5, unless otherwise authorized.
                            </P>
                            <P>
                                (b) 
                                <E T="03">Eligible commodities, software, and technology.</E>
                                 Items controlled by ECCNs 3A001.z; 3A090; 3D001 (for “software” for commodities controlled by 3A001.z or 3A090); 3E001 (for “technology” for commodities controlled by 3A001.z or 3A090); 4A003.z; 4A004.z; 4A005.z; 4A090; 4D001 (for “software” for commodities controlled by 4A003.z, 4A004.z, and 4A005.z); 4D090 (for “software” for commodities controlled by 4A090); 4E001 (for commodities controlled by 4A003.z, 4A004.z, 4A005.z, 4A090 or “software” specified by 4D001 (for 4A003.z, 4A004.z, or 4A005.z), or 4D090 (for “software” for commodities controlled by 4A090)); 5A002.z; 5A004.z; 5A992.z; 5D002.z; 5D992.z; 5E002 (for “technology” for commodities controlled by 5A002.z or 5A004.z or “software” specified by 5D002 (for 5A002.z or 5A004.z commodities)); or 5E992 (for “technology” for commodities controlled by 5A992.z or “software” controlled by 5D992.z).
                            </P>
                            <P>
                                (c) 
                                <E T="03">Ineligible destinations.</E>
                                 License Exception ACM does not authorize the export, reexport, or transfer (in-country) to Macau or any destination specified in Country Group D:5, or to any consignee wherever located when the ultimate consignee is headquartered in, or the ultimate consignee's ultimate parent company is headquartered in, Macau or a destination specified in Country Group D:5.
                            </P>
                            <P>
                                (d) 
                                <E T="03">Private sector end user.</E>
                                 A `private sector end user' is either an individual who is not acting on behalf of any government (other than the U.S. Government), or a commercial firm (including its subsidiary and parent firms, and other subsidiaries of the same parent) that is not wholly owned by, or otherwise controlled by any government (other than the U.S. Government).
                            </P>
                            <P>
                                (e) 
                                <E T="03">Accounting.</E>
                                 Exporters, reexporters, and transferors must maintain a system of distribution that allows them to account for the number of controlled items transferred to, and subsequently out, of the facility. Such accounting should be done for each facility, with records updated every six months or more frequently.
                            </P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 740.29 </SECTNO>
                            <SUBJECT>License Exception Low Processing Performance (LPP).</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Scope.</E>
                                 License Exception LPP authorizes the export and reexport of up to 26,900,000 cumulative total processing performance (TPP) of advanced computing integrated circuits per-calendar year directly to a single ultimate consignee. If the ultimate consignee is headquartered in a destination specified in paragraph (a) of supplement no. 5 to part 740, then the ultimate consignee may apply the cumulative TPP of exports and reexports of eligible commodities under this license exception toward the cumulative TPP limit of a different entity that will operate the items in paragraph (b). This license exception does not authorize transfers (in-country).
                            </P>
                            <P>
                                (b) 
                                <E T="03">Eligible commodities.</E>
                                 Eligible commodities are those under ECCNs 3A001.z.1.a, z.2.a, z.3.a, z.4.a; 3A090.a; 4A003.z.1.a, z.2.a; 4A004.z.1; 4A005.z.1; 4A090.a; 5A004.z.1.a, z.2.a; and 5A992.z.1.
                            </P>
                            <P>
                                (c) 
                                <E T="03">Eligible destinations.</E>
                                 This License Exception is available except:
                            </P>
                            <P>(1) To destinations specified in Country Group D:5 or Macau, or</P>
                            <P>(2) To any destination when the ultimate consignee is headquartered in or has an ultimate parent company headquartered in Macau or a destination specified in Country Group D:5.</P>
                            <P>
                                (d) 
                                <E T="03">Restriction on annual processing power volume of LPP.</E>
                                 The total TPP volume of all exports and reexports of eligible commodities under this license exception made by all exporters and reexporters to a single ultimate consignee per calendar year may not exceed 26,900,000 TPP; however, there is no restriction on the number of shipments or the number of exporters and reexporters, provided that TPP volume is not exceeded. This annual TPP limit applies to shipments by all exporters and reexporters to the same ultimate consignee even though the shipments are made through more than one intermediate consignee.
                            </P>
                            <P>
                                (e) 
                                <E T="03">Prohibited end use and end user.</E>
                                 This license exception cannot be used to export or reexport items to any end use or end user prohibited under Part 744.
                            </P>
                            <P>
                                (f) 
                                <E T="03">Ultimate Consignee Statement.</E>
                                 Prior to use of this license exception the exporter or reexporter must obtain a certification from the ultimate consignee that: [INSERT NAME(S) OF ULTIMATE CONSIGNEE(S)]:
                            </P>
                            <P>
                                (i) Is aware that [INSERT GENERAL DESCRIPTION AND APPLICABLE ECCN(S) OF ITEMS TO BE SHIPPED (
                                <E T="03">e.g.,</E>
                                 Boards classified under ECCN 4A090.a)] will be shipped pursuant to License Exception Low Processing Performance;
                            </P>
                            <P>(ii) Agrees not to export, reexport, or transfer these items to any use or user prohibited under Part 744 of the Export Administration Regulations;</P>
                            <P>(iii) Certifies that they have not received a `cumulative TPP' of 26,900,000 of ECCNs 3A001.z.1.a, z.2.a, z.3.a, z.4.a; 3A090.a; 4A003.z.1.a, z.2.a; 4A004.z.1; 4A005.z.1; 4A090.a; 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a; 5A004.z.1.a, z.2.a; 5A992.z.1, 5A004.z.1.a, z.2.a; and 5A992.z.1 items in the relevant calendar year under License Exception LPP.</P>
                            <P>(iv) Inserts [NAME(S), SIGNATURE(S), AND TITLE(S) OF PERSON(S) AUTHORIZED TO SIGN THIS DOCUMENT ON BEHALF OF THE ULTIMATE CONSIGNEE, AND DATE(S) DOCUMENT IS SIGNED].</P>
                            <P>
                                (g) 
                                <E T="03">Reporting requirement.</E>
                                 (1) Exporters and reexporters, having obtained the required certification in paragraph (f) prior to exporting or reexporting eligible items, must provide a copy of that certification to BIS by email to 
                                <E T="03">EARReports@bis.doc.gov</E>
                                 with subject line “LPP Shipment” within 30 days of the date on which the export or reexport takes place.
                            </P>
                            <P>
                                (2) Ultimate consignees receiving eligible commodities under this License Exception TPP must notify BIS by email to 
                                <E T="03">EARReports@bis.doc.gov</E>
                                 with subject line “LPP TPP Limit Reached” whenever they have received the maximum allowable 26,900,000 TPP under this license exception in a calendar year in all shipments from all exporters and reexporters. Notification to BIS should be made as soon as the ultimate consignee actually receives the final shipment of eligible commodities that exhausts the consignee's annual TPP volume limit.
                            </P>
                            <P>
                                (3) Exporters and reexporters, prior to exporting or reexporting the eligible items, must notify BIS by email to 
                                <E T="03">EARReports@bis.doc.gov</E>
                                 with the subject line “LPP Shipment” of any shipment with an aggregate TPP of 3,200,000.
                            </P>
                            <P>
                                (h) 
                                <E T="03">Definitions</E>
                                —(1) 
                                <E T="03">Ultimate consignee.</E>
                                 For purposes of this license exception, the ultimate consignee is the ultimate parent entity that has ultimate ownership over the items in paragraph (b).
                            </P>
                            <P>
                                (2) 
                                <E T="03">Cumulative TPP.</E>
                                 The `cumulative TPP' is the total amount of TPP, as defined in the Technical Notes to 3A090, of all eligible commodities in 
                                <PRTPAGE P="4561"/>
                                paragraph (b) that are received by a single ultimate consignee in all shipments from all exporters and reexporters in a calendar year. Cumulative TPP should be calculated by adding the individual TPP for any items specified in 3A090.a and 4A090.a and any items specified in 3A001.z, 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, or 5A992.z that meet or exceed the parameters of 3A090.a or 4A090.a.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="740">
                        <AMDPAR>9. Part 740 is amended by adding Supplement No. 5 to read as follows:</AMDPAR>
                        <HD SOURCE="HD1">Supplement No. 5 to Part 740—Artificial Intelligence Authorization Countries</HD>
                        <EXTRACT>
                            <P>(a) Destinations eligible:</P>
                            <FP SOURCE="FP-1">Australia</FP>
                            <FP SOURCE="FP-1">Belgium</FP>
                            <FP SOURCE="FP-1">Canada</FP>
                            <FP SOURCE="FP-1">Denmark</FP>
                            <FP SOURCE="FP-1">Finland</FP>
                            <FP SOURCE="FP-1">France</FP>
                            <FP SOURCE="FP-1">Germany</FP>
                            <FP SOURCE="FP-1">Ireland</FP>
                            <FP SOURCE="FP-1">Italy</FP>
                            <FP SOURCE="FP-1">Japan</FP>
                            <FP SOURCE="FP-1">Netherlands</FP>
                            <FP SOURCE="FP-1">New Zealand</FP>
                            <FP SOURCE="FP-1">Norway</FP>
                            <FP SOURCE="FP-1">Republic of Korea</FP>
                            <FP SOURCE="FP-1">Spain</FP>
                            <FP SOURCE="FP-1">Sweden</FP>
                            <FP SOURCE="FP-1">Taiwan</FP>
                            <FP SOURCE="FP-1">United Kingdom</FP>
                            <FP SOURCE="FP-1">United States</FP>
                            <P>(b) Destinations that have provided government assurances to the U.S. Government and therefore are subject to a higher country allocation. </P>
                        </EXTRACT>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 742—CONTROL POLICY—CCL BASED CONTROLS</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="742">
                        <AMDPAR>10. The authority citation for part 742 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 22 U.S.C. 3201 
                                <E T="03">et seq.;</E>
                                 42 U.S.C. 2139a; 22 U.S.C. 7201 
                                <E T="03">et seq.;</E>
                                 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Notice of November 7, 2024, 89 FR 88867 (November 8, 2024). 
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="742">
                        <AMDPAR>11. Section 742.6 is amended by</AMDPAR>
                        <AMDPAR>a. Revising paragraph (a)(6)(iii);</AMDPAR>
                        <AMDPAR>b. Adding paragraph (a)(13);</AMDPAR>
                        <AMDPAR>c. Revising paragraph (b)(10)(iii); and</AMDPAR>
                        <AMDPAR>d. Adding (b)(14).</AMDPAR>
                        <P>The revisions and additions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 742.6</SECTNO>
                            <SUBJECT> Regional stability.</SUBJECT>
                            <STARS/>
                            <P>(a) * * *</P>
                            <P>(6) * * *</P>
                            <P>
                                (iii)(A) 
                                <E T="03">Worldwide license requirement.</E>
                                 A license is required to export, reexport, or transfer (in-country) items specified in ECCNs 3A001.z.1.a, z.2.a, z.3.a, z.4.a; 3A090.a; 3D001 (for “software” for commodities controlled by 3A001.z.1.a, z.2.a, z.3.a, z.4.a, or 3A090.a); 3E001 (for “technology” for commodities controlled by 3A001.z.1.a, z.2.a, z.3.a, z.4.a, or 3A090.a); 4A003.z.1.a, z.2.a; 4A004.z.1; 4A005.z.1; 4A090.a; 4D001 (for “software” for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, and 4A005.z.1); 4D090 (for “software” for commodities controlled by 4A090.a); 4E001 (for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, 4A005.z.1, 4A090.a or “software” specified by 4D001 (for 4A003.z.1.a, z.2.a, 4A004.z.1, or 4A005.z.1), or 4D090 (for “software” for commodities controlled by 4A090.a)); 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a; 5A004.z.1.a, z.2.a; 5A992.z.1; 5D002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a, z.6.a, z.7.a, z.8.a, and z.9.a; 5D992.z.1; 5E002 (for “technology” for commodities controlled by 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a or 5A004.z.1.a, z.2.a or “software” specified by 5D002 (for 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a or 5A004.z.1.a, z.2.a commodities)); or 5E992 (for “technology” for commodities controlled by 5A992.z.1 or “software” controlled by 5D992.z.1.) to or within any destination worldwide.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Country Groups D:1, D:4, or D:5 license requirement excluding destination also specified in Country Groups A:5 or A:6.</E>
                                 A license is required to export, reexport, or transfer (in-country) items specified in ECCNs 3A001.z.1.b, z.2.b, z.3.b, z.4.b; 3A090.b; 3D001 (for “software” for commodities controlled by 3A001.z.1.b, z.2.b, z.3.b, z.4.b; 3A090.b); 3E001 (for “technology” for commodities controlled by 3A001.z.1.b, z.2.b, z.3.b, z.4.b, or 3A090.b); 4A003.z.1.b, z.2.b; 4A004.z.2; 4A005.z.2; 4A090.b; 4D001 (for “software” for commodities controlled by 4A003.z.1.b, z.2.b, 4A004.z.2, and 4A005.z.2); 4D090 (for “software” for commodities controlled by 4A090.b); 4E001 (for commodities controlled by 4A003.z.1.b, z.2.b, 4A004.z.2, 4A005.z.2, 4A090.b or “software” specified by 4D001 (for 4A003.z.1.b, z.2.b, 4A004.z.2, or 4A005.z.2), or 4D090 (for “software” for commodities controlled by 4A090.b)); 5A002.z.1.b, z.2.b, z.3.b, z.4.b, z.5.b; 5A004.z.1.b, z.2.b; 5A992.z.2; 5D002.z.1.b, z.2.b, z.3.b, z.4.b, z.5.b, z.6.b, z.7.b, z.8.b, and z.9.b; 5D992.z.2; 5E002 (for “technology” for commodities controlled by 5A002.z.1.b, z.2.b, z.3.b, z.4.b, z.5.b or 5A004.z.1.b, z.2.b or “software” specified by 5D002 (for 5A002. z.1.b, z.2.b, z.3.b, z.4.b, z.5.b or 5A004.z.1.b, z.2.b commodities)); or 5E992 (for “technology” for commodities controlled by 5A992.z.2 or “software” controlled by 5D992.z.2.) to or within a destination in Country Groups D:1, D:4, or D:5 excluding destinations also specified in Country Groups A:5 or A:6.
                            </P>
                            <STARS/>
                            <P>
                                (13) 
                                <E T="03">RS requirement that applies to artificial intelligence model weights.</E>
                                 A license is required for the export, reexport, and transfer (in-country) of items specified in ECCN 4E091 to all destinations worldwide. The license requirements in this paragraph (a)(13) do not apply to deemed exports or deemed reexports for `permanent regular employees,' as that term is defined § 734.20(d)(2), employed by entities headquartered in or with an ultimate parent headquartered in a destination specified in paragraph (a) of Supplement No. 5 to Part 740.
                            </P>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(10) * * *</P>
                            <P>
                                (iii) 
                                <E T="03">License review policy for paragraph (a)(6)(iii)(A)</E>
                                —(A)(
                                <E T="03">1</E>
                                ) 
                                <E T="03">Policy for Country Group D:5 and Macau.</E>
                                 For items specified in paragraph (a)(6)(iii)(A) of this section, applications for exports, reexports, or transfers (in-country) to or within Macau or destinations specified in Country Group D:5 or to an entity headquartered in, or whose ultimate parent company is headquartered in, either Macau or a destination specified in Country Group D:5 will be reviewed under a presumption of denial.
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) 
                                <E T="03">Policy for countries in paragraph (a)of supplement no. 5 to part 740.</E>
                                 For items specified in paragraph (a)(6)(iii)(A) of this section, applications for exports, reexports, or transfers (in-country) to or within destinations listed in paragraph (a) to supplement no. 5 of Part 740, or to entities headquartered in, or whose ultimate parent company is headquartered in, a destination listed in paragraph (a) to supplement no. 5 of Part 740 will be reviewed under a presumption of approval.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Country Allocations and licensing policy for all other destinations.</E>
                                 For items specified in paragraph (a)(6)(iii)(A) of this section, applications for exports, reexports, or transfers (in-country) to or within a destination or to entities headquartered, or whose ultimate parent is headquartered, in a destination not listed in either paragraph (a) or (b) of supplement no. 5 of Part 740:
                                <PRTPAGE P="4562"/>
                            </P>
                            <P>
                                (
                                <E T="03">1</E>
                                ) 
                                <E T="03">Not exceeding the country allocation.</E>
                                 Applications for exports, reexports, or transfers (in-country) will be reviewed under a presumption of approval, up to a per-country allocation of 790,000,000 TPP for the period from 2025 to 2027, to or within destinations other than Country Group D:5 or Macau or to entities not headquartered in or whose ultimate parent company is not headquartered in destinations in Country Group D:5 or Macau. These TPP allocations represent permitted cumulative installed base, not newly available TPP in addition to previous-year installed bases. BIS will calculate progress toward country allocations by totaling the TPP of 3A090.a, 4A090.a, and corresponding .z items licensed to each destination cumulatively beginning in 2025. Items exported, re-exported, or transferred (in-country) before 2025 will not count toward country allocations. Please visit 
                                <E T="03">www.bis.gov</E>
                                /advanced-compute-resources for an update on whether the country allocations have been met.
                            </P>
                            <P>
                                (
                                <E T="03">2</E>
                                ) 
                                <E T="03">Exceeding the country allocation.</E>
                                 After the country allocations above are met, applications will be reviewed under a policy of denial. Together with the Departments of State, Energy, and Defense, BIS will review allocations for subsequent years on an annual basis.
                            </P>
                            <P>(C) For items specified in paragraph (a)(6)(iii)(A) of this section, applications for exports, reexports, or transfers (in-country) to or within destinations listed in paragraph (b) of supplement no. 5 to Part 740, TPP allocations may be increased up to 100% for that destination pursuant to government-to-government assurances, as applicable. Accordingly, the licensing policy in paragraph (b)(10)(iii)(B) will apply, up to the adjusted country allocations.</P>
                            <P>(iv) For items specified in paragraph (a)(6)(iii)(B) of this section:</P>
                            <P>
                                (A) 
                                <E T="03">Presumption of approval.</E>
                                 Applications for exports, reexports, or transfers (in-country) will be reviewed with a presumption of approval to or within destinations not specified in Country Group D:5 or Macau or to an entity not headquartered in, and whose ultimate parent company is not headquartered in, either Macau or a destination specified in Country Group D:5.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Presumption of denial.</E>
                                 Applications for exports, reexports, or transfers (in-country) will be reviewed under a presumption of denial to or within Macau or destinations specified in Country Group D:5 or to an entity headquartered in, or whose ultimate parent company is headquartered in, either Macau or a destination specified in Country Group D:5.
                            </P>
                            <STARS/>
                            <P>
                                (14) 
                                <E T="03">License Review Policy for AI Model Weights in (a)(13) of this section.</E>
                                 Applications to export, reexport, or transfer (in-country) items classified under ECCN 4E091 will be reviewed under a presumption of denial for end users headquartered, or with an ultimate parent headquartered, outside of destinations listed in paragraph (a) to supplement No. 5 to part 740.
                            </P>
                            <NOTE>
                                <HD SOURCE="HED">Note to paragraph (b)(14):</HD>
                                <P> Note 2 to ECCN 4E091 explains that 4E091 does not control the `parameters' of any artificial intelligence model trained utilizing fewer `operations' than the number needed to train an artificial intelligence model as capable, according to an aggregate of widely used benchmarks, as the most advanced artificial intelligence model that has been “published” as defined in § 734.7(a) of the EAR.</P>
                            </NOTE>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 744—CONTROL POLICY: END-USER AND END-USE BASED</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="744">
                        <AMDPAR>12. The authority citation for part 744 is revised to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 22 U.S.C. 3201 
                                <E T="03">et seq.;</E>
                                 42 U.S.C. 2139a; 22 U.S.C. 7201 
                                <E T="03">et seq.;</E>
                                 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice of September 18, 2024, 89 FR 77011 (September 20, 2024); Notice of November 7, 2024, 89 FR 88867 (November 8, 2024).
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="744">
                        <AMDPAR>13. Revise § 744.23(a)(3)(i) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 744.23 </SECTNO>
                            <SUBJECT>“Supercomputer,” “advanced-node integrated circuits,” and semiconductor manufacturing equipment end use controls.</SUBJECT>
                            <STARS/>
                            <P>(a) * * *</P>
                            <P>(3) * * *</P>
                            <P>
                                (i)(A) Any item subject to the EAR and specified in ECCN 3A001.z.1.b, z.2.b, z.3.b, z.4.b; 3A090.b; 4A003.z.1.b, z.2.b; 4A004.z.2; 4A005.z.2; 4A090.b; 5A002.z.1.b, z.2.b, z.3.b, z.4.b, z.5.b; 5A004.z.1.b, z.2.b; 5A992.z.2, 5D002.z.1.b, z.2.b, z.3.b, z.4.b, z.5.b, z.6.b, z.7.b, z.8.b, and z.9.b; 5D992.z.2 destined to any destination other than those specified in Country Groups D:1, D:4, or D:5 (excluding any destination also specified in Country Groups A:5 or A:6) for an entity that is headquartered in, or whose ultimate parent company is headquartered in, either Macau or a destination specified in Country Group D:5 (
                                <E T="03">e.g.,</E>
                                 a PRC-headquartered cloud or data server provider located outside of Country Groups D:1, D:4, or D:5 (excluding any destination also specified in Country Groups A:5 or A:6)).
                            </P>
                            <P>(B) Any item subject to the EAR and specified in ECCN 3A090.c destined to any destination other than Macau or those specified in Country Group D:5, for an entity that is headquartered in, or whose ultimate parent company is headquartered in, either Macau or a destination specified in Country Group D:5.</P>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 748—APPLICATIONS (CLASSIFICATION, ADVISORY, AND LICENSE) AND DOCUMENTATION</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="748">
                        <AMDPAR>14. The authority citation for part 748 is revised to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 13, 2024, 8 FR 66187 (August 15, 2024). 
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="748">
                        <AMDPAR>15. Section 748.3 is amended by adding paragraph (f) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 748.3 </SECTNO>
                            <SUBJECT>Classification requests and advisory opinions.</SUBJECT>
                            <STARS/>
                            <P>
                                (f) 
                                <E T="03">Classification requests for artificial intelligence models.</E>
                                 Classification requests may be submitted to confirm that technology is not controlled under ECCN 4E091 because the artificial intelligence model has been trained utilizing fewer computational `operations' than the number needed to train a model as capable, according to an average of widely used benchmarks, as the most advanced artificial intelligence model that has been “published” as defined in § 734.7(a) of the EAR. Refer to the technical notes to ECCN 4E091 for instructions regarding self-classifications of artificial intelligence models. 
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="748">
                        <AMDPAR>16. Section 748.15 is amended by revising the introductory text and paragraphs (a)(1), (a)(2), (b), (d)(2), and (f) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 748.15</SECTNO>
                            <SUBJECT> Authorization Validated End-User (VEU).</SUBJECT>
                            <P>
                                Validated end-users (VEU) are those who have been previously approved by BIS pursuant to the requirements of this section. To be eligible for authorization VEU, exporters, reexporters, and validated end-user applicants must adhere to the conditions and restrictions set forth in paragraphs (a) through (f) of this section. If a request for VEU 
                                <PRTPAGE P="4563"/>
                                Authorization for a particular end-user is not granted, no new license requirement is triggered. In addition, such a result does not render the end user ineligible for license approvals from BIS. There are two types of VEU authorization: General VEU Authorization and Data Center VEU Authorization. General VEU Authorizations permit the export, reexport, and transfer to validated end-users of any eligible items that will be used in a specific eligible destination. Data Center VEU Authorizations permit the export and reexport to validated end-users of any eligible items that will be used in specific data centers. A data center is a facility or “facilities” that house a multi-racked, networked computer system that include servers, storage devices, and networking equipment. Data Center VEU Authorizations may be either universal or national authorizations.
                            </P>
                            <P>
                                (a)(1) 
                                <E T="03">Eligible end-users for General VEU Authorizations and Data Center VEU Authorizations.</E>
                                 The only end users to whom eligible items may be exported, reexported, or transferred under a General VEU Authorization or a Data Center VEU Authorization are those validated end-users identified in Supplement No. 7 to this part. Those entities were added as VEUs according to the provisions in this Section and Supplement Nos. 8 and 9 to this part.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Requests for authorizations</E>
                                —(i) 
                                <E T="03">Advisory opinion.</E>
                                 To apply for a General VEU Authorization or Data Center VEU Authorization, requests for authorization must be submitted in the form of an advisory opinion request, as described in § 748.3(c), and must include a list of items (except as excluded by paragraph (c) of this section), identified by ECCN, intended for export, reexport, or transfer (in-country) to an eligible end-user, once approved.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Applications for Universal VEU (UVEU) Authorization—</E>
                                (A) 
                                <E T="03">Application Overview.</E>
                                 A UVEU authorization should be submitted by the owner of the advanced computing ICs. To qualify for UVEU authorization, the owner of the advanced computing ICs must certify that it will follow the guidelines in Supplement No. 10 to this part. The owner of the advanced compute must certify that it will follow the guidelines in paragraphs 14, 15, and 18 of Supplement No. 10 to this part on or before January 15, 2026. If the owner of the advanced computing ICs cannot certify to all of the guidelines in Supplement No. 10 to this part, it must notify BIS in its application of the other entities involved in its operations. The applicant must also provide signed certifications from such entities as set forth in Supplement No. 10 to this part. For UVEUs, if the operator of the advanced compute is different from the owner of the advanced compute, the operator must itself have an Authorization UVEU. As appropriate, BIS will adjudicate complete UVEU applications within 30 days of receipt. A UVEU will need to file a notification with BIS when building a datacenter in a new location 180 days before any exports, reexports, or transfers (in-country) to the new datacenter. The notification should include the physical address of the new data center location. BIS will use this information to update the eligible destination column in the validated end user list in Supplement No. 7 to this part. The UVEU may choose whether to list a corporate address or a physical address of the new data center location. The UVEU may furnish its BIS authorization letter as proof of its authorization to receive exports, reexports, or transfers (in-country) prior to the publication of an amendment to Supplement No. 7 to this part that includes a physical address, or where Supplement No. 7 includes a corporate address but not a physical address. No other requirements may be placed on the UVEU beyond those described in Supplement No. 10 to this part as a condition for granting the original UVEU application.
                            </P>
                            <P>
                                (B) 
                                <E T="03">UVEU Compute Geographic Allocations.</E>
                                 UVEUs will be subject to the geographic allocations identified in paragraph 6 or Supplement No. 10 to this part.
                            </P>
                            <P>
                                (iii) 
                                <E T="03">Applications for National VEU (NVEU) Authorization</E>
                                —(A) 
                                <E T="03">Application Overview.</E>
                                 The NVEU Authorization will allow an entity to receive exports and reexports in a specific country as specified in their NVEU authorization. For every additional country in which the NVEU wants to operate, the owner of the advanced compute must obtain a separate NVEU authorization. To qualify for NVEU authorization, the owner of the advanced computing ICs must adhere to guidelines provided in Supplement No. 10 to this part but, depending on its location and the national security and foreign policy risks associated with that location, may be subject to other requirements. The owner of the advanced compute must certify that it will follow the guidelines in paragraphs 14, 15, and 18 of Supplement No. 10 to this part on or before January 15, 2026. If the owner of the advanced computing ICs cannot certify to all of the guidelines in Supplement No. 10 to this part, it must notify BIS in its application of the other entities involved in its operations. Applicants must provide written assurances from those other entities consistent with Supplement No. 10 to this part during the application review process. Government-to-Government assurances between the United States and the government of the country in which the NVEU wishes to operate may be sought before a NVEU is granted. Where multiple entities will own and operate the NVEU they should submit a joint application. For NVEUs, if the operator of the advanced compute is different from the owner of the advanced compute, the operator must itself have its own Authorization NVEU. After receiving NVEU Authorization, the NVEU will be listed as such in Supplement No. 7 to this part. The NVEU may inform BIS if it prefers that Supplement No. 7 list a corporate address or a physical address of the new data center location. Once approved for Authorization NVEU by BIS, the NVEU may furnish its BIS authorization letter that includes physical addresses as proof of its authorization to receive exports, reexports, or transfers (in-country) prior to the publication of an amendment to Supplement No. 7 that includes a physical address, or where Supplement No. 7 includes a corporate address but not a physical address.
                            </P>
                            <P>
                                (B) 
                                <E T="03">NVEU TPP Allocation.</E>
                                 NVEUs will be subject to a per-NVEU per-country installed base allocation of total processing performance (TPP), as measured by the collective computing power of items subject to ECCNs 3A090.a, 4A090.a, or corresponding .z paragraphs, as provided below:
                            </P>
                            <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s25,14">
                                <TTITLE>
                                    Table 1 to Paragraph 
                                    <E T="01">(a)(2)(iii)(B)</E>
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Quarter</CHED>
                                    <CHED H="1">
                                        Cumulative
                                        <LI>per-company</LI>
                                        <LI>per-country</LI>
                                        <LI>allocation</LI>
                                        <LI>in TPP</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">2025 Q1</ENT>
                                    <ENT>633,000,000</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2025 Q2</ENT>
                                    <ENT>949,500,000</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2025 Q3</ENT>
                                    <ENT>1,266,000,000</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2025 Q4</ENT>
                                    <ENT>1,582,500,000</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2026 Q1</ENT>
                                    <ENT>1,899,000,000</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2026 Q2</ENT>
                                    <ENT>2,690,250,000</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2026 Q3</ENT>
                                    <ENT>3,481,500,000</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2026 Q4</ENT>
                                    <ENT>4,272,750,000</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">2027 Q1-4</ENT>
                                    <ENT>5,064,000,000</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                These TPP allocations represent permitted cumulative installed base during a given quarter, not newly available TPP in addition to previous-quarter installed bases, and do not count towards or impact country allocations. Advanced computing ICs that suffer attrition due to factors such as loss, damage, failure, relocation, and resale do not count toward allocations.
                                <PRTPAGE P="4564"/>
                            </P>
                            <P>
                                (iv) 
                                <E T="03">Information to include and address for submissions.</E>
                                 To ensure a thorough review, applications for Authorization VEU must include the information described in Supplement No. 8 to this part. Applications for UVEU and NVEU should also include information demonstrating that the applicant can adhere to the guidelines described in Supplement No. 10 to this part. Requests for authorization will be accepted from exporters, reexporters, or end users. Submit the request to: The Office of Exporter Services, Bureau of Industry and Security, U.S. Department of Commerce, 14th Street and Pennsylvania Avenue NW, Room 2099B, Washington, DC 20230. Mark the package “Request for [insert “General,” “Data Center—Universal,” or “Data Center—National” as appropriate] Authorization Validated End-user.”
                            </P>
                            <STARS/>
                            <P>
                                (b) 
                                <E T="03">Eligible destinations</E>
                                —(1) 
                                <E T="03">General VEU Authorizations.</E>
                                 General VEU Authorizations may be used for the following destinations:
                            </P>
                            <P>(i) The People's Republic of China.</P>
                            <P>(ii) India.</P>
                            <P>
                                (2) 
                                <E T="03">Data Center VEU Authorizations.</E>
                                 (i) UVEU must be headquartered in, or have their ultimate parent company headquartered in, destinations listed in paragraph (a) of Supplement No. 5 to Part 740, and UVEU data centers may be located anywhere, except in Macau or destinations specified in Country Group D:5.
                            </P>
                            <P>(ii) NVEU may be headquartered, have an ultimate parent headquartered, or located in a destination specified in Country Groups A, B, or D:1-D:4, except Macau or destinations specified in Country Group D:5. NVEU data centers can be built around the world, except in Macau or destinations specified in Country Group D:5.</P>
                            <STARS/>
                            <P>(d) * * *</P>
                            <P>
                                (2) 
                                <E T="03">Data Center VEU Authorizations.</E>
                                 Items obtained under Data Center VEU Authorizations may not be used for any activities described in part 744 of the EAR. Eligible validated end users who obtain items under VEU may only:
                            </P>
                            <P>(i) Use such items at the end user's own facility located in an authorized destination;</P>
                            <P>(ii) Consume such items during use; or</P>
                            <P>(iii) In-country transfers and reexports are not permitted under Data Center VEU Authorization unless the transfer (in-country) or reexport is to a VEU authorized location by the same VEU or a separate authorization is obtained.</P>
                            <NOTE>
                                <HD SOURCE="HED">Note 1 to paragraph (d): </HD>
                                <P>Authorizations set forth in supplement no. 7 to this part for General VEUs and Data Center NVEUs are country-specific. Authorization as a validated end-user for one country specified in paragraph (b) of this section does not constitute authorization as a validated end-user for any other country specified in that paragraph for those types of VEUs.</P>
                            </NOTE>
                            <STARS/>
                            <P>
                                (f) 
                                <E T="03">Reporting and review requirements</E>
                                —(1) 
                                <E T="03">Reports—</E>
                                (i) 
                                <E T="03">Reexport Information Required for both types of VEU authorizations.</E>
                                 Reexporters who make use of General VEU Authorizations are required to submit annual reports to BIS. Reexporters who make use of Data Center VEU Authorizations are required to submit semi-annual reports to BIS. For either authorization, reexporters must include, for each validated end user to whom the exporter or reexporter exported or reexported eligible items:
                            </P>
                            <P>(A) The name and address of each validated end-user to whom eligible items were reexported;</P>
                            <P>(B) The eligible destination to which the items were reexported;</P>
                            <P>(C) The quantity of such items;</P>
                            <P>(D) The value of such items; and</P>
                            <P>(E) The ECCN(s) of such items.</P>
                            <P>
                                (ii) 
                                <E T="03">End user reports for Data Center VEU Authorizations.</E>
                                 End users who make use of Data Center VEU Authorizations must submit reports to BIS semi-annually. End users must submit the following information, including, as appropriate:
                            </P>
                            <P>(A) A record of current inventory of eligible items received;</P>
                            <P>(B) Dates of when eligible items were received; and</P>
                            <P>(C) For NVEUs, a list of current customers.</P>
                            <P>
                                (iii) 
                                <E T="03">Deadlines.</E>
                                 For reexporters making use of General VEU Authorization, reports are due by February 15 of each year, and must cover the period from January 1 through December 31 of the prior year. For reexporters and end users making use of Data Center VEU Authorization, reports are due semiannually:
                            </P>
                            <P>(A) The first report is due July 15 of each year and must cover the period from January 1 through June 30;</P>
                            <P>(B) The second report is due January 15 of each year and must cover the period from July 1 to December 31 of the previous year.</P>
                            <P>
                                (iv) 
                                <E T="03">Addresses.</E>
                                 Reports must be sent to: Office of Exporter Services, Bureau of Industry and Security, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Room 2099B, Washington, DC 20230. Mark the package “General Authorization Validated End-User Report” or “Data Center Authorization Validated End-user Report.”
                            </P>
                            <P>
                                (2) 
                                <E T="03">Reviews.</E>
                                 Records related to activities covered by General or Data Center VEU Authorizations that are maintained by exporters, reexporters, transferors, and VEU will be reviewed on a periodic basis. Upon request by BIS, exporters, reexporters, transferors, and validated end-users must allow review of records, including on-site reviews covering the information set forth in paragraphs (e) and (f)(1) of this section.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="748">
                        <AMDPAR>17. Amend supplement No. 2 to part 748 by adding paragraphs (c)(3) and (4) to read as follows:</AMDPAR>
                        <HD SOURCE="HD1">Supplement No. 2 to Part 748—Unique Application and Submission Requirements</HD>
                        <EXTRACT>
                            <STARS/>
                            <P>(c) * * *</P>
                            <P>
                                (3) 
                                <E T="03">Purchase orders for Artificial Intelligence commodities.</E>
                                 License applications for items controlled under ECCNs 3A090.a, 4A090.a, 3A001.z, 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, or 5A992.z require the submission of a purchase order or equivalent contractual agreement with the submission of the license application. The purchase order may be contingent on approval of the license. Upon approving a license for these items, BIS will generally limit the licensed quantity to the quantity specified on the purchase order.
                            </P>
                            <P>
                                (4) 
                                <E T="03">License applications for Artificial Intelligence commodities.</E>
                                 Applicants are required to submit the total aggregated TPP value of each export item on their license application. This information should be included in block 22(j) in SNAP-R. If applicants are submitting a license for items destined to a country that is subject to a per-country TPP allocation, the applicant must fill out an individual license for each country and calculate the TPP per individual country. Applicants are encouraged to include information to support their TPP calculation in their Letter of Explanation (LOE). Calculate the aggregate TPP for each export item by adding the TPP for each integrated circuit. For additional information on calculating TPP, please refer to the Technical Notes to 3A090.
                            </P>
                            <STARS/>
                        </EXTRACT>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="748">
                        <AMDPAR>18. Amend supplement No. 8 to part 748 by revising paragraphs B(2), (6), (9), and (10), and adding B(11) to read as follows:</AMDPAR>
                        <HD SOURCE="HD1">Supplement No. 8 to Part 748—Information Required in Requests for VEU Authorization</HD>
                        <EXTRACT>
                            <STARS/>
                            <HD SOURCE="HD1">B * * *</HD>
                            <P>(2) An overview of any business activity or corporate relationship that the candidate has with either government or military organizations of Macau or a destination specified in Country Group D:5;</P>
                            <STARS/>
                            <PRTPAGE P="4565"/>
                            <P>(6) For NVEUs, absent a legal prohibition or other such exceptional circumstances, a list of current and potential customers of the data center;</P>
                            <STARS/>
                            <P>(9) An overview of the applicant's supply chain risk management plan to limit PRC-origin equipment specified in paragraph 3 of Supplement No. 10 to Part 748 from entering the data-center environment and supply chain;</P>
                            <P>(10) An overview of the applicant's export control training program and compliance program procedures; and</P>
                            <P>
                                (11) (NVEU applicants only) An overview of the applicant's ability to verify that items subject to the license requirement in § 742.6(a)(6)(iii) have not been moved from the specific country authorized for export or reexport by the NVEU (
                                <E T="03">e.g.</E>
                                 from the ping times to nearby secure servers);
                            </P>
                            <STARS/>
                        </EXTRACT>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="748">
                        <AMDPAR>19. Supplement No. 10 to part 748 is added to read as follows:</AMDPAR>
                        <HD SOURCE="HD1">Supplement No. 10 to Part 748—Data Center VEU Authorization Guidelines</HD>
                        <EXTRACT>
                            <HD SOURCE="HD1">I. Certification and Policy Requirements Relating to National and Universal Validated End Users (VEU)</HD>
                            <HD SOURCE="HD2">Vetting Requirements</HD>
                            <P>
                                <E T="03">1. General Compliance and Proven Track Record.</E>
                                 The VEU must have a credible plan to meet or demonstrated track record of meeting established physical, cyber, and personnel security standards for large-scale data center operations and of complying with U.S. export control laws, a credible plan to or demonstrated track record of respecting human rights, as well as a clear and feasible plan for doing so in a destination that is not Macau, specified in Country Group D:5, or listed in paragraph (a) to Supplement No. 5 to Part 740.
                            </P>
                            <P>
                                <E T="03">2. Foreign Military and Intelligence Ties.</E>
                            </P>
                            <P>a. The VEU, to include all subsidiary and parent entities (as well as their personnel in their professional capacities), must be free of ties to any `military end users' (as that term is defined in § 744.21(g)) or `military-intelligence end users' (as that term is defined in § 744.22(f)(2)).</P>
                            <P>b. Ties include research and development agreements and joint activities.</P>
                            <P>
                                3. 
                                <E T="03">Foreign Technology Ties.</E>
                                 The VEU, to include all subsidiary and parent entities (as well as their personnel in their professional capacities), must adhere to the U.S. rules on outbound investment at 31 CFR part 850 as applied to U.S. persons regardless of whether such VEU, entity, or individual is a U.S. person, without giving effect to any exception under 31 CFR 850.501(g), except that non-U.S. persons must submit materials to BIS, not the Department of the Treasury. Any notifications or other information that, because of this paragraph, would be required to be submitted in order to adhere to 31 CFR part 850 should be submitted to BIS as part of the VEU application. (For the avoidance of doubt, any notification or other information that would be required to be submitted pursuant to 31 CFR part 850 should continue to be submitted to the Department of the Treasury). The VEU must also adhere to determinations, including any prohibitions and mitigations, made under Commerce's Information Communication Technology Services program at 15 CFR part 791, and the VEU must demonstrate that it has eliminated supply chain dependencies on advanced semiconductors specified in ECCN 3A090.a, 4A090.a, or .z derivatives meeting or exceeding the parameters of ECCN 3A090.a or 4A090.a and advanced networking equipment specified in ECCN 4A003.g, 5A001, 5A002.a, or 5A992.a. produced by any entities headquartered in Macau or destinations specified in Country Group D:5. The VEU must also demonstrate that it has eliminated supply chain dependencies on equipment and services listed by the Federal Communications Commission as covered by Section 2 of the Secure and Trusted Communications Networks Act of 2019. The VEU must also notify the U.S. Government, through the VEU program, of all cooperative activities, such as joint ventures, with any entities headquartered in Macau or a destination specified in Country Group D:5 or any individuals or entities that are on the EAR's Entity List or OFAC's Specially-Designated Nationals and Blocked Persons List. The VEU must report to BIS all equity interests (including contingent equity interests) or ownership stakes in the VEU by, or debt or obligations of the VEU from similar financial arrangements to, any entity. headquartered in Macau or a destination specified in Country Group D:5 or any individual or entities that are on the EAR's Entity List or OFAC's Specially-Designated Nationals and Blocked Persons List, with the exception of investments under 1 percent or $1 million, whichever is lower, individually or as aggregated across (a) entities that are affiliated or have formal or informal arrangements to act in concert, or (b) departments, agencies, or instrumentalities of, or that are controlled by, the national or subnational governments of Macau or a destination specified in Country Group D:5, in a VEU whose equity securities are primarily traded on an exchange in a country listed in paragraph (a) to Supplement No. 5 to Part 740.
                            </P>
                            <HD SOURCE="HD2">Export Restrictions</HD>
                            <P>
                                <E T="03">4. Transfer of Chips.</E>
                                 The VEU may not, without authorization from BIS, transfer chips, assemblies, or computers that meet or exceed the scope of ECCN 3A090.a, 4A090.a, or .z items meeting or exceeding the parameters of ECCN 3A090.a or 4A090.a to any of the following:
                            </P>
                            <P>a. Any entity located in, or headquartered in, Macau or a destination specified in Country Group D:5;</P>
                            <P>b. Persons of any nationality working for or on behalf of a party on the EAR's Entity List, ISN's nonproliferation sanctions lists, or OFAC's Specially Designated Nationals and Blocked Persons List;</P>
                            <P>c. Persons of any nationality employed by a government entity of Macau or a government entity of a destination specified in Country Group D:5 or presenting a high risk of facilitating diversion to Macau or a destination specified in Country Group D:5.</P>
                            <P>These requirements should not be read as allowing any transfers that otherwise require a license.</P>
                            <P>
                                <E T="03">5. Intra-company Transfer Notification.</E>
                                 [
                                <E T="03">Only for VEUs accredited via a UVEU</E>
                                ] The UVEU must notify the BIS 60 days in advance of its intention to transfer any chips between countries in which the UVEU is using the UVEU authorization for such transfer, as well as any planned construction or installations of data centers in countries not previously included in prior notifications to BIS. BIS retains the right to impose licensing requirements for transfers of chips and/or to require additional conditions for entry into these countries.
                            </P>
                            <P>
                                6. 
                                <E T="03">Geographic allocations. Only for entities headquartered in countries listed in paragraph (a) to Supplement no. 5 to Part 740 with UVEU status:</E>
                                 The UVEU cannot transfer or install more than 25% of its total AI computing power, measured as the aggregate Total Processing Power (TPP) of chips that meet or exceed the scope of ECCN 3A090.a and are owned by the entity and all its subsidiary and parent entities, to or in locations outside of countries listed in paragraph (a) to Supplement No. 5 to Part 740, and cannot transfer or install more than 7% of its total AI computing power to or in any single country outside of those listed in paragraph (a) to Supplement No. 5 to Part 740). 
                                <E T="03">Only for U.S.-headquartered entities with UVEU status:</E>
                                 The UVEU cannot transfer or install more than 50% of its total AI computing power outside of the United States, as measured on the reporting dates outlined in Section 10.
                            </P>
                            <HD SOURCE="HD2">Acceptable Use Policies</HD>
                            <P>
                                <E T="03">7. Advanced AI Training.</E>
                                 The VEU, to include all subsidiary and parent entities, may not, without authorization from BIS, train an AI model specified in ECCN 4E091, in whole or in part, in a location outside of, or as Infrastructure-as-a-Service (IaaS) for an entity headquartered outside of, countries listed in paragraph (a) to Supplement No. 5 to Part 740. Fine-tuning an AI model specified in ECCN 4E091 is permitted if such fine-tuning constitutes no more than 25 percent of the training operations of the original AI model specified in ECCN 4E091. Provision of application programming interface (API) access to AI models or infrastructure-as-a-service (IaaS) access for AI inference are not prohibited, and would only become prohibited if equivalent restrictions are put in place for U.S.-based computing resources.
                            </P>
                            <P>
                                <E T="03">8. Model Weight Storage.</E>
                                 The VEU may only store or transfer the model weights of an advanced AI model specified in ECCN 4E091 to facilities located in countries listed in paragraph (a) to Supplement No. 5 to Part 740, or to facilities located in jurisdictions other than Macau or those specified in Country Group D:5, provided such facilities are owned or operated by entities headquartered in, or with an ultimate parent headquartered in countries listed in paragraph (a) to Supplement No. 5 to Part 740, and provided the facility complies with the provisions of paragraphs 14, 15, and 18 of Supplement No. 10 to this part by January 15, 2026.
                                <PRTPAGE P="4566"/>
                            </P>
                            <P>
                                <E T="03">9. Prohibited Uses and Human Rights Safeguards.</E>
                                 The VEU is responsible for ensuring that no items subject to the EAR are used to support any of the following:
                            </P>
                            <P>a. Activities described in part 744 and all relevant supplemental notices;</P>
                            <P>b. Military and intelligence entities headquartered, or located in, Macau, destinations specified in Country Group D:5, and military and intelligence entities whose activities BIS informs the VEU could pose an unacceptable risk to U.S. national security or could enable human rights abuses or repression of democracy; or</P>
                            <P>c. Activities that enable human rights abuses and/or repression of democracy including through censorship; arbitrary or unlawful surveillance; and abusive genetic collection and analysis schemes.</P>
                            <HD SOURCE="HD2">Documentation, Auditing, and Reporting Requirements</HD>
                            <P>
                                <E T="03">10. Reporting of Chip Installations.</E>
                                 The VEU will report to BIS and other agencies on a semi-annual basis (each February 1 and August 1), a complete facility-specific chip accounting for itself and all parent and subsidiary entities, including:
                            </P>
                            <P>a. The quantities and types of chips that meet or exceed the parameters of 3A090.a, purchased, approved for export to facilities in given countries, reexported, transferred to relevant destinations and entities to which transfers have occurred, and installed in all data center facilities in destinations except Macau, destinations specified in Country Group D:5, and countries not listed in paragraph (a) to Supplement No. 5 to Part 740.</P>
                            <P>b. A breakdown of the VEU's total aggregate compute for chips, assemblies, and computers specified in 3A090.a, 4A090.a, or .z derivatives meeting or exceeding the parameters of ECCN 3A090.a or 4A090.a, in destinations except Macau and destinations specified in Country Group D:5 (including chips transferred but not yet installed). This accounting must also include information about chip attrition due to factors such as loss, damage, failure, relocation, and resale.</P>
                            <P>
                                <E T="03">11. Monitoring, Recordkeeping, and Reporting.</E>
                                 The VEU must perform ongoing monitoring, evaluation, and end user due diligence of all the vetting requirements, export restrictions, acceptable use policies, and security requirements herein. The VEU must further notify BIS if, at any time, any requirements have not been met and it must maintain for five years all records in conjunction with these conditions. These records must be made available pursuant to a request from BIS, whether through an end use check or otherwise. The VEU must also cooperate with BIS's auditing of records and facilities described in this document. Failure to comply with BIS may result in revocation of VEU status.
                            </P>
                            <P>
                                <E T="03">12. Certification as VEU.</E>
                                 An entity is certified as a VEU through the process described in Supplement No. 9 to this part. Entities headquartered in countries listed in paragraph (a) to Supplement No. 5 to Part 740 are eligible if they meet the standards provided in Section I and II. Entities in destinations except Macau, destinations specified in Country Group D:5, or those listed in paragraph (a) to Supplement No. 5 to Part 740 are eligible if they meet the appropriate standards outlined in Supplement No. 10 to part 748 and, for NVEUs, if there is a government-to-government arrangement between their government and the United States. If a government-to-government arrangement is rescinded by either party, the NVEU status of NVEUs and, as appropriate, the ability of a UVEU to operate in that country may be revoked.
                            </P>
                            <HD SOURCE="HD1">II. Security Requirements</HD>
                            <HD SOURCE="HD2">Ownership Security</HD>
                            <P>
                                <E T="03">13. Ownership Security of VEUs:</E>
                                 The VEU, to include all subsidiary and parent entities, must meet ownership security standards to ensure there are no Foreign Ownership, Control, or Influence (FOCI) factors related to Macau or a destination specified in Country Group D:5. Factors relating to the entity, its relevant foreign interest, and the government of such foreign interest shall be assessed against the requirements outlined in National Industrial Security Program Operating Manual (NISPOM) 32 CFR 117.11(b) and additional factors to include:
                            </P>
                            <P>a. The VEU's financial viability;</P>
                            <P>b. Counterintelligence concerns, especially regarding key management or leadership personnel and company owners with regard to the government of Macau or the government of a destination specified in Country Group D:5, or to entities headquartered in, or nationals of, Macau or a destination specified in Country Group D:5;</P>
                            <P>c. Record of enforcement and/or engagement in unauthorized technology transfer;</P>
                            <P>d. The nature of any relevant bilateral and multilateral security agreement and information exchange agreements; and</P>
                            <P>e. Any other factor that demonstrates a capability on the part of foreign interests to control or influence the operations or management of the VEU of concern.</P>
                            <HD SOURCE="HD2">Baseline Security</HD>
                            <P>
                                <E T="03">14. Baseline Security of Chips and Data.</E>
                                 The VEU's datacenters must be compliant with NIST 800-53 in a fashion certified as appropriate for compliance with these conditions and consistent with the security requirements associated with FedRAMP High, as well as with controls AC-3(7), AT-2(1), CA-8(3), CM-7(4), CM-11(2), IR-4(14), PE-3(3), PM-3, and PS-7 from NIST 800-53. This includes:
                            </P>
                            <P>a. Advanced AI model weights and proprietary techniques used for advanced AI training must be treated as an information type with FIPS-199 security category {(confidentiality, HIGH), (integrity, HIGH), (availability, HIGH)}.</P>
                            <P>b. Certification of compliance with the above NIST 800-53 requirements must be attested annually by a Third-Party Assessment Organization (3PAO) and made available to BIS. 3PAOs must be accredited and recognized by the FedRAMP Program Management Office, and have successfully completed the certification of a FedRAMP-high Cloud Service Provider;</P>
                            <P>c. The VEU must have procedures in place to address and prevent seizure of chips;</P>
                            <P>d. The VEU must put in place software and hardware mechanisms to detect and defeat tampering, such as illicit modification;</P>
                            <P>e. Plans for the secure operation of data centers supporting a VEU shall be implemented in accordance with a security management defense-in-depth framework that includes a review of the following factors:</P>
                            <P>i. Threat analysis. Assess the capabilities, intentions, and opportunity of an adversary to exploit or damage assets or information.</P>
                            <P>ii. Vulnerability analysis. Assess the inherent susceptibility to attack of a procedure, facility, information system, equipment, or policy.</P>
                            <P>iii. Probability analysis. Assess the probability of an adverse action, incident, or attack occurring.</P>
                            <P>iv. Consequence analysis. Assess the consequences of such an action (expressed as a measure of loss, such as cost in dollars, resources, programmatic effect/mission impact, etc.)</P>
                            <P>f. The following physical and technical security requirements are required for all VEU data centers:</P>
                            <P>i. Compliance with Department of Defense Unified Facilities Criteria 4-010-05, Sections 3-4.4.1, 3-4.6.10, and 3-4.17.3;</P>
                            <P>ii. No windows permitted in server core areas; and</P>
                            <P>iii. 24/7/365 roving guard patrol or Perimeter Intrusion Detection System (PIDS) with a 15-minute response time;</P>
                            <HD SOURCE="HD2">Software and Network Security</HD>
                            <P>
                                <E T="03">15. AI-Specific Cybersecurity.</E>
                                 The VEU will establish and bear responsibility for the following additional practices for AI security:
                            </P>
                            <P>a. Ensure compliance with all best practices in the NSA cybersecurity information sheet “Deploying AI Systems Securely,” and the recommended actions for every CISA CPG 1.0 goal cross-referenced therein.</P>
                            <P>b. Establish accountability for usage; generate logs and other records of usage, to include logging and monitoring usage of third-party APIs and fine-tuning mechanisms;</P>
                            <P>c. Comply with the following requirements on model weights specified in ECCN 4E091, in addition to complying with the best practices listed in (a):</P>
                            <P>i. Model weights must be stored on dedicated devices not used by, or hosting the data of, other organizations.</P>
                            <P>ii. Every interface by which model weights can be accessed, directly or indirectly, must be reviewed to determine the appropriate output rate of information necessary for its legitimate functionality. The output rate must be monitored, and rate limitations must be implemented to ensure the output rate is unable to exceed the rate established for the interface's legitimate functionality.</P>
                            <P>
                                iii. Every interface, for which the established output rate is such that the model weights may be extracted in six months or less, must provide access only through a narrow, well-defined API, such as for inference or fine-tuning. The API must be thoroughly reviewed and secured to prevent model extraction attacks.
                                <PRTPAGE P="4567"/>
                            </P>
                            <HD SOURCE="HD2">Supply Chain Security</HD>
                            <P>
                                <E T="03">16. Transit Security.</E>
                                 The VEU must work with the chip provider to develop, implement, and maintain a shipment security plan, to include working with validated shipping providers, establishing a positive chain of custody, employing anti-theft and anti-tampering measures, conducting inspection/inventory upon receipt, and reporting any theft, loss, or tampering incidents to BIS within 30 days. The VEU will bear responsibility for tracking and security of chips and other items subject to export control while in transit and shall report any anomalies to BIS, as outlined in Section 11.
                            </P>
                            <P>
                                <E T="03">17. Sanitization and Disposal Procedures.</E>
                                 The VEU must incorporate appropriate end-of-life procedures for chip sanitization and disposal that are verifiable and that ensure such chips do not enable prohibited activities, including by exceeding relevant caps.
                            </P>
                            <HD SOURCE="HD2">Personnel Security</HD>
                            <P>
                                <E T="03">18. Personnel Security Standards and Practices.</E>
                                 In addition to the personnel security requirements in Section 13, the VEU must follow the below practices:
                            </P>
                            <P>a. The VEU must develop a plan to implement a personnel vetting model covering all individuals granted access to the VEU data center facility or corresponding systems.</P>
                            <P>b. Personnel granted unescorted access to the VEU data center must be vetted under the following categories:</P>
                            <P>i. Individuals specifically named on the U.S. Department of Treasury, Office of Foreign Assets Control (OFAC) Specially Designated Nationals List (SDN) or other OFAC sanctions lists; and</P>
                            <P>ii. Individuals with employment history by a government, intelligence service, or military based in Macau or a destination specified in Country Group D:5, or with any parties on the EAR's Entity List or OFAC's SDN, Blocked Persons List, or other sanctions lists should be excluded from consideration. Individuals with employment history with entities headquartered in Macau or a destination specified in Country Group D:5 require additional vetting of their continuing ties, relationships, obligations, or other factors that could incentivize them to act on behalf of an entity headquartered in Macau or a destination specified in Country Group D:5.</P>
                            <P>c. The VEU must establish and maintain a comprehensive program for detecting, assessing, disclosing, and managing insider threats, in accordance with the Cybersecurity and Infrastructure Security Agency Insider Threat Mitigation Guide, with particular consideration for insider threats that could enable access or prohibited uses by individuals or any other entities.</P>
                            <HD SOURCE="HD2">Adherence to This Agreement</HD>
                            <P>
                                <E T="03">19. Enforcement.</E>
                                 Failure to adhere to this agreement may result in the revocation of VEU status on a national or global basis, denial of chip allocations or export licenses, as well as other penalties as appropriate under U.S. laws and regulations.
                            </P>
                            <HD SOURCE="HD2">Exemption for Intentional Publication</HD>
                            <P>None of the provisions of this document shall be interpreted as to apply to or prevent intentional publication of model weights, data, or code.</P>
                        </EXTRACT>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 750—APPLICATION PROCESSING, ISSUANCE, AND DENIAL</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="750">
                        <AMDPAR>19. The authority citation for part 750 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2013 Comp., p. 223; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320.
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="750">
                        <AMDPAR>20. Section 750.7 is amended by revising paragraph (g) introductory text to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 750.7 </SECTNO>
                            <SUBJECT>Issuance of licenses.</SUBJECT>
                            <STARS/>
                            <P>
                                (g) 
                                <E T="03">License validity period.</E>
                                 Licenses involving the export or reexport of items will generally have a four-year validity period, unless a different validity period has been requested and specifically approved by BIS or is otherwise specified on the license at the time that it is issued. Exceptions from the four-year validity period include: license applications for items controlled for short supply reasons, which will be limited to a one-year validity period during which the items must be exported, re-exported, or transferred (in country) and license applications reviewed and approved as an “emergency” (see § 748.4(h) of the EAR); and items controlled under ECCNs 0A501, 0A502, 0A504, 0A505, 0A506, 0A507, 0A508, 0A509, or listed in § 742.6(a)(6)(iii)(A) of the EAR, which will generally be limited to a one-year validity period during which the items must be exported, re-exported, or transferred (in country). Emergency licenses will expire no later than the last day of the calendar month following the month in which the emergency license is issued. The expiration date will be clearly stated on the face of the license. If the expiration date falls on a legal holiday (Federal or State), the validity period is automatically extended to midnight of the first business day following the expiration date.
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 762—RECORDKEEPING</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="762">
                        <AMDPAR>21. The authority citation for part 762 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783.
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="762">
                        <AMDPAR>22. Section 762.2 is amended by adding paragraphs (b)(58), (59), and (60) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 762.2 </SECTNO>
                            <SUBJECT>Records to be retained.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(58) § 740.27, License Exception AIA.</P>
                            <P>(59) § 740.28, License Exception ACM.</P>
                            <P>(60) § 740.29, License Exception LPP.</P>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 772—DEFINITIONS OF TERMS</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="772">
                        <AMDPAR>23. The authority citation for part 772 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783.
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="772">
                        <AMDPAR>24. Section 772.1 is amended by adding, in alphabetical order, the definition for “Model Weights” to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 772.1 </SECTNO>
                            <SUBJECT>Definitions of terms as used in the Export Administration Regulations (EAR).</SUBJECT>
                            <STARS/>
                            <P>
                                <E T="03">Model Weights.</E>
                                 See ECCN 4E091 (Supplement No. 1 to part 774).
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 774—THE COMMERCE CONTROL LIST</HD>
                    </PART>
                    <REGTEXT TITLE="15" PART="774">
                        <AMDPAR>25. The authority citation for part 774 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                                <E T="03">et seq.;</E>
                                 50 U.S.C. 1701 
                                <E T="03">et seq.;</E>
                                 10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C. 287c, 22 U.S.C. 3201 
                                <E T="03">et seq.;</E>
                                 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 
                                <E T="03">et seq.;</E>
                                 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783.
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="15" PART="774">
                        <AMDPAR>26. Supplement no. 1 to part 774 is amended by:</AMDPAR>
                        <AMDPAR>a. Revising ECCNs 3A001, 3A090, 3D001, 3E001, 4A003, 4A004, 4A005, 4A090, 4D001, 4D090, and 4E001;</AMDPAR>
                        <AMDPAR>b. Adding, in numerical order, ECCN 4E091;</AMDPAR>
                        <AMDPAR>c. Revising, 5A002, 5A992, 5A004, 5D002, 5D992, 5E002, and 5E992.</AMDPAR>
                        <P>The revisions and addition read as follows:</P>
                        <HD SOURCE="HD1">Supplement No. 1 to Part 774—The Commerce Control List</HD>
                        <EXTRACT>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">3A001 Electronic items as follows (see List of Items Controlled).</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, RS, MT, NP, AT
                                <PRTPAGE P="4568"/>
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to “Monolithic Microwave Integrated Circuit” (“MMIC”) amplifiers in 3A001.b.2 and discrete microwave transistors in 3A001.b.3, except those 3A001.b.2 and b.3 items being exported or reexported for use in civil telecommunications applications</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">NS applies to entire entry</ENT>
                                    <ENT>NS Column 2.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies “Monolithic Microwave Integrated Circuit” (“MMIC”) amplifiers in 3A001.b.2 and discrete microwave transistors in 3A001.b.3, except those 3A001.b.2 and b.3 items being exported or reexported for use in civil telecommunications applications</ENT>
                                    <ENT>RS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to 3A001.z.1.a, z.2.a, z.3.a, z.4.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to 3A001.z.1.b, z.2.b, z.3.b, z.4.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">MT applies to 3A001.a.1.a when usable in “missiles”; and to 3A001.a.5.a when “designed or modified” for military use, hermetically sealed and rated for operation in the temperature range from below −54 °C to above +125 °C; and 3A001.z.2</ENT>
                                    <ENT>MT Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">NP applies to pulse discharge capacitors in 3A001.e.2 and superconducting solenoidal electromagnets in 3A001.e.3 that meet or exceed the technical parameters in 3A201.a and 3A201.b, respectively; and 3A001.z.3</ENT>
                                    <ENT>NP Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <FP SOURCE="FP-1">
                                <E T="03">Reporting Requirements: See § 743.1 of the EAR for reporting requirements for exports under 3A001.b.2 or b.3 under License Exceptions, and Validated End-User authorizations.</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">License Requirements:</E>
                                 See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.
                            </FP>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">LVS:</E>
                                 N/A for MT, NP; N/A for “Monolithic Microwave Integrated Circuit” (“MMIC”) amplifiers in 3A001.b.2, discrete microwave transistors in 3A001.b.3, except those that are being exported or reexported for use in civil telecommunications applications; N/A for and 3A001.z.
                            </FP>
                            <P>Yes for:</P>
                            <P>$1500: 3A001.c.</P>
                            <P>$3000: 3A001.b.1, b.2 (exported or reexported for use in civil telecommunications applications), b.3 (exported or reexported for use in civil telecommunications applications), b.9, .d, .e, .f, and .g.</P>
                            <P>$5000: 3A001.a (except a.1.a and a.5.a when controlled for MT), b.4 to b.7, and b.12.</P>
                            <FP SOURCE="FP-1">
                                <E T="03">GBS:</E>
                                 Yes for 3A001.a.1.b, a.2 to a.14 (except .a.5.a when controlled for MT), b.2 (exported or reexported for use in civil telecommunications applications), b.8 (except for “vacuum electronic devices” exceeding 18 GHz), b.9., b.10, .g, .h, .i, and z.1.b (exported or reexported for use in civil telecommunications applications).
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 3A001.z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 3A001.z.1.a, z.2.a, z.3.a, z.4.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for 3A001.z
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">LPP:</E>
                                 Yes for 3A001.z.1.a, z.2.a, z.3.a, z.4.a
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 3A001.z.</E>
                            </P>
                            <HD SOURCE="HD1">Special Conditions for STA</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">STA:</E>
                                 License Exception STA may not be used to ship any item in 3A001.b.2 or b.3, except those that are being exported or reexported for use in civil telecommunications applications, or 3A001.z to any of the destinations listed in Country Group A:5 or A:6 (See Supplement No. 1 to part 740 of the EAR).
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 (1) See Category XV of the USML for certain “space-qualified” electronics and Category XI of the USML for certain ASICs, 'transmit/receive modules,' 'transmit modules,' or 'MMICs' “subject to the ITAR.” (2) See also 3A090, 3A101, 3A201, 3A611, 3A901 for cryogenic CMOS integrated circuits and parametric signal amplifiers or quantum limited amplifiers not controlled by 3A001, 3A991, and 9A515.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 'Microcircuit' means a device in which a number of passive or active elements are considered as indivisibly associated on or within a continuous structure to perform the function of a circuit. For the purposes of integrated circuits in 3A001.a.1, 5 × 10
                                <SU>3</SU>
                                 Gy(Si) = 5 × 10
                                <SU>5</SU>
                                 Rads (Si); 5 × 10
                                <SU>6</SU>
                                 Gy (Si)/s = 5 × 10
                                <SU>8</SU>
                                 Rads (Si)/s.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. General purpose integrated circuits, as follows:</P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">Integrated circuits include the following types:</E>
                            </P>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">“Monolithic integrated circuits”;</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">“Hybrid integrated circuits”;</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">“Multichip integrated circuits”;</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">“Film type integrated circuits”, including silicon-on-sapphire integrated circuits;</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">“Optical integrated circuits”;</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">“Three dimensional integrated circuits”;</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">“Monolithic Microwave Integrated Circuits” (“MMICs”).</E>
                            </FP>
                            <P>a.1. Integrated circuits designed or rated as radiation hardened to withstand any of the following:</P>
                            <P>
                                a.1.a. A total dose of 5 × 10
                                <SU>3</SU>
                                 Gy (Si), or higher;
                            </P>
                            <P>
                                a.1.b. A dose rate upset of 5 × 10
                                <SU>6</SU>
                                 Gy (Si)/s, or higher; 
                                <E T="03">or</E>
                            </P>
                            <P>
                                a.1.c. A fluence (integrated flux) of neutrons (1 MeV equivalent) of 5 × 10
                                <SU>13</SU>
                                 n/cm
                                <SU>2</SU>
                                 or higher on silicon, or its equivalent for other materials;
                            </P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">3A001.a.1.c does not apply to Metal Insulator Semiconductors (MIS).</E>
                            </P>
                            <P>a.2. “Microprocessor microcircuits,” “microcomputer microcircuits,” microcontroller microcircuits, storage integrated circuits manufactured from a compound semiconductor, analog-to-digital converters, integrated circuits that contain analog-to-digital converters and store or process the digitized data, digital-to-analog converters, electro-optical or “optical integrated circuits” designed for “signal processing”, field programmable logic devices, custom integrated circuits for which either the function is unknown or the control status of the equipment in which the integrated circuit will be used in unknown, Fast Fourier Transform (FFT) processors, Static Random-Access Memories (SRAMs), or 'non-volatile memories,' having any of the following:</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.a.2, 'non-volatile memories' are memories with data retention over a period of time after a power shutdown.</E>
                            </P>
                            <P>a.2.a. Rated for operation at an ambient temperature above 398 K (+125 °C);</P>
                            <P>
                                a.2.b. Rated for operation at an ambient temperature below 218 K (−55 °C); 
                                <E T="03">or</E>
                            </P>
                            <P>a.2.c. Rated for operation over the entire ambient temperature range from 218 K (−55 °C) to 398 K (+125 °C);</P>
                            <P>
                                <E T="04">N.B.:</E>
                                 For cryogenic CMOS integrated circuits not specified by 3A001.a.2, see 3A901.a.
                            </P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">3A001.a.2 does not apply to integrated circuits designed for civil automobile or railway train applications.</E>
                            </P>
                            <P>a.3. “Microprocessor microcircuits”, “microcomputer microcircuits” and microcontroller microcircuits, manufactured from a compound semiconductor and operating at a clock frequency exceeding 40 MHz;</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">3A001.a.3 includes digital signal processors, digital array processors and digital coprocessors.</E>
                            </P>
                            <P>a.4. [Reserved]</P>
                            <P>a.5. Analog-to-Digital Converter (ADC) and Digital-to-Analog Converter (DAC) integrated circuits, as follows:</P>
                            <P>a.5.a. ADCs having any of the following:</P>
                            <P>
                                a.5.a.1. A resolution of 8 bit or more, but less than 10 bit, with a “sample rate” greater than 1.3 Giga Samples Per Second (GSPS);
                                <PRTPAGE P="4569"/>
                            </P>
                            <P>a.5.a.2. A resolution of 10 bit or more, but less than 12 bit, with a “sample rate” greater than 600 Mega Samples Per Second (MSPS);</P>
                            <P>a.5.a.3. A resolution of 12 bit or more, but less than 14 bit, with a “sample rate” greater than 400 MSPS;</P>
                            <P>
                                a.5.a.4. A resolution of 14 bit or more, but less than 16 bit, with a “sample rate” greater than 250 MSPS; 
                                <E T="03">or</E>
                            </P>
                            <P>a.5.a.5. A resolution of 16 bit or more with a “sample rate” greater than 65 MSPS;</P>
                            <P>
                                <E T="04">N.B.:</E>
                                  
                                <E T="03">For integrated circuits that contain analog-to-digital converters and store or process the digitized data see 3A001.a.14.</E>
                            </P>
                            <P>
                                <E T="04">Technical Notes:</E>
                                  
                                <E T="03">For the purposes of 3A001.a.5.a:</E>
                            </P>
                            <P>
                                <E T="03">
                                    1. A resolution of n bit corresponds to a quantization of 2
                                    <SU>n</SU>
                                     levels.
                                </E>
                            </P>
                            <P>
                                <E T="03">2. The resolution of the ADC is the number of bits of the digital output that represents the measured analog input. Effective Number of Bits (ENOB) is not used to determine the resolution of the ADC.</E>
                            </P>
                            <P>
                                <E T="03">3. For “multiple channel ADCs”, the “sample rate” is not aggregated and the “sample rate” is the maximum rate of any single channel.</E>
                            </P>
                            <P>
                                <E T="03">4. For “interleaved ADCs” or for “multiple channel ADCs” that are specified to have an interleaved mode of operation, the “sample rates” are aggregated and the “sample rate” is the maximum combined total rate of all of the interleaved channels.</E>
                            </P>
                            <P>a.5.b. Digital-to-Analog Converters (DAC) having any of the following:</P>
                            <P>
                                a.5.b.1. A resolution of 10-bit or more but less than 12-bit, with an 'adjusted update rate' of exceeding 3,500 MSPS; 
                                <E T="03">or</E>
                            </P>
                            <P>a.5.b.2. A resolution of 12-bit or more and having any of the following:</P>
                            <P>a.5.b.2.a. An 'adjusted update rate' exceeding 1,250 MSPS but not exceeding 3,500 MSPS, and having any of the following:</P>
                            <P>
                                a.5.b.2.a.1. A settling time less than 9 ns to arrive at or within 0.024% of full scale from a full scale step; 
                                <E T="03">or</E>
                            </P>
                            <P>
                                a.5.b.2.a.2. A 'Spurious Free Dynamic Range' (SFDR) greater than 68 dBc (carrier) when synthesizing a full scale analog signal of 100 MHz or the highest full scale analog signal frequency specified below 100 MHz; 
                                <E T="03">or</E>
                            </P>
                            <P>a.5.b.2.b. An 'adjusted update rate' exceeding 3,500 MSPS;</P>
                            <P>
                                <E T="04">Technical Notes:</E>
                                  
                                <E T="03">For the purposes of 3A001.a.5.b:</E>
                            </P>
                            <P>
                                <E T="03">1. 'Spurious Free Dynamic Range' (SFDR) is defined as the ratio of the RMS value of the carrier frequency (maximum signal component) at the input of the DAC to the RMS value of the next largest noise or harmonic distortion component at its output.</E>
                            </P>
                            <P>
                                <E T="03">2. SFDR is determined directly from the specification table or from the characterization plots of SFDR versus frequency.</E>
                            </P>
                            <P>
                                <E T="03">3. A signal is defined to be full scale when its amplitude is greater than −3 dBfs (full scale).</E>
                            </P>
                            <P>
                                <E T="03">4. 'Adjusted update rate' for DACs is:</E>
                            </P>
                            <P>
                                <E T="03">a. For conventional (non-interpolating) DACs, the 'adjusted update rate' is the rate at which the digital signal is converted to an analog signal and the output analog values are changed by the DAC. For DACs where the interpolation mode may be bypassed (interpolation factor of one), the DAC should be considered as a conventional (non-interpolating) DAC.</E>
                            </P>
                            <P>
                                <E T="03">b. For interpolating DACs (oversampling DACs), the 'adjusted update rate' is defined as the DAC update rate divided by the smallest interpolating factor. For interpolating DACs, the 'adjusted update rate' may be referred to by different terms including:</E>
                            </P>
                            <FP SOURCE="FP-1">
                                • 
                                <E T="03">input data rate</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                • 
                                <E T="03">input word rate</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                • 
                                <E T="03">input sample rate</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                • 
                                <E T="03">maximum total input bus rate</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                • 
                                <E T="03">maximum DAC clock rate for DAC clock input</E>
                            </FP>
                            <P>a.6. Electro-optical and “optical integrated circuits”, designed for “signal processing” and having all of the following:</P>
                            <P>a.6.a. One or more than one internal “laser” diode;</P>
                            <P>
                                a.6.b. One or more than one internal light detecting element; 
                                <E T="03">and</E>
                            </P>
                            <P>a.6.c. Optical waveguides;</P>
                            <P>a.7. 'Field programmable logic devices' having any of the following:</P>
                            <P>
                                a.7.a. A maximum number of single-ended digital input/outputs of greater than 700; 
                                <E T="03">or</E>
                            </P>
                            <P>a.7.b. An 'aggregate one-way peak serial transceiver data rate' of 500 Gb/s or greater;</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">3A001.a.7 includes:</E>
                            </P>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Complex Programmable Logic Devices (CPLDs);</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Field Programmable Gate Arrays (FPGAs);</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Field Programmable Logic Arrays (FPLAs);</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Field Programmable Interconnects (FPICs).</E>
                            </FP>
                            <P>
                                <E T="04">N.B.:</E>
                                 For integrated circuits having field programmable logic devices that are combined with an analog-to-digital converter, see 3A001.a.14.
                            </P>
                            <P>
                                <E T="04">Technical Notes:</E>
                                  
                                <E T="03">For the purposes of 3A001.a.7:</E>
                            </P>
                            <P>
                                <E T="03">1. Maximum number of digital input/outputs in 3A001.a.7.a is also referred to as maximum user input/outputs or maximum available input/outputs, whether the integrated circuit is packaged or bare die.</E>
                            </P>
                            <P>
                                <E T="03">2. 'Aggregate one-way peak serial transceiver data rate' is the product of the peak serial one-way transceiver data rate times the number of transceivers on the FPGA.</E>
                            </P>
                            <P>a.8. [Reserved]</P>
                            <P>a.9. [Reserved]</P>
                            <P>a.10. Custom integrated circuits for which the function is unknown, or the control status of the equipment in which the integrated circuits will be used is unknown to the manufacturer, having any of the following:</P>
                            <P>a.10.a. More than 1,500 terminals;</P>
                            <P>
                                a.10.b. A typical “basic gate propagation delay time” of less than 0.02 ns; 
                                <E T="03">or</E>
                            </P>
                            <P>a.10.c. An operating frequency exceeding 3 GHz;</P>
                            <P>a.11. Digital integrated circuits, other than those described in 3A001.a.3 to 3A001.a.10 and 3A001.a.12, based upon any compound semiconductor and having any of the following:</P>
                            <P>
                                a.11.a. An equivalent gate count of more than 3,000 (2 input gates); 
                                <E T="03">or</E>
                            </P>
                            <P>a.11.b. A toggle frequency exceeding 1.2 GHz;</P>
                            <P>
                                a.12. Fast Fourier Transform (FFT) processors having a rated execution time for an N-point complex FFT of less than (N log
                                <E T="52">2</E>
                                 N)/20,480 ms, where N is the number of points;
                            </P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.a.12, when N is equal to 1,024 points, the formula in 3A001.a.12 gives an execution time of 500 μs.</E>
                            </P>
                            <P>a.13. Direct Digital Synthesizer (DDS) integrated circuits having any of the following:</P>
                            <P>
                                a.13.a. A Digital-to-Analog Converter (DAC) clock frequency of 3.5 GHz or more and a DAC resolution of 10 bit or more, but less than 12 bit; 
                                <E T="03">or</E>
                            </P>
                            <P>a.13.b. A DAC clock frequency of 1.25 GHz or more and a DAC resolution of 12 bit or more;</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.a.13, the DAC clock frequency may be specified as the master clock frequency or the input clock frequency.</E>
                            </P>
                            <P>a.14. Integrated circuits that perform or are programmable to perform all of the following:</P>
                            <P>a.14.a. Analog-to-digital conversions meeting any of the following:</P>
                            <P>a.14.a.1. A resolution of 8 bit or more, but less than 10 bit, with a “sample rate” greater than 1.3 Giga Samples Per Second (GSPS);</P>
                            <P>a.14.a.2. A resolution of 10 bit or more, but less than 12 bit, with a “sample rate” greater than 1.0 GSPS;</P>
                            <P>a.14.a.3. A resolution of 12 bit or more, but less than 14 bit, with a “sample rate” greater than 1.0 GSPS;</P>
                            <P>
                                a.14.a.4. A resolution of 14 bit or more, but less than 16 bit, with a “sample rate” greater than 400 Mega Samples Per Second (MSPS); 
                                <E T="03">or</E>
                            </P>
                            <P>
                                a.14.a.5. A resolution of 16 bit or more with a “sample rate” greater than 180 MSPS; 
                                <E T="03">and</E>
                            </P>
                            <P>a.14.b. Any of the following:</P>
                            <P>
                                a.14.b.1. Storage of digitized data; 
                                <E T="03">or</E>
                            </P>
                            <P>a.14.b.2. Processing of digitized data;</P>
                            <P>
                                <E T="04">N.B.</E>
                                  
                                <E T="03">1: For analog-to-digital converter integrated circuits see 3A001.a.5.a.</E>
                            </P>
                            <P>
                                <E T="04">N.B.</E>
                                  
                                <E T="03">2: For field programmable logic devices see 3A001.a.7.</E>
                            </P>
                            <P>
                                <E T="04">Technical Notes:</E>
                                  
                                <E T="03">For the purposes of 3A001.a.14:</E>
                            </P>
                            <P>
                                <E T="03">
                                    1. A resolution of n bit corresponds to a quantization of 2
                                    <SU>n</SU>
                                     levels.
                                </E>
                            </P>
                            <P>
                                <E T="03">2. The resolution of the ADC is the number of bits of the digital output of the ADC that represents the measured analog input. Effective Number of Bits (ENOB) is not used to determine the resolution of the ADC.</E>
                            </P>
                            <P>
                                <E T="03">3. For integrated circuits with non- interleaving “multiple channel ADCs”, the “sample rate” is not aggregated and the “sample rate” is the maximum rate of any single channel.</E>
                            </P>
                            <P>
                                <E T="03">4. For integrated circuits with “interleaved ADCs” or with “multiple channel ADCs” that are specified to have an interleaved mode of operation, the “sample rates” are aggregated and the “sample rate” is the maximum combined total rate of all of the interleaved channels.</E>
                            </P>
                            <P>b. Microwave or millimeter wave items, as follows:</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.b, the parameter peak saturated power output may also be referred to on product data sheets as output power, saturated power output, maximum power output, peak power output, or peak envelope power output.</E>
                                <PRTPAGE P="4570"/>
                            </P>
                            <P>
                                <E T="04">N.B.:</E>
                                  
                                <E T="03">For parametric signal amplifiers or Quantum-limited amplifiers (QLAs) not specified by 3A001.b, see ECCN 3A901.b.</E>
                            </P>
                            <P>b.1. “Vacuum electronic devices” and cathodes, as follows:</P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">3A001.b.1 does not control “vacuum electronic devices” designed or rated for operation in any frequency band and having all of the following:</E>
                            </P>
                            <P>
                                <E T="03">a. Does not exceed 31.8 GHz; and</E>
                            </P>
                            <P>
                                <E T="03">b. Is “allocated by the ITU” for radio-communications services, but not for radio-determination.</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">3A001.b.1 does not control non-“space-qualified” “vacuum electronic devices” having all the following:</E>
                            </P>
                            <P>
                                <E T="03">a. An average output power equal to or less than 50 W; and</E>
                            </P>
                            <P>
                                <E T="03">b. Designed or rated for operation in any frequency band and having all of the following:</E>
                            </P>
                            <P>
                                <E T="03">1. Exceeds 31.8 GHz but does not exceed 43.5 GHz; and</E>
                            </P>
                            <P>
                                2. 
                                <E T="03">Is “allocated by the ITU” for radio-communications services, but not for radio-determination.</E>
                            </P>
                            <P>b.1.a. Traveling-wave “vacuum electronic devices,” pulsed or continuous wave, as follows:</P>
                            <P>b.1.a.1. Devices operating at frequencies exceeding 31.8 GHz;</P>
                            <P>b.1.a.2. Devices having a cathode heater with a turn on time to rated RF power of less than 3 seconds;</P>
                            <P>b.1.a.3. Coupled cavity devices, or derivatives thereof, with a “fractional bandwidth” of more than 7% or a peak power exceeding 2.5 kW;</P>
                            <P>b.1.a.4. Devices based on helix, folded waveguide, or serpentine waveguide circuits, or derivatives thereof, having any of the following:</P>
                            <P>b.1.a.4.a. An “instantaneous bandwidth” of more than one octave, and average power (expressed in kW) times frequency (expressed in GHz) of more than 0.5;</P>
                            <P>b.1.a.4.b. An “instantaneous bandwidth” of one octave or less, and average power (expressed in kW) times frequency (expressed in GHz) of more than 1;</P>
                            <P>
                                b.1.a.4.c. Being “space-qualified”; 
                                <E T="03">or</E>
                            </P>
                            <P>b.1.a.4.d. Having a gridded electron gun;</P>
                            <P>b.1.a.5. Devices with a “fractional bandwidth” greater than or equal to 10%, with any of the following:</P>
                            <P>b.1.a.5.a. An annular electron beam;</P>
                            <P>
                                b.1.a.5.b. A non-axisymmetric electron beam; 
                                <E T="03">or</E>
                            </P>
                            <P>b.1.a.5.c. Multiple electron beams;</P>
                            <P>b.1.b. Crossed-field amplifier “vacuum electronic devices” with a gain of more than 17 dB;</P>
                            <P>
                                b.1.c. Thermionic cathodes, designed for “vacuum electronic devices,” producing an emission current density at rated operating conditions exceeding 5 A/cm
                                <SU>2</SU>
                                 or a pulsed (non-continuous) current density at rated operating conditions exceeding 10 A/cm
                                <SU>2</SU>
                                ;
                            </P>
                            <P>b.1.d. “Vacuum electronic devices” with the capability to operate in a 'dual mode.'</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.b.1.d, 'dual mode' means the “vacuum electronic device” beam current can be intentionally changed between continuous-wave and pulsed mode operation by use of a grid and produces a peak pulse output power greater than the continuous-wave output power.</E>
                            </P>
                            <P>b.2. “Monolithic Microwave Integrated Circuit” (“MMIC”) amplifiers that any of the following:</P>
                            <P>
                                <E T="04">N.B.:</E>
                                  
                                <E T="03">For “MMIC” amplifiers that have an integrated phase shifter see 3A001.b.12.</E>
                            </P>
                            <P>b.2.a. Rated for operation at frequencies exceeding 2.7 GHz up to and including 6.8 GHz with a “fractional bandwidth” greater than 15%, and having any of the following:</P>
                            <P>b.2.a.1. A peak saturated power output greater than 75 W (48.75 dBm) at any frequency exceeding 2.7 GHz up to and including 2.9 GHz;</P>
                            <P>b.2.a.2. A peak saturated power output greater than 55 W (47.4 dBm) at any frequency exceeding 2.9 GHz up to and including 3.2 GHz;</P>
                            <P>
                                b.2.a.3. A peak saturated power output greater than 40 W (46 dBm) at any frequency exceeding 3.2 GHz up to and including 3.7 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.2.a.4. A peak saturated power output greater than 20 W (43 dBm) at any frequency exceeding 3.7 GHz up to and including 6.8 GHz;</P>
                            <P>b.2.b. Rated for operation at frequencies exceeding 6.8 GHz up to and including 16 GHz with a “fractional bandwidth” greater than 10%, and having any of the following:</P>
                            <P>
                                b.2.b.1. A peak saturated power output greater than 10 W (40 dBm) at any frequency exceeding 6.8 GHz up to and including 8.5 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.2.b.2. A peak saturated power output greater than 5 W (37 dBm) at any frequency exceeding 8.5 GHz up to and including 16 GHz;</P>
                            <P>b.2.c. Rated for operation with a peak saturated power output greater than 3 W (34.77 dBm) at any frequency exceeding 16 GHz up to and including 31.8 GHz, and with a “fractional bandwidth” of greater than 10%;</P>
                            <P>b.2.d. Rated for operation with a peak saturated power output greater than 0.1 nW (−70 dBm) at any frequency exceeding 31.8 GHz up to and including 37 GHz;</P>
                            <P>b.2.e. Rated for operation with a peak saturated power output greater than 1 W (30 dBm) at any frequency exceeding 37 GHz up to and including 43.5 GHz, and with a “fractional bandwidth” of greater than 10%;</P>
                            <P>b.2.f. Rated for operation with a peak saturated power output greater than 31.62 mW (15 dBm) at any frequency exceeding 43.5 GHz up to and including 75 GHz, and with a “fractional bandwidth” of greater than 10%;</P>
                            <P>
                                b.2.g. Rated for operation with a peak saturated power output greater than 10 mW (10 dBm) at any frequency exceeding 75 GHz up to and including 90 GHz, and with a “fractional bandwidth” of greater than 5%; 
                                <E T="03">or</E>
                            </P>
                            <P>b.2.h. Rated for operation with a peak saturated power output greater than 0.1 nW (−70 dBm) at any frequency exceeding 90 GHz;</P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">[Reserved]</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">The control status of the “MMIC” whose rated operating frequency includes frequencies listed in more than one frequency range, as defined by 3A001.b.2.a through 3A001.b.2.h, is determined by the lowest peak saturated power output control threshold.</E>
                            </P>
                            <P>
                                <E T="04">Note 3:</E>
                                  
                                <E T="03">Notes 1 and 2 following the Category 3 heading for product group A. Systems, Equipment, and Components mean that 3A001.b.2 does not control “MMICs” if they are “specially designed” for other applications, e.g., telecommunications, radar, automobiles.</E>
                            </P>
                            <P>b.3. Discrete microwave transistors that are any of the following:</P>
                            <P>b.3.a. Rated for operation at frequencies exceeding 2.7 GHz up to and including 6.8 GHz and having any of the following:</P>
                            <P>b.3.a.1. A peak saturated power output greater than 400 W (56 dBm) at any frequency exceeding 2.7 GHz up to and including 2.9 GHz;</P>
                            <P>b.3.a.2. A peak saturated power output greater than 205 W (53.12 dBm) at any frequency exceeding 2.9 GHz up to and including 3.2 GHz;</P>
                            <P>
                                b.3.a.3. A peak saturated power output greater than 115 W (50.61 dBm) at any frequency exceeding 3.2 GHz up to and including 3.7 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.3.a.4. A peak saturated power output greater than 60 W (47.78 dBm) at any frequency exceeding 3.7 GHz up to and including 6.8 GHz;</P>
                            <P>b.3.b. Rated for operation at frequencies exceeding 6.8 GHz up to and including 31.8 GHz and having any of the following:</P>
                            <P>b.3.b.1. A peak saturated power output greater than 50 W (47 dBm) at any frequency exceeding 6.8 GHz up to and including 8.5 GHz;</P>
                            <P>b.3.b.2. A peak saturated power output greater than 15 W (41.76 dBm) at any frequency exceeding 8.5 GHz up to and including 12 GHz;</P>
                            <P>
                                b.3.b.3. A peak saturated power output greater than 40 W (46 dBm) at any frequency exceeding 12 GHz up to and including 16 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.3.b.4. A peak saturated power output greater than 7 W (38.45 dBm) at any frequency exceeding 16 GHz up to and including 31.8 GHz;</P>
                            <P>b.3.c. Rated for operation with a peak saturated power output greater than 0.5 W (27 dBm) at any frequency exceeding 31.8 GHz up to and including 37 GHz;</P>
                            <P>b.3.d. Rated for operation with a peak saturated power output greater than 1 W (30 dBm) at any frequency exceeding 37 GHz up to and including 43.5 GHz;</P>
                            <P>
                                b.3.e. Rated for operation with a peak saturated power output greater than 0.1 nW (−70 dBm) at any frequency exceeding 43.5 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.3.f. Other than those specified by 3A001.b.3.a to 3A001.b.3.e and rated for operation with a peak saturated power output greater than 5 W (37.0 dBm) at all frequencies exceeding 8.5 GHz up to and including 31.8 GHz;</P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">The control status of a transistor in 3A001.b.3.a through 3A001.b.3.e, whose rated operating frequency includes frequencies listed in more than one frequency range, as defined by 3A001.b.3.a through 3A001.b.3.e, is determined by the lowest peak saturated power output control threshold.</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">
                                    3A001.b.3 includes bare dice, dice mounted on carriers, or dice mounted in packages. Some discrete transistors may also 
                                    <PRTPAGE P="4571"/>
                                    be referred to as power amplifiers, but the status of these discrete transistors is determined by 3A001.b.3.
                                </E>
                            </P>
                            <P>b.4. Microwave solid state amplifiers and microwave assemblies/modules containing microwave solid state amplifiers, that are any of the following:</P>
                            <P>b.4.a. Rated for operation at frequencies exceeding 2.7 GHz up to and including 6.8 GHz with a “fractional bandwidth” greater than 15%, and having any of the following:</P>
                            <P>b.4.a.1. A peak saturated power output greater than 500 W (57 dBm) at any frequency exceeding 2.7 GHz up to and including 2.9 GHz;</P>
                            <P>b.4.a.2. A peak saturated power output greater than 270 W (54.3 dBm) at any frequency exceeding 2.9 GHz up to and including 3.2 GHz;</P>
                            <P>
                                b.4.a.3. A peak saturated power output greater than 200 W (53 dBm) at any frequency exceeding 3.2 GHz up to and including 3.7 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.4.a.4. A peak saturated power output greater than 90 W (49.54 dBm) at any frequency exceeding 3.7 GHz up to and including 6.8 GHz;</P>
                            <P>b.4.b. Rated for operation at frequencies exceeding 6.8 GHz up to and including 31.8 GHz with a “fractional bandwidth” greater than 10%, and having any of the following:</P>
                            <P>b.4.b.1. A peak saturated power output greater than 70 W (48.45 dBm) at any frequency exceeding 6.8 GHz up to and including 8.5 GHz;</P>
                            <P>b.4.b.2. A peak saturated power output greater than 50 W (47 dBm) at any frequency exceeding 8.5 GHz up to and including 12 GHz;</P>
                            <P>
                                b.4.b.3. A peak saturated power output greater than 30 W (44.77 dBm) at any frequency exceeding 12 GHz up to and including 16 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.4.b.4. A peak saturated power output greater than 20 W (43 dBm) at any frequency exceeding 16 GHz up to and including 31.8 GHz;</P>
                            <P>b.4.c. Rated for operation with a peak saturated power output greater than 0.5 W (27 dBm) at any frequency exceeding 31.8 GHz up to and including 37 GHz;</P>
                            <P>b.4.d. Rated for operation with a peak saturated power output greater than 2 W (33 dBm) at any frequency exceeding 37 GHz up to and including 43.5 GHz, and with a “fractional bandwidth” of greater than 10%;</P>
                            <P>b.4.e. Rated for operation at frequencies exceeding 43.5 GHz and having any of the following:</P>
                            <P>b.4.e.1. A peak saturated power output greater than 0.2 W (23 dBm) at any frequency exceeding 43.5 GHz up to and including 75 GHz, and with a “fractional bandwidth” of greater than 10%;</P>
                            <P>
                                b.4.e.2. A peak saturated power output greater than 20 mW (13 dBm) at any frequency exceeding 75 GHz up to and including 90 GHz, and with a “fractional bandwidth” of greater than 5%; 
                                <E T="03">or</E>
                            </P>
                            <P>
                                b.4.e.3. A peak saturated power output greater than 0.1 nW (−70 dBm) at any frequency exceeding 90 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.4.f. [Reserved]</P>
                            <P>
                                <E T="04">N.B.:</E>
                            </P>
                            <P>
                                1. For “
                                <E T="03">MMIC” amplifiers see 3A001.b.2.</E>
                            </P>
                            <P>
                                2. 
                                <E T="03">For `transmit/receive modules' and `transmit modules' see 3A001.b.12.</E>
                            </P>
                            <P>
                                3. 
                                <E T="03">For converters and harmonic mixers, designed to extend the operating or frequency range of signal analyzers, signal generators, network analyzers or microwave test receivers, see 3A001.b.7.</E>
                            </P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">[Reserved]</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">The control status of an item whose rated operating frequency includes frequencies listed in more than one frequency range, as defined by 3A001.b.4.a through 3A001.b.4.e, is determined by the lowest peak saturated power output control threshold.</E>
                            </P>
                            <P>
                                b.5. Electronically or magnetically tunable band-pass or band-stop filters, having more than 5 tunable resonators capable of tuning across a 1.5:1 frequency band (f
                                <E T="52">max</E>
                                /f
                                <E T="52">min</E>
                                ) in less than 10 ms and having any of the following:
                            </P>
                            <P>
                                b.5.a. A band-pass bandwidth of more than 0.5% of center frequency; 
                                <E T="03">or</E>
                            </P>
                            <P>b.5.b. A band-stop bandwidth of less than 0.5% of center frequency;</P>
                            <P>b.6. [Reserved]</P>
                            <P>b.7. Converters and harmonic mixers, that are any of the following:</P>
                            <P>b.7.a. Designed to extend the frequency range of “signal analyzers” beyond 90 GHz;</P>
                            <P>b.7.b. Designed to extend the operating range of signal generators as follows:</P>
                            <P>b.7.b.1. Beyond 90 GHz;</P>
                            <P>b.7.b.2. To an output power greater than 100 mW (20 dBm) anywhere within the frequency range exceeding 43.5 GHz but not exceeding 90 GHz;</P>
                            <P>b.7.c. Designed to extend the operating range of network analyzers as follows:</P>
                            <P>b.7.c.1. Beyond 110 GHz;</P>
                            <P>b.7.c.2. To an output power greater than 31.62 mW (15 dBm) anywhere within the frequency range exceeding 43.5 GHz but not exceeding 90 GHz;</P>
                            <P>
                                b.7.c.3. To an output power greater than 1 mW (0 dBm) anywhere within the frequency range exceeding 90 GHz but not exceeding 110 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.7.d. Designed to extend the frequency range of microwave test receivers beyond 110 GHz;</P>
                            <P>b.8. Microwave power amplifiers containing “vacuum electronic devices” controlled by 3A001.b.1 and having all of the following:</P>
                            <P>b.8.a. Operating frequencies above 3 GHz;</P>
                            <P>
                                b.8.b. An average output power to mass ratio exceeding 80 W/kg; 
                                <E T="03">and</E>
                            </P>
                            <P>
                                b.8.c. A volume of less than 400 cm
                                <SU>3</SU>
                                ;
                            </P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">3A001.b.8 does not control equipment designed or rated for operation in any frequency band which is “allocated by the ITU” for radio-communications services, but not for radio-determination.</E>
                            </P>
                            <P>b.9. Microwave Power Modules (MPM) consisting of, at least, a traveling-wave “vacuum electronic device,” a “Monolithic Microwave Integrated Circuit” (“MMIC”) and an integrated electronic power conditioner and having all of the following:</P>
                            <P>b.9.a. A 'turn-on time' from off to fully operational in less than 10 seconds;</P>
                            <P>
                                b.9.b. A volume less than the maximum rated power in Watts multiplied by 10 cm
                                <SU>3</SU>
                                /W; 
                                <E T="03">and</E>
                            </P>
                            <P>
                                b.9.c. An “instantaneous bandwidth” greater than 1 octave (f
                                <E T="52">max</E>
                                 &gt; 2f
                                <E T="52">min</E>
                                ) and having any of the following:
                            </P>
                            <P>
                                b.9.c.1. For frequencies equal to or less than 18 GHz, an RF output power greater than 100 W; 
                                <E T="03">or</E>
                            </P>
                            <P>b.9.c.2. A frequency greater than 18 GHz;</P>
                            <P>
                                <E T="04">Technical Notes:</E>
                                  
                                <E T="03">For the purposes of 3A001.b.9:</E>
                            </P>
                            <P>
                                <E T="03">
                                    1. To calculate the volume in 3A001.b.9.b, the following example is provided: for a maximum rated power of 20 W, the volume would be: 20 W × 10 cm
                                    <SU>3</SU>
                                    /W = 200 cm
                                    <SU>3</SU>
                                    .
                                </E>
                            </P>
                            <P>
                                <E T="03">2. The 'turn-on time' in 3A001.b.9.a refers to the time from fully-off to fully operational, i.e., it includes the warm-up time of the MPM.</E>
                            </P>
                            <P>
                                b.10. Oscillators or oscillator assemblies, specified to operate with a single sideband (SSB) phase noise, in dBc/Hz, less (better) than − (126 + 20log
                                <E T="52">10</E>
                                F − 20log
                                <E T="52">10</E>
                                f) anywhere within the range of 10 Hz ≤ F ≤ 10 kHz;
                            </P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.b.10, F is the offset from the operating frequency in Hz and f is the operating frequency in MHz.</E>
                            </P>
                            <P>b.11. `Frequency synthesizer' “electronic assemblies” having a “frequency switching time” as specified by any of the following:</P>
                            <P>b.11.a. Less than 143 ps;</P>
                            <P>b.11.b. Less than 100 µs for any frequency change exceeding 2.2 GHz within the synthesized frequency range exceeding 4.8 GHz but not exceeding 31.8 GHz;</P>
                            <P>b.11.c. [Reserved]</P>
                            <P>b.11.d. Less than 500 µs for any frequency change exceeding 550 MHz within the synthesized frequency range exceeding 31.8 GHz but not exceeding 37 GHz;</P>
                            <P>b.11.e. Less than 100 µs for any frequency change exceeding 2.2 GHz within the synthesized frequency range exceeding 37 GHz but not exceeding 75 GHz;</P>
                            <P>
                                b.11.f. Less than 100 µs for any frequency change exceeding 5.0 GHz within the synthesized frequency range exceeding 75 GHz but not exceeding 90 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>b.11.g. Less than 1 ms within the synthesized frequency range exceeding 90 GHz;</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.b.11, a `frequency synthesizer' is any kind of frequency source, regardless of the actual technique used, providing a multiplicity of simultaneous or alternative output frequencies, from one or more outputs, controlled by, derived from or disciplined by a lesser number of standard (or master) frequencies.</E>
                            </P>
                            <P>
                                <E T="04">N.B.:</E>
                                  
                                <E T="03">For general purpose “signal analyzers”, signal generators, network analyzers and microwave test receivers, see 3A002.c, 3A002.d, 3A002.e and 3A002.f, respectively.</E>
                            </P>
                            <P>b.12. 'Transmit/receive modules, `transmit/receive MMICs, `transmit modules,' and `transmit MMICs,' rated for operation at frequencies above 2.7 GHz and having all of the following:</P>
                            <P>
                                b.12.a. A peak saturated power output (in watts), P
                                <E T="52">sat</E>
                                , greater than 505.62 divided by the maximum operating frequency (in GHz) squared [P
                                <E T="52">sat</E>
                                &gt;505.62 W*GHz
                                <SU>2</SU>
                                /f
                                <E T="52">GHz</E>
                                <SU>2</SU>
                                ] for any channel;
                            </P>
                            <P>b.12.b. A “fractional bandwidth” of 5% or greater for any channel;</P>
                            <P>
                                b.12.c. Any planar side with length d (in cm) equal to or less than 15 divided by the lowest operating frequency in GHz [d ≤ 
                                <PRTPAGE P="4572"/>
                                15cm*GHz*N/f
                                <E T="52">GHz</E>
                                ] where N is the number of transmit or transmit/receive channels; 
                                <E T="03">and</E>
                            </P>
                            <P>b.12.d. An electronically variable phase shifter per channel;</P>
                            <P>
                                <E T="04">Technical Notes:</E>
                                  
                                <E T="03">For the purposes of 3A001.b.12:</E>
                            </P>
                            <P>
                                <E T="03">1. A `transmit/receive module' is a multifunction “electronic assembly” that provides bi-directional amplitude and phase control for transmission and reception of signals.</E>
                            </P>
                            <P>
                                <E T="03">2. A `transmit module' is an “electronic assembly” that provides amplitude and phase control for transmission of signals.</E>
                            </P>
                            <P>
                                <E T="03">3. A `transmit/receive MMIC' is a multifunction “MMIC” that provides bi-directional amplitude and phase control for transmission and reception of signals.</E>
                            </P>
                            <P>
                                <E T="03">4. A `transmit MMIC' is a “MMIC” that provides amplitude and phase control for transmission of signals.</E>
                            </P>
                            <P>
                                <E T="03">5. 2.7 GHz should be used as the lowest operating frequency (f</E>
                                <E T="52">GHz</E>
                                ) 
                                <E T="03">in the formula in 3A001.b.12.c for transmit/receive or transmit modules that have a rated operation range extending downward to 2.7 GHz and below [d≤15cm*GHz*N/2.7 GHz].</E>
                            </P>
                            <P>
                                <E T="03">6. 3A001.b.12 applies to `transmit/receive modules' or `transmit modules' with or without a heat sink. The value of d in 3A001.b.12.c does not include any portion of the `transmit/receive module' or `transmit module' that functions as a heat sink.</E>
                            </P>
                            <P>
                                <E T="03">7. `Transmit/receive modules' or `transmit modules,' `transmit/receive MMICs' or `transmit MMICs' may or may not have N integrated radiating antenna elements where N is the number of transmit or transmit/receive channels.</E>
                            </P>
                            <P>c. Acoustic wave devices as follows and “specially designed” “components” therefor:</P>
                            <P>c.1. Surface acoustic wave and surface skimming (shallow bulk) acoustic wave devices, having any of the following:</P>
                            <P>c.1.a. A carrier frequency exceeding 6 GHz;</P>
                            <P>c.1.b. A carrier frequency exceeding 1 GHz, but not exceeding 6 GHz and having any of the following:</P>
                            <P>c.1.b.1. A `frequency side-lobe rejection' exceeding 65 dB;</P>
                            <P>c.1.b.2. A product of the maximum delay time and the bandwidth (time in µs and bandwidth in MHz) of more than 100;</P>
                            <P>
                                c.1.b.3. A bandwidth greater than 250 MHz; 
                                <E T="03">or</E>
                            </P>
                            <P>
                                c.1.b.4. A dispersive delay of more than 10 µs; 
                                <E T="03">or</E>
                            </P>
                            <P>c.1.c. A carrier frequency of 1 GHz or less and having any of the following:</P>
                            <P>c.1.c.1. A product of the maximum delay time and the bandwidth (time in µs and bandwidth in MHz) of more than 100;</P>
                            <P>
                                c.1.c.2. A dispersive delay of more than 10 µs; 
                                <E T="03">or</E>
                            </P>
                            <P>c.1.c.3. A `frequency side-lobe rejection' exceeding 65 dB and a bandwidth greater than 100 MHz;</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.c.1, `frequency side-lobe rejection' is the maximum rejection value specified in data sheet.</E>
                            </P>
                            <P>c.2. Bulk (volume) acoustic wave devices that permit the direct processing of signals at frequencies exceeding 6 GHz;</P>
                            <P>c.3. Acoustic-optic “signal processing” devices employing interaction between acoustic waves (bulk wave or surface wave) and light waves that permit the direct processing of signals or images, including spectral analysis, correlation or convolution;</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">3A001.c does not control acoustic wave devices that are limited to a single band pass, low pass, high pass or notch filtering, or resonating function.</E>
                            </P>
                            <P>d. Electronic devices and circuits containing “components,” manufactured from “superconductive” materials, “specially designed” for operation at temperatures below the “critical temperature” of at least one of the “superconductive” constituents and having any of the following:</P>
                            <P>
                                d.1. Current switching for digital circuits using “superconductive” gates with a product of delay time per gate (in seconds) and power dissipation per gate (in watts) of less than 10
                                <E T="51">−14</E>
                                 J; 
                                <E T="03">or</E>
                            </P>
                            <P>d.2. Frequency selection at all frequencies using resonant circuits with Q-values exceeding 10,000;</P>
                            <P>e. High energy devices as follows:</P>
                            <P>e.1. `Cells' as follows:</P>
                            <P>e.1.a `Primary cells' having any of the following at 20 °C:</P>
                            <P>
                                e.1.a.1. `Energy density' exceeding 550 Wh/kg and a `continuous power density' exceeding 50 W/kg; 
                                <E T="03">or</E>
                            </P>
                            <P>e.1.a.2. `Energy density' exceeding 50 Wh/kg and a 'continuous power density' exceeding 350 W/kg;</P>
                            <P>e.1.b. `Secondary cells' having an `energy density' exceeding 350 Wh/kg at 20 °C;</P>
                            <P>
                                <E T="04">Technical Notes:</E>
                                  
                                <E T="03">1. For the purposes of 3A001.e.1, `energy density' (Wh/kg) is calculated from the nominal voltage multiplied by the nominal capacity in ampere-hours (Ah) divided by the mass in kilograms. If the nominal capacity is not stated, energy density is calculated from the nominal voltage squared then multiplied by the discharge duration in hours divided by the discharge load in Ohms and the mass in kilograms.</E>
                            </P>
                            <P>
                                <E T="03">2. For the purposes of 3A001.e.1, a `cell' is defined as an electrochemical device, which has positive and negative electrodes, an electrolyte, and is a source of electrical energy. It is the basic building block of a battery.</E>
                            </P>
                            <P>
                                <E T="03">3. For the purposes of 3A001.e.1.a, a `primary cell' is a `cell' that is not designed to be charged by any other source.</E>
                            </P>
                            <P>
                                <E T="03">4. For the purposes of 3A001.e.1.b, a `secondary cell' is a `cell' that is designed to be charged by an external electrical source.</E>
                            </P>
                            <P>
                                <E T="03">5. For the purposes of 3A001.e.1.a, `continuous power density' (W/kg) is calculated from the nominal voltage multiplied by the specified maximum continuous discharge current in ampere (A) divided by the mass in kilograms. `Continuous power density' is also referred to as specific power.</E>
                            </P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">3A001.e does not control batteries, including single-cell batteries.</E>
                            </P>
                            <P>e.2. High energy storage capacitors as follows:</P>
                            <P>e.2.a. Capacitors with a repetition rate of less than 10 Hz (single shot capacitors) and having all of the following:</P>
                            <P>e.2.a.1. A voltage rating equal to or more than 5 kV;</P>
                            <P>
                                e.2.a.2. An energy density equal to or more than 250 J/kg; 
                                <E T="03">and</E>
                            </P>
                            <P>e.2.a.3. A total energy equal to or more than 25 kJ;</P>
                            <P>e.2.b. Capacitors with a repetition rate of 10 Hz or more (repetition rated capacitors) and having all of the following:</P>
                            <P>e.2.b.1. A voltage rating equal to or more than 5 kV;</P>
                            <P>e.2.b.2. An energy density equal to or more than 50 J/kg;</P>
                            <P>
                                e.2.b.3. A total energy equal to or more than 100 J; 
                                <E T="03">and</E>
                            </P>
                            <P>e.2.b.4. A charge/discharge cycle life equal to or more than 10,000;</P>
                            <P>e.3. “Superconductive” electromagnets and solenoids, “specially designed” to be fully charged or discharged in less than one second and having all of the following:</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">3A001.e.3 does not control “superconductive” electromagnets or solenoids “specially designed” for Magnetic Resonance Imaging (MRI) medical equipment.</E>
                            </P>
                            <P>e.3.a. Energy delivered during the discharge exceeding 10 kJ in the first second;</P>
                            <P>
                                e.3.b. Inner diameter of the current carrying windings of more than 250 mm; 
                                <E T="03">and</E>
                            </P>
                            <P>
                                e.3.c. Rated for a magnetic induction of more than 8 T or “overall current density” in the winding of more than 300 A/mm
                                <SU>2</SU>
                                ;
                            </P>
                            <P>
                                e.4. Solar cells, cell-interconnect-coverglass (CIC) assemblies, solar panels, and solar arrays, which are “space-qualified,” having a minimum average efficiency exceeding 20% at an operating temperature of 301 K (28 °C) under simulated `AM0' illumination with an irradiance of 1,367 Watts per square meter (W/m
                                <SU>2</SU>
                                );
                            </P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.e.4, `AM0', or `Air Mass Zero', refers to the spectral irradiance of sun light in the earth's outer atmosphere when the distance between the earth and sun is one astronomical unit (AU).</E>
                            </P>
                            <P>f. Rotary input type absolute position encoders having an “accuracy” equal to or less (better) than 1.0 second of arc and “specially designed” encoder rings, discs or scales therefor;</P>
                            <P>g. Solid-state pulsed power switching thyristor devices and `thyristor modules', using either electrically, optically, or electron radiation controlled switch methods and having any of the following:</P>
                            <P>
                                g.1. A maximum turn-on current rate of rise (di/dt) greater than 30,000 A/µs and off-state voltage greater than 1,100 V; 
                                <E T="03">or</E>
                            </P>
                            <P>g.2. A maximum turn-on current rate of rise (di/dt) greater than 2,000 A/µs and having all of the following:</P>
                            <P>
                                g.2.a. An off-state peak voltage equal to or greater than 3,000 V; 
                                <E T="03">and</E>
                            </P>
                            <P>g.2.b. A peak (surge) current equal to or greater than 3,000 A;</P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">3A001.g. includes:</E>
                            </P>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Silicon Controlled Rectifiers (SCRs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Electrical Triggering Thyristors (ETTs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Light Triggering Thyristors (LTTs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Integrated Gate Commutated Thyristors (IGCTs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Gate Turn-off Thyristors (GTOs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">MOS Controlled Thyristors (MCTs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Solidtrons</E>
                            </FP>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">3A001.g does not control thyristor devices and `thyristor modules' incorporated into equipment designed for civil railway or “civil aircraft” applications.</E>
                                <PRTPAGE P="4573"/>
                            </P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.g, a `thyristor module' contains one or more thyristor devices.</E>
                            </P>
                            <P>h. Solid-state power semiconductor switches, diodes, or `modules', having all of the following:</P>
                            <P>h.1. Rated for a maximum operating junction temperature greater than 488 K (215 °C);</P>
                            <P>
                                h.2. Repetitive peak off-state voltage (blocking voltage) exceeding 300 V; 
                                <E T="03">and</E>
                            </P>
                            <P>h.3. Continuous current greater than 1 A.</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.h, `modules' contain one or more solid-state power semiconductor switches or diodes.</E>
                            </P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">Repetitive peak off-state voltage in 3A001.h includes drain to source voltage, collector to emitter voltage, repetitive peak reverse voltage and peak repetitive off-state blocking voltage.</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">3A001.h includes:</E>
                            </P>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Junction Field Effect Transistors (JFETs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Vertical Junction Field Effect Transistors (VJFETs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Metal Oxide Semiconductor Field Effect Transistors (MOSFETs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Double Diffused Metal Oxide Semiconductor Field Effect Transistor (DMOSFET)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Insulated Gate Bipolar Transistor (IGBT)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">High Electron Mobility Transistors (HEMTs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Bipolar Junction Transistors (BJTs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Thyristors and Silicon Controlled Rectifiers (SCRs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Gate Turn-Off Thyristors (GTOs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Emitter Turn-Off Thyristors (ETOs)</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">PiN Diodes</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Schottky Diodes</E>
                            </FP>
                            <P>
                                <E T="04">Note 3:</E>
                                  
                                <E T="03">3A001.h does not apply to switches, diodes, or `modules', incorporated into equipment designed for civil automobile, civil railway, or “civil aircraft” applications.</E>
                            </P>
                            <P>i. Intensity, amplitude, or phase electro-optic modulators, designed for analog signals and having any of the following:</P>
                            <P>i.1. A maximum operating frequency of more than 10 GHz but less than 20 GHz, an optical insertion loss equal to or less than 3 dB and having any of the following:</P>
                            <P>
                                i.1.a. A `half-wave voltage' (`Vπ') less than 2.7 V when measured at a frequency of 1 GHz or below; 
                                <E T="03">or</E>
                            </P>
                            <P>
                                i.1.b. A `Vπ' of less than 4 V when measured at a frequency of more than 1 GHz; 
                                <E T="03">or</E>
                            </P>
                            <P>i.2. A maximum operating frequency equal to or greater than 20 GHz, an optical insertion loss equal to or less than 3 dB and having any of the following:</P>
                            <P>
                                i.2.a. A `Vπ' less than 3.3 V when measured at a frequency of 1 GHz or below; 
                                <E T="03">or</E>
                            </P>
                            <P>i.2.b. A `Vπ' less than 5 V when measured at a frequency of more than 1 GHz.</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">3A001.i includes electro-optic modulators having optical input and output connectors (e.g., fiber-optic pigtails).</E>
                            </P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 3A001.i, a `half-wave voltage' (`Vπ') is the applied voltage necessary to make a phase change of 180 degrees in the wavelength of light propagating through the optical modulator.</E>
                            </P>
                            <P>j. through y. [Reserved]</P>
                            <P>z. Any commodity described in 3A001 that meets or exceeds the performance parameters in 3A090, as follows:</P>
                            <P>z.1.a “Monolithic Microwave Integrated Circuit” (“MMIC”) amplifiers described in 3A001.b.2 and discrete microwave transistors in 3A001.b.3 that also meet or exceed the performance parameters in ECCN 3A090.a, except those 3A001.b.2 and b.3 items being exported or reexported for use in civil telecommunications applications;</P>
                            <P>z.1.b “Monolithic Microwave Integrated Circuit” (“MMIC”) amplifiers described in 3A001.b.2 and discrete microwave transistors in 3A001.b.3 that also meet or exceed the performance parameters in ECCN 3A090.b, except those 3A001.b.2 and b.3 items being exported or reexported for use in civil telecommunications applications;</P>
                            <P>z.2.a Commodities that are described in 3A001.a.1.a when usable in “missiles” that also meet or exceed the performance parameters in ECCN 3A090.a; and to 3A001.a.5.a when “designed or modified” for military use, hermetically sealed and rated for operation in the temperature range from below −54 °C to above +125 °C and that also meet or exceed the performance parameters in ECCN 3A090.a;</P>
                            <P>z.2.b Commodities that are described in 3A001.a.1.a when usable in “missiles” that also meet or exceed the performance parameters in ECCN 3A090.b; and to 3A001.a.5.a when “designed or modified” for military use, hermetically sealed and rated for operation in the temperature range from below −54 °C to above +125 °C and that also meet or exceed the performance parameters in ECCN 3A090.b;</P>
                            <P>z.3.a. Pulse discharge capacitors described in 3A001.e.2 and superconducting solenoidal electromagnets in 3A001.e.3 that meet or exceed the technical parameters in 3A201.a and 3A201.b, respectively and that also meet or exceed the performance parameters in ECCN 3A090.a;</P>
                            <P>z.3.b Pulse discharge capacitors described in 3A001.e.2 and superconducting solenoidal electromagnets in 3A001.e.3 that meet or exceed the technical parameters in 3A201.a and 3A201.b, respectively and that also meet or exceed the performance parameters in ECCN 3A090.b;</P>
                            <P>z.4.a. All other commodities specified in this ECCN that meet or exceed the performance parameters of ECCN 3A090.a; or</P>
                            <P>z.4.b All other commodities specified in this ECCN that meet or exceed the performance parameters of ECCN 3A090.b.</P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">3A090 Integrated circuits as follows (see List of Items Controlled).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">RS applies to 3A090.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to 3A090.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to 3A090.c</ENT>
                                    <ENT>
                                        To or within Macau or a destination specified in Country Group D:5 of supplement no. 1 to part 740 of the EAR. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(i)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">LVS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">GBS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 3A090.a, if the item is not designed or marketed for use in datacenters and has a `total processing performance' of 4800 or more; yes, for 3A090.b, if the item is designed or marketed for use in datacenters. N/A for 3A090.c.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">HBM:</E>
                                 Yes, for 3A090.c. See § 740.25 of the EAR.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 3A090.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">LPP:</E>
                                 Yes for 3A090.a
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 (1) See ECCNs 3D001, 3E001, 5D002.z, and 5D992.z for associated technology and software controls. (2) See ECCNs 3A001.z, 5A002.z, 5A004.z, and 5A992.z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. Integrated circuits having one or more digital processing units having either of the following:</P>
                            <P>
                                a.1. A `total processing performance' of 4800 or more, 
                                <E T="03">or</E>
                            </P>
                            <P>a.2. A `total processing performance' of 1600 or more and a `performance density' of 5.92 or more.</P>
                            <P>b. Integrated circuits having one or more digital processing units having either of the following:</P>
                            <P>
                                b.1. A `total processing performance' of 2400 or more and less than 4800 and a `performance density' of 1.6 or more and less than 5.92, 
                                <E T="03">or</E>
                            </P>
                            <P>b.2. A `total processing performance' of 1600 or more and a `performance density' of 3.2 or more and less than 5.92.</P>
                            <P>
                                <E T="04">Note 1 to 3A090.a and 3A090.b:</E>
                                  
                                <E T="03">3A090.a and 3A090.b do not apply to items that are not designed or marketed for use in datacenters and do not have a `total processing performance' of 4800 or more. For 3A090.a and 3A090.b items that are not designed or marketed for use in datacenters and that have a `total processing performance' of 4800 or more, see license exceptions NAC and ACA.</E>
                            </P>
                            <P>
                                <E T="04">Note 2 to 3A090.a and 3A090.b:</E>
                                  
                                <E T="03">
                                    Integrated circuits specified by 3A090 include graphical processing units (GPUs), tensor processing 
                                    <PRTPAGE P="4574"/>
                                    units (TPUs), neural processors, in-memory processors, vision processors, text processors, co-processors/accelerators, adaptive processors, field-programmable logic devices (FPLDs), and application-specific integrated circuits (ASICs). Examples of integrated circuits are in the Note to 3A001.a.
                                </E>
                            </P>
                            <P>
                                <E T="04">Note 3 to 3A090.a and 3A090.b:</E>
                                  
                                <E T="03">For ICs that are excluded from ECCN 3A090 under Note 2 or 3 to 3A090, those ICs are also not applicable for classifications made under ECCNs 3A001.z, 4A003.z, 4A004.z, 4A005.z, 4A090, 5A002.z, 5A004.z, 5A992.z, 5D002.z, or 5D992.z because those other CCL classifications are based on the incorporation of an IC that meets the control parameters under ECCN 3A090 or otherwise meets or exceeds the control parameters or ECCNs 3A090 or 4A090. See the Related Controls paragraphs of 3A001.z, 4A003.z, 4A004.z, 4A005.z, 4A090, 5A002.z, 5A004.z, 5A992.z, 5D002.z, or 5D992.z.</E>
                            </P>
                            <P>
                                <E T="04">Technical Notes to 3A090.a and 3A090.b:</E>
                            </P>
                            <P>
                                <E T="03">1. `Total processing performance' (`TPP') is 2 × `MacTOPS' × `bit length of the operation', aggregated over all processing units on the integrated circuit.</E>
                            </P>
                            <P>
                                <E T="03">
                                    a. For purposes of 3A090, `MacTOPS' is the theoretical peak number of Tera (10
                                    <SU>12</SU>
                                    ) operations per second for multiply-accumulate computation (D = A × B + C).
                                </E>
                            </P>
                            <P>
                                <E T="03">b. The 2 in the `TPP' formula is based on industry convention of counting one multiply-accumulate computation, D = A × B + C, as 2 operations for purpose of datasheets. Therefore, 2 × MacTOPS may correspond to the reported TOPS or FLOPS on a datasheet.</E>
                            </P>
                            <P>
                                <E T="03">c. For purposes of 3A090, `bit length of the operation' for a multiply-accumulate computation is the largest bit-length of the inputs to the multiply operation.</E>
                            </P>
                            <P>
                                <E T="03">d. Aggregate the TPPs for each processing unit on the integrated circuit to arrive at a total. `TPP' = TPP1 + TPP2 + . . . . + TPPn (where n is the number or processing units on the integrated circuit).</E>
                            </P>
                            <P>
                                <E T="03">2. The rate of `MacTOPS' is to be calculated at its maximum value theoretically possible. The rate of `MacTOPS' is assumed to be the highest value the manufacturer claims in annual or brochure for the integrated circuit. For example, the `TPP' threshold of 4800 can be met with 600 tera integer operations (or 2 × 300 `MacTOPS') at 8 bits or 300 tera FLOPS (or 2 × 150 `MacTOPS') at 16 bits. If the IC is designed for MAC computation with multiple bit lengths that achieve different `TPP' values, the highest `TPP' value should be evaluated against parameters in 3A090.</E>
                            </P>
                            <P>
                                <E T="03">3. For integrated circuits specified by 3A090 that provide processing of both sparse and dense matrices, the `TPP' values are the values for processing of dense matrices (e.g., without sparsity).</E>
                            </P>
                            <P>
                                <E T="03">4. `Performance density' is `TPP' divided by `applicable die area'. For purposes of 3A090, `applicable die area' is measured in millimeters squared and includes all die area of logic dies manufactured with a process node that uses a non-planar transistor architecture.</E>
                            </P>
                            <P>c. High bandwidth memory having a `memory bandwidth density' greater than 2 gigabytes per second per square millimeter.</P>
                            <P>
                                <E T="04">Technical note to 3A090.c:</E>
                                  
                                <E T="03">`Memory bandwidth density' is the memory bandwidth measured in gigabytes per second divided by the area of the package or stack measured in square millimeters. In the case where a stack is contained in a package, use the memory bandwidth of the packaged device and the area of the package. High bandwidth memory includes dynamic random access memory integrated circuits, regardless of whether they conform to the JEDEC standards for high bandwidth memory, provided they have a `memory bandwidth density' greater than 2 gigabytes per second per square millimeter. This control does not cover co-packaged integrated circuits with both high bandwidth memory and logic integrated circuit where the dominant function of the co-packaged integrated circuit is processing. It does include high bandwidth memory permanently affixed to a logic integrated circuit designed as a control interface and incorporating a physical layer (PHY) function.</E>
                            </P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">3D001 “Software” “specially designed” for the “development” or “production” of commodities controlled by 3A001.b to 3A002.h, 3A090, or 3B (except 3B001.a.4, c, d, f.1, f.5, k to n, p.2, p.4, r, 3B002.c, 3B903, 3B904, 3B991, 3B992, 3B993, or 3B994).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to “software” for equipment controlled by 3B001.q</ENT>
                                    <ENT>
                                        Worldwide control. 
                                        <E T="03">See § 742.4(a)(5) and (b)(10) of the EAR.</E>
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” for equipment controlled by 3B001.q</ENT>
                                    <ENT>
                                        Worldwide control. 
                                        <E T="03">See § 742.6(a)(10) and (b)(11) of the EAR.</E>
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">NS applies to “software” for commodities controlled by 3A001.b to 3A001.h, 3A001.z, and 3B (except as specified in the heading)</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” for commodities controlled by 3A001.z.1.a, z.2.a, z.3.a, z.4.a and 3A090.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” for commodities controlled by 3A001.z. 1.b, z.2.b, z.3.b, z.4.b and 3A090.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” for commodities controlled by 3A090.c</ENT>
                                    <ENT>
                                        To or within Macau or a destination specified in Country Group D:5 of supplement no. 1 to part 740 of the EAR. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(i) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">Reporting Requirements</HD>
                            <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">TSR:</E>
                                  
                                <E T="03">Yes, except for “software” “specially designed” for the “development” or “production” of Traveling Wave Tube Amplifiers described in 3A001.b.8 having operating frequencies exceeding 18 GHz; or commodities specified in 3A090.</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for “software” for commodities controlled by 3A001.z.1.a, z.2.a, z.3.a, z.4.a, and 3A090.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for “software” for commodities controlled by 3A001.z
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 3D001 “software” for commodities controlled by 3A001.z and 3A090.</E>
                            </P>
                            <FP SOURCE="FP-1">
                                <E T="03">IEC:</E>
                                 Yes, for “software” for equipment controlled by 3B001.q, see § 740.2(a)(22) and § 740.24 of the EAR.
                            </FP>
                            <HD SOURCE="HD1">Special Conditions for STA</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">STA:</E>
                                 License Exception STA may not be used to ship or transmit “software” “specially designed” for the “development” or “production” of equipment specified by 3A090.a or 3B001. q to any of the destinations listed in Country Group A:5 or A:6 (See Supplement No.1 to part 740 of the EAR); and 3A090.b or 3A002.g.1 to any of the destinations listed in Country Group A:6.
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                                 The list of items controlled is contained in the ECCN heading.
                            </FP>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">3E001 “Technology” according to the General Technology Note for the “development” or “production” of commodities controlled by 3A (except 3A901, 3A904, 3A980, 3A981, 3A991, 3A992, or 3A999), 3B (except 3B001.a.4, c, d, f.1, f.5, k to n, p.2, p.4, r, 3B002.c, 3B903, 3B904, 3B991, 3B992, 3B993, or 3B994) or 3C (except 3C907, 3C908, 3C909, or 3C992).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, MT, NP, RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to “technology” for commodities controlled by 3A001, 3A002, 3A003, 3B001 (except as noted in the heading), 3B002 (except 3B002.c), or 3C001 to 3C006</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">MT applies to “technology” for commodities controlled by 3A001 or 3A101 for MT Reasons</ENT>
                                    <ENT>MT Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">NP applies to “technology” for commodities controlled by 3A001, 3A201, or 3A225 to 3A234 for NP reasons</ENT>
                                    <ENT>NP Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <PRTPAGE P="4575"/>
                                    <ENT I="01">RS applies to “technology” for commodities controlled in 3A090, when exported from Macau or a destination specified in Country Group D:5</ENT>
                                    <ENT>Worldwide (See § 742.6(a)(6)(ii).</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 3A001.z.1.a, z.2.a, z.3.a, z.4.a, and 3A090.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 3A001.z.1.b, z.2.b, z.3.b, z.4.b and 3A090.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 3A090.c</ENT>
                                    <ENT>
                                        To or within Macau or a destination specified in Country Group D:5 of supplement no. 1 to part 740 of the EAR. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(i)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 3A001.a.15 or b.13, 3A004, 3B003, 3C007, 3C008, or 3C009</ENT>
                                    <ENT>RS Column 2.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                <E T="04">License Requirements Note:</E>
                                  
                                <E T="03">See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.</E>
                            </P>
                            <HD SOURCE="HD1">Reporting Requirements</HD>
                            <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">TSR:</E>
                                 Yes, except N/A for MT, and “technology” for the “development” or “production” of: (a) vacuum electronic device amplifiers described in 3A001.b.8, having operating frequencies exceeding 19 GHz; (b) solar cells, coverglass-interconnect-cells or covered-interconnect-cells (CIC) “assemblies”, solar arrays and/or solar panels described in 3A001.e.4; (c) “Monolithic Microwave Integrated Circuit” (“MMIC”) amplifiers in 3A001.b.2; and (d) discrete microwave transistors in 3A001.b.3; and (e) commodities described in 3A090.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for “technology” for commodities controlled by 3A001.z.1.a, z.2.a, z.3.a, z.4.a, and 3A090.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for “technology” for commodities controlled by 3A001.z and 3A090
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 3E001 “technology” for commodities controlled by 3A001.z, 3A090.</E>
                            </P>
                            <FP SOURCE="FP-1">
                                <E T="03">IEC:</E>
                                 Yes, for “technology” for equipment controlled by 3B001.q, see § 740.2(a)(22) and § 740.24 of the EAR.
                            </FP>
                            <HD SOURCE="HD1">Special Conditions for STA</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">STA:</E>
                                 License Exception STA may not be used to ship or transmit “technology” according to the General Technology Note for the “development” or “production” of equipment specified by ECCNs 3A002.g.1 or 3B001.a.2 to any of the destinations listed in Country Group A:6 (See Supplement No.1 to part 740 of the EAR). License Exception STA may not be used to ship or transmit “technology” according to the General Technology Note for the “development” or “production” of components specified by ECCN 3A001.b.2, b.3, or commodities specified in 3A090, to any of the destinations listed in Country Group A:5 or A:6 (See Supplement No.1 to part 740 of the EAR).
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 (1) “Technology” according to the General Technology Note for the “development” or “production” of certain “space-qualified” atomic frequency standards described in Category XV(e)(9), MMICs described in Category XV(e)(14), and oscillators described in Category XV(e)(15) of the USML are “subject to the ITAR” (see 22 CFR parts 120 through 130). See also 3E101, 3E201 and 9E515. (2) “Technology” for “development” or “production” of “Microwave Monolithic Integrated Circuits” (“MMIC”) amplifiers in 3A001.b.2 is controlled in this ECCN 3E001; 5E001.d refers only to that additional “technology” “required” for telecommunications.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definition:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                                 The list of items controlled is contained in the ECCN heading.
                            </FP>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">3E001 does not control “technology” for equipment or “components” controlled by 3A003.</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">3E001 does not control “technology” for integrated circuits controlled by 3A001.a.3 to a.14 or .z, having all of the following:</E>
                            </P>
                            <P>
                                <E T="03">(a) Using “technology” at or above 0.130</E>
                                  
                                <E T="8153">m</E>
                                <E T="03">m; and</E>
                            </P>
                            <P>
                                <E T="03">(b) Incorporating multi-layer structures with three or fewer metal layers.</E>
                            </P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">4A003 “Digital computers”, “electronic assemblies”, and related equipment therefor, as follows (see List of Items Controlled) and “specially designed” “components” therefor.</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, RS, CC, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to 4A003.b, .c, and .z.1</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">NS applies to 4A003.g and z.2</ENT>
                                    <ENT>NS Column 2.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to 4A003.z.1.a, z.2.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to 4A003.z.1.b, z.2.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">CC applies to “digital computers” for computerized finger-print equipment</ENT>
                                    <ENT>CC Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry (refer to 4A994 for controls on “digital computers” with an APP &gt;0.0128 but ≤70 WT)</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">For all destinations, except those countries in Country Group E:1 or E:2 of Supplement No. 1 to part 740 of the EAR, no license is required (NLR) for computers with an “Adjusted Peak Performance” (“APP”) not exceeding 70 Weighted TeraFLOPS (WT) and for “electronic assemblies” described in 4A003.c that are not capable of exceeding an “Adjusted Peak Performance” (“APP”) exceeding 70 Weighted TeraFLOPS (WT) in aggregation, except certain transfers as set forth in § 746.3 (Iraq).</E>
                            </P>
                            <HD SOURCE="HD1">Reporting Requirements</HD>
                            <P>Special Post Shipment Verification reporting and recordkeeping requirements for exports of computers to destinations in Computer Tier 3 may be found in § 743.2 of the EAR.</P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">LVS:</E>
                                 $5000; N/A for 4A003.b, c, and z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">GBS:</E>
                                 Yes, for 4A003.g and “specially designed” “parts” and “components” therefor, exported separately or as part of a system.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">APP:</E>
                                 Yes, for computers controlled by 4A003.b, and “electronic assemblies” controlled by 4A003.c, to the exclusion of other technical parameters. See § 740.7 of the EAR.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 4A003.z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 4A003.z.1.a, z.2.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for 4A003.z
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">LPP:</E>
                                 Yes for 4A003.z.1.a, z.2.a
                            </FP>
                            <P>
                                <E T="04">Note to List Based License Exceptions:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 4A003.z.</E>
                            </P>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 See also ECCNs 4A090, 4A994 and 4A980.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">4A003 includes the following:</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">`Vector processors' (as defined in Note 7 of the “Technical Note on “Adjusted Peak Performance” (“APP”)”);</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Array processors;</E>
                                <PRTPAGE P="4576"/>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Digital signal processors;</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Logic processors;</E>
                            </FP>
                            <FP SOURCE="FP-1">
                                —
                                <E T="03">Equipment designed for “image enhancement.”</E>
                            </FP>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">The control status of the “digital computers” and related equipment described in 4A003 is determined by the control status of other equipment or systems provided:</E>
                            </P>
                            <P>
                                <E T="03">a. The “digital computers” or related equipment are essential for the operation of the other equipment or systems;</E>
                            </P>
                            <P>
                                <E T="03">b. The “digital computers” or related equipment are not a “principal element” of the other equipment or systems; and</E>
                            </P>
                            <P>
                                <E T="04">N.B. 1:</E>
                                  
                                <E T="03">The control status of “signal processing” or “image enhancement” equipment “specially designed” for other equipment with functions limited to those required for the other equipment is determined by the control status of the other equipment even if it exceeds the “principal element” criterion.</E>
                            </P>
                            <P>
                                <E T="04">N.B. 2:</E>
                                  
                                <E T="03">For the control status of “digital computers” or related equipment for telecommunications equipment, see Category 5, Part 1 (Telecommunications).</E>
                            </P>
                            <P>
                                <E T="03">c. The “technology” for the “digital computers” and related equipment is determined by 4E.</E>
                            </P>
                            <P>
                                <E T="03">a. [Reserved]</E>
                            </P>
                            <P>
                                <E T="03">b. “Digital computers” having an “Adjusted Peak Performance” (“APP”) exceeding 70 Weighted TeraFLOPS (WT);</E>
                            </P>
                            <P>
                                <E T="03">c. “Electronic assemblies” “specially designed” or modified to be capable of enhancing performance by aggregation of processors so that the “APP” of the aggregation exceeds the limit in 4A003.b.;</E>
                            </P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">4A003.c applies only to “electronic assemblies” and programmable interconnections not exceeding the limit in 4A003.b when shipped as unintegrated “electronic assemblies.”</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">4A003.c does not control “electronic assemblies” “specially designed” for a product or family of products whose maximum configuration does not exceed the limit of 4A003.b.</E>
                            </P>
                            <P>d. to f. [Reserved]</P>
                            <P>
                                <E T="04">N.B.:</E>
                                  
                                <E T="03">For “electronic assemblies,” modules or equipment, performing analog-to-digital conversions, see 3A002.h.</E>
                            </P>
                            <P>g. Equipment “specially designed” for aggregating the performance of “digital computers” by providing external interconnections which allow communications at unidirectional data rates exceeding 2.0 Gbyte/s per link.</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">4A003.g does not control internal interconnection equipment (e.g., backplanes, buses) passive interconnection equipment, “network access controllers” or “communication channel controllers”.</E>
                            </P>
                            <P>h. through y. [Reserved]</P>
                            <P>z. Commodities specified in this ECCN 4A003 that also meet or exceed the performance parameters in 4A090.</P>
                            <P>z.1.a. Commodities specified in 4A003.b or .c that also meet or exceed the performance parameters in ECCN 4A090.a;</P>
                            <P>z.1.b Commodities specified in 4A003.b or .c that also meet or exceed the performance parameters in ECCN 4A090.b;</P>
                            <P>z.2.a. Commodities specified in 4A003.g that also meet or exceed the performance parameters in ECCN 4A090a; or</P>
                            <P>z.2.b Commodities specified in 4A003.g that also meet or exceed the performance parameters in ECCN 4A090.b.</P>
                            <FP SOURCE="FP-2">
                                <E T="04">4A004 Computers as follows (see List of Items Controlled) and “specially designed” related equipment, “electronic assemblies” and “components” therefor.</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to entire entry</ENT>
                                    <ENT>NS Column 2.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to 4A004.z.1</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to 4A004.z.2</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">LVS:</E>
                                 $5000, N/A for 4A004.z
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">GBS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 4A004.z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 4A004.z.1
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">LPP:</E>
                                 Yes for 4A004.z.1
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 4A004.z.</E>
                            </P>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 See also ECCN 4A090.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. `Systolic array computers';</P>
                            <P>b. `Neural computers';</P>
                            <P>c. `Optical computers'.</P>
                            <P>
                                <E T="04">Technical Notes:</E>
                            </P>
                            <P>
                                <E T="03">1. For the purposes of 4A004.a, `systolic array computers' are computers where the flow and modification of the data is dynamically controllable at the logic gate level by the user.</E>
                            </P>
                            <P>
                                <E T="03">2. For the purposes of 4A004.b, `neural computers' are computational devices designed or modified to mimic the behavior of a neuron or a collection of neurons, i.e., computational devices which are distinguished by their hardware capability to modulate the weights and numbers of the interconnections of a multiplicity of computational components based on previous data.</E>
                            </P>
                            <P>
                                <E T="03">3. For the purposes of 4A004.c, `optical computers' are computers designed or modified to use light to represent data and whose computational logic elements are based on directly coupled optical devices.</E>
                            </P>
                            <P>d. through y. [Reserved]</P>
                            <P>z.1. Commodities that are described in 4A004 and that also meet or exceed the performance parameters in 4A090.a; or</P>
                            <P>z.2 Commodities that are described in 4A004 and that also meet or exceed the performance parameters in 4A090.b.</P>
                            <FP SOURCE="FP-2">
                                <E T="04">4A005 “Systems,” “equipment,” and “components” therefor, “specially designed” or modified for the generation, command and control, or delivery of “intrusion software” (see List of Items Controlled).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>to part 738)</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to entire entry</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to items controlled by 4A005.z.1</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to items controlled by 4A005.z.2</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">Reporting Requirements</HD>
                            <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">LVS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">GBS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">APP:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACE:</E>
                                 Yes, except to Country Group E:1 or E:2. See § 740.22 of the EAR for eligibility criteria.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 4A005.z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 4A005.z.1
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for 4A005.z
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">LPP:</E>
                                 Yes for 4A005.z.1
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 4A005.z.</E>
                            </P>
                            <HD SOURCE="HD1">Special Conditions for STA</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">STA:</E>
                                 License Exception STA may not be used to ship items specified by ECCN 4A005.
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 (1) Defense articles described in USML Category XI(b), and software directly related to a defense article, are “subject to the ITAR” (see 22 CFR parts 120 through 130). (2) See also ECCN 4A090.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                                 The list of items controlled is contained in the ECCN heading, except for the commodities controlled under 4A005.z.
                            </FP>
                            <P>a. through y. [Reserved]</P>
                            <P>
                                z.1. Commodities that are specified in 4A005 that also meet or exceed the performance parameters in 4A090.a.
                                <PRTPAGE P="4577"/>
                            </P>
                            <P>z.2 Commodities that are specified in 4A005 that also meet or exceed the performance parameters in 4A090.b.</P>
                            <FP SOURCE="FP-2">
                                <E T="04">4A090 Computers as follows (see List of Items Controlled) and related equipment, “electronic assemblies,” and “components” therefor.</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">RS applies to 4A090.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to 4A090.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">LVS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">GBS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 4A090.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">LPP:</E>
                                 Yes for 4A090.a
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 (1) For associated “software” for commodities in this ECCN, see 4D090, 5D002.z, and 5D992.z and for associated “technology” for commodities in this ECCN, see 4E001. (2) Also ECCNs 4A003.z, 4A004.z, 4A005.z, 5A002.z, 5A004.z, and 5A992.z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. Computers, “electronic assemblies,” and “components” containing integrated circuits, any of which meets or exceeds the limits in 3A090.a.</P>
                            <P>b. Computers, “electronic assemblies,” and “components” containing integrated circuits, any of which meets or exceeds the limits in 3A090.b.</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For purposes of 4A090.a and .b, computers include “digital computers,” “hybrid computers,” and analog computers.</E>
                            </P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">4D001 “Software” as follows (see List of Items Controlled).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, RS, CC, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to entire entry</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, and 4A005.z.1</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” for commodities controlled by 4A003.z.1.b, z.2.b, 4A004.z.2, and 4A005.z.2</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">CC applies to “software” for computerized finger-print equipment controlled by 4A003 for CC reasons</ENT>
                                    <ENT>CC Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">Reporting Requirements</HD>
                            <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">TSR:</E>
                                 Yes, except for “software” for the following:
                            </FP>
                            <P>(1) The “development” or “production” of commodities with an “Adjusted Peak Performance” (“APP”) exceeding 29 WT;</P>
                            <P>(2) The “development” or “production” of commodities controlled by 4A005 or “software” controlled by 4D004; or</P>
                            <P>(3) Commodities controlled by 4A003.z, 4A004.z, and 4A005.z</P>
                            <FP SOURCE="FP-1">
                                <E T="03">APP:</E>
                                 Yes to specific countries (see § 740.7 of the EAR for eligibility criteria).
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACE:</E>
                                 Yes for 4D001.a (for the “development”, “production” or “use” of equipment or “software” specified in ECCN 4A005 or 4D004), except to Country Group E:1 or E:2. See § 740.22 of the EAR for eligibility criteria.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for “software” for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, and 4A005.z.1
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for “software” for commodities controlled by 4A003.z
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) for license exception restrictions for “software” for commodities controlled by 4A003.z, 4A004.z, and 4A005.z.</E>
                            </P>
                            <HD SOURCE="HD1">Special Conditions for STA</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">STA:</E>
                                 License Exception STA may not be used to ship or transmit “software” “specially designed” or modified for the “development” or “production” of equipment specified by ECCN 4A001.a.2 or for the “development” or “production” of “digital computers” having an `Adjusted Peak Performance' (`APP') exceeding 29 Weighted TeraFLOPS (WT) to any of the destinations listed in Country Group A:6 (See Supplement No.1 to part 740 of the EAR); may not be used to ship or transmit “software” specified in 4D001.a “specially designed” for the “development” or “production” of equipment specified by ECCN 4A005; and may not be used to ship or transmit “software” for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, and 4A005.z.1 to any of the destinations listed in Country Group A:5 or A:6.
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. “Software” “specially designed” or modified for the “development” or “production”, of equipment or “software” controlled by 4A001, 4A003, 4A004, 4A005 or 4D (except 4D090, 4D906, 4D980, 4D993 or 4D994).</P>
                            <P>b. “Software”, other than that controlled by 4D001.a, “specially designed” or modified for the “development” or “production” of equipment as follows:</P>
                            <P>b.1. “Digital computers” having an “Adjusted Peak Performance” (“APP”) exceeding 24 Weighted TeraFLOPS (WT);</P>
                            <P>b.2. “Electronic assemblies” “specially designed” or modified for enhancing performance by aggregation of processors so that the “APP” of the aggregation exceeds the limit in 4D001.b.1.</P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">4D090 “Software” “specially designed” or modified for the “development” or “production,” of computers and related equipment, “electronic assemblies,” and “components” therefor specified in ECCN 4A090.</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">RS applies to “software” for commodities controlled by 4A090.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” for commodities controlled by 4A090.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">TSR:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for commodities controlled by 4A090.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 For associated “technology” for software in this ECCN, see 4E001.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                                 The list of items controlled is contained in the ECCN heading.
                            </FP>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">4E001 “Technology” as follows (see List of Items Controlled).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, MT, RS, CC, AT
                                <PRTPAGE P="4578"/>
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to entire entry, except for “technology” for 4A090 or “software” specified by 4D090</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">MT applies to “technology” for items controlled by 4A001.a and 4A101 for MT reasons</ENT>
                                    <ENT>MT Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, 4A005.z.1, 4A090.a or “software” specified by 4D001 (for 4A003.z.1.a, z.2.a, 4A004.z.1 and 4A005.z.1), or 4D090.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 4A003.z.1.b, z.2.b, 4A004.z.2, 4A005.z.2, 4A090.b or “software” specified by 4D001 (for 4A003.z.1.b, z.2.b, 4A004.z.2, and 4A005.z.2), or 4D090.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">CC applies to “technology” for computerized finger-print equipment controlled by 4A003 for CC reasons</ENT>
                                    <ENT>CC Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">Reporting Requirements</HD>
                            <P>See § 743.1 of the EAR for reporting requirements for exports under License Exceptions, and Validated End-User authorizations.</P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">TSR:</E>
                                 Yes, except for the following:
                            </FP>
                            <P>(1) “Technology” for the “development” or “production” of commodities with an “Adjusted Peak Performance” (“APP”) exceeding 70 WT or for the “development” or “production” of commodities controlled by 4A005 or “software” controlled by 4D004;</P>
                            <P>(2) “Technology” for the “development” of “intrusion software”; or</P>
                            <P>(3) “Technology” for commodities controlled by 4A003.z, 4A004.z, 4A005.z, 4A090 or “software” specified by 4D001 (for 4A003.z, 4A004.z, and 4A005.z), or 4D090</P>
                            <FP SOURCE="FP-1">
                                <E T="03">APP:</E>
                                 Yes, to specific countries (see § 740.7 of the EAR for eligibility criteria).
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACE:</E>
                                 Yes for 4E001.a (for the “development”, “production” or “use” of equipment or “software” specified in ECCN 4A005 or 4D004); and for 4E001.c, except to Country Group E:1 or E:2. See § 740.22 of the EAR for eligibility criteria.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for “technology” for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, 4A005.z.1, 4A090.a or “software” specified by 4D001 (for 4A003.z.1.a, z.2.a, 4A004.z.1 and 4A005.z.1), or 4D090.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for “technology” for commodities controlled by 4A003.z, 4A004.z, 4A005.z, 4A090 or “software” specified by 4D001 (for 4A003.z, 4A004.z and 4A005.z), or 4D090.
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for technology for .z paragraphs under ECCNs 4A003, 4A004, 4A005 or 4A090, or “software” specified by 4D001 (for 4A003.z, 4A004.z, 4A005.z, and 4A090).</E>
                            </P>
                            <HD SOURCE="HD1">Special Conditions for STA</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">STA:</E>
                                 License Exception STA may not be used to ship or transmit “technology” according to the General Technology Note for the “development” or “production” of any of the following equipment or “software”: a. Equipment specified by ECCN 4A001.a.2; b. “Digital computers” having an `Adjusted Peak Performance' (`APP') exceeding 70 Weighted TeraFLOPS (WT); c. “software” specified in the License Exception STA paragraph found in the License Exception section of ECCN 4D001; or “technology” for commodities controlled by 4A003.z.1.b, z.2.b, 4A004.z.2, 4A005.z.2, 4A090.b or “software” specified by 4D001 (for 4A003.z.1.b, z.2.b, 4A004.z.2, and 4A005.z.2), or 4D090.b to any of the destinations listed in Country Group A:6 (See Supplement No. 1 to part 740 of the EAR). License Exception STA may not be used to ship or transmit “technology” for commodities controlled by 4A003.z.1.a, z.2.a, 4A004.z.1, 4A005.z.1, 4A090.a or “software” specified by 4D001 (for 4A003.z.1.a, z.2.a, 4A004.z.1 and 4A005.z.1), or 4D090.a to any of the destinations listed in Country Group A:5 or A:6 (See Supplement No. 1 to part 740 of the EAR).
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. “Technology” according to the General Technology Note, for the “development”, “production”, or “use” of equipment or “software” controlled by 4A (except 4A906, 4A980 or 4A994 and “use” of equipment controlled under 4A090) or 4D (except 4D906, 4D980, 4D993, 4D994 and “use” of software controlled under 4D090).</P>
                            <P>b. “Technology” according to the General Technology Note, other than that controlled by 4E001.a, for the “development” or “production” of equipment as follows:</P>
                            <P>b.1. “Digital computers” having an “Adjusted Peak Performance” (“APP”) exceeding 24 Weighted TeraFLOPS (WT);</P>
                            <P>b.2. “Electronic assemblies” “specially designed” or modified for enhancing performance by aggregation of processors so that the “APP” of the aggregation exceeds the limit in 4E001.b.1.</P>
                            <P>c. “Technology” for the “development” of “intrusion software.”</P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">4E001.a and .c do not apply to “vulnerability disclosure” or “cyber incident response”.</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">Note 1 does not diminish national authorities' rights to ascertain compliance with 4E001.a and .c.</E>
                            </P>
                            <FP SOURCE="FP-2">
                                <E T="04">
                                    4E091 `Parameters' for an artificial intelligence model trained utilizing 10
                                    <SU>26</SU>
                                     or more `operations.'
                                </E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">RS applies entire entry</ENT>
                                    <ENT>To or within any destination worldwide. See § 742.6(a)(13).</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">TSR:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 No
                            </FP>
                            <HD SOURCE="HD1">Special Conditions for STA</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">STA:</E>
                                 License Exception STA may not be used to ship or transmit “technology” specified by ECCN 4E091 to any of the destinations listed in Country Group A:5 or A:6 (See Supplement No.1 to part 740 of the EAR).
                            </FP>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definition:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                                 The list of items controlled is contained in the ECCN heading.
                            </FP>
                            <P>
                                <E T="04">Technical Notes:</E>
                                  
                                <E T="03">For the purposes of 4E091:</E>
                            </P>
                            <P>
                                1. 
                                <E T="03">`Parameters' refers to any value learned during training (e.g., network weights, biases, etc.). `Parameters' for an artificial intelligence model are also known as model weights.</E>
                            </P>
                            <P>
                                <E T="03">2. `Operations' refers to mathematical operations used for pre-training and any subsequent training, such as fine-tuning the pre-trained model, but does not include the collection and curation of the input training data. Training `operations' should account for operations required to perform all steps in the pre-training and subsequent training process, including those for forward and backward propagation for all relevant layers, pooling, and convolutions, regardless of the implementation and hardware limitations, and applied to all relevant operations. For example, consider a model composed of a single densely connected layer with I input neurons, O output neurons, and no biases being trained with backpropagation. Such a model would have a total of N = I * O learned parameters. Each forward pass would require N multiply accumulate operations, or (assuming floating point arithmetic) 2N FLOP. Each backward pass would require 2N multiply accumulate operations, or 4N FLOP. Then, in total, each training data point would require 6N FLOP. Training on a data set of size D would require 6ND total FLOP.</E>
                            </P>
                            <P>
                                <E T="03">
                                    3. If more than ten percent of the `operations' involve training on data that was not “published” as defined in § 734.7(a) and was generated by a single data-generation model, then `operations' the data-generation model used to generate the data should be counted, and if the data-generation model's `parameters' were not “published,” then the training `operations' used to train the data-generating model should be counted as well. A single data-generation model includes variants of the same model, such as different checkpoints or fine-tuned variants. If multiple models with `parameters' that were not “published” were used to generate data used for more than ten percent of the training `operations,' then only the training 
                                    <PRTPAGE P="4579"/>
                                    `operations' of the data-generation model using the most training `operations' should be counted. No actual training `operation' should be counted more than once, so if data-generation model A is used to train data-generation model B and data-generation model C, and models B and C are used to train model D, then the operations to train A are only added to the number of operations for model D once.
                                </E>
                            </P>
                            <P>
                                <E T="04">Notes:</E>
                                  
                                <E T="03">
                                    1. In accordance with § 734.7 of the EAR, 4E091 does not control the `parameters' of any artificial intelligence model that have been “published” as defined in § 734.7(a). 4E091 also does not control the `parameters' of any artificial intelligence model derived from a model whose parameters have been `published,' except where the model has been derived using additional training `operations' that constitute more than 2.5 × 10
                                    <SU>25</SU>
                                     `operations' or more than 25 percent of the training `operations' defined in Note 2, whichever is higher.
                                </E>
                            </P>
                            <P>
                                <E T="03">2. 4E091 does not control the `parameters' of any artificial intelligence model trained utilizing fewer `operations' than the number needed, based on the most efficient “published” methods to train artificial intelligence models, to train an artificial intelligence model as capable, according to an aggregate of widely used benchmarks, as the most advanced artificial intelligence model that has been “published” as defined in § 734.7(a) of the EAR. To provide certainty for this exclusion, the number of `operations' needed should not decrease with algorithmic improvements.</E>
                            </P>
                            <P>
                                <E T="03">2.a. An exporter may determine whether an AI model falls within this exclusion by either:</E>
                            </P>
                            <P>
                                <E T="03">2.a.1. Self classifying by relying on guidance published by BIS or technical opinions issued by the U.S. AI Safety Institute and the Department of Energy, should such opinions have been published, or</E>
                            </P>
                            <P>
                                <E T="03">2.a.2. A classification request to BIS in accordance with the procedures in §§ 748.1 and 748.3 of the EAR.</E>
                            </P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">5A002 “Information security” systems, equipment and “components,” as follows (see List of Items Controlled).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, RS, AT, EI
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to entire entry</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to items controlled by 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to items controlled by 5A002.z.1.b, z.2.b, z.3.b, z.4.b, z.5.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">EI applies to entire entry</ENT>
                                    <ENT>Refer to § 742.15 of the EAR.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                <E T="04">License Requirements Note:</E>
                                  
                                <E T="03">See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.</E>
                            </P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">LVS:</E>
                                 Yes: $500 for “components,”
                            </FP>
                            <P>N/A for systems and equipment. N/A for 5A002.z.</P>
                            <FP SOURCE="FP-1">
                                <E T="03">GBS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ENC:</E>
                                 Yes for certain EI controlled commodities, see § 740.17 of the EAR for eligibility.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 5A002.z.1.b, z.2.b
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for 5A002.z
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">LPP:</E>
                                 Yes for 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 5A002.z.</E>
                            </P>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <P>
                                <E T="03">Related Controls:</E>
                                 (1) ECCN 5A002.a controls “components” providing the means or functions necessary for “information security.” All such “components” are presumptively “specially designed” and controlled by 5A002.a. (2) See USML Categories XI (including XI(b)) and XIII(b) (including XIII(b)(2)) for controls on systems, equipment, and components described in 5A002.d or .e that are “subject to the ITAR” (see 22 CFR parts 120 through 130). (3) For “satellite navigation system” receiving equipment containing or employing decryption see 7A005, and for related decryption “software” and “technology” see 7D005 and 7E001. (4) Noting that items may be controlled elsewhere on the CCL, examples of items not controlled by ECCN 5A002.a.4 include the following: (a) An automobile where the only `cryptography for data confidentiality' having a `described security algorithm' is performed by a Category 5—Part 2 Note 3 eligible mobile telephone that is built into the car. In this case, secure phone communications support a non-primary function of the automobile but the mobile telephone (equipment), as a standalone item, is not controlled by ECCN 5A002 because it is excluded by the Cryptography Note (Note 3) (See ECCN 5A992.c). (b) An exercise bike with an embedded Category 5—Part 2 Note 3 eligible web browser, where the only controlled cryptography is performed by the web browser. In this case, secure web browsing supports a non-primary function of the exercise bike but the web browser (“software”), as a standalone item, is not controlled by ECCN 5D002 because it is excluded by the Cryptography Note (Note 3) (See ECCN 5D992.c). (5) After classification or self-classification in accordance with § 740.17(b) of the EAR, mass market encryption commodities that meet eligibility requirements are released from “EI” and “NS” controls. These commodities are designated 5A992.c. (6) See also ECCNs 3A090 and 4A090.
                            </P>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. Designed or modified to use `cryptography for data confidentiality' having a `described security algorithm', where that cryptographic capability is usable, has been activated, or can be activated by any means other than secure “cryptographic activation”, as follows:</P>
                            <P>a.1. Items having “information security” as a primary function;</P>
                            <P>a.2. Digital communication or networking systems, equipment or components, not specified in paragraph 5A002.a.1;</P>
                            <P>a.3. Computers, other items having information storage or processing as a primary function, and components therefor, not specified in paragraphs 5A002.a.1 or .a.2;</P>
                            <P>
                                <E T="04">N.B.:</E>
                                  
                                <E T="03">For operating systems see also 5D002.a.1 and .c.1.</E>
                            </P>
                            <P>a.4. Items, not specified in paragraphs 5A002.a.1 to a.3, where the `cryptography for data confidentiality' having a `described security algorithm' meets all of the following:</P>
                            <P>
                                a.4.a. It supports a non-primary function of the item; 
                                <E T="03">and</E>
                            </P>
                            <P>a.4.b. It is performed by incorporated equipment or “software” that would, as a standalone item, be specified by ECCNs 5A002, 5A003, 5A004, 5B002 or 5D002.</P>
                            <P>
                                <E T="04">N.B. to paragraph a.4:</E>
                                  
                                <E T="03">See Related Control Paragraph (4) of this ECCN 5A002 for examples of items not controlled by 5A002.a.4.</E>
                            </P>
                            <P>
                                <E T="04">Technical Notes:</E>
                            </P>
                            <P>
                                <E T="03">1. For the purposes of 5A002.a, `cryptography for data confidentiality' means “cryptography” that employs digital techniques and performs any cryptographic function other than any of the following:</E>
                            </P>
                            <P>
                                <E T="03">1.a. “Authentication;”</E>
                            </P>
                            <P>
                                <E T="03">1.b. Digital signature;</E>
                            </P>
                            <P>
                                <E T="03">1.c. Data integrity;</E>
                            </P>
                            <P>
                                <E T="03">1.d. Non-repudiation;</E>
                            </P>
                            <P>
                                <E T="03">1.e. Digital rights management, including the execution of copy-protected “software;”</E>
                            </P>
                            <P>
                                <E T="03">1.f. Encryption or decryption in support of entertainment, mass commercial broadcasts or medical records management; or</E>
                            </P>
                            <P>
                                <E T="03">1.g. Key management in support of any function described in paragraphs 1.a to 1.f of this Technical Note paragraph 1.</E>
                            </P>
                            <P>
                                <E T="03">2. For the purposes of 5A002.a, `described security algorithm' means any of the following:</E>
                            </P>
                            <P>
                                <E T="03">2.a. A “symmetric algorithm” employing a key length in excess of 56 bits, not including parity bits;</E>
                            </P>
                            <P>
                                <E T="03">2.b. An “asymmetric algorithm” where the security of the algorithm is based on any of the following:</E>
                            </P>
                            <P>
                                <E T="03">2.b.1. Factorization of integers in excess of 512 bits (e.g., RSA);</E>
                            </P>
                            <P>
                                <E T="03">2.b.2. Computation of discrete logarithms in a multiplicative group of a finite field of size greater than 512 bits (e.g., Diffie-Hellman over Z/pZ); or</E>
                            </P>
                            <P>
                                <E T="03">
                                    2.b.3. Discrete logarithms in a group other than mentioned in paragraph 2.b.2 of this 
                                    <PRTPAGE P="4580"/>
                                    Technical Note in excess of 112 bits (e.g., Diffie-Hellman over an elliptic curve); or
                                </E>
                            </P>
                            <P>
                                <E T="03">2.c. An “asymmetric algorithm” where the security of the algorithm is based on any of the following:</E>
                            </P>
                            <P>
                                <E T="03">2.c.1. Shortest vector or closest vector problems associated with lattices (e.g., NewHope, Frodo, NTRUEncrypt, Kyber, Titanium);</E>
                            </P>
                            <P>
                                <E T="03">2.c.2. Finding isogenies between Supersingular elliptic curves (e.g., Supersingular Isogeny Key Encapsulation); or</E>
                            </P>
                            <P>
                                <E T="03">2.c.3. Decoding random codes (e.g., McEliece, Niederreiter).</E>
                            </P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">An algorithm described by Technical Note 2.c. may be referred to as being post-quantum, quantum-safe or quantum-resistant.</E>
                            </P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">Details of items must be accessible and provided upon request, in order to establish any of the following:</E>
                            </P>
                            <P>
                                <E T="03">a. Whether the item meets the criteria of 5A002.a.1 to a.4; or</E>
                            </P>
                            <P>
                                <E T="03">b. Whether the cryptographic capability for data confidentiality specified by 5A002.a is usable without “cryptographic activation.”</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">5A002.a does not control any of the following items, or specially designed “information security” components therefor:</E>
                            </P>
                            <P>
                                <E T="03">a. Smart cards and smart card `readers/writers' as follows:</E>
                            </P>
                            <P>
                                <E T="03">a.1. A smart card or an electronically readable personal document (e.g., token coin, e-passport) that meets any of the following:</E>
                            </P>
                            <P>
                                <E T="03">a.1.a. The cryptographic capability meets all of the following:</E>
                            </P>
                            <P>
                                <E T="03">a.1.a.1. It is restricted for use in any of the following:</E>
                            </P>
                            <P>
                                <E T="03">a.1.a.1.a. Equipment or systems, not described by 5A002.a.1 to a.4;</E>
                            </P>
                            <P>
                                <E T="03">a.1.a.1.b. Equipment or systems, not using `cryptography for data confidentiality' having a `described security algorithm'; or</E>
                            </P>
                            <P>
                                <E T="03">a.1.a.1.c. Equipment or systems, excluded from 5A002.a by entries b. to f. of this Note; and</E>
                            </P>
                            <P>
                                <E T="03">a.1.a.2. It cannot be reprogrammed for any other use; or</E>
                            </P>
                            <P>
                                <E T="03">a.1.b. Having all of the following:</E>
                            </P>
                            <P>
                                <E T="03">a.1.b.1. It is specially designed and limited to allow protection of `personal data' stored within;</E>
                            </P>
                            <P>
                                <E T="03">a.1.b.2. Has been, or can only be, personalized for public or commercial transactions or individual identification; and</E>
                            </P>
                            <P>
                                <E T="03">a.1.b.3. Where the cryptographic capability is not user-accessible;</E>
                            </P>
                            <P>
                                <E T="04">Technical Note to paragraph a.1.b.1 of Note 2:</E>
                                  
                                <E T="03">For the purposes of 5A002.a Note 2.-a.1.b.1, `personal data' includes any data specific to a particular person or entity, such as the amount of money stored and data necessary for “authentication.”</E>
                            </P>
                            <P>
                                <E T="03">a.2. `Readers/writers' specially designed or modified, and limited, for items specified by paragraph a.1 of this Note;</E>
                            </P>
                            <P>
                                <E T="04">Technical Note to paragraph a.2 of Note 2:</E>
                                  
                                <E T="03">'For the purposes of 5A002.a Note 2.a.2, `readers/writers' include equipment that communicates with smart cards or electronically readable documents through a network.</E>
                            </P>
                            <P>
                                <E T="03">b. Cryptographic equipment specially designed and limited for banking use or `money transactions';</E>
                            </P>
                            <P>
                                <E T="04">Technical Note to paragraph b. of Note 2:</E>
                                  
                                <E T="03">For the purposes of 5A002.a Note 2.b, `money transactions' in 5A002 Note 2 paragraph b. includes the collection and settlement of fares or credit functions.</E>
                            </P>
                            <P>
                                <E T="03">c. Portable or mobile radiotelephones for civil use (e.g., for use with commercial civil cellular radio communication systems) that are not capable of transmitting encrypted data directly to another radiotelephone or equipment (other than Radio Access Network (RAN) equipment), nor of passing encrypted data through RAN equipment (e.g., Radio Network Controller (RNC) or Base Station Controller (BSC));</E>
                            </P>
                            <P>
                                <E T="03">d. Cordless telephone equipment not capable of end-to-end encryption where the maximum effective range of unboosted cordless operation (i.e., a single, unrelayed hop between terminal and home base station) is less than 400 meters according to the manufacturer's specifications;</E>
                            </P>
                            <P>
                                <E T="03">e. Portable or mobile radiotelephones and similar client wireless devices for civil use, that implement only published or commercial cryptographic standards (except for anti-piracy functions, which may be non-published) and also meet the provisions of paragraphs a.2 to a.4 of the Cryptography Note (Note 3 in Category 5—Part 2), that have been customized for a specific civil industry application with features that do not affect the cryptographic functionality of these original non-customized devices;</E>
                            </P>
                            <P>
                                <E T="03">f. Items, where the “information security” functionality is limited to wireless “personal area network ” functionality implementing only published or commercial cryptographic standards;</E>
                            </P>
                            <P>
                                <E T="03">g. Mobile telecommunications Radio Access Network (RAN) equipment designed for civil use, which also meet the provisions of paragraphs a.2 to a.4 of the Cryptography Note (Note 3 in Category 5—Part 2), having an RF output power limited to 0.1W (20 dBm) or less, and supporting 16 or fewer concurrent users;</E>
                            </P>
                            <P>
                                <E T="03">h. Routers, switches, gateways or relays, where the “information security” functionality is limited to the tasks of “Operations, Administration or Maintenance” (“OAM ”) implementing only published or commercial cryptographic standards;</E>
                            </P>
                            <P>
                                <E T="03">i. General purpose computing equipment or servers, where the “information security” functionality meets all of the following:</E>
                            </P>
                            <P>
                                <E T="03">i.1. Uses only published or commercial cryptographic standards; and</E>
                            </P>
                            <P>
                                <E T="03">i.2. Is any of the following:</E>
                            </P>
                            <P>
                                <E T="03">i.2.a. Integral to a CPU that meets the provisions of Note 3 in Category 5—Part 2;</E>
                            </P>
                            <P>
                                <E T="03">i.2.b. Integral to an operating system that is not specified by 5D002; or</E>
                            </P>
                            <P>
                                <E T="03">i.2.c. Limited to “OAM ” of the equipment; or</E>
                            </P>
                            <P>
                                <E T="03">j. Items specially designed for a `connected civil industry application', meeting all of the following:</E>
                            </P>
                            <P>
                                <E T="03">j.1. Being any of the following:</E>
                            </P>
                            <P>
                                <E T="03">j.1.a. A network-capable endpoint device meeting any of the following:</E>
                            </P>
                            <P>
                                <E T="03">j.1.a.1. The “information security” functionality is limited to securing `non-arbitrary data' or the tasks of “Operations, Administration or Maintenance” (“OAM ”); or</E>
                            </P>
                            <P>
                                <E T="03">j.1.a.2. The device is limited to a specific `connected civil industry application'; or</E>
                            </P>
                            <P>
                                <E T="03">j.1.b. Networking equipment meeting all of the following:</E>
                            </P>
                            <P>
                                <E T="03">j.1.b.1. Being specially designed to communicate with the devices specified by paragraph j.1.a. above; and</E>
                            </P>
                            <P>
                                <E T="03">j.1.b.2. The “information security” functionality is limited to supporting the `connected civil industry application' of devices specified by paragraph j.1.a. above, or the tasks of “OAM ” of this networking equipment or of other items specified by paragraph j. of this Note; and</E>
                            </P>
                            <P>
                                <E T="03">j.2. Where the “information security” functionality implements only published or commercial cryptographic standards, and the cryptographic functionality cannot easily be changed by the user.</E>
                            </P>
                            <P>
                                <E T="04">Technical Notes:</E>
                            </P>
                            <P>
                                <E T="03">1. For the purposes of 5A002.a Note 2.j, `connected civil industry application' means a network-connected consumer or civil industry application other than “information security”, digital communication, general purpose networking or computing.</E>
                            </P>
                            <P>
                                <E T="03">2. For the purposes of 5A002.a Note 2.j.1.a.1, `non-arbitrary data' means sensor or metering data directly related to the stability, performance or physical measurement of a system (e.g., temperature, pressure, flow rate, mass, volume, voltage, physical location, etc.), that cannot be changed by the user of the device.</E>
                            </P>
                            <P>b. Being a `cryptographic activation token';</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 5A002.b, a `cryptographic activation token' is an item designed or modified for any of the following:</E>
                            </P>
                            <P>
                                <E T="03">1. Converting, by means of “cryptographic activation”, an item not specified by Category 5—Part 2 into an item specified by 5A002.a or 5D002.c.1, and not released by the Cryptography Note (Note 3 in Category 5—Part 2); or</E>
                            </P>
                            <P>
                                <E T="03">2. Enabling by means of “cryptographic activation”, additional functionality specified by 5A002.a of an item already specified by Category 5—Part 2;</E>
                            </P>
                            <P>c. Designed or modified to use or perform “quantum cryptography”;</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 5A002.c,”quantum cryptography” is also known as Quantum Key Distribution (QKD).</E>
                            </P>
                            <P>d. Designed or modified to use cryptographic techniques to generate channelizing codes, scrambling codes or network identification codes, for systems using ultra-wideband modulation techniques and having any of the following:</P>
                            <P>
                                d.1. A bandwidth exceeding 500 MHz; 
                                <E T="03">or</E>
                            </P>
                            <P>d.2. A “fractional bandwidth” of 20% or more;</P>
                            <P>e. Designed or modified to use cryptographic techniques to generate the spreading code for “spread spectrum” systems, not specified by 5A002.d, including the hopping code for “frequency hopping” systems.</P>
                            <P>f. through y. [Reserved]</P>
                            <P>z. Other commodities, as follows:</P>
                            <P>z.1.a. Commodities that are described in 5A002.a and that also meet or exceed the performance parameters in 3A090.a or 4A090.a;</P>
                            <P>
                                z.1.b Commodities that are described in 5A002.a and that also meet or exceed the performance parameters in 3A090.b or 4A090.b;
                                <PRTPAGE P="4581"/>
                            </P>
                            <P>z.2.a Commodities that are described in 5A002.b and that also meet or exceed the performance parameters in 3A090.a or 4A090.a;</P>
                            <P>z.2.b Commodities that are described in 5A002.b and that also meet or exceed the performance parameters in 3A090.b or 4A090.b;</P>
                            <P>z.3.a Commodities that are described in 5A002.c and that also meet or exceed the performance parameters in 3A090.a or 4A090.a;</P>
                            <P>z.3.b Commodities that are described in 5A002.c and that also meet or exceed the performance parameters in 3A090.b or 4A090.b;</P>
                            <P>z.4.a Commodities that are described in 5A002.d and that also meet or exceed the performance parameters in 3A090.a or 4A090.a;</P>
                            <P>z.4.b Commodities that are described in 5A002.d and that also meet or exceed the performance parameters in 3A090.b or 4A090.b;</P>
                            <P>z.5.a Commodities that are described in 5A002.e and that also meet or exceed the performance parameters in 3A090.a or 4A090.a; or</P>
                            <P>z.5.b Commodities that are described in 5A002.e and that also meet or exceed the performance parameters in 3A090.b or 4A090.b.</P>
                            <FP SOURCE="FP-2">
                                <E T="04">5A992 Equipment not controlled by 5A002 (see List of Items Controlled)</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">RS applies to items controlled by 5A992.z.1</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to items controlled by 5A992.z.2</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                <E T="04">License Requirements Note:</E>
                                  
                                <E T="03">See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.</E>
                            </P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">LVS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">GBS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 5A992.z.2; N/A for all other 5A992 commodities.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 5A992.z.1
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for 5A992.z
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">LPP:</E>
                                 Yes for 5A992.z.1
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 5A992.z.</E>
                            </P>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 See also ECCNs 3A090 and 4A090.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. [Reserved]</P>
                            <P>b. [Reserved]</P>
                            <P>c. Commodities classified as mass market encryption commodities in accordance with § 740.17(b) of the EAR.</P>
                            <P>d. through y. [Reserved]</P>
                            <P>z.1. Commodities that are described in 5A992.c and that also meet or exceed the performance parameters in 3A090.a or 4A090.a; or</P>
                            <P>z.2 Commodities that are described in 5A992.c and that also meet or exceed the performance parameters in 3A090.b or 4A090.b.</P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">5A004 “Systems,” “equipment” and “components” for defeating, weakening or bypassing “information security,” as follows (see List of Items Controlled).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, RS, AT, EI
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to entire entry</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to items controlled by 5A004.z.1.a, z.2.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to items controlled by 5A004.z.1.b, z.2.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">EI applies to entire entry</ENT>
                                    <ENT>Refer to § 742.15 of the EAR.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <P>See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.</P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">LVS:</E>
                                 Yes: $500 for “components”; N/A for 5A004.z. N/A for systems and equipment.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">GBS:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ENC:</E>
                                 Yes for certain EI controlled commodities. See § 740.17 of the EAR for eligibility.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 5A004.z.1.b, z.2.b
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 5A004.z.1.a, z.2.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for 5A004.z
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">LPP:</E>
                                 Yes for 5A004.z.1.a, z.2.a
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 5A004.z.</E>
                            </P>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 (1) ECCN 5A004.a controls “components” providing the means or functions necessary for “information security.” All such “components” are presumptively “specially designed” and controlled by 5A004.a. (2) See also ECCNs 3A090 and 4A090.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. Designed or modified to perform `cryptanalytic functions.'</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">5A004.a includes systems or equipment, designed or modified to perform `cryptanalytic functions' by means of reverse engineering.</E>
                            </P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 5A004.a, `cryptanalytic functions' are functions designed to defeat cryptographic mechanisms in order to derive confidential variables or sensitive data, including clear text, passwords or cryptographic keys.</E>
                            </P>
                            <P>b. Items, not specified by ECCNs 4A005 or 5A004.a, designed to perform all of the following:</P>
                            <P>
                                b.1. `Extract raw data' from a computing or communications device; 
                                <E T="03">and</E>
                            </P>
                            <P>b.2. Circumvent “authentication” or authorization controls of the device, in order to perform the function described in 5A004.b.1.</P>
                            <P>
                                <E T="04">Technical Note:</E>
                                  
                                <E T="03">For the purposes of 5A004.b.1, `extract raw data' from a computing or communications device means to retrieve binary data from a storage medium, e.g., RAM, flash or hard disk, of the device without interpretation by the device's operating system or filesystem.</E>
                            </P>
                            <P>
                                <E T="04">Note 1:</E>
                                  
                                <E T="03">5A004.b does not apply to systems or equipment specially designed for the “development” or “production” of a computing or communications device.</E>
                            </P>
                            <P>
                                <E T="04">Note 2:</E>
                                  
                                <E T="03">5A004.b does not include:</E>
                            </P>
                            <P>
                                <E T="03">a. Debuggers, hypervisors;</E>
                            </P>
                            <P>
                                <E T="03">b. Items limited to logical data extraction;</E>
                            </P>
                            <P>
                                <E T="03">c. Data extraction items using chip-off or JTAG; or</E>
                            </P>
                            <P>
                                <E T="03">d. Items specially designed and limited to jail-breaking or rooting.</E>
                            </P>
                            <P>c. through y. [Reserved]</P>
                            <P>z. Other commodities, as follows:</P>
                            <P>z.1.a Commodities that are described in 5A004.a and that also meet or exceed the performance parameters in 3A090.a or 4A090.a;</P>
                            <P>z.1.b Commodities that are described in 5A004.a and that also meet or exceed the performance parameters in 3A090.b or 4A090.b;</P>
                            <P>z.2.a Commodities that are described in 5A004.b and that also meet or exceed the performance parameters in 3A090.a or 4A090.a; or</P>
                            <P>z.2.b Commodities that are described in 5A004.b and that also meet or exceed the performance parameters in 3A090.b or 4A090.b.</P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">5D002 “Software” as follows (see List of Items Controlled).</E>
                                <PRTPAGE P="4582"/>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 NS, RS, AT, EI
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to entire entry</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” controlled by 5D002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a, z.6.a, z.7.a, z.8.a, and z.9.a</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” controlled by 5D002.z.1.b, z.2.b, z.3.b, z.4.b, z.5.b, z.6.b, z.7.b, z.8.b, and z.9.b</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">EI applies to “software” in 5D002.a.1, a.3, .b, c.1 and c.3, for commodities or “software” controlled for EI reasons in ECCN 5A002, 5A004 or 5D002</ENT>
                                    <ENT>
                                        Refer to § 742.15 of the EAR. 
                                        <LI>
                                            <E T="03">Note: Encryption software is controlled because of its functional capacity, and not because of any informational value of such software; such software is not accorded the same treatment under the EAR as other “software'; and for export licensing purposes, encryption software is treated under the EAR in the same manner as a commodity included in ECCN 5A002.</E>
                                        </LI>
                                    </ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                <E T="04">License Requirements Note:</E>
                                  
                                <E T="03">See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.</E>
                            </P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">TSR:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ENC:</E>
                                 Yes for certain EI controlled software. See § 740.17 of the EAR for eligibility.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 5D002.z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 5D002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a, z.6.a, z.7.a, z.8.a, and z.9.a
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for 5D002.z
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 5D002.z.</E>
                            </P>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 (1) After classification or self-classification in accordance with § 740.17(b) of the EAR, mass market encryption software that meets eligibility requirements is released from “EI” and “NS” controls. This software is designated as 5D992.c. (2) See also ECCNs 3D001 as it applies to “software” for commodities controlled by 3A001.z and 3A090, and 4D001 as it applies to “software” for commodities controlled by 4A003.z, 4A004.z, and 4A005.z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 5D002.a controls “software” designed or modified to use “cryptography” employing digital or analog techniques to ensure “information security.”
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. “Software” “specially designed” or modified for the “development,” “production” or “use” of any of the following:</P>
                            <P>a.1. Equipment specified by 5A002 or “software” specified by 5D002.c.1;</P>
                            <P>
                                a.2. Equipment specified by 5A003 or “software” specified by 5D002.c.2; 
                                <E T="03">or</E>
                            </P>
                            <P>a.3. Equipment or “software”, as follows:</P>
                            <P>a.3.a. Equipment specified by 5A004.a or “software” specified by 5D002.c.3.a;</P>
                            <P>a.3.b. Equipment specified by 5A004.b or “software” specified by 5D002.c.3.b;</P>
                            <P>b. “Software” having the characteristics of a `cryptographic activation token' specified by 5A002.b;</P>
                            <P>c. “Software” having the characteristics of, or performing or simulating the functions of, any of the following:</P>
                            <P>c.1. Equipment specified by 5A002.a, .c, .d or .e;</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">5D002.c.1 does not apply to “software” limited to the tasks of “OAM” implementing only published or commercial cryptographic standards.</E>
                            </P>
                            <P>
                                c.2. Equipment specified by 5A003; 
                                <E T="03">or</E>
                            </P>
                            <P>c.3. Equipment, as follows:</P>
                            <P>c.3.a. Equipment specified by 5A004.a;</P>
                            <P>c.3.b. Equipment specified by 5A004.b.</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">5D002.c.3.b does not apply to “intrusion software”.</E>
                            </P>
                            <P>d. [Reserved]</P>
                            <P>
                                <E T="04">N.B.:</E>
                                  
                                <E T="03">See 5D002.b for items formerly specified in 5D002.d.</E>
                            </P>
                            <P>e. through y. [Reserved]</P>
                            <P>z. Other software, as follows:</P>
                            <P>z.1.a Software that is described in 5D002.a.1, and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a;</P>
                            <P>z.1.b Software that is described in 5D002.a.1, and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b;</P>
                            <P>z.2.a Software that is described in 5D002.a.2, and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a;</P>
                            <P>z.2.b Software that is described in 5D002.a.2, and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b;</P>
                            <P>z.3.a Software that is described in 5D002.a.3a, and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a;</P>
                            <P>z.3.b Software that is described in 5D002.a.3a, and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b;</P>
                            <P>z.4.a Software that is described in 5D002.a.3.b, and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a;</P>
                            <P>z.4.b Software that is described in 5D002.a.3.b, and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b;</P>
                            <P>z.5.a Software that is described in 5D002.b and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a;</P>
                            <P>z.5.b Software that is described in 5D002.b and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b;</P>
                            <P>z.6.a Software that is described in 5D002.c.1 and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a;</P>
                            <P>z.6.b Software that is described in 5D002.c.1 and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b;</P>
                            <P>z.7.a Software that is described in 5D002.c.2 and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a;</P>
                            <P>z.7.b Software that is described in 5D002.c.2 and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b;</P>
                            <P>z.8.a Software that is described in 5D002.c.3.a and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a;</P>
                            <P>z.8.b Software that is described in 5D002.c.3.a and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b;</P>
                            <P>z.9.a Software that is described in 5D002.c.3.b and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a; or</P>
                            <P>z.9.b Software that is described in 5D002.c.3.b and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b.</P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">5D992 “Information Security” “software,” not controlled by 5D002, as follows (see List of Items Controlled).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">RS applies to “software” controlled by 5D992.z.1</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “software” controlled by 5D992.z.2</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                <E T="04">License Requirements Note:</E>
                                  
                                <E T="03">See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.</E>
                                <PRTPAGE P="4583"/>
                            </P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">TSR:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 Yes, for 5D992.z.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for 5D992.z.1
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for 5D992.z
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 5D992.z.</E>
                            </P>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <P>
                                <E T="03">Related Controls:</E>
                                 (1) This entry does not control “software” designed or modified to protect against malicious computer damage, 
                                <E T="03">e.g.,</E>
                                 viruses, where the use of “cryptography” is limited to authentication, digital signature and/or the decryption of data or files. (2) See also ECCNs 3D001 as it applies to “software” for commodities controlled by 3A001.z and 3A090, and 4D001 as it applies to “software” for commodities controlled by 4A003.z, 4A004.z, and 4A005.z.
                            </P>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. [Reserved]</P>
                            <P>b. [Reserved]</P>
                            <P>c. “Software” classified as mass market encryption software in accordance with § 740.17(b) of the EAR.</P>
                            <P>d. through y. [Reserved]</P>
                            <P>z.1 Other software that is described in 5D992 and that also meet or exceed the performance parameters in 3D001 for 3A090.a or 4D001 for 4A090.a; or</P>
                            <P>z.2 Other software that is described in 5D992 and that also meet or exceed the performance parameters in 3D001 for 3A090.b or 4D001 for 4A090.b.</P>
                            <STARS/>
                            <FP SOURCE="FP-2">
                                <E T="04">5E002 “Technology” as follows (see List of Items Controlled).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <P>
                                <E T="03">Reason for Control:</E>
                                 NS, RS, AT, EI
                            </P>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">NS applies to entire entry</ENT>
                                    <ENT>NS Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a or 5A004.z.1.a, z.2.a or “software” specified by 5D002 (for 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a or 5A004.z.1.a, z.2.a commodities)</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 5A002.z.1.b, z.2.b, z.3.b, z.4.b, z.5.b or 5A004.z.1.b, z.2.b or “software” specified by 5D002 (for 5A002.z.1.b, z.2.b, z.3.b, z.4.b, z.5.b or 5A004.z.1.b, z.2.b commodities)</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">EI applies to “technology” in 5E002.a for commodities or “software” controlled for EI reasons in ECCNs 5A002, 5A004 or 5D002, and to “technology” in 5E002.b</ENT>
                                    <ENT>Refer to § 742.15 of the EAR.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                <E T="04">License Requirements Notes:</E>
                            </P>
                            <P>
                                <E T="03">(1) See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.</E>
                            </P>
                            <P>
                                <E T="03">(2) When a person performs or provides technical assistance that incorporates, or otherwise draws upon, “technology” that was either obtained in the United States or is of U.S.-origin, then a release of the “technology” takes place. Such technical assistance, when rendered with the intent to aid in the “development” or “production” of encryption commodities or software that would be controlled for “EI” reasons under ECCN 5A002, 5A004 or 5D002, may require authorization under the EAR even if the underlying encryption algorithm to be implemented is from the public domain or is not of U.S.-origin.</E>
                            </P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">TSR:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ENC:</E>
                                 Yes for certain EI controlled technology. See § 740.17 of the EAR for eligibility.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for “technology” for commodities controlled by 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a or 5A004.z.1.a, z.2.a or “software” specified by 5D002 (for 5A002.z.1.a, z.2.a, z.3.a, z.4.a, z.5.a or 5A004.z.1.a, z.2.a commodities)
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for “technology” for commodities controlled by 5A002.z or 5A004.z or “software” specified by 5D002 (for 5A002.z or 5A004.z commodities
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for technology for .z paragraphs under ECCNs 5A002, 5A004 or “software” specified by 5D002 (for 5A002.z or 5A004.z commodities).</E>
                            </P>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 See also 5E992. This entry does not control “technology” “required” for the “use” of equipment excluded from control under the Related Controls paragraph or the Technical Notes in ECCN 5A002 or “technology” related to equipment excluded from control under ECCN 5A002.
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. “Technology” according to the General Technology Note for the “development,” “production” or “use” of equipment controlled by 5A002, 5A003, 5A004 or 5B002, or of “software” controlled by 5D002.a, z.1 through z.3, or 5D002.c, z.6 through z.8.</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">5E002.a does not apply to “technology” for items specified by 5A004.b, z.3 or z.4, 5D002.a.3.b, z.4, or 5D002.c.3.b.</E>
                            </P>
                            <P>b. “Technology” having the characteristics of a `cryptographic activation token' specified by 5A002.b, z.2.</P>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">5E002 includes “information security” technical data resulting from procedures carried out to evaluate or determine the implementation of functions, features or techniques specified in Category 5—Part 2.</E>
                            </P>
                            <FP SOURCE="FP-2">
                                <E T="04">5E992 “Information Security” “technology” according to the General Technology Note, not controlled by 5E002, as follows (see List of Items Controlled).</E>
                            </FP>
                            <HD SOURCE="HD1">License Requirements</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Reason for Control:</E>
                                 RS, AT
                            </FP>
                            <GPOTABLE COLS="2" OPTS="L0,nj,tp0,p7,7/8,i1" CDEF="s10,r10">
                                <TTITLE> </TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        <E T="03">Control(s)</E>
                                    </CHED>
                                    <CHED H="1">
                                        <E T="03">Country chart</E>
                                        <LI>
                                            <E T="03">(see Supp. No. 1</E>
                                        </LI>
                                        <LI>
                                            <E T="03">to part 738)</E>
                                        </LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 5A992.z.1 or “software” controlled by 5D992.z.1</ENT>
                                    <ENT>
                                        To or within any destination worldwide. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(A) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">RS applies to “technology” for commodities controlled by 5A992.z.2 or “software” controlled by 5D992.z.2</ENT>
                                    <ENT>
                                        To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. 
                                        <E T="03">See</E>
                                         § 742.6(a)(6)(iii)(B) of the EAR.
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">AT applies to entire entry</ENT>
                                    <ENT>AT Column 1.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                <E T="04">License Requirements Note:</E>
                                  
                                <E T="03">See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.</E>
                            </P>
                            <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                            <FP SOURCE="FP-1">TSR: N/A</FP>
                            <FP SOURCE="FP-1">
                                <E T="03">NAC/ACA:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">AIA:</E>
                                 Yes for “technology” for commodities controlled by 5A992.z.1 or “software” controlled by 5D992.z.1
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">ACM:</E>
                                 Yes for “technology” for commodities controlled by 5A992.z or “software” controlled by 5D992.z
                            </FP>
                            <P>
                                <E T="04">Note:</E>
                                  
                                <E T="03">See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for technology for .z paragraphs under</E>
                                 “
                                <E T="03">technology” for commodities controlled by 5A992.z or “software” controlled by 5D992.z.</E>
                            </P>
                        </EXTRACT>
                        <PRTPAGE P="4584"/>
                        <EXTRACT>
                            <HD SOURCE="HD1">List of Items Controlled</HD>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Controls:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Related Definitions:</E>
                                 N/A
                            </FP>
                            <FP SOURCE="FP-1">
                                <E T="03">Items:</E>
                            </FP>
                            <P>a. [Reserved]</P>
                            <P>b. “Technology”, n.e.s., for the “use” of mass market commodities controlled by 5A992 or mass market “software” controlled by 5D992.</P>
                            <STARS/>
                        </EXTRACT>
                    </REGTEXT>
                    <SIG>
                        <NAME>Thea D. Rozman Kendler,</NAME>
                        <TITLE>Assistant Secretary for Export Administration. </TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2025-00636 Filed 1-13-25; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 3510-33-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
</FEDREG>
